SECURITIES PURCHASE AGREEMENT

Exhibit 10.1

REGENERX BIOPHARMACEUTICALS, INC.

SECURITIES PURCHASE AGREEMENT

SEPTEMBER 30, 2009

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SECURITIES PURCHASE AGREEMENT

THIS SECURITIES PURCHASE AGREEMENT (this “ Agreement ”), dated as of September 30, 2009, is entered into by and between RegeneRx Biopharmaceuticals, Inc., a Delaware corporation (the “ Company ”), and Chaumiere-Consultadoria & Servicos SDC Unipessoal LDA ( hereinafter the “ Investor ”).

RECITALS

Whereas , the Company has authorized the sale and issuance of (i) an aggregate of 1,219,512 shares of its Common Stock (the “ Shares ”) and (ii) a warrant, in substantially the form attached hereto as Exhibit A (the “ Warrant ”), to purchase an aggregate of 609,756 shares of its Common Stock (the “ Warrant Shares ” and, along with the Warrant and the Shares, the “ Securities ”) for an aggregate purchase amount of no more than $1,000,000, pursuant to the terms of this Agreement;

Whereas , the Investor desires to purchase the Securities on the terms and conditions set forth herein; and

Whereas , the Company desires to issue and sell the Securities to the Investor on the terms and conditions set forth herein.

AGREEMENT

Now, Therefore , in consideration of the foregoing recitals and the mutual promises, representations, warranties, and covenants hereinafter set forth and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

SECTION 1. DEFINITIONS

The following terms when used in this Agreement shall have the following respective meanings:

“ Affiliate ” has the meaning set forth in Rule 501(b) of Regulation D.

“ Applicable Laws ” has the meaning set forth in Section 4.1(f) hereof.

“ Board of Directors ” means the Board of Directors of the Company.

“ Capital Stock ” means (i) with respect to any Person that is a corporation, any and all shares, interests or equivalents in capital stock (whether voting or nonvoting and whether common or preferred) of such corporation and (ii) with respect to any Person that is not a corporation, any and all partnership, membership, limited liability company or other equity interests of such Person; and in each case, any and all warrants, rights or options to purchase any of the foregoing.

“ Certificate of Incorporation ” means the Certificate of Incorporation of the Company, as in effect and on file with the Secretary of State of the State of Delaware on the date of this Agreement.

“ Closing ” has the meaning set forth in Section 3.1 hereof.

“ Closing Date ” has the meaning set forth in Section 3.1 hereof.

“ Common Stock ” means the Common Stock of the Company, par value $0.001 per share.

“ Exchange Act ” means the Securities Exchange Act of 1934, as amended.

“ Governmental Authority ” means the United States, any state, county or municipality, the government of any foreign country, any subdivision of any of the foregoing or any authority, department, commission, board, bureau, agency, court or instrumentality of any of the foregoing.

“ Holding Period ” has the meaning set forth in Section 5 hereof.

“ Knowledge of the Company ,” including the terms “ Know ,” “ Known ” and other derivatives thereof, means, with respect to the Company, the actual knowledge, after reasonable investigation, of any Responsible Officer.

“ Lien ” means any mortgage, lien, pledge, security interest, easement, conditional sale or other title retention agreement or other encumbrance of any kind except for liens relating to taxes that have accrued but are not yet payable which do not have a Material Adverse Effect.

“ Material Adverse Effect ” means a material adverse effect upon (i) the condition (financial or otherwise), operations, business, properties or assets of the Company, (ii) the ability of the Company to perform its obligations under this Agreement or any of the other agreements or documents contemplated hereby to which it is a party or (iii) the legality, validity or enforceability of this Agreement or any of the other agreements or documents contemplated hereby or the rights and remedies of the Investor and the other parties hereunder and thereunder.

“ Material Agreements ” has the meaning set forth in Section 4.1(e) hereof.

“ Parties ” refers collectively to the Company and the Investor.

“ Person ” means an individual, corporation, partnership, joint venture, trust, unincorporated organization, or Governmental Authority.

“ Purchase Price ” has the meaning set forth in Section 2 hereof.

“ Regulation D ” has the meaning set forth in Section 4.2(c) hereof.

“ Responsible Officer ” means, with respect to the Company, the President and Chief Executive Officer, the Chief Financial Officer, the Vice President of Clinical and Regulatory Affairs or the Chairman of the Board of Directors.

“ Returns ” has the meaning set forth in Section 4.1(i) hereof.

“ SEC ” means the U.S. Securities and Exchange Commission.

“ SEC Reports ” has the meaning set forth in Section 4.1(h)(i) hereof.

“ Securities ” has the meaning set forth in the Preamble.

“ Securities Act ” means the Securities Act of 1933, as amended.

“ Shares ” has the meaning set forth in the Preamble.

“ Stockholders ” has the meaning set forth in Section 4.1(b) hereof.

“ Tax ” or “ Taxes ” refers to any and all federal, state, national, local, foreign and other taxes, assessments and other governmental charges, duties, levies, impositions and liabilities relating to taxes, including taxes based upon or measured by gross receipts, income, profits, sales, use and occupation, and value added, ad valorem, transfer, franchise, withholding, payroll, recapture, employment, excise and property taxes, together with all interest, penalties and additions imposed with respect to such amounts and any obligations under any agreements or arrangements with any other person with respect to such amounts and including any liability for taxes of a predecessor entity.

“ Transfer ” has the meaning set forth in Section 5 hereof.

“ Warrant ” has the meaning set forth in the Preamble.

“ Warrant Shares ” has the meaning set forth in the Preamble.

SECTION 2. ISSUANCE AND SALE OF THE SECURITIES

At the Closing, the Company shall issue and sell to the Investor and the Investor shall purchase from the Company (i) 1,219,512 Shares at a purchase price equal to $0.82 per Share (the “ Purchase Price ”), for aggregate gross proceeds of no more than $1,000,000 and (ii) a Warrant to purchase 609,756 Warrant Shares, representing 50% of the Shares purchased, at an exercise price of $1.12 per share.

SECTION 3. THE CLOSING

3.1 Closing

The closing of the issuance and sale of the Securities pursuant to Section 2 hereof and certain of the other transactions contemplated hereby (the “ Closing ”) shall take place at the offices of Cooley Godward Kronish LLP, One Freedom Square, Reston Town Center, 11951 Freedom Drive, Reston, Virginia 20190, within one business day following the satisfaction of the conditions specified in Section 8 below, or at such other time or place as the Parties shall mutually agree (the actual date being referred to herein as the “ Closing Date ”). The Parties agree that the Closing may occur by facsimile signature and delivery and that the Parties need not appear in person at the Closing.

3.2 Deliveries by the Company

At or prior to the Closing, the Company shall deliver or cause to be delivered to the Investor the following items:

(a) One or more stock certificates evidencing a number of Shares purchased by the Investor hereunder, registered in the name of such Investor and subject to the legends and other restrictions set forth herein;

(b) a Warrant, executed by the Company and registered in the name of such Investor, pursuant to which such Investor shall have the right to acquire the Warrant Shares issuable to such Investor pursuant to Section 2 on the terms set forth therein;

(c) a copy of the Certificate of Incorporation certified by the Secretary of State of the State of Delaware as of a date within thirty days prior to the Closing Date;

(d) a certificate of the Secretary of State of the State of Delaware as to the good standing of the Company dated within thirty days prior to the Closing Date;

(e) a certificate of the Secretary or Assistant Secretary of the Company, in form and substance satisfactory to counsel for the Investor, certifying that attached thereto are true and correct copies of (i) the bylaws of the Company, and (ii) resolutions duly and validly adopted by the Board of Directors authorizing the allotment and issuance of the Securities to the Investor, execution and delivery of this Agreement and the consummation of the transactions contemplated hereby; and

(f) a counterpart of this Agreement duly executed by the Company.

3.3 Deliveries by the Investor

At or prior to the Closing, the Investor shall deliver or cause to be delivered to the Company the following items:

(a) payment of the Purchase Price in immediately available funds by wire transfer to an account designated in writing by the Company prior to the Closing Date;

(b) a fully completed and duly executed Accredited Investor Certification in the form attached hereto as Exhibit B ; and

(c) a counterpart of this Agreement duly executed by the Investor.

SECTION 4. REPRESENTATIONS, WARRANTIES AND COVENANTS

4.1 Representations and Warranties of the Company

In order to induce the Investor to purchase the Securities it is purchasing hereunder, the Company represents and warrants to the Investor as of the date hereof that:

(a)  Organization and Standing . The Company is duly incorporated and validly existing under the laws of the State of Delaware and has all requisite corporate power and authority to own or lease its properties and assets and to conduct its business as it is presently being conducted.

(b)  Capitalization . Immediately subsequent to the consummation of the transactions contemplated by this Agreement, the authorized Capital Stock of the Company shall be as set forth on Schedule 4.1(b) hereto. The outstanding shares of Capital Stock are all duly and validly authorized and issued, fully paid and nonassessable, and based in part on the representations of the stockholders of the Company (the “ Stockholders ”) made in connection with the issuance thereof, were issued in compliance with all applicable federal and state securities laws.

(c)  Capacity of the Company; Consents; Execution of Agreements . The Company has all requisite power, authority and capacity to enter into this Agreement and to perform the transactions and obligations to be performed by it hereunder. The execution and delivery of this Agreement and any agreements contemplated hereby by the Company, and the performance by the Company of the transactions and obligations contemplated hereby and thereby, including, without limitation, the issuance and delivery of the Securities to the Investor, has been duly authorized by all requisite action of the Company and Stockholders. This Agreement has been duly executed and delivered by a duly authorized officer of the Company and constitutes a valid and legally binding agreement of the Company, enforceable in accordance with its respective terms, except as enforcement thereof may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws of the United States (both state and federal), affecting the enforcement of creditors’ rights or remedies in general and general equity principles.

(d)  Status of the Shares and Warrant Shares; Reservation of Common Stock . The Shares and Warrant Shares to be issued and purchased hereunder, when issued by the Company to the Investor and paid for by the Investor pursuant to the terms of this Agreement and the Warrant, will (i) be duly authorized, validly issued, fully paid and nonassessable, (ii) based on the Investor’s representations in Section 4.2, have been issued in compliance with all applicable United States federal and state securities laws and (iii) be free and clear of all Liens. The Company has available sufficient shares of Common Stock for issuance pursuant to the terms of this Agreement.

(e)  Conflicts; Defaults . The execution and delivery of this Agreement by the Company and the performance by the Company of the transactions and obligations contemplated hereby to be performed by it will not (i) materially violate, conflict with, or constitute a default under any of the terms or provisions of, the Certificate of Incorporation, the bylaws, or any provisions of, or result in the acceleration of any obligation under, any material contract, note, debt instrument, security agreement, or other instrument to which the Company is a party or by which the Company, or any of their assets is bound (collectively, the “ Material Agreements ”); (ii) result in the creation or imposition of any Liens or claims upon the Company’s assets or upon the Company’s Common Stock; (iii) assuming the accuracy of the Investor’s representations in Section 4.2, constitute a material violation of any law, statute, judgment, decree, order, rule, or regulation of a Governmental Authority applicable to the Company; or (iv) constitute an event which, after notice or lapse of time or both, would result in any of the foregoing. The Company is not presently in violation of its Certificate of Incorporation or bylaws.

(f)  Compliance with Laws . The Company is not in violation of, nor do any of its respective operations violate in any respect, any statute, law, or regulation of any Governmental Authority applicable to the Company (“ Applicable Laws ”), which violation would have a Material Adverse Effect.

(g)  Litigation . As of the date hereof: (i) the Company is not subject to any order of, or written agreement or memorandum of understanding with, any Governmental Authority which would have a Material Adverse Effect; (ii) there are no material actions, suits, claims, investigations, or proceedings pending at law or in equity or before or by any Governmental Authority, or, to the Knowledge of the Company, threatened, against the Company or any of its assets or properties or the transactions contemplated by this Agreement, and to the Knowledge of the Company, there exist no facts or circumstances which reasonably could be anticipated to result in any such action, suit, claim, investigation, or proceeding; and (iii)&nbs