0000950162-05-000085.txt : 20120703 0000950162-05-000085.hdr.sgml : 20120703 20050119185850 ACCESSION NUMBER: 0000950162-05-000085 CONFORMED SUBMISSION TYPE: SC 13D/A PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20050120 DATE AS OF CHANGE: 20050119 FILED BY: COMPANY DATA: COMPANY CONFORMED NAME: DEFIANTE FARMACEUTICA LDA CENTRAL INDEX KEY: 0001168857 FILING VALUES: FORM TYPE: SC 13D/A MAIL ADDRESS: STREET 1: RUA DOS FERREIROS,260 CITY: FUNCHAL MADEIRA STATE: S1 ZIP: 9000-082 FORMER COMPANY: FORMER CONFORMED NAME: DEFIANTE FARMACEUTICA UNIPESSOAL LDA DATE OF NAME CHANGE: 20020312 FORMER COMPANY: FORMER CONFORMED NAME: DEFIANTE FARMACEUTICA UNIFESSOAL LDA DATE OF NAME CHANGE: 20020311 SUBJECT COMPANY: COMPANY DATA: COMPANY CONFORMED NAME: REGENERX BIOPHARMACEUTICALS INC CENTRAL INDEX KEY: 0000707511 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 521253406 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: SC 13D/A SEC ACT: 1934 Act SEC FILE NUMBER: 005-37889 FILM NUMBER: 05537363 BUSINESS ADDRESS: STREET 1: 3 BETHESDA METRO CENTER STREET 2: SUITE 700 CITY: BETHESDA STATE: MD ZIP: 20814 BUSINESS PHONE: 3019611992 MAIL ADDRESS: STREET 1: 3 BETHESDA METRO CENTER STREET 2: SUITE 700 CITY: BETHESDA STATE: MD ZIP: 20814 FORMER COMPANY: FORMER CONFORMED NAME: ALPHA 1 BIOMEDICALS INC DATE OF NAME CHANGE: 19950719 SC 13D/A 1 defiante13dano4-011905.txt AMENDMENT NO. 4 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________ SCHEDULE 13D/A4 (Amendment No. 4) Under the Securities Exchange Act of 1934 RegeneRx Biopharmaceuticals, Inc. -------------------------------------------------------------------------------- (Name of Issuer) Common Stock, Par Value $0.01 per share -------------------------------------------------------------------------------- (Title of Class of Securities) 020910105 -------------------------------------------------------------------------------- (CUSIP Number) James Robinson, Esq. Cahill Gordon & Reindel LLP 80 Pine Street New York, NY 10005 (212) 701-3000 -------------------------------------------------------------------------------- (Name, Address and Telephone Number of Person Authorized to Receive Notices and Communications) January 7, 2005 -------------------------------------------------------------------------------- (Date of Event which Requires Filing of this Statement) If the filing person has previously filed a statement on Schedule 13G to report the acquisition that is the subject of this Schedule 13D, and is filing this schedule because of ss.ss. 240.13d-1(e), 240.13d-1(f) or 240.13d-1(g), check the following box [ ]. NOTE: Schedules filed in paper format shall include a signed original and five copies of the schedule, including all exhibits. See Rule 240.13d-7 for other parties to whom copies are to be sent. *The remainder of this cover page shall be filled out for a reporting person's initial filing on this form with respect to the subject class of securities, and for any subsequent amendment containing information which would alter disclosures provided in a prior cover page. The information required on the remainder of this cover page shall not be deemed to be "filed" for the purpose of Section 18 of the Securities Exchange Act of 1934 ("Act") or otherwise subject to the liabilities of that section of the Act but shall be subject to all other provisions of the Act (however, see the Notes). Page 1 of 12 -------------------------------------------------------------------------------- CUSIP No. 020910105 -------------------------------------------------------------------------------- (1) NAME OF REPORTING PERSONS I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (entities only) Sigma-Tau Finanziaria S.pA. -------------------------------------------------------------------------------- (2) CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (See Instructions) (a) [ ] (b) [ ] -------------------------------------------------------------------------------- (3) SEC USE ONLY -------------------------------------------------------------------------------- (4) SOURCE OF FUNDS AF -------------------------------------------------------------------------------- (5) CHECK IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(d) or 2(e) [ ] -------------------------------------------------------------------------------- (6) CITIZENSHIP OR PLACE OF ORGANIZATION Italy -------------------------------------------------------------------------------- Number of (7) SOLE VOTING POWER Shares 1,230,769 -------------------------------------------------------------- Beneficially (8) SHARED VOTING POWER Owned 10,138,310 -------------------------------------------------------------- by Each (9) SOLE DISPOSITIVE POWER Reporting 1,230,769 -------------------------------------------------------------- Person With (10) SHARED DISPOSITIVE POWER 10,138,310 -------------------------------------------------------------------------------- (11) AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON 11,369,079 -------------------------------------------------------------------------------- (12) CHECK IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES [ ] -------------------------------------------------------------------------------- (13) PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11) 31.3% (based on 34,011,486 shares of Common Stock outstanding on September 30, 2004, as reported in the Issuer's quarterly report on Form 10-QSB for the fiscal quarter ended September 30, 2004, 1,803,076 shares of Common Stock issued in the Company's private placement in December 2004 and January 2005, 263,158 shares of Common Stock issuable upon exercise of the 2004 Warrant (as defined below) and 246,154 shares of Common Stock issuable upon exercise of the 2005 Warrants (as defined below). -------------------------------------------------------------------------------- (14) TYPE OF REPORTING PERSON CO -------------------------------------------------------------------------------- Page 2 of 12 -------------------------------------------------------------------------------- CUSIP No. 020910105 -------------------------------------------------------------------------------- (1) NAME OF REPORTING PERSONS I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (entities only) Defiante Farmaceutica L.d.a. -------------------------------------------------------------------------------- (2) CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (See Instructions) (a) [ ] (b) [ ] -------------------------------------------------------------------------------- (3) SEC USE ONLY -------------------------------------------------------------------------------- (4) SOURCE OF FUNDS WC -------------------------------------------------------------------------------- (5) CHECK IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(d) or 2(e) [ ] -------------------------------------------------------------------------------- (6) CITIZENSHIP OR PLACE OF ORGANIZATION Portugal -------------------------------------------------------------------------------- Number of (7) SOLE VOTING POWER Shares 0 -------------------------------------------------------------- Beneficially (8) SHARED VOTING POWER Owned 10,138,310 -------------------------------------------------------------- by Each (9) SOLE DISPOSITIVE POWER Reporting 0 -------------------------------------------------------------- Person With (10) SHARED DISPOSITIVE POWER 10,138,310 -------------------------------------------------------------------------------- (11) AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON 10,138,310 -------------------------------------------------------------------------------- (12) CHECK IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES [ ] -------------------------------------------------------------------------------- (13) PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11) 28.1% (based on 34,011,486 shares of Common Stock outstanding on September 30, 2004, as reported in the Issuer's quarterly report on Form 10-QSB for the fiscal quarter ended September 30, 2004, 1,803,076 shares of Common Stock issued in the Company's private placement in December 2004 and January 2005 and 263,158 shares of Common Stock issuable upon exercise of the 2004 Warrants (as defined below)). -------------------------------------------------------------------------------- (14) TYPE OF REPORTING PERSON CO -------------------------------------------------------------------------------- Page 3 of 12 Item 1. Security and Issuer. Item 1 of the Schedule 13D is hereby amended and restated in its entirety as follows: This Amendment No. 4 amends the Schedule 13D filed with the Securities and Exchange Commission (the "SEC") on June 23, 2003, as amended by Amendment No. 1 filed with the SEC on January 26, 2004, Amendment No. 2 filed with the SEC on September 9, 2004 and Amendment No. 3 filed with the SEC on September 22, 2004 (the "Schedule 13D") by Sigma-Tau Finanziaria S.p.A., an Italian corporation ("Sigma Tau") and Defiante Farmaceutica, L.d.a., a Portuguese corporation ("Defiante", and together with Sigma Tau, the "Reporting Parties") with respect to the Common Stock, $0.01 par value (the "Common Stock"), of RegeneRx Biopharmaceuticals, Inc. (the "Issuer"), a Delaware corporation whose principal offices are located at 3 Bethesda Metro Center, Suite 700, Bethesda, Maryland 20814. Item 2. Identity and Background. Item 2 of the Schedule 13D is hereby amended and restated in its entirety as follows: This Schedule 13D is being filed jointly on behalf of Sigma Tau, and Defiante. Sigma Tau owns 58% of Defiante directly and 42% indirectly through its wholly-owned subsidiary, Sigma-Tau International S.A. The business address of Sigma Tau is Via Sudafrica, 20, Rome, Italy 00144. The principal business of Sigma Tau is as a parent holding company whose principal assets consists of the common stock of its subsidiaries which form a fully integrated pharmaceutical company operating in Europe, the United States and Africa. The business address of Defiante is Rua dos Ferreiros, 260 Funchal, Madeira, Portugal 9000-082. Defiante is a commercial pharmaceutical company. The name, address, principal occupation or employment and citizenship of each of the executive officers and directors of, and each person controlling, Sigma Tau and Defiante are set forth in Schedule A hereto. Neither the Reporting Parties nor any of the persons listed on Schedule A has been, during the last five years, (a) convicted in a criminal proceeding (excluding traffic violations or similar misdemeanors) or (b) a party to a civil proceeding of a judicial or administrative body of competent jurisdiction and as a result of such proceeding was or is subject to a judgment, decree or final order enjoining future violations of, or prohibiting or mandating activities subject to, federal or state securities laws or finding any violation with respect to such laws. Item 3. Source and Amount of Funds or Other Consideration. Item 3 of the Schedule 13D is hereby amended and restated in its entirety as follows: On March 7, 2002, pursuant to a Securities Purchase Agreement, dated as of March 7, 2002, between the Issuer and Defiante, Defiante purchased 4,255,319 shares of Common Stock at a cash purchase price of $0.235 per share as part of a private placement. Defiante used its working capital to purchase such shares. On June 11, 2003, pursuant to a Securities Purchase Agreement, dated as of June 11, 2003, between the Issuer and Defiante, Defiante purchased 3,184,713 shares of Common Stock at Page 4 of 12 $0.628 per share. Defiante used its working capital to purchase such shares. In consideration for the purchase of such shares, on June 11, 2003, the Issuer issued to Defiante a warrant ("Warrant A") to purchase 750,000 shares of Common Stock exercisable at a price of $1.00, in whole or in part, at any time and from time-to-time from issuance of such warrant through December 11, 2004 and (ii) a warrant ("Warrant B" and, collectively with Warrant A, the "2003 Warrants") to purchase up to a number of shares of Common Stock determined by dividing $750,000 by the Warrant B Exercise Price (as defined below) during the Warrant B Period (as defined below). The Warrant B Period was defined as the period commencing on the earlier of (a) the date the Issuer closed the next round of private financing (after June 11, 2003) totaling at least $2,000,000 (the "Next Private Placement") or (b) December 11, 2003, and ending on December 11, 2004. The initial Warrant B Exercise Price was equal to the greater of (a) $1.25 or (b) the price per common share (either directly or after giving effect to any conversion into common shares) at which the Company closed the Next Private Placement. As a result of the 2004 Common Stock Transaction (as defined below), the Warrant B Exercise Price became fixed at $1.25 on January 23, 2004. The Warrant B was then exercisable for 600,000 shares of Common Stock. The terms of Warrant A and Warrant B were amended on September 2, 2004 pursuant to a Warrant Amendment Agreement dated as of September 2, 2004 to provide that, if the holder exercised the 2003 Warrants, by not later than September 6, 2004, the 2003 Warrants would be exercisable for a total of 1,382,488 shares of Common Stock at an exercise price of $1.085 per share. Defiante exercised the 2003 Warrants on September 3, 2004 at an exercise price of $1.085 per share and received 1,382,488 shares of Common Stock. On January 23, 2004, pursuant to a Securities Purchase Agreement, dated as of January 23, 2004, between Issuer and Defiante, Defiante purchased 1,052,632 shares of Common Stock at $0.95 per share (the "2004 Common Stock Transaction"). Defiante used its working capital to purchase such shares. In consideration for the purchase of such shares, on January 23, 2004, the Issuer issued to Defiante a warrant (the "2004 Warrant") to purchase 263,158 shares of Common Stock exercisable at a price of $1.50, in whole or in part, at any time and from time-to-time from issuance of such warrant through July 23, 2006. On January 7, 2005, pursuant to a Purchase Agreement, dated as of January 7, 2005 between Issuer and Sigma Tau, Sigma Tau purchased 984,615 shares of Common Stock at $3.25 per share as part of a private placement. Sigma Tau used its working capital to purchase such shares. In consideration for the purchase of such shares, on January 7, 2005, the Issuer issued to Sigma Tau warrants (the "2005 Warrants") to purchase 246,154 shares of Common Stock exercisable at a price of $4.06 per share, in whole or in part, at any time and from time-to-time from issuance of such Warrant through January 3, 2008. Item 4. Purpose of the Transaction. Item 4 of the Schedule 13D is hereby amended and restated in its entirety as follows: The purpose of the transactions was to acquire an equity investment interest in the Issuer. The 2004 Warrant is exercisable for 263,158 shares of Common Stock at an exercise price of $1.50, subject to customary antidilution adjustments. Page 5 of 12 The 2005 Warrants are exercisable for 246,154 shares of Common Stock at an exercise price of $4.06, subject to customary antidilution adjustments. Other than as set forth above, none of the Reporting Parties has any present plans or proposals which relate to or would result in any transaction, change or event specified in clauses (a) through (j) of Item 4 of Schedule 13D. Item 5. Interest in Securities of Issuer. Item 5 of the Schedule 13D is hereby amended and restated in its entirety as follows: (a) Sigma Tau is the beneficial owner of 11,369,079 shares of Common Stock representing 31.3% (based on 34,011,486 shares of Common Stock outstanding on September 30, 2004, as reported in the Issuer's quarterly report on Form 10-QSB for the fiscal quarter ended September 30, 2004, 1,803,076 shares of Common Stock issued in the Company's private placement in December 2004 and January 2005, 263,158 shares of Common Stock issuable upon exercise of the 2004 Warrants and 246,154 shares of Common Stock issuable upon exercise of the 2005 Warrants). Defiante is the beneficial owner of 10,138,310 shares of Common Stock representing 28.1% (based on 34,011,486 shares of Common Stock outstanding on September 30, 2004, as reported in the Issuer's quarterly report on Form 10-QSB for the fiscal quarter ended September 30, 2004, 1,803,076 shares of Common Stock issued in the Company's private placement in December 2004 and January 2005, and 263,158 shares of Common Stock issuable upon exercise of the 2004 Warrants). (b) The number of shares of Common Stock as to which Sigma Tau has the sole power to vote or direct the vote is 1,230,769. The number of shares of Common Stock as to which Sigma Tau shares the power to vote or direct the vote is 10,138,310. The number of shares of Common Stock as to which Sigma Tau has the sole power to dispose or direct the disposition is 1,230,769. The number of shares of Common Stock as to which Sigma Tau shares the power to dispose or direct the disposition is 10,138,310. The number of shares of Common Stock as to which Defiante has the sole power to vote or direct the vote is zero. The number of shares of Common Stock as to which Defiante shares the power to vote or direct the vote is 10,138,310. The number of shares of Common Stock as to which Defiante has the sole power to dispose or direct the disposition is zero. The number of shares of Common Stock as to which Defiante shares the power to dispose or direct the disposition is 10,138,310. (c) See Item 3. On January 7, 2005, Sigma Tau purchased 984,615 shares of Common Stock at a price of $3.25 per share as part of a private placement. In consideration for the purchase of such shares, on January 7, 2005, the Issuer issued to Sigma Tau warrants to purchase 246,154 shares of Common Stock exercisable at a price of $4.06 per share, subject to customary antidilution adjustments. (d) N/A. (e) N/A. Page 6 of 12 Item 7. Material to Be Filed as Exhibits. Item 7 of the Schedule 13D is hereby amended by adding the following exhibits: 1. Warrant Agreement dated as of January 7, 2005 between Issuer and Sigma Tau.(1) ---------- 1 Filed herewith. Page 7 of 12 SIGNATURE After reasonable inquiry and to the best of my knowledge and belief, I certify that the information set forth in this statement with respect to Sigma-Tau Finanziaria S.p.A. is true, complete and correct. Date: January 19, 2005 SIGMA-TAU FINANZIARIA S.P.A. By: /s/ Antonio Nicolai ------------------------------------- Name: Antonio Nicolai Title: Managing Director After reasonable inquiry and to the best of my knowledge and belief, I certify that the information set forth in this statement with respect to Defiante Farmaceutica L.d.a. is true, complete and correct. Date: January 19, 2005 DEFIANTE FARMACEUTICA L.D.A. By: /s/ Pedro Moreira da Cruz Quintas --------------------------------------- Name: Pedro Moreira da Cruz Quintas Title: Director The original statement shall be signed by each person on whose behalf the statement is filed or his authorized representative. If the statement is signed on behalf of a person by his authorized representative (other than an executive officer or general partner of the filing persons, evidence of the representative's authority to sign on behalf of such persons shall be filed with the statement: provided, however, that a power of attorney for this purpose which is already on file with the Commission may be incorporated by reference. The name and any title of each person who signs the statement shall be typed or printed beneath his signature. Attention: Intentional misstatements or omissions of fact constitute Federal criminal violations (See 18 U.S.C. 1001) Page 8 of 12 SCHEDULE A Sigma Tau Finanziaria SpA The (a) name, (b) business address, (c) present principal occupation or employment and the name, principal business and address of any corporation or other organization in which such employment is conducted and (d) citizenship of each executive officer and director (other than Messrs. E. Cavazza, Ripa di Meana and Belletti) of Sigma Tau are set forth below: 1. (a) Claudio Cavazza, (b) Via Sudafrica, 20, Rome, Italy 00144, (c) President, and (d) Italy. 2. (a) Mario Artali, (b) Via Sudafrica, 20, Rome, Italy 00144, (c) Vice President, and (d) Italy. 3. (a) Emilio Plate, (b) Via Pontina Km. 30.400, 20, Pomezia (Rome), Italy 00144, (c) Vice President, and (d) Italy. 4. (a) Mauro Bove, (b) Via Sudafrica, 20, Rome, Italy 00144, (c) Chief Business Development Officer, and (d) Italy. 5. (a) Antonio Nicolai, (b) Via Sudafrica, 20, Rome, Italy 00144, (c) General Manager, and (d) Italy. 6. (a) Maurizio Terenzi, (b) Via Sudafrica, 20, Rome, Italy 00144, (c) Chief Financial Officer, and (d) Italy. The (a) name, (b) business address, (c) present principal occupation or employment and the name, principal business and address of any corporation or other organization in which such employment is conducted and (d) citizenship of each director (other than Messrs. C. Cavazza, Artali, Plate, Bove, Nicolai and Terenzi) of Sigma Tau are set forth below: 1. (a) Enrico Cavazza, (b) Via Pontina Km. 30.400, Pomezia (Rome), Italy, (c) Business Development Manager, Sigma-Tau Industrie Farmaceutica SpA, and (d) Italy. 2. (a) Vittorio Ripa di Meana, (b) Piazza dei Caprettari n. 70, Rome, Italy, (c) lawyer, Studio Ripa di Meana, and (d) Italy. 3. (a) Piero Belletti, (b) Viale Shakespeare n. 47, Rome, Italy, (c) consultant, and (d) Italy. The (a) name, (b) business address, (c) present principal occupation or employment and the name, principal business and address of any corporation or other organization in which such employment is conducted and (d) citizenship of each controlling person of Sigma Tau are set forth below: 1. (a) Claudio Cavazza, (b) Via Sudafrica, 20, Rome, Italy 00144, (c) President, Sigma Tau, and (d) Italy. 2. (b) Paolo Cavazza, (b) Via Tesserete, 10, Lugano, Switzerland (c) entrepreneur, Sigma Tau, Aptafin SpA and Esseti S.A., and (d) Italy. Page 9 of 12 Claudio Cavazza directly and indirectly owns 60% of Sigma Tau and Paolo Cavazza directly and indirectly owns 40% of Sigma Tau. Sigma Tau owns 58% of Defiante directly and 42% indirectly through its wholly-owned subsidiary, Sigma-Tau International S.A. Page 10 of 12 Defiante Farmaceutica L.d.a The (a) name, (b) business address, (c) present principal occupation or employment and the name, principal business and address of any corporation or other organization in which such employment is conducted and (d) citizenship of each executive officer and director (other than Messrs. Frutuoso de Melo and Quintas and Ms. Arruda Jardim Fernandes) of Defiante are set forth below: (a) (a) Antonio Nicolai, (b) Via Sudafrica, 20, Rome, Italy 00144, (c) General Manager, Sigma Tau Finanziaria SpA and (d) Italy. 7. (a) Raffaele Sanguigni, (b) Via Pontina km. 30.400, Rome, Italy (c) Manager- Corporate Logistics, License Operations & Purchasing, Sigma Tau Farmaceutiche Riunite SpA, and (d) Italy. The (a) name, (b) business address, (c) present principal occupation or employment and the name, principal business and address of any corporation or other organization in which such employment is conducted and (d) citizenship of each director (other than Messrs. Nicolai and Sanguigni) of Defiante are set forth below: 1. (a) Antonio Guilherme Rodrigues Frutuoso de Melo, (b) Av. ala Liberdande, 38-7u, 1250-145 Lisbon, Portugal, (c) lawyer, AFMA Sociedade de Advocatos, and (d) Portugal. 2. (a) Pedro Moreira da Cruz Quintas, (b) Rua dos Ferreiros, 260 Funchal, Madeira, Portugal 9000-082, (c) lawyer, Quintas, Jardim Fernandes Sociedade de Advocatos, and (d) Portugal. 3. (a) Carla Emanuel Arruda Jardim Fernandes, (b) Rua dos Ferreiros, 260 Funchal, Madeira, Portugal 9000-082, (c) lawyer, Quintas, Jardim Fernandes Sociedade de Advocatos, and (d) Portugal. Page 11 of 12 EXHIBIT INDEX Page No. 1. Warrant Agreement dated as of January 7, 2005 between Issuer and Sigma Tau.(1)................................................... 7 ---------- 1 Filed herewith. Page 12 of 12 EX-1 2 sigma13dano4-011205ex1.txt WARRANT AGREEMENT Exhibit 1 WARRANT THE SECURITIES REPRESENTED BY THIS WARRANT HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR APPLICABLE STATE SECURITIES LAWS. THE SECURITIES HAVE BEEN ACQUIRED FOR INVESTMENT AND MAY NOT BE OFFERED, SOLD, TRANSFERRED OR ASSIGNED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR AN OPINION OF COUNSEL, REASONABLY SATISFACTORY TO THE COMPANY, THAT REGISTRATION IS NOT REQUIRED UNDER THE SECURITIES ACT OR APPLICABLE STATE SECURITIES LAWS UNLESS SOLD PURSUANT TO RULE 144 UNDER THE SECURITIES ACT. REGENERX BIOPHARMACEUTICALS, INC. WARRANT TO PURCHASE COMMON STOCK Warrant No.: P-5 Number of Shares: 246,154 Issuance Date: January 7, 2005 THIS CERTIFIES THAT, for value received, Sigma-Tau Finanziaria S.p.A. or registered assigns (the "Holder") is entitled to purchase from RegeneRx Biopharmaceuticals, Inc., a Delaware corporation (the "Company"), at any time after January 7, 2005 and before the Expiration Date (defined below) at $4.06 per share (the "Exercise Price") Two Hundred Forty-Six Thousand One Hundred Fifty-Four (246,154) fully paid nonassessable shares of Common Stock (defined below) (the "Warrant Shares"), all subject to adjustment and upon the terms and conditions provided herein. Section 1. Definitions. The following terms as used in this Warrant have the following meanings: (a) "Business Day" means any day other than Saturday, Sunday or federal holiday. (b) "Common Stock" means (i) the Company's common stock, $.001 par value per share, and (ii) any capital stock into which the Common Stock is changed or any capital stock resulting from a reclassification of the Common Stock. (c) "Exercise Price" is equal to $4.06, subject to adjustment. (d) "Expiration Date" means the date three years after the Issuance Date or, if such date falls on a day that is not a Business Day or a day on which trading does not take place on the principal exchange or automated quotation system on which the Common Stock is traded (a "Holiday"), the next day that is not a Holiday. (e) "Issuance Date" means January 7, 2005. (f) "Person" means a natural person or company, or a government or any division, department or agency thereof. (g) "Purchase Agreement" means the purchase agreement dated January 7, 2005 between the Company and Holder. (h) "Securities Act" means the Securities Act of 1933, as amended. (i) "Warrant" means this Warrant and all Warrants issued in exchange, transfer or replacement thereof. Section 2. Exercise of Warrant. (a) This Warrant may be exercised by the Holder registered on the books of the Company, in whole or in part, at any time on any Business Day after January 7, 2005 and prior to 11:59 p.m. Eastern Time on the Expiration Date by (i) delivery of a written notice, in the form attached as Exhibit A (the "Exercise Notice"), of Holder's election to exercise this Warrant, specifying the number of Warrant Shares to be purchased, (ii) payment to the Company of an amount equal to the Exercise Price multiplied by the number of Warrant Shares being purchased (the "Payment") in cash or wire transfer of immediately available funds or by means of a cashless exercise pursuant to Section 2(c) and (iii) the surrender to a common carrier for overnight delivery to the Company, as soon as practicable following such date, of this Warrant, (or an indemnification undertaking with respect to this Warrant in the case of its loss, theft or destruction). The Company shall, not later than the second Business Day (the "Delivery Date") following receipt of an Exercise Notice, the Payment and this Warrant or an indemnification (the "Exercise Documents"), arrange for its transfer agent, on or before the Delivery Date, to issue and surrender to a common carrier for overnight delivery to the address specified in the Exercise Notice, a certificate, registered in the name of the Holder, for the number of shares of Common Stock to which the Holder is entitled. Upon delivery of the Exercise Notice and the Payment, the Holder shall be deemed for all corporate purposes to have become the holder of record of the Warrant Shares with respect to which this Warrant has been exercised on the Delivery Date, irrespective of the date of delivery of the certificates evidencing the Warrant Shares. (b) Unless the rights represented by this Warrant have expired or been fully exercised, the Company shall, as soon as practicable and in no event later than five Business Days after receipt of the Exercise Documents and at its own expense, issue a new Warrant identical in all respects to this Warrant, except it shall represent rights to purchase the number of Warrant Shares purchasable immediately prior to exercise, less the number purchased. (c) If, but only if, at any time after one year from the date of issuance of this Warrant there is no effective Registration Statement registering the resale of the Warrant Shares by the Holder, this Warrant may also be exercised at such time by means of a "cashless exercise" in which the Holder shall be entitled to receive a certificate for the number of Warrant Shares equal to the quotient obtained by dividing [(A-B) (X)] by (A), where: 2 (A) = the average closing price for the five trading days immediately prior to (but not including) the date of such election; (B) = the Exercise Price of the Warrants, as adjusted; and (X) = the number of Warrant Shares issuable upon exercise of the Warrants in accordance with the terms of this Warrant. (d) No fractional shares of Common Stock are to be issued upon the exercise of this Warrant, but rather the number of shares of Common Stock issued shall be rounded up or down to the nearest whole number. Section 3. Covenants as to Common Stock. The Company hereby covenants and agrees as follows: (a) This Warrant is, and any Warrants issued in substitution for or replacement of this Warrant upon issuance will be, duly authorized, executed and delivered. (b) All Warrant Shares upon issuance will be validly issued, fully paid and nonassessable and free from all liens and charges with respect to the issue thereof. (c) As long as this Warrant may be exercised, the Company will have authorized and reserved at least the number of shares of Common Stock needed to provide for the exercise of the rights then represented by this Warrant. Section 4. Warrant Holder Not Deemed a Shareholder. Except as specifically provided in Section 2(a), nothing contained in this Warrant shall be construed to (a) grant the Holder any rights to vote or receive dividends or be deemed the holder of shares of the Company for any purpose, (b) confer upon the Holder any of the rights of a shareholder of the Company or any right to vote, give or withhold consent to any corporate action (whether any reorganization, issue of stock, reclassification of stock, consolidation, merger, conveyance or otherwise), receive notice of meetings, receive dividends or subscription rights, or otherwise, or (c) impose any liabilities on the Holder to purchase any securities or as a shareholder of the Company, whether asserted by the Company or creditors of the Company, prior to the issuance of the Warrant Shares. Section 5. Representations of Holder. The Holder, by the acceptance hereof, represents that it is acquiring this Warrant and the Warrant Shares for its own account for investment only and not with a view towards, or for resale in connection with, the public sale or distribution of this Warrant or the Warrant Shares, except pursuant to sales registered or exempted under the Securities Act. The Holder further represents, by acceptance hereof, that, as of this date, Holder is an "accredited investor" as defined in Rule 501(a)(1) of Regulation D promulgated under the Securities Act (an "Accredited Investor"). Upon exercise of this Warrant, the Holder shall, if requested by the Company, confirm in writing, in a form satisfactory to the Company, that the Warrant Shares are being acquired solely for the Holder's own account and not as a nominee for any other party, for investment, and not with a view toward distribution or resale and that Holder is an Accredited Investor. If Holder cannot make 3 such representations because they would be factually incorrect, it shall be a condition to Holder's exercise of this Warrant that the Company receive such other representations as the Company considers reasonably necessary to assure the Company that the issuance of its securities upon exercise of this Warrant shall not violate any federal or state securities laws. The Company shall not be penalized or disadvantaged by a Holder's inability to exercise this Warrant due to its inability to make the required representations in connection with the exercise of this Warrant. Section 6. Ownership and Transfer. (a) The Company shall maintain at its principal executive offices (or such other office or agency of the Company as it may designate by notice to the holder hereof), a register for this Warrant, in which the Company shall record the name and address of the Person in whose name this Warrant has been issued, as well as the name and address of each transferee who has acquired this Warrant in accordance with applicable law and the terms of this Warrant. The Company may treat the Person in whose name any Warrant is registered on the register as the owner and holder thereof for all purposes, notwithstanding any notice to the contrary, but in all events recognizing any transfers made in accordance with the terms of this Warrant. (b) This Warrant may be offered, sold, transferred or assigned in compliance with the Securities Act and applicable state securities laws without the consent of the Company, except as may otherwise be required by the Purchase Agreement. Section 7. Adjustment of Exercise Price and Number of Shares. The Exercise Price and the number of Warrant Shares shall be adjusted from time to time as follows: (a) Stock Splits. If the Company subdivides (by any stock split, recapitalization or otherwise) its outstanding shares of Common Stock into a greater number of shares, the Exercise Price in effect immediately prior to the subdivision will be proportionately reduced and the number of Warrant Shares will be proportionately increased. If the Company combines (by combination, reverse stock split or otherwise) its outstanding shares of Common Stock into a smaller number of shares, the Exercise Price in effect immediately prior to the combination will be proportionately increased and the number of Warrant Shares will be proportionately decreased. Any adjustment under this Section shall become effective at the close of business on the date the subdivision or combination becomes effective. (b) Stock Dividends. If the Company declares a dividend or any other distribution upon the Common Stock that is payable in shares of Common Stock or securities convertible into shares of Common Stock, the Exercise Price in effect immediately prior to the declaration of the dividend or distribution will be reduced to the quotient obtained by dividing (i) the number of shares of Common Stock outstanding immediately prior to the declaration multiplied by the then effective Exercise Price by (ii) the total number of shares of Common Stock outstanding immediately after the declaration. Section 8. Purchase Rights; Reorganization, Reclassification, Consolidation, Merger or Sale. (a) Any recapitalization, reorganization, reclassification, consolidation, merger, sale of all or substantially all of the Company's assets to another Person or other 4 transaction in each case that is effected in such a way that holders of Common Stock are entitled to receive (either directly or upon subsequent liquidation) stock, securities or assets with respect to or in exchange for Common Stock is referred to herein as an "Organic Change." Upon the consummation of any (i) sale of all or substantially all of the Company's assets to an acquiring Person or (ii) other Organic Change following which the Company is not a surviving entity, the Company will secure from the Person purchasing the assets or the successor resulting from the Organic Change (in each case, the "Acquiring Entity") a written agreement to deliver to Holder in exchange for this Warrant, a security of the Acquiring Entity evidenced by a written instrument substantially similar in form and substance to this Warrant and reasonably satisfactory to the Holder. Prior to the consummation of any other Organic Change, the Company shall make appropriate provision to insure that Holder will thereafter have the right to acquire and receive in lieu of the shares of Common Stock immediately theretofore acquirable and receivable upon the exercise of this Warrant, such shares of stock, securities or assets that would have been issued or payable in the Organic Change with respect to or in exchange for the number of Warrant Shares that would have been acquirable as of the date of the Organic Change. Section 9. Lost, Stolen, Mutilated or Destroyed Warrant. If this Warrant is lost, stolen, mutilated or destroyed, the Company shall promptly, on receipt of an indemnification undertaking reasonably satisfactory to the Company (or, in the case of a mutilated Warrant, the Warrant), issue a new Warrant of like denomination and tenor as this Warrant so lost, stolen, mutilated or destroyed. Section 10. Notice. Any notices, consents, waivers or other communications required or permitted to be given under the terms of this Warrant must be in writing and will be deemed to have been delivered: (i) upon receipt, when delivered personally; (ii) upon receipt, when sent by fax transmittal (provided confirmation of transmission is mechanically or electronically generated and kept on file by the sending party); or (iii) one Business Day after deposit with a nationally recognized overnight delivery service, in each case properly addressed to the party to receive the same. The addresses and fax numbers for communications shall be: If to the Company: RegeneRx Biopharmaceuticals, Inc. 3 Bethesda Metro Center, Suite 700 Bethesda, Maryland 20814 Fax: (301) 961-1991 Attention: President, Chief Executive Officer and Principal Financial Officer With a copy to: Patton Boggs LLP 2550 M Street, N.W. Washington, DC 20037 Fax: (202) 457-6315 Attention: Philip G. Feigen, Esq. 5 If to the Holder, at the address and fax number set forth on Appendix I to the Purchase Agreement. Each party shall provide five days' prior written notice to the other party of any change in address or fax number. Written confirmation of receipt (A) given by the recipient of any notice, consent, waiver or other communication, (B) mechanically or electronically generated by the sender's fax machine containing the time, date, recipient fax number and an image of the first page of the transmission, or (C) provided by a nationally recognized overnight delivery service, shall be rebuttable evidence of receipt. Section 11. Remedies, Other Obligations, Breaches and Injunctive Relief. The remedies provided in this Warrant shall be cumulative and in addition to all other remedies available under this Warrant and the Purchase Agreement, at law or in equity (including a decree of specific performance and/or other injunctive relief), and nothing herein shall limit the right of the Holder to pursue actual damages for any failure by the Company to comply with the terms of this Warrant. The Company acknowledges that a breach of its obligations hereunder will cause irreparable harm to the Holder and that the remedy at law for any such breach may be inadequate. The Company therefore agrees that, in the event of any such breach or threatened breach, the Holder shall be entitled, in addition to all other available remedies, to an injunction restraining any breach, without the necessity of showing economic loss and without any bond or other security being required. Section 12. Amendment and Waiver. Except as otherwise provided herein, this Warrant may not be modified or amended except pursuant to an instrument in writing signed by the Company and the Holder. No provision hereunder may be waived other than in a written instrument executed by the waiving party. Section 13. Governing Law. This Warrant shall be construed and enforced in accordance with, and all questions concerning the construction, validity, interpretation and performance of this Warrant shall be governed by, the internal laws of the State of California, without giving effect to any choice of law or conflict of law provision or rule (whether of the State of California or any other jurisdictions) that would cause the application of the laws of any jurisdictions other than the State of California. Section 14. Restrictive Legends. At all times this Warrant and until such time as the Registration Statement (as defined in the Purchase Agreement) has been declared effective or the Warrant Shares may be sold pursuant to Rule 144(k) under the Securities Act without any restriction as to the number of securities that can then be immediately sold, certificates for any Warrant Shares will, in addition to any legend required under applicable securities law, bear a restrictive legend substantially in the form first set forth above. [Signature Page Follows] 6 IN WITNESS WHEREOF, the Company has caused this Warrant to be signed as of January 7, 2005. RegeneRx Biopharmaceuticals, Inc. By: /s/ J.J. FINKELSTEIN ------------------------------- Name: J.J. Finkelstein Title: President, Chief Executive Officer and Principal Financial Officer Exhibit A To Warrant REGENERX BIOPHARMACEUTICALS, INC. EXERCISE NOTICE TO BE EXECUTED BY THE REGISTERED HOLDER TO EXERCISE THIS WARRANT The undersigned holder hereby exercises the right to purchase _________________ shares of Common Stock ("Warrant Shares") of RegeneRx Biopharmaceuticals, Inc., a Delaware corporation (the "Company"), evidenced by the attached Warrant (the "Warrant"). Capitalized terms used herein and not otherwise defined shall have the respective meanings set forth in the Warrant. 1. Payment of Exercise Price (check applicable box). [ ] Payment in the sum of $__________ [is enclosed] [has been wire transferred to the Company at the following account: __________] in accordance with the terms of the Warrant. [ ] The cancellation of such number of Warrant Shares as is necessary, in accordance with the formula set forth in subsection 2(c)of the Warrant, to exercise this Warrant with respect to the maximum number of Warrant Shares purchasable pursuant to the cashless exercise procedure set forth in subsection 2(c). 2. Delivery of Warrant Shares. The Company shall deliver the Warrant Shares in the name of the undersigned or in such other name as is specified below in accordance with the terms of the Warrant at the following address: _________________________ _________________________ _________________________ 3. Accredited Investor. The undersigned is an "accredited investor" as defined in Regulation D promulgated under the Securities Act of 1933, as amended. Date: _______________ __, ______ By: --------------------------------------- Name: Title: ACKNOWLEDGMENT The Company hereby acknowledges this Exercise Notice and hereby directs _________. to issue the above indicated number of shares of Common Stock in accordance with the Transfer Agent Instructions dated ______, 200_ from the Company and acknowledged and agreed to by ___________. RegeneRx Biopharmaceuticals, Inc. By: ------------------------------- Name: Title: