Insider filing report for Changes in Beneficial Ownership

  • Schedule 13G & 13D forms are used to report a party's ownership of stock which exceeds 5% of a company's total stock issue.
  • Schedule 13G is a shorter version of Schedule 13D with fewer reporting requirements.
"Insiders might sell their shares for any number of reasons, but they buy them for only one: they think the price will rise"
- Peter Lynch
What is insider trading>>

SECURITIES AND EXCHANGE COMMISSION
 
Washington, D.C. 20549
____________________________________________
 
SCHEDULE 13D/A14 (Amendment No. 14)

Under the Securities Exchange Act of 1934
 
RegeneRx Biopharmaceuticals, Inc.

(Name of Issuer)
 
Common Stock, Par Value $0.001 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)
 

October 8, 2009

(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 §§ 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 29

 


CUSIP No.  020910105
 
(1)
NAME OF REPORTING PERSONS
I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (entities only)
Sigma-Tau Finanziaria S.p.A.
(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
Shares
(7)
SOLE VOTING POWER
0
Beneficially Owned
(8)
SHARED VOTING POWER
13,831,435
by Each
Reporting
(9)
SOLE DISPOSITIVE POWER
0
Person With
(10)
SHARED DISPOSITIVE POWER
13,831,435
(11)
AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
13,831,435
(12)
CHECK IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES
[   ]
(13)
PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
22.6% (based on 54,675,122 shares of Common Stock outstanding as of August 7, 2009, as reported in the Issuer’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on August 14, 2009, plus 4,512,195 shares issued in connection with a registered direct offering by the Issuer as reported in the Issuer’s Current Report on Form 8-K filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on September 30, 2009, plus 1,219,512 shares issued in connection with the October 2009 Private Placement (as defined below), 246,154 shares of Common Stock issuable upon exercise of the 2005 Warrants (as defined below), 256,148 shares of Common Stock issuable upon exercise of the Defiante March 2006 Warrant (as defined below) and 333,333 shares of Common Stock issuable upon exercise of the Defiante December 2006 Warrant (as defined below)).
(14)
TYPE OF REPORTING PERSON
CO


 
Page 2 of 29

 


CUSIP No.  020910105
 
(1)
NAME OF REPORTING PERSONS
I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (entities only)
Defiante Farmacêutica S.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
Shares
(7)
SOLE VOTING POWER
0
Beneficially Owned
(8)
SHARED VOTING POWER
12,600,666
by Each
Reporting
(9)
SOLE DISPOSITIVE POWER
0
Person With
(10)
SHARED DISPOSITIVE POWER
12,600,666
(11)
AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
12,600,666
(12)
CHECK IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES
[  ]
(13)
PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
20.7% (based on 54,675,122 shares of Common Stock outstanding as of August 7, 2009, as reported in the Issuer’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on August 14, 2009, plus 4,512,195 shares issued in connection with a registered direct offering by the Issuer as reported in the Issuer’s Current Report on Form 8-K filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on September 30, 2009, plus 1,219,512 shares issued in connection with the October 2009 Private Placement (as defined below), 256,148 shares of Common Stock issuable upon exercise of the Defiante March 2006 Warrant (as defined below) and 333,333 shares of Common Stock issuable upon exercise of the Defiante December 2006 Warrant (as defined below)).
(14)
TYPE OF REPORTING PERSON
CO


 
Page 3 of 29

 


CUSIP No.  020910105
 
(1)
NAME OF REPORTING PERSONS
I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (entities only)
Paolo Cavazza
(2)
CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (See Instructions)
(a)  [  ]
(b)  [  ]
(3)
SEC USE ONLY
 
(4)
SOURCE OF FUNDS
PF
(5)
CHECK IF DISCLOSURE OF LEGAL PROCEEDINGS IS REQUIRED PURSUANT TO ITEMS 2(d) or 2(e)  [ 0; ]
(6)
CITIZENSHIP OR PLACE OF ORGANIZATION
Italy
Number of
Shares
(7)
SOLE VOTING POWER
0
Beneficially Owned
(8)
SHARED VOTING POWER
24,107,945
by Each
Reporting
(9)
SOLE DISPOSITIVE POWER
0
Person With
(10)
SHARED DISPOSITIVE POWER
24,107,945
(11)
AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
24,107,945
(12)
CHECK IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES
[  ]
(13)
PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
38.1% (based on 54,675,122 shares of Common Stock outstanding as of August 7, 2009, as reported in the Issuer’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on August 14, 2009, plus 4,512,195 shares issued in connection with a registered direct offering by the Issuer as reported in the Issuer’s Current Report on Form 8-K filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on September 30, 2009, plus 1,219,512 shares issued in connection with the October 2009 Private Placement (as defined below), 246,154 shares of Common Stock issuable upon exercise of the 2005 Warrants (as defined below), 256,148 shares of Common Stock issued upon exercise of the Defiante March 2006 Warrant (as defined below), 22,601 shares of Common Stock issuable upon exercise of the Chaumiere March 2006 Warrant (as defined below), 333,333 shares of Common Stock issuable upon exercise of the Defiante December 2006 Warrant (as defined below), 333,333 shares of Common Stock issuable upon exercise of the Chaumiere December 2006 Warrant (as defined below), 500,000 shares of Common Stock issuable upon exercise of the Chaumiere February 2008 Warrant (as defined below), 372,552 shares of Common Stock issuable upon exercise of the Chaumiere December 2008 Warrant (as defined below), 263,158 shares of Common Stock issuable upon exercise of the April 2009 Warrant (as defined below) and 609,756 shares of Common Stock issuable upon exercise of the October 2009 Warrant (as defined below)).
(14)
TYPE OF REPORTING PERSON
IN

 
Page 4 of 29

 


CUSIP No.  020910105
 
(1)
NAME OF REPORTING PERSONS
I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (entities only)
Claudio Cavazza
(2)
CHECK THE APPROPRIATE BOX IF A MEMBER OF A GROUP (See Instructions)
(a)  [  ]
(b)  [  ]
(3)
SEC USE ONLY
 
(4)
SOURCE OF FUNDS
PF
(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
Shares
(7)
SOLE VOTING POWER
0
Beneficially Owned
(8)
SHARED VOTING POWER
20,112,503
by Each
Reporting
(9)
SOLE DISPOSITIVE POWER
0
Person With
(10)
SHARED DISPOSITIVE POWER
20,112,503
(11)
AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
20,112,503
(12)
CHECK IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES
[  ]
(13)
PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
32.2% (based on 54,675,122 shares of Common Stock outstanding as of August 7, 2009, as reported in the Issuer’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on August 14, 2009, plus 4,512,195 shares issued in connection with a registered direct offering by the Issuer as reported in the Issuer’s Current Report on Form 8-K filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on September 30, 2009, plus 1,219,512 shares issued in connection with the October 2009 Private Placement (as defined below), 246,154 shares of Common Stock issuable upon exercise of the 2005 Warrants (as defined below), 256,148 shares of Common Stock issuable upon exercise of the Defiante March 2006 Warrant (as defined below), 22,601 shares of Common Stock issuable upon exercise of the Inverlochy March 2006 Warrant (as defined below), 333,333 shares of Common Stock issuable upon exercise of the Defiante December 2006 Warrant (as defined below), 333,333 shares of Common Stock issuable upon exercise of the Inverlochy December 2006 Warrant (as defined below), 500,000 shares of Common Stock issuable upon exercise of the Inverlochy February 2008 Warrant (as defined below) and 372,552 shares of Common Stock issuable upon exercise of the Inverlochy December 2008 Warrant (as defined below)).
(14)
TYPE OF REPORTING PERSON
IN

 
Page 5 of 29

 


CUSIP No.  020910105
 
(1)
NAME OF REPORTING PERSONS
I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (entities only)
Chaumiere-Consultadoria e Servicos SDC Unipessoal LDA
(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
Shares
(7)
SOLE VOTING POWER
0
Beneficially Owned
(8)
SHARED VOTING POWER
10,276,510
by Each
Reporting
(9)
SOLE DISPOSITIVE POWER
0
Person With
(10)
SHARED DISPOSITIVE POWER
10,276,510
(11)
AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
10,276,510
(12)
CHECK IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES
[  ]
(13)
PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
16.4% (based on 54,675,122 shares of Common Stock outstanding as of August 7, 2009, as reported in the Issuer’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on August 14, 2009, plus 4,512,195 shares issued in connection with a registered direct offering by the Issuer as reported in the Issuer’s Current Report on Form 8-K filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on September 30, 2009, plus 1,219,512 shares issued in connection with the October 2009 Private Placement (as defined below), 22,601 shares of Common Stock issuable upon exercise of the Chaumiere March 2006 Warrant (as defined below), 333,333 shares of Common Stock issuable upon exercise of the Chaumiere December 2006 Warrant (as defined below), 500,000 shares of Common Stock issuable upon exercise of the Chaumiere February 2008 Warrant (as defined below), 372,552 shares of Common Stock issuable upon exercise of the Chaumiere December 2008 Warrant  (as defined below), 263,158 shares of Common Stock issuable upon exercise of the April 2009 Warrant (as defined below) and 609,756 shares of Common Stock issuable upon exercise of the October 2009 Warrant (as defined below)).
(14)
TYPE OF REPORTING PERSON
CO


 
Page 6 of 29

 


CUSIP No.  020910105
 
(1)
NAME OF REPORTING PERSONS
I.R.S. IDENTIFICATION NOS. OF ABOVE PERSONS (entities only)
Inverlochy-Consultadoria e Servicos (S.U.) LDA
(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
Shares
(7)
SOLE VOTING POWER
0
Beneficially Owned
(8)
SHARED VOTING POWER
6,281,068
by Each
Reporting
(9)
SOLE DISPOSITIVE POWER
0
Person With
(10)
SHARED DISPOSITIVE POWER
6,281,068
(11)
AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON
6,281,068
(12)
CHECK IF THE AGGREGATE AMOUNT IN ROW (11) EXCLUDES CERTAIN SHARES
[  ]
(13)
PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW (11)
10.2% (based on 54,675,122 shares of Common Stock outstanding as of August 7, 2009, as reported in the Issuer’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on August 14, 2009, plus 4,512,195 shares issued in connection with a registered direct offering by the Issuer as reported in the Issuer’s Current Report on Form 8-K filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on September 30, 2009, plus 1,219,512 shares issued in connection with the October 2009 Private Placement (as defined below), 22,601 shares of Common Stock issuable upon exercise of the Inverlochy March 2006 Warrant (as defined below), 333,333 shares of Common Stock issuable upon exercise of the Inverlochy December 2006 Warrant (as defined below), 500,000 shares of Common Stock issuable upon exercise of the Inverlochy February 2008 Warrant (as defined below) and 372,552 shares of Common Stock issuable upon exercise of the Inverlochy December 2008 Warrant (as defined below)).
(14)
TYPE OF REPORTING PERSON
CO


 
Page 7 of 29

 

Item 1.
Security and Issuer.
 
Item 1 of the Schedule 13D is hereby amended and restated in its entirety as follows:
 
This Amendment No. 14 by Sigma-Tau Finanziaria S.p.A., an Italian corporation (“Sigma Tau”), Defiante Farmacêutica S.A., a Portuguese corporation (“Defiante”), Paolo Cavazza, an Italian citizen, and Chaumiere-Consultadoria e Servicos SDC Unipessoal L.d.a., a Portuguese corporation (“Chaumiere”), Claudio Cavazza, an Italian citizen and Inverlochy-Consultadoria e Servicos (S.U.) LDA, a Portuguese corporation (“Inverlochy” and together with Paolo Cavazza, Claudio Cavazza, Chaumiere, Defiante and Sigma Tau, the “Reporting Parties”) 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, Amendment No. 3 filed with the SEC on September 22, 2004, Amendment No. 4 filed with the SEC on January 19, 2005, Amendment No. 5 filed with the SEC on June 24, 2005, Amendment No. 6 filed with the SEC on March 16, 2006, Amendment No. 7 filed with the SEC on July 24, 2006, Amendment No. 8 filed with the SEC on January 3, 2007, Amendment No. 9 filed with the SEC on January 10, 2008, Amendment No. 10 filed with the SEC on March 10, 2008, Amendment No. 11 filed with the SEC on April 4, 2008, Amendment No. 12 filed with the SEC on December 19, 2008 and Amendment No. 13 filed with the SEC on April 13, 2009 (the “Schedule 13D”) with respect to the Common Stock, $0.001 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 630, 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 Paolo Cavazza, Claudio Cavazza, Sigma Tau, Defiante, Inverlochy and Chaumiere.  Sigma Tau owns 58% of Defiante directly and 42% indirectly through its wholly-owned subsidiary, Sigma-Tau International S.A.  Claudio Cavazza directly and indirectly owns 57% of Sigma Tau.  Paolo Cavazza directly and indirectly owns 38% of Sigma Tau.  Claudio Cavazza indirectly owns 100% of Inverlochy.  Chaumiere is an indirect wholly-owned subsidiary of Aptafin S.p.A. (“Aptafin”).  Aptafin is owned by Paolo Cavazza and members of his family.
 
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 business address of Chaumiere is 77-6°F Avenida Arriaga Edificio Forum P-9000 FUNCHAL Madeira (Portugal).  Chaumiere is an investment company.
 
The business address of Inverlochy is Avenida Arriaga N 77 Edif. Marina, Forum 6 Andar Sala 605 Funchal - Madeira 10209 Portugal.  Inverlochy is an investment company.
 
The name, address, principal occupation or employment and citizenship of each of the executive officers and directors of, and each person, including Claudio Cavazza and Paolo Cavazza, controlling Sigma Tau, Defiante, Inverlochy and Chaumiere 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 sub-
 

 
Page 8 of 29

 

ject 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 $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.  Defiante used its working capital to pay the exercise price.
 
On January 23, 2004, pursuant to a Securities Purchase Agreement, dated as of January 23, 2004, between the 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.
 
Defiante exercised the 2004 Warrant on July 14, 2006, at an exercise price of $1.50 per share and received 263,158 shares of Common Stock.  Defiante used its working capital to pay the exercise price.
 
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 o f $4.06 per share, in whole or in part, at any time and from time-to-time from issuance of such Warrant through January 7, 2008.
 

 
Page 9 of 29

 


 
On June 22, 2005, pursuant to Purchase Agreements dated as of June 22, 2005 (the “2005 Purchase Agreements”) between Issuer and each of Defiante, Inverlochy and Chaumiere (together with Inverlochy and Defiante, the “Purchasers”), Defiante purchased 307,692 shares of Common Stock, Inverlochy purchased 307,692 shares of Common Stock and Chaumiere purchased 923,077 shares of Common Stock at $3.25 per share as part of a private placement.  The Purchasers used working capital to purchase their shares.  The 2005 Purchase Agreements provide that the Purchasers may not dispose of the shares for a five-year period (the “Holding Period”), that the Issuer, rather than the Purchasers, has all voting rights in respect of the shares during the Holding Period, and that the Issuer shall have the right to repurchase the shares within 30 days of the expiration of the Holding Period at a price of $5.00 per share, provided that the Issuer may only repurchase an amount of shares that would leave the Purchasers, when combined with all of their affiliates, with no less than 30.1% of the Issuer’s shares of Common Stock.
 
On August 1, 2005, pursuant to a Stock Purchase Agreement dated August 1, 2005 between Allan L. Goldstein and Chaumiere, Chaumiere purchased 110,000 shares of the Issuer’s Common Stock from the Seller at a purchase price of $3.20 per share.
 
On March 16, 2006, pursuant to Securities Purchase Agreements dated as of March 6, 2006 (the “March 2006 Purchase Agreements”) between Issuer and each of the Purchasers, Defiante purchased 731,850 shares of Common Stock, Inverlochy purchased 64,575 shares of Common Stock and Chaumiere purchased 64,575 shares of Common Stock for a cash purchase price of $2.81 per share in a registered direct offering.  The Purchasers used working capital to purchase these shares.  In consideration for the purchase of such shares, on March 16, 2006, the Issuer issued warrants (i) to Defiante to purchase 256,148 shares of Common Stock (the “Defiante March 2006 Warrant”), (ii) to Inverlochy to purchase 22,601 shares of Common Stock (the “Inverlochy March 2006 Warrant”) and (iii) to Chaumiere to purchase 22,601 shares of Common Stock (the “Chaumiere March 2006 Warrant” and, together with the Defiante March 2006 Warrant and the Inverlochy March 2006 Warrant, the “March 2006 Warrants”), in each case exercisable at a price of $4.06 per share, in whole or in part, at any time and from time to time from September 16, 2006 through March 16, 2011.
 
On May 26, 2006, pursuant to a Securities Purchase Agreement dated as of March 26, 2006 between J.J. Finkelstein and Chaumiere, Chaumiere purchased in a private transaction 125,000 shares of Common Stock at a price of $2.80 per share.  Chaumiere used its working capital to purchase such shares.
 
On December 21, 2006, pursuant to Securities Purchase Agreements dated as of December 18, 2006 (the “December 2006 Purchase Agreements”) between Issuer and each of the Purchasers, Defiante purchased 833,333 shares of Common Stock, Inverlochy purchased 833,333 shares of Common Stock and Chaumiere purchased 833,333 shares of Common Stock for a cash purchase price of $1.80 per share in a private placement.  The Purchasers used working capital to purchase these shares.  In consideration for the purchase of such shares, on December 21, 2006, the Issuer issued warrants (i) to Defiante to purchase 333,333 shares of Common Stock (the “Defiante December 2006 Warrant”), (ii) to Inverlochy to purchase 333,333 shares of Common Stock (the “Inverlochy December 2006 Warrant”) and (iii) to Chaumiere to purchase 333,333 shares of Common Stock (the “Chaumiere December 2006 Warrant” and, together with the Defiante December 2006 Warrant and the Inverlochy December 2006 Warrant, the “December 2006 Warrants”), in each case exercisable at a price of $2.75 per share, in whole or in part, at any time and from time to time from December 21, 2006 through December 21, 2011.
 
The terms of the 2005 Warrants were amended on December 31, 2007, pursuant to an Amendment to Warrant to Purchase Common Stock, dated as of December 31, 2007 to provide that the 2005 Warrants would be exercisable at any time prior to 11:59 p.m. Eastern Time on March 31, 2008 (the “Expiration 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 a principal exchange or automated quotation system on which the Common Stock is traded (a “Holiday”), the next day that is not a Holiday.
 

 
Page 10 of 29

 


 
On February 29, 2008, pursuant to Securities Purchase Agreements dated as of February 27, 2008 (the “February 2008 Purchase Agreements”) between Issuer and each of Chaumiere and Inverlochy, Chaumiere purchased 2,500,000 shares of Common Stock and Inverlochy purchased 2,500,000 shares of Common Stock for a cash purchase price of $1.00 per share in a private placement (the “February 2008 Private Placement”).  Chaumiere and Inverlochy used working capital to purchase these shares.  The February 2008 Purchase Agreements provide that (i) the Purchasers may not transfer the shares through December 31, 2010 (the “Restricted Period”) except for transfers to Affiliates (as defined therein), (ii) the Issuer, rather than the Purchasers, has all voting rights in respect of the shares during the Restricted Period, and (iii) the Issuer shall have the right to repurchase the shares at any time during the Restricted Period at a price of $2.00 per share, with respect to any repurchases made on or prior to December 31, 2009, and at a price of $2.50 per share with respect to any repurchases made between and including January 1, 2010 and December 31, 2010.  In consideration for the purchase of such shares, on February 29, 2008, the Issuer issued warrants (i) to Inverlochy to purchase 500,000 shares of Common Stock (the “Inverlochy February 2008 Warrant”) and (ii) to Chaumiere to purchase 500,000 shares of Common Stock (the “Chaumiere February 2008 Warrant” and, together with the Inverlochy February 2008 Warrant, the “February 2008 Warrants”), in each case exercisable at a price of $1.60 per share.  One-third of the warrants vested on February 29, 2008, one-third vested on December 31, 2008, and one-third is scheduled to vest on December 31, 2009.  However, should the Issuer repurchase all of the shares prior to December 31, 2009, any unvested warrants would terminate as of the date of repurchase.
 
The terms of the 2005 Warrants were further amended pursuant to a Second Amendment to Warrant to Purchase Common Stock, dated as of March 31, 2008, to extend the Expiration Date from March 31, 2008 to December 31, 2009.
 
On December 10, 2008, pursuant to Securities Purchase Agreements dated as of December 10, 2008 (the “December 2008 Purchase Agreements”) between Issuer and each of Chaumiere and Inverlochy, Chaumiere purchased 1,034,482 shares of Common Stock and Inverlochy purchased 1,034,482 shares of Common Stock for a cash purchase price of $1.45 per share in a private placement (the “December 2008 Private Placement”).  Chaumiere and Inverlochy used working capital to purchase these shares.  In consideration for the purchase of such shares, on December 10, 2008 the Issuer issued warrants (i) to Inverlochy to purchase 372,552 shares of Common Stock ( the “Inverlochy December 2008 Warrant”) and (ii) to Chaumiere to purchase 372,552 shares of Common Stock (the “Chaumiere December 2008 Warrant” and, together with the Inverlochy December 2008 Warrant, the “December 2008 Warrants”), in each case exercisable at a price of $1.74 per share, in whole or in part, at any time and from time to time from December 10, 2008 through December 31, 2011.  The December 2008 Purchase Agreements provide that (i) the Purchasers may not transfer the shares, the December 2008 Warrants or any shares issued upon exercise of the December 2008 Warrants through December 31, 2011 except for transfers to Affiliates (as defined therein) and (ii) the Issuer, rather than the Purchasers, has all voting rights in respect of the shares and any shares issued upon exercise of the December 2008 Warrants through December 31, 2011.
 
On April 13, 2009, pursuant to a Securities Purchase Agreement dated as of April 13, 2009 ( the “April 2009 Purchase Agreement”) between Issuer and Chaumiere, Chaumiere purchased 1,052,631 shares of Common Stock for a cash purchase price of $0.57 per share in a private placement (the “April 2009 Private Placement”).  Chaumiere used working capital to purchase these shares.  In consideration for the purchase of such shares, on April 13, 2009 the Issuer issued a warrant to Chaumiere to purchase 263,158 shares of Common Stock, exercisable at a price of $0.91 per share, in whole or in part, at any time and from time to time from April 13, 2009 through April 20, 2012 (the “April 2009 Warrant”).  The April 2009 Purchase Agreement provides that (i) the Purchaser may not transfer the shares, the April 2009 Warrant or any shares issued upon exercise of the April 2009 Warrant through April 30, 2012 except for transfers to Affiliates (as defined therein) and (ii) the Issuer, rather than the Purchaser, has all voting rights in respect of the shares and any shares issued upon exercise of the April 2009 Warrant through April 30, 2012.
 

 
Page 11 of 29

 


 
On May 2, 2009, each of Chaumiere and Inverlochy purchased 312,500 shares of Common Stock for a cash purchase price of $0.40 per share in a private transaction.  Chaumiere and Inverlochy used working capital to purchase these shares.
 
On October 15, 2009, pursuant to a Securities Purchase Agreement dated as of September 30, 2009 (the “September 2009 Purchase Agreement”) between Issuer and Chaumiere, Chaumiere purchased 1,219,512 shares of Common Stock for a cash purchase price of $0.82 per share in a private placement (the “October 2009 Private Placement”).  Chaumiere used working capital to purchase these shares.  In consideration for the purchase of such shares, on October 15, 2009 the Issuer issued a warrant to Chaumiere to purchase 609,756 shares of Common Stock, exercisable at a price of $1.12 per share, in whole or in part, at any time and from time to time from April 15, 2010 through September 30, 2014 (the “October 2009 Warrant”).  Any material conditions precedent to the obligation of Chaumiere to purchase the shares and the obligation of the Issuer to issue the shares and the October 2009 Warrant were satisfied on October 8, 2009  The September 2009 Purchase Agreement provides that (i) the Purchaser may not transfer the shares, the October 2009 Warrant or any shares issued upon exercise of the October 2009 Warrant through September 30, 2012 except for transfers to Affiliates (as defined therein) and (ii) the Issuer, rather than the Purchaser, has all voting rights in respect of the shares and any shares issued upon exercise of the October 2009 Warrant through September 30, 2012.
 
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.
 
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 13,831,435 shares of Common Stock representing 22.6% of the outstanding Common Stock (based on 54,675,122 shares of Common Stock outstanding as of August 7, 2009, as reported in the Issuer’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on August 14, 2009, plus 4,512,195 shares issued in connection with a registered direct offering by the Issuer as reported in the Issuer’s Current Report on Form 8-K filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on September 30, 2009, plus 1,219,512 shares issued in connection with the October 2009 Private Placement, 246,154 shares of Common Stock issuable upon exercise of the 2005 Warrants, 256,148 shares of Common Stock issuable upon exercise of the Defiante March 2006 Warrant and 333,333 shares of Common Stock issuable upon exercise of the Defiante December 2006 Warrant).
 
Defiante is the beneficial owner of 12,600,666 shares of Common Stock representing 20.7% of the outstanding Common Stock (based on 54,675,122 shares of Common Stock outstanding as of August 7, 2009, as reported in the Issuer’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on August 14, 2009, plus 4,512,195 shares issued in connection with a registered direct offering by the Issuer as reported in the Issuer’s Current Report on Form 8-K filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on September 30, 2009, plus 1,219,512 shares issued in connection with the October 2009 Private Placement, 256,148 shares of Common Stock issuable upon exer-
 

 
Page 12 of 29

 

cise of the Defiante March 2006 Warrant and 333,333 shares of Common Stock issuable upon exercise of the Defiante December 2006 Warrant).
 
Paolo Cavazza is the beneficial owner of 24,107,945 shares of Common Stock representing 38.1% of the outstanding Common Stock (based on 54,675,122 shares of Common Stock outstanding as of August 7, 2009, as reported in the Issuer’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on August 14, 2009, plus 4,512,195 shares issued in connection with a registered direct offering by the Issuer as reported in the Issuer’s Current Report on Form 8-K filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on September 30, 2009, plus 1,219,512 shares issued in connection with the October 2009 Private Placement, 246,154 shares of Common Stock issuable upon exercise of the 2005 Warrants, 256,148 shares of Common Stock issued upon exercise of the Defiante March 2006 Warrant, 22,601 shares of Common Stock issuable upon exercise of the Chaumiere March 2006 Warrant, 333,333 shares of Common Stock issuable upon exercise of the Defiante December 2006 Warrant, 333,333 shares of Common Stock issuable upon exercise of the Chaumiere December 2006 Warrant, 500,000 shares of Common Stock issuable upon exercise of the Chaumiere February 2008 Warrant, 372,552 shares of Common Stock issuable upon exercise of the Chaumiere December 2008 Warrant, 263,158 shares of Common Stock issuable upon exercise of the April 2009 Warrant and 609,756 shares of Common Stock issuable upon exercise of the October 2009 Warrant).
 
Claudio Cavazza is the beneficial owner of 20,112,503 shares of Common Stock representing 32.2% of the outstanding Common Stock (based on 54,675,122 shares of Common Stock outstanding as of August 7, 2009, as reported in the Issuer’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on August 14, 2009, plus 4,512,195 shares issued in connection with a registered direct offering by the Issuer as reported in the Issuer’s Current Report on Form 8-K filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on September 30, 2009, plus 1,219,512 shares issued in connection with the October 2009 Private Placement, 246,154 shares of Common Stock issuable upon exercise of the 2005 Warrants, 256,148 shares of Common Stock issuable upon exercise of the Defiante March 2006 Warrant, 22,601 shares of Common Stock issuable upon exercise of the Inverlochy March 2006 Warrant, 333,333 shares of Common Stock issuable upon exercise of the Defiante December 2006 Warrant, 333,333 shares of Common Stock issuable upon exercise of the Inverlochy December 2006 Warrant, 500,000 shares of Common Stock issuable upon exercise of the Inverlochy February 2008 Warrant and 372,552 shares of Common Stock issuable upon exercise of the Inverlochy December 2008 Warrant).
 
Chaumiere is the beneficial owner of 10,276,510 shares of Common Stock representing 16.4% of the outstanding Common Stock (based on 54,675,122 shares of Common Stock outstanding as of August 7, 2009, as reported in the Issuer’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on August 14, 2009, plus 4,512,195 shares issued in connection with a registered direct offering by the Issuer as reported in the Issuer’s Current Report on Form 8-K filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on September 30, 2009, plus 1,219,512 shares issued in connection with the October 2009 Private Placement, 22,601 shares of Common Stock issuable upon exercise of the Chaumiere March 2006 Warrant, 333,333 shares of Common Stock issuable upon exercise of the Chaumiere December 2006 Warrant, 500,000 shares of Common Stock issuable upon exercise of the Chaumiere February 2008 Warrant, 372,552 shares of Common Stock issuable upon exercise of the Chaumiere December 2008 Warrant, 263,158 shares of Common Stock issuable upon exercise of the April 2009 Warrant and 609,756 shares of Common Stock issuable upon exercise of the October 2009 Warrant).
 
Inverlochy is the beneficial owner of 6,281,068 shares of Common Stock representing 10.2% of the Common Stock outstanding (based on 54,675,122 shares of Common Stock outstanding as of August 7, 2009, as reported in the Issuer’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2009, filed pur-
 

 
Page 13 of 29

 

suant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on August 14, 2009, plus 4,512,195 shares issued in connection with a registered direct offering by the Issuer as reported in the Issuer’s Current Report on Form 8-K filed pursuant to the Securities Exchange Act of 1934, as amended, with the Securities and Exchange Commission on September 30, 2009, plus 1,219,512 shares issued in connection with the October 2009 Private Placement, 22,601 shares of Common Stock issuable upon exercise of the Inverlochy March 2006 Warrant, 333,333 shares of Common Stock issuable upon exercise of the Inverlochy December 2006 Warrant, 500,000 shares of Common Stock issuable upon exercise of the Inverlochy February 2008 Warrant and 372,552 shares of Common Stock issuable upon exercise of the Inverlochy December 2008 Warrant).
 
(b) The number of shares of Common Stock as to which Sigma Tau has the sole power to vote or direct the vote is zero.  The number of shares of Common Stock as to which Sigma Tau shares the power to vote or direct the vote is 13,831,435.  The number of shares of Common Stock as to which Sigma Tau has the sole power to dispose or direct the disposition is zero.  The number of shares of Common Stock as to which Sigma Tau shares the power to dispose or direct the disposition is 13,831,435.
 
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 12,600,666.  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 12,600,666.
 
The number of shares of Common Stock as to which Paolo Cavazza has the sole power to vote or direct the vote is zero.  The number of shares of Common Stock as to which Paolo Cavazza shares the power to vote or direct the vote is 24,107,945.  The number of shares of Common Stock as to which Paolo Cavazza has the sole power to dispose or direct the disposition is zero.  The number of shares of Common Stock as to which Paolo Cavazza shares the power to dispose or direct the disposition is 24,107,945.
 
The number of shares of Common Stock as to which Claudio Cavazza has the sole power to vote or direct the vote is zero.  The number of shares of Common Stock as to which Claudio Cavazza shares the power to vote or direct the vote is 20,112,503.  The number of shares of Common Stock as to which Claudio Cavazza has the sole power to dispose or direct the disposition is zero.  The number of shares of Common Stock as to which Claudio Cavazza shares the power to dispose or direct the disposition is 20,112,503.
 
The number of shares of Common Stock as to which Chaumiere has the sole power to vote or direct the vote is zero.  The number of shares of Common Stock as to which Chaumiere shares the power to vote or direct the vote is 10,276,510.  The number of shares of Common Stock as to which Chaumiere has the sole power to dispose or direct the disposition is zero.  The number of shares of Common Stock as to which Chaumiere shares the power to dispose or direct the disposition is 10,276,510.
 
The number of shares of Common Stock as to which Inverlochy has the sole power to vote or direct the vote is zero.  The number of shares of Common Stock as to which Inverlochy shares the power to vote or direct the vote is 6,281,068.  The number of shares of Common Stock as to which Inverlochy has the sole power to dispose or direct the disposition is zero.  The number of shares of Common Stock as to which Inverlochy shares the power to dispose or direct the disposition is 6,281,068.
 
(c) On October 15, 2009, Chaumiere purchased 1,219,512 shares of Common Stock for a cash purchase price of $0.82 per share in a private placement.  In consideration for the purchase of such shares, on October 15, 2009, the Issuer issued a warrant to Chaumiere to purchase 609,756 shares of Common Stock, exercisable at a price of $1.12 per share.
 
(d) N/A.
 

 
Page 14 of 29

 


 
(e) N/A.
 
Item 6.  
Contracts, Arrangements, Understanding or
Relationships with Respect to Securities of the Issuer.
 
 
Item 6 is hereby restated in its entirety as follows:
 
Except as otherwise set forth in Items 3 and 4 of this Schedule 13D, to the best knowledge of the Reporting Parties there are no contracts, arrangements, understandings or relationships (legal or otherwise) among the persons named in Item 2 and between such persons and any person with respect to any securities of the Issuer, including but not limited to, transfer or voting of any of the securities of the Issuer, finders fees, joint ventures, loan or oppositions arrangements, puts or calls, guarantees of profits, division of profits or loss, or the giving or withholding of proxies, or a pledge or contingency the occurrence of which would give another person voting power over the securities of the Issuer.
 
Item 7.  
Material to Be Filed as Exhibits.
 
Item 7 of the Schedule 13D is hereby amended and restated in its entirety as follows:
 
 
1.
Joint Filing Agreement.
 
 
2.
Power of Attorney (Sigma Tau).1
 
 
3.
Power of Attorney (Defiante).2
 
 
4.
Power of Attorney (Claudio Cavazza).3
 
 
5.
Power of Attorney (Paolo Cavazza).4
 
 
6.
Power of Attorney (Chaumiere).5
 


 
1
Incorporated by reference to the Reporting Persons’ Amendment No. 5 to Schedule 13D filed with the SEC on June 24, 2005.
 
 
2
Incorporated by reference to the Reporting Persons’ Amendment No. 5 to Schedule 13D filed with the SEC on June 24, 2005.
 
 
3
Incorporated by reference to the Reporting Persons’ Amendment No. 12 to Schedule 13D filed with the SEC on December 19, 2008.
 
 
4
Incorporated by reference to the Reporting Persons’ Amendment No. 10 to Schedule 13D filed with the SEC on March 10, 2008.
 
 
5
Incorporated by reference to the Reporting Persons’ Amendment No. 10 to Schedule 13D filed with the SEC on March 10, 2008.
 

 
Page 15 of 29

 


 
 
7.
Power of Attorney (Inverlochy).6
 
 
8.
Warrant Agreement dated as of January 7, 2005 between Issuer and Sigma Tau.7
 
 
9.
Form of Stock Purchase Agreement dated as of June 22, 2005.8
 
 
10.
Form of Securities Purchase Agreement dated as of March 6, 2006.9
 
 
11.
Form of March 2006 Warrant.10
 
 
12.
Form of Securities Purchase Agreement dated as of December 15, 2006.11
 
 
13.
Form of December 2006 Warrant.12
 
 
14.
Amendment to Warrant to Purch ase Common Stock.13
 
 
15.
Form of Securities Purchase Agreement dated as of February 27, 2008.14
 
 
16.
Form of February 2008 Warrant.15
 


 
6
Incorporated by reference to the Reporting Persons’ Amendment No. 10 to Schedule 13D filed with the SEC on March 10, 2008.
 
 
7
Incorporated by reference to the Reporting Persons’ Amendment No. 4 to Schedule 13D filed with the SEC on January 19, 2005.
 
 
8
Incorporated by reference to Exhibit 99.2 to the Issuer’s Form 8-K filed on June 23, 2005.
 
 
9
Incorporated by reference to Exhibit 10.1 to the Issuer’s Form 8-K filed with the SEC on March 7, 2006.
 
 
10
Incorporated by reference to Exhibit 4.1 to the Issuer’s Form 8-K filed with the SEC on March 7, 2006.
 
 
11
Incorporated by reference to Exhibit 10.1 to the Issuer’s Form 8-K filed with the SEC on December 18, 2006.
 
 
12
Incorporated by reference to Exhibit 4.1 to the Issuer’s Form 8-K filed with the SEC on December 18, 2006.
 
 
13
Incorporated by reference to the Reporting Persons’ Amendment No. 9 to Schedule 13D filed with the SEC on January 10, 2008
 
 
14
Incorporated by reference to Exhibit 99.1 to the Issuer’s Form 8-K filed with the SEC on February  27, 2008.
 
 

 
Page 16 of 29

 


 
 
17.
Second Amendment to Warrant to Purchase Common Stock.16
 
 
18.
Form of Securities Purchase Agreement dated as of December 10, 2008.17
 
 
19.
Form of December 2008 Warrant.18
 
 
20.
Form of Securities Purchase Agreement dated as of April 13, 2009.19
 
 
21.
Form of April 2009 Warrant.20
           
 
22.
Form of Securities Purchase Agreement dated as of September 30, 2009.21
 
 
23.
Form of October 2009 Warrant.22
 


Footnote continued from previous page.
 
 
15
Incorporated by reference to Exhibit 4.1 to the Issuer’s Form 8-K filed with the SEC on
February 27, 2008.
 
 
16
Incorporated by reference to the Reporting Person’s Amendment No. 11 to Schedule 13D filed with the SEC on April 4, 2008.
 
 
17
Incorporated by reference to Exhibit 99.1 to the Issuer’s Form 8-K filed with the SEC on December 12, 2008.
 
 
18
Incorporated by reference to Exhibit 4.1 to the Issuer’s Form 8-K filed with the SEC on December 12, 2008.
 
 
19
Incorporated by reference to Exhibit 10.1 to the Issuer’s Form 8-K filed with the SEC on April 16, 2009.
 
 
20
Incorporated by reference to Exhibit 10.1 to the Issuer’s Form 8-K filed with the SEC on April 16, 2009.
 
 
21
Incorporated by reference to Exhibit 10.1 to the Issuer’s Form 8-K filed with the SEC on October 5, 2009.
 
 
22
Incorporated by reference to Exhibit 4.1 to the Issuer’s Form 8-K filed with the SEC on October 5, 2009.
 

 
Page 17 of 29

 

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:  October19 , 2009
 
 
SIGMA-TAU FINANZIARIA S.P.A.
   
   
 
By:    /s/  Maurizio Terenzi   
 
          Name:  Maurizio Terenzi
 
          Title:    Attorney-in-fact


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 Farmacêutica S.A. is true, complete and correct.
 
Date:  October 19, 2009
 
 
DEFIANTE FARMACEUTICA S.A.
   
   
 
By:    /s/  Maurizio Terenzi   
 
          Name:  Maurizio Terenzi
 
          Title:    Attorney-in-fact


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 Claudio Cavazza is true, complete and correct.
 
Date:  October 19, 2009
 
 
CLAUDIO CAVAZZA
   
   
 
By:    /s/  Nicola Wullschleger   
 
          Name:  Nicola Wullschleger
 
          Title:    Attorney-in-fact

 
Page 18 of 29

 

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 Inverlochy - Consultadoria e Servicos (S.U.) LDA is true, complete and correct.
 
Date:  October 19, 2009

 
INVERLOCHY – CONSULTADORIA E
 
SERVICOS (S.U.) LDA
   
   
 
By:    /s/  Nicola Wullschleger   
 
          Name:  Nicola Wullschleger
 
          Title:    Attorney-in-fact

 
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 Paolo Cavazza is true, complete and correct.
 
Date:  October 19, 2009
 
 
PAOLO CAVAZZA
   
< font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: times new roman">   
 
By:    /s/  Fabio Poma   
 
          Name:  Fabio Poma
 
          Title:    Attorney-in-fact

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 Chaumiere-Consultadoria & Servicos SDC Unipessoal LDA is true, complete and correct.
 
Date:  October 19, 2009
 
 
CHAUMIERE-CONSULTADORIA &
 
SERVICOS SDC UNIPESSOAL LDA
   
   
 
By:    /s/  Fabio Poma   
 
          Name:  Fabio Poma
 
          Title:   Attorney-in-fact

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 19 of 29

 

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, Jones, Platé, Artali and Cerrina Feroni) of Sigma Tau are set forth below:
 
1.  
(a) Claudio Cavazza, (b) Via Pontina Km. 30,400, Pomezia (Rome), Italy, 00040, (c) President, and (d) Italy.
 
2.  
(a) Ugo Di Francesco, (b) Via Sudafrica, 20, Rome, Italy 00144, (c) Vice President and Chief Executive Officer, and (d) Italy.
 
3.  
(a) Marco Codella, (b) Via Sudafrica, 20, Rome, Italy 00144, (c) Managing Director, and (d) Italy.
 
4.  
(a) Mauro Bove, (b) Via Sudafrica, 20, Rome, Italy 00144, (c) Managing Director, and (d) Italy.
 
5.  
(a) Stefano Marino, (b) Via Pontina Km. 30,400, Pomezia (Rome), Italy, 00040, (c) General Counsel of Sigma-Tau Industrie Farmaceutiche Riunite SpA; Corporate Legal and Intellectual Property Director at Sigma-Tau Finanziaria 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. C. Cavazza, Di Francesco, Codella, Bove and Marino) of Sigma Tau are set forth below:
 
1.
(a) Enrico Cavazza, (b) Via Pontina Km. 30,400, Pomezia (Rome), Italy, (c) executive, Sigma-Tau Industrie Farmaceutica Riunite SpA, and (d) Italy.
 
2.
(a) Trevor Jones, (b) Woodhyrst House, 18 Friths Drive, REIGATE, Surrey, Great Britain, (c) professor, and (d) Great Britain.
 
3.
(a) Emilio Platé, (b) Via Finocchiaro Aprile n.5,Varese, Italy, (c) business consultant, and (d) Italy.
 
4.
(a) Mario Artali, (b) Piazza F. Meda 4, Milano, Italy 20121, (c) Deputy Chairman, Banca Popolare di Milano, and (d) Italy.
 
5.
(a) Marco Cerrina Feroni, (b)  Piazza Paolo Ferrari 10, Milano, Italy 20121, (c) executive, Intesa Sanpaolo 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 controlling person of Sigma Tau are set forth below:
 
1.
(a) Claudio Cavazza, (b) Pontina Km. 30,400, Pomezia (Rome), Italy 00040, (c) President, Sigma Tau, and (d) Italy.
 
2.
(a) Paolo Cavazza, (b) Via Tesserete, 10, Lugano, Switzerland (c) entrepreneur, Sigma Tau, Aptafin SpA and Esseti S.A., and (d) Italy.
 

 
Page 20 of 29

 


 
Claudio Cavazza directly and indirectly owns 57% of Sigma Tau and Paolo Cavazza directly and indirectly owns 38% of Sigma Tau.  Sigma Tau owns 58% of Defiante directly and 42% indirectly through its wholly-owned subsidiary, Sigma-Tau International S.A.
 

 
Page 21 of 29

 

Defiante Farmacêutica S.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 of Defiante are set forth below:
 
1.
(a) Massimo Mineo, (b) Via Pontina km. 30,400, Pomezia, Rome, Italy 00040, (c) Executive, Sigma Tau Industrie Farmaceutiche Riunite SpA, and (d) Italy.
 
2.
(a) Raffaele Sanguigni, (b) Via Pontina km. 30,400, Pomezia, Rome, Italy 00040, (c) Director-President, Defiante, and Executive, Sigma Tau Industrie Farmaceutiche Riunite SpA, and (d) Italy.
 
3.
(a) Paolo Alexandre da Mota Viegas, (b) Rua da Alfanadega, n.78, Funchal, Madeira, Portugal, 9000-059, (c) general manager of Defiante, and (d) Portugal.
 
4.
(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.
 
5.
(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 22 of 29

 

Chaumiere-Consultadoria & Servicos SDC Unipessoal
 
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 of Chaumiere are set forth below:
 
1.
(a) Roberto Carlos de Castro Abreu, (b) Avenida da República, 32, 4.º Esquerdo, 1050-193 Lisboa, Portugal, (c) business consultant and (d) Portugal.
 
2.
(a) João Josè de Freitas Rodrigues, (b) Avenida da República, 32, 4.º Esquerdo, 1050-193 Lisboa, Portugal, (c) business consultant and (d) Portugal.
 

 
Page 23 of 29

 

Inverlochy-Consultadoria e Servicos (SU) Unipessoal
 
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 of Chaumiere are set forth below:
 
1.
(a) Roberto Carlos de Castro Abreu, (b) Avenida da República, 32, 4.º Esquerdo, 1050-193 Lisboa, Portugal, (c) business consultant and (d) Portugal.
 
2.
(a) João Josè de Freitas Rodrigues, (b) Avenida da República, 32, 4.º Esquerdo, 1050-193 Lisboa, Portugal, (c) business consultant and (d) Portugal.
 

 
Page 24 of 29

 

EXHIBIT INDEX
 
 
1.
Joint Filing Agreement
 
 
2.
Power of Attorney (Sigma Tau).1
 
 
3.
Power of Attorney (Defiante).2
 
 
4.
Power of Attorney (Claudio Cavazza).3
 
 
5.
Power of Attorney (Paolo Cavazza).4
 
 
6.
Power of Attorney (Chaumiere).5
 
 
7.
Power of Attorney (Inverlochy).6
 
 
8.
Warrant Agreement dated as of January 7, 2005 between Issuer and Sigma Tau.7
 
 
9.
Form of Stock Purchase Agreement dated as of June 22, 2005.8
 
 
10.
Form of Securities Purchase Agreement dated as of March 6, 2006.9
 


 
1
Incorporated by reference to the Reporting Persons’ Amendment No. 5 to Schedule 13D filed with the SEC on June 24, 2005.
 
 
2
Incorporated by reference to the Reporting Persons’ Amendment No. 5 to Schedule 13D filed with the SEC on June 24, 2005.
 
 
3
Incorporated by reference to the Reporting Persons’ Amendment No. 12 to Schedule 13D filed with the SEC on December 19, 2008.
 
 
4
Incorporated by reference to the Reporting Persons’ Amendment No. 10 to Schedule 13D filed with the SEC on March 10, 2008.
 
 
5
Incorporated by reference to the Reporting Persons’ Amendment No. 10 to Schedule 13D filed with the SEC on March 10, 2008.
 
 
6
Incorporated by reference to the Reporting Persons’ Amendment No. 10 to Schedule 13D filed with the SEC on March 10, 2008.
 
 
7
Incorporated by reference to the Reporting Persons’ Amendment No. 4 to Schedule 13D filed with the SEC on January 19, 2005.
 
 
8
Incorporated by reference to Exhibit 99.2 to the Issuer’s Form 8-K filed on June 23, 2005.
 

 
Page 25 of 29

 


 
 
11.
Form of March 2006 Warrant.10
 
 
12.
Form of Securities Purchase Agreement dated as of December 15, 2006.11
 
 
13.
Form of December 2006 Warrant.12
 
 
14.
Amendment to Warrant to Purchase Common Stock.13
 
 
15.
Form of Securities Purchase Agreement dated as of February 27, 2008.14
 
 
16.
Form of February 2008 Warrant.15
 
 
17.
Second Amendment to Warrant to Purchase Common Stock.16
 
 
18.
Form of Securities Purchase Agreement dated as of December 10, 2008.17
 
 
19.
Form of December 2008 Warrant.18
 


Footnote continued from previous page.
 
 
9
Incorporated by reference to Exhibit 10.1 to the Issuer’s Form 8-K filed with the SEC on March 7, 2006.
 
 
10
Incorporated by reference to Exhibit 4.1 to the Issuer’s Form 8-K filed with the SEC on March 7, 2006.
 
 
11
Incorporated by reference to Exhibit 10.1 to the Issuer’s Form 8-K filed with the SEC on December 18, 2006.
 
 
12
Incorporated by reference to Exhibit 4.1 to the Issuer’s Form 8-K filed with the SEC on December 18, 2006.
 
 
13
Incorporated by reference to the Reporting Persons’ Amendment No. 9 to Schedule 13D filed with the SEC on January 10, 2008
 
 
14
Incorporated by reference to Exhibit 99.1 to the Issuer’s Form 8-K filed with the SEC on February  27, 2008
 
 
15
Incorporated by reference to Exhibit 4.1 to the Issuer’s Form 8-K filed with the SEC on
February 27, 2008
 
 
16
Incorporated by reference to the Reporting Person’s Amendment No. 11 to Schedule 13D filed with the SEC on April 4, 2008.
 
 
17
Incorporated by reference to Exhibit 99.1 to the Issuer’s Form 8-K filed with the SEC on December 12, 2008.
 
 
18
Incorporated by reference to Exhibit 4.1 to the Issuer’s Form 8-K filed with the SEC on December 12, 2008.
 

 
Page 26 of 29

 


 
20.           Form of Securities Purchase Agreement dated as of April 13, 2009.19
 
21.           Form of April 2009 Warrant.20
 
22.           Form of Securities Purchase Agreement dated as of September 30, 2009.21
 
23.           Form of October 2009 Warrant.22
 


Footnote continued from previous page.
 
 
19
Incorporated by reference to Exhibit 10.1 to the Issuer’s Form 8-K filed with the SEC on April 16, 2009.
 
 
20
Incorporated by reference to Exhibit 10.1 to the Issuer’s Form 8-K filed with the SEC on April 16, 2009.
 
 
21
Incorporated by reference to Exhibit 10.1 to the Issuer’s Form 8-K filed with the SEC on October 5, 2009.
 
 
22
Incorporated by reference to Exhibit 4.1 to the Issuer’s Form 8-K filed with the SEC on October 5, 2009.
 

 
Page 27 of 29

 

EXHIBIT 1
 

 
JOINT FILING AGREEMENT
 
The undersigned hereby agree that the amended and restated statement on Schedule 13D with respect to the Common Stock of RegeneRx Biopharmaceuticals, Inc. dated as of October 19, 2009 is, and any amendments thereto signed by such of the undersigned shall be, filed on behalf of each of us pursuant to and in accordance with the provisions of Rule 13d-1(k) under the Securities Exchange Act of 1934.
 
Dated:  October 19, 2009
SIGMA-TAU FINANZIARIA SPA
   
   
 
By:    /s/  Maurizio Terenzi   
 
          Name:  Maurizio Terenzi
 
          Title:    Attorney-in-fact
   
   
Dated:  October 19, 2009
DEFIANTE FARMACEUTICA S.A.
   
   
 
By:    /s/  Maurizio Terenzi   
 
          Name:  Maurizio Terenzi
 
          Title:    Attorney-in-fact
   
   
Dated:  October 19, 2009
PAOLO CAVAZZA
   
   
 
By:    /s/  Fabio Poma   
 
          Name:  Fabio Poma
 
          Title:    Attorney-in-fact
   
   
Dated:  October 19, 2009
CLAUDIO CAVAZZA
   
   
 
By:    /s/  Nicola Wullschleger   
 
          Name:  Nicola Wullschleger
 
          Title:    Attorney-in-fact
   
   
Dated:  October 19, 2009
INVERLOCHY – CONSULTADORIA E
 
SERVICOS (S.U.) LDA
   
   
 
By:    /s/  Nicola Wullschleger   
 
          Name:  Nicola Wullschleger
 
          Title:    Attorney-in-fact

 
Page 28 of 29

 


Dated:  October 19, 2009
CHAUMIERE-CONSULTADORIA E
 
SERVICOS SDC UNIPESSOAL LDA
   
   
 
By:    /s/  Fabio Poma   
 
         Name:  Fabio Poma
 
         Title:    Attorney-in-fact



 
 
 
 
 
Page 29 of 29