SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
                                                        
 
FORM 8-K
 
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15 (d) OF
THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported):  June 24, 2011
               

SIGA TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)

Delaware
0-23047
13-3864870
(State or other jurisdiction of
incorporation or organization)
(Commission file number)
(I.R.S. employer
identification no.)

35 East 62nd Street
New York, New York
(Address of principal executive offices)
 
 
10065
(Zip code)

Registrant’s telephone number, including area code:  (212) 672-9100
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below):
 
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 

 

 
 

 

 
Item 1.01.      Entry into a Material Definitive Agreement.

On June 27, 2011, SIGA Technologies, Inc., a Delaware corporation (“SIGA”), issued a press release announcing that the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (“BARDA”) had advised that the protest filed against the contract it awarded to SIGA for the sale of SIGA’s smallpox antiviral ST-246® (the “Smallpox Bioshield Contract”) had been withdrawn following execution of a contract modification by BARDA (the “Contract Modification”).  As a result, the stay on performance of the Smallpox Bioshield Contract, originally awarded last month, has been lifted.

The Contract Modification deletes the option for BARDA to purchase up to 12 million courses of ST-246® beyond the 1.7 million courses to be purchased under the base contract.  The base contract and the other options remain unchanged.  The contract modification does not prevent BARDA from purchasing additional courses of ST-246® or other products in the future if it desires.
 
The foregoing description is qualified in its entirety by reference to the text of the Contract Modification, which is attached hereto as Exhibit 10.1, and the text of the Smallpox Bioshield Contract, which was filed as Exhibit 10.1 to SIGA’s Current Report on Form 8-K filed on May 17, 2011.

Item 8.01      Other Events.

The disclosure set forth above under Item 1.01 is hereby incorporated by reference into this Item 8.01.

Item 9.01.      Financial Statements and Exhibits.
 
(c) Exhibits
 
Exhibit No .
 
Description
 
10.1
 
Amendment of Solicitation/Modification of Contract dated as of June 24, 2011, between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services.
 
99.1
 
Press Release, dated June 27, 2011
 


 
 

 

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
SIGA TECHNOLOGIES, INC.
 
By: /s/ Daniel J. Luckshire         
Name: Daniel J. Luckshire
Title:   Chief Financial Officer
 
 
Date:  June 28, 2011


 
 
 
 

 
Exhibit 10.1
 
 

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
1. CONTRACT ID CODE
N/A
PAGE OF PAGES
1
2
2. AMENDMENT/MODIFICATION NO.
Modification 0001
3. EFFECTIVE DATE
See Block 16 C
4. REQUISITION/PURCHASE REQ. NO
N/A
5. PROJECT NO. (if applicable)
N/A
6. ISSUED BY
CODE
N/A
7. ADMINISTERED BY ( If other than Item 6 )
         CODE
N/A
DHHS/ASPR/AMCG
330 Independence Avenue, SW,
Room G640,
Washington, DC  20201
     
8. NAME AND ADDRESS OF CONTRACTOR ( No., street, county, State, and Zip Code )
 
SIGA TECHNOLOGIES, INC.
35 E 62nd Street
New York, NY  10065
 
 
 
   (X)
9A. AMENDMENT OF SOLICITATION NO.
 
9B. DATED ( SEE ITEM 11 )       
 
 
     X
10A. MODIFICATION OF CONTRACT/ORDER NO.
 
HHSO100201100001C
 
CODE:   N/A
 
FACILITY CODE:   N/A
10B. DATED ( SEE ITEM 13 )
05/13/2011
 
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS
 
 
--- The above numbered solicitation is amended as set forth in item 14.  The hour and date specified for receipt of Offers --- is extended --- is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:
(a) By completing Items 8 and 15, and returning _____ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers.  FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment, you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.
12. ACCOUNTING AND APPROPRIATION DATA ( If Required )  N/A
 
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS, IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
 
    (Y)
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: ( Specify authority ) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.
     X
FAR 52.243-1 Changes - Fixed Price (AUG 1987)
 
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES ( such as changes in paying office, appropriation date, etc. ) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43,103 (b).
 
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
FAR 1.605-1:  Mutual Agreement of all parties
 
D. OTHER ( Specify type of modification and authority )
     
 
E. IMPORTANT : Contractor [X] is not, [ ] is required to sign this document and return   0    copies to the issuing office.
 
14. DESCRIPTION OF AMENDMENT/MODIFICATION ( Organized by UCF section headings, including solicitation/contract subject matter where feasible. )
PURPOSE:  The purpose of this modification is to delete Contract Line Item (CLIN) 14.  The Price Schedule is revised as noted on the continuation sheet.
 
FUNDS ALLOTTED PRIOR TO MOD #10 $432,885,825.00  
FUNDS ALLOTTED WITH MOD #10 $                   0.00  
TOTAL FUNDS ALLOTTED TO DATE $432,885,825.00  (Unchanged)
EXPIRATION DATE: May 12, 2016 (Unchanged)
CONTRACT FUNDED THROUGH: May 12, 2016 (Unchanged)
 
 
 
Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.
 
15A. NAME AND TITLE OF SIGNER ( Type or print )
           
16A. NAME AND TITLE OF CONTRACTING OFFICER ( Type or print )
       Brian K. Goodger, Contracting Officer  DHHS/ASPR/AMCG
 
15B. CONTRACTOR/OFFEROR
15C. DATE  SIGNED
16B. UNITED STATES OF AMERICA
BY         /s/ Brian K. Goodger                   
 
16C. DATE  SIGNED
     6/24/2011
(Signature of person authorized to sign)
 
(Signature of Contracting Officer)
 
NSN 7540-01-152-8070     OMB No. 0990-0115                                                     STANDARD FORM 30 (REV. 10-83)
 
 
 
 
 
 

 
 

 
Contract No.
HHSO100201100001C
Modification No. 1
Continuation Sheet
Page 2 of 2



By effect of this Modification 0001, the Contract is revised as follows:
 
1.   Contract Line Item 14 (as seen below) is deleted in entirety from the Contract.
 
Option
         
CLIN#
Cost
Type
Supply or Service
U/I
Qty
Unit Price
Extended Price
0014
FFP
Purchase of Additional
Treatment Courses (Up to 12
Million).  As described in
Section C.7.5
EA
TBD
 
TBD


2.   The following requirements in Section C are deleted in their entirety:
 
C.7.5
BARDA may exercise optional CLINs to purchase additional antiviral treatment courses.  (CLIN 0014)
 
C.7.5.1
The Contractor shall submit a plan and schedule for antiviral drug product manufacture and control at large-scale production and under cGMP compliance to deliver up to an additional 12 million treatment courses
 
C.7.5.2.
The plan shall provide unit prices as well as cost and price data that support the unit prices (See Section B.8.) offered for the purchase of additional treatment courses using the following increments.  The government shall evaluate the prices as well as the cost or price data as part of its best value analysis prior to award of Base Contract and prior to award of any option orders of treatment courses:
 

All other terms and conditions of Contract HHSO100201100001C remain unchanged.


END OF MODIFICATION 1 TO HHSO100201100001C

 
 

 


Exhibit 99.1

 
SIGA TO SELL 1.7 MILLION COURSES OF ST-246 ® TO NATIONAL
STOCKPILE UNDER MODIFIED BARDA CONTRACT

GAO PROTEST WITHDRAWN

New York, New York, June 27, 2011 – SIGA Technologies, Inc. (NASDAQ: SIGA) announced today that the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services (BARDA) has advised that the protest filed against the contract it awarded to SIGA for the sale of SIGA’s smallpox antiviral ST-246 ® has been withdrawn following execution of a contract modification by BARDA.  As a result, the stay on performance of the contract, originally awarded last month, has been lifted.
 
The contract modification deletes the option for BARDA to purchase up to 12 million courses of ST-246 beyond the 1.7 million courses to be purchased under the base contract.  The base contract and the other options remain unchanged.  The contract modification does not prevent BARDA from purchasing additional courses of ST-246 or other products in the future if it desires.
 
SIGA’s groundbreaking drug, ST-246, is an oral therapeutic agent active against orthopoxviruses including smallpox. It is the only drug from any source ever to have demonstrated efficacy in non-human primate models of orthopox virus disease, which was a requirement of the request for proposal that resulted in the current contract.  ST-246 will be the first entirely new small-molecule drug delivered to the Strategic National Stockpile under Project Bioshield.  Smallpox, even though no longer present naturally in the environment, is considered a formidable bioterrorism threat, and there is currently no FDA-approved treatment for symptomatic individuals.  ST-246   works by blocking the ability of the virus to spread to other cells, preventing it from causing disease.  The FDA has designated ST-246 for “fast-track” status, creating a path for expedited FDA review and eventual regulatory approval.
 
Further information concerning ST-246 and the BARDA contract are available in the separate press release issued by SIGA on May 13, 2011.
 
About SIGA Technologies, Inc.
 
In the United States and around the world, populations face a serious but unmet need for drugs to protect against potentially catastrophic emerging viral pathogens and biological weapons of mass destruction.  SIGA Technologies, Inc. is a pharmaceutical company specializing in the development and commercialization of therapeutic solutions for some of the most lethal disease-causing pathogens in the world, including smallpox, Ebola, dengue, Lassa fever and other dangerous viruses. Our business is to discover, develop and commercialize drugs to prevent and treat these high-priority threats.  Our mission is to disarm dreaded viral diseases and create robust, modern biodefense countermeasures.  For more information about SIGA, please visit SIGA’s web site at www.siga.com.
 
 
 
 
 

 
 
 
The SIGA Technologies, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=4504
 
Forward-looking Statements
 
This press release contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements relating to the safety and efficacy of its products, the progress of its development programs and timelines for bringing products to market and the enforceability of the BARDA contract.  Forward-looking statements are based on management's estimates, assumptions and projections, and are subject to uncertainties, many of which are beyond the control of SIGA. Actual results may differ materially from those anticipated in any forward-looking statement. Factors that may cause such differences include (i) the risk that potential products that appear promising to SIGA or its collaborators cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (ii) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products, (iii) the risk that SIGA may not be able to obtain anticipated funding for its development projects or other needed funding, (iv) the risk that SIGA may not be able to secure funding from anticipated or current government contracts and grants, (v) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including patent protection, (vi) the risk that any challenge to our patent and other property rights, if adversely determined, could affect our business and, even if determined favorably, could be costly, (vii) the risk that regulatory requirements applicable to SIGA’s products may result in the need for further or additional testing or documentation that will delay or prevent seeking or obtaining needed approvals to market these products, (viii) the risk that the BARDA contract may be subject to one or more protests or other governmental actions, which may cause such contract to be delayed or denied, (ix) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA's efforts, (x) the risk that the changes in domestic and foreign economic and market conditions may adversely affect SIGA’s ability to advance its research or its products, and (xi) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA’s businesses. More detailed information about SIGA and risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this presentation, is set forth in SIGA's filings with the Securities and Exchange Commission, including SIGA's Annual Report on Form 10-K for the fiscal year ended December 31, 2010, and in other documents that SIGA has filed with the SEC.  SIGA urges investors and security holders to read those documents free of charge at the SEC's Web site at http://www.sec.gov. Interested parties may also obtain those documents free of charge from SIGA. Forward-looking statements speak only as of the date they are made, and except for our ongoing obligations under the federal securities laws, we undertake no obligation to publicly update any forward-looking statement whether as a result of new information, future events or otherwise.
 
Contact:
 
KCSA Strategic Communications
Todd Fromer / Robert Fink
212-896-1215 / 212-896-1206
tfromer@kcsa.com / rfink@kcsa.com