ex_184040.htm


 


 


Exhibit 10.1


 


Certain portions of this exhibit have been omitted pursuant to Rule 601(b)(10) of Regulation S-K. The omitted information is (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed. Information that has been omitted has been noted in this document with a placeholder identified by the term “{redacted}”.


 


 


	
			AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

				
			1. CONTRACT ID CODE

				
			PAGE OF PAGES

			
	 	 	
			1

				
			4

			
	
			2. AMENDMENT/MODIFICATION NO.


			P00004

				
			3. EFFECTIVE DATE


			See Block 16C

				
			4. REQUISITION/PURCHASE REQ. NO.

				
			5. PROJECT NO. (If applicable)

			ASPR-19-03461


			 

			
	
			6. ISSUED BY                                                                                                                      CODE

				
			ASPR-BARDA

				
			7. ADMINISTERED BY (If other than Item 6)                                                                   CODE

				
			 

			
	
			ASPR-BARDA


			200 Independence Ave., S.W.


			Room 640-G


			Washington DC 20201

				 	 
	 	
			 

			
	
			8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)


			 


			SIGA TECHNOLOGIES, INC. 1385150

			Attn: Daniel Luckshire

			SIGA TECHNOLOGIES, INC.

			31 East 62nd street

			NEW YORK, NY 100658446

				
			(x) 

				
			9A. AMENDMENT OF SOLICITATION NO.

			
	 	 	9B. DATED (SEE ITEM 11)
	 	 	
			 

			
	 	
			x

				
			10A. MODIFICATION OF CONTRACT/ORDER NO.

			HHSO100201800019C

			
	 	 	
			10B. DATED (SEE ITEM 13)


			09/10/2018

			
	
			CODE 1385150

				
			FACILITY CODE

				 	 



 


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 electronic communication 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 letter or electronic communication, provided

each letter or electronic communication 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)


			See Schedule

				 
	
			13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.


			 

				 
	
			CHECK ONE

				
			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.

				 
	 	 	 
	 	
			B.THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

				 
	
			X

				
			C.THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:


			 FAR 43.103 (a) By Mutual Agreement between the parties

				 
	
			 

				
			D.OTHER (Specify type of modification and authority)

				 
	
			E.IMPORTANT: Contractor☐is not☒is required to sign this document and return _____1___ copies to the issuing office.

				 
	
			14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)


			Tax ID Number: 13-3864870


			DUNS Number: 932651516


			The purpose of this modification P00004 is to revise Article B.2 to:


			(a)   Remove Phase 3 multiple dose study, and add TPOXX-phosphate binders

			study conduct and PFR formulation development to CLIN 0001


			(b) Extend the Base Period of Performance (CLIN 0001) from 09/09/2023 through 12/31/2025


			(c) Revise the verbiage for the TPOXX-phosphate binders study and PFR


			formulation development in CLIN 0007 to ensure there are no overlaps


			in activities between CLIN 0001 and CLIN 0007


			See the attached Statement of Work for further details


			 


			Continued ...


			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)


			 


			Dennis E. Hruby, CSO

				
			16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)


			 


			George J. Keane

			
	
			15B. CONTRACTOR/OFFEROR


			/s/ Dennis E. Hruby


			(Signature of person authorized to sign)

				
			15C. DATE SIGNED


			27 Jan 2020

				
			16B.UNITED STATES OF AMERICA


			/s/ George J. Keane


			(Signature of Contracting Officer)

				
			16C. DATE SIGNED


			2/4/20

			



 


	Previous edition unusable   	 	STANDARD FORM 30 (REV. 11/2016)
	 	 	Prescribed by GSA FAR (48 CFR) 53.243



                                                                                                                                                                                                                                                                                                                              


 


 


	
			CONTINUATION SHEET

				
			REFERENCE NO. OF DOCUMENT BEING CONTINUED


			HHSO100201800019C/P00004

				
			Page of

			
	 	 	
			2

				
			4

			
	
			NAME OF OFFEROR OR CONTRACTOR


			SIGA TECHNOLOGIES, INC. 1385150

			
	
			ITEM NO.


			(A)

				
			SUPPLIES/SERVICES

			(B)

				
			QUANTITY

			(C)

				
			UNIT

			(D)

				
			UNIT PRICE

			(E)

				
			AMOUNT

			(F)

			
	 	
			All other terms and conditions remain unchanged as a result of this modification


			Period of Performance: 09/10/2018 to 09/09/2028


			-


			PSC: AN13 NAICS: 541714 HHS/BARDA COR is David Simon, David.Simon@hhs.gov, (202) 260-1101


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 


			 

				 	 	 	 



                                                                                                                                                                                                                                                                                                                                                                                     


	NSN 7540-01-152-8067   	 	 OPTIONAL FORM 336 (4-86)   
	 	 	 Sponsored by GSA
	 	 	 FAR (48 CFR) 53.110



                                                                                                                                                                                                                                                                                                                                                                                                                                     

                                                                                                                                                                                                                                                                                                                                                                                                                                 


 


Statement of Work


 


SIGA will furnish all the necessary services, qualified personnel, materials, supplies, equipment, facilities, transportation and travel not otherwise provided by the USG as required to fulfill the programmatic objectives. SIGA has completed the New Drug Application and has manufactured and delivered a total of 2 million courses of nonparenteral (oral) smallpox antiviral formulation to the USG, and has advanced the early stage development activities for parenteral (IV) formulation. The overall goal of this proposal is to complete the late-stage development of the parenteral formulation and to supply the USG with both parenteral and nonparenteral formulations.


 


The scope of this proposal includes the following activities:


	 	
			1.

				
			CLIN0001 (Base): {redacted}

			



	 	
			2.

				
			CLIN0002 (Base): Immediate delivery of approximately 23,000 treatment courses of oral formulation

			



	 	
			3.

				
			CLIN0003 (Base): {redacted}

			



{Added to Contract: Procurement of BDS for manufacturing of IV TPOXX}


	 	
			4.

				
			CLIN0004 (Base): Manufacture/fill/package/stability IV TPOXX

			



	 	
			5.

				
			CLIN0005 (Base): Storage of packaged IV TPOXX in VMI for up to 5 years

			



	 	
			6.

				
			CLIN0006 (Base): Delivery of up to 20,000 treatment courses of IV TPOXX to SNS

			



	 	
			7.

				
			CLIN0007 (Option): {redacted}

			



	 	
			8.

				
			CLIN0008 (Option): Post-marketing field study, maintenance and support of NDA and electronic IND and NDA submissions for IV formulation, and relabeling (if needed)

			



	 	
			9.

				
			CLIN0009 (Option): Delivery of up to 363,070 treatment courses of oral TPOXX to SNS

			



	 	
			10.

				
			CLIN0010 (Option): Delivery of up to 363,070 treatment courses of oral TPOXX to SNS

			



	 	
			11.

				
			CLIN0011 (Option): Delivery of up to 363,070 treatment courses of oral TPOXX to SNS

			



	 	
			12.

				
			CLIN0012 (Option): Delivery of up to 363,072 treatment courses of oral TPOXX to SNS

			



	 	
			13.

				
			CLIN0013 (Option): Procurement of BDS for manufacturing of IV TPOXX

			



	 	
			14.

				
			CLIN0014 (Option): Storage of BDS for manufacturing of IV TPOXX

			



	 	
			15.

				
			CLIN0015 (Option): Manufacture/fill/package/stability IV TPOXX

			



	 	
			16.

				
			CLIN0016 (Option): Storage of packaged IV TPOXX in VMI for up to 5 years

			



	 	
			17.

				
			CLIN0017 (Option): Delivery of up to 64,000 treatment courses of IV TPOXX to SNS

			



	 	
			18.

				
			CLIN0018 (Option): Procurement of BDS for manufacturing of IV TPOXX

			



	 	
			19.

				
			CLIN0019 (Option): Storage of BDS for manufacturing of IV TPOXX

			



	 	
			20.

				
			CLIN0020 (Option): Manufacture/fill/package/stability IV TPOXX

			



	 	
			21.

				
			CLIN0021 (Option): Storage of packaged IV TPOXX in VMI for up to 5 years

			



	 	
			22.

				
			CLIN0022 (Option): Delivery of up to 64,000 treatment courses of IV TPOXX to SNS

			



	 	
			23.

				
			CLIN0023 (Option): Procurement of BDS for manufacturing of IV TPOXX

			



	 	
			24.

				
			CLIN0024 (Option): Storage of BDS for manufacturing of IV TPOXX

			



	 	
			25.

				
			CLIN0025 (Option): Manufacture/fill/package/stability IV TPOXX

			



	 	
			26.

				
			CLIN0026 (Option): Storage of packaged IV TPOXX in VMI for up to 5 years

			



	 	
			27.

				
			CLIN0027 (Option): Delivery of up to 64,000 treatment courses of IV TPOXX toSNS

			



	 	
			28.

				
			CLIN0028 (Option): Delivery of up to 50,000 treatment courses of IV TPOXX to SNS

			



 


A detailed plan indicating how each aspect of the Statement of Objectives shall be accomplished, information pertaining to project organization, staffing, and management, including the management and coordination of consultant and sub-contractor effort, and Deliverables Table are located in the technical section of the proposal. Where applicable, the technical proposal denotes activities already accomplished against a given objective. The project plan, Work Breakdown Structure, and critical milestones are located in the Integrated Master Project Plan.


 


END OF MODIFICATION 0004 TO HHSO100201800019C