ex_420884.htm


Exhibit 10.4


 


CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY "[***]," HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.


 


	
			AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT                   

				 	1. CONTRACT ID CODE	PAGE OF PAGES	 
	 	 	 	 	 	 	 	
			 

				 	1	
			5

			
	
			2. AMENDMENT/MODIFICATION NO.


			P00012

				
			3. EFFECTIVE DATE


			See Block 16C


			 

				
			4. REQUISITION/PURCHASE REQ. NO.


			See Schedule


			 


			 

				5. PROJECT NO. (If applicable)
			 

			
	
			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


			 

				 	 
	 	 
	CODE         1385150	 	 FACILITY CODE	 	
			 10B. DATED (SEE ITEM 13)


			 09/10/2018

				
			 

				 
	 	 	
			 

				 	 	
			 

				 
	
			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 ACKNOWLEDGEMENT 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

				 	
			Net Increase:         $29,212,406.00

				 
	
			13. THIS ITEM ONLY APPLIES TO MODIFICATION 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 Part 43.103(a) - Bilateral Modifications

				 
	 	 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

				 
	
			UEI: VJRNRTSL22K4

				 
	 	 
	
			The purpose of this bilateral modification is to exercise and fully fund Option CLINs 0008, 0013, 0015, and 0017.

				 
	 	 
	
			The total amount, scope, period of performance and all other terms and conditions of the contract remain unchanged.

				 
	 	 
	
			By signing this modification, SIGA Technologies Inc., hereby releases the Government from

				 
	Continued...	 
	 	 
	
			Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect.

				 
	
			15A. NAME AND TITLE OF SIGNER (Type or print)


			DENNIS HRUBY, CSO & EVP

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


			 JONATHAN F. GONZALEZ

				 
	 	 	 	 
	
			15B. CONTRACTOR/OFFEROR

				 	 	15C. DATE SIGNED	
			  16B. UNITED STATES OF AMERICA

				
			 

				 	
			 16C. DATE SIGNED


			 

				
			 

				 
	
			/s/ Dennis Hruby

				 	 	Aug. 5, 2022	
			 /s/ Jonathan F. Gonzalez

				
			 

				 	 Aug. 5, 2022	 	 
	
			(Signature of person authorized to sign)

				 	 	 	(Signature of Contracting Officer)	
			 

				 	 	 	 
	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/P00012

				
			 

				
			 

				
			PAGE

				 	
			OF

			
	2	 	5
	
			NAME OF OFFEROR OR CONTRACTOR


			SIGA TECHNOLOGIES, INC. 1385150

			
	
			ITEM NO.


			(A)

				
			SUPPLIES/SERVICES


			(B)


			 

				 	
			QUANTITY


			(C)

				
			UNIT


			(D)

				
			UNIT PRICE


			(E)

				
			AMOUNT


			(F)


			 

			
	
			 

				any and all liability under this contract for further equitable adjustments attributable to such fact or circumstance giving rise to this modification.
			 

				 	 	 	 
	 	 	 	 	 	 	 	 
	 	
			Discount Terms: HHS NET 30P


			Period of Performance: 01/01/2020 to 09/09/2028

				 	 	 	 	 	 
	 	 	 	 	 	 	 	 
	 	Add Item 9 as follows:	 	
			 

				 	 	 	 
	 	 	 	 	 	 	 	 
	9	
			ASPR-22-01725 Siga Technologies -- to exercise


			CLIN0008 post-marketing field study for [***]

				
			 

				 	 	 	
			3,586,806.00

			
	 	 	 	 	 	 	 	 
	 	
			Accounting Info:


			2022.1992126.25106 Appr. Yr.: 2022 CAN: 1992126 Object Class: 25106


			Funded: $3,586,806.00

				 	 	 	 	 
	 	 	 	 	 	 	 	 
	 	Add Item 10 as follows:	 	
			 

				 	 	 	 
	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 
	
			10

				
			ASPR-22-01723 Siga Technologies -- to procure 64


			000 TC of the Intravenous (IV) Tecovirimat as defined by CLIN0013 0015 0017 to be delivered to [***] SNS locations Per contract definition 1 TC


			14 vials under contract


			HHSO100201800019C


			Obligated Amount: $25,625,600.00


			Requisition No: OS299284


			 

				 	 	 	
			25,625,600.00

			
	 	 	 	 	 	 	 	 
	 	
			Accounting Info:


			2022.1992126.25103 Appr. Yr.: 2022 CAN: 1992126 Object Class: 25103


			Funded: $25,625,600.00

				
			 

				 	 	 	 
	 	 	 	 	 	 	 	 
	NSN 7540-01-152-8067         	 	 	
			OPTIONAL FORM 336 (4-86)


			Sponsored by GSA


			FAR (48 CFR) 53.110

			



                                                                           





 










 








 


	
			Base Period Cost Reimbursement CLIN

				 	 
	
			Item

				Period of Performance	Supplies/Services	
			Estimated Cost

				Fixed Fee	Cost + Fixed 

			Fee (CPFF)
	
			0001 Base

				[***]	Late Stage development activities towards FDA approval for parenteral (IV) antiviral	[***]	[***]	
			$32,009,375

			(Funded)

			
	
			Total

				 	 	$30,197,522	$1,811,853	$32,009,375



 


 


	
			Base Period Fixed Price CLINS


			 

			
	
			Item

				
			Period of Performance

				
			Supplies/Services

				
			Units (# of 

			Doses or Dose 

			Equivalents)

				
			Unit Price


			($)

				
			Total ($)

			
	
			0002 Base

				
			[***]

				
			Initial purchase and delivery of nonparenteral (oral) formulated antiviral as final drug product (FDP) to SNS

				
			35,718

				
			[***]

				
			$11,072,580

			(Funded)

			
	
			0003 Base

				
			[***]

				
			Initial procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *course = 14 vials

				
			20,000

				
			[***]

				
			$3,200,000

			(Funded)

			
	
			0004 Base

				
			[***]

				
			Fill/finish of final drug product (from bulk drug substance procured under CLIN0003)

				
			20,000

				
			[***]

				
			$4,800,000

			(Funded)

			
	
			0005 Base

				
			[***]

				
			Storage of final drug product in VMI for 5 years (from bulk drug substance procured under CLIN0003) *Monthly rate/TC = [***]

				
			20,000

				
			[***]

				
			[***]

			
	
			0006 Base

				
			[***]

				
			Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0003)

				
			20,000

				
			[***]

				
			[***]

			
	
			Total

				
			 

				
			 

				
			 

				 	
			[***]

			



 


 


	
			Optional Cost Reimbursement CLINs

			
	
			Item

				
			Period of Performance

				
			Supplies/Services

				
			Estimated Cost

				
			Fixed Fee

				
			Cost + Fixed 

			Fee (CPFF)

			
	
			0007 (Option)

				
			 [***]

				
			Phase IV post marketing commitments (no parenteral (oral) formulation )) including [***]

				
			[***]

				
			[***]

				
			$40,812,609

			Funded

			
	
			0008 

			(Option)

				
			[***]

				
			Phase IV post 

			marketing


			commitments (parenteral (IV) formulation)) including [***]

				
			[***]

				
			[***]

				
			$3,586,806 

			Funded

			
	
			Total

				
			 

				
			 

				
			$41,886,242

				
			$2,513,173

				
			[***]

			



 


 


	
			Optional Fixed CLINs

			
	
			Item

				
			Period of


			Performance

				Supplies/Services	
			Treatment


			Courses (# of Product)

				Unit Price ($)	Total ($)
	
			0009A


			(Option Funded)

				
			1/1/19-12/31/20

				
			Procurement of raw materials used in manufacturing of unmicronized API in sufficient quantity to support the production of 363,070 courses of nonparenteral (oral) formulated antiviral for SNS replenishment. Such raw materials may be forward processed.

				
			363,070 (raw material)

				[***]	
			$11,255,170


			Funded

			
	
			0009B


			(Option Funded)

				
			1/1/19-12/31/20

				
			Additional procurement of nonparenteral (oral) formulated antiviral as FDP and delivery to the SNS

				
			121,023 (raw material)

				[***]	
			$33,765,417


			Funded

			
	
			0009C


			(Option Funded)


			 

				
			1/1/19-12/31/20

				
			Additional procurement of nonparenteral (oral) formulated antiviral as FDP and delivery to the SNS

				
			121,023 (raw material)

				[***]	
			$33,765,417


			Funded

			
	
			0009D


			(Option Funded)


			 

				
			1/1/19-12/31/20

				
			Additional procurement of nonparenteral (oral) formulated antiviral as FDP and delivery to the SNS

				
			121,024 (raw material)

				[***]	
			$33,765,696


			Funded

			
	
			0010 (Option


			Funded)


			 

				
			1/1/20-12/31/21

				
			Additional procurement


			of nonparenteral (oral) formulated antiviral as


			FDP and delivery to the SNS

				363,070	[***]	
			$112,551,700


			Funded

			
	
			0011 (Option)


			 

				[***]	
			Additional procurement


			of a nonparenteral


			(oral) formulated antiviral as FDP and delivery to the SNS

				363,070	[***]	$112,551,700
	
			0012 (Option)


			 

				[***]	
			Additional procurement of a nonparenteral


			(oral) formulated antiviral as FDP and delivery to the SNS

				363,072	[***]	$112,552,320
	
			0013


			(Option)


			 

				[***]	
			Surge Capacity – Additional procurement of parenteral (IV) formulated antiviral as bulk drug substance


			(BDS) *course = 14 vials

				64,000	[***]	
			$10,240,000


			(Funded)

			
	
			0014 (Option)


			 

				[***]	
			Surge Capacity – Storage of parenteral (IV) formulated antiviral as bulk drug substance (BDS) in VMI for 5 years (from bulk drug substance procured under CLIN0013). *Monthly rate per TC = [***]

				64,000	[***]	[***]
	
			0015


			(Option)


			 

				[***]	
			Surge Capacity –


			Fill/finish of final drug product (from bulk drug substance procured under


			CLIN0013)

				64,000	[***]	
			$15,360,000


			(Funded)

			
	
			0016 (Option)


			 

				[***]	
			Surge Capacity – Storage of final drug


			product in VMI for 5 years (from bulk drug substance procured under CLIN0013).


			*Monthly rate per TC = [***]

				64,000	[***]	[***]
	
			0017


			(Option)


			 

				[***]	
			Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0013) *[***] SNS Shipments @ [***]

				64,000	[***]	[***] (Funded)
	
			0018 (Option)


			 

				[***]	
			Surge Capacity – Additional procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *course = 14 vials

				64,000	[***]	$10,240,000
	
			0019 (Option)


			 

				[***]	
			Surge Capacity – Storage of parenteral (IV) formulated antiviral as bulk drug substance (BDS) in VMI for 5 years (from bulk drug substance procured under CLIN0018). *Monthly rate per TC = [***]

				64,000	[***]	[***]
	
			0020 (Option)


			 

				[***]	
			Surge Capacity – Fill/finish of final drug product from bulk drug substance procured under CLIN0018).

				64,000	[***]	$15,360,000
	
			0021 (Option)


			 

				[***]	
			Surge Capacity – Storage of final drug product in VMI for 5 years (from bulk drug substance procured under CLIN0018). *Monthly rate per TC: [***]

				64,000	[***]	[***]
	
			0022 (Option)

				[***]	
			Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0018). *[***] SNS Shipments @ [***]

				64,000	[***]	[***]
	
			0023 (Option)

				[***]	
			Surge Capacity – Additional procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *course = 14 vials

				64,000	[***]	$10,240,000
	
			0024 (Option)

				[***]	
			Surge Capacity – Storage of parenteral (IV) formulated antiviral as bulk drug substance (BDS) in VMI for 5 years (from bulk drug substance procured under CLIN0023). *Monthly rate per TC = [***]

				64,000	[***]	[***]
	
			0025 (Option)

				[***]	Surge Capacity – Fill/finish of final drug product (from bulk drug substance procured under CLIN0023).	64,000	[***]	$15,360,000
	
			0026 (Option)

				[***]	
			Surge Capacity – Storage of final drug product in VMI for 5 years (from bulk drug substance procured under CLIN0023). *Monthly rate per TC: [***]

				64,000	[***]	[***]
	
			0027 (Option)

				[***]	
			Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0023). *[***] SNS Shipments @ [***]

				64,000	[***]	[***]
	
			Total

				 	 	 	 	[***]



 


 


	
			Total Funded

				
			 

				 	                                                    $320,585,711



 


 


                   End of Modification P00012