ex_348185.htm


Exhibit 10.1


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 	4
	
			2. AMENDMENT/MODIFICATION NO.


			P00023

				
			3. EFFECTIVE DATE


			01/14/2022

				
			4. REQUISITION/PURCHASE REQ. NO.


			OS288262

				
			 5. PROJECT NO. (if applicable)


			ASPR-22-00229

			
	
			6. ISSUED BY

				CODE  	HHS/OS/ASPR/BARDA	7. ADMINISTERED BY (if other than Item 6)      	 CODE  	ASPR-BARDA02
	
			HHS/OS/ASPR/BARDA


			330 Independence Ave., S.W.


			Room 640-G


			Washington DC 20201 

				 	
			 


			ASPR-BARDA


			330 Independence Ave., S.W., Rm G640


			Washington DC 20201

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


			 


			SIGA TECHNOLOGIES, INC. 1385150


			Attn: Kady Honeychurch


			SIGA TECHNOLOGIES, INC.         35  E  6


			35 E 62ND ST


			NEW YORK NY 100658014

				 	(x)	9A. AMENDMENT OF SOLICITATION NO.
	 	 	 
	 	 	9B. DATED (SEE ITEM 11)
	 	x	
			10A. MODIFICATION OF CONTRACT/ORDER NO.


			HHSO100201100023C

			
	
			CODE  1385150

				FACILITY CODE	 	
			10B. DATED (SEE ITEM 13)


			06/01/2011

				 
	
			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 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:         $219,872.37	 
	
			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 date, 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:


			52.243-2   Changes – Cost Reimbursement, Alt V

			
	 	
			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

			
	
			1.         The purpose of this cost-reimbursement type modification P00023 is to provide supplemental funding in the amount of $219,872.37 to fund budget shortages for CLIN 00005 pursuant to indirect rate redetermination and in accordance with accepted contractor revised CLIN 0005 Shortage Table received 01/14/2022.


			2.         The total contract amount funded under this contract (inclusive of fixed fee) is increased by $219,872.37 from $[***] to $[***]. For further provisions on funding, see the Limitations of Costs clause in PART II Section I, Clauses.


			3.         The overall revised contract value $[***].


			4.         the Contractor is hereby notified that mandatory U.S. Treasury Invoice Processing

			
	
			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 & EVP

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


			JOHN K. WARNER

			
	
			15B. CONTRACTOR/OFFEROR

			/s/ Dennis E. Hruby

			(Signature of person authorized to sign)

				15C. DATE SIGNED

			15 Feb 2022	16B. UNITED STATES OF AMERICA

			/s/ John K. Warner

			(Signature of Contracting Officer)	16C. DATE SIGNED

			02/03/2022
	
			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


			HHSO100201100023C/P00023

				
			 

				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)

			
	 	
			Platform (IPP) invoice submittal system will be incorporated at yet an undetermined date into this contract upon formal authorization of HHS IPP clause.


			 

				 	 	 	 
	 	
			(See block 14 continuation sheet).

				 	 	 	 
	 	
			 


			Discount Terms: HHS NET 30P

			Period of Performance: 09/01/2008 to 02/08/2024

				 	 	 	 
	 	
			 


			Change Item 7 to read as follows (amount shown is the obligated amount):

				 	 	 	 
	
			7

				
			 


			ASPR-17-00856 Exercise of CLINS 3 4 5 7 8

				 	 	 	
			219,872.37

			
	 	
			 


			Accounting Info:

			2017.1992017.25103 Appr. Yr.: 2017 CAN: 1992017  Object Class: 25103

			Funded: $0.00

				 	 	 	 
	 	
			 


			Accounting Info:

			2019.1992019.25106 Appr. Yr.: 2019 CAN: 1992019  Object Class: 25106

			Funded: $0.00

				 	 	 	 
	 	
			 


			Accounting Info:

			2019.1992018.25106 Appr. Yr.: 2019 CAN: 1992018  Object Class: 25106

			Funded: $0.00

				 	 	 	 
	 	
			 


			Accounting Info:

			2022.1992022.25106 Appr. Yr.: 2022 CAN: 1992022  Object Class: 25106

			Funded: $219,872.37

				 	 	 	 
	 	
			 


			ASPR-22-00229 CLIN 0005 Phase I - IV DP Stability: funding per re-determined indirect rates

			         Original funding: $959,798.00 + Mod 23 funding $219,872.37 = Revised funding $1,179,670.37

				 	 	 	 
	 	
			 


			PSC: AN13 NAICS: 541711 COR is Annie Lu, Ph.D.  (202) 604-5814, Xi.Lu@hhs.gov

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


			Sponsored by GSA


			FAR (48 CFR) 53.110

			



 





 










 








 


	
			Contract No. HHSO100201100023C

				
			Continuation Sheet Block 14

				
			Page 3 of 4

			
	
			Mod P00023

				 	 



 


5. ARTICLE B.4 ADVANCE UNDERSTANDINGS


 


The following final indirect cost rates incorporated under modification P00019 remain in effect and apply to the following item 5 and 6 supplemental funding:


 


	 	
			●

				
			G&A: [***]

			



 


	 	
			●

				
			Overhead: [***]

			



 


	 	
			●

				
			Fringe: [***]

			



 


6. ARTICLE 4.B ADVANCE UNDERSTANDINGS, subsection j. Subcontracts/Consultant Agreements is modified as follows:


 


	
			Change From

				
			[***]

			
	
			CLIN

				
			Scope

				
			[***]

				
			[***]

				
			[***]

				
			[***]

			
	
			0005

				
			Stability and Storage

				
			[***]

				
			[***]

				
			[***]

				
			[***]

			
	 	 	 	 	 	 
	
			Change To

				
			[***]

			
	
			CLIN

				
			Scope

				
			[***]

				
			[***]

				
			[***]

				
			[***]

			
	
			0005

				
			Stability and Storage

				
			[***]

				
			[***]

				
			[***]

				
			[***]

			



 


7. Article B.5 – Option(s)  The pricing (to include the subcontract by Options Period Chart) is updated as follows (adjustments reflect API/Kleptose credit in the amount of -$[***]).


 


ARTICLE B.5 – OPTION(S)


 


	
			Change From

				
			[***]

			
	
			CLINS

				
			Specified Time

				
			Date

				Description of Work	
			[***]

				
			[***]

				
			[***]

			
	
			CLIN 0005

				
			IV Option 4

				
			12/30/2020-12/30/2020

				Scale-Up, Process Validation and DP Stability	
			[***]

				
			[***]

				
			[***]

			
	 	 	 	 	 	 	 
	
			Change To

				
			[***]

			
	
			CLINS

				
			Specified Time

				
			Date

				
			Description of Work

				
			[***]

				
			[***]

				
			[***]

			
	
			CLIN 0005

				
			IV Option 4

				
			02/08/2024-02/08/2024

				
			Scale-Up, Process Validation and DP Stability

				
			[***]

				
			[***]

				
			[***]

			



 


8. ARTICLE C.2. REPORTING REQUIREMENTS, subsection b. Other Reports/Deliverables,

10. FDA Communications, Correspondence and Meeting Summaries is amended as follows:


 


a)  Within two (2) calendar days of the submission of any communication to the FDA, send copies of the communication to the Project Officer (PO):


 


b)  Within thirty (30) calendar days of receiving correspondence or meeting with the FDA, submit copies of correspondence or meeting minutes/summaries to the PO.


 


c)  No mention of BARDA involvement in FDA meeting, BARDA review prior to FDA submissions, notification of FDA IRs to BARDA of correspondences in real time.

FDA Meeting Notification



 




 




 


	
			Contract No. HHSO100201100023C

				
			Continuation Sheet Block 14

				
			Page 4 of 4

			
	
			Mod P00023

				 	 



 


a)  No later than 10 business days prior to the scheduled meeting, or as soon as meeting is scheduled.


 


b)  Contractor shall forward the dates and times of any meeting with the FDA to BARDA and arrange for appropriate BARDA staff to attend the FDA meetings.


 


FDA correspondence and meeting minute

Within three (3) calendar days of receiving correspondence from the FDA


 


FDA Submissions

a)  At least fifteen (15) business days prior to submission to the FDA, or as soon as available.


 


b)   Contractor shall provide BARDA the opportunity to review and comment upon all draft regulatory documents before submission to the FDA. Contractor shall provide BARDA with an electronic copy of the final FDA submission.


 


c)  Contractor shall address in writing all concerns raised by BARDA before FDA submission