Amendment of Solicitation/Modification of Contract 00016, dated July 18, 2024, to Agreement, dated September 10, 2018, by and between SIGA and the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

2. AMENDMENT/MODIFICATION NO.

P00016

3. EFFECTIVE DATE

See Block 16C

4. REQUISITION/PURCHASE REQ. NO.

See Schedule

5. PROJECT NO. (If applicable)

6. ISSUED BY

CODE

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 J. LUCKSHIRE

SIGA TECHNOLOGIES,         INC.         31, EA

31, EAST 62ND STREET

NEW YORK NY 10065

(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 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:         $112,552,320.00

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

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).

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

x

D.    OTHER (Specify type of modification and authority)

 FAR 43.103(a) Modification by mutual agreement of the parties.

E.         IMPORTANT:         Contractor           ☒ is not          ☐ is required to sign this document and return            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 ###-###-####

UEI: VJRNRTSL22K4

The purpose of this modification is to exercise and fully fund Option CLIN 0012 and revise

Section G Contract Administration, Article G.1 Contracting Officer from Jonathan Gonzalez

to Audrey Glover.

All other terms and conditions remain unchanged.

OTA: N

Discount Terms: HHS NET 30P

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

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

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

JONATHAN F. GONZALEZ

15B. CONTRACTOR/OFFEROR

/s/ Dennis Hruby

15C. DATE SIGNED

July 18, 2024

16B. UNITED STATES OF AMERICA

/s/ Jonathan F. Gonzalez

16C. DATE SIGNED

July 18, 2024

(Signature of person authorized to sign)

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED

HHSO100201800019C/P00016

NAME OF OFFEROR OR CONTRACTOR

SIGA TECHNOLOGIES, INC. 1385150

ITEM NO.
(A)

SUPPLIES/SERVICES

(B)

QUANTITY

(C)

UNIT

(D)

UNIT PRICE

(E)

AMOUNT

(F)

16

Add Item 16 as follows:

Option 0012 - Additional procurement of a nonparenteral (oral) formulated antiviral as FDP delivery to the SNS

Period of Performance: [***]

Obligated Amount: $56,276,160.00

Requisition No: ASP331498

Accounting Info:

2024.Q990100.26088 Appr. Yr.: 2024 CAN: Q990100 Object Class: 26088

Funded: $56,276,160.00

Add Item 17 as follows:

56,276,160.00

17

Exercise Option 12 - Additional procurement of a nonparenteral (oral) formulated antiviral as FDP and delivery to SNS

Period of Performance: [***]

Obligated Amount: $56,276,160.00

Requisition No: ASP329562

Accounting Info:

2024.Q99SN24.26088 Appr. Yr.: 2024 CAN: Q99SN24 Object Class: 26088

Funded: $56,276,160.00

56,276,160.00

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 toward FDA approval for parenteral (IV) antiviral

[***]

$32,009,375
(Funded)

Total (CLIN 0001)

Base Period Fixed CLINs

Item

Period of Performance

Supplies/Services

Unit (# 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) *TC = 28 vials

10,000

$3,200,000 (Funded)

0004 Base

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

10,000

$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 = [***]

10,000

0006 Base

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

Validation lot manufactured under CLIN0001)

10,000

Total (CLINs 0002-0006)

Optional Cost Reimbursement CLINs

Item

Period of Performance

Supplies/Services

Estimated Cost

Fixed Fee

Cost + Fixed Fee (CPFF)

0007 (Option Funded)

Phase IV post-marketing commitments
(nonparenteral (oral) formulation)) including [***]

$14,612,790
(Funded)

0008 (Option Funded)

Phase IV Post Marketing commitments (parenteral (IV) formulation)) including [***]

$3,586,806
(Funded)

Total (CLINs 0007-0008)

Optional Fixed CLINs

Item

Period of Performance

Supplies/Services

Treatment
Courses (# of
Product)

Unit Price ($)

Total ($)

0009A (Option Funded)

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)

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)

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)

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)

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

363,070

$112,551,700
(Funded)

0012 (Option Funded)

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

363,072

$112,552,320
(Funded)

0013 (Option Funded)

Surge Capacity – Additional procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *TC = 28 vials

32,000

$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 = [***]

32,000

0015 (Option Funded)

Surge Capacity Fill/finish of final drug product (from bulk drug substance procured under CLIN0013)

32,000

$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 = [***]

32,000

0017 (Option Funded)

Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0013)

32,000

0018 (Option Funded)

Surge Capacity – Additional procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *TC = 28 vials

32,000

$10,240,000
(Funded)

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 = [***]

32,000

0020 (Option Funded)

Surge Capacity Fill/finish of final drug product from bulk drug substance procured under CLIN0018)

32,000

$15,360,000
(Funded)

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 = [***]

32,000

0022 (Option Funded)

Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0018).

32,000

[***] (Funded)

0023 (Option)

Surge Capacity – Additional procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS) *TC = 28 vials

32,000

$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 = [***]

32,000

0025 (Option)

Surge Capacity Fill/finish of final drug product (from bulk drug substance procured under CLIN0023)

32,000

$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: [***]

32,000

0027 (Option)

Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN0023).

32,000

Total (CLINs 0009A – 0027)

Total Contract Value

Total Funded