Amendment No. P00018 to Contract HHSO100201800019C between ASPR-BARDA and SIGA Technologies, Inc.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

2. AMENDMENT/MODIFICATION NO.

P00018

3. EFFECTIVE DATE

See Block 16C

4. REQUISITION/PURCHASE REQ. NO.

ASP340063

6. ISSUED BY

CODE  

ASPR-BARDA

7. ADMINISTERED BY (If other than Item 6)

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

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)

2025.Q99BS25.25106

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).

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 provide supplemental funding to CLIN0001 for the technical transfer of Intravenous Tecovirimat to a new Contract Development and Manufacturing Organization (CDMO), update Section B - Supplies or Services and Prices/Costs, Article B.2 Base Period, and update Section J - List of Attachments, Attachment 2, Statement of Work dated October 29, 2024. The total obligated amount is increased by $14,324,736 to [***] from [***].

All other terms and conditions remain unchanged.

OTA: N

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)

AUDREY A. GLOVER

15B. CONTRACTOR/OFFEROR

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED

HHSO100201800019C/P00018

PAGE         OF

2

11

NAME OF OFFEROR OR CONTRACTOR

SIGA TECHNOLOGIES, INC. 1385150

ITEM NO.

(A)

SUPPLIES/SERVICES

(B)

QUANTITY

(C)

UNIT

(D)

UNIT PRICE

(E)

AMOUNT

(F)

Discount Terms: HHS NET 30P

Appr. Yr.: 2025 CAN: Q99BS25 Object Class: 25106

Period of Performance: 01/01/2020 to 09/08/2028

Add Item 21 as follows:

21

ASPR-25-00789 Base CLIN0001

Additional funding to base periods to support tech transfer of their IV manufacturing to a new CDMO

Period of Performance: 9/9/2024-9/8/2028

Obligated Amount: $14,324,736.00

14,324,736.00

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

[***]

[***]

[***]

Total

(CLIN0001)

[***]

[***]

[***]

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 [***] 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 = [***] 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 = [***] 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
(Funded
Option)

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

[***]