EX-10.6 7 ex_703019.htm EXHIBIT 10.6 ex_703019.htm

Exhibit 10.6

 

CERTAIN INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY "[***]," HAS BEEN OMITTED BECAUSE IT IS BOTH (1) 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 9

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

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 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.

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: 13-3864870

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)

 

 

(Signature of Contracting Officer)      

 

 

 

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED

HHSO100201800019C/P00016

 

PAGE OF
   

 

 

2 9

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

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 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

[***]

 

 

Section G Contract Administration

 

ARTICLE G.1. CONTRACTING OFFICER

 

The following Contracting Officer (CO) will represent the Government for the purpose of this contract:

 

Audrey A. Glover

Contracting Officer

U.S. Department of Health and Human Services

Administration of Strategic Preparedness and Response

Biomedical Research and Development Authority (BARDA)

Contract Management and Acquisition (CMA)

Washington, DC 20515

Email: Audrey.Glover@hhs.gov

 

The Contracting Officer is the only individual who can legally commit and bind the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions or other stipulations of this contract. Any other commitment, either explicit or implied, is invalid.

 

The CO is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of objectives; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) obligate or de-obligate funds into the contract; (6) sign written licensing agreements; or (7) otherwise change any terms and conditions of this contract.

 

No information, other than that which may be contained in an authorized modification to this contract duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

 

The Government may unilaterally change its CO designation.

 

All other terms and conditions of this contract remain unchanged and in full force and effect.

 

END OF MODIFICATION P00016 to HHSO100201800019C