Amendment of Solicitation/Modification of Contract 00014, dated October 18, 2023, 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 (portions of this exhibit have been omitted pursuant to Item 601(b)(2)(ii) or 601(b)(10)(iv) of Regulation S-K, as applicable)

EX-10.MMM 2 ex_598879.htm EXHIBIT 10.MMM ex_598879.htm

Exhibit 10(mmm)

 

CERTAIN 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         |         6

2. AMENDMENT/MODIFICATION NO.

P00014

3. EFFECTIVE DATE

10/17/2023

 

4. REQUISITION/PURCHASE REQ. NO.   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

 

 

 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

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 ###-###-####

UEI: VJRNRTSL22K4

The purpose of this modification is to correct the total value of CLIN0014 from [***] to [***], change Option CLINs 0023, 0024, 0025, 0026, and 0027 from Treatment Course (TC) to Vials, CLIN0007 total value should read $14,612,790 versus $40,812,609, add travel under Contracting Officer Authorizations shall not exceed $150,000, and the overall funded value of the contract is [***] versus [***].

 

All other terms and conditions remain unchanged.

 

 

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

 

15C. DATE SIGNED

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

/s/ Dennis Hruby                                 

(Signature of person authorized to sign)

October 18, 2023

/s/ Jonathan F. Gonzalez                  

 (Signature of Contracting Officer)

October 18, 2023

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/P00014

PAGE OF

2         |         6

NAME OF OFFEROR OR CONTRACTOR

SIGA TECHNOLOGIES, INC. 1385150

ITEM NO.
(A)

SUPPLIES/SERVICES
(B)

QUANTITY
(C)

UNIT
(D)

UNIT PRICE
(E)

AMOUNT
(F)

 

 

 

OTA: N

Discount Terms: HHS NET 30P

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

       

NSN 7540-01-152-8067

     

OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

 

ARTICLE B. 2. PRICE/COSTS, revisions are highlighted in yellow:
B.2. PRICES/COSTS

 

B.2.1. ESTIMATED COST AND FIXED FEE

 

 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

 

 

[***]

[***]

[***]

 

B.2.2. FIRM FIXED PRICE

 

 Base Period Fixed Price CLINS

 Item

 Period of Performance

 Supplies/Services

Treatment Courses

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 CLIN 0003)

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 per TC = [***]

10,000

[***] [***]

 0006 Base

 [***]

Delivery of FDP to the SNS/USG designated location (from bulk drug substance procured under CLIN 0003 and Process Validation lot manufactured under CLIN 0001)

10,000

[***] [***]

 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 (nonparenteral (oral) formulation )) including [***]

[***]

[***]

$14,612,790 Funded

 0008 (Option)

 [***]

Phase IV post marketing commitments (parenteral (IV) formulation)) including [***]

[***] [***]

$3,586,806 Funded

 Total

 

 

[***]

[***]

[***]

 

 Optional Fixed Price CLINs

 Item

 Period of Performance

 Supplies/Services

Treatment Courses

Unit Price

Total

 0009A (Option)

 [***]

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)

 [***]

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

121,023 (raw material)

[***]

$33,765,417 Funded

 0009C (Option)

 [***]

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

121,023 (raw material)

[***]

$33,765,417 Funded

 0009D (Option)

 [***]

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

121,024 (raw material)

[***]

$33,765,696 Funded

 0010 (Option)

 [***]

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

363,070

[***]

$112,551,700 Funded

 0011 (Option)

 [***]

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

363,070

[***]

$112,551,700 (Funded)

 0012 (Option)

 [***]

Additional procurement of a nonparenteral (oral) formulated antiviral as FDP & 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) *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 CLIN 0013). *Monthly rate per TC = [***]

32,000

[***] [***]

 0015 (Option)

 [***]

Surge Capacity – Fill/finish of final drug product (from bulk drug substance procured under CLIN 0013)

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 CLIN 0013). *Monthly rate per TC = [***]

32,000

[***] [***]

 0017 (Option)

 [***]

Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN 0013)

32,000

[***] [***]

 0018 (Option)

 [***]

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 CLIN 0018). *Monthly rate per TC = [***]

32,000

[***] [***]

 0020 (Option)

 [***]

Surge Capacity – Fill/finish of final drug product from bulk drug substance procured under CLIN 0018).

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 CLIN 0018). *Monthly rate per TC = [***]

32,000

[***] [***]

 0022 (Option)

 [***]

Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN 0018).

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 CLIN 0023). *Monthly rate per TC = [***]

32,000

[***] [***]

 0025 (Option)

 [***]

Surge Capacity – Fill/finish of final drug product (from bulk drug substance procured under CLIN 0023).

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 CLIN 0023). *Monthly rate per TC = [***]

32,000

[***] [***]

 0027 (Option) 

 [***]

Surge Capacity – Delivery of FDP to the SNS (from bulk drug substance procured under CLIN 0023).

32,000

[***] [***]

Total Contract Value Including All Options 

[***]

Total Funded Options 

[***]