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)
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
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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
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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 | ||||||||||||||||||||||||||||
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.
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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).
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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)
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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. | SUPPLIES/SERVICES (B) | QUANTITY | UNIT | UNIT PRICE | AMOUNT | |
OTA: N Discount Terms: HHS NET 30P Period of Performance: 01/01/2020 to 09/09/2028
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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 |
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| [***] | [***] | [***] |
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 |
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| [***] |
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 |
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| [***] | [***] | [***] |
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 | [***] |