B08-JA Sole Source FAR Part 13.5 (APR 2021)_KO FINAL-redacted.pdf

Control Number: 21-04-00283 CUI

CUI

(Source Selection information - See FAR 2.101 and 3.104-4)

APR 2021

Sole Source Justification and Approval Review Document Under FAR 13.501*

(*Format follows FAR 6.303-2, but modified to reflect FAR subpart 13.5 procedures)

Program/Equipment: Brand Name Artesunate for Injection

Authority: 41 U.S.C.1901 as implemented in FAR 13.501(a)(1)(i)

Amount: The estimated total cost is $395,200

Prepared by:

Ireneusz A. Jozwiak DSN: 343-9276 Contract Specialist Date: 04/07/2022 Email: ireneusz.a.jozwiak.civ@mail.mil

Contracting Officer:

Ayi J. Ayayi DSN: 343-4018 Contract Officer Date Reviewed: 14 MAY 2021 Email: ayi.j.ayayi.civ@mail.mil

Technical Representative:

Gail Wolcott DSN: 343-7239 Product Manager Date Reviewed:

Requirements Representative:

Alan Harner DSN: 343-7860 Product Manager Date Reviewed:

mailto:ireneusz.a.jozwiak.civ@mail.mil mailto:ayi.j.ayayi.civ@mail.mil

Artesunate for Injection to be shipped to various military treatment facilities (MTF)

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(Source Selection information - See FAR 2.101 and 3.104-4)

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: The Contracting Office is the U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702

2. Description of Action: U.S. Army Medical Materiel Development Agency (USAMMDA) requests a new Firm-Fixed Price (FFP) contract. 1-Year Defense Health Program (O&M) – Operation & Maintenance type funds will be used.

3. Description of Supplies/Services: Purchase of 104 vials (equal to 13 TED’s) of Artesunate for Injection and pre-position the drug at key OCONUS Military Treatment Facilities and activities worldwide to ensure timely availability. Contractor shall provide storage, shipping, and labeling. The estimated total cost is $395,200.

4. Authority Cited: 41 U.S.C.1901 as implemented in FAR 13.501(a)(1)(i)

5. Reason for Authority Cited: The USAMMDA-WPAC Project Management Office requires brand name Artesunate for Injection in order to pre-position the drug at key OCONUS Military Treatment Facilities and activities worldwide to ensure timely availability. Brand name Artesunate for Injection is the only Food and Drug Administration (FDA) approved drug for the treatment of severe malaria. Prior to this approval, there had been no FDA-approved drug for treatment of severe malaria in the U.S since the marketing of quindine was discontinued by the manufacturer in March 2019. The FDA has granted Amivas, LLC exclusivity for U.S. marketing of Artesunate for Injection. Amivas, LLC is using Cardinal Specialty, AmerisourceBergen and McKesson as their Prime Vendors. No other vendor can develop and market this product until Amivas’ exclusivity period of seven years ends on September 30, 2026.

See Tentative Approval NDA 213170 and NDA approval NDA 213036 in PCF.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201 and any bids or proposals received shall be considered.

7. Actions to Increase Competition: Amivas, LLC and their Prime Vendor distributors are the only source capable of providing the required drug. Amivas, LLC has the exclusive rights to manufacture and market brand name Artesunate for Injection. The Contracting Officer shall publish the notices required by FAR 5.201 for thirty (30) days, and any bids or proposals received shall be considered.

8. Market Research: Market analysis was conducted in December 2020 to identify a U.S. Food and Drug Administration (FDA) approved Artesunate for Injection and only

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(Source Selection information - See FAR 2.101 and 3.104-4) one (1) pharmaceutical company for the requirement was located. Artesunate for Injection is the only U.S. Food and Drug Administration (FDA) approved treatment medication for severe malaria. FDA approval was obtained 26 May 2020. See additional Market Research documentation in the PCF file.

9. Interested Sources: In accordance with Federal Acquisition Regulation (FAR) 5.201, Sources Sought (SS) / Request for Information (RFI) W81XWH-21-IJ-43021 was posted on 30 April 2021 to beta.sam.gov, with responses due by 12 May 2021. The only one response received, was from Amivas, LLC. Amivas, LLC and its prime vendors are the only sources that can provide the required brand name Artesunate for Injection.

Interested sources purporting to have the ability to provide the required brand name Artesunate for Injection will be considered for award.

10. Other Facts:

a. Procurement history. N/A

b. Other facts. N/A

11. Technical Certification: I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

ADAMS.RYAN.C.1366544 Digitally signed by

212 ADAMS.RYAN.C.1366544212 Date: 2021.05.14 11:25:02 -04'00'

Signature: Date:

Typed Name: Ryan C. Adams Title: Contracting Officer’s Representative

12. Requirements Certification: I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

ADAMS.RYAN.C.136 Digitally signed by ADAMS.RYAN.C.1366544212

Signature: 6544212 Date: 2021.05.14 11:25:25 -04'00' Date:

Typed Name: Ryan C. Adams Title: Contracting Officer’s Representative

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable based on price analysis.

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(Source Selection information - See FAR 2.101 and 3.104-4)

AYAYI.AYI.JODZRO.1257645505

Signature:

Digitally signed by AYAYI.AYI.JODZRO.1257645505 DaDte:a2t0e21:.05.18 09:24:44 -04'00'

Typed Name: Ayi J. Ayayi Title: Contracting Officer

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Digitally signed by AYAYI.AYI.JODZRO.1257645505 Signature: DaDte:a2t0e21:.05.18 09:25:06 -04'00'

Typed Name: Ayi J. Ayayi Title: Contracting Officer

AYAYI.AYI.JODZRO.1257645505