JA Sole Source __Redacted_8.23.2024.pdf

CUI

Control Number: JA-24-05-1555

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

5. Reason for Authority Cited: Market research examined if there are other sources capable of providing the required IFNAR-1 MA1-5A3 mAb. It was determined that although there are multiple vendors in the market capable of providing similar antibody products, the similar products are not validated for in vivo use. Further, the particular lot capable of providing consistent lethality in USAMRIID’s CCHFV mouse models is not available from vendors other than Leinco Technologies. The IFNAR-1 MA1-5A3 mAbs manufactured by Leinco Technologies are the only mAb’s capable of providing transient immunosuppression in mice allowing for CCHFV disease. Further, Leinco Technologies does not have any authorized resellers. Therefore, Leinco Technologies is determined to be the only vendor capable of providing mAb’s meeting the government's minimum essential characteristics.

6. Efforts to Obtain Competition: In accordance with FAR 5.2 – Synopses of Proposed Contract Actions, a Notice of Intent (NOI) to award a sole source contract will be published on the www.sam.gov website for 15 days. All capability statements received in response to the NOI to Sole Source, by the due date specified, will be considered by the Government solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract.

7. Actions to Increase Competition: USAMRIID and USAMRAA will periodically conduct future market research and analysis to determine if other potential sources emerge that are capable of providing the required head impact/acceleration monitoring capability in a mouthguard form factor. Additionally, all future requirements will be synopsized in accordance with FAR 5.201 and if other potential sources do emerge, USAMRAA will assess whether competition for future requirements is feasible.

8. Market Research: Market research conducted in accordance with FAR Part 10 was multifaceted and was undertaken to ascertain 1) if the requirement meets the FAR definition of a Commercial Product, 2) if two or more small businesses exist that can meet the government's requirements, and 3) if there is more than one source capable of meeting the government's requirement.

Market research examined if the required materiel met the FAR definition of a commercial product, which is a product, other than real property, that is of a type customarily used by the general public or by nongovernmental entities for purposes other than governmental purposes and (i) has been sold, leased, or licensed to the general public; or (ii) has been offered for sale, lease, or license to the general public.

Market research determined that the required materiel does meet the definition and is commercially available; thus, standard commercial terms and conditions will apply.

Market research conducted in accordance with FAR Part 10 does not support that a minimum of two or more capable small business could potentially satisfy this requirement. Therefore, this requirement is not appropriate for a small business set-aside. However, it is noted that Leinco Technologies is registered as a small business.

CUI

Control Number: JA-24-05-1555

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

OCT 2023

Lastly, market research examined if there are other sources capable of providing the required IFNAR-1 MA1-5A3 mAb. It was determined that although there are multiple vendors in the market capable of providing similar antibody products, the similar roducts are not validated for in vivo use. Further, the particular lot capable of providing consistent lethality in USAMRIID’s CCHFV mouse models is not available from vendors other than Leinco Technologies. The IFNAR-1 MA1-5A3 mAbs manufactured by Leinco Technologies are the only mAb’s capable of providing transient immunosuppression in mice allowing for CCHFV disease. Further, Leinco Technologies does not have any authorized resellers. Therefore, Leinco Technologies is determined to be the only vendor capable of providing mAb’s meeting the government's minimum essential characteristics.

9. Interested Sources: The synopsis required by FAR 5.201 will be posted on the System for Award Management (SAM) website as this requirement meets the threshold stipulated in FAR 5.101(a)(1). Any written inquiries, bids or proposals received shall be considered.

10. Other Facts:

a. Procurement history: Approximately 2000mg have been purchased via government purchase card over the course of four separate orders totaling in 2023/2024 to the Virology Division.

b. Other facts: N/A