25-MRCO-P-268 Cerus Blood Bags REDACTED.pdf

CUI//SP-PROCURE

25-MRCO-P-268

JUNE 2025

5. Authority Cited: Title 41 U.S.C. §1901(e)(2) as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

6. Reason for Authority Cited:

a. Background: The Cerus INTERCEPT Platelet Pathogen Reduction Sets uses a chemical agent (amotosalen) that is activated by ultraviolet A (UVA) light to bind nucleic acids so that DNA cannot replicate and thus the cell cannot replicate. Used together with the government-owned Cerus Illuminator, this Intercept Platelet Pathogen Blood System provides a proactive, FDA-approved approach to significantly reduce the risk of transfusion-transmitted infection (TTI) in platelets, including sepsis and transfusion-associated graft-versus-host disease caused by bacterial contamination.

Further, per FDA guidance dated Dec 2020, platelets treated by FDA approved pathogen reduction devices according to device instructions for use need no further measures to control the risk of bacterial contamination of platelets. This ensures safety and availability of platelets for transfusion to recipients. The Cerus Corporation�s INTERCEPT Platelet Pathogen Reduction Set is the only United States (US) FDA approved device/kit in the US to conduct platelet pathogen reduction and the only authorized platelet sets for use with the Cerus INTERCEPT Illuminator. Additionally, Cerus Corporation confirmed that they are the manufacturer and exclusive provider of their INTERCEPT supplies and services in the US. Therefore, Cerus Corporation is the only source that can meet the government�s needs.

1) This is not a justification for a follow-on contract for the continued development or production of a major system, highly specialized equipment, or major components thereof.

2) This is not justification for a brand name or brand name equivalent requirement.

b. Alternatives: There are no acceptable alternatives to approving this justification and contracting without providing for full and open competition. There are no other FDA approved platelet pathogen reduction sets in the US available to meet the Government�s requirement and Cerus Corporation is the only source of these sets, as such the requirement is not available for competition. The current contract will expire on 30 September 2025 and does not have any available extensions remaining.

c. Impact if not approved: If this justification is not approved, the TAMC Blood Donor could shut down and patient safety and soldier readiness would be adversely affected.

25-MRCO-P-268

CUI//SP-PROCURE

JUNE 2025

7. Efforts to Obtain Competition:

a. Effective competition: All INTERCEPT supplies and services are proprietary to Cerus Corporation and not shared with any third-party vendors, therefore, effective competition cannot be obtained for this effort. However, the Contracting Officer will publish the notices required by FAR 5.201 and any quotes received shall be considered.

b. Subcontracting competition: Not applicable in accordance with FAR 19.702(a)(1)(i) as this requirement is less than $750,000.

8. Actions to Increase Competition: The previous contract, W81K02-21-P-0132, was justified as a sole source procurement per FAR 13.106-1(b)(1). The justification for this previous contract did not include a description of efforts to increase competition.

However, the requiring activity conducted ongoing market research to determine if alternative sources were available in the local market to meet the Government�s requirements. None were identified since Cerus Corporation is the exclusive distributor and service provider for all INTERCEPT products and services in the US. Based on these results, it is not possible to compete the current acquisition. Nevertheless, the Government will continue to survey the market to determine if new entrants become available in the future.

9. Market Research: The requiring activity and contract specialist conducted market research within the last 12 months by conducting internet searches and contacting knowledgeable people (government and industry) regarding this requirement. The research has shown that this service is commercial in nature and is provided to private, public and government medical institutions. In addition, Cerus Corporation confirmed that they are the only supplier of INTERCEPT for use in the US as they have not authorized any distributor or third party to sell, distribute or commercialize INTERCEPT to customers in the US. They also confirmed that the pathogen reduction platelet sets from Cerus Corporation are the only authorized sets for use with the Cerus INTERCEPT Illuminator. A sources sought notice was posted on SAM.gov on 6 June 2025 inviting all responsible sources to submit a capability statement before the closing date of 10 June 2025. One (1) company responded to the notice -- BHPE LLC (BHPE). After review of BHPE�s capabilities statement on their website, the requiring activity determined that BHPE cannot meet the government�s needs since the products and services they provide do not pertain to medical supplies that align with the FDA for pathogen reduction.

10. Interested Sources: To date, no other sources have written to express interest.

11. Other Facts:

a. Procurement history � paragraphs a.1) through a.3) are provided in the table below.