6_PR 1301258977 J_n_A.pdf

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Research Command (NMRC), Silver Spring, MD, on behalf of the Navy to meet Navy Expeditionary Medical Research requirements.

2. Nature and/or description of the action.

The need is for continued service maintenance. This equipment is manufactured and serviced by Life Technologies Corporation. The Government intends on awarding a Firm Fixed Price contract.

The proposed source is Life Technologies Corporation, 5781 Van Allen Way, Carlsbad, CA 92008.

3. Description of Supplies or Services:

The Molecular Diagnostics Department of the Biological Defense Research Directorate, Naval Medical Research Command produces reagents for biological defense applications. These reagents are employed by a variety of Navy, Department of Defense, and other US Government agencies for the detection and identification of biological warfare agents. The development process for the production of these reagents included extensive testing of the reagent components to produce the best combination. For testing the Naval Medical Research Center (Biological Defense Research Directorate) requires a service agreement be in place for the Applied Biosystems/ Life Technologies Real Time PCR Instrument Platform to cover repairs and service throughout FY25.

RDT&E funds in the amount of $XXXXwill be used to procure the service agreement.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c)(1) and FAR 6.302-1 sole source (including brand name) acquisitions or FAR 13.106-1(b)(1) soliciting from a single source.

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

Biological Defense Research Directorate has been engaged by the DoD to perform specific tasks that employ the Applied Biosystems/Life Technologies Real Time PCR Instrument Platform. The instrument is highly specialized, and the company is the only entity that can provide service and repair to the platform. Any service or repairs by another company may damage or incapacitate the instrument and would invalidate any warranties. Switching to another vendor would invalidate all previous optimization and evaluation efforts. Reagents produced with these components from another vendor without extensive re-optimization and evaluation would result in reduced and scientifically questionable performance of the reagents. This is unacceptable to the agencies that employ the current reagents in ongoing operations

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Life Technologies is the OEM of the equipment and therefore, the service agreement must be with Life Technologies. This purchase requirement will be posted to NECO and/or FedBizOpps in accordance with FAR 5.202.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the Life Technologies Corporation commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

See accompanying Market Research Memorandum.

9. Other facts supporting the use of other than full and open competition.

As above, the only acceptable vendor for service maintenance is Life Technologies/Invitrogen.

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

For the reasons set forth in Paragraph 5, NMRC has no plans at this time to compete future contacts for the reagent components covered by this document. If another potential source emerges, NMRC will assess whether competition for future requirements is feasible.

12. Point of Contact:

The point of contact at the Naval Medical Research Command, Silver Spring, MD, regarding the contents of the sole source justification are the Contracting Officers in the Material Management Department (MMD) and can be reached by emailing usn.detrick.nmrc.mbx.mmd-contracts@health.mil.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance

Name: LCDR Stephen Lizewski Phone Date Title: Department Head, Molecular Diagnostics Department/Command: BDRD/NMRC

Requirements Cognizance

LIZEWSKI.STEPHEN.EU

GENE.1272396309

Digitally signed by

LIZEWSKI.STEPHEN.EUGENE.1272396309

Date: 2025.05.07 10:30:48 -04'00'

301-619-1507 07MAY2025

Name: LCDR Stephen Lizewski Phone Date Title: Department Head, Molecular Diagnostics Department/Command: BDRD/ NMRC

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

301-319-9948 08 Aug 2025

Contracting Officer Phone Date

LIZEWSKI.STEPHEN.E Digitally signed by

UGENE.1272396309

LIZEWSKI.STEPHEN.EUGENE.12723963

Date: 2025.05.07 10:30:08 -04'00' 301-619-1507 07MAY2025 mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil