JA ARRK AmalgamSeparator_TC_ACO.doc_rev. (4).pdf

NAVAL MEDICAL RESEARCH UNIT SAN ANTONIO

FY ‘25 Page 1

JUSTIFICATION & APPROVAL FOR USE OF OTHER THAN FULL & OPEN COMPETITION

1. Identification of the agency and the contracting activity, and specific identification of the document as a “Justification for other than full and open competition.”

This Justification and Approval (J&A) is executed by the Naval Medical Research Command (NMRC), 503 Robert Grant Avenue, Silver Spring, MD 20910, on behalf of the requesting agency, Naval Medical Research Unit San Antonio (NAMRU-SA), 3650 Chambers Pass, Building 3610, JBSA Fort Sam Houston, TX 78234.

2. Nature and/or description of the action being approved.

Award of a contract on a sole source basis will be made to ARRK North America Inc. for a one-time purchase of injection molding products based on NAMRU-SA’s propriety novel amalgam separator design (25 units of each component). The proposed source is:

ARRK North America Inc.

Attn: Ivania Silva 4660 La Jolla Village Drive, Suite 100 & 200, San Diego, CA 92122 Tel: 858-552-1587 Email: isilva@arrk.com

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

The approval is for a sole source fixed price purchase of injection molding prototypes produced by ARRK, holder of an NDA with NAMRU-SA for the protection of the proprietary design for a novel amalgam separator (Navy Case 212,263; U.S. Provisional Patent Application Serial No. 63/704,271 filed October 7, 2024). This agreement includes the custom tooling and production costs for all 6 components of the amalgam separator with 25 units of each component. This service is required to progress the development and commercialization of NAMRU-SA’s novel amalgam separator for implementation into currently operated military dental treatment facilities. Due to the sensitivity of the amalgam separator design, this work must be completed by an entity covered under an NDA such as ARRK North America Inc. Additionally, this work requires customized tooling methods for injection molding based on the amalgam separator design which cannot be completed by any other group without needlessly exposing proprietary information and threatening full patentability.

Estimated Dollar Value

The estimated value of this purchase order is $XXXX for the one-time purchase of tooling and component production.

mailto:isilva@arrk.com

FY ‘25 Page 2

4. An identification of the statutory authority 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) as implemented by FAR 13.106-1; only one responsible source and no other supplies or services will satisfy agency requirements.

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

NAMRU-SA’s novel amalgam separator design is currently protected by a provisional patent (Navy Case 212,263; U.S. Provisional Patent Application Serial No. 63/704,271 filed October 7, 2024) that is expected to mature into a full patent by the end of 2025. However, until full patent maturation, the novel design must be fully protected during prototype production by an NDA. ARRK North America Inc. has satisfied the NDA requirements and established customized tooling designs specific to the novel amalgam separator.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

ARRK North America Inc. has an established NDA with NAMRU-SA and is the only service provider with this agreement for the protection and production of the proprietary amalgam separator design. Additionally, ARRK provides the required ability to export the injection molding tooling to the intended commercialization partner, DDSHgSolutions (NDA active).

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

The Contracting Officer will perform a cost and price analysis to determine that the anticipated quotes received by the Government for the services cover by this J&A will be within fair market value and reasonable. Fair and reasonable pricing has been determined by researching FPDS-NG for the same or similar items. As such, the market research showed that no other vendor can provide the production services required.

8. A description of the market research conducted (see Part 10) and the results or a statement of the reason market research was not conducted.

Market research was conducted by technical experts in January 2024. This research consisted of market survey through previously utilized injection molding companies and search engines of open market contractors. Search engines utilized include Google, using the following search words: Small-scale Injection Molding, Customized Injection Molding Prototyping, Exportable Injection Molding Design.

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

Due to the sensitivity of the amalgam separator design, this work must be completed by an entity covered under an NDA such as ARRK North America Inc. Additionally, this work requires customized tooling methods for injection molding based on the amalgam separator design which cannot be completed by any other group without needlessly exposing proprietary information and threatening full patentability.

FY ‘25 Page 3

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

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

11. A statement of the 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.

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.

mailto:usn.detrick.nmrc.mbx.mmd-contracts@health.mil

FY ‘25 Page 4

I certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein, are complete and accurate to the best of my knowledge and belief.

Technical Cognizance

9 May 2025

Todd A. Collins, DVM, MPH, DACLAM, DACVPM Date Interim Director, Craniofacial Health and Restorative Medicine Naval Medical Research Unit San Antonio

Requirements Cognizance

12 May 2025

CDR Nicholas J. Hamlin Date Commanding Officer, Acting Naval Medical Research Unit San Antonio

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have determined this Justification is legally sufficient.

Office of Counsel Date

CONTRACTING OFFICERS CERTIFICATION

I certify that this Justification is accurate and complete to the best of my knowledge and belief. The Contracting Officer’s signature below also represents approval of the J&A.

June 9, 2025

Contracting Officer Date Naval Medical Research Command

SHARPE.DEBORA

H.M.1232127429

Digitally signed by

SHARPE.DEBORAH.M.1232127429

Date: 2025.06.09 10:37:28 -04'00'

COLLINS.TODD.ALA Digitally signed by

N.1136036048 COLLINS.TODD.ALAN.1136036048

Date: 2025.05.09 15:18:52 -05'00'

HAMLIN.NICHOLAS. HAMLIN.NICHOLAS.JAMES.12836

Digitally signed by

JAMES.1283653362 53362

Date: 2025.05.12 09:13:55 -05'00'