A02. J&A Redacted.pdf

MCMR-AAP-A

SUBJECT: USAMRAA Policy 16-08, Sole Source Justifications (SSJ) in accordance with FAR Subparts 13.106 or 13.5 using Simplified Acquisitions Procedures (SAP)

ENCLOSURE 1

Control No: JA-22-02-1106

Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 or 13.5 using

Simplified Acquisitions Procedures (SAP)

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S. Army

Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD, 21702.

2. Requiring Activity: U.S. Army Medical Research Institute of Chemical Defense

(USAMRICD), 8350 Ricketts Point Road, BLDG E2900, Aberdeen Proving Ground, MD 21010

3. Nature of Action:

D Commercial Item D Non-Commercial Item l}sl New Requirement D Follow-on Requirement

D Mod to Existing Purchase Order/Contract Number_

Pricing: irm-Fixed Price* D Time & Materials**

* See FAR 12.207(a)

** See FAR 12.207(b)

D Cost*

For Hybrid Contracts, list percentage of each type of pricing:

* Firm Fixed Price:

**Time & Materials:

* Cost:

Funds: RDT&E D Operations and Maintenance, Army (OMA)

D Other Funds: _

Fiscal Year of Funds: 2021

Estimated Total Dollar Value including Options:

4. Contractor Name:

Name of Proposed: Contractor(s): MIP Diagnostics

Street Address: The Exchange, Colworth Park, City, State, Zip: Shambrook, Bedfordshire. MK44 1LQ

Phone: +44(0)1234 589725

DUNS: 220738500

Cage Code: U1TK7

5. Description of Services:

Contract Year 1: Specificity, Optimization, Refinement, and Production of nanoMIP sensors targeted for detection of nor-fentanyl in biological samples or extracts at biologically relevant levels

Contract Year 2: Development of nanoMIP sensors capable of detecting nor-carfentanyl and remifentanil acid in biological samples or extracts at biologically relevant levels

6. Authority Cited: 41 U.S.C. 1901 OR O 41 U.S.C.1903

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

D (b) FAR 13.106-1(b)(1)(ii): Onlyonesourcecanprovideaportionofthe purchase that is a particular brand-name item; OR

D (c) FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name); OR

D (d) FAR 13.501(a)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited:

The USAMRICD has a requirement for the development of a novel electrochemical sensors based on molecular imprinted polymers (MIPs) technology, specifically nanoMIP-sensors, for the detection of norfentanyl, norcarfenanil, and remifentanil acid in biological samples, such as urine or blood/serum/plasma. Ultimately, the USAMRICD would like to integrate these novel sensors into the ChemDx platform to expand its current capability for the Warfighter. The ChemDx test system is currently in Advanced Development.

The USAMRICD has already developed early prototype nanoMIP sensors targeted for detection of norfentanyl via a collaboration with MIP Diagnonstics Inc (MIP-Dx) in FY20. This effort lead to the production of prototypes with the capability of detecting biologically relevant concentrations of nor• fentanyl in solvent (i.e., water, buffer). MIP-Dx holds all intellectual property to include rights and patents to the norfentanyl nanoMIP sensors. MIP-Dx utilized proprietary technology to develop tenable nanoMIP-based sensors unique to any other technology commercially available. The

USAMRICD requires further specificity assessment, optimization, and refinement of the nanoMIP sensors to allow detection of norfentanyl in biological matrices. The proprietary nature of the nanoMIP sensors combined with experimental continuity provides impetus for further development of sensors based on MIP-Dx's technology and expertise.

Detecting or sensing exposure to synthetic opioids (i.e., fentanyl) is critical to properly treating chemical exposures on the battlefield. Symptoms of exposure can be contraindicative as some symptoms can overlap with those associated with nerve agent exposure. The ChemDx device is designed to provide indication of exposure to chemical threats far-forward on the battlefield. A nanoMIP-sensor integrated into the ChemDx for detection of exposure to synthetic opioids would assist in the rapid assessment and decision matrix utilized by medics to determine courses of action with respect to the medical response. The rapid assessment would save lives and lower the burden on the medical system especially for a mass casualty event when every second counts and resources must be used at the utmost efficiency.

8. Efforts to obtain Competition:

Efforts were made in FY20/21 to find companies that offer a wide-range of services for the early development, prototyping, and production of MIP-based electrochemical sensors. Several companies (i.e., Affinisep, Biotage/MIP Technologies, Sigma-Aldrich, Ligar Polymers, and

Semorex) that develop MIP technologies were identified via Google searches; however, only MIP•

Dx was found to offer state-of-the-art prototyping and sensor production services in alignment with the requirements of the USAMRICD. These other companies were only found to develop MIPs for separation science purposes; applications targeted at analytical extractions or chromatographic purifications and did not offer MIP-based electrochemical sensor prototyping/development services.

Only MIP-Dx offered the potential to translate MIP-based sensors into the ChemDx platform using their proprietary MIP technology in tandem with nanoMIP-sensor production. Therefore, no other companies are suitable replacements for MIP-Dx in the continuation of this effort. The continuity of the previous FY20 effort with respect to prior R&D and time would be lost if another company was selected to continue the work. There is no guarantee another company could provide the already promising solution that MIP-Dx has demonstrated in a timely and relevant manner to accelerating to a product for the warfighter.

9. Actions to remove or overcome barriers Competition: None.

10. Market Survey:

Market research was conducted by the USAMRICD through the World Wide Web (WWW). Six companies were found to have products related to MIP technology. The following websites were surveyed as they claimed to utilize MIP technologies in their products: www.affinisep.com/, www.biotage.com/, www.sigmaaldrich.com/US/en/technical-documents/technical-article/analytical• chemistry/solid-phase-extraction/supelmi,phttps://ligar.nz/, and www.semorex.com. Only a sole company, MIP-Dx (www.mip-dx.com), offered prototyping services for developing actual MIP-based sensors that could be translated to the ChemDx test system currently in Advanced Development.

11. Interested Sources:

MIP Diagnostics is the sole provider for this prototyping service.

12. Procurement History and any other facts:

a) Procurement History- The USAMRICD procured prototype sensors from MIP-Dx during a feasibility effort conducted in FY20 under the DTRA JSTO CB10687 project. These prototypes demonstrated high specificity for the target biomarker, nor-fentanyl, utilizing proprietary technology developed by MIP-Dx; however, it was evident that more optimizations were needed to allow tenable detection in biological matrices and for integration into the ChemDx test system.

b) Acquisition Data Availability - Work statements suitable for full and open competition are not available for this acquisition.

c) Unusual and compelling urgency- Not Applicable.

d) Subcontracting Competition - Not applicable.

13. Technical/ Requirements Certification:

I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief.

Date: 2021.11.09 08:54:43 -05'00' . 8 8 . Submitted by Signature: S http://www.affinisep.com/ http://www.biotage.com/ http://www.biotage.com/ http://www.semorex.com/

Erin Maddox 02072022

02072022 y

D

- 0' 2

Approval

(Use this signature block for the Special Advocate for Competition Approval)

[The approval statement is drafted on a separate page from the certifications and tailored to the instant contract action]

Based on the foregoing justification, I hereby approve the procurement of (state equipment/services being procured) on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 or 41 U.S.C. 1903, as implemented by FAR subpart

13.106-1(b)(1) or FAR 13.501(a)(1)(ii), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Date: Signature: