A02-Redacted JA-PendoTech_Sensor_Data_Acquisition_ System.pdf

Control No: JA-23-06-1346

Version – February 2017

Memorandum for Record – Limiting Competition at or below the Simplified

Acquisition Threshold

1. Contracting Activity: The Contracting Activity responsible for this action is the US Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD acting on behalf of the Walter Reed Army Institute Research.

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Contract Vehicle: Purchase Order Number (PR 11937789) Blanket Purchase Agreement (BPA) Number Order/BPA# against FSS Contract # Order # against Multiple Award IDIQ Contract Name or # Order # against a single award IDC Contract

Modification # to existing PO/TO/DO/Call Order

Pricing/Contract Type:

Cost Reimbursable

Fixed Price Hybrid

Time & Materials/Labor Hours

Funds: Operations & Maintenance, Army (OMA) Other Funds: Research Development, Technology & Engineering (RDT&E)

FY: 2023

Name of Proposed Contractor(s) and Address:

Mayfair Technology LLC, DBA PendoTECH LLC

3490 US-1, Princeton, NJ 08540

Brand Name Buy: Yes No

3. Description of Services or Supplies: The equipment will capture chromatography data and allow us to save chromatograms with critical parameters that are key for good manufacturing practices (GMP) productions and for historical purposes for use with existing Pilot Bioproduction Facility (PBF) -owned PendoTECH equipment.

Period of Performance: 01 August 2023 – 31 October 2023 (09 October 2023 Delivery date)

Total Value: 44,602.02

4. Authority:

FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

Or

FAR 8.405-6(a)(1)(i)(B) and 8.405-6(b)(1)Brand Name FAR 8.405-6(a)(1)(i)(A) Urgency FAR 8.405-6(a)(1)(i)(B) Only One Source is Capable FAR 8.405-6(a)(1)(i)(C) Logical Follow-on

Or

FAR 16.505(b)(2)(i)(B) Only One Awardee is Capable FAR 16.505(a)(4) Brand Name FAR 16.505(b)(2)(i)(A) Urgency FAR 16.505(b)(2)(i)(C) Logical Follow-on FAR 16.505(b)(2)(i)(D) Minimum Guarantee

5. Reasons for Authority Cited:

Presently, the current in-line spectrophotometer for chromatography operations does not have a disposable flow cell and needs to be cleaned and sanitized between uses.

Proving that no carry over from prior operations can be labor intensive. The desire is to be able to assure our customers that our equipment has had no prior contact with other products is very important. Not having the disposable flow cell capability will make it hard to provide the necessary documentation to assure our clients that no prior product contamination is present. Also, having the capability to capture and save data is important for historical purposes.

The Pilot Bioproduction Facility performed an analysis of alternatives and determined that the PendoTech Sensor Data Acquisition System is the only unit that will meet the minimal essential characteristics required to support operations. The equipment needed is proprietary to equipment already acquired by, and currently utilized by the Pilot Bioproduction Facility, thus requesting purchase of a PendoTech instrument to support the capture of chromatography data and to save chromatograms with critical parameters that are key for GMP productions and for historical purposes.

PendoTech is a trademark of Mayfair Technology LLC and is the manufacturer of the PendoTech Sensor Data Acquisition System. Based on Market Research, Mayfair/PendoTECH is the only vendor identified that is able to provide the required instrument.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 do not apply due to the $ threshold, apply and will be followed, or do not apply due to an exception at 5.202

Requirement to post justification in accordance with FAR 8.405-6(b)(3), FAR 13.105(c), or FAR 16.505(a)(4)(iii)(A)

Action is NOT a brand name restriction and is under $150K, no posting required Action is a brand name restriction, under $25K, no posting required Action is a brand name restriction, over $25K. It will be redacted and posted with the solicitation.

Action is a brand name restriction over $25K but will not be posted due to exception:

FAR 6.305(f) FAR 8.405-6(b)(3)(iii)(A) FAR 8.405-6(b)(3)(iii)(B) FAR 8.405-6(b)(3)(iii)(C) FAR 16.505(a)(4)(iii(C)

7. Market Research: Market research was conducted by Contracting Officer Representative (COR) on 6 April 2023 through internet searches to identify all qualified sources. The market research concluded that Pendo Tech, LLC is the only vendor that can provide the required services.

A request for information was posted to SAM.gov by the Contracting Office on 24 May 2023 for 7 days and no response was received from the industry.

A Notice of Intent to sole source was posted to SAM.gov by the Contracting Office on 2 June 2023 with a due date of 16 June 2023 and no response was received from the industry.

Based on market research, only one source, Pendo Tech, LLC is capable providing the instrument to support GMP productions and services

8. Other Facts: This is a new requirement with no procurement history associated with the equipment.

SCOTT.AALIYA

9. Technical/Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name: Aaliyah L. Scott Date: 29 APRIL 2023 Title: COR/Administrative Officer Signature: Digitally signed by

SCOTT.AALIYAH.L.1594059804

H.L.1594059804 Date: 2023.06.29 17:04:04 -04'00'

10. Contracting Officer Certification/Approval:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon price analysis.

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government. Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Typed Name: Jennifer E. Hayden Date: 11 July 2023 Title: Contracting Officer Signature: Digitally signed by

HAYDEN.JENNIFER.ELAINE.12913

LAINE.1291393477 93477

Date: 2023.07.11 16:21:11 -04'00'

HAYDEN.JENNIFER.E