D03 LSJ_HT942524F0275_Redacted.pdf

Control Number: JA-24-05-1540

Limited Source Justification - FAR Part 8

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

Army Medical Research Acquisition Activity (USAMRAA), 808 Schreider Street, Fort Detrick, MD 21702.

2. Description of Action: This is a limited source action to be awarded to Xybion Corporation, 105 College Road East, Princeton, NJ 08540. The Government intends on awarding a firm fixed-price delivery order against Federal Supply Schedule (FSS) contract, GS-35F-120CA, pursuant to the authority of the Multiple Award Schedule Program.

The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) Fiscal Year 24 Research Develo ment Test & Evaluation RDT&E funds t is anticipated that future options will be funded with RDT&E funds; however, the fiscal year of funds will vary depending on when the options are exercised.

3. Description of Supplies/Services: USAMRIID has a requirement for the continued use of the PristimaXD software developed solely by Xybion. Pristima XD provides the USAMRIID Pathology Division protocol support and data repository for Good Laboratory Practices (GLP) and non-GLP histopathology. Continued use constitutes annual license renewal, software upgrades/updates and telephonic or email support.

The proposed source is Xybion Corporation, 105 College Road East, Princeton, NJ 08540.

4. Authority Cited: FAR 8.405-6(a)(1)(i)(B) - Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

5. Reason for Authority Cited: USAMRIID has a continued requirement for the Xybion Unified Preclinical Laboratory Information Management System called PristimaXD.

PristimaXD has provided the USAMRIID Pathology Division protocol support and data repository for GLP and non-GLP histopathology for approximately five years.

Source Selection Information - See FAR 2.101 and 3.104-4

OCT2023

Xybion is the sole distributor and provider of software support and maintenance for PristimaXD software currently in use by the USAMRIID Pathology Division. There are no resellers of this product, and no other vendors are capable of fulfilling the requirements of the Government.

6. Efforts to Obtain Competition:

a. Effective competition. Market research was performed and is summarized in paragraph 8 below. Per Federal Acquisition Regulation (FAR) 8.404(a), when placing orders under FSS contracts using the procedures at 8.405, ordering activities shall not seek competition outside of the FSS or synopsize the requirement.

b. Subcontracting competition. The Pristima software currently licensed to USAMRIID is developed solely by Xybion Corporation. Further, Xybion Corporation is the sole distributor and sole provider of the software support and maintenance for Pristima. As the developer, Xybion is the only company capable of fully supporting the software and there are no subcontracting opportunities.

7. Actions to Increase Competition: All future requirements will be handled on a case- by case basis. As the barriers that preclude the agency from the requirements of FAR 8.405-1 are due to limited vendors in the market and on schedule, no actions can be taken by this agency to remove those barriers. If additional vendors are added to the FSS for this service, they will be considered as applicable.

8. Market Research: Market research was conducted March 2024 and indicated that PristimaXD is a proprietary software only offered through Xybion. Market research conducted ascertained that although there are commercial software products available in the market, Pristima is the software system used by USAMRIID as the institute's auditable data collection system for clinical data which is in compliance with the Food and Drug Administration (FDA) and International Organization for Standardization (ISO) requirements. The sole vendor for Pristima is Xybion. The proprietary vendor Xybion, who has extensive experience in well-regulation environments (GLP, Good Clinical Manufacturing Practice (cGMP), etc.) will need to continue to provide software updates and license renewals for the accepted Period of Performance (Base plus four Options) without any disruption in service. It would not be cost effective for the Government to procure a whole new software system as this would entail a break in capabilities (time, module development, installation, training, etc.).

Three sources were either contacted or researched. Of the three researched sources, only one is identified as a small business (Xybion). Efforts to locate sources included internet research and searching on General Services Administration's (GSA). Sources were excluded if deemed not capable of fulfilling the requirements of the Government.

Based on the specifications of this requirement, and the information obtained from

Source Selection Information - See FAR 2.101 and 3.104-4 market research and assessments, a sole source award to Xybion is the recommended acquisition strategy for this requirement.

9. Other Facts:

a. Procurement history:

1) Contractnumber -GS-35F-120CA/W81XWH-19-F-0611 was awarded on 13 Sep 2019 and included a 12-month base period and four, 12-month option periods for a total of 60 months (PoP: 9/13/2019 - 9/12/2024).

2) Competitive Status - Competed as 100% small business set-aside

3) Authority Previously Cited - Not applicable

4) Summary of Contents of Previous Justification - Not applicable

5) Explanation of the changed circumstances causing this action to now limit the sources - Original requirement was competed as 100% small business set aside; only one response was received from the manufacturer Xybion. Given the continued need for the Pristima software and Xybion being the sole vendor capable of providing the required software support services the new requirement is being awarded on a sole source basis.

6) Unusual Patterns that May be Revealed by the history - No unusual patterns have been identified as a result of the history of this requirement.

7) If justification was prepared to support procurement made before this one, describe circumstances justifying the procurement and whether there have been any significant changes - Not applicable

b. Other facts. Not applicable.

Source Selection Information - See FAR 2.101 and 3.104-4