A02. Justification and Approval Modified for FAR Part 13.501 - CN Bio Innovations_signed REDACTED.pdf

CUI

Control Number: FY25-0122

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

1 NOV 2024

Justification and Approval (J&A) Modified for Federal Acquisition Regulation (FAR) 13.501

1. Identification of the Agency and Contracting Activity: Defense Health Agency (DHA), U.S.

Army Medical Research Institute of Infectious Diseases (USAMRIID) / Defense Health Agency (DHA), United States Army Medical Research Acquisition Activity (USAMRAA), Contracts Group 1, Contracts Branch 4.

2. Nature and/or Description of Action being Approved: The USAMRIID has a new requirement for one (1) PhysioMimix Organ-on-a-Chip (OOC) Multi-Organ Standard System and one (1) PhysioMimix Organ-on-a-Chip (OOC) Multi-Organ Full System.

DTRA JSTO Fiscal Year 25 funds will be used to procure the equipment.

3. Description of Supplies/Services: USAMRIID has a requirement for one (1) PhysioMimix Organ-on-a-Chip (OOC) Multi-Organ Standard System and one (1) PhysioMimix Organ-on-a- Chip (OOC) Multi-Organ Full System. The multi-organ OOC shall be able to support single and multi-organ on a chip systems. The equipment must allow for perfusion and fluidics that mimic the blood stream by allowing for flow rates in the low uL range. These flow rates must be adjustable for both inter-organ and intra-organ. The equipment must allow for 3D organ model formation and inclusion of a circulating immune cells. The equipment must support both 2D and 3D cell culture and allow for automation for long-term experiments. The controller must be capable of supporting up to 6 multi-chip plates and have a plate-based design. Up to 1mL of media must be available for sampling.

For full system functionality, the equipment shall include the necessary accessories: three single-organ MPS drivers and liver monoculture onsite training for a minimum of two (2) USAMRIID personnel.

The systems shall be covered under warranty for two (2) years commencing on the date of delivery. The power requirements are 100-240 V, 50/60 Hz.

Period Required Delivery Date Estimated Value Type of Funding

Base Period By 7/30/2025 $465,500.00 DTRA JSTO Total $465,500.00

Controlled by: Defense Health Agency (DHA) Controlled by: USAMRAA CUI Category(ies): Source Selection Limited Dissemination Control: FEDCON POC: Matthew Gembe, 301-619-1350

CUI

2 NOV 2024

4. Statutory Authority Permitting the Sole Source Acquisition: 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii) sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Rationale Justifying Use of Authority Cited: Market research examined if there are other sources capable of providing the required PhysioMimix OOC Multi-Organ Systems. It was determined that although there are multiple vendors in the market capable of providing similar equipment, the similar equipment does not meet all government Minimum Essential Characteristics (MECs). Further, CN Bio Innovations does not have any authorized resellers.

Therefore, CN Bio Innovations is determined to be the only vendor capable of providing systems that meets all requirements of the government.

The market research team performed internet searches seeking to determine what companies have the capabilities required to fulfill the requirements of the government. Four (4) sources were either contacted or researched. Of the four (4) researched sources, only CN Bio Innovations was found to be capable of meeting the required MECs as follows:

1. The systems must support single and multi-organ on a chip systems.

2. The systems must allow for perfusion and fluidics that mimic the blood stream.

3. The systems must allow for 3D organ model formation and inclusion of circulating immune cells.

4. The systems must support both 2D and 3D cell culture.

5. The systems must have automation for the experiment.

6. The systems must have a controller that is capable of operation of multi-chip plates.

7. The systems must have a plate-based design.

8. The systems must allow up to 1mL of media available for sampling.

9. The systems must allow for flow rates in the low uL range and can adjust inter-organ and intra-organ flow rates.

10. The systems shall be covered under warranty for two (2) years commencing on the date of delivery.

11. One of the systems for Virology shall be covered under BSL-3 support package for two (2) years.

12. The Contractor shall provide onsite training for a minimum of two (2) USAMRIID personnel.

13. The Contractor shall provide onsite installation of systems.

14. Shipping shall be included.

15. Three (3) single-organ driver units shall be included for that standard system.

6. Efforts to Obtain Competition: There is no effective competition for the reasons stated in Section 5.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition: Not applicable

CUI

3 NOV 2024

8. Market Research: Market research conducted in accordance with FAR Part 10 was multifaceted and was undertaken to ascertain 1) if the requirement meets the FAR definition of a Commercial Product, 2) if two or more small businesses exist that can meet the government’s requirements, and 3) if there is more than one source capable of meeting the government's requirement.

Market research examined if the required equipment met the FAR definition of a commercial product, which is a product, other than real property, that is of a type customarily used by the general public or by nongovernmental entities for purposes other than governmental purposes and (i) has been sold, leased, or licensed to the general public; or (ii) has been offered for sale, lease, or license to the general public. Market research determined that the required equipment does meet the definition and is commercially available; thus, standard commercial terms and conditions will apply.

Market research conducted in accordance with FAR Part 10 does not support that a minimum of two or more capable small business could potentially satisfy this requirement. Therefore, this requirement is not appropriate for a small business set-aside.

Lastly, market research examined if there are other sources capable of providing the required PhysioMimix OOC Multi-Organ Systems. It was determined that although there are multiple vendors in the market capable of providing similar equipment, the similar equipment does not meet all government Minimum Essential Characteristics (MECs). Further, CN Bio Innovations does not have any authorized resellers. Therefore, CN Bio Innovations is determined to be the only vendor capable of providing a system that meets all requirements of the government.

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? Yes

(2) If 9.a.(1) is No, was the action just prior to this one competed? Not Applicable

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed? Not Applicable

10. Interested Sources: To date, no other sources have written to express interest in the acquisition. No responses were received from Notice of Intent to Sole Source posted to SAM.gov for 15 days with a closing date of 14 April 2025.

CUI

4 NOV 2024

11. Technical Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Kathleen Huie Program Manager Virology Division, USAMRIID

12. Requirements Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Kathleen Huie Program Manager Virology Division, USAMRIID

13. Fair and Reasonable Cost Determination:

I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable.

Basis for Determination: A price analysis comparison to similar and identical items as well as comparison to the Independent Government Estimate. In accordance with FAR 15.403-1(b)(3) and (b)(5), the Contracting Officer shall not require certified cost and pricing data to support any action when a commercial product or service is being acquired.

Amanda Best Contracting Officer

USAMRAA

HUIE.KATHLEEN.E Digitally signed by

LIZABETH.1523224 HUIE.KATHLEEN.ELIZABETH.15

HUIE.KATHLEEN.E Digitally signed by

LIZABETH.1523224 HUIE.KATHLEEN.ELIZABETH.15

BEST.AMANDA. Digitally signed by

LEE.1369630896 Date: 2025.04.29 11:57:28 -04'00'

15. Contracting Officer Certification:

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

CUI

5 NOV 2024

Amanda Best Contracting Officer

USAMRAA

BEST.AMANDA. Digitally signed by

LEE.1369630896 Date: 2025.04.29 11:57:57 -04'00'