A02 JA FAR Part 6 Manufacture ALF55 cGMP Signed Redacted.pdf

OCT 2023

Justification and Approval for Other than Full and Open Competition – FAR Part 6

Manufacture of ALF55 under cGMP

1. Contracting Activity: United States Army Medical Research Acquisition Activity (USAMRAA) 808 Schreider Street, Fort Detrick, MD 21702-5014.

2. Description of Action: This is a new Firm Fixed Price (FFP) contract using Research, Development, Test and Evaluation (RDT&E) Fiscal Year (FY) 2024 funds.

3. Description of Supplies/Services: The Military HIV Research Program (MHRP) requires 2.75 liters of the compound Army Liposome Formulation (ALF) containing 55 mol% cholesterol (ALF55) is required for the MHRP, WRIAR to create two new lots of Army Liposome Formulation with QS-21 saponin (ALFQ). The ALF55 shall be manufactured by current Good Manufacturing Practices (cGMP). A minimum of 2.75 liters is required.

4. Authority Cited: 10 United States Code 3204(a)(1) as implemented in Federal Acquisition Regulation 6.302-1Only one responsible source and no other supplies or services will satisfy agency requirements..

5. Reason for Authority Cited: Avanti Polar Lipids Inc. is the only vendor capable of producing the ALF55 compound within the specifications identified in the Minimal Essential Characteristics (MEC). The requirement of this specified formulation includes monophosphoryl 3-deacyl lipid A (3D-PHAD®). This synthetic lipid is trademarked and owned by Avanti Polar Lipids Inc., under patent number 9,241,988. This vendor is vetted and found acceptable by the Food and Drug Administration (FDA). A change of vendor would require a substantial cost burden for us to qualify a new vendor and test the product. For this effort we need to keep the manufacturing method the same.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201 and any bids or proposals received shall be considered. A Request for Information (RFI) was posted in SAM.Gov on March 15, 2024, and closed on 22 March 2024. As a result of the RFI no response were received from the industry.

A Notice of Intent to Sole Source was also posted in SAM.Gov for 15 days from 28 March 2024 to 12 April 2024. However, no response were received from the industry.

a. Effective competition. Not Applicable, as this requirement contains a trademarked ingredient only to be manufactured by the originating manufacturer.

b. Subcontracting competition. Not Applicable. There are no subcontracting possibilities and is below the threshold for subcontracting requirement..

8. Market Research: Market research was conducted in January 2024 to identify all viable vendors that have the specialized adjuvant manufacturing capabilities to meet the requirements of the MEC. Market research included through internet searches, assessed potential vendors, and relied upon the experience of clinicians and scientists within the relevant field. Market research found that Congressional Directed Medical Research program and NAID both historical acquired the ALF55 under two contracts as a subaward from Avanti Polar Lipids, Inc. Market research has demonstrated that there is only one capable source to provide the product as a result of patent trademark restrictions.

9. Interested Sources: See Paragraph 6 for the synopsis information. To date, no other sources have written to express an interest.

10. Other Facts: Discuss any other facts supporting the use of other than full and open competition, such as the following:

a. Procurement history. This is a new requirement with no contract history.

b. Other Facts: Not Applicable

11. Technical 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.

Signature: _______

Typed Name:

12. 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.

Signature: _______

Typed Name:

13. Fair and Reasonable Cost Determination:

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

The determination will be made using a price analysis utilizing the IGE. As part of the basis, certified cost and pricing data will not be required.

Signature ___

Typed N

14. Contracting Officer Certification:

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

Signature: __

Typed Na