JnA ALTHEA_Gold_SCFV.pdf

NAVAL MEDICAL RESEARCH UNIT SAN ANTONIO

FY ‘23 Page 1

JUSTIFICATION & APPROVAL FOR USE OF OTHER THAN FULL & OPEN COMPETITION

1. Identification of the agency and the contracting activity, and specific identification of the document as a “Justification for other than full and open competition.”

This Justification and Approval (J&A) is executed by the Naval Medical Research Command (NMRC), 503 Robert Grant Avenue, Silver Spring, MD 20910, on behalf of the requesting agency, Naval Medical Research Unit San Antonio (NAMRU-SA), 3650 Chambers Pass, Building 3610, JBSA Fort Sam Houston, TX 78234.

2. Nature and/or description of the action being approved.

Award of a contract will be made to provide fixed price contract to Gene Infinity LLC, dba Antibody Design Laboratories for the production and delivery of aliquots of the ALTHEA Gold, single-chain fragment variable (SCFV) phage display library in pursuit of antibody fragment discovery for diagnostic and therapeutic applications for a base period of 12-months, with no option periods. The proposed source is Gene Infinity LLC, dba Antibody Design Laboratories, 4901 Morena Blvd #203, San Diego, CA 92117.

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

The Naval Medical Research Unit – San Antonio has a need for humanized SCFV phage display libraries.

Antibody Design Laboratories sells kits commercially known as the ALTHEA Gold phage display library and will provide 100 kits (200 biopanning attempts). The phage display library provided produces antibody fragments known as SCFV, which are high binding biomolecules for diagnostic and therapeutic purposes while maintaining low molecular weight compared to full antibodies.

Estimated Dollar Value.

The estimated value of this contract is $XXXXXX.

4. An identification of the statutory authority permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C.

2304(c) (1) as implemented by FAR 6.302-1; only one responsible source and no other supplies or services will satisfy agency requirements. (2) When the supplies or services required by the agency are available from only one responsible source, or, for DoD, NASA, and the Coast Guard, from only one or a limited number of responsible sources, and no other type of supplies or services will satisfy agency requirements, full and open competition need not be provided for.

5. A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

Antibody Design Laboratories is one of the few commercial SCFV phage display library producers and has 25 years of experience in various phage display platforms including peptide libraries.

FY ‘23 Page 2

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to FedBizOpps in accordance with FAR 5.202. No other source is expected to express interest in this effort.

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis prior to award. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. A description of the market research conducted (see Part 10) and the results or a statement of the reason market research was not conducted.

Market research was conducted by technical experts in the August 2022 timeframe. This research consisted of a market survey through search engines of open market contractors. Search engines utilized using Google and the following search words: SCFV phage display library. The full results of the market research are attached.

1. Creative Biolabs has three licenses research (one-time), research (unlimited), and commercial (one-time).

The commercial license can be bought for $xxxxxx or at a lower price (undisclosed) but with royalties and milestone payments.

4. Antibody Design Laboratories: $xxxxx per kit, two screens per kit, variable number of SCFV from one screen. Every SCFV discovered and used for diagnostics results in a $xxxxxxx payment to the company and for therapeutics $xxxxx per SCFV marketed. Buying 100 kits (~$xxxxxxxx-$xxxxx) results in the discovery fees being waived. Verbally, it was stated that they can perform the screening and it costs.

$xxxxxx per target.

9. Any other facts supporting the use of other than full and open competition.

N/A

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

1. Creative Biolabs

2. Gene Infinity LLC, dba Antibody Design Labs

This requirement will be posted on FedBizOpps in accordance with FAR 5.203. Any sources expressing interest in response to the synopsis will receive consideration.

FY ‘23 Page 3

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

12. Point of Contact.

The point of contact at the Naval Medical Research Command, regarding the contents of the sole source justification is Ms. Deborah M. Sharpe, who may be reached at: (301) 319-6481 or deborah.m.sharpe2.civ@health.mil.

mailto:deborah.m.sharpe2.civ@health.mil

FY ‘23 Page 4

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

I certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein, are complete and accurate to the best of my knowledge and belief.

Technical Cognizance

17APR23

Yoon Hwang, Ph.D. Date Research Microbiologist/Maxillofacial Injury and Disease Department Naval Medical Research Unit San Antonio

Requirements Cognizance

CAPT Gerald T. DeLong, PhD, CIH, MSC, USN Date Commanding Officer Naval Medical Research Unit San Antonio

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have determined this Justification is legally sufficient.

Office of Counsel Date

CONTRACTING OFFICERS CERTIFICATION

I certify that this Justification is accurate and complete to the best of my knowledge and belief. The Contracting Officer’s signature below also represents approval of the J&A.

8-09-2023

Ms. Deborah M. Sharpe Date Contracting Officer Naval Medical Research Command

HWANG.YOON.Y Digitally signed by

EOP.1399614631 Date: 2023.04.17 08:00:53 -05'00'

HWANG.YOON.YEOP.1399614631

SHARPE.DEBORA Digitally signed by

H.M.1232127429

SHARPE.DEBORAH.M.123212742

Date: 2023.08.09 12:09:43 -04'00'