J_and_A_-_Illumina_BPA_-_SIGNED_Redacted.pdf

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

FOR OFFICIAL USE ONLY

25 May 2018 FOR OFFICIAL USE ONLY Page 2 of 4

I. Contracting Activity.

Air Force Life Cycle Management Center Installation Contracting Division Operational Contracting Branch Base Support Contracting

AFLCMC/PZIBA

1940 Allbrook Drive, Room 109

QPAFB, OH 45433-5344

Organization Activity:

711th USAFSAM/FHT 2510 Fifth Street, Building 20840, Area B

WPAFB, OH 45433-5344

II. Nature and/or description of the action being processed.

This individual J&A authorizes the use of Other Than Full and Open Competition procedures for a 5-year Firm-Fixed-Price Blanket Purchase Agreement (BPA) to Illumina, Inc. to purchase a diverse variety of proprietary Illumina reagents and kits to be used with Illumina sequencers in order to meet currently existing, as well as, future research protocols. The U.S. Air Force School of Aerospace Medicine, Applied Technology and Genomics Division (USAFSAM/FHT) conducts numerous Defense Health Program (DHP) funded research , sampling, and disease surveillance efforts, which require a variety of DNA sequence methods that can be produced by Illumina Next Generation Sequencing (NGS) systems, such as the HiSeq 2500, MiSeq and the MiSeqDX sequencers. These Illumina instruments are already owned by USAFSAM.

III. Description of supplies/services required to meet agency needs.

This requirement is for Illumina reagents and kits to support USAFSAM/FHT. FHT requires various Illumina proprietary reagents and kits needed for the labs to perform research, sampling, and disease surveillance. The Illumina HiSeq 2500, MiSeq, and MiSeqDX NGS sequencers are platforms for identifying the genetic sequence of microbial genomic and molecular samples. Evaluated samples will be screened using assays to determine the causative agents responsible for the research areas as selected by the researchers. Sequenced samples will be evaluated and compared to gene sequences using a database on an isolated server.

IV. Statutory authority permitting other than full and open competition.

10 USC 2302(b), Implementation of Simplified Acquisition Procedures (41U.S.C.1901)

V. Demonstration that the contractor's unique qualifications or nature of the acquisition requires the use of the authority cited above (applicability of authority).

The HiSeq, MiSeq, and MiSeqDX are sequencer instruments which are already owned by USAFSAM. The required diverse kits, reagents and other supply items are the only items able to meet the requirement due to compatibility with the sequencers. These items are solely produced by Illumina, Inc., with no authorized resellers. They are the only kits, reagents, and other supply items that meet the requirements called for in the operation of the NGS systems and the standardization of analysis. If these items are not purchased from Illumina, Inc., new sequencers would have to be

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

25 May 2018 FOR OFFICIAL USE ONLY Page 3 of 4 procured resulting in substantial duplication of costs estimated to be , as well as an unacceptable delay of approximately 6 months to procure the new equipment and have them automated, validated, and have personnel trained.

VI. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Illumina was contacted regarding other retailers providing their next generation sequencing kits. Illumina does not provide third party retailers with their kits for resale in North America. Other companies compete in the Next Generation Sequencing market, but only provide reagent support and validation for their own proprietary sequencers. Each vendor's sequencer typically uses a proprietary set of reagents based on either the sequencing technology or detection methods. Additionally, to our knowledge, the Illumina sequencing systems are the only sequencing instruments on the market that use these supply items, so it is unlikely that any other vendors could provide the appropriate reagents. A Sources Sought notice, FA8601-19-R-0017, was posted on FBO.gov on 24 October 2018 and did not receive any responses.

VII. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The price will be determined fair and reasonable based on prices that Illumina, Inc. has charged other commercial customers for the same or similar supplies as required by the Government and comparison to prices previously paid by the Government. This is IAW FAR 13.106-3.

VIII. Description of the market research conducted and the results, or a statement of the reasons market research was not conducted.

IAW with FAR part 10, market research was conducted. As mentioned above, Illumina was contacted regarding other retailers providing their next generation sequencing kits, and Illumina confirmed that they do not sell their kits through third party retailers. In order to verify that no other third party retailers could provide kits that would meet the unit's requirements documented in the last paragraph of section III above, we evaluated the product line offerings among three different companies. The three companies evaluated were: Pacific Biosciences, Oxford Nanopore, and Illumina. It was determined that only Illumina can produce the supplies required to satisfy the FHT's sequencing requirements on the HiSeq 2500, MiSeq and the MiSeqDX sequencers. In addition, the Contract Specialist posted a Sources Sought notice, FA8601-19-R-0017, on FBO.gov on 24 October 2018 and did not receive any responses. See the Market Research Report in File Item 2 for additional details.

IX. Any other facts supporting the use of Other Than Full and Open Competition.

None.

X. List of any sources that expressed, in writing, an interest in the acquisition.

See Section VI above.

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

USAFSAM will continue to perform market research in order to determine when and if Illumina kits and reagents can be purchased from multiple vendors acting as third party resellers. Additionally, it should be noted that USAFSAM owns other sequencing equipment from a variety of bioscience companies. Each of these instruments serves a different purpose in support of the mission requirements. For example, while bacterial genomes can be more easily sequenced with the other sequencers, the Illumina NGS systems performs better at sequencing human

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

25 May 2018 FOR OFFICIAL USE ONLY Page 4 of 4 genomes with fewer runs as it has the highest throughput per test and lowest error rate. Therefore, USAFSAM does purchase reagents from other companies, but the sequencer that must be used in each case is driven by the type of sequencing output required in order to successfully execute our scientific protocols. Whichever sequencer is determined to be appropriate, our team must then purchase the reagents/supplies from the same company that manufactured the sequencer since all of the reagents/supplies used are proprietary.

XII. Certification by the Contracting Officer.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

XIII. Certification by the technical/requirements personnel.

As evidenced by my (our) signature(s) above, I (we) certify that any supporting data contained herein, which is my (our) responsibility, is both accurate and complete.