United States Department of Agriculture Justification to Restrict Competition

Identification Number: 1232SA26Q0547

Rev. 11/6/2025

In accordance with the Revolutionary Federal Acquisition Regulation (FAR) 12.102 (b), the following justification documents the decision to restrict competition for this acquisition.

(1) Mission Area and Contracting Activity.

Requesting Activity Agency:

Unites States Department of Agriculture (USDA), Agricultural Research Service (ARS), Contracting Operations Branch (COB) Amber Sampson, Contract Specialist Nicole McKenzie, Contracting Officer

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

This J&A authorizes and approves the award of a sole-source indefinite delivery indefinite quantity (IDIQ) contract. This IDIQ will replace the current IDIQ 12405B21D0002 with Pacific Biosciences of California that expires on June 30, 2026. This IDIQ is for sequencing instrumentation, supplies, and warranty support that are only available through Pacific Biosciences of California. These supplies and warranties are only available through Pacific Biosciences of California due to the current active inventory within USDA, thus maintaining warranty and continuity of active research is critical.

Pacific Biosciences of California, Inc., 1305 O'Brien Drive, Menlo Park, CA 94025-1439

SAM UEI: CP22V46XYQK6

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

The USDA/ARS is creating a contract vehicle to be utilized by all REE agencies to procure scientific equipment, reagents, supplies, and warranty support for instrumentation to perform single molecule real time (SMRT) based HiFi high-throughput sequencing on Pacific Biosciences (PacBio) sequencing platforms.

The requirement must include:

1. Revio and Vega classes of sequencing platforms, support, supplies, and reagents necessary for preparing and performing samples for HiFi runs, including SPRQ-NX chemistry and reagents.

2. Library preparation for input sample types for Kinnex, IsoSeq, and High molecular weight DNA extraction.

3. Support plans for existing PacBio platforms and equipment.

The estimated total value of this contract is $9,000,000.

It is anticipated that one (1) IDIQ contract consisting of one (1) Five-year base period and inclusion of FAR52.217-8. The estimated total for the base year plus all options is $9,000,000 as shown below:

Period Total

07-01-2026 – 06-30-2031 $ 9,000,000 Grand Total $9,000,000

(4) Identify the statutory authority permitting other than full and open competition.

The statutory authority permitting other than full and open competition is 41 U.S.C. 1901 - FAR 12.201-1, Simplified Procedures.

(5) Demonstrate that the proposed contractor's unique qualifications or the nature of the acquisition requires using the authority cited.

USDA has a requirement for all product and service types listed in this justification which are only available from Pacific Biosciences of California and no other supplies or services will satisfy agency requirements based on a need to maintain scientific research consistency.

Multiple locations throughout the REE have an ongoing need for sequencing kits and chemistry to support continued operation of Pacific Biosciences sequencing platforms. For those locations that have been utilizing Pacific Biosciences technology; there is a need for continued use of the equipment, supplies, and reagents for these instruments to provide consistency in availability that allows scientists to process samples and generate data to meet the research needs of critical high impact research within the agency. The chemistry and reagents are specific to Pacific Biosciences products and cannot be obtained from any other company, and are not compatible with any other manufacturer's equipment.

The Revio and Vega systems are the main instruments used for sequencing, and are essential to USDA research. All the other items, kits and accessories are essential periphery items to make the instruments work. Due to the highly specialized nature of the experiments being conducted by USDA, Pacific Biosciences reagents can only be used on their own equipment. The chemistries involved in assays run with this equipment were developed by Pacific Biosciences and are proprietary to them. The reagents and equipment are not interchangeable with any other system.

The placement of any other sequencing reagent on the instruments would void any warranty or service issue under a support contract. Costs are not anticipated to be recovered through competition, further, Pacific Biosciences is the only known source to utilize SMRT HiFi sequencing technology which produces necessary and desired compatible results. Reagents for sequencing are often higher than the single purchase threshold for a cardholder and often require contracting. An IDIQ contract reduces redundant burden on the contracting division, by allowing a single contract to streamline the acquisition of these reagents, instead of processing many individual awards each year. Delays in contracting can also impact the fiscal cost of loss of productivity of the equipment, and the downtime waiting for contracting delays can justify the need for a single IDIQ contract.

The original contract was awarded (12405B21D0002) demonstrated the contractor’s capability and efficiency in meeting the requirements for the agency. Using other than full and open competition under these circumstances is necessitated due to the proprietary nature and specialized experience required, which is solely possessed by the incumbent contractor.

(6) Provide a description of efforts made to ensure that offers are solicited from as many potential sources as possible, including whether a notice was or will be publicized as required by Part 5 and, if not, which exception under Part 5 applies.

The proposed contract action was not synopsized on the SAM website. IAW RFO FAR 12.202 (b), a combined pre-solicitation notice, and solicitation will be posted to the SAM website.

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

The contracting officer has determined the anticipated cost to the Government of the supplies/services covered by this J&A will be fair and reasonable based on publicly available data for these products from this vendor as well as historical data for similar and like supplies and services from other sequencing instrumentation companies. Further, additional discounts from published prices are expected to be negotiated by using the leverage of combining all of the USDA agencies’ requirements, the prior contract had a 5% discount from published pricing. In the case of updated pricing and products, a fair and reasonable price for updates and replacements will be determined by the contracting officer at time of contract modification award.

(8) A description of the market research conducted, and the results or a statement of the reason

Market Research was not conducted.

The contracting officer has also conducted their own market research as below. Mandatory Sources reviewed per FAR 8.103 and 8.104. This requirement cannot be provided by any mandatory sources. GSA Multiple Award Schedules (MAS) were searched and found unable to meet all the needs of the requirement. There are no authorized third-party vendors that can be utilized to maintain warranty. Pacific Biosciences of California will provide the best pricing on the market for their products.

(9) Any other facts supporting use of other than full and open competition, such as:

Pacific Biosciences is the sole developer, supplier, and distributor of HiFi SMRT SPRQ sequencing instrumentation and chemistry, no other vendor or supplier can provide this technology.

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

Pacific Biosciences of California, Inc., 1305 O'Brien Drive, Menlo Park, CA 94025-1439

SAM UEI: CP22V46XYQK6

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

The USDA scientific community keeps abreast of current and emerging technologies in the marketplace and is regularly considering new technologies to enhance their research efforts. If something comes available that will satisfy the Agency’s needs and is competitive with Pacific Biosciences product offering, it will be considered.

Certifications & Approvals

Technical / Requirements Personnel Certification I certify this requirement meets the Government’s minimum need and that the supporting data, which forms a basis for this justification, is complete and accurate.

Scott Geib Date Research Bioscientist

Contracting Officer’s Certification I certify that the data supporting the recommended use of other than full and open competition accurate and complete to the best of my knowledge and belief.

Nicole McKenzie Date Contracting Officer