C04d_JOFOC_1232SA26Q0759.pdf

United States Department of Agriculture Justification to Restrict Competition

Identification Number: 1232SA26Q0759

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.

The United States Department of Agriculture, Agricultural Research Service, Contracting Operations Branch, proposes to enter into a contract on the basis of other than full and open competition for genome sequencing instrumentation, supplies, and support. This is a new contract for an indefinite delivery/indefinite quantity (IDIQ) contract with Element Biosciences for sequencing instrumentation, supplies, and warranty support. The new contract will provide the critical resources and support needed to maintain and enhance the operations of research critical genomic instrumentation.

ELEMENT BIOSCIENCES

10055 BARNES CANYON RD STE 100

SAN DIEGO, CA 92121 USA

SAM UEI: CZ2CHES131A5

(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 USDA agencies to procure scientific equipment, reagents, supplies, and warranty support for instrumentation to perform Avidite-based sequencing-by-binding high-throughput sequencing on Element Biosciences sequencing platforms.

The requirements include:

1. Aviti, Aviti24, and Vitari classes of sequencing platforms, support, supplies, and reagents necessary for preparing and performing samples for Avidite sequencing, including Elevate Cloudbrake Freestyle chemistry and reagents.

2. Library preparation for input sample types including Trinity and Teton methodologies.

3. Support plans for existing Element platforms and equipment.

The estimated total for the base year plus all options is $8,000,000 as shown below:

Period Total

BASE $ 7,250,000

Identification Number: 1232SA26Q0759

Rev. 11/6/2025

Period Total Evaluation of FAR 52.217-8 $750,000

Grand Total $8,000,000

(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 addressed above which are only available from Element Biosciences and no other supplies or services will satisfy agency requirements based on a need to maintain scientific research consistency.

Multiple locations throughout the USDA have an ongoing need for sequencing kits and chemistry to support continued operation of Element Biosciences sequencing platforms. There is a need for continued use of the equipment, supplies, and reagents for instruments currently in use by USDA.

This is necessary in order to provide consistency in processing samples and generating data to meet the research needs of critical high impact research within the agency. The chemistry and reagents are specific to Element Biosciences products and cannot be obtained from any other company and are not compatible with any other manufacturer's equipment.

The Aviti and Vitari systems are the main instruments currently 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, Element Biosciences reagents can only be used on their own equipment. The chemistries involved in assays run with this equipment were developed by Element 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, Element Biosciences is the only known source to utilize Avidite Base Chemistry (ABC) sequencing-by-binding technology which produces necessary and desired compatible results. The instrumentation and sequencing costs for this technology are industry leading in their data quality and lowest in price per billion sequenced reads. 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.

Prior USDA contracts 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. These specialized and proprietary products are necessary to be

Identification Number: 1232SA26Q0759

Rev. 11/6/2025 procured directly from Element Biosciences in order to maintain the integrity of the research and reduce overall cost to the government.

(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.

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 equipment 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 9% 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.

Mandatory Sources were reviewed per FAR 8.002 and FAR 8.004. This requirement cannot be provided by the sources listed under FAR 8.002 and FAR 8.004. GSA Multiple Award Schedules (MAS) were searched and there are no sources available that can meet this requirement.

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

Element Biosciences is the sole developer, supplier, and distributor of Avidite Base Chemistry (ABC) sequencing-by-binding instrumentation and chemistry and Cloudbreak Freestyle Flowcell technology, 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.

ELEMENT BIOSCIENCES

10055 BARNES CANYON RD STE 100

SAN DIEGO, CA 92121 USA

SAM UEI: CZ2CHES131A5

(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.

Identification Number: 1232SA26Q0759

Rev. 11/6/2025

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 Element Biosciences product offering, it will be considered.