Redacted J A HT942524P0014.pdf

Control Number:JA-24-10-1458

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S.

Army Medical Research Acquisition Activity (USAMRAA), FCMR-ACO-AC, Contracts Branch 3, 808 Schreider Street, Fort Detrick 21702-9220.

2. Description of Action: The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) has a requirement for a sole source, Firm-Fixed priced contract for one (1) benchtop DNA Synthesizer and preventative and corrective maintenance.

3. Description of Supplies/Services:

The Synthetic Biology Branch of the Molecular Biology Division requires a benchtop DNA synthesizer to bring oligonucleotide synthesis capabilities in-house. DNA synthesis capability at USAMRIID is a high-priority, mission critical acquisition and ensures the confidentiality and security of our projects.

The benchtop DNA synthesizer shall meet the following minimum essential characteristics:

Source Selection Information - See FAR 2.101 and 3.104-4

JULY 2023

1. The synthesizer shall have same-day throughput: 96 oligonucleotides of 120 nucleotides in length in approximately 24 hours.

2. The synthesizer shall synthesize oligos labeled with fluorophores, quenchers, or biotin.

3. The generated DNA will have 5' phosphate groups on the oligonucleotides to facilitate ligation.

4. The synthesizer shall be fully automated: oligos are synthesized, quantified, and normalized in a single synthesis run without user interaction following an approximate range of 15 to 30 minutes of setup.

5. The synthesizer shall have console software that can be installed and hosted on a stand-alone, off-network computer connected to the synthesizer.

6. The synthesizer shall have no harsh organic solvents: the product uses biochemistry, composed of water-based reagents, proprietary enzymes, and proprietary nucleotides that are typically compliant with standard laboratory waste management systems.

7. The synthesizer can perform without any specific environmental control (no need for Argon or any Gas).

8. The synthesizer should produce oligos that are free of molecular defects.

9. Training and initial setup for the synthesizer will be provided by the contractor.

USAMRIID also has a need for a four (4) year maintenance plan to continue maintenance after the initial manufacturer warranty elapses.

The contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, distributor or reseller for the proposed equipment such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warrant and service associated with the equipment shall be in accordance with the OEM terms and conditions.

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501 (a)(1 )(ii), sole source under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: DNA Script, Inc. is the only vendor who has a benchtop DNA synthesizer capable of producing 96 oligonucleotides of 20 nucleotides in length in six (6) hrs and 120 nucleotides in length in 24 hrs. DNA Script, Inc's benchtop DNA

Source Selection Information - See FAR 2.101 and 3.104-4

Synthesizer is the only product on the market capable of adding biotin, quenchers, and fluorescent molecules to the oligonucleotides for downstream applications, reducing the cost of targeted pathogen discovery oligonucleotide panels. Another unique advantage of the systems is the addition of a terminal 5' phosphate group to the generated DNA, making it easier to ligate the other DNA oligonucleotides to obtain longer DNA fragments, if needed.

DNA Script is the only vendor with the capacity to provide a benchtop DNA synthesizer meeting all of the government's minimum essential characteristics including the utilization of biochemistry and not having to be connected to the network. Additionally, DNA Scripts benchtop DNA synthesizer includes safety features to protect users; will have minimal waste impacts on The Institute; does not require the use of hazardous chemicals storage, hazardous waste disposal, dedicated fume vents, and gas cylinders to operate unlike another benchtop DNA synthesizer.

Given the information above, DNA Script is determined to be the only vendor capable of providing a benchtop DNA synthesizer meeting the government's minimum essential characteristics. All of the benchtop DNA synthesizer's critical components are designed and fabricated to meet the requirements and specifications of the DNA Script, Inc synthesizer; thus, all supplies must be fabricated to the specific requirements that were established under the original design. Equipment clearances and components are specific to the engineering requirements and all items are designed to a specific part number and manufacturer through DNA Script design requirements; no part or system shall ever be modified unless it has been authorized and fabricated for DNA Script, Inc.

Further, the benchtop DNA Synthesizer, manufactured by DNA Script, Inc., includes software that is considered proprietary in nature to DNA Script, Inc. Therefore, DNA Script, Inc. is the only source in the marketplace capable of providing the required preventative and corrective maintenance. Furthermore, DNA Script, Inc is the sole owner of the technical data packages, specifications, and engineering designs of its benchtop DNA synthesizer and maintains the proprietary knowledge required to maintain the piece of equipment.

There are no alternatives to the Government for acquiring preventive and corrective maintenance from sources other than DNA Script, Inc. As previously stated, DNA Script, Inc is the manufacturer and owner of the technical data packages, specifications, and engineering designs and there are no other sources in the marketplace capable of satisfying USAMRIID's requirement.

6. Efforts to Obtain Competition: A Notice of Intent (NOi) to sole source will be posted to www.sam.gov for a period of 15 days. All capability statements received in response to the NOi to Sole Source, by the due date specified, will be considered by the Government solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source contract.

Source Selection Information - See FAR 2.101 and 3.104-4

7. Actions to Increase Competition: USAMRIID and USAMRAA will periodically conduct future market research and analysis to determine if other potential sources emerge that are capable of providing the required equipment. Additionally, future requirements will be synopsized in accordance with FAR 5.201. If other potential sources emerge, USAMRAA, in conjunction with USAMRIID, will assess whether full and open competition for future requirements is feasible.

8. Market Research:

Market research conducted in accordance with FAR Part 10 was undertaken to ascertain 1) if the requirement meets the FAR definition of Commercial Supplies and commercial services and 2) if two or more small businesses exist that can meet the government's requirements.

Market research examined if the required products met the FAR definition of a commercial product as specified in FAR Part 2. Additionally, market research examined if the required maintenance services met the FAR definition of a commercial service, which is services of a type offered and sold competitively in substantial quantities in the commercial marketplace. Market research determined that the required products and services do meet these definitions and are commercially available; thus, standard commercial terms and conditions will apply.

Market research conducted in accordance with FAR Part 10 does not support that a minimum of two or more capable small businesses could potentially satisfy this requirement. Therefore, this requirement is not appropriate for a small business set aside.

Market research was conducted in July 2023 and identified the following vendors capable of providing a benchtop DNA synthesizers: Telesis Bio, Inc.; Sierra Biosystems, Inc.; Nuclera; Biolytic; Evonetix; and, DNA Script. Telesis Bio was determined to not be able to meet the government's requirement because they require sequences to be sent off site to the company and does not allow for synthesis without disclosing sensitive information. Sierra Biosystems, Inc. was determined to not be able to meet the government's requirement due to not allowing for synthesis without disclosing sensitive information. Nuclera does not yet have a benchtop DNA synthesizer on the market and can therefore not meet the government's requirement. Biolytic's product uses phosphoramidite chemistry vice biochemistry and therefore does not meet the government's minimum requirements. Evonetix's product is not yet available and is marketed as utilizing cloud-based software, therefore, the Evonetix is not capable of meeting the government's requirement because its product does not have console software capable of being installed and hosted on a stand-alone, off-network computer.

DNA Script was the only vendor with the capacity to provide a benchtop DNA synthesizer meeting all of the government's minimum essential characteristics including the utilization of biochemistry and not having to be connected to the network.

Source Selection Information - See FAR 2.101 and 3.104-4

Additionally, DNA Scripts benchtop DNA synthesizer includes safety features to protect users; will have minimal waste impacts on The Institute; does not require the use of hazardous chemicals storage, hazardous waste disposal, dedicated fume vents, and gas cylinders to operate unlike another benchtop DNA synthesizer.

Given the information above, DNA Script is determined to be the only vendor capable of providing a benchtop DNA synthesizer meeting the government's minimum essential characteristics.

9. Interested Sources: The synopsis required by FAR 5.201 will be posted on the System for Award Management (SAM) website as this requirement meets the threshold stipulated in FAR 5.101 (a)(1 ). Any written inquiries or quotes received shall be considered.

10. Other Facts:

a. Procurement history. NIA-this is a new requirement.