D03 - Limiting-Competition-under-SAT_ACC rev 4.20.2023_redacted.pdf

CUI

Control No: JA-23-04-1309

Version – February 2017

Memorandum for Record – Limiting Competition at or below the Simplified

Acquisition Threshold

1. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA)

2. Description of Action: Acquisition of three (3) ea. Kilobaser one-XT - Extended Edition Benchtop Synthesizers for standard and advanced oligonucleotides (modified DNA, RNA). Includes software, touch screen, gas appliances and online training for setup, basic and extended features. Additional equipment required: Kilobaser cartridges, Kilobaser microfluidic chips, argon or nitrogen gas tank, cartridges, Chips, and consumables.

Nature: ☒ New Requirement ☐ Follow-on Requirement

Contract Vehicle:

☒ Purchase Order Number:

☐ Blanket Purchase Agreement (BPA) Number:

☐ Order/BPA #_ against FSS Contract #_ ☐ Order #_ against Multiple Award IDIQ Contract # ☐ Order #_ against a single award IDC Contract #_ ☐ Modification #_ to existing PO/TO/DO/Call Order #

Pricing/Contract Type:

☒ Fixed Price ☐ Time & Materials/Labor Hours ☐ Cost Reimbursable ☐ Hybrid

Funds:

☐ Operations & Maintenance, Army (OMA) ☒ Other Funds: Army Research & Development (R&D)

FY: 22

Controlled by: Defense Health Agency Controlled by: USAMRAA CUI Category(ies): General Procurement and Acquisition Limited Dissemination Control: FEDCON

Name of Proposed Contractor and Address:

Vendor Name Website Kilobaser Corp. (CAGE 97HG6) 405 Lexington AVENUE, STE.

New York, New York 1017 https://kilobaser.com/dna-and-rna-synthesizer/

Brand Name Buy: ☒ Yes ☐ No

3. Description of Services or Supplies: Acquisition of three (3) ea. Kilobaser one-XT

- Extended Edition Benchtop Synthesizers for standard and advanced oligonucleotides (modified DNA, RNA). Includes software, touch screen, gas appliances and online training for setup, basic and extended features. Additional equipment and supplies required: Kilobaser cartridges, Kilobaser microfluidic chips, argon or nitrogen gas tank, cartridges, Chips, and consumables.

The following consumables with quantities listed are required to be purchased with the Kilobaser one-XT – Extended Edition Benchtop Synthesizer:

Item Description Quantity (Qty.)

1. 6-FAM DNA Cartridges - 10 piece

2. BHQ-1 Quencher Chips - 40 piece

3. 2’-MOE RNA Cartridges - 5 piece

4. 2’-OMe RNA Cartridges – 5 piece

5. 2’-F RNA Cartridges – 5 piece

6. Standard Chips – 90 piece

7. OliPure Magnetic Bead Oligo Purification Kit – 4 piece

8. OliPure Magnetic Rack – 1 piece

Total Estimated Value (for all Contract Line-Item Numbers):

is for commercial supplies and is not for (performance based) services.

4. Authority:

☒ FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

Or https://kilobaser.com/dna-and-rna-synthesizer/

☐ FAR 8.405-6(a)(1)(i)(B) and 8.405-6(b)(1)Brand Name ☐ FAR 8.405-6(a)(1)(i)(A) Urgency ☐ FAR 8.405-6(a)(1)(i)(B) Only One Source is Capable ☐ FAR 8.405-6(a)(1)(i)(C) Logical Follow-on Or ☐ FAR 16.505(b)(2)(i)(B) Only One Awardee is Capable ☐ FAR 16.505(a)(4) Brand Name ☐ FAR 16.505(b)(2)(i)(A) Urgency ☐ FAR 16.505(b)(2)(i)(C) Logical Follow-on ☐ FAR 16.505(b)(2)(i)(D) Minimum Guarantee

5. Reasons for Authority Cited:

The Kilobaser one-XT - Extended Edition Benchtop Synthesizer is required to conduct a performance comparison to other commercially available DNA/RNA synthesizers.

DTRA’s mission is to assess the ability to establish a rapid synthetic biology response capability in response to real-time biological threats. Failure to complete this project would impair DSD and USAMRIID’s abilities to provide diagnostic capabilities to address time-sensitive biothreats. The Kilobaser one-XT - Extended Edition Benchtop Synthesizer can produce DNA and RNA oligonucleotides. The Kilobaser can modify these oligonucleotides for use as a TaqMan probe, thus generating all of the custom reagents needed for a real-time PCR assay. Transitioning real-time PCR assays to a Laboratory Developed Test (LDT) for formal clinical patient testing is a defined process.

The Kilobaser Personal DNA and RNA synthesizer utilizes cartridges and microfluidics to synthesize RNA and DNA oligonucleotides in less than two hours. The DNA oligonucleotides can be modified to include Taqman probes with the Kilobaser, allowing for the synthesis of a real-time PCR assay primers/probe within hours of identifying a new pathogen sequence. It is for the reasons stated above that the Kilobaser Personal DNA and RNA synthesizer is the best suited choice to accomplish DTRA’s mission.

Only one (1) source is a qualified to supply the Kilobaser one-XT - Extended Edition Benchtop Synthesizer. This product must be purchased directly by institutions from Kilobaser Corporation. There are no agents or dealers authorized to represent this product. As a result, the Government intends to make an award to the Kilobaser Corporation (a small business – CAGE Code 97HG6), 405 Lexington AVENUE, STE.

2601, New York, New York 10174

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 ☐ do not apply due to the $ threshold, ☐ apply and will be followed, or ☒ do not apply due to an exception at 5.202(a)(13)(i) Is for an amount not expected to exceed the simplified acquisition threshold.

Requirement to post justification in accordance with FAR 8.405-6(b)(3), FAR 13.105(c), or FAR 16.505(a)(4)(iii)(A)

☐ Action is NOT a brand name restriction and is under $150K, no posting required ☐ Action is a brand name restriction, under $25K, no posting required ☒ Action is a brand name restriction, over $25K. It will be redacted and posted with the solicitation.

☐ Action is a brand name restriction over $25K but will not be posted due to exception:

☐ FAR 6.305(f) ☐ FAR 8.405-6(b)(3)(iii)(A) ☐ FAR 8.405-6(b)(3)(iii)(B) ☐ FAR 8.405-6(b)(3)(iii)(C) ☐ FAR 16.505(a)(4)(iii(C)

7. Market Research:

Market research was conducted during the Jan-March 2023 timeframe in accordance with FAR Part 10 was multifaceted and was undertaken to ascertain 1) if the requirement meets the FAR definition of a Commercial Product and 2) if two or more small businesses exist that can meet the government’s requirements.

Market research determined that the required product(s) do meet the definition of a Commercial Product and are commercially available; thus, standard commercial terms and conditions will apply.

Vendor Name Website

Kilobaser Corp. https://kilobaser.com/dna-and-rna-synthesizer/ Biolytic Lab Performance, Inc. https://www.biolytic.com/t-dr-oligo-48-dna-rna-oligo-synthesizer.aspx Sierra Biosystems https://sierrabio.com/dna-synthesizers/sierra-biosystems-synthesizers/shasta-96-192-dna-synthesizer/

K&A Labs GMBH https://ka-labs.de/dna-rna-synthesizers/

Only one (1) source is a qualified to supply the Kilobaser one-XT - Extended Edition Benchtop Synthesizer. This product must be purchased directly by institutions from Kilobaser Corporation. There are no agents or dealers authorized to represent this product. As a result, the Government intends to make an award to the Kilobaser Corporation (a small business – CAGE Code 97HG6), 405 Lexington AVENUE, STE.

2601, New York, New York 10174

8. Other Facts:

There are no previous procurements for the Kilobaser one-XT - Extended Edition Benchtop Synthesizer.

https://kilobaser.com/dna-and-rna-synthesizer/ https://www.biolytic.com/t-dr-oligo-48-dna-rna-oligo-synthesizer.aspx https://www.biolytic.com/t-dr-oligo-48-dna-rna-oligo-synthesizer.aspx https://sierrabio.com/dna-synthesizers/sierra-biosystems-synthesizers/shasta-96-192-dna-synthesizer/ https://sierrabio.com/dna-synthesizers/sierra-biosystems-synthesizers/shasta-96-192-dna-synthesizer/ https://sierrabio.com/dna-synthesizers/sierra-biosystems-synthesizers/shasta-96-192-dna-synthesizer/ https://ka-labs.de/dna-rna-synthesizers/

USAMRIID’s research Subject Matter Experts (SMEs) reviewed alternative solutions to the Kilobaser one-XT - Extended Edition Benchtop Synthesizer. It was determined that procuring the required equipment brand name only was in the best interest of the Government. The Government will continue to survey the industry to determine if other alternatives become available.