BRAND NAME ONLY JA_Open Market_Redacted.pdf

Control No: JA 22-05-1161

Memorandum for Record – Limiting Competition at or below the Simplified Acquisition Threshold

1. Contracting Activity: The U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD, 21702 on behalf of the U.S. Army Medical Research Institute of Chemical Defense (USAMRICD), Building E2900, 8350 Ricketts Point Rd, APG-EA, MD 21010.

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Contract Vehicle: Purchase Order Number _TBD___________________________ Blanket Purchase Agreement (BPA) Number _______________ Order/BPA# _____ against FSS Contract #_Multiple Award BPA Order #___________ against Multiple Award IDIQ Contract Name or #______________

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: Research, Development, Test and Evaluation, Army – 2 year

FY: 21/22

Version – February 2017

Brand Name Buy: Yes No

3. Description of Services or Supplies: USAMRICD requires a quantity of forty (40) unique plasmid DNA preparations capable of directing custom gene expression. A “plasmid” is a circular piece of DNA that will replicate inside of living cells. The number of plasmids is greatly increased inside of cells, to an amount required for use in experiments. A “plasmid DNA preparation” is the DNA isolated and purified from cells after several rounds of plasmid replication. The plasmid preparations are the products we will use in our experiments. Each plasmid preparation will be distinguished by having one of 40 different genes inserted into the plasmid DNA. The particular type of plasmid to be used is referred to as an “expression vector”. This means that the protein product of the gene insert is “expressed” (i.e., produced) in experiments when the plasmid is transferred to a cell type of interest.

Delivery required no later than 30 September 2022.

Total Value:

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

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:

This work includes the validation of potential targets for treating toxicant injury, and follows a highly similar National Institute of Health Inter-Agency Agreement (NIH-IAA) completed in 2019. Plasmid preparations for the 2019 project were produced by GeneArt, a subsidiary of Life Technologies Corporation, now owned and operated by Fisher Scientific. For consistency in results and maintenance of data quality, there are strict requirements on the type of gene expression vector used and the methodology followed to produce the final DNA plasmid preparations:

1. The expression vector must be pcDNA3.1.

2. The gene inserts must have a gene sequence that is optimized to express the human protein.

3. The gene inserts must be capable of directing protein expression in the presence of a specific siRNA sequence (an RNA molecule that inhibits gene expression).

4. Plasmid preparations must contain 500 ug of DNA.

5. Sequence complexity must be considered as part of gene insert design.

GeneArt is the only supplier that can fulfill the subject requirement. Similar products were previously ordered from GeneArt via Fisher Scientific via BPA call order W81XWH-19-F-0536. These products were used in the foundational work conducted to develop the same experimental protocols that will be used in the research supported by this contract. GeneArt uses a proprietary version of the plasmid pcDNA™3.1. The specific plasmid used to generate the required product is central to project success.

This is because the plasmid is what controls the expression (or “production”) of the gene under investigation. To maintain research comparability and continuity, the same version of plasmid DNA must be used to ensure that gene expression is regulated in the same manner as in previous work.

The gene sequences inserted into the pcDNA™3.1 plasmid will direct the synthesis of each of the 40 proteins under study. There are multiple gene sequences that can produce the same protein. However, certain variations of the gene sequence are expressed better than others. GeneArt uses a proprietary algorithm referred to as “GeneOptimizer” to identify a gene sequence that demonstrates significant improvement in protein synthesis compared to other gene sequence variations. Up to 20 different characteristics of potential gene sequences are evaluated by the algorithm. The previously purchased products contained specific sequences that were determined by GeneArt’s GeneOptimizer technology. No brand other than GeneArt will meet USAMRICD’s requirement.

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)(11)

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 through the World Wide Web (WWW), consulting vendors, collaborators, other laboratories, and reviewing previous purchases. No vendor other than GeneArt was found to be capable of performing the necessary function. DNA products are available for purchase from two other suppliers (Integrated DNA Technologies and Eurofins Genomics); however, neither of these vendors offer the proprietary plasmid pcDNA™3.1. Integrated DNA Technologies and Eurofins Genomics do not have access to the specific version of the vector used by GeneArt, and therefore products purchased from these companies are incapable of generating experimental results that can be compared to data obtained in earlier studies. Additionally, neither company offers a genetic sequence optimization service comparable to GeneArt’s proprietary GeneOptimizer technology. If purchased from Integrated DNA Technologies or Eurofins Genomics, the required products would lack significant features related to gene sequence optimization that were present in products previously purchased from GeneArt to for use in the research that preceded the work supported by this contract.

8. Other Facts: USAMRAA awarded a delivery order to Thermo Fisher on 08 August 2019: BPA W81XWH-17-A-0018 Order W81XWH19-F-0536. The award amount was $ . The ordering period for that BPA expired.

9. Technical/Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name:

Date: See electronic signature Title:

Signature:

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10. Contracting Officer Certification/Approval:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon price analysis.

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government. Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Typed Name:

Date: See electronic signature Title:

Signature:

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