SS Justification_5439_Redacted.pdf

U.S. Department of Navy Naval Research Laboratory - Small Purchase Branch

USE OF OTHER THAN FULL AND OPEN COMPETITION FOR AN

ACQUISITION UNDER THE SIMPLIFIED ACQUISITION THRESHOLD –

(exceeding $10,000 - $250,000)

Purchase Request No.

PR : 1301045349

FAR 13.106-1(b)(1)(i) states for purchases not exceeding the simplified acquisition thre one source if the Contracting Officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization).

As required by FAR 13.106-3(b)(3)(i), this justification explains the absence of competition for this acquisition, as only one source will be solicited for this requirement (or for a portion of the requirement) and the requirement is not expected to exceed the simplified acquisition threshold.

DESCRIPTION OF ITEM OR SERVICE: (Provide a description of the item or service required, to include its intended use, the name of the required source or brand name, and the required delivery date/period of performance.)

The Naval Research Laboratory (NRL), Code 6900 has a requirement to procure an EVOcard from Eurofins Genomics (Eurofins).

These EvoCards are a same-as-cash form of payment used to procure oligonucleotides, synthesized and cloned genes, and sequencing reactions directly from Eurofins. These products are required for molecular biology, biotechnology and DNA nanotechnology work done by many researchers in 6900, and timely delivery is absolutely necessary for that type of work to move forward at a reasonable pace. Oligonucleotides are used to amplify DNA sequences for bioproduction of proteins of molecules of high DoD importance, to modify DNA or RNA sequences for threat detection, and to specifically assemble proteins and molecules on nanoparticles for sensors and bioproduction. Synthesized genes provide unique capabilities for production of DoD materials and molecules, and sequencing reactions allow researchers to proofread their DNA constructs as well as discover new DNA sequences from organisms.

The required delivery date is 12/22/2022 THE DETERMINATION FOR USE OF OTHER THAN FULL AND OPEN COMPETITION IS BASED ON THE FOLLOWING (select all that apply):

A. ONLY ONE RESPONSIBLE SOURCE (select all that apply):

1. RESTRICTIVE RIGHTS. The source has established proprietary rights, limited rights in data, patent rights, copyrights or secret processes in the item or service required. (Explain what rights are restricted, why the restrictive rights make the required item or service available from only one source, and why another company could not satisfy the Government’s need.)

2. EXCLUSIVE LICENSING AGREEMENTS. The item or service is only available from the Original Equipment Manufacturer (OEM), or there is only one authorized distributor or technical representative for the OEM. (Identify the OEM and explain the circumstances surrounding why the item or service is only available from the OEM).

OR

Identify the distributor(s)/authorized technical representative(s) for the item or service. Provide evidence of the exclusive licensing agreement as an attachment to this document. NOTE: If there is more than one distributor/authorized technical representative for an OEM part, then Part B, BRAND NAME SOLE SOURCE, is applicable, and Part A, ONLY ONE RESPONSIBLE SOURCE, should be left blank).

3. OTHER REASONS. Other reason not identified above. Provide details on mission impact if requirement is not solicited from only one source.

Oligonucleotides are used to amplify DNA sequences for bioproduction of proteins or molecules of high DoD importance, to modify DNA or RNA sequences for threat detection, and to specifically assemble proteins and molecules on nanoparticles for sensors and bioproduction. Synthesized genes provide unique capabilities for production of DoD materials and molecules, and sequencing reactions allow researchers to proofread their DNA constructs as well as discover new DNA sequences from organisms.

The Government’s minimum requirements for DNA sequencing and oligo synthesis are as follows:

Oligos:

- Oligonucleotides from 5-125 bp each, quantified by UV spectrophotometry and verified by ESI- mass spectrometry

- 10 nmole scale up to 10 umole

- Shipped in tubes or plate format

- Purification options – desalting, PAGE, HPLC, IE-HPLC, RNase-Free HPLC, Dual HLPL, and Dual PAGE & HPLC (these are necessary for high purity for NGS and other work).

- Option for specialized oligos up to 200 bp each – verified by ESI-MS

- Custom long oligo synthesis for NGS applications – already validated in internal sequencing workflows and instruments

- SARS-CoV-2: Validated use of primers, probes and sequencing panels already validated and in use in CoVID related research and environmental monitoring.

- Modifications: various fluorescent dyes, degenerate bases, attachment mods, non-fluorescent labels, quenchers, and modified bases or spacers.

- Option for next day delivery of ordered primers

- RNA oligonucleotides: single-stranded or duplexed RNA up to 80 bp

Gene fragments:

- Tube, or plate format

- Options for ordering gene fragments (dsDNA) or cloned genes

- Shipped in no more than 15 BD

- 200ng minimum delivered

- Codon optimization services for bacterial, yeast, or mammalian genes

- Option for sequencing validation of construct

- Can be provided in a plasmid and sequence validated Sequencing services:

- Sanger sequencing of different templates: purified or unpurified plasmids, purified or unpurified PCRs, cells in glycerol stock

- Sequencing of whole plasmids using primer walking protocols

- Whole genome sequencing

- Amplicon sequencing (such as 16S or other mixed population PCR)

- Metagenomics sequencing

- RNA-Seq and other targeted sequencing

- NGS platforms must include a range of Illumina and the PacBio instruments for scalable depth and read length requirements.

- Workflows include customizable data analysis option, which have also been utilized and will be needed for consistent and comparable analyses across new and existing datasets.

Eurofins is the only company that can fulfill these requirements within a required 24-hour turn around. The 24 hour turnaround time is required, as this is essential to avoid Government research centers from entering a standstill, and halting research production. All the above-mentioned work is already severely impacted and programs will miss deadlines. This is affecting critical Navy Laboratory research on novel biothreats such as emerging diseases and pathogens that impact the safety of the warfighter.

A Notice of Intent was posted to Sam.gov on 29 November 2022 with a closing date of 2 December 2022. The purpose of this notice was to notify the public of the Government’s intent to sole source this effort to DNA Technologies. By the closing date and time, no responses were received from industry.

B. BRAND NAME. Item required must be a brand name product, or feature of a product, particular to one manufacturer. (Discuss why you are precluding consideration of a product manufactured by another company. Describe how the particular brand name, product, or feature is essential to the Government’s requirements and why a “brand name or equal” purchase description cannot be used (see FAR 11.104). Describe how market research indicates other companies’ similar products or products lacking the particular feature do not meet, or cannot be modified to meet, the agency’s needs.)

C. UNUSUAL AND COMPELLING URGENCY. The supplies or services are of such unusual and compelling urgency that the Government would be seriously injured unless the agency is permitted to limit the number of sources from which it solicits bids or proposals. Urgent requirements are supplies or services that will result in a work stoppage, or are mission critical and the routine processing time would result in injury to the Government. The determination that the procurement for the above item/service is an urgent and compelling requirement is based on the following:

1. Date on which the requirement was first identified:

2. Required delivery date/period of performance: