SOLE_SOURCE_STATEMENT-_Illumina_REDACTED.pdf

SOLE SOURCE STATEMENT

RCP/PR Number: N4485218RCP0064

1. IDENTIFICATION OF THE AGENCY AND THE CONTRACTING ACTIVITY:

This is a Sole Source Statement. The Naval Medical Logistics Command is the contracting activity, acting on behalf of behalf of the Naval Medical Research Unit – Six (NAMRU-6).

2. NATURE/DESCRIPTION OF CONTRACT ACTION:

The proposed acquisition is for a Firm Fixed Price single contract to Illumina, Inc., 5200 Illumina Way, San

Diego, CA, 92122-4616, to provide reagent kits designed for library preparation and sequencing.

3. DESCRIPTION OF REQUIRED SUPPLIES/SERVICES:

The kits must be designed for library preparation and sequencing. The library preparation kit should include a variety of steps that include enzymatic fragmentation, size selection, end-repair, a-tail and ligation step in the same reaction. The process should allow including dual index at the 5 and 3 prime end for later sample identification. The library preparation kit should be designed to construct libraries with a low DNA input (-50ng) with master-mixed reagents ready to use. Similarly, the sequencing kit should allow us to run more than 150 sequencing cycles. Those cycles are needed to run paired-end libraries with a high quality performance. We expect to have more than 2.0Gb per sequencing run with high Q30 values. Finally, the sequencing kit should include an internal control to validate the sequencing run.

The items being purchased have all been validated and are compatible with the equipment in use and owned by

NAMRU-6: 7500 Fast Real-Time PCR, MiSeq and MiniSeq Illumina systems. All Standard Operating

Procedures (SOPs) have been developed over the years using the same reagents and are the gold standard for

NAMRU-6 laboratories. Design and validation of all laboratory procedures have been standardized with these items, since they have shown to perform up to standard. Assays have been developed independently for each

SOP followed in the laboratories; therefore, the reagents must remain the same as the ones specified in the SOPs, otherwise, the design and validation of these processes would have to be reinitiated from zero, which would delay all processing and the timely diagnosis of public health relevant pathogens. Changing the source of reagents would mean altering the validity of the results for the surveillance studies that measure rates of disease across years.

Market research, based on NAMRU-6 scientific staff, prior procurements, and Internet research concluded that the items are available from only one source. In addition, items must arrive at NAMRU-6 in Lima, Peru in accordance with a defined schedule in order to sustain the laboratory activities to meet the mission of NAMRU-

6. The only way to assure that the items will arrive as required is by purchasing from one vendor. Peruvian customs clearance usually takes between 3-4 weeks, and having multiple shipments from multiple orders pending in customs could lead to some reagents being unavailable when needed for conducting testing, this would be detrimental to mission-critical processes and ultimately lead to a delay in reporting research results and findings to our funders.

The contract will have three delivery periods within a 3-4 month timeframe. The estimated dollar value of the subsequent contract is (to include specialized shipping to Lima Peru.).

funds will be utilized.

4. STATUTORY AUTHROITY PERMITTING OTHER THAN FULL AND OPEN COMPETITION.

The statutory exception permitting other than full and open competition for this acquisition is 10 USC 2304(c)(1)

(as implemented by FAR 13.106-1(b)) only one responsible source and no other supplies or services will satisfy agency requirements.

5. IDENTIFICATION OF THE JUSTIFICATION RATIONALE AND/OR DEMONSTRATION

OF CONTRACTOR’S UNIQUE QUALIFICATIONS:

Market research was conducted to ascertain if multiple sources existed in the marketplace that could meet the

Government’s requirement. Market research conducted using Internet searches and prior procurement history produced no other sources that could meet the Government’s requirements except for Illumina Inc.

6. SYNOPSIS OF INTENT TO SOLE SOURCE:

To solicit capable offerors, a sources sought notice will be synopsized on the Federal Business Opportunities

(FBO) website for 5 days. Thereafter, a notice of intent to sole source will be synopsized on the FBO website for

15 days. Unless a capable source is identified through these notices, no other sources will be solicited for the reasons discussed in Paragraph 5.

7. TECHNICAL CERTIFICATION:

I certify that the technical facts and information included herein are complete and accurate.

8. CONTRACTING OFFICER APPROVAL:

I certify that this Justification is accurate and complete to the best of my knowledge and belief.