1.5232248_Att.2.SSJunder13.5_Monolith_NT.automated-signed.pdf

Sole Source Justification Under Simplified Procedures for Certain Commercial Items in Accordance with FAR 13.5

1. Identification of the Agency and Contracting Activity.

a. Federal Agency and Contracting Activity.

Department of Health and Human Services

National Institutes of Health

National Institute on Drug Abuse

b. Sponsoring Organization.

National Center for Advancing Translational Sciences (NCATS)

Division of Preclinical Innovation (DPI)

NCATS Chemical Genomics Center (NCGC)

c. Project Officer Information.

• Project Officer Name. Bolormaa Baljinnyam

• Mailing Address. NIH/NCATS 9800 Medical Center Dr. Rockville, MD

20850-3370

• E-mail Address.baljinnb@mail.nih.gov

• Telephone Number. 301.827.0952

2. Nature and/or Description of the Action Being Approved.

a. Acquisition Purpose and Objectives.

The Chemical Genomics Center of National Center for Advancing Translational

Science regularly discovers and develops small molecule inhibitors, activators and chaperons of different proteins that are implicated in development of diseases. The binding affinity of a small molecule to its target protein is one of most important characteristics to evaluate these small molecules. Several biophysical methods are available to measure the binding affinity, but they are time and material consuming, and have to be performed by highly experienced user. Moreover some of these methods are not compatible with difficult to study target proteins.

Microscale thermophoresis technology (MST) is an easy to use method compatible with a wide range of targets under almost any condition, uses the least amount of material compared to the other biophysical methods, and can deliver results in a short time. MST is a patented technology that is only available from Nanotemper Technologies, Inc. The Monolith NT.Automated from Nanotemper Technologies, Inc. is the only available instrument on the market to perform microscale thermophoresis experiments in high throughput.

N/A

c. Total Estimated Dollar Value and Performance/Delivery Period.

The estimated total cost of the required item is $467,683 with a one-time inside delivery within 12 weeks ARO.

4. The Statutory Authority Permitting Sole Source.

This acquisition is conducted in accordance with FAR 13.501(a) and 41 U.S.C. 1901.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Nano Temper Technologies, Inc.

c/o Wyatt Strutz

400 Oyster Point Blvd. Suite 336

South San Francisco, CA 94080, USA

b. Nature of the acquisition and proposed unique qualifications of the contractor( s ).

Monolith NT. Automated is capable to measure binding affinity of 96 samples at a time using microscale thermophoresis technology (MST) in any buffer system including whole cell lysates. Monolith NT.Automated Base Module will be equipped with UV (label-free) reader to collect protein signal in a truly label-free manner using intrinsic fluorescence of a protein, and with pico-red, red and blue fluorescence channels to measure MST of a target using corresponding fluorophore labels. The specific labeling of target proteins allows the determination of binding affinity in total cell lysates, which allows to avoid the necessity of having highly pure recombinant material for experiments. This makes the experiments cost effective and opens a whole ray of possibilities to interrogate ligand interaction with hard to purify proteins, mechanism of action of small molecules by testing mutant forms of target protein or measure binding affinity of hit molecules with suspected targets.

MST is the cheapest, most time efficient and user friendly method compared to the other biophysical methods used to determine binding affinity. Surface plasmon resonance (SPR) experiments require approximately 12 times, isothermal calorimetry (ITC) about 40 times more material than MST. A single experiment using SPR takes about 14 times and ITC - about 6 times more run times. The total cost of a single experiment by SPR is almost 6 times, by ITC -almost 22 times more expensive taken material usage and consumables prices into account. Another technology for binding affinity which comes close to MST in regards of expence and time consumption is Bio Layer Interferometry.

However this method is not compatible with whole cell lysates and certain buffer additives, and requires immobilization of one of the binding partners to a surface which makes the experiment set-up more challenging. This makes MST a superior method to all other available biophysical methods for determination of binding affinity.

Nanotemper Technologies holds the patents for microscale thermophoresis and is the only vendor that produces an instrument for microscale thermophoresis, and as such is the only vendor that can meet NCATS's stated needs for this requirement.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

A non-competitive combined synopsis/solicitation will be posted. The CSS will allow for all interested parties to respond to the solicitation.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

NCATS' program office has determined that alternative methods of binding affinity are more costly and wasteful than MST. Prices quoted will be confirmed against published price lists.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Nano Temper Technologies, Inc. is the only vendor that distributes the Monolith NT.

Automated. This equipment is not on GSA Schedule. Conducting a search on GSA

Advantage confirms this.

9. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed an interest, in writing, in the proposed acquisition.

Jeffrey R. Schmidt -S Digitally signed by Jeffrey R. Schmidt -S Date: 2019.04.11 08:51:46 -04'00'