Notice of Intent_Retrogenix Limited.docx

Title: Small-Molecule Target Deconvolution via radiolabeled small molecule-celluar protein interactions

PRE-SOLICITATION NON-COMPETITIVE - NOTICE OF INTENT

Date: September 11, 2020 Solicitation #75N95020Q00327

I. INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), NIDA Section, Contracts Management Branch Red on behalf of the National Institute on Drug Abuse (NIDA), Intramural Research Program (IRP) intends to negotiate and award a purchase order without providing for full and open competition (Including brand-name) to Retrogenix Limited, Inc. located at High Peak Business Park Buxton Road, Chinley, High Park, SK23 6FJ, United Kingdom.

II. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541380 – Medical Laboratory Testing with a business size standard classification of 1000 employees.

III. REGULATORY AUTHORITY

The resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2020-09 effective date 08-31-2020.

This acquisition is conducted under the procedures as prescribed in FAR subpart 13—Simplified Acquisition Procedures at an amount not exceeding the SAT.

IV. STATUTORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements.

V. DESCRIPTION OF REQUIREMENT

Background The research in the Biobehavioral Imaging & Molecular neuropsychopharmacology Unit involves the testing of receptor-protein and receptor-drug interactions. The laboratory relies on the use of radiochemical-based assays for performing this testing and these types of assays provide the most robust and reliable results. Target deconvolution is a key aspect of small molecule therapeutics. Many small molecule therapeutics provide a desired phenotypic response for a given disease or disease model. However, the small molecule molecular targets often remain unknown. In order to better understand the disease and the small molecule therapeutics, it is critical to discover and understand the molecular target. Target deconvolution allows for the identification of this molecular target through a variety of methods, including the use of radiolabeled small molecules.

Purpose and Objectives The purpose of this acquisition is to obtain results from small molecule target deconvolution studies on two different radiolabeled small molecules in order to determine the target of the small molecules.

Purchase Description:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

1. The government will provide two target radiolabeled compounds to the contractor.

In addition, the government will provide the “cold” (non‐radiolabeled) compounds to the contractor. Government will have the option to provide unlabeled, inactive compound. The government will provide no more than 2000 nmoles of each radiolabeled compound and no more than 200 mg of each cold compound will be provided.

2. Contractor will evaluate the background binding and compound suitability of the two radiolabeled compounds at two concentrations in HEK293T cells.

3. Contractor will screen the radiolabeled compounds against a library of over 5,900 human proteins.

a. Proteins will be in reverse transfected HEK293T cells

b. Contractor will provide the appropriate controls to ensure the cells are transfected

c. Contractor will image the cells for radioactivity, to observe hits

4. Contractor will confirm any hits with cold displacement studies.

5. Contractor will provide a comprehensive report on the results of the assessment

a. Report will include images on the confirmation screen

b. Report will include the names of all proteins screened

c. Report will include all hits

d. Contractor will be available for verbal communication regarding the results of the screen

6. Contractor will be available via e‐mail or phone concerning the progress of the project, with an update no less than every four weeks on progress.

Delivery Date & Address :

Seven (7) weeks from the date of award.

Biomedical Research Center 251 Bayview Boulevard, Room 07A711 Baltimore, MD 21224

Packaging, Packing, and Shipping Instructions:

The Contractor shall ensure that all items are preserved, packaged, packed and marked in accordance with best commercial practices to meet the packing requirements of the carrier and to ensure safe and timely delivery at the intended destination. All data and correspondence submitted shall reference:

1) The Contract Number

2) The government end user agency

3) The name of the recipient

4) Name of contractor

5) Description of items contained therein

6) Consignee(s) name and address

Inspection and Acceptance Criteria:

The Government will review, for completeness, preliminary or draft products that the Contractor submits, and may return them to the Contractor for correction. Final approval and acceptance required herein shall be by written approval and acceptance by the Government. The Contractor shall not construe any letter of acknowledgment of receipt as a waiver of review, or as an acknowledgment of conformance with this purchase description. Any approval given during preparation, or approval for shipment shall not guarantee the final acceptance of the completed product.

VI. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10—Market Research.

The sole source determination is based on the fact that the proposed project aims to perform target deconvolution studies, using radiolabeled 3H-psilocin (the active form of psilocybin) and 3H-LSD. Retrogenix has a history of working with illicit drug substances and has screened numerous other radiolabeled small molecules. Retrogenix will work to identify new receptors that bind to these radiolabeled small molecules. Retrogenix Ltd is the only company that has the proprietary technology necessary to test these radiolabeled compounds against over 5900 proteins that are expressed in their native conformation in human cells, the largest screening library of its kind available on the market.

VII. CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.”

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by September 14, 2020 by 2:00 pm EST. Responses must be submitted electronically to Andrew Varley, Contract Specialist at Andrew.Varley@nih.gov .