NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER:

75N95023Q00639

1. TITLE: Synthesis of tert-butyl (R)-3-(5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)piperidine-1-carboxylate

1. CLASSIFICATION CODE:

B504 – Special Studies/Analysis-Chemical/Biological

NAICS CODE: 325414 – Biological Product (except Diagnostic) Manufacturing

1. RESPONSE DATE:

August 21, 2023, 4:00 pm EST

1. PRIMARY POINT OF CONTACT:

Michele Pastorek

michele.pastorek@nih.gov

Phone: 301.827.1739

1. DESCRIPTION:

INTRODUCTION

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

1. National Center for Advancing Translational Sciences (NCATS) intends to negotiate on a sole source basis with ChemoGenics BioPharma for the synthesis of tert-butyl (R)-3-(5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)piperidine-1-carboxylate in 75 gram quantity.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS

The intended procurement is classified under NAICS code 325414 – Biological Product (except Diagnostic) Manufacturing with a Size Standard of 1,250 employees.

REGULATORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from 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).

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2023-04 dated June 02, 2023

DESCRIPTION OF REQUIREMENT

PURPOSE AND OBJECTIVES:

The purpose of this requirement is to procure the synthesis of tert-butyl (R)-3-(5-oxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)piperidine-1-carboxylate.

QTY:

75 grams

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION

This is a follow-up request to a previous acquisition that NCATS procured to get the chemical intermediate listed in this requisition (tert-butyl (R)-3-(5-oxo-4,5-dihydro-1H-1,2,4-triazol-3- yl)piperidine-1-carboxylate in 75 gram quantity.). The program needs to use the same intermediate to synthesize a less active compound compared to the more active compound that was already synthesized using the intermediate from Chemogenics BioPharma. It is important we receive these intermediates from Chemogenics BioPharma for consistency of data and continuity of research.

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, ChemoGenics BioPharma is the only vendor in the marketplace that can provide the services required by NCATS .

The intended source is:

ChemoGenics BioPharma

3325 Durham Chapel Hill Blvd, Suite 250

Durham, NC 27707

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.

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.

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 Unique Entity ID (UEI), 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.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number 75N95023Q00639. Responses must be submitted electronically to Michele Pastorek, Contract Specialist, at

Michele.pastorek@nih.gov and Valerie Whipple, Contracting Officer, at valerie.whipple@nih.gov. U.S. Mail and fax responses will not be accepted.

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