CYCLOPE BIO SL.NOTICE OF INTENT.75N94024Q00155.pdf

RFQ# 75N94024Q00155

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 Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the on behalf of the National Institute of Digestive, Diabetes & Kidney Diseases intends to award a purchase order without providing for full and open competition (Including brand-name) to CYCLOPE BIO SL for the Acquisition of Enantiomers of Cyclopentane Diamine and Tetrahydrofuran Diamine.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 325199, All Other Basic Organic Chemical Manufacturing, with a Size Standard of 1,250.

PRIMARY PRODUCT/SERVICE CODE

6810 - CHEMICALS

PURCHASE ORDER TYPE

This purchase order will be Firm-Fixed Price.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular FAC 2024-05 Effective May 22, 2024.

This acquisition is conducted under the procedures as prescribed in FAR subpart 13—Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000).

STATUTORY AUTHORITY

This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1—Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1).

PAYMENT

Payment shall be made in one lump sum. Payment terms per the vendor allowance being a large business (net 30).

DELIVERY/PERIOD OF PERFORMANCE

Delivery Within 4 Months of Award

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

The Contractor shall deliver materials to: The National Institutes of Health, NIDDK, Bldg 8, Room 404, 9000 Rockville Pike, Bethesda, Maryland 20892. POC to be contacted for scheduling delivery and receiving of the required goods.

The Contractor shall plan with their shipper to transfer and deliver material and will coordinate all aspects of US customs especially when dealing with sensitive or controlled materials.

Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 8 Center Drive Bethesda, MD 20892

DESCRIPTION OF REQUIREMENT

The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life.

The NIDDK supports a wide range of medical research through grants to universities and other medical research institutions across the country. The Institute also supports government scientists who conduct basic, translational, and clinical research across a broad spectrum of research topics and serious, chronic diseases and conditions related to the Institute's mission. In addition, the NIDDK supports research training for students and scientists at various stages of their careers and a range of education and outreach programs to bring science-based information to patients and their families, health care professionals, and the public.

Chemists in the NIDDK Synthetic Bioactive Molecules Section (HNK6MA) have designed and synthesized a series of new molecules called thyclotides. Some of these molecules are potential components for diagnostic kits to be used for the rapid detection of nucleic acids associated with diseases. The development of new diagnostic kits to signal the early stages of infections or cancers could be of great benefit to human health and thus to NIDDK's mission. In order to make thyclotides and study their binding to nucleic acid sequences, it is essential to have the correct starting materials. The Appella lab has shown that the incorporation of trans-cyclopentanediamine into PNA backbones improves binding to target nucleic acid sequences. Our research on thyclotide development for the detection of nucleic acids associated with diseases therefore depends on the purchase of the chemicals in this order. These are the essential starting materials we must have for our research to continue. Substantial in vitro and in vivo work has been done to select thyclotides to move forward as probes for diseases, which has incurred substantial investment. The objective of this requirement is to procure the starting materials needed to make thyclotide molecules that are a critical part of the Appella lab’s research program.

PURPOSE AND OBJECTIVES

The objective of the research is to advance the testing of thyclotides as probes to signal the presence of infection or disease. To properly make thyclotide oligomers, the lab must have the correct building blocks that will be made from the materials to be purchased in this contract. These materials will be converted into the monomers needed to make thyclotide probes to target specific nucleic acids sequences associated with infection or disease. Results from each set of tests done are added to the file that will eventually be submitted for FDA approval as a new diagnostic test. The continuity of the project is enhanced by the use of as few CRO’s as possible and only ones technically qualified to meet the specific needs of the research.

SALIENT / REQUIRED FEATURES AND SPECIFICATIONS

The following product features/characteristics are required for this requirement:

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. Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined CYCLOPE BIO SL to be the only reasonable available source to provide the Acquisition of Enantiomers of Cyclopentane Diamine and Tetrahydrofuran Diamine.

This acquisition was pursued on a sole source basis centered on the following. CyclopeBioSL, is an established chemical company with specific expertise to make and analyze the molecules in this purchase. CyclopeBioSL has proprietary technology to make these desired molecules. This is a highly specific research-based purchase to acquire materials that are not commonly produced. These are synthetic materials that do not occur naturally and must be made using custom protocols. There is no other vendor that can provide the same materials in the quantity and enantiopurity that we require. Failure to use the vendor CyclopeBioSL will critically delay future research and increase costs of these studies for NIDDK.

Chemists in the NIDDK Synthetic Bioactive Molecules Section (HNK6MA) have designed and synthesized a series of new molecules called thyclotides. Some of these molecules are potential components for diagnostic kits to be used for the rapid detection of nucleic acids associated with diseases. The development of new diagnostic kits to signal the early stages of infections or cancers could be of great benefit to human health and thus to NIDDK's mission. In order to make thyclotides and study their binding to nucleic acid sequences, it is essential to have the correct starting materials. The Appella lab has shown that the incorporation of trans-cyclopentanediamine into PNA backbones improves binding to target nucleic acid sequences. Our research on thyclotide development for the detection of nucleic acids associated with diseases therefore depends on the purchase of the chemicals in this order. These are the essential starting materials we must have for our research to continue. Substantial in vitro and in vivo work has been done to select thyclotides to move forward as probes for diseases, which has incurred substantial investment.

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: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity Identifier (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.”

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. 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 to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Wednesday, July 17, 2024 to the Contract Specialist, Amber Harris, at amber.harris@nih.gov .

Assessment of Capability Lowest Price Technically Acceptable http://www.sam.gov/ mailto:amber.harris@nih.gov