75N94023Q00088.pdf

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation, and a separate written solicitation will not be issued. This solicitation number is 75N94023Q00088 and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2023-04. The North American Industry Classification (NAICS) Code is 541380 and the business size standard is $19M. It is the intent of The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), in support of the work of the National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK) to award a purchase order, without providing for full and open competition, to Polyorg, Inc.

10 Powers Street · Leominster, MA 01453, to procure Bhoc Nucleobase Acids.

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 thyclotides oligomers, the lab must have the correct building blocks that will be made from the materials to be purchased in this contract.

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 using as few Clinical Research Organizations (CROs) as possible and only CROs technically qualified to meet the specific needs of the research.

SALIENT / REQUIRED FEATURES AND SPECIFICATIONS

• Experience in drug synthesis and compliance with FDA requirements and drug development protocols is required.

• Purify each molecule via recrystallization or silica gel chromatography.

• Perform characterization by Nuclear Magnetic Resonance (NMR) and check purity by Mass Spectrometry (MS)

• Final products must be delivered with requested quantity for each molecule, with purity more than 98%.

• Final products will be analytically tested by NIDDK before final acceptance.

• Scale of synthesis – Synthesis may be performed in batches. A complete certificate of testing (Analysis) will be provided for each synthetic batch. Obtaining synthesis service will allow NIDDK lab to pursue advanced experiments without needing to continually repeat established protocols.

• 40 g A(Bhoc)-OH, 60 g C(Bhoc)-OH, 80 g G(Bhoc)-OH – These materials will be converted into the monomers needed to make cyPNA probes and thyclotides to target specific nucleic acids sequences associated with infection or disease.

• Certificate of Analysis (COA) for each molecule synthesized (per batch)

TASK AREAS

Task Area 1 – Nucleobase Acetic Acids – The Contractor shall provide synthesis, and analysis for 40 g A(Bhoc)-OH, 60 g C(Bhoc)-OH, and 80 g G(Bhoc)-OH

Task Area 2 – Lab Protocol Adherence – The Contractor shall follow the confidential synthetic protocols from the NIDDK lab and provide written documentation of all deviations from established protocols (upon request from Project Officer). NIH Laboratory Protocol(s) will be provided upon award.

Task Area 3 – Shipping Instructions – The Contractor shall ship 40 g A(Bhoc)-OH, 60 g C(Bhoc)-OH, 80 g G(Bhoc)-OH in a glass or plastic canister inside a protected shipping box or package to NIH campus, Bethedsa, MD, 90-days from contract award. NIH Fed Ex shipping account to be charged and will be provided at time of award.

The offeror must include a completed copy of the following provisions: 1) FAR Clause 52.212-1 Instructions to Offerors – Commercial items; 2) FAR Clause 52.212-2, Evaluation

– Commercial Items. As stated in FAR Clause 52.212-2 (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be advantageous to the Government, price and other factors considered. The following factors will be used equally to evaluate offers: Technical Evaluation, Price, and Past Performance. The Government will make award based on Best Value.

Note: Past Performance Information: Vendors must submit a listing of the most recent contracts/awards (minimum of 3) which demonstrate similar work in nature to this Solicitation. Contracts/awards may include those entered with the Federal Government, state and local governments and commercial concerns. Include the following information for each contract or subcontract:

1. Name of Contracting Organization

2. Contract Number (for subcontracts provide the prime contract number and the subcontract number)

3. Contract Type

4. Total Contract Value

5. Description of Requirement

6. Contracting Officer’s Name and Telephone Number

7. Program Manager’s Name and Telephone Number

3) FAR Clause 52.212-3, Offeror Representations and Certifications – Commercial Items;

4) FAR Clause 52.212-4, Contract Terms and Conditions – Commercial Items; 5) FAR Clause 52-212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items – Deviation for Simplified Acquisitions. The DUNS Number is no longer valid for federal award identification, 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 . The clauses are available in full text at http://www.arnet.gov/far. NOTE TO CONTRACTOR: The contractor shall provide a completed copy of FAR 52.204-24, "Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment" with their quote in response to this solicitation.

Interested vendors capable of providing the Government with the items specified in this synopsis should submit their quotation to the below email address. Quotations will be due 09:00AM EST July 26,2023. Offerors shall send the quotation/proposal to Verne

Griffin at verne.griffin@nih.gov. The quotation must reference Solicitation number RFQ- 75N94023Q00088. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement, 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 Vendor/Contractor’s (UEI) the Unique Entity ID from SAM.gov is now the authoritative identifier for those doing business with the federal government. The DUNS Number is no longer valid for federal award identification, 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 . The contractor will be evaluated on their capability to provide the product to the specifications as stated on the solicitation and shall be required to provide required service with certification from the OEM.