Synthesis of - 960 for NCATS ETB

(i) This is a Small Business non-competitive combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is 75N95024R00111 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13'Simplified Acquisition Procedures; and FAR Part 12'Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of The National Center for Advancing Translational Sciences (NCATS), Division of Preclinical Innovation (DPI) intends to negotiate and award a Firm Fixed Priced contract without providing for full and open competition to Cell Mosaic, 10A Roessler Road, Woburn, MA 01801 for synthesis and delivery of 100g the lead NNMT inhibitor '960 after 6-step synthesis for animal studies. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). Only this suggested source can furnish the requirements, to the exclusion of other sources, because the project entails the synthesis of the key inhibitor - 960. The synthesis has six steps. The contractor has prior experience in the scale up synthesis of the third intermediate which is a chiral material and thus has the ability to carry out the first three steps in >50 g scale; this will ensure significant cost savings for the government as the work order won't rely on scale up optimization. This PO is essentially a continuation to carry out three additional steps from the key chiral intermediate and to prepare - 960 on a 100 g scale.changing the vendor at this step would lead to potential differing results rendering previous data unusable. A new vendor would require re-synthesis of the same material and then doing three more steps to scale the final compound. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2024-05 dated May 22, 2024. (iv) The associated NAICS code 325998 - All Other Miscellaneous Chemical Product and Preparation Manufacturing and the size standard in employees is 650. (v) This requirement is for synthesis and delivery of 100g the lead NNMT inhibitor '960 after 6-step synthesis for animal studies. (vi) Background: The Green Button Go is a critical piece of software which allows users to interface the mobile robot with other 3rd party instrumentation which is critical for developing automated workflows in chemistry as part of the ASPIRE project. This system will allow us to develop various tasks and protocols around it which can reduce the time sink for chemists to perform routine tasks. This piece of instrument is very critical to the success of ASPIRE. Purpose: The purpose of this requirement is for synthesis and delivery of 100g the lead NNMT inhibitor '960 after 6-step synthesis for animal studies. Project Requirements: 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. Specific Requirements: Delivery of 100 g of - 960 with QC indicating >99% purity (vii) The Government anticipates award of a firm fixed-price contract for this acquisition, and the anticipated delivery is: 12 months after receipt of award (viii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) FAR 52.204-29, Federal Acquisition Supply Chain Security Act Orders - Representation and Disclosures (Dec 2023) FAR 52.212-1, Instructions to Offerors-Commercial Items Sep 2023) FAR 52.212-3, Offeror Representations and Certifications-Commerical Products and Commercial Services (May 2024) HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of clause) The following clauses apply to this acquisition and are incorporated by reference: FAR 52.204-13, System for Award Management Maintenance (Oct 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020) FAR 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (Nov 2023) Addendum to this FAR clause applies to this acquisition and is attached. HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions below and submit completed copies as separate documents with their quote. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jan 2022) FAR 52.222-52 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification (May 2014). NIH Invoice and Payment Provisions (MAR 2023) (ix) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: a. Technical capability of the item offered to meet the Government requirement; b. Price; and c. Past performance [see FAR 13.106-2(b)(3)]. (x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer. (xi) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiii) Responses to this solicitation must include sufficient information to establish the interested parties bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s), product description, and any other information or factors that may be considered in the award decision. Such factors may include: past performance, special features required for effective program performance, trade-in considerations, probable life of the item selected as compared with that of a comparable item, warranty considerations, maintenance availability, and environmental and energy efficiency considerations. The Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All offers must be received by 2:00p.m., Eastern Daylight/Standard Time, on August 9, 2024, and reference solicitation number 75N95024R00111. Responses must be submitted electronically to Morgen Slager, Contract Specialist at morgen.slager@nih.gov. Fax responses will not be accepted.