Synthesis of GS-443902, GS-443902-13C5, and their mono-phosphate for NCATS in support of Covid-19 Research

Amendment 1 - 1) The purpose of this amendment is to revise the solicitation description to replace the following from: Line 1: 50 mg (10%) each of GS-443902-13C5 and GS-443902 and 10 mg (10%) each of mono-phosphate and mono-phosphate-13C5, 1 each to Line 1: 50 mg (10%) each of GS-443902-13C5 and GS-443902 and 50 mg (10%) each of mono-phosphate and mono- phosphate-13C5, 1 each 2) This amendment also revises the following due date from: All responses must be received by Friday, January 22nd, 2021 at 9:00 a.m. Eastern time, and reference solicitation number 75N95021P00067. to All responses must be received by Monday, January 25th, 2021 at 7:00 a.m. Pacific time (10:00 a.m. Eastern time), and reference solicitation number 75N95021P00067. (end of amendment 1) This is a 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. The solicitation number is 75N95021P00067 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. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular Number 2021-02, dated 11/23/2020. The associated NAICS code 325413 and the small business size standard is 1,250 employees. This requirement is full and open with no set-aside restrictions. This requirement is for the following services: The Contractor shall synthesize the following compound structures and shall be delivered within 12 weeks of ARO. - Synthesize 50 mg of GS-443902-13C5 (purity >95%) - Synthesize 50 mg of mono-phosphate-GS-443902-13C5 (purity >95%) - Synthesize 50 mg of GS-443902 (purity >95%) - Synthesize 50 mg of mono-phosphate-GS-443902 (purity >95%) Line 1: 50 mg (10%) each of GS-443902-13C5 and GS-443902 and 10 mg (10%) each of mono-phosphate and mono- phosphate-13C5, 1 each Line 2: Shipping and handling (if applicable) Background: The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved remdesivir for treatment of suspected or laboratory confirmed COVID-19 in hospitalized adult and pediatric patients. Remdesivir is a prodrug. It metabolized into an alanine metabolite (GS-704277), further processed into the nucleoside momphosphate and ultimately into the nucleoside triphosposphate (GS-443902), which sterically interacts with the viral RdRp to induce delayed chain termination. To understand the metabolic process of remdesivir and GS-441524 to form GS-443902 and its mono-phosphate, The stable isotope labelled GS-443902 and its mono-phosphate are needed to quantify the amount of GS-443902 and mono-phosphate produced in both in vivo and in vitro studies. The high-quality unlabeled GS-443902 and its mono-phosphate are also needed as an standard in the studies. The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is 12 weeks from time of award. The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. 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 52.212-1, Instructions to Offerors-Commercial Items (Jun 2020) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2020) 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 Items (Oct 2018). Addendum to this FAR clause applies to this acquisition and is attached. The following provisions and clauses apply to this acquisition and are attached in full text: FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (Nov 2020) 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020) 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) Instructions for Submitting Electronic Invoices NIH Invoice and Payment Provisions (12/2020) 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)]. Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications'Commercial Items, with offers. The FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders'Commercial Items, applies to this acquisition and is attached in full text. The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. There are no additional contract requirement(s) or terms and conditions applicable to this acquisition The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. Any resultant award made from this solicitation shall include the following language required for all COVID-19 procurements: HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A'Health Resources Priorities and Allocations System. In addition, the Dun & Bradstreet Number (DUNS), 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. The following FAR certifications must be completed and submitted with offers: - 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020) - 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) All responses must be received by Friday, January 22nd, 2021 at 9:00 a.m. Eastern time, and reference solicitation number 75N95021P00067. Responses must be submitted by email to Nick Niefeld, contract specialist at contact@example.gov. The name and telephone number of the individual to contact for information regarding the solicitation. Nick Niefeld Contract Specialist Email: contact@example.gov Phone: +1 (555) 000-0000