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Title: Acquisition of pMLV-SARS-CoV-2-Luciferase pseudovirus particles (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as suppl... Title: Acquisition of pMLV-SARS-CoV-2-Luciferase pseudovirus particles (i) 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. (ii) The solicitation number is 22-005203 and the solicitation is issued as a non-competitive combine synopsis/solicitation 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 Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Codex BioSolutions Inc for MLVs for Omicron variants. The anticipated award date is 10 June 2022 This acquisition is non-competitive due to the need for continuity of research and data consistency. See FAR 13.106(b). (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-06 dated 5/26/2022. (iv) The associated NAICS code is 541714 and the small business size standard is 1000. No set-aside restriction is applicable. (v) This purchase consists of: 1 CB-97100-167-C pMLV-SARS-CoV-2-Luciferase-BA.1 puedovirus particle (10X concentrated) 10 each 2 CB-97100-168-C pMLV-SARS-CoV-2-Luciferase-BA.2 puedovirus particle (10X concentrated) 10 each 3 CB-97100-170-C pMLV-SARS-CoV-2-Luciferase-BA.4 puedovirus particle (10X concentrated) 15 each 5 CB-97100-172-C pMLV-SARS-CoV-Luciferase-BA.2.12.1 puedovirus particle (10X concentrated) 15 each 6 CB-97100-222 Custom SARS_CoV2 Spike gene synthesis and sucloning 2 each (vi) NCATS proposes to purchase pMLV-SARS-CoV-2-Luciferase pseudovirus particle (10X concentrated) BA.1, BA.2, BA.4, BA.2.12.1 for SARS-CoV-2 virus testing to support SARS-CoV-2 research for DPI_SARS-CoV-2_Variant Trace Project. These synthetic viral particles are safer surrogates of native viruses and acquire the tropism and host entry pathway characteristics governed by the heterologous envelope glycoprotein used. They have proven to be very useful tools used in research with many applications, such as enabling the study of entry pathways of enveloped viruses and to generate effective gene-delivery vectors. The basis for their generation lies in the capacity of some viruses, such as murine leukemia virus (MLV), to incorporate envelope glycoproteins of other viruses into a pseudotyped virus particle. These can be engineered to contain reporter genes such as luciferase, enabling quantification of virus entry events upon pseudotyped particle infection with susceptible cells. (vii) Delivery shall be to: The National Center for Advancing Translational Sciences (NCATS) 9800 Medical Center Drive Rockville, MD 20850 Delivery shall be within 4 weeks after receipt of order, FOB destination. Offers must include shipping costs. (viii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition. (ix) The award resulting from this solicitation will be made to the responsible offeror whose proposal is most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotations: Technical Capability, Past Performance, and Price. (x) Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Items, with offers. (xi) The FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition. The following addendum applies: The following FAR provisions or clauses are incorporated by reference: 52.204-7, System for Award Management (Oct 2018) 52.204-13, System for Award Management Maintenance (Oct 2020) 52.204-16, Commercial and Entity Code Reporting (Aug 2020) 52.204-18, Commercial and Entity Code Maintenance (Aug 2020) HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015). Offerors must complete and return the FAR representation 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021), attached. (xii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items, applies to this acquisition. (xiii) 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. None (xiv) 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. (xv) This synopsis is not a request for competitive proposals. All responsible sources may submit a bid, proposal or quotation which shall be considered by the agency. However, interested parties may identify their interest and capability to respond to this notice. Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. A determination by the Government whether to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered to determine whether to proceed on a non-competitive basis as indicated above, or to conduct a competitive procurement. If the Government opts to use a competitive procurement, offers will be evaluated using a comparative evaluation approach in accordance with FAR 13.106-2(b)(3). In that case, award will be made to the responsible offeror whose response meets the solicitation’s requirements and, as a whole, will be most advantageous to the Government, price and other factors considered. The comparative evaluation will include: Technical Capability of the item(s)/service(s) to meet the Government requirement, Price, Terms and Conditions, and Past Performance. Responses may exceed capability or performance characteristics of the solicitation’s requirements. The Government reserves the right, but is not required, to award to a response that exceeds capability or performance characteristics of the solicitation’s requirements if it provides a benefit to the Government. 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. (xvi) In addition, the Unique Entity Identifier (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 responses must be received by 3 June 2022 0800hr and reference solicitation number 22-005203. Responses must be submitted by email to Karen Elmore, Program Specialist, karen.elmore@nih.gov, tel. 240-550-0242 Attachments: Purchase Description or Statement of Work ( PD, include: dated 5/26/2022 FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items NIH Invoice and Payment Instructions