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NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Liver Assay in Liver Spheroids for siRNA/ASOs (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the ... NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Liver Assay in Liver Spheroids for siRNA/ASOs (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 75N95024Q00441 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), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to InSphero, Inc., TechPlace, 74 Orion Street, Brunswick, ME 04011 for the Liver Assay in Liver Spheroids for siRNA/ASOs. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2024-05, with effective date 05/22/2024. (iv) The associated NAICS code is 541380 - Testing Laboratories and Services and the small business size standard is $19.0 million. This requirement is non-competitive with no set-aside restrictions. (v) This requirement is for the following services: Liver Assay in Liver Spheroids for siRNA/ASOs. (vi) siRNA/ASOs are short strands of modified RNA and DNA that bind to target RNA and can act by modulating splicing, inhibiting translation, or inducing mRNA degradation. siRNA/ASOs are increasingly being deployed as individualized medicines as they are rapidly customizable, relatively easy to deliver, and inexpensive to manufacture. Although there is a growing number of clinical examples and safety data for ASOs, there is a need to reduce the cost and development timelines to test these therapies in more patients with rapidly progressing life-threatening diseases faster without compromising safety. Antisense oligonucleotides comprise 16 to 20 nucleotide bases, often with chemical modifications of the phosphate backbone. It is thought that the sequence and backbone chemistry of the siRNA/ASOs determines whether administering a particular siRNA/ASO molecule will lead to liver toxicity. However, the broader development of high-affinity gapmer siRNA/ASOs has been hampered by hepatotoxicity. The objective of this contract is to generate proof-of-concept data for evaluating the toxicity of siRNA/ASO using 3D liver microtissue platform to predict the safety of future candidate siRNA/ASOs intended for clinical use. See Attachment 1 - Statement of Work. (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is 8/05/2024-10/28/2024 (approximately 12 weeks from award of Purchase Order). (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 Products and Commercial Services (Sep 2023) FAR 52.212-3, Offeror Representations and Certifications-Commercial 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 applicable provisions and submit completed copies as separate documents with their proposal. 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 Products and Commercial Services (May 2024) 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) Offerors must include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (May 2024), 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 clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price quote must include the price for the following line items: 1) Liver Assay in Liver Spheroids for siRNA/ASOs. The Unique Entity ID from SAM.gov, 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 quotations must be received by 12:00pm Eastern Daylight Time, on July 23, 2024, and reference Solicitation Number 75N95024Q00441. Responses must be submitted electronically to Michele Pastorek, Contracting Officer at michele.pastorek@nih.gov. Fax responses will not be accepted.