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STREAMLINED SOLICITATION FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Bioanalytical Assay Methods Development and Performance for the Evaluat... STREAMLINED SOLICITATION FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Bioanalytical Assay Methods Development and Performance for the Evaluation of Safety and Efficacy of an AAV-Based Gene Therapy Candidate in Methyl Malonic Acidemia (MMA) disease (i) This is a combined synopsis/solicitation for commercial products and commercial services 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 75N95025R00039 and the solicitation is issued as a request for proposal. This acquisition is for a commercial product or commercial service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures; FAR Subpart 13.5— Simplified Procedures for Certain Commercial Products and Commercial Services; and FAR Part 12—Acquisition of Commercial Products and Commercial Services and is 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 AND 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), through its Therapeutics for Rare and Neglected Diseases (TRND) program, intends to negotiate and award a contract without providing for full and open competition (including brand-name) to BioAgilytix Labs LLC 2300 Englert Drive, Durham, NC 27713 for development of qualified bioanalytical assay methods and testing of clinical samples collected before and after administration of the AAV gene therapy product. This acquisition is conducted as non-competitive for a commercial product or commercial service and is conducted pursuant to FAR Subpart 13.5—Simplified Procedures for Certain Commercial Products and Commercial and FAR 13.501, Special Documentation Requirements, in accordance with 41 United States Code (U.S.C.) 1901 Simplified acquisition procedures. Pursuant to FAR Subpart 13.501(a)(1)(iii) the justification (excluding brand-name) will be made available within 14 days after contract award or in the case of unusual and compelling urgency within 30 days after contract award. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2024-03, with effective date February 23, 2024. (iv) The associated NAICS code is 541380 and the small business size standard is $19,000,000. (v) This requirement is for the development of qualified bioanalytical assay methods and testing of clinical samples collected before and after administration of the AAV gene therapy product. The results of the testing will be indicative of the safety and efficacy of the gene therapy product for MMA. Project Management: The Contractor shall provide project management for its own core team to ensure planning, execution, delivery of reports, and accurate and timely communication with the Contracting Officer’s Representative (COR), Contracting Officer (CO), and other stakeholders. The Contractor shall immediately (within 1 working day) contact the COR if there are any adverse results or difficulties with the study that would impact the project or timeline. The communications shall include proposed solutions. The Contractor shall immediately (within 1 working day) respond to any email communications sent by the Government and flagged as important. The Contractor shall manage bi-weekly teleconference meetings to keep the COR and the project team apprised of project progress. At the discretion of the COR, the frequency or method of meetings may be changed. It is expected that during each task initiation and study protocol development, communication will be more frequent. The Contractor shall communicate via e-mail when teleconferences are cancelled as agreed upon by the Government. The Contractor shall also manage ad hoc meetings as requested by COR, which shall be scheduled by the Contractor within 48 hours of request. The Contractor shall be responsible for setting up the meeting with technology that enables screen sharing (ex. Teams, Zoom, etc.), including a call-in number and passcode for the relevant participants and be responsible for moderating and participating in the meeting. The Contractor shall submit Pre-Meeting Status Updates/Agendas, and Post-Meeting Minutes, as described in Paragraphs E and F below. The Contractor shall provide any CRO Standard Operating Procedures, protocols, and methods within forty-eight (48) hours upon request as outlined in Paragraph F below. Status updates and progress of experiments including new preliminary data generated between meetings will be reviewed and discussed at each teleconference meeting. Standard Operating Procedures: The Contractor shall follow all site-specific standard operating procedures (SOPs); or if a deviation from an SOP is required, notify the COR of the deviation and document as appropriate. At the request of the COR, the Contractor shall submit to the Government any SOPs, method descriptions, and references used in the implementation of studies. The Government will treat Contractor SOPs as confidential. Record Retention: The Contractor shall provide all data, information, and records required for the writing and submission of regulatory documentation including but not limited to Investigator’s Brochures and Investigational New Drug, New Drug, and Biologics License applications. Upon study completion, the Government may require all study documentation to be placed in secure storage for a period of up to seven years. During this period, the Contractor shall be responsible for the integrity and organization of the material and its confidentiality. At the end of the period, all such documentation will be transferred or disposed at the direction of the COR. Government-Furnished Data: The Contractor will have access to any data available at NCATS or the NCATS partner related to each task order that the Government deems necessary to successfully perform under the task order. The Government will ensure all candidate therapeutics and any known safety data for storage and handling are supplied to the Contractor. Research Involving Live Vertebrate Animals: There is no research involving live animals. Technical Requirements: Contractor must perform method development and qualification or validation as well as sample analysis for methods to be conducted in compliance with Good Clinical Practice (GCP), International Council for Harmonization (ICH), or Clinical Laboratory Improvement Amendments (CLIA), as required. The Contractor shall perform the following tasks (and options, if exercised): Task A (Base): to provide a qualified assay for the measurement of T-cell responses to AAV8 and MMUT in clinical samples collected before and after administration of AAV8-MMUT gene therapy The contractor shall: Establish and qualify an immunological Elispot assay to quantitate T-cell responses to AAV8 (capsid) and MMUT (transgene) in clinical samples from patients receiving AAV gene therapy in the clinical trial. Provide a complete separate qualification report (IND and cGCP format) for the assay, including all data for assay qualification, calibration standards, and QCs. Task B (Option): to provide a validated qPCR assay for the measurement of viral shedding in clinical samples collected after administration of AAV8-MMUT gene therapy The contractor shall: Establish and validate a qPCR assay for viral shedding to quantitate the AAV8-MMUT vector shed into the saliva of patients receiving AAV gene therapy in the clinical trial Provide a complete separate validation report (IND format) for the assay, including all data for assay validation, calibration standards, and QCs. Task C (Option): set-up of AAV8 and MMUT antibody IgG/IgM assay and AAV8 neutralizing antibody assay performance for testing of clinical trial samples The Contractor shall: Get ready and set up the existing AAV8 and MMUT antibody (IgG and IgM) assay and the AAV8 neutralizing antibodies assay previously developed for this investigational product in order to initiate testing of clinical samples from the planned Phase 1/2 clinical trial. Task D (Option): perform AAV8 and MMUT immunological testing and viral shedding on clinical samples collected before and after administration of AAV8-MMUT gene therapy The Contractor shall: Evaluate AAV8 neutralizing antibodies using a CLIA AAV8 Neutralizing Antibody assay in clinical samples from screening of research participants for eligibility and transmit results to the IND Sponsor of the clinical trial in compliance with ICH, GCP and CLIA to determine participant eligibility Evaluate anti-AAV8 and anti-MMUT antibodies (IgG and IgM) in clinical samples using validated assays, prepare report with the results, and submit report to IND sponsor of the clinical trial Evaluate anti-AAV8 and anti-MMUT T-cell responses in clinical samples using the Elispot assay developed in Task A, prepare report with the results, and submit report to IND sponsor of the clinical trial, in compliance with ICH and GCP Evaluate viral shedding in human saliva using the assay developed in Task B, prepare report with the results, and submit report to IND sponsor of the clinical trial, in compliance with ICH and GCP Deliverables: See Statement of Work document found in attachments. (vii) The Government anticipates award of a firm fixed price contract for this acquisition, and the anticipated period of performance is will a 1 Base and 4 Option Periods. Each period will be 12-months. (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 https://www.acquisition.gov/caac-letters (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Nov 2024) 52.204-8, Annual Representations and Certifications (JAN 2025) (DEVIATION FEB 2025) See CAAC_Letter_2025-01_Supplement-1.pdf and CAAC_Letter_2025-02_Supplement-1.pdf 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) (DEVIATION Feb 2025) CAAC_Letter_2025-01_Supplement-1.pdf and CAAC_Letter_2025-02_Supplement-1.pdf FAR 52.217-5, Evaluation of Options (July 1990). FAR 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Certification (May 2014) FAR 52.222-52, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification (May 2014) 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 https://www.acquisition.gov/caac-letters (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). 52.217-8, Option to Extend Services (Nov 1999) FAR 52.217-9, Option to Extend the Term of the Contract (Mar 2000). 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 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 ( Jan 2025) (DEVIATION Feb 2025) Per CAAC Letters 2025-01 and 2025-02, FAR 52.222-21, Prohibition of Segregated Facilities and FAR 52.222-26 - Equal Opportunity will not be considered when making award decisions or enforce requirements. FAR 52.222-52 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Certification (May 2014). HHSAR 352.239-78, Information and Communication Technology Accessibility Notice (Feb 2024) (DEVIATION). FAR DEVIATION STATEMENT: The CAAC Letter 2025-01 -Supplement 1 and CAAC Letter 2025-02-Supplement 1 are applicable to this acquisition. System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Examples include 52.222-25, Affirmative Action Compliance, and paragraph (d) of 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM. The mentioned CAAC Letters may be accessed electronically at this address: CAAC Letters | Acquisition.GOV. The following invoice instruction is included and will be incorporated in the final award: NIH Invoicing Instructions with IPP (Mar 2023). Include the following in all (ix) The provision at FAR clause 52.212-2, Evaluation-Commercial Products and Commercial Services (Nov 2021), applies to this acquisition. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: (i) Technical capability of the services offered to meet the Government requirement; (ii) price; (iii) past performance. Technical and past performance, when combined, are significantly less important than cost or price. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). This includes the potential six (6) month extension in accordance with FAR 52.217-8. A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (x) Offerors must include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (May 2024) (DEVIATION Feb 2025), 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. See DEVIATION STATEMENT above regarding applicable CAAC Letters. (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 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. 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 questions must be received by 4:00 p.m., Eastern Standard Time, on 31, March, 2025, and reference Solicitation Number 75N95025R00039. Questions may be submitted electronically to Kaitlyn Landi, Contracting Specialist via Kaitlyn.landi@nih.gov. All offers must be received by 4:00 p.m., Eastern Standard Time, on 7, April, 2025, and reference Solicitation Number 75N95025R00039. Questions may be submitted electronically to Kaitlyn Landi, Contracting Specialist via Kaitlyn.landi@nih.gov. 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. Fax responses will not be accepted.