MMA-101 Stability and Compatibility Studies and CMC

(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 75N95025R00041 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 Center for Advancing Translational Sciences (NCATS) is collaborating with the National Human Genome Institute (NHGRI) to advance an adeno-associated virus gene therapy candidate as possible treatment for isolated methyl malonic acidemia (MMA), and intends to negotiate and award a contract without providing for full and open competition (including brand-name) to Viralgen, with the address at: Parque Tecnol'gico de Guipuzcoa, Paseo Mikeletegui, 83, 2a Planta, 20009 San Sebasti'n, SPAIN (1) to perform the stability testing of the cGMP lots for additional time points up to 48 months for MMA-101 using the program specific and validated analytical methods; b) provide Chemistry Manufacturing and Controls (CMC) regulatory support for the investigational product MMA-101; and c) to per-form a compatibility study for MMA-101 and the clinical devices that will be used in the clinical trial. 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) The overall objectives of this order are for the contractor: a) to extend the stability testing of the cGMP lots for additional time points up to 48 months; b) provide Chemistry Manufacturing and Controls (CMC) regulatory support for the investigational product; and c) to perform a compatibility study of cGMP material with devices used in the clinical trial of MMA-101. General Requirements: 1. Stability Testing Using the already existing stability testing protocol, the Contractor shall perform testing on the cGMP material, and analyze the data generated on the quality attributes for MMA-101 and diluent. The final protocol will be reviewed by the government prior to study start. The Contractor shall compare these data with the historical lot release results and provide a quality report that will used to support the use of MMA-101 and the diluent in clinical trial testing. 2. Record Retention and regulatory support 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, and Biologics License applications. The contractor shall provide subject matter expertise (SME) support, as needed during the submissions. Government assumes no more than 100 hours of such SME support. 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. 3. Compatibility of delivery devices used for administration of MMA-101 Using the already existing compatibility protocol and the MMA-101 product-specific assays as a reference, the Contractor shall perform a compatibility study of MMA-101 with the new devices that will be used to deliver this gene therapy in the clinical trial that will be performed at the NIH Clinical Center (CC). The protocol design shall be finalized after discussions with the Government and final protocol will be reviewed by the government prior to study start. At the end of the study, the Contractor shall prepare a compatibility study report with the data generated on the quality attributes for MMA-101. The report shall be in IND format and will be used to support the use of the devices to deliver MMA-101 in the clinical trial. The study must include up to 4 devices (government will share details of these devices planned to be used in the clinical study), one dose of MMA-101, and the same number of timepoints and controls as used for the compatibility study previously performed (Selecta-sponsored study). 4. 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. Technical 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 tasks described below. The overall objectives of this task order are for the contractor: a) to extend the stability testing of the cGMP material (see Table 1 below for details), to analyze the data generated on the quality attributes, to compare these data to the historical lot release results, and to ascertain if the MMA-101 material meets acceptance quality criteria for testing in clinical trials; b) to provide Chemistry Manufacturing and Controls (CMC) regulatory support; and c) to perform a compatibility study of cGMP material with de-vices that will be used in the clinical trial of MMA-101, using the same protocol and assays previously performed for the same product and a different set of devices (Selecta-sponsored clinical trial). See Statement of work for Table 1: 48-month extended stability plan, up to Month 84 (product is currently under a 36-month stability testing plan) The contractor shall analyze the data generated on the quality attributes for MMA-101 clinical lot G-NORMA-30 and diluent/formulation buffer lot FFB-G-004, and clinical lot G-NORMA-57 and diluent/formulation buffer lot FFB-G-023. The contractor shall compare these data to the historical lot release results and ascertain if the MMA-101 material meets acceptance quality criteria for testing in clinical trials. The Contractor shall prepare stability Study Reports for MMA101 and diluent at the specified timepoints and deliver to the government. The contractor shall review and/ or provide IND related documentation for the MMA101 product, as requested by the government. The Contractor shall test up to 4 more devices that are planned to be used to deliver MMA-101 to research subjects. The Contractor shall prepare a Compatibility Study Report in IND-ready format and deliver to the government. Deliverables and Schedule/Reporting Requirements: 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 (if applicable). 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 9, May, 2025, and reference Solicitation Number 75N95025R00041. 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 16 May, 2025, and reference Solicitation Number 75N95025R00041. 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.