Notice of Intent to Sole Source: Viralgen stability timepoints data

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA) 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 Viralgen, with the address at: Parque Tecnológico de Guipuzcoa, Paseo Mikeletegui, 83, 2a Planta, 20009 San Sebastián, SPAIN for Viralgen stability timepoints data for a) Month 18 and M24 for MMA-101 lot G-NORMA-057 and diluent lot FFB-G-023; and b) Month 36 for MMA-101 lot G-NORMA-030, diluent lot FEB-G-004, MMA-101 lot G-NORMA-057 and diluent lot FFB-G-023.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS

The intended procurement is classified under NAICS code 325412 Pharmaceutical Preparation Manufacturing with size of 1,250.

REGULATORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases not exceeding the simplified acquisition threshold, Contracting officers may solicit from one source IF the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization).

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2022-08 dated October 22, 2022.

DESCRIPTION OF REQUIREMENT

PURPOSE AND OBJECTIVES:

The purpose of this procurement is the acquisition of Viralgen stability timepoints data for a) Month 18 and M24 for MMA-101 lot G-NORMA-057 and diluent lot FFB-G-023; and b) Month 36 for MMA-101 lot G-NORMA-030, diluent lot FEB-G-004, MMA-101 lot G-NORMA-057 and diluent lot FFB-G-023.

Viralgen Inc. manufactured MMA-101, a gene therapy product, to meet current good manufacturing practices (cGMP) for Selecta Biosciences Inc under contract to support a Selecta-sponsored clinical trial at the NIH Clinical Center.  Selecta was the collaborator under a CRADA with NHGRI, who developed MMA-101. In 2023, Selecta withdrew the FDA-approved Investigatory New Drug (IND) application, after opening the MMA-101 study at the NIH Clinical Center, and then merged with Cartesian Inc. towards the end of 2023. At that point, Selecta/Cartesian donated the cGMP MMA-101 gene therapy product along with its rights and IND documentation to NIH/NHGRI, enabling the MMA-101 product to be tested in MMA patients.

The objective of this purchase is to acquire the stability data and related documentation produced and owned by Viralgen in order to demonstrate the stability and chain-of-custody for the MMA-101 cGMP material, to ensure it has not been compromised and can be tested in a clinical trial at NIH.

ESTIMATED PERIOD OF PERFORMANCE:

First Delivery of the following to be made within 60 days after receipt of order (ARO): Month 18 and M24 for MMA-101 lot G-NORMA-057 and diluent lot FFB-G-023; Month 36 for MMA-101 lot G-NORMA-030, diluent lot FEB-G-004

Second Delivery of the following to be made within 60 days after Nov 2025: Month 36 MMA-101 lot G-NORMA-057 and diluent lot FFB-G-023

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, Viralgen, with the address at: Parque Tecnológico de Guipuzcoa, Paseo Mikeletegui, 83, 2a Planta, 20009 San Sebastián, SPAIN is the only vendor in the marketplace that can provide the services required by NIDA .

The intended source is:

Viralgen, with the address at: Parque Tecnológico de Guipuzcoa, Paseo Mikeletegui, 83, 2a Planta, 20009 San Sebastián, SPAIN

CLOSING STATEMENT

THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number, 75N95025Q00061. Responses must be submitted electronically to Kaitlyn Landi, Contract Specialist, at kaitlyn.landi@nih.gov and KJ Shaikh, Contracting Officer, at kj.shaikh@nih.gov.  U.S. Mail and fax responses will not be accepted.