SAM #NOI-NIAID-26-0001

Sole Source Maintenance of Biologics Master Files for HIV Adenoviral Vaccine Candidates

The National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), is seeking specialized regulatory and laboratory services for HIV adenoviral vaccine candidates: - Government Buyer: - Department of Health and Human Services - National Institutes of Health (NIH) - National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS - OEM/Vendor: - Emergent Travel Health Inc. (sole source) - Services Requested: - Maintenance of Biologics Master File (BB-MF) 018816 for HIV-1 Adenovirus Type 4-Vectored (A549 cells) Vaccines, Live, Aqueous (Ad4-HIV) - Maintenance and annual report submission for Biologics Master File 14883 (A549 Master Cell Bank, PXVX0329 drug substance) - Ongoing regulatory file upkeep and support for stability testing at multiple timepoints - Unique Requirements: - Only Emergent Travel Health Inc. has access to the required master files - No products are being procured; only specialized laboratory and regulatory services - Services are essential for ongoing IND 030255 updates and regulatory compliance - Period of Performance: - Base period plus two option years - Place of Performance: - NIH facility in Rockville, Maryland

Description

Document Type: Notice of Intent to Sole Source

Solicitation Number: NOI-NIAID-26-0001

Posted Date: 04/13/2026

Response Date: 04/23/2026, 12:00 PM EST

Set Aside: N/A

NAICS Code: 541714 – RESEARCH AND DEVELOPMENT IN BIOTECHNOLOGY (EXCEPT NANOBIOTECHNOLOGY)

Product Service Code:  Q301 – MEDICAL – LABORATORY TESTING

Contracting Office Address:

Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases, 5601 Fishers Lane, Rockville, MD 20852

Title: Emergent Stability Testing for HIV Adenoviral Vaccine Candidates

Description:

THIS IS A NOTICE OF INTENT AND NOT A REQUEST FOR QUOTATIONS

This notice is published in accordance with Federal Acquisition Regulation (FAR) 5.101(a)(1) requiring the dissemination of information regarding proposed contract actions.  This is a Notice of Intent to award a sole source, firm-fixed price purchase order under the authority of 41 U.S.C. 3304(a)(1), as implemented by FAR 13.106-1(b)(2) and 13.501(a) - Only One Responsible Source and No Other Supplies or Service Will Satisfy Agency Requirements and is not a request for competitive proposals. 

The National Institute of Allergy and Infectious Diseases (NIAID), Division of AIDS (DAIDS) intends to negotiate on a sole source basis with Emergent Travel Health Inc., 555 Twin Dolphin Dr, Ste 360, Redwood City, CA 94065-2142.  This acquisition will provide maintenance of the Biologics Master File 018816 – Human Immunodeficiency Virus Type 1, Recombinant (Adenovirus Type 4; Ad4Env150KN and Ad4-Env145FL; 1086 clade C Env; A549 Cells) Vaccines, Live Master File (BB-MF 018816). 

BB-MF 018816 was originally established by Emergent under Purchase Order 75N93022PO1224 and contains CMC and nonclinical study information for the HIV-1 Adenovirus Type 4-Vectored (A549 cells) Vaccines, Live, Aqueous (Ad4-HIV). Purchase Order 75N93022PO1224 ended with stability work being transitioned to a testing lab contracted by NIAID. While Emergent is no longer directly involved in stability testing, Emergent owns BB-MF 018816, which must remain open and current for NIAID to continue to update IND 030255. NIAID has requested that Emergent maintain BB-MF 018816 throughout the remaining 84, 96, 108, and 120-month stability timepoints.

Emergent is the owner of the Biologics Master File 14883 – Manufacture and Characterization of A549 (human lung adenocarcinoma derived) Master Cell Bank, Type II (BB-MF 14883), which concerns the PXVX0329 drug substance, manufactured by inoculating expanded A549 suspension cells with an Ad4-Env150KN viral seed. Emergent’s understanding is that BB-MF 14883 must also remain open and current for NIAID to update IND 030255. To maximize collaborative efforts between Emergent, NIAID, and its other contractors, Emergent will assume responsibility for funding the annual report submissions required for BB-MF 14883 in October 2025, October 2026, October 2027, October 2028, and October 2029.

Period of Performance:

Period              Date          

Base                 April 27, 2026 to March 31, 2027*

Option Year 1   April 1, 2027 to March 31, 2028

Option Year 2   April 1, 2028 to March 31, 2029

*Note: This requirement has a lapse in the period of performance of October 1, 2025 to the expected date of April 26, 2026.  Vendor accepts the reinstatement of the coverage with a new period of performance of April 27, 2026 to March 31, 2029.  The reinstatement will be included the pricing of the award.

The North American Industry Classification (NAICS) code for this acquisition is 541714 - Research and Development in Biotechnology (Except Nanobiotechnology), which has a size standard of 1,000 employees.  Emergent Travel Health Inc. is a large business.

This will be the only notice of the Government's intent to solicit, negotiate, and award to one source to satisfy this requirement.  The Government plans to award a contract for this requirement within 14 days of this notice.

While this synopsis does not constitute a solicitation, interested vendors may identify their interest and capability to satisfy this requirement. The government understands that Emergent Travel Health is the only vendor who has access to the Biologics Master File 018816 – Human Immunodeficiency Virus Type 1, Recombinant (Adenovirus Type 4; Ad4Env150KN and Ad4-Env145FL; 1086 clade C Env; A549 Cells) Vaccines, Live Master File (BB-MF 018816). 

THIS IS NOT A SOLICITATION FOR COMPETITIVE QUOTATIONS. However, firms that believe they can provide the capability required to fully meet the Government's requirement may submit a capabilities statement, including past performance, in writing to the identified point of contact within 10 days after publication of this notice.  Such documentation shall be evaluated solely for the purpose of determining whether or not to conduct this procurement on a competitive basis.  A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.  Interested parties may identify their interest and capability to respond to the requirement or submit offers on NOI-NIAID26-0001.

This notice does not obligate the Government to award a contract or otherwise pay for any information provided in response.  The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate.  Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work.  Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. For additional information or to submit responses, please contact Linda Smith, Contracting Officer at Linda.smith2@nih.gov

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