Stability Testing for HIV Adenoviral Vaccine Candidates

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 obtain stability testing for two HIV adenoviral vaccines candidates in ongoing clinical trials. The design and manufacture by Emergent of two adenoviral-based HIV vaccines require highly specialized assays to measure the ongoing stability to allow for continued testing for Phase I clinical evaluation in accordance with FDA guidelines. By design, unique HIV sequences are inserted into the adenoviral vector to allow the adenovirus vaccine to function as a live replicating virus. In contrast, most other adenoviral vector-based vaccines are unable to replicate in humans. Emergent has developed proprietary stability assays with unique reagents to demonstrate potency and replicative potential of the adenoviral vaccine. Only Emergent is capable of providing the required stability testing for these adenoviral vaccine candidates. Therefore, DAIDS requires Emergent Travel Health Inc. stability testing for a 12-month base period with four, 12-month option periods. For more information on the requirement, please see the attached Statement of Work.

Period of Performance: The total period of performance for this requirement is August 26, 2022 August 25, 2023, for the base year, and an overall period of performance from August 26, 2022 August 25, 2027 if all options are exercised.

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 24 days of this notice.

The statutory authority for this sole source requirement is 41 U.S.C. 253 (c)(1) as implemented by FAR 6.302-1(b)(1)(i) only one source available, no substitutions possible. THIS IS NOT A SOLICITATION FOR COMPETITIVE QUOTATIONS. All responsible sources that can provide the reagents should submit a capability statement via email to Seth Schaffer at Seth.Schaffer@nih.gov by 10:00am EST on Monday, August 8, 2022. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Any responses received by NIAID after this date and exact time specified are late and will not be considered.

This is 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 Seth Schaffer, Contract Specialist, at seth.schaffer@nih.gov.