SERVICE PLAN AGREEMENTS FOR WYATT TECHNOLOGY LIGHT SCATTERING AND DIFFERENTIAL REFRACTIVE INDEX INSTRUMENTS (AMBIS 2205288)

This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with Wyatt Technology Corporation, 6330 Hollister Avenue, Goleta, CA 93117-3115, to procure a Silver Service agreement for the T-REX, DAWN, QELS, Optilab, and a Gold Service agreement for the µDAWN, QELS, and UT-REX instruments. Only one award will be made as a result of this solicitation. This will be awarded as a firm-fixed price type of contract. Period of Performance(s) are as follows:

03/05/2024 – 03/04/2025 Optilab TrEX, Ser #1282-TrEX ?DAWN, Ser #1119-T2UD QELS Ser, #1216-WIQ UT-REX, Ser #1490-TRXU 05/10/2024 – -3/04/2025 DAWN Heated/Cooled, Ser #4079-D3HC QELS, Ser #1864-WIQ Optilab, Ser #4120-OP1 Service shall be performed at the following locations: NIH/NIAID/DIR/LMIV, 29 Lincoln Drive, Bethesda, MD 20892. The Laboratory of Malaria Immunology & Vaccinology (LMIV), Vaccine Development Unit develops and performs the clinical evaluation of prototype malaria vaccines.

Each candidate vaccine has to undergo a rigorous development process that requires the input of many highly skilled scientists with specific areas of expertise. These include creation of expression systems, fermentation optimization, scale-up of purification technology, clinical good manufacturing practices (cGMP) production, formulation, quality control, preclinical testing, and clinical trials.

The light scattering and differential refractive index detectors characterize the recombinant proteins and protein conjugates that are made for vaccine research, development, and manufacturing, usually as online detectors following fractionation by size-exclusion chromatography HPLC.

A maintenance/services award is required to maintain various light scattering and differential refractive index detectors that are CRITICAL to characterizing the recombinant proteins and protein conjugates that are made as part of the mission of the LMIV. This includes materials that are prepared for clinical trials in human volunteers. The equipment manufacturer is the only vendor qualified to maintain these specialized equipment.

They have certified technicians to repair these sensitive detectors and perform the same quality control with every annual service of the instruments that they would do before shipping out new instruments. The equipment parts are not distributed to other companies for resale, and using non-manufacturer parts would be inadvisable.

The National Institute of Allergy and Infectious Diseases (NIAID) has a requirement for service agreements for seven (7) instruments, including: Optilab TrEX, Ser #1282-TrEX ?DAWN, Ser #1119-T2UD QELS Ser, #1216-WIQ UT-REX, Ser #1490-TRXU DAWN Heated/Cooled, Ser #4079-D3HC QELS, Ser #1864-WIQ Optilab, Ser #4120-OP1 Please see the attached service requirements. The statutory authority for this sole source requirement is 41 U.S.C.

253 (c) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A SOLICITATION FOR COMPETITIVE QUOTATIONS.

All responsible sources that could provide the required services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-24-2205288 to Rita Davis at rita.davis@nih.gov, by 11:00am eastern standard time Monday, January 22, 2024. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.