GXP SOFTWARE WITH SERVICES BUNDLE (AMBIS 2209316)

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 Molecular Devices LLC, 3860 N First Street, San Jose, CA 95134, to procure a GXP Software with services bundle.

This is a follow-on purchase of a GXP software program currently used by the Vaccine Immunology Program (VIP), aids the Vaccine Research Center (VRC) to perform comprehensive statistical modeling of data for experiments. This request is to secure a renewal and upgrade for a GXP Software bundle package. This package includes analytical software for performing testing. The purpose of the procurement is for the vendor to provide one (1) software package of SMP version 7.1.1 or higher.

The objective is to supply the reader for the VIP to perform the assay testing in support of clinical trial end point testing.

Description of the supplies/services to be purchased: 1) GXP Software bundle package, CAT # SMP7-GXP-STARTER, QTY 1 2) Additional user licenses for SoftMax Pro GxP Single Computer Software version 7.1.1 or higher, CAT # SMP GXP ADD, QTY 8 3) Annual maintenance and technical support plan for SoftMax Pro GxP (SMP GxP) at site location(s), CAT # SMPCARE-GXP, QTY 1 4) SMPCare GxP technical support plan includes one year of advanced technical support for SMP GXP software, CAT # SMPCAREGXP, QTY 1 5) Email delivery of SoftMax Pro 7 GxP Software key containing 2 activations per user, CAT # SMP7 GXP ACT, QTY 8 6) One-time Professional Services fee for installation of SoftMax Pro 7.1.1 GxP or higher on one single computer workstation, CAT # SMPGXP-INSTALLICOMP-OS, QTY 1 J&A: Currently, VIP has three Molecular Devices readers for performing an array testing.

To enable use of these for phase 3 trials, the current software versions on these readers are not CFR 21 part 11 compliant, which is a standing lapse in the VIP’s ability to perform phase 3 testing. To address this effort, the VRC-VIP will use upgrade the Molecular Devices readers with the GxP software suite of Softmax (GxP SMP) so that it meets CFR21 part 11 compliance. Molecular Devices is the sole-source for software on the Molecular Devices readers that VIP already employees. Period of Performance(s) are as follows:

April 18, 2024 to April 17, 2025 Service shall be performed at the following locations: NIH/NIAID/VRC/VIP, 9 West Watkins Mill Road, Gaithersburg, MD 20878. 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-24-2209316 to Rita Davis at rita.davis@nih.gov, by 11:00am eastern standard time Friday, February 20, 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.