2_JA 2156775 Meso Scale Panels.rtf

Justification for Other than Full and Open Competition:

Meso Scale Discovery at or Below the Simplified Acquisition Threshold

Project Title: Screening SARS CoV-2 monoclonal antibodies against circulating coronavirus spike proteins and CoV-2 proteins of interest Identification of the agency and contracting activity

DHHS, NIH, NIAID, VRC, VIP

Address of the requesting lab/office: 9 West Watkins Mill Road Gaithersburg, 20878

Description of the project and supplies or services required to meet the agency’s needs Project Background

The objective is to supply the plates for the VIP to perform the assay testing in support of SARS CoV2 theraputic antibody isolation and development projects as well as correlates of protection testing.

Description of the supplies/services to be purchased

1. V-PLEX SARS-CoV-2 Panel 23 (IgG) Kit (25 PL)

Catalog #K15567U-4

QTY: 1

2. V-PLEX SARS-CoV-2 Key Variant Spike Panel 1 (IgG) Kit 25PL Catalog # K15651U-4

QTY: 4

Identification of the statutory authority permitting other than full and open competition

41 USC 1901(a)(1) a n d F A R P a r t 13.103-1 : Only one responsible source/Brand Name

Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

Name and address of the proposed contractor(s) Meso Scale Discovery A division ofMeso Scale Diagnostic LLC (MSD) 1601 Research Boulevard Rockville MD 20850 Phone (240) 314 2600

Describe why only the requested brand or brand name feature of the supply/service will meet the government’s needs

As the threat of COVID-19 continues in the international community with new variants emerging every week, the need for a safe and efficacious monoclonal antibody therapy at an accelerated timeline is a health care priority.To assist in this effort,the VRC-VIP will use the electrochemiluminescent (ECL) assay format which they have recently developed for a SARS CoV-2 specific assay for the detection of specific antibodies directed towards SARS CoV-2 S-2P and RBD (or other stabilized version of this same protein), variants and subvariants (e.g. B.1.1.529, B.1.351, B.1.617). Spike proteins are 'printed' or 'spotted' in a single well of a MSD 96-well microtiter plate. The VRC-VIP identified the ECL assay as the most reliable and sensitive assay system over the last 10 years, that offers high dynamic range in the detection of specific serum antibodies generate towards a variety of viral proteins. The platform offers extremely high throughput for the simultaneous measurement of antibodies to their epitopes.

MSD are the sole owners of the intellectual property of the ECL assay designed in collaboration with VIP specifically for VIP endpoint testing for COVID-19 Phase 1,3 trials, correlate of protection testing and screening of SARS CoV-2 mAbs.