2 - Justifaction for Posting.docx

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold

Project Title:

COVID-19 Response Project 1. Development of a broad Beta-Coronovirus Vaccine Project 2. Identification, structures, and ontogenies of SARS-CoV-2 neutralizing antibodies

I. Identification of the agency and contracting activity

40 Convent Drive

NIH. NIAID

Bethesda, MD 20814

II. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value) A. Project Background Vaccine Research Center (VRC) develops a vaccine against human immunodeficiency virus (HIV). With an increase in the vaccines needed for COVID19, the Vaccine Research Center (VRC) and concomitant expansion of the clinical trial capabilities. The Vaccine Research Center (VRC) requires an increased capacity to identify, develop, implement and perform high throughput immunological analyses that reflect various stages of COID19 vaccines and clinical development.

Currently, the VRC is working to study emerging infectious diseases, researchers at the VRC are seeking to find a suitable animal model to evaluate countermeasures against SARS-CoV-2, the virus that causes COVID-19. The requested consumables are made to be used with the Octet Machine purchased from Fortebio (now a part of Sartorius). This machine allows us to assess antibodies and immunogens involved in active immunization studies and passive protection studies in a high-throughput manner with high reproducibility and reliability. To assist with efforts combating COVID-19, we need these biosensors for ongoing CoV-2 animal immunization efforts.

This requirement is being requested as a brand name / sole source request to purchase this brand of consumables, since earlier experiments were conducted with these biosensors from Sartorius Corporation. Maintaining this brand will ensure consistency and reliability in our immunization experiments and prevent variances in experimental data results. Previous History of orders include: 75N93021P00055 from October 2020.

B. Description of the supplies or services to be purchased This request is for purchasing biosensors, including Streptavidin (SA) Biosensors, Anti-human IgG Fc Capture Biosensors, Ni-NTA (NTA) Biosensors, Anti-Penta-HIS (HIS1K) Biosensors, and Anti-mouse IgG Fc Capture Biosensors from Sartorius Corporation for measuring protein-protein interactions, including Sera readout in ongoing immunization experiments on an Octet instrument.

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE) (

· 41 USC 1901(a)(1) and FAR Part 13.106: Only one responsible source

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

A. Name and address of the proposed contractor(s) Sartorius Corporation 565 Johnson Avenue

BOHEMIA, NY 11716

United States of America

B. Describe why only the requested supply/service will meet the government’s needs These consumables are made to be used with the Octet Machine we purchased from Forte bio. This machine allows us to assess antibodies and immunogens involved in active immunization studies and passive protection studies in a high-throughput manner with high reproducibility and reliability. To assist with efforts combating COVID-19, we need these biosensors for ongoing CoV-2 animal immunization efforts.

C. Describe why only the proposed contractor is capable of providing the requested supply/service:

Sartorius Corporation (previously Forte Bio) is the sole manufacturer for the Octet Machine and its consumables. Since earlier experiments were conducted with biosensors from Sartorius Corporation, maintaining the same brand will create consistency and reliability in our immunization experiments.