2_JA 2088271.docx

Justification for Other than Full and Open Competition at or Below the Simplified Acquisition Threshold Project Title: Next Generation Sequencing Reagents

I. Identification of the agency and contracting activity

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

The mission of the Vaccine Research Center at the National Institutes of Health is to conduct research that facilitates the development of effective vaccines. Activities in the center will include 1) basic research to establish mechanisms of inducing long-lasting protective immunity against different pathogens that present special challenges to vaccine development, 2) the conception, design, and preparation of vaccine candidates, and 3) laboratory analysis, animal testing, and clinical trials of such candidates.

B. Project Description

Much of the ground work performed in the VRC require the characterization of vaccine-induced immune responses to prepare for biological threats. This characterization is important as it allows us to understand correlates of protection and determine whether vaccines could be effective against certain pathogens. To guaranty the success of candidate vaccines, carefully validate vaccine lots are needed. Herein we are requesting the manufacture of chimpanzee adenovirus serotype 3 (ChAd3) encoding the glycoprotein from the Ebola virus, Sudan virus, and Marburg virus. This research is critical to the mission of the VRC and to further dvance our undersdtanding of vaccinology. Not only will be learn about an important aspect of the immune response, but it will help us prepare for the emergence of novel viruses and how we can better prepare to protect against them.

III. Identification of the statutory authority permitting other than full and open competition ☒ 41 USC 253(c)(1) and FAR Part 6.302-1: 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) ReiThera Via di Castel Romano, 100 00128 – Rome – IT www.reithera.com B. Describe why only the requested supply/service will meet the government’s needs

ReiThera provides complete vaccine production solutions from state-of-the-art laboratories. ReiThera’s management and scientific teams have successfully developed genetic vaccines against major infectious diseases, including hepatitis C, malaria, HIV, Respiratory Syncytial Virus and Ebola using the highly innovative chimpanzee-derived adenovirus (ChAd) platform within Okairos. After the acquisition of the brand by GlaxoSmithKline (GSK) in 2014, Okairos changed its name to ReiThera and worked with GSK to further develop the technology and promote clinical development of viral vectored vaccines against infectious diseases. These vaccines have been evaluated in thousands of healthy subjects of all ages, as well in patients with chronic viral infections and shown to be safe and highly immunogenic. In addition to this platform, ReiThera has a unique expertise in large-scale GMP production of genetic vaccines The GMP manufacturing facility meets the most stringent criteria to produce material to be used in human clinical studies.

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

ReiThera, a subsidiary of GSK, is the only company licensed to make ChAd3 vaccines.