2-Sole source justification.docx

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

E. Justification for Other than Full and Open Competition:

41 USC 1901(e)(2) and FAR Part 13.106-1: Sole-source

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

A. Name and address of the proposed contractor(s) GenScript USA Inc.

860 Centennial Ave Piscataway, NJ 08854

B. Describe why only the requested supply/service will meet the government’s needs Genscript has the stock virus needed to provide the required services. NIH has already invested in the development of a proprietary expression plasmid at GenScript. This plasmid is engineered to express our our patented VHH4.1 sequence in bacteria. Preliminary data show that this plasmid gives high yields of purified VHH4.1 protein that bind to norovirus VLPs. We are unable to express and purify the quantity of protein needed in our lab, and we seek to utilize the plasmid and production pipeline that we have already established at GenScript. GenScript has the necessary experience, equipment. and expertise to produce the candidate therapeutic nanobody that will be tested in a preclinical animal study. A production pipeline has been established and no other vendor has the specific plasmid expression vector that will be used