POSTING Other than Full and Open Competition.docx

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

I. Identification of the agency and contracting activity

DHHS, NIH, NIAID

II. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value) A. Type of action. Check the appropriate box:

New requirement: 2032389 ☒ Follow-on Project Background: : Diverse HIV-1 Env from different clades and strains stabilized in the prefusion closed conformation can be used as immunogens for vaccine development to achieve broad immune responses. These proteins can also be used as molecular probes for isolation of neutralizing antibodies and reagents for evaluation of clinical trial samples. The structural bioinformatics section at VRC has developed computational algorithms that incorporate current state-of-the-art stabilization approaches for the design of stabilized HIV-1 Env. We did a pilot design with a subset of HIV-1 sequences and obtained high quality HIV-1 Env trimers with confirmed antigenicity by a panel of neutralizing antibodies and correct morphology as confirmed by negative stain EM. We decided to expand the design to large panel of HIV-1 strains to obtain diverse stabilized HIV-1 Env. The HIV-1 strains we choose to design is the VRC neutralization panel which contains carefully selected strains that represent different clades and tier of sensitivity to neutralizing antibodies. One advantage to use this panel of sequences for design is that we have obtained large amount of neutralization data of antibodies against these strains during the past decade, those information will guide immunization studies with our designed and stabilized HIV-1 Env from this panel. The designed sequence will be synthesized and clone into to vectors, one for expression as soluble HIV-1 Env as immunogens and the other for expression as AVI-tagged proteins to be used as molecular probes.

Description of the supplies or services to be purchased: This request will include DNA synthesis of HIV-1 Env sequences we designed based on the VRC neutralization-panel of viruses (211 strains), subcloning of the synthesized sequences into two different expression vectors, and preparation of 1 mg of DNA for each of the 422 plasmids III. Justification for Other than Full and Open Competition

a. ☒ 41 USC 1901(e)(2) and FAR Part 13.106-1: Sole 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) GenScript USA, Inc. 860 Centennial Ave. Piscataway, NJ 08854 Phone: 1-732-885-9188 B. Describe why only the requested supply/service will meet the government’s needs GenScript is focusing exclusively on early drug discovery and development services, it offers molecular biology services ranging from gene synthesis and custom cloning, to advanced genetic engineering and mutant libraries. With in-house oligo synthesis capability and well-equipped molecular biology laboratory, this company provides reliable and flexible molecular biology service solutions that cover almost all aspects in discovery research. This company also stores synthesized plasmids that we ordered before so that we can conveniently clone genes needed for our previous DNA plasmids.

C. Describe why only the vendor described can provide the item:

We have been using this company for our molecular services, such as DNA synthesis, subcloning, and mutagenesis. The company also provides VectorArk/CloneArk System for customer to archive, share and reuse their vectors and clones at GenScript. NIH uses the Archive System to design and reuse our archived clones. Different companies use different algorithms and different methods of generating synthetic genes which may generate different results. GenScript’s optimization service has been used for many years. Their gene synthesis projects work exceptionally well for expression of proteins. Using a different vendors optimization algorithm will not yield the same results and would therefore cause a significant loss of time and money involved with our research.