1-GeneImmune__JOFOC_(1)-redacted.pdf

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

Project Title: __Site Directed Mutagenesis, Subcloning and DNA Prep___

I . Identification of the agency and contracting activity

DHHS, NIH, NIAID, ____VRC________________

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

☒ Follow-on

• Name of the previous contractor(s): _GeneImmune Biotechnology_____

• Sequence number(s), if available: _________

• Was the initial and any subsequent awards competed? ☒ Yes ☐ No B. AMBIS Sequence number for this requirement: ______ C. Total estimated dollar value of the requirement (including options, if applicable): ______ D. Period of performance, inclusive of options:_-12 months from the day the PO is awarded E. Project Background

The mission of the NIH Vaccine Research Center (VRC) is to facilitate the development of vaccines against HIV-AIDS. Our goal is to develop immunogens that will elicit broadly neutralizing antibodies and will be used in vaccine design. One of the aims of the project is to obtain atomic level structures of the envelope glycoproteins that are the sole exterior target for neutralizing antibodies. Another aim is to develop neutralizing antibodies against HIV.

In order to rich our goal a large varieties of proteins need to be made and, GeneImmune Biotechnology has been selected for its competitive price and also for their proven capability in quality large-scale production of purified plasmid DNA. GeneImmune has successfully provided expert molecular biology services for the VRC in the past at low cost. Most importantly, GeneImmune is a local company and has a proven record of rapid turnaround on large-scale site directed mutagenesis/subcloning requests, and its plasmid production is of high quality, a critical factor in ensuring no interruption or delay of ongoing VRC research in HIV vaccine development.

F. Project Description

The VRC requires the Contractor to perform site directed mutagenesis and subcloning and /or to produce megaprep amounts (at least 5mg) or maxiprep (1-2mgs) of column purified plasmid DNA. The plasmid DNA will be evaluated for purity, quantified, and verified by single-pass sequencing prior to shipping. In addition, bacterial glycerol stocks will be stored on-site for 1 year and additional troubleshooting services are available, if needed.

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

☐ 41 USC 253(c)(1) a n d F A R P a r t 6 . 3 0 2 - 1 : Only one responsible source ☐ 41 USC 501 a n d F A R P a r t 8 . 4 0 5 - 6 : Federal Supply Schedule (FSS), limited competition

☐ An urgent and compelling need exists, and following the procedures would result in unacceptable delays

☐ Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or

☐ In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole-source or limited-sources procedures.

Important Note: The statutory authorities listed below will rarely ever be used in NIH. Before selecting one of these authorities, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

☐ 41 USC 253(c)(2) a n d F A R P a r t 6 . 3 0 2 - 2 : Unusual & compelling urgency ☐ 41 USC 253(c)(3) a n d F A R P a r t 6 . 3 0 2 - 3 : Industrial mobilization; or engineering, developmental, or research capability; or expert services ☐ 41 USC 253(c)(4) a n d F A R P a r t 6 . 3 0 2 - 4 : International agreement

☐ 41 USC 253(c)(5) a n d F A R P a r t 6 . 3 0 2 - 5 : Authorized or required by statute

☐ 41 USC 253(c)(6) a n d F A R P a r t 6 . 3 0 2 - 6 : National security

☐ 41 USC 253(c)(7) a n d F A R P a r t 6 . 3 0 2 - 7 : Public interest

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)

GeneImmune Technology 9700 Great Seneca Hwy. suite 214 Rockville, MD 20850

301-861-4366 order@geneimmuneusa.com

B. Describe why only the requested supply/service will meet the government’s needs

The goal of the VRC is to translate basic research into concrete vaccine products that can be rapidly deployed to protect public health. Our goal is to develop immunogens that will elicit broadly neutralizing antibodies and will be used in vaccine design. This protocol requires large varieties of proteins to be made. GeneImmune has been proven to support our need.

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

We have been using GeneImmune for “Site directed mutagenesis, subcloning and DNA Prep “service for many few years. GeneImmune has been selected for its competitive price and also for their proven capability in quality large-scale production of purified plasmid DNA. GeneImmune has successfully provided expert molecular biology services for the VRC in the past at low cost. GeneImmune is a local company and has a proven record of rapid turnaround on large-scale site directed mutagenesis/subcloning requests, and its plasmid production is of high quality, a critical factor in ensuring no interruption or delay of ongoing VRC research in HIV vaccine development. GeneImmune guarantees yield and time line in performing sequencing to verify the DNA identity, and stores bacterial stock for one year.

V . Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The price is determined to be fair and reasonable based on (provide a narrative describing how the determination was made and the rational for the determination):

VI. Certification This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support my request (for the requestor) and approval (for the CO) of is accurate and complete.