JA_below_SAT FULLY SIGNED_Redacted.pdf

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

Project Title: ATUM Evaluation License and Materials – Cell Line Development Expression Vector Optimization

I . Identification of the agency and contracting activity

DHHS, NIH, NIAID, VRC

Requestors name:

Requestors phone number:

Requestors email address:

Address of the requesting lab/office:

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): ________________________________

• Sequence number(s), if available: ____________________________________

• Was the initial and any subsequent awards competed? ☐ Yes ☐ No

B. AMBIS Sequence number for this requirement: 2075993 C. Total estimated dollar value of the requirement (including options, if applicable):

D. Period of performance, inclusive of options: from August 06, 2021 to August 05, 2022 E. Project Background

The Cell Line Development team at the Vaccine Production Program (VPP) under NIAID’s Vaccinee Research Center (VRC) is responsible for generating specific clonally-derived cell lines expressing monoclonal antibodies and vaccine candidates that will be used for manufacturing material that is acceptable for use in human clinical trials. This process begins with transfection of a mammalian cell line with plasmid DNA encoding the protein of interest.

F. Project Description The expression vector used in the process of manufacture of clinical material is a key component of the process that can impact the subsequent productivity and stability of the cell lines generated.

Optimization of the expression vector is one way to improve these metrics and shorten the time required to identify a candidate cell line for clincal production - both factors are critical for the cell line development team to rapidly develop new products for high impact diseases such as HIV, influenza, malaria and others.

DNA TwoPointO, Inc., d/b/a ATUM (“ATUM”) has expression vectors that are based on unique proprietary technology, synthetic transposons. ATUM’s unique technology provides the only commercially available transposon-based system, which is a specific way of integrating the genes into the host cell line that uniquely meets the requirements of our project. This specific technology results in higher-producing clones than the random integration system that the VPP currently uses. More importantly, this transposon based technology results in faster and more reproducible pool and clone generation, which would potentially allow the VPP to move projects forward much more quickly.

Other alternative methods for exogenous gene expression are vulnerable to truncation, deletion, scrambling, and other problems that can occur during the random integration processes that are commonly used in cell line development. ATUM’s transposon based process is able to avoid these issues and the selection process is therefore accelerated; creating higher-producing clones at a consistent product quality, which will save significant time and money.

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 FA R P a r t 8 . 40 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)

DNA TwoPointO, Inc., d/b/a ATUM 37950 Central Court Newark, CA 94560

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

The technology offered by ATUM is the only commercially available transposon-based expression system that we are aware of after searching for other alternatives. The unique advantages of this system allow for an improved ability to generate cell pools or cell lines quickly to support rapid clinical manufacturing. High efficiency in clone production is essential for product development.

Having higher-producing clones allows projects to move forward more quickly and requires fewer production runs, thereby eliminating the significant associated costs. ATUM’s technology is projected to decrease initial phases of cell line development process time by 2X, reduce time cost from clone screening, reduce the cost of non-conformance from unstable pools, and simplify transition between pools for consistent clinical production. For example, if the VPP has one clone that produces 2X more than another clone, it could mean that we only need one production run at the pilot plant instead of two productions runs, which will save time and potentially save several hundreds of thousands of dollars per project. This is expecially critical when there is a high impact disease target, such as the VRC has experienced in recent years with Zika, COVID-19, Ebola and others.

Furthermore, ATUM also have a demonstrated track record in industry for the manufacture of products that are approved by the FDA for clinical trial use – including 1 approved protocol to date and 3 more approved protocols expected by 2021. Working with ATUM’s technology is more likely to allow in the creation of successful products that will be approved by the FDA.

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

This unique transponson based technology is proprietary to the company ATUM and is not available from other sources.

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.

Official Name & Title Signature Date

Requestor Certification

Contracting Officer Approval