2_JA 2270196.docx

Justification for Other than Full and Open Competition:

Brand Name at or Below the Simplified Acquisition Threshold

Project Title: Life Tech Freestyle 293 Expression Medium and EXPI293 Expression Medium AI-005022-23:Antibody Neutralization Mechanisms Enter the project title as it will appear in the solicitation and contract/order.

(To be completed by the requestor)

Note: An acquisition or portion of an acquisition that requires the provision of a specific brand name or manufacturer-specific product or feature of a product does not provide for full and open competition, regardless of the number of sources solicited. A brand-name acquisition is allowed if the particular brand name product or feature is essential to the government’s requirements and market research indicates that similar products do not meet or cannot be modified to meet the agency’s needs.

This type of JOFOC does not attempt to justify a vendor but a type of product.

Ensure that your narratives are written in a manner to permit an individual without any technical knowledge of the requirement to understand the supporting rationale. Don’t use trade language, or jargon. You don’t need to get into the scientific “weeds” of the requirement. While you should include all technical requirements of the product or service, there is no need to elaborate unnecessarily on the science. The purpose of this justification is to document an acquisitions file and should not be written in the same manner as a scientific paper. Use plain language when possible.

Identification of the agency and contracting activity (The requestor will complete this section.)

I. Description of the project, and supplies or services required to meet the agency’s needs (including the estimated value) (This section is to be completed by the requestor.)

Type of action: (check the appropriate box) New requirement Follow-on Name of the previous contractor(s): _Life Technologies ___ Sequence number, if available: 2112600, 2115855, 2125105, 2123731, 2131893, 2125261, Was the initial and any subsequent awards competed? Yes No AMBIS Sequence number for this requirement: xxxxxxx Total estimated dollar value of the requirement (including options, if applicable): $63,396.00

Period of performance, inclusive of options: Standing Order Bi-Monthly Performance Period August 1, 2023 to July 31, 2024

Project Background and Justification:

a. Begin with a brief description of the overarching goals of your lab/office and how this procurement fits into it. Provide a brief (i.e., one paragraph) description of the project.

b. The Vaccine Research Center is developing vaccines for HIV-1 and SARS-CoV-2 and other viruses. Production of various wild-type and mutant viral proteins and anti-viral antibodies is critical in vaccine development. Making different mutations of viral proteins and expressing antibodies against such proteins is critical for vaccine development. To make these proteins the, the EXPI293 EXPRESSION MEDIUM and FREESTYLE 293 EXPRESSION MED reagents are critical to the success of protein and antibody productions.

c. Discuss any project background important to understanding the acquisition and the need it will satisfy. You do not need to “dumb it down,” but keep in mind that your audience is not scientists; they are business professionals such as the Government Accountability Office, the Inspector General, contracting officers, and purchasing agents who must understand what you need and why in order to purchase it in compliance with policy and regulation.

d. The SBS makes protein immunogens and antibodies for vaccine studies. The EXPI293 EXPRESSION MEDIUM and FREESTYLE 293 EXPRESSION MEDIUM is unique in that it allows for high-density growth, and protein production which is needed regularly to satisfy daily protein production requests. The VRC aims to translate basic research into concrete vaccine products that can be rapidly deployed to protect public health. The EXPI293 EXPRESSION MEDIUM and FREESTYLE 293 EXPRESSION MED is unique in that it allows for high-density growth and protein production, accompanied by other 293Expi components, such as specific cell lines. We have been using the EXPI293 EXPRESSION MEDIUM, FREESTYLE 293 EXPRESSION MED, and OPTI MEM I for four to fivethis project. years. It has proven to support the production of the proteins that we require for our protocols in the development of vaccines for HIV and other viruses.

IV. Description of the supplies/services to be purchased Describe the products/services (including the salient physical, functional, or performance characteristics of the brand name product or feature). A statement of work (SOW) or statement of objectives (SOO) may be referenced and attached in lieu of providing a project description. In this case, write “See statement of work” or “See statement of objectives” in this section. Include technical specifications or salient characteristics that are required to ensure that the product or service performs as it should. Include the following:

· Complete common generic identification of the item required.

Applicable model, make, or catalog number for each brand name product referenced and the commercial catalog’s identity.

EXPI293 EXPRESSION MEDIUM 1000 mL total of 30 (packs/6) Catalog # A1435101, QTY 240

FREESTYLE 293 EXPRESSION MED 6 X1000ML Catalog #12338018, QTY 12

Manufacturer:

· Name of manufacturer, producer, or distributor of each brand name product referenced (and address if not well known).

Life Technologies Corporation 3175 Staley Road Grand Island, New York 14072 USA To Order:1-800-955-6288 Email: CustomerCare@thermofisher.com www.thermofisher.com/ordersupport NIH Rep. Pat Wooden

QUOTATION NO.: D5084169

· Any other information necessary to describe the item required.

SV. Identification of the statutory authority permitting other than full and open competition (SELECT ONE) (This section is to be completed by the purchasing agent.)

The agent must review the JOFOC and ensure that the narrative is factually based and supports the statutory authority selected. If it cannot be supported, then the product or service must be competed.

41 USC 3304(a)(1) and FAR Part 6.302-1: Only one responsible source/Brand Name This is the citation for most brand name purchases. Although the title references the “source,” in this case refers to the brand.

FAR Part 8.405-6: Federal Supply Schedule (FSS), limited competition/Brand Name Use this for brand name acquisitions that may be competed through FSS.

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

41 USC 3304(a)(5) and FAR Part 6.302-2: Authorized or required by statute/Brand Name This is used in the rare case when a specific brand is required or authorized by statute.

VI. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires the use of the authority cited. (This section is to be completed by the requestor.)

A. Name and address of the proposed contractor(s) Enter the name and address of the proposed contractor if only one vendor sells the brand-name product.

Name and address of the proposed contractor(s)

Life Technologies Corporation 3175 Staley Road Grand Island,New York 14072 USA Fax No:1-800-331-2286 To Order:1-800-955-6288 Email: CustomerCare@thermofisher.com www.thermofisher.com/ordersupport Attn: Pat Wooten;

NIH Rep. Pat Wooden Email: Pat.Wooten@thermofisher.com Sr. Account Manager, Biosciences Thermo Fisher Scientific Pat.wooten@thermofisher.com Direct: 240-401-0964

B. Describe why only the requested brand or brand name feature of the supply/service will meet the government’s needs Demonstrate that the prospective brand name item(s) has unique attributes and/or specialized capabilities not available from another commercial source. Explain what unique attributes and special capabilities the brand name item(s) possesses. Describe why only the attributes of this brand name feature of the supply/service will meet the government’s needs or are essential to the requirement, thereby precluding consideration of a product manufactured by another company.

The goal of the VRC is to translate basic research into concrete vaccine products that can be rapidly deployed to protect public health. The EXPI293 EXPRESSION MEDIUM and FREESTYLE 293 EXPRESSION MED is unique in that it allows for high density growth and protein production, with the accompanied use of other 293Expi components such as specific cell lines. We have been using the EXPI293 EXPRESSION MEDIUM, FREESTYLE 293 EXPRESSION MED, and OPTI MEM I for four to five years. It has proven to support the production of the proteins that we require for our protocols in the development for vaccines for HIV and other viruses.

VII. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable Price reasonableness determination will be included in the acquisition file.

We have been using Life Technologies products for several years, and they are currently the only company that supplies EXPI293 and FREESTYLE 293 Expression medias, and their associated reagents. In addition, we have been using these reagent for many years, and Life Technologies has been a reliable (and only available) source of this product.

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.

Requestor Certification

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