JUSTIFICATION BRAND NAME.docx

Justification for Other than Full and Open Competition:

Brand Name at or Below the Simplified Acquisition Threshold

Project Title: Terumo Welders for Sterile Bioreactor Tubing Changes

I. Identification of the agency and contracting activity

DHHS, NIH, NIAID, VRC, VPP

Address of the requesting lab/office: 9 West Watkins Mill Rd, Rm 200, Gaithersburg MD, 20878

DHHS, NIH, NIAID, VRC, VPP

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, 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): $279852.20 D. Period of performance, inclusive of options: from 2023 to 2034 E. Project Background The mission of the Vaccine Production Program (VPP) is rapid, reliable development of investigational vaccine candidates and other therapeutic biologics that are suitable for use in clinical trials. The Cell Culture Development (CCD) team commits to the VPP’s mission through study and optimization of cell culture options followed by scaling up successful culture production techniques for vaccine and therapeutic candidates. Successful process development is transferred to a GMP facility to manufacture materials for phase 1 Clinical trials.

A fundamental and essential element of CCD process development is the use of 3, 15, and 50 liter bio-reactors. This array of instrumentation enables scientific staff to study the effects of various growth and scale up conditions via the production and harvest of cell culture process runs. This technology requires the transfer of nutrients and the cells themselves into the bio-reactor throughout a seven to fourteen day process. Said transfer must be performed under sterile conditions or the bio-reactor may become contaminated and culture will fail.

To prevent bio-reactor failure, a closed and sterile circuit must be maintained when adding or removing feed stock, cells, or other samples. The CCD team requires a tubing welder than can rapidly and effectively create reliable sterile welds between tubes while remaining small enough to not impact our limited laboratory storage options and portability requirements.

F. Description of the supplies/services to be purchased

SCD IIB Sterile Tubing Welder, 120/240V - Vendor: Terumo - 10 ea, $23,042.22/ea Service Contract SCD IIB – Vendor: Terumo – 10 ea, $4,943.00/ea

Identification of the statutory authority permitting other than full and open competition (SELECT ONE 41 USC 3304(a)(1) and FAR Part 6.302-1: Only one responsible source/Brand Name

FAR Part 8.405-6: Federal Supply Schedule (FSS), limited competition/Brand Name 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

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

Name and address of the proposed contractor(s) Vendor: Terumo Address: 2115 E Jefferson St Commercial ACCTS – MSC 8500, Rm 4B-432 POC: Benjamin Stark POC E-mail: HYPERLINK "mailto:Benjamin.Stark@TerumoBCT.com" Benjamin.Stark@TerumoBCT.com POC Phone: 303-239-2032

D escribe why only the requested brand or brand name feature of the supply/service will meet the government’s needs Terumo SCD IIB is the recommended product. At ~$26k for both a welder and post warranty preventative maintenance contract, it is very affordable compared to the competition, such as Sartorius' Biowelder TC (~$51k).

The SCD IIB creates strong, dependable tubing welds within a closed system which significantly mitigates contamination and product loss. This welder speeds up production time with sterile welds created in about 30 seconds, as opposed to the 1.5 to 3 minutes required by competitors.. Its small form factor and lightweight design also exceeds options put forth by competitors enabling better use of our limited space and a more ergonomic option for our staff. SCD IIB units have been used by the CCD team for over 100 years, and meaning we not only have high confidence in the reliability and efficacy of these machines, but they are known to match our facility fit in terms of power supply, SOP related documentation, and employee training.

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

IV. 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

Contracting Officer Approval