2_JA 2132847 Nova Biomedical.pdf

Justification for Other than Full and Open Competition:

Brand Name at or Below the Simplified Acquisition Threshold

Project Title: NOVA Biomedical consumables

I . Identification of the agency and contracting activity

DHHS, NIH, NIAID, VRC, VPP

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

II. Description of the project, and supplies or services required to meet the agency’s needs A. Project Background

The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 50 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world.

The Vaccine Research Center (VRC) is an intramural research center within NIAID dedicated to discovery and translational science for infectious disease indications. The VRC has full bench-to-bedside capabilities that enable rapid clinical evaluation of VRC discoveries. The VRC’s Vaccine Production Program Laboratory has process, formulation, and analytical development groups and oversees cGMP manufacturing at the VRC’s pilot plant.

Since the VRC/Vaccine Production Program (VPP) group is responsible for developing a scale able GMP process the items requested need to be standardized with what will be utilized in the VRC’s pilot plant and applicable to a GMP process and analytical standards that are used to characterize and release therapeutic and vaccine candidates to treat diseases including Covid-19 (SARS2-CoV), HIV, Influenza, Malaria, and Ebola. Understanding these attributes are required for moving forward with a candidate to GMP manufacturing and clinical trials. We are requesting these Cell Line Development and Cell Culture Development supplies in support of the VPP’s 7 Nova Flex 2 Systems. VPP requests receiving these supplies in 4 shipments.

4 Delivery Dates:

1st Delivery 30 days ARO 2nd Delivery 10/26/2022 3rd Delivery 01/26/2023 4th Delivery 04/26/2023

B. Description of the supplies/services to be purchased

Item Item

Number Per

Shipment Per

Year Usage Consumables pH/Gas Microsensor Card LV 57510 16 64 pH/Gas Microsensor Card HV 57526 4 16 Chem Microsensor Card LV 57512 16 64 Chem Microsensor Card HV 57528 4 16 pH/Gas Calibrator Cartridge

MV 58102 16 64

Chem Calibrator Cartridge MV 58101 24 96

CDV Reagent Cartrdige 55297 16 64 pH/Gas Auto QC Cartridge 56073 16 64 Chem Auto QC Cartridge 57035 24 96 ESM Reagent Cartridge 56227 4 16

Shut Down Consumables pH/Gas Shutdown Cartridge 60608 4 16

Chemistry Shutdown Cartridge 60610 4 16 CDV Shutdown Cartridge 60611 4 16 ESM Shutdown Cartridge 60612 4 16 pH/Gas Auto QC Shutdown Cartridge 60613 4 16

Misc. Consumables for Maintenance

CDV Advanced Cleaning Solution 63940 6 24

Osmo48 Micro tubes 59859 3 12 Controls Level 8 43472 1 4 Controls Level 9 43473 1 4

Chemistry DePro Card 58644 1 4 pH/Gas DePro Card 58645 1 4

Sample Cups 58275 2 8 Syringe 42400 2 8

ESM Syringe 60018 1 4

III. Identification of the statutory authority permitting other than full and open competition

41 USC 1901(a)(1) a nd FAR Pa r t 13 .106- 1 ( b ) : Only one responsible source/Brand Name

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)

NOVA Biomedical 200 Prospect Street Waltham, MA 02454

Phone: 443.847.9488

B. Describe why only the requested brand or brand name feature of the supply/service will meet the government’s needs

The items ordered herein fall into two categories: 1) They are specific to an instrument that require the specific items listed in section F to be from this manufactured by the requested manufacturer and/or 2) these items have historical applications and have already proven to be effective with our specific biological candidates, are currently under VPP’s Cell Culture and Cell Line Development SOPs. Additionally, the instrument for which these supplies are being requested are currently in use at the GMP Pilot plant and are currently validated in their process’.

Attempts to modify the items the VPP utilizies in the development of the next generation vaccine and or theriapeutics would result in the pilot plant having to re tool and then re validated existing materials at the pilot plant. This would then cause significant (greater than 12 months) delays in the VRC’s program goals.