JOFOC 2175870.pdf

Justification for Other than Full and Open Competition:

Brand Name at or Below the Simplified Acquisition Threshold

Project Title: ____Purchase of Visium CytAssist for FFPE Spatial Gene Expression 11mm Kits, Human, from

10X Genomics (AMBIS 2175870)_________________________________________

I . Identification of the agency and contracting activity DHHS, NIH, NIAID, Laboratory of Virology______________________ Requestors name: Dan Chertow, MD, MPH Requestors phone number: 301-496-9320 Requestors email address: chertowd@cc.nih.gov Address of the requesting lab/office: Building 10, Room 2C145, 10 Center Drive, Bethesda, MD 20892

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: ___2175870_______________ C. Total estimated dollar value of the requirement (including options, if applicable): ______$95,000_________ D. Period of performance, inclusive of options: from ___________ to ________________ E. Project Background

The Chertow group’s research program utilizes human natural history studies and advanced animal models to improve understanding of the pathophysiology and molecular pathogenesis of severe emerging infectious agents including Ebola virus, antibiotic-resistant bacteria, and SARS-CoV-2. COVID-19 is associated with neurologic complications, and we have previously demonstrated that SARS-CoV-2 infects brain cells of patients with COVID-19.

Our next goal is to utilize the human brain tissues from COVID-19 autopsies that we have collected to assess how SARS-CoV-2 changes human brain tissue cells and immune cells. We need the 10X Genomics Visium Spatial Gene Expression CytAssist kits to compare genetic changes between virus-infected brain tissue regions and non-infected brain tissue regions. This technology allows us to map the cell-by-cell genetic changes back to images of the tissue which include information about the location of cell types and the location of the virus. Importantly, this technology is compatible with our tissue preservation methods. With the resulting data, we will have novel insight into how the virus changes genes in the brain that could contribute to disease of the central nervous system and long COVID.

F. Description of the supplies/services to be purchased

The 10X Genomics Visium Spatial Gene Expression CytAssist kits are unique in that the technology allows mapping of the cell-by-cell genetic changes into images of the tissue. The capabilities that make this the only brand on the market capable to perform our research are:

• FFPE Spatial Gene Expression

• 11mm Kit,

• Human,

• 8 rxns;

• Dual Index kit TS Set A,

• 96 rxn.

• This is a commericall offered kit, and the catalog number for each requested kit are referenced below:

1. Visium CytAssist for FFPE Spatial Gene Expression 11mm Kit, Human 8 rxns, Catalog # 1000444

2. Dual Index Kit TS Set A 96 rxn, catalog # 1000251

• Estimated Shipping and handling added $158.00

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

☒ 41 USC 1901(a)(1) a n d F A R P a r t 1 3 . 1 0 6 : 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.

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)

10x Genomics 6230 Stoneridge Mall Road Pleasanton, CA 94588-3260 +1 925 401 7300 +1 800 709 1208 customerservice@10Xgenomics.com

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

We need the 10X Genomics Visium Spatial Gene Expression CytAssist kits to compare genetic changes between SARS-CoV-2-infected human brain tissue regions and non-infected human brain tissue regions. Critically, the kits are uniquely capable of mapping the cell-by-cell genetic changes back to images of the tissue which include information about the location of cell types and the location of the virus. It is also essential that the kits are compatible with the methods we used to preserve the brain tissues. Our Research specifically needs the CytAssist kits provided by 10X Genomics to eliminate variability that could be introduced by using kits from other vendors.

Such variability could limit our ability to compare our data to other existing and future data sets produced by kits provided by 10X Genomics. Being able to compare data is critical for current and future interpretation of the data and resulting publications.

V . 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.

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