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Notice of Intent to Sole Source Materials and Reagents from 10X Genomics
Solicitation number
NIAID-NOI-22-2123356
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This notice of intent announces the National Institute of Allergy and Infectious Diseases' plan to sole source a contract with 10X Genomics, Inc. to provide materials and reagents for sequencing and genomics analysis. The reagents and materials will support a Vaccine Research Center clinical trial over a 12-month period of performance from July 2022 through July 2023. The notice specifies that 10X Genomics will provide reagents and materials in three shipments on July 29, 2022, September 29, 2022, and December 29, 2022 to allow analysis at different trial time points using products from the same lot numbers. Only 10X Genomics can meet this requirement to ensure consistent results without additional testing. Responses to the notice were due by July 22, 2022, and the agency plans to award a firm-fixed price contract within seven days thereafter.

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ATTACHMENT 1: STATEMENT OF WORK

Title: 10X Genomics Sequencing Materials and Reagents for G002 Clinical Trial

1.0 INTRODUCTION/OVERVIEW

The Vaccine Immunology Program (VIP) of the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) is an intramural research component of the NIAID, that is dedicated to translating the latest concepts in disease pathogenesis and immunology into new vaccine strategies by conducting basic, translational, and clinical research dedicated to improving public health through discovery, design, and development of vaccines of public health importance. VRC scientific staff have expertise in immunology, virology, structural biology, pathogenesis, laboratory animal medicine, regulatory science, clinical research, bioengineering, and vaccinology. While the Center's primary focus is to develop vaccines and broadly neutralizing antibodies protecting against HIV/AIDS, the VRC also performs basic, translational, and clinical research to develop vaccine candidates for biodefense and emerging and re-emerging infectious diseases of public health importance. This includes vaccines for Ebola/Marburg, influenza, respiratory syncytial virus (RSV), malaria, tuberculosis (TB), Chikungunya and other alphaviruses, Zika virus, severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS) coronaviruses. To carry out parts of this mission, the VIP regularly seeks to obtain the necessary materials and reagents within the same lot number to avoid complications and additional unnecessary costs for planned clinical trials. For this particular trial VIP seeks to obtain reagents and materials for 10X sequencing analysis to complete several time points over the course of six months.

2.0 BACKGROUND

The Vaccine Immunology Program (VIP) of the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) provides state-of-the-art clinical trial research that helps guide determinations of effectiveness as well as providing insight into complex interactions down to the single cell level of the immunological response. Sequencing and genomic work that helps characterize and clarify these complex interactions are essential to a better understanding of the fundamental questions of vaccine effectiveness. The ability to provide these answers in sequencing and genomics using a platform that allows multiple samples of a specific trial over several time points is a key component of our mission to provide this insight while finding ways to reduce the time and cost as technology changes. Securing the materials and reagents from the same manufacturing lot prior to the start of a trial is key requirement to ensure this success and avoid unforeseen delays.

3.0 SCOPE

The purpose of this contract is to secure materials and reagents to perform 10X sequencing and genomics for this entire phase of G002 clinical trial, an HIV vaccine trial funded by the Collaboration for AIDS Vaccine Development (CAVD). Methods have been predeveloped and optimized so that materials and reagents for all samples and time points could be met.

4.0 REQUIREMENT

Independently, and not as an agent of the Government, the Contractor must provide the following reagents and materials at the expected delivery dates for a total of three shipments. The reagents, materials and expected delivery dates are as follows. Each item type should be the same lot number for all quantities.

Deliverables:

All Shipment 1 7/29/2022er Price QTY Total Price

Item Description
Item Catalog Number
Quantity
Chromium Next GEM Chip N Single Cell Kit, 16 rxns
1000375
7
Chromium X & Accessory Kit,12 Mo. Warranty
1000331
1
Chromium Next GEM Single Cell 5' HT Kit v2, 48 rxns
1000356
1
Chromium Next GEM Single Cell HT Training Kit, 32 rxns
1000386
1
Dual Index Kit TT Set A 96 rxns
1000215
2
Chromium Next GEM Single Cell 5' Kit v2, 16 rxns
1000263
6
Chromium Next GEM Chip K Single Cell Kit, 48 rxns
1000286
3
Chromium Single Cell Human BCR Amplification Kit, 16 rxns
1000253
6
5' Feature Barcode Kit, 16 rxns
1000256
6
Dual Index Kit TN Set A, 96 rxn
1000250
1

Date Shipment 2 9/29/2022er Price QTY Total Price

Item Description
Item Catalog Number
Quantity
Dual Index Kit TT Set A 96 rxns
1000215
1
Chromium Next GEM Single Cell 5' Kit v2, 16 rxns
1000263
4
Chromium Next GEM Chip K Single Cell Kit, 48 rxns
1000286
3
Chromium Single Cell Human BCR Amplification Kit, 16 rxns
1000253
4
5' Feature Barcode Kit, 16 rxns
1000256
4
Dual Index Kit TN Set A, 96 rxn
1000250
1

Shipment 3 12/29/2022

Item Description
Item Catalog Number
Quantity
Dual Index Kit TT Set A 96 rxns
1000215
1
Chromium Next GEM Single Cell 5' Kit v2, 16 rxns
1000263
4
Chromium Next GEM Chip K Single Cell Kit, 48 rxns
1000286
3
Chromium Single Cell Human BCR Amplification Kit, 16 rxns
1000253
4
5' Feature Barcode Kit, 16 rxns
1000256
4
Dual Index Kit TN Set A, 96 rxn
1000250
1

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9.0 PERIOD OF PERFORMANCE

The anticipated period of performance will be for one (1) twelve (12) month year of 7-29-22 through 7-28-23.

10.0 PLACE OF PERFORMANCE

The Contractor’s principal delivery place will be at the Vaccine Immunology Program’s laboratories located at 9 West Watkins Mill Rd., Gaithersburg, MD 20879

11.0 GOVERNMENT FURNISHED EQUIPMENT AND FACILITIES

11.1 Facilities, Supplies and Services

N/A

11.2 Information

N/A

11.3 Documentation

N/A

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