JOFOC Sartorius_10X Genomics_EDLI.docx

Justification for Other than Full and Open Competition (Under the SAT) Open Market FAR 13.106-1

1. AGENCY IDENTIFICATION AND CONTRACTING ACTIVITY

The Department of Health and Human Services.

National Institutes of Health Clinical Center Purchasing and Contracts Department 6701 Democracy Blvd Bethesda, MD 20892

POTS: 26-009223

NAICS Code:

PSC/FSC:

2. NATURE AND/OR DESCRIPTION OF THE ACQUISITION BEING APPROVED

The National Institutes of Health, Office of Purchasing and Contracts, on behalf of the Critical Care Medicine Department, intends to establish a procurement agreement with 10X Genomics for the acquisition of reagents and consumables required for the Early Detection of Lung Diseases (EDLI) project.

These reagents are specifically designed and exclusively compatible with the 10X Genomics Chromium platform, a proprietary system that enables high-resolution gene expression analysis. The EDLI project relies on these reagents to ensure experimental continuity, data accuracy, and reproducibility in studies focused on identifying early biomarkers and understanding the mechanisms of infectious and noninfectious lung diseases.

As sole-source items, these reagents cannot be substituted without disrupting ongoing experiments and compromising the integrity of the research. The acquisition will support the project’s critical mission to advance diagnostic and therapeutic approaches for lung diseases.

3. DESCRIPTION OF THE SUPPLIES AND SERVICES REQUIRED TO MEET THE AGENCY’S NEEDS

The National Institutes of Health requires the procurement of the 10X Genomics GEM-X Universal 5' Gene Expression v3 Kit to support the Early Detection of Lung Diseases (EDLI) project. This kit is a specialized reagent set designed exclusively for the 10X Genomics Chromium platform/instrument, enabling cutting-edge single-cell and multiomic analyses.

The GEM-X Universal 5' Gene Expression v3 Kit facilitates high-resolution gene expression profiling, immune repertoire analysis, and other advanced applications critical to identifying early biomarkers and understanding the molecular mechanisms of infectious and noninfectious lung diseases. These capabilities are essential to achieving the EDLI project’s objectives, which aim to advance diagnostic and therapeutic strategies for lung health.

This acquisition includes proprietary reagents, consumables, and supporting components optimized for use with the Chromium platform. The compatibility and precision of the 5' v2 Kit are necessary to ensure data integrity, reproducibility, and experimental consistency across ongoing and future studies.

Due to the proprietary nature of the GEM-X Universal 5' Gene Expression v3 and its unique compatibility with the 10X Genomics system, no alternative supplies can meet the technical requirements of the EDLI project. Procuring this kit is essential for ensuring the continuity and success of the research.

4. THE TOTAL ESTIMATE FOR THIS PROJECT: $

5. IDENTIFICATION OF STATUTORY AUTHORITY PERMITTING OTHER THAN FULL AND OPENCOMPETITION. Check the applicable below.

_X_ FAR 13.106-1(b) (1): For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available (e.g. urgency, inclusive licensing agreements, brand name, or industrial mobilization).

___FAR 13.501 (a) (1) (ii) &2(i): For actions for commercial supplies or services greater than the SAT but not exceeding $6.5M, the citation is: Test Program for commercial Items, Section 4202 of the Clinger-Cohen Act of 1996.

6. DEMONSTRATION THAT THE PROPOSED CONTRACTOR’S UNIQUE QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES USE OF THE AUTHORITY CITED.

Proposed Contractor:

Name: 10x Genomics, Inc.

6230 Stoneridge Mall Road Pleasanton, California, 94588-3260 United States

The GEM-X Universal 5' Gene Expression v3 Kit is a proprietary product designed exclusively for use with the 10X Genomics Chromium platform. This platform employs unique, patented technology that is only compatible with reagents and consumables manufactured and supplied by 10X Genomics. The GEM-X Universal 5' Gene Expression v3 Kit is integral to high-resolution single-cell and multiomic analyses, which are essential components of the Early Detection of Lung Diseases (EDLI) project.

The proposed contractor, 10X Genomics, is the sole source for these reagents, as no other vendor produces kits that meet the technical specifications and compatibility requirements of the Chromium system. Substituting reagents or using third-party alternatives would result in significant disruptions to ongoing experiments, compromising the reproducibility, accuracy, and integrity of the research data.

Given the unique capabilities of the 10X Genomics platform and the critical role of the GEM-X Universal 5' Gene Expression v3 in supporting the EDLI project’s objectives, 10X Genomics is uniquely qualified to fulfill this requirement. The proprietary nature of their reagents necessitates the use of the cited authority to ensure the continuity and success of this vital research.

7. A DESCRIPTION OF EFFORTS MADE TO ENSURE THAT OFFERS ARE SOLICITED FROM ASMANY POTENTIAL SOURCES AS PRACTIABLE

8. DEMONSTRATION THAT THE ANTICIPATED COST WILL BE FAIR AND REASONABLE.

9. DESCRIPTION OF MARKET RESEARCH CONDUCTED AND THE RESULTS OR STATEMENT OFTHE REASON MARKET RESEARCH WAS NOT CONDUCTED

This is a Sole Source Items

10. ANY OTHER FACTS SUPPORTING THE USE OF OTHER THAN FULL AND OPENCOMPETITION.

The use of other than full and open competition is justified due to the proprietary nature of the 10X Genomics GEM-X Universal 5' Gene Expression v3 Kit, which is uniquely designed for exclusive compatibility with the 10X Genomics Chromium platform. No other supplier offers reagents or consumables that can be used with this platform without compromising the accuracy, consistency, and reliability of experimental results.

Furthermore, 10X Genomics supports NIH by offering a 15.93 % discount on their products, which ensures cost-effectiveness while maintaining the high quality of research. The availability of this discount demonstrates the contractor’s commitment to fostering collaborative research and highlights the value of continuing to use their proprietary products.

The specific technical requirements of the EDLI project, the lack of viable alternatives, and the critical role of the GEM-X Universal 5' Gene Expression v3 Kit in ensuring experimental continuity collectively support the use of other than full and open competition for this acquisition.

11. LISTING OF SOURCES, IF ANY, THAT EXPRESSED, IN WRITING, AN INTEREST IN THEACQUISITION.

12. STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OROVERCOME ANY BARRIERS TO COMPETITION BEFORE ANY SUBSEQUENT ACQUISITIONFOR THE REQUIRED SUPPLIES OR SERVICES.

13. ADMINISTRATIVE OFFICER/PROGRAM OFFICIAL CERTIFICATION

“I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.”

Name and Title

14. Contracting Officer Certification “I hereby certify that the information contained in this justification is accurate and complete to the best of my knowledge and belief.”

Malinda Dehner Contracting Officer