SAM #75N98026Q00272

Sole Source Annual Service and Maintenance Agreement for Sony SH800SFP Cell Sorter at NIH NCATS Functional Genomics Lab

NCATS Functional Genomics Lab at NIH is seeking a sole source, 12-month service and maintenance contract for its Sony SH800SFP Cell Sorter. - Contract is for one Sony SH800SFP Cell Sorter (S/N 314054) - Only Sony Biotechnology, Inc., the OEM, is authorized to provide service - Services include: - One onsite preventive maintenance visit per year - Unlimited remote technical support (phone, email, diagnostics) - Onsite repair response within 72 hours if needed - OEM-certified repairs, parts replacement, and use of OEM diagnostic tools - Software and firmware updates during contract period - All replacement parts must be OEM-certified and shipped at no cost to the government - Services performed by Sony factory-trained engineers - Place of performance is NCATS Functional Genomics Lab - Contracting office is NIH NCATS Functional Genomics Lab - Period of performance is 12 months, base year only - Procurement is sole source, not set aside for small businesses - No options or additional years mentioned

Technical and Business Details - Only Sony Biotechnology, Inc. can provide the required maintenance due to proprietary technology - All work must comply with OEM standards for calibration, alignment, cleaning, and lubrication - Unlimited support ensures rapid response and minimal downtime - Software and firmware support ensures system remains current and secure - No competing vendors or products identified due to sole source justification - Estimated contract value likely in the $10,000-$30,000 range for annual OEM service

Locations - Place of performance: NCATS Functional Genomics Lab, NIH - Contracting office: NIH NCATS Functional Genomics Lab, Bethesda, MD

Description

Special Notice – Notice of Intent to Sole Source

SOLICITATION NUMBER: 75N98026Q00272

TITLE: Annual Service and Maintenance Agreement for Waters QDa system

RESPONSE DATE: May 8, 2026, at 11:00 am EST.

1. PRIMARY POINT OF CONTACT: Jaddua Johnston Email: jaddua.johnston@mail.nih.gov Phone: 240-569-0006

2. INTRODUCTION: This is a pre-solicitation non-competitive (Notice of Intent) synopsis to award a contract without providing for full or open competition (including brand-name). The National Center for Advancing Translational Sciences (NCATS) Formulation Group requires a comprehensive annual service and maintenance agreement for the Waters QDa system used in the NCATS Formulation Laboratory. The purpose of this agreement is to ensure continuous operation, reliability, and data integrity of the instrument used by NCATS scientists for research activities. Due to the proprietary nature of the Waters QDa system hardware, software, firmware, and diagnostic tools, maintenance and repair services must be performed by technicians specifically trained and authorized by the original equipment manufacturer (OEM), Waters Corporation. The use of OEM service personnel and components ensures instrument compatibility, protects system performance specifications, and prevents voiding manufacturer warranties.

3. NAICS CODE and SET ASIDE STATUS: NAICS code 334516 - Analytical Laboratory Instrument Manufacturing, with a size standard of 1000. This acquisition is NOT set aside for small businesses.

4. REGULATORY AUTHORITY: This acquisition will be conducted using FAR Part 12 – Acquisition of Commercial Items in conjunction with FAR Part 13 – Simplified Acquisition Procedures, as applicable. The resultant contract will include all appropriate provisions and clauses in effect through the current Federal Acquisition Circular (FAC).

5. STATUTORY AUTHORITY: This acquisition is being conducted under the authority of: FAR 6.302-1 – Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements (41 U.S.C. 3304(a)(1)).

6. DESCRIPTION OF REQUIREMENT: 6.1. PURPOSE AND OBJECTIVES: The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The Waters QDa system is an ultra-performance liquid chromatography (UPLC) system equipped with photodiode array (PDA), evaporative light scattering (ELSD), and mass spectrometry (MS) detection capabilities. The system is used to determine identity, purity, stability, and solubility of drug substances and excipients used in NCATS pre-clinical formulation development. Because this instrument is routinely used to support critical research activities, its operational reliability is essential. Regular preventive maintenance and prompt repair services are required to ensure optimal system performance, maintain analytical reproducibility, and minimize instrument downtime. Due to the integrated and proprietary design of the Waters QDa system and its associated software and firmware, only manufacturer-authorized service engineers with access to proprietary diagnostics and OEM replacement parts can properly maintain and repair the system. Period of Performance: Base Period (Year 1): to begin upon acceptance of Purchase Order by vendor.

7. SCOPE OF WORK: General Requirements: The Contractor shall provide all necessary labor, materials, tools, equipment, transportation, and qualified personnel required to perform service and maintenance for the Waters QDa system identified in this Statement of Work. The Contractor shall perform services independently and not as an agent of the Government. Services must be performed by field service engineers who are certified and trained by Waters Corporation and who have demonstrated expertise servicing Waters UPLC and QDa mass detection systems. All replacement parts, assemblies, firmware updates, and accessories provided under this agreement shall be original equipment manufacturer (OEM) parts manufactured or authorized by Waters Corporation to ensure full compatibility with the existing system and to maintain manufacturer performance specifications. The Contractor shall have access to proprietary Waters diagnostic tools, calibration procedures, firmware updates, and service documentation required for proper servicing of the instrument. Specific Requirements: NCATS requires a full coverage service maintenance agreement for the following: Waters QDa (UPLC with PDA, ELSD, and MS components with SN# listed below): Column Manager SN#: E23CMP079G Sample Manager FTN SN# B23FNP721G Binary Solvent Manager SN#: C23BSP427G Evaporative Light Scattering Detector SN#: H23UPE608M Isocratic Solvent Manager SN#: H23QDI495M Photo Diode Array Detector SN#: K22UPL250A QDa MS Detector SN#: KBF7548 Edwards Vacuum pump SN#: 230106560 The contract shall include the following services: Dispatch of a Waters-certified field service engineer to NCATS facilities for troubleshooting, diagnostics, and repair of the instrument. Scheduled onsite preventive maintenance performed according to manufacturer specifications to ensure optimal system performance and reliability. Inspection, calibration, and verification of system performance using proprietary manufacturer diagnostics and service tools. Repair or replacement of defective system components necessary to restore the instrument to full operational status. Provision and installation of OEM replacement parts required for maintenance or repair. Replacement components shall be new or manufacturer-certified parts fully compatible with the Waters QDa system. Delivery of replacement components to NCATS when required, including instructions or assistance for proper installation when applicable. Access to manufacturer technical support resources for troubleshooting and service coordination. Access to proprietary manufacturer software, firmware updates, calibration protocols, and diagnostic tools required to properly maintain and repair the Waters QDa system. Completion of all maintenance and repair services in accordance with Waters manufacturer performance standards and specifications. LEVEL OF EFFORT: Only authorized field service engineers with proven experience servicing the instruments listed in this SOW shall provide service.

8. GOVERNMENT RESPONSIBILITIES: Government shall provide contractor access to NCATS facilities: 9808 Medical Center Dr, Rockville MD 20850. Access will be restricted during federal holidays and after business hours (8am – 5pm, Monday through Friday).

9. DELIVERABLES: The Contractor shall provide: Preventive maintenance services Repair services Replacement parts as required Labor and materials necessary to maintain the instrument in operational condition All travel, labor, parts, materials, and service costs shall be included in the contractor’s quoted service agreement price.

10. REPORTING REQUIREMENTS: Following each service visit, the Contractor shall provide written documentation including: Description of maintenance or repair performed Parts replaced System performance verification results Confirmation that the instrument meets manufacturer performance specifications Service documentation shall be provided to the NCATS laboratory point of contact.

11. OTHER CONSIDERATIONS: All travel expenses associated with service visits shall be included in the contractor’s quoted service agreement price. The Government will not separately reimburse travel expenses. N/A N/A N/A N/A N/A Travel: Key Personnel: Information System Security Plan: Section 508—Electronic and Information Technology Standards: Publications and Publicity: Confidentiality of Information:

12. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION: The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, Waters Technologies Corporation is the only vendor in the marketplace that can provide the services required by NCATS. The equipment is proprietary to its manufacturer, Waters Technologies Corporation, and this company is the sole provider of maintenance for this equipment. In accordance with FAR part 10, extensive market research was conducted to reach this determination. Additionally, contacts with knowledgeable individuals both in industry and Government, as well as reviews of available product literature, revealed no other sources. Finally, a review of the GSA Advantage, Dynamic Small Business Search, and previous government acquisitions returned no results that meet all of the requirements. Therefore, only Waters Technologies Corporation is capable of meeting the needs of this requirement. The intended source is: Waters Technologies Corporation 34 Maple Street Milford, MA 01757

13. CLOSING STATEMENT: This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must be received by the closing date and time of this announcement and must reference the solicitation number, 75N98026Q00272. Responses must be submitted electronically to Jaddua Johnston, Contract Specialist at Jaddua.Johnston@nih.gov.

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