JOFOC_Redacted.pdf

Justification for Other than Full and Open Competition:

Brand-Name at or Below the Simplified Acquisition Threshold

Project Title: Service Contract for Cytek Aurora Instruments

I . Identification of the agency and contracting activity

DHHS, NIH, NIAID,

Requestors name:

Requestors phone Requestors email a

Address of the req

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): Cytek Biosciences Sequence numbers: 2161755, 2138777, 2048579, 2112248, 2165876, 2165876, 2258890 Was the initial and any subsequent awards competed? Yes No

B. AMBIS Sequence number for this requirement: 2278154 C. Total estimated dollar value of the requirement (including options, if applicable): $68,560 D. Period of performance, inclusive of options: from 04/28/26 to 04/27/27 E. Project Background: The laboratory of Immunoregulation (LIR) focuses its research efforts on the elucidation of cellular and molecular mechanisms that regulate human immune response in health and disease. A major component of these research efforts involves high-dimensional immunophenotyping of lymphocytes isolated from the peripheral blood and lymphoid tissues of individuals enrolled in our HIV and other infectious and non-infectious clinical research protocols, including protocols with Clinicaltrials.org identifiers NCT01306019, NCT00001281, NCT00001316, NCT00039689, NCT05078905, NCT06339177, NCT00789009, NCT05612178, NCT06908083, NCT06819176, NCT04097561, NCT00867269, NCT02147405, NCT02015013, NCT03092505, and NCT05580458. The first Cytek Aurora Flow Cytometer was purchased in 2019 and a second Aurora was purchased in 2021 to accommodate the growing needs from several sections and units in the LIR (Chun, Moir, Rocco, and Sereti labs).

These two instruments have been critical to our ability to pursue the research efforts of each section/unit and to provide expertise to other collaborators and colleagues. The Cytek Aurora provides maximum capabilities in terms of numbers of parameters that can be studied simultaneously on a relatively small sample size with an instrument that is designed for high through-put, sensitivity, flexibility in reagents and computational tools while minimizing bias and background issues. Both Aurora instruments are used daily for several hours by multiple users and the samples must be analyzed the same day they are processed. In addition, the samples are collected from research protocol participants where collections cannot be repeated without compromising the health of the participants.

Thus, it is critical that both instruments be fully functional at all times. The Cytek Aurora instrument is a sensitive, delicate and highly complex instrument that must thus be under a service contract at all times and only Cytek engineers are qualified to service the instruments. These instruments are located in a room that is designed for working with cells isolated from individuals infected with HIV and other transmissible pathogens and as such, the samples cannot easily be analyzed on most other similar instruments on campus.

F. Description of the supplies/services to be purchased: The LIR owns two Cytek Aurora Flow Cytometer located in BSL-II/III lab 6A30 of Building 10. The instrument is used to immunophenotype cells isolated from peripheral blood and lymphoid tissues of participants in clinical research protocols with Clinicaltrials.org identifiers NCT01306019, NCT00001281, NCT00001316, NCT00039689, NCT05078905, NCT06339177, NCT00789009, NCT05612178, NCT06908083, NCT06819176, NCT04097561, NCT00867269, NCT02147405, NCT02015013, NCT03092505, and NCT05580458. In order to maintain the integrity of ongoing research it is imperative that this instrument be maintained in fully operational status. This service will protect the investment of the laboratory in both the instrument and the research in progress. We are purchasing this service contract in order to maintain the instrument and be able to get a priority repair response due to the heavy use and importance of the samples.

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

41 USC 3304(a)(1) a n d F A R P a r t 6 . 3 0 2 - 1 : Only one responsible source / Brand Name

F A R P a r t 8 . 4 0 5 - 6 : Federal Supply Schedule (FSS), limited competition / Brand Name

Important Note: The statutory authority listed below will rarely ever be used in NIH. Before selecting this authority, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

41 USC 3304(a)(5) a n d F A R P a r t 6 . 3 0 2 - 5 : Authorized or required by statute / Brand Name

IV. Demonstration that the proposed brand name product’s salient charictoristics (specific features, qualities and/or the nature of the acquisition) requires use of the authority cited.

A. Name and address of the proposed contractor(s) Cytek Biosciences 46107 Landing Parkway Fremont, CA 94538

G. Describe why only the requested supply/service will meet the government’s needs This service contract will protect the investment of the LIR in both the instrument and the research in progress. The Cytek Aurora instrument is a sensitive, delicate and highly complex instrument that must thus be under a service contract at all times and only Cytek engineers are qualified to service the instruments. These instruments are located in a room that is designed for working with cells isolated from individuals infected with HIV and other transmissible pathogens and as such, the samples cannot easily be analyzed on most other similar instruments on campus.

A priority response is required to maintain this instrument due to heavy usage and critical nature of the samples (human clinical study samples). Any delays in obtaining service would damage our ability to process these precious samples. A prolonged time for service would seriously disrupt the data collection and analysis as written into and required by the associated Clinical Studies, as well as being unethical to lose irreplaceable human samples.

B. Describe why only the proposed contractor is capable of providing the requested supply/service Cytek is the owner and manufacturer of the Aurora Flow Cytometer. Cytek is the only qualified source to provide factory certified service, maintenance, and parts for this equipment. They are also the only vendor to certify the service personnel to work on this equipment. Based on their service agreement parameters and past responses, Cytek is highly reliable for same day service, which is critically needed and is not guaranteed from a third party vendor.

Changing vendors will void any remaining warranties on the system, which would be costly to the government in downtime and incomplete experiments. Cytek will provide a priority response for repairs and we have had excellent experience with them providing a same-day response. A third party repair service would not be able to provide support in this required response time. The only exception would be if they obtained a priority service contract with Cytek and they were able to provide this to the gov’t as part of their RFQ package.

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.