JandA_CytekAuroraMaint_Redacted.pdf

ii. Cytek Aurora Spectral Flow Cytometer (Serial # U0588) Laboratory of Pathology

iii. Cytek Aurora Spectral Flow Cytometer (Serial # U1191) Laboratory of Pathology

iv. Cytek Aurora Spectral Flow Cytometer (Serial # U1217) Neuro-Oncology Branch

v. Cytek Aurora Cell Sorter (Serial # S0128) Laboratory of Pathology

vi. Cytek Aurora model N7-00002-0A custom configured Flow Cytometer (Serial # Y0275) Laboratory of Pathology

See accompanying statement of work (SOW) for more details.

Requirement type.

Research & development (R&D) R & D support services

X Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

X New requirement Follow-on:

Other (specify):

Proposed contract/order type.

X Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number. 75N91023Q00007

c. Total estimated dollar value and performance/delivery period.

The total estimated dollar value for this service, including all option periods, is , with a total performance period of four (4) years. The base period of performance shall be for twelve (12) months, followed by three (4) 12-month option periods as follows:

Base Period April 1, 2023 – March 31, 2024 Option Period 1 April 1, 2024 – March 31, 2025

Option Period 2 April 1, 2025 – March 31, 2026 Option Period 3 April 1, 2026 – March 31, 2027

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under FAR 13.106-1 (b)(2), for soliciting from a single source for purchases exceeding the simplified acquisition threshold, which states that the requirements of FAR 13.501(a) apply to sole-source acquisitions of commercial products and commercial services conducted pursuant to subpart FAR 13.5.

5. 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).

Cytek Biosciences Inc.

46107 Landing Parkway Fremont, CA 94538

SAM UEID: TD2JM5U24NF8

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

This acquisition is to acquire continuous maintenance service for six (6) Government-owned Cytek Aurora devices. These devices are used by NIH CCR research staff to analyze samples from various animal vaccine studies, to analyze samples for over 20 clinical trials, simultaneously providing data on the expression of more than 50 cell surface markers and proteins to guide patient treatment. The Cytek Aurora devices are highly specialized instruments capable of analyzing 35 colors using the total spectrum of each fluorochrome. The system includes a patented components software that is proprietary to Cytek Biosciences.

Cytek Biosciences is the manufacturer and distributor of the Cytek Aurora Flow Cytometers and Aurora Cell Sorter. This vendor owns the proprietary software needed to provide the required support on its device. The Cytek Aurora Flow Cytometers and Aurora Cell Sorter have specialized operating systems that only service engineers at Cytek Biosciences are authorized to handle. The vendor’s service engineers are factory-trained to provide service on these highly specialized pieces of equipment. The Cytek Aurora devices are used daily by research and clinical staff.

Downtime due to a malfunctioning device would directly impact the NCI mission by delaying research efforts and patient treatment. These devices cannot be down for an extended period of time. Therefore, vendor response timeframe is critical to keeping the instruments running at optimal performance despite heavy usage.

The Cytek Aurora devices require intense upkeep and regular maintenance is necessary for their continuous proper function. Only one source is capable of providing the supplies and services required at the level of quality required. The maintenance services are highly specialized and must be maintained by the original manufacturer. The only way to maintain proper calibration, maintenance, and parts of these critical cytometers and cell sorter is to acquire maintenance agreement with Cytek Biosciences. The manufacturer does not license third party technicians;

therefore, Cytek Biosciences is the only known provider to the NCI that can meet the Government’s needs at this time.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a SAM.gov Contracting Opportunities notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

A Pre-Solicitation Notice of Intent to Sole Source was published on SAM.gov Contract Opportunities in accordance with FAR Part 5.2. Special Notice 75N91023Q00007 was posted from 1/25/2023 – 2/3/2023, which received one response from The Remi Group (UEI# X458FNVQ1YX9). Based on the information provided in their response, Program assessed that The Remi Group cannot guarantee the required onsite response time and therefore could not be considered a competitive alternative to the manufacturer.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The NCI Contract Specialist will consider the Independent Government Estimate and similar purchase order prices as determining factors for price reasonableness. Based on this information, there is no reason to believe that the price will not be fair and reasonable to the Government.

A final determination will be conducted prior to the award of this contract. The contract file will be documented to support the Contracting Officer’s fair and reasonable price determination.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market research was conducted utilizing Required Sources, Federal Supply Schedules, NIH Strategic Sources, Commercial Websites, historical data, and correspondence with industry. The Contracting Officer has determined that only Cytek Biosciences, Inc. can provide service, maintenance and replacement parts for their Aurora devices. Cytek Biosciences, Inc. is a manufacturer and distributor of Cytek Aurora devices and authorized service on these devices is only available directly through Cytek’s service organization. As such, Cytek Biosciences, Inc. is considered as a Sole Source for proprietary parts and service on these devices.

The Project Officers conducted market research via internet search engine and their own technical and scientific knowledge of the marketplace. Building on the Project Officers’ work, the Contract Specialist’s market research consisted of: 1) reviewing the CCR ARC

IGE; 2) searching purchases in FPDS-NG over the last 3 years for similar maintenance services, all of which were made to Cytek, the manufacturer; 3) searching GSA eLibrary;

however, the required services are not available under any GSA Multiple Award Schedules and 4) an internet search with the keywords “Cytek Aurora Maintenance.” The internet search resulted in Cytek the manufacturer. NCI OA has determined that the appropriate NAICS Code is 811210 - Electronic and Precision Equipment Repair and Maintenance

9. Any other facts supporting the use of other than full and open competition.

All facts have been previously stated.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

As described in section 6 above, the one inquiry received in response to the Pre-Solicitation Notice of Intent to Sole Source did not demonstrate reasonable capability from an interested third-party provider. No other sources have expressed written interest in the proposed acquisition.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

The Government requires unique maintenance services and propriety supplies from the original source, Cytek Biosciences, Inc. This vendor provides unique maintenance capabilities for the continued utilization of their highly specialized Aurora systems.

Subsequent acquisitions for maintenance are anticipated, and the Government will monitor the market to avoid or reduce continued noncompetitive acquisition of this requirement in the future. However, the Government does not expect changes to the current market situation in the foreseeable future, i.e. during the anticipated period of performance of this contract, since propriety software and propriety supplies are, at present, the major barriers to competition.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

13. Contracting Officer 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 the rationale and recommendation for approval is accurate and complete.