Miltenyi Biotec Inc CliniMACS® Plus Preventative Maintenance Service

Miltenyi Biotec Inc CliniMACS® Plus Preventative Maintenance Service

NAICS Code: 811210- Electronic and Precision Equipment Repair and Maintenance
Product Service Code: J066- Maintenance/Repair/Rebuild of Equipment- Instruments and Laboratory Equipment

Place of Performance:
National Institutes of Health
Clinical Center
10 Center Drive
Building 10, Room TBD
Bethesda, Maryland 20892

POTS: 25-000076

Description
This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested.

The National Institutes of Health, Office of Purchasing and Contracts on behalf of the Department of Laboratory Medicine, Center for Cellular Engineering intends to award a firm-fixed priced sole source award to Miltenyi Biotec Inc located at 2303 Lindbergh Street, Auburn, California 95602 for a one-year preventative maintenance service contract. 

Line Item: 0001 CliniMACS® Plus Serial Number 2600-Quantity 1
Line Item: 0002 CliniMACS® Plus Serial Number 2602-Quantity 1
Line Item: 0003 CliniMACS® Plus Serial Number 2632-Quantity 1
Line Item: 0004 CliniMACS® Plus Serial Number:2635-Quantity 1
Line Item:  0005 CliniMACS® Plus Serial Number 2634-Quantity 1

The Department of Laboratory Medicine, Center for Cellular Engineering has a requirement for a preventative maintenance service agreement for CliniMACS® Plus devices serial numbers: 2600, 2602, 2632, 2635, and 2634.  Center for Cellular Engineering uses the CliniMACS® Plus devices in the manufacture cell-based therapies for patients with advanced metastatic cancer enrolled on clinical trials

Miltenyi Biotech, Inc is the only known source capable of performing preventative maintenance services on the Miltenyi CliniMACS® Plus Instruments.  Miltenyi Biotec products are offered exclusively by Miltenyi Biotec B.V. & Co. KG, its subsidiaries and distributors.  Miltenyi Biotec software is proprietary in nature.  Miltenyi Biotec is the only contractor capable of providing authorized and trained service technicians with the knowledge and expertise to perform the preventative maintenance services and supplier of original equipment manufacturer parts.  In addition, these instruments will require software updates and software patches that only the original equipment manufacturer can perform.  Any failure due to service errors could potentially harm patients or if the instrument becomes operable would result in the loss of extensive research efforts.

Funding is currently not available for this requirement.

FAR 52.232-18-Availability of Funds
Funds are not presently available for this contract. The Government’s obligation under this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer. (End of Clause)

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 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.  Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

Interested Parties:
Interested parties capable of providing the same or similar products or services described in this notice may submit a capability statement outlining their capability to perform the described work.  Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. The determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

Comments to this announcement, referencing this posting number on the email subject line, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Sheri Eiri, Contract Specialist, at sheri.eiri@.nih.gov by the due date September 30, 2024, by 12:00 pm Noon EST and time marked in this notice.