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INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). This is... INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). This is not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Center for Cellular Engineering (CCE), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (including brand-name) to: BIOLIFE SOLUTIONS, INC. 3303 MONTE VILLA PKWY. STE. 310 BOTHELL, WA, 98021-6200 USA NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 325413 with a Size Standard 1250. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2022-06, May 26, 2022. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold. STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. GENERAL INFORMATION 1. Title: Biolife / 600x CryoStor CS10, 100mL Bag, UL 2. Background Information: The National Institutes of Health (NIH) is the nation’s foremost federally funded biomedical research institution. It is comprised of twenty-seven Institutes and Centers. The NIH Clinical Center (CC) is the onsite hospital for the NIH campus, providing full support for clinical studies in inpatient and outpatient settings. The NIH CC is an 870,000 square-foot facility with the capacity to serve 240 inpatient beds and 82 day-hospital stations. The Center of Cellular Engineering (CCE), Department of Transfusion Medicine, NIH CC is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes to support more than 50 intramural clinical trials. These services include (1) development, evaluation, and validation of investigational new drugs (INDs) for cellular therapies and (2) manufacture of cellular therapy products for approved clinical trials. The majority of these trials are early phase (I/II) trials not intended to result in the development of a commercial product. To provide these services, CCE operates a core facility (Charles S. Carter Cellular Therapy Laboratory) for the manufacture, storage, and distribution of cellular therapy products. CCE manufactures cellular therapy products from more than 800 collections from patients or healthy donors per year. The products manufactured by the laboratory are used to treat NIH CC patients with cancer, hematological malignancies, marrow failure, genetic immune disorders and autoimmune diseases. All products are manufactured using good manufacturing practices (GMP). The NIH protocols are institutional review board (IRB) approved and in the case of INDs approval by the US Food and Drug Administration (FDA) for treatment of human subjects. Each subject must consent to participate in a NIH Clinical Research Study. 3. Purpose or Objective: To procure 6-month contract from Biolife Solution for the Center for Cellular Engineering cell manufacturing facilities. The primary objective of this project is to supply CS10 material for the CCE labs. The contract is to prevent issues with back orders due to supply chain issues associated with the Covid-19 Pandemic. 4. The Vendor will supply reagents as needed in a timely manner for the period of performance, which is 7/27/22 – 12/31/22. The reagents include but not are not limited to those listed below: SCOPE: 1. The contractor will supply 100 bags of CryoStor CS10 per month during the performance period July 27, 2022 thru December 31,2022 2. Shelf Life-Minimum – shelf life is required to be one year from the date of receipt unless Cell Processing previously agrees to another arrangement. 3. The reagents and disposables may include but not limited to those listed below: - CryoStor CS10, Bag, 100 ml, 4. The Contractor shall supply technical support for all supplies and their performance characteristics at no additional cost to the Government. Period of Performance This contract is the base 6-month scheduled delivery order: 07/27/2022-12/31/2022: base 6 months 600 bags V. Delivery Schedule: Per Month. 1. July 27, 2022 100 Bags 2. August 31, 2022 100 Bags 3. September 28, 2022 100 Bags 4. October 26, 2022 100 Bags 5. November 30, 2022 100 Bags 6. December 28, 2022 100 Bags The Vendor shall supply technical support for all reagents and their performance characteristics at no additional cost to the Government. The Company shall deliver the supplies on a standing order, on a monthly basis. Each month the company shall ship 100 bags of CryoStor CS10 without any notification from the Center of Cellular. Delivery service will include inside delivery to the Cell Processing Section. These supplies will be shipped for delivery Monday through Thursday to: NIH/CC/DTM/Cell Processing Section 10 Center Drive Bldg. 10/ Rm. 3C720 Bethesda, MD 20892-1288 Attention: Mohammed Khan The contractor shall bear the cost of replacement for reagents and disposables found to be damaged or defective upon receipt by NIH or for incorrect or incomplete shipments. Requirements The vendor will provide full report documenting the safe transport of cryopreserved patient cells from outside institutions to the NIH. The Vendor will ensure that temperature and other parameters are maintained during the shipment of reagents and kits. This will ensure the desired outcomes in the center for cellular engineering clinical research protocols. Government Responsibilities The CCE shall inspect shipments upon receipt and report any damage, defects or errors in shipment to the contractor. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION This system is on site and has been validated for use on CC patients. It would be detrimental to the government to attempt to change systems and quite impossible as these instruments are proprietary and only distributed by Biolife Solutions, Inc. With the continuation of using the same system will also help reduces the risk of a disruption in patient care. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research. 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. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, and the period of performance, 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. 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. 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. All responses must be received by July 1st, 2022, 1:00 PM Eastern time and must reference solicitation number 22-009864 via email. Responses may be submitted electronically to Ms. Grace Wong-Darko, Contracting Specialist at Grace.Wong-Darko@nih.gov. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."