Wilson Wolf/ G-Rex 500M-CS Gas Permeable Cell Culture Device

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).

The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Department of Transfusion Medicine (DTM), 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:

Wilson Wolf Manufacturing Corp.
33 5TH AVE NW, STE 700
Saint Paul, MN 55112-3251

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 334516 with a Size Standard 1000.

REGULATORY AUTHORITY
The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-100, August 22, 2018. 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: Wilson Wolf / G-Rex 500M-CS Gas Permeable Cell Culture Device.

2. Background Information: The CCE 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 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: CCE uses the G-Rex 500M-CS to grow sufficient quantities of T-cell Receptor transduced T-cells to treat malignant tumors patients. To date, specific TCR's endowed with enhanced therapeutic potential have been identified for the treatment of malignancies; however, these cells cannot be grown to achieve therapeutic use by conventional methods. Using the G-Rex culture flask supplied by Wilson Wolf, we can now readily grow sufficient quantities of these cells for therapeutic purposes. The GatheRex pump which we are requesting is the only system compatible with the Grex culture flasks and allows for the concentration and harvesting of the T-cells at the end of the culture. Wilson Wolf is the only known system that can provide these quality cells for our cellular manufacturing.

4. Period of Performance: Base year approximately start date on or around 5/1/19.

CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

1. The contractor will supply sufficient disposables to process approximately 20 cellular therapy products per year.
2. Shelf Life-Minimum - Shelf life of disposables shall be at least 6 months from date of delivery at the DTM Cell Processing Laboratory.

3. The disposables include to those listed below:
- Total of 183 Cases of the G-Rex 500M-CS.

4. The Contractor shall supply technical support for all reagents and supplies and their performance characteristics at no additional cost to the Government.

Period of Performance
Base Year: May 1, 2019 to April 30, 2020

Delivery Schedule: Upon Request ONLY

These medical product will be shipped delivery Monday through Thursday 8:00 AM to 4:00PM to:
NIH/CC/DTM/Center Cellular Engineering
10 Center Drive
Bldg. 10/ Rm. 3C720
Bethesda, MD 20892-1288
Attention: Timmy Ton or John Salsgiver

The contractor shall bear the cost of replacement for reagents found to be damaged or defective upon receipt by NIH or for incorrect or incomplete shipments.

Government Responsibilities
1. The Center Cellular Engineering shall use the reagents in accordance with manufacturer's package inserts and approved IND/IDE uses if applicable.

2. The NIH CC Center Cellular Engineering 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 Wilson Wolf. 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, 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 April 15th, 2019, 11:30 AM Eastern time and must reference solicitation number 19-007395. Responses may be submitted electronically to Mrs. 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."

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