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:

Takara Bio USA, Inc.
PO Box 45794
San Francisco, CA 94145-0794

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 325413 with a Size Standard 1,250.

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: Takara / RetroNectin GMP grade - 2.5 ml reagents.

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: The CCE used Takara's RetroNectin for used during the manufacturing process of clinical T-cells. This includes but is not limited to: Gene Transduction for X-Linked Severe Combined Immunodeficiency (XSCID), CAR 19 T-cells, Preparation of Autologous Transduced T Lymphocytes Expressing Anti-GD2 Chimeric Antigen Receptor (GD2 CAR), and Transduced T-cells expressing B-cell maturation antigen.

4. Period of Performance: Base year with an approximately start date on or around 3/1/19.

CONTRACTOR REQUIREMENTS (SCOPE OF WORK)

1. The contractor will supply sufficient reagents to process approximately 30 clinical products for each paid period of performance.

2. Shelf Life-Minimum - shelf life of any unopened reagent shall be at least 1 year from receipt unless otherwise agreed to from date of delivery at the DTM Cell Processing Laboratory.

3. The reagents and disposables may include but not limited to those listed below:

Retronectin 2.5mg/vial

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 March 1st, 2019 - September 30th, 2019.

Delivery Schedule

These reagents and disposables will be shipped overnight delivery 77 vials on Monday March 18, 2019 and 77 vials on Monday September 16, 2019 to:

NIH/CC/DTM/Cell Processing Section
10 Center Drive Bldg. 10/ Rm. 3C720
Bethesda, MD 20892-1288
Attention: Timmy Ton

Shipments will use government carrier at the expense of the government unless otherwise arranged.

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 Roche. 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 Feb 12th, 2018, 2:30 PM Eastern time and must reference solicitation number 19-004308. Responses may be submitted electronically to Mrs. Grace Wong-Darko, Contracting Specialist at [email protected]. Fax responses will not be accepted.

"All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."