AAV9 Microdystrophin Vectors

INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Station Support and Simplified Acquisitions (SSSA) Branch intends to solicit by confirming a written quotation from University of Penn for award on or around September 18, 2015. The purpose of this purchase order will be to provide the National Center for Advancing Translational Sciences (NCATS) with AVV9 Microdystrophin Vectors as described in this notice. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 325414 with a Size Standard of 500 employees. This acquisition is NOT set aside for small businesses. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases not exceeding the simplified acquisition threshold, Contracting officers may solicit from one source IF the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization). The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-83 dated August 3, 2015. DESCRIPTION OF REQUIREMENT The mission of the Therapeutics for Rare and Neglected Diseases (TRND) program, which is part of the National Center for Advancing Translational Sciences (NCATS), is to facilitate therapeutic development for rare and neglected diseases. PURPOSE AND OBJECTIVES: The purpose of this acquisition is to produce three different non-GLP (Good Laboratory Practice) grade gene vectors of microdystrophin to be tested in a mouse Duchenne Muscular Dystrophy (DMD) disease model for efficacy. Once tested in the animal model, the TRND team and its collaborators can move forward with selecting an effective vector to be developed as a potential disease modifying therapy for DMD patients. PROJECT REQUIREMENTS: Three (3) different AAV9 (adeno-associated virus) microdystrophin gene vectors synthesized, cloned, manufactured (1 Mega Prep per construct) and characterized/released per required testing for animal administration: viral titer, purity, endotoxin, and any additional steps required for quality assurance. Upon award, the Government will provide the associated data indicating the specific vectors to be produced. Performance shall include: - Cloning of the new plasmid - Plasmid DNA production - DNA Structure and Sequence Analysis (for quality assurance purposes) - Production of 1 Mega Prep per construct - Testing & Release of each production lot ANTICIPATED PERIOD OF PERFORMANCE: Within 12 months of the date of award. DELIVERY LOCATION: All items shall be delivered for inspection and acceptance to: 9800 Medical Center Dr. Rockville, MD 20850 OTHER CONSIDERATIONS: The vendor will not retain any intellectual property (IP) rights on the vector lots produced nor is there any expectation that novel IP will result from this work. The sequences being used already fall under existing IP; the importance of this work is to help determine if any of them hold a true functional benefit over the others and may therefore translate to a better therapy in DMD patients. Special shipping considerations must be used to maintain product integrity. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, University of Penn is the only vendor in the marketplace that can provide the products required by NCATS. In accordance with FAR part 10, extensive market research was conducted to reach this determination. Specifically, a sources sought notice was posted to FedBizOpps referencing the above detailed requirements and no responses were received from other vendors. Additionally, contacts with knowledgeable individuals both in industry and Government, as well as reviews of available product literature, revealed no other sources. Finally, a review of the GSA Advantage, Dynamic Small Business Search, and previous government acquisitions returned no results that meet all of the requirements. Therefore, only University of Penn is capable of meeting the needs of this requirement. The intended source is: University of Penn 3451 Walnut St Philadelphia, PA, 19104-6205 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. 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. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. 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. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), 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. All responses must be received by the closing date and time of this announcement and must reference the solicitation number, HHS-NIH-NIDA-SSSA-NOI-15-792. Responses must be submitted electronically to Matthew Antonini, Contract Specialist, at matthew.antonini@nih.gov. U.S. Mail and Fax responses will not be accepted.