NOI- Preparation of chemical compounds needed for a Janus kinase 2 (JAK2) enzyme project

NAICS code 325199 All Other Basic Organic Chemical Manufacturing @ 1250. This acquisition is NOT set aside for small businesses. 

1. REGULATORY AUTHORITY  

This acquisition will be conducted using FAR Part 12 – Acquisition of Commercial Items in conjunction with FAR Part 13 – Simplified Acquisition Procedures, as applicable. The resultant contract will include all appropriate provisions and clauses in effect through the current Federal Acquisition Circular (FAC). 

1. STATUTORY AUTHORITY 

This acquisition is being conducted under the authority of: 

FAR 6.302-1 – Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements (41 U.S.C. 3304(a)(1)) 

1. DESCRIPTION OF REQUIREMENT: 

1. PURPOSE AND OBJECTIVES: 

JAK2 inhibitors are medications that block the activity of the Janus kinase 2 (JAK2) enzyme, which is involved in signaling pathways related to inflammation and immune response. These inhibitors are used to treat various conditions, including some cancers and inflammatory diseases like rheumatoid arthritis and atopic dermatitis.  We have discovered a compound that targets brain cancer cells and we require the synthesis of it an analog for evaluation in various brain-cancer cell targeted assays. These two compounds will be evaluated for their potential for treatment in brain cancer. 

- (1) 4-amino-N,N-dicyclopropyl-6-ethyl-1-methyl-1,6-dihydroimidazo[4,5-d]pyrrolo[2,3-b]pyridine-7-carboxamide; and 

- (2) N,N-dicyclopropyl-4-((1,5-dimethyl-1H-pyrazol-3-yl)amino)-6-ethyl-1-methyl-1,6-dihydroimidazo[4,5-d]pyrrolo[2,3-b]pyridine-7-carboxamide. 

Period of Performance: 

Two months after receipt of approved order. 

SCOPE OF WORK 

General Requirements: 

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below: 

Specific Requirements: 

• Synthesis of specified two (2) compounds at a 95% purity (confirmed by NMR and LCMS)/ 

• Shall provide NCATS with 10g, 95% purity of 4-amino-N,N-dicyclopropyl-6-ethyl-1-methyl-1,6-dihydroimidazo[4,5-d]pyrrolo[2,3-b]pyridine-7-carboxamide)  

• Shall provide NCATS with 2.5g, 95% purity of N,N-dicyclopropyl-4-((1,5-dimethyl-1H-pyrazol-3-yl)amino)-6-ethyl-1-methyl-1,6-dihydroimidazo[4,5-d]pyrrolo[2,3-b]pyridine-7-carboxamide) 

• The purity will be assessed by both NMR and LCMS.   

LEVEL OF EFFORT: 

Contractor will carry out the synthetic steps that will result in the synthesis of both compounds in this SOW with the appropriate amounts of each as stated.   

GOVERNMENT RESPONSIBILITIES 

All of the synthetic work will be carried out by contractor in their facilities.  Government will pay for completed work.  

DELIVERY OR DELIVERABLES 

Contractor will deliver both compounds in the appropriate amounts and purity.  The work must be completed 2 months after receipt of the approved order.  Contractor will provide NCATS biweekly reports of the progress being made (please send to [email protected]). 

REPORTING REQUIREMENTS  

Contractor will provide NCATS biweekly reports of the progress being made (please send to [email protected]). 

OTHER CONSIDERATIONS 

N/A 

Contractor will provide the personnel responsible for carrying out the synthesis.  Raul Calvo ([email protected]) and Juan Marugan ([email protected]) will track progress and provide guidance, as needed, to ensure the compounds are delivered in a timely manner. 

N/A 

The government has sole possession of the compounds generated and any data.  Any publications need to be approved by Juan Marugan ([email protected]). 

N/A 

The government has all the rights to any publication and any disclosure of any information generated in the synthesis of both compounds. 

All the information generated in the synthesis of both compounds is the sole property of the government and so strict confidentiality is expected from the Contractor 

Travel: 

Key Personnel: 

Information System Security Plan: 

Data Rights: 

Section 508—Electronic and Information Technology Standards: 

Publications and Publicity: 

Confidentiality of Information: 

1. 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, KareBay BioChem INC is the only vendor in the marketplace that can provide the ​services​ required by NCATS. The equipment is proprietary to its manufacturer, KareBay BioChem INC, and this company is the sole provider of maintenance for this equipment. 

In accordance with FAR part 10, extensive market research was conducted to reach this determination. ​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 KareBay BioChem INC is capable of meeting the needs of this requirement.​ 

The intended source is: 

KareBay BioChem INC 

15 Bernett DR 

Fredonia, New York 

14063-1643, United States 

1. 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. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. 

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, 75N98026Q00251. Responses must be submitted electronically to Jaddua Johnston, Contract Specialist at [email protected].