Custom Synthesis of Methylated Hydroxynorketamine Isomers

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is HHS-NIH-NIDA-SSSA-CSS-2017-062 and the solicitation is issued as request for quotation (RFQ) This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures; FAR Subpart 13.5-Simplified Procedures for Certain Commercial Items; and FAR Part 12-Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-93-1 dated January 1, 2017 The associated NAICS code 541711 and the small business size standard 1000 employees. This requirement is full and open, unrestricted. The purpose of this project is to obtain a custom synthesis of derivatives of hydroxynorketamine, which installs a methyl group in the "5" position of the ring. Background: The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people's health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a translational science center that prides itself on its tremendously productive pipeline and is innovative in a number of ways. NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, in order to ultimately translate basic science into real products and services that help improve people's lives. Hydroxynorketamine and analogs thereof are interest for NCATS for the potential treatment of a variety of mental illnesses. By synthesis and testing of selected analogs, NCATS hopes to better understand the mechanisms that underlie certain mental illnesses and potentially provide superior treatment options. Contractor Requirements: 1. Contractor will synthesize the following compounds a. (2R,5R,6R)-2-amino-2-(2-chlorophenyl)-6-hydroxy-5-methylcyclohexan-1-one i. SMILES: O=C1[C@H](O)[C@H](C)CC[C@]1(C2=CC=CC=C2Cl)N b. (2R,5S,6R)-2-amino-2-(2-chlorophenyl)-6-hydroxy-5-methylcyclohexan-1-one i. SMILES: O=C1[C@H](O)[C@@H](C)CC[C@]1(C2=CC=CC=C2Cl)N c. (2R,5S,6S)-2-amino-2-(2-chlorophenyl)-6-hydroxy-5-methylcyclohexan-1-one i. SMILES: O=C1[C@@H](O)[C@@H](C)CC[C@]1(C2=CC=CC=C2Cl)N d. (2R,5R,6S)-2-amino-2-(2-chlorophenyl)-6-hydroxy-5-methylcyclohexan-1-one i. SMILES: O=C1[C@@H](O)[C@H](C)CC[C@]1(C2=CC=CC=C2Cl)N 2. Contractor will provide 100 mg of each of these compounds 3. Compound purity will exceed 95% 4. Compound enantiomeric excess will exceed 95% LEVEL OF EFFORT Contractor will have 10+ years previous experience in the field of custom organic synthesis (small molecule). GOVERNMENT RESPONSIBILITIES Government will have the responsibility to review and approve the final report and analysis of the final delivered compounds. Government will not furnish property, facilities, workspace, computers, or other equipment. Contractor will not use federal facilities. DELIVERY OR DELIVERABLES In addition to the compounds, contractor will provide a final comprehensive report with synthesis, analytical data, and single crystal X-ray crystallization data: 1. The synthetic route utilized to provide the compounds 2. Analytical data including 1H NMR and LC-MS of the final compounds 3. Structural conformation by single crystal X-ray crystallography, with the associated data and data files. REPORTING REQUIREMENTS Contractor will provide monthly updates via email on the progress of the project, or more often as appropriate. TRAVEL N/A KEY PERSONNEL N/A OTHER CONSIDERATIONS Information System Security Plan: N/A Data Rights: Data generated as a result of the synthesis will be the property of NCATS Section 508-Electronic and Information Technology Standards: N/A Publications and Publicity: Contractor will not publish the results of the work Confidentiality of Information: Contractor will keep the results of the work confidential. Period of Performance: Delivery within 18 weeks ARO Delivery to: National Institutes of Health 9800 Medical Center Drive Building B Rockville, MD 20850 The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. The provision at FAR clause 52.212-2, Evaluation - Commercial Items, applies to this acquisition. (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: 1. Technical capability of the item offered to meet the Government requirement 2. Past Performance 3. Price Technical and past performance, when combined, are (1) significantly more important than cost or price. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer. The FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition: 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) 52.222-3 Convict Labor (June 2003). 52.222-19 Child Labor-Cooperation with Authorities and Remedies (Oct 2016) 52.222-21 Prohibition of Segregated Facilities (Apr 2015). 52.222-26 Equal Opportunity (Sept 2016). 52.222-36 Equal Oppurtunity for Workers with Disabilities (JUL 2014) 52.222-50 Combating Trafficking in Persons (March 2015) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) 52.225-13 Restrictions on Certain Foreign Purchases (June 2008) 52.232-33 Payment by Electronic Funds Transfer- System for Award Management (JUL 2013). The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination, Origin, etc), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; maintenance availability; and environmental and energy efficiency considerations. In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." All responses must be received by January 20, 2017 Eastern Standard Time and reference number HHS-NIH-NIDA-SSSA-CSS-2017-062. Responses may be submitted electronically to Stacey Polk, contact@example.gov. Fax responses will not be accepted. Request for additional information may be sent to Stacey Polk, contact@example.gov