SOLICITATION NOTICE
Q -- Scale Up Synthesis of NCGC Chemical Probe ML321 and Intermediate Scaffold - Solicitation Attachments
- Notice Date
- 7/19/2018
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 4211, MSC 9559, Bethesda, Maryland, 20892-9559, United States
- ZIP Code
- 20892-9559
- Solicitation Number
- NIHDA201800366
- Archive Date
- 8/10/2018
- Point of Contact
- Mark E. McNally, Phone: (301) 827-5869, Jeffrey Schmidt, Phone: (301) 402-1488
- E-Mail Address
-
mcnallyme@mail.nih.gov, schmidtjr@mail.nih.gov
(mcnallyme@mail.nih.gov, schmidtjr@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Attachment 4 - Scale Up of AED007-046 and AED008-032 Attachment 3 - Invoice and Payment Provisions Attachment 2 - FAR 52.212-5 (Jan 2018) Attachment 1 - Statement of Work (i) 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. (ii) The solicitation number is NIHDA201800366 and the solicitation is issued as a 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. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-97, dated July 16, 2018. (iv) The associated NAICS code 325412 and the small business size standard is 1,250 employees. This requirement is full and open with no set-aside restrictions. (v) Project Purpose or Objectives: The National Center for Advancing Translational Sciences (NCATS) is in need of scale up synthesis of a common intermediate scaffold, as well as the NCATS Chemical Genomics Center (NCGC) chemical probe ML321 in the D2 Antagonist project. This fee for service will entail the scale up synthesis of two compounds: an intermediate scaffold and the lead probe molecule. Scale up of the lead probe compound will be used in efficacy studies in animal models. The intermediate scaffold will be used to further structure- activity relationship (SAR) studies. Background Information: 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. NCATS is a part of NIH, whose mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. NCATS is in need of scaling up a promising NCGC probe compound, as well as the general scaffold leading to the probe. The lead NCGC probe compound will be used for efficacy studies in animal models, in order to determine the feasibility of taking the NCGC probe ML321 forward as a pre-clinical candidate. In addition, the key intermediate scaffold will be used to further develop the SAR. (vi) 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: NCATS needs the scale up synthesis and delivery of the D2 NCGC probe molecule ML321, for use in long-term efficacy studies in animal models. NCATS also needs the scale up of D2 key intermediate scaffold AED007-046 for further developing the SAR in this particular scaffold against central nervous system (CNS) disorders. This service should provide the following deliverables: 1. Execute a multistep synthesis and produce 10 grams of the optically active NCGC probe compound ML321 (AED008-032). 2. Execute a multistep synthesis and produce 50 grams of the optically active D2 scaffold AED007-046. GOVERNMENT RESPONSIBILITIES NCATS will provide medicinal chemistry route and experimental details of the multistep synthesis of compounds ML321 (AED008-032), and the intermediate AED007-046, if necessary. DELIVERY OR DELIVERABLES Vendor is responsible for providing the following deliverables: 1. 10 grams of optically active ML321 (AED008-032). 2. 50 grams of optically active AED007-046. 3. Material shall have a purity greater than 98% [>98% by High Performance Liquid Chromotography (HPLC)]. 4. Material shall have certificate of analysis, including, but not limited to 1H-NMR, LC-MS. 5. Weekly progress reports and final report including detailed protocols of synthesis, chromatography conditions and analytics for each step provided to Andres Dulcey (dulceyan@mail.nih.gov) and Juan Marugan (maruganj@mail.nih.gov) at NCATS via email. REPORTING REQUIREMENTS Contractor shall provide weekly progress reports and presentations to Andres Dulcey (dulceyan@mail.nih.gov) and Juan Marugan (maruganj@mail.nih.gov) at NCATS via email or conference calls. (vii) Period of Performance: shall be six (6) months from receipt of order. (viii) The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. (ix) 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: i. Technical Approach: vendor's ability to meet or exceed all requirements in the Statement of Work; ii. Price; and iii. Past Performance (see FAR 13.106-2). Technical and past performance, when combined, are 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. (x) 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. (xi) The FAR clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. Paragraph 52.212-4(g) is replaced with the NIH Invoice and Payment Provisions (2/2014), attached. (xii) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition and is attached. (xiii) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiv) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xv) Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. 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. Questions must be received by 12:00 PM, Eastern Time, Tuesday, July 24, 2018, and all responses must be received by 5:00 PM, Eastern Time, Thursday, July 26, 2018, and reference number NIHDA201800366. Responses and questions may be submitted electronically to Contract Specialist Mark McNally at mcnallyme@mail.nih.gov. Fax responses will not be accepted. (xvi) The name and contract information of the individuals to contact for information regarding the solicitation: Contracting Officer Jeffrey Schmidt: schmidtjr@mail.nih.gov Contract Specialist Mark McNally: mcnallyme@mail.nih.gov
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