CSS_Attachment_No._01-Statement_of_Work.pdf

STATEMENT OF WORK (SOW)

GENERAL INFORMATION

Title of Project:

Scale Up Synthesis of Three Synthetic Intermediates

Project Purpose or Objectives:

NCATS needs the scale up synthesis of three compounds. These intermediates will be used to synthesize antibody conjugates.

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.

The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (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 NCATS Chemical Genomics Center (NCGC) compound, as well as the general scaffold leading to the compound. The lead NCGC compound will be used for efficacy studies in animal models to determine its feasibility as a pre-clinical candidate. In addition, the key intermediate scaffold will be used to further develop the SAR.

Period of Performance:

March 2019 through September 2019.

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:

RFQ No. 75N95019Q00102 Attachment No. 01

The Contractor shall provide the scale up synthesis and delivery of three synthetic intermediates that will enable NCATS to make analogs. The structures of the three intermediates are included herein under SOW EXHIBIT A.

The Contractor shall provide the following services and deliverables:

1. Execute a multistep synthesis and produce 20 grams of intermediate 1.

2. Execute a multistep synthesis and produce 20 grams of intermediate 2.

3. Execute a multistep synthesis and produce 20 grams of intermediate 3.

The intermediates must be packaged to withstand leakage of contents, shocks, pressure changes, and other conditions incident to ordinary handling in transportation.

Delivery shall be FOB Destination and delivery location for the intermediates shall be:

Attn: Juan Marugan

NCATS/NIH

9800 Medical Center Drive Room C201W Rockville, MD 20850

Level of Effort:

GOVERNMENT RESPONSIBILITIES

NCATS will place the order for the three intermediates

DELIVERY OR DELIVERABLES

Vendor is responsible for providing the following deliverables:

1. 20 grams of each of the three intermediates

2. Material shall have a purity greater than 95% (>95% by HPLC).

3. Material shall have certificate of analysis, including, but not limited to 1H-NMR, LC-MS.

4. Weekly progress reports and final report including detailed protocols of synthesis, chromatography conditions and analytics for each step provided to Raul Calvo (raul.calvo@nih.gov) and Juan Marugan (maruganj@mail.nih.gov) at NCATS via email.

REPORTING REQUIREMENTS

Vendor will be responsible for providing weekly progress reports and presentations to Raul Calvor (raul.calvo@nih.gov) and Juan Marugan (maruganj@mail.nih.gov) at NCATS via email or conference calls as service work is rendered.

RFQ No. 75N95019Q00102 Attachment No. 01 mailto:maruganj@mail.nih.gov mailto:dulceyan@mail.nih.gov mailto:maruganj@mail.nih.gov

SOW EXHIBIT A

The structures of the three intermediates are:

RFQ No. 75N95019Q00102 Attachment No. 01