SOW_SOW for scaleup-2024_LC240703164439.docx

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

non-GMP scale up synthesis of (4-(1-(3-Fluorobenzyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)(4-((3-fluorobenzyl)oxy)-3-methoxyphenyl)methanone in 250 g quantity with >99% purity for non-human use.

Statement of Need and Purpose:

This requisition is for the non-GMP scale-up synthesis of (4-(1-(3-Fluorobenzyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)(4-((3-fluorobenzyl)oxy)-3-methoxyphenyl)methanone in a 250 g quantity with >99% purity, as characterized by LCMS, NMR, and other analytical techniques. The amount of material is crucial for performing toxicity and efficacy studies in different animal models to further facilitate in developing as a non-opioid pain medication.

Background Information and Objective:

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), which 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. The Early Translational Branch (ETB) is tasked with identifying and developing novel small molecule leads for the treatment of pain and addiction under the NCATS HEAL program.

In pursuit of this goal, the Center has a strong internal trans-disciplinary team of scientists who continually discover novel small molecules to modulate molecular targets for pain and addiction. As such, discovering lead molecules that could serve as starting points for therapeutic development for the patients is a key part of discovery. Therefore, it is important to determine the toxicity and efficacy for a lead compound in multiple animal species.

Period of Performance:

Period of performance is within three (4) weeks from the contract award and receipt of the first batch of material.

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 Specific Requirements:

Provide all the data generated including raw data and reports. The test materials are not transferable or shall not be used for any other purposes

LEVEL OF EFFORT:

Not applicable

GOVERNMENT RESPONSIBILITIES

The government will not furnish the property, facilities, workspace, computers, or other equipment. The contractor will not use federal facilities. The government will have the responsibility to review and approve the final report. The government will have the responsibility to provide sufficient quantities of the test compound to the contractor to accomplish the necessary work

DELIVERY OR DELIVERABLES

The contractor will provide the 250 g material in >99 % purity, data analysis and report for the contents of this statement of work either electronically or as a written report.

REPORTING REQUIREMENTS

One time report from the study

OTHER CONSIDERATIONS

Travel:

N/A

Key Personnel:

Information System Security Plan:

Data Rights:

Data and materials are the right of NCATS and the contractor shall not share/disclose the data or materials with any third parties Section 508—Electronic and Information Technology Standards:

The contractor will not be involved in EIT Standards.

Publications and Publicity:

All the data are rights of NCATS and Contractor will not use for any publication or advertising

Confidentiality of Information:

The contractor will keep the results of the acquisition confidential.

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs