75N95020Q00070

Submitted by tjugumha on
Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Custom Synthesis of NV-5138 (0.5 grams of NV-5138)
Contracting Office
National Center for Advancing Translational Sciences (NCATS)

Contact Points

Primary Contract Specialist

Alexander
Beraud
alexander.beraud@nih.gov
NAICS Code Number
541380
Testing Laboratories
Small Business Size Standard
$15 million
Estimated Period of Performance
12 weeks from the award date
Delivery of Goods
12 weeks after Receipt of Order
Set-Aside Status
Not Set Aside
Competition Status
Non-Competitive
Vendor Name
WuXi AppTec (HongKong) Limited
Vendor Address
RM 826 8/F OCEAN CTR HARBOUR CITY 5 CANTON RD TSIM SHA TSUI, HONG KONG
Single-Sole Source Determination
This acquisition is limited to WuXi AppTec. This acquisition is of significant synthetic difficulty, and previous vendors have failed to deliver the desired material. Only WuXi AppTec has the necessary synthetic capability in combination high throughput chiral columns, and in combination with its analytical in-house crystallgraphy in order to properly synthesize, purify, and properly characterize the desired material. Use of an alternative vendor may lead to unacceptable delays and significantly increased time and/or failures in the synthetic process.
Background/Description of Requirement

he 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.


NCATS is currently interested in the small molecule NV-6138 for a variety of neurological studies. Towards that goal, it is looking at acquiring the molecule of interest as a tool compound.

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:


1. Contractor will synthesize 0.5 grams of NV-5138
a. SMILES code: CC(C)(CC(C(=O)O)N)C(F)F
b. CAS: 2095886-80-7

c. Purity will be 95% or above

d. Enantiopurity will be 95% or above

2. Contractor will provide a comprehensive report detailing
a. Synthesis steps and procedures
b. NMR, LC-MS, and Chiral LC traces, especially of the final product
3. Contractor will provide evidence of the absolute stereochemistry.
4. Contractor will provide the desired compound within 12 weeks of the award date
5. Contractor will be available via e-mail for discussions, as necessary

Specific Requirements:
Technical Requirements - Contractor must have the capability to do chiral resolutions of small molecules.

Government Responsibilities:
Government has the responsibility to review the data, reports, and products generated. Government’s responsibility includes final approval on reports.


Government will not provide telephones, workspace, or desktop computers. Contractor will not require access to government facilities.

Delivery or Deliverables:
1. 0.5 grams of NV-5138, pursuant to the purity qualifications above
2. 1 report detailing the synthesis and including purity information.
3. 1 Report providing evidence for the absolute stereochemistry

Reporting Requirements:
Contractor will be expected to stay in e-mail contact with the government representative, with reports issued at least monthly.

Level Of Effort:
1. One Ph.D. level synthetic chemist, 80 hours
2. One Master’s level synthetic chemist, 80 hours
3. One Bachelor’s level analytical chemist, 20 hours

Travel:
No travel is required.

OTHER CONSIDERATIONS


Information System Security Plan: N/A

Data Rights:
Data generated as a result of the custom synthesis will be the properties of NCATS

Section 508 - Electronic and Information Technology Standards: N/A

Publications and Publicity:
The contractor will not publish any result of the work

Confidentiality of Information:
The Contractor will keep the results of the contract confidential

Delivery/Contract Type:
Delivery of results shall be completed and provided to the Government within 12 weeks of receiving an order and samples to be analyzed. A Fixed-Price type of Purchase Order contract award is anticipated as a result of this RFQ not to exceed the Simplified Acquisition Threshold (SAT) in the FAR as $250,000.

Key Personnel: N/A

Interested parties may identify in writing their interest and capability in response to this requirement. 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 closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.