75N95020Q00075

Submitted by dsonti on
Post Date/ Solicitation Issue Date
Closing Response Date
Proposed Award Date
Project Title
Custom Synthesis of one (1) specified intermediate HY-43927A
Contracting Office
National Center for Advancing Translational Sciences (NCATS)

Contact Points

Primary Contract Specialist

Andrew
Varley
Andrew.Varley@nih.gov
NAICS Code Number
325414
Biologic Product (except Diagnostic) Manufacturing
Small Business Size Standard
1,250 employees
Estimated Period of Performance
8 weeks from the award date
Competition Status
Non-Competitive
Vendor Name
MedChemExpress LLC.
Vendor Address
1 Deer Park Dr, Suite Q, Monmouth Junction, NJ 08852
Single-Sole Source Determination
I hereby determine that the compounds to be acquired for the NNMT project herein are available from only one source, and competition is precluded for the reasons indicated below. There are no substitutes available. The vendor has an established synthesis route that no other vendors possess and has prior experience in synthesizing this compound. The vendor offers synthesis and chiral purification that meets 95 % enantiomeric excess criteria for a reasonable price. In addition, they delivered small quantities of materials multiple occasions on time (past performance on quality and delivery time). Based on extensive market research this vendor provides the high quality and purity that we require for this compound. Only this vendor agreed to provide this compound in 8 weeks along with the required Certificate of Analysis and chiral purity. Since only this vendor has the proprietary synthetic route to this intermediate, no other vendors can make this compound in 8 weeks as it will take more lead time to develop a synthetic route. Any further delay in delivery time will incur loss of hours to chemists and loss of animals ordered for the in vivo experiments.
Background/Description of Requirement

The specific brand-name item is: MedChem Express LLC

Custom synthesis of one (1) NCATS specified intermediate HY-43927A.

NCATS is in need of a service for custom synthesis of one (1) specified intermediate compound in the amount of 30 gram with >95 % purity as assessed by LCMS and NMR and  >95 % ee as analyzed by chiral analytical HPLC. This is a key intermediate to support in vivo study of the NNMT project.

The contractor will synthesize the NCATS specified compound and ship 30-gram material within the specified performance period. The contractor is responsible for planning the synthetic routes and executing the synthesis and purification. If needed, NCATS can provide consultation as to the synthetic planning and experiment design.

Custom synthesis 20200116_NIH

a. One (1) specified compound will be prepared.

b. Thirty (30) gram of the compound will be delivered to NCATS.

c. Purity of the compound will be over 95%, based on 1H NMR and LC/MS analysis.

d. Enantiomeric excess of this compound should be over 95%, based on chiral LC analysis.

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.