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SAMDAILY.US - ISSUE OF JULY 30, 2022 SAM #7547
SPECIAL NOTICE

A -- Notice to Intend to Sole Source for Drug Formulation, QA/QC, Method Development and Sample Analysis of drug molecule, CS-1131

Notice Date
7/28/2022 6:36:47 AM
 
Notice Type
Special Notice
 
NAICS
541715 — Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
 
Contracting Office
W4PZ USA MED RSCH ACQUIS ACT FORT DETRICK MD 21702-5014 USA
 
ZIP Code
21702-5014
 
Solicitation Number
W81XWH22IJ0722
 
Response Due
8/12/2022 7:00:00 AM
 
Point of Contact
Ireneusz Jozwiak
 
E-Mail Address
ireneusz.a.jozwiak.civ@mail.mil
(ireneusz.a.jozwiak.civ@mail.mil)
 
Description
THIS IS A NOTICE OF INTENT TO AWARD A SOLE-SOURCE CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. The United States Army Medical Research Acquisition Activity (USAMRAA) in support of the U.S. Army Medical Research Institute of Chemical Defense (USAMRICD) intends to negotiate on a sole source basis, IAW FAR 13.106-1(b)(1)(i), with Clear Scientific, LLC, 737 Concord Avenue, MA 02138, as the only responsible source that can provide Drug Formulation, QA/QC, Method Development and Sample Analysis of drug molecule, CS-1131. This acquisition is being conducted under FAR Part 13 Simplified Acquisition Procedures. Provisions and clauses in effect through Federal Acquisition Circular 2005-83 are incorporated. U.S. Army Medical Research Institute of Chemical Defense (USAMRICD) intends to procure a firm-fixed-price requirement for a non-personal services contract to provide Drug Formulation, QA/QC, Method Development and Sample Analysis of drug molecule, CS-1131. Clear Scientific, LLC. will supply a formulation, based on its proprietary drug product, CS-1131, for injection, with accompanying QA/QC analytical report. Clear Scientific, LLC. will perform quantitative analysis of CS-1131 and the opioids carfentanil and fentanyl, in 500 non-human primate plasma samples and 200 non-human primate urine samples provided by USAMRICD using its proprietary validated methodology. This work effort is a continuation of previous laboratory experiments performed at the USAMRICD using Clear Scientific�s proprietary drug molecule, CS-1131, a novel scavenger of synthetic opioids. Clear Scientific is the sole company capable of manufacturing this proprietary drug as they hold an exclusive license to the patent rights on the drug. The molecule�s specific chemical structure and the methods of synthesis are protected by law. Specifically, Clear Scientific Inc. has licensed (MGH Agreement #2020-1873) the entire intellectual property portfolio including (but not limited to), the composition of matter, application, and commercial use of acyclic cucurbiturils from the collective patent holders (University of Maryland and Massachusetts General Hospital). In addition to the licensed portfolio, the company has several pending patent applications for methods of synthesis and therapeutic use of the compounds. As such Clear Scientific Inc. is the only company that can legally make, supply, and use the therapeutic for the program. The intended procurement will be classified under North American Industry Classification System (NAICS) 541715 - Research and Development in the Physical, Engineering, and Life Sciences (Except Nanotechnology and Biotechnology with a Small Business Size Standard of 1000 Employees. This notice of intent is not a request for competitive proposals and no solicitation document will be posted for this requirement. However, parties interested in responding to this notice shall submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received by closing of this notification of this synopsis will be considered by the Government. Submissions that request documentation, request additional information or that solely ask questions will be determined to not be an affirmative response. Responses determined to be not an affirmative response are not valid and no further action will be taken with the response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. This announcement fulfills the synopsis requirements under FAR 5.102(a)(6) and 5.203(a). Based on the above information, the only technically acceptable Drug Formulation, QA/QC, Method Development and Sample Analysis of drug molecule, CS-1131 are provided by Clear Scientific, LLC, 737 Concord Avenue, MA 02138. Submit email capabilities statements (using PDF, MS Word, Excel attachments) to Ireneusz Jozwiak at ireneusz.a.jozwiak.civ@mail.mil. Statements are due no later than 10:00 A.M. Eastern Daylight Time (EDT) on 12 August 2022. No phone calls accepted.
 
Web Link
SAM.gov Permalink
(https://sam.gov/opp/227b441b0b9343cc84f9f1687017e069/view)
 
Place of Performance
Address: Gunpowder, MD 21010, USA
Zip Code: 21010
Country: USA
 
Record
SN06405117-F 20220730/220728230109 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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