Category: Technology Licenses
Created On: 2022-04-28
Record Count: 3
- Drug Discovery
IPSCIO Report Record List
IPSCIO Record ID: 309817
The License Agreement grants an exclusive, worldwide license, excluding Italy and Spain where the Licensee is not licensed and Licensor remains entitled to commercialize the Licensed Products, to research, manufacture and commercialize products.
The License also gives Licensee the right to use the Licensed IP in the development of a prescription drug for the treatment of the cytokine storm associated with COVID-19. In addition, under the terms of the License, if Licensor develops or commercializes a prescription drug for the treatment of any other human condition unrelated to pain and chronic pain (a Different Prescription Drug) in its territory, the Licensee has a first refusal right to use Licensors patents to develop and commercialize this Different Prescription Drug in its territory (i.e. worldwide excluding Italy and Spain). Should the Licensee exercise this right, but then fail to demonstrate commercially reasonable efforts to develop the Different Prescription Drug in the two years following, Licensor would be free to exploit and/or license to third parties the use of the patents for the Different Prescription Drug. The Licensees -201 COVID-19 Trials are subject to such requirements.
Finally, the License provides the Licensee with a non-exclusive license to use Licensors scientific and technical know-how with respect to ultramicronized-PEA in connection with the development or commercialization of the Licensed Products.
The proprietary formulations will relate to patents and other intellectual property rights to ultramicronized-PEA owned by Licensor. PEA is a naturally occurring substance that is produced within the body in response to inflammation and interacts with endocannabinoid receptors throughout the body, including the central nervous system.
The synthetic drug, known as ultramicronized palmitoylethanolamide (micro PEA), mimics a molecule found in cannabis and is believed to have anti-inflammatory properties.
The Licensee plans to advance the research & development of ultramicronized-palmitoylethanolamide (ultramicronized-PEA or -201) to commercialization through studies and clinical trials, including anticipated timing and associated costs; the status of the Corporations IND application with the FDA to conduct the -201 COVID-19 Trials for the use of -201 to treat COVID-19, including the timing, completion and outcomes of any trials or whether -201 may be effective and feasible in treating COVID-19.
The Licensee is a clinical-stage biotechnology company that is focused on bioscience, including research and development and clinical development of synthetic cannabinoid based treatments of certain disease conditions with an aim to improve patient outcomes.
FSD-201 mimics endocannabinoids, neurotransmitters found in marijuana that bind to CB2 receptors.
These receptors play a large role in the bodyâ€™s immune system, particularly in mitigating pain and fighting inflammation.
The hope its that FSD-201 could help mitigate a dangerous overreaction to the virus by the bodyâ€™s immune system called a cytokine storm.
These so-called storms occur when the body doesnâ€™t just fight off the virus but also attacks its own cells and tissues.
In cases of COVID-19, the disease caused by the virus, cytokine storms can trigger respiratory distress.
This can lead to multi-system organ failure and cause the lungsâ€™ airs sacs to fill up with fluid, the result being pneumonia.
â€˜Severe COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm.
IPSCIO Record ID: 359060
In accordance with the terms of the Research Agreement, Israelis Licensee and Israelis Licensor will have joint ownership of any IP created as a result of research programs covered by such agreement. In connection with the Research Agreement, Licensor agreed not to work, study or develop any technologies with other entities that compete with our work with Licensor for our COVID-19 product candidate or RA product candidate for a term of three and seven years, respectively, from the end of the partiesâ€™ collaboration with respect to the COVID-19 product candidate and seven years from the end of the term of the Research Agreement with respect to the RA product candidate.
The Licensor have been conducting research on the use of cannabis to treat disorders with widespread inflammatory responses, such as RA and COVID-19. Parties hope that by decoding the cannabinoid mechanism of action during inflammatory storms, the Parties can treat inflammation associated with COVID-19 where conventional drugs and other therapies have failed.
Rheumatoid arthritis (RA) is a long-term autoimmune disorder. COVID-19 is a virus infection.
IPSCIO Record ID: 340061