Royalty Report: Drugs, Cannabis, Drug Discovery – Collection: 289077

If proof of concept is achieved, Licensee will grant the Canadian Company an exclusive, worldwide license over any use of prescription drugs that can treat diseases affecting the central nervous system using a subset of the Project Cannabinoids.

This agreement is for the research and early stage development of pharmaceutical preparations based upon Research Compounds (as defined below) for the treatment of CNS and cancer indications.

Research Compounds shall mean collectively, all Selected BDCs and Selected Drug Candidates. For clarity, Research Compounds shall include Synthetic Cannabinoids synthesized under the Research Plan and which subsequently become Selected BDCs and/or Selected Drug Candidates.

Botanical Drug Candidate or BDC shall mean
—  any cannabinoid from a single chemovar of a chemically and genetically characterized Cannabis sativa plant (Phytocannabinoid) at any stage of research or development made using any extraction method and in any degree of purification in which only a single cannabinoid is present in a concentration which has the potential to be therapeutically active including, without limitation, the THC fraction and the CBD fraction separately; and
—  a combination of two or more Phytocannabinoid extracts described above containing two or more Phytocannabinoids present in concentrations such that both have the potential to be therapeutically active mixed in a precise ratio i.e. the THC and CBD fractions mixed (without other fractions) in the ratio of THC CBD of 90 10. For clarity specifically excluded from the definition of BOC is any combination of the THC and CBD fractions when mixed (without other fractions) in a ratio of CBD to THC that falls inside the range of 2575 to 7525; and,
—  any biological or chemical modification of the Phytocannabinoids in above including any metabolite or degradant.

Synthetic Cannabinoid shall mean any Phytocannabinoid produced by synthetic methods either pursuant to a Research Plan (a Type 1 Synthetic Cannabinoid) or outside of the Research Collaboration but with information resulting from the Research Collaboration (Type 2 Synthetic
Cannabinoid).

Synthetic Cannabinoid Product shall mean any pharmaceutical product containing a Type 1 Synthetic Cannabinoid (Type 1 Synthetic Product) or a Type 2 Synthetic Cannabinoid (Type 2 Synthetic Cannabinoid Product).

Synthetic Molecule shall mean a synthetic molecule whose chemistry is not based on a Phytocannabiooid but which has been developed with information resulting from the Research Collaboration and for which one or more patent.

Synthetic Molecule Product shall mean any pharmaceutical product containing a Synthetic Molecule.

The Research Field shall mean the treatment, diagnosis, prevention, or palliation of diseases, conditions, syndromes, and maladies of the central and peripheral nervous. systems of humans and animals and cancer in humans and animals.

Upon notice by Licensee to Licensor from time to time during the period permitted therefor pursuant to this Agreement, Licensor shall granted to Licensee under Collaboration IP and Licensor Background IP, without the need for further action by either of the Parties, an exclusive, license to make, have made, use, offer for sale, sell, import and otherwise exploit the Product Candidates referenced in such notices in the Territory in the Research Field.

Licensor of the United Kingdom grants to the Licensee of Japan under Licensor Background IP and Collaboration IP, the sole right to use the same in any way whatsoever for the purpose of the Research Collaboration including to research and use Research Compounds for the purposes necessary to perform its obligations and exercise its rights under the Research Plan but excluding the right to manufacture Research Compounds or have Research Compounds manufactured on its
behalf other than by Licensor. This right shall not be capable of sub-license.

Research Compounds shall mean collectively, all Selected BDCs and Selected Drug Candidates. For clarity, Research Compounds shall include Synthetic Cannabinoids synthesized under the Research Plan and which subsequently become Selected BDCs and/or Selected Drug Candidates.

Botanical Drug Candidate or BDC shall mean
—  any cannabinoid from a single chemovar of a chemically and genetically characterized Cannabis sativa plant (Phytocannabinoid) at any stage of research or development made using any extraction method and in any degree of purification in which only a single cannabinoid is present in a concentration which has the potential to be therapeutically active including, without limitation, the THC fraction and the CBD fraction separately; and
—  a combination of two or more Phytocannabinoid extracts described containing two or more Phytocannabinoids present in concentrations such that both have the potential to be therapeutically active mixed in a precise ratio i.e. the THC and CBD fractions mixed (without other fractions) in the ratio of THC CBD of 90 10. For clarity specifically excluded from the definition of BOC is any combination of the THC and CBD fractions when mixed (without other fractions) in a ratio of CBD to THC that falls inside the range of 2575 to 7525; and
— any biological or chemical modification of the Phytocannabinoids including any metabolite or degradant.

Synthetic Cannabinoid shall mean any Phytocannabinoid produced by synthetic methods either pursuant to a Research Plan (a Type 1 Synthetic Cannabinoid), or, outside of the Research Collaboration but with information resulting from the Research Collaboration (Type 2 Synthetic
Cannabinoid).

Synthetic Cannabinoid Product shall mean any pharmaceutical product containing a Type 1 Synthetic Cannabinoid (Type 1 Synthetic Product) or a Type 2 Synthetic Cannabinoid (Type 2 Synthetic Cannabinoid Product).

Synthetic Molecule shall mean a synthetic molecule whose chemistry is not based on a Phytocannabinoid but;
—  which has been developed with information resulting from the Research Collaboration and,
—  for which one or more patent· applications have been filed by Licensee on an invention conceived within three years following expiration of the Research Term or any Extended Research Term claiming a novel composition of matter and a cannabinomimetic or cannabinergic effect through direct, or indirect (i.e. modulation of related metabolic enzyme systems), effects on one or more cannabinoid receptors (including their allosteric sites).

Synthetic Molecule Product shall mean any pharmaceutical product containing a Synthetic Molecule.

Research Field shall mean the treatment, diagnosis, prevention, or palliation of diseases, conditions, syndromes, and maladies of the central and peripheral nervous. systems of humans and animals and cancer in humans and animals.

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 body’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 body’s immune system called a cytokine storm.
These so-called storms occur when the body doesn’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 lungs’ airs sacs to fill up with fluid, the result being pneumonia.
‘Severe COVID-19 is characterized by an over-exuberant inflammatory response that may lead to a cytokine storm.