Royalty Report: Drugs, Cannabis, Therapeutic – Collection: 235008

License Grant

Licensor hereby grants Licensee, including Licensees Affiliates,

(a) during the Term, a royalty-bearing, Territory-wide license in the Licensed Field under the Patent Rights to the Licensed Technology, as well as under the Licensed Patents, the Licensed Know-how, and the Licensed Technology, regardless of whether such Licensed Patents are actually granted, to use the Licensed Know-how and Licensed Technology and to develop and have developed, make and have made, use and have used, sell and have sold, offer for sale and have offered for sale, import and have imported, export and have exported, any and all inventions claimed in the Licensed Patents related to the Licensed Products and/or any compounds, chemicals, substrates, devices, tools, dies, molds or any other materials whatsoever that are useful in the development and/or manufacturing and/or sale of the Licensed Products, and particularly including, without limitation, such license to develop and have developed, make and have made, use and have used, sell and have sold, offer for sale and have offered for sale, import and have imported, export and have exported Licensed Products, which license shall be exclusive even as to Licensor, and

(b) the right to grant bona fide sublicenses to third parties, to develop and have developed, to make and have made, use and have used, sell and have sold, import and have imported, export and have exported, Licensed Products, and to exercise all other rights under the License; provided, however, Licensee shall not have the right to grant any sublicense or to transfer any of its rights under the License unless each such sublicense or other transfer granted by Licensee contains terms and conditions under which the Sublicensee or transferee will be bound in the same manner as Licensee is under this Agreement. A copy of the proposed agreement shall be provided to Licensor prior to the execution of the Agreement.

License Property

Lcensed Products shall mean any and all products comprising tablets with Cannabinoids) utilizing the Licensed Technology for the delivery of a recreational, Medicinal or Pharmaceutical Cannabinoids product in specific dosage forms.

Cannabinoids means any of the chemical compounds that are the active components of the Cannabis genus of plants and its three species, Cannabis sativa, Cannabis indica, and Cannabis ruderalis; whether the compounds are synthetically produced or plant-derived, as well as cannabinoid compounds, formulations or products, that include single and/or multiple Cannabinoids including both synthetic and plant-derived Cannabinoids, as well as any and all Cannabinoid analogues. For formulations or compounds which may include combinations of API’s, other than Cannabinoids or terpenes, it is being agreed that if the API is another FDA approved Pharmaceutical, Licensor approval will be required to ensure that the API is not the subject of a current Licensor product, or the product of another licensee of the Licensor.

Medicinal shall mean any product containing marijuana, hemp or cannabis produced and sold for health, wellness, or nutritional purposes, including as herbal medicine, including products produced or sold through U.S. state-licensed or regulated marijuana programs and comparable programs in other countries and jurisdictions.

Licensed Technology shall mean the aggregate of the Licensed Inventions, the Licensed Know-how, the Licensed Products and the Licensed Patents and any other information and/or technology related to the Licensed Products and/or the design and/or the manufacturing of the Licensed Products

Licensed Patents shall mean any and all rights arising out of or resulting from (i) the patents and patent application set forth in Schedule 1.14 attached to this Agreement, as well as any additional patents or patent applications related to any aspect of any Licensed Technology Improvements, Licensed Know-how, Licensed Products, and/or Licensed Technology (as herein defined) filed prior to or during the term of this Agreement and (ii) any patent granted in respect of all such applications, as well as, without limitation, any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, re-examinations, extensions, supplementary protection certificates, confirmations, registrations, revalidations and the like, of any and all such patents and patent applications and any international equivalents thereof.

Field of Use

Licensed Field shall mean the use of Cannabinoids, together with the Licensed Technology for recreational, Medicinal and Pharmaceutical purposes in humans and animals.

License Grant

Licensor hereby grants Licensee, including Licensees Affiliates a royalty-bearing, Territory-wide license in the Licensed Field under the Patent Rights to the Licensed Technology, as well as under the Licensed Patents, the Licensed Know-how, and the Licensed Technology, regardless of whether such Licensed Patents are actually granted, to use the Licensed Know-how and Licensed Technology and to develop and have developed, make and have made, use and have used, sell and have sold, offer for sale and have offered for sale, import and have imported, export and have exported, any and all inventions claimed in the Licensed Patents related to the Licensed Products and/or any compounds, chemicals, substrates, devices, tools, dies, molds or any other materials whatsoever that are useful in the development and/or manufacturing and/or sale of the Licensed Products, and particularly including, without limitation, such license to develop and have developed, make and have made, use and have used, sell and have sold, offer for sale and have offered for sale, import and have imported, export and have exported Licensed Products, which license shall be exclusive even as to Licensor, permitted to seek funding for the development of the Licensed Product and the right to grant bona fide sublicenses to third parties.

License Property

Licensed Products shall mean any and all products, (including any and all) doses, strengths, formulations, compositions and methods thereof containing cannabinoids alone or in combination with various other active pharmaceutical ingredients and/or excipients for use in the Licensed Field utilizing the Licensed Technology.

Licensed Patents shall mean any and all rights arising out of or resulting from (i) the patents and patent application set forth in this Agreement, as well as any additional patents or patent applications related to any aspect of any Licensed Technology Improvements, Licensed Know-how, Licensed Products, and/or Licensed Technology (as herein defined) filed prior to or during the term of this Agreement and (ii) any letters patent granted in respect of all such applications, as well as, without limitation, any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, re-examinations, extensions, supplementary protection certificates, confirmations, registrations, revalidations and the like, of any and all such patents and patent applications and any international equivalents thereof.

Country                          Status                     Application #         Filing Date              Publication #                Publication Date
United States

Published

14/649,951

05-Jun-2015

2015-0313868

05-Nov-2015
United States

Expired
        
61/738,782

18-Dec-2012

Licensed Technology shall mean the aggregate of the Licensed Inventions, the Licensed Know-how, the Licensed Products and the Licensed Patents and any other information and/or technology related to the Licensed Products and/or the design and/or the manufacturing of the Licensed Products.

Licensed Inventions shall mean the inventions claimed in the Licensed Patents.

Field of Use

Licensed Field the use of cannabinoids alone or in combination with various other active pharmaceutical ingredients and/or excipients (i) as preventative and therapeutic neuroprotectives against nerve agents and pesticides and (ii) for the treatment of diseases for a variety of therapeutic categories.

The licensed intellectual property includes patent applications relating to the use of cannabinoid receptor modulators and terpenes in the acute treatment during exposure to organophosphorus nerve agents and/or organophosphorus insecticides.

License Grant

Canadian Licensor hereby grants to Israeli Licensee an exclusive license to exploit the Licensor solely as necessary to develop, manufacture, market, use, sell, offer for sale, import, export, commercialize and distribute the Licensed Products (the License).

License Property

Licensed Product relates to an orally dissolved film containing CBD, as an active material, for medical treatment.

Licensed Product shall mean Licensor’s patch described below hereto in combination with Cannabidiol (CBD) for medical or recreational cannabis, where latter permitted for the transmucosal delivery of medicinal or recreational cannabis, where latter permitted (other than in the field of oral care) or any other product exploiting the Licensee Cannabis IP for the transmucosal delivery of medicinal or recreational cannabis, where latter permitted.

Description of Patch – A “Eluting Transmucosal Patch Platform (ETP)” for non-invasive drug delivery.

Licensor Patents shall mean those patents and patent applications listed below, as well as patents issuing therefrom, and any substitutions, divisions, continuations, continuations-in-part (but only to the extent that they cover the same invention claimed in the foregoing), reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like, and any provisional applications, of any such patents or patent applications.

Patent(s)/Patent Application(s)
1. WO 2012/104834 A1
New oral dissolving films for insulin administration, for treating diabetes.
filed on December 2011. National Phase at Israel and the USA.
2. WO 2010/135053 A2
Dual and single layer dosage forms.
Issued USA patent on April 28, 2015.
3. PCT/IL 2017/050845
Adhesive Oral dissolved Films in Managing Oral Care.
PCT on 31 July 2017.

Field of Use

This agreement pertains to the drug industry relating to Cannabis.

License Grant

Licensor of Japan grants to Licensee of the United Kingdom under the Collaboration IP, the nonexclusive right to use the same in any way whatsoever for the purpose of the Research Collaboration including to research, make, have made and use  Research Compounds for the purposes necessary to perform its obligations and exercise its rights under the Research Plan.

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.

License Property

Licensor has intellectual property of botanical extracts from chemovars of Cannabis sativa 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.

Field of Use

The  fields of use are neuropsychopharmacology, with special reference to schizophrenia; cannabinoid/opioid analgesic combinations; and, oncology.

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.

License Grant

The Canadian Licensor and Licensee have agreed to collaborate to develop and manufacture a line of at least 3 co-branded topical cosmetic products formulated with a cannabinoid or cannabinoids.

License Property

Cannabis is a plant used in products for medical proposes.

Field of Use

This agreement pertains to the drug industry relating to cannabis.

License Grant

By this agreement, for the Clinical Development of product candidates, Licensee may chose Product Candidates, if any, for Clinical Development. Licensee of Japan shall notify Licensor of the United Kingdom in writing of whether it is has chosen one or more Product Candidates.

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.

License Property

Licensor has expertise in the research and development of pharmaceutical preparations based upon botanical extracts from chemovars of Cannabis sativa, and, has proprietary knowledge and interests in the research and development of pharmaceutical preparations based upon botanical extracts from different chemovars of Cannabis sativa in addition to that combination of botanical extracts used in SATIVEXâ„¢ oromucosal spray.

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.

Field of Use

The field of use is neuropsychopharmacology, with special reference to schizophrenia, cannabinoid/opioid analgesic combinations, and, oncology.

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.

License Grant

The Israeli Licensor and the Cayman Islands Licensee hereby agree to the amendment of the License Agreement (the 'First Amendment') to amend the product definition and the royalty consideration for Over the Counter Pharmaceutical Products.

License Property

Pharmaceutical Product shall mean, with respect to each jurisdiction in which it is sold or intended for sale (the 'Applicable Jurisdiction'), any cannabis-based product, compound or medicine which under the laws of the Applicable Jurisdiction would be regulated and subject to approval and restrictions in the same manner and degree and for specific indications as an approved or registered pharmaceutical product (“Pharmaceutical-Level Regulation”), whether or not prescribed or used for that specific indication, and whether used or sold pursuant to a prescription or over the counter; provided, however, that for purposes of this Agreement (a) the following shall not be considered a “Pharmaceutical Product” (i) cannabis plants (including flowers) in their natural form; (ii) food supplements containing cannabis as part of their ingredients, unless they are subject in the Applicable Jurisdiction to Pharmaceutical-Level Regulation; (iii) cosmetic products containing cannabis as part of their ingredients, unless they are subject in the Applicable Jurisdiction to Pharmaceutical-Level Regulation; and (iv) cannabis-based toothpastes, (b) cannabis-based extracts, oils and mixtures shall not be considered a “Pharmaceutical Product”, unless and to the extent such extracts, oils or mixtures are or were subject in the Applicable Jurisdiction to Pharmaceutical-Level Regulation or have potency levels equal to or higher than an identical or substantially similar product which is subject in the Applicable Jurisdiction to Pharmaceutical-Level Regulation, and (c) notwithstanding the foregoing, in the event that identical or substantially similar cannabis-based products can be sold in any Applicable Jurisdiction as both a pharmaceutical product which is subject to Pharmaceutical-Level Regulation and as a medical or adult use cannabis product which is not subject to Pharmaceutical-Level Regulation, for purposes of this Agreement, the form of such cannabis-based product which is permitted to be sold without being subject to Pharmaceutical-Level Regulation shall not be considered a “Pharmaceutical Product”. '

Field of Use

Licensee is an early stage biopharmaceutical company engaged in the business of discovering, developing and commercializing drugs containing cannabinoids, which are based on a proprietary cannabinoid-based product platform, for the treatment of various diseases, disorders and medical conditions.