Royalty Report: Therapeutic, Drugs, Disease – Collection: 204328

License Grant

The Irish Licensor grants a worldwide license or sublicense, as applicable, with the right to sublicense, under the Licensor Technology, the Joint Data and the Joint Patents to research, develop, make, have made, use, and import Development Candidates and Approved Products in the Field.   The Irish Licensor grants a worldwide license or sublicense, as applicable, with the right to sublicense, under the Licensor Technology, the Joint Data and the Joint Patents to sell and offer for sale Approved Products in the Field in the Shared Territory.  The licenses granted shall be co exclusive.

License Property

Licensor possesses proprietary intellectual property that may be useful in the development and manufacturing of mirtazapine and its enantiomers in various forms in the Field.

Field of Use

Field shall mean the treatment and/or prevention of sleep related breathing disorders in humans.  The parties agree that the development and commercialization of products for the treatment and/or prevention of insomnia are outside the Field.

Mirtazapine has been independently evaluated as a potential Obstructive Sleep Apnea (OSA) treatment in a small preliminary investigator.
Obstructive sleep apnea (OSA) is the most common type of sleep apnea and is caused by complete or partial obstructions of the upper airway.

License Grant

Licensor grants the Licensee of Ireland a license or sublicense, as applicable, under the Licensor Technology, the Joint Data and the Joint Patents to research, develop, make, have made, use and import Development Candidates and Approved Products in the Field in the Shared Territory.   Licensor grants a license or sublicense, as applicable, under the Licensor Technology, the Joint Data and the Joint Patents to sell and offer for sale Approved Products in the Field in the Shared Territory.  These licenses are co-exclusive.

License Property

Licensor possesses proprietary intellectual property that may be useful in the development of combination products with mirtazapine (in various forms) in the Field.

The patents relate to Methods for treating sleep-related breathing disorders.

Field of Use

Field shall mean the treatment and/or prevention of sleep related breathing disorders in humans.  The parties agree that the development and commercialization of products for the treatment and/or prevention of insomnia are outside the Field.

License Grant

For the Research Program License, Licensor grants, during the Research Term, a non-exclusive, worldwide license, without the right to sublicense, except to subcontractors as provided in this Agreement, under the Licensor Technology solely to perform Licensee’s obligations under the Research Program.

For the Evaluation License Grant, Licensor grants, during the Option Period, a non-exclusive, limited research-use only license, without the right to sublicense, except to subcontractors as provided in this Agreement, under the Licensor Technology solely to perform Preliminary Evaluation Work and Evaluation Studies as provided in this Agreement.

For the Muscarinic Product Development and Commercialization License, Licensor grants, during the Term, an exclusive, worldwide license, with the right to sublicense even through multiple tiers of sublicense, under Licensor Technology and Licensor’s interest in Joint Patents, to develop, make, have made, use, distribute, promote, sell, offer for sale, have sold, import, and export Muscarinic Products in the Muscarinic Field.

For the Fixed Co-Formulation Product Development and Commercialization Exclusive License, effective only upon exercise of the Option and payment in full of the Option Exercise Fee, Licensor grants, during the Term, an exclusive, worldwide license, with the right to sublicense even through multiple tiers of sublicense, under Licensor Technology to develop, make, have made, use, distribute, promote, sell, offer for sale, have sold, import, and export Fixed Co-Formulation Products in the Sleep Field. For the avoidance of doubt, the license granted excludes any license under Licensor Technology to develop, make, have made, use, distribute, promote, sell, offer for sale, have sold, import, and export N-Dealkylated Licensed Compound Metabolites, and any license under Licensor Technology containing claims directed only to N-Dealkylated Licensed Compound Metabolites.

For the Fixed Co-Formulation Product Development and Commercialization Non-Exclusive License, Licensor grants, during the Term, a non-exclusive, worldwide license, with the right to sublicense even through multiple tiers of sublicense, under Licensor Technology and any other Patents directed to N-Dealkylated Licensed Compound Metabolites that are Controlled by Licensor to develop, make, have made, use, distribute, promote, sell, offer for sale, have sold, import, and export Fixed Co-Formulation Products in the Sleep Field.

For the Grant of Option, Licensor grants an option, exercisable during the Final Evaluation Period with respect to one (1) Chosen Compound, to obtain an exclusive, worldwide license, with the right to sublicense, under the Licensor Technology to develop, make, have made, use, distribute, distribute for sale, promote, sell, offer for sale, have sold, or import Fixed Co-Formulation Products in the Sleep Field.

License Property

Licensor Patents shall mean all Patents that Licensor or any of its Affiliates Controls as of the Effective Date or during the Research Term that are necessary or useful for performance of the Research Program or the Evaluation, or for the development, manufacture, use, import, offer for sale, or sale of any Selected Muscarinic Compound, Licensed Compound or Product, but excluding the Joint Patents.

The Licensor Know-How, beyond the patents, during the research term, excludes any such information relating to Licensors compounds known as -103 and -104, -104 Analogs and/or Topical Eyecare Compounds, which is Confidential Information of Licensor.

Licensor Muscarinic Compounds shall mean any compound Controlled by Licensor on the Effective Date, the primary mode of action of which is [activity as a selective] allosteric modulator, agonist, or antagonist of any one (1) or more of the five (5) muscarinic receptor subtypes, including, without limitation, Licensors proprietary [m3 antagonists), but subject to exclusion of [m1] Agonists.  Notwithstanding the foregoing or any other provision of this Agreement to the contrary, neither Licensors compound known as -104 (N-desmethylclozapine) nor any -104 Analogs shall be considered Licensor Muscarinic Compounds for purposes of this Agreement.

Muscarinic receptors are receptors that respond to acetylcholine, a neurotransmitter in the central nervous system.

Field of Use

Muscarinic Field shall mean the treatment, prevention, or both, of any disease or disorder in humans, but excluding the prevention or treatment of ocular disease.

Sleep Field shall mean the treatment, prevention, or management, or any combination thereof, as a primary objective, of any condition, disturbance, disease, or disorder in humans the principal effect(s) of which are on sleep time, sleep quality, sleep onset, sleep architecture, or sleep maintenance, or to disrupt or disturb normal sleep or sleep patterns, including without limitation insomnia, including without limitation transient, chronic, primary, and secondary insomnia; jet lag; bruxism; breathing related sleep disorders, including without limitation sleep apnea; sleep terror disorders, including sleep terrors and pavor nocturnus; sleep walking disorders; sleep paralysis; circadian rhythm sleep disorders, including without limitation delayed sleep phase syndrome, and advanced phase sleep syndrome; shift work sleep disorder; sleep enuresis; sudden infant death syndrome; narcolepsy; periodic limb movement disorder; rapid eye movement behavior disorder; other parasomnias; and other dysomnias, and also including, without limitation, any such condition, disturbance, disease, or disorder where the treatment, prevention, or management, or any combination thereof, of any such condition, disturbance, disease, or disorder may result, as a secondary objective, in [improving cognitive function, alertness, physical dexterity, coordination, symptoms of fatigue, and other detrimental symptoms associated with or arising from any of the foregoing conditions, disturbances, diseases, or disorders.

License Grant

The University hereby grants to Licensee an exclusive license under the University's Patent Rights, in jurisdictions where the University's Patent Rights exist, to make, have made, use, sell, offer for sale and import Licensed Products and to practice Licensed Methods in the Field of Use to the extent permitted by law. Licensee will not make, use, have made, sell, offer for sale, or import Licensed Products outside the Field of Use.

The agreement also includes a non-exclusive license to the copyright over certain user interface software for controlling and monitoring nerve stimulation. The agreement allows for sublicensing.

License Property

Licensed products and to practice licensed methods for treatment of conditions related to sleep-disordered breathing, including sleep apnea, congenital central hypoventilation syndrome and the improvement of sleep quality.

Sleep Disorders. One innovation consists of technology designed to take advantage of the fact that signals from the limbs interpreted by the brain as movement can elicit enhanced breathing rates. The device we would expect to develop would use a nerve stimulation technique to enhance the breathing rate without actual limb movement. The target market for the commercialization of this technology would include people who suffer sleep disorders mostly due to irregular breathing, the most common of which is sleep apnea.

Provisional Patent Application No. 61/856,883 entitled, 'Device, System and Method for Facilitating Breathing Via Stimulation of Limb Movement'

Patent Cooperation Treaty Application No. PCT/US14/047642 entitled, 'Device, System and Method for Facilitating Breathing Via Simulation of Limb Movement'

“Copyright Graphical User Interface Software to Control and Monitor Nerve Stimulation Device'

Field of Use

'Field of Use' means treatment of conditions related to sleep-disordered breathing (including sleep apnea, congenital central hypoventilation syndrome (CCHS), or primary alveolar hypoventilation) and for improvement of sleep quality.