Royalty Report: Drugs, Therapeutic, Pharmaceuticals – Collection: 2518

License Grant

The agreement involves the purchase of rights to the drug Indiplon.  The purchase agreement includes all of the licensee's interest — financial and otherwise.

License Property

Through this transaction, the licensor now controls the indiplon composition of matter patents and other details associated with the transaction.  The drug is nearing the end of Phase III trials.

Indiplon is a nonbenzodiazepine, hypnotic sedative was developed in 2 formulations – an immediate release product for sleep onset and a modified-release version for sleep maintenance.  Indiplon is a unique nonbenzodiazepine agent that acts on a specific site of the GABAA receptor.  It has been shown to bind selectively to the specific subtype of GABAA receptors within the brain believed to be responsible for promoting sleep.

Field of Use

The field of use relates to the medical industry for the treatment of neurological and endocrine-related diseases and disorders.

License Grant

In February 2004, we reorganized our sublicense agreement with sublicensee in respect to Indiplon. As part of the reorganization, sublicensee acquired original licensor's interest under the license covering Indiplon entered into between original licensor and the company in 1998. The restated sublicense agreement with sublicensee expands the royalty term to include the life of sublicensee patents as well as original licensor patents covering Indiplon.

License Property

Indiplon is a unique non-benzodiazapine agent that acts on a specific site of the GABAA receptor. It has been shown to bind selectively to the specific subtype of GABAA receptors within the brain believed to be responsible for promoting sleep.  Agreement is exclusive and territory is worldwide.  Milestones will be paid upon NDA filing and approval.  Update:  The high-dose, extended-release insomnia treatment was rejected by the FDA in May 2006.  The company reported that FDA could approve 5-milligram and 10-milligram doses of the insomnia treatment Indiplon with a little more information, but a 15-milligram extended-release dose was out of the question given current clinical trial data.

License Grant

Licensor hereby grants to Licensee an exclusive license under Patents and Know-How to make, have made, use, import, offer for sale and/or sell Marketed Product in the Territory.

License Property

Marketed Product means the pharmaceutical preparation in finished form containing Product suitable for human administration, whether alone or in combination with other active ingredients.  Licenses and obligations relate to the compound designated as CL 285,489 (also known as Indiplon).

Indiplon (INN and USAN) is a nonbenzodiazepine, hypnotic sedative being developed in 2 formulations – an immediate release product for sleep onset and a modified-release version for sleep maintenance.

U.S. 6,399,621             expires 8/9/2020
U.S. 4,900,836             expires 2/13/2007
U.S. 4,521,422             expires 6/23/2003

Field of Use

The rights granted apply for human administration.

License Grant

Licensor grants to the Japanese Licensee the sole and exclusive, even as to Licensor, right and license, with the right to sub license, under the Licensor Technology to identify, make, have made, use, develop, sell, offer for sale, have sold and import Products in the Field of Use in the Territory and make, have made, use, sell, offer for sale, have sold and import Indiplon in bulk, active ingredient form in the Territory.

Licensor grants an exclusive option to obtain exclusive, even as to Licensor, right and license, with the right to sublicense, under the MR Program Data to identify, make, have made, use, develop, sell, offer for sale, have sold and import MR Product in the Field of Use in the Territory and make, have made, use, sell, offer for sale, have sold and import Indiplon in bulk, active ingredient form in the Territory.

In the event that Licensee determines to use the Licensor Trademarks, Licensor grants the exclusive license and right, free of charge, to use the Licensor Trademarks solely and exclusively for the purpose of Commercialization of Products in the Territory in accordance with this Agreement and shall register the Licensees license of the Licensor Trademark at the Japan Patent Office.

License Property

Licensor is the owner or licensee of certain patent rights and know how relating to Indiplon, a proprietary sleep hypnotic compound.

Indiplon shall mean the nonbenzodiazepine insomnia agent compound.

IR Product shall mean the immediate release tablet, capsule or other formulation of Indiplon whose release profiles are proved to be equivalent.

MR Product shall mean the modified or extended release tablet, capsule or other formulation of Indiplon.

Field of Use

Indiplon is for the treatment of insomnia.

License Grant

The UK Licensor grants the Licensee rights to develop and market a reformulation of a leading anti depressant using a proprietary delivery method.  Nebo 177 a drug intended to be marketed for treatment of depression.

License Property

The Ebo 177 is a noradrenergic and selective serotonergic antidepressant (NaSSA).  Its active compound has a dual-action effect aimed at rectifying the chemical imbalances in the brain that are understood to cause depression.  A deficiency in the brain of two chemicals norepinephrine and serotonin-is believed to contribute to depressed mood, poor sleep, anxiety, weight loss, and other symptoms of depression.  Nebo 177 is understood to act by increasing the release of both these chemicals from nerve cells in the brain, thereby relieving symptoms.  In addition, Nebo 177 blocks two specific serotonergic receptor sites so that they do not become stimulated.  Some other types of antidepressant stimulate these sites, which may account for their serotonergic side effects such as insomnia, nervousness, nausea and loss of sexual drive.

Field of Use

The rights granted apply to the healthcare industry.

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.