Royalty Report: Drugs, Therapeutic, Disease – Collection: 203342

Japanese Licensor hereby grants to Licensee and its Affiliates an irrevocable, exclusive (even as to Licensor) license in the Licensee Territory under the Licensor Intellectual Property, including the right to grant sublicenses, to practice the Licensor Intellectual Property, and to develop, make, have made, use, offer for sale, market, sell, import and distribute the Compound, solely for the formulation of Product intended for importation, marketing, distribution, use, offer for sale, and sale by Licensee, its Affiliates and its sublicensees in the Licensee Territory and/or, if the provisions are applicable, for the formulation of Product in the Licensor Territory.

Licensor Intellectual Property shall mean all intellectual property and proprietary rights in (i) all Licensor Patent Assets and (ii) all Licensor Know-How.

Licensor Patent Assets shall mean (i) those Patent Assets listed, including any patents issuing thereon, and (ii) all Patent Assets owned or controlled by Licensor or its Affiliates, in the Licensee Territory, during the term of this Agreement which, absent the rights granted to Licensee and its Affiliates hereunder, would be infringed by the research, development, manufacture, use, importation, sale or offer for sale of a Compound or a Product.

6069176 – Phenylethanolamine compounds useful as .beta. 3 agonists, process for producing the same, and intermediates in the production of the same.

Product shall mean any product in final form, packaged and labeled for commercial sale by prescription, or by any other method (or, where the context so indicates, the product being tested in clinical trials), which contains Compound as the sole therapeutically active ingredient in any dosage form or package configuration.

Compound shall mean a chemical compound which is (i) known as {ethy1.3-(IR,3R)-3-{(2R)-2-(3-chlorophenyl)-2-hydroxyethylamino}cyclohexyl}-phenoxyacetate maleate} and designated TT-138 (the “Main Compound”), as diagrammed on Schedule 1.10 hereto, and any isomer, salt, hydrate, solvate, metabolite, or prodrug of any of the foregoing, or (ii) disclosed or claimed in the Licensor Patent Assets listed hereto.

MN-305 is a novel, potent and highly selective serotonin 5-HT1A receptor agonist under development by Licensee for the treatment of anxiety disorders beginning with Generalized Anxiety Disorder (GAD).

Licensor grants a co-exclusive license with Licensor under the Licensor Intellectual Property, including the right to grant sublicenses, to make and have made the Compound solely for the formulation anywhere in the world of Product intended for importation, marketing, distribution, use, offer for sale, and sale by each Party in each Partys respective Territory.

MN-305 is a serotonin receptor agonist with high affinity and selectivity for the serotonin 5-HT1A receptor subtype. Drugs that act through this mechanism, such as buspirone, have been proven to be clinically effective in treating Generalized Anxiety Disorder.

Compound shall mean that certain compound -A757 and its primary active metabolite -A907 (ketone of A757 converted to alcohol).

The Product shall mean the final dosage form of a product for commercial sale by prescription, over-the-counter, or by any other method (or, where the context so indicates, the product being tested in clinical trials), incorporating pharmaceutical compositions containing Compound as at least one of the therapeutically active ingredients in any final dosage form or package configuration, other than an Ophthalmic Solution, for any indication.

Ophthalmic Solution shall mean a liquid formulation of pharmaceutical compositions containing Compound as the therapeutically active ingredient that is applied directly to the eyes.

This agreement also includes a non-exclusive grant back to Licensor.

Product means any and all pharmaceutical preparations in the Field in any finished dosage packaged form for sale to Third Parties which contains the Compound or combinations thereof as at least one of the primary therapeutically active ingredients.

MN-221 is a novel, highly selective ß2-adrenergic receptor agonist for use in the treatment of premature labor.

And, for the Exclusive License Grant, Licensor grants an exclusive license to use and exploit the NOS Patent Assets and the Licensors NOS Know-How to develop, make, have made, use, import, offer for sale, market, commercialize, distribute and sell and otherwise dispose of the NOS Inhibitor Technology and any NOS Inhibitor and the Split Dose Patent Assets and the Licensors Split Dose Know-How to develop, make, have made, use, import, offer for sale, market, commercialize, distribute and sell and otherwise dispose of Compound or Product using the Split Dose Technology, each solely in connection with the use of Compound and/or Product in the Territory.  The exclusive license granted includes the right to grant sublicenses.

The Product shall mean any product in final form for commercial sale by prescription, over-the-counter, or by any other method, or, where the context so indicates, the product being tested in clinical trials, which contains Compound as at least one of the therapeutically active ingredients, in all final dosage forms and package configurations for any indication, or any line extension thereof.

The Compound shall mean the chemical compounds known as benzimidazole carbamate class vascular targeting agents,including those designated ANG-600 Series, whose more specific chemical names are 5 (6) substituted benzimidazole-2-carbamates, and any derivative, homolog, analog or conjugate of any of the foregoing, and any isomer, salt, hydrate, solvate, metabolite, or prodrug or the like of any of the foregoing.

The NOS Inhibitor shall mean a chemical composition that inhibits the formation or action of nitric oxide, including those disclosed in the NOS Patent Assets.

NOS Inhibitor Technology shall mean technology relating to the combination of vascular targeting agents, including Compound, and an NOS Inhibitor, including the inventions disclosed in the NOS Patent Assets.

NOS Patent Assets shall mean United States and foreign patents and patent applications, which shall be deemed to include certificates of invention and applications for certificates of invention, which as of the Effective Date or at any time during the term of this Agreement
– are owned by Llicensor (including Licensors interest in jointly owned patents and patent applications) or which Licensor through license or otherwise has or acquires rights, and
– relate to the combination with Compound or Product of an NOS Inhibitor or the NOS Inhibitor Technology including but not limited to methods of their manufacture, methods of their use, or otherwise relate to Licensor NOS Know-How, including all certificates of invention, divisions, continuations, continuations-in-part, reissues, supplementary protection certificates or the like of any such patents and current and future patent applications.

Split Dose Patent Assets shall mean United States and foreign patents and patent applications, which shall be deemed to include certificates of invention and applications for certificates of invention, which as of the Effective Date or at any time during the term of this Agreement
– are owned by Licensor including Licensors interest in jointly owned patents and patent applications or which Licensor through license or otherwise has or acquires rights, and
– relate to the use of Compound or Product in divided doses including but not limited to methods of their manufacture, methods of their use, or otherwise relate to Licensor Split Dose Know-How, including all certificates of invention, divisions, continuations, continuations-in-part, reissues, supplementary protection certificates or the like of any such patents and current and future patent applications.

The Split-Dose Technology shall mean a method of administering any vascular damaging agent in a divided dose, including the inventions disclosed in the Split-Dose Patent Assets.

Japanese  Licensor hereby grants Licensee an exclusive option (the Licensee Option) to acquire an exclusive (even as to Licensor) license in the Licensee Territory under the Licensor Intellectual Property Rights, including the right to grant sublicenses, to develop, make, have made, evaluate, use, offer for sale, market, sell, import, distribute, practice processes and methods and otherwise commercialize Compound and Licensed Product for the Optional Indications on the terms and conditions set forth in this agreement (the Expanded License).

U.S. Patent  6,395,747 – Remedies for multiple sclerosis

Licensed Product shall mean any product other than Ophthalmic Product in final dosage form for commercial sale by prescription, over-the-counter, or by any other method (or, where the context so indicates, the product being tested in clinical trials), incorporating Compound as the primary therapeutically active ingredient in any dosage form or package configuration, such Licensed Product to include a combination product with other chemically or biologically active components.

Compound shall mean the chemical compound known as Ibudilast whose specific chemical name 3-isobutyryl-2isopropylpyrazolo (1,5-a)pyridine and designated KC-404, as diagrammed on hereto in this agreement.

MS Indication shall mean use of Licensed Product to treat, alleviate or prevent any of the symptoms associated with multiple sclerosis.
Optional Indications shall mean all indications or uses of Licensed Product other than the MS Indication.

The Product shall mean any product in final form for commercial sale by prescription, over-the-counter, or by any other method (or, where the context so indicates, the product being tested in clinical trials), which contains Compound as at least one of the therapeutically active ingredients, in all final dosage forms and package configurations for any indication, or any line extension thereof, in the Field.

Licensee are investigating the regulation of calcium signaling through store-operated calcium channels, or SOCCs, and inositol-1,4,5-triphosphate, or IP3, receptors as a novel approach to the treatment of cancer and inflammatory diseases.