Royalty Report: Drugs, Disease, Therapeutic – Collection: 237214

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.

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 non-exclusive, worldwide sublicense to make or use any analytical reference standards, intermediate or metabolite of the Compound or Product which may be claimed in Patents limited solely to making or using the Compound or Product.

Licensee represents and warrants that during the term of this Sub license Agreement, neither it, an Affiliate or a Sublicensee shall license, develop, have developed, manufacture, have manufactured, sell or have sold any of the following compounds or products classified as an atypical antipsychotic: i.e. Olanzapine, Sertindole, Seroquel, Ziprasadone, Risperidone.

Compound shall mean the chemical compound known as Iloperidone, whose specific chemical name is 1 -[ 4-(3-[ 4-(6-fluoro-l ,2-benzisoxazol-3-y 1)-1-piperidinyl]propoxy ]-3-methoxyphcnyl]ethanone, including any salts, hydrates, solvates, and/or stereoisomers thereof, and only the metabolites listed hereto, including any salts, hydrates, solvates and/or stereoisomers of such metabolites.

The initial compound means the compound ICA-17043 having the molecular structure set forth and any hydrates, anhydrides, solvates, salts, esters, isomers, prodrugs, metabolites or polymorphs thereof.

The Product means a pharmaceutical product that contains, incorporates or is comprised of the Compound, whether in development or approved by any Regulatory Authority, including all formulations, line extensions and modes of administration thereof.

The Licensor Patents means all Patents, other than CMCC Patents, Controlled by Licensor as of the Effective Date or during the Term, that, absent rights thereunder, would be infringed by the Development, Manufacture, formulation, use, distribution, importation, sale, or offer for sale of Compound or Product, including without limitation any such Patents claiming the composition of matter or the use of Compound or Product or any Improvements thereto.

Licensors know-how means all Information, except for CMCC Know-How, that Licensor Controls as of the Effective Date or during the Term.

The product is the proprietary compound known as ORI-9020.  ORI-9020 means ORI-9020 and its analogs, the chemical composition of which are described in the patent and any prodrug, metabolite, analog, salt, hydrate, solvate, polymorph, chimeric or inverted chimeric or isomer of ORI-9020.

Licensor possesses significant expertise in the field of antiinflammatory therapeutics, and dersalazine represents the culmination of years of internal research.

Dersalazine is a new chemical entity that combines a well-known anti-inflammatory agent, 5-ASA, with a novel potent agent that acts as a PAF antagonist and an inhibitor of key interleukin cytokines to achieve a synergistic therapeutic effect when compared to the activities of each component separately. Chemical cleavage of dersalazine by colonic bacteria releases the two active compounds for the topical treatment of inflammation in the colon. The 5-ASA molecule contained in dersalazine has known antioxidant properties which may ameliorate the deleterious inflammatory effects ascribed to the overproduction of free radicals.

The Licensor of England grants back to Licensee the following licenses, with the right to grant sublicenses, under all Program Improvements and Program Patents:  
(i) a co-exclusive license to Develop Products in the Field and in the Territory,
(ii) subject to Licensor’s rights and obligations to Manufacture Products for Development activities, an exclusive license, exclusive even as to Licensor, to make and have made and otherwise Manufacture Compound and Products, other than Co-Formulation Products, in the Field and anywhere in the Territory for the Licensee Territory; and
(iii) an exclusive license, exclusive even as to Licensor, to use, sell, offer for sale, import and otherwise Commercialize Products in the Field in the Licensee Territory.

Licensor grants the following licenses, with the right to grant sublicenses, under the Co-Formulation Product IP:
(i) a co-exclusive license to Develop Co-Formulation Products in the Field in the Territory, and
(ii) an exclusive license, exclusive even as to Licensor, to use, sell, offer for sale, import and otherwise Commercialize Co-Formulation Products in the Field in the Amicus Territory.

Licensor grants to Licensee a worldwide, non-exclusive, right and license, with the right to grant sublicenses,
(a) under Licensor’s and its Affiliates’ rights in the Program Patents to make, have made, use, sell, offer for sale, and import products, and to otherwise practice and exploit the Program Improvements and
(b) under Licensor’s and its Affiliates’ rights in the Patents within the Co-Formulation Product IP to make and have made, other than JR051 or Co-Formulation Product in which the ERT enzyme is JR051, use, sell, offer for sale and import products, other than JR051, and to otherwise practice and exploit the Patents within the Co-Formulation Product IP claimed in such Program Patents and/or Patents within the Co-Formulation Product IP.

In the original agreement, Amicus granted to Licensee exclusive, worldwide, rights to Compounds and Products (each as defined below) and pursuant to which Amicus and GSK have collaborated and are collaborating on the Development of the Compound and Product;

The Co-Formulation Product ERT Enzyme means JR051; or any other alpha Galactosidase A enzyme selected by the Parties to be used as a ERT enzyme in co-formulation with the Compound.  ERT means enzyme replacement therapy.

Co-development of all current and future formulations of migalastat HCl for Fabry disease, including a co-formulation of migalastat HCl with Licensee’s investigational enzyme replacement therapy (ERT) for Fabry disease.

Fabry disease is a rare genetic disease a deficiency of the enzyme alpha-galactosidase A (a-Gal A) that causes a buildup of a type of fat called globotriaosylceramide (Gb3, or GL-3) in the body. Fabry disease is classified as a type of lysosomal storage disorder.

Licensor grants to the English Licensee the following licenses, with the right to grant sublicenses, under the Licensor Technology:  a co-exclusive license, co-exclusive with Licensor, to Develop Products in the Field in the Territory, and, an exclusive license to make, have made and otherwise Manufacture Compound and Products in the Field and anywhere in the Territory for the Licensee Territory; and,  an exclusive license to make, have made and otherwise Manufacture Co-Formulation Products in the Field and anywhere in the Territory for the Licensor Territory; and, an exclusive license to Manufacture Compound and Products for use in connection with Development activities; and, an exclusive license to use, sell, offer for sale, import and otherwise Commercialize Products in the Field in the Licensee Territory.

The Co-Formulation Product ERT Enzyme means JR051; or any other alpha Galactosidase A enzyme selected by the Parties, to be used as a ERT enzyme in co-formulation with the Compound.

ERT means enzyme replacement therapy.

Companies jointly to develop proprietary enzyme replacement therapy (ERT) for Fabry disease co-formulated with chaperone migalastat HCl.

Fabry disease is an inherited disorder that results from the buildup of a particular type of fat, called globotriaosylceramide, in the body's cells. Beginning in childhood, this buildup causes signs and symptoms that affect many parts of the body.

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.

Licensor grants a license, with the right to sublicense, in accordance with the terms of the Trademark License Agreement, to use the Licensor Trademark(s) in such country(ies) in the Territory in connection with the making, having made, use, sale, offering for sale, importation, packaging, distributing and promoting of Product in the Field and in such country(ies) in the Territory.

Migalastat, trade name Galafold (formerly known as Amigal) is a drug for the treatment of Fabry disease, a rare genetic disorder.  Amigal, is an orally-administered, small molecule pharmacological chaperone for the treatment of Fabry disease.

Fabry disease is an inherited disorder that results from the buildup of a particular type of fat, called globotriaosylceramide, in the body's cells. Beginning in childhood, this buildup causes signs and symptoms that affect many parts of the body.

The specific treatment available for Fabry disease (FD) is enzyme replacement therapy (ERT) with agalsidase alfa or beta.

Compound means 1-(1-methylethyl)-N-[2-[4-[(tricyclo[3.3.1.1 (3,7)]-dec-1-ylcarbonyl)amino]-1-piperidinyl]ethyl]-1H-indazole-3-carboxamide and all pharmaceutically acceptable salts and solvates thereof.