Royalty Report: Drugs, Disease, Therapeutic – Collection: 245896

License Grant

Licensor grants an exclusive, even as to Licensor, sublicensable license under the Licensor Technology, to use, distribute, import, Promote, market, sell, offer for sale, and otherwise Commercialize Products in the Field in the Licensee Territory; and, make and have made Products in the Manufacturing Territory, where such Product is solely for use or sale in the Field in the Licensee Territory, and, to conduct certain Development activities on the Product in the Field solely in support of Regulatory Approval in the Licensee Territory; and, an exclusive, sublicensable license to use the Licensor Trademarks solely in connection with the
Commercialization of the Product in the Field in the Licensee Territory.

License Property

The Licensor has rights to a therapeutic drug known as STENDRA TM (avanafil).

Compound means the compound identified by the International NonProprietary Name avanafil and chemically known as (S)-4-(3-Chloro-4-methoxybenzylamino)-2-(2-hydroxymethylpyrrolidin-1-yl)-N-pyrimidin-2-ylmethyl-5-pyrimidinecarboxyamide, including any metabolites, polymorphs, salts, esters, free acid forms, free base forms, pro-drug forms, racemates and all optically active forms thereof.

Product means pharmaceutical compositions containing the Compound, including but not limited to that drug product known as STENDRA â„¢, in the form, formulation, and dosage strength(s) as defined in the NDA approved by the FDA as of the Effective Date and any other improvements, line extensions, delivery mechanisms, dosage strengths, formulations, or forms as may be approved in the future by the FDA or Health Canada that, in each case, contain a Compound.

Licensor Trademarks means the mark STENDRA.

Field of Use

The Field means the treatment of any urological disease or condition in humans, including male erectile dysfunction.

STENDRA is now the only FDA-approved erectile dysfunction (ED) medication indicated to be taken as early as approximately 15 minutes before sexual activity.

License Grant

For the Exclusive License Grant, Licensor grants, as of the Effective Date, an exclusive license, exclusive even as to Licensor, in the Territory, under the Patent Rights and to use the Licensor Know-How, each to discover, develop, make, have made, import, export, use, distribute, market, promote, offer for sale and sell Licensed Compound and Licensed Products , each for use in the Field.

For the Non-Exclusive License Grant, in the event that the discovery, development, making, having made, importing, exporting, use, distribution, marketing, promotion, offering for sale or sale by Licensee, its Affiliates and/or sublicensees of Licensed Compounds and/or Licensed Products would infringe during the Term of this Agreement a claim of an issued patent, and/or any patent rights which Licensor owns or has the rights to license and which patents are not covered by the exclusive grant, Licensor grants, to the extent Licensor is legally able to do so, a non-exclusive license in the Territory under such issued patents solely for Licensee, its Affiliates and/or sublicensees to discover, develop, make, have made, import, export, use, distribute, market, promote, offer for sale and sell Licensed Compounds and/or Licensed Products in the Field in the Territory.

License Property

Licensed Compound shall mean phentolamine, phentolamine mesylate, phentolamine hydrochloride and/or any active metabolites, isomers, salts, analogues or non-covalently bonded derivatives of any of the foregoing.

Licensed Products shall mean any form or dosage of pharmaceutical compositions or preparations, including, without limitation, Licensee Combination Products, in final form for sale by prescription, over-the-counter or any other method, which contain as an active ingredient the Licensed Compound. Licensed Products shall not include Licensor Combination Products, injectable formulations of pharmaceutical compositions containing, as an active ingredient, the Licensed Compound or vaginal suppository formulations containing, as an active ingredient, the Licensed Compound.

The patents relate to male sexual function methods and formulation for modulating the human sexual response.

Field of Use

Field shall mean the use of the Licensed Product in the Male Sexual Function Indication and/or any Licensee Additional Indication.

Licensed Product relates to Vasomax product for the treatment of male erectile dysfunction.  Vasomax(TM) is an oral treatment for male erectile dysfunction, commonly referred to as impotence.

License Grant

Licensor grants an exclusive right and license in the Licensee Territory, under the Licensor Technology, for all uses in the Field, with the right to grant sublicenses, to research, develop, modify and improve Compound and Product;  apply for and obtain Regulatory Approvals; and use, import/export, market, offer to sell and sell, Product and Compound; and make, or have made, the Compound and Product for use in the Field.

License Property

The Compound means the compound identified as LU 135252 (Darusentan) and its racemates, isomers, Prodrugs, active metabolites and any pharmaceutically acceptable salt or complex thereof, in its current and any other formulation.

Field of Use

The Field means all human and non-human diagnostic, prophylactic and therapeutic uses of the Compound and/or Product in any formulation or dosage form for any and all indications except therapeutic uses and indications in the Cancer Field.

Cancer Field means the prophylactic or therapeutic administration to humans or non-human animals as an agent, either alone or in combination with other agents, for the prevention, treatment or palliation of cancer including neoadjuvant, adjuvant or supportive care and/or as part of combination with radiotherapy, surgery, chemo-, biologic- or other therapy associated with cancer, including, but not limited to, pain and bone/skeletal complications or indications from bone metastasis.

License Grant

Licensor grants to the Licensee of Puerto Rico an exclusive license, with the right to sublicense, under the Licensor Compound Patents, Other Licensor Patents and Licensor Know-How, to research, develop, make, have made, use, sell, have sold, offer for sale and import the Compound and Products in the Field in the Territory.

Licensor grants a non-exclusive, royalty free license to use Licensors corporate Trademarks solely for purposes of Commercializing Products, which license shall terminate upon the expiration or earlier termination of this Agreement for any reason.

License Property

Licensor is engaged in manufacturing, research and development of pharmaceutical products and is currently engaged in the development of AGI-1067.  

Compound means AGI-1067, which is chemically defined as Butanedioic acid, including its pharmacologically acceptable salts, solvates, hydrates, hemihydrates, polymorphs, metabolites; free base forms, pro-drugs, esters, tautomers and if applicable, any isomers, stereoisomers, racemates, enantiomers and all optically active forms thereof.

AGI-1067 is a novel vascular protectant, anti-inflammatory drug and mild antiplatelet agent for treatment of atherosclerosis.
Atherosclerosis is a disease in which the inside of an artery narrows due to the build up of plaque.

Field of Use

Licensee is engaged in the research, development, manufacture and marketing of pharmaceutical products.  AGI-1067 is designed to benefit patients with coronary heart disease (CHD), which is atherosclerosis of the blood vessels of the heart.   Atherosclerosis is a common disease that results from inflammation and the buildup of plaque in arterial blood vessel walls.

License Grant

Licensor grants a worldwide, exclusive license, with the right to sublicense, under the Licensors Rights, to Develop, make, have made, use, sell, offer for sale, have sold and import the Compound and Products in the Field, and otherwise to perform its obligations expressly set forth in this Agreement and the Co-Promotion Agreement.

License Property

The Compound means either (a) the Initial Compound or (b) any compound that is claimed in U.S. Patent No. 6,288,122 Bl and any hydrates, anhydrides, solvates, salts, esters or polymorphs thereof.

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.

Field of Use

The field means prevention and treatment of all human and animal diseases and disorders.  The licensed technology is for use of these compounds include treating sickle cell disease, preventing erythrocyte dehydration and inhibiting potassium flux.