Royalty Report: Drugs, Disease, Therapeutic – Collection: 237221

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

For the Exclusive License Grant, Licensor grants to the Licensee of Switzerland, 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 Compound(s) 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 Licensee and its Affiliates, 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

The patents relate to methods and formulations for modulating human sexual response.

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.

Field of Use

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

License Grant

It is understood and agreed by the parties that it is no longer in their respective best interest to continue under the Agreements. This Letter of Agreement sets forth the terms and conditions on which the parties have mutually agreed to terminate the Agreements.

Licensor hereby grants to Licensee (or its designee) an exclusive, worldwide, royalty-bearing license under all of Licensors right, title and interest in the Combination Patents. Licensor will retain responsibility for the prosecution, maintenance, defense and enforcement of the Combination Patents, at its expense and in its sole discretion. In the event that Licensor intends to abandon one or more of the Combination Patents, it will first offer to assign and transfer such patents to Licensee.

All licenses, options and other rights with respect to Licensed Compounds, Licensed Products, Licensee Combination Products, Patent Rights, Licensee Know-How and Licensee Trademarks granted to Licensor by Licensee under the Agreements are hereby terminated and shall revert to Licensee in their entirety. On or promptly after the Termination Date, Licensor will transfer and assign to Licensee or its designee all of Licensors right, title and interest in Licensed Patent Rights.

License Property

Combination Patents shall mean those granted patents existing as of the Termination Date which are owned or controlled by Licensor and have one or more claims covering Combination Products and/or the use thereof, as listed in hereto.
US Patent No. 6,136,818 – Combination of phentolamine and apomorphine for the treatment of human sexual function and dysfunction
US Patent No. 6,011,043 – Combination of phentolamine and apomorphine for the treatment of human sexual function and dysfunction
US Patent No. 6,001,845 – Combination of phentolamine and apomorphine for the treatment of human sexual function and dysfunction

Combination Product shall mean any pharmaceutical composition or product containing a combination of phentolamine and apomorphine as active ingredients.

Licensed Patent Rights shall mean all Patent Rights (as defined in the Agreements) existing as of the Termination Date and having one or more claims related to Vasomax(TM) that are assigned to Licensor and/or with respect to which Licensor is responsible for the filing, prosecution, maintenance, enforcement or defense.

Field of Use

This agreement relates to the US license of Vasomax(TM) and the non-U.S. license of Vasomax(TM).  Vasomax(TM) is included in the phentolamine-based technologies for sexual dysfunction.

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 VLA-4 License Grant,  Licensor grants to the Swiss Licensee an exclusive license in the Territory in the Field under the VLA-4 Patent Rights and to use the VLA-4 Know-How to discover, develop, make, have made, import, export, use, manufacture, have manufactured, distribute, market, promote, offer for sale and sell Licensed Compound(s) and/or Licensed Product(s). Licensor shall retain the right to use the YLA-4 Patent Rights and VLA-4 Know-How solely in connection with the Research Program.

For the VLA-4 Non-Exclusive License Grant,  in the event that the discovery, development, making, having made, importing, exporting, use, manufacturing, having manufactured, distribution, marketing, promotion, offering for sale or sale by Licensee, its Affiliates and/or sublicensees of Licensed Compound(s) and/or Licensed Product(s) would, during the term of this Agreement, infringe a claim of an issued letters patent, or any other patent rights which Licensor owns or has the rights to license and which patents are not covered by the grant, Licensor hereby grants, to the extent Licensor is legally able to do so, a non-exclusive license in the Territory under such issued letters patent solely for Licensee to discover, develop, make, have made, import, export, use, manufacture, have manufactured, distribute, market, promote, offer for sale and sell Licensed Compound(s) and/ or Licensed Product(s) in the Territory.

Licensor grants an exclusive option right to include under this Agreement an exclusive license in the Territory for the development and commercialization of Alpha-4-Beta-7 Compounds.

License Property

Licensed Compound(s) shall mean any VLA-4 Compound and, upon the Option Date, any Alpha-4-Beta-7 Compound owned or controlled by Licensor and/or any of its Affiliates as of the Effective Date or the Option Date, as the case may be, or discovered by or on behalf of Licensor and /or any of its Affiliates in performance of the Research Program during the Research Term or during the one (1) year period following the Research Term. In addition, Licensed Compound shall include any compounds claimed in VLA-4 Patent Rights and Alpha-4-Beta-7 – Patent Rights.

Field of Use

The Field shall mean the use of VLA-4 Compounds to treat or prevent any disease, disorder or condition in humans or animals.

VLA-4 antagonists represent a new class of compounds that has shown promise in multiple preclinical animal models of asthma. The primary focus of the collaboration will be to discover orally available VLA-4 antagonists as treatments for asthma.

License Grant

For the VLA-4 License Grant,  Licensor grants to the Swiss Licensee an exclusive license in the Territory in the Field under the VLA-4 Patent Rights and to use the VLA-4 Know-How to discover, develop, make, have made, import, export, use, manufacture, have manufactured, distribute, market, promote, offer for sale and sell Licensed Compound(s) and/or Licensed Product(s). Licensor shall retain the right to use the YLA-4 Patent Rights and VLA-4 Know-How solely in connection with the Research Program.

For the VLA-4 Non-Exclusive License Grant,  in the event that the discovery, development, making, having made, importing, exporting, use, manufacturing, having manufactured, distribution, marketing, promotion, offering for sale or sale by Licensee, its Affiliates and/or sublicensees of Licensed Compound(s) and/or Licensed Product(s) would, during the term of this Agreement, infringe a claim of an issued letters patent, or any other patent rights which Licensor owns or has the rights to license and which patents are not covered by the grant, Licensor hereby grants, to the extent Licensor is legally able to do so, a non-exclusive license in the Territory under such issued letters patent solely for Licensee to discover, develop, make, have made, import, export, use, manufacture, have manufactured, distribute, market, promote, offer for sale and sell Licensed Compound(s) and/ or Licensed Product(s) in the Territory.

Licensor grants an exclusive option right to include under this Agreement an exclusive license in the Territory for the development and commercialization of Alpha-4-Beta-7 Compounds.

License Property

Licensed Compound(s) shall mean any VLA-4 Compound and, upon the Option Date, any Alpha-4-Beta-7 Compound owned or controlled by Licensor and/or any of its Affiliates as of the Effective Date or the Option Date, as the case may be, or discovered by or on behalf of Licensor and /or any of its Affiliates in performance of the Research Program during the Research Term or during the one (1) year period following the Research Term. In addition, Licensed Compound shall include any compounds claimed in VLA-4 Patent Rights and Alpha-4-Beta-7 – Patent Rights.

VLA-4 antagonists represent a new class of compounds that has shown promise in multiple preclinical animal models of asthma.

Field of Use

The Field shall mean the use of VLA-4 Compounds to treat or prevent any disease, disorder or condition in humans or animals.

The primary focus of the collaboration will be to discover orally available VLA-4 antagonists as treatments for asthma.