Royalty Report: Drugs, Disease, Therapeutic – Collection: 215177

License Grant

Pursuant to this agreement, the Parties agree to collaborate on an exclusive basis in the Development and Commercialization of Product in the Field.

Licensor grants an exclusive license in the Territory, with the right to sublicense, under the Licensor Rights existing as of the Effective Date, solely to develop, make, have made, use, sell, offer for sale, have sold and import Compound and Product in the Field in the Territory as contemplated by this Agreement and otherwise to perform its obligations expressly set forth in this Agreement or the Related Agreements in the Territory.

Licensor grants a non-exclusive, worldwide license, including the right to sublicense in conjunction with a sublicense permitted by this agreement, to use the Licensors Marks on Product packaging, labeling, advertising and Promotional Material.

For IT improvements, Licensor grants a worldwide, nonexclusive license in the Territory to practice under the rights of Licensor to any such Licensor Rights and Improvements to develop, make, have made, use, sell, offer for sale, have sold and import Compound and Product in the Territory as contemplated by this Agreement and otherwise to perform its obligations expressly set forth in this Agreement or the Related Agreements in the Territory.

Each Party grants the other Party an exclusive option to enter into an agreement for the Development of Option Compound(s) Controlled by the granting Party.

License Property

The Neogenesis patents are claiming differentiation of non-insulin producing cells into insulin producing cells by GLP-1 or Exendin-4.

The Compound means exendin-4, an amino acid sequence.

AC2993 (synthetic exendin-4) is a peptide that has been shown to stimulate insulin secretion when blood glucose concentrations are high, but not when blood glucose levels are low.

The Product means a pharmaceutical product that contains or incorporates Compound, whether in development or approved by any Regulatory Authority, including all formulations, line extensions and modes of administration (including, without limitation, all delivery devices or other peripherals and consumables).

U.S. 5,424,286

Field of Use

The field means prevention and treatment of all human and animal diseases and disorders.

This collaboration agreement is for development and sale of a potential new treatment for type 2 diabetes.

License Grant

Pursuant to this agreement, the Parties agree to collaborate on an exclusive basis in the Development and Commercialization of Product in the Field.

Licensor grants an exclusive license in the Territory except for the U.S. with the right to sublicense, under the Licensor Rights existing as of the Effective Date, solely to develop, make, have made, use, sell, offer for sale, have sold and import Compound and Product in the Field in the Territory except for the U.S. as contemplated by this Agreement, and otherwise to perform its obligations expressly set forth in this Agreement or the Related Agreements in the Territory.

Licensor grants a non-exclusive, worldwide license, including the right to sublicense, to use the Licensor Marks on Product packaging, labeling, advertising and Promotional Material.

For IT improvements, Licensor grants a worldwide, nonexclusive license in the Territory to practice under the rights of Licensor to any such Licensor Rights and Improvements to develop, make, have made, use, sell, offer for sale, have sold and import Compound and Product in the Territory as contemplated by this Agreement, and otherwise to perform its obligations expressly set forth in this Agreement or the Related Agreements in the Territory.

Each Party hereby grants the other Party an exclusive option to enter into an agreement for the Development of Option Compound(s) Controlled by the granting Party.

License Property

The Neogenesis patents are claiming differentiation of non-insulin producing cells into insulin producing cells by GLP-1 or Exendin-4.

The Compound means exendin-4, an amino acid sequence.

AC2993 (synthetic exendin-4) is a peptide that has been shown to stimulate insulin secretion when blood glucose concentrations are high, but not when blood glucose levels are low.

The Product means a pharmaceutical product that contains or incorporates Compound, whether in development or approved by any Regulatory Authority, including all formulations, line extensions and modes of administration (including, without limitation, all delivery devices or other peripherals and consumables).

U.S. 5,424,286

Field of Use

The field means prevention and treatment of all human and animal diseases and disorders.

This collaboration agreement is for development and sale of a potential new treatment for type 2 diabetes.

License Grant

This amendment is for the collaboration for the product Byetta.  This amendment does not address exclusivity.  The original agreement is an exclusive agreement.

In the original agreement, the Parties agreed to collaborate on an exclusive basis in the Development and Commercialization of Product in the Field.  The Licensor granted an exclusive license in the Territory except for the U.S. with the right to sublicense, under the Licensor Rights existing as of the Effective Date, solely to develop, make, have made, use, sell, offer for sale, have sold and import Compound and Product in the Field in the Territory except for the U.S. as contemplated by this Agreement, and otherwise to perform its obligations expressly set forth in this Agreement or the Related Agreements in the Territory.
Each Party granted the other Party an exclusive option to enter into an agreement for the Development of Option Compound(s) Controlled by the granting Party.

License Property

The BID Product for this amendment shall mean the Product sold under the Product Trademark BYETTA®, or such other Trademark if BYETTA is unavailable as a Trademark in a given country, as a fixed dose injection of exenatide administered twice per day for any indication provided for in the first Marketing Approval received in a relevant country.

Byetta (exenatide) is an injectable medicine used to treat type 2 (non-insulin dependent) diabetes.

Field of Use

The field, in the original agreement, means prevention and treatment of all human and animal diseases and disorders.

License Grant

Licensor grants an exclusive, even as to Licensor, except to allow Licensor to perform its obligations under the Development Program, worldwide license, with the right to sublicense through multiple tiers, under the Licensor Technology, Licensor Inventions, Joint Inventions and Joint Patents to develop, use, offer for sale, sell, have sold and import Products, including, without limitation, any Licensed Intranasal Formulation included therein, in the Field in the Territory, and to make, have made and import Licensed Intranasal Formulations in order to make, have made, use, offer for sale, sell, have sold and import Products.

Licensor grants the right to grant sublicenses permitting Third Parties to exercise, in furtherance of the purposes of this Agreement, one or more of the rights granted to Licensee hereunder in the Territory.

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

License Property

Licensor owns or controls certain patent rights and know-how relating to the Exendin-4 Compound.

Exendin-4 Compound means the molecule known as Exendin-4 and with the chemical structure described in Exhibit E. Exendin-4 Compound shall include any chemical compounds with alternative names but with the same chemical structure as the Exendin-4 Compound; but, for clarification, shall not include any chimeric, hybrid or other compound or peptide which incorporates any other active molecule or which otherwise links another active molecule with the Exendin-4 Compound.

The patents include, but not limited to Intranasal Administration of Glucose-regulating Peptides; A Method of Treatment of a Metabolic Disease Using Intranasal Administration of Exendin Peptide;  Mucosal Delivery of Glucose-regulating Peptides in Formulations Having Viscosity Enhancers;  and, Stabilized Formulations of Exendin.

Field of Use

The Parties will jointly develop the nasal spray formulation utilizing Licensor’s proprietary nasal delivery technology.
The Licensor and Licensee agree to develop a nasal spray formulation of exenatide.

Exenatide is an injectable drug that reduces the level of sugar (glucose) in the blood. It is used for treating type 2 diabetes. Exenatide belongs in a class of drugs called incretin mimetics because these drugs mimic the effects of incretins.

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.

License Grant

Licensor hereby grants to Licensee and its Affiliates, and Licensee hereby accepts on its and their behalf, a sole and exclusive license, with full rights to sublicense , under the Licensor Know-How, to (a) develop, use, sell, offer for sale, and import Licensed Products containing the Compound, Derivative or Additional Licensed Compound in the Field, in the Territory, and (b) make and have made Licensed Products in the Territory for such development, use, sale, offering for sale, and importation. Licensor hereby assigns to Licensee all of its rights, title and interest in and to the Licensor Patent Rights.

License Property

US Patent #7,317,125 – Diacylglycerol acyltransferase inhibitors

Licensed Product means any product containing a Compound, a Derivative or an Additional Licensed Compound, including all formulations, dosages, and dosage forms thereof.

Compound means the compound 4-(4-(4-[(2-phenyl-5-trifluoromethyloxazole-4-carbonyl)-amino]-phenyl)-piperidine-1-carbonyl)-cyclohexanecarboxylic acid, also known as RO5131723.

Field of Use

Field means all therapeutic, prophylactic, and other pharmaceutical uses and applications for the treatment of diseases such as, for example, obesity, type II diabetes mellitus and metabolic syndrome.

Metabolic syndrome is a cluster of conditions that occur together, increasing your risk of heart disease, stroke and type 2 diabetes. These conditions include increased blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol or triglyceride levels.

License Grant

For the Research, Development, Marketing and Manufacturing License, Licensor grants to the Japanese Licensee,  a non-exclusive license, or, in the case of any Third Party Patent Rights licensed to Licensor a non-exclusive sublicense, including the right to grant sublicenses, under the Patent Rights licensable or sublicensable by Licensor, including Licensors rights in any jointly owned Patent Rights, to further develop Research Compounds in connection with the development of pharmaceutical compositions for use in the Field, and an exclusive license, or, in the case of Third Party Patent Rights licensed to Licensor, an exclusive sub license or, in the event that an exclusive sublicense may not be granted to Licensee under the terms of the license granted to Licensor, a sublicense to the full extent permitted under the terms of the license granted to Licensor, including the right to grant sublicenses, under the Patent Rights licensable or sublicensable by Licensor, including Licensors rights in any jointly owned Patent Rights, to further develop Candidate Compounds and Recommended Compounds in connection with the development of pharmaceutical compositions for use in the Field, and make, have made, use, offer to sell, sell and import Products incorporating Licensed Compounds, and Licensed Compounds for use in Products, in the Territory.

For the Manufacturing, the Licensee, its Affiliates and permitted sublicensees shall have the exclusive license to manufacture Compounds and Products.

For the Transfer of Screening Technology, Licensor grants a nonexclusive, perpetual, irrevocable, worldwide license, including the right to grant sublicenses, under all of its intellectual property rights related to the FBPase screening technology to enable Licensee to exercise its rights, including, without
limitation, the development of Candidate Compounds, Recommended Compounds and Research
Compounds.

License Property

The Licensed Compound is CS917, a product candidate for the treatment of type 2 diabetes.

Compound shall mean a Research Compound, Recommended Compound, Candidate Compound or Licensed Compound.

Licensed Compound shall mean a Candidate Compound which Licensee has deemed a Licensed Compound.

Products shall mean pharmaceutical compositions incorporating a Licensed Compound. All formulations of the same drug substance for the same route of administration, such as oral, parenteral or intravenous, shall constitute a single Product.

Field of Use

Field means the treatment of Diabetes by means of lowering blood glucose levels by direct suppression of hepatic gluconeogenesis by inhibiting fructose-1, 6-bisphosphatase.