Royalty Report: Drugs, Diabetes Treatment, Disease – Collection: 383600

Licensed Products means any pharmaceutical formulation suitable for administration to humans where such formulation contains at least one Product in combination with a Program Carrier.

GLP-1 Receptor Agonist means a compound that has the ability to bind the GLP-1 receptor in vitro and initiate an increase in cAMP where such compounds include but are not limited to GLP-1 and GLP-1 analogs and derivatives and Exendin-4 and Exendin-4 analogs and derivatives but excluding Native GLP-1.

Native GLP-1 means GLP-1(7-36) amide and GLP-1 (7-37).

Products means any GLP-1 Receptor Agonists.

Program Carriers means up to 6 Carriers that are selected by Licensee, at its sole discretion, in writing during or before the Term of this Agreement from the Carriers made available by Licensee. Program Carriers may be either Exclusive Program Carriers or Non-Exclusive Program Carriers. Carrier 1082 and SNAC have been selected by License as an Exclusive Program Carrier and a Non-Exclusive Program Carrier respectively as of the Effective Date.  Carrier 1082 and SNAC are sodium salts.

The proprietary transdermal drug delivery technology is known as transdermal microprojection patch technology for use with GLP-1 Receptor Agonist(s).

GLP-1 Receptor Agonist(s) means any substance that binds to the GLP-1 receptor in vitro and activates it, as measured by initiation of an increase in cAMP, with at least 10 fold higher potency than native glucagon. For the avoidance of doubt, native glucagon is not a GLP-1 receptor agonist according to this definition.

Eligen® technology, is broad-based oral drug delivery technology platform based on the use of proprietary, synthetic chemical compounds.

Licensor is a biopharmaceutical company specializing in the oral delivery of therapeutic molecules and compounds.

The Product means any Oral Formulation containing a Gallium Compound and the Program Carrier.  A Gallium Compound means a compound containing the element gallium, including, without limitation, a Gallium Salt, as its Active Pharmaceutical Ingredient.

Gallium compounds are bone-targeting agents that are potent inhibitors of bone breakdown and may be broadly useful for diseases associated with accelerated bone loss.

Ganite® (gallium nitrate injection) is Licensee's first commercialized product that is derived from this class of compounds. Ganite is approved in the U.S. for the treatment of symptomatic patients with cancer-related hypercalcemia that is resistant to hydration. Hypercalcemia, which is the most common life-threatening metabolic complication in patients with advanced cancer, represents the most aggressive medical example of accelerated bone loss.

Licensor grants an exclusive, worldwide license in the Field under Licensor Patents and Licensor Know-How, together with the right to grant sublicenses, to make, have made, use, import, offer to sell, sell and have sold Products.

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

AC2993 means synthetic exendin-4.

The patents include Preparation of Biodegradable Microparticles Containing a Biologically Active Agent, Preparation of Extended Shelf-Life Biodegradable, Biocompatible Microparticles Containing a Biologically Active Agent,  Method for Preparing Microparticles Having a Selected Release Profile, Apparatus and Method for Preparing Microparticles Using an In-line Solvent Extraction;  and, Apparatus and Method for Preparing Micropartides.

Field Products mean Exendins (including AC2993), exendin agonists, GLP-1 and GLP-1 agonists. The initial Field Product will be AC2993.

AC2993 is a diabetes drug candidate.

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.

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

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

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.

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

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