Royalty Report: Drugs, Disease, Gastrointestinal – Collection: 271161

License Grant

For the Research and Development License, Licensor grants to the German Licensee during the R&D Term a co-exclusive, with Licensor, right and license in the Territory under the Licensor Patents and the Licensor Know-How and Research Technology and under Licensors rights in the Joint Patents, Joint Research Technology and Joint Know-How, solely to conduct the Research, to characterize, optimize, research and develop the Development Compounds into Licensed Products in the Field and to make, have made and use Collaboration Compounds in the Field solely for research and development purposes in accordance with the Research and Development Plan and each Semi-Annual R&D Plan.

For the Commercialization License, Licensor grants to Licensee and its Affiliates a co-exclusive, with Licensor, right and license in the Territory under the Licensor Patents and the Licensor Know-How and Research Technology, and under Licensors rights in the Joint Know-How, Joint Research Technology and Joint Patents, to make, have made, import and use Licensed Products for use in the Field; and an exclusive, including with regard to Licensor right and license in the Territory under the Licensor Patents and the Licensor Know-How and Research Technology, and under Licensors rights in the Joint Know-How, Joint Research Technology and Joint Patents, to sell and offer for sale Licensed Products for use in the Field.

License Property

Licensor possesses proprietary technology and know-how related to the discovery, identification and synthesis of nicotinic agonists and has identified and applied for patents on certain nicotinic agonist compounds.

Licensed Product means any product, including any formulation thereof, containing or comprising a Development Compound.  Development Compound means any Collaboration Compound that has been selected as such hereunder, or any salt, solvate, prodrug form, inclusion complex, metabolite or other formulation thereof.

The technology means proprietary know-how of Licensee and its Affiliates concerning structure activity, relationships of Nicotinic Compounds and nicotinic receptors, pharmacophore mapping of nicotinic receptors and computational and quantum mechanical methods for use in the design, synthesis and evaluation of pharmacologically active agents, including but not limited to Nicotinic Compounds.

Compounds include -240312 Enema-Induction, and, -240312 Oral-Induction/Maintenance.

Field of Use

Field means the treatment or prevention in humans of one or more Indications.   Indication means ulcerative colitis; and other gastrointestinal and liver diseases.

Ulcerative colitis is a long-term condition that results in inflammation and ulcers of the colon and rectum.

License Grant

The German Licensor grants an exclusive, except with regard to Licensor, world-wide right and license under the Licensor Patents and Licensor Know-How and Licensors rights in the Joint Patents, Joint Know-How and Joint Research Technology, to conduct the Research.

Licensor grants the exclusive right to use and to disclose to Third Parties all regulatory and clinical documentation and data developed by or on behalf of Licensor in the Territory in connection with this Agreement and required to be disclosed to Licensee under this Agreement, as reasonably necessary or desirable in connection with the development and commercialization of pharmaceutical products in the Field in the Rest of World or outside the Field throughout the world.

Licensor agrees to negotiate in good faith with Licensee concerning the terms of a license under the Licensor Patents and the Licensor Know-How covering the composition of matter or the use of the Terminated Compounds, to permit Licensee to research, develop, make, have made, import, use, sell and offer for sale the Terminated Compounds outside the Field throughout the world.

Licensor grants an exclusive, including with regard to Licensor, right and license in the Rest of World under the Licensor Patents and the Licensor Know-How and under Licensors rights in the Joint Patents, Joint KnowHow and Joint Research Technology, to research and develop, and to make, have made, import, use, sell and offer for sale pharmaceutical products, including Licensed Products, in the Field.

License Property

Licensor is engaged in the research, development and marketing of products for the treatment of, among other things, ulcerative colitis.

Licensed Product means any product, including any formulation thereof, containing or comprising a Development Compound.  Development Compound means any Collaboration Compound that has
been selected as such hereunder, or any salt, solvate, prodrug form, inclusion complex, metabolite or other formulation thereof.

The technology means proprietary know-how of Licensee and its Affiliates concerning structure activity, relationships of Nicotinic Compounds and nicotinic receptors, pharmacophore mapping of nicotinic receptors and computational and quantum mechanical methods for use in the design, synthesis and evaluation of pharmacologically active agents, including but not limited to Nicotinic Compounds.

Compounds include -240312 Enema-Induction, and, -240312 Oral-Induction/Maintenance.

Field of Use

Field means the treatment or prevention in humans of one or more Indications.   Indication means ulcerative colitis; and other gastrointestinal and liver diseases.

Licensee possesses proprietary technology and know-how related to the discovery, identification and synthesis of nicotinic agonists and has identified and applied for patents on certain nicotinic agonist compounds.

License Grant

The Company executed a license agreement with the University for a worldwide, exclusive license to manufacture, market, sell and sublicense Extracellular Matrix Hydrogel.

License Property

ExtraCellular Matrix Hydrogel (“ECMH”), targets the treatment of multiple gastrointestinal diseases, including Ulcerative Colitis, Crohn’s Disease, and Rectal Mucositis.

Field of Use

This agreement pertains to the drug industry with a field of use limited to human and animal colonic and small intestine therapeutic indications.

ExtraCellular Matrix Hydrogel (ECMH), is a first-in-class, non-pharmacologic, non-surgical treatment option for patients suffering from Ulcerative Colitis.
Ulcerative colitis (UC) is a long-term condition that results in inflammation and ulcers of the colon and rectum. The primary symptoms of active disease are abdominal pain and diarrhea mixed with blood. Weight loss, fever, and anemia may also occur.

License Grant

Licensor and its Affiliates hereby grant Netherland Licensee (i) an exclusive (even as to Licensor and its Affiliates, royalty-bearing license (with the right to grant sublicenses at one or more tier(s) under the Licensor Technology, (a) to research, have researched, Develop, have Developed, use and have used TZP-101 and Product in the Field in the Licensed Territory and (b) to sell, offer for sale, have sold, import and otherwise Commercialize or have Commercialized Product in the Field in the Licensed Territory; (ii) a nonexclusive, worldwide, royalty-free license (with the right to grant sublicenses at one or more tier(s), under the Licensor Technology, to manufacture and have manufactured TZP-101 and Product worldwide solely for research, Development, use or Commercialization of such Products in the Field in the Licensed Territory under the license granted to Licensee; (iii) an exclusive (even as to Licensor and its Affiliates, royalty free license (with the right to grant sub-licenses at one or more tier(s) under Licensor’s interest in the Joint Inventions to (a) research, have researched, Develop, have Developed and use and have used TZP-101 and Product in the Field in the Licensed Territory and (b) sell, offer for sale, have sold, import and otherwise Commercialize or have Commercialized the Products in the Field in the Licensed Territory; and (iv) a nonexclusive, worldwide, royalty-free license (with the right to grant sublicenses at one or more tier(s), under the Joint Inventions, to manufacture and have manufactured TZP-101 and Product worldwide solely for Development, use or Commercialization of such Product in the Field in the Licensed Territory under the license granted to Licensee. Licensee shall not have the right to conduct or have conducted research and/or Development activities in the Retained Territory for the generation of data in support of Regulatory Filings to the Regulatory Authorities in the Licensed Territory except as expressly permitted under this Agreement or with the prior written consent of Licensor.  For clarity, the licenses granted to Licensee by Licensor and its Affiliates shall not include any rights for Licensee to research, Develop, make, have made, use, sell, offer for sale, distribute, import, export and otherwise commercialize any other proprietary compound of Licensor (including any proprietary compound which Licensor licenses to a Third Party) that is not TZP-101.

License Property

The compound under development, called ghrelin agonist ulimorelin (TZP-101), is entering Phase III clinical trials.
TZP-101 means Licensor’s proprietary ghrelin agonist known as TZP-101 (ulimorelin), having the chemical structure set forth in Agreement, including any salt, ester, solvate, polymorphic form, stereoisomer, metabolite, and pro-drug thereof.

Product means any pharmaceutical product comprising TZP-101 as an active ingredient irrespective of its formulation.

US 7,476,653 – Macrocyclic modulators of the ghrelin receptor

Licensor Product-Specific Patent means (a) the Patents set forth and (b) any other Patent that becomes Controlled by Licensor or its Affiliates at any time after the Effective Date (including Licensor Sole Patents but excluding Licensor’s interest in any Joint Patents) that (i) is necessary for Licensee and/or its Affiliates to have rights under in order to Develop, manufacture, use and/or Commercialize TZP-101 and/or Products in the Field; and (ii) is not a Licensor Other-Product Patent.

US 7,452,862 – Conformationally-controlled biologically active macrocyclic small molecules as motilin antagonists or ghrelin agonists

Licensor Other-Product Patent means (a) the Patents set forth and (b) any other Patent that becomes Controlled by Licensor or its Affiliates after the Effective Date (including Licensor Sole Patents but excluding Licensor’s interest in any Joint Patents) that (i) is necessary for Licensee and/or its Affiliates to have rights under in order to Develop, manufacture, use and/or Commercialize TZP-101 and/or Products in the Field; and (ii) covers any of Licensor’s proprietary technology (A) that is generally applicable or can be applied to Licensor’s discovery or development program in addition to the development program relating to TZP-101 and Product, or (B) that is applicable or can be applied to one or more compounds or products in addition to TZP-101 or Product, or (C) that covers the composition of matter of, or the method of discovering, making or using, any compounds or products (or any design, component, formulation or part thereof) in addition to TZP-101 or Product.

US 7,491,695 – Methods of using macrocyclic modulators of the ghrelin receptor

Field of Use

TZP-101 is for the acceleration of gastrointestinal (GI) recovery in patients undergoing abdominal surgery.

The deal is for development of a treatment targeting diseases of the muscles of the gastrointestinal track – called gastrointestinal dysmotility –

License Grant

The Licensor of England grants to Licensee of Bermuda the exclusive right and license under the Patent Rights, the Technical Information and Manufacturing Technology to develop, have developed, make, have made, use, sell and have sold Products within the Territory. Notwithstanding the foregoing, Licensor may authorize a Specific Third Party, its Affiliates and successors to manufacture Balsalazide within the Territory solely for sale and use outside the Territory.

License Property

The patents and technology are related to Balsalazide, or to prodrugs, analogs or isomers thereof or improvements of any of the foregoing, obtained in any country within the Territory.

Balsalazide means 5-[4(2-Carboxyethelcarbamoyl)-phenylazo] – salicylic acid disodium salt dihydrate.

Products means products incorporating Balsalazide, whether or not such products are covered by the Patent Rights, or any other material whose manufacture, use or sale by an unlicensed third party would constitute an infringement of any Valid Claim included within the Patent Rights.

Field of Use

The product is used for gastrointestinal disease.

First marketed product, Colazal, was the first new molecular entity approved in 10 years by the FDA for the treatment of mildly to moderately active ulcerative colitis and the first new oral therapy approved by the FDA for this indication in seven years.  Ulcerative colitis is a chronic form of inflammatory bowel disease characterized by inflammation of the lining of the colon. Symptoms of active ulcerative colitis include rectal bleeding, abdominal pain, increased stool frequency, loss of appetite, fever and weight loss.

License Grant

For the Research Licenses, Licensor grants, during the Research Term an exclusive, world-wide right and license under the Licensor Patents and the Licensor Know-How and Licensors rights in the Joint Patents and Joint Know-How, solely to conduct the Research, and to discover, synthesize, and, in connection with the Research, make and use Active Compounds for use in the Field.

Licensor grants, commencing at the expiration of the Research Term and for a period of six years thereafter, a non-exclusive, world-wide right and license under the Licensor Patents and Licensor Know-How, and Licensors rights in the Joint Patents and Joint Know-How, solely to discover, synthesize, and, in connection with Licensees activities under this Agreement, make and use Active Compounds for use in the Field.

For the Commercialization License to Licensee, Licensor grants an exclusive, world-wide right and license under the Licensor Patents, the Licensor Know-How and under Licensors rights in the Joint Know-How and Joint Patents, solely to [conduct development on, and to make, have made and use for such purpose, Back-Up Compounds and Collaboration Compounds for use in the Field and to make, have made, import, use, sell and offer for sale Licensed. Products) for use in the Field.

For the Cross-License of Know-How Licensor grants a non-exclusive license under the Licensor Know-How for any purpose or use.

License Property

Licensor has proprietary technology and know-how related to the discovery, identification and/or synthesis of cathepsin S inhibitors and have identified chemical compounds that are cathepsin S inhibitors.

Licensed Product means any product, including any formulation thereof, containing or comprising a Collaboration Compound.

Active Compound means any compound that
—  has the ability to inhibit (or, in the case of a prodrug, an active species of which inhibits) cathepsin S with a [K; equal to or less than 100 nM];
—  has greater than [100- fold selectivity] for cathepsin S against an [appropriate panel of cathepsins in appropriate assays,] as determined by the JRC; and
—  has appropriate [in-cell activity in concentrations of less than IO µMin a relevant cell based assay(s)] selected by the JRC.

Field of Use

Field means the treatment and/or prevention of one or more Indications by means of inhibition of cathepsin S.

Cathepsin S is associated with certain inflammatory diseases, such as arthritis, asthma, atherosclerosis and a variety of autoimmune diseases.

Cysteine proteases are enzymes that are responsible for the cleavage and breakdown of other natural proteins in normal biological processes. In disease conditions, cystein proteases can often be misregulated, providing an entry point for drug intervention. Cathepsin S has been associated with the processing and activation of the antigen receptor called MHC-II, essential for the initiation of both normal and pathological immune responses mediated by T-cells. Drugs designed to inhibit this enzyme may provide a novel method for control of antigen-induced response in multiple inflammatory and autoimmune disease states, the companies believe.

License Grant

Licensor grants the Licensee of Italy
—   an exclusive license, with the right to grant sublicenses, under Licensor’s right, title and interest in and to the Licensor Patents, the Licensor Know-How, the Joint IP, the Joint Patents and the New IP owned or Controlled by Licensor specifically for and limited to Develop the Product in the Licensee Territory for the Indication, and
—  an exclusive license, with the right to grant sublicenses, under Licensor’s right, title and interest in and to the Licensor Patents, the Licensor Know-How, the Joint IP, the Joint Patents and the New IP owned or Controlled by Licensor to Manufacture, have Manufactured and Commercialize the Product in the Licensee Territory for the Indication.

License Property

Compound means Licensor’s proprietary molecule known as Brilacidin, including any back-up compounds and analogues (including, prodrugs, metabolites, complexes, degradants, impurities, mixtures and other combinations) their salts, solvates, hydrates, stereoisomers, crystalline and amorphous forms, owned or Controlled by Licensor as of the Effective Date or during the Term.

Field of Use

The filed of use is for the prevention, treatment, amelioration, diagnosis or monitoring of Ulcerative Proctitis/Proctosigmoiditis (UP/UPS) using finished formulation(s) for local administration (e.g., gel, foam, enema) to the rectum and/or colon.