Royalty Report: Drugs, Gastrointestinal, Surgical – Collection: 367311

License Grant

Canadian Licensor hereby grants to German Licensee an exclusive, royalty-bearing right and license, with the right to grant sublicenses solely as set forth in this agreement, under the Licensor Intellectual Property and Licensor’s rights in the Joint Intellectual Property to the extent necessary or useful to Develop and Commercialize the Compound and Product in the Field in the Territory.

Licensor hereby grants to Licensee a co-exclusive right and license, with the right to grant sublicenses solely as set forth in this agreement, under the Licensor Intellectual Property and Licensor’s rights in the Joint Intellectual Property to the extent necessary or useful to Manufacture the Compound and Product in the Field in the Territory for Development and Commercialization by Licensee in the Territory.

License Property

Compound shall mean the compound known as teduglutide, as further described, and any analogues, fragments, derivatives, receptors and compositions thereof.
USAN – TEDUGLUTIDE

Therapeutic Claim – treatment of intestinal diseases characterized by chemical or surgical damage of the intestinal epithelium such as Short Bowel Syndrome (SBS) or damage to the intestinal epithelium due to disease (glucagon-like peptide-2 (GLP-2) analog)

Licensor Patent Rights shall mean Patent Rights, to the extent that they (a) Cover Licensor Know-How or are directly related to the Manufacture, use, Commercialization or Development of Compound or Product in the Field, and (b) are Controlled by Licensor, but shall not include Joint Patent Rights.

GATTEX is an analog of glucagon-like peptide 2, a naturally occurring hormone that regulates proliferation of the cells lining the small intestine. Licensor is independently investigating GATTEX as a potential treatment for short bowel syndrome, or SBS, and other indications, including Crohn’s disease, chemotherapy-induced enteritis, necrotizing enterocolitis and various other gastrointestinal diseases.

Field of Use

Field shall mean the treatment and diagnosis of all Indications in humans and animals relating to treatment of intestinal diseases characterized by chemical or surgical damage of the intestinal epithelium such as Short Bowel Syndrome (SBS) or damage to the intestinal epithelium due to disease.

License Grant

The Canadian Licensor, an individual,  hereby grants to the Canadian Licensee in the field and territory, a license under Patent Rights and Trade Secrets to develop and to make, have made, use, sell, have sold and otherwise dispose of Product.

License Property

Licensor has invented (1) a peptide to treat various medical conditions including conditions resulting from the impaired growth or loss of tissue, (2) a pharmaceutical composition including such a peptide, (3) a salt of such peptide, and (4) a method of medical treatment including the use of such pharmaceutical composition.

Product means all products which are Glucagon-Like Peptide-2 (GLP-2), and all analogues, fragments, derivatives, receptors and compositions thereof whether developed by Licensee and/or Licensor pursuant to the Sponsored Research Agreement or otherwise.

Basic Patents means (1) the United States patent application filed April 14, 1995 entitled “Glucagon-Like Peptide-2 and Its Therapeutic Use” and includes (2) patents to be issued pursuant to (1) and all divisions, continuations in whole and in part, reissues, re-examinations, substitutes, extensions and foreign counterparts thereof.

Improvement Patents means (1) patent applications for those inventions that (a) arise from research that is sponsored by Licensor and performed by or on behalf of Licensors and (b) relates to Product or to a method of making, using or selling Product, and all divisions, continuations in whole and in part, reissues, re-examinations, substitutes, extensions and foreign counterparts thereof.

Patent Rights includes Basic Patents and Improvement Patents.

Trade Secrets means all information, expertise, technical assistance and other trade secrets developed by or for Licensor or Licensor relating to the manufacture, use or sale of Product and which constitute confidential information and which he discloses in writing to Licensee

Field of Use

GATTEX is an analog of glucagon-like peptide 2, a naturally occurring hormone that regulates proliferation of the cells lining the small intestine. We are independently investigating GATTEX as a potential treatment for short bowel syndrome, or SBS, and other indications, including Crohn’s disease, chemotherapy-induced enteritis, necrotizing enterocolitis and various other gastrointestinal diseases.

License Grant

The Canadian Licensor grant to the Canadian Licensee any right in or transfer title to the Project Technology, Intellectual Property, or in any applicable technology incorporated in Special-Purpose Equipment, including the assignment, sale, licence and lease to any person from a program of the Canadian government.

License Property

Products' means the ALX 0600 compound as well as formulations thereof, a peptide analog of human glucagon-like peptide-2[GLP-2] for the treatment of various intestinal disorders for the treatment of any disease and other applications, approved by any regulatory authorities, worldwide.

Field of Use

Licensee are independently developing ALX-0600 for the treatment of short bowel syndrome and Crohn’s Disease. ALX-0600 is an analog of glucagon-like peptide 2, a naturally occurring hormone that regulates proliferation of the cells lining the small intestine. Animal studies indicate that ALX-0600 stimulates the repair and regeneration of cells lining the small intestine, expanding the surface area for absorption of nutrients. In animal studies, ALX-0600 induced an approximately 50 percent increase in the weight of the small intestine within 10 days of administration. Further, these studies suggest the growth-promoting properties of ALX-0600 appear to be highly tissue-specific, predominantly affecting the small intestine, and thereby potentially reducing the risk of adverse side effects.

ALX-0600 may also be useful in treating other gastrointestinal conditions characterized by malabsorption, altered absorptive capacity and inflammation or deterioration of the intestinal wall. Examples of these conditions include inflammatory bowel disease, like Crohn’s Disease, and intestinal mucositis in cancer patients.

License Grant

South Korean Licensor shall, and hereby does, grant to Licensee an exclusive (even as to Licensor and its Affiliates), royalty-bearing right and license, including the right to sublicense in accordance with this Agreement, under the Licensor Intellectual Property and Licensor’s interest in the Joint Intellectual Property, to Develop, Manufacture, use and Commercialize, including filing for, obtaining and maintaining Regulatory Approval for, Products in the Field in the Territory.

License Property

Product means any pharmaceutical preparation containing one or more Compounds either as its only active ingredient(s) or as part of a Combination Product. For the avoidance of doubt, nothing in this Agreement grants to Licensee or Licensor any right or license under any Patent Rights or Know-How Controlled by Licensor or Licensee, respectively, with respect to any Other API.

Compound means YH12852, which has the chemical structure set forth in this agreement, together with all analogs, derivatives, metabolites, stereoisomers, polymorphs, formulations, mixtures or compositions thereof, and any existing or future improved or modified versions of the foregoing developed by or on behalf of Licensee, its Affiliates or Sublicensees.

Compound (S)-N-(1-(2-((4-amino-3-nitrophenyl)amino)-6-propylpyrimidin-4-yl)pyrrolidin-3-yl)acetamide

Licensor Patent Rights means all Patent Rights in the Territory that are Controlled by Licensor or any of its Affiliates as of the Effective Date or thereafter during the Term (other than Joint Patent Rights) that Cover any Compound or Product. The Licensor Patent Rights existing as of the Effective Date are set forth on Schedule 1.57; provided, however, that, if Licensor is acquired by a Third Party, “Licensor Patent Rights” shall exclude any Patent Rights that (a) are Controlled by such Third Party or the Affiliates of such Third Party (other than Licensor and Licensor Pre-Existing Affiliates) and (b) were not Controlled by Licensor or any of the Licensor Pre-Existing Affiliates immediately prior to the closing of such acquisition transaction; provided further that, if, after the closing of such acquisition, any such Licensor Excluded Affiliate has or acquires Control of any Patent Right that Covers the Development, Manufacture or Commercialization of any Compound or Product and that is used to Develop, Manufacture or Commercialize any such Compound or Product, such additional Patent Right that is Controlled by such Licensor Excluded Affiliate shall be included in Licensor Patent Rights.

9,890,138 – Diaminopyrimidine derivatives and processes for the preparation thereof
10,227,330 – Diaminopyrimidine derivatives and processes for the preparation thereof
9,850,227 – Diaminopyrimidine derivatives and processes for the preparation thereof

Licensee is a global pharmaceutical company offering one-stop custom synthesis services of active pharmaceutical products (APIs) and intermediates.

YH12852 is a novel, potent and highly selective 5-hydroxytryptamine 4 (5-HT4) receptor agonist. Other 5-HT receptor agonists with less 5-HT4 selectivity have been shown to successfully treat GI mobility disorders such as chronic constipation, constipation-predominant irritable bowel syndrome, functional dyspepsia and gastroparesis.

Field of Use

YH12852 is a small molecule drug in development for the treatment of functional gastrointestinal (GI) disorders (FGID).

License Grant

This agreement is in respect to a research and collaboration for the development of Glucagon & GLP-1 Dual Agonists between the Licensee and the Denmark Licensor.

License Property

Glucagon & GLP-1 Dual Agonists is part of the portfolio that includes ZP 7570, a potential once-weekly GLP-1-GLP-2 agonist for treatment of SBS in phase 2 development.

Glucagon is a peptide hormone, produced by alpha cells of the pancreas. It works to raise the concentration of glucose and fatty acids in the bloodstream, and is considered to be the main catabolic hormone of the body.[3] It is also used as a medication to treat a number of health conditions. GLP-1 and GLP-2 are identifiers. Glucagon binds to the glucagon receptor, a G protein-coupled receptor, located in the plasma membrane of the cell.

Field of Use

Field of use is for the treatment of SBS (short bowel syndrome).

SBS is a complex chronic and severe condition associated with reduced or complete loss of intestinal function.