Royalty Report: Drugs, Pharmaceuticals, Gastrointestinal – Collection: 2810

License Grant

Licensor grants an exclusive license to make, have made, use or sell for use in the Field within the United States and its territories (Puerto Rico, Guam), Canada and Mexico.  The Compound and Product pursuant to all Licensor’s Intellectual Property Rights.

License Property

Licensor has discovered a compound internally designated as LY315535 (5,434,174) which may be useful in the treatment of functional gastrointestinal disorders and other indications.

Compound means 2-di-n-propylamino-8-(isoxazol-5-yl)-1,2,3,4-tetrahydronaphthalene and all pharmaceutically acceptable salts and solvates.

Field of Use

Field means products for Gastrointestinal Indications.  
Gastrointestinal Indications means disease states, such as excess gastric acid secretion, inflammatory bowel disease, irritable bowel syndrome, gastroesophagael reflux disease, esophagitis, dyspepsia, proctitis, hemorrhoids, gastrointestinal ulceration, nausea and vomiting and constipation and diarrhea, which are characterized by abnormalities of the Digestive System, regardless of the mechanism involved in such disease states.

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

The Company grants an exclusive license to make, have made, use or sell within the Territory the Compound and Product.

License Property

The Company has discovered a compound internally designated as LY213829, Tazofelone.  Compound means (+/-)-5- 3,5-bis(1,1-dimethylethyl)-4- hydroxyphenyl methyl -4-thiazolidinone and all pharmaceutically acceptable salts and solvates thereof.

Field of Use

The Compound may be useful in the treatment of functional gastrointestinal disorders and other indications.

License Grant

Licensor grants an exclusive, worldwide license to make, have made, use or sell the Compound and Product pursuant to all Licensor Intellectual Property Rights.  With respect to any patent rights licensed hereunder, such license shall be limited solely to those patent claims necessary to provide Licensee with the ability to make, have made, use or sell Product.

License Property

Licensor has discovered a compound internally designated as LY246736  which may be useful in the treatment of functional gastrointestinal disorders and other indications.

Compound means (+)-[[2(S)-[[4(R)-(3-hydroxyphenyl)-3(R),4-dimethyl-1-piperidinyl]methyl]-1-oxo-3-phenylpropyl]amino]-acetic acid and all pharmaceutically acceptable salts and solvates thereof.

License Grant

Licensor grants an exclusive, worldwide license to make, have made, use or sell the Compound and Product pursuant to all Licensor Intellectual Property Rights.

License Property

Licensor has discovered a compound internally designated as LY353433 which may be useful in the treatment of functional gastrointestinal disorders and other indications.

Compound means 1-(1-methylethyl)-N-[2-[4-[(tricyclo[3.3.1.1 (3,7)]-dec-1-ylcarbonyl)amino]-1-piperidinyl]ethyl]-1H-indazole-3-carboxamide and all pharmaceutically acceptable salts and solvates thereof.

License Grant

Licensor grants an exclusive, world-wide license to make, have made, use, sell or import Product pursuant to the Intellectual Property Rights or any other Licensor Technical Information. The term of the license shall be either the term of Phase A or, if Licensee elects to proceed with Phase B, the sum of the terms of Phase A and Phase B.

Phase A is for completing studies sufficient to establish the therapeutic index of the Compound and of whether Licensee intends to initiate Phase B.  Phase B is for developing and commercializing the Compound or Product.

License Property

Licensor has acquired from a third party, an exclusive, world-wide license to make, have made, use or sell (+)-[2(S)-[4(R)-(3-hydroxyphenyl)-3(R),4-dimethyl-1-piperidinyl]methyl]-1-oxo-3-phenylpropyl]amino]-acetic acid and all pharmaceutically acceptable salts and solvates thereof (the Compound), with the right to sublicense.

ADL 8-2698 is a peripherally-acting, gastrointestinal tract-restricted mu opioid receptor antagonist.  ADL 8-2698 is for treatment of narcotic bowel dysfunction.
Narcotic bowel syndrome (NBS) is a subset of opioid bowel dysfunction that is characterized by chronic or frequently recurring abdominal pain that worsens with continued or escalating dosages of narcotics.  As a result of the undesired action of opioids on the gastrointestinal (GI) tract, patients receiving opioid medication for chronic pain often experience opioid-induced bowel dysfunction (OBD), the most common and debilitating symptom of which is constipation.

Field of Use

Licensee is engaged in the development and marketing of therapeutic products utilizing opiate receptor-mediated pathways.

Licensee are developing orally-administered ADL 8-2698 to block the adverse gastrointestinal side effects of narcotics without blocking the beneficial analgesic effects. These gastrointestinal side effects include narcotic bowel dysfunction, ileus, which is delayed recovery of bowel function after surgery, and nausea.

License Grant

On May 2, 2010, the Licensee received a worldwide, exclusive and perpetual license to use patents and know how relating to BEKINDAâ„¢ from the previous Licensor, a U.S. company, who is now out of business.  On March 7, 2014, the Company entered into a licensing agreement with a U.S. University to secure certain patent rights related to the drug candidate. The Company therefore terminated the agreement with the U.S. company and licensed the patents directly from the U.S. university, the original owner of the patents. Under the agreement, the Company agreed to pay the U.S. university certain future payments.

License Property

BEKINDAâ„¢ is a once-daily controlled release oral formulation of ondansetron, a leading member of the family of 5HT-3 serotonin receptor inhibitors for the treatment of gastroenteritis and gastritis.

Gastroenteritis, also known as infectious diarrhea, is inflammation of the gastrointestinal tract—the stomach and small intestine.
Gastritis is inflammation of the lining of the stomach.

Field of Use

The biopharmaceutical company is focused on the development and acquisition of late clinical-stage, proprietary, orally-administered drugs for the treatment of inflammatory and gastrointestinal diseases and cancer.

1)
Gastroenteritis and gastritis – 24 mg strength

2)
Irritable Bowel Syndrome with Diarrhea (IBS-D) – 12 mg strength

3)
Prevention of chemotherapy and radiotherapy induced nausea and vomiting (oncology support) – 24 mg strength