Royalty Report: Drugs, Disease, Therapeutic – Collection: 266829

License Grant

With this agreement, the University grants an exclusive license to make, have made, use, and sell Licensed Products under Patent Rights in the Licensed Field.

License Property

The University has the rights to an invention entitled Glycohydrolase Inhibitors, Their Preparation and Use Thereof was developed during the course of research conducted by the University.

Field of Use

The original agreement Licensed Field means the treatment of Gaucher disease.  With the amendment, the Licensed Field is updated to mean the prevention or treatment of any human disease, Indication or clinical condition.

Gaucher disease is a rare genetic disorder characterized by the deposition of glucocerebroside in cells of the macrophage-monocyte system. The disorder results from the deficiency of the enzyme glucocerebrosidase.

License Grant

Licensor grants to the English Licensee an exclusive license, with the right to grant sublicenses, under all Licensed Technology, to Develop, make, use, sell, offer for sale and import Compound and Products, in each case, solely in the Field and in the Territory.

Licensor grants a license, with the right to sublicense, in accordance with the terms of the Trademark License Agreement, to use the Licensor Trademark(s) in such country(ies) in the Territory in connection with the making, having made, use, sale, offering for sale, importation, packaging, distributing and promoting of Product in the Field and in such country(ies) in the Territory.

License Property

The Compound means migalastat, and includes any compounds with alternative names but with the same chemical structure as Migalastat, and any metabolites, prodrugs, isomers and enantiomers, excluding the isomer/enantiomer “1-deoxynorjirimycin” or “(2R,3R,4R,5S)-2-(hydroxymethyl)piperidine-3,4,5-triol”, esters, salts, hydrates, solvates, and polymorphs, whether alone or in a mixture.

Migalastat, trade name Galafold (formerly known as Amigal) is a drug for the treatment of Fabry disease, a rare genetic disorder.  Amigal, is an orally-administered, small molecule pharmacological chaperone for the treatment of Fabry disease.

Fabry disease is an inherited disorder that results from the buildup of a particular type of fat, called globotriaosylceramide, in the body's cells. Beginning in childhood, this buildup causes signs and symptoms that affect many parts of the body.

Field of Use

The Field means any and all uses or purposes, including, without limitation, the treatment, palliation, and/or prevention and diagnosis of any human or animal disease, disorder or condition, including use of the Product in combination with ERT or enzyme replacement therapy.

The specific treatment available for Fabry disease (FD) is enzyme replacement therapy (ERT) with agalsidase alfa or beta.

License Grant

Whereas, the University, has waived its interest to certain parts of the Technology, inter alia, the multipotent postnatal derived progenitor cells, and that waived part of the Technology, which is now Licensee Company Technology is assigned to and owned by the Licensee; and
Whereas, the remaining part of the Technology, known as the University Technology, is owned by the University and ownership of the Licensee Technology and the University Technology is governed by a separate agreement between the University and the Licensee,
The University is granting to the Licensee an exclusive license to the University Technology.

The University grants an irrevocable, exclusive right and license in any and all Fields of Use, including the right to sub license to Affiliates or unrelated third parties, to the Licensed Patents and the University Technology to make, have made, use, sell, offer to sell, import and export, lease or otherwise dispose of Licensed Product in the Territory.

License Property

The University developed Technology relating to multipotent postnatal derived progenitor cells, their precursors, progeny and components, products made therefrom, processes used in their production and processing, and methods for their use.

The technology shall mean Licensees Technology and University Technology, including but not limited to, multipotent postnatal derived progenitor cells, precursors, progeny or components thereof, products and information obtained from the foregoing, processes and products utilized in production or processing of any of the foregoing, methods of utilizing any of the foregoing, and any Trade Secret Information or know-how relating to the foregoing. The term Technology shall also include any invention involving multipotent postnatal derived progenitor cells (a) that is the result of research conducted.

Licensed Patent shall mean a Patent that claims as an invention one or more aspects of the Technology.

Licensed Product shall mean any Technology which is within the scope of one or more claims of a Licensed Patent and, but for the license granted in this Agreement, would infringe, constitute contributory infringement, or constitute inducement to infringe of one or more such claims when made by, made for, used, sold, offered for sale, imported, exported, leased, or otherwise disposed of by the Licensee.

Field of Use

The Field of Use shall mean any and all fields of use, including but not limited to diagnostic, therapeutic and research applications.

Lysosomal storage disorders are a group of more than 40 recessive genetic diseases resulting in deficiencies in lysosomal acid hydrolases. Although individually rare, lysosomal storage disorders have a prevalence of 1 per 7700 live births. Such diseases include Gaucher's disease, Fabry disease, Niemann-Pick disease, mucopolysaccharidoses Type I through VII, Tay-Sachs disease, among many others. Loss of lysosomal enzyme activity results in the progressive accumulation of undegraded substrate within the lysosomes, resulting in engorgement of the organelle, subsequent cellular, tissue, and organ dysfunction, and often death. Lysosomal storage diseases affect multiple organ systems, many of them before birth, resulting in irreversible defects. Clinical treatments for metabolic storage disorders are limited to bone marrow transplantation and enzyme replacement therapy.

License Grant

The Israelite Licensee entered into a Research and License Agreement with the Israelite Licensor, the technology transfer arm of Israel’s Weizmann Institute of Science, pursuant to which Yeda is using its technology to design a next generation of Glucocerebrosidase (GCD) for the treatment of Gaucher Disease that can be expressed using our plant cell system.

License Property

In connection with the upfront and milestone payments made under the Pfizer license and supply agreement, the sub-licensee has accrued a sublicense fee equal to $1.6 million payable to the academic institution from whom it licensed certain technology relating to taligluceraze alfa.

Taliglucerase alfa is used as an enzyme replacement therapy for the treatment of Gaucher disease.  Taliglucerase alfa is our proprietary recombinant form of glucocerebrosidase (GCD), an enzyme naturally found in human cells that is mutated or deficient in patients with Gaucher disease.

Field of Use

The rights granted apply to the healthcare industry relating to replacement therapy.