Royalty Report: Drugs, Disease, Osteoarthritis – Collection: 263903

License Grant

Licensor grants to the Swiss Licensee an exclusive license under the Licensed Technology to develop, manufacture, sell, use, import and export API, Intermediate and Amidating Enzyme in the Territory solely for the purpose of developing, having developed, manufacturing, using, selling, having sold importing and exporting Licensee Drug Products and/or manufacturing and selling API to Licensor for use in Licensor Drug Products, by Licensor its Affiliates, licensees or distributors.

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

License Property

Know-how and patent rights relate to all cell lines, cell banks, clones, vectors, cassettes, separations, purifications, ideas, inventions, data, instructions, processes (including, without limitation, the process of manufacturing API through a fermentation process or through the employment of an Amidating Enzyme, formulas, expert opinions and information, including, without limitation, biological, chemical, pharmacological, physical and analytical, clinical, safety, manufacturing and quality control data and information, in each case, which are necessary or useful for the development, testing, use, manufacture or sale of API, Amidating Enzyme or Intermediates and which is in the possession of and owned or Controlled by Licensor and/or its Affiliate as applicable.

Amidating Enzyme means a recombinant enzyme used to convert non amidated peptides or proteins to amidated peptides or proteins.

Licensor sole improvements are Improved Bacterial Host Cell For the Direct Expression of Peptides; Recombinant Cell Lines Expressing Alpha-Amidating Enzyme; and,  Improved Conditions For Amidation Of Peptides.

In organic chemistry, peptide synthesis is the production of peptides, compounds where multiple amino acids are linked via amide bonds, also known as peptide bonds. Peptides are chemically synthesized by the condensation reaction of the carboxyl group of one amino acid to the amino group of another.

Field of Use

Field means the use by oral administration of the APl for the prophylactic and/or therapeutic treatment of any human diseases or disorders, including, but not limited to, osteoporosis.

License Grant

This agreement is an exclusive license throughout the world to discover, develop, make, have made, market, sell and import certain Licensed Products throughout the world under the Licensor Patent Rights and Licensor Know-How.

Licensor grants an exclusive license, even as to Licensor, under the Licensed Technology, to make, have made, use, sell, offer for sale and import Licensed Product in the Territory in the Field and an exclusive license, even as to Licensor, under the Licensed Technology, to make, have made, use, and import Active Pharmaceutical Ingredient (API) and PTH in the Territory.

License Property

Licensor has certain proprietary technology related to oral PTH, and has patents and know-how relating to pharmaceutical compositions for oral delivery of an active PTH peptide and the manufacture thereof.

PTH means all forms of parathyroid hormone.  Parathyroid hormone (PTH), also called parathormone or parathyrin, is a hormone secreted by the parathyroid glands that is important in bone remodeling, which is an ongoing process in which bone tissue is alternately resorbed and rebuilt over time.

Licensed Product means a drug product in finished pharmaceutical form, in any formulation containing or incorporating PTH, alone or in combination with any pharmacologically active ingredient which is a non-peptide or non-peptidomimetic or proprietary Licensee peptide, which product incorporates Licensor Know-How and/or is covered by Licensor Patent Rights and/or Joint Patent Rights.

Field of Use

The Field means the use of the Licensed Product for the prophylactic and/or therapeutic treatment of human diseases including, but not limited to, osteoporosis.

The licensing agreement is to develop an oral formulation of an analog of PTH currently in clinical development for the treatment of osteoporosis.

License Grant

The Parties previously entered into the Agreement to provide for the license grant of certain Licensed Technology to discover, develop, make, have made, market, sell and import certain Licensed Products throughout the world under the Licensees Patent Rights and Licensees Know-How.

With this amendment, Licensor consents and agrees that Licensee may enter into one or more agreements with a designated Third Party providing for the development, manufacturing, marketing or sale of 1-34 PTH into a drug product in the Field in finished pharmaceutical form in an oral formulation containing or incorporating 1-34 PTH, alone or in combination with a peptide or a small molecule that is not proprietary to Licensor, and which such oral formulation of 1-34 PTH product incorporates Licensee Know-How or is covered by Licensee Patent Rights, a 1-34 PTH Product.

With this amendment, Licensor grants back to Licensee, but only to the extent necessary to effectuate the specific Third Party Agreement, an exclusive license, even as to Licensor, under the Licensed Technology that relates solely to the manufacturing of 1-34 PTH API for use solely in a 1-34 PTH Product for Licensee to make and sell to Third Party, and for Third Party as Licensee’s licensee to subsequently sell, have sold, make, have made and import 1-34 PTH API for use solely in a 1-34 PTH Product in the Territory in the Field. For the avoidance of doubt, the foregoing license back to Licensee shall only apply to Licensed Technology that is solely related to the manufacturing of 1-34 PTH API for use solely in a 1-34 PTH Product and not any other aspects of Licensed Technology such as, but not limited to, Licensed Technology as to the oral delivery method or amidation technology relating to 1-34 PTH API or a 1-34 PTH Product, and Licensor retains all other rights to the Licensed Technology granted to Licensor under the Agreement.

License Property

1-34 PTH means all formulations of PTH 1-34OH including, but not limited to fusion proteins, muteins and chemical modifications of any or all of the aforementioned PTH 1-34OH. For the avoidance of doubt, 1-34 PTH shall not include any other formulations of PTH 1-34 or any other formulations of PTH.

Field of Use

This amendment further defines that the product in the Field may be in the finished pharmaceutical form in an oral formulation.  The original agreement defines the Field as the use of the Licensed Product for the prophylactic and/or therapeutic treatment of human diseases including, but not limited to, osteoporosis.

License Grant

Licensor, a non-profit organization, grants the Israeli Licensee a license under Patent Rights to make, have made, use, sell, offer for sale, and import Licensed Products and to practice Licensed Methods, in the Field within the Territory and during the Term.  The license granted is non-exclusive.

License Property

Licensor has rights in the inventions titled Production of Lysosomal Enzymes in Plant-Based Expression Systems.

Lysosomal storage diseases are a group of about 50 rare inherited metabolic disorders that result from defects in lysosomal function.[1] Lysosomes are sacs of enzymes within cells that digest large molecules and pass the fragments on to other parts of the cell for recycling. This process requires several critical enzymes. If one of these enzymes is defective, because of a mutation, the large molecules accumulate within the cell, eventually killing it.

Field of Use

The Field means all uses.

License Grant

Licensor grants an exclusive, worldwide license, including the right to grant sublicenses, under the Licensor Technology to use the System to produce, make, have made, use, offer for sale, sell and import Products and other enzymes, with the exception that Licensee shall not use the System to contract manufacture any enzyme for any third party.

License Property

System means Licensors proprietary Pseudomonas fluorescens gene expression system used to produce the Products.

Products means any enzyme which is obtained by expressing any gene or combination of genes owned by or licensed to Licensee using the System, including, without limitation, any enzyme sold as an industrial enzyme or pharmaceutical intermediate.

Field of Use

The purpose is to utilize such gene expression System to produce Product, including, without limitation, as an industrial enzyme or pharmaceutical intermediate.