Royalty Report: Drugs, Cancer, Disease – Collection: 203444

License Grant

The Canadian Licensor grants to the Israeli Licensee an exclusive, even as to Licensor, right and license throughout the Territory, with the right to grant sublicenses, under the Licensor Intellectual Property:
– to Develop, have Developed, make, have made, and use the Licensed Compound and Licensed Product in the Field, and
– to sell, offer for sale, register, Commercialize and otherwise exploit the Licensed Product in the Field; provided that notwithstanding the exclusive rights granted to Licensee in the foregoing grant, Licensor shall retain the limited right to use the Licensor Intellectual Property to the extent necessary to perform its express obligations under this Agreement, including the Clinical Development Plan,  to conduct the Licensor Clinical Studies,  subject to the approval of the Joint Steering Committee, and as otherwise agreed to in writing by the Parties.

The exclusivity of the sublicense granted under such Licensor Intellectual Property is subject to the applicable non-exclusivity terms in the another Agreement.

Included with this agreement is also a non-exclusive, non-sublicensable, except to subcontractors as
permitted under this Agreement, solely to permit such subcontractors to perform Licensors assigned responsibilities under the Clinical Development Plan, royalty-free, fully-paid right and license, by Licensee to Licensor under the Licensee Know-How and Licensee Patent Rights, solely to the extent necessary to conduct the activities assigned to Licensor by the Joint Steering Committee under the Clinical Development Plan.

License Property

The licensed property includes:
TRPM-2 Antisense Therapy;
TRPM-2 Antisense Therapy and Combination composition;
TRPM-2 Antisense Therapy Using ai Oligonucleotide Having 2-0-(2- Methoxy)Ethyl Modifications Compound;
Chemo-and radiation-sensitization or cancer by antisense TRPM-2 oligodcoxynucleotides;
Treatment of Melanoma by Reduction in Clusterin Levels;
Clusterin antisense therapy for treatment of cancer;
Treatment of Cancer By Perturbation of Clusterin Levels;
Human Type 2 RNASE H;
Gapped Oligonucleotides, Directed to: Gapmer and Hemimer Compounds with 2-O-ALKYL modifications;
2-O-Modified Nucleosides and Phosphoramidites; and others.

The collaboration agreement is for developing and commercializing OGX-011. OGX-011 is a Phase III cancer therapy designed to inhibit cancer treatment resistance. OGX-011 is expected to be used as adjunct therapy to enhance the effectiveness of chemotherapy and has shown promising results when added to currently available chemotherapies in several tumor types addressing a significant unmet medical need.

Field of Use

The Field means the prevention, diagnosis or treatment of any disease or medical condition in humans.  Specific fields addressed in the patents include prostate cancer cells, human renal cell cancer (RCC) cells and some breast cancer cells.

License Grant

For the Exclusive License,  Licensor grants an exclusive, worldwide license, with the right to sublicense, to Licensor Intellectual Property that relates to a Joint p53-PMO Item, solely in the Licensee Field, to research, develop, make, have made, use, import, put into use, modify, distribute, offer for sale, sell and have sold Licensed Licensor IP Products and to practice Licensed Licensor IP Methods during the term of this Agreement.

For the Semi-Exclusive License, Licensor shall grant a semi-exclusive, worldwide license to Licensor Intellectual Property that relates to a Joint p53-PMO Item, solely in the Joint Field and within the context of such joint development activities with Licensor, to research, develop, make, have made, use, import, put into use, modify, distribute, offer for sale, sell and have sold Licensed Licensor IP Products and to practice Licensed Licensor IP Methods during the term of this Agreement.

License Property

The patents licensed include Antisense Oligonucleotides to p53, and, Methods and compositions for selectively treating cancer cells characterized by p53 expression, and, Therapeutic Oligonucleotides targeting human MDR-! and MRP Genes, and, Methods and compositions for treatment of cancer using Oligonucleotides, and, Methods and Compositions for Cellular Reprogramming.

p53 is a protein.  PMO refers to  phosphorodiamidate morpholino oligomer chemistry.

Antisense drugs targeting p53 is a well-studied human protein that controls cellular response to genetic damage.

Field of Use

Licensees main field of interest in p53-PMO technology is as a potential target for antiviral therapies, and the Parties wish to cooperate in the development and commercialization of therapies using p53-PMO technology in other fields.

License Grant

This letter agreement  memorializes the terms of the settlement of the Lawsuit reached between the Licensor and the Licensee regarding the product custirsen and other antisense inhibitors.

License Property

Product –  custirsen and certain other antisense inhibitors. Antisense therapy is a form of treatment for genetic disorders or infections.

Custirsen is an experimental drug that is designed to block the production of the protein clusterin, which may play a fundamental role in cancer cell survival and treatment resistance. Clusterin is upregulated in tumor cells in response to treatment interventions such as chemotherapy, hormone ablation and radiation therapy and has been found to be overexpressed in a number of cancers, including prostate, lung, breast and bladder. Increased clusterin production has been linked to faster rates of cancer progression, treatment resistance and shorter survival duration

License Grant

The Licensor grants the Licensee an exclusive royalty-bearing, sub-licensable license under the Licensor Technology and sub-license under the UCLA Technology, in each case to research, develop, use, manufacture, have manufactured, sell, offer for sale, commercialize, import, and otherwise exploit Collaboration Molecules and Products in the Field in the Territory.

Subject to the terms and conditions of this Agreement, the Licensee hereby grants the Licensor a non-exclusive, non-sub-licensable solely to permit subcontractors to perform Licensor's assigned responsibilities under any Joint Development Plan, Joint Manufacturing Plan, Joint Medical Affairs Plan or Joint Commercialization Plan, royalty-free, fully-paid license under the Technology, and sub-license under the Licensor Technology and UCLA Technology licensed to the Licensee.

License Property

The Parties desire and intend to collaborate with respect to the Development and Commercialization of Products in the Field in the Territory. Field means the prevention, diagnosis and treatment of all human diseases.

Field of Use

The Global Agreement is to develop and commercialize MDV3100, the Licensor's investigational drug for the treatment of prostate cancer. MDV3100 is currently being evaluated in the Phase 3 AFFIRM clinical trial in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy.

License Grant

Licensor established a drug development collaboration with licensee, a biotechnology company committed to the development of cancer therapeutics for patients with drug resistant and metastatic cancers, to co-develop and commercialize OGX-011, an anti-cancer antisense drug that targets clusterin.  In July 2008, the agreement was amended to which licensee became solely responsible for the costs, development and commercialization of OGX-011.  In exchange, licensee agreed to pay licensor royalties on sales of OGX-011 and to share consideration received from licensing OGX-011 to a third party, except for consideration licensee receives for the fair market value of equity and reimbursement of research and development expenses.

Under the amended Agreement, licensor assigned to licensee rights in the patents claiming the composition and therapeutic methods of using OGX-011 and granted licensee a worldwide, nonexclusive License to know-how and patents covering core antisense technology and manufacturing technology solely for use with OGX-011.  The key product-related patent that was assigned to licensee was U.S. Patent number 6,900,187 having an expiration date of at least 2020; and the key core antisense technology patents that were Licensed are U.S. Patent number 7,919,472 having an expiration date of 2026 and its foreign equivalents pending in Australia, Canada, the European Patent Convention and Japan.  

In December 2009, licensee granted sublicensee the exclusive worldwide right and License to develop and commercialize any products containing OGX-011 and related compounds, with licensee having an option to co-promote OGX-011 in the United States and Canada.

License Property

In August 2003, licensor and licensee entered into a separate collaboration and License Agreement for the development of a second-generation antisense anti-cancer drug, OGX-225.

In January 2005, licensor entered into a further Agreement with OncoGenex to allow for the development of an additional second-generation antisense anti-cancer drug. In April 2005, licensee selected OGX-427 to develop under the collaboration.

Field of Use

The rights granted apply to the medical industry.

License Grant

Licensor grants an exclusive, worldwide, non-transferable, license, with the right to sublicense, under the Licensor Patent Rights and Know-How to make, use, including in activities directed at the research and Development of Licensed Compounds, have made, sell, have sold, offer to sell, export, import and otherwise exploit or Commercialize Licensed Compounds and Licensed Products in the Field in the Territory.

Licensor grants a non-transferable, non-exclusive license, with the right to sublicense, under the Licensor Other Patent Rights solely to the extent reasonably necessary to make, use (including in activities directed at the research and Development of Licensed Compounds), have made, sell, offer to sell, export and import and otherwise exploit or Commercialize Licensed Compounds and Licensed Products in the Field in the Territory.

License Property

MS564929 Toxicology Studies means the two (2) toxicology reports due n the IND covering the BMS compound designated BMS564929, specifically the 6 onth oral toxicology studies in rats and dogs.

6,670,386 – Bicyclic modulators of androgen receptor function

The licensed compounds and patents relate to controlling various diseases and cancers.

Field of Use

The Field means the diagnosis, prevention, treatment or control of any human or animal disease, disorder or condition, excluding the prevention, treatment or control of any human or animal hyperproliferative disease, disorder or condition. For purposes of clarity, hyperproliferative diseases, disorders and conditions are those diseases, disorders or conditions which are characterized by an abnormal increase in the proliferation or accumulation of cells and include conditions such as cancers and benign hyperplasia, but not diseases, disorders or conditions incident to an abnormal increase in the proliferation or accumulation of cells.