Royalty Report: Drugs, Cancer, Therapeutic – Collection: 238982

License Grant

University hereby grants to Licensee an exclusive, worldwide right and license, with the right to grant Sublicenses and to permit Sub-sublicenses to practice under and use the Licensed Patents and the Licensed Technology to make, have made, use, market, sell, have sold, import, distribute, and offer for sale any Licensed Product, Licensed Process or Generic Product. University hereby agrees, subject to the terms and conditions herein contained, that the term 'exclusive' means that University shall not grant any other license to any third party or take any action inconsistent with the rights granted to Licensee under this Agreement relating to the Licensed Patents or Licensed Technology.

License Property

Licensed Patents shall mean the issued patents and the pending patent applications and made a part hereof, and any patents issuing therefrom, and any other patent applications not identified that have been filed or that may in the future be filed by Licensee on the Licensed Technology and any patents issuing therefrom, including any application(s) filed by Licensee, whether in the United States of America or any other country, including any and all substitutions for and divisions, continuations, continuation-in-part, provisionals, and non-provisionals, renewals, reissues, any foreign patent applications and divisionals or national phase applications which claim priority from any of the pending patent applications.

6,265,448 – Method for chemoprevention of prostate cancer
6,413,533 – Method for chemoprevention of prostate cancer
6,413,534 – Method for chemoprevention of prostate cancer
6,410,043 – Method for chemoprevention of prostate cancer
6,413,535 – Method for chemoprevention of prostate cancer

Licensed Product(s) shall mean any product that:
            (I)   is covered in whole or in part by a Valid Claim of the Licensed Patents; or
            (II)  is manufactured by using a process or is employed to practice a process which is covered in whole or in part by a Valid Claim of the Licensed Patents.

Licensed Technology shall mean any technology, trade secrets, methods, processes, know-how, show-how, data, information, or results relating to the patent applications, developed by the Contributors and owned by University, including the chemoprevention of prostate cancer and, more particularly, to a method of administering to a subject an effective dose of a chemopreventive agent or pharmaceutical preparation comprising an anti-estrogen or SERM, including, toremifene and analogs or metabolites thereof, to prevent recurrence of, suppress or inhibit prostate carcinogenesis.

Field of Use

This agreement pertains to the drug industry.

License Grant

The Licensor of Finland grants to Licensee an exclusive right and license, with the right to grant sublicenses under Licensor Patent Rights and Know-How, to develop, use, have used, sell, have sold, import, market and distribute the Product in the Field in the Licensee Territory, except in the Licensor Field in the Licensor Territory; and a non-exclusive right and license, with the right to grant sublicenses, under the Licensor Patents and Know-How, to perform research and preclinical development activities, using the Powder to be provided to Licensor, except in the Licensor Field in the Licensee Territory.

License Property

The Product shall mean any pharmaceutical product for human use within the Field containing Toremifene as a therapeutically active ingredient.

The Fareston Product shall mean the Orion Product in 60 mg tablet form containing Toremifene that was promoted in the USA under the brand name Fareston by Shire prior to the Restatement Date for use in the Breast Cancer Field.

Toremifene shall mean [tore mi f ene citrate and/or the Z-isomer of 4-chloro-1, 2 diphenyl-1-(4-(2-(N,N-dimethylamino)-ethoxy) – phenyl]- 1 -butene].

Field of Use

The field means all uses of a Product in humans, with a current use of treatment of prostate cancer. The Parties expressly acknowledge that the use of Product in the field of animal health is excluded from the scope of this Agreement.

License Grant

The Licensor of Finland grants an exclusive right and license, with the right to grant sublicenses, under Licensor Patent Rights and Know-How, to develop, use, have used, sell, have sold, import, market and distribute the Product in the North American Territory and in Japan in the Field;
– a non-exclusive right and license, with the right to grant sublicenses, under Licensor Patent Rights and
Licensor Know-How, to develop, use, have used, sell, have sold, import, market and distribute the Product in the ROW Territory for exclusive use in the Field;
– a non-exclusive license, under the Licensor Patents and Know-How, to perform research and preclinical development activities using the Powder.

License Property

The product means any pharmaceutical product for human use within the Field containing Toremifene as a therapeutically active ingredient.

Toremifene' shall mean [toremifene citrate and/or 4-chloro-l, 2 diphenyl-1-(4(2-(N,N-dimethylamino)-ethoxyl) – phenyl] -I-butene].

Toremifene is a selective estrogen receptor modulator (SERM) of the triphenylethylene group related to tamoxifen which opposes the actions of estrogens like estradiol in the body and is approved for use in the treatment of advanced (metastatic) breast cancer.

Field of Use

The field means the prevention and treatment of prostate cancer, which shall mean for purposes hereof: preventing prostate carcinogenesis; suppressing or inhibiting prostate cancer; reducing the risk of developing prostate cancer; increasing the survival rate of a subject with prostate cancer; and treating prostate cancer.

License Grant

University grants a worldwide, exclusive license under the Patent Rights to make and have made, to use and have used, and to offer to sell, sell or import, and have offered to sell, sold or imported, the Licensed Products in the Field of Use, and to practice and have practiced the Licensed Processes and Know-How.

University also grants the right to enter into sublicensing agreements under the Patent Rights.

License Property

The University rights are for the Method for Synthesizing Epothilones and Epothilone Analogs and any other U.S. application owned by the University that has Valid Claims covering the manufacture, use, or sale of [trans-9,10-dehydro-epothilon,D].

Epothilones inhibit cell division with a mechanism of action similar to taxanes, one of the most successful classes of anti-tumor agents.

KOS-1584 is our epothilone anticancer clinical candidate that is being evaluated in dose-escalating Phase 1 clinical trials in patients with solid tumors.

Field of Use

The Licensee is developing its epothilone, KOS-1584, in Phase 1 clinical trials and it has shown activity in patients with non-small cell lung, ovarian, breast, pancreatic, prostate and other cancers.

License Grant

University hereby grants to Israel Corporation and Corporation hereby accepts from University the License. License shall mean the exclusive worldwide license to practice University’s share in the University Research Technology (as hereinafter defined) for the development, manufacture, use and sale of the Licensed Products (as hereinafter defined). At the initiative of Corporation or University, the parties shall consult with each other regarding the prosecution of all patent applications with respect to the University Research Technology. University and Corporation shall assist, and cause their respective employees and consultants to assist, each other in assembling inventorship information and data for the filing and prosecution of patent applications on inventions pertaining to the Research Technology. Corporation shall be entitled to grant sublicenses under the License on terms and conditions in compliance and not inconsistent with the terms and conditions of this Agreement (except that the rate of royalty may be at higher rates than those set forth in this Agreement) (i) to a Corporation Entity or (ii) to other third parties for consideration and in an arms-length transaction.

License Property

Licensed Products shall mean all products, drugs, diagnostic reagents, diagnostic methods, therapeutic agents and therapeutic methods covered by a claim of any unexpired University Patents (as hereinafter defined) which has not been disclaimed or held invalid by a court of competent jurisdiction from which no appeal has been or can be taken.

University Research Technology shall mean all University Patents and all University Know-How.

University Patents shall mean all United States and foreign patents and patent applications, and any divisions, continuations, in whole or in part, reissues, renewals and extensions thereof, and pending applications therefor:
(1)  
which claim Pre-Existing Inventions and which are identified hereto; or
(2)  
which claim inventions that are made, in whole or in part, by students or employees of SAMSF during the term and in the course of the Research Project;  
with the exception of all such patents which are Corporation Patents as hereinafter defined.
U.S. Patent Application Serial No. 08/801,301, filed February 18, 1997 entitled Use if Nekatibub To Prevent Cytotoxic effects of Amyloid Protein by Pappolla.
U.S. Provisional Patent Application Serial No. 60/075,555 filed February 23, 1998 entitled Use of 3-Indol-Proprionic acid by Pappolla
U.S. Provisional Patent Application Serial No. 60/079,349 filed March 25, 1998 entitled Inhibition of Alzheimer of Alzheimer Beta-Fibrillogenesis by Mela Tonm by Pappolla.

Corporation Patents shall mean all United States and foreign patents and patent applications, and any divisions, continuations, in whole or in part, reissues, renewals and extensions thereof, and pending applications therefor which claim inventions that are made, in whole or in part, by students or employees of Corporation.

Research Technology shall mean all University Patents, University Know-How, Corporation Patents and Corporation Know-How.

Field of Use

Field shall mean research, development and testing within pharmaceutical, biotechnological and diagnostic development programs in the field of Alzheimer’s Disease and other central nervous system and neurodegenerative diseases, and in the field of all other possible utilities for melatonin analogs.

License Grant

University grant to Licensee, and Licensee hereby accepts, a royalty-bearing, exclusive license under Licensed Subject Matter to make, have made, manufacture, have manufactured, use, import, offer to sell, sell and/or have sold products within Licensed Territory for use within Licensed Field. This grant is subject herein below, the payment by Licensee to University of all consideration as provided herein, and is further subject to the following rights retained by University to:
(a) publish the general scientific findings from research related to Licensed Subject Matter, subject to the terms of Article XI-Confidential Information and Publication; and
(b) use Licensed Subject matter solely for its own internal, non-commercial research, teaching, and other educationally-related purposes; and
(c) request that the Licensee transfer Licensed Subject Matter to academic or research institutions for non-commercial research use or for purposes of collaboration upon terms reasonably acceptable to the Licensee and such third party; provided, however, that Licensee will not unreasonably withhold consent to University’s use of the Licensed Subject Matter in collaborations between University, and/or the National Cancer Institute (NCI).

License Property

Licensed Subject Matter means Patent Rights, Improvements and Technology Rights within Licensed Field.

Patent Rights means University’s rights in information or discoveries described in invention disclosures below or in the subsequent reductions to practice of such information or discoveries (so long as such subsequent reductions to practice are not obligated to a third party), or claimed in any patents, and/or patent applications, whether domestic or foreign, based on such invention disclosures and such reductions to practice (that are not obligated to a third party) and all domestic and foreign divisionals, continuations, continuations-in-part, reissues, reexaminations or extensions thereof, including any foreign counterparts thereto and any letters patent that issue thereon, including but not limited to: (a) Provisional Application entitled, “Compounds and Methods for the Treatment of Cancer” filed July 16, 2004; (b) U.S. Application Serial Number 60/346,492 filed January 7, 2002; (c) WO 2003/057012 filed January 7, 2003; (d) U.S. Application Serial Number 10/337,969 filed January 7, 2003; and (e) national stage filings for MDA01-063 in Europe, Japan, Canada and Australia.

MDA01-063 “New Organic Arsenic Derivatives as a Treatment for Cancer,” Srdan Verstovsek, M.D., Ph.D., Ralph A. Zingaro Ph.D., Emil J. Freireich, M.D., Hatice Duzkale, M.D., Hagop M. Kantarjian, M.D.

MDA04-076 “Arsenic-Lipid Derivatives as a Treatment for Cancer,” Srdan Verstovsek, M.D., Ph.D., Ralph A. Zingaro Ph.D., Hagop M. Kantarjian, M.D., M. Gao

Licensed Products means any product or service that is covered in whole or in part by a valid claim contained in the Patent Rights in the country in which the product is made, used, leased or sold.

Field of Use

Patent applications and related improvements and know-how) are for the manufacture and commercialization of two classes of organic arsenicals (water- and lipid-based) for human and animal use. The class of water-based organic arsenicals includes ZIO-101.

ZIO-101 is an organic arsenic compound covered by an issued U.S. patent and applications internationally. A form of commercially available inorganic arsenic (arsenic trioxide (Trisenox®) or ATO) has been approved for the treatment of acute promyelocytic leukemia (APL), a precancerous condition, and is on the compendia listing for the therapy of multiple myeloma as well as having been studied for the treatment of various other cancers.

License Grant

University hereby grants to Licensee a worldwide sole and exclusive license under the Patent Rights and Know-How to make, have made, use, import, export, offer for sale and sell the Licensed Products.

License Property

Patent Rights shall mean the interest of University in:

(a)
the United States and foreign patents and/or patent applications listed;

(b)
United States and foreign patents issued from the applications listed and from divisionals, continuations and continuations-in-part of these applications;

(c)
claims of U.S. and foreign continuation-in-part applications, and of the resulting patents, which are directed to subject matter specifically described in the U.S. and foreign applications listed; and

(d)
claims of all foreign patent applications, and of the resulting patents, which are directed to subject matter specifically described in the United States patents and/or patent applications described in (a), (b) or (c) above.

6,087,350 – Use of pretreatment chemicals to enhance efficacy of cytotoxic agents
6,559,139 – Combination chemotherapy

Licensed Product shall mean Vitamin D and one or more cytotoxic agents administered or otherwise used or offered for use in a manner which would, but for the license granted herein, infringe one or more of the Patent Rights.

Vitamin D shall mean cholecalciferol, as well as all derivatives and analogs thereof or thereto.

Field of Use

One of the issued U.S. patents claims a method of killing cells such as cancer cells with any vitamin D derivative together with paclitaxel or cyclophosphamide. The second issued patent claims a method of killing neoplastic cells with any vitamin D derivative together with  carboplatin, cisplatin, paclitaxel or Taxotere.

License Grant

The University grants an exclusive, worldwide right and license, with the right to grant Sublicenses and to permit Sub-sublicenses to practice under and use the Licensed Patents and the Licensed Technology to make, have made, use, market, sell, have sold, import, distribute, and offer for sale any Licensed Product, Licensed Process or Generic Product.

License Property

The Licensed Technology shall mean any technology, trade secrets, methods, processes, know-how, show-how, data, information, or results relating to Licensor items developed by the Contributors, and owned by Licensor, including:  agents, compositions, compounds, or analogs or isomers thereof, of nonsteroidal molecules which bind to androgen receptors, including radiolabeled, fluorescent, and radioisotopes incorporated thereto and small molecules of R-bicalutamide, androgen receptor targeting agents, oral testosterone compositions;  methods of making developing, or characterizing such agents, compositions, and composition, compounds; and  any therapeutic, diagnostic, and prognostic methods of use, of such compounds or agents, including but not limited to methods of treating prostate cancer, methods of imaging, or methods related to fertility, contraceptive, andropause and muscle or bone mass uses.

The Licensed Process shall mean any process which is covered in whole or in part by a Valid Claim of the Licensed Patents.

The Licensed Product shall mean any product that is covered in whole or in part by a Valid Claim of the Licensed Patents; or is manufactured by using a process or is employed to practice a process which is covered in whole or in part by a Valid Claim of the Licensed Patents.

Patents relate toremifene for the reduction in the incidence of prostate cancer in men with high grade PIN and its composition of matter and method of use patents and patent applications relating to Andarine, Ostarine and Prostarine.

Prostarine is used for the treatment of benign prostatic hyperplasia; and andromustine, an anticancer product candidate for hormone refractory prostate cancer.

Acapodene is an antineoplastic hormonal agent primarily used in the treatment of advanced breast cancer.

Ostarine is an investigational selective androgen receptor modulator (SARM) developed by GTX, Inc for the treatment of conditions such as muscle wasting and osteoporosis.

Field of Use

Licensee is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics primarily related to the treatment of serious men’s health conditions.

Licensee will be able to use these microRNAs to advance multiple research and development programs targeting new microRNA-based diagnostic tools for a variety of diseases.