Royalty Report: Drugs, Cancer, Therapeutic – Collection: 203384

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.

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 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

Licensor hereby grants to Licensee an exclusive license under the Licensed Patents in the Territory to: make, have made, develop, use, practice, import, export, distribute, market, promote, offer for sale, and sell Licensed Products in the Licensed Field.

Licensor hereby grants to Licensee a non-exclusive license in the Territory under Licensor’s rights in the Know-How to use and practice any method, process, or procedure within the Know-How and otherwise use and exploit the Know-How; all in the Licensed Field; provided however, that with respect to Project Information, such non-exclusive license shall be limited to the Project Information Licensed Field.

License Property

The technology relates to drugs used in the treatment of various cancers.

Licensed Patents means Licensor’s rights in and to: (i) the patent applications described below and all patents anywhere in the world issued thereon; and (ii) all continuations, continuations in part to the extent the claims are directed to subject matter specifically described in such corresponding parent application, divisionals, reexaminations, extensions, and reissue applications thereof, and all foreign applications and patents corresponding thereto, with respect to any of the foregoing applications.

Patent Applications: 61/249,596; 61/423,842; 61/423,825; 61/392,296; 61/423,832; 61/254,395; 61/423,838

Licensed Products means any and all products and processes that contain, employ or are in any way made or produced using, or by the practice of the Licensed Patents, licensed Improvement Inventions, the Technology, or the Know-How.

Project Information means Licensor’s rights in all inventions, data, results, trade secrets, methods, developments, materials, compositions of matter of any type or kind, expertise, formulas, technology and processes, whether patentable or not, arising during and in the course of carrying out those projects described in this agreement, which may be amended from time to time by mutual consent of the Parties.

Licensor Intellectual Property means the Licensed Patents, Technology, Know-How, and any Improvement Inventions licensed or optioned to Licensee pursuant to this Agreement.

Technology means Licensor’s rights in all inventions, data, results, know-how, trade secrets, techniques, methods, developments, ideas, creations, concepts, materials, compositions of matter of any type or kind, expertise, formulas, technology, process, or discoveries, whether patentable or not, directly relating to or involving the use or development, of four lines of drug candidates, namely Revercom, Mobilan, Antimycon and Arkil (as further described in this agreement) during the five years after the Effective Date.

1.
REVERCOM

·
Drug summary: Liposome-packaged combination of proprietary molecule, inhibitor of multidrug resistance transporter, and conventional chemotherapeutic agent.

·
Potential use: adjuvant applied as part of chemotherapy of cancer patients.

2.
MOBILAN

·
Drug summary: Adenovirus-based treatment inducing immune response. Ready for final stage of preclinical development.

·
Potential use: Universal anti-cancer vaccine.

3.
ARKIL

·
Drug summary: Androgen receptor inhibitor, prepared for Hit-2-Lead optimization studies.

·
Potential use: Nanodrugs for treatment of prostate cancer (both hormone (androgen)-dependent and –independent/refractory forms).

4.
ANTIMYCON

·
Drug summary: MYC inhibitor.

·
Potential use: Drugs for treatment of a broad range of solid tumors (breast, prostate, colon, non-small cell lung carcinoma, etc.) and hematological malignancies.

Projects and Licensed Patents
1. Projects

Drug
Definition

Mobilan = Research, development and support of an immunotherapeutic drug candidate based on recombinant adenovirus vector, stimulating immune response in humans as a vaccine-like treatment for cancer or other indications.

Revercom = Research, development, formulation and support of a drug candidate based on proprietary Reversan compound as an adjuvant for chemotherapy.

Antimycon = Research, development, lead optimization, formulation and support of a drug candidate regulating cMyc transcription factor for cancer indications.

Arkil = Research, development, lead optimization, formulation and support of a drug candidate regulating androgen receptor for prostate cancer.

Xenomycin = Research, development, lead optimization, formulation and support of a drug candidates based on proprietary Curaxin family of compounds for anti-infective/anti-biotic/anti-fungal applications.

2. Licensed Patents

Product
Title
Inventors
Country
Application No.
Patent No.

MOBILAN = Use of Toll-Like Receptor and Agonist for Treating Cancer
Andrei Gudkov (RPCI, CBLI)
U.S.
61/249,596
n/a

MOBILAN = Toll-like receptor 5 agonist produced and secreted by mammalian cells
Andrei Gudkov (RPCI), Venkatesh Natarajan (RPCI)
U.S.
61/423,842
n/a

MOBILAN = Functional bacreriophage-based nanoparticles coated by Toll-like receptor 5 agonist
Andrei Gudkov (RPCI, CBLI), Venkatesh Natarajan (RPCI)
U.S.
61/423,825
n/a

ANTIMYCON = Small molecules inhibiting oncoprotein MYC
Andrei Gudkov (RPCI), Catherine Burkhart (CBLI), Mikhail Nikiforov (RPCI), Michelle Haber (CCIA), Murray Norris (CCIA)
U.S.
61/392,296
n/a

ANTIMYCON = Small Molecules Inhibiting Oncoprotein MYC
Andrei Gudkov (RPCI), Catherine Burkhart (CBLI), Mikhail Nikiforov (RPCI), Michelle Haber (CCIA), Murray Norris (CCIA)
U.S.
61/423,832
n/a

ARKIL = Method for treating androgen receptor positive cancers
Katerina Gurova (RPCI), Natalia Narizhneva (CBL)
U.S.
61/254,395
n/a

REVERCOM = Dual cargo nanoparticles combining MRP1 inhibitors with chemotherapeutic drugs
Andrei Gudkov (RPCI, CBLI), Aridam Sen (RPCI), Catherine Burkhart (CBLI), Padmaja Kunapuli (RPCI)
U.S.
61/423,838
n/a

Field of Use

“Application” means the intended use for a Licensed Product, including the diagnosing, treating, curing, mitigating, and/or preventing a disease or other condition in a human or other animal, such as small cell lung cancer, large cell lung cancer, or other specific disease state.

License Grant

Licensor agrees to grant to the United Kingdom Licensee, pursuant to the License Agreement: (i) a non-exclusive royalty-free license to develop the Licensed Product for any Indication under the Licensor Know-how and Licensor Patent as well as (ii) an exclusive, royalty-bearing license to conduct Commercialization Activities, including the right to sublicense, within the Licensee Territory for any Indication under the Licensor Patent, Licensor Know-how and the Licensed Trademark. In accordance with the Parties’ agreement to extend the licensed territory, the Parties agree that the License Agreement related to all Patents and Patent Applications Controlled by Licensor in the European Territory which Cover the Licensed Products shall be amended and incorporated herein by reference, to include all Patents and Patent Applications Controlled by Licensor in the Licensee Territory (the Licensor Patent).

Licensee and Licensor entered into the Original Collaboration and License Agreement which, among other things, provides for certain terms and conditions relating to the conduct of certain development activities for the purpose of obtaining Regulatory Approvals in the United States of America and its territories and possessions (“US”) and in the European Territory for the Initial Products in certain indications, including the ADT Indication and the PIN Indication, for Commercialization Activities by Licensee of the Licensed Product in the European Territory.

Licensee and Licensor have agreed to collaborate in the design of the Additional Phase III Study to gain Regulatory Approvals by the FDA and the EMEA, and to get input from the FDA on the protocol for the Additional Phase III Study to better ascertain the FDA’s commitment that the Additional Phase III Study will be sufficient to support Regulatory Approval in the US, assuming the study achieves the agreed upon efficacy endpoints and the product candidate is determined to be safe.

Licensor has sought from Licensee an Additional Milestone Payment in consideration of additional rights granted hereunder, including but not limited to expanding Licensee’s territory and co-promoting the Licensed Product in the ADT Indication in the US; and Licensee desires to effect payment in respect thereof.

License Property

Licensor Patent shall have the meaning prescribed to it in this First Amendment. For the avoidance of doubt, Licensor Patent, as defined herein, shall supersede the definition of Licensor Patent defined in the License Agreement. The list of the Licensor Patent identified are International Patents.

The Licensed Product shall mean Toremifene 80 mg for the prevention of bone fractures and serious side effects in men with prostate cancer on androgen deprivation therapy (ADT), identified in the License Agreement as being within the scope of the ADT Indication.

Toremifene 20 mg is in an ongoing pivotal Phase III clinical trial for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia (PIN).

Additional Phase III Study – Phase III Clinical Study of toremifene 80mg for the ADT Indication be conducted by Licensor for the obtaining of Regulatory Approval in the ADT Indication in the US.

Toremifene is a selective estrogen receptor modulator, or SERM, developed by GTx as a daily tablet for the treatment of the multiple estrogen related side effects of androgen deprivation therapy for advanced prostate cancer and for the prevention of prostate cancer in high risk patients with High Grade Prostatic Intraepithelial Neoplasia lesions (HGPIN). Toremifene was designed to bind to and selectively modulate estrogen receptors depending on the tissue type.

Field of Use

This agreement pertains to the drug industry in the Field that shall have the meaning relating to the side effects of ADT in men with prostate cancer include among others bone fractures.

The development and commercialization of toremifene 80 mg is for the reduction of fractures in men with advanced prostate cancer on androgen deprivation therapy (ADT) and toremifene 20 mg is for the prevention of prostate cancer in high risk patients with High Grade Prostatic Intraepithelial Neoplasia lesions (HGPIN).

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.

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 granted an exclusive worldwide license, with the right to sublicense, under certain patents and patent applications to make, have made, use, sell, offer to sell and import certain anti-androgen steroids including galeterone. In addition, the Licensor granted a first option to receive an exclusive license to its rights in certain improvements to the licensed products.

License Property

Galeterone, is a highly selective, multi-targeted, oral small molecule drug candidate that is believed to have advantages over existing prostate cancer therapies. Galeterone disrupts the activation of the pathway through multiple mechanisms of action: inhibition of the enzyme CYP17, which blocks the synthesis of testosterone; androgen receptor antagonism, which blocks the binding of testosterone or DHT with the androgen receptor; and androgen receptor degradation, which reduces the amount of androgen receptor protein in the tumor cells. The license includes rights to a U.S. patent covering compositions and methods of use of a class of compounds encompassing galeterone, which expires in 2017.

Field of Use

The Licensee exercised their option and acquired exclusive rights to licensed improvements under three amendments to the license agreement. In March 2009, the license agreement was amended to grant an exclusive license to oral prodrugs of the licensed products. In April 2012, the license agreement was amended to grant an exclusive license to compositions and methods of inducing endoplasmic reticulum stress. In October 2013, the license agreement was amended to grant an exclusive license to a patent application directed to analogs of galeterone that disrupt androgen receptor signaling by degrading the androgen receptor.

The Licensee had administered galeterone to over 250 prostate cancer patients and healthy volunteers in Phase I and Phase II clinical trials. The plans for a Phase III clinical trial are for the first half of 2015.

License Grant

The Parties, one U.S. and the other Japanese, desire and intend to collaborate with respect to the Development and Commercialization of Products in the Field in the Territory.

License Property

Two pharmaceutical companies entered into a global agreement to develop and commercialize MDV3100, a 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.

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.

MDV3100, a new generation of oral anti-androgen, which shows different pharmacological profiles from current anti-androgens, has been shown in preclinical studies to provide more complete suppression of the androgen receptor pathway than bicalutamide, the most commonly used anti-androgen. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions – MDV3100 blocks testosterone binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation), and inhibits binding to DNA. Preclinical data published in Science earlier this year demonstrated that MDV3100 is superior to bicalutamide in each of these three actions.

Field of Use

The rights granted apply to the healthcare industry.

License Grant

The Company obtains an exclusive worldwide license to the Licensed Patents, probasin gene (PG) and to practice, use or sell the Licensed Processes from Canadian University.

License Property

Licensed Patents shall mean all patent applications respecting PG: (a) International PCT Application Serial No. PCT CA 9300319 filed August 9, 1993 entitled DNA Sequences of Rat Probasin Gene; and (b) all patent applications respecting PG which may be filed from time to time by University pursuant to this Agreement.

Field of Use

Field of Use shall mean human gene therapy involving the transfer of genetic material into target mammalian cells in vitro or in vivo for the purpose of intercellular drug delivery and/or treatment of a disease or medical condition.

License Grant

The Licensor grants the right and license to use, develop, manufacture, market, and commercialize the patent rights for technology relating to APP-111.

License Property

APP-111 is a novel oral tubulin targeting chemotherapy for metastatic prostate cancer as well as metastatic breast and ovarian cancers.

Field of Use

Licensee is a privately held therapeutics company focused on the development and commercialization of pharmaceutical and consumer health products for men’s and women’s health and oncology.