Royalty Report: Drugs, Cancer, Disease – Collection: 282944

License Grant

Licensor hereby grants to Licensee and its Affiliates a license under the Licensor Licensed IP to research, develop,  make, have made, use,  sell, offer for sale, import, and export the Products within the Asian Territories, within the Field.  The license granted herein is exclusive within the Asian Territories without any reservation of rights by Licensor, and will remain in effect until this Agreement is terminated in accordance.  For avoidance of doubt, the  foregoing license shall also include the right to practice the Licensor Licensed IP to manufacture Products anywhere in the world.

License Property

Clofarabine is a purine nucleoside antimetabolite which is FDA-approved for treating relapsed or refractory acute lymphoblastic leukaemia (ALL) in children after at least two other types of treatment have failed.

Product shall mean any product, service, test, or information, including Clofarabine, which, but for the license granted herein, would infringe one or more claims of a Licensor Patent or is discovered, developed, manufactured, approved, marketed or sold using Licensor Know-How or used with Licensor Know-How.

Licensor has rights in patents and technical information relating to the development and uses of 2-flouro-2-halo substituted purine nucleosides Clofarabine.

Patent shall mean (i) patent applications filed in any country within the Asian Territories; (ii) all divisional,  continuation (in whole or in part), reissues, substitute applications and extensions with respect to any of the applications described in (i); (iii) all issued or granted patents resulting from any of the applications described  above; and (iv) all issued or granted reissue, re-examination, renewal or extension patents, supplementary protection certificates, and confirmation or registration patents based on any of the patents described in (iii).

Intellectual Property shall mean all inventions, discoveries, know-how, methods, processes, data, information,  technology, research tools, compositions, tangible materials and formulas that are invented, discovered, developed or otherwise generated by or for either party or their respective Affiliates prior to or during the term of this Agreement, and all Intellectual Property Rights therein and thereto anywhere in the world.

Intellectual Property Rights shall mean any and all now known or hereafter existing:  (i) rights associated with works of authorship, including exclusive exploitation rights, copyrights, and moral rights; (ii) trademark and trade name rights and similar rights; (iii) trade secret rights; (iv) patents and industrial property rights; (v) other  proprietary rights in Intellectual Property of every kind and nature, whether arising by operation of law, by contract or license, or otherwise; and (vi) all registrations, applications, renewals, extensions, combinations,  divisions, or reissues of the foregoing, in each case in any jurisdiction throughout the Asian Territories.

Field of Use

Clofarabine has been shown to be effective in vitro and in vivo against hematologic malignancies and solid tumors, as well as potentially effective for various other therapeutic indications such as autoimmune diseases and transplantation immunity.

License Grant

Licensor hereby grants to the Dutch Licensee, and Licensee hereby accepts from Licensor, a sole and exclusive and royalty bearing license, with the right to sublicense, in the Territory, under the Technology Rights during the Term of this Agreement, to research, develop, make, have made, use, import, export, market and sell Products and to practice and have practiced Processes, without any limitations except for those limitations expressly set forth herein.

License Property

Core Business means the core business of Licensor i.e. antiviral and anticancer drug discovery, development, and commercialization.

Products mean any composition(s), compound(s), product(s), apparatus or Material(s) of which its research, development, manufacture, use, sale, supply or other disposition is covered by, incorporates or utilizes the Technology Rights and which could not be conceived, developed or reduced to practice but for the use of the Technology Rights.

Processes mean any process of which its research, development, manufacture, use, sale, supply, service testing or other disposition is covered by, incorporates or utilizes the Technology Rights.

Technology Rights means one or more of Materials, Know How and Patent Rights.

Patent Rights means (i) the Patents listed and (ii) any Patents based on any of the Patents listed, and (iii) any other Patents that would be infringed by or useful for the manufacture, use, sale, offer for sale or import of a Product or Process and that are owned by Licensor or any of its Affiliates, as of the Effective Date or at any time during the term of this Agreement and (iv) any Patents that would be infringed by or useful for the manufacture, use, sale, offer for sale or import of a Product or Process and that are licensed to Licensor as of the Effective Date or at any time during the term of this Agreement. Patents Rights will include any reissues, confirmations, renewals, extensions, counterparts, divisions, continuations, continuations-in-part, supplemental protection certificates or utility models relating to the patents or patent applications described or referred to herein. It is expressly understood that Patent Rights exclude Licensee Background Patents and Improvements.

Licensor’s patent application, now published as WO 02/33128 and entitled, “Simultaneous quantification of nucleic acids in diseased cells,” and all divisionals, continuations, continuations-in-part, reissues, substitutions, confirmations, updates, registrations, revalidations, reexaminations, renewals, extensions or the like of any such patents and patent applications, to the extent that they relate to the mitochondrial toxicity technology.

Know how means the information, inventions and data (including, but not limited to, formulae, procedures, processes, protocols, techniques and results of experimentation and testing) concerning the Technology Rights owned or licensed by Licensor or any of its Affiliates as of the Effective Date or at any time during the term of this Agreement and that are useful for the research and/or development and/or manufacture and/or use of the Product or Processes, excluding Patent Rights therein.

Material means any and all materials, compositions, products and biologicals owned or licensed by Licensor or any of its Affiliates as of the Effective Date or at any time during the term of this Agreement and that are useful for the research and/or development and/or manufacture and/or use of the Product or Process, and any and all intellectual property rights therein, excluding Patent Rights.

Field of Use

The license is to further develop and commercialize Licensor's (anticancer and antiviral drug discovery) mitochondrial DNA and RNA detection and toxicity technology.

License Grant

Licensor hereby grants to Licensee and Licensee hereby accepts from Licensor, subject to the terms, conditions and restrictions of this agreement, the exclusive, worldwide right and sublicenseable license under the Licensor Intellectual Property rights, until the end of the term for which the Licensor Patent rights are granted, unless this agreement shall be sooner terminated according to the terms hereinafter provided to:
(a)  develop, make, have made, import, use, lease, offer for sale, sell, and distribute Licensed Products;
(b)  develop, make, have made, import, use, lease, offer for sale, sell, and distribute Licensed Processes
(c)  develop, make, have made, perform, provide, import, use, lease, offer for sale, sell, and distribute Licensed Services; and/or
(d)  practice and use the Licensor Intellectual Property rights, other than Licensor Patent rights, and to use the Licensor materials, insofar as such practice and use is required to carry out the activities under subsections (a)-(c) above.

License Property

The Intellectual Property rights relating to technology which enhances human weight loss associated with the use of certain therapeutics.

Licensed Product means any product or part thereof containing mirtazapine or setiptiline in any form, (including, without limitation, any and all enantiomers, analogs, derivatives and salts thereof) used in combination with one or more active ingredients, which:
(a)  is covered in whole or in part by any valid claim contained in the Licensor Patent rights in the country in which any such product or part thereof is made, used or sold; and/or
(b)  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 contained in the Licensor Patent rights in the country in which any Licensed Process is used or in which such product or part thereof is used or sold; and/or
(c)  in its intended use, practices, incorporates, or otherwise utilizes, in whole, or in part, a valid claim contained in the Licensor Patent rights in the country in which any such product or part thereof is made, used, or sold.

Licensed Products shall also mean, unless the context otherwise clearly requires, the following terms, collectively: Licensed Products, Licensed Processes, and Licensed Services, and a Licensed Process and Licensed Service shall be included within such term notwithstanding such process or service is not literally a physical product.

Licensed Process means any process which is covered in whole or in part by a valid claim contained in the Licensor Patent rights and is used, performed or practiced with respect to any Licensed product.

Licensor Patent Rights (Duke Patents)
Serial No. 60/535,799 – Method of reducing weight gain risk associated with antidepressant therapy.
Serial No. 60/567,896 – Compositions for affecting weight loss.
Serial No. 60/616,393 – Compositions of an anticonvulsant and an antipsychotic drug and methods of using the same for affecting weight loss.

Licensed Service means any service provided by Licensee (and/or sublicensees, as the case may be) to a third party which utilizes Licensed Products and/or Licensed processes.

Intellectual Property Rights means any and all Licensor patent rights, pre-collaboration Licensor Intellectual Property, collaboration Licensor Intellectual Property, and Licensor rights in or to collaboration joint Intellectual Property.

Patent Rights means:
(a)  the Duke Patent Rights; and
(b)  any and all patents, patent applications and rights to file any patent applications with respect to any Collaboration Licensor Intellectual Property, together with all divisions, continuations, continuations-in-part (but only to the extent that the subject matter of each such continuation-in-part application is described in and enabled by the disclosure of any such patent applications), re-examinations, reissues, substitutions, or extensions thereof and patents issuing from any such patent applications in the United States and non-U.S. jurisdictions; and or
(c)  Licensor rights in or to all patents, patent applications and rights to file any patent applications with respect to any Collaboration Intellectual Property, together with all divisions, continuations, continuations-in-part (but only to the extent that the subject matter of each such continuation-in-part application is described in and enabled by the disclosure of any such patent applications), re-examinations, reissues, substitutions, or extensions thereof and patents issuing from any such patent applications in the United States and non-U.S. jurisdictions.

Licensor Materials means any proprietary materials provided by Licensor to Licensee.

Intellectual Property means all intellectual property rights worldwide arising under statutory or common law, and whether or not perfected, including, without limitation, all (A) patents and patent applications now existing or hereafter filed, issued or acquired, together with all divisions, continuations, continuations-in-part (but only to the extent that the subject matter of each such continuation-in-part application is described in and enabled by the disclosure of any such patent application), re-examinations, reissues, substitutions, or extensions thereof and patents issuing therefrom in the United States and non-U.S. jurisdictions; (B) rights associated with works of authorship including copyrights, copyright applications and copyright registrations; and (C) rights relating to the protection of trade secrets, know-how and confidential information.

Field of Use

The technology sublicensed relates to the use of zonisamide with either of two specified therapeutics: mirtazapine and setipiline.

One of the specified uses under the agreement is development program for obstructive sleep apnea.

License Grant

The Canadian Institutions grant to Company an exclusive, royalty-bearing license, with the further right to grant sublicenses, in any and all of their rights in and to the Licensed Technology to commercialize said Licensed Technology for the Field in the Territory, which includes the right to research, develop, manufacture, have manufactured, use, have used, sell or have sold, offer for sale, import and export Product(s) and Service(s) (the License).

License Property

The Licensed Patents relate to methods and compounds for the modulation of the SIRPa-CD47 interaction for therapeutic cancer applications.

Licensed Patents means the patents and patent applications further described and listed:
US13/320,629
United States
Utility
Patent – pending

Licensed Technology means: (i) the Licensed Patents, (ii) the Institutions Research Program IP, and (iii) all of the right, title and interest of each of the Institutions in the Joint Research Program IP, all as further described and listed in this agreement (as amended).

Product means any product the manufacture, sale or use of which either (a) exploits Licensed Technology, or (b) would, but for the License, infringe a Valid Claim.

Intellectual Property or “IP” mean inventions (whether patentable or unpatentable), discoveries, written material, compounds, information, know-how, trade secrets, copyright, designs, plant breeders’ rights, integrated circuit topographies, ideas (including but not limited to any computer software), formulae, algorithms, concepts, proprietary data, techniques, instructions, processes, expert opinions, information, materials, program listings, flow charts, logic diagrams, manuals, specifications, instructions, or any copies of the foregoing in any medium, or the expression thereof.

Intellectual Property Rights or “IP Rights” means any rights in Intellectual Property which a Party owns or is seeking to own, including any regular or provisional patent applications filed in the U.S., Canada or any other jurisdiction, and any divisions, continuations, patents issuing thereon or renewals, or reissues, or extensions and any and all patents and patent applications in other countries corresponding thereto, for the Licensed Technology.

Research Program(s) means the sponsored research relating to the research and development of methods and compounds for the modulation of the SIRPa-CD47 interaction for therapeutic cancer applications undertaken by one or both of the Institutions under the SRA #2, SRA #3, SRA #4 and SRA #5A, SRA #5B, and the Collaboration Agreement.

Field of Use

Field means use in, and applications for, therapeutic cancer applications.

License Grant

Licensor hereby grants to Licensee, and Licensee hereby accepts, an exclusive, irrevocable, perpetual, license, with the right to grant sublicenses, under the Assigned Technology to Develop, Manufacture, Commercialize, make, have made, use, have used, offer for sale, sell, have sold and import Covered Products in the Licensee Field in the Territory.

Assignment; License-Back.  Licensee hereby assigns, transfers, conveys and delivers to Licensor, and Licensor hereby accepts all and every right, title and interest of Licensee in and to the Licensee Patent Rights listed, together with all ancillary rights thereto, including the right to sue for damages by reason of past infringement of any such rights; and the Licensee Intellectual Property owned by Licensee that relates directly to such Licensee Patent Rights (collectively, the Assigned Technology).

License Property

Intellectual property relates to superentolimod product candidate and entolimod vaccine product candidate.

Covered Product(s) means any product the Development, Manufacture, use or sale of which is covered by the Licensee Patent Rights or makes use of any Licensee Intellectual Property.

Patent Rights means any and all (a) issued patents and (b) pending patent applications, including all provisional applications, substitutions, divisionals, continuations, continuations-in-part, renewals, and all letters of patent granted with respect to any of the foregoing, (c) patents of addition, restorations, reissues, extensions, supplementary protection certificates, registration or confirmation patents, patents resulting from post-grant proceedings, re-examinations; (d) inventor’s certificates; and (e) other forms of government issued rights substantially similar to any of foregoing, in each any country in the Territory.

Licensee Intellectual Property means Know-How that is Controlled by Licensee or its Affiliates during the term of this Agreement and that is reasonably necessary or useful for or directly related to the Development, Manufacture or Commercialization of the Covered Products. The term Licensee Intellectual Property does not include (a) any Know-How, which is, as of the Effective Date or later becomes, generally available to the public, excluding Licensee Confidential Information or Know-How Controlled by Licensee or its Affiliates that is publicly disclosed by a Third Party without the consent of Licensee, and Know-How included in Licensee Patent Rights

Licensee Patent Rights means those Patent Rights that Cover Licensee Intellectual Property and are Controlled by Licensee or its Affiliates at any time during the term of this Agreement.  Licensee Patent Rights as of the Effective Date are listed which shall be updated in writing from time to time, at least annually, during the term of this Agreement.

Title: Flagellin compositions
Jurisdiction: USA
Application Detials: 15/329,870, Filing Date: 07-29-2015, Priority Date: 07-30-2014
Patent Details: N/A
Status: Pending

Title:  Flagellin compositions and uses including effective vaccination
Jurisdiction:  USA
Application Details:  15/500,133, Filing Date: 07-30-2015, Priority Date: 07-30-2014
Patent Details:  N/A
Status:  Pending

Field of Use

Licensor Field means the prevention or treatment of any disease or condition in humans that is caused by the recent exposure to ionizing radiation including mitigation and prevention of Acute Radiation Syndrome (as defined by the Center for Disease Control and Prevention) and concurrent radiation treatment of humans or animals diagnosed with oncological conditions at the time of treatment to treat this condition. For the avoidance of doubt, it is understood and agreed that the Licensee Field shall not include (i) prevention or treatment of sickness, diseases, disorders, and frailties caused by prior exposure to radiation treatment of cancer, and (ii) prevention or treatment of any disease, disorder or frailty in humans that are “cancer survivors” (i.e., persons who has completed initial cancer management and has no apparent evidence of active disease).

License Grant

Licensor hereby grants to Licensee and its Affiliates an exclusive license, with the right to sublicense, under the Licensor Technology to make, have made, use, sell, offer for sale, import, and export Products in the Field in the Territory.

License Property

Licensor has developed and owns or controls certain intellectual property rights with respect to a controlled release formulation of anagrelide.

Licensor Patents means (a) those Patents set forth hereto (the Initial Licensor Patents); (b) any other Patents owned, licensed, or controlled by Licensor or any Affiliate thereof, or subject to an obligation of assignment to Licensor or any Affiliate thereof, Covering or relating to any portion of the Technology; (c) any additions, divisionals, continuations, continuations-in-part, conversion, supplemental examinations, extensions, term restorations, registrations, re-instatements, amendments, reissuances, corrections, substitutions, re-examinations, registrations, revalidations, supplementary protection certificates, renewals, and foreign counterparts of the Initial Licensor Patents or the Patents described in (b) above, and any other Patents owned, controlled, or licensed by Licensor claiming priority to any of the foregoing or any of the Patents referenced in clause (a) or (b) above; and (d) all patents issuing from any of the Patents mentioned in clause (a), (b), or (c) above and any foreign counterparts of any such Patents, and which shall include, in any case, patents surviving post grant review and inter partes review.

US patent 6,585,995  Methods and compositions for treating platelet-related disorders
US Patent Application 20130022671

Product means a product that is Covered by one or more Licensor Patents in any country in which such product or any part thereof is made, used, or sold.

Licensor Technology means the Licensor Know-How and the Licensor Patents.

Patent(s) means any granted or issued patents and pending patent applications, together with all additions, divisionals, continuations, continuations-in-part, substitutions, reissues, re-examinations, supplemental examinations, patents reviewed under post grant review or inter partes review, extensions, registrations, patent term extensions, revalidations, supplementary protection certificates, and renewals of any of the foregoing, and all foreign applications and patents corresponding to or claiming priority from any of the foregoing.

Field of Use

GALE-401 contains the active ingredient anagrelide, an FDA-approved product, which has been in use since the late 1990s for the treatment of essential thrombocythemia (ET).

Essential thrombocythemia (ET) is a rare chronic blood cancer (myeloproliferative neoplasm) characterised by the overproduction of platelets (thrombocytes) by megakaryocytes in the bone marrow.

Cardiovascular Field means the direct prevention, treatment, diagnosis of myocardial infarction, strokes and peripheral arterial disease in humans or other animals. For sake of clarity the Cardiovascular Field will not include the prevention, treatment or diagnosis of conditions that may ultimately lead to a decrease in the risk of thrombotic events, such as Myeloproliferative Disorders and other hematological indications.

License Grant

The Licensor sublicensed the right to manufacture, market and distribute Clofarabine in the U.S. and Canada with respect to human cancer applications.

License Property

In 2004, Clofarabine was in pivotal Phase II Clinical Trials for the treatment of pediatric acute leukemias.  Clofarabine is also in Clinical Trials in a range of hematological cancers solid tumors.

Field of Use

Clofarabine is a purine nucleoside analogue, or a small molecule, which, is believed to be effective in the treatment of leukemia. Clofarabine may also be an effective agent to treat patients with solid tumor cancers.

License Grant

Licensor hereby grants Licensee, including Licensees Affiliates a royalty-bearing, Territory-wide license in the Licensed Field under the Patent Rights to the Licensed Technology, as well as under the Licensed Patents, the Licensed Know-how, and the Licensed Technology, regardless of whether such Licensed Patents are actually granted, to use the Licensed Know-how and Licensed Technology and to develop and have developed, make and have made, use and have used, sell and have sold, offer for sale and have offered for sale, import and have imported, export and have exported, any and all inventions claimed in the Licensed Patents related to the Licensed Products and/or any compounds, chemicals, substrates, devices, tools, dies, molds or any other materials whatsoever that are useful in the development and/or manufacturing and/or sale of the Licensed Products, and particularly including, without limitation, such license to develop and have developed, make and have made, use and have used, sell and have sold, offer for sale and have offered for sale, import and have imported, export and have exported Licensed Products, which license shall be exclusive even as to Licensor, permitted to seek funding for the development of the Licensed Product and the right to grant bona fide sublicenses to third parties.

License Property

Licensed Products shall mean any and all products, (including any and all) doses, strengths, formulations, compositions and methods thereof containing cannabinoids alone or in combination with various other active pharmaceutical ingredients and/or excipients for use in the Licensed Field utilizing the Licensed Technology.

Licensed Patents shall mean any and all rights arising out of or resulting from (i) the patents and patent application set forth in this Agreement, as well as any additional patents or patent applications related to any aspect of any Licensed Technology Improvements, Licensed Know-how, Licensed Products, and/or Licensed Technology (as herein defined) filed prior to or during the term of this Agreement and (ii) any letters patent granted in respect of all such applications, as well as, without limitation, any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, re-examinations, extensions, supplementary protection certificates, confirmations, registrations, revalidations and the like, of any and all such patents and patent applications and any international equivalents thereof.

Country                          Status                     Application #         Filing Date              Publication #                Publication Date
United States

Published

14/649,951

05-Jun-2015

2015-0313868

05-Nov-2015
United States

Expired
        
61/738,782

18-Dec-2012

Licensed Technology shall mean the aggregate of the Licensed Inventions, the Licensed Know-how, the Licensed Products and the Licensed Patents and any other information and/or technology related to the Licensed Products and/or the design and/or the manufacturing of the Licensed Products.

Licensed Inventions shall mean the inventions claimed in the Licensed Patents.

Field of Use

Licensed Field the use of cannabinoids alone or in combination with various other active pharmaceutical ingredients and/or excipients (i) as preventative and therapeutic neuroprotectives against nerve agents and pesticides and (ii) for the treatment of diseases for a variety of therapeutic categories.

The licensed intellectual property includes patent applications relating to the use of cannabinoid receptor modulators and terpenes in the acute treatment during exposure to organophosphorus nerve agents and/or organophosphorus insecticides.

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

The Institute of Australia hereby grants to Licensee an exclusive license under the Licensed Patents and the Know-How in the Territory and within the Licensed Field to (a) make, have made, develop, use, practice, import, export, distribute, market, promote, offer for sale, and sell the Licensed Products, (b) use and practice any method, process, or procedure within the Licensed Patents, and (c) otherwise use and exploit the Licensed Patents.

The Institute hereby grants to Licensor an exclusive option to exclusively license any and all Improvement Inventions and Non-Improvement Inventions (the Option).

License Property

Licensed Patent shall mean any and all 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.
U.S. Patent Application #61/392,296 – Small Molecules Inhibiting Oncoprotein MYC
U.S. Patent Application #61/423,832 – Small Molecules inhibiting Oncoprotein MYC

Licensed Product shall mean any and all products that employ or are in any way contains or is made or produced using, or by the practice of the Licensed Patents, licensed Improvement Inventions, the Technology, or the Know-How, including the drug candidates set forth.
ANTIMYCON
· Drug summary: MYC inhibitor.
· Indications: Drugs for treatment of a broad range of solid tumors (breast, prostate, colon, non-small cell lung carcinoma, etc.) and hematological malignancies (various types of leukemia and lymphoma).
· Mechanism of action: CBLC-M compounds were generated to selectively target and inactivate oncoproteins of the Myc family, which are frequently upregulated in tumor cells. Although Myc has long been recognized as a highly attractive target for anti-cancer treatment, there are no experimental
or approved drugs targeting this transcription factor. CBLC-M compounds target Myc family proteins with a high degree of specificity and cause their selective degradation. This mechanism of action is translated into both a direct tumor-suppressive effect and increased susceptibility of tumor cells to conventional chemotherapeutic drugs. Combining CBLC-M with such drugs as doxorubicin, 5FU, irinotecan and others within composite nanoparticles will result in improved anti-tumor effects due to precise targeted drug delivery that will concentrate the synergistic effects of the combined compounds on the tumor cells while reducing toxicity to normal cells.

Option Products shall mean Licensed Products and any and all products that employ or are in any way contained or made or produced using, or by the practice of the Projects set forth.

Improvement Invention shall mean any Institute Invention and Institute’s rights as a joint owner in a Joint Invention that is sufficiently different from the scope of a Licensed Patent to be separately patentable, and covered by the claims of Licensed Patents.
Non-Improvement Invention shall mean any Institute Invention and Institute’s rights as a joint owner in a Joint Invention that is not an Improvement Invention.

Field of Use

The rights granted apply to the healthcare industry.  Licensed Field shall mean all fields of use.

License Grant

Licensor hereby grant to Licensee an exclusive (even to Licensor), royalty-bearing, freely sublicenseable license in the Territory under the Licensed Patents and Information for  all purposes, including without limitation, to develop, use, make, have made, import, have imported, export, have exported, offer for sale, have sold and sell Licensed Products.

License Property

Licensed Product means a product that utilizes or incorporates a Valid Claim for the therapeutic treatment of a specific fibrotic human disease, which product has been approved after the Effective Date for the therapeutic treatment of such specific fibrotic human disese by the United States Food and Drug Administration (FDA) and/or any Regulatory Agenciies through the granting of a New Drug Application (NDA) or equivalent foreign approval document.

Licensed Patents means that certain U.S. Patent No. 5,310,562; and all corresponding foreign patent applications and patents throughout the Territory, including any and all divisions, re-issues, re-examinations, renewals, continuations and substitutes in whole or in part of such patents and patent applications in the Territory with respect to the anti-fibrotic  uses of Pirfenidone; and all Patents defined. The Licensed Patents shall specifically exclude U.S. Patent No. 5,962,478 titled Tumor Necrosis Factor Alpha.
5,310,562 – Composition and method for reparation and prevention of fibrotic lesions

Patents means all of Licensors (a) anti-fibrotic, Pirfenidone patent applications heretofore or hereafter filed or having legal force in any country including without limitation divisionals, continuations, continuation-in-part and provisional applications; (b) issued, unexpired anti-fibrotic Pirfenidone patents in any country, including utility, model and design patents and certificates of invention; and (c) substitutions, extensions, reissues, renewals, and supplementary protection certificates with respect to any such issued patents. For clarity, such patent applications and patents shall include those owned, as well as those controlled with the right to grant licenses, by any of Licensors. The Patents shall not include patent applications and patents to the extent claiming uses of Pirfenidone other than for anti-fibrotic uses, nor uses of compounds for anti-fibrotic applications other than Pirfenidone.

Field of Use

This agreement pertains to the drug industry relating to products potentially useful in the prevention, mitigation and treatment of fibrotic and other diseases.

Fibrosis, also known as Fibrotic scarring, is a pathological wound healing in which connective tissue replaces normal parenchymal tissue to the extent that goes unchecked, leading to considerable tissue remodelling and the formation of permanent scar tissue.

License Grant

The English Licensor hereby grants to Licensee and Licensee hereby accepts for the term of this License Agreement the non-transferable, exclusive, royalty-bearing license under Licensed Patents in the Field of Use to make, have made, use, lease, sell and otherwise dispose of Licensed Products in the Licensed Territory.

Licensor hereby grants to Licensee and Licensee hereby accepts for the term of this Agreement the non-transferable, exclusive, royalty-bearing license to use the Licensed Knowhow the Field of Use to make, have made, use, lease, sell and otherwise dispose of Licensed Products in the Licensed Territory.

License Property

The patents relate to pyridyl-steroid synthesis.

Licensed Product means any product made, sold, or otherwise disposed of by or on behalf of Licensee which: (i) falls within the scope of, or utilizes any method or process that falls within the scope of, the Licensed Patents; or (ii) incorporates, or is itself, the invention which is the subject of the Licensed Patents; or (iii) embodies or uses, or the design, manufacture, production or sale of which embodies or uses, any of the Licensed Knowhow.

Licensed Patents means: (i) the patents and patent applications (and any patents issuing therefrom) listed and all foreign counterpart patents and patent applications; (ii) all continuation, divisional, extension, reissue patents and reexamination certificates granted thereon, including Supplementary Protection Certificates; and (iii) patents and patent applications (and any patents issuing therefrom) that may hereafter be filed by Licensor relating or pertaining to any Licensed Knowhow, together with all continuations, divisional, extension, reissue patents and reexamination certificates granted thereon, including Supplementary Protection Certificates.

Licensee Technology means all inventions, ideas, conceptions or reductions-to-practice, patentable or not, information, works and data that are generated, identified, discovered, created, made or controlled by Licensee, its employees or a third party on behalf of Licensee, relating to the Licensed Product or its production, including, without limitation, technical data, knowhow, chemical compounds, biological material, reports, manufacturing processes, formulations, modes of delivery and methods of use, pre-clinical and clinical data, documentation relating to regulatory submissions and marketing authorizations (including any Investigational New Drug Applications, New Drug Applications and equivalent documents), and post-registration clinical trial information and data relating to the Licensed Products.

Licensed Knowhow means all trade secrets, inventions, confidential or proprietary information and data: (i) that is disclosed to Licensee by or at the direction of Licensor or Licensor’s assignor; (ii) that is owned by or licensed to Licensor or Licensor’s assignor at the time of such disclosure; and (iii) that relates to the inventions that are the subject matter of the Licensed Patents. Licensed Knowhow includes, without limitation, technical data, knowhow, chemical compounds, biological material, reports, manufacturing processes, formulations, modes of delivery and methods of use, pre-clinical and clinical data, documentation relating to regulatory submissions and marketing authorizations (including any Investigational New Drug Applications, New Drug Applications and equivalent documents), and post-registration clinical trial information and data relating to the Licensed Products.

Field of Use

Field of Use shall mean any therapeutic use that is intended to prevent, treat, ameliorate or cure a human disease, pathology or condition.

Licensee's goal is to perfonn clinical trials of abiraterone acetate that will support its indication as a second line therapy for patients with metastatic prostate cancer that has progressed following treatment with hormonal therapy that includes an LHRH agonist/antagonist and antiandrogen therapy.

License Grant

The Canadian Licensor hereby grants to Licensee and Licensee hereby accepts an exclusive sublicense under the Technology to make, have made, use, sell, offer for sale, sublicense, distribute, import, and have imported Product in the Licensee Field in the Territory.

License Property

Technology means the Patent(s) and any and all knowledge, know-how and/or technique or techniques invented, developed and/or acquired, being invented, developed and/or acquired by the University solely or jointly with Licensor relating to the Patent(s) as listed hereto, as amended from time to time, including, without limitation, all research, data, specifications, instructions, manuals, papers or other materials of any nature whatsoever, whether written or otherwise, relating to same.

US Patent Number 5,837,282 – Ionophore-Mediated Liposome Loading

Product means any one or more of Sphingosomal Vinorelbine and Sphingosomal Topotecan.

Sphingosomal Vinorelbine means a liposome that includes sphingomyelin and cholesterol and contains encapsulated vinorelbine, wherein the sphingomyelin comprises less than 20% dihydrosphingomyelin.

Sphingosomal Topotecan means a liposome that includes sphingomyelin and cholesterol and contains encapsulated topotecan, wherein the sphingomyelin comprises less than 20% dihydrosphingomyelin.

Intellectual Property Rights means all intellectual property rights subject to protection by intellectual property laws in any country of the world, arising under statutory or common law, contract, or otherwise, and whether or not perfected, including without limitation, all (a) patents, reissues of and re-examined patents, and patent applications, whenever filed and wherever issued, including without limitation, continuations, continuations-in-part, substitutes and divisions of such applications and all priority rights resulting from such applications; (b) rights associated with works of authorship including without limitation copyrights, moral rights, copyright applications, copyright registrations, synchronization rights, mask work rights, mask work applications, mask work registrations; (c) rights associated with trademarks, service marks, trade names, logos, trade dress, goodwill and the applications for registration and registrations thereof; (d) rights relating to the protection of trade secrets and confidential information; (e) rights analogous to those set forth in this Section and any and all other proprietary rights relating to intangible property; and (f) divisions, continuations, renewals, reissues and extensions of the foregoing (as and to the extent applicable) now existing, hereafter filed, issued or acquired.

Field of Use

Marqibo (sphingosomal vincristine), INX-0125 (sphingosomal vinorelbine) and INX-0076 (sphingosomal topotecan) are proprietary drugs using INEX's proprietary sphingosomal drug delivery technology. This technology is designed to provide prolonged blood circulation, tumor accumulation and extended drug release at the cancer site. These characteristics are intended to increase the effectiveness while reducing the side effects of the encapsulated drug.
Marqibo has completed phase 2 clinical trials and is ready to enter phase 3 clinical trials in first-line aggressive non-Hodgkin's lymphoma and acute lymphoblastic leukemia. An Investigational New Drug (IND) application has been approved for the commencement of phase 1 clinical trials for INX-0125 in both the US and Canada and preclinical development is being completed for INX-0076.

License Grant

The Company hereby grants to the Licensee of the United Kingdom an exclusive license to make, have made, use and sell Product(s). Invention means patented and unpatented, patentable and un-patentable, proprietary technology related to a 2’-fluoro-2-halo substituted purine nucleoside (hereafter Technology) developed by or on behalf of SRI, that is (i) related to human health applications of the Technology or (ii) necessary for the practice of Technology for human health applications as disclosed and claimed in the Patent(s).

License Property

The agreement is to co-develop the purine-based nucleoside technology that may be effective in the treatment of leukemia and lymphoma.  The lead compound of such purine-based nucleosides is known as clofarabine.

The Product(s) are Drugs effective against hematologic malignancies and solid tumors as well as other therapeutic indications, such as (but not exclusively) skin disorders and transplantation immunity. All modes of administration, particularly oral and iv., are included in these terms as are specialized formulations such as those imparting controlled-release characteristics.

Field of Use

The rights granted apply to the healthcare industry.