Royalty Report: Drugs, Cancer, Therapeutic – Collection: 202789

License Grant

Pursuant to prior agreements between Licensor and a University, and Licensor and a third party for the technology development, the Licensor has the right to sublicense the technology to the Licensee.  Licensor grants to the Licensee the identical terms that it receives, and this amendment identifies the royalty rate and patent application information and expands the field of use to exclusive and include sales.

In the original sublicense agreement Sublicensor grants to Sublicensee a non-exclusive, perpetual, non-cancellable sublicense to manufacture, have manufactured, use and research Licensed Products and to otherwise exploit Licensed Technology, but only for research purposes and not for commercial use, in the Field throughout the Territory, including the right to grant further sublicenses, it being intended that the sublicense herein granted covers all rights of Sublicensor in the Licensed Subject Matter in the Field and in the Territory.

The original License the University grants to this agreement Licensor, an exclusive license to manufacture, have manufactured, use and/or sell the Licensed Produces, to practice any method, process or procedure and to otherwise exploit the Licensed Subject Matter, within the Licensed Territory for use within the field.

License Property

The technology is U.S. Provisional Patent Application No. 61/512,244 TUSC2 Therapies for Cancer; Methods of predicting a response to a TUSC2 (also known as FUS1) therapy, improved constructs of TUSC2 preparations including use of a “mini-CMV promoter” and TUSC2 therapy combined with EGFR TKI drugs,  UTSC.P1085US.

The original agreement license property is:
Patent and technology rights for U.S. and Foreign Patent Application entitled:
•Methods and Compositions for the Selective Inhibition of Gene Expression
•Australia Serial No. 15704/92; Canada Serial No. 2108144; European Serial No. 92908663-5; and
•Methods and Compositions for Retroviral Vector Mediated Transduction, Continuation-in-part U.S. Serial No. 960513; and
•Methods and Compositions for the Selective Inhibition of Gene Expression, Continuation-in-part U.S. Serial No. 987235; and
•Recombinant p53 Adenovirus Methods and Compositions, Continuation-in-part U.S. Serial No. 145826;
•An Adenovirus Supervector System, Continuation-in-part patent has not been filed yet; and
•Recombinant p53 Adenovirus Methods and Compositions, U.S. Serial No. 224232; and
•Methods and Compositions Comprising DNA Damaging Agents and p53, Continuation-in-part patent has not been filed yet; and
•Use of Lectins for the Delivery and Translocation of Genetic Material Across Cell Membranes, patent has not filed yet; and
•Reconstruction of a-FAS/APO-1 Mediated-Apoptosis in Human Cancer Cells by Adenovirus-Mediated transduction of the Wildtype p53 Gene, patent has not filed yet

Field of Use

This agreement is for the drug industry relating to cancer therapy.

Cancer can spread when cells’ natural cancer suppression functions are impaired. The tumor suppressor gene called Tumor Suppressor Candidate 2, or TUSC2 (which was formerly known as FUS1) has been shown to affect both cell proliferation and apoptosis. TUSC2 is a pan-kinase inhibitor, which means that it has the ability to inhibit multiple kinase receptors, such as EGFR and platelet-derived growth factor receptor, or PDGFR. TUSC2 is frequently inactivated early in the development of lung cancer, and loss of TUSC2 expression in NSCLC is associated with significantly worse overall survival compared to patients with normal TUSC2 expression. Many types of cancer cells, including approximately 85% of NSCLC cells, lack expression of TUSC2.

License Grant

Licensor hereby grants to Licensee a license under the Licensor Patents to the extent necessary to conduct research and development of, and to make, have made, use, offer for sale, sell, have sold and import all Licensed Products throughout the world during the term of this Agreement, which license shall be exclusive (except as to Licensor) in the Shared Territory and shall be exclusive (even as to Licensor) outside of the Shared Territory except that Licensor shall retain such rights in Licensor Patents as shall be necessary to perform its obligations under this Agreement.

License Property

ONYX-015 means any and all formulations of the genetically engineered adenovirus DL1520 described in US Patent Numbers 5,677,178 and 5,846,945 that selectively replicates in and kills cancer cells based on abnormal p53 pathway function and is currently in clinical trials sponsored by Licensor.

Licensor Patent means a Patent that (A) is Controlled by Licensor, and (B) claims any Invention, or the composition of matter, manufacture, and/or use of ONYX-015 or a Licensed Product (or any part or aspect of a Licensed Product), or any technology necessary to research, develop or commercialize Licensed Products, and including Licensors interest in any Joint Patents.

5,801,029 – Cytopathic viruses for therapy and prophylaxis of neoplasia
5,846,945 – Cytopathic viruses for therapy and prophylaxis of neoplasia
5,677,178 – Cytopathic viruses for therapy and prophylaxis of neoplasia

Gene Product means the adenovirus product selected by Licensee. The parties collaborate to identify a Gene Product based on incorporation of a specific gene, selected by Licensee and encoding a specific member of one of three classes of proteins, into ONYX-015, or another adenovirus agreed to by the Parties that selectively replicates in and kills cancer cells based on abnormal p53 pathway function, for the purpose of expressing in cancer cells a particular protein with useful anti-cancer activity.

Independent Product shall have the meaning If, Licensee either (A) is not deemed to be diligent(b) or (c) or terminates Development as to a Licensed Product, in each case after the filing of an IND therefor and prior to the End of Phase II Clinical Trials for such Licensed Product, or (B) fails to fulfill its obligations with respect to diligent Development of a Licensed Product after the End of Phase II Clinical Trials.

Pro-Drug Product means the adenovirus product selected by Licensee to identify a Pro-Drug Product based on incorporation of a gene for a prodrug activating enzyme into ONYX-015, or another adenovirus agreed to by the Parties that selectively replicates in and kills cancer cells based on abnormal p53 pathway function, for the purpose of activating a prodrug into a specific active drug form.

Licensed Product means Local/Regional ONYX-015, Systemic ONYX-015, the Pro-Drug Product (upon selection of the Selected Drug System pursuant to this agreement(b)) or the Gene Product (upon selection of the Selected Gene pursuant to this agreement(c)), but excluding those of the foregoing that become Independent Products unless and until such time as Licensee exercises its buy-back rights under this agreement or that become Terminated Products.

Local/Regional ONYX-015 means the unmodified ONYX-015 currently in clinical trials sponsored by Licensor, and including any formulation thereof, such as, but without limitation, lyophilized formulations, mouthwash formulations, and formulations that stabilize ONYX-015 for storage at refrigerated or room temperature, but excluding modified formulations that comprise Systemic ONYX-015.

Invention shall have the meaning that Inventorship of any invention that is developed, discovered or made by a Party or the Parties jointly (as applicable, the Inventor) pursuant to work conducted under this Agreement (an Invention) shall be determined in accordance with United States laws of inventorship.

Field of Use

ONYX-015 is a novel therapy that uses a genetically modified virus to kill cancer cells.  Onyx-015 is an adenovirus that has been genetically altered so that it only replicates in cells that are lacking a gene called P-53, which is a known tumor suppressor. Because cancer cells lack the gene, the virus multiplies in them and ultimately destroys them. It has no effect on normal cells.

License Grant

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

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

License Property

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

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

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

Field of Use

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

License Grant

Licensor grants to Licensee an exclusive (except as to Licensor) license under the Licensor Patents to the extent necessary to conduct research and development of, and to make, have made, use, offer for sale, sell, have sold and import Licensed Products in the Shared Territory during the term of this Agreement.

Licensor hereby grants Licensee a paid-up non-exclusive license to use Licensor Know-How in the Shared Territory to the extent necessary to research, develop and Commercialize the Licensed Products during the Research Term and while Licensee is co-promoting the applicable Licensed Product in the Shared Territory.

License Property

ONYX-015 means any and all formulations of the genetically engineered adenovirus DL1520 described in US Patent Numbers 5,677,178 and 5,846,945 that selectively replicates in and kills cancer cells based on abnormal p53 pathway function and is currently in clinical trials sponsored by Licensee.

5,677,178 – Cytopathic viruses for therapy and prophylaxis of neoplasia
5,846,945 – Cytopathic viruses for therapy and prophylaxis of neoplasia

Neoplasia is the formation or presence of a new, abnormal growth of tissue.

Gene Product means the adenovirus product selected by Licensor.  The parties collaborate to identify a Gene Product based on incorporation of a specific gene, selected by Licensor and encoding a specific member of one of three classes of proteins, into ONYX-015, or another adenovirus agreed to by the Parties that selectively replicates in and kills cancer cells based on abnormal p53 pathway function, for the purpose of expressing in cancer cells a particular protein with useful anti-cancer activity.

Independent Product shall have the meaning If, Licensor either (A) is not deemed to be diligent(b) or (c) or terminates Development as to a Licensed Product, in each case after the filing of an IND therefor and prior to the End of Phase II Clinical Trials for such Licensed Product, or (B) fails to fulfill its obligations with respect to diligent Development of a Licensed Product after the End of Phase II Clinical Trials.

Pro-Drug Product means the adenovirus product selected by Licensor to identify a Pro-Drug Product based on incorporation of a gene for a prodrug activating enzyme into ONYX-015, or another adenovirus agreed to by the Parties that selectively replicates in and kills cancer cells based on abnormal p53 pathway function, for the purpose of activating a prodrug into a specific active drug form.

Licensed Product means Local/Regional ONYX-015, Systemic ONYX-015, the Pro-Drug Product (upon selection of the Selected Drug System pursuant to this agreement(b)) or the Gene Product (upon selection of the Selected Gene pursuant to this agreement(c)), but excluding those of the foregoing that become Independent Products unless and until such time as Licensor exercises its buy-back rights under this agreement or that become Terminated Products.

Licensor Patent means a Patent that (a) is Controlled by Licensor, and (b) claims the composition of matter, manufacture, and/or use of a Licensed Product, Independent Product or Terminated Product (or any part or aspect of a Licensed Product, Independent Product or Terminated Product), or any aspect of Licensees activities under the Research Program, and including Licensors interest in any Joint Patents.

Local/Regional ONYX-015 means the unmodified ONYX-015 currently in clinical trials sponsored by Licensee, and including any formulation thereof, such as, but without limitation, lyophilized formulations, mouthwash formulations, and formulations that stabilize ONYX-015 for storage at refrigerated or room temperature, but excluding modified formulations that comprise Systemic ONYX-015.

Licensee Patent means a Patent that (A) is Controlled by Licensee, and (B) claims any Invention, or the composition of matter, manufacture, and/or use of ONYX-015 or a Licensed Product (or any part or aspect of a Licensed Product), or any technology necessary to research, develop or commercialize Licensed Products, and including Licensees interest in any Joint Patents.

Invention shall have the meaning that Inventorship of any invention that is developed, discovered or made by a Party or the Parties jointly (as applicable, the Inventor) pursuant to work conducted under this Agreement (an Invention) shall be determined in accordance with United States laws of inventorship.

Field of Use

The rights granted apply to the drug industry.

License Grant

Licensor hereby grants to Japanese Licensee an exclusive, royalty-bearing license under the Licensor Technology and Licensors interest in the Joint Technology, to make, have made use, sell and otherwise commercialize Collaboration Products for all uses in the Field in the Territory.

License Property

Licensor Technology shall mean Licensor Patent Rights, Licensor Know-How and Gene Therapy Technology.

Licensor Patent Rights shall mean (i) all patents and patent applications, or conceived and reduced to practice by Licensor alone, or Licensor and/or its agents (including researchers at DFCI) in connection with the Research Program during the Research Program Term, and (ii) any divisions, continuations, continuations-in-part, reissues, reexaminations, extensions or other governmental actions which extend any of the subject matter of the patent applications or patents in (i) above, and any substitutions, confirmations, registrations or revalidations of any of the foregoing, in each case, which is owned or controlled, in whole or part, by license, assignment or otherwise by Licensor, to the extent Licensor has the right to license or sublicense, and subject to any limitations of such license or sublicense. For the avoidance of doubt, the Licensor Patent Rights shall not include Licensor Know-How.

Licensor know-how shall mean confidential information and materials, including, but not limited to, pharmaceutical, chemical, biological and biochemical products, technical and non-technical data, and information relating to the results of tests.

U.S. Patent Application Serial No. 08/745,375 entitled 'Methods for Promoting Wound Healing and Transplant-Assoctaed Vasculopathy'

U.S. Patent Application Serial No. 08/816,346 entitled 'Chimeric Adenoviral Coat Protein and Methods of Using Same'

U.S. Patent Application Serial No. 08/854,601 entitled 'Multigene HSV Vectors for Cancer Immunotherapy'

U.S. Patent Application Serial No. 08/861,773 entitled 'An Improved Method for the Production of Non-Group C Adenoviral Vectors'

U.S. Patent Application Serial No. 60/047,849 entitled 'Alternately Targeted Adenovirus'

U.S. Patent Application Serial No. 60/049,072 entitled 'Phage Vector and Methods of Use'

U.S. Patent Application Serial No. 60/054,329 entitled.'Targeted HSV Vectors'

Field of Use

Field shall mean Gene Therapy for the treatment of human cancer excluding any use of the vascular endothelial growth factor (VEGF) gene or tumor necrosis factor alpha (TNF) gene or, in each case, any portion or derivative thereof.

The collaboration involves the development of Ad.CD for immunotherapy of cancer based on the delivery of tumor antigen genes. Ad.CD, an adenovirus vector containing the cytosine deaminase ('CD') gene, is designed to convert a nontoxic precursor drug into fluorouracil to effect tumor destruction, either alone or in combination with radiation therapy.

License Grant

The Licensor hereby grants to the Licensee an exclusive license under the Licensed Rights to under the Licensed Property.  The Licensee has a unique opportunity to accelerate our development by utilizing intellectual property, drug leads, new research technologies, technical know-how and original scientific concepts derived from 25 years of research achievements relevant to cancer by licensed patent applications and patents.

License Property

CCF Technology shall mean all CCF’s unpatented inventions, know-how, trade secrets, analysis, discoveries, techniques, methods, clinical and other data, and other intellectual property relating to the research of Doctor or arising out of or in direct connection with work of Doctor in the field of regulating cell death: (I) curing cancer treatment side effects by differential modulation cell death / survival mechanisms uniquely deregulated in cancer cells; (ii) selective sensitization of cancer cells to treatment by using the same approach; (iii) using anti-apoptotic proteins secreted by microbial parasites to cure tissue damage associated with cancer treatment, inflammation and other pathologies (stroke, heart attack).

Provisional Patent Application 60/526,538 – Methods of Inhibiting Apoptosis Using Latent TGFβU.S. Provisional Patent Application 60/526,666 – Methods of Identifying of Modulators of Apoptosis From Parasites and Uses Thereof U.S. Provisional Patent Application 60/526,496 – Methods of Inhibiting Apoptosis Using Inducer's of NF-kB U.S. Provisional Patent Application 60/526,667 – Methods of Inhibiting Apoptosis Using Latent TGFβU.S. Provisional Patent Application 60/526,460 – Methods of Protecting Against Radiation Using Inducer's of NF-kB U.S. Provisional Patent Application 60/526,461 – Methods of Protecting Against Radiation Using Flagellin U.S. Provisional Patent Application 60/571,149 – Small Molecules Inhibitors of MRP1 and Other Multi drug Transporters U.S. Provisional Patent Application 60/589,637 – Activation of p53 and Inhibition of NF-kB for cancer treatment.

Field of Use

Licensed Field shall mean shall mean the practice, production, manufacture, sale and use of the Licensed Rights for the discovery, development and commercialization of methods, techniques, devices, systems, animals and therapeutics in the field of regulating cell death:

CBLC100 series: small molecules that restore the activity of p53 tumor suppressor in cancers, including renal cell carcinomas, sarcomas, prostate cancers and other types of malignancies; curaxines and derivatives thereof are representative examples of this category;
CBLB101 series: substances of biological nature (i.e., cytokine, chemokines and other secreted molecules) and their bioactive derivatives produced by tumor cells and capable of modulating cell survival; TGFß2 and derivatives thereof and derivatives thereof are representative examples of this category;
CBLB501 series: natural factors produced by extracellular parasites and symbiont of humans and other mammalian species and their bioactive derivatives capable of modulating cell survival mechanisms of host cells; flagellin of Salmonella typhimurium and derivatives thereof are representative examples of this category;
CBLC500 series: small molecules modulating tumor and normal cell sensitivity to cytotoxic chemicals by altering activity and substrate specificity of multi drug transporters; inhibitors of MRP1 and derivatives thereof are representative examples of this category.

License Grant

The Parties have an acquisition agreement.  Upon consummation of the Acquisition, the Parties desire to establish a new cooperative development program intended to discover, develop, and certify for use in humans one or more new pharmaceutical products.

Licensor grants an exclusive, worldwide license under the Ad Interferon-beta Product Licensor Patents and the Ad Interferon-beta Product Technology to develop, research, make, have made, use, have used, sell, offer for sale, import and have sold the Ad Interferon-beta Product in the Cancer Field and the Beta Interferon Field .

For the Manufacturing License,  Licensor will provide a transferable, limited license or subiicense as the case may be under the Licensor Technology and the Licensor Patents to manufacture such Clinical Vectors and Commercial Vectors to the extent necessary to enable Licensee to manufacture quantities of the Clinical Vectors and Commercial Vectors that otherwise would have been supplied by Licensor to Licensee under this Agreement, solely for use and application by Licensee for the uses and applications in the Territory that would be permitted under this Agreement with respect to such Clinical Vectors and Commercial Vectors purchased from Licensor.

Licensor grants a license, with right to grant sublicenses, under the Licensor Technology and the Licensor Patents to research, develop, manufacture, have manufactured, use, import, export, offer to sell or sell Products in the Territory.

Licensor grants  a nonexclusive, worldwide license, with right to sublicense to Contractors permitted under this Agreement,  to the Licensed Technology, other than the Applied Licensor Technology, as designated in the applicable Project Plan and Budget, and under any Licensor Patents, other than the Exhausted Licensed Patents and the Exempted Licensed Patents, as designated in the applicable Project Plan and Budget, which would, but for this license grant, be infringed by Licensees performance of its Development Tasks solely as necessary for performance of Licensees Development Tasks during and in the course of any approved Development Project.

In addition to the other rights granted under this Agreement, Licensor hereby grants an option to acquire a license, with the right to grant sublicenses, to Licensor Technology, that is not otherwise designated as Applied Licensor Technology in the applicable Project Plan and Budget, and under any and all Targeted Patents, that are not designated as Exhausted Licensor Patents or as Exempted Licensor Patents in the applicable Project Plan and Budget.

License Property

The patents include Adenovirus Vectors for Gene Therapy, and, .Method of Reducing an Immune Response to a Recombinant Adenovirus.

AAV Interferon-beta Product means a Product incorporating the Beta Interferon Gene and any AAV Vector as the delivery platform.

AAV Vector means an adeno-associated viral vector useful or potentially useful for the delivery of Genes to human cells.

Ad Interferon-beta Product means the Product incorporating the Beta Interferon Gene and an Ad Vector that is the subject of the Ad Interferon-beta Project.

Ad Vector means an adenoviral vector useful or potentially useful for the delivery of Genes to human cells.

Field of Use

Beta Interferon Field means the treatment or prevention in humans of one or more diseases through the use or application of one or more gene therapy vectors to deliver Genes; such Genes being defined herein as the Beta Interferon Genes.

Cancer Field means the treatment or prevention in humans of one or more cancers through the use or application of AAV Vectors or Ad Vectors.

License Grant

University hereby grants to Licensee and the Covered Affiliates for the term of this Agreement the worldwide right and license, with the right to grant sublicenses, to develop, have developed, make, have made, use, have used, import, have imported, sell, offer for sale and have sold University Licensed Products under the Group 1 Patents in all fields of use. Such right and license shall be non-exclusive to Licensee.

Group 2 License Grant. University hereby grants to Licensee and the Covered Affiliates for the term of this Agreement the worldwide right and license, with the right to grant sublicenses, to develop, have developed, make, have made, use, have used, import, have imported, sell, offer for sale and have sold University Licensed Products under the Group 2 Patents in all fields of use. Such right and license shall be non-exclusive to Licensee in the LSD Field.  Subject to this Agreement, such right and license shall be exclusive to Licensee outside the LSD Field.

University hereby grants to Licensee and the Covered Affiliates for the term of this Agreement the worldwide right and license, with the right to grant sublicenses, to develop, have developed, make, have made, use, have used, import, have imported, sell, offer for sale and have sold University Licensed Products under the Group 3 Patents in in all fields of use.   Subject to this Agreement, such rights and license shall be exclusive to Licensee.

License Property

Group 1 Patents means the following patents:
US 6,475,769 – Methods and cell line useful for production of recombinant adeno-associated viruses
US 7,238,526 – Methods and cell line useful for production of recombinant adeno-associated viruses

Group 2 Patents means the following patents:
US 6,759,237 – Adeno-associated virus serotype 1 nucleic acid sequences, vectors and host cells containing same
US 7,186,552 – Adeno-associated virus serotype 1 nucleic acid sequences, vectors and host cells containing same

Group 3 Patents means
US 7,056,502 – Recombinant aav vectors with AAV5 capsids and AAV5 vectors pseudotyped in heterologous capsids

University Licensed Product(s) means products that in the absence of this Agreement would, where and when made, used, sold, or imported, infringe at least one issued claim or pending claim of University Patent Rights; and products that are made using a process or machine that in the absence of this Agreement would, where and when used, infringe at least one issued claim or pending claim of University Patent Rights. All University Licensed Products intended to deliver the same Gene shall be considered a single University Licensed Product for purposes of this Agreement.

University Patent Rights means those patents and patent applications listed in this Agreement and all foreign counterparts thereof, as well as continuation, continuation-in-part, provided that such continuation-in-part relates directly to existing patents or patent applications and not to any new matter, divisional and re-issue applications
thereof, together with any and all patents issuing thereupon or upon any foreign counterparts thereof; provided, however, that Licensee acknowledge that the invention relating to non-invasive delivery of transgenes into the bloodstream, which is disclosed in Example 6 of International Patent Application No. PCT/USO1/13000 (M2304PCT), and in a US CIP application No. 09/955,444 (N2605), was made at University following termination of the research under the Sponsored Research Agreement.  Licensee hereby acknowledge that they have no rights in this invention relating to non-invasive delivery of transgenes into the bloodstream, as defined in these applications and divisionals, continuations, re-examinations, re-issues, and any foreign counterparts thereof, and any patents issuing therefrom. Licensee agree that they will not make or pursue any claims that this invention as so defined is or should have been part of the University Patent Rights.

Gene means any nucleotide sequence that is capable of encoding, or of causing or modulating the expression of, a proteiin, protein fragment, or other genetic element.  For the purposes hereof, a Gene having 90% homology to that of another Gene, and which expresses essentially the same protein for at least one biological function, shall be considered the same Gene as such other Gene.

LSD Field means the prevention, treatment, or cure of lysosomal storage diseases whether by in vivo or ex vivo means (together with preparation, research, development, and attempts to do the foregoing).

Cancer Field means the prevention, treatment or cure of malignancies whether by in vivo or ex vivo means together with preparation, research, development, and attempts to do the foregoing).

TNFr/Inflammatory Field means the prevention, treatment, or cure of any disease or diseases in whole or in part through use or delivery of the TNFr Gene or any other Gene acting in the Inflammatory Pathway, whether by in vivo or ex vivo means (together with preparation, research, development, and attempts to do the foregoing).

Field of Use

This agreement pertains to the drug industry relating to Gene Therapy.

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

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, a medical research centers, grants an exclusive license under the Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import any Licensed Products in the Licensed Fields of Use and to practice and have practiced any Licensed Processes in the Licensed Fields of Use.

License Property

The patents and patent applications relate to Modified Adena-Associated Virus Vector Capable of Expression from a Novel Promoter.

Adeno-associated viruses are small viruses that infect humans and some other primate species. They belong to the genus Dependoparvovirus, which in turn belongs to the family Parvoviridae.

Field of Use

The field of use is the development of compositions and methods utilizing Adeno-Associated Viral Vectors embodied in the Licensed Patent Rights which are useful in the treatment and prophylaxis of human and animal diseases, and does not include compositions and methods for the treatment and prophylaxis of cystic fibrosis.

Cystic fibrosis is a hereditary disease that affects the lungs and digestive system. The body produces thick and sticky mucus that can clog the lungs and obstruct the pancreas. Cystic fibrosis (CF) can be life-threatening, and people with the condition tend to have a shorter-than-normal life span.