Royalty Report: Drugs, Cancer, Disease – Collection: 245722

License Grant

Licensor hereby grants to Licensee (a) an exclusive license to its rights under the Licensed Patents, with the right to grant sublicenses, to make, have made, use, sell, have sold, import or export products within the Field in the Licensed Territory, and to practice processes and methods covered by the Licensed Patents in connection with the foregoing, and (b) a non-exclusive license under the Licensed Information to make, have made, use, sell, have sold, import or export products within the Field in the Licensed Territory and to practice processes and methods covered by the Licensed Information in connection with the foregoing.

License Property

The compounds designated LB-100 and LB-151 were used in the research inventions claimed in the Licensed Technologies.  Licensed Technologies shall mean the Licensed Patents and the Licensed Information.

Licensed Patents shall mean Licensor’s and its Affilates’ rights in and to: (i) the patents and patent applications listed; (ii) any other patent or patent application covering an invention made, in whole or part, in the course of the Research or which was derived from use of the Material, or which discloses or claims any Licensed Information; (iii) any additional patents or patent applications that Licensee elects to be included in Licensed Patents pursuant to the Section of the CTA (Clinical Trial Research Agreement); (iv) any continuations, continuations-in-part (to the extent that they do not include new subject matter), divisionals, reissues, re-examinations, extensions or substitutions of any of the foregoing; (v) foreign equivalents or counterparts to any of the foregoing; and (vi) any patents that issue from any of the foregoing. Nothing in this Agreement is intended to establish or stipulate the owner(s) or ownership of the Licensed Patents.

Licensed Information shall mean all inventions, concepts, processes, information, data, know-how, research results, clinical data, and the like (other than the Licensed Patents that are owned or controlled by Licensor or its Affiliates as of the effective date, and necessary or useful for (i) the practice of any claim of a Licensed Patent or (ii) the use, development, manufacture or sale of any Royalty-Bearing Product.

U.S. Patent Application No. 62/028,729 entitled “Protein Phosphatase 2A Inhibitors for Treating Myelodysplastic Syndromes” filed July 24, 2014, (14MA063PR0).
U.S. Patent Application No. 62/029,327 entitled “Protein Phosphatase 2A Inhibitors for Treating Myelodysplastic Syndromes” filed July 25, 2014, (14MA063PR).
U.S. Patent Application No. 15/328,838 entitled Protein Phosphatase 2A Inhibitors for Treating Myelodysplastic Syndromes filed on January 24, 2017 (14MA063PRW0US1)
U.S. Patent Application No. 15/328,235 entitled Protein Phosphatase 2A Inhibitors for Treating Myelodysplastic Syndromes filed on January 23, 2017 (14MA063PRW0US2)
U.S. Patent Application No. 62/287,858 entitled “Clinical Regimen for Treating Myelodysplastic Syndrome with Phosphatase Inhibitor” filed on January 27, 2016. (17MB046PR)

Field of Use

Royalty-Bearing Product shall mean any product approved for use and used in connection with the treatment of MDS (Myelodysplastic Syndromes) whose manufacture, use, sale, offer for sale or import would, but for the License granted hereunder, infringes a Valid Claim in the country in which such product is manufactured or sold.

License Grant

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

License Property

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

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

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

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

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

Field of Use

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

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

License Grant

Hospital hereby grants Licensee (a) an exclusive, worldwide, royalty-bearing license  to all of its interests  in, to, and under Licensed Patents to import, make, have made, use, have used, offer for sale and sell Products; (b) to the extent an exclusive license is not available to Licensee in a particular country because of government action in that country a non-exclusive, royalty bearing license to all of HospitalS interests in, to, and under the Licensed Patents  to import, make, use, offer for sale and sell Products;  (c) the right to grant sublicenses  under the Licensed Patents exclusively licensed to Licensee.

License Property

The term Licensed Patents shall mean the patent applications listed hereto and the non-U.S. equivalents of such applications, including any utility patent application based on any provisional application included in Licensed Patents, and any division, continuation or any Letters Patent or the equivalent thereof issuing thereon or reissue, reexamination or extension thereof.  Licensed Patents shall also include those claims in any continuation-in-part of the aforementioned patent applications owned, controlled, or available for license from the Hospital,  which claims an invention described or claimed in said patent application.

U.S. Patent Applications Ser. No. 08/263,607, filed June 20, 1994, Ser. Nos. 08/458,061 and 08/458,085, both filed June 1, 1995, all  entitled 'Administration of Pirenzipine, Methyl Scopolamine, and Other Muscarinic Receptor Antagonists for Treatment of Lipid Metabolism Disorders'
U.S. Patent Applications Ser. No. 08/271, 881, filed July 7, 1994, Ser. Nos. 08/458,960 and 08/459,114, both filed June 2, 1995, all entitled 'Method of Regulating Immune Function'
U.S. Patent Application Ser. No. 08/475,296, filed June 7, 1995,  entitled 'Method of Inhibiting Neoplastic Disease in Mammals'
U.S. Provisional Patent Application Ser. No. 60/001,428, filed July 25, 1995, entitled 'Neuroendocrine Therapy for Inhibiting Neoplastic Disease'

The term Product shall mean any article, device, composition, method or service, the importation,  manufacture, use, offer for sale or sale of which, absent the licenses granted herein, would infringe an enforceable claim of any Licensed Patent.

Field of Use

This agreement pertains to the drug industry relating to inventions pertaining to the administration of muscarinic receptor antagonists, certain enzyme inhibitors,  a method of regulating immune function, and methods of treating neoplastic disease.

Neoplastic diseases are conditions that cause tumor growth — both benign and malignant. Benign tumors are noncancerous growths. They usually grow slowly and can't spread to other tissues.

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, government organization, hereby grants and Licensee of the Netherlands accepts an exclusive license and non-exclusive license, as specified, 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

Licensed Patent Rights shall mean:
(a) Patent applications (including provisional patent applications and PCT patent applications) or patents listed, all divisions and continuations of these applications, all patents issuing from these applications, divisions, and continuations, and any reissues, reexaminations, and extensions of these patents;
(b) to the extent that the following contain one or more claims directed to the invention or inventions disclosed in 2.8(a):
    (i)     continuations-in-part of 2.8(a);
    (ii)    all divisions and continuations of these continuations-in-part;
    (iii)   all patents issuing from these continuations-in-part, divisions, and continuations;
    (iv)   priority patent application(s) of 2.8(a); and
    (v)    any reissues, reexaminations, and extensions of these patents;
    (c)    to the extent that the following contain one or more claims directed to the invention or inventions disclosed in 2.8(a): all counterpart foreign and U.S. patent applications and patents to 2.8(a) and 2.8(b), including those listed; and
    (d)    Licensed Patent Rights shall not include 2.8(b) or 2.8(c) to the extent that they contain one or more claims directed to new matter which is not the subject matter disclosed in 2.8(a).

Patent(s) or Patent Application(s):
1. U. S. Patent 6,984,517, issued January 10, 2006, entitled “AAV5 Vector and Uses Thereof; U.S. Patent 7,479,554, issued January 20, 2009, entitled “AA V5 Nucleic Acids”as well as all issued and pending foreign counterparts [HHS Ref. No. E-127-1998/0];

2. U. S. Patent 6,855,314, issued February 15, 2005, entitled “AAV5 Vector for Transducing Brain Cells and Lung Cells” [HHS Ref. No. E-072-2000/0].

Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

Adeno-associated virus (AAV) is a small virus which infects humans and some other primate species.

Field of Use

This agreement pertains to the drug industry.

Exclusive Licensed Field of Use: (i) Use of the Licensed Patent Rights for the development and sale of AAV5 based therapeutic products to be delivered to the brain or liver for treatment of human diseases originating in the brain or liver; (ii) Note that arthritis related diseases are expressly excluded.

Non-Exclusive Licensed Field of Use: Use of the Licensed Patent Rights for the development and sale of AAV5 based therapeutic products to treat human diseases other than the ones covered under (a)(i).

License Grant

Licensor, a non-profit biomedical research company, grants to Licensee an exclusive, royalty-bearing license, with the right to grant sublicenses pursuant to Section 2.5, in the Territory under and to use the Licensed Intellectual Property to research, develop, make, have made, use, sell, offer for sale and import Licensed Products in the Field.

License Property

Licensed Patents means (a) the Patents listed below to this Agreement; (b) any and all Patents that claim Licensed Know-How and are Controlled by Licensor on the Effective Date and during the Term, including without limitation Licensors interest in any Joint Patent that claims Licensed Know-How; (c) all divisionals, continuations (in whole or in part, including without limitation conversions of provisional applications into utility patent applications), and substitutions of any of the preceding, and any letters patent and/or registrations (including, without limitation, all reissues, renewals, extensions, confirmations, re-examinations, supplementary protection certificates) that may be granted on any of the foregoing; and ( d) any and all United States and foreign counterparts of any of the foregoing.

Licensed Patents:
U.S. provisional patent application USSN 60/965,135 entitled Therapeutic Compositions for Treatment of Inflammation of Ocular and Adnexal Tissues

PCT/US08/09776 filed on 15.08.2008 claiming priority to Provisional 60/965,135, filed on August 16 2007. Published on February 26, 2009 WO/2009/025763, entitled Therapeutic Compositions for Treatment of Inflammation of Ocular and Adnexal Tissues

Provisional 61/143,561 filed January 09. 2009 entitled Therapeutic Compositions For Treatment of Corneal Disorders

Licensed Product means any product the manufacture, use or sale of which would, but for the licenses granted in this Agreement, infringe a Valid Claim of a Licensed Patent.

An amendment to the license agreement dated 01/01/1990 is amended by deleting it in its entirety the above Licensed Patent Information and replacing it hereto:
Licensed Patents:
U.S. Patent Appln. No. 121685.510
U.S. Patent Appln. No. 13/183,231

Field of Use

The patent applications cover methods of treating diseases of the eye using an inhibitor of the inflammatory cytokine IL-1.

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

Licensor and its Affiliates hereby grant to Licensee an exclusive, worldwide royalty-bearing license, with the right to grant sublicenses, under any Licensor Patent Rights and to use any Licensor Know-How to make, have made, use and sell Licensed Products containing Acolbifene in the Field in the Territory (including Canada). The foregoing licenses shall be exclusive even as to Licensor. Licensor shall remain solely responsible (at its own expense) for the filing, prosecution, maintenance, enforcement and defense of the Licensor Patent Rights covering Licensed Products containing Acolbifene in the Territory which activities shall be governed by the terms of the Agreement.  This become effective as of the date on which Licensor’s licenses to Acolbifene are terminated pursuant to this agreement.

The Parties have been collaborating in the development of a certain antiestrogen compound as a Licensed Compound under the terms of the Agreement.

Licensee now desires to assume sole responsibility for the continued development of such antiestrogen compound.

License Property

Acolbifene shall mean the specific antiestrogen compound known as acolbifene (also referred to by the parties as EM-652 or SCH 57068) and having the chemical structure.

Licensed products means any pharmaceutical products in dosage form which contain one or more Licensed Compounds, including without limitation, Licensed Combinations.

Licensed Compounds means (i) any compounds existing on the effective date of this Agreement which were conceived of as antiestrogen or antiandrogen compounds by or on behalf of Licensee and (ii) any additional novel or existing compounds which are conceived of as compounds in the Field by or on behalf of Licensee while carrying out research in the program as that term is defined.

Patent Rights means (i) all pending United States patent applications and issued patents relating to Licensed Compounds, including without limitation, the pending United States patent applications and issued patents listed, as of the effective date of this Agreement; (ii) all claims of any patent applications or issued patents filed or issued during or after the term of this Agreement to which Licensee have rights covering any compositions for, processes for or methods of use of any Licensed Compounds in the Field; (iii) all claims of any foreign counterpart patent applications and/or issued patents of (i) and (ii) and (iv) any reissues, extensions, substitutions, confirmations, registrations, revalidations, additions, continuations, continuations-in-part or divisions of or to any of the foregoing which are hereafter granted in the Territory.

Field of Use

Acolbifene is a nonsteroidal selective estrogen receptor modulator which, as of 2015, is in phase III clinical trials for the treatment of breast cancer.