Royalty Report: Drugs, Cancer, Biotechnology – Collection: 284140

$150.00

Curated Royalty Rate Report
Created On: 2020-07-15, Record Count: 20

Description

This collection of transactions and supporting information was developed using our AI algorithm to curate similar royalty reports into a cohesive collection to support your licensing, transfer pricing or other transaction scenarios where documented royalty rates and/or deal terms are important.
Created On: 2020-07-15
Record Count: 20

Primary Industries

  • Drugs
  • Cancer
  • Biotechnology
  • Disease
  • Pharmaceuticals
  • Diagnostic
  • Therapeutic
  • Antibody
  • Assay

IPSCIO Report Record List

Below you will find the records curated into this collection.  This summary includes the complete licensed property description so that you can review and determine if this collection covers the topics, technology or transaction type that is relevant for your needs.  The full report will include all relevant deal data such as the royalty base, agreement date, term description, royalty rates and other deal terms.  For reference, here is a sample of a full IPSCIO curated royalty rate report: Sample Report

IPSCIO Record ID: 284140

License Grant
Licensor granted Licensee worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications.
License Property
Capmatinib is a potent and highly selective MET inhibitor. The investigational compound has demonstrated inhibitory activity in cell-based biochemical and functional assays that measure MET signaling and MET dependent cell proliferation, survival and migration.
c-Met inhibitors are a class of small molecules that inhibit the enzymatic activity of the c-Met tyrosine kinase, the receptor of hepatocyte growth factor/scatter factor (HGF/SF). These inhibitors may have therapeutic application in the treatment of various types of cancers.
Field of Use
Capmatinib is being evaluated in patients with hepatocellular carcinoma, non-small cell lung cancer and other solid tumors, and may have potential utility as a combination agent.

IPSCIO Record ID: 35129

License Grant
The Hong Kong Company  granted a co-exclusive, worldwide rights to develop, and exclusive worldwide rights to manufacture and commercialize savolitinib for all diagnostic, prophylactic and therapeutic uses.
License Property
Savolitinib is a potential global first-in-class inhibitor of the mesenchymal epithelial transition factor, or c-Met, receptor tyrosine kinase, an enzyme which has been shown to function abnormally in many types of solid tumors. We developed savolitinib as a potent and highly selective oral inhibitor that was designed to address renal toxicity, the primary issue that has prevented all other selective c-Met inhibitors from gaining regulatory approval. In Phase I clinical studies, savolitinib has shown promising signs of clinical efficacy, causing tumor size reduction in patients with c-Met gene amplification in papillary renal cell carcinoma, non-small cell lung cancer, colorectal cancer and gastric cancer.
Field of Use
This agreement pertains to drugs for all diagnostic, prophylactic and therapeutic uses in the medical industry.

IPSCIO Record ID: 4661

License Grant
The parties entered into an exclusive license agreement to develop and commercialize lucitanib on a global basis, excluding China.
License Property
Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors 1 through 3 (FGFR1-3), vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3) and platelet-derived growth factor receptors alpha and beta (PDGFR α-ß).
Field of Use
A Phase I/IIa clinical trial of lucitanib was initiated in 2010 and has demonstrated multiple objective responses in FGFR1 gene-amplified breast cancer patients, and objective responses were also observed in patients with tumors often sensitive to VEGFR inhibitors, such as renal cell and thyroid cancer. FGFR amplification is common in a number of tumor types, including breast cancer and squamous non-small cell lung cancer, and we intend to study lucitanib in these cancers as well as other solid tumors exhibiting FGFR pathway activation.

IPSCIO Record ID: 135967

License Grant
This amendment includes commercialization rights for cabozantinib in Canada.
License Property
Cobimetinib is a potent, highly selective inhibitor of MEK, a kinase that is a component of the RAS/RAF/MEK/ERK pathway. This pathway mediates signaling downstream of growth factor receptors, and is prominently activated in a wide variety of human tumors.  It is indicated in combination with vemurafenib as a treatment for patients with BRAF V600E or V600K mutation-positive advanced melanoma.  The company is a biopharmaceutical company that discovers, develops and commercializes small molecule therapies for the treatment of cancer.  The business focuses predominantly on the development and commercialization of cabozantinib, an internally-discovered inhibitor of multiple receptor tyrosine kinases, in various tumor indications. Cabozantinib is currently approved in the United States and European Union for the treatment of progressive, metastatic medullary thyroid cancer, or MTC, and is marketed under the brand name COMETRIQ®.
Field of Use
The Company is developing its proprietary compound known as cabozantinib for the treatment of cancer, and owns or controls certain patents, know-how and other intellectual property relating to such compound.

IPSCIO Record ID: 256505

License Grant
The 2018 Amendment covers adjustments in the respective roles and responsibilities of the Chinese parties, in China, for the development and commercialization of fruquintinib in the areas of future life cycle planning and development, collaborations for co-development of fruquintinib with other third-party anti-cancer agents as well as promotion and distribution rights of fruquintinib.  The 2018 Amendment now gives Licensor all planning, execution and decision making responsibilities for LCI development on fruquintinib in China.  The 2018 Amendment provides Licensor the right to promote fruquintinib in provinces that represent 30% of the sales of fruquintinib in China (“Licensor Territory”) upon the occurrence of certain commercial milestones.
License Property
Fruquintinib (brand name: Elunate®) is a small molecule, selective and highly potent inhibitor of VEGFR 1, 2 and 3. VEGFR inhibitors play a pivotal role in tumor-related angiogenesis, cutting off the blood supply that a tumor needs to grow rapidly.
Fruquintinib is an orally available, small molecule inhibitor of vascular endothelial growth factor receptors (VEGFRs), with potential anti-angiogenic and antineoplastic activities. Upon oral administration, fruquintinib inhibits VEGF-induced phosphorylation of VEGFRs 1, 2, and 3 which may result in the inhibition of migration, proliferation and survival of endothelial cells, microvessel formation, the inhibition of tumor cell proliferation, and tumor cell death. Expression of VEGFRs may be upregulated in a variety of tumor cell types.
Field of Use
Fruquintinib is under investigation for the treatment of NSCLC. Fruquintinib has been investigated for the treatment of ColoRectal Cancer.

IPSCIO Record ID: 278110

License Grant
The Parties entered this agreement to develop and commercialize ficlatuzumab.  The non-opting out party shall have sole decision-making authority with respect to further development and commercialization of ficlatuzumab.

Licensor granted the perpetual, non-exclusive rights to certain intellectual property, including diagnostic data related to VeriStrat, with respect to the development and commercialization of ficlatuzumab.

License Property
Ficlatuzumab is a hepatocyte growth factor (HGF) inhibitory antibody.

VeriStrat®, is Licensor’s proprietary companion diagnostic test.

A retrospective exploratory analysis uses VeriStrat®, a commercially available serum protein test, to identify patients most likely to benefit from the addition of ficlatuzumab, AVEO’s HGF inhibitory antibody, to epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI) therapy in a randomized Phase 2 study of ficlatuzumab and gefitinib (IRESSA®) in previously untreated Asian subjects with non-small cell lung cancer (NSCLC).

Field of Use
The field of use is the treatment of non-small cell lung cancer in poor prognosis patients.  Licensee is a biopharmaceutical company.

IPSCIO Record ID: 263778

License Grant
This is a global collaboration covering two novel cancer programs:  XL 184, a small molecule inhibitor currently in Phase III development and its associated development program; and,  XL281, a small molecule inhibitor of RAF kinase currently in Phase I development and its associated development program.

Licensor grants a co-exclusive license under the Licensors Licensed Know-How to clinically develop, make, have made, use, sell, offer for sale and import Co-Developed Products in the U.S.

Licensor grants a co-exclusive license under the Licensors Licensed Patents to clinically develop, make, have made, use, sell, offer for sale and import Co-Developed Products in the U.S.

Licensor grants an exclusive, subject to Licensors right to conduct Licensor Clinical Trials and work under the Backup Programs pursuant to this Agreement, license under the Licensor Licensed Know-How to clinically develop, make, have made, use, sell, offer for sale and import:  Royalty-Bearing Products in the U.S.; and Products in the Royalty Territory.

Licensor grants an exclusive, subject to Licensors right to conduct Licensor Clinical Trials and work under the Backup Programs pursuant to this Agreement, license under the Licensor Licensed Patents to clinically develop, make, have made, use, sell, offer for sale and import:  Royalty-Bearing Products in the U.S.; and Products in the Royalty Territory.

Licensor will grant a non-exclusive license to use such Licensor Marks solely in connection with the Commercialization of the Products in the Territory, the Trademark License Agreement.

License Property
Trademark is EXELIXIS®

Product means any therapeutic or prophylactic product that contains or comprises a Collaboration Compound. The Collaboration Compounds means:  XL184; and  XL281.

XL184 means:  the small molecule compound with Licensor identifier 02977184; the small molecule compounds listed in the Letter Agreement; any Program Backups to 02977184; and any isomer, racemate, salt, solvate, hydrate, metabolite, conjugate, ester, or prodrug of the compound.

XL281 means: the small molecule compound with Licensor identifier 03832819;  the small molecule compounds listed in the Letter Agreement; any Program Backups to 03832819; and any isomer, racemate, salt, solvate, hydrate, metabolite, conjugate, ester, or prodrug of the compound.

XL184 provides a novel approach to the treatment of a variety of solid tumors where signaling through MET, VEGFR2 or RET plays an important role in dysregulated tumor growth and progression. XL184 has recently begun a Phase III clinical trials in medullary thyroid cancer, a disease in which RET mutations are found in a large proportion of patients. In addition, clinical trials to exploit the MET and VEGFR2 targeting of XL 184 are ongoing in patients with non-small cell lung cancer and glioblastoma. Preclinically, XL184 also exhibits inhibitory activity for .MET and VEGFR2 in a variety of breast, colon and brain tumor models.

XL28 l is a novel small molecule designed to selectively inhibit RAF kinase, which lies immediately downstream of RAS and is a key component of the RAS/RAF/MEK/ERK kinase signaling pathway. The RAS/RAF/MEK/ERK pathway plays a key role in the transmission of growth-promoting signals downstream of receptor tyrosine kinases. Dysregulation of this pathway plays a pivotal role in the progression of many human tumors, and inhibition of the pathway may be useful in the treatment of cancer. Phase I trials with this molecule are underway in order to select a dose and schedule for Phase II disease-directed trials.

Field of Use
The field of use is oncology in animals or humans.  XL 184 is currently in Phase III development for medullary thyroid cancer.  XL281 is currently in Phase I development for the treatment of patients with advanced solid tumor malignancies.

IPSCIO Record ID: 226529

License Grant
The parties agreed to collaboratively develop sitravatinib in Asia (excluding Japan and certain other countries), Australia and New Zealand (the Licensed Territory). Under this Agreement, Licensor granted Licensee an exclusive license to develop, manufacture and commercialize sitravatinib in the Licensed Territory, with Licensor retaining exclusive rights for the development, manufacturing and commercialization of sitravatinib outside the Licensed Territory.
License Property
Sitravatinib is an oral, spectrum-selective kinase inhibitor that potently inhibits specific receptor tyrosine kinases (“RTKs”). RTKs are families of kinases involved in the transmission of signals that regulate cell growth, survival, and migration and include TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. Sitravatinib addresses cancer via two distinct mechanisms: directly, by targeting RTKs that drive tumor growth through mutation, and indirectly, by modulating immune regulatory cells to stimulate the body’s immune response to tumors. Sitravatinib’s potent inhibition of TAM and split family receptors may help overcome resistance to immune checkpoint inhibitors and stimulate the body’s immune response to help detect and destroy tumor cells. Blocking the signaling of these RTKs enhances the ability of T-cells (a type of white blood cell that is of key importance to the immune system) to recognize and eliminate tumor cells and modifies the tumor immune environment to enable a more productive immune response. The ability of sitravatinib to enhance the activity of immune checkpoint inhibitors was demonstrated in nonclinical cancer models.
Field of Use
This agreement pertains to the drug industry.

IPSCIO Record ID: 26536

License Grant
The Licensee announced that the Licensor decided not to exercise its option under the product development and commercialization Agreement between the Licensee and the Licensor to License XL647 for further development and commercialization. The Licensee reported in May 2007 that it had notified the Licensor of it's determination that it had achieved proof-of-concept for XL647 based on data from a phase 2 clinical trial, thereby triggering a 90-day review period in which the Licensor could exercise its option. As a result of the decision by the Licensor not to exercise its option, the Licensee retains the right to develop and commercialize XL647 either independently or in collaboration with third parties.
Field of Use
The Licensee intends to move forward with the full development of XL647 in patients with non-small cell lung cancer and potentially other indications.  XL647 is a potent inhibitor of multiple RTKs implicated in driving tumor cell proliferation and tumor vascularization (blood vessel formation). XL647 inhibits the EGF, HER2, and VEGF RTKs, each of which is a target of currently approved cancer therapies. In addition, XL647 inhibits EphB4, an RTK that is highly expressed in many human tumors and plays a role in promoting angiogenesis. In a broad array of preclinical tumor models including breast, lung, colon and prostate cancer, XL647 demonstrated potent inhibition of tumor growth and causes tumor regression. In cell culture models, XL647 retains significant potency against mutant EGFRs that are resistant to current EGFR inhibitors.

IPSCIO Record ID: 7387

License Grant
Licensor, Chief Scientific Officer of Licensee, hereby grants to Licensee and its Affiliates during the Term an exclusive, worldwide, royalty bearing license, with the right to grant sublicenses through multiple tiers of sublicenses, in and to, the Technology, Licensed Products, Licensed Improvements, and Patents; and to develop, distribute, market, make, have made, use, have used, sell, have sold, offer for sale, and import Licensed Products.
License Property
Licensed Technology: Primary human cells that secrete factors inhibiting tumor cell proliferation.

Recent experiments have led to the identification of a novel source of primary human cells that secrete a factor capable of inhibiting tumor cell growth. Co culture of tumor cell lines with these human cells results in inhibition of proliferation of the tumor cells and ultimate death. Further media conditioned by the primary human cells also inhibits proliferation of the tumor cells lines and death of the cells. The technology consists of methods for isolation and propagation of the primary human cells, gene profiles obtained from the cells identifying candidate micro RNAs and growth factor genes, and methods for generating media conditioned by these cells for isolation of the inhibitory factor(s).

This technology offers the potential to identify molecules that can kill tumor cells and further provides insight into the potential use of cells for delivery of these inhibitory factors in vivio.

Field of Use
The Licensee is a biotechnology company engaged in the discovery and development of cell therapeutic products and is developing pre-clinical-stage therapeutic agents and treatments for cancer, diabetes, heart, lung, and kidney diseases as well as for bone marrow and organ transplants. The Licensee's discoveries involve cell treatments.

IPSCIO Record ID: 29334

License Grant
Parties hereto shall work together to complete the research and development of anti-tumor drug AL6802 (a chemical compound that covered by the pending U.S. patent and the future PCT patent application mentioned above) in China (and other countries and regions outside China), and finally have AL6802 Pharmaceutical registration and invention patent granted in China mainland and carry out relevant commercial development in China and other countries and regions outside China. The period for the royalties shall be the patent protection period of AL6802 in China.  Al-6802 belongs to a series of small molecules developed that have very potent activity at in vitro human cancer cell proliferation assay and in vivo human cancer cell A431 xenograft model.
Field of Use
This compound is targeting epidermal growth factor receptor (EGFR) for cancer treatment.

IPSCIO Record ID: 33130

License Grant
The Hong Kong Company entered into an agreement that grants to the Chinese Licensee an exclusive license to develop, manufacture and commercialize fruquintinib for all uses in China and Hong Kong.
License Property
Fruquintinib is a highly selective and potent oral inhibitor of the vascular endothelial growth factor receptor, or VEGFR, and consequently we believe it has the potential to be a global best-in-class VEGFR inhibitor for many types of solid tumors. Based on pre-clinical and clinical data to date, fruquintinibs kinase selectivity has been shown to reduce off-target toxicity. This allows for drug exposure that is able to fully inhibit VEGFR, a protein ligand which contributes to the growth of tumors, and use in potential combinations with other targeted therapies and chemotherapy in earlier lines of treatment with larger patient populations.
Field of Use
This agreement pertains to drugs in the medical industry. Fruquintinib is a targeted oncology therapy for the treatment of various types of solid tumors.

IPSCIO Record ID: 7426

License Grant
This in-License of RXDX-101 and RXDX-102 from the Licensor, an Italian state-owned biopharmaceutical company, grants the Licensee exclusive global rights to develop and commercialize RXDX-101 and RXDX-102.

The development rights under the License Agreement are exclusive for the term of the Agreement with respect to RXDX-101 and RXDX-102 and also, as to the Licensor, are exclusive for a five-year period with respect to any product candidate with activity against the target proteins of RXDX-101 and RXDX-102, and include the right to grant subLicenses.

License Property
RXDX-101 is a tyrosine kinase inhibitor directed to the TrkA, ROS1 and ALK proteins, which is in a Phase I/II clinical study in molecularly defined patient populations for the treatment of solid tumors.

RXDX-102 is a tyrosine kinase inhibitor directed to the Trk family tyrosine kinase receptors, TrkA, TrkB and TrkC, which is currently in preclinical development for the treatment of multiple cancers. Tyrosine kinases are enzymes that transfer phosphate groups from adenosine triphosphate (ATP) to cellular proteins and can function as an on/off switch for cellular functions, including cancer signaling.

IPSCIO Record ID: 183924

License Grant
The China based Licensor and Licensee of Sweden enter the amendment to the joint development agreement is for the global pivotal Phase III study in c-Met-driven PRCC. The original agreement is co-exclusive.
License Property
Savolitinib is an inhibitor of c-Met, an enzyme which has been shown to function abnormally in many types of solid tumors.  It is designed to be a potent and highly selective oral inhibitor, which through chemical structure modification addressed human metabolite-related renal toxicity, the primary issue that halted development on several other selective c-Met inhibitors.
Field of Use
Phase III clinical trial is related to developing savolitinib for papillary renal cell carcinoma.

IPSCIO Record ID: 161808

License Grant
This collaboration and license agreement for the commercialization and further clinical development of cabozantinib in Japan. Licensee will have exclusive commercialization rights for current and potential future cabozantinib indications in Japan. The companies have also agreed to collaborate on the future clinical development of cabozantinib in Japan.  As part of the collaboration, the parties will enter into a supply agreement covering the manufacture and supply of cabozantinib and a quality agreement setting forth in detail the quality assurance arrangements and procedures for manufacture of cabozantinib.
License Property
The license covers the further clinical development of cabozantinib, an inhibitor of multiple tyrosine kinases including MET, AXL, and VEGF receptors. They are CABOMETYX™ tablets for the treatment of advanced kidney cancer and COMETRIQ® capsules for the treatment of certain forms of thyroid cancer.

CABOMETYX (cabozantinib) was approved by the U.S. Food and Drug Administration, or FDA, on April 25, 2016, for the treatment of patients with advanced renal cell carcinoma, or RCC, who have received prior anti-angiogenic therapy.

Field of Use
The developed product is used as cancer treatment.

IPSCIO Record ID: 245935

License Grant
Licensor hereby grants to Swiss Licensee and its Affiliates an exclusive, non-transferable (except as expressly authorized in this Agreement), royalty-bearing license, with the right to sublicense as qualified, under the Licensed Patents, Licensed Products Improvements to the extent Controlled by Licensor, and Licensed Know-How to use, develop, import, offer for sale, have sold and sell, the Licensed Products in the Territory, and a non-exclusive license thereunder to make and have made the Licensed Products worldwide, for all diagnostic, preventive and therapeutic uses in the human diseases Myelodysplastic Syndromes (“MDS”) Acute Myelogenous Leukemia (“AML”) and any other indications or uses (the “Field”).  Licensor also hereby grants Licensee a license to use the Dacogen Trademark as provided in this Agreement. Licensor reserves all rights not expressly granted herein, and no other rights shall be considered granted by Licensor by implication, estoppel, reliance, or otherwise. Notwithstanding anything to the contrary, no rights or licenses are granted by Licensor in this Agreement with respect to any active ingredient other than Decitabine or with respect to any product other than the Licensed Products.
License Property
Licensed Patents shall mean: (i) the patents and patent applications listed and any patents issuing therefrom, and all reissues, continuations, continuations-in-part, extensions, reexaminations, and foreign counterparts thereof; and (ii) patents and patent applications Licensor or its Affiliates may own or control which are infringed by any of the activities of Licensee performing in accord with this Agreement, including without limitation, all patents and patent applications relating to Product Improvements Controlled by Licensor.

Licensed Patents:
6,613,753 – Restore cancer-suppressing functions to neoplastic cells through DNA hypomethylation
6,982,253 – Liquid formulation of decitabine and use of the same
6,998,391 – Method for treating diseases associated with abnormal kinase activity
6,905,669 – Compositions and methods for reestablishing gene transcription through inhibition of DNA methylation and histone deacetylase

DACOGEN Trademark shall me mean the DACOGEN mark and accompanying logos associated with it.

Products shall mean (i) the product containing Decitabine which is the subject of Licensor’s NDA No. 21-790 as of the date of signing of this Agreement; and (ii) any other pharmaceutical product containing as an active ingredient Decitabine.

Decitabine shall mean the compound identified below, and all stereoisomers, salts and polymorphs of the compound identified below. Esters and acids of the compound identified below shall be included to the extent they constitute the same active ingredient as the compound identified below.

Decitabine:
C8H12N404
Exact Mass: 228.086
Mol. Wt.: 228.205

Field of Use
The Field shall mean preventive and therapeutic uses in the human diseases Myelodysplastic Syndromes (“MDS”) Acute Myelogenous Leukemia (“AML”) and any other indications or uses.

Myelodysplastic syndromes (MDS) are a group of cancers in which immature blood cells in the bone marrow do not mature and therefore do not become healthy blood cells.

IPSCIO Record ID: 26594

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.

IPSCIO Record ID: 25786

License Grant
Licensee received an exclusive worldwide license from the University.  This includes the rights to sublicense and the intellectual property associated with SDX-101 and SDX-102, as well as issued patents and patent applications for several pre-clinical-stage projects, including the SDX-103 program.
License Property
SDX-101 is an oral compound which does not suppress the body’s immune system for the treatment of CLL. SDX-101 is an isomer, or component, of Lodine®, a marketed anti-inflammatory drug. The U.S. Food and Drug Administration, or FDA, has granted orphan drug status, a designation for drugs intended to treat a rare disease or condition affecting no more than 200,000 individuals in the U.S., for SDX-101 for the treatment of CLL.

SDX-102 is an intravenously administered small molecule which laboratory studies have shown kills tumors which cannot produce an important metabolic enzyme. Safety and tolerability data on SDX-102 were collected in clinical trials conducted at academic centers sponsored by the National Cancer Institute, or the NCI. These clinical trials tested the drug across a variety of cancers which are now known to produce this enzyme with a high frequency. The Licensee developed a proprietary, practical laboratory assay, or test, to identify patients whose cancers cannot produce this metabolic enzyme. In 2004, the Licensee was conducting Phase II trials of SDX-102 and are using their assay to select patients for these trials in difficult-to-treat cancers, including non-small cell lung cancer, or NSCLC, pancreatic and mesothelioma, none of which was previously studied by the NCI. The SDX-103 program involves analogs of the compound indanocine. Indanocine and indanocine analogs were synthesized and characterized at the University by the Licensee's founders. Indanocine displayed potent anti-proliferative activity when tested against a multitude of cancer cell lines at the NCI. These compounds differ from many clinically used drugs that block cell division in that they are active against multi-drug resistant cells and selectively kill non-dividing malignant cells. Anti-tumor activity of SDX-103 analogs has been observed in preliminary animal studies.

Field of Use
SDX-101 is covered by two use patents in the U.S. that prohibit third parties from using etodolac and etodolac analogs to treat CLL and NHL and R-etodolac and R-etodolac analogs to treat leukemias. These use patents expire in 2019. In the U.S. and selected foreign countries, the Licensee is pursuing additional use patents for etodolac, R-etodolac and etodolac analogs as well as composition of matter patents for etodolac analogs in the U.S. and in selected foreign countries.  SDX-102 and assay methods were covered by two use patents in the U.S. that prohibit third parties from using an assay to measure MTAP status in a patient and then treating with an adenyl succinate synthetase inhibitor such as alanosine. These patents expired in 2013. SDX-102 is also covered by a patent in the U.S. that prohibits third parties from treating multiple drug resistance in MTAP-deleted tumors using an adenine synthesis inhibitor, such as l-alanosine. A patent application covering an assay method and monoclonal antibody for determining the presence or absence of MTAP is currently pending. Similar applications are being pursued or have issued in selected foreign countries.

IPSCIO Record ID: 289241

License Grant
Licensor grants the German Licensee an exclusive, worldwide, sublicensable license under the Licensor Technology to research, develop, make, have made, use, sell and import for sale Licensed Compounds and Licensed Products in the Field.

Licensor also grants a nonexclusive, worldwide, sublicensable license under Non-uPA Inhibitor Patents to carry out research and development in respect of uPA Inhibitor Compounds during the Research Program and to use any results of such research and development for the development, manufacture or commercialization of Licensed Compounds and Licensed Products.

Licensor also grants a nonexclusive, worldwide, sublicensable license under Improvements that are Controlled by Licensor during the term of this Agreement to research, develop, make, have made, use, sell and import for sale Licensed Products in the Field.

License Property
Licensor has identified a class of non-peptidic, potent urokinase plasminogen activator (uPA) inhibitors with potential application in various therapeutic fields.

Urokinase Plasminogen Activator (uPA) Inhibitor means a compound that has uPA Ki as determinated by Licensor using a standardized assay reasonably acceptable to the Joint Research Committee less than 1.0 micromolar, and selectivity with respect to the Ki for the compound for uPA of at least 2X with respect to the Ki, as determined by Licensor using a standardized assay reasonably acceptable to the Joint Research Committee, for complement proteases; and selectivity with respect to the Ki for the compound for uPA of at least 10X with respect to the Ki, as determined by Licensor using a standardized assay reasonable acceptable to the Joint Research Committee, for Thrombin, Factor VIIa and Xa.

Licensor Technology means Licensor Know-How and Licensor Patents.

Licensed Compound means a Base Compound or a New Compound.

Licensed Product means a product in finished dosage form containing a Licensed Compound as active ingredient for use in the Field.

Base Compound' means a uPA Inhibitor existing at the Effective Date which falls within the claims of the Patents referenced or falls within the same Chemical Class as such compounds; or falls within Licensors orally available uPA Inhibitor lead series, exemplified by 5-bromo-4 (phenylamino) thiophene-2-carboxamidine hydrochloride and derivatives thereof, as described in the Outline Research Plan.

New Compound means any uPA Inhibitor and members of the same Chemical Class which is identified, discovered, created or synthesized by Licensor in the course of the Research Program; any chemical entity, and any member of the same Chemical Class as such chemical entity, that is identified, discovered, created or synthesized by Licensor and is  discovered during the Research Term, but outside of the Research Program, to be a uPA Inhibitor, to the extent that such chemical entity is Controlled by Licensor; and any chemical entity, and any member of the same Chemical Class as such chemical entity that is identified, discovered, created or synthesized by Licensor and is discovered to be a uPA Inhibitor after the end of the Research Term but within 6 months thereafter, to the extent that such chemical entity is Controlled by Licensor.

Licensor Non-uPA Inhibitor Compounds mean compounds and data relating to such compounds discovered during the Research Program by Licensor which do not constitute uPA Inhibitors but which the Joint Research Committee considers have some biological activity of interest to the Research Program or are of potential commercial interest to Licensee.

Licensor Non-uPA Inhibitor Patents means Patents Controlled by Licensor which claim Non-uPA Inhibitor Compounds.

Licensor Patents means Heteroaryl Amidines, Methyl Amidines and Guanidines…; Patents to be filed by Licensor that claim Licensors orally available uPA Inhibitor lead series, and derivatives thereof, as described in the Outline Research Plan; and Patents that claim New Compounds.

Field of Use
The Field means all uses of Licensed Products for the prevention, treatment, cure or mitigation of all disease states, conditions, disorders and indications in humans.   Among the therapeutic indications under consideratlon are: Solid Tumor Growth ( Chemotherapy) e.g. breast. lung, prostate;  Aortic Aneurysm (prevention); Post-PTCA Restenosis (:t stent); Rheumatoid Arthtitis, Inflammation; Macular Degeneration; and, Wound Fibrosis (keloid formation, scarring).

IPSCIO Record ID: 280840

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.
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