Royalty Report: Drugs, Cancer, Therapeutic – Collection: 263778

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Curated Royalty Rate Report
Created On: 2020-07-15, Record Count: 17

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: 17

Primary Industries

  • Drugs
  • Cancer
  • Therapeutic
  • Disease
  • Drug Discovery
  • Diagnostic
  • Pharmaceuticals
  • Biotechnology
  • DNA
  • Proteins
  • Drug Testing
  • Antibody
  • Genome

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: 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: 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: 61018

License Grant
The Company hereby grants to French Licensee, during the Term:
(a) an exclusive royalty-bearing license, with the right to grant sublicenses solely as provided under the Company Technology to use, sell, offer for sale, import and otherwise Commercialize (but not to make or have made) the Products in the Field and in the Licensee Territory; and
(b) a non-exclusive license, with the right to grant sublicenses solely as provided under the Company Technology to Develop (but not to make or have made) the Products on a worldwide basis under the GDP, and to use the Products for that purpose. Exelixis agrees not to grant any further license to Develop the Products except to Future Exelixis Licensees.
License Property
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.

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 agreement pertains to the drug industry.

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: 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: 253970

License Grant
For the Research, Licensor grants a non-exclusive, worldwide license, without the right to sublicense except with prior written consent of Licensor, under the Licensor Licensed Patents and Know-How solely to perform pre-IND testing activities that are approved by the Parties in writing for a Provisional Collaboration Program and in connection with a Backup Program.

For the Clinical Development and Commercialization, Licensor grants a co-exclusive license under the Licensor Licensed Patents and Know-How to clinically develop, make, use, sell, offer for sale and import Co-Promotion Products in the U.S., and,  Licensor grants an exclusive license under the Licensor Licensed Patents and Know-How to clinically develop, make, use, sell, offer for sale and import Royalty-Bearing Products in the U.S. and Products in the Royalty Territory.

License Property
Licensor is a drug discovery company that has expertise and proprietary technology relating to therapeutics that modulate signal transduction pathways involved in oncology and other disease areas.

Product means any therapeutic or prophylactic product, for use in animals or humans, that contains or comprises a Collaboration Compound for which Licensee has exercised its Co-Development Option in accordance with the terms of this Agreement.

Field of Use
The field of use is the collaboration to discover, develop and commercialize novel targeted therapies for the treatment of cancer.

The Screening Targets for Contract Year 1 are Hsp70, pan-PLK, mTOR, iPFK.2, ACL, DVTI, DNAmt, and, EnZst.

The Lead Op Targets for Contract Year 1 are HSP90 (Heat Shock Protein 90), PIM (Pro viral Integration of MML V serine/threonine kinases), and, SMO (Smoothened).

IPSCIO Record ID: 245939

License Grant
The Parties desire to form a collaboration for the co-development and commercialization of certain products.

For each Project as to which Licensee is the Selling Party, Licensor grants an exclusive, exclusive even as to Licensor,  worldwide sublicensable exclusive right and license under Collaboration Rights, Licensor Patent Rights, and Licensor Know-How to make, have made, use, sell, offer to sell and import Product and such license shall automatically terminate for each Product of a Project as to which Licensee becomes an Opt-Out Party effective as of the Opt-Out Date.  

For each Project, Licensor grants a non-exclusive license under Patent Rights owned by Licensor to perform research under the Research Plan for such Project, which license shall terminate for each Project when Licensee becomes an Opt-Out Party for such Project.

License Property
Licensor possesses know-how, expertise, intellectual property rights and technology with respect to screening of libraries to identify compounds of interest and the development of compounds.

Project means research activities with respect to identifying compounds with activity against an Approved Target, synthesizing compounds based on such identified compounds, identifying and selecting a Development Compound, developing, manufacturing, obtaining Regulatory Approval and commercializing a Product.

Product means a Development Compound and/or a Replacement Compound and/or a pharmaceutical composition that includes a Development Compound and/or Replacement Compound.

The Selected Compounds shall be provided as 384 well plates with each well containing 0.7 micromoles of compound per well, dissolved in 70 microliters of DMSO, with the compound being at a final concentration of 10 micromoles.

Field of Use
Licensee has know-how, expertise, intellectual property rights and technology with respect to chemical libraries and chemical synthesis.

The target means a protein and/or peptide and/or polynucleotide.

The collaboration is for the discovery and development of small molecule oncology therapeutics.

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: 246201

License Grant
The Parties desire to form a collaboration for the co-development and commercialization of certain products.

For each Project, Licensor grants an exclusive, exclusive even as to Licensor, worldwide, sublicensable exclusive right and license under Collaboration Rights, Licensor Patent Rights, and Licensor Know-How to make, have made, use, sell, offer to sell and import Product and such license shall automatically terminate for each Product of a Project as to which Licensee becomes an Opt-Out Party effective as of the Opt-Out Date or as to which Licensee becomes a Non-Selling Party.

For each Project, Licensor grants a non-exclusive license under Patent Rights owned by Licensor to perform research under the Research Plan for such Project, which license shall terminate for each Project when Licensee becomes an Opt-Out Party for such Project.

License Property
Licensor has know-how, expertise, intellectual property rights and technology with respect to chemical libraries and chemical synthesis.

Project means research activities with respect to identifying compounds with activity against an Approved Target, synthesizing compounds based on such identified compounds, identifying and selecting a Development Compound, developing, manufacturing, obtaining Regulatory Approval and commercializing a Product.

Product means a Development Compound and/or a Replacement Compound and/or a pharmaceutical composition that includes a Development Compound and/or Replacement Compound.

The Selected Compounds shall be provided as 384 well plates with each well containing 0.7 micromoles of compound per well, dissolved in 70 microliters of DMSO, with the compound being at a final concentration of 10 micromoles.

Licensor will provide Licensee access to its Discovery outSource(TM) services platform, including the world's largest commercially available chemical library, as well as medicinal and synthetic chemistry for the discovery and development of new active compounds.

Field of Use
Licensee possesses know-how, expertise, intellectual property rights and technology with respect to screening of libraries to identify compounds of interest and the development of compounds.

The target means a protein and/or peptide and/or polynucleotide.

The Parties have entered into a collaboration for the discovery and development of small molecule oncology therapeutics.

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: 300744

License Grant
This agreement is to identify Prognostic Signatures capable of predicting responsiveness of an organism to therapeutic compounds upon the terms and conditions.

For Therapeutic Use, upon exercise of the Option for a specified Non-MAP Collaboration Target,  Licensor grants  an exclusive license in the Territory under the Licensor Patent Rights and Licensor Know-How, with a right to sublicense for any and all Therapeutic Uses, to develop, make, have made, use, offer to sell, sell and/or import Collaboration Compounds and/or Products Directed at such Non-MAP Collaboration Target for Therapeutic Use.

For Diagnostic Use, upon exercise of the Option for a specified Non-MAP Collaboration Target Licensor grants a non-exclusive license in the Territory under the Licensor Patent Rights and Licensor Know-How, with a right to sublicense for any and all Diagnostic Use, to develop, make, have made, use, offer to sell, sell and/or import Collaboration Compounds and/or Products Directed at such Non-MAP Collaboration Target for Diagnostic Use.

For Biologicals, upon exercise of the Option for a specified Non-MAP Collaboration Target that is not an Additional Biological Target,  Licensor grants a non-exclusive license in the Territory under the Licensor Patent Rights and Licensor Know-How, with a right to sublicense, to develop, make, have made and use Biologicals Directed to a NonMAP Collaboration Target or Discovery Target for the sole purpose of the research and/or development of a Product for Therapeutic Use and/or Diagnostic Use.

For MAP Collaboration Targets, upon Licensees payment of the MAP Technology Access Fee for a specified MAP Collaboration Target Licensor grants a non-exclusive license under the Licensor Patent Rights and Licensor Know-How that arise from the activities under the MAP Target Research Plan to develop, make, have made, use, ·
offer to sell, sell and/or import inhibitors or modulators directed to such MAP Collaboration Target for Therapeutic Use and Diagnostic Use.

For the Option for Non-MAP Collaboration Targets, Licensor grants an exclusive Option to obtain an exclusive license, and a non-exclusive license for up to seven Non-MAP Nominated Targets at any one time.

License Property
Collaboration Model means:
—   INK4A-/-/kRAS Spontaneous Inducible Breast Cancer Model:
—   INK4A-/-/HER2 Spontaneous Inducible Breast Cancer Model:
—   INK4A-/-/kRAS Spontaneous Inducible Lung Cancer Model.

Product means any preparation in final form, either for sale by prescription, over-the-counter or any other method or for administration to human patients in Clinical Trials, for any and all uses in the Field, which preparation contains a Collaboration Compound, or in the case of a Product for Diagnostic Use, utilizes the relevant Discovery Target and/or Collaboration Compound for Diagnostic Use.

Human Response Platform is a novel method of building preclinical models of human cancer, which are intended to more accurately represent cancer biology in patients.

Human Response Prediction platform is based on AVEO's proprietary, genetically-defined mouse models of human cancer. Each of these models is engineered to contain signature genetic mutations that are present in human disease. Beyond these cancer-initiating engineered mutations, the resultant tumors acquire common and distinct spontaneous mutations during tumor progression, providing additional natural genetic variation more akin to the range of genetic heterogeneity encountered across different primary human tumors. The tumor-to-tumor genetic variation in the system provides the opportunity to identify genetic correlations between responding and non- responding tumor populations, and to apply such genetic profiles in clinical development.

Field of Use
Human Response Platform provides an unique insights into cancer biology and mechanisms of drug response and resistance, and represents a significant improvement over traditional approaches.  The parties will use the Human Response Prediction platform to identify patient populations likely to be responsive to a number of investigational cancer drugs currently being developed.  The collaboration is focused on identifying genetic profiles that correlate with drug response to more effectively guide the clinical and market development of Licensee's cancer compounds.

Field means the use of Non-MAP Collaboration Targets, MAP Collaboration Targets, Discovery Targets, Collaboration Compounds and/or Products for any and all Therapeutic Uses and/or Diagnostic Uses.

IPSCIO Record ID: 182116

License Grant
The parties entered an agreement for one of the Licensors programs.
License Property
This program is for MM-121 or Seribantumab. Seribantumab is an antibody-drug that targets ErbB3 that was developed using the Selexis SUREtechnology Platform.
Field of Use
Licensee is currently conducting a Phase 2 trial of seribantumab (MM-121) in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer whose disease has progressed following immunotherapy.

IPSCIO Record ID: 243433

License Grant
For the Licensed IP Rights, the Italian Licensor grants an exclusive license under the Licensed IP Rights to conduct research and to develop, make, have made, use, offer for sale, sell and import Products in the Territory for use in the Field, and, Licensor grants a non-exclusive license under any patent, know-how or other intellectual property rights Controlled by Licensor to research and to develop, make, have made, use, offer for sale, sell and import any diagnostic product for one or more of the Exclusive Targets.
License Property
Product(s) shall mean any product that incorporates one or both of the APls and if made, used, sold, offered for sale or imported absent the license granted hereunder would infringe a Valid Claim, or that otherwise uses or incorporates the Licensor Know-How.

The patent is for Substituted Indazole Derivatives Active as Kinase Inhibitors.

RXDX-103 is an inhibitor of the cell division cycle 7-related (Cdc7) protein kinase, and RXDX-104 is a program to identify a highly selective inhibitor of the rearranged during transfection (RET) tyrosine kinase. Each of these programs is in preclinical development for the potential treatment of multiple cancers.

Loss of cell cycle control is a hallmark of cancer, and interfering with the DNA replication process is a proven strategy for cancer therapy. Currently available chemotherapies, such as anti-metabolites, topoisomerase inhibitors, and crosslinking and intercalating agents, classically take a broad-based approach to inhibiting the elongation step of DNA replication. This strategy has led to successful treatment outcomes, but off-target effects can lead to dose-limiting toxicity. Cdc7 is a serine/threonine protein kinase essential for the initiation step of DNA replication during the synthesis (S) phase.

Field of Use
The Field shall mean all fields of use, including without limitation the diagnosis, prevention or treatment of any disease, state or condition in humans or other animals.

Licensee has capabilities in the development of oncology products.

IPSCIO Record ID: 233462

License Grant
Licensor grants to Licensee:
(a) an exclusive, worldwide license, under Licensor Field Patent Rights and Licensor Field Know-How, to make, have made, use, and have used Candidate Genes and Validated Targets within Oncology; such license shall include the right to grant sublicenses on prior notice to Licensor;
(b) an exclusive, worldwide license, under Licensor Field Patent Rights and Licensor Field Know-How to make, have made, import, use, have used, offer to sell and sell Products; such license shall include the right to grant sublicenses on prior notice to Licensor;
(c) an option to obtain exclusive licenses to Non-Program Field Projects;
(d) a right to either negotiate for rights to collaborate on Gene Therapy Drugs, which embody or are discovered or developed using Licensor Field Patent Rights or Licensor Field Know-How, or a co-exclusive right to make, have made, import, use, have used, offer to sell and sell Gene Therapy Drugs, which embody or are discovered or developed using Licensor Field Patent Rights or Licensor Field Know-How;
(e) an option to co-develop and/or co-promote certain Diagnostic Products, for use in the Field and the area of Oncology, which embody or are discovered or developed using Licensor Field Patent Rights or
Licensor Field Know-How; and
(f) a co-exclusive with Licensor, worldwide license, under Licensor Field Patent Rights and Licensor Field Know-How, to make, have made, use, and have used Program Genes Outside of the Field and to make, have made, use, and have used Candidate Genes and Validated Targets outside of Oncology; such license shall include the right to grant sublicenses on prior written notice to Licensor.
License Property
Gene Therapy Drug means any drug or drug candidate, excluding an Antisense Drug, which consists of nucleic acid or a functional analog, derivative or homologue thereof and which, upon delivery by any means, provides a gene product encoded therein which is expressed.

Modified Drug means a compound in the Field which, other than through the use of Licensor Field Know-How or Licensor Field Patent Rights, prior to or outside of the Program, was identified by Licensee to have pharmacological properties of relevance -to its development as a therapeutic product in the Field, and was modified through the use of Licensor Field Know: How or Licensor Field Patent Rights to improve its therapeutic properties at any time during the term of the Program or the Licensee Development Program. Modified Drug does not include any Candidate Protein Drug, Peptido Mimetic, Analog Protein Drug, Small Molecule Drug, Gene Therapy Drug or Antisense Drug.

Candidate Protein Drug means a Protein encoded by a Candidate Gene or other Protein, the identification of which other Protein was based upon the identification of a Candidate Gene, and which, in either case, is potentially suitable for development into a therapeutic product.

Analog Protein Drug means a protein or polypeptide which has been modified through a change in its primary structure resulting in a functionally significant change (such as a change in its pharmacokinetic or pharmacodynamic properties) to allow it to become a therapeutic Product demonstrating relevant In Vitro and In Vivo activity. For purposes of this definition, a polypeptide constituting the pharmacologically active fragment of a protein, that has not been modified through a change in its primary structure resulting in a functionally significant change, shall not be considered an Analog Protein Drug.

Peptido Mimetic Drug means a synthetic organic molecule which is a mimetic of, or is designed or developed using medicinal, SAR or combinatorial chemistry techniques to incorporate, key structural features of a Candidate Protein Drug and which is a therapeutic product.

Small Molecule Drug means a small molecule therapeutic product within the Field originating from a screen using a Validated Target, other than a Candidate Protein Drug, an Analog Protein Drug, a Peptido Mimetic Drug, a Modified Drug, a Gene Therapy Drug or an Antisense Drug.

Field of Use
Field means the application in Oncology of:
(a) All genes located at chromosome 8p22, including but not limited to loss of prostate cancer hormone-sensitivity, and prostate cancer metastasis to bone;
(b) Mechanisms of drug resistance including but not limited to the association with drug transporters such as P-glycoprotein and MRP, and the mechanism of action of factors that mediate cell death of drug resistant cells or tissues, including but not limited to apoptosis;
(c) Mechanisms of prostatic proliferative conditions including but not limited to the discovery of novel genes implicated in the susceptibility, progression and metastasis of prostate cancer, analysis of prostatic cells and variants of these cells, and malignant tissues;
(d) All cell cycle control mechanisms including but not limited to inhibition of cyclin DI/CDK4 kinase activity; and
(e) All Ras signal transduction mechanisms including but not limited to the inhibition of the Ki-ras pathway, Ras/GTP interaction, Ras/Raf interaction, Raf kinase activity, and Ras/FTase interaction.

Outside of the Field means all human medical indications other than those in the Field and all animal medical indications.

IPSCIO Record ID: 249348

License Grant
Licensor grants a sublicensable right and license under Collaboration Rights and Licensor General Rights that is co-exclusive with Licensor to make and have made such Product in any country of the world for sale in such countries, and use, sell, offer to sell and import such Products in such countries in the Field, in accordance with the terms and conditions of this Agreement, and such license shall automatically terminate for a Project, and for each Product in the Project, as to which Licensee becomes an Opt-Out Party effective as of the Opt-Out Date.
License Property
Product means an Hsp90 Product and/or Hedgehog Product.  Project means Hedgehog Project and/or Hsp90 Project.

Hsp90 Diagnostic means a product or service for determining a person that is susceptible to treatment with a Hsp90 Therapeutic and/or monitoring such treatment and/or providing a prognosis of such treatment, in each case such treatment being for the purpose of treating and/or preventing a disease, disorder or condition.

Hsp90 Therapeutic means one or more molecules that primarily (i.e. the most potent activity) target and modulate one or more of Heat Shock Protein 90 (Hsp90) [and/or cochaperones of Heat Shock Protein 90 ( e.g. Hip and Hop), but not client proteins of Heat Shock Protein 90 such as c-Kit and EGFR,] and compositions that contain such a molecule(s). For the avoidance of doubt, the chemical entities disclosed and/or claimed in the Patent Rights indicated in Exhibit Y and IPI 504 are included as Hsp90 Therapeutics.

Hedgehog Diagnostic means a product or service for determining a person that is susceptible to treatment with a Hedgehog Therapeutic and/or monitoring such treatment and/or providing a prognosis of such treatment, in each case such treatment being for the purpose of treating and/or preventing a disease, disorder or condition.

Hedgehog Therapeutic means one or more molecules that primarily target (i.e. the most potent activity) and modulate one or more member(s) of the Hedgehog pathway and compositions that contain such a molecule(s). For the avoidance of doubt, the chemical entities disclosed and/or claimed in the Patent Rights [, and IPI 609, the IPI 609 polymorph, and reduced A-ring analogs of IPI 609] are included as Hedgehog Therapeutics.

The Licensee Patents are for Analogs ofBenzoquinone-Containing Ansamycins and Methods of Use Thereof, and,  Ansamycin Formulations and Methods of use Thereof, and,  Methods of Treatment Using Hydroquinone Ansamycins, and,  Crystal Form, and, Cyclopamine Analogs and Methods of Use Thereof , and, Dosing Regimens for the Treatment of Cancer, and,  Methods for Synthesizing Cyclopamine Analogs.

Field of Use
The collaborative agreement is to jointly develop and commercialize novel small molecule cancer drugs targeting Heat Shock Protein 90 (“Hsp90”) and the Hedgehog cell-signaling pathway.

IPSCIO Record ID: 203362

License Grant
The parties wish to collaborate in connection with the research, development and commercialization of Licensors HDAC Inhibitors.

The Licensor of Denmark grants a co-exclusive, solely with Licensor, license in the Field throughout the Territory under the Licensors Licensed Technology, Licensors Collaboration Technology, and Licensors interest in the Joint Collaboration Technology to conduct the Research Program and to make and use Collaboration Products in connection with the Research Program, each in accordance with the terms of this Agreement.

License Property
Licensor is a biotechnology company with a development program, a library of compounds, and other intellectual property rights relating to HDAC Inhibitors.  HDAC Inhibitor shall mean a small molecule that inhibits the activity of histone deacetylase.

The patents cover Carbamic acid compounds comprising an ether linkage as HDAC inhibitors – short name HDAC-B (Ethers);  an amide linkage as HDAC inhibitors – short name HDAC-E (Amides) ;  a sulfonamide linkage as HDAC inhibitors – short name HDAC-F (Sulfonamides);  an ester or ketone linkage as HDAC inhibitors – short name HDAC-H (Ketones/Esters);  a piperazine linkage as HDAC inhibitors – short name HDAC-1 (Piperazines); and a bicyclic heteroaryl group as HDAC inhibitors – short name HDAC-J (Quinoxalines).

PXD101 is a novel histone deacetylase (HDAC) inhibitor for the treatment of solid and hematological cancers. PXD101 is currently in a Phase I clinical trial in patients with advanced solid tumors and is one of the most advanced HDAC inhibitors in development. HDAC inhibitors are a new class of potential anti-cancer agents that have shown promise in preclinical and clinical studies.

Patent family: 'Carbamic acid compounds comprising an amide linkage as HDAC inhibitors' – short name ' HDAC-E (Amides)'
USA 10/381794
USA 10/381791

Patent family: 'Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors – short name 'HDAC-F (Sulfonamides) '
USA 60/297784
USA 60/308136
USA 10/381790

Field of Use
The Field shall mean the prevention, diagnosis, control or treatment of any human disease or condition by use of a Collaboration Product, either as a single agent or in combination with any other therapy.

IPSCIO Record ID: 203330

License Grant
For the License, Licensor grants an exclusive, sublicensable license under the Licensed IP, to make, use, offer for sale, sell and import Compounds in the Field in the Territory; and to otherwise perform its obligations and exercise its rights under this Agreement.

For the research license, Licensor grants a non-exclusive, non-sublicensable, but exercisable by a Third Party, license, under the Licensed IP, for internal research purposes other than the discovery of Compounds.

Licensor grants a first right to negotiate pursuant to which Licensor shall notify Licensee in writing if it wishes to license to another party rights to develop and/or commercialize a given Ex Vivo Application; and provide to Licensee all material information related to such Ex Vivo Application that exists and is available to Licensor at the time of such notification.

Licensor grants a first right to negotiate pursuant to which Licensor shall notify Licensee in writing if it wishes to license to another party rights to develop and/or commercialize a given Licensor Compound;  identify in such notice the Therapeutic Area in which Licensor is developing, or intends to develop, such Licensor Compound; and provide to Licensee all material information related to such Licensor Compound that exists and is available to Licensor at the time of such notification.

License Property
Licensor possesses proprietary technologies, including small molecules and biological screening assays, relating to the Wnt Pathway.  Licensor possesses significant biological expertise in the discovery of drugs that modulate regulatory pathways, such as the Wnt Pathway that control repair and regeneration.

The Licensed Product means any Valid Claim Product, Licensee Modified Product, Know-How Product and/or Non-Collaboration Product, mean a Licensed Product that contains a unique Lead Compound, which includes the salts, solvates, isomers, polymorphs and prodrugs of such Lead Compound. Notwithstanding the foregoing, if Licensor performs Funded Work on any salts, solvates, isomers, polymorphs and/or prodrugs of a given Lead Compound, each new Lead Compound resulting from such Funded Work shall be deemed a unique Lead Compound.

A Valid Claim Product means any formulation of a Lead Compound that is Covered by the Licensed IP; provided, however, Valid Claim Product excludes any Licensee Modified Product; Licensed Product that is Covered by a Licensee Collaboration Patent and is not Covered by either a Licensor Collaboration Patent or a Joint Collaboration Patent; and Non-Collaboration Product.

A Know-How Product means any formulation of a Lead Compound that is not a Valid Claim Product, a Licensee Modified Product, or a Non-Collaboration Product.

If Licensor does not perform Funded Work on such Lead Compound, any formulation of such Lead Compound shall be referred to as a Non-Collaboration Product.

The Compound means any molecule that, as one of its primary mechanisms of therapeutic action,  specifically binds to or interacts with at least one component of the Wnt Pathway: and/or modulates the signaling of the Wnt Pathway; provided, however, Compound shall exclude any molecule that is or incorporates:
– a polypeptide (e.g., an antibody, antibody fragment, peptide, protein) or a nucleic acid (e.g., antisense, RNAi oligos, DNA);
– an antagonist of the Hedgehog Pathway that was tested under the Hedgehog Agreement for activity in modulating the signaling of the Hedgehog Pathway before being tested under this Agreement, in which case, such molecule shall be governed by the Hedgehog Agreement; or
– a molecule that is independently developed by Licensee or in-licensed by Licensee, including as may be subsequently modified by Licensee, from a Third Party, in the case of either, unless Licensee elects, in its sole discretion, by written notice to Licensor at any time while the Licensee License is in effect, to include such molecule as a Compound.

The Wnt Pathway means a signaling pathway activated by any Wnt protein. where the components of such pathway include. but are not limited to, frizzled receptors, B-catenin, Bcl9/legless, CBP, TCF/LEF and Pygopus.

Field of Use
The Field means any use excluding Ex Vivo Applications.  Ex Vivo Application means the use of Compounds to manipulate cells in vitro solely for the purpose of autologous or heterologous cell therapy for Non-Oncology Indications in humans.  Ex Vivo Application excludes any administration of a Compound, by any route of administration, to a subject for any purpose including, without limitation, any residual Compound, or active metabolite thereof, included in the final formulation of a therapeutic that is administered to a subject.

This new collaboration, in which Licensor will work exclusively with Licensee, involves the discovery and development of small molecule modulators of an undisclosed pathway that plays an important role in cell proliferation. This pathway is a key regulator of tissue formation and repair, and its abnormal activation is associated with certain cancers.

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