Royalty Report: Drugs, Drug Discovery, Assay – Collection: 328341

License Grant

Licensor grants
a. an exclusive, worldwide license in the Fields of Use to practice Licensor Technical Information to develop, identify, make, use and sell Product(s); and
b. an exclusive, worldwide license to practice Licensor Technical Information to develop, make, use, license and sell Assays that utilize or incorporate Licensor Technical Information.

License Property

Licensor developed various technologies relating to signal transduction within cells, and Licensor owns all rights, title and interest in and to such technologies, including related patents, patent applications and unpatented technology relating to mammalian cell and/or enzyme- based assays useful in identifying compounds that regulate cellular transduction pathways.

Products shall mean any compound, formulation or composition whose utility is identified using an Assay.

Assay shall mean one or more mammalian cell and/or enzyme-based assays relating to the regulation of cellular transduction pathways, including G protein-coupled and/or tyrosine kinase-coupled receptor signal transduction pathways, which incorporates or utilizes Licensor Technical Information.

The patents include
–  Method and product for regulating cell responsiveness to external signals,
–  Using tyrosine phosphorylation of map kinase and characterization of the components of the map kinase activation pathway as a drug discovery assay system,
–  Product and process for regulating signal transduction pathways, and,
–  Method and product for regulating cell responsiveness to external signals.

Field of Use

The Fields of Use shall mean all agricultural, veterinary and human therapeutic and diagnostic uses for Licensor Technical Information.

Licensee is engaged in the discovery of novel small molecule therapeutics that act on targets in human cell signaling pathways.

License Grant

The Research Collaboration will focus on Targets in the Pathways, both in finding new proprietary Targets as well as with respect to Targets identified by Licensor prior to the Effective Date, and the use of Targets for HTS assay development to discover proprietary drug leads.  The Research Collaboration will initially focus on elucidating proprietary drug discovery Targets in the Pathways and is anticipated to be restricted to proprietary Targets in the Pathways.  Licensee and Licensor shall conduct the Research Collaboration on a collaborative basis with the goal of identifying Research Compounds that are suitable for development into Products for commercialization.  The Research Collaboration is intended to be flexible to allow for pursuit of unforeseen opportunities in the area of inflammation biology involving the Targets and the Pathways.

License Property

Product means any product incorporating a Development Compound, in any formulation, designed for treatment of a Licensee Indication, Licensor Indication or an Additional Indication, delivered by any route of administration.

Research Compound means any analog or other derivative compound, including a peptidomimetic, that has been synthesized or acquired pursuant to the Research Plan or at the direction of the Officers, and is based upon any Validated Hit.

Target means an enzyme or other molecule that is in a Pathway and is either (a) listed as an included target or (b) discovered by one or both Parties as part of the Research Collaboration (excluding any molecule that is subject to prior rights of any Third Party under an agreement with either Party at the time it is discovered, which agreement is listed on Agreement or (c) licensed by either Party during the Research Collaboration.

Pathways means the Tumor Necrosis Factor-alpha receptor signaling pathway, the IL-1 signaling pathway, and the CD40 signaling pathway, and any additional pathways added to this Agreement upon the written agreement of the Parties.

Targets and Pathways
TNF-R1 Signaling Pathway
TNF-R2 Signaling Pathway
IL-1R Signaling Pathway
CD40 Pathway

Field of Use

Field means research, development and commercialization of small molecule agonists or antagonists of Targets identified in the Pathways, for use in the treatment of Roche Bioscience Indications, Tularik Indications or Additional Indications.

License Grant

The Research Collaboration will focus on Targets in the Pathways, both in finding new proprietary Targets as well as with respect to Targets identified by Licensee prior to the Effective Date, and the use of Targets for HTS assay development to discover proprietary drug leads.  The Research Collaboration will initially focus on elucidating proprietary drug discovery Targets in the Pathways and is anticipated to be restricted to proprietary Targets in the Pathways.  Licensor and Licensee shall conduct the Research Collaboration on a collaborative basis with the goal of identifying Research Compounds that are suitable for development into Products for commercialization.  The Research Collaboration is intended to be flexible to allow for pursuit of unforeseen opportunities in the area of inflammation biology involving the Targets and the Pathways.

License Property

Product means any product incorporating a Development Compound, in any formulation, designed for treatment of a Licensor Indication, Licensee Indication or an Additional Indication, delivered by any route of administration.

Research Compound means any analog or other derivative compound, including a peptidomimetic, that has been synthesized or acquired pursuant to the Research Plan or at the direction of the Officers, and is based upon any Validated Hit.

Target means an enzyme or other molecule that is in a Pathway and is either (a) listed as an included target or (b) discovered by one or both Parties as part of the Research Collaboration (excluding any molecule that is subject to prior rights of any Third Party under an agreement with either Party at the time it is discovered, which agreement is listed on Agreement or (c) licensed by either Party during the Research Collaboration.

Pathways means the Tumor Necrosis Factor-alpha receptor signaling pathway, the IL-1 signaling pathway, and the CD40 signaling pathway, and any additional pathways added to this Agreement upon the written agreement of the Parties.

Targets and Pathways
TNF-R1 Signaling Pathway
TNF-R2 Signaling Pathway
IL-1R Signaling Pathway
CD40 Pathway

Field of Use

Intellectual property relates to inflammation.

Field means research, development and commercialization of small molecule agonists or antagonists of Targets identified in the Pathways, for use in the treatment of Licensor Indications, Licensee Indications or Additional Indications.

License Grant

For the license grant for Exclusive Screens Licensor grants an exclusive right and license, under the Technology, Patents and Know-How, to use and practice the Exclusive Screens, including, without limitation, the right to grow sufficient amounts of Materials provided by Licensor to Licensee.

For the license grant for Non-Exclusive Screens, License grants an exclusive right and license, under the Technology, Patents and Know-How, to use and practice Non-Exclusive Screens, including, without limitation, the right to grow sufficient amounts of Materials provided by Licensor to Licensee, during the term of the Research Programs, but in no event for less than nine months after Licensee receives Materials and other information from Licensor identifying and enabling Licensee to use such Non-Exclusive Screen.

License Property

Licensor has the exclusive rights to certain technology involving the transfection and expression of G-protein- coupled receptors into yeast.  Licensor exploits similarities between the yeast and human genome to identify new drug discovery targets.

The Autocrine System shall mean that part of Licensors Technology whereby any yeast cells into which human Receptors have been inserted and grow in response to compounds produced and secreted by the same yeast cells.

Compound shall mean any Lead Compound or any Analog of any Lead Compound.

Receptor shall mean any human, G-protein-coupled, seven transmembrane receptor (including, without limitation, genes, vectors and cDNAs), and shall include any Licensee Receptor or Other Receptor.

Licensee Receptor shall mean a Receptor which is proprietary to Licensee and is provided by Licensee to Licensor for use in the Research Programs, or a Receptor which is proprietary to Licensee and is cloned or obtained by Licensor pursuant to research performed under the Research Programs, or a Receptor provided by Licensee to Licensor for use in the Research Programs which is deemed to be a Licensee Receptor.

Technology shall mean all inventions, improvements, discoveries, claims, formulae, processes, trade secrets, technologies, Patents and Know-How owned by Licensor or to which Licensor has the rights to grant licenses or sublicenses, and relating to or derived from Licensors yeast-based, human G-protein-coupled receptor technology, or the Research Programs.

The Patents are titled
Expression of G Protein Coupled Receptors in Yeast, Yeast-Based Peptide Libraries for identification of G Protein-Coupled Receptor Agonists and Antagonists, and, Functional Expression of Mammalian Adenylyl cyclase in Yeast.

Field of Use

The field of use is screening assays.

Licensee recognizes that the technology represents a valuable source of development of screening assays for the discovery of potential products for manufacture, use and sale in the Territory.

License Grant

By this amendment the Parties extend their oncology research collaboration designed to identify and validate molecular targets implicated in cancer, with the goal of increasing the total number and degree of validation of cancer targets Licensor will deliver to Licensee. The Parties will each maintain the option to obtain exclusive worldwide rights to equal numbers of validated targets arising from the collaboration.

For Research, Licensor grants a non-exclusive, worldwide license, with the right to sublicense to its Affiliates, but without the right to sublicense to Third Parties except with prior written consent of Licensor, under any Licensor Know-How and Patents solely (A) to perform the research tasks assigned, and (B) to perform research, during the first six months after the end of the Initial Research Term, upon mammalian orthologues of certain Model System Targets.

For Licensee Selected Targets, Licensor grants an exclusive, worldwide, royalty-bearing license, with the right to sublicense, under any Licensor Know-How and Patents covering the composition, manufacture, or use of one or more Licensee Selected Targets, to make and use each such Licensee Selected Target
(A) to perform research within the Research Field upon each such Licensee Selected Target, including using such Licensee Selected Target to search for Collaboration Compounds,
(B) to develop, and make or have made for use in the Development Field, Licensee Products comprising or incorporating Collaboration Compounds,
(C) to develop, following the commencement of a clinical trial of a Licensee Product in the Development Field, such Licensee Product for any human indication , and
(D) to make, have made, use, import, sell, offer to sell and have sold Licensee Products.

For Assays, Licensor grants an exclusive, worldwide license, with the right to sublicense, under any Licensor Know-How and Patents covering the composition or use of one or more Assays,
(A) to make and have made such Assay,
(B) to use each such Assay to search for, make and have made (1) Collaboration Compounds with activity against the Licensee Selected Target for which such Assay was developed, and (2) compounds that lack activity against the Licensee Selected Target for which such Assay was developed,
(C) to develop, and make or have made, for use in the Development Field, and in any defined field licensed by Licensee, Licensee Collaboration Products, and
(D) to develop, following the commencement of a clinical trial of a Licensee Collaboration Product in the Development Field, such Licensee Collaboration Product for any human indication.

For Lead Compounds/Back-Up Compounds, Licensor grants a worldwide license, with the right to sublicense, under any Licensor Know-How and Patents during the term of this Amended and Restated Agreement covering the composition, manufacture, or use of a Lead Compound delivered to Licensee or a Back-up Compound for such Lead Compound,
(A) to make derivatives of such Lead Compounds and Back-up Compounds,
(B) to research, develop, and make or have made for use in the Development Field, Licensee Collaboration Products comprising or incorporating such a Lead Compound or Back-up Compound or derivative thereof,
(C) to develop, following commencement of a clinical trial of such a Licensee Collaboration Product in the Development Field, such Licensee Collaboration Product for any human indication, and
(D) to make, have made, use, import, sell, offer to sell and have sold such Licensee Collaboration Products.

For Pharmacogenomic Uses, Licensor grants a nonexclusive, worldwide, royalty-bearing license, with the right to sublicense, under the Licensor Know-How and Patents covering the composition, manufacture or use of any Selected Target of either Party, to use such Selected Target in the research, development, manufacture, use, import, sale and offer for sale of a Pharmacogenomic Product for use
(A) in connection with the research, development, manufacture, use, import, sale and offer for sale, for any indication, of a (i) Licensee Product or (ii) a product that modulates the same Selected Target as such Licensee Product via substantially the same molecular mechanism of action (a Target Product), and
(B) in the labeling, promotion, and registration of any Licensee Product or Target Product for any indication. Such license for a particular Pharmacogenomic Product shall be sublicensable solely (x) together with a sublicense under with respect to a related Licensee Product or (y) by Licensee or its sublicensee, for the purpose of developing or commercializing a Pharmacogenomic Product for use in conjunction with a related Licensee Product that Licensee or its sublicensee is developing or commercializing.

For Negative Screening Using Licensor Targets, Licensor grants to a non-exclusive, worldwide, license under any Licensor Patents and Know-How covering the composition, manufacture, or use of an Licensor Selected Target, to use such Licensor Selected Target solely in secondary screening assays developed by or for Licensee to identify, research and develop Collaboration Compounds and Licensee Products that lack the ability to inhibit, activate or otherwise modulate the activity of such Licensor Selected Target.

For Licensor Validation Protocols and Reagents, Licensor grants a non-exclusive, worldwide license under the Licensor Know-How and Patents relating to
(A) the Licensor validation protocols and reagents listed and
(B) all validation protocols and reagents that are developed by Licensor in the course of performing its duties under the Research Plan, to use same for all-purposes.

For Improvements to Licensee Validation Protocols and Reagents, Licensor grants a non-exclusive, worldwide license, with the right to sublicense, under the Licensor Know-How and Patents to use for all purposes, all improvements to the validation protocols and reagents licensed by Licensor that incorporate or contain any of such validation protocols and reagents licensed by Licensee.

For Target Inventions
–  Subject to the terms of this Amended and Restated Agreement, Licensor grants an exclusive, worldwide license, under the Target Inventions invented solely by Licensee and all Patents Controlled by Licensor that claim such Target Inventions, to use such Target Inventions for all purposes other than those for which Licensor has exclusive rights, and,
–  Subject to the terms of this Amended and Restated Agreement, Licensor grants a worldwide license, under the Target Inventions invented jointly by Licensee and Licensor and all Patents Controlled by Licensor that claim such Target Inventions, to use, without any accounting or obligation to, or consent required of, Licensor, such Target Inventions for all purposes other than those for which Licensor has exclusive rights.

For the Option for Non-exclusive License, Subject to the terms of this Amended and Restated Agreement, Licensor grants an option to receive a non-exclusive, worldwide license, with the right to sublicense, under the Licensor Know-How and Patents covering the composition, manufacture, or use of one or more Licensee Selected Targets
(A) to perform research in a defined field outside the Research Field upon each such Licensee Selected Target, including using such Licensee Selected Target to search for Collaboration Compounds with activity outside the Development Field,
(B) to develop, and make or have made, for use in a defined .field outside the Development Field, Licensee Products comprising or incorporating Collaboration Compounds, and
(C) to make, have made, use, import, sell, offer to sell and have sold such Licensee Products.

License Property

The technology is for Entry points for Oncology Genetic Screens including Apoptosis, DNA Repair, Cell Adhesion, and Larval tumor suppressors. C. elegans or S2 cell culture screens, and, Mammalian cell culture screens.

Genetic Screen means a systematic analysis, for the purpose of Model System Target identification, of the functions of a Genetic Entry Point and of other genes or gene products in the same or related pathway, such analysis involving
(a) in vivo or in vitro alteration (via mutation or introduction of inhibitory molecules such as small molecules, antibodies, antisense molecules, or peptides) of such Genetic Entry Point or its encoded product, such alteration having an assayable phenotype or activity,
(b) isolation of mutations, genes or gene products that modify the phenotype or activity of the altered Genetic Entry Point,
(c) characterization of the modifying mutations, genes or gene products, and
(d) cell based assays or phenotypic assays that look directly at biological processes in oncology.

Phenotypic Screen means a screen performed in a wild-type cell or organism in which certain genes are turned on or off and the effect thereof is measured through the use of an assay that measures a biological response in the Research Field.

Field of Use

The Research Field means cancer research regarding
(a) growth regulation,
(b) cell cycle control,
(c) DNA damage response,
(d) cell survival,
(e) cell adhesion, or
(f) apoptosis
as they pertain to cancer, as well as the adenomatous polypossis coli gene (ape).

The Development Field means the treatment or prophylaxis of any type of human cancer.

The Parties desire to establish a collaboration to apply such Licensor technology and expertise to the identification and characterization of biochemical pathways and targets in specific research areas relevant to cell growth and proliferation, to generate small molecule therapeutic or prophylactic compounds directed against such targets, and to provide for the development and commercialization of novel therapeutic and prophylactic products based on such research.

License Grant

Included with this collaboration agreement is information for a third party license.  The collaboration is to screen the Materials against the Assays.

In the third party license, the University grants the use of the assay.

License Property

The assay is for the mutant cystic fibrosis transmembrane regulator or CFTR.

Field of Use

Licensee has Assays which have the potential to identify therapeutic and/or diagnostic products.

License Grant

For the Commercial License to Clinical Candidates and Corresponding Products, Licensor grant an exclusive license, with the right to grant and authorize sublicenses through multiple tiers, under the Licensor Technology and Licensors interest in the applicable Collaboration Technology, to make, have made, use, offer for sale, sell, import, export and otherwise exploit Active Compounds, Clinical Candidates, Lead Compounds and Products for use in the Field and in the Territory.

License Property

The Parties have each identified multiple oncology kinase targets that have the potential to be used as the basis for drug discovery programs.

Active Compound shall mean a Compound that modulates a Target, the mechanism of which is a binding interaction with a Target, having a level of activity against a Target, expressed as an IC50, that is – less than forty (40) nanomolar- as measured in the applicable in vitro biochemical assay set forth in the Discovery Plan; and a Compound that modulates at least two of the following receptors TrkA, TrkB or TrkC, the mechanism of which is a binding interaction with the applicable Trk receptor, having a level of activity against the applicable Trk receptor, expressed as an ICso, that is less than forty (40) nanomolar as measured in the applicable in vitro biochemical assay set forth in the Discovery Plan.

Clinical Candidate shall mean, with respect to each Target or Trk, any Active Compound that meets the Clinical Candidate Criteria set forth in the Discovery Plan.

Compound shall mean any one or more chemical entity(ies) made and tested against Trk in the course of Licensors pan-Trk program prior to the Effective Date, or synthesized by Licensor in the course of performing or in connection with the Discovery Program, in each case together with any salt, hydrate, solvate, clathrate, polymorph or isomer thereof.

Product shall mean any pharmaceutical product incorporating as an active ingredient an Active Compound.

Trk shall mean the Trk family of receptors TrkA, Tr kB and TrkC.
—  TrkA shall mean the protein known as UniProtKB/Swiss-Prot # P04629.
—  TrkB shall mean the protein known as UniProtKB/Swiss-Prot # Q16620.
—  TrkC shall mean the protein known as UniProtKB/Swiss-Prot # Q16288.

The Targets are
—  The protein family commonly known as Firbroblast Growth Factor Receptors (FGFR),
—  The protein commonly known as [p70S6 Kinase], identified with the following SwissProt entries
a) Ribosomal protein S6 kinase beta-1 (P23443)
b) Ribosomal rotein S6 kinase beta-2 (Q9UBS0]—  The protein commonly known as Telomerase reverse transcriptase, identified with the following SwissProt entries
a) Telomerase reverse transcriptase (014746)
b) Telomerase protein component 1 (Q99973)

Field of Use

The development and commercialization agreement pertain to certain Array-invented compounds targeted at a specified novel oncogenic activating mutation.

Licensee possesses pharmaceutical research, development and commercialization capabilities, as well as proprietary technology in the field of cancer treatment.