Royalty Report: Drugs, Drug Discovery, Assay – Collection: 245923

License Grant

With this amendment Licensor and Japanese Licensee desire to add and include their cooperative research relationship to develop and market novel therapeutic products whose action is based upon the regulation of STATs involved in IL-18, except to the extent such activation occurs through a protein that is also active within the IL-1 pathway function.

In the agreement, the parties previously entered into, the Collaboration Agreement which, established a cooperative research and development relationship in order to discover, develop and market novel products whose action is based upon the regulation of Signal Transducers and Activators of Transcription ('STATs') involved in [IL-4, IL-12 and gamma interferon] functions.

In the original agreement, the Licensor grants the Japanese Licensee
– an exclusive license to make, have made, use, offer to sell, sell and import Product in the Licensee Territory under the Licensor Technology; and
– a nonexclusive,  worldwide license under Licensors rights in and to the Program Know-How and Program Patents for any purpose outside the Field.

License Property

Licensor is engaged in the research and development of therapeutic pharmaceutical products based upon the regulation of transcription factors.

With the amendment, the compound is updated and shall mean a substance which is identified by the Parties during the term of the Research Program as either inhibiting or promoting the activity of STATs activated by IL-4, IL-12, gamma interferon or IL-18, except to the extent such activation occurs through a protein that is also active within the IL-1 pathway.

Product shall mean a Drug Candidate, when used as an active ingredient in a pharmaceutical product for use in the Field, including all indications, formulations, line extension or modes of administration thereof.

Field of Use

The Field shall mean the therapeutic modulation of human immune function where use is initially restricted to prescription use, whether or not such restriction to prescription use continues.

Licensor have discovered two human transcription factors, STAT6 and STAT4, that are key proteins involved in immune regulation. When overstimulated, these proteins are instrumental in the development of allergy and asthma in the case of STAT6, and in the development of autoimmune diseases such as rheumatoid arthritis and inflammatory bowel disease in the case of STAT4.  Experiments in animals have demonstrated that disabling these proteins is safe and blocks inappropriate immune responses. These results demonstrate that STAT6 and STAT4 are excellent drug discovery targets.  The goal is to discover drugs capable of selectively blocking STAT6 or STAT4 function.

License Grant

The original agreement established a cooperative research relationship based on screening of their respective compound libraries using their respective assays and other jointly developed assays, and intend continue their cooperative research relationship.  With this amendment, the Parties will develop and market novel therapeutic products based on compounds identified during such research as having viral regulatory properties.

Licensor grants, during the Research Term, an exclusive, non-transferable license to use the Program Assays to screen the Program Substances in accordance with the Research Program and a nontransferable, non-exclusive license under the Licensor-owned Program Patents and the Licensor Technology other than the Program Assays to the extent necessary to screen the Program Substances against the Program Assays in accordance with the terms of the Research Program.

For the Preliminary Development by Licensee of Option-Compounds, Licensor grants to an exclusive license under the Licensor-owned and jointly owned Program Patents, the Licensor-owned and jointly owned Program Know-How and the LicensorTechnology for the limited purpose of conducting biological studies, medicinal chemistry, pharmacological development, preliminary animal safety studies or other pre-IND development activities with respect to any Option Compound within any Option Program.

License Property

Products. shall mean, collectively, the Option Products and the Program Products.

Program Product shall mean any pharmaceutical product which results during the Research Term from research conducted with respect to a Program Compound. Each Program Product shall be deemed to include all indications, formulations, line extensions or modes of administration thereof.

Option Compound shall mean a Program Substance which as a result of screening activities under the Research Program, reveals Anti-Viral Activity in only one or more Option Targets,  which is not designated by Licensee as a Restricted Compound and as to which Licensor has commenced and is proceeding with preliminary development activities within two (2) years after the expiration of the Research Term.
—  Option Product shall mean any pharmaceutical product which results during the Research Term or within two (2) years thereafter, from research conducted with respect to an Option Compound. Each Option Product shall be deemed to include all indications, formulations, line extensions or modes of administration thereof.
—  Option Program shall mean either the  Herpes Simplex Virus Option Program or the Cytomegalovirus Option Program, as the case may be.

Field of Use

The Field shall mean all uses in the prevention or treatment of human or animal viral diseases and other diseases which may be designated from time to time by mutual agreement of the parties.

The Targets and Assays are
• Human Immunodeficiency Virus Integrase
• Human Immunodeficiency Virus Tat
• Hepatitis C Virus Helicase
The Core Target Assays are
• Human Immunodeficiency Virus Integrase
• Human Immunodeficiency Virus Tat
• Hepatitis C Virus Helicase
The Option Targets are
• Cytomegalovirus E2
• Herpes Simplex Virus HelicasePrimase
The Option Target Assays are
• Recombinant Cytomegalovirus
• Cytomegalovirus E2
• Recombinant Herpes Simplex Virus
• Herpes Simplex Virus HelicasePrimase

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

The original agreement established a cooperative research relationship based on screening of their respective compound libraries using their respective assays and other jointly developed assays, and intend continue their cooperative research relationship.  With this amendment, the Parties will develop and market novel therapeutic products based on compounds identified during such research as having viral regulatory properties.

Licensor grants to Merck, during the Research Term an exclusive, non-transferable license to use the Program Assays to screen the Program Substances in accordance with the terms of the Research Program; and a non-exclusive, nontransferable license under Licensor-owned Program Patents and the Licensor Technology other than the Program Assays, to the extent necessary to screen the Program Substances in accordance with the terms of the Research Program.

For the Preliminary Development by Licensee of Program Compounds. Licensor grants an exclusive license under the Licensor-owned and jointly owned Program Patents,  the Licensor owned and jointly owned Program Know-How and the Licensor Technology for the limited purpose of conducting biological studies, medicinal chemistry, pharmacological development, preliminary animal studies or such other pre-IND development activities as are necessary for Licensee to fulfill its obligations under the Research Program.

For the License to Licensee for Program Products, Licensor grants an exclusive, worldwide license to develop, make, have made, use, sell and have sold Program Products in the Field under the Licensor-owned and jointly owned Program Patents, the Licensor-owned and jointly owned Program Know-How and the Licensor Technology.

Licensee shall have the exclusive right to develop and commercialize any Program Compound for applications outside the Field.

License Property

Products. shall mean, collectively, the Option Products and the Program Products.

Program Product shall mean any pharmaceutical product which results during the Research Term from research conducted with respect to a Program Compound. Each Program Product shall be deemed to include all indications, formulations, line extensions or modes of administration thereof.

Option Compound shall mean a Program Substance which as a result of screening activities under the Research Program, reveals Anti-Viral Activity in only one or more Option Targets,  which is not designated by Licensee as a Restricted Compound and as to which Licensor has commenced and is proceeding with preliminary development activities within two (2) years after the expiration of the Research Term.
—  Option Product shall mean any pharmaceutical product which results during the Research Term or within two (2) years thereafter, from research conducted with respect to an Option Compound. Each Option Product shall be deemed to include all indications, formulations, line extensions or modes of administration thereof.
—  Option Program shall mean either the  Herpes Simplex Virus Option Program or the Cytomegalovirus Option Program, as the case may be.

Field of Use

The Field shall mean all uses in the prevention or treatment of human or animal viral diseases and other diseases which may be designated from time to time by mutual agreement of the parties.

The Targets and Assays are
• Human Immunodeficiency Virus Integrase
• Human Immunodeficiency Virus Tat
• Hepatitis C Virus Helicase
The Core Target Assays are
• Human Immunodeficiency Virus Integrase
• Human Immunodeficiency Virus Tat
• Hepatitis C Virus Helicase
The Option Targets are
• Cytomegalovirus E2
• Herpes Simplex Virus HelicasePrimase
The Option Target Assays are
• Recombinant Cytomegalovirus
• Cytomegalovirus E2
• Recombinant Herpes Simplex Virus
• Herpes Simplex Virus HelicasePrimase

License Grant

With this amendment, where Licensee desires Licensor to generate Knock-Out Mice and ES Cell Lines for Licensee based on human gene sequences provided by Licensee and then to analyze such Knock-Out Mice and ES Cell Lines, the licensed products have been updated regarding restricted rights projects, and, adds patent information.

For the Exclusive License under Licensor Pre-Existing Patents and Know-How and Restricted Rights Project Patents and Know-How for the Research, Development and Commercialization of Licensed Products,  Licensor grants an exclusive, even as to Licensor, world-wide right and license under the Licensor Pre-Existing Patents and Know-How, and, to the extent specified in the Parties designation(s) of Restricted Rights Project(s), an exclusive, even as to Licensor, or non-exclusive, world-wide right and license under the Restricted Rights Project Patents and Know-How, in each case to research, develop, make (or have made), use, sell, offer for sale, and import Licensed Products in the Field.

For the License under Licensor Pre-Existing Patents and Know-How and Restricted Rights Project Patents and Know-How for the Research, Development and Commercialization of Products Other than Licensed Products in the Field,  Licensor grants a worldwide right and license under the Licensor Pre-Existing Patents and Know-How and, to the extent specified in the Parties designation(s) of Restricted Rights Project(s), the Restricted Rights Project Patents and Know-How to research, develop, make (or have made), use, offer for sale, sell, and import products, including, but not limited to Small Molecule Drugs, other than Licensed Products for use in the Field.

For the Non-Exclusive Research License Grant under Licensor Knock-Out Technology to Knock-Out Mice and Progeny,  Licensor grants a worldwide, non-exclusive right and license under the Licensor Knock-Out Technology to use, breed, cross-breed and have bred and cross-bred KnockOut Mice and Progeny, at the internal research facilities of Licensee and its Academic Collaborators or Contract Service Providers, for research directed toward the discovery, identification, selection, characterization, development or commercialization of products for use in the Field.

License Property

Patent is for Isogenic DNA.
U.S. Patent No. 5,789,215 issued August 4, 1998 entitled 'Gene Targeting in Animal Cells Using Isogenic DNA Constructs'

Licensor possesses certain knowledge and experience in the design, generation, and phenotypic analysis of Knock-Out Mice and ES Cell Lines.

Restricted Rights Project means a Project involving a Project Gene which is subject to the exclusive rights Licensor  has granted to a Third Person prior to the initial proposal of such Project Gene by Genentech.

Licensor Knock-Out Technology means all Patents and Know How which are owned, controlled or licensed by Licensor as of the Effective Date or created or acquired by Licensor during the course of this Agreement and related to a process or method used in the creation or generation of Knock-Out or transgenic mice, including the process for creating Knock-Out Mice and Overexpression Mice.

Licensed Product means a pharmaceutical preparation other than a Small Molecule Drug that is ready for administration to the ultimate consumer and that contains as the active pharmaceutical ingredient a Protein Candidate or that directly modulates a Protein Candidate, or the gene that encodes a Protein Candidate.

Field of Use

Licensor established a drug discovery alliance with Licensee to discover novel therapeutic proteins and antibody targets based on its isogenic DNA gene targeting technology.

Field means any human or animal healthcare applications including, without limitation, the diagnosis, prevention and treatment of diseases or conditions.

License Grant

For the Research Licenses, Licensor grants, during the Research Term an exclusive, world-wide right and license under the Licensor Patents and the Licensor Know-How and Licensors rights in the Joint Patents and Joint Know-How, solely to conduct the Research, and to discover, synthesize, and, in connection with the Research, make and use Active Compounds for use in the Field.

Licensor grants, commencing at the expiration of the Research Term and for a period of six years thereafter, a non-exclusive, world-wide right and license under the Licensor Patents and Licensor Know-How, and Licensors rights in the Joint Patents and Joint Know-How, solely to discover, synthesize, and, in connection with Licensees activities under this Agreement, make and use Active Compounds for use in the Field.

For the Commercialization License to Licensee, Licensor grants an exclusive, world-wide right and license under the Licensor Patents, the Licensor Know-How and under Licensors rights in the Joint Know-How and Joint Patents, solely to [conduct development on, and to make, have made and use for such purpose, Back-Up Compounds and Collaboration Compounds for use in the Field and to make, have made, import, use, sell and offer for sale Licensed. Products) for use in the Field.

For the Cross-License of Know-How Licensor grants a non-exclusive license under the Licensor Know-How for any purpose or use.

License Property

Licensor has proprietary technology and know-how related to the discovery, identification and/or synthesis of cathepsin S inhibitors and have identified chemical compounds that are cathepsin S inhibitors.

Licensed Product means any product, including any formulation thereof, containing or comprising a Collaboration Compound.

Active Compound means any compound that
—  has the ability to inhibit (or, in the case of a prodrug, an active species of which inhibits) cathepsin S with a [K; equal to or less than 100 nM];
—  has greater than [100- fold selectivity] for cathepsin S against an [appropriate panel of cathepsins in appropriate assays,] as determined by the JRC; and
—  has appropriate [in-cell activity in concentrations of less than IO µMin a relevant cell based assay(s)] selected by the JRC.

Field of Use

Field means the treatment and/or prevention of one or more Indications by means of inhibition of cathepsin S.

Cathepsin S is associated with certain inflammatory diseases, such as arthritis, asthma, atherosclerosis and a variety of autoimmune diseases.

Cysteine proteases are enzymes that are responsible for the cleavage and breakdown of other natural proteins in normal biological processes. In disease conditions, cystein proteases can often be misregulated, providing an entry point for drug intervention. Cathepsin S has been associated with the processing and activation of the antigen receptor called MHC-II, essential for the initiation of both normal and pathological immune responses mediated by T-cells. Drugs designed to inhibit this enzyme may provide a novel method for control of antigen-induced response in multiple inflammatory and autoimmune disease states, the companies believe.

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.