Royalty Report: Drugs, Cancer, Drug Discovery – Collection: 26036

License Grant

Cephalon and Ambit wish to enter into a collaboration employing the Parties’ medicinal chemistry and biology capabilities, in order to discover, develop and commercialize pharmaceutical compounds in the field of treatment of any and all oncological diseases.

License Property

Cephalon has expertise in the research, development and commercialization of pharmaceutical compounds and will perform in vivo biology (xenograft and other models) and drug development qualifying activities prior to designation of the Collaboration Clinical Candidate.

Field of Use

Ambit has expertise in the profiling of pharmaceutical compounds against human protein kinases and expertise in the research and development of pharmaceutical compounds.

License Grant

The parties wish to enter into a collaboration employing Licensees medicinal chemistry, analytical chemistry and primary biology capabilities and Licensors chemistry, in vitro biology, and in vivo biology capabilities, in order to develop and commercialize pharmaceutical compounds subject to and in accordance with the terms and conditions of this Agreement (the “Collaboration”).

License to Commercialize Collaboration Compounds – With respect to all Collaboration Compounds for which Licensee has received Licensors approval to develop and commercialize, Licensor grants to Licensee a worldwide, exclusive license, with the right to sublicense, under the Licensor IP and Licensor’s interest in the Collaboration IP, to make, have made, use, sell, offer to sell and import Collaboration Compounds, and/or Collaboration Products based on such Collaboration Compounds, for any and all uses and indications in the Licensee Field.

License to Compounds (Other than Collaboration Compounds) Derived from Licensee Compounds –  Licensor grants to Licensee a worldwide, perpetual, exclusive, royalty-free license, with the right to sublicense, under Licensors interest in the Collaboration IP, to exploit for any and all purposes all compounds (other than Collaboration Compounds) derived, directly or indirectly, from Licensee Compounds.

Research Licenses – The Parties hereby grant each other non-exclusive, worldwide, royalty-free research licenses, without the right to sublicense, under their respective interests in the Licensee IP, Licensor IP and Collaboration IP, in order for each Party to perform its research obligations pursuant to Research Plans during the Collaboration Term.

License Property

Collaboration Compound shall mean a Licensee Compound or a Non-Exclusive Compound or a compound that is derived, directly or indirectly, from a Licensor Compound, Licensor Compound, or Non-Exclusive Compound; in each case, that modulates the biological activity of a Collaboration Target at a level of potency to be established by the JRC.  A compound shall be deemed to have been derived directly from another compound if it (i) is the result of a chemical modification made to such a compound, (ii) is otherwise obtained from a chemical synthesis program based on one or more such compounds, (iii) is based on proprietary structure-activity data obtained from the testing of one or more such compounds, or (iv) is specifically or generically within the scope of one or more claims of any patent application or patent filed by Licensee or Licensor or their Affiliates to protect any compound in category (i), (ii) or (iii) above.  A compound shall be deemed to have been derived indirectly from another compound if it is the result of a series of iterations of any or all of (i) through (iv) above.  For purposes of clarity, any compound synthesized in the course of the Collaboration and based on a Licensor Compound, Licensee Compound, or Non-Exclusive Compound which is active against a Collaboration Target at the level of potency established by the JRC shall be deemed a Collaboration Compound.

Licensee IP shall mean Licensee Patents and Licensee Know-how.  Licensee IP shall not include any intellectual property owned or licensed by Licensee or its Affiliates relating to the ECLiPSâ„¢ technology (i.e., the creation or use of encoded combinatorial libraries or any tag and/or marker compounds).

Field of Use

Licensee Field shall mean, with respect to each Collaboration Compound for which Licensee has received approval to develop pursuant, all human and animal disorders and diseases treated by modulation of a Collaboration Target by such Collaboration Compound.

Licensor Field shall mean, with respect to each Collaboration Compound, all human and animal disorders and diseases treated by modulation of a Collaboration Target by such Collaboration Compound.

The primary objective of the alliance is to identify active molecules and bring them forward to clinical proof of concept, yielding novel candidates for drug development in various therapeutic areas.

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.

License Grant

The Licensor and the Licensee desire to enter into a collaborative relationship to conduct research to identify novel targets for drug discovery, as generally described in the Research Plan, with Licensee developing and commercializing any compounds resulting therefrom.

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.

License Grant

By this agreement, for the Clinical Development of product candidates, Licensee may chose Product Candidates, if any, for Clinical Development. Licensee of Japan shall notify Licensor of the United Kingdom in writing of whether it is has chosen one or more Product Candidates.

Upon notice by Licensee to Licensor from time to time during the period permitted therefor pursuant to this Agreement, Licensor shall granted to Licensee under Collaboration IP and Licensor Background IP, without the need for further action by either of the Parties, an exclusive, license to make, have made, use, offer for sale, sell, import and otherwise exploit the Product Candidates referenced in such notices in the Territory in the Research Field.

Licensor of the United Kingdom grants to the Licensee of Japan under Licensor Background IP and Collaboration IP, the sole right to use the same in any way whatsoever for the purpose of the Research Collaboration including to research and use Research Compounds for the purposes necessary to perform its obligations and exercise its rights under the Research Plan but excluding the right to manufacture Research Compounds or have Research Compounds manufactured on its
behalf other than by Licensor. This right shall not be capable of sub-license.

License Property

Licensor has expertise in the research and development of pharmaceutical preparations based upon botanical extracts from chemovars of Cannabis sativa, and, has proprietary knowledge and interests in the research and development of pharmaceutical preparations based upon botanical extracts from different chemovars of Cannabis sativa in addition to that combination of botanical extracts used in SATIVEXâ„¢ oromucosal spray.

Research Compounds shall mean collectively, all Selected BDCs and Selected Drug Candidates. For clarity, Research Compounds shall include Synthetic Cannabinoids synthesized under the Research Plan and which subsequently become Selected BDCs and/or Selected Drug Candidates.

Botanical Drug Candidate or BDC shall mean
—  any cannabinoid from a single chemovar of a chemically and genetically characterized Cannabis sativa plant (Phytocannabinoid) at any stage of research or development made using any extraction method and in any degree of purification in which only a single cannabinoid is present in a concentration which has the potential to be therapeutically active including, without limitation, the THC fraction and the CBD fraction separately; and
—  a combination of two or more Phytocannabinoid extracts described containing two or more Phytocannabinoids present in concentrations such that both have the potential to be therapeutically active mixed in a precise ratio i.e. the THC and CBD fractions mixed (without other fractions) in the ratio of THC CBD of 90 10. For clarity specifically excluded from the definition of BOC is any combination of the THC and CBD fractions when mixed (without other fractions) in a ratio of CBD to THC that falls inside the range of 2575 to 7525; and
— any biological or chemical modification of the Phytocannabinoids including any metabolite or degradant.

Synthetic Cannabinoid shall mean any Phytocannabinoid produced by synthetic methods either pursuant to a Research Plan (a Type 1 Synthetic Cannabinoid), or, outside of the Research Collaboration but with information resulting from the Research Collaboration (Type 2 Synthetic
Cannabinoid).

Synthetic Cannabinoid Product shall mean any pharmaceutical product containing a Type 1 Synthetic Cannabinoid (Type 1 Synthetic Product) or a Type 2 Synthetic Cannabinoid (Type 2 Synthetic Cannabinoid Product).

Synthetic Molecule shall mean a synthetic molecule whose chemistry is not based on a Phytocannabinoid but;
—  which has been developed with information resulting from the Research Collaboration and,
—  for which one or more patent· applications have been filed by Licensee on an invention conceived within three years following expiration of the Research Term or any Extended Research Term claiming a novel composition of matter and a cannabinomimetic or cannabinergic effect through direct, or indirect (i.e. modulation of related metabolic enzyme systems), effects on one or more cannabinoid receptors (including their allosteric sites).

Synthetic Molecule Product shall mean any pharmaceutical product containing a Synthetic Molecule.

Field of Use

The field of use is neuropsychopharmacology, with special reference to schizophrenia, cannabinoid/opioid analgesic combinations, and, oncology.

Research Field shall mean the treatment, diagnosis, prevention, or palliation of diseases, conditions, syndromes, and maladies of the central and peripheral nervous. systems of humans and animals and cancer in humans and animals.

License Grant

For the research program, the general goals and intent of the Collaboration are to apply the Exelixis technology to discovering Eligible Targets that may be useful for the discovery and development of small molecule drugs for the prevention, treatment or cure of cancer.

Regarding the Licensor Know-How and Patents.
For Research, Licensor grants a non-exclusive, worldwide, license, under any Licensor Know-How and Patents solely to perform the research tasks assigned and and to perfom research, during the first six months after the end of the Research Term, upon mammalian orthologues of certain Model System Targets.

For Licensee Selected Targets, Licensor grants an exclusive, worldwide license, 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 BMS 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, 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. Such license shall convert to a nonexclusive license, on an Assay-by-Assay basis, on the earlier of the date that is twenty (20) years after the end of the Research Term, or the Licensee Selected Target relating to such Assay becomes an Abandoned Target and is selected by Licensor as a Licensee Selected Target.

For Lead Compounds/Back-Up Compounds, Licensor grants a worldwide, license, under any Licensor Know-How and Patents during the term of this 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, Licensor 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 Licensor 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 license, 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 Licensee Product or 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.

For Negative Screening Using Licensor Targets, Licensor grants a non-exclusive, worldwide, bearing license under any Licensee 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 Licensee Selected Target.

Foe 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 under the Licensor Know-How and Patents to use for all purposes, all improvements to the validation protocols and reagents licensed by Licensee that incorporate or contain any of such validation protocols and reagents licensed by Licensee.

Regarding Target Inventions
– 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.

– Licensor grants a worldwide license, under the Target Inventions invented jointly by the Parties 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. The foregoing license is exclusive, with respect to Licensee Selected Targets, for those purposes for which Licensee has exclusive rights; such license is co-exclusive for all other permitted purposes.

License Property

Licensor is a multinational biotechnology company that has expertise and proprietary
technology relating to genetic model systems, functional genomics and computational biology and is applying such technology to discover and validate targets for drug discovery in a variety of disease areas.

Collaboration Compound means any molecule that
(a) has a molecular weight less than or equal to one thousand (1,000) daltons,
(b) is known, prior to the initiation of the first clinical trial for a Product containing such molecule, to have the ability to directly inhibit, activate or otherwise modulate the activity of a Selected Target, or inhibit, activate or otherwise modulate the activity of a Selected Target or its encoded protein in an assay measuring the activity of such Selected Target, and
(c) such ability is identified by or on behalf of a Party or its Affiliate or sublicensee, after the selection of a Selected Target by such Party, through the use to any material extent of such Selected Target or any Information relating to such Selected Target.

DPI Orthologue means a human orthologue.

Eligible Target means a human gene that is
(a) a human orthologue of a Model System Target,
(b) identified prior to the Research Term and during the Research Term or, after the end of the Research Term;
(c) not subject to any previously granted, prior to the identification of such gene as a human orthologue of a Model System Target, and currently in effect license from
Licensor to a Third Party for such Third Party to use such gene or its encoded protein for research in the Research Field or development, in the Development Field, of a small molecule product directed at such gene or its encoded protein or to make, use, import, offer for sale or sell such a product; provided, that so long as such license is not exclusive, the Licensee members of the JSC may elect to waive the requirements under this subsection (c) as to any given gene, and
(d) either not claimed in an issued Third Party patent covering its composition of matter or method of use in oncology,

Model System Target means an invertebrate or non-human, vertebrate gene.

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

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 (apc} For clarity, the Research Field does not include angiogenesis/lymphangiogenesis research or research regarding cell motility or cell-cell communication (it being understood that cell-cell communication does not encompass cell adhesion which shall be included within the Research Field.

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

The Parties are establishing 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.  In a cooperative effort that will leverage each Licensees technology and expertise in the fields of genomics and target validation, Licensor will identify and validate molecular targets that trigger cell death in cancer cells, while leaving normal cells unharmed. Licensee will then further validate these targets in human models.