Royalty Report: Drugs, Diagnostic, Therapeutic – Collection: 233495

Upon a Research Project becoming an Elected Project,  the Licensor of Iceland grants the Swiss Licensee sole and exclusive worldwide right and license under Joint Know-How and Joint Patents, sole and exclusive worldwide right and license to use Licensor Know-How and all Licensor Patents, and a non-exclusive right and license to use Licensor Generalized Technology, to make, have made, use, offer for sale, sell, have sold, and import Diagnostic Products developed a result of the Elected Project, in the Field throughout the Territory.

Upon a Research Project becoming an Elected Project, Licensor grants a non-exclusive right and license under Licensor Intellectual Property, solely to the extent necessary to make, have made, use, offer for sale, sell, have sold and import Diagnostic Products in the Field throughout the Territory.

Licensor grants a non-exclusive worldwide right and license under Licensor Know-How and Licensor Patents, and a non-exclusive right and license to use Licensor Generalized Technology, solely for Licensees internal research purposes relating to the development of Diagnostic Products in the Field throughout the Territory.

Licensor grants a  world-wide, license and immunity from suit to practice, make, have made, use and sell and have sold, any products or other materials but for the license granted herein would infringe a Valid Claim under the Licensor Patent commonly known as the Lupus Patent; and a subscription fee-free, world-wide license to Licensors database commonly known as the Clinical Genome Miner.

For the Research Programs, during the Research Term, each Party grants to the other Party and its Affiliates a fully paid-up, non-royalty bearing non-exclusive right and license, without the right to grant sublicenses, under such Partys respective Know-How and Patents, for the sole and exclusive purpose of the other Party fulfilling its research obligations under any and all Research Projects under this Agreement.

For subscription to the database Licensor shall grant Licensee and its Affiliates as defined in the Diagnostics Agreement, a non-exclusive non-transferable license to the CGM, for Licensees use in the conduct of its internal research and development programs in the Field.

Diagnostic Product shall mean any product in the form of a device, compound kit or service useful in the Field which contains a component which is able to detect and/or quantify the presence or amount of  a disease gene that affects the pathogenesis of the Disease, or a product of a Disease Gene that affects the pathogenesis of the Disease, or a biological marker or set of biological markers shown to indicate a predisposition to a Disease, or is derived from Biological Material or any product in the form of a device, compound, kit or service useful for the measurement or prediction of individual patient response to a therapeutic product, which device, compound, kit or service contains a component which is able to defect and or quantify the presence or amount of a Disease Gene, or a product of a Disease Gene or is derived from Biological Materials and is discovered, developed, made or created during, or as part of or as a direct result of a Research Project by a Party, its Affiliates or its Collaborator at any time during the Research Term.

CGM is Licensors database commonly known as the Clinical Genome Miner.

RNA Amplification Technology
Licensor hereby grants to Licensee a worldwide, non-transferable (except as provided in Section 14.6), royalty-bearing, non-sublicensable, non-exclusive license under (i) the Licensor Background Technology directed to RNA Amplification and (ii) the RNA Amplification Technology, in each case, to practice and use the subject matter within the foregoing to research, develop, make, have made, import, use, offer for sale, and sell products for use in the Licensee Database Field of Use, Diagnostic Field of Use, Homebrew Field of Use, and Personal Research Field of Use.

Paraffin Extraction Technology
Licensor hereby grants to Licensee a worldwide, non-transferable (except as provided in Section 14.6), royalty-free, fully paid-up, non-sublicensable, non-exclusive license under Licensor’s Background Technology directed to Paraffin Extraction to practice and use the subject matter within the foregoing to research, develop, make, have made, import, use, offer for sale, and sell products for use in the Licensee Database Field of Use, Diagnostic Field of Use, Homebrew Field of Use, and Personal Research Field of Use.

Research License
Licensor hereby grants to Licensee a worldwide, non-transferable (except at provided in Section 14.6), royalty-free, fully paid-up, non-sublicensable, non-exclusive license under the Licensor Background Technology and the Program Technology owned by Licensor to practice and use the subject matter within the Licensor Background Technology and the Program Technology to conduct internal research.

Development License
Licensor hereby grants to Licensee a worldwide, non-sublicenseable, royalty-free, fully paid-up, non-exclusive license under the Licensor Background Technology and the Program Technology owned by Licensor to practice and use the subject matter within the Licensor Background Technology and Program Technology to conduct its activities under the Development Program.

Licensee hereby grants to Licensor a worldwide, non-sublicenseable, royalty-free, fully paid-up, non-exclusive license under the Program Technology owned by Licensee to practice and use the subject matter within the Program Technology to conduct its activities under the Development Program.

Commercialization Licenses
Licensee hereby grants to Licensor a worldwide, non-transferable (except as provided in Section 14.6), royalty-free, fully paid-up, non-sublicensable, non-exclusive license under the Paraffin Extraction Technology to research, develop, make, have made, import, use, offer for sale, and sell products for use in the Licensor Field and to conduct internal research.

Improvement
Licensee hereby grants to Licensor a worldwide, perpetual, irrevocable, fully paid up, royalty-free, non-transferable (except as provided in Section 14.6), non-exclusive license, under the Improvements Controlled by Licensee to practice and use the subject matter within such Improvements to research, develop, make, have made, import, use, offer for sale, and sell products, in each case, for use in the Licensor Field.

Licensor hereby grants to Licensee a worldwide, perpetual, irrevocable, fully paid up, royalty-free, non-transferable (except as provided in Section 14.6), non-exclusive license under the Improvements Controlled by Licensor to practice and use the subject matter within such Improvements to research, develop, make, have made, import, use, offer for sale, and sell products, in each case, for use in the Licensee Database Field of Use, Diagnostic Field of Use, Homebrew Field of Use, and Personal Research Field of Use.

Paraffin Extraction shall mean the recovery and extraction of native nucleic acids, polypeptides, peptides and/or proteins from tissues embedded in paraffin.

RNA Amplification Technology shall mean all Program Technology relating to the selective amplification, labeling or conjugation of RNA segments in a close to linear fashion. RNA Amplification shall mean the selective amplification, labeling or conjugation of RNA segments in a close to linear fashion.

Products shall mean Licensee Database Products, Personalized Research Products, Homebrew Products and/or Diagnostic Products.

Diagnostic Product(s) shall mean an assay provided as a product or service performed on a human tissue or other human biological sample containing nucleic acids or proteins that are collectively intended to establish or identify an association between the presence or absence of such nucleic acids or proteins and
(a) diagnosis of the presence of, or absence of, a specific disease(s), state(s) or condition(s) in humans;
(b) predisposition to the presence of, or absence of, a specific disease(s), state(s) or condition(s) in humans;
(c) response or lack of response to disease therapy(ies) in humans or preventative strategies in humans;
(d) prediction of the disease course in humans, and or other changes in state(s) or condition(s) in humans over time;
(e) clinical traits in humans for which a medical professional should be consulted; or variation(s) in specific trait(s) and/or characteristics among individuals;
(f) variation(s) in specific trait(s) and/or characteristics among individuals; and/or
(g) predisposition to development of toxicities to disease therapies or preventative strategies in humans.

the results of which are provided to payors, providers or patients, and for which FDA approval (or comparable regulatory agency in other jurisdictions) is required. Diagnostic Products exclude Homebrew Products, Personalized Research Products and Licensee Database Products.

Homebrew Product(s) shall mean a Single Analyte Assay(s) provided as a product or a service performed by a service provider that would constitute a Diagnostic Product with the sole exception that it is provided prior to receipt of approval by the FDA or comparable regulatory agency in any jurisdiction outside of the United States. Homebrew Products exclude Diagnostic Products, Personalized Research Products and Licensee Database Products. For purposes of the foregoing, “Single-Analyte Assays” shall mean a assay designed for testing or measuring only a single analyte.

Personal Research Products shall mean shall mean a Multi-Analyte Assay(s) provided as a product or a service containing nucleic acids or proteins that are collectively intended to establish or identify an association between the presence or absence of such nucleic acids or proteins and
(a) diagnosis of the presence of, or absence of, a specific disease(s), state(s) or condition(s) in humans;
(b) predisposition to the presence of, or absence of, a specific disease(s), state(s) or condition(s) in humans;
(c) response or lack of response to disease therapy(ies) in humans or preventative strategies in humans;
(d) prediction of the disease course in humans, and or other changes in state(s) or condition(s) in humans over time;
(e) clinical traits in humans for which a medical professional should be consulted;
(f) variation(s) in specific trait(s) and/or characteristics among individuals; and/or
(g) predisposition to development of toxicities to disease therapies or preventative strategies in humans.

Such an assay will be considered a “Personalized Research Product” only where the results are provided directly to the tested individual and/or to the tested individual’s health care provider, and where the approval by the FDA or comparable regulatory agency in any jurisdiction outside of the United States is not required. “Personalized Research Products” exclude Homebrew Products, Diagnostic Products and Licensee Database Products. For purposes of the foregoing, “Multi-Analyte Assay(s)” shall mean an assay designed for testing or measuring more than a single analyte.

Licensee Database Products shall mean a collection of information derived from or by testing a person or persons in the Diagnostic Field of Use, Homebrew Field of Use or the Personalized Research Field of Use. Licensee Database Products exclude Diagnostic Products, Homebrew Products, and Personalized Research Products.

Licensor Background Technology shall mean the Intellectual Property that Licensor Controls as of the Effective Date and during the Development Program which is necessary for the conduct of the Development Program and the exploitation of the Program Technology and/or the Improvements,  and which is directed to (a) the recovery and extraction of native nucleic acids, polypeptides, peptides and/or proteins from tissues embedded in paraffin for use in the research, development and commercialization of assays, including without limitation microarrays (“Paraffin Extraction”); or (b) the selective amplification, labeling or conjugation of RNA segments in a close to linear fashion (“RNA Amplification”). Licensor Background Technology shall exclude those patents licensed to Licensee under the Patent License Agreement.

Program Technology shall mean all Intellectual Property created by Licensor or Licnesee after the Effective Date and during the Development Period (i) in the course of performing the Development Program, or (ii) using Confidential Information provided by the other Party to the inventing Party in connection with the Development Program.

Intellectual Property shall mean trade secrets, Patents, copyrights, Know-How, and similar rights of any type under the laws of any governmental authority, domestic or foreign, including all applications and registrations relating to any of the foregoing.

Homebrew Field of Use shall mean the research, development, manufacture, importation, use and/or sale of Homebrew Product(s). The Homebrew Field of Use excludes the Diagnostic Field of Use, the Internal Research Field of Use and the Personalized Research Field of Use.

Personal Research Field of Use shall mean the research, development, manufacture, importation, use and/or sale of Personalized Research Product(s). The Personalized Research Field of Use excludes the Diagnostic Field of Use, the Homebrew Field of Use, and the Licensor Field of Use.

Licensee Database Field of Use shall mean the research, development, manufacture, importation, use and/or sale of Licensee Database Product(s) to end users.

Licensor Field shall mean all internal research and development applications of Paraffin Extraction Technology or Improvements, including the use of such technology to develop therapeutic products and the use of such technology in connection with the commercialization of research tools, such as databases, use of a biochemical test for detecting and/or quantifying a specific nucleic acid target sequence within a nucleic acid mixture which is designed and intended “For Research Use Only” or “For Investigational Use Only” or as a general purpose laboratory reagent. For the avoidance of doubt, the Licensor Field shall exclude any, Diagnostic Field of Use, Homebrew Field of Use, and Personal Research Field of Use.

The Collaborative Agreement pertains to certain of Licensor’s patent rights and know-how regarding cloning, DNA sequencing, and data analysis technologies.
Under the Patent License Agreement, Licensee licenses various classes of patents from Licensor pertaining to the manipulation of genes, the detection of pathological conditions, comparative gene analysis, methods for fabricating tests of biological samples and the use proteins as markers for cancers.

For the Grant of Rights and Licenses in the Research Field,  Licensor grants to Licensee and its Affiliates, within the Territory, a non-exclusive right and license, without any right to sublicense, under the Licensor Patent Rights and Know-How with respect to Research Program Gene Products and, to the extent licensed to Licensee in the Commercialization Field, Licensed Gene Products solely in the Research Field.

For the Grant of Rights and Licenses to Therapeutic Proteins in the Commercialization field, Licensor  grants to Licensee and its Affiliates, within the Territory, a non-exclusive license, with the right to sublicense under Licensee Know-How with respect to Licensed Gene Products to discover, develop, make, have made, import, use, have used, offer for sale, sell and have sold Therapeutic Proteins in the Commercialization Field and an exclusive license, with the right to sublicense, under the Licensor PatentbRights and Licensors interest in any Joint Patent Rights and Joint Know-How with respect to Licensed Gene Products, including any Therapeutic Protein that incorporates or is derived from any such Licensed Gene Product, to discover, develop, make, have made, import, use, have used, offer for sale, sell and have sold Therapeutic Proteins in the Commercialization Field.

For the Grant of Rights and Licenses to Products Other than Therapeutic Proteins in the
Commercialization Field, Licensor grants to Licensee and its Affiliates, within the Territory, a non-exclusive license, with the limited right to sublicense, under the Licensor Patent Rights, Know-How and Licensors interest in any Joint Patent Rights and Joint Know-How with respect to Licensed Gene Products, including any Diagnostic Product that incorporates or is derived from any such Licensed Gene Product, to discover, develop, make, have made, import, use, have used, offer for sale, sell and have sold Diagnostic Products and Drug Products in the Commercialization Field.

Licensor Know-How means trade secrets and other rights in or to Research Program Gene Products and Licensed Gene Products.

Diagnostic Product means any product or service derived from or directed to Research Program Gene Products or Licensed Gene Products for use in the Diagnostic Field.

Therapeutic Protein shall mean any product or service, including gene therapy, which uses a protein, peptide or polypeptide which is a Gene Product in the treatment or prevention of any disease, state or condition in humans.

Licensed Gene Product means any Gene Product for which Licensee and /or Licensor is granted a license in the Commercialization Field.

Diagnostic Field means in vitro or in vivo diagnosis or pre-screening of human patients to determine therapeutic eligibility for a Product in the Therapeutic Field or for monitoring human patients receiving a Product in the Therapeutic Field; provided, however, that the Diagnostic Field excludes the commercialization of diagnostic products for which no Regulatory Approval has been obtained and which are not the subject of an active application for Regulatory Approval, multi-gene diagnostic products, and diagnostic products directed to quantitative detection of relative RNA transcript abundance of multiple RNA species.

Research Field means use by Licensee, Licensor and their respective Affiliates, at the internal research facilities of Licensee, Licensor and their respective Affiliates, for research directed toward the discovery, identification, selection, or characterization of Products.

For the Grant of Rights and Licenses in the Research Field, Licensor grants to Licensee and its Affiliates, within the Territory, a non-exclusive right and license, without any right to sublicense, under the Licensor Patent Rights and Know-How with respect to Research Program Gene Products and, to the extent licensed to Licensee in the Commercialization Field, Licensed Gene Products solely in the Research Field.

For the Grant of Rights and Licenses to Therapeutic Proteins in the Commercialization field,  Licensor grants to Licensee and its Affiliates, within the Territory, an exclusive license, with the right to sublicense, under the Licensor Patent Rights, Licensor KnowHow and Licensors interest in any Joint Patent Rights and Joint Know-How with respect to Licensed Gene Products, including any Therapeutic Protein that incorporates or is derived from any such Licensed Gene Product, to discover, develop, make, have made, import, use, have used, offer for sale, sell and have sold Therapeutic Proteins in the
Commercialization Field.

For the Grant of Rights and Licenses to Products Other than Therapeutic Proteins in the Commercialization Field,  Licensor grants to Licensee and its Affiliates, within the Territory, a non-exclusive license, with the limited right to sublicense, under the Licensor Patent Rights, Licensor Know-How and Licensors interest in any Joint Patent Rights and Joint Know-How with respect to Licensed Gene Products, including any Diagnostic Product that incorporates or is derived from any such Licensed Gene Product, to discover, develop, make, have made, import, use, have used, offer for sale,sell and have sold Diagnostic Products andDrug Products in the Commercialization Field.

The Cre-Lox Patents means United States patent number 4,959,317, any foreign counterpart patents and patent applications.

Diagnostic Product means any product or service derived from or directed to Research Program Gene Products or Licensed Gene Products for use in the Diagnostic Field.

Therapeutic Protein shall mean any product or service, including gene therapy, which uses a protein, peptide or polypeptide which is a Gene Product in the treatment or prevention of any disease, state or condition in humans.

Licensed Gene Product means any Gene Product for which Licensee and /or Licensor is granted a license in the Commercialization Field.

A protein that is extruded from inside the cell through the cell membrane is referred to as a 'secreted protein.' These proteins contain a signal sequence that guides them from interior of the cell through the cell membrane and into the general circulation. Many secreted proteins, such as cytokines and hormones, are of therapeutic importance and have been commercialized by other companies to be very successful therapeutic agents.

Diagnostic Field means in vitro or in vivo diagnosis or pre-screening of human patients to determine therapeutic eligibility for a Product in the Therapeutic Field or for monitoring human patients receiving a Product in the Therapeutic Field; provided, however, that the Diagnostic Field excludes the commercialization of diagnostic products for which no Regulatory Approval has been obtained and which are not the subject of an active application for Regulatory Approval, multi-gene diagnostic products, and diagnostic products directed to quantitative detection of relative RNA transcript abundance of multiple RNA species.

Research Field means use by Licensee, Licensor and their respective Affiliates, at the internal research facilities of Licensee, Licensor and their respective Affiliates, for research directed toward the discovery, identification, selection, or characterization of Products.

The parties desire to establish a technology sharing program that relates to its high throughput lead optimization technology, and Licensor will transfer to Licensee its proprietary technology that relates to genetics and molecular biology in C. elegans and Drosophila.

Licensor grants a limited, non-exclusive, non-transferable, worldwide, perpetual license to use and practice the Licensors Core Technology, Core Technology Patents, and any Improvement Inventions made solely by Licensor to the Licensees Core Technology solely for its own internal research and discovery efforts in the Field.

Licensor grants a limited, non-exclusive, non-transferable, world-wide, perpetual license to use, adapt, reproduce, modify, localize, and create derivative works of the FlyTag Database, provided that all such uses of the FlyTag Database are solely for Licensees internal or collaborative research purposes, are used in the same manner, and subject to the same terms and conditions, as apply to the FlyTag Database Research Results.

For Research Results, Licensor grants an exclusive, worldwide, royalty-bearing license to use Research Results pertaining to Selected Targets, Product Targets, Mammalian Targets and Pursued Disclosed Targets for research and drug discovery and development in the Field, and to research, develop, import, use, sell, offer for sell, and commercialize Collaboration Compounds, Licensed Products and New Indications in the Field.

For Target Patents, Licensor grants a non-exclusive, worldwide, royalty-bearing license under any Patents that are Controlled by Licensor or its Affiliates and claim any of the Research Results and/or any Selected Targets, Pursued Disclosed Targets or Mammalian Targets, solely to discover, research and develop Collaboration Compounds, Licensed Products, and New Indications in the Field, and to research, develop, import, use, sell, offer for sell, and commercialize Licensed Products and New Indications in the Field.

For Novel Target Patents, Licensor grants an exclusive, worldwide, royalty-bearing license under any and all Novel Target Patents that, but for the license granted hereunder, would be infringed by the manufacture, use or sale of Gene Products and other Biotherapeutics, solely to discover, research, develop, import, use, sell, offer for sell, and commercialize Gene Products and Biotherapeutic Products.

A Novel Target means a mammalian orthologue of a Selected Target, which orthologue was identified by or on behalf of Licensor pursuant to work conducted under the Mode of Action Program.

An Unlinked Related Target means a Related Target that, at the time of identification of such target by Licensee or Licensor, is not Known to be a target for drug discovery.

A Biotherapeutic Product means any therapeutic or prophylactic product for treatment or prevention of diseases or conditions in humans that comprises or incorporates an antibody against a Mammalian Target, or an antisense compound based upon a Mammalian Target sequence, or a gene therapy product based upon the sequence of a Mammalian Target.

A Diagnostic Product means a product that facilitates identification of patients having a particular disease or having a predisposition to a particular disease, and/or monitors the prognosis or progression of a disease in a patient, by the detection of either sequence differences in different alleles of a Mammalian Target, or the presence or absence of a certain Mammalian Target, or the presence or absence of the protein product of a certain Mammalian Target.

A Gene Product means any therapeutic or prophylactic product for treatment of humans that comprises or incorporates the gene product of a Mammalian Target or a mutein or fusion protein based thereon.

A Pharmacogenomic Product means a product that is primarily used to select between two or more therapeutic or prophylactic regimens for a human, wherein at least one such therapeutic or prophylactic regimen involves a compound that could be used to treat and/or prevent a disease, and where the selected regimen is judged based on the use of the pharmacogenomic product to be of most likely benefit and/or to do the least harm to a patient, and provided that such selection is made based on the genotype of such human at certain genetic loci (including by detection of certain protein products indicative of the necessary genotype) as determined by use of such product to detect either sequence differences in different alleles of a Mammalian Target, or the presence or absence of a certain Mammalian Target, or the presence or absence of the protein product of a certain Mammalian Target.

The FlyTag Database means the sequence data within the database maintained by Licensor under the name FlyTag as of the Effective Date in the form previously released by Licensor to a contractual partner