Royalty Report: Drugs, Diagnostic, Therapeutic – Collection: 121121

License Grant

The purpose of this agreement is to establish a research collaboration to apply such Licensors technology and expertise to the identification and characterization of targets that mediate the effect of test compounds in model organisms, and to provide for the development and commercialization, based on such research, of novel prophylactic, therapeutic and diagnostic products or new indications or expanded labeling for existing 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.

License Property

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

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

Field of Use

The Field is the treatment, prophylaxis and diagnosis of disease in humans.  Licensee is a multinational health care company that has expertise and capability in developing and marketing human pharmaceuticals and has research and development programs in the area of medicinal chemistry.

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.

License Grant

The Swedish Licensee and the Licensor 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 metabolic syndrome and Alzheimers disease, and to provide for the development and commercialization of novel prophylactic and therapeutic products based on such research.

Licensor grants an exclusive, worldwide license under the Pre-existing Technologies and Sole Inventions Controlled by Licensor and under Licensors interest in the Joint Inventions to use each Selected Target to search for Collaboration Compounds directed at such Selected Target for activity within the Applicable Field, to develop, for use in the Applicable Field, Products comprising or incorporating such Collaboration Compounds, to develop, following, such Product for any human indication, and to make, have made, use, sell, offer to sell and have sold such Products.

License Property

The Pre-existing Technologies means any and all inventions, developments, results, know-how and other Information, and all intellectual property relating thereto, made, created or invented by a Party.

The Sole Inventions means any and all inventions, developments, results, know-how and other Information, and all intellectual property relating thereto, made, discovered or developed solely by a Party.

Homolog is a gene or gene product that has homology to a Selected Target.

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

Field of Use

This agreement is for either the Field of Alzheimers Disease or the Field of Metabolic Syndrome.

Metabolic syndrome is a cluster of conditions — increased blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol or triglyceride levels — that occur together, increasing your risk of heart disease, stroke and diabetes.

Licensee is a multinational health care company that has expertise and capability in developing and marketing human pharmaceuticals and has research and development programs in the areas of, inter alia, metabolic syndrome and Alzheimers disease.

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

The Parties are collaborating in the validation of targets for, and the discovery, development and commercialization of small molecules, antibodies, antisense molecules, proteins and other therapeutic agents, and diagnostic products.

For the Research Licenses, Licensor grants a worldwide, co-exclusive license during the Research Program Term, under Licensors rights to the Program Intellectual Property, to validate Program Targets for the identification, evaluation and optimization of Small Molecules, Antibodies, Antisense Molecules, Proteins and/or Other Molecules for use as Small Molecule Drugs or Biotherapeutic Products, as the case may be, in the Metabolic Disease Field, and, identify, evaluate and optimize Small Molecules, Antibodies, Antisense Molecules, Proteins and/or Other Molecules through the use of such Program Targets for use as Small Molecule Drugs or Biotherapeutic Products. as the case may be, in the Metabolic Disease Field, and, undertake Candidate Characterization of Program Compounds and Program Biotherapeutics in the conduct of the Research Program, and, undertake such other activities as may be necessary in furtherance of the Research Program.

Licensor grants a worldwide, non-exclusive license, under Licensors rights to the Program Intellectual Property, to validate Licensee Unilateral Targets for the identification, evaluation and optimization of Small Molecules. Antibodies, Antisense Molecules, Proteins and/or Other Molecules for use as Small Molecule Drugs or Biotherapeutic Products, as the case may be, in the Metabolic Disease Field, and, identify, evaluate and optimize Small Molecules, Antibodies. Antisense Molecules, Proteins and/or Other Molecules, including those that constitute the Associated Chemistry or the Associated Biotherapeutics, if any, of a Program Target that becomes a Licensee Unilateral Target, through the use of such Millennium Unilateral Targets for use as Small Molecule Drugs or Biotherapeutic Products. as the case may be, in the Metabolic Disease Field, and,  undertake Candidate Characterization of such Small Molecules, Antibodies, Antisense Molecules, Proteins and/or Other Molecules.

Licensor grants a worldwide, non-exclusive license, under Licensors rights to the Program Intellectual Property, to use the Licensor Released Compounds for internal research purposes only.

Licensor grants a worldwide, co-exclusive license, under Licensors rights to the Program Intellectual Property, to Develop and Manufacture Joint Drug Development Candidates or DDCs for use as Joint Products; and, make, have made, use, sell, offer for sale, import and export Joint Products in the Territory; and, undertake such other activities as may be necessary in furtherance of the Development Program and the Commercialization Program.

Licensor grants a worldwide, non-exclusive license, under Licensors rights to the Program Intellectual Property, to Develop and Manufacture Small Molecules, Antibodies, Antisense Molecules, Proteins and/or Other Molecules, as the case may be, identified through the use of Licensee Unilateral Targets for use as Licensee Unilateral Products, and, a worldwide, exclusive license, under Licensors rights to the Program Intellectual Property, to Develop and Manufacture Small Molecules included in a Licensee Unilateral Targets Associated Chemistry, and, Antibodies, Antisense Molecules, Proteins and/or Other Molecules included in a Licensee Unilateral Targets Associated Biotherapeutics, and, Licensee Unilateral DDCs, in each case, for use as Licensee Unilateral Products and, a worldwide, exclusive, license, under Licensors rights to the Program Intellectual Property, to make. have made, use, sell, offer for sale, import and export Licensee Unilateral Products in the Territory,

Licensor grants a worldwide, co-exclusive license, under Abbotts rights to the Program Intellectual Property, to develop, make, have made, use, sell, offer for sale, import and export Third Party Program Diagnostics for use in the Metabolic Disease Field in the Territory, and, to develop Joint Program Diagnostics for use in the Metabolic Disease Field in the Territory. Such license shall carry an obligation of profit-sharing with respect to Third Party Program Diagnostics sold in the Territory.

Licensor grants a worldwide license, under Licensors rights to the Program Intellectual Property, to develop, make, have made, use, sell, offer for sale, import and export Licensee Unilateral Diagnostics for use in the Metabolic Disease Field in the Territory.

License Property

Program Target means any Druggable Target or Biotherapeutic Gene for which the Joint Research Committee determines that there exists reasonable scientific rationale for the utility of such target or gene for the identification of Small Molecules, Antibodies, Antisense Molecules, Proteins or Other Molecules intended for use as Small Molecule Drugs or Biotherapeutic Products, as the case may be, in the Metabolic Disease Field.

Antisense Molecule means a nucleic acid or a functional analog, derivative or homologue thereof which is complementary to a segment of DNA of a target gene or such target genes cognate RNA and which, upon delivery by any means, alters the transcription, processing, elaboration, RNA expression or protein production of or by such target gene.

Associated Biotherapeutics means, with respect to a Program Target that has been designated a Unilateral Target or a Released Target, as the case may be, all Program Biotherapeutics that interact with such target or are encoded by such target or are chemically modified versions of the Program Biotherapeutics encoded by such target.

Biotherapeutic Product means a Therapeutic Antibody Product, a Therapeutic Antisense Product, a Therapeutic Protein Product, and/or a Therapeutic Other Molecular Product, as the case may be.

Field of Use

The use is to aid in the diagnosis, prognosis, monitoring, prevention and treatment of certain metabolic diseases.  Metabolic Disease Field means Obesity, Type 1 Diabetes and Type 2 Diabetes. The Metabolic Disease Field specifically excludes insulin therapy and autoimmune and immunomodulating mechanisms for Type 1 Diabetes.

License Grant

The Parties are collaborating in the validation of targets for, and the discovery, development and commercialization of small molecules, antibodies, antisense molecules, proteins and other therapeutic agents, and diagnostic products.

For the Research Licenses,  Licensor grants a worldwide, co-exclusive, non-royalty-bearing license during the Research Program Term, under Licensors rights to the Program Intellectual Property, to validate Program Targets for the identification. evaluation and optimization of Small Molecules, Antibodies, Antisense Molecules, Proteins and/or Other Molecules for use as Small Molecule Drugs or Biotherapeutic Products, as the case may be, in the Metabolic Disease Field, and, identify, evaluate and optimize Small Molecules, Antibodies, Antisense Molecules, Proteins and/or Other Molecules through the use of such Program Targets for use as Small Molecule Drugs or Biotherapeutic Products, as the case may be, in the Metabolic Disease Field, and, undertake Candidate Characterization of Program Compounds and Program Biotherapeutics in the conduct of the Research Program, and, undertake such other activities as may be necessary in furtherance of the Research Program.

Licensor grants a worldwide, non-exclusive license, under Licensors rights to the Program Intellectual Property, to validate Abbott Unilateral Targets for the identification, evaluation and optimization of Small Molecules, Antibodies, Antisense Molecules, Proteins and/or Other Molecules for use as Small Molecule Drugs or Biotherapeutic Products. as the case may be. in the Metabolic Disease Field, and, identify. evaluate and optimize Small Molecules, Antibodies, Antisense Molecules, Proteins and/or Other Molecules, including those that constitute the Associated Chemistry or the Associated Biotherapeutics, if any, of a Program Target that becomes an Licensee Unilateral Target, through the use of such Licensee Unilateral Targets for use as Small Molecule Drugs or Biotherapeutic Products, as the case may be, in the Metabolic Disease Field, and,
undertake Candidate Characterization of such Small Molecules, Antibodies, Antisense Molecules, Proteins and/or Other Molecules.

Licensor grants a worldwide, non-exclusive, license, under Licensors rights to the Program Intellectual Property, to use the Licensor Released Compounds for internal research purposes only.

For the Development and Commercialization Licenses,  Licensor grants a worldwide, co-exclusive license, under Licensors rights to the Program Intellectual Property, to Develop and Manufacture Joint Drug Development Candidates or DDCs for use as Joint Products; and, make, have made, use, sell, offer for sale, import and export Joint Products in the Territory; and, undertake such other activities as may be necessary in furtherance of the Development Program and the Commercialization Program.

Licensor grants a worldwide, non-exclusive license, under Licensors rights to the Program Intellectual Property, to Develop and Manufacture Small Molecules, Antibodies, Antisense Molecules, Proteins and/or Other Molecules, as the case may be, identified through the use of Licensee Unilateral Targets for use as Licensee Unilateral Products (ii) a worldwide, exclusive,  license, under Licensors rights to the Program Intellectual Property, to Develop and Manufacture Small Molecules included in a Licensee Unilateral Targets Associated Chemistry, and, Antibodies, Antisense Molecules, Proteins and/or Other Molecules included in an Licensee Unilateral Targets Associated Biotherapeutics, and, Licensee Unilateral DDCs, in each case, for use as Licensee Unilateral Products, and, a worldwide, exclusive, license, under Licensors rights to Program Intellectual Property, to make, have made, use, sell, offer for sale, import and export Licensee Unilateral Products in the Territory.

Licensor grants a worldwide, co-exclusive license, under Licensors rights to the Program
Intellectual Property, to develop, make, have made, use, sell, offer for sale, import and export Third Party Program Diagnostics for use in the Metabolic Disease Field in the Territory, and, a worldwide, co-exclusive license, under Licensors rights to the Program Intellectual Property, to develop Joint Program Diagnostics for use in the Metabolic Disease Field in the Territory and, a worldwide, exclusive license, under Licensors rights to the Program Intellectual Property, to make, have made, use, sell, offer for sale, import and export Joint Program Diagnostics for use in the Metabolic Disease Field in the Territory.

Licensor grants a worldwide license, under Licensors rights to the Program Intellectual Property, to develop, make, have made, use, sell, offer for sale, import and export Licensee Unilateral Diagnostics for use in the Metabolic Disease Field in the Territory.

Licensor grants a worldwide, co-exclusive license, under Licensors rights to the Program Intellectual Property, to use Released Targets to develop Diagnostics for use in the Metabolic Disease Field, and, a worldwide, exclusive license, under Licensors rights to the Program Intellectual Property, to make, have made, use, sell, offer for sale, import and export Licensee Released Diagnostics for use in the Metabolic Disease Field in the Territory.

License Property

Program Target means any Druggable Target or Biotherapeutic Gene for which the Joint Research Committee determines that there exists reasonable scientific rationale for the utility of such target or gene for the identification of Small Molecules, Antibodies, Antisense Molecules, Proteins or Other Molecules intended for use as Small Molecule Drugs or Biotherapeutic Products, as the case may be, in the Metabolic Disease Field.

Antisense Molecule means a nucleic acid or a functional analog, derivative or homologue thereof which is complementary to a segment of DNA of a target gene or such target genes cognate RNA and which, upon delivery by any means, alters the transcription, processing, elaboration, RNA expression or protein production of or by such target gene.

Associated Biotherapeutics means, with respect to a Program Target that has been designated a Unilateral Target or a Released Target, as the case may be, all Program Biotherapeutics that interact with such target or are encoded by such target or are chemically modified versions of the Program Biotherapeutics encoded by such target.

Biotherapeutic Product means a Therapeutic Antibody Product, a Therapeutic Antisense Product, a Therapeutic Protein Product, and/or a Therapeutic Other Molecular Product, as the case may be.

Field of Use

The use is to aid in the diagnosis, prognosis, monitoring, prevention and treatment of certain metabolic diseases.  Metabolic Disease Field means Obesity, Type 1 Diabetes and Type 2 Diabetes. The Metabolic Disease Field specifically excludes insulin therapy and autoimmune and immunomodulating mechanisms for Type 1 Diabetes.

License Grant

For the Research Database and Gene ExpressTM Normal Database License to Licensee,  Licensor grants to the Licensee of the Netherlands an exclusive, worldwide license to use the Research Database, together with a non-exclusive, worldwide license to use the Gene Expressâ„¢ Normal Database, in each case solely for its internal research purposes to identify Gene Targets during the Research Term.

For the Gene Target License, with respect to each Gene Target for which Licensee has paid the appropriate fee
(a) Licensor grants a non-exclusive, worldwide license,without the right to sublicense, under the Patent Rights and Gene Target Know-How Controlled by Licensor, if any, to develop, make, have made, use, import, offer for sale and sell such Gene Target in the Field of Use; and (b) If Licensee has requested rights to such Gene Target in the Protein Product Field of Use and provided that Licensor has not previously granted an exclusive license or right to such Gene Target to a Third Party in the Protein Product Field of Use, Licensor grants an exclusive, worldwide license, with the right to sublicense, under the Patent Rights and Gene Target Know-How Controlled by Licensor, if any, to develop, make, have made, use, import,offer for sale and sell such Gene Target in the Protein Product Field of Use.

For the Option Right of First Negotiation, with respect to each Gene Target for which Licensee has paid the fee and Patent Rights and other proprietary rights have been exclusively licensed to Licensee, Licensor grants an exclusive right of first negotiation to obtain an exclusive, worldwide license, with the right to sublicense, under the Patent Rights and Gene Target Know-How Controlled by, if any, to develop, make, have made, use, import. offer for sale and sell such Gene Target as a Nucleic Acid Product or Diagnostic Product for all indications other than Heart failure, Skeletal muscle atrophy, and, Osteoarthritis.

License Property

Protein Product shall mean any product for the prevention or treatment of any disease or disorder, in any dosage form or formulation for delivery by any route of administration, which is or comprises a protein or peptide encoded by the full, partial or mutated RNA or DNA sequence corresponding to a Gene Target RNA or DNA sequence, but excluding any such protein or peptide that has been substantially modified, including any therapeutic antibody.

Therapeutic Product shall mean any product for the prevention or treatment of any disease or disorder, in any dosage form or formulation by any route of administration, which product is or comprises a molecule, compound or other agent, regardless of its function or utility, which is discovered or whose utility is discovered utilizing, in whole or in part a Gene Target, whether or not in the course of the Research Program, or, a protein or peptide encoded by the full, partial or mutated RNA or DNA sequence corresponding to a Gene Target RNA or DNA sequence, which protein or peptide has been substantially modified, and in each case excluding any Nucleic Acid Diagnostic Product or Protein Product.

Field of Use

Field of Use shall mean all internal research uses by Licensee of Gene Targets and the development and commercialization of the Therapeutic Products – a molecule, compound or other agent, regardless of its function or utility, which is discovered or whose utility is discovered utilizing, in whole or in part, a Gene Target, whether or not in the course of the Research Program. All uses of Gene Targets as Protein Products, Nucleic Acid Products or Diagnostic Products are excluded from the Field of Use.

License Grant

Licensor grants to the German Licensee an exclusive license in the Territory, under Licensors rights to Licensors Know-How and Patent Rights,  to research, develop, make and use Selected Qualified Targets (QT), other than Returned QTs and Non-Exclusive QTs and Configured Assays that embody or are based on such Selected QTs, to the extent necessary to discover or develop Licensee Royalty Products and to make, have made, import, use, have used, offer for sale, sell and have sold, in the Field, Licensee Royalty Products that are discovered or developed through the use of Selected QTs, other than Returned QTs and NonExclusive QTs, subject, in the case of both, to any applicable field restrictions or exclusivity limitations in the case of any Selected QTs that are
Restricted Targets.

With Respect to Returned QTs, Licensor grants a non-exclusive license in the Territory, under Licensors rights to Licensor Know-How and Patent Rights, to research, develop, make and use the Returned QTs and Configured Assays that embody or are based on such Returned QTs, to the extent necessary to discover or develop Licensee Royalty Products, and make, have made, import, use, have used, offer for sale, sell and have sold, in the Field, Licensee Royalty Products that are discovered or developed through the use of Returned QTs, subject, in the case of both, to any applicable field restrictions in the case of any Restricted Targets.

License Property

Licensee is engaged in the business of conducting research in the field of human genomics, an objective of which is to discover potential biological targets and assays for use in drug discovery.

Cell-Based Assay means a Licensee Configured Assay that uses a QT incorporated in a cell or presented on the surface of a cell, as distinct from a biochemical assay in which the QT is assayed in a cell-free context.

Qualified Target or QT means a target for Small Molecule drug discovery identified or developed in the course of the Target Discovery Program that has all of the following characteristics
– is a Druggable Target that is a complete coding sequence of a human gene;
– has a Disease/Therapeutic Hypothesis;
– is either a Novel Protein, or fill Unrecognized Protein, or a Druggable Target that is otherwise approved by the Licensee Program Director as a Qualified Target; and
– the use of such target in the manner contemplated in the Research Plan would not, at the time of its identification or annotation in the Target Discovery Program, infringe one or more claims of an issued patent in the country in which such use of the target is expected to occur, unless such target is otherwise approved by the Licensee Program Director.

Non-Exclusive QT means a QT that has a Disease/Therapeutic Hypothesis in both a CFA and Non-CFA and that is designated by Licensor as a Non-Exclusive QT within seven (7) business days after such QT is entered into the QT Pool and a Licensor-Designated NonCFA means one Non-CFA that is associated, on the basis of a Disease/Therapeutic Hypothesis, with a QT, as designated by Licensor at the time such QT is designated a Non-Exclusive QT by Millennium.

Field of Use

This agreement is to identify and develop small molecule drugs for the treatment of certain human diseases and conditions.

'COLLABORATIVE FOCUS AREA' means one or more of the following human diseases and/or conditions (a) osteoporosis; (b) liver fibrosis; (c) hematological diseases and/or conditions (not including diseases and/or conditions excluded under subsections (d) and (e) below); (d) oncology, including, but not limited to, lung cancer, breast cancer, ovarian cancer and colon cancer, but excluding prostate cancer; (e) cardiovascular diseases and/or conditions, including, but not limited to, arrhythmia, abnormal hemodynamics, and hypertension, PROVIDED THAT the following diseases and/or conditions shall not be included (i) atherosclerosis (including the related diseases of thrombosis and restenosis); (ii) excessive clotting, and (iii) cardiomyopathy of any origin. (f) pain (including all therapies for relieving pain as distinct from curing or treating the underlying diseases or conditions that cause pain); and (g) viral diseases.

License Grant

The parties grant each other certain rights and licenses on the terms set forth in this Agreement and to collaborate on a research and development relating to “Paraffin Extraction Technology”.  

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.

License Property

Paraffin Extraction Technology shall mean all Program Technology relating to the recovery and extraction of native nucleic acids, polypeptides, peptides and/or proteins from tissues embedded in paraffin and its use in the research, development and commercialization of assays, including without limitation microarrays. Paraffin Extraction Technology excludes RNA Amplification Technology.

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.

Field of Use

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

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.

License Grant

The Parties of Switzerland and Iceland, wish to expand the relationship created under the 1998 Research Agreement with respect to diagnostic products to include expansion of their collaboration with respect to the certain of the diseases covered by the 1998 Research Agreement and the addition of new targets, products and diseases.

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.

License Property

The patents are referred to as the Lupus Patents.

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.

Field of Use

The field is the Analysis of genes, micro-satellite markers, polymorphisms, SNPs and their association with diseases, symptoms, drug response and other phenotypes for the purposes of developing know-how for the research, development and commercialization of products within agreed classes to include diagnostic, therapeutic and pharmacogenetic products.

License Grant

This restated, amended agreement is to provide for the expansion of the collaborative efforts of the parties.

For the Research Database License,  Licensor grants an exclusive, worldwide license to use the Research Databases solely for its internal research purposes to identify Gene Targets during the Research Term.

For the Gene Target License
(a) Licensor grants and agrees to grant a non-exclusive, worldwide license, without the right to sublicense, under the Patent Rights and Gene Target Know-How Controlled by Licensor, if any, to use such Gene Target in the Field of Use.
(b) If Licensee has requested rights to such Gene Target in an Additional Field of Use and provided that Licensor has not previously granted an exclusive license or right to such Gene Target to a Third Party in such Additional Field of Use, Licensor grants and agrees to grant an exclusive, worldwide license, with the right to sublicense, under the Patent Rights and Gene Target Know-How Controlled by Licensor, if any, to develop, make, have made, use, import, offer for sale and sell such Gene Target in such Additional Product Field of Use.

For Ownership of Improvements to Licensee Technology, Licensor grants an exclusive, irrevocable, perpetual, worldwide license, with right to sublicense through multiple tiers of sublicense, to such rights.

License Property

Licensor has developed technologies and know~how with respect to high throughput analysis of gene expression and gene regulation for use in the identification of drug targets and the discovery of pharmaceutical and diagnostic products.

Research Databases shall mean the databases created by Licensor using the Licensor Technology pursuant to the Research Plans and containing all of the data derived from experiments conducted with respect to Samples.

Research Programs shall mean the programs of research performed by the parties for the research, discovery and characterization of genes through the application of genomic technologies and bioinformatics to analyze Samples, and the use of such genes for the development and commercialization of Products. The term genomic technologies shall mean, without limitation, technologies for the analysis of gene expression and gene regulation, hybridization array techniques, high speed sequencing and generation of expressed sequence tags.

Product shall mean a Therapeutic Product, Protein Product, Diagnostic Product or Nucleic Acid Product, as applicable.

Gene Products shall mean all partial cDNAs, DNAs, genes, full length cDNAs corresponding thereto and proteins encoded therefrom.

Field of Use

Field of Use shall mean all internal research uses by Licensee of Gene Targets and the development and commercialization of those Therapeutic Products. All uses of Gene Targets as Protein Products, Therapeutic Products, Nucleic Acid Products or Diagnostic Products are excluded from the Field of Use.

Additional Field of Use shall mean all uses of Gene Targets for the development and commercialization of Gene Targets as Protein Products or those Therapeutic Products, Nucleic Add Products and/or Diagnostic Products, as applicable.

Excluded indications are Intrinsic kidney disease, including but not limited to glomerulonepbritis and diabetic nephropathy;  Benign prostatic hypertrophy {specifically excluding prostate cancer); and, Atherosclerosis.

Licensor has been using its Reads gene expression technology to build a database of genes differentially expressed between normal heart tissue and heart tissue from people with heart failure. Under the expansion, the Licensor will enlarge the Licensee database to include new indications, beginning with osteoporosis.

License Grant

At Licensees option, The German Licensor shall grant a non-exclusive license in the Territory, under Licensors rights in Licensor Returned QT Know-How and Returned QT Patent Rights to the extent necessary
– to research, develop, make and use any or all of the following in connection with the use of the Returned QT to discover or develop Small Molecule Drugs
(1) the Licensor Configured Assay that embodies or is based on a Returned QT, together with the standard operating procedures and reagents necessary,  to use such Licensor Configured Assay for such purpose;
(2) if a Second Stage QT is designated as a Returned QT, the most promising lead structure under development by Licensor, and the optimization history of such lead structure and the data pertinent to critical optimization decisions that relate to such lead structure, the Second Stage Information, including without limitation, information on the major structural templates that were evaluated by Licensor and relevant SAR data; and
(3) if a Third Stage QT is designated as a Returned QT, the most promising lead structure under development by Licensor, and the optimization history of such lead structure and the data pertinent to critical optimization decisions that relate to such lead structure, the Third Stage Information, including without limitation, related SAR data, related pharmacological data, including toxicology and ADME information, and information related to chemical synthesis, provided, however, that, in the case of a Second Stage QT or a Third Stage QT, Licensor shall not be obligated to grant any such license with respect to the most promising lead structure if such lead structure is under development by Licensor as a Development Candidate or later stage drug candidate outside of the Licensor Development Program, in which event Licensor shall be obligated to grant such a license with respect to the next most promising lead structure that is not a Development Candidate or later stage drug candidate outside of the Licensor Development Program, and,
– to make, have made, import, use, have used, offer for sale, sell and have sold Small Molecule Drugs that are discovered or developed by Licensee through the use of Returned QTs.

This agreement includes exclusive and non-exclusive grants back to Licensor from Licensee.

License Property

Licensor is engaged in the business of conducting research in the field of human genomics, an objective of which is to discover potential biological targets and assays for use in drug discovery.

Cell-Based Assay means a Licensor Configured Assay that uses a QT incorporated in a cell or presented on the surface of a cell, as distinct from a biochemical assay in which the QT is assayed in a cell-free context.

Qualified Target or QT means a target for Small Molecule drug discovery identified or developed in the course of the Target Discovery Program that has all of the following characteristics
– is a Druggable Target that is a complete coding sequence of a human gene;
– has a Disease/Therapeutic Hypothesis;
– is either a Novel Protein, or fill Unrecognized Protein, or a Druggable Target that is otherwise approved by the Licensor Program Director as a Qualified Target; and
– the use of such target in the manner contemplated in the Research Plan would not, at the time of its identification or annotation in the Target Discovery Program, infringe one or more claims of an issued patent in the country in which such use of the target is expected to occur, unless such target is otherwise approved by the Licensor Program Director.

Non-Exclusive QT means a QT that has a Disease/Therapeutic Hypothesis in both a CFA and Non-CFA and that is designated by Licensee as a Non-Exclusive QT within seven (7) business days after such QT is entered into the QT Pool and a Licensee-Designated NonCFA means one Non-CFA that is associated, on the basis of a Disease/Therapeutic Hypothesis, with a QT, as designated by Licensee at the time such QT is designated a Non-Exclusive QT by Millennium.

Field of Use

Field means therapeutic and prophylactic treatment of all human diseases and conditions.  This agreement is to identify and develop small molecule drugs for the treatment of certain human diseases and conditions.

License Grant

The Parties have entered into that certain Collaboration Agreement, with respect to a collaborative research and joint development and profit-sharing commercialization program between the Parties with respect to specified targets, antibodies and technology.

For the DCVax-Prostate Product,  Licensor grants an exclusive, worldwide, license, with a right to sublicense, to Licensee under the Designated Target IP that relates to PSMA, to research, develop, manufacture, have manufactured, use, sell, offer for sale, import and otherwise commercialize the DCVax-Prostate Product.

For the PSMA Related Diagnostic Products,  Licensor grants an exclusive, worldwide, irrevocable, perpetual, license, with a right to sublicense, to Licensee under the Designated Target IP that relates to, or is necessary to Exploit, Flt-4, to research, develop, manufacture, have manufactured, use, sell, offer for sale, import and otherwise commercialize Licensee Diagnostic Products for the in vitro or in vivo diagnosis of cancer, screening, monitoring, or selection of patients for specific treatment modalities, or for determining the dose of a therapeutic product the Licensee Flt-4 Diagnostic Field, each such Licensee Diagnostic Product, a Licensee Flt-4 Diagnostic Product, and Non-Antibody Products for the in vitro or in vivo diagnosis and treatment of cancer, and Licensor reserves for itself solely the right to research, develop, manufacture, have manufactured, use, sell, offer for sale, import or otherwise commercialize any Reserved Dovetailing Product provided, however, Licensor shall not promote Reserved Dovetailing Products for use in the Northwest Flt-4 Diagnostic Field, including providing written or other materials relating to use of the Reserved Dovetailing Products in the Licensee Flt-4 Diagnostic Field.

For the HuMAb® Licenses, Licensor grants the right to obtain from Licensor five (5) licenses under the HuMAb® Technology to develop, make, have made, use, sell, offer for sale and import on a worldwide basis selected antibody-based products directed against biological targets,  each a Licensee Target, on the terms set forth to this Agreement, used by Licensor in its standard cash-and-carry agreements.

License Property

Fucosyltransferase Fucosyl GM-1 shall mean the ganglioside fucosyl gm-1 FucGM-1.

Flt-4 shall mean the gene that is associated with Genbank Accession No, XP 003852 and allelic polymorphisms associated with such genes.

PSMA shall mean prostate specific membrane antigen related to the gene described in Genbank Accession No. NP 004467 and allelic polymorphisms associated with such gene.

CXCR-4 Product shall mean any antibody product, including any Antibody Product, with a therapeutically meaningful binding affinity for CXCR-4.

DCVax-Prostate Product shall mean that version of Licensors proprietary product that was in Phase III clinical trials under IND number BB IND 8602.

Designated Target shall mean each of PSMA , Fucosyl GM-1 or Flt-4 .

Field of Use

The field of use is Flt-4 Diagnostic Field and  PSMA Diagnostic Field.  The antibody products are for the diagnosis, prophylaxis or treatment of human diseases or conditions.

License Grant

For the Access Grant, Licensor agrees to provide Licensee with access to the Licensor Database Products solely in accordance with the terms and conditions of this Agreement, and Updated Releases and Updates.

For the Designated Gene Products, during the Access Term and pursuant to the Annual Reporting Mechanism, Licensee shall have the right to use, disclose and transfer Database Information specifically regarding a Designated Gene Product, including to Affiliates of Licensee, academic and third party collaborators, licensees, governmental agencies or offices or otherwise solely for use in the discovery, research, development and/or commercialization of Drug Products.

For the Non-Exclusive License Under Licensor Technology-Research Serine Proteases, during the Access Term, Licensor grants a worldwide, non-exclusive license, with a right to sublicense, under the Licensor Technology to conduct research with respect to Gene Products in the Research Field of Use and to discover, develop, make, have made, use, offer to sell, sell, import, and distribute Drug Products.

For the Non-Serine Proteases. During the Access Term  Licensor grants a worldwide, non-exclusive license, with a right to sublicense, under the Licensor Technology to conduct research and development activities with respect to Gene Products in the Research Field of Use and to discover, develop, make, have made, use, offer to sell, sell, import, and distribute Drug Products.

License Property

The Licensor has certain high-throughput partial cDNA sequencing, cloning, and data analysis
technologies.

Licensor has compiled and is compiling, and owns, certain information and data regarding certain cDNAs in confidential databases which may be useful in the study of biological phenomena.

Licensor owns or has rights in certain patent rights and know-how regarding certain cDNAs as well as certain of the proteins they encode.

Drug Products shall mean any compositions of matter which are ligands or inhibitors of Gene Products which are agonists, antagonists, and/ or modulators of Gene Products, for use in the treatment or prevention of any disease in humans; provided, however, that Drug Product(s) shall not include Therapeutic Protein Products or Antisense Products or Substrates of Gene Products.  Antisense Products shall mean oligonucleotides or modified oligonucleotides derived from or targeted to Gene Product(s) for use in the Antisense Field of Use.

LifeSeq® Database Products shall mean Licensors proprietary database of human Annotation Information and DNA Sequence Information and corresponding cDNA Clones and Full Length Clones.

Field of Use

Therapeutic Field of Use shall mean the treatment or prevention of any disease, state or condition in humans by any means, including without limitation, gene therapy, excluding the Antisense Field of Use. The Therapeutic Field of Use does not include the sale or license of Database Information or Gene Products as research tools, or the use of Database Information or Gene Products to develop database products or services.

License Grant

Research License hereby grants Licensee a non-exclusive, worldwide, non-transferable, royalty-free license for internal use under the Licensor Patents, Licensor Know-How and Licensors interest in the Joint Patents to the extent necessary (i) to permit Licensee to conduct its obligations and (ii) to use and characterize Targets, including, without limitation, the Overlap Targets. The license set forth above includes the right to sublicense.

Pre-Opt-In Products and Licensee Products. Subject to the terms of this Agreement, Licensor hereby grants Licensee a worldwide, exclusive license, including the right to sublicense, under the Licensor Patents, Licensor Know-How and Licensors interest in the Joint Patents (i) to use the Targets (other than Overlap Targets) for the purpose of creating, developing and marketing antibodies for commercial purposes, (ii) to use Antibody Target Candidates and Antibody Targets to make, have made, use, develop and test Antibodies, and (iii) to make, have made, use, develop, test, sell, offer to sell, have sold and import Pre-Opt-In Products and Licensee Products. Such license shall include all human prophylactic and therapeutic indications for Pre-Opt-In Products and Licensee Products and shall be milestone and royalty-bearing as set forth. The exclusivity of the license set forth is subject to Licensors retained rights.

Co-Funded Products  Licensor hereby grants Licensee a worldwide, co- exclusive license (with Licensor), including the right to sublicense, under the Licensor Patents, Licensor Know-How and Licensors interest in the Joint Patents to make, have made, use, develop, test, sell, offer to sell, have sold and import Co-Funded Products. Such license shall include all human prophylactic and therapeutic indications and shall involve profit-sharing with respect to any such Product in lieu of royalties and milestones.

Licensee Diagnostic Products  Licensor hereby grants Licensee a worldwide, co-exclusive license, including the right to sublicense, under the Licensor Patents, Licensor Know-How and Licensors interest in the Joint Patents to make, have made, use, develop, test, sell, offer to sell, have sold and import Licensee Diagnostic Products. At the time Licensee identifies a Third Party manufacturer for any such Licensee Diagnostic Product, Licensee may request the co-exclusive license be converted to an exclusive license. Licensor agrees to grant Licensee an exclusive license unless_a diagnostic product for the same Antibody Target has been submitted to the FDA for marketing approval. Such license shall include all human diagnostic indications and shall be, with respect to Licensee Diagnostic Products developed for use with Licensee Products, milestone and royalty-bearing as set forth and shall involve profit-sharing, with respect to Licensee Diagnostic Products developed for use with Co-Funded Products, in lieu of royalties as set forth.   Any exclusive license granted shall be subject to a retained right by Licensor and its licensees to make, have made, use, have used, develop, have developed and test Licensee Diagnostic Products for (i) internal research purposes or (ii) drug discovery, clinical development, pharmacogenomics analysis and inclusion in the labeling of non-antibody therapeutics and prophylactics against the same Antibody Target.

Antibody Inventions  Licensor hereby grants Licensee a worldwide, exclusive license, including the right to sublicense, under the Antibody Patents that claim Antibody Inventions invented solely or jointly by Licensee to practice such Antibody Inventions for all purposes.

License Property

Product means any therapeutic or prophylactic product developed under this Agreement, for any indication, incorporating all or substantially all of at least one variable region of an Antibody.

Licensee Diagnostic Product means a product that is being or has been developed for detection of an Antibody Target for use with a Licensee Product or a Co-Funded Product.

Antibody Inventions means an Invention directed to Antibodies, including without limitation, composition of matter, methods of manufacture, methods of use, formulations, dosing regimens, etc.

Pre-Opt-In Product means a Product for which Licensor has not made a decision whether to co-fund and for which the Opt-In Period has not expired.

Target(s) means [a gene or gene product from the Target Pool]. The term Target(s)' shall include Antibody T~get Candidates and Antibody Targets, but shall exclude specified Targets if and when such Targets cease to be Targets.

Target Pool means all human orthologues whenever identified, of the Model System Targets.

Field of Use

This agreement pertains to the drug industry to utilize the technology and expertise to identify and characterize targets for the treatment of cancer and precancerous conditions, controlling cell growth, apoptosis, and proliferation, to generate antibodies directed against such targets, and to develop and commercialize novel antibody products for diagnostic, prophylactic and therapeutic uses.

License Grant

Licensor grants the exclusive, worldwide right and license under the Licensors DNA Sequence Patent Rights and, for the period of the Research Collaboration, exclusive access, without the right to permit Third Parties any right of access, to the Licensors PathoGenome-TM- Database to research, develop, use, manufacture, have manufactured, market, promote, import, export, sell and have sold Licensee Products.

Licensee may grant sublicenses and licenses, respectively, to the Licensors PathoGenome-TM- Database and Research Collaboration Database to any Third Party only for the purpose of developing, manufacturing, marketing and selling Licensee Products.

Licensor grants the non-exclusive right and license to use the Licensor Technology to research, develop, use, manufacture, have manufactured, market, promote, import, export, sell and have sold Licensee Products and the non-exclusive right and license to use the Licensed Software for the purpose of obtaining access to, pursuing searches in, and/or interpreting or analyzing the data contained in the Research Collaboration Database, the Licensors PathoGenome-TM- Database and other genomic databases which may be or become available to Licensee.

Licensor grants to Licensee the exclusive right and license under its interest in all inventions and under any patents covering such inventions in the Licensees Field which are licensed to Licensor by any Third Party having access to the Licensor PathoGenome-TM- Database under terms in any license relating to the Licensor PathoGenome-TM- Database.

License Property

Licensor has compiled and is compiling a PathoGenome-TM- Database containing certain genomic sequence information and has compiled and is compiling additional pathogen genomic sequence information.

Licensor has expertise in molecular biology, high-throughput sequencing microarrays and the development and utilization of the software tools necessary to assemble, annotate, process, search, manipulate and analyze the genomic sequence information it generates in its research programs (Licensors bioinformatics capability).

The PathoGenomeTM database provides genome sequence information for nearly 30 microbial organisms assembled through Genome Therapeutics’ pathogen genomics research in combination with public domain sources. The database utilizes proprietary bioinformatics software and enables researchers to search for novel target genes among multiple pathogens and cross-reference genomic information.

Field of Use

Licensee is in pathogen diagnostics and molecular diagnostics.

License Grant

Pursuant to this agreement, the Licensee has the right to grant sub-licenses to Licensees product.  The Licensee may grant a Sublicense with respect to any Licensee Product for use in the Therapeutic Field, and, the Diagnostic Field.

During the Research term of this agreement, Licensee shall not make any other grant to the related antigens.

License Property

Licensee Product shall mean, with respect to any Licensee Licensed Antigen, any product comprising an Antibody which binds to such Licensee Licensed Antigen, or Genetic Material that encodes such an Antibody wherein, in respect of each Licensee Product, said Genetic Material does not encode multiple antibodies.

Antigens shall mean, collectively, the Research Antigens, Eligible Antigens, Optioned Antigens and Licensed Antigens, and Antigen shall mean any one of the Antigens.

Research Antigens shall mean, collectively, the antigens which are selected by the Collaboration, Licensor or Licensee for use in the Research Program, for which Licensor and Licensee have the right to grant the other party the commercial license, and which are not Optioned Antigens or Licensed Antigens, and Research Antigen shall mean any one of the Research Antigens.

Field of Use

The Commercial Field shall mean, collectively, the Therapeutic Field and the Diagnostic Field.

The Diagnostic Field shall mean the use of Products for the following human medical purposes the detection, diagnosis and monitoring of any disease, predisposition, state or condition in humans or the selection of a particular patient(s) to receive a particular therapeutic treatment(s).

The Therapeutic Field shall mean the use of Products for the following human medical purposes the prevention or treatment of any disease, state or condition in humans.

The goal of the five-year alliance is to develop antibody therapeutics against promising antibody drug targets in the human genome. The candidates are intended to treat a broad range of diseases, including metabolic diseases, cancer, inflammation, and autoimmune disorders.

License Grant

Pursuant to this agreement, Licensee shall solely own all marketing rights to Products, including, not limited to, the exclusive, worldwide, transferable rights to market, sell, have sold, import, export and distribute solely Products.

Licensor will provide all Compounds to Licensee on an exclusive basis, and Licensor is expressly prohibited from providing any and all such Compounds to a Third Party as part of the Licensor Library, without the prior written consent of Licensee.

Licensor grants a nonexclusive, worldwide, transferable and sublicensable right and license to Licensor Technology to the extent that it is necessary for Licensee, to develop, make, have made, use, import, export, offer for sale, have sold and sell Development Compound(s) and/or Product(s).

And, for the research, Licensor grants a worldwide, non-exclusive, non-transferable, non-sublicensable, right and license under the Licensor Technology solely to conduct activities assigned to Licensee under the Research Plan during the term of the Research Collaboration.

License Property

Product shall mean any human diagnostic, human therapeutic and/or human prophylactic product for use within the Field and incorporating a Compound.

Compound shall mean any one or more chemical entity(ies) that is specifically designed by Licensee and/or Licensor in the course of performing or in connection with the Research Plan; or designed by Licensee and/or Licensor, and synthesized by Licensor, in the course of performing or in connection with the Research Plan; or synthesized by Licensor in the course of performing or in connection with the Research Plan; or has been designated as a Development Compound.

LC-MS/ELSD shall mean liquid chromatography mass spectrometry with evaporative light scattering detector.

“Target(s)” shall mean any one or more of (a) the HIV gp120 glycoprotein, including all genetic variants of such glycoprotein, or (b) the HIV gp41 glycoprotein, including all genetic variants of such glycoprotein.

Under the terms of the agreement, the Companies will work to identify small molecule inhibitor compounds against two HIV entry targets, gp41 and gp120. The Companies will collaborate to identify orally active lead compounds and then optimize preclinical candidates.

Field of Use

Field shall mean the discovery, development and commercialization of small chemical molecules for the diagnosis of, or the therapeutic and/or prophylactic treatment of all human conditions and/or diseases.

Collaborative agreement relates to discover and develop small molecule entry inhibitors of the human immunodeficiency virus (HIV).

License Grant

Licensor hereby grants and agrees to grant to Licensee the following licenses

Licensor in which Licensee holds approximately a 32% interest, grants to Licensee the exclusive right to screen Initial Targets (including New Targets  accepted into the Research Plan as Initial Targets) until the later of (I) the end of the Research Term or (ii) two and one-half years from the date that such New Target was accepted into the Research Plan (the 'Discovery Period'). Subject to the obligation of Licensor to perform screening under the Research Plan, Licensor also grants Licensee the exclusive right to utilize the Collaboration Technology pursuant to the terms of this Agreement during the Discovery Period for the sole purpose of screening New Targets to discover Collaboration Compounds.

Licensor grants to Licensee (a) the exclusive right to screen targets in the antibacterial or antifungal portion of the Licensee Field using Surrogate Genetics technology and Collaboration Technology for a period of ten (10) years from the Effective Date, and thereafter on a non-exclusive basis, subject to a royalty in the case of Licensee Targets included in the Research Plan (iii) of this Agreement, but otherwise royalty-free and (b) the non-exclusive perpetual right to screen targets in the non-antibacterial, non-antifungal and non-antiviral portion of the Licensee Field using Surrogate Genetics technology and Collaboration Technology on a royalty-free basis.

Licensor grants to Licensee a worldwide exclusive license to make, use and develop Collaboration Compounds for the purpose of developing Licensed Products for the period from the Effective Date until the earlier of (I) five years after the end of the Research Term or (ii) any time after one year from the end of the Research Term in the event that Licensee is not using reasonable commercial efforts as provided to pursue development of Licensed Products including without limitation, the selection of appropriate Reserved Drug Classes. After such period, Licensees right to make, use and develop Collaboration Compounds for the purpose of developing Licensed Products shall then become nonexclusive except with regard to Reserved Drug Classes.

Licensor grants to Licensee a worldwide license (with a right to sublicense) under all Know-How and Patent Rights in and to the Collaboration Technology, (I) on an exclusive, perpetual basis to develop, have developed, make, have made, use, sell, have sold, distribute, and have distributed Licensed Products and (ii) on an exclusive basis for a period of ten years from the Effective Date solely to develop, have developed, make, have  made, use, offer to sell, sell, have sold, distribute, and have distributed products in the field of infectious diseases caused by bacteria and fungi (the antibacterial and antifungal portion of the Licensee Field), and thereafter, on a non-exclusive basis, within and outside the Licensee Field, to develop, have developed, make, have made, use, offer to sell, sell, have sold, distribute, and have distributed products.

License Property

Initial Target shall mean those targets listed hereto and those New Targets which are included as Initial Targets under the Research Plan.
Hepatitis C Virus (HCV)
Hepatitis B Virus
Herpes Simplex Viruses and Cytomegalovirus (HCMV)
Human Immunodeficiency Virus ( HIV)
Influenza viruses
Rhinovirus

New Target shall have the meaning of a target identified within the field and is not an initial target.

Licensee Target shall have the meaning a target that Licensee identifies in the antibacterial or antifungal portion of the Licensee field for which Licensee seeks to utilize Surrogate Genetics to discover, develop or commercialize products.

Collaboration Technology shall mean all Know-How and Patent Rights that a Party owns or Controls, which is conceived, reduced to practice or otherwise developed by Licensor (or its agents) or Licensee (or its agents) or jointly by Licensor and Licensee (or their respective agents) during the Research Term arising out of the Research Program.

Collaboration Compound shall mean any compositions of matter to be used in the Field that incorporate, are derived from, developed using, or based upon the Initial Targets (i) discovered, identified, synthesized or acquired by or on behalf of Licensor or Licensee during the Research Term and meet the Validation Criteria during the Research Term or within 24 months after the end of the Research Term or (ii) contained within a chemical genus as defined in any issued patent or any patent application being prosecuted in good faith by Licensor or Licensee, for which one member or such chemical genus is defined in (i) above; provided, however, that compositions of matter that incorporate, are derived from, developed using or based upon the New Targets accepted into the Research Plan as Initial Targets shall be considered Collaboration Compounds for the purposes of this Agreement, only if such compositions are (a) discovered, identified, synthesized or acquired by or on behalf of Licensor or Licensee during the Discovery Period and meet the Validation Criteria during or within six months after the Discovery Period or (b) contained within a chemical genus as defined in any issued patent or any patent application being prosecuted in good faith by Licensor or Licensee.

Licensed Product means any product based upon or derived from a Collaboration Compound and approved for sale by the USFDA or its foreign equivalent.

Surrogate Genetics shall mean the use of genetically engineered recipient cells, such as, but not limited to  bacteria, fungi, worm, fly, or mamalian cells, to create heterologous systems useful for gene-based functional assays for any gene, in applications such as, but not limited to gene discovery, functional genomics, drug screening, phenoprinting and diagnostics.

Patent Rights shall mean all United States and foreign patents (including all reissues, extensions, substitutions, confirmations, re-registrations, re-examinations, revalidations and patents of addition) and patent applications (including, without limitation, all provisionals, continuations, continuations-in-part and divisions thereof) in each case, claiming an invention which is necessary or useful for the design, development, testing, use, manufacture or sale of (i) Licensed Products, in the case of Licensee or (ii) Licensor Products, in the case of Licensor.

Field of Use

Licensee will apply the genetics technology to a number of viral disease targets in a search for novel antiviral agents.

Field shall mean viral therapeutics for human, animal and agricultural applications using small molecule approaches and viral disease diagnostic tools.

Licensee Field shall mean research and development of products for infectious diseases caused by bacteria, fungi, viruses, or other infectious agents, for use in viruses, or other infectious agents, for use in human health, animal health, agriculture, or other applications, which products may include but not be limited to, small molecules, vaccines, antisense, gene, antibody, protein, peptides, or diagnostics.

License Grant

For the Commercialization the Licensor of Iceland grants an exclusive license in the Territory under Licensor Collaboration Patents, Joint Collaboration Patents, and Know-How, with a right to sublicense
–  to make, have made, use, offer to sell, sell or import IRCT Compound and Products and related Tests and
–  to practice any other invention claimed in the foregoing patents solely with IRCT Compounds and Products or use any licensed Know-How solely with IRCT Compounds and Products and related Tests.

For the Compound Development Grants
– Licensor grants an exclusive license in the Territory under Licensor Collaboration Patents, Joint Collaboration Patents and Licensor KnowHow with a right to sublicense for the development of compounds Controlled by Licensee and related Tests in the Therapeutic Field for Disease Areas and Associated Information.
– Licensor grants to an non-exclusive license in the Territory under Licensor Prior Know-How and Patents with a right to sublicense for the development of compounds Controlled by Licensee and related Tests in the Therapeutic Field for Disease Areas and Associated Information.

During the Research Term, for each Licensor Compound in a Non-exclusive Disease Area that Licensor Controls, Licensor grants an exclusive option to negotiate for an exclusive license to that Licensor Compound in the Territory.

License Property

IRCT is Information Rich Clinical Trial relating to Patient genotyping with respect to allelic variants of the genes in the pathways involved and/or activated by the Selected Compound.

IRCT Compound shall mean a Selected Compound that has produced a Successful Clinical Result in an Information Rich Clinical Trial in accordance with the Agreement.

Field of Use

The field of use is human genetics and genomics and in the conduct of clinical trials.

The therapeutic Field shall mean any and all application of technology to evaluate in an IRCT the safety and efficacy of a compound in alleviating, treating or curing a patient suffering from at least one disease or condition.

The alliance will employ Licensor's population genetics capabilities and expertise in pharmacogenomic analysis to enhance and complement Licensee's on-going clinical development process. Licensor's population approach facilitates the selection of optimal trial cohorts and the analysis of patient responsiveness to drugs in relation to a range of phenotypic and genetic data. On the basis of trial results for particular compounds, the companies may also pursue the development of pharmacogenomic tests to identify patients for whom a given drug may be particularly effective.