Royalty Report: Medical, cardiac, Diagnostic – Collection: 336372

License Grant

Canadian Licensor hereby grants to Licensee a license to Licensor’s intellectual property rights in the Reagents and the POC Rapid Assays to manufacture the POC Rapid Assays in accordance with the POC Rapid Assay Specifications, subject to the terms and conditions of this Agreement, for the sole and exclusive purpose of incorporating the Reagents into P~C Rapid Assays.

License Property

Licensor has developed, and is in the process of further developing, certain unique, proprietary biomarkers and protein targets for the diagnosis of congestive heart failure, insulin resistance, Alzheimer’s disease, traumatic brain injury and other various diseases, excluding stroke.

Reagents shall mean biomarkers and protein targets developed and produced by Licensor for the diagnosis of congestive heart failure, insulin resistance, Alzheimer’s disease, traumatic brain injury and other various diseases, excluding stroke. The term “Reagents” shall also include all other biomarkers and protein targets developed and produced by Licensor (other than for stroke) for which there shall be application in the point of care diagnostic products.

POC Rapid Assays shall mean rapid assay diagnostic point of care products, utilizing Reagents; provided, however, that “POC Rapid Assays” shall not include devices for test procedures performed in a hospital’s central clinical laboratory or in a reference laboratory setting. In addition, “POC Rapid Assays” shall not include any assay that can be used on any instrument with random access capability and/or any instrument with the ability to analyze multiple samples.

POC Rapid Assay Specifications shall mean the standards and specifications for the manufacture of the POC Rapid Assays, as developed and agreed to by the Parties, as amended from time to time, and shall be appended to and form part of this Agreement.

Reagent Specifications shall mean the standards and specifications for the manufacture of the Reagents, as developed and agreed to by the Parties, as amended from time to time, and shall be appended to and form part of this Agreement.

Field of Use

The biomarkers are used to determine the diagnosis of congestive heart failure, insulin resistance, Alzheimer’s disease, traumatic brain injury and other various diseases, excluding stroke.  Biomarkers can be measured through a blood sample.

License Grant

Licensor hereby grants to Canadian Licensee a license to Licensor’s intellectual property rights, if any, in the POC Rapid Assays, to distribute, use and sell the POC Rapid Assays throughout the world, subject to the terms and conditions of this Agreement.

License Property

POC Rapid Assays shall mean rapid assay diagnostic point of care products, utilizing Reagents; provided, however, that “POC Rapid Assays” shall not include devices for test procedures performed in a hospital’s central clinical laboratory or in a reference laboratory setting. In addition, “POC Rapid Assays” shall not include any assay that can be used on any instrument with random access capability and/or any instrument with the ability to analyze multiple samples.

Reagents shall mean biomarkers and protein targets developed and produced by Licensee for the diagnosis of congestive heart failure, insulin resistance, Alzheimer’s disease, traumatic brain injury and other various diseases, excluding stroke. The term “Reagents” shall also include all other biomarkers and protein targets developed and produced by Licensee (other than for stroke) for which there shall be application in the point of care diagnostic products.

POC Rapid Assay Specifications shall mean the standards and specifications for the manufacture of the POC Rapid Assays, as developed and agreed to by the Parties, as amended from time to time, and shall be appended to and form part of this Agreement.

Reagent Specifications shall mean the standards and specifications for the manufacture of the Reagents, as developed and agreed to by the Parties, as amended from time to time, and shall be appended to and form part of this Agreement.

Field of Use

The biomarkers are used to determine the diagnosis of congestive heart failure, insulin resistance, Alzheimer’s disease, traumatic brain injury and other various diseases, excluding stroke.  Biomarkers can be measured through a blood sample.

License Grant

German Licensor hereby grants to Canadian Licensee, subject to the terms and conditions set forth herein, a non-exclusive license, under the Licensor Licensed Patent Rights to use, have used, develop, have developed, make, have made, possess, import, have imported, export, have exported, market, have marketed, offer for sale, have offered for sale, sell and have sold or otherwise distribute Licensee Licensed Products under its own trademark and/or trade name in the Licensee Licensed Field throughout the Territory.

License Property

proBNP shall mean the N-terminal pro brain natriuretic peptide.

Licensed proBNP Test shall mean the smallest unit of a Licensee Licensed Product sufficient for generating a single proBNP test result from a single sample independent of its origin ( e.g. patient sample, calibrator or control).

U.S. Patent #5,786,163 – BNP antibody and immunoassay using it

Licensee Licensed Product shall mean any product (including, without limitation, a diagnostic kit or packaged assay in its entirety, any component part of a diagnostic kit or packaged assay, any human in-vitro diagnostic assay or research-use-only assay, any investigational-use-only assay, or any Analyte Specific Reagents (ASRs) or General Purpose Reagents (GPRs» sold by Licensee, the development, manufacture, offering, distribution, use, import, export or sale of which, but for the license granted hereunder would infringe one (1) or more Valid Licensor Claims in the country in which such product is developed, manufactured, offered, distributed, sold, imported, exported or used.

Field of Use

The intellectual property relates to the cardiovascular marker proBNP  The license is in the field of point-of-care diagnostics relating to the development, manufacture and marketing of immunoassays for point-of-care diagnostics that detect the congestive heart failure marker NT-proBNP.

Licensee Licensed Field shall mean the field of human in vitro diagnostics restricted to Point of Care market segments, whereby Point of Care means analysis conducted in an instrument or in a system which is designed for a throughput of less than 10 specimens or samples per hour.

RDG Licensed Field shall mean the field of research and in vitro diagnostics.

License Grant

Licensor grants an exclusive, perpetual, worldwide license under all Licensor Biomarker IP, Licensor Collaboration IP and Licensor Platform IP to  use Instruments, and Proprietary Supplies supplied by Licensor solely to develop and commercialize such Licensed Laboratory Test; and, make, have made, use, sell, offer for sale, import and otherwise exploit any and all subject matter within the Licensor Licensed Technology that is not supplied to Licensee by Licensor hereunder or the applicable Supply Agreement or made generally commercially available to Third Parties by Licensor, in each case to develop and commercialize such Licensed Laboratory Test.

This agreement has exclusive and non-exclusive territories.

License Property

Licensor develops, manufactures and markets its Protein Chip Systems using its patented surface enhanced laser desorption/ionization (SELDI) technology and also owns and operates a division directed toward the development and commercialization of products for the field of Clinical Diagnostics, including the discovery, principally through Licensor Collaboration Agreements, of disease-specific Biomarkers and protein signatures that could be utilized in Licensed Laboratory Tests and Test Kits.

Clinical Diagnostic means, in connection with clinical medical practice, the assaying, testing, or determination outside of a living organism of one or more Biomarkers in or on any test sample for the purpose of identifying, characterizing, defining, or diagnosing a disease state or other condition in humans or animals, including without limitation determining the state of an individual’s health to treat or prevent disease as well as the screening, prognosis, therapeutic monitoring, and/or evaluation of the progression of any disease or other condition.

Biomarker means any
—  nucleic acid (whether DNA, RNA or otherwise), protein or organic molecule;
—  set of nucleic acids, proteins and/or organic molecules or
—  profile, i.e., presence and/or quantity, of the items described.  As used herein, the term protein refers to any polypeptide and the term nucleic acid refers to any nucleotide sequence, in either case whether naturally occurring, synthesized, modified or otherwise.

The patents relate to cancers and heart disease.

Field of Use

Field means all potential Clinical Diagnostics.   Licensor products are for the field of Clinical Diagnostics, including the discovery of disease-specific Biomarkers and protein signatures that could be utilized in Licensed Laboratory Tests and Test Kits .

Licensee is a provider of diagnostic testing, information and services and has substantial experience in the development and commercialization of products having Clinical Diagnostic Applications.  This alliances activities are directed toward discovery of Biomarkers for Clinical Diagnostic applications, and, modifications to the Licensors Platform Technology to meet the requirements of the Clinical Diagnostics markets and FDA.

License Grant

The Licensor of the Netherlands grants to a license to any and all Intellectual Property Rights as may be agreed by the Parties and set forth from time to time in one or more addenda to this Agreement on the terms set forth herein and on such additional terms as may be set forth in such addenda. Any such Intellectual Property Rights are sometimes hereinafter referred to as Subject IP, and any such addendum is sometimes hereinafter referred to as a Licensing Addendum.  The License granted under this Licensing Addendum shall be exclusive.

License Property

The licensed property is for certain Intellectual Property Rights and capabilities in the field of cardiac disease markers, in particular in the area of heart failure.

For this Addendum 1, the following Intellectual Property Rights shall constitute Subject IP and
therefore be licensed
—  all rights of any nature in and to patent/application entitled 'Method for identifying a subject at risk of developing heart failure by determining the level of Galactin-3 or Thrombospondin-2, and all related patents and patent applications.

Field of Use

The License granted under this Licensing Addendum shall permit Licensee to use and exploit the Licensor Pre-Existing IP and Jointly Developed IP for any purpose whatsoever.  The Field of Interest shall include the field of congestive heart failure.  Licensee owns advanced proteomic and metabolomic capabilities that are applied for biomarker discovery and validation.

License Grant

The Company has the rights to use certain raw materials in the manufacture of Vitamin D diagnostic tests.

License Property

Vitamin D diagnostic tests are for reagents that are used in its FastPack Vitamin D Assay.

The FastPack System is for the treatment of cancer and infectious diseases using nanoparticle coating technology similar to the core nanoparticle coating technology.

The FastPack System is a proprietary diagnostics platform launched in 2001. This novel, rapid and highly accurate immunoassay testing system consists of the FastPack Analyzer and the FastPack test pouch; a single-use, disposable, foil packet which includes the FastPack reagent chemistry. Since the initial conception of the system, the Company has developed two versions of its analyzer and test pouch (1.0 and IP) and has expanded its assay menu to 10, including tests for prostate cancer, thyroid function, metabolic disorders and research applications.

Field of Use

FastPack® IP Vitamin D Immunoassay
Vitamin D, known as the sunshine vitamin, is part of a group of fat-soluble prohormones which encourage the metabolism of calcium and phosphorus in the body. Increasing research is now uncovering evidence illustrating the importance of vitamin D in the protection against a whole host of health issues. It is also estimated that as much as half the population in the world is deficient in vitamin D. The FastPack® IP Vitamin D immunoassay is intended for the quantitative determination of total 25-hydroxyvitamin D and other hydroxylated metabolites in human serum and plasma. This assay is designed for use with the FastPack® IP System which is designed specifically for use in the practice laboratory setting.

License Grant

The University grants a worldwide, exclusive license under Licensed Subject matter to discover, research, develop, make, have made, use offer for sale, sell and import Licensed Products and Identified Products for use within Licensed Field.

License Property

Licensed Product means any compound, assay, method, reagent, technology, product or service comprising Licensed Subject Matter.

Licensed Subject Matter means inventions, discoveries, assays and processes covered by Patent Rights and/or Technology Rights within Licensed Field.

The patents are for Methods and Compositions Relating to Muscle Selective Calcineurin Interacting Protein (MCIP).

Field of Use

Licensed field means treatment, prevention, diagnosis and/or prognosis of cardiac hypertrophy, heart disease and heart failure; and determination of predisposition to cardiac hypertrophy, heart disease and heart failure.