Royalty Report: Diagnostic, Assay, Drugs – Collection: 286050

License Grant

The Licensor of England grants a non-exclusive license, without sublicensing rights, under Licensed Patents to make, have made, use, and sell or otherwise dispose of Licensed Products bearing the name and trademark of Licensee prominently displayed thereon to End-Users, Authorized Distributors and Royalty-Bearing Distributors.

License Property

Licensor has the rights for the US patent titled Method of performing assay for analyte in liquid medium, as well as corresponding patents and patent applications applied for in the European Patent Office and in the United Kingdom, France, Germany, and Japan.

Class A Licensed Products shall mean any human, in vitro diagnostic immunoassay products, including but not limited to instruments, instrument kits, systems, assays or chemical products, but excluding assay products using genetic probe reagents or a combination of immunoassay reagents and genetic probe reagents, employing a labelled reagent to form a chemiluminescent label and another reagent which is bound to magnetically attractable particles, the manufacture, use or sale of which would, but for the license granted in Article II hereof, infringe one or more of the License Patents.

Class B Licensed Products shall mean any human, in vitro diagnostic genetic probe products, including but not limited to instruments, instrument kits, systems, assays, or chemical products,  including assay products using a combination of genetic probe reagents and immunoassay reagents, employing a labelled reagent to form a chemiluminescent label and another reagents which is bound to magnetically attractable particles, the manufacture, use or sale of which would, but for the license granted in Article II hereof, infringe one or more of the Licensed Patents.

Licensed Products shall mean Class A Licensed Products and Class B Licensed Products.

Field of Use

The field of use is for the conduct of human, in vitro diagnostic immunoassays and genetic probe assays for detection of an analyte in a human sample contained in a liquid medium characterized by the use of a labelled reagent which forms a chemiluminescent label system and another reagent bound to magnetically attractable particles.

License Grant

Licensor grants to a worldwide, nonexclusive, nontransferable right and license, with no right to grant any sublicenses, to make, have made, use, and sell Licensed products. Accordingly, the license includes the right of Licensee and purchasers of its Licensed products to practice methods covered by the Licensed patents and Licensed patent applications only by using such licensed products.

License Property

Licensor owns all rights to United States Patent titled Heterogenous chemiluminescent specific binding assay, and, its corresponding foreign-filed counterparts covering certain chemiluminescent specific binding assay methods and reagent systems.

Licensed Product shall mean a product for performing a Chemilumniescent Immunoassay only, and no other product, which when made, used, or sold would infringe a claim of a Licensed patent.

Chemilumniescent Immunoassay shall mean a liquid-phase heterogeneous chemiluminescent assay employing a chemiluminescent reactant as label and wherein the substance or condition to be determined, i.e., analyte of interest, is determined by binding thereto of an antibody or other specific binding protein.

Field of Use

Licensee intends to develop and market instruments and reagent systems for performing chemiluminescent immunoassays.

License Grant

With this amended and restated agreement, Licensee desires a non-exclusive license under the patent applications, and patents that may issue therefrom, to develop and perform Assays and market Kits in one or more fields.

Licensor grants a non-exclusive immunity from suit in the Territory under Licensor Patent Rights:
– to itself perform Licensed Assays;
– to make, have made, use, sell and promote Licensed Kits, and to pass on to end-user purchasers the right to use those Licensed Kits in the Licensed Fields under PHRI Patent Rights; and,
– to develop Licensed Assays and Licensed Kits, and to test Licensed Kits for quality control.

License Property

The licensed property is improvements in fluorescently labeled nucleic acid detection probes, and kits and assays employing such probes.  The patents include but are not limited to Hybridization Probes for Nucleic Acid Detection, Universal Stems, Methods and Kits, and, Detectably Labeled Dual Conformation Oligonucleotide Probes, Assays and Kits, and, Nucleic Acid Detection Probes Having Non-FRET Fluorescence Quenching and Kits and Assays Including Such Probes, and, Non-competitive Co-Amplification Methods, and, Wavelength-Shifting Probes and Primers and Their Use In Assays and Kits, and, Assays for short sequence Variants.

Field of Use

Licensed Fields shall mean the fields of Human In Vitro Diagnostics, Food Testing, and Environmental Testing.

Human In Vitro Diagnostics ( HIVD) shall mean the field of use comprising the in vitro measurement, observation or determination of one or more protein or nucleic acid targets in a sample obtained from a human being for medical management of that human being or for blood banking, bone marrow banking or similar banking of human tissues for human medical management, and pre-clinical uses and clinical trials for the foregoing uses, even if kits for such purposes are labeled Research Use Only or Investigational Use Only.

Food Testing shall mean the field of use comprising the in vitro measurement, observation, or determination of one or more protein or nucleic acid targets of an organism in a sample obtained from food and/or sources of food intended for human consumption in order to determine whether or not that food is fit for consumption.

Environmental Testing shall mean the field of use comprising the in vitro measurement, observation or determination of one or more protein or nucleic acid targets of microorganisms (including bacteria, yeast, viruses and parasites) for the purpose of detecting and/or monitoring environmental contamination in (a) materials associated with a manufacturing process, excluding samples of food intended for consumption, or (b) samples collected from air, soil, water or other liquids, particles or surfaces. Environmental Testing includes testing for the presence of microbiological agents used for bioterrorism and biowarfare.

License Grant

The University of Wales grants to the Licensee registered in England:
– an exclusive license to use the Technical Information and under the Licensors copyright to use the Process to manufacture Products; and
– an exclusive license to use sell or otherwise deal in Products manufactured under the license anywhere in the Territory.

The Licensor hereby agrees to grant to the Licensee:
– an exclusive license under the Patent Rights to use the Process to manufacture Products; and
– an exclusive license to use sell or otherwise deal in Products manufactured under the license anywhere in the Territory.

License Property

The Licensor has developed and is the beneficial owner of a substantial body of valuable Technical Information relating to the measurement of analytes based upon the phenomenon of chemiluminescence which is applicable to immunoassay binding protein and other assay systems and is the beneficial owner of the Patent Rights.

Process is the chemiluminescence technology and defined in the Patent Rights.

Products are clinical diagnostic kits and/or components thereof and/or any other products incorporating the Process.

Field of Use

The Licensee wishes to use such information and to work under the said Patent Rights in order to manufacture, use, sell or otherwise deal in the said chemiluminescence technology save and except the excluded uses.

License Grant

The University of Wales grants to the Licensee, also of Wales, an exclusive right and license to develop manufacture market and sell either by itself or with such other parties as Licensee and Licensor shall determine clinical diagnostic kits and/or components thereof and/or any other related products incorporating the Chemiluminescence Technology covered by the Patents.

License Property

University has developed techniques for the measurement of the presence of antibodies binding proteins and other analytes based upon the phenomenon of chemiluminescence which it believes may be applicable to immunoassay binding protein and other assay systems.

The patents relate to Luminescent Protein Labelling, and, Homogeneous Assay.

Field of Use

Licensee has assisted in the development of the techniques and has a number of commercial contacts who would be interested in manufacturing and marketing clinical diagnostic kits components for such kits and other related products on a commercial scale and is also interested in manufacturing and marketing such kits and other products itself.

License Grant

Licensor grants the following licenses for the Licensed Field only, which shall be exclusive, for the Bacteriology Field and non-exclusive for the balance of the Licensed Field:
—  A worldwide license under the Patent Rights, Know-How and Copyrights included in Licensor Licensed Core Technology and Licensor Collaboration Technology to import, use, distribute and sell Licensed DNA Probe Arrays, and to incorporate or cause the incorporation of such Licensed DNA Probe Arrays, through processes of manufacture, into Licensed Diagnostic Assays, and to manufacture and have manufactured Licensed Diagnostic Assays, and to use, import, distribute and sell Licensed Diagnostic Assays.

With respect to Other Licensed Diagnostic Products that are to be used solely with a DNA Probe Array that has 10 or fewer Probes/cm(2) and is not included as a High Density Probe Array (Low Density  Probe Array), Licensor agrees to grant a nonexclusive, worldwide license in the Licensed Field under the Patent Rights included in the Licensor Licensed  Core Technology and the Licensor Collaboration Technology to make, have made,  use, import, distribute and sell and  under the Know-how and Copyrights included in the Licensor Licensed Core Technology and the Licensor Collaboration Technology to make, have made, copy, display, distribute, use, import and sell, all such Other Licensed Diagnostic Products for use with such Low Density Probe Arrays solely for use in the Licensed Field.

In addition to the foregoing license, Licensor grants with respect to Licensor Collaboration Technology, a nonexclusive, worldwide, research-use only license to use the Licensor Collaboration Technology outside of the Licensed Field for Licensees own research purposes pertaining to Clinical Diagnostics, and for the Licensed Field for Licensees purposes pertaining to this Collaboration and research and development in furtherance thereof.

For the option for non-exclusive Licenses in the Virology and HLA Fields, subject to pre-existing agreements, Licensor grants non-exclusive options to enter into non-exclusive licenses under Licensor Licensed Core Technology to expand Licensees products that would use Licensed DNA Probe Arrays to include categories of products for viral agents and products for the testing of human leukocyte antigens (HLA Class I and Class II allelic polymorphis) any condition, except for the diagnosis of cardiopulmonary disease to the extent that such rights have been previously granted on an exclusive basis to a third party (HLA option).

License Property

Licensed Diagnostic Product means a Licensed Diagnostic Assay or any Other Licensed Diagnostic Product.

Licensed Diagnostic Assay means a disposable diagnostic assay or reagent kit for use in Clinical Diagnosis,  which assay or kit incorporates a Licensed DNA Probe Array supplied by Licensor to Licensee pursuant to the Manufacturing Agreement or permissibly manufactured by Licensee in accordance with the Manufacturing Agreement.
    
Licensed DNA Probe Array means any High Density DNA Probe Array developed in the Collaboration, or based on specifications derived from prototypes so developed.

The Viral Agent Candidates include Adenovirus, Rotavirus, Herpes Simplex Virus Type II (when done in an STD panel), Enterovirus, Viral Influenza, Respiratory Syncytial Virus (as part of a respiratory panel), Viral encephalitis and Viral meningitis.

GeneChip system is the platform of choice for acquiring, analyzing and managing complex genetic information in order to improve the diagnosis, monitoring and treatment of disease.

GeneChip system consists of four integrated parts: disposable DNA probe arrays containing genetic information on a chip housed in a cartridge, a fluidics station for introducing the test sample to the probe arrays, a scanner to read the data from the probe arrays, and software to control the instruments and to analyze and manage the genetic information. The GeneChip system is designed for use by pharmaceutical and biotechnology companies, academic research centers and reference laboratories.

Field of Use

The collaboration agreement is to develop GeneChip probe arrays for clinical diagnostic kits for bacterial identification and antibiotic resistance analysis.

The Licensed Field means the field which encompasses only the Bacteriology Field and the field of detection, identification and/or determination of resistance to treatment of four viral agents commonly included in bacteriology testing, to be elected by Licensee for use only in Clinical Diagnosis.

Bacteriology Field means the field of only detection and/or identification of bacterial and fungal microorganisms, and the determination of antibiotic resistance of such bacterial and fungal microorganisms, both for use in the Clinical Diagnosis of human disease.

License Grant

The Licensor of England grants the exclusive rights to make have made use and sell Products and to practice the methods described in the said Patent Rights to conduct clinical assays.

Licensor shall promptly after the date hereof disclose to Licensee all Proprietary Information owned or controlled by Licensor which is reasonably necessary to enable Licensee to make have made use and sell Products and to apply Chemiluminescence Technology to clinical diagnostic assay products and procedures and Licensor grants to Licensee the right and license to use such Proprietary Information to make or have made Products in the Countries identified and to use and sell Products and to perform clinical assays throughout the world.

Licensor agrees to grant to Licensee an exclusive license under all patent rights inventions know-how and proprietary information that it may hereafter come to own or control or shall have the right to sublicense during the Term of this Agreement and which cover or relate to improvements to Licensors licensed Patent Rights Products or to the assays agreed by Licensor and Licensee to enable Licensee to use such Patent rights inventions know-how and Proprietary Information to improve such Products and assays.

If Licensor develops new diagnostic immunoassay and binding protein tests based upon the Chemiluminescence Technology during the Term other than the assays identified and which are not improvements to such assays Licensor shall promptly and exclusively advise Licensee in writing of the availability of such assays and shall make available to Licensee all information in the possession of Licensor regarding such assays and shall give Licensee 120 days to make a proposal to Licensor whereby Licensee shall obtain licenses to make have made use and sell such assays Licensor shall accept or reject Licensees proposal.

License Property

The Licensor property was granted to Licensor by a University, the rights to the techniques for the measurement of the presence of antibodies, binding proteins and other analytes based upon the phenomenon of chemiluminescence.  The University inventions are specifically pertaining to Chemiluminescence Technology.

The technology is a proprietary technique for measurements based upon the phenomenon of chemiluminescence for which the University has applied for patent protection.

The Chemiluminescence technology is the body of knowledge inclusive of the Universitys Patent Rights and Proprietary Information relating to the quantification of substances utilizing light energy emissions resulting from reactions involving such substances that is useful in immunoassay and binding protein assay systems.

The Products are Clinical diagnostic kits and components of diagnostic kits the manufacture sale or use of which would constitute an infringement of the Universitys Patent rights but for the licenses granted hereby or which incorporate to a substantial degree technical Proprietary Information.

Field of Use

The field of use is measurement technology to clinical diagnostic immunoassay and binding protein assay systems developed.

License Grant

Licensor grants to Licensee and its Affiliates a limited non-exclusive, personal and non-transferable, right and subLicense under the Licensed Patents, to make, have made for its own use and sale, use, offer to sell, sell and import product within the field and within the territory, and to practice the methods claimed in the Licensed Patents in connection with such product, and to extend to its customers purchasing product the right to use and sell the product purchased and to practice the methods claimed in the Licensed Patents in connection with such product.

License Property

Licensed Patent shall mean United States Patent Nos. 5,073,484, 5,654,162 and 6,020,147 and any patents resulting from a re-examination or reissue from any of the foregoing patents.

The patents are for a device for detecting the presence of an analyte in a carrier liquid suspected of containing said analyte, which device comprises a liquid permeable solid medium which defines a path for fluid flow capable of supporting capillary flow, along which are a site for application of the carrier liquid, a diffusively bound labeled reactant specific for the analyte or a chemical moiety which is itself the reaction product of the analyte with another chemical moiety, said labeled reactant being capable of flow along the flow path, wherein said diffusively bound labeled reactant and said analyte or chemical moiety are of a specific ligand-anti ligand pair, and one or more zones spaced along said flow path, each zone having a predetermined amount of a reactant bound to it which is specific for either the analyte or a chemical moiety which is itself the reaction product of the analyte with another chemical moiety.

Wherein said device can be used by contacting a carrier liquid with said application site in such a manner that permits said liquid to pass along the flow path by capillary flow such that analyte or reaction product of the analyte with another chemical moiety becomes bound to both the labeled reactant and the reactant bound to the solid medium;  and wherein the labeled reactant, with the reactant bound to the solid medium, sandwiches the analyte or a chemical moiety which is itself the reaction product of the analyte with another chemical moiety.

Lateral flow tests also known as lateral flow immunochromatographic assays, are simple devices intended to detect the presence (or absence) of a target analyte in sample (matrix) without the need for specialized and costly equipment, though many lab based applications exist that are supported by reading equipment.[2] Typically, these tests are used for medical diagnostics either for home testing, point of care testing, or laboratory use.

License Grant

The Great Britain University grants to Licensee and its Affiliates a worldwide exclusive license under its Patent Rights, Technology, and Tangible Technical Materials to make, have made, import, use, offer to sell, or sell Licensed Subject Matter during the Term of this Agreement.

License Property

Licensed Subject Matter shall mean Licensed Patent Product, Patent Rights, Technology, and Tangible Technical Materials for in-vitro diagnostic assays, using labeled nucleic acid probes.

UK Patent Application Number 9704054.7 entitled 'Chromosome-specific Paint Probes'

The University owns Technology and Tangible Technical Materials related to Assays to Detect and Analyze Chromosomal Aberrations in various species using labeled DNA from a related species as a set of probes and, the United Kingdom patent for Chromosome-specific Paint Probes.

Based upon a novel method developed by scientists at the University, the Company's RxFISH(TM) assay develops a unique fluorescent color banding pattern for human chromosomes that is then analyzed by the CytoVision software.

Field of Use

The field is in-vitro diagnostic assays, using labeled nucleic acid probes.  The Licensee is in the business of automated clinical analysis systems used by cytogenetic laboratories for prenatal and other genetic testing applications.

License Grant

Licensor grants a worldwide, non-exclusive, non-transferable, license under Licensed Patents and Licensed Know-How, to make (not including have made), import, export, use, offer to sell, and sell Licensed Products in the Licensed Field.

License Property

The licensed patents relate to Hybridization assay using self-quenching fluorescence probe.

'Licensed Patents' means U.S. Patent Nos. 6,030,787; 5,723,591; and 5,876,930, including any Related Patent

'Licensed Product' means any product for use in the Licensed Field, (A) that does not comprise a nucleic acid probe that is susceptible to the 5'-nuclease activity of a polymerase and, (B) (a) which, but for the license granted herein, manufacture, use or sale thereof would infringe at least one Valid Claim of a Licensed Patent, and/or (b) which otherwise uses, incorporates or was developed or manufactured using Licensed Know-How.

Licensed Know-How means any Confidential Information transferred by Licensor to Licensee in connection with activities performed pursuant to the Collaboration Agreement.

'Authorized Oligonucleotide Synthesizer' means an Instrument whose use for automated oligonucleotide synthesis is covered by the up-front fee component of a license under the Process Patents. That up-front fee component may be obtained through the purchase of Instruments bearing a valid label conveying that up-front component, such Instruments being available from Licensor (all Licensor's synthesizers are Authorized) or from other suppliers who have contracted with Licensor to pay that up-front fee component on behalf of their customers. Alternatively, that up-front fee component may be purchased from Licensor.

'Cleavage Assay' means an assay in which the detection of a nucleic acid sequence includes the cleavage of a nucleic acid probe, including, but not limited to, the TaqMan assay.

Field of Use

The Licensed Field means nucleic acid analysis techniques that do not comprise a Cleavage Assay.

Epoch's Eclipse(TM) probe assays, scheduled for release this summer, will allow affordable, reproducible and sensitive measurement of gene expression and detection of genetic polymorphisms for academic, biotech, diagnostic and pharmaceutical researchers.

License Grant

For the Exclusive License, Licensor grants a world-wide exclusive license under Licensed Patents and Licensed Know-How to make, use, offer to sell, sell and import Licensed Products in the Exclusive Licensed Field.

For the Non-Exclusive License, Licensor grants a world-wide non-exclusive license under Licensed Patents and Licensed Know-How to make, use, offer to sell, sell and import Licensed Products in the Non-Exclusive Licensed Field.

License Property

The licensed know-how is certain know-how relating to the synthesis of MGB Oligonucleotides, and the design of sequence-specific probes comprising such oligonucleotides.

The Licensed Patent is titled Covalently Linked Oligonucleotide Minor Groove Binder Conjugates.

MGB Oligonucleotide means Licensed Product comprising an oligonucleotide having a minor-groove binding moiety covalently attached thereto, and, at Perkin-Elmers option, further comprising a fluorescent label and/or a fluorescence quencher. A Purified MGB Oligonucleotide means an MGB Oligonucleotide that is at least 90% pure based on the HPLC assay.

Field of Use

Exclusive Licensed Field means  the  5-Nuclease Assay Field.

Non-Exclusive Licensed Field means use of MGB Oligonucleotides as ligation probes in an oligonucleotide ligation assay, generally as described in U.S. Patent No. 4,883,750; use of MGB Oligonucleotides in an assay employing a sequence-specific hybridization pull-out step subsequent to a ligation and/or primer extension reaction;  use of MGB Oligonucleotides as primers in a primer extension reaction, including but limited to a PCR reaction or a DNA sequencing reaction, and use of MGB Oligonucleotides in the Real-Time Nucleic Acid Monitoring Field.

Human In Vitro Diagnostics Field (HIVD Field) means products and processes for the measurement of attributes, characteristics, diseases, traits or other conditions of a human being for the medical management of that human being.

License Grant

The Licensor of England grants to the Licensee a non-exclusive license under the Patent Rights in the Territory to make, use and sell Licensed Products.

Licensor grants to the Licensee a non-exclusive option to a license to make, use and sell Products Under Option. This option may be exercised on a per analyte basis at any time within the two (2) year period subsequent to the Effective Date of the Agreement, whereupon it will cease on a per analyte basis.

License Property

Licensed Product shall mean any device for qualitative or quantitative detection of the analytes Fetal Fibronectin, and, Interleukin 6 for Group B Strep and Chlamydia.

Products Under Option shall mean any device for qualitative or quantitative detection of the analytes Fetal Fibronectin, and, Interleukin 6 for Group B Strep and Chlamydia.

Fetal fibronectin (fFN) is a fibronectin protein produced by fetal cells. It is found at the interface of the chorion and the decidua (between the fetal sac and the uterine lining). It can be thought of as an adhesive or 'biological glue' that binds the fetal sac to the uterine lining.

Field of Use

Fetal fibronectin (fFN) is used to test pregnant women who are between 22 weeks and 35 weeks of gestation and are having symptoms of premature labor. The test helps predict the likelihood of premature delivery. Many pregnant women experience symptoms that suggest preterm labor.

Licensee designs, develops, manufactures and markets innovative products for women’s health, with focus on reproductive healthcare, using proprietary technologies to predict preterm birth and assess infertility.