Royalty Report: Drugs, Diagnostic, Biotechnology – Collection: 2119

License Grant

Under two license agreements, the Company has been granted the right and license throughout the world to use Licensor’s magnetocluster technology in connection with RaPID Assay products.  These agreements grant the right to develop, manufacture, market and sell products embodying Licensor-developed methods and techniques, for the production of magnetically separable particles used for the detection of environmental analytes.

License Property

The RaPID Assay product line for detection of pesticides and toxic organic contaminants employs magnetic particle immunoassay technology for highly precise determination of very low concentrations of contaminants.  Magnetic particle assays have a greater number of steps and require more technical expertise to execute than latex filtration assays, but are more suited to processing of larger number of samples at a single time, can be highly quantitative, and are relatively inexpensive on a cost-per-test basis.  These characteristics make magnetic particle immunoassays effective measurement tools in both laboratory and certain field applications, especially where highly precise results are required.

Field of Use

Licensee develops and sells on-site test systems, based primarily on immunoassay technology, designed for fast and inexpensive detection of contaminants in soil and water and other media samples relating to environmental remediation and environmental monitoring purposes.

License Grant

The Netherlands Company hereby grants to Licensee a non-transferable, non-exclusive license, without the right to sublicense, to use the NASBA Technology and/or the Accusphere Technology and the Patent Rights for the sole purpose of manufacturing, using, selling and/or having sold by resellers Licensed Products under its own label in the Research Market, Water Testing Market and the Air Testing Market in the Territory for the life of this Agreement.

License Property

The term NASBA means isothermal transcription based enzymatic nucleic acid amplification procedure, method or system.

The term Accusphere Technology means a proprietary processing method which conveys thermal protective characteristics to enzymes and other biologically active molecules when stored at temperatures above 00C and as set out in more detail in Annex A.

The term Licensed Products shall mean any in vitro diagnostic test, assay, method or kit, the development, manufacture, use, or sale of which make use of the NASBA Technology and/or are covered by one or more claims of the Patent Rights and/or which make use of the Accusphere Technology and includes services for providing test results or other services which utilize such product(s).

The Company has begun development of products for rapid detection of biological contaminants in environment related locations (drinking water and air), as well as in food and certain samples used to identify the causative agent of certain human diseases. All of the Company’s planned environmental and clinical diagnostic products for detection of viral or bacterial pathogens are based on the Licensee’s NASBA technology.

The Company has licensed the NASBA technology from the Licensee for certain specific applications and expects to reach agreement with other unaffiliated parties to expand the scope of LSI’s NASBA related activities.

The NASBA method employs all of the Company’s internally produced enzyme products in conjunction with other substrates to cause rapid replication (amplification) of specific segments of nucleic acids.  Confirmation of the presence of large numbers of a single segment of RNA or DNA after the amplification reaction is the basis for determination of the identity of contaminating viruses or bacteria.

Field of Use

The rights granted apply in the Research Market, Water Testing Market and the Air Testing Market.

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.