Royalty Report: Drugs, Diagnostic, Biotechnology – Collection: 7119

License Grant

Licensor, government organization, grants (a) Under Initial Patents and Research Patents, a worldwide exclusive license, including the right to grant sublicenses, to make, have made, use and sell or otherwise dispose of Royalty-Bearing Products including the right to grant immunity from suit under Initial Patents and Research Patents to authorized third parties for the use and sale of such Royalty-Bearing Products hereunder.

License Property

(a)  U.S. Serial No. 08/004,993 entitled Diagnostic Assays And Kits For RNA Using RNA Binary Probes And A Protein That Is An    RNA-Directed RNA Ligase
(b) U.S. Serial No. 08/006,073 entitled Sensitive Nucleic Acid Sandwich Hybridization Assays And Kits by Tyagi et al., filed January 15, 1993 and otherwise designated as A38 by PHRI; and
(c) U.S. Serial No. 08/005,893 entitled Diagnostic Assays And Kits For RNA Using RNA Binary Probes And A Ribozyme Ligase by Lizardi et al., filed January 15, 1993 and otherwise designated as A39 by PHRI.

Field of Use

The Royalty-Bearing Product is used or expected to be used to perform a method or process within the scope of one or more claims of a pending patent application or an issued patent.

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

Licensor grants a non-exclusive, non-transferable license under Patent Rights to practice Licensed Methods in the Field within Licensors laboratories and to make, have made, use, and export Licensed Products solely for use byLicensee, in the practice of Licensed Methods in the Field. License grant shall not include the right to sell Licensed Product and/or Licensed Method to third parties.

License Property

Licensor owns certain patents covering compositions and processes for detecting ribosomal nucleic acid subsequences belonging to groups of non-viral organisms.

The patents refer to Methods for Detection. Identification and Quantification of NonViral Organisms.

Field of Use

The Field shall mean the performance of human, clinical diagnostic Assays and Assay Series using one or more nucleic acid probes, including peptide nucleic acid probes and probes with modified sugar or phosphate groups, which are designed to detect whether or not bacteria are present in a sample by hybridizing to one or more pan-bacterial regions of ribosomal nucleic acid, whether ribosomal RNA or ribosomal DNA, in order to determine the presence or amount of bacteria which may be present in a human sample. 'Field' shall not include Assays and Assay Series only to detect, quantitate or identify any group of organisms less than or different than that encompassing all bacteria.

License Grant

The University and Salk grant to Licensee, upon and subject to all terms and conditions of this Agreement  a worldwide exclusive license under the Licensed Patents to manufacture, have manufactured, use, sell, rent and lease Licensed Products for the term provided hereof.

License Property

Whereas, Columbia is the assignee of U.S. Patent Application Serial No.614,350, entitled Autocatalytic Replication of Recombinant RNA and Salk and Columbia are coassignees of U.S. Patent Application Serial No. 852,692, entitled Replicative RNA Reporter System.

Licensed Products shall mean all assays, kits, compositions,  reagents used in assays, and Diagnostic Instruments for performing assays where Licensee realizes a profit on cumulative Net Sales of such Diagnostic Instruments, which relate  to RNA-based amplification/detection systems which employ exponential amplification of replicative RNA by QB Replicase or a  related enzyme, whether or not used in or on Diagnostic Instruments, and which are covered by a claim of a Licensed  Patent that has neither expired nor been declared invalid by a court of last resort (Issued Valid Claim), or which use Licensed Research Information. Licensed Products shall exclude  reusable physical structures such as, by way of example,  containment, filters, detection means, temperature control  elements, transport mechanisms, sonication means, mixing elements, film software, computing hardware, manuals, recording  devices, paper and packing.

Field of Use

The rights granted relate to RNA-based amplification/detection systems which employ exponential amplification of replicative RNA by QB Replicase or a related enzyme.

License Grant

The Licensor gave an exclusively license to the Company of patent titled One-Step In Situ Hybridization Assay.

License Property

The patent applications owned or co-owned by the Company either seek to cover improvements in reagents and methods of performing an in situ hybridization process or seek to cover methods of identifying and isolating fetal cells for prenatal diagnosis by in situ hybridization.

Among its claims is one that recites a method for assaying nucleic acids in a sample of cells having substantially intact membranes. The claimed method consists essentially of the steps of contacting the sample with a medium comprising a fixative agent, a denaturing agent, a hybrid stabilizing agent, a buffering agent, a membrane pore-forming agent and at least one nucleic acid probe. The contacting is under hybridizing conditions. The sample is incubated with the medium in the presence of at least one detectable label, and duplex formation is detected by means of the label, wherein the method is capable of detecting as few as one to five copies of a target nucleic acid per cell. Another claim applies to the foregoing process, in which the detection is carried out by flow cytometry. The patent also contains claims for kits.

License Grant

The Licensee has the exclusive License to the rights to the NTP testing technology, which measures the level of a brain protein called neural thread protein (NTP), and which is elevated early in Alzheimer's disease, effective in 1997.   University and the Licensor are part of a sponsored research and licensing agreement, under which the Licensee sponsored the research of the principal investigations into the use of neural thread protein, its antibodies or genes for diagnostic or therapeutic purposes. The Licensee also paid the patent costs for the patent applications filed arising out of this research. In return under the agreement, the licensee received an exclusive worldwide license of the patents to sell products and to use processes encompassed by them.

License Property

The Licensor have discovered Neural Thread Protein, and developed antibodies, probes, and other reagents, patents, and information associated with this protein and are interested in the development of new diagnostic strategies for Alzheimer's Disease and other neurodegenerative diseases ('TECHNOLOGY');

The term 'PATENT RIGHT' shall mean (a) (i) the United States Patent Application Serial No. 07/287,207 filed December 20, 1988 entitled 'Method of Detecting Neurological Disease or Dysfunction,' (ii) the United States CIP Patent Application Serial No. 07/451,975 filed on December 20, 1989, (iii) the United States Patent Application Serial Number 08/055,778 filed May 3, 1993 as a file wrapper continuation, and, (iv) the United States Patent Application Serial Number to be assigned, filed June 6, 1995 as a divisional application,

b) (i) the United States Patent Application Serial No. 08/050,559 filed on April 20, 1993 entitled 'Neural Thread Protein Gene Expression and Detection of Alzheimer's Disease, ' (ii) the United States CIP Patent Application Serial No. 08/230,139 filed on April 20, 1994, (iii) the United States CIP Patent Application 08/340,426 filed on November 14, 1994, (iv) the United States Patent Application Serial No. 08/454,557 filed on May 30, 1995 as a divisional application, and (v) the United States Patent Application Serial No. 08/450,673 filed on May 30, 1995 as a divisional application;

Field of Use

The term 'FIELD OF RESEARCH' shall mean research pertaining to the use of any form of neural thread protein, its antibodies, and any cDNAs or genes or genomic fragments coding for neural thread protein, for diagnostic purposes.