Royalty Report: Diagnostic, Drugs, Disease – Collection: 237259

License Grant

Licensor grants the Japanese Licensee, a non-exclusive, non-transferable license in the Territory under the Licensor Patent Rights to develop, make, have made, use, offer for sale, sell and have sold, Licensed Products in the Field, Future Licensed Products and to practice Licensed Methods in the Field.

License Property

The patents include Method for Detecting, Identifying and quantitating organisms and viruses, and, a Method for Determining  the sensitivity of Microorganisms, and, a Nucleic Acid Probe, and, Method for releasing RNA and DNA from Cells, and, Accelerated Nucleic Acid re-association method, and, Nucleic Acid Probes for Detection of non-viral organisms.

Licensor has developed proprietary technology relative to the performance of diagnostic assays based on genetic probe technology for the detection of agents causing infectious diseases, including viruses, and for the detection of cancer.

Licensor Patent Rights shall mean the Japanese patents, patent applications and international applications, to the extent they enter the national stage in Japan; all patents that have been issued or in the future issue, that are derived from or are related to, all patents to this Agreement, including without limitation utility model and design patents and certificates of invention.  

Licensed Product shall mean any already developed product or product in development as of the effective date of this agreement.  The products relate to DNA Probe – HBV Quantitative HBV, Infectious Disease , and Cancer.

Licensed Method shall mean any method, the use or practice of which would constitute, but for the license granted herein, an infringement of any issued Valid Claim within the Licensor Patent Rights.

Field of Use

Field shall mean the field of diagnostics, including but not limited to human, animal and environmental diagnostics and food testing and of investigational use only (IUO) applications.

The Field specifically does not include nucleic acid probe based testing of human blood, plasma or other blood products intended for direct transfusion or administration to humans. The Field also does not include nucleic acid probe based testing for infectious agents in blood in connection with organ transplants.  Excluded Assay Targets are Hepatitis Viruses, Herpes Viruses, HIV-1, HIV-2, HTLV-I, HTLV-11, MSRV,  and, HMMT-like Virus.

License Grant

For TMA Qual Assays for Existing Instruments, Licensor grants a worldwide, non-exclusive, non-transferable, right and license, with no right to grant any sublicense to any Third Party, to research, develop, make, have made, use, import, offer to sell and sell Licensed Products for Existing Instrumentation.

For TMA Qual Assays for Future Instruments, Licensor grants a worldwide, non-exclusive, non-transferable right and license, with no right to grant any sublicense to any Third Party,

For the Option to Extend License{s), Licensor grants an option to extend the period(s) of these license rights granted.

License Property

The property include instrumentation, assays and patents.

bDNA means the fundamental branched nucleic acid method of signal amplification of nucleic acids.

bDNA Nucleic Acid Assays means Nucleic Acid Assays with respect to which bDNA is the sole method of amplification.

Blood Screening means: (i) the screening of blood, plasma or blood components intended for transfusion or for use in blood products (e.g., immunoglobulins), and (ii) the screening of any biological materials intended for transfusion or transplantation, in each case, from any donor, including autologous donors.

HCV means hepatitis C virus.

HIV means human immunodeficiency virus.

Field of Use

Licensed is for nucleic acid test (NAT) for the detection of human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) in donated blood.

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

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

For the Grant of Research License, Licensor grants to French Licensee a non-exclusive, non-transferable license under the Licensed Patents, without the right to grant sublicenses except to its Affiliates, to conduct research activities,  in the Field in the Territory and, in connection therewith, to practice the Licensed Methods on the Potential Targets for the limited purpose of evaluating the possibility of selecting such Potential Targets as Targets and pursuing the commercial development of Licensed Products directed to such Targets.

For the Grant of Commercial License Option, Licensor grants the Commercial License Option.  The term Commercial License Option shall mean the non-exclusive, nontransferable option, exercisable only in accordance with the terms and conditions of this Agreement, granted to Licensee to exercise the license rights to commercialize Licensed Products.

For the Grant of Commercial License, Licensor grants a non-exclusive, non-transferable, license under the Licensed Patents, without the right to grant sublicenses except to Affiliates, to develop, have developed, to make, have made, use, offer for sale, sell, have sold, export or otherwise commercialize Licensed Products in the Field in the Territory solely under Licensees name and labels and, in connection with such Licensed Products, to practice the Licensed Methods.

License Property

Licensed Patents shall mean, collectively, the Hybrid Patents, RNA Patents and the Sequence Patents.  Licensor owns certain patents covering compositions, kits and processes for determining the presence or amount of nucleic acid derived from an organism or members of a group of target organisms.

Licensed Product shall mean Real Time NASBA Assays that may be developed by or for Licensee or its Affiliates for the detection or quantification of Targets in the Field and for operation solely on the Licensees Instrument.

Licensees Instrument shall mean the GeneXpert Instrument.  GeneXpert Instrument shall is the proprietary Licensee diagnostic system and related components, currently known as the GeneXpert System, which reads a fluorescence signal from reaction tubes utilizing· molecular beacons in specific assays.

NASBA shall mean Nucleic Acid Sequence Based Amplification, Licensees proprietary nucleic amplification method.

Field of Use

Field shall mean the field of clinical testing of human specimens for the purpose of diagnosis, prognosis or monitoring the progress of disease in the human from whom the specimens were taken and safety testing of finished food products for human consumption to detect the presence of harmful organisms, but excluding testing of food production processes and quality control methods in food production processes. For the avoidance of doubt, the Field specifically does not include (y) nucleic acid probe-based testing of human blood, plasma or other blood products intended for direct transfusion or administration to humans or (z) clinical diagnostic testing to measure the sensitivity of an organism to antimicrobial agents.

Potential targets.
Streptococcus pneumoniae**
2. Haemophilus influenzae
3. Escherichia coli
4. Mycoplasma pneumoniae**
5. Chlamydia pneumoniae**
6. Legionella spp**
7. Campylobacter
8. Staphylococcus
9. Neisseria meningitiidis
10. Candida spp*'
11. Aspergillus**
12 Mycobacterium Tubercu.losis**

License Grant

Licensor grants a nonexclusive immunity from suit under PCR Technology solely to perform Licensed Services.

Licensor grants to Licensee the right to credit the Licensor as the source of PCR Technology in Licensees promotional materials and any other materials intended for distribution.

License Property

PCR or polymerise chain reaction is a nucleic acid amplification process.

Licensed Services means the performance of an IN VITRO diagnostic procedure utilizing PCR Technology to detect the presence, absence or quantity of a nucleic acid sequence associated with a human disease or condition within the Licensed field.

The Diagnostic product shall mean an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

The licensed credit is 'This test is performed pursuant to a license agreement with Licensor.'

Field of Use

Licensor has expertise in validating, documenting and performing sophisticated diagnostic procedures.  The field is that of human IN VITRO diagnostics solely for the detection of genetic diseases, genetic predisposition to disease, agents associated with infectious diseases, cancer; and for tissue transplant typing, including testing performed on animal tissue intended for use in xenotransplantation; Parentage determination; disease management; and clinical trials.

License Grant

Licensor grants to the Swiss Licensee a worldwide, semi-exclusive license, without the right to sublicense, under the Licensor Licensed Patents to research, develop, make, have made, import, use, offer for sale and sell Licensor Licensed Products for use in the Field.

For Licensor Transplantation Field License, Licensor grants a worldwide, non-exclusive license, without the right to sublicense, under Licensor Licensed Patents to research, develop, make, have made, import, use, offer for sale and sell Licensor Licensed Products for use in the Transplantation Field.

For Licensor Future HGV Sequence Patent Rights, Licensor grants to a non-exclusive option to obtain one or more non-exclusive, worldwide licenses, or sublicenses, as the case may be, with a right to sublicense to Licensee Affiliates only, under the Licensor Future HGV Sequence Patent Rights, to make, have made, use, import, offer for sale and sell Licensor Licensed products.

License Property

Licensed Patents means the Licensor Licensed Patents and the Licensee Optioned Patents.

Products  means reagents, compositions or kits suitable for use in the Field or the Transplantation Field.

The patents include NANBV Diagnostics and Vaccines;  Heteroduplex Tracking Assay for Gene Typing; and, Polynucleotide Probes Useful for Screening for HCV.

Both Parties currently own or control certain patent rights relating to the hepatitis C virus (HCV).

Field of Use

The Licensees purpose is for use in assays for the detection of nucleic acid sequences for use in in vitro diagnostics, excluding use in Blood Screening, but without limiting the effect of the Blood Screening Agreement.

Field means the commercial use of human in vitro diagnostic products that detect nucleic acid sequences of HCV. Expressly excluded from the Field are: products in Blood Screening; products specifically labeled or promoted for use in the Transplantation Field.

Transplantation Field means the commercial use of products that detect nucleic acid sequences for the screening of any biological materials intended for transfusion or transplantation, in each case from any donor, including autologous donors, other than the transfusion or transplantation of blood or its derivatives, components or replacements.

License Grant

Licensor grants a non-exclusive, non-transferable immunity from suit under licensed technology solely to perform Licensed Clinical Services within the Territory.

Licensor grants the right for Licensee to credit Licensor as the source of Licensed Technology rights in Licensees, promotional materials and any other materials intended for distribution to Third Parties.

License Property

Licensor owns the right to grant immunities from suit to practice under certain United States Patents describing and claiming, inter alia, nucleic acid amplification processes known as 'homogeneous PCR. '

The Licensed Technology shall mean the Homogeneous PCR Technology and only so much of RT and RT-PCR Technology and Other Technology as is necessary for Licensee to practice the Homogeneous PCR Technology in conjunction with Licensees separately licensed PCR Technology.

The credit licensed is 'This test [ or assay] is performed pursuant to a license agreement with Licensor.'

Field of Use

Licensed Field shall mean the field of human in vitro diagnostics solely for the detection of genetic diseases, genetic pre-disposition to disease, agents associated with infectious diseases, cancer; and for tissue transplant typing, including testing performed on [ animal tissue intended for use in xenotransplantation; Parentage Determination; disease management; and clinical trials.

License Grant

The parties previously entered a Clinical Diagnostics Agreement and Blood Screening Agreement.

Pursuant to the settlement, the parties hereby irrevocably stipulate the Licensor Licensed Patents in the Territory are valid and enforceable; and, the making, use, offer for sale, sale, or importation of any Licensee Product in the Territory, where a Licensor Licensed Patent has issued and prior to the expiration of such Licensor Licensed Patent, would, in the absence of the licenses granted in the Agreements, as applicable, constitute infringement of one or more claims of such Licensor Licensed Patent.

Per the original agreement, the Parties entered a nonexclusive license in the Territory, without the right to sublicense, under the Licensor Licensed Patents to make, import, use, offer for sale and sell Licensor Licensed Products for use in Blood Screening solely for sale to or use by or on behalf of Existing Customers under the Existing Agreements and Existing Offers.

License Property

The Licensee Products means all assays sold by Licensee for the detection, quantitation, genotyping or other analyses of nucleic acid sequences Directed to HIV for use in in vitro diagnostics and/or Blood Screening, including without limitation the following products of Licensee: Amplicor HIV-1 test, v. 1.0; Amplicor HIV-1 Monitor test, v. 1.0; Amplicor HIV-1 Monitor test, v. 1.5; COBAS Amplicor HIV-1 Monitor test, v. 1.5; Ampliscreen HIV-1 test, v. 1.5; and COBAS Ampliscreen HIV-1 test, v. 1.5; and all versions and successors and substitutes therefor.

Blood Screening means the commercial use of products that detect nucleic acid sequence(s) for: the screening of blood, plasma or blood components intended for transfusion or for use in blood products (e.g., without limitation, immunoglobulins); or confirmatory or supplemental testing of the same samples otherwise screened for purposes described.

Directed to HIV means that the claim or technology in question is directed to methods, compositions, reagents or kits specifically for use in nucleic acid-based diagnostic assays for the detection of HIV nucleic acid sequence(s), or specifically for use in the manufacture of any compositions or reagents for use in, or manufacture of nucleic acid-based diagnostic assays for detection of HIV nucleic acid sequence(s) (excluding, for example, polymerase chain reaction claims and technology and other methods for detection of nucleic acid sequence(s) generally which involve nucleic acid amplification).

HIV means any viral isolate of the human immunodeficiency virus classified as HIV by the International Committee on the Taxonomy of Viruses (or any body that replaces such Committee) or any subtype of such isolate and further includes any isolate that is at least forty percent (40%) homologous to any such isolate and of the same genomic type and substantially the same genomic organization, any isolate that has a genome that either hybridizes to or is substantially identical to any such isolate or its compliment, and any defective or modified form of any of the above isolates.

''Patent' means U.S. Patent No. 6,531,276 Bl

Field of Use

This agreement is for the HIV Qualitative Assay field.

License Grant

Licensor grants to the Swiss Licensee a worldwide, semi-exclusive license, without the right to sublicense, under the Licensor Licensed Patents to research, develop, make, have made, import, use, offer for sale and sell Licensor Licensed Products for use in the Field.

For the Licensor Transplantation Field License, Licensor grants a worldwide, non-exclusive license, without the right to sublicense, under  Licensoe Licensed Patents to research, develop, make, have made, import, use, offer for sale and sell Licensor Licensed Products for use in the Transplantation Field.

License Property

The patent rights relate to the human immunodeficiency virus (HIV).

Products means reagents, compositions or kits suitable for use in the Field or the Transplantation Field.

Field of Use

The Licensee intended application is for use in assays for the detection of nucleic acid sequences for use in in vitro diagnostics (excusing use in Blood Screening, but without limiting the effect of the Blood Screening Agreement.

Field means the commercial use of human in vitro diagnostic products that detect nucleic acid sequences of HIV. Expressly excluded from the Field are products in Blood Screening; and products specifically labeled or promoted for use in the Transplantation Field.

Transplantation Field means the commercial use of products that detect nucleic acid sequences for the screening of any biological materials intended for transfusion or transplantation, in each case from any donor, including autologous donors, other than the transfusion or transplantation of
blood or its derivatives, components or replacements.

License Grant

Licensor hereby grants to Licensee, and Licensee hereby accepts from Licensor, a royalty-bearing, non-exclusive immunity from suit under PCR Technology solely to perform licensed services within the United States and its possessions and the Commonwealth of Puerto Rico.

License Property

PCR technology shall mean polymerase chain reaction technology covered by United States Patent Nos. B2 4,683,195, B1 4,683,202 and 4,965,188 and any reissue or reexamination patents thereof. The performance of an in vitro diagnostic procedure utilizing PCR Technology to detect the presence, absence or quantity of a nucleic acid sequence associated with a specific human disease or condition within the licensed field.

It is understood by the parties that Licensor may, from time to time, come into possession or control of additional patents or claims of patents relating to PCR technology rights to which Licensor may decide to offer to add to the Diagnostic Services Agreement and which Licensee may desire to accept.

Additional Patents:
U.S. Patent Number 5,008,182
U.S. Patent Number 5,176,995
U.S. Patent Number 5,219,727
U.S. Patent Number 5,110,920

Field of Use

Licensed Field shall mean the field of human in vitro diagnostics solely for the detection of genetic diseases, genetic pre-disposition to disease, cancer, tissue transplant typing, Parentage, and microorganisms associated with infectious diseases.

License Grant

The German Licensor hereby grants to Licensee an exclusive license (including the right to grant sublicenses) under the Licensed Patent Rights to conduct research and to develop, make, use, offer for sale, sell and import Licensed Products and to provide Services in the Territory.

License Property

Licensed Patent Rights shall mean (a) those certain patent applications and patents listed hereto; (b) all patents that have issued or in the future issue from such foregoing patent applications, including utility, model and design patents and certificates of invention; (c) all patents that have issued or in the future issue from any patent application that claims priority from, or common priority with, any of the foregoing patent applications, including utility, model and design patents and certificates of invention; and (d) all divisionals, continuations, continuations-in-part, reissues, renewals, extensions or additions to any such foregoing patent
applications and patents.

W003023057 (PCT /EP02/05489) – Method and Diagnosis Kit for Selection and/or for Qualitative and/or Quantitative Detection of Cells

Licensed Products shall mean in-vitro diagnostic assays to isolate, detect, identify, quantify, or test for drug susceptibility of, one or more proteins or nucleic acid sequences as diagnostic indicators for the presence of prostate cancer and/or bladder cancer, for the purpose of research, diagnosis or medical care, the  manufacture, use, sale offer for sale or importation of which would, but for the license herein granted by AdnaGen to Gen-Probe, infringe one or more Valid Claims of the AdnaGen Patent Rights.

Field of Use

This agreement pertains to the medical industry relating to certain technology concerning the qualitative and quantitative detection of cells which may be useful in connection with nucleic acid diagnostic assays. The diagnostic indicators are used for the presence of prostate cancer and/or bladder cancer, for the purpose of research, diagnosis or medical care.

'Group 1 Additional Products' shall mean in-vitro diagnostic assays to isolate, detect, identify or quantify, or test for drug susceptibility of, one or more proteins or nucleic acid sequences as diagnostic indicators for the presence of kidney cancer, cervical cancer, and/or ovarian cancer, for the purpose of research, diagnosis or medical care, the manufacture, use, sale offer for sale or importation of which would, but for the license herein granted by AdnaGen to Gen-Probe, infringe one or more Valid Claims of the Licensed Patent Rights.

'Group 2 Additional Products' shall mean in-vitro diagnostic assays to isolate, detect, identify or quantify, or test for drug susceptibility of, one or more proteins or nucleic acid sequences as diagnostic indicators for the presence of lung cancer, colon cancer, and/or breast cancer, for the purpose of research, diagnosis or medical care, the manufacture, use, sale offer for sale or importation of which would, but for the license herein granted by AdnaGen to Gen-Probe, infringe one or more Valid Claims of the Licensed Patent Rights.

License Grant

Swiss Licensor grants to Licensee and its Affiliates, a non-exclusive worldwide right and license under the Licensed Patents as follows: to perform in vitro human and/or animal diagnostic testing procedures on a sample of material obtained from a human or animal, as applicable, solely to detect the presence, absence or quantity of a nucleic acid sequence associated with a disease or condition in the Licensed Fields.

License Property

Other Technology shall mean the processes covered by the method claims (if they are Valid Claims) of United States Patent Nos. 5,008,182, 5,677,152, 5,773,258 and 5,176,995, and any reissue or reexamination patents thereof, and the claims (if they are Valid Claims) of United States Patent No. 5,110, 920, and any reissue or reexamination patents thereof; and any Valid Claims of the foreign counterparts of the foregoing listed patents or claims.

PCR Technology shall mean polymerase chain reaction technology covered by Valid Claims of United States Patent Nos. B1 4,683,195, B1 4,683,202, and 4,965,188 and any reissue or reexamination patents thereof; and any Valid Claims of the foreign counterparts of the foregoing listed patents or claims.

Quantitation Technology shall mean the method claims (if they are Valid Claims) of United States Patent Nos. 5,389,512 and 5,219,727, and any reissue or reexamination patents thereof, and claims 1-4, 8, 9 and 15-18 (if they are Valid Claims) of United States Patent No. 5, 476,774, and any reissue or reexamination patents thereof; and any Valid Claims of the foreign counterparts of the foregoing listed patents or claims.

RT and RT-PCR  Technology shall mean the reverse transcription process covered by the method claims (if they are Valid Claims) of United States Patent Nos. 5,407,800, 5,310,652, 5,561,058, 5,618,703 and 5,322,770, and any reissue or reexamination patents thereof, and the claims (if they are Valid Claims) of United States Patent No. 5,693,517, and any reissue or reexamination patents thereof; and any Valid Claims of the foreign counterparts of the foregoing listed patents or claims.

'5' Nuclease Technology' shall mean only the processes defined by the method claims (if they are Valid Claims) of United States Patent Nos. 5,210,015 and 5,487,972 and any reissue or reexamination patents thereof and the reaction mixture claims (if they are Valid Claims) of United States Patent No. 5,804,375 and any reissue or reexamination patents thereof; and any Valid Claims of the foreign counterparts of the foregoing listed patents or claims.

Field of Use

Diagnostic Services Field means the field of human in vitro diagnostics for the detection, quantitation, monitoring, genotyping, or phenotyping, of genetic and infectious diseases, disease susceptibility, genetic pre-disposition to disease or cancer; analyzing specimens taken from a human being for the purpose of testing, with respect to that human being, for a physiological or pathological state, for a congenital abnormality, for safety and compatibility of a treatment or to monitor therapeutic measures; or any use of PCR as a testing service to provide to a person data, results or interpretations of any application of PCR for purposes of therapy or diagnosis of a human being, including, without limitation, clinical laboratory services, whether or not a fee is charged for such services; tissue transplant typing, including testing performed on animal tissue intended for use in xenotransplantation; Parentage Determination; diagnosis, disease management; and clinical trials, whether or not a patient result is provided directly or indirectly to a patient.  Licensed Field shall specifically exclude any services performed for screening of blood and/or blood products.

License Grant

Licensor grants a non-exclusive license, without the right to grant or authorize sublicenses, under the Licensed Patent Rights to develop and perform the Services solely at the Facilities, and to use, and offer for sale and sell the Services to Third Parties solely in the Territory.

License Property

Licensed Patent Rights shall mean, collectively, Licensors rights in all patent applications, including provisional patent applications, heretofore or hereafter filed in the Territory;  all patents that have issued or in the future issue in the Territory from any of such patent applications, including without limitation utility models, design patents and certificates of invention; and,  all divisionals, continuations, continuations-in-part, substitutions, reissues, renewals, extensions, restorations or additions to any such patent applications and patents, in each case that claim, and only to the extent they claim, compositions, uses, methods, equipment, devices and other technology for the use of cell-free fetal nucleic acids from biological samples, including plasma, serum, whole blood and urine, obtained from pregnant women for prenatal diagnostic testing by whole genome massively parallel sequencing, used in the performance of the MaterniT21 PLUS Test by Licensors Laboratories as of the Effective Date, or any improvements to such test; provided, however, that the Licensed Patent Rights shall exclude any of the foregoing licensed by a University to Licensor under another agreement.

MatemiT21 PLUS Test shall mean the laboratory-developed test for the non-invasive testing of a plasma sample from a pregnant woman for the detection and diagnosis of prenatal aneuploidy and/or fetal abnormalities by use of cell-free fetal nucleic acids, currently known as the MatemiT21 PLUS test, as performed by Licensors Laboratories.

Field of Use

The Field shall mean the non-invasive detection and diagnosis of prenatal aneuploidy and fetal abnormalities by use of cell-free fetal nucleic acids from biological samples, including plasma, serum, whole blood and urine, obtained from pregnant women.
The MaterniT® 21 PLUS test analyzes genetic information that enters your bloodstream from the placenta.  It analyzes the amount of chromosome 21 in fetal DNA picked up from the maternal blood sample. It can detect an increased amount of chromosome 21 material which is associated with trisomy 21 (Down syndrome). It is completely non-invasive as it only involves a blood sample from the mother.

License Grant

This license agreement is Included with an asset purchase agreement between this Licensee/Seller and a Third Party Buyer.

University hereby grants to Licensee a right and license to make, have made, use, lease, offer to sell, sell, otherwise commercially dispose of, export and import Licensed Products,  to practice Licensed Processes, in each case directly or by sublicense and only for commercial purposes, including providing services to third parties and for Licensees research and/or development in the Field of Use within the Territory during the Term.  

For the Option,  University hereby grants Licensee an option to acquire a non-exclusive, worldwide, royalty-bearing license within the Field of Use under the Optioned Patent Rights to make, have made. use, sell and offer for sale products, processes and services within the Field of Use.

License Property

The intellectual property relates to Sequencing of Biopolymers by Mass Spectrometry.

The Products associated with the Claimed Technologies are specifically: SpectroCHlPs; QGE Software;  and,  QGE assays sold through Assays by Licensee. The Products may be amended from time to time.

Field of Use

The field of use is all uses.

License Grant

The University hereby grants to Licensee exclusive, worldwide licenses under Regents’ Patent Rights within the Field of Interest to make, have made, use, sell, distribute, and lease machines, articles of manufacture, and compositions-of-matter and to perform processes and have others perform processes.

License Property

The Invention has utility for the detection of chromosome abnormalities.

Patent Rights shall mean all U.S. and foreign patents and patent applications related to Pending U.S. Patent Application Serial No. 819,314 & 6-937,793 entitled Method and Compositions for Chromosome-Specific Staining ;.Pending U.S. Patent Application Serial No. 6-934,188 entitled Method of Preparing and Applying Single Stranded DNA Probes to Double Stranded Target DNAs; Any U.S. Patent Application based on subject matter described in UC Case Number 87-095-1 (renumbered UC Case Number 85-157-4) entitled Method for Determining Aneuploidy in Fetal Cells from Maternal Blood Samples.

Field of Use

'Field of Interest' shall mean relating to analytical, research, and diagnostic applications of technology based on chromosomal staining, marking, and labeling.  Field of Interest shall specifically exclude therapies and treatments derived from analytical, research, and diagnostic applications.

License Grant

The Licensor hereby grants to the Israeli Company, a non-exclusive, worldwide license to make, have made, market, distribute (directly or by means of local distributors), and Sell Licensed Products. Technology, generally characterized as Diagnostic Methods for Chlamydia Pneumoniae, Tech I.D. #07-86-34,  is covered by certain patent and know-how rights.

License Property

The Technology is comprised of three methods and associated materials for the detection and/or diagnosis of Chlamydia Pneumoniae, namely Monoclonal antibody-based antigen detection, serological antibody detection, and nucleic acid probe based detection.

Field of Use

“Field of Use”, as used herein, shall mean those portions of the Technology directly pertaining to methods and materials for the serological detection of antibodies, and their use by the Licensee to develop arid market assays.  The Field of Use expressly excludes the nucleic acid probe and Monoclonal antibody – based detection materials and methods of detecting Chlamydia Pneumoniae and expressly excludes the right to sell the diagnostic test results.

License Grant

The Licensee was granted the non-exclusive right to polymerase chain reaction technology or 'PCR' to perform the Licensed Services within the United States and its possessions and the Commonwealth of Puerto Rico.

The Licensed Services shall mean the performance of an Assay by BTRL to detect nucleic acid sequences associated with a human disease or condition within the Licensed Field.  Licensed Services include but are not limited to, any combination of the steps of collecting a sample for analysis, isolating nucleic acid sequences therein, amplifying one or more desired sequences, analyzing the amplified material and reporting the results.

License Property

PCR Technology shall mean polymerase chain reaction technology covered by United States Patent Nos. B1 4,683,195 and B1 4,683,202.

Field of Use

The Licensed Field shall mean the field of human in vitro diagnostics solely for the detection of genetic diseases, genetic pre-disposition to disease, microorganisms associated with infectious diseases, cancer, or for tissue transplant typing or Parentage.

License Grant

The Licensor of England grants to the Licensee a non-exclusive, non-sublicensable license within the Field and the Territory to use the Patents and the Know-How, to develop and have developed, make and have made, to Supply and have Supplied, either directly or through distributors, to import and have imported and to use and have used the Products within the Field.

License Property

The Scorpions technology is the means, methods and compositions used to detect nucleic acid amplification based on compositions that have one or more amplification primer portions linked to one or more nucleic acid probe portions and that are detectable as a result of the extension of one of the primers without concomitant amplification of the probe portion as described.

The products are any assay kit or other composition manufactured for use within the Field, the manufacture, use, sale, or import of which would, but for the license, infringe one or more valid claims of one or more of the issued Patents.

U.S.A. Patent 5,525,494 – Non-amplifiable Tails Patents

Scorpions(TM) probes are highly sensitive, sequence-specific, bi-functional molecules containing a PCR primer covalently linked to a probe. Scorpions probes provide strong fluorescent signals, excellent sequence discrimination, short reaction times, and predictable probe design. The interaction of the probe and the desired target occurs very rapidly and in advance of any competing side reactions such as the formation of internal secondary structures or re-annealing. The unique intra-molecular nature of the Scorpions reaction means that it is ideally suited for fast, quantitative, real-time PCR analysis.

Field of Use

This agreement is for the human in vitro diagnostics field.

Scorpions(TM) technology will provide benefits in speed and in developing highly multiplexed tests.  The first commercial products expected to use the Scorpions probes for Licensee will be in the recreational water testing area.

License Grant

The parties are entering this agreement to manufacture and commercialize in-vitro diagnostic tests.

Licensor grants a non-exclusive, non-transferable, worldwide, right and license to make, use, and sell the Licensed Products and to practice the Licensed Method for the Field of Use for the term of this  Agreement.

License Property

The patents are for Methods and Compositions for Detecting Human Tumors, and, Determination of Status In Neoplastic Disease.

Licensed Product, as used herein, shall mean any kit, composition of matter, or material either covered by the Patent Rights or produced by the Licensed Method, the use of which would constitute, but for the license granted to Licensee pursuant to this Agreement, an infringement of any pending or issued claim within the Patent Rights.

Licensed Method, as used herein, shall mean any process or method that is covered by the Patent Rights, the use of which would constitute, but for the license granted to Licensee pursuant to this Agreement, an infringement of any claim within the Patent Rights.

Field of Use

Field of Use shall mean for use as nucleic acid probe, protein or antibodies, or a combination thereof for research or diagnostic purposes.