Royalty Report: Diagnostic, Medical, Cancer – Collection: 294268

$150.00

Curated Royalty Rate Report
Category: Technology Licenses, Created On: 2022-04-28, Record Count: 20

Description

This collection of transactions and supporting information was developed using our AI algorithm to curate similar royalty reports into a cohesive collection to support your licensing, transfer pricing or other transaction scenarios where documented royalty rates and/or deal terms are important.
Category: Technology Licenses
Created On: 2022-04-28
Record Count: 20

Primary Industries

  • Diagnostic
  • Medical
  • Cancer
  • Assay
  • Device
  • Proteins
  • Drugs
  • Disease
  • cardiac
  • Test/Monitoring
  • Technical Know How
  • Therapeutic
  • Biotechnology
  • Software
  • Medical Info
  • Genome
  • DNA

IPSCIO Report Record List

Below you will find the records curated into this collection.  This summary includes the complete licensed property description so that you can review and determine if this collection covers the topics, technology or transaction type that is relevant for your needs.  The full report will include all relevant deal data such as the royalty base, agreement date, term description, royalty rates and other deal terms.  For reference, here is a sample of a full IPSCIO curated royalty rate report: Sample Report

IPSCIO Record ID: 294268

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.

IPSCIO Record ID: 306181

License Grant
For Biomarker IP, Licensor will grant an exclusive, perpetual, royalty-bearing license under Licensor Biomarker IP to make, have made, use, sell, offer for sale, import and otherwise exploit any and all Consumable Products, and have any and all of the foregoing performed on its behalf, in each case solely for applications other than developing and commercializing Clinical Laboratory Tests.  

This agreement has exclusive and non-exclusive territories.

License Property
Test Kit means a kit, biochip or other supply developed by Licensee pursuant to a Test Kit Development Program for an Application that corresponds to a Licensed Laboratory Test developed by Licensor and cleared or approved by the FDA or other Regulatory Authority, as relevant, for marketing in the applicable jurisdiction. A Test Kit will include components and instructions required for performing such Application.

Licensor is a leading provider of diagnostic testing, information and services and has substantial experience in the development and commercialization of products having Clinical Diagnostic Applications.

Test Kit Service means a clinical laboratory test that is performed by a member of the  Licensors Network or a Third Party using a Test Kit that has been approved or cleared by the FDA or other applicable Regulatory Authority for marketing in the applicable jurisdiction, if necessary, and has been developed by Licensee pursuant to a Test Kit Development Program.

Field of Use
This strategic alliance is to collaborate in the development and commercialization of proteomic diagnostic tests based on Licensee’s SELDI ProteinChip technology.

The ProteinChip Array technology is used for the discovery, validation, identification, and characterization of disease-associated proteins from biological samples. The versatile nature of this technology is enabling for a wide variety of applications in both research and clinical proteomics and will be reviewed in three application areas. A recent publication presents the use of the flexibility and power of the ProteinChip Array platform to elucidate the nature of novel protein inhibitors of HIV-1 replication, the molecules previously known as the CD8+ antiviral factors. Numerous cancer-related publications have demonstrated the discovery and development of biomarkers and multimarker patterns for protein-based predictive medicine.

Surface-enhanced laser desorption/ionization time-of-flight mass spectrometry (SELDI-TOF-MS) represents the successful combination of retentate chromatography and mass spectrometry, and this technology is an integral part of Ciphergen's ProteinChip System, which was designed to answer biomedical questions by performing protein analyses on a single experimental platform. The quantification capability of the ProteinChip System is essential in all proteomic applications for which this technology is used. Here we describe methods and results for three short experiments mimicking realistic analytical challenges to provide practical examples of quantification.

Field means all potential Clinical Diagnostics.  Licensee develops, manufactures and markets its ProteinChip 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 of disease-specific Biomarkers and protein signatures that could be utilized in Licensed Laboratory Tests and Test Kits.

Licensee develops, manufactures and sells ProteinChip Systems for life science researchers.  The systems consist of ProteinChip Readers, ProteinChip Software and related accessories, which are used in conjunction with consumable ProteinChip Arrays.  These products are sold primarily to biologists at pharmaceutical and biotechnology companies, and academic and government research laboratories.  The Company also provides research services primarily through its Biomarker Discovery Center® laboratories.

IPSCIO Record ID: 26038

License Grant
The Licensor grants to Licensee a non-exclusive right and license, without the right to sublicense, under the Licensed Patent Rights as licensed to Licensor pursuant to the Original Agreement, to make, have made, use, sell, offer for sale and import Licensed Products and to practice the Licensed Methods in the Field in the Territory to the extent permitted by law.
License Property
The Licensor is involved in the discovery, development and commercialization of medical tests that diagnose, treat and improve outcomes for patients with gynecologic cancers and related diseases. Field shall mean in-vitro diagnostics for screening, diagnosing and monitoring for Ovarian Cancer in humans in the form of OVA1 tests.
Field of Use
The Licensee is a provider of clinical laboratory services.

Field” shall mean in vitro diagnostics for screening, diagnosing and monitoring for Ovarian Cancer in humans in the form of OVA1 tests.

IPSCIO Record ID: 329692

License Grant
Prior to the Effective Date of this Agreement, the Parties have been involved in collaborative efforts to jointly develop assays for the ANAIS Instrumentation.

By this agreement, the Parties shall cooperate in the Development Transition and in the transfer of any information and Know-How necessary for Licensee to assume the development of the ANAIS Products.

Licensor grants a non-exclusive, non-transferable, worldwide license in the ANAIS Field to use the Licensor Technology to develop, make and have made, use, sell, offer for sale, have sold, and import the ANAIS Products, solely and exclusively for use on the ANAIS Instrumentation.

License Property
The ANAIS Instrument shall be an automated laboratory instrument for performing nucleic acid assays utilizing High Density DNA Probe Arrays.
Key BioChemistry Components include
– All enzymes used in transcription-based amplification for use in ANAIS Assays.
– All biochemical components used for amplification of amplicon of target with TMA, which is Licensors patents and technology relating to Nucleic Acid Sequence Amplification Methods.
– All probes, primers, and oligonucleotides used in ANAIS Assays.
– Nucleic acids used for ,positive and negative controls, standards, calibrators, and for quality control of ANAIS Assay components.

ANAIS products shall mean the following Probe Assays, in each case made, used, or sold under the license granted by Licensor and solely and exclusively for use on ANAIS Instrumentation
– Probe Assays for the detection, identification, quantification, and/or susceptibility testing for panels of microorganisms or agents (but specifically excluding single organisms) in specimens taken from humans, solely for the purpose of diagnosis and medical care of the persons from whom the tested samples were taken. A panel shall test for 10 or more distinct species of organisms or agents in the following groups of microorganisms
or agents  Bacteria; Viruses; Yeast/Fungi; or, Parasites.The panels shall be medically relevant.

– Probe Assays for the detection, identification, quantification, and/or susceptibility testing for an individual organism, drawn only from the groups or families listed below, in specimens taken from humans, solely for the purpose of diagnosis and medical care of the persons from whom the tested samples were taken Hepatitis virus; HIV virus; Herpes virus; Human papilloma virus; HTLV Virus; Yeast; Fungus; Parasite; and, Bacterium other than Neisseria gonorrhoeae or Chlamydia trachomatis.

– Probe Assays for testing of sequences encoding human leukocyte antigens in specimens taken from humans and/or

– Probe Assays to detect and /or precisely identify microorganisms or agents including bacteria, yeast, viruses and parasites for use in quality control processes of water, food products, and/or previously developed pharmaceutical or cosmetic products, and/or identify foods coming or derived from plants and/or/ animals for the purpose of confirming anticipated source(s) of the food.

Assay shall mean a diagnostic process or procedure applied to a sample, or a portion of a sample, whereby a particular chemical compound, or a collection of compounds, or a portion of a chemical compound, is detected and optionally quantified.

Field of Use
The ANAIS Field shall mean
– the detection, identification, quantification, and/or susceptibility testing of organisms or agents causing human clinical infectious diseases, as present in the human body, solely for the purpose of diagnosis and medical care of the persons from whom the tested samples were taken;
– testing for sequences encoding human leukocyte antigens;
– testing for microorganisms or agents, including bacteria, yeast, viruses and parasites in quality control processes of water, food products, and/or previously developed pharmaceutical or cosmetic products; and/or
– testing for the purposes of identifying genetically-modified foodstuffs or identifying animal species in foodstuffs.

The ANAIS Field specifically does not include testing for infectious agents in blood and blood products intended for transfusion, or the testing for infectious agents in blood in connection with organ transplants, or the testing of specimens from non-human animals or environmental sources except as specifically provided above, even if such testing is for the purpose of detecting or identifying organisms which are associated with infectious diseases in man.

IPSCIO Record ID: 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.

IPSCIO Record ID: 315834

License Grant
For the Licensed Technology, Licensor grants a non-exclusive license under the Licensed Technology to make, have made, use, sell, offer for sale and import Licensed Uses in the Territory in the Field.

For the Research, Licensee shall perform primary testing associated with a validation study of its laboratory -developed test using the Licensed Technology in connection with MD Anderson Cancer Center or an equivalent academic cancer center (with the exception of tissue biopsy) including expression testing, the PSA and send-out of the PCA-3, the Validation Study.  Licensee shall have the right to perform research on remnants after all testing required for the Validation Study is completed, and will be provided reasonable access to the patient data related to the applicable samples.  Licensor shall obtain IRB approval for the study with MD Anderson Cancer Center by February 28, 2009 or, with an equivalent academic institution by June 30, 2009.

For the Purchasing Rights, upon issuance of FDA clearance or approval of an in vitro diagnostic kit using the Licensed Technology (IVD Kit), Licensee shall have the obligation to purchase IVD Kits for reference laboratory use from Licensor’s designated manufacturer or distributor pursuant to a purchasing agreement between Licensee and the applicable manufacturer or distributor, provided however that Licensor shall negotiate to cause such manufacturer or distributor to provide Most Favored Terms to Licensee.

License Property
Licensor has rights in the Licensed Technology covering genomic biomarkers related to prostate cancer.  Licensor is a machine learning company that uses advanced mathematical techniques to analyze large amounts of data to uncover patterns that might otherwise be undetectable. The Company operates primarily in the field of molecular diagnostics where such tools are critical to scientific discovery.

The patents include
Method of Identifying Patterns in Biological Systems and Uses Thereof;
Biomarkers Overexpressed in Prostate Cancer;
Biomarkers Upregulated in Prostate Cancer; and,
Methods for Screening, Predicting and Monitoring Prostate Cancer.

Field of Use
Field shall mean clinical diagnostic applications using biomarkers in urine for differentiating clinically significant prostate cancer from other prostate conditions, including without limitation clinical laboratory testing and clinical trials, but expressly excluding manufacture of in vitro diagnostic kits.

Licensees focus is developing a test for and performing clinical laboratory diagnostic testing using gene biomarkers detected in patient urine samples for differentiating clinically significant prostate cancer from other prostate conditions.

IPSCIO Record ID: 338029

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.

IPSCIO Record ID: 204348

License Grant
The English Licensor grants to the Licensee an exclusive license with the right to sub-license under the Licensed Technology to develop, manufacture, use, sell, offer for sale and/or import Licensed Product(s) and any improvement thereto, or have done any of these on its behalf and otherwise exploit the Licensed Technology, but only in the Licensed Field in the Territory.
License Property
The licensed technology means Resulting Intellectual Property and Licensed Patents.   The resulting intellectual property, identified in the research agreement, is any Intellectual Property which is conceived, created, discovered, developed, identified or first reduced to practice in the course of the Project, derived directly from the use of Surface Enhanced Laser Desorption/Ionization, SELDI, or from the use of SELDI together with any other technology(ies) and any patents and patent applications, including any continuations, continuations in part, extensions, reissues or divisions thereof and any patents, supplementary protection certificates and similar rights that are based on or derive priority from the foregoing.

The licensed products are any and all processes, products and services practiced, sold or otherwise supplied by the Licensee or a Group Company of Licensee or its sub-licensee, and which Licensed Products or the use of such Licensed Products are within any Valid Claim of the Licensed Patents in the jurisdiction in which such Licensed Products are sold. A Licensed Product may include, without limitation a Diagnostic Test Kit, a Diagnostic Test, a Medical Implement or a Therapeutic.

Surface-enhanced laser desorption/ionization (SELDI) is a soft ionization method in mass spectrometry (MS) used for the analysis of protein mixtures.

Field of Use
The research, development and commercialization of Licensed Products for Diagnostics and Therapeutics for cancer.  The Licensee is in the Laboratory analytical instrument industry.

IPSCIO Record ID: 7158

License Grant
Licensor hereby grants to Licensee and its Affiliates, and Licensee accepts the licenses under the Licensed Technology to exclusively use, develop, make, have made, sell, offer to sell, modify, import and otherwise commercially exploit the Licensed Uses and the Licensed Products in the Licensed Territory including, but not limited to, as follows
(1) an exclusive license for the use of the SVM Technology and the Licensed Patents in the Field in the Licensed Territory relating to Licensed Uses and Licensed Products; and

(2) an exclusive license to the Licensed Know-How in the Field in the Licensed Territory, including access to and use of the Computer Software that has been developed by or for Licensor or will be developed by or for the Licensor that may be applicable to Licensed Uses or Licensed Products; and

(3) an exclusive license for the use of Licensed Products in the Licensed Territory.
Sublicense Rights. Licensee may grant sublicenses under any of the licenses granted herein, to import, develop, make, have made, use, modify, offer for sale, and/or sell Licensed Products within the Field.

License Property
LICENSOR is the owner of intellectual property, including patents, pending and issued, and know-how relating to support vector machine and other machine learning technologies which is included within the “SVM Technology” (as defined below), based upon which it has developed, or is engaged in developing, applications including, inter alia, digital image analysis and interpretation, biomarker discovery, and gene/gene product-based and protein-based diagnostic, prognostic and predictive tests.

“SVM Technology” shall mean all technology and ownership claims related to support vector machines and other pattern-recognition algorithms (“SVM”), SVM-Recursive Feature Elimination (“RFE”), and Fractal Genomic Modelling (“FGM”) included in the Licensed Technology.

Licensor owns the Licensed Technology (as defined below), which includes inter alia, coverage of genomic biomarkers related to prostate cancer, pancreatic cancer, colon cancer and other cancers as well as certain interpretation methodologies and software associated with automated image analysis for cytogenetics and flow cytometry testing.

“IVD Test Kit” shall mean any kit or instrument manufactured for sale to third parties, which includes reagents and other supplies that enables such third party purchasers to perform in vitro diagnostic tests on biological samples or any instrument used therewith; provided that, any such IVD Test Kit must be approved by the U.S. Food and Drug Administration (“FDA”) for sales of the IVD Test Kit in the United States, or be approved by any other foreign regulatory bodies for sales of the IVD Test Kit in countries other than the United States. Notwithstanding the foregoing, any instruments sold in conjunction with or pursuant to Licenses E and F described in Sections 1.12.4 and 1.12.5 are excluded from the definition of IVD Test Kit.

“Laboratory Developed Test” shall mean any test, process or procedure used to test or assay any type of patient biological sample, the results of which would then normally be entered into the medical record of the patient providing such biological sample; provided, however, any test, process or procedure performed using an IVD Test Kit shall not be considered to be a Laboratory Developed Test.

“Plasma Prostate Cancer Test” shall mean any Laboratory Developed Test using genes, gene products, or other biomarkers present in blood plasma for differentiating clinically significant prostate cancer from other prostate conditions, including without limitation clinical laboratory testing and clinical trials, but expressly excluding manufacture of IVD Test Kits. For reference purposes, the license granted for the Plasma Prostate Cancer Test is identified as “License B”.

“Pancreatic Cancer Test” shall mean any Laboratory Developed Test using genes, gene products, or other biomarkers present in any type of biological sample for differentiating clinically significant pancreatic cancer from other pancreatic conditions, including without limitation clinical laboratory testing and clinical trials, but expressly excluding manufacture of IVD Test Kits. For reference purposes, the license granted for the Pancreatic Test is identified as “License C”.

“Colon Cancer Test” shall mean any Laboratory Developed Test using genes, gene products or other biomarkers for differentiating clinically significant colon cancer from other colon conditions, including without limitation clinical laboratory testing and clinical trials, but expressly excluding manufacture of IVD Test Kits. For reference purposes, the license granted for the Colon Cancer Test is identified as “License D”.

“Cytogenetics Interpretation System” shall mean any interpretive software and related technology for computer-aided karyotype analysis for genetic screening and detection of chromosomal abnormalities. For reference purposes, the license granted for the Cytogenetics Interpretation System is identified as “License E”.

“Flow Cytometry Interpretation System” shall mean interpretive software and related technology for computer-aided analysis of flow cytometry tests. For reference purposes, the license granted for the Flow Cytometry Interpretation System is identified as “License F”.

“Urine Prostate Cancer Test” shall mean any Laboratory Developed Test using genes, gene products, or other biomarkers present in urine samples for differentiating clinically significant prostate cancer from other prostate conditions, including without limitation clinical laboratory testing and clinical trials, but expressly excluding manufacture of IVD Test Kits. For reference purposes, the license granted for the Urine Prostate Cancer Test is identified as “License G”.

“Tissue Prostate Cancer Test” shall mean any Laboratory Developed Test using genes, gene products, or other biomarkers present in tissue samples for differentiating clinically significant prostate cancer from other prostate conditions, including without limitation clinical laboratory testing and clinical trials, but expressly excluding manufacture of IVD Test Kits. For reference purposes, the license granted for the Tissue Prostate Cancer Test is identified as “License H”.

Licensed Patents
Patent/Application No.
Title
Filing Date/
Expires

Issue Date

Patent/Application No.
Title
Filing Date/
Expires

Issue Date

U.S. Patent No. 6,128,608
Enhancing Knowledge Discovery Using Multiple Support Vector Machines
05-01-1999/
5/1/2019

10/3/2000

U.S. Patent No. 6,157,921
Enhancing Knowledge Discovery Using Support Vector Machines in a Distributed Network Environment
05-01-1999/
5/1/2019

12/5/2000

U.S. Patent No. 6,427,141
Enhancing Knowledge Discovery Using Multiple Support Vector Machines.
05-09-2000/
5/1/2019

7/30/2002

U.S. Patent No. 6,658,395
Enhancing Knowledge Discovery from Multiple Data Sets Using Multiple Support Vector Machines.
05-24-2000/
5/1/2019

12/2/2003

U.S. Patent No. 6,714,925
System for Identifying Patterns in Biological Data Using a Distributed Network.
08-07-2000/
5/1/2019

3/30/2004

U.S. Patent No. 6,760,715
Enhancing Biological Knowledge Discovery Using Multiple Support Vector Machines.
08-07-2000/
5/1/2019

7/6/2004

U.S. Patent No. 6,789,069
Method of Identifying Patterns in Biological Systems and Method of Uses.
08-07-2000/
4/13/2020

9/7/2004

U.S. Patent No. 6,882,990
Method of Identifying Biological Patterns Using Multiple Data Sets.
08-07-2000/
5/1/2019

4/19/2005

U.S. Patent No. 6,944,602
Spectral Kernels for Learning Machines
03-01-2002/
2/19/2023

9/13/2005

U.S. Patent No. 6,996,549
Computer-Aided Image Analysis
01-23-2002/
4/21/2021

2/7/2006

U.S. Patent No. 7,117,188
Methods of Identifying Patterns in Biological Systems and Uses Thereof
01-24-2002/
3/9/2022

10/3/2006

U.S. Patent No. 7,299,213
Method of Using Kernel Alignment to Extract Significant Features from a Large Dataset
09-12-2005/
3/1/2022

11/20/2007

U.S. Patent No. 7,318,051
Methods for Feature Selection in a Learning Machine
11-18-2003/
2/25/2021

1/8/2008

U.S. Patent No. 7,353,215
Kernels and Methods for Selecting Kernels for Use in Learning Machines
11-07-2003/
1/27/2023

4/1/2008

U.S. Patent No. 7,383,237
Computer-Aided Image Analysis
02-06-2006/
11/4/2019

6/3/2008

U.S. Patent No. 7,444,308
Data Mining Platform for Bioinformatics and Other Knowledge Discovery
12-15-2003/
5/28/2022

10/28/2008

U.S. Patent No. 7,475,048
Pre-Processed Feature Ranking for a Support Vector Machine
05-07-2004/
7/22/2021

1/6/2009

U.S. Patent No. 7,542,947
Data Mining Platform for Bioinformatics and Other Knowledge Discovery
10-30-2007/
5/20/2022

6/2/2009

U.S. Patent No. 7,542,959
Feature Selection Method Using Support Vector Machine Classifier
08-21-2007/
8/7/2020

6/2/2009

U.S. Patent No.  7,617,163
Kernels and Kernel Methods for Spectral Data
10-09-2002/

11/10/2009

U.S. Patent No. 7,624,074
Methods for Feature Selection in a Learning Machine
10-30-2007/
8/7/2020

11/24/2009

U.S. Patent No. 7,676,442
Selection of Features Predictive of Biological Conditions Using Protein Mass Spectrographic Data
10-30-2007/
8/7/2020

3/9/2010

U.S. Patent No. 7,788,193
Kernels and Methods for Selecting Kernels for Use in Learning Machines
10-30-2007/
8/6/2023

8/31/2010

U.S. Patent No. 7,797,257
System for Providing Data Analysis Services Using a Support Vector Machine for Processing Data Received from a Remote Source
10-31-2007/
7/28/2020

9/14/2010

U.S. Patent No. 7,805,388
Method for Feature Selection in a Support Vector Machine Using Feature Ranking
10-30-2007/
8/7/2020

9/28/2010

U.S. Patent No. 7,890,445
Model Selection for Cluster Data Analysis
10-30-2007/
6/8/2024

12/15/2011

U.S. Patent No.  7,921,068
Data Mining Platform for Knowledge Discovery from Heterogeneous Data Types and/or Heterogeneous Data Sources
10-30-2007/
5/20/2022

4/5/2011

U.S. Patent No.  7,970,718
Method for Feature Selection and for Evaluating Features Identified as Significant for Classifying Data
09-26-2010/
1/24/2022

6/28/2011

U.S. Patent No.  8,008,012
Biomarkers Downregulated in Prostate Cancer
09-30-2008/
1/13/2026

8/30/2011

U.S. Patent  No. 8,095,483
Support Vector Machine-Recursive Feature Elimination (SVM-RFE)
12-01-2010/
8/7/2020

1/10/2012

U.S. Patent Publ. No. 2005/0165556
Colon Cancer-Specific Biomarkers
01-11-2005/
08-07-2020 + PTA

U.S. Patent Publ. No. 2010/0256988
System for Providing Data Analysis Services Using a Support Vector Machine for Processing Data Received from a Remote Source
06-11-2010/
5/1/2019

U.S. Patent Publ. No. 2011/0106735
Recursive Feature Elimination Method Using Support Vector Machines
11/11/2010
08-07-2020 + PTA

U.S.Patent Publ. No. 2010/0318482
Kernels for Identifying Patterns in Datasets Containing Noise or Transformation Invariances
08-25-2010/
05-07-2022 + PTA

U.S.Patent Publ. No. 2011/0184896
Method for Visualizing Feature Ranking of a Subset of Features for Classifying Data Using a Support Vector Machine
04-04-2011/
05-20-2022  PTA

U.S. Patent Publ. No. 2010/0205124
Support Vector Machine-Based Method for Analysis of Spectral Data
02-04-2010/
08-07-2020 + PTA

U.S.Patent Publ. No. 2011/0125683
Identification of Co-Regulation Patterns by Unsupervised Cluster Analysis of Gene Expression Data
02-02-2011/
05-17-2022 + PTA

U.S. Patent Publication No. 2009/0204557
Method and System for Analysis of Flow Cytometry Data Using Support Vector Machines
02-08-2009/
02-08-2029 + PTA

U.S. Patent Publication No. 2008/0050836
Biomarkers for Screening, Predicting, and Monitoring Benign Prostate Hyperplasia
07-26-2007/
11-14-2025 + PTA

U.S. Patent Publication No. 2009/0215024
Biomarkers Upregulated in Prostate Cancer
02-04-2008/
11-14-2025 + PTA

U.S. Patent Publication No. 2009/0286240
Biomarkers Overexpressed in Prostate Cancer
09-30-2008/
11-14-2025 + PTA

U.S. Patent Publication No. 2009/0215058
Methods for Screening, Predicting and Monitoring Prostate Cancer
12-04-2008/
11-14-2025 + PTA

U.S. Patent Publication No. 2009/0226915
Methods for Screening, Predicting and Monitoring Prostate Cancer
01-06-2009/
11-14-2025 + PTA

U.S.Patent Publication No.  2011/0312509
Biomarkers Downregulated in Prostate Cancer
08-29-2011/
11-14-2025 + PTA

U.S. Patent No. 6,920,451
Method for the Manipulation, Storage, Modeling, Visualization and Quantification of Datasets
01-19-2001/
6/9/2021

7/19/2005

U.S. Patent No. 7,366,719
Method for the Manipulation, Storage, Modeling, Visualization and Quantification of Datasets
10-06-2004/

4/29/2008

Field of Use
“Field” or “Field of Use” shall mean the fields of laboratory testing, molecular diagnostics, clinical pathology, anatomic pathology, and digital image analysis, excluding non-pathology-related radiologic and photographic image analysis, relating to the development, marketing, production or sale of any Laboratory Developed Tests or other products used for diagnosing, ruling out, predicting a response to treatment, and/or monitoring treatment of any or all hematopoietic and solid tumor cancers excluding cancers affecting the retina and breast cancer; provided, however, the manufacture and sale of IVD Test Kits for sales to third parties and the melanoma screening system and methods described in the patent applications listed in Exhibit D are specifically excluded from the Field or Field of Use; and provided further that the foregoing exclusion of “and breast cancer” immediately prior to the first proviso of this section shall be in effect only so long as the License Agreement among and between LICENSOR.

The Licensee is a high-complexity CLIA-certified clinical laboratory that specializes in cancer genetics diagnostic testing. The Licensee's testing services include cytogenetics, fluorescence in-situ hybridization (FISH), flow cytometry, immunohistochemistry, morphology studies, anatomic pathology and molecular genetic testing. Headquartered in Fort Myers, FL, The Licensee services the needs of pathologists, oncologists, urologists and other clinicians, and hospitals throughout the United States.

IPSCIO Record ID: 273468

License Grant
The parties grant each other certain rights and licenses on the terms set forth in this Agreement and to collaborate on a research and development relating to “Paraffin Extraction Technology”.  

RNA Amplification Technology
Licensor hereby grants to Licensee a worldwide, non-transferable (except as provided in Section 14.6), royalty-bearing, non-sublicensable, non-exclusive license under (i) the Licensor Background Technology directed to RNA Amplification and (ii) the RNA Amplification Technology, in each case, to practice and use the subject matter within the foregoing to research, develop, make, have made, import, use, offer for sale, and sell products for use in the Licensee Database Field of Use, Diagnostic Field of Use, Homebrew Field of Use, and Personal Research Field of Use.

Paraffin Extraction Technology
Licensor hereby grants to Licensee a worldwide, non-transferable (except as provided in Section 14.6), royalty-free, fully paid-up, non-sublicensable, non-exclusive license under Licensor’s Background Technology directed to Paraffin Extraction to practice and use the subject matter within the foregoing to research, develop, make, have made, import, use, offer for sale, and sell products for use in the Licensee Database Field of Use, Diagnostic Field of Use, Homebrew Field of Use, and Personal Research Field of Use.

Research License
Licensor hereby grants to Licensee a worldwide, non-transferable (except at provided in Section 14.6), royalty-free, fully paid-up, non-sublicensable, non-exclusive license under the Licensor Background Technology and the Program Technology owned by Licensor to practice and use the subject matter within the Licensor Background Technology and the Program Technology to conduct internal research.

Development License
Licensor hereby grants to Licensee a worldwide, non-sublicenseable, royalty-free, fully paid-up, non-exclusive license under the Licensor Background Technology and the Program Technology owned by Licensor to practice and use the subject matter within the Licensor Background Technology and Program Technology to conduct its activities under the Development Program.

Licensee hereby grants to Licensor a worldwide, non-sublicenseable, royalty-free, fully paid-up, non-exclusive license under the Program Technology owned by Licensee to practice and use the subject matter within the Program Technology to conduct its activities under the Development Program.

Commercialization Licenses
Licensee hereby grants to Licensor a worldwide, non-transferable (except as provided in Section 14.6), royalty-free, fully paid-up, non-sublicensable, non-exclusive license under the Paraffin Extraction Technology to research, develop, make, have made, import, use, offer for sale, and sell products for use in the Licensor Field and to conduct internal research.

Improvement
Licensee hereby grants to Licensor a worldwide, perpetual, irrevocable, fully paid up, royalty-free, non-transferable (except as provided in Section 14.6), non-exclusive license, under the Improvements Controlled by Licensee to practice and use the subject matter within such Improvements to research, develop, make, have made, import, use, offer for sale, and sell products, in each case, for use in the Licensor Field.

Licensor hereby grants to Licensee a worldwide, perpetual, irrevocable, fully paid up, royalty-free, non-transferable (except as provided in Section 14.6), non-exclusive license under the Improvements Controlled by Licensor to practice and use the subject matter within such Improvements to research, develop, make, have made, import, use, offer for sale, and sell products, in each case, for use in the Licensee Database Field of Use, Diagnostic Field of Use, Homebrew Field of Use, and Personal Research Field of Use.

License Property
Paraffin Extraction Technology shall mean all Program Technology relating to the recovery and extraction of native nucleic acids, polypeptides, peptides and/or proteins from tissues embedded in paraffin and its use in the research, development and commercialization of assays, including without limitation microarrays. Paraffin Extraction Technology excludes RNA Amplification Technology.

Paraffin Extraction shall mean the recovery and extraction of native nucleic acids, polypeptides, peptides and/or proteins from tissues embedded in paraffin.

RNA Amplification Technology shall mean all Program Technology relating to the selective amplification, labeling or conjugation of RNA segments in a close to linear fashion. RNA Amplification shall mean the selective amplification, labeling or conjugation of RNA segments in a close to linear fashion.

Products shall mean Licensee Database Products, Personalized Research Products, Homebrew Products and/or Diagnostic Products.

Diagnostic Product(s) shall mean an assay provided as a product or service performed on a human tissue or other human biological sample containing nucleic acids or proteins that are collectively intended to establish or identify an association between the presence or absence of such nucleic acids or proteins and
(a) diagnosis of the presence of, or absence of, a specific disease(s), state(s) or condition(s) in humans;
(b) predisposition to the presence of, or absence of, a specific disease(s), state(s) or condition(s) in humans;
(c) response or lack of response to disease therapy(ies) in humans or preventative strategies in humans;
(d) prediction of the disease course in humans, and or other changes in state(s) or condition(s) in humans over time;
(e) clinical traits in humans for which a medical professional should be consulted; or variation(s) in specific trait(s) and/or characteristics among individuals;
(f) variation(s) in specific trait(s) and/or characteristics among individuals; and/or
(g) predisposition to development of toxicities to disease therapies or preventative strategies in humans.

the results of which are provided to payors, providers or patients, and for which FDA approval (or comparable regulatory agency in other jurisdictions) is required. Diagnostic Products exclude Homebrew Products, Personalized Research Products and Licensee Database Products.

Homebrew Product(s) shall mean a Single Analyte Assay(s) provided as a product or a service performed by a service provider that would constitute a Diagnostic Product with the sole exception that it is provided prior to receipt of approval by the FDA or comparable regulatory agency in any jurisdiction outside of the United States. Homebrew Products exclude Diagnostic Products, Personalized Research Products and Licensee Database Products. For purposes of the foregoing, “Single-Analyte Assays” shall mean a assay designed for testing or measuring only a single analyte.

Personal Research Products shall mean shall mean a Multi-Analyte Assay(s) provided as a product or a service containing nucleic acids or proteins that are collectively intended to establish or identify an association between the presence or absence of such nucleic acids or proteins and
(a) diagnosis of the presence of, or absence of, a specific disease(s), state(s) or condition(s) in humans;
(b) predisposition to the presence of, or absence of, a specific disease(s), state(s) or condition(s) in humans;
(c) response or lack of response to disease therapy(ies) in humans or preventative strategies in humans;
(d) prediction of the disease course in humans, and or other changes in state(s) or condition(s) in humans over time;
(e) clinical traits in humans for which a medical professional should be consulted;
(f) variation(s) in specific trait(s) and/or characteristics among individuals; and/or
(g) predisposition to development of toxicities to disease therapies or preventative strategies in humans.

Such an assay will be considered a “Personalized Research Product” only where the results are provided directly to the tested individual and/or to the tested individual’s health care provider, and where the approval by the FDA or comparable regulatory agency in any jurisdiction outside of the United States is not required. “Personalized Research Products” exclude Homebrew Products, Diagnostic Products and Licensee Database Products. For purposes of the foregoing, “Multi-Analyte Assay(s)” shall mean an assay designed for testing or measuring more than a single analyte.

Licensee Database Products shall mean a collection of information derived from or by testing a person or persons in the Diagnostic Field of Use, Homebrew Field of Use or the Personalized Research Field of Use. Licensee Database Products exclude Diagnostic Products, Homebrew Products, and Personalized Research Products.

Licensor Background Technology shall mean the Intellectual Property that Licensor Controls as of the Effective Date and during the Development Program which is necessary for the conduct of the Development Program and the exploitation of the Program Technology and/or the Improvements,  and which is directed to (a) the recovery and extraction of native nucleic acids, polypeptides, peptides and/or proteins from tissues embedded in paraffin for use in the research, development and commercialization of assays, including without limitation microarrays (“Paraffin Extraction”); or (b) the selective amplification, labeling or conjugation of RNA segments in a close to linear fashion (“RNA Amplification”). Licensor Background Technology shall exclude those patents licensed to Licensee under the Patent License Agreement.

Program Technology shall mean all Intellectual Property created by Licensor or Licnesee after the Effective Date and during the Development Period (i) in the course of performing the Development Program, or (ii) using Confidential Information provided by the other Party to the inventing Party in connection with the Development Program.

Intellectual Property shall mean trade secrets, Patents, copyrights, Know-How, and similar rights of any type under the laws of any governmental authority, domestic or foreign, including all applications and registrations relating to any of the foregoing.

Field of Use
Diagnostic Field of Use shall mean the research, development, manufacture, importation, use and/or sale of Diagnostic Product(s). The Diagnostic Field of Use excludes the Personalized Research Field of Use, the Licensor Field of Use and the Homebrew Field of Use.

Homebrew Field of Use shall mean the research, development, manufacture, importation, use and/or sale of Homebrew Product(s). The Homebrew Field of Use excludes the Diagnostic Field of Use, the Internal Research Field of Use and the Personalized Research Field of Use.

Personal Research Field of Use shall mean the research, development, manufacture, importation, use and/or sale of Personalized Research Product(s). The Personalized Research Field of Use excludes the Diagnostic Field of Use, the Homebrew Field of Use, and the Licensor Field of Use.

Licensee Database Field of Use shall mean the research, development, manufacture, importation, use and/or sale of Licensee Database Product(s) to end users.

Licensor Field shall mean all internal research and development applications of Paraffin Extraction Technology or Improvements, including the use of such technology to develop therapeutic products and the use of such technology in connection with the commercialization of research tools, such as databases, use of a biochemical test for detecting and/or quantifying a specific nucleic acid target sequence within a nucleic acid mixture which is designed and intended “For Research Use Only” or “For Investigational Use Only” or as a general purpose laboratory reagent. For the avoidance of doubt, the Licensor Field shall exclude any, Diagnostic Field of Use, Homebrew Field of Use, and Personal Research Field of Use.

The Collaborative Agreement pertains to certain of Licensor’s patent rights and know-how regarding cloning, DNA sequencing, and data analysis technologies.
Under the Patent License Agreement, Licensee licenses various classes of patents from Licensor pertaining to the manipulation of genes, the detection of pathological conditions, comparative gene analysis, methods for fabricating tests of biological samples and the use proteins as markers for cancers.

IPSCIO Record ID: 203343

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.

IPSCIO Record ID: 26771

License Grant
We entered into a collaborative research.
License Property
Transaction is a research and license agreement using the licensor's technology involving a surface enhanced laser desorption/ionization system ('SELDI,' a technology described in United States Patent Application 08/068,896 and Patent No. 5,719,060 and U.S. Patent 6,225,047) along with certain related know-how and capacities that are uniquely enabling in the investigation of biomarkers.

These biomarkers are to be used biomarkers for diagnostic or therapeutic uses in the treatment of preeclampsia/ toxemia.

Pre-eclampsia or preeclampsia is a medical condition characterized by high blood pressure and significant amounts of protein in the urine of a pregnant woman.

Toxemia is a generic term for the presence of toxins in the blood.

IPSCIO Record ID: 452

License Grant
Licensor grants an exclusive, worldwide sublicense, with a right to further sublicense, under the Baylor Technology and Improvements to make, use, sell, offer for sale and import any instrumentation, device or non-drug consumable for use by customers in the Other Markets; and an exclusive, worldwide license, with a right to sublicense, under the Licensor Technology to make, use, sell, offer for sale and import any instrumentation, device or non-drug consumable for use by customers in the Other Markets.  These sublicense agreements with Licensor provide the Licensee with the exclusive right under the Baylor patents to make, use and sell instruments, devices and non-drug consumables for use by customers in the life science laboratory and drug discovery laboratory markets worldwide.
License Property
The Company develops, manufactures and markets a proprietary ProteinChip System that enables protein discovery, characterization and assay development to provide a better understanding of biological functions at the protein level.  The ProteinChip System is a novel, enabling tool in the emerging field of protein-based biology research, known as proteomics.  While recent technological advances in DNA tools have substantially changed the field of genomics, the absence of enabling protein analysis tools has limited progress in proteomics research.  Proteomics provides a direct approach to understanding the role of proteins in the biology of disease, monitoring of disease progression and the therapeutic effects of drugs.
Field of Use
The ProteinChip System incorporates the Licensee's proprietary Surface-Enhanced Laser Desorption/Ionization, or SELDI, technology on a disposable chip.  This allows proteins to be captured, separated and quantitatively analyzed directly from crude biological materials, such as whole blood, tissue and saliva, with minimal sample preparation.

IPSCIO Record ID: 211942

License Grant
For the Grant of Research License,  Licensor grants the Licensee of the Netherlands, 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 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.

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 Licensee’s name and labels and, in connection with such Licensed Products, to practice the Licensed Methods.

License Property
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.

The Licensees Instrument is the Easy Q Instrument, the proprietary diagnostic system and related components, currently known as the NucliSens Easy Q System, which reads a fluorescence signal from reaction tubes utilizing molecular beacons in specific assays.

Licensed Patents shall mean, collectively, the Hybrid Patents, RNA Patents and the Sequence Patents.

Field of Use
The 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.

IPSCIO Record ID: 233461

License Grant
The Swiss Licensor grants a non-exclusive license under the Licensed Patents as follows
– to make, have made, import, use, offer to Sell and Sell Licensed Products in the In Vitro Human Diagnostics Field in the Territory, and authorize End-Users to perform Diagnostic Services using such Licensed Products in processes covered by the Licensed Patents in accordance with the label license provided with the purchase of such Licensed Products.
– to grant a limited, non-transferable, royalty free sublicense under the Licensed Patents to Research Collaborators of Licensee and/or its Affiliates to practice PCR under their respective contracts with Licensee and/or its Affiliates, in accordance with the terms and conditions of this Agreement, solely for purposes of doing applied research and development for Licensee and/or its Affiliates of Licensed Products to be Sold in the In Vitro Human Diagnostics Field in accordance with the other terms and conditions of this Agreement; and
– to use PCR technology for the research, development, improvement and quality control and quality assurance of Licensed Products, in each case by Licensee and its Affiliates, internally, for Sale in the In Vitro Human Diagnostics Field.

For Label Licenses on Licensed Products Sold in the In Vitro Human Diagnostics
– Licensees right to sublicense is limited to the right to convey use rights pursuant to a Label License under process claims and composition of matter claims,not apparatus, device or system claims, only to End-User customers, and only through the Sale of Licensed Products.
– Licensee agrees that it shall mark conspicuously all Complete Diagnostic Kits made by or for it,
– Licensee agrees that it shall mark conspicuously all Component Systems for amplification made by or for it
– Licensee agrees that it shall mark conspicuously all Component Systems for detection made by or for it
– Licensee agrees that it shall mark conspicuously all Component Systems for amplification and detection made by or for it
– Licensee agrees that it shall mark conspicuously all Royalty Products other than Complete Diagnostic Kits, Component Systems for amplification, Component Systems for detection and Component Systems for amplification and detection made by or for it and Sold in the In Vitro Human Diagnostics Field.

License Property
The Complete Diagnostic Kit means a product dedicated for use in connection with the practice of PCR in the In Vitro Human Diagnostics Field, it being understood that a product shall be deemed to be so dedicated if it is either  a product having a package insert indicating its use primarily in connection with the practice of PCR; or a product which by virtue of its design, operation or construction has no other substantial practical utility, and which product is comprised of, at a minimum, the essential active reagents for amplification and detection of a target nucleic acid in the In Vitro Human Diagnostics Field. For purposes of this Agreement, Licensee shall only convey the necessary rights for End-Users to perform PCR in the In Vitro Human Diagnostics Field with the Sale of a Complete Diagnostic Kit.

Licensed Product means a product for use in the In Vitro Human Diagnostics Field, the manufacture, importation, use, offer for Sale or Sale of which would infringe a Valid Claim of Licensed Patents, made by or specifically for Licensee or any of its Affiliates only pursuant to Licensees or its Affiliates specifications, which is any of the following or a combination of any of the following
(a) Complete Diagnostic Kit;
(b) A reagent, accessory, device or system which is used or Sold to be used by End-Users in connection with the practice of PCR, including the steps of sample preparation, amplification and detection;
(c) A Component System; and/or
(d) Reagents Sold to be used by End-Users as replacement components in regard to a Component System.

PCR means the polymerase chain reaction process and technology.

Patents relate to Process for Amplifying, Detecting, and/or Cloning Nucleic Acid Sequences.

Field of Use
This agreement is for the purpose of developing and commercializing PCR based in vitro human diagnostic products for use in clinical diagnostic testing;

The Human Identity Field means the field of use comprising products and processes utilizing PCR for the sole purpose of determining human identity or distinguishing among human beings, whether living or dead. The Term Human Identity Field shall included parentage testing to determine if two or more human beings are biologically related as parent and child and forensic testing for use in, or in preparation for, death investigations or other legal proceedings, but such term shall specifically exclude testing for tissue typing.

In Vitro Human Diagnostics Field means the field of use comprising products and processes utilizing PCR for the measurement, observation or determination of attributes, characteristics, diseases, traits or other conditions of a human being for the medical management of that human being, including without limitation
(a) genetic testing, including determinations of genetic predisposition;
(b) oncology and cancer predisposition testing;
(c) testing for tissue typing (excluding the Human Identity Field);
(d) infectious disease detection, screening, confirmation and monitoring; and
(e) therapeutic drug monitoring.

For purposes of this Agreement, the term 'In Vitro Human Diagnostics Field' shall not include the Human Identity Field.

“PCR” means the polymerase chain reaction process and technology involving the amplification of a nucleic acid sequence and the complement of that sequence by repeated cycles of oligonucleotide mediated, template directed synthesis involving the extension of a component primer oligonucleotide by incorporation of monomeric nucleotide triphosphates whereby the sequence, its complement and subsequent synthetic copies thereof are repeatedly separated and used as templates for further cycles of synthesis.

IPSCIO Record ID: 237229

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.

IPSCIO Record ID: 286051

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.

IPSCIO Record ID: 328168

License Grant
This License provide Test Kit Services to Licensee of India for the OVA1 Test in India. The parties will establish royalties, fees and other payments for the OVAl Test as a Test Kit Service in India different from the methodology set forth in Strategic Alliance Agreement.
License Property
OVA1® shall mean ovarian tumor triage test. OVA1 is a qualitative serum test that utilizes five well-established biomarkers and proprietary FDA-cleared software to determine the likelihood of malignancy in women over age 18 with a pelvic mass for whom surgery is planned.

Except as amended hereby, the Strategic Alliance Agreement shall remain unaltered and in full force and effect, and each of the Parties hereby ratifies and confirms the Strategic Alliance Agreement. Without limiting the foregoing, the Parties agree that (i) Schedule E-1 to the Strategic Alliance Agreement shall remain in effect for the OVAl Test performed by Quest Diagnostics outside India and (ii) Schedule E to the Strategic Alliance Agreement shall remain in effect for any Licensed Laboratory Services and any Test Kit Services other than the OVAl Test and PAD Test (which is covered in Amendment No.2) regardless of whether any such Licensed Laboratory Service or Test Kit Service involves any Proprietary Supplies or Test Kits purchased from or through Licensor.

Field of Use
Field of Use is for the pre-surgical identification of women who are at high risk of having a malignant ovarian tumor.

Ovarian cancer is a type of cancer that begins in the ovaries, the female reproductive system.

IPSCIO Record ID: 6506

License Grant
Licensor grants a non-exclusive license, with the right to grant sublicenses to Affiliates, and, upon prior approval by Licensor, to third parties under the Licensed Technology to import, make, have made, use and sell any Licensed Product with respect to both the commercial reference laboratory field and the academic and research fields.
License Property
The Parties are working on development of a new molecular diagnostic test for prostate cancer based on our discovered prostate cancer biomarker signature.

7,117,188 Method of Identifying Patterns in Biological Systems and Uses Thereof
U.S. 2007/0092917 Biomarkers for Screening, Predicting, and Monitoring Prostate Disease

IPSCIO Record ID: 329693

License Grant
Licensor grants a non-exclusive, non-transferable, worldwide license in the VIDAS Field to use the Licensor Technology solely to develop, make and have made, use, sell, offer for sale, have sold and import the VIDAS Products, solely and exclusively for use on the VIDAS Instrumentation.
License Property
Licensor possesses technology, knowledge, know-how and proprietary rights pertaining to nucleic acid hybridization and amplification technologies, detection and identification technologies, including specific probes targeting ribosomal RNA and specific target sequences and regions, microbiological culture collections, Probe Assay formats, specimen collection and processing, multiple analyte detection technologies and related intellectual property.

VIDAS Instrumentation shall mean, collectively, the Licensee instrument system currently known as the VIDAS system and the Licensee instrument system currently known as the mini-VIDAS system, as such systems existed on the date of the VIDAS Agreement and as hereafter modified or supplemented by additional instrumentation or devices as required to accommodate VIDAS Products, each of which modified and/or supplemented systems shall consist of instrumentation which is generally sold for processing and interpreting both Probe Assays and immunoassays, excluding, in any event, all VIDAS Products to be run on such instrumentation, provided, however, that such term may include a Probe Assay-only VIDAS system that Licensee may elect to develop at its expense, and provided, further, such modified and/or supplemented Probe Assay-only instrumentation system shall
–  be semi-automated, meaning it does not accept the sample container itself and performs all steps needed to produce the tests results.
–  use as its test format (i) a multi-well plastic cassette, currently referred to as a VIDAS strip which contains pre-dispensed reagents, tests for analytes and controls which is manually loaded into and resident in individual incubation and processing slots, and (ii) a pipette tip, currently referred to as an SPA, containing immobilized capture ligands; and
–   accommodate, on any single unit capable of stand-alone operation of such modified and/or supplemented instrument system, no more than thirty (30) test cassettes at one time.

VIDAS Products shall mean the following Probe Assays, in each case made, used, or sold under the license granted by Licensor in this Agreement and solely and exclusively for use on VIDAS Instrumentation
–   VIDAS Initial Products, which shall mean, collectively, Probe Assays for the detection of Chlamydia trachomatis (VIDAS Probe CT); Probe Assays for the detection of Neisseria gonorrhoeae (VIDAS Probe GC), Probe
Assays for the detection of Neisseria gonorrhoeae and/or Chlamydia trachomatis in combination VIDAS CT/GC Screen and Probe Assays for the detection of Mycobacterium tuberculosis (VIDAS Probe MTB)
–   VIDAS QHIV Product, means the Probe Assay for the quantitative detection of human immunodeficiency virus which has been the subject of joint Parties development efforts prior to the Effective Date. IF Licensee elects to develop an alternative QHIV probe assay for the VIDAS Instrumentation and a new regulatory submission is required for such assay, then (i) if Licensee ceases to market the original VIDAS QHIV Product and markets only the alternative QHIV probe assay, such alternative QHIV probe assay shall thereafter be prospectively considered to be the VIDAS QHIV Product for purposes of this Agreement, but (ii) if Licensee continues to market the original VIDAS QHIV Product and also markets the alternative QHIV probe assay, such alternative QHIV probe assay shall be considered to be a VIDAS Future Infectious Disease Product for purposes of this Agreement.
–  VIDAS HLA Product, which shall mean Probe Assays for the detection and quantification of sequences encoding·human leukocyte antigens;
–  VIDAS Food Testing Products, which shall mean Probe Assays for the detection of microorganisms in any and all materials associated with the production (including quality control) of foodstuffs or beverages, including water, intended for human or animal consumption.
–  VIDAS Future Infectious Disease Products, which shall mean Probe Assays, other than the VIDAS Initial Products and VIDAS QHIV Product, for detection, identification, quantification of, and/or susceptibility testing for agents causing human clinical infectious diseases, as present in the human body, solely for the purpose of diagnosis and medical care of the persons from whom the tested samples were taken.
–  VIDAS Other Future Products, which shall mean any Probe Assays which are directed at one or more Option Targets selected by Licensee.

Assay shall mean a diagnostic process or procedure applied to a sample, or a portion of a sample, whereby a particular chemical compound, or a collection of compounds, or a portion of a chemical compound, is detected and optionally quantified.

Probe Assay shall mean an Assay using a nucleic acid as a necessary and active reagent or which detects a set of nucleic acid sequences or a specific nucleic acid sequence, as a means of obtaining useful information relevant to the sample being assayed.

Key Biochemistry Components or KBCs shall mean (a) the lysing tubes, enzymes, nucleic acids and other biochemical compounds and reagents.  Key Biochemistry Components are
–  All enzymes used in transcription-based amplification, including TMA and variations and improvements to TMA, for use in VIDAS Assays.
–  All biochemical components used for amplification of amplicon of target with TMA.
–  All probes, primers, and oligonucleotides used in VIDAS Assays.
–  Nucleic acids used for positive and negative controls, standards, calibrators, and for quality control of VIDAS Assay components and VIDAS kits.

Field of Use
Technology covers semi-automated probe assays and advanced fully-automated, probe assays for the diagnosis of infectious diseases and detection of food pathogens.

Licensee and its Affiliates maintain and operate a worldwide network of semi-automated instruments known as VIDAS and mini-VIDAS for the diagnosis of infectious disease and other indications.

VIDAS Field shall mean
–  the detection, identification, quantification, and/or susceptibility testing of agents causing human clinical infectious diseases, as present in the human body, solely for the purpose of diagnosis and medical care of the persons from whom the tested samples were taken;
–  testing for sequences encoding human leukocyte antigen;
–  testing for microorganisms in any and all materials associated with the production, including quality control, of foodstuffs or beverages, including water, intended for human or animal consumption;
–  testing for any analyte listed and selected by Licensee, as present in a clinical sample from the human body, solely for the purpose of diagnosis and medical care of the person from whom the tested sample was taken.

The VIDAS Field specifically does not include testing for infectious agents in blood and blood products intended for transfusion, or the testing for infectious agents in blood in connection with organ transplants, or the testing of specimens from non-human animals or environmental sources except as specifically provided above, even if such testing is for the purpose of detecting or identifying organisms which are associated with infectious diseases in man.

The target markers are
–  Cancer Markers
1. Prostase,
2. Mammaglobin,
3. Kras,
4. p53,
5. Cancer related mutations of the mitoch9ndrial RNA in the D-Loop regulatory region, the NADH (nicotinamide adenine dinucleotide) region, and the dehydrogenase subunit 4.
–  Cardiac Markers
6. Factor II (Prothrombiri) mutation (20210)
7. Factor V Leiden mGtation
–  Alzheimer Markers
8. ApoE
9. presenilin,
–  Sepsis Markers
10. Sepsis specific cytokine.

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