Royalty Report: Diagnostic, Medical, Cancer – Collection: 342823

License Grant

University granted the Licensee an exclusive, worldwide, sublicensable license in all fields under University’s Codex patent estate under certain patent rights to make, use, import and commercialize products for diagnostic, industrial and research and development purposes.

License Property

Patents shall mean the ones under Universitys Codex patent estate.

CODEX, is an ultra-high parameter and cost-effective platform ideally suited for discovery research with the ability to identify more than 40 biomarkers in a tissue sample.

Field of Use

Field of use is in all fields to identify biomarkers for diagnostic, industrial and research and development purposes.

Biomarkers are objective measures that capture what is happening in a cell or tissue at a given moment. Current genomic and proteomic methods, such as next-generation sequencing (NGS), single-cell analysis, flow cytometry and mass spectrometry, are providing meaningful data but require the destruction of the tissue sample for analysis.

License Grant

The Licensor, government public health organization, has granted the Licensee an exclusive license to commercialize LCM, isolation of cells with proteomic analysis for cancer diagnostics and companion diagnostics and RPPA,  Reverse phase protein array.

License Property

The Licensor has licensed 3 patents to the Licensee in the area of RPPA technology. Reverse phase protein array (RPPA) is a high-throughput technology that performs protein assays on thousands of samples simultaneously, including tissue and cell lysates, serum, plasma or other body fluids. Laser capture microdissection (LCM) is used to isolate a concentrated population of individual cells or precise anatomical regions of tissue.

The TheraLink® platform, cancer biomarker technology, makes it possible to generate an accurate and comprehensive portrait of protein pathway activation in diseased cells from each patient, and thereby determine which individuals may be better responders to certain targeted molecular therapies.

The TheraLink® platform makes it possible to generate an accurate and comprehensive portrait of protein pathway activation in diseased cells from each patient, and thereby determine which individuals may be better responders to certain targeted molecular therapies. The platform enables the quantitative measurement of the level of activation. Moreover, the sensitivity is many times greater than conventional mass spectrometry and other protein immunoassays.

Field of Use

The Licensee will utilize the licensed technology in the diagnostics industry, both for biopharmas and for oncologists and their patients. The application of the technology enables TheraLink® to work with both freshly frozen and formalin-preserved research and clinical samples.

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.

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.

License Grant

The Canadian Licensor grants the Licensee, under the Licensed IP, a non-exclusive, royalty-bearing, worldwide License, with the right to grant subLicenses solely to Licensee Affiliates, to make, have made, use, lease, sell, and otherwise commercialize Licensed Products in the Field of ICP-based Flow Cytometry.

The Licensor has the right to grant sublicenses, under certain patent rights in the field of ICP-based flow cytometry.

License Property

Flow Cytometer means an analytical instrument that provides assay of a biological sample based on the analysis of individual cells or particles.
Flow Cytometry means the art of conducting assays with a Flow Cytometer.

Field of Use

The Licensee wishes to complement its existing technology and products and to achieve its goal to address diagnostic and other worldwide health issues through advanced genomics, using their innovative microfluidic chips, instruments, and other products, including through the development of products using the Licensed IP.