Royalty Report: Diagnostic, Cancer, Drugs – Collection: 5622

License Grant

The Licensor hereby grants an exclusive license without the right to grant sublicenses in the Territory to the Licensed Intellectual Property to (a) confirm performance of the Colon 101 ELISA Test and (b) use the Colon 101 ELISA Test to offer and provide services within the cDx Field and the rDx Field.

Licensee and its Affiliates shall have the right to use the Trademarks, solely in connection with the use of the Colon 101 ELISA Test.

CDX field means clinical diagnostic testing services performed by a reference laboratory using a test on human samples, the results of which are provided to hospitals, physicians, payers, and/or patients for use in the clinical management of patients.

RDX Field means use in vitro diagnostic testing services in Clinical Trials.

The Licensee shall have the right to use the Trademarks.

License Property

The Licensor has developed a blood test known as the Colon 101 ELISA Test  to detect and quantify the Colon 101 protein in serum.

Field of Use

'CDX Field' means clinical diagnostic testing services performed by a reference laboratory using a test on human samples, the results of which are provided to hospitals, physicians, payers, and/or patients for use in the clinical management of patients.

'RDX Field' means use in in vitro diagnostic testing services in Clinical Trials.

License Grant

The Licensor hereby grants to Licensee and its Affiliates an exclusive license without the right to grant sublicenses in the Territory to the Licensed Intellectual Property to (a) confirm performance of the Cathepsin K ELISA Test and (b) use the Cathepsin K ELISA Test to offer and provide services within the cDx Field and the rDx Field.  The Licensee shall have the right to use the Trademarks.

License Property

The Licensor has developed a blood test known as the Cathepsin K ELISA Test to detect and quantify the Cathepsin K protein inserum, and holds rights to certain intellectual property in and to the Cathepsin K ELISA Test.  Cathepsin K, abbreviated CTSK, is an enzyme which in humans is encoded by the CTSK gene.

Cathepsin K is a lysosomal cysteine protease involved in bone remodeling and reabsorption. This protein, which is a member of the peptidase C1 protein family, is predominantly expressed in osteoclasts.

Field of Use

CDX Field means clinical diagnostic testing services performed by a reference laboratory using a test on human samples, the results of which are provided to hospitals, physicians, payers, and/or patients for use in the clinical management of patients.

RDX Field means use in vitro diagnostic testing services in Clinical Trials.

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.

License Grant

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

License Property

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

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

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

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

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

Field of Use

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

License Grant

Licensor 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

Licensor entered into a worldwide Agreement with the Licensee to develop and commercialize Licensor's hepatocyte growth factor (HGF) inhibitory antibody ficlatuzumab, with Licensee's proprietary companion diagnostic test, VeriStrat®.
Licensor grants Licensee perpetual, non-exclusive rights to certain intellectual property, including all clinical and biomarker data related to ficlatuzumab, to develop and commercialize VeriStrat and Licensee granted Licensor perpetual, non-exclusive rights to certain intellectual property, including diagnostic data related to VeriStrat, with respect to the development and commercialization of ficlatuzumab; each license includes the right to sublicense.

License Property

VeriStrat®, a serum protein test that is commercially available to help physicians guide treatment decisions for patients with advanced non-small cell lung cancer (NSCLC).

Field of Use

The VeriStrat test will be a companion diagnostic for ficlatuzumab, The Licensee will make the VeriStrat test available and use commercially reasonable efforts to seek reimbursement in all geographies where ficlatuzumab is approved.

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.

License Grant

The Licensor, a nonprofit American academic medical center, hereby grants Licensee a non-exclusive sublicense, without the right to sublicense others, under the Licensed Patents to make, have made, use, import, have sold, offer to sell and sell Licensed Products within the Field and within the territory.

License Property

UGT1A1 or uridine diphosphate glucuronosyltransferaseisoform 1A1, test, which is designed to help determine the initial dosing of irinotecan, a leading drug for a broad variety of cancers.

The UGT1A1 gene is part of a complex that encodes several UDP-glucuronosyltransferases.

Patents
    Domain    Status    Pat App No    Filing Date    Patent No
    US    Issued    08/423,641    04/17/95    5,786,344
    US    Issued    09/251,274    02/16/99    6,395,481
    US    Issued    10/061,693    02/01/02    6,472,157

Field of Use

Field means commercial diagnostic testing services for detection of UGT1A1 in humans. Field does not include the research, development, manufacture, marketing, or sale of therapeutic products. Commercial diagnostic testing services shall include, but not be limited to, in-house laboratory tests pursuant to CLIA, clinical trials testing, and the manufacture, use and sale of diagnostic kits.