Royalty Report: Diagnostic, Cancer, Drugs – Collection: 891

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.

License Grant

The Licensor, a nonprofit American academic medical center, grants a non-exclusive subLicenses to such patents to the Licensee in the field of commercial diagnostic testing services for detection of UGT1A1 in humans effective April 14, 2006. The Licensee will pay an upfront fee and royalties.

The Licensor Licensed certain patents related to UGT1A1, from a University pursuant to a License Agreement dated November 18, 2005.

License Property

UGT1A1 is a hepatic enzyme primarily responsible for conjugation of bilirubin. UGT1A1 also catalyzes the glucuronidation of SN-38, the active metabolite of irinotecan and the main source of treatment-related toxicity.

US Issued Pat App No. 08/423,641, filing date 04/17/95, Patent No. 5,786,344
US Issued Pat App No. 09/251,274, filing date 02/16/99, Patent No. 6,395,481
US Issued Pat App No. 10/061,693, filing date 02/01/02, Patent No. 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.

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.

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

Licensor hereby grants to Licensee, subject to all the terms and conditions of this Agreement, a worldwide, nonexclusive right and license (without the right to grant sublicenses) under the Patent Rights to (a) use, offer to sell, sell and practice Diagnostic Services in the Field; (b) make, have made, use, offer to sell, sell and import Licensed Reagents in the Field; and (c) make, have made, use, offer to sell, sell and import Kits in the Field. Notwithstanding the foregoing, Licensor hereby grants to Licensee the worldwide, non-exclusive right to convey to the end-user (purchaser) of FDA (U.S. Food and Drug Administration) Approved Kits manufactured by Licensee the right to perform Diagnostic Services solely in conjunction with the use of FDA Approved Kits manufactured by or on behalf of Licensee (without the right to grant sublicenses).

License Property

Patent Rights shall mean collectively the Gene Patent Rights and the Methodology Patent Rights.

Diagnostic Service(s) shall mean the performance of laboratory-based assays covered in whole or in part by a Valid Claim of the Patent Rights.

Gene Patent Rights shall mean the United States and foreign patents and patent applications relating to the APC (Adenomamus polyposis coli) gene and/or the p53 gene and licensed (with the right to grant sublicenses) to Licensor pursuant to the JHU (Johns Hopkins University) License Agreement together with patents arising therefrom and any extensions, registrations, confirmations, reissues, divisions, continuations or continuations-in-part, re-examinations or renewals thereof, including without limitation the patents and patent applications listed hereto (which may be updated from time to time to include such additional patents and patent application that may arise therefrom); provided, however, that Gene Patent Rights expressly excludes any claims of such patents and patent applications that fall outside of the Field, including, without limitation, claims to antibodies, to the treatment, prevention or remedying of a gene deficiency, to purified proteins, or to DNA (Deoxyribonucleic acid) sequences other than those sequences that correspond to the p53 gene and the APC (Adenomatous polyposis coli) gene; provided further that DNA sequences which are (i) immediately adjacent to the p53 or APC genes and (ii) necessary to the use of the p53 or APC genes, respectively, in the Field shall be considered within the Gene Patent Rights.

US Patent No.  5,352,775 – APC gene and nucleic acid probes derived therefrom
US Patent No.  5,527,676 – Detection of loss of the wild-type P53 gene and kits therefor

Methodology Patent Rights shall mean the United States and foreign patents and patent applications relating to methods of detecting mammalian nucleic acids isolated from stool specimens and reagents therefor and licensed (with the right to grant sublicenses) to Licensor pursuant to the JHU (Johns Hopkins University) License Agreement together with patents resulting therefrom and any extensions, registrations, confirmations, reissues, divisions, continuations or continuations-in-part, re-examinations or renewals thereof, including without limitation the patents and patent application listed hereto (which may be updated from time to time to include such additional patents and patent applications that may arise therefrom).

US Patent Application No. W093/20235 and 08/861,910 (detecting mammalian nucleic acids from stool)

Licensed Reagent shall mean any Reagent covered in whole or in part by a Valid Claim of the Patent Rights.

Kit shall mean a collection of one or more Reagents, including at least one Licensed Reagent, packaged in the form of a kit (including an FDA Approved kit).

Field of Use

Field shall mean (a) stool-based detection of any disease or condition (including pre-cancers, staging and monitoring of the foregoing, and therapeutic response) for research and development, Clinical Laboratory Improvement Amendments (CLIA) testing services (and their foreign equivalents), and FDA Approved Kits; and (b) a screening assay (regardless of other uses to which such assay is put) for colorectal cancer in any type of patient samples, excluding tests solely for staging and/or monitoring of colorectal cancer which do not obsolete or adversely impact such screening assay.