Royalty Report: Cancer, Diagnostic, Medical – Collection: 369332

License Grant

Licensor grants an exclusive license, with the right to grant sublicenses, under the Licensed Technology to use, sell, have sold, offer for sale, promote, market and advertise Licensed Solutions within the Field in the Territory.

Licensor grants a non-exclusive, non-transferable license to use and reproduce the Licensor Trademarks.

License Property

Licensor has developed and owns GeneRxâ„¢ Breast Cancer Profile, a laboratory developed multiple marker profile useful in the clinical prognosis of breast cancer.

The Licensor Algorithm is a mathematical equation that combines scored molecular markers and clinicopathologic features. The equation may be represented as one or more equations. The equation contains parameters used to relate specific biomarkers and/or sets of biomarkers to a relevant breast cancer outcome.

Licensors sciences markers are
IHC markers ER; PGR; ERBB2 (HER2/neu); BCL2; CDKN1B (p27/Kip1); EGFR; and, TP53
FISH marker MYC

Of these, the Pre-Screening Markers are ER, PGR, ERBB2 (HER2/neu), and, the Non-Standard Markers are BCL2, CDKN1B (p27/Kip1), EGFR, TP53 MYC.

The patents are titled Diagnostic markers predictive of outcomes in breast cancer treatment and progression and methods of use thereof.

The trademark is GeneRxTM.

Field of Use

Licensee's Insight(TM) Dx Breast Cancer Profile is a series of molecular assays that, when combined using Licensor' proprietary algorithm, offer information designed to help individual patients and their physicians understand the risk of recurrence and assist them in selecting the most appropriate therapy. The profile could allow patients to avoid the toxic effects of unnecessary chemotherapy, thereby reducing the overall cost of care.

The Field shall mean the prognosis of breast cancers in the commercial reference laboratory space, which includes, without limitation, any facility or academic institution to the extent engaging in a commercial reference laboratory business.

License Grant

The Licensee agreed to sublicense certain intellectual property related to breast cancer biomarkers with the intent to develop, manufacture and commercialize a diagnostic test utilizing this technology.

License Property

The non-exclusive license is to a worldwide portfolio of patents and patent applications directed to Diagnosis and Prognosis of Breast Cancer Patients (e.g., claiming priority to U.S. Provisional Patent Nos. 60/298918 and/or 60/380710) in the fields of research, diagnosis, prognosis and/or prediction of therapeutic outcome or risk for humans or animals in the area of oncology.

License Grant

The parties entered into a nonexclusive license agreement on the patented ChemoFx technology.

License Property

ChemoFx ®, is a proprietary drug response marker which measures an individuals malignant tumor response to a range of standard therapeutic alternatives under consideration by a physician. Newly published prospective data demonstrates a 14 -month improvement in overall survival (OSI and improved progression free survival (PFS) when ovarian cancer patients are treated with responsive therapies as indicated by ChemoFx ®.

Field of Use

The ChemoFx assay is an ex vivo chemosensitivity and resistance assay for predicting patient response to cancer chemotherapy.

License Grant

Licensor of Italy, acting on behalf of the FIRC (the Italian Foundation for Cancer Research) Institute for Molecular Oncology (IFOM), and the European Institute of Oncology (IEO)) grants to Licensee of United Kingdom, and its Affiliates, a worldwide, exclusive license, including the right to grant sublicenses, under the Licensed Patents and under Licensor’s right, title and interest in and to Improvements, for Licensee and its Affiliates to research, develop, make, have made, use, offer for sale, sell, have sold and import Licensed Products for any and all uses in the Field.

License Property

The agreement is to develop and commercialize licensed products in connection with a multi-gene prognostic tool.

The TOP 20 model is a gene expression signature capable of predicting disease aggressiveness and prognosis in breast cancer patients. It is different from all other signatures available today because it is derived from cancer stem cells and therefore it predicts cancer behaviour based on its stem cell content. The TOP 20 genes have been defined based on published expression profiles of breast stem cells, and further selected based on their levels of expression and likelihood of reduction into practice for patient stratification in breast cancer.

Field of Use

The TOP 20 model covers the use of twenty defined stem cell markers (the “TOP 20”) for patient stratification in breast cancer.

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.