Royalty Report: Diagnostic, Medical, Disease – Collection: 308532

License Grant

The Company of the United Kingdom obtained a worldwide, royalty-bearing, exclusive license under any patents and any related know-how Licensor, a diabetes research center,  related to the patent application filed with respect to the use the TNFR1 and TNFR2 biomarkers (Licensor IP).  This includes to make, have made, use, offer for sale and sell licensed products covered by claims in the Licensor IP, and to perform, practice offer for sale and sell certain licensed processes related to the Licensor IP.

License Property

Licensor IP means the Tumor Necrosis Factor (TNFR1 and TNFR2) biomarkers that are in the multiplex assay plate used for determining whether a patient has an increased risk of developing chronic kidney disease (CKD) or end-stage kidney disease (ESKD). Blood-based biomarkers are typically genes or proteins that indicate the existence and severity of certain conditions (such as kidney disease) and can be measured from a simple blood sample.

Licensor is an institution devoted to diabetes research, care, and education.

Field of Use

The biomarkers are used to determine the patients risk of developing kidney disease.  Biomarkers can be measured through a blood sample.

The Licensee is an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease.

License Grant

Licensor, diabetes research center, diabetes clinic, and provider of diabetes education, grants, and the United Kingdom Licensee accepts, an exclusive, royalty-bearing, fee-bearing, world-wide license, to make, have made, use, offer for sale and sell Licensed Products, and to perform, practice, offer for sale and sell Licensed Processes, under and utilizing the Intellectual Property and the Know-How, in the Territory. Licensor will not for the duration of this Agreement, make or sell products based on the Intellectual Property in the Territory, except for non-commercial research purposes.

License Property

Licensed Products means products manufactured or sold by Licensee and/or any Licensee Associate Company and/or Licensee Licensees which are covered by claims in the Intellectual Properly.

Licensor has developed a novel methodology of diagnosing and predicting renal disease, using one, two, or more biomarkers, including sTNFR1, sTNFR2, sFAS, TNF, and IL-6 (only as defined and covered in Intellectual Property under this License Agreement).

Licensed Processes means processes practiced, performed or sold by Licensee and/or any Licensee Associate Company and/or Licensee Licensees which are covered by the Intellectual Property.

Intellectual Property means The Licensor Patent and any conversions, continuation, division or substitution thereof, any patents issuing thereon, any reissues, re-examinations or extensions of the patents and any foreign counterparts of the patent application and patents and all related and relevant Know-How as defined hereinafter.

Field of Use

TNFR1 and TNFR2 biomarkers are used for determining whether a patient has an increased risk of developing chronic kidney disease (CKD) or end-stage kidney disease (ESKD).

Tumor Necrosis Factor, or TNFR, 1 and 2 biomarkerscan help identify patients with Type 1 and Type 2 diabetes that are at an increased risk of developing end stage renal disease (ESRD), up to ten years in advance.

Levels of circulating tumor necrosis factor receptor 1 and 2 (TNFR1 and TNFR2) predict kidney disease in both type 1 and type 2 diabetes, according to the results of two 12-year studies.

License Grant

The Medical School, a significant shareholder of the licensee, granted the Licensee of England (i) an exclusive license, with sub-license rights, to use certain patent rights covering specific inventions concerning the utilization of biomarkers guided artificial intelligence techniques for detecting kidney functional decline (the Technology), (ii) a non-exclusive license under unregistered licensed copyrights and licensed know-how and (iii) an exclusive option to obtain licensed technology conceived after May 30, 2018.

License Property

Biomarkers are typically genes or proteins that indicate the existence and severity of certain conditions (such as kidney disease) and can be measured from a simple blood sample.

FractalDx, a technology portfolio of diagnostic and prognostic products.  The FractalDx technology is based principally on sequencing biomarkers from a patient’s blood using widely available instrument platforms. Two products have been developed from the portfolio a prognostic test performed prior to kidney transplant to predict which transplant recipients are most at risk of acute rejection and a diagnostic test for evidence of rejection of the transplanted kidney in advance of any clinical symptoms.

Licensor is a pioneer company in kidney health and devoted to discovering causes, prevention and treatment of kidney disorders.

Field of Use

The field of use relating to sequencing biomarkers from a patients blood for diagnostic testing prior to kidney transplant to predict rejection.

Licensee is an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and lower healthcare costs.

License Grant

The Licensee of England obtained a worldwide, royalty-bearing, exclusive license under certain patents and a worldwide, royalty-bearing, non-exclusive license under certain know-how from the Licensor, a medical school and a shareholder of the Licensee, to develop and commercialize licensed products in connection with the application of artificial intelligence for the diagnosis of kidney disease.

License Property

Licensed Product relates to KidneyIntelX, a diagnostic platform, that employs a proprietary artificial intelligence-enabled algorithm that combines diverse data inputs, including validated blood-based biomarkers, inherited genetics and personalized patient data from electronic health record, or EHR, systems, to generate a unique patient risk score. This patient risk score enables prediction of progressive kidney function decline in chronic kidney disease, or CKD, allowing physicians and healthcare systems to optimize the allocation of treatments and clinical resources to patients at highest risk.

The collaborative research studies with Licensor utilize the Licensors BioMe biobank. BioMe is designed to enable researchers to conduct genetic, epidemiologic, molecular and genomic studies using research specimens from consented participants, which are linked with each participant’s de-identified health information. All BioMe participants have consented to allow their de-identified data and samples to be used for research purposes.  For KidneyIntelX, this has allowed the Company to conduct rapid prospective validation of the platform using samples banked at “time zero” (i.e. time of sample collection), prior to the occurrence of progressive kidney function decline.

Licensors plan is to deploy KidneyIntelX to patient populations with diabetic kidney disease (DKD) on a regional basis through partnerships with healthcare systems and insurance payors that provide coverage to those healthcare systems’ patients.

Licensor is a pioneer company in kidney health and devoted to discovering causes, prevention and treatment of kidney disorders.

Field of Use

The licensed diagnostic platform enables the prediction of progressive kidney function decline.

Licensee is an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and lower healthcare costs.

License Grant

Pursuant to an agreement dated February 9, 2009 between the Company, and the Licensor, a California Corporation, the Licensee, is obligated to make payments, from earnings generated from Research derived from the biological specimens from Parkinson's disease patients and control patients provided by the Licensor.

License Property

IP relates to biomarkers for Parkinson's disease.

Field of Use

The Field of Use apply to the healthcare industry.  Licensee has an ongoing collaboration with the Parkinson’s Institute to test known Parkinson’s Disease (PD) patients’ blood to identify biomarkers for Parkinson’s Disease from the human plasma proteome microarray marketed as PlasmaScanâ„¢.  Licensee is also using the H25K Whole Human Genome Microarray to examine PD samples and has identified the world’s first functional mRNA biomarkers for Parkinson’s Disease. An expanded patient study will be used to further validate the PD biomarkers.  Licensee is also working with Stanford University to test known Alzheimer’s patients’ blood to identify biomarkers for Alzheimer’s Disease using PlasmaScan and other tools.

License Grant

Licensee acquired an exclusive royalty-bearing worldwide license from Licensor of Singapore to develop, make, have made, use, practice, research, distribute, lease, sell, offer for sale, license, import or otherwise dispose of certain rights owned or controlled by Licensor and/or any of its affiliates, related to UNI 494 and a non-exclusive license to certain know-how and technology related to the UNI 494 Rights.

License Property

UNI 494 (a patented prodrug of nicorandil) has the potential to be a first-in-class drug for the treatment of acute kidney injury (AKI).

UNI 494 is a patented pro-drug that was designed to be absorbed into the systemic circulation, and once absorbed, to release nicorandil into the bloodstream. By avoiding direct exposure to the gastrointestinal tract of nicorandil, it is believed that UNI 494 may be able to minimize or avoid the gastrointestinal side effects of nicorandil. Also, based on the rate of conversion of UNI 494 to nicorandil in the systemic circulation, UNI 494 may offer greater and/or more prolonged exposure to nicorandil for the treatment of patients with acute kidney injury.

Nicorandil, marketed in such products as Ikorel and Dancor, is indicated for the treatment of chronic stable angina pectoris. Nicorandil is a dual-action potassium channel opener that relaxes vascular smooth muscle through membrane hyperpolarization via increased transmembrane potassium conductance and increased intracellular concentration of cyclic guanosine monophosphate (GMP). It is shown to dilate normal and stenotic coronary arteries and reduces both ventricular preload and afterload.

Field of Use

Field of use is for treatment of acute kidney injury (AKI).

AKI is a sudden episode of kidney failure or kidney damage (within the first 90 days of injury). After 90 days, the patient is considered to have progressed into CKD. Chronic kidney disease (CKD) is the gradual loss of kidney function that can get worse over time leading to lasting damage.

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.