Royalty Report: Medical, Diagnostic, Cancer – Collection: 261698

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

The Licensees agreement with the University grants an exclusive worldwide license, with the right to grant sublicenses to, among other things, develop and sell certain in vitro diagnostic services used in clinical lab applications based on their TheraLink® technology which is a part of othe Licensees TheraLink® services. TheraLink® technology focuses on the oncology discipline of molecular pathology.

License Property

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.

Field of Use

The Licensee will utilize the licensed technology in the diagnostics industry, both for biopharmas and for oncologists and their patients.

License Grant

The Parties collaborate in the evaluation, continued development, validation, and use of Licensor’s platform designed for the early detection and diagnosis of diseases and conditions and for quality control and monitoring purposes, in conjunction with the Licensee’s systems and Licensor grants to the Licensee a worldwide exclusive license to sell such products in the Licensee’s point-of-care network of hospitals, clinics and institutions for quality control and monitoring of manufacturing and processing of autologous immune cells manipulated by cell and gene therapies.

License Property

The platform identifies multiple diseases and may be used to track treatment effectiveness, including immunotherapy. Disease intrusion and cell malformation, including cancer, are first detected in the body by the immune system, which is energized to rid the body of the malignancy. The initial immune response is intricate, deploying different metabolic pathways and subtypes of cells.  The platform technology is designed to detect and interpret these differential metabolic responses.

Patented ImmunoBiopsyâ„¢ immunometabolism platform with a goal of (I) developing and validating diagnostic kits for enhanced quality control (QC) and monitoring purposes to be used by Licensee in manufacturing and processing of its cell and gene therapies; (ii) developing new assays to enhance the potency of cell and gene therapies for use within its point-of-care (POCare) platform; and (iii) developing companion diagnostics for potential enhanced patient targeting of cell and gene therapies.

Field of Use

ImmunoBiopsy platform non-invasively measures the metabolic state of the immune system and acts as a diagnostic link to early diseases.

ImmunoBiopsy platform has shown promise in early detection of cancer. The Parties look forward to leveraging this technology in a number of key areas within our POCare platform.

Licensee will use ImmunoBiopsy to help develop and validate diagnostic kits and create new assays to strengthen the potency of cell and gene therapies.  Licensee will also develop companion diagnostics to identify those patients most likely to respond to appropriate therapies.

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

In the original agreement, Licensor granted
— For the Layton and Stanford Patent Rights a nonexclusive, non-transferrable, limited sub-licensable, world-wide license under the Layton Patent Rights and the Stanford Patent Rights to practice and use the subject matter within the Layton Patent Rights and the Stanford Patent Rights in the Licensee Database Field of Use, Diagnostic Field of Use, the Homebrew Field of Use and the Personalized Research Field of Use.
— For the Montefiore Patent Rights, a non-transferrable, limited sub-licensable, world-wide license under the Montefiore Patent Rights to practice and use the subject matter within the Montefiore Patent Rights in the Licensee Database Field of Use, the Diagnostic Field of Use, the Homebrew Field of Use and the Personalized Research Field of Use.
— For the Cancer Marker Patent Rights, Licensor grants a non-transferrable, limited sub-licensable, world-wide license under the Cancer Marker Patent Rights to practice and use the subject matter within the Cancer Marker Patent Rights in the Licensee Database Field of Use, the Diagnostic Field of Use, the Homebrew Field of Use and the Personalized Research Field of Use, only with respect to cancer.
— For the Database Patent Rights and Seilhamer/Scott Patent Rights, Licensor grants a nonexclusive, non-transferable, non-sublicensable , world-wide license under the Database Patent Rights and Seilhamer/Scott Patent Rights to practice and use the subject matter within the Database Patent Rights and the Seilhamer/Scott Patent Rights in the Licensee Database Field of Use, the Diagnostic Field of Use, the Homebrew Field of Use, and the Personalized Research Field of Use.
— For the Sublicenses, Licensee shall have the right to grant sublicenses to third parties under such Patent Rights on a Product-by-Product basis to make, use, import, sell, and offer for sale Products developed by Licensee or its Affiliates.
— For the Co-Exclusive Licenses in the Homebrew and Diagnostic Fields of Use, Co-Exclusive shall mean that each Party has the right to exercise all of the rights under the Patent Rights in question in the field of use for which the parties have co-exclusive rights, without obligation to the other except to the extent provided in this Agreement, and neither Party alone has the right to grant sublicenses to third parties under such Patent Rights without express written consent of the other Party.

License Property

Cancer Marker Patent Rights shall mean all Valid Claims listed in any of the following patents and patent applications, to the extent that they are owned by Licensor with the right to license under this Agreement, and to the extent that they claim the composition of matter or use of any nucleic acids or proteins as markers or diagnostics for cancer.

The patents include
— Processes for Genetic Manipulations Using Promoters;
— Method for Detecting Pathological Conditions;
— Comparative Gene Transcript Analysis; and,
— Methods for Fabricating Micro Arrays of Biological Samples.

Field of Use

Licensee licenses various classes of patents from Licensor pertaining to the manipulation of genes, the detection of pathological conditions, comparative gene analysis, methods for fabricating tests of biological samples and the use of proteins as markers for cancers.

License Grant

For Biomarker IP, Licensor will grant an exclusive, perpetual, royalty-bearing license under Licensor Biomarker IP to make, have made, use, sell, offer for sale, import and otherwise exploit any and all Consumable Products, and have any and all of the foregoing performed on its behalf, in each case solely for applications other than developing and commercializing Clinical Laboratory Tests.  

This agreement has exclusive and non-exclusive territories.

License Property

Test Kit means a kit, biochip or other supply developed by Licensee pursuant to a Test Kit Development Program for an Application that corresponds to a Licensed Laboratory Test developed by Licensor and cleared or approved by the FDA or other Regulatory Authority, as relevant, for marketing in the applicable jurisdiction. A Test Kit will include components and instructions required for performing such Application.

Licensor is a leading provider of diagnostic testing, information and services and has substantial experience in the development and commercialization of products having Clinical Diagnostic Applications.

Test Kit Service means a clinical laboratory test that is performed by a member of the  Licensors Network or a Third Party using a Test Kit that has been approved or cleared by the FDA or other applicable Regulatory Authority for marketing in the applicable jurisdiction, if necessary, and has been developed by Licensee pursuant to a Test Kit Development Program.

Field of Use

This strategic alliance is to collaborate in the development and commercialization of proteomic diagnostic tests based on Licensee’s SELDI ProteinChip technology.

The ProteinChip Array technology is used for the discovery, validation, identification, and characterization of disease-associated proteins from biological samples. The versatile nature of this technology is enabling for a wide variety of applications in both research and clinical proteomics and will be reviewed in three application areas. A recent publication presents the use of the flexibility and power of the ProteinChip Array platform to elucidate the nature of novel protein inhibitors of HIV-1 replication, the molecules previously known as the CD8+ antiviral factors. Numerous cancer-related publications have demonstrated the discovery and development of biomarkers and multimarker patterns for protein-based predictive medicine.

Surface-enhanced laser desorption/ionization time-of-flight mass spectrometry (SELDI-TOF-MS) represents the successful combination of retentate chromatography and mass spectrometry, and this technology is an integral part of Ciphergen's ProteinChip System, which was designed to answer biomedical questions by performing protein analyses on a single experimental platform. The quantification capability of the ProteinChip System is essential in all proteomic applications for which this technology is used. Here we describe methods and results for three short experiments mimicking realistic analytical challenges to provide practical examples of quantification.

Field means all potential Clinical Diagnostics.  Licensee develops, manufactures and markets its ProteinChip 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 of disease-specific Biomarkers and protein signatures that could be utilized in Licensed Laboratory Tests and Test Kits.

Licensee develops, manufactures and sells ProteinChip Systems for life science researchers.  The systems consist of ProteinChip Readers, ProteinChip Software and related accessories, which are used in conjunction with consumable ProteinChip Arrays.  These products are sold primarily to biologists at pharmaceutical and biotechnology companies, and academic and government research laboratories.  The Company also provides research services primarily through its Biomarker Discovery Center® laboratories.

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.