Royalty Report: Medical, Diagnostic, Cancer – Collection: 328168

License Grant

This License provide Test Kit Services to Licensee of India for the OVA1 Test in India. The parties will establish royalties, fees and other payments for the OVAl Test as a Test Kit Service in India different from the methodology set forth in Strategic Alliance Agreement.

License Property

OVA1® shall mean ovarian tumor triage test. OVA1 is a qualitative serum test that utilizes five well-established biomarkers and proprietary FDA-cleared software to determine the likelihood of malignancy in women over age 18 with a pelvic mass for whom surgery is planned.

Except as amended hereby, the Strategic Alliance Agreement shall remain unaltered and in full force and effect, and each of the Parties hereby ratifies and confirms the Strategic Alliance Agreement. Without limiting the foregoing, the Parties agree that (i) Schedule E-1 to the Strategic Alliance Agreement shall remain in effect for the OVAl Test performed by Quest Diagnostics outside India and (ii) Schedule E to the Strategic Alliance Agreement shall remain in effect for any Licensed Laboratory Services and any Test Kit Services other than the OVAl Test and PAD Test (which is covered in Amendment No.2) regardless of whether any such Licensed Laboratory Service or Test Kit Service involves any Proprietary Supplies or Test Kits purchased from or through Licensor.

Field of Use

Field of Use is for the pre-surgical identification of women who are at high risk of having a malignant ovarian tumor.

Ovarian cancer is a type of cancer that begins in the ovaries, the female reproductive system.

License Grant

The Licensee has an exclusive license to offer OVA1 in the reference laboratory market as a clinical laboratory test in the US, Mexico, the United Kingdom and India through September 11, 2014, which may be extended for an additional year beyond September 11, 2014.

License Property

Under the terms of the Amendment, the Licensor is to be paid for each OVA1 performed by the Licensee.

On March 9, 2010, the Licensor commercially launched the OVA1® ovarian tumor triage test and on September 20, 2010, OVA1 was CE marked, a requirement for marketing the test in the European Union.

Field of Use

Licensor has received approval from the FDA for the OVA1 Test and has independently developed a Test Kit for a clinical laboratory test for ovarian cancer.

License Grant

The Licensor grants to Licensee a non-exclusive right and license, without the right to sublicense, under the Licensed Patent Rights as licensed to Licensor pursuant to the Original Agreement, to make, have made, use, sell, offer for sale and import Licensed Products and to practice the Licensed Methods in the Field in the Territory to the extent permitted by law.

License Property

The Licensor is involved in the discovery, development and commercialization of medical tests that diagnose, treat and improve outcomes for patients with gynecologic cancers and related diseases. Field shall mean in-vitro diagnostics for screening, diagnosing and monitoring for Ovarian Cancer in humans in the form of OVA1 tests.

Field of Use

The Licensee is a provider of clinical laboratory services.

Field” shall mean in vitro diagnostics for screening, diagnosing and monitoring for Ovarian Cancer in humans in the form of OVA1 tests.

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

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

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.