Royalty Report: Diagnostic, Drugs, Cancer – Collection: 273391

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.

License Grant

Licensor, is willing to grant to the sublicensee a worldwide, nonexclusive, royalty-bearing sublicense to use such patent rights for the development and commercialization of Diagnostic Services, Licensed Reagents and Kits.  Certain patent rights including but not limited to screening, diagnosis, prognosis and monitoring tests, for the purpose of detecting changes associated with colorectal cancer, were licensed under the agreement dated as of February 5, 1992.

License Property

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.

U.S. Patent No. 5,352,775 & U.S.  Patent Application No.  08/861,910

Field of Use

Field shall mean the determination, in stool or samples prepared from stool, of the presence of, absence of or variation(s) within a nucleic acid of interest, or differences between a nucleic acid of interest and a reference standard or sample, including but not limited to screening, diagnosis, prognosis and monitoring tests, for the purpose of detecting changes associated with colorectal cancer.

License Grant

The German Licensor hereby grants to Licensee an exclusive license (including the right to grant sublicenses) under the Licensed Patent Rights to conduct research and to develop, make, use, offer for sale, sell and import Licensed Products and to provide Services in the Territory.

License Property

Licensed Patent Rights shall mean (a) those certain patent applications and patents listed hereto; (b) all patents that have issued or in the future issue from such foregoing patent applications, including utility, model and design patents and certificates of invention; (c) all patents that have issued or in the future issue from any patent application that claims priority from, or common priority with, any of the foregoing patent applications, including utility, model and design patents and certificates of invention; and (d) all divisionals, continuations, continuations-in-part, reissues, renewals, extensions or additions to any such foregoing patent
applications and patents.

W003023057 (PCT /EP02/05489) – Method and Diagnosis Kit for Selection and/or for Qualitative and/or Quantitative Detection of Cells

Licensed Products shall mean in-vitro diagnostic assays to isolate, detect, identify, quantify, or test for drug susceptibility of, one or more proteins or nucleic acid sequences as diagnostic indicators for the presence of prostate cancer and/or bladder cancer, for the purpose of research, diagnosis or medical care, the  manufacture, use, sale offer for sale or importation of which would, but for the license herein granted by AdnaGen to Gen-Probe, infringe one or more Valid Claims of the AdnaGen Patent Rights.

Field of Use

This agreement pertains to the medical industry relating to certain technology concerning the qualitative and quantitative detection of cells which may be useful in connection with nucleic acid diagnostic assays. The diagnostic indicators are used for the presence of prostate cancer and/or bladder cancer, for the purpose of research, diagnosis or medical care.

'Group 1 Additional Products' shall mean in-vitro diagnostic assays to isolate, detect, identify or quantify, or test for drug susceptibility of, one or more proteins or nucleic acid sequences as diagnostic indicators for the presence of kidney cancer, cervical cancer, and/or ovarian cancer, for the purpose of research, diagnosis or medical care, the manufacture, use, sale offer for sale or importation of which would, but for the license herein granted by AdnaGen to Gen-Probe, infringe one or more Valid Claims of the Licensed Patent Rights.

'Group 2 Additional Products' shall mean in-vitro diagnostic assays to isolate, detect, identify or quantify, or test for drug susceptibility of, one or more proteins or nucleic acid sequences as diagnostic indicators for the presence of lung cancer, colon cancer, and/or breast cancer, for the purpose of research, diagnosis or medical care, the manufacture, use, sale offer for sale or importation of which would, but for the license herein granted by AdnaGen to Gen-Probe, infringe one or more Valid Claims of the Licensed Patent Rights.

License Grant

Swiss Licensor grants to Licensee and its Affiliates, a non-exclusive worldwide right and license under the Licensed Patents as follows to perform in vitro human and/or animal diagnostic testing procedures on a sample of material obtained from a human or animal, as applicable, solely to detect the presence, absence or quantity of a nucleic acid sequence associated with a disease or condition in the Licensed Fields.

License Property

Other Technology shall mean the processes covered by the method claims (if they are Valid Claims) of United States Patent Nos. 5,008,182, 5,677,152, 5,773,258 and 5,176,995, and any reissue or reexamination patents thereof, and the claims (if they are Valid Claims) of United States Patent No. 5,110, 920, and any reissue or reexamination patents thereof; and any Valid Claims of the foreign counterparts of the foregoing listed patents or claims.

PCR Technology shall mean polymerase chain reaction technology covered by Valid Claims of United States Patent Nos. B1 4,683,195, B1 4,683,202, and 4,965,188 and any reissue or reexamination patents thereof; and any Valid Claims of the foreign counterparts of the foregoing listed patents or claims.

Quantitation Technology shall mean the method claims (if they are Valid Claims) of United States Patent Nos. 5,389,512 and 5,219,727, and any reissue or reexamination patents thereof, and claims 1-4, 8, 9 and 15-18 (if they are Valid Claims) of United States Patent No. 5, 476,774, and any reissue or reexamination patents thereof; and any Valid Claims of the foreign counterparts of the foregoing listed patents or claims.

RT and RT-PCR  Technology shall mean the reverse transcription process covered by the method claims (if they are Valid Claims) of United States Patent Nos. 5,407,800, 5,310,652, 5,561,058, 5,618,703 and 5,322,770, and any reissue or reexamination patents thereof, and the claims (if they are Valid Claims) of United States Patent No. 5,693,517, and any reissue or reexamination patents thereof; and any Valid Claims of the foreign counterparts of the foregoing listed patents or claims.

'5' Nuclease Technology' shall mean only the processes defined by the method claims (if they are Valid Claims) of United States Patent Nos. 5,210,015 and 5,487,972 and any reissue or reexamination patents thereof and the reaction mixture claims (if they are Valid Claims) of United States Patent No. 5,804,375 and any reissue or reexamination patents thereof; and any Valid Claims of the foreign counterparts of the foregoing listed patents or claims.

Field of Use

Diagnostic Services Field means the field of human in vitro diagnostics for the detection, quantitation, monitoring, genotyping, or phenotyping, of genetic and infectious diseases, disease susceptibility, genetic pre-disposition to disease or cancer; analyzing specimens taken from a human being for the purpose of testing, with respect to that human being, for a physiological or pathological state, for a congenital abnormality, for safety and compatibility of a treatment or to monitor therapeutic measures; or any use of PCR as a testing service to provide to a person data, results or interpretations of any application of PCR for purposes of therapy or diagnosis of a human being, including, without limitation, clinical laboratory services, whether or not a fee is charged for such services; tissue transplant typing, including testing performed on animal tissue intended for use in xenotransplantation; Parentage Determination; diagnosis, disease management; and clinical trials, whether or not a patient result is provided directly or indirectly to a patient.  Licensed Field shall specifically exclude any services performed for screening of blood and/or blood products.

License Grant

Licensor hereby grants to Licensee, and Licensee hereby accepts from Licensor, a royalty-bearing, non exclusive, personal, non-transferable license under the Licensed Technology solely to perform Licensed Services within the Territory.

Licensor hereby grants to Licensee the right and Licensee accepts and agrees to credit Licensor as the source of its Licensed Technology rights in Licensees promotional materials and any other materials intended for distribution to Third Parties as follows

License Property

Licensor owns and has the right to grant licenses to practice under certain United States Patents describing and claiming, inter alia, nucleic acid amplification processes known as polymerase chain reaction ('PCR'), homogeneous PCR, and RT-PCR ('reverse transcription PCR').

Licensed Technology shall mean, subject to the following limitations, the Valid Claims of the United States patents listed in Agreement and any reissue or reexamination patents thereof. No rights under any kit claims of such patents are included in this definition or licensed under this Agreement. With the exception of the reaction mixture claims of United States Patents Nos. 5,804,375, 5,693,517, 5,476,774 and 6,127,155, the plasmid claims of the 5,476,774 patent, the primer claims of United States Patent No. 5,573,906, and the probe claims of United States Patent No. 5,110,920, no rights under any apparatus, device, composition of matter, reagent or substance claims of such patents are included in this definition or licensed under this Agreement.
4,683,195 – Process for amplifying, detecting, and/or-cloning nucleic acid sequences
4,683,202 – Process for amplifying nucleic acid sequences
4,965,188 – Process for amplifying, detecting, and/or cloning nucleic acid sequences using a thermostable enzyme

Diagnostic Product shall mean an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

Licensed Service(s) shall mean the performance by Licensee of an in vitro procedure within the Licensed Field which utilizes the Licensed Technology. Licensed Services include, but are not limited to, any combination of the steps of collecting a sample for analysis, isolating nucleic acid sequences from the sample, amplifying one or more desired sequences, analyzing the amplified material, including sequence analysis, and reporting the results.

Field of Use

Licensed technology includes specified nucleic acid amplification processes, to perform certain polymerase chain reaction-based human in vitro clinical laboratory services.

Licensed Field shall mean the field of clinical laboratory services that detect the presence, absence and/or quantity of a nucleic acid sequence for the detection, diagnosis, confirmation, prognosis, management and/or treatment of a human disease or condition, including, but not limited to, such services to identify predisposition to disease, disease susceptibility, confirm disease, predict therapeutic effectiveness or monitor disease progress; used in the course of human clinical trials; for Parentage Determination; and for tissue transplant typing, including testing performed on animal tissue intended for use in xenotransplantation. Licensed Field shall specifically exclude any services performed for the screening of blood and/or blood products.

License Grant

The Sub-Licensor is the exclusive licensee of the Patent Rights under the Exclusive License Agreement dated May 2006 and is willing to grant to the Sub-Licensee a royalty-bearing co-exclusive Sublicense in the Territory to use such Patent Rights in the Field.

License Property

Laboratory Services shall mean services performed by reference laboratories in the Territory.

Patent Rights shall mean Patent Application PCT/IT 2005000634 filed October 28, 2005 entitled Nucleophosmin protein (NPM)  mutants, corresponding gene sequences and uses thereof (published as WO 2006/046270), and foreign equivalents, as well as all continuations, divisions, reissues, re-examinations, renewals, or extensions of such patents subject to the rights granted by Original Licensor to the Sub Licensor pursuant to the Exclusive License Agreement, as limited by this Agreement, and any related improvements necessary for Products in the Field.

Field of Use

Field shall mean diagnostic products that assay for nucleophosmin protein (NPM1) mutants, corresponding nucleic acid sequences and uses thereof, including research use only, analyte specific reagent, and in vitro diagnostic products. For the avoidance of doubt, the Field specifically excludes laboratory service testing and therapeutic uses.

License Grant

The Swiss Licensor grants a non-exclusive license under the Licensed Patents as follows
– to make, have made, import, use, offer to Sell and Sell Licensed Products in the In Vitro Human Diagnostics Field in the Territory, and authorize End-Users to perform Diagnostic Services using such Licensed Products in processes covered by the Licensed Patents in accordance with the label license provided with the purchase of such Licensed Products.
– to grant a limited, non-transferable, royalty free sublicense under the Licensed Patents to Research Collaborators of Licensee and/or its Affiliates to practice PCR under their respective contracts with Licensee and/or its Affiliates, in accordance with the terms and conditions of this Agreement, solely for purposes of doing applied research and development for Licensee and/or its Affiliates of Licensed Products to be Sold in the In Vitro Human Diagnostics Field in accordance with the other terms and conditions of this Agreement; and
– to use PCR technology for the research, development, improvement and quality control and quality assurance of Licensed Products, in each case by Licensee and its Affiliates, internally, for Sale in the In Vitro Human Diagnostics Field.

For Label Licenses on Licensed Products Sold in the In Vitro Human Diagnostics
– Licensees right to sublicense is limited to the right to convey use rights pursuant to a Label License under process claims and composition of matter claims,not apparatus, device or system claims, only to End-User customers, and only through the Sale of Licensed Products.
– Licensee agrees that it shall mark conspicuously all Complete Diagnostic Kits made by or for it,
– Licensee agrees that it shall mark conspicuously all Component Systems for amplification made by or for it
– Licensee agrees that it shall mark conspicuously all Component Systems for detection made by or for it
– Licensee agrees that it shall mark conspicuously all Component Systems for amplification and detection made by or for it
– Licensee agrees that it shall mark conspicuously all Royalty Products other than Complete Diagnostic Kits, Component Systems for amplification, Component Systems for detection and Component Systems for amplification and detection made by or for it and Sold in the In Vitro Human Diagnostics Field.

License Property

The Complete Diagnostic Kit means a product dedicated for use in connection with the practice of PCR in the In Vitro Human Diagnostics Field, it being understood that a product shall be deemed to be so dedicated if it is either  a product having a package insert indicating its use primarily in connection with the practice of PCR; or a product which by virtue of its design, operation or construction has no other substantial practical utility, and which product is comprised of, at a minimum, the essential active reagents for amplification and detection of a target nucleic acid in the In Vitro Human Diagnostics Field. For purposes of this Agreement, Licensee shall only convey the necessary rights for End-Users to perform PCR in the In Vitro Human Diagnostics Field with the Sale of a Complete Diagnostic Kit.

Licensed Product means a product for use in the In Vitro Human Diagnostics Field, the manufacture, importation, use, offer for Sale or Sale of which would infringe a Valid Claim of Licensed Patents, made by or specifically for Licensee or any of its Affiliates only pursuant to Licensees or its Affiliates specifications, which is any of the following or a combination of any of the following
(a) Complete Diagnostic Kit;
(b) A reagent, accessory, device or system which is used or Sold to be used by End-Users in connection with the practice of PCR, including the steps of sample preparation, amplification and detection;
(c) A Component System; and/or
(d) Reagents Sold to be used by End-Users as replacement components in regard to a Component System.

PCR means the polymerase chain reaction process and technology.

Patents relate to Process for Amplifying, Detecting, and/or Cloning Nucleic Acid Sequences.

Field of Use

This agreement is for the purpose of developing and commercializing PCR based in vitro human diagnostic products for use in clinical diagnostic testing;

The Human Identity Field means the field of use comprising products and processes utilizing PCR for the sole purpose of determining human identity or distinguishing among human beings, whether living or dead. The Term Human Identity Field shall included parentage testing to determine if two or more human beings are biologically related as parent and child and forensic testing for use in, or in preparation for, death investigations or other legal proceedings, but such term shall specifically exclude testing for tissue typing.

In Vitro Human Diagnostics Field means the field of use comprising products and processes utilizing PCR for the measurement, observation or determination of attributes, characteristics, diseases, traits or other conditions of a human being for the medical management of that human being, including without limitation
(a) genetic testing, including determinations of genetic predisposition;
(b) oncology and cancer predisposition testing;
(c) testing for tissue typing (excluding the Human Identity Field);
(d) infectious disease detection, screening, confirmation and monitoring; and
(e) therapeutic drug monitoring.

For purposes of this Agreement, the term 'In Vitro Human Diagnostics Field' shall not include the Human Identity Field.

“PCR” means the polymerase chain reaction process and technology involving the amplification of a nucleic acid sequence and the complement of that sequence by repeated cycles of oligonucleotide mediated, template directed synthesis involving the extension of a component primer oligonucleotide by incorporation of monomeric nucleotide triphosphates whereby the sequence, its complement and subsequent synthetic copies thereof are repeatedly separated and used as templates for further cycles of synthesis.

License Grant

Licensor grants a non-exclusive license, without the right to grant or authorize sublicenses, under the Licensed Patent Rights to develop and perform the Services solely at the Facilities, and to use, and offer for sale and sell the Services to Third Parties solely in the Territory.

License Property

Licensed Patent Rights shall mean, collectively, Licensors rights in all patent applications, including provisional patent applications, heretofore or hereafter filed in the Territory;  all patents that have issued or in the future issue in the Territory from any of such patent applications, including without limitation utility models, design patents and certificates of invention; and,  all divisionals, continuations, continuations-in-part, substitutions, reissues, renewals, extensions, restorations or additions to any such patent applications and patents, in each case that claim, and only to the extent they claim, compositions, uses, methods, equipment, devices and other technology for the use of cell-free fetal nucleic acids from biological samples, including plasma, serum, whole blood and urine, obtained from pregnant women for prenatal diagnostic testing by whole genome massively parallel sequencing, used in the performance of the MaterniT21 PLUS Test by Licensors Laboratories as of the Effective Date, or any improvements to such test; provided, however, that the Licensed Patent Rights shall exclude any of the foregoing licensed by a University to Licensor under another agreement.

MatemiT21 PLUS Test shall mean the laboratory-developed test for the non-invasive testing of a plasma sample from a pregnant woman for the detection and diagnosis of prenatal aneuploidy and/or fetal abnormalities by use of cell-free fetal nucleic acids, currently known as the MatemiT21 PLUS test, as performed by Licensors Laboratories.

Field of Use

The Field shall mean the non-invasive detection and diagnosis of prenatal aneuploidy and fetal abnormalities by use of cell-free fetal nucleic acids from biological samples, including plasma, serum, whole blood and urine, obtained from pregnant women.
The MaterniT® 21 PLUS test analyzes genetic information that enters your bloodstream from the placenta.  It analyzes the amount of chromosome 21 in fetal DNA picked up from the maternal blood sample. It can detect an increased amount of chromosome 21 material which is associated with trisomy 21 (Down syndrome). It is completely non-invasive as it only involves a blood sample from the mother.

License Grant

Licensor hereby grants to the Dutch Licensee, and Licensee hereby accepts from Licensor, a sole and exclusive and royalty bearing license, with the right to sublicense, in the Territory, under the Technology Rights during the Term of this Agreement, to research, develop, make, have made, use, import, export, market and sell Products and to practice and have practiced Processes, without any limitations except for those limitations expressly set forth herein.

License Property

Core Business means the core business of Licensor i.e. antiviral and anticancer drug discovery, development, and commercialization.

Licensor’s patent application, now published as WO 02/33128 and entitled, “Simultaneous quantification of nucleic acids in diseased cells,” and all divisionals, continuations, continuations-in-part, reissues, substitutions, confirmations, updates, registrations, revalidations, reexaminations, renewals, extensions or the like of any such patents and patent applications, to the extent that they relate to the mitochondrial toxicity technology.

Field of Use

The license is to further develop and commercialize Licensor's (anticancer and antiviral drug discovery) mitochondrial DNA and RNA detection and toxicity technology.

License Grant

Licensor, a non-profit institution, hereby grants to Licensee and its Affiliates a worldwide, non-exclusive license, under Licensor Know-How and Licensed Patents (I) for all internal research and development purposes, including without limitation, the right to make, use and import Licensor Know How and inventions claimed in the Licensed Patents and (ii) to develop, make, use, market, sell, offer for sale, export and import, in the Field of Use, Licensed Products, including without limitation those covered by Valid Claims in the Licensed Patents.

License Property

Intellectual property relates to the induction of gene silencing in mammalian cells through RNAi.

RNA interference, or RNAi, is a naturally occurring mechanism within cells for selectively silencing specific genes, an ability that could become the basis for a whole new class of therapeutic products. The discovery of RNAi has been heralded by many as a major breakthrough, and the journal Science named RNAi the top scientific achievement of 2002 as well as one of the top ten scientific advances of 2003. Because many diseases are caused by the inappropriate activity of specific genes, the ability to silence such genes selectively through RNAi could provide a means to treat a wide range of human diseases.

Licensed Patents means the U.S. Patent Applications listed below and any divisions, continuations, reissues, reexamines, extensions and continuations-in-part applications thereof and any patents issuing thereto; and any and all foreign patents, foreign applications, extensions and supplemental protection certificates or patent applications corresponding thereto having the Principal Investigator as an inventor and claiming the same priority date as a parent application.

Licensor Patents
Serial No.                  Type      Tite                                                                                       Date            Filed Status
PCT/US01/08435      PCT      Methods and Compositions for RNA Interference       3/16/01       Published
09/858,862                CIP       Methods and Compositions for RNA Interference       5/16/01       Pending
09/866,551                CIP       Methods and Compositions for RNA Interference       5/24/01       Pending
10/055,797                CIP       Methods and Compositions for RNA  Interference      1/22/02       Pending

Licensed Product means any product, including but not limited to any lyophilized liquid, sustained release or aerosolized formulation or other formulation, or process for which Licensee, or its Affiliate has received FDA Approval and/or Regulatory Approval, which is made through the use of Licensor Know-How or falls within the scope of a Valid Claim of a Licensed Patent.

Field of Use

The field of Use means all therapeutic uses in humans, including without limitation the diagnosis, prevention and treatment of diseases or conditions and all other healthcare applications. Field of Use shall not include research reagent sales.

License Grant

Licensor hereby grants to Licensee, and Licensee hereby accepts from Licensor, a royalty-bearing, non-exclusive immunity from suit under PCR Technology solely to use Licensed Technology to perform Licensed Services within the United States and its possessions and the Commonwealth of Puerto Rico. The Parties understand and agree that no rights are hereby granted, expressly or by implication, under U.S. Patent No. 4,965,188.

License Property

PCR Technology shall mean polymerase chain reaction technology covered by United States Patent Nos. B1 4,683,195 and B1 4,683,202 and any reissue or reexamination patents thereof.
4,683,195 – Process for amplifying, detecting, and/or-cloning nucleic acid sequences
4,683,202 – Process for amplifying nucleic acid sequences

Licensed Services shall mean the performance of an Assay by Specialty Labs to detect nucleic acid sequences associated with a human disease or condition within the Licensed Field. Licensed Services include but are not limited to, any combination of the steps of collecting a sample for analysis, isolating nucleic acid sequences therein, amplifying one or more desired sequences, analyzing the amplified material and reporting the results.

Diagnostic Product shall mean an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing an Assay.

Assay shall mean an IN VITRO diagnostic procedure utilizing PCR Technology to detect the presence, absence or quantity of a nucleic acid sequence associated with a specific human disease or condition.

Field of Use

Licensed Field shall mean the field of human IN VITRO diagnostics solely for the detection of genetic diseases, genetic pre-disposition to disease, cancer, tissue transplant typing, Parentage, and microorganisms associated with infectious diseases.

License Grant

The parties previously entered a Clinical Diagnostics Agreement and Blood Screening Agreement.

Pursuant to the settlement, the parties hereby irrevocably stipulate the Licensor Licensed Patents in the Territory are valid and enforceable; and, the making, use, offer for sale, sale, or importation of any Licensee Product in the Territory, where a Licensor Licensed Patent has issued and prior to the expiration of such Licensor Licensed Patent, would, in the absence of the licenses granted in the Agreements, as applicable, constitute infringement of one or more claims of such Licensor Licensed Patent.

Per the original agreement, the Parties entered a nonexclusive license in the Territory, without the right to sublicense, under the Licensor Licensed Patents to make, import, use, offer for sale and sell Licensor Licensed Products for use in Blood Screening solely for sale to or use by or on behalf of Existing Customers under the Existing Agreements and Existing Offers.

License Property

The Licensee Products means all assays sold by Licensee for the detection, quantitation, genotyping or other analyses of nucleic acid sequences Directed to HIV for use in in vitro diagnostics and/or Blood Screening, including without limitation the following products of Licensee Amplicor HIV-1 test, v. 1.0; Amplicor HIV-1 Monitor test, v. 1.0; Amplicor HIV-1 Monitor test, v. 1.5; COBAS Amplicor HIV-1 Monitor test, v. 1.5; Ampliscreen HIV-1 test, v. 1.5; and COBAS Ampliscreen HIV-1 test, v. 1.5; and all versions and successors and substitutes therefor.

Blood Screening means the commercial use of products that detect nucleic acid sequence(s) for the screening of blood, plasma or blood components intended for transfusion or for use in blood products (e.g., without limitation, immunoglobulins); or confirmatory or supplemental testing of the same samples otherwise screened for purposes described.

Directed to HIV means that the claim or technology in question is directed to methods, compositions, reagents or kits specifically for use in nucleic acid-based diagnostic assays for the detection of HIV nucleic acid sequence(s), or specifically for use in the manufacture of any compositions or reagents for use in, or manufacture of nucleic acid-based diagnostic assays for detection of HIV nucleic acid sequence(s) (excluding, for example, polymerase chain reaction claims and technology and other methods for detection of nucleic acid sequence(s) generally which involve nucleic acid amplification).

HIV means any viral isolate of the human immunodeficiency virus classified as HIV by the International Committee on the Taxonomy of Viruses (or any body that replaces such Committee) or any subtype of such isolate and further includes any isolate that is at least forty percent (40%) homologous to any such isolate and of the same genomic type and substantially the same genomic organization, any isolate that has a genome that either hybridizes to or is substantially identical to any such isolate or its compliment, and any defective or modified form of any of the above isolates.

''Patent' means U.S. Patent No. 6,531,276 Bl

Field of Use

This agreement is for the HIV Qualitative Assay field.

License Grant

Licensor hereby grants to Licensee a license to the Optimized Assays. This grant to Licensee shall be for its internal use in Licensees diagnostic service business and during the term of the collaboration shall be without royalty, but without any rights to sublicense or transfer to any third party. After the termination of the collaboration, the Optimized Assays will be licensed to Licensee for its internal diagnostic services for a royalty.

The parties collaborate so that Licensor will obtain access to the Licensor Patent Rights and the Licensor Assays so that Licensee may develop, optimize, manufacture and sell assays for research, investigational and in vitro diagnostic use (Optimized Assays).

License Property

Licensor owns certain patent rights, has developed certain technology, and possesses expertise relating to the preparation of assays;

Optimized Assays means assays for research, investigational and in vitro diagnostic use.

The phrase Licensor Patents Rights shall mean and include (i) all United States and foreign applications for patents listed, as well as all United States and foreign patents that have or may hereafter issue in respect of such applications for patents, and (ii) all applications for patents whose subject matter in whole or in part is entitled to the benefit of the filing date(s) of any of the applications for patents listed and all United States and foreign patents that have or may hereafter issue in respect of such applications for patents, including in each case of the foregoing clauses, without limitation, all continuations, continuations-in-part, divisionals, substitutions, Patent Cooperation Treaty applications, United States provisional patent applications, continued prosecution applications, utility models, supplementary protection certificates, reexaminations, renewals, extensions and reissues thereof.
6,428,963 – Isolation of RNA from formalin-fixed paraffin-embedded tissue specimens
6,248,535 – Method for isolation of RNA from formalin-fixed paraffin-embedded tissue specimens
6,610,488 – Isolation of RNA, DNA and proteins from formalin-fixed paraffin-embedded tissue specimens

Licensor Assay mean the research assays the Licensee develops.

Field of Use

The term Field shall mean the research, development, manufacture and sale of assays by Licensee, including but not limited to the Optimized Assays.

License Grant

For the Exclusive License Grant, Licensor grants an exclusive, worldwide license under the Licensed Patents in the Exclusive Field, for use , to make, have made, use, offer to sell, sell and import Licensed Products and Licensed Processes.

For the Non-Exclusive License Grant, Licensor grants a non-exclusive, worldwide license under the Licensed Patents in the Non-Exclusive Field, with the right to sublicense as herein provided to make, have made, use, offer to sell, sell and import Licensed Products or Licensed Processes.

For Sublicensing, Licensee shall have the right to sublicense the rights granted solely for use with Licensees Hybrigel Technology to a Sublicensee.

License Property

The Licensor has proprietary acrydite chemistry technology described and claimed in the Licensed Patents. The Technology expressly includes the Licensed Patents, Licensed Products, and the Licensed Process.

Hybrigel Technology shall mean Licensees proprietary electrophoretic hybridization technology that relies on gel-based capture technology and that is  useful in the isolation of nucleic acid and the diagnosis of disease as disclosed in the U.S. patents, and foreign patents relating thereto.

Field of Use

The exclusive field means nucleic acid isolation from human stool samples for the purpose of screening, detecting or diagnosing colorectal cancer.

The non-exclusive field means any field, other than the exclusive field, in which the Hybrigel Technology is employed.

License Grant

Israeli Licensor on behalf of itself and its Affiliates hereby grants to Licensee and Licensee’s Affiliates, a Limited Exclusive, sublicensable, royalty-bearing license under the Licensed Patents to Exploit the Licensed Products in the Field in the Licensee Territory during the Term through any and all means and channels of distribution now known or hereinafter discovered.

Licensor hereby grants to Licensee and Licensee’s Affiliates, a Limited Exclusive, sublicensable, royalty-bearing license under Licensor’s intellectual property rights in the Product Technical Information to Exploit the Licensed Products in the Field in the Licensee Territory during the Term through any and all means and channels of distribution now known or hereinafter discovered.

License Property

Licensed Product shall mean any Diagnostic Test (a) the Exploitation of which, or of any process, method, material, composition or assay used therein or for the performance thereof, would infringe a Valid Claim but for the licenses granted herein, (b) which was developed or manufactured using a Licensed Process, or (c) which incorporates or is developed using Royalty-Bearing Technical Information.

Product Patent(s) shall mean all Patents in the Licensee Territory now or in the future owned or Controlled by Licensor and/or its Affiliates that are necessary or useful for any of the Diagnostic Tests and are specifically directed to one or more elements of any of the Diagnostic Tests that are unique to such Diagnostic Test (as contrasted to methods of performance in general of tests based on microRNAs or composition of matter claims that are relevant to multiple indications), including but not limited to (a) the Patents listed as may be amended from time to time by the Parties; and (b) all Patents in the Licensee Territory (i) to which any of the Patents set forth claim priority or (ii) for which any of the Patents listed a basis for priority, including any divisionals, continuations, substitutions, continuations-in-part, extensions, renewals, re-examinations or reissues of such Patents listed, provided that Product Patents(s) shall not include the Excluded Acquisition Patents or the Platform Patents. For the avoidance of doubt, (e), the Product Patents include all methods of use claims directed to the use of microRNAs for the indications that are the targets of the Diagnostic Tests, but exclude all composition of matter claims directed to microRNAs.

Platform Patent(s) shall mean all Patents in the Licensee Territory now or in the future owned or Controlled by Licensor and/or its Affiliates that are necessary or useful for the Exploitation of a Licensed Product and cover one or more compositions of matter or technologies which can be used across two or more products, including but not limited to (a) the Patents listed as may be amended from time to time by the Parties; and (b) all Patents in the Licensee Territory (i) to which any of the Patents set forth claim priority or (ii) for which any of the Patents listed a basis for priority, including any divisionals, continuations, substitutions, continuations-in-part, extensions, renewals, re-examinations or reissues of such Patents listed, provided that Platform Patents(s) shall not include the Excluded Acquisition Patents.  For the avoidance of doubt, the Platform Patents include all composition of matter claims directed to microRNAs within the Licensed Patents.

Licensed Patents shall mean the Platform Patents and the Product Patents.

Product Technical Information shall mean any Technical Information which is necessary or useful to Exploit the Licensed Products in the Licensee Territory and owned or otherwise Controlled by Licensor or any of its Affiliates as of the Effective Date or during the Term, including Licensor Improvements incorporated into the Licensed Products, if any, but excluding any Excluded Acquisition Technical Information and any Technical Information that is claimed or disclosed in the Licensed Patents.

Mets Software shall mean the source code and object code forms of a certain software application which contains, among other things, an algorithm created by or on behalf of Licensor for the purpose of processing the results of the Mets Test, in the forms that such software exists as of the Effective Date, and any updates and Improvements adopted by Licensor for the Mets Test and distributed by Licensor to Licensee during the Term.

Licensed Intellectual Property shall mean the Licensed Patents, the Product Technical Information and the Mets Software.

Field of Use

Field shall mean the diagnosis of any disease or any human condition. For the purposes of this definition, diagnosis shall mean use (a) where the medical management of a human  is involved, for (i) the measurement, observation or determination of (x) the presence of a human disease, (y) the stage, progression or severity of a human disease, (z) the risk of contracting a human disease, and/or (ii) the selection of patients for a particular treatment with respect to a disease; and/or (b) in a clinical laboratory for tracking, testing or quality controlling of human body fluids or tissue samples; and/or (c) designated and regulated by the FDA as a diagnostic test or analyte specific reagent, to the extent used according to (a) and/or (b) above.

Licensee has the exclusive right to develop and commercialize miRviewâ„¢ mets, miRviewâ„¢ meso and miRviewâ„¢ squamous tests in the United States.

Licensor has initiated microRNA-based diagnostic programs for various cancers
1.      miRviewTM mets For identification of  the origin of the primary tumor of metastases;
2.      miRviewTM squamous For differentiating squamous from non squamous non-small cell lung cancer; and
3.      miRviewTM meso For differentiating mesothelioma from other carcinomas in the lung and pleura.

License Grant

Licensor grants a nonexclusive immunity from suit under PCR Technology solely to perform Licensed Services.

Licensor grants to Licensee the right to credit the Licensor as the source of PCR Technology in Licensees promotional materials and any other materials intended for distribution.

License Property

PCR or polymerise chain reaction is a nucleic acid amplification process.

Licensed Services means the performance of an IN VITRO diagnostic procedure utilizing PCR Technology to detect the presence, absence or quantity of a nucleic acid sequence associated with a human disease or condition within the Licensed field.

The Diagnostic product shall mean an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

The licensed credit is 'This test is performed pursuant to a license agreement with Licensor.'

Field of Use

Licensor has expertise in validating, documenting and performing sophisticated diagnostic procedures.  The field is that of human IN VITRO diagnostics solely for the detection of genetic diseases, genetic predisposition to disease, agents associated with infectious diseases, cancer; and for tissue transplant typing, including testing performed on animal tissue intended for use in xenotransplantation; Parentage determination; disease management; and clinical trials.

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

The parties grant each other certain rights and licenses on the terms set forth in this Agreement and to collaborate on a research and development relating to “Paraffin Extraction Technology”.  

RNA Amplification Technology
Licensor hereby grants to Licensee a worldwide, non-transferable (except as provided in Section 14.6), royalty-bearing, non-sublicensable, non-exclusive license under (i) the Licensor Background Technology directed to RNA Amplification and (ii) the RNA Amplification Technology, in each case, to practice and use the subject matter within the foregoing to research, develop, make, have made, import, use, offer for sale, and sell products for use in the Licensee Database Field of Use, Diagnostic Field of Use, Homebrew Field of Use, and Personal Research Field of Use.

Paraffin Extraction Technology
Licensor hereby grants to Licensee a worldwide, non-transferable (except as provided in Section 14.6), royalty-free, fully paid-up, non-sublicensable, non-exclusive license under Licensor’s Background Technology directed to Paraffin Extraction to practice and use the subject matter within the foregoing to research, develop, make, have made, import, use, offer for sale, and sell products for use in the Licensee Database Field of Use, Diagnostic Field of Use, Homebrew Field of Use, and Personal Research Field of Use.

Research License
Licensor hereby grants to Licensee a worldwide, non-transferable (except at provided in Section 14.6), royalty-free, fully paid-up, non-sublicensable, non-exclusive license under the Licensor Background Technology and the Program Technology owned by Licensor to practice and use the subject matter within the Licensor Background Technology and the Program Technology to conduct internal research.

Development License
Licensor hereby grants to Licensee a worldwide, non-sublicenseable, royalty-free, fully paid-up, non-exclusive license under the Licensor Background Technology and the Program Technology owned by Licensor to practice and use the subject matter within the Licensor Background Technology and Program Technology to conduct its activities under the Development Program.

Licensee hereby grants to Licensor a worldwide, non-sublicenseable, royalty-free, fully paid-up, non-exclusive license under the Program Technology owned by Licensee to practice and use the subject matter within the Program Technology to conduct its activities under the Development Program.

Commercialization Licenses
Licensee hereby grants to Licensor a worldwide, non-transferable (except as provided in Section 14.6), royalty-free, fully paid-up, non-sublicensable, non-exclusive license under the Paraffin Extraction Technology to research, develop, make, have made, import, use, offer for sale, and sell products for use in the Licensor Field and to conduct internal research.

Improvement
Licensee hereby grants to Licensor a worldwide, perpetual, irrevocable, fully paid up, royalty-free, non-transferable (except as provided in Section 14.6), non-exclusive license, under the Improvements Controlled by Licensee to practice and use the subject matter within such Improvements to research, develop, make, have made, import, use, offer for sale, and sell products, in each case, for use in the Licensor Field.

Licensor hereby grants to Licensee a worldwide, perpetual, irrevocable, fully paid up, royalty-free, non-transferable (except as provided in Section 14.6), non-exclusive license under the Improvements Controlled by Licensor to practice and use the subject matter within such Improvements to research, develop, make, have made, import, use, offer for sale, and sell products, in each case, for use in the Licensee Database Field of Use, Diagnostic Field of Use, Homebrew Field of Use, and Personal Research Field of Use.

License Property

Paraffin Extraction Technology shall mean all Program Technology relating to the recovery and extraction of native nucleic acids, polypeptides, peptides and/or proteins from tissues embedded in paraffin and its use in the research, development and commercialization of assays, including without limitation microarrays. Paraffin Extraction Technology excludes RNA Amplification Technology.

Paraffin Extraction shall mean the recovery and extraction of native nucleic acids, polypeptides, peptides and/or proteins from tissues embedded in paraffin.

RNA Amplification Technology shall mean all Program Technology relating to the selective amplification, labeling or conjugation of RNA segments in a close to linear fashion. RNA Amplification shall mean the selective amplification, labeling or conjugation of RNA segments in a close to linear fashion.

Products shall mean Licensee Database Products, Personalized Research Products, Homebrew Products and/or Diagnostic Products.

Diagnostic Product(s) shall mean an assay provided as a product or service performed on a human tissue or other human biological sample containing nucleic acids or proteins that are collectively intended to establish or identify an association between the presence or absence of such nucleic acids or proteins and
(a) diagnosis of the presence of, or absence of, a specific disease(s), state(s) or condition(s) in humans;
(b) predisposition to the presence of, or absence of, a specific disease(s), state(s) or condition(s) in humans;
(c) response or lack of response to disease therapy(ies) in humans or preventative strategies in humans;
(d) prediction of the disease course in humans, and or other changes in state(s) or condition(s) in humans over time;
(e) clinical traits in humans for which a medical professional should be consulted; or variation(s) in specific trait(s) and/or characteristics among individuals;
(f) variation(s) in specific trait(s) and/or characteristics among individuals; and/or
(g) predisposition to development of toxicities to disease therapies or preventative strategies in humans.

the results of which are provided to payors, providers or patients, and for which FDA approval (or comparable regulatory agency in other jurisdictions) is required. Diagnostic Products exclude Homebrew Products, Personalized Research Products and Licensee Database Products.

Homebrew Product(s) shall mean a Single Analyte Assay(s) provided as a product or a service performed by a service provider that would constitute a Diagnostic Product with the sole exception that it is provided prior to receipt of approval by the FDA or comparable regulatory agency in any jurisdiction outside of the United States. Homebrew Products exclude Diagnostic Products, Personalized Research Products and Licensee Database Products. For purposes of the foregoing, “Single-Analyte Assays” shall mean a assay designed for testing or measuring only a single analyte.

Personal Research Products shall mean shall mean a Multi-Analyte Assay(s) provided as a product or a service containing nucleic acids or proteins that are collectively intended to establish or identify an association between the presence or absence of such nucleic acids or proteins and
(a) diagnosis of the presence of, or absence of, a specific disease(s), state(s) or condition(s) in humans;
(b) predisposition to the presence of, or absence of, a specific disease(s), state(s) or condition(s) in humans;
(c) response or lack of response to disease therapy(ies) in humans or preventative strategies in humans;
(d) prediction of the disease course in humans, and or other changes in state(s) or condition(s) in humans over time;
(e) clinical traits in humans for which a medical professional should be consulted;
(f) variation(s) in specific trait(s) and/or characteristics among individuals; and/or
(g) predisposition to development of toxicities to disease therapies or preventative strategies in humans.

Such an assay will be considered a “Personalized Research Product” only where the results are provided directly to the tested individual and/or to the tested individual’s health care provider, and where the approval by the FDA or comparable regulatory agency in any jurisdiction outside of the United States is not required. “Personalized Research Products” exclude Homebrew Products, Diagnostic Products and Licensee Database Products. For purposes of the foregoing, “Multi-Analyte Assay(s)” shall mean an assay designed for testing or measuring more than a single analyte.

Licensee Database Products shall mean a collection of information derived from or by testing a person or persons in the Diagnostic Field of Use, Homebrew Field of Use or the Personalized Research Field of Use. Licensee Database Products exclude Diagnostic Products, Homebrew Products, and Personalized Research Products.

Licensor Background Technology shall mean the Intellectual Property that Licensor Controls as of the Effective Date and during the Development Program which is necessary for the conduct of the Development Program and the exploitation of the Program Technology and/or the Improvements,  and which is directed to (a) the recovery and extraction of native nucleic acids, polypeptides, peptides and/or proteins from tissues embedded in paraffin for use in the research, development and commercialization of assays, including without limitation microarrays (“Paraffin Extraction”); or (b) the selective amplification, labeling or conjugation of RNA segments in a close to linear fashion (“RNA Amplification”). Licensor Background Technology shall exclude those patents licensed to Licensee under the Patent License Agreement.

Program Technology shall mean all Intellectual Property created by Licensor or Licnesee after the Effective Date and during the Development Period (i) in the course of performing the Development Program, or (ii) using Confidential Information provided by the other Party to the inventing Party in connection with the Development Program.

Intellectual Property shall mean trade secrets, Patents, copyrights, Know-How, and similar rights of any type under the laws of any governmental authority, domestic or foreign, including all applications and registrations relating to any of the foregoing.

Field of Use

Diagnostic Field of Use shall mean the research, development, manufacture, importation, use and/or sale of Diagnostic Product(s). The Diagnostic Field of Use excludes the Personalized Research Field of Use, the Licensor Field of Use and the Homebrew Field of Use.

Homebrew Field of Use shall mean the research, development, manufacture, importation, use and/or sale of Homebrew Product(s). The Homebrew Field of Use excludes the Diagnostic Field of Use, the Internal Research Field of Use and the Personalized Research Field of Use.

Personal Research Field of Use shall mean the research, development, manufacture, importation, use and/or sale of Personalized Research Product(s). The Personalized Research Field of Use excludes the Diagnostic Field of Use, the Homebrew Field of Use, and the Licensor Field of Use.

Licensee Database Field of Use shall mean the research, development, manufacture, importation, use and/or sale of Licensee Database Product(s) to end users.

Licensor Field shall mean all internal research and development applications of Paraffin Extraction Technology or Improvements, including the use of such technology to develop therapeutic products and the use of such technology in connection with the commercialization of research tools, such as databases, use of a biochemical test for detecting and/or quantifying a specific nucleic acid target sequence within a nucleic acid mixture which is designed and intended “For Research Use Only” or “For Investigational Use Only” or as a general purpose laboratory reagent. For the avoidance of doubt, the Licensor Field shall exclude any, Diagnostic Field of Use, Homebrew Field of Use, and Personal Research Field of Use.

The Collaborative Agreement pertains to certain of Licensor’s patent rights and know-how regarding cloning, DNA sequencing, and data analysis technologies.
Under the Patent License Agreement, 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 proteins as markers for cancers.

License Grant

Licensor grants to the Swiss Licensee a worldwide, semi-exclusive license, without the right to sublicense, under the Licensor Licensed Patents to research, develop, make, have made, import, use, offer for sale and sell Licensor Licensed Products for use in the Field.

For the Licensor Transplantation Field License, Licensor grants a worldwide, non-exclusive license, without the right to sublicense, under  Licensoe Licensed Patents to research, develop, make, have made, import, use, offer for sale and sell Licensor Licensed Products for use in the Transplantation Field.

License Property

The patent rights relate to the human immunodeficiency virus (HIV).

Products means reagents, compositions or kits suitable for use in the Field or the Transplantation Field.

Field of Use

The Licensee intended application is for use in assays for the detection of nucleic acid sequences for use in in vitro diagnostics (excusing use in Blood Screening, but without limiting the effect of the Blood Screening Agreement.

Field means the commercial use of human in vitro diagnostic products that detect nucleic acid sequences of HIV. Expressly excluded from the Field are products in Blood Screening; and products specifically labeled or promoted for use in the Transplantation Field.

Transplantation Field means the commercial use of products that detect nucleic acid sequences for the screening of any biological materials intended for transfusion or transplantation, in each case from any donor, including autologous donors, other than the transfusion or transplantation of blood or its derivatives, components or replacements.

License Grant

Licensor hereby grants to Licensee and its Affiliates, and Licensee accepts the licenses under the Licensed Technology to exclusively use, develop, make, have made, sell, offer to sell, modify, import and otherwise commercially exploit the Licensed Uses and the Licensed Products in the Licensed Territory including, but not limited to, as follows
(1) an exclusive license for the use of the SVM Technology and the Licensed Patents in the Field in the Licensed Territory relating to Licensed Uses and Licensed Products; and

(2) an exclusive license to the Licensed Know-How in the Field in the Licensed Territory, including access to and use of the Computer Software that has been developed by or for Licensor or will be developed by or for the Licensor that may be applicable to Licensed Uses or Licensed Products; and

(3) an exclusive license for the use of Licensed Products in the Licensed Territory.
Sublicense Rights. Licensee may grant sublicenses under any of the licenses granted herein, to import, develop, make, have made, use, modify, offer for sale, and/or sell Licensed Products within the Field.

License Property

LICENSOR is the owner of intellectual property, including patents, pending and issued, and know-how relating to support vector machine and other machine learning technologies which is included within the “SVM Technology” (as defined below), based upon which it has developed, or is engaged in developing, applications including, inter alia, digital image analysis and interpretation, biomarker discovery, and gene/gene product-based and protein-based diagnostic, prognostic and predictive tests.

“SVM Technology” shall mean all technology and ownership claims related to support vector machines and other pattern-recognition algorithms (“SVM”), SVM-Recursive Feature Elimination (“RFE”), and Fractal Genomic Modelling (“FGM”) included in the Licensed Technology.

Licensor owns the Licensed Technology (as defined below), which includes inter alia, coverage of genomic biomarkers related to prostate cancer, pancreatic cancer, colon cancer and other cancers as well as certain interpretation methodologies and software associated with automated image analysis for cytogenetics and flow cytometry testing.

“IVD Test Kit” shall mean any kit or instrument manufactured for sale to third parties, which includes reagents and other supplies that enables such third party purchasers to perform in vitro diagnostic tests on biological samples or any instrument used therewith; provided that, any such IVD Test Kit must be approved by the U.S. Food and Drug Administration (“FDA”) for sales of the IVD Test Kit in the United States, or be approved by any other foreign regulatory bodies for sales of the IVD Test Kit in countries other than the United States. Notwithstanding the foregoing, any instruments sold in conjunction with or pursuant to Licenses E and F described in Sections 1.12.4 and 1.12.5 are excluded from the definition of IVD Test Kit.

“Laboratory Developed Test” shall mean any test, process or procedure used to test or assay any type of patient biological sample, the results of which would then normally be entered into the medical record of the patient providing such biological sample; provided, however, any test, process or procedure performed using an IVD Test Kit shall not be considered to be a Laboratory Developed Test.

“Plasma Prostate Cancer Test” shall mean any Laboratory Developed Test using genes, gene products, or other biomarkers present in blood plasma for differentiating clinically significant prostate cancer from other prostate conditions, including without limitation clinical laboratory testing and clinical trials, but expressly excluding manufacture of IVD Test Kits. For reference purposes, the license granted for the Plasma Prostate Cancer Test is identified as “License B”.

“Pancreatic Cancer Test” shall mean any Laboratory Developed Test using genes, gene products, or other biomarkers present in any type of biological sample for differentiating clinically significant pancreatic cancer from other pancreatic conditions, including without limitation clinical laboratory testing and clinical trials, but expressly excluding manufacture of IVD Test Kits. For reference purposes, the license granted for the Pancreatic Test is identified as “License C”.

“Colon Cancer Test” shall mean any Laboratory Developed Test using genes, gene products or other biomarkers for differentiating clinically significant colon cancer from other colon conditions, including without limitation clinical laboratory testing and clinical trials, but expressly excluding manufacture of IVD Test Kits. For reference purposes, the license granted for the Colon Cancer Test is identified as “License D”.

“Cytogenetics Interpretation System” shall mean any interpretive software and related technology for computer-aided karyotype analysis for genetic screening and detection of chromosomal abnormalities. For reference purposes, the license granted for the Cytogenetics Interpretation System is identified as “License E”.

“Flow Cytometry Interpretation System” shall mean interpretive software and related technology for computer-aided analysis of flow cytometry tests. For reference purposes, the license granted for the Flow Cytometry Interpretation System is identified as “License F”.

“Urine Prostate Cancer Test” shall mean any Laboratory Developed Test using genes, gene products, or other biomarkers present in urine samples for differentiating clinically significant prostate cancer from other prostate conditions, including without limitation clinical laboratory testing and clinical trials, but expressly excluding manufacture of IVD Test Kits. For reference purposes, the license granted for the Urine Prostate Cancer Test is identified as “License G”.

“Tissue Prostate Cancer Test” shall mean any Laboratory Developed Test using genes, gene products, or other biomarkers present in tissue samples for differentiating clinically significant prostate cancer from other prostate conditions, including without limitation clinical laboratory testing and clinical trials, but expressly excluding manufacture of IVD Test Kits. For reference purposes, the license granted for the Tissue Prostate Cancer Test is identified as “License H”.

Licensed Patents
Patent/Application No.
Title
Filing Date/
Expires

Issue Date

Patent/Application No.
Title
Filing Date/
Expires

Issue Date

U.S. Patent No. 6,128,608
Enhancing Knowledge Discovery Using Multiple Support Vector Machines
05-01-1999/
5/1/2019

10/3/2000

U.S. Patent No. 6,157,921
Enhancing Knowledge Discovery Using Support Vector Machines in a Distributed Network Environment
05-01-1999/
5/1/2019

12/5/2000

U.S. Patent No. 6,427,141
Enhancing Knowledge Discovery Using Multiple Support Vector Machines.
05-09-2000/
5/1/2019

7/30/2002

U.S. Patent No. 6,658,395
Enhancing Knowledge Discovery from Multiple Data Sets Using Multiple Support Vector Machines.
05-24-2000/
5/1/2019

12/2/2003

U.S. Patent No. 6,714,925
System for Identifying Patterns in Biological Data Using a Distributed Network.
08-07-2000/
5/1/2019

3/30/2004

U.S. Patent No. 6,760,715
Enhancing Biological Knowledge Discovery Using Multiple Support Vector Machines.
08-07-2000/
5/1/2019

7/6/2004

U.S. Patent No. 6,789,069
Method of Identifying Patterns in Biological Systems and Method of Uses.
08-07-2000/
4/13/2020

9/7/2004

U.S. Patent No. 6,882,990
Method of Identifying Biological Patterns Using Multiple Data Sets.
08-07-2000/
5/1/2019

4/19/2005

U.S. Patent No. 6,944,602
Spectral Kernels for Learning Machines
03-01-2002/
2/19/2023

9/13/2005

U.S. Patent No. 6,996,549
Computer-Aided Image Analysis
01-23-2002/
4/21/2021

2/7/2006

U.S. Patent No. 7,117,188
Methods of Identifying Patterns in Biological Systems and Uses Thereof
01-24-2002/
3/9/2022

10/3/2006

U.S. Patent No. 7,299,213
Method of Using Kernel Alignment to Extract Significant Features from a Large Dataset
09-12-2005/
3/1/2022

11/20/2007

U.S. Patent No. 7,318,051
Methods for Feature Selection in a Learning Machine
11-18-2003/
2/25/2021

1/8/2008

U.S. Patent No. 7,353,215
Kernels and Methods for Selecting Kernels for Use in Learning Machines
11-07-2003/
1/27/2023

4/1/2008

U.S. Patent No. 7,383,237
Computer-Aided Image Analysis
02-06-2006/
11/4/2019

6/3/2008

U.S. Patent No. 7,444,308
Data Mining Platform for Bioinformatics and Other Knowledge Discovery
12-15-2003/
5/28/2022

10/28/2008

U.S. Patent No. 7,475,048
Pre-Processed Feature Ranking for a Support Vector Machine
05-07-2004/
7/22/2021

1/6/2009

U.S. Patent No. 7,542,947
Data Mining Platform for Bioinformatics and Other Knowledge Discovery
10-30-2007/
5/20/2022

6/2/2009

U.S. Patent No. 7,542,959
Feature Selection Method Using Support Vector Machine Classifier
08-21-2007/
8/7/2020

6/2/2009

U.S. Patent No.  7,617,163
Kernels and Kernel Methods for Spectral Data
10-09-2002/

11/10/2009

U.S. Patent No. 7,624,074
Methods for Feature Selection in a Learning Machine
10-30-2007/
8/7/2020

11/24/2009

U.S. Patent No. 7,676,442
Selection of Features Predictive of Biological Conditions Using Protein Mass Spectrographic Data
10-30-2007/
8/7/2020

3/9/2010

U.S. Patent No. 7,788,193
Kernels and Methods for Selecting Kernels for Use in Learning Machines
10-30-2007/
8/6/2023

8/31/2010

U.S. Patent No. 7,797,257
System for Providing Data Analysis Services Using a Support Vector Machine for Processing Data Received from a Remote Source
10-31-2007/
7/28/2020

9/14/2010

U.S. Patent No. 7,805,388
Method for Feature Selection in a Support Vector Machine Using Feature Ranking
10-30-2007/
8/7/2020

9/28/2010

U.S. Patent No. 7,890,445
Model Selection for Cluster Data Analysis
10-30-2007/
6/8/2024

12/15/2011

U.S. Patent No.  7,921,068
Data Mining Platform for Knowledge Discovery from Heterogeneous Data Types and/or Heterogeneous Data Sources
10-30-2007/
5/20/2022

4/5/2011

U.S. Patent No.  7,970,718
Method for Feature Selection and for Evaluating Features Identified as Significant for Classifying Data
09-26-2010/
1/24/2022

6/28/2011

U.S. Patent No.  8,008,012
Biomarkers Downregulated in Prostate Cancer
09-30-2008/
1/13/2026

8/30/2011

U.S. Patent  No. 8,095,483
Support Vector Machine-Recursive Feature Elimination (SVM-RFE)
12-01-2010/
8/7/2020

1/10/2012

U.S. Patent Publ. No. 2005/0165556
Colon Cancer-Specific Biomarkers
01-11-2005/
08-07-2020 + PTA

U.S. Patent Publ. No. 2010/0256988
System for Providing Data Analysis Services Using a Support Vector Machine for Processing Data Received from a Remote Source
06-11-2010/
5/1/2019

U.S. Patent Publ. No. 2011/0106735
Recursive Feature Elimination Method Using Support Vector Machines
11/11/2010
08-07-2020 + PTA

U.S.Patent Publ. No. 2010/0318482
Kernels for Identifying Patterns in Datasets Containing Noise or Transformation Invariances
08-25-2010/
05-07-2022 + PTA

U.S.Patent Publ. No. 2011/0184896
Method for Visualizing Feature Ranking of a Subset of Features for Classifying Data Using a Support Vector Machine
04-04-2011/
05-20-2022  PTA

U.S. Patent Publ. No. 2010/0205124
Support Vector Machine-Based Method for Analysis of Spectral Data
02-04-2010/
08-07-2020 + PTA

U.S.Patent Publ. No. 2011/0125683
Identification of Co-Regulation Patterns by Unsupervised Cluster Analysis of Gene Expression Data
02-02-2011/
05-17-2022 + PTA

U.S. Patent Publication No. 2009/0204557
Method and System for Analysis of Flow Cytometry Data Using Support Vector Machines
02-08-2009/
02-08-2029 + PTA

U.S. Patent Publication No. 2008/0050836
Biomarkers for Screening, Predicting, and Monitoring Benign Prostate Hyperplasia
07-26-2007/
11-14-2025 + PTA

U.S. Patent Publication No. 2009/0215024
Biomarkers Upregulated in Prostate Cancer
02-04-2008/
11-14-2025 + PTA

U.S. Patent Publication No. 2009/0286240
Biomarkers Overexpressed in Prostate Cancer
09-30-2008/
11-14-2025 + PTA

U.S. Patent Publication No. 2009/0215058
Methods for Screening, Predicting and Monitoring Prostate Cancer
12-04-2008/
11-14-2025 + PTA

U.S. Patent Publication No. 2009/0226915
Methods for Screening, Predicting and Monitoring Prostate Cancer
01-06-2009/
11-14-2025 + PTA

U.S.Patent Publication No.  2011/0312509
Biomarkers Downregulated in Prostate Cancer
08-29-2011/
11-14-2025 + PTA

U.S. Patent No. 6,920,451
Method for the Manipulation, Storage, Modeling, Visualization and Quantification of Datasets
01-19-2001/
6/9/2021

7/19/2005

U.S. Patent No. 7,366,719
Method for the Manipulation, Storage, Modeling, Visualization and Quantification of Datasets
10-06-2004/

4/29/2008

Field of Use

“Field” or “Field of Use” shall mean the fields of laboratory testing, molecular diagnostics, clinical pathology, anatomic pathology, and digital image analysis, excluding non-pathology-related radiologic and photographic image analysis, relating to the development, marketing, production or sale of any Laboratory Developed Tests or other products used for diagnosing, ruling out, predicting a response to treatment, and/or monitoring treatment of any or all hematopoietic and solid tumor cancers excluding cancers affecting the retina and breast cancer; provided, however, the manufacture and sale of IVD Test Kits for sales to third parties and the melanoma screening system and methods described in the patent applications listed in Exhibit D are specifically excluded from the Field or Field of Use; and provided further that the foregoing exclusion of “and breast cancer” immediately prior to the first proviso of this section shall be in effect only so long as the License Agreement among and between LICENSOR.

The Licensee is a high-complexity CLIA-certified clinical laboratory that specializes in cancer genetics diagnostic testing. The Licensee's testing services include cytogenetics, fluorescence in-situ hybridization (FISH), flow cytometry, immunohistochemistry, morphology studies, anatomic pathology and molecular genetic testing. Headquartered in Fort Myers, FL, The Licensee services the needs of pathologists, oncologists, urologists and other clinicians, and hospitals throughout the United States.