Royalty Report: Test/Monitoring, Assay, Medical – Collection: 282844

License Grant

The Netherland Licensor hereby grants to Licensee, for the term of this Agreement, a non-transferable, worldwide, non-exclusive license under the Patents for the sole purpose of conducting research activities, developing, having developed, manufacturing, having manufactured, using, offering for sale, selling, having sold, exporting and/or otherwise commercializing Products, solely under Licensee’s name and labels, each for operation solely on and with a Licensee Instrument. The license granted is granted only for the Field. No license is granted to Licensee outside the Field.  The license rights granted by Licensor to Licensee are without right to grant sublicenses, except that Licensee shall have the right to sublicense such license rights to its Affiliates

License Property

The term Patent means the Factor II (Mutated) Patents and the Factor V (Mutated) Patents, listed in this Agreement.

Title A method for screening for the presence of genetic defect associated with thrombosis and/or poor anticoagulant response to activated prot. c

US8,454,353 – Method for evaluating the state of a fuel/air mixture
US9,165,019 – Self recovery
US8,658,340 – Toner, development agent, and image forming method

The term Factor V (Mutated) means the Factor V gene, which comprises the single mutation as described in the relevant patents listed, and/or the corresponding Factor V/Va protein expressed by said gene, said single mutation to be used for the detection of a condition associated with a poor anticoagulant response to activated protein C.

The term Factor II (Mutated) means the Factor II gene, which comprises the single mutation as described in the relevant patent listed, and/or the corresponding protein expressed by said gene, said single mutation to be used for the detection of a condition associated with thrombosis.

The term Licensee Instrument means any diagnostic platform of Licensee for nucleic acid testing which is designed to run more than one hundred (100) tests per day, to the exclusion of any other instrument.

Field of Use

The term Field means clinical in-vitro diagnostics, including, without limitation, genetic predisposition testing.  A genetic predisposition (sometimes also called genetic susceptibility) is an increased likelihood of developing a particular disease based on a person's genetic makeup. A genetic predisposition results from specific genetic variations that are often inherited from a parent.

Intellectual property is for detecting genetic mutations that predispose people to blood clotting disorders.  Intellectual property is to develop tests that detect mutations in the genes that code for factor V and prothrombin, proteins that control the blood clotting process.

License Grant

University grants an exclusive, world-wide right and license, with the right to grant sublicenses, to make, have made, use and sell joint licensed products.

License Property

The University jointly owns and is a joint proprietor of certain intellectual property relating to the human BRCA-2 breast cancer gene.

Field of Use

The field of use means any and all applications and uses of the BRCA-2 breast cancer gene, including but not limited to all diagnostic and therapeutic applications.

License Grant

Licensor hereby grants Licensee a, worldwide, non-transferable, non-exclusive license under Licensor Licensed Technology, to, (1) develop Generic Kits and Standard Kits as authorized in this Agreement, (2) make, have made, and use (which use includes the right to modify) Licensor OEM Kits and (3) distribute, market and sell such Licensor OEM Kits (OEM License) pursuant to the license granted to Licensee as set forth in this Agreement. Licensee agrees to forbear from the use and exercise of the OEM License otherwise a royalty payment will be due.  If Licensee grants any Third Party a license to exploit the TAG Improvements, Licensee shall pay Licensor a royalty.

The purpose of the Collaboration is to develop, manufacture, market and sell (i) Products, and (ii) software applications for Approved Instruments all as set forth in this agreement. The purpose of the Collaboration may be modified and/or extended upon mutual agreement of the Parties in writing.

License Property

Licensor Licensed Technology means Technology Controlled by Licensor and its Affiliates as of the Effective Date that is useful in the Field of Use, as listed or described hereto. Licensor represents and warrants that the items listed hereto comprise all of the Licensor Licensed Technology as of the Effective Date of this agreement. As of the Effective Date the Licensor Licensed Technology does not require payment of royalties to third parties. Licensor and its Affiliates will amend this from time to time to keep it current. Licensor and its Affiliates warrant that all Controlled Technology for carrying out the marketing, sale, and other disposition of Products will be included in the Licensor Licensed Technology.

US Patent 5,888,819 – Method for determining nucleotide identity through primer extension

Product means any of a Standard Kit, a Custom Kit and/or a Generic Kit.

Combination Kit means any Custom Kit that contains Primers more than 50% of which are identical to Primers contained in any part of any Standard Kits existing at the time of launch of such Custom Kit, or any combination of Standard Kits existing at the time of launch of such Custom Kit.

Custom Kit means a kit consisting of certain Reagents, certain Primers that have been customized by Licensor or Licensors subcontractors for use in the Field of Use and an End User License, and shall not include use of or refer to any use of TAG Arrays other than for genotyping with GBA.

Standard Kit means a kit consisting of Reagents, CMC Approved Primers for use in the Field of Use and an End User License.

Generic Kit means a kit consisting of Reagents and an End User License.

Primer means GBA primers (a synthetic oligonucleotide of a sequence known to be complementary with the oligonucleotide sequence immediately adjacent, 5, to a SNP) or either PCR primers or information to generate PCR primers.

Reagent means buffers, enzymes and terminators (but not Primers) useful in GBA.

GBA means Genetic Bit Analysis, or single nucleotide primer extension methods designed to detect the identity of a single nucleotide at a predetermined location in the DNA of a sample.

SNP means Single Nucleotide Polymorphism.

Technology means and includes all inventions, discoveries, improvements, trade secrets and proprietary methods and materials, whether or not patentable, including but not limited to, samples of, methods of production or use of, and structural and functional information pertaining to, chemical compounds, proteins or other biological substances; other data; formulations; techniques; and know-how; including any negative results.

TAG Array means a tag array GeneChip probe array. Each set of probes consists of four probes with the following relationship to a defined target sequence — a perfect match to target sequence, a single base mismatch to target sequence, a perfect match to the complement of target sequence, and, a single base mismatch to the complement of target sequence. For the avoidance of doubt, TAG Arrays include no license (express or implied) authorizing use for any purpose except genotyping with GBA.

TAG Assay means any assays for hybridization to a TAG Array.

TAG improvement is any improvements to TAG Assays.

Field of Use

These new assays will allow researchers to customize high density SNP analyses solely by designing GBA primers for use on a standard GeneChip array.

The first products to be commercialized by the alliance will include reagent kits for use with Licensee's new universal array designed to perform thousands of user-defined SNP analyses.  Licensee has developed and intends to establish its GeneChip® system as the platform of choice for acquiring, analyzing and managing complex genetic information in order to improve the diagnosis, monitoring and treatment of disease.

Field of Use means the use of Product to practice GBA in Tag Array format in Approved Instruments for Research Purposes and clinical reference laboratories where work is performed under the Clinical Laboratory Improvements Act and explicitly excludes Products that have received marketing approval from the FDA.

GeneChip system is a commercial microarray platform that allows whole genome gene expression analysis for a wide variety of experimental organisms.

License Grant

Licensor grants a non-exclusive, non-transferable, worldwide license in the VIDAS Field to use the Licensor Technology solely to develop, make and have made, use, sell, offer for sale, have sold and import the VIDAS Products, solely and exclusively for use on the VIDAS Instrumentation.

License Property

Licensor possesses technology, knowledge, know-how and proprietary rights pertaining to nucleic acid hybridization and amplification technologies, detection and identification technologies, including specific probes targeting ribosomal RNA and specific target sequences and regions, microbiological culture collections, Probe Assay formats, specimen collection and processing, multiple analyte detection technologies and related intellectual property.

VIDAS Instrumentation shall mean, collectively, the Licensee instrument system currently known as the VIDAS system and the Licensee instrument system currently known as the mini-VIDAS system, as such systems existed on the date of the VIDAS Agreement and as hereafter modified or supplemented by additional instrumentation or devices as required to accommodate VIDAS Products, each of which modified and/or supplemented systems shall consist of instrumentation which is generally sold for processing and interpreting both Probe Assays and immunoassays, excluding, in any event, all VIDAS Products to be run on such instrumentation, provided, however, that such term may include a Probe Assay-only VIDAS system that Licensee may elect to develop at its expense, and provided, further, such modified and/or supplemented Probe Assay-only instrumentation system shall
–  be semi-automated, meaning it does not accept the sample container itself and performs all steps needed to produce the tests results.
–  use as its test format (i) a multi-well plastic cassette, currently referred to as a VIDAS strip which contains pre-dispensed reagents, tests for analytes and controls which is manually loaded into and resident in individual incubation and processing slots, and (ii) a pipette tip, currently referred to as an SPA, containing immobilized capture ligands; and
–   accommodate, on any single unit capable of stand-alone operation of such modified and/or supplemented instrument system, no more than thirty (30) test cassettes at one time.

VIDAS Products shall mean the following Probe Assays, in each case made, used, or sold under the license granted by Licensor in this Agreement and solely and exclusively for use on VIDAS Instrumentation
–   VIDAS Initial Products, which shall mean, collectively, Probe Assays for the detection of Chlamydia trachomatis (VIDAS Probe CT); Probe Assays for the detection of Neisseria gonorrhoeae (VIDAS Probe GC), Probe
Assays for the detection of Neisseria gonorrhoeae and/or Chlamydia trachomatis in combination VIDAS CT/GC Screen and Probe Assays for the detection of Mycobacterium tuberculosis (VIDAS Probe MTB)
–   VIDAS QHIV Product, means the Probe Assay for the quantitative detection of human immunodeficiency virus which has been the subject of joint Parties development efforts prior to the Effective Date. IF Licensee elects to develop an alternative QHIV probe assay for the VIDAS Instrumentation and a new regulatory submission is required for such assay, then (i) if Licensee ceases to market the original VIDAS QHIV Product and markets only the alternative QHIV probe assay, such alternative QHIV probe assay shall thereafter be prospectively considered to be the VIDAS QHIV Product for purposes of this Agreement, but (ii) if Licensee continues to market the original VIDAS QHIV Product and also markets the alternative QHIV probe assay, such alternative QHIV probe assay shall be considered to be a VIDAS Future Infectious Disease Product for purposes of this Agreement.
–  VIDAS HLA Product, which shall mean Probe Assays for the detection and quantification of sequences encoding·human leukocyte antigens;
–  VIDAS Food Testing Products, which shall mean Probe Assays for the detection of microorganisms in any and all materials associated with the production (including quality control) of foodstuffs or beverages, including water, intended for human or animal consumption.
–  VIDAS Future Infectious Disease Products, which shall mean Probe Assays, other than the VIDAS Initial Products and VIDAS QHIV Product, for detection, identification, quantification of, and/or susceptibility testing for agents causing human clinical infectious diseases, as present in the human body, solely for the purpose of diagnosis and medical care of the persons from whom the tested samples were taken.
–  VIDAS Other Future Products, which shall mean any Probe Assays which are directed at one or more Option Targets selected by Licensee.

Assay shall mean a diagnostic process or procedure applied to a sample, or a portion of a sample, whereby a particular chemical compound, or a collection of compounds, or a portion of a chemical compound, is detected and optionally quantified.

Probe Assay shall mean an Assay using a nucleic acid as a necessary and active reagent or which detects a set of nucleic acid sequences or a specific nucleic acid sequence, as a means of obtaining useful information relevant to the sample being assayed.

Key Biochemistry Components or KBCs shall mean (a) the lysing tubes, enzymes, nucleic acids and other biochemical compounds and reagents.  Key Biochemistry Components are
–  All enzymes used in transcription-based amplification, including TMA and variations and improvements to TMA, for use in VIDAS Assays.
–  All biochemical components used for amplification of amplicon of target with TMA.
–  All probes, primers, and oligonucleotides used in VIDAS Assays.
–  Nucleic acids used for positive and negative controls, standards, calibrators, and for quality control of VIDAS Assay components and VIDAS kits.

Field of Use

Technology covers semi-automated probe assays and advanced fully-automated, probe assays for the diagnosis of infectious diseases and detection of food pathogens.

Licensee and its Affiliates maintain and operate a worldwide network of semi-automated instruments known as VIDAS and mini-VIDAS for the diagnosis of infectious disease and other indications.

VIDAS Field shall mean
–  the detection, identification, quantification, and/or susceptibility testing of agents causing human clinical infectious diseases, as present in the human body, solely for the purpose of diagnosis and medical care of the persons from whom the tested samples were taken;
–  testing for sequences encoding human leukocyte antigen;
–  testing for microorganisms in any and all materials associated with the production, including quality control, of foodstuffs or beverages, including water, intended for human or animal consumption;
–  testing for any analyte listed and selected by Licensee, as present in a clinical sample from the human body, solely for the purpose of diagnosis and medical care of the person from whom the tested sample was taken.

The VIDAS Field specifically does not include testing for infectious agents in blood and blood products intended for transfusion, or the testing for infectious agents in blood in connection with organ transplants, or the testing of specimens from non-human animals or environmental sources except as specifically provided above, even if such testing is for the purpose of detecting or identifying organisms which are associated with infectious diseases in man.

The target markers are
–  Cancer Markers
1. Prostase,
2. Mammaglobin,
3. Kras,
4. p53,
5. Cancer related mutations of the mitoch9ndrial RNA in the D-Loop regulatory region, the NADH (nicotinamide adenine dinucleotide) region, and the dehydrogenase subunit 4.
–  Cardiac Markers
6. Factor II (Prothrombiri) mutation (20210)
7. Factor V Leiden mGtation
–  Alzheimer Markers
8. ApoE
9. presenilin,
–  Sepsis Markers
10. Sepsis specific cytokine.

License Grant

The parties amend and replace the Original Agreement to separate the next generation recombinant coagulation Factor IX into its own Agreement.  Licensor hereby grants, and agrees to grant, to Danish Licensee, as of the Original Date , the following rights and licenses
Exclusive License.  As of the Original Date, Licensor hereby grants, and agrees to grant, to Licensee an exclusive (even as to Licensor), royalty-bearing license in the Field of Use under the Licensor Intellectual Property used or required to be used in the Field of Use during the Term, (i) to conduct research, sample, develop (including clinical development), manufacture, make, use, market, promote, sell, offer for sale, have sold, distribute, import and export New Products in the Territory, and (ii) to use the Reagents in the Territory solely for the purpose of making New Products.  
Limited Sublicense Rights.  Licensee shall be entitled to grant full sublicenses to its Affiliates and limited sublicenses to its distribution, marketing and/or sales partners.

License Property

Licensor Patents means (a) all Patent Rights relating to methods and processes for glycosylation design and remodeling of proteins, peptides and antibodies that are   Controlled by Licensor, including, but not limited to, (i) the Patent Rights listed.

6,800,468 – UDP-galactose .beta.-N-acetyl-glucosamine .beta.1,3galactosyltransferases, .beta.3Gal-T5
6,995,004 – UDP-N-ACETYLGLUCOSAMINE GALACTOSE-.beta. 1,3-N-ACETYLGALACTOSAMINE-.alpha.-R / N-ACETYLGLUCOSAMINE-.beta. 1,3,-N-ACETYLGALACTOSAMINE-.alpha.-R (GLCNAC TO GALNAC) .beta.1,6-N-ACETYLGLUCOSAMINYLTRANSFERASE, C2/4GNT
6,635,461 – UDP-N-acetylglucosamine galactose-.beta.1, 3-N-acetylgalactosamine-.alpha.-R/(GlcNAc to GalNAc) .beta.1,6-N-acetylglucosaminyltransferase, C2GnT3

Carved Factor IX Claims shall mean any Potential Carved Factor IX Claim with respect to which the parties have filed a separate patent application.

Potential Carved Factor IX Claims shall mean any composition-of-matter claims and any method of treatment claims that are supported by Patent Rights Controlled by Licensor that (i) do or could explicitly and solely recite and claim Licensee Materials, or (ii any Licensee Improvements made or reduced to practice by Licensor.

Reagents means the enzymes and sugar nucleotides required to use the Licensor Technology in the manufacture of New Products.

New Product shall mean the following (a) any of the Licensee Materials modified using either (i) the Licensor Technology, (ii) any Licensor Improvements, or (iii) any combination of all or some of (i) and (ii) above, and (b) any Licensee Materials covered by any Carved Factor IX Claims (except to the extent such claims constitute Licensee Improvements).

Licensor Exclusive Compounds shall mean any and all forms of erythropoietin and granulocyte colony stimulating factor including, but not limited to, with respect to either of the foregoing full length proteins, truncated proteins, fusion proteins, analogs, mutants, splice variants, and conjugates with other molecular entities such as proteins, peptides, organic or inorganic substances.

M1 Profile for the New Factor IX Product means the parameters for candidate selection required for PEG-F9, as amended from time to time.

Licensor Intellectual Property means Licensor Technology and the Licensor Improvements.

Licensor Technology means the Licensor Patents and any Know-How Controlled by Licensor relating to methods and processes for the  glycosylation design and remodeling of proteins, peptides and antibodies, including, without limitation, its GlycoAdvance®, GlycoPEGylationâ„¢ and GlycoConjugationâ„¢ technologies, and other carbohydrate synthesis processes, and all Know-How resulting from work conducted by Licensor during the Term.

Licensor Improvements means any and all Improvements relating to the Licensor Technology made, conceived, or reduced to practice by (i) either Licensor or Licensee or both in the conduct of the Original Work Plan under the Original Agreement or the Work Plan under this Agreement, (ii) either Licensor or Licensee or both under this Agreement.

Patent Rights shall mean individually and collectively any and all patents and/or patent applications and provisional applications, all inventions disclosed therein, and any and all continuations, continuations-in-part, continued prosecution applications, divisions, renewals, patents of addition, reissues, confirmations, registrations, revalidations, revisions and re-examinations thereof, utility models, petty patents, design registrations and any and all patents issuing therefrom and any and all foreign counterparts thereof and extensions of any of the foregoing including without limitation extensions under the U.S. Patent Term Restoration Act, extensions under the Japanese Patent Law, and Supplementary Protection Certificates (SPCs) according to Counsel Regulation (EEC) No. 1768/92 and similar extensions for other patents under any applicable law in any country of the world.

Field of Use

Factor VIIa is used in the treatment of bleeding episodes and for the prevention of bleeding during surgery or invasive procedures in patients with congenital hemophilia with inhibitors to coagulation Factors VIII or IX.

License Grant

Licensor hereby grants to Licensee a limited, worldwide, nonexclusive, nontransferable, nonsublicensable license, during the term of this Agreement, under the Licensor Technology (to the extent Licensor is not prevented under its existing contracts to license such Licensor Technology to Licensee and its Licensor) to import, Sell and have Sold Diagnostic Products to Customers for a Diagnostic Use.  Notwithstanding the foregoing, Licensee shall have no right to, and will not (i) Sell, distribute or otherwise transfer or dispose of Arrays alone, as a component of or bundled with any products qr services except as part of Diagnostic Products, (ii) make or have made Arrays in any manner or (iii) make or have made Licensor  Instruments or components thereof.

Licensor hereby grants to Licensor a nonexclusive, worldwide, nontransferable, nonsublicensable, royalty-free license, during the term of this Agreement, to use and display Licensor Trademarks on Diagnostic Products, Diagnostic Instruments, components of such Diagnostic Products or Diagnostic Instruments, and materials related to the marketing, promotion and/or use of Diagnostic Products or Diagnostic Instruments.  No other right to use the Licensor name or any Licensor Trademark is granted or implied by this Agreement.

License Property

Licensed Patent shall have the meaning of a patent included in the Licensor Technology.

Defined Technology shall mean all Intellectual Property owned by Licensor (other than as set forth below) useful for the detection of nucleic acids for any human diagnostic purpose that, (i) insofar as it relates to microarrays, utilizes less than 200 single nucleotide polymorphisms (SNPs) or genes per microarray on a single support and has a density of less than 100 spots per square centimeter; or (ii) insofar as it involves standard microtiter plates, utilizes plates with up to 384 wells per standard microtiter plate, provided that each well contains no more than four individual  analytes; provided that “Defined Technology” does not include any Licensor Content or Licensor Intellectual Property pertaining to photolithographic technology, or, in addition, any Licensor Intellectual Property that is subject to existing exclusive rights that would prevent the granting of the covenant contained in agreement.

Authorized Use of Logo & Trademark 'Powered by Affymetrix. The Way Ahead.â„¢

Field of Use

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 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
(1)           genetic testing, including determinations of genetic predisposition;
(2)           oncology and cancer predisposition testing;
(3)           testing for tissue typing (excluding the Human Identity Field);
(4)           infectious disease detection, screening, confirmation and monitoring; and
(5)           therapeutic drug monitoring.
For purposes of this Agreement, the term In Vitro Human Diagnostics Field shall not include the Human Identity Field, nor shall such term include the measurement or observation of samples of material other than samples of material obtained from human beings. In no event shall the term “In Vitro Human Diagnostics Field” include or be construed to include the performance of PCR for the detection of pathogens for use in blood bank screening and the plasma fractionation industry.

License Grant

Prior to the Effective Date of this Agreement, the Parties have been involved in collaborative efforts to jointly develop assays for the ANAIS Instrumentation.

By this agreement, the Parties shall cooperate in the Development Transition and in the transfer of any information and Know-How necessary for Licensee to assume the development of the ANAIS Products.

Licensor grants a non-exclusive, non-transferable, worldwide license in the ANAIS Field to use the Licensor Technology to develop, make and have made, use, sell, offer for sale, have sold, and import the ANAIS Products, solely and exclusively for use on the ANAIS Instrumentation.

License Property

The ANAIS Instrument shall be an automated laboratory instrument for performing nucleic acid assays utilizing High Density DNA Probe Arrays.
Key BioChemistry Components include
– All enzymes used in transcription-based amplification for use in ANAIS Assays.
– All biochemical components used for amplification of amplicon of target with TMA, which is Licensors patents and technology relating to Nucleic Acid Sequence Amplification Methods.
– All probes, primers, and oligonucleotides used in ANAIS Assays.
– Nucleic acids used for ,positive and negative controls, standards, calibrators, and for quality control of ANAIS Assay components.

ANAIS products shall mean the following Probe Assays, in each case made, used, or sold under the license granted by Licensor and solely and exclusively for use on ANAIS Instrumentation
– Probe Assays for the detection, identification, quantification, and/or susceptibility testing for panels of microorganisms or agents (but specifically excluding single organisms) in specimens taken from humans, solely for the purpose of diagnosis and medical care of the persons from whom the tested samples were taken. A panel shall test for 10 or more distinct species of organisms or agents in the following groups of microorganisms
or agents  Bacteria; Viruses; Yeast/Fungi; or, Parasites.The panels shall be medically relevant.

– Probe Assays for the detection, identification, quantification, and/or susceptibility testing for an individual organism, drawn only from the groups or families listed below, in specimens taken from humans, solely for the purpose of diagnosis and medical care of the persons from whom the tested samples were taken Hepatitis virus; HIV virus; Herpes virus; Human papilloma virus; HTLV Virus; Yeast; Fungus; Parasite; and, Bacterium other than Neisseria gonorrhoeae or Chlamydia trachomatis.

– Probe Assays for testing of sequences encoding human leukocyte antigens in specimens taken from humans and/or

– Probe Assays to detect and /or precisely identify microorganisms or agents including bacteria, yeast, viruses and parasites for use in quality control processes of water, food products, and/or previously developed pharmaceutical or cosmetic products, and/or identify foods coming or derived from plants and/or/ animals for the purpose of confirming anticipated source(s) of the food.

Assay shall mean a diagnostic process or procedure applied to a sample, or a portion of a sample, whereby a particular chemical compound, or a collection of compounds, or a portion of a chemical compound, is detected and optionally quantified.

Field of Use

The ANAIS Field shall mean
– the detection, identification, quantification, and/or susceptibility testing of organisms or agents causing human clinical infectious diseases, as present in the human body, solely for the purpose of diagnosis and medical care of the persons from whom the tested samples were taken;
– testing for sequences encoding human leukocyte antigens;
– testing for microorganisms or agents, including bacteria, yeast, viruses and parasites in quality control processes of water, food products, and/or previously developed pharmaceutical or cosmetic products; and/or
– testing for the purposes of identifying genetically-modified foodstuffs or identifying animal species in foodstuffs.

The ANAIS Field specifically does not include testing for infectious agents in blood and blood products intended for transfusion, or the testing for infectious agents in blood in connection with organ transplants, or the testing of specimens from non-human animals or environmental sources except as specifically provided above, even if such testing is for the purpose of detecting or identifying organisms which are associated with infectious diseases in man.