Royalty Report: Diagnostic, Medical, Test/Monitoring – Collection: 230776

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

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 appoints Canadian Licensee and each of its Affiliates as (i) a distributor, developer, marketer, manufacturer, and seller of the Kits in the Territory; and (ii) a distributor, marketer and reseller of the Licensor Instruments in the Territory, the whole in accordance with prices, terms and conditions determined by Licensee, in its discretion; provided, however, that the Beads are sold only as part of Kits, and further provided that Kits are designed and sold solely for use within the Field(s) and subject to the End User restrictions and provided such Licensor Instruments and Beads are not purchased from a then-existing licensee of Licensor technology. Licensee shall have the right to advertise the Beads and Licensor Instrument under the trademarks, marks, and trade names of Licensor set forth.

License Property

Beads means fluorescently-dyed carboxylated microsphere beads supplied by Licensor for use with Licensor Instruments and made available by Licensor generally to customers for use in tests as specifically set forth in this Agreement.

Kit means the combination of (i) Beads conjugated to biological reactants, (ii) Beads conjugated to universal sequences, (iii) standards for use with (i) and (ii), and (iv) other ancillary materials (e.g. buffers) intended for use with (i) and/or (ii) and required for performance of Tests. A “Kit(s)” must contain all of the foregoing components and must be branded by Licensee in accordance with this Agreement.

Licensor Instrument means a laser-based fluorescent analytical test system consisting of Licensor’s instrumentation and the Software, with computer components, as specifically identified as Licensors 200 IS 2.3 Total System.

Licensor Intellectual Property Rights means Patent Rights, copyrights and all other intellectual property rights that Licensor has or acquires during the Term in connection with the Beads or the Licensor Instruments, by way of sale, license or otherwise, but shall exclude the intellectual property rights licensed to Licensor under the License Agreement between the Parties dated March 28, 2001.

Trademarks
Flowmetrix®
Luminex®
Lumavidin®
LabMAP®
xMAP®
Luminex® 100TM
Luminex® 100TM IS
Luminex® 200TM
Suspension Array TM
Luminex® XYPTM
Luminex® SDTM
Luminex® HTSTM
Luminex® FlexMAPTM
Luminex® SeroMAPTM

Field of Use

Field One means the field of DNA-based In-Vitro Diagnostics. DNA-based In-Vitro Diagnostics means DNA-based testing used for clinical diagnosis within the Territory for the quantitative or qualitative testing or measurement of human samples to assist clinicians (i) in determining the predisposition and/or prediction and/or diagnosis and/or carrier screening, of familial and/or other genetic related diseases or conditions; (ii) in the diagnosis or epidemiological surveillance or screening, of infectious related diseases or conditions; (iii) in determining the predisposition and prediction and/or diagnosis of cancers of all types, including solid and lymphatic.

Field Two means the field of Custom Swine SNP Assays for Maxxam Analytics. Custom Swine SNP Assays for Maxxam Analytics means custom swine assays sold to Maxxam, incorporating sequences/SNPs provided to Licensee by Maxxam Analytics, a Canadian corporation, with its principal offices at 6740 Campobello Rd., Mississauga, Ontario LSN 2L8, Canada.

Licensees research and development efforts and product pipeline are focused in the fields of human genetic disorders, personalized medicine (pharmacogenomics or PGx – the use of genetic testing to help determine the prescription of drugs) and infectious diseases.

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.

License Grant

Licensor offers to the polymerase chain reaction (PCR) process users commercial and non commercial license rights under these patents and patent applications for automated performance of the PCR process for research and certain other fields that include, inter alia, an up-front fee component based on the capacity of thermal cyclers used to perform the process.

Licensor grants to the Thermal Cycler Supplier the following personal, non-transferable, non-exclusive rights in the Territory under the Amplification Patent Rights
—  Thermal Cycler Supplier is hereby authorized to sell and distribute to end users under Thermal Cycler Suppliers name and trademarks the specific thermal cyclers and temperature cycling instruments, i.e. the Smart Cycler(R) System, Smart Cycler(R) XC System and GeneXpert(TM) Prototype, in the configurations described) and any thermal cycler or temperature cycling instrument containing one or more I-CORE(TM) modules manufactured by Thermal Cycler Supplier, but not otherwise to sell or distribute to thermal cycler suppliers, with a label conveying to end users, including Thermal Cycler Supplier itself, in the Fields the up-front rights of PCR process licenses under the Amplification Patent Rights, that  is, with an Authorized Thermal Cycler label; and
—  Thermal Cycler Supplier may advertise and promote such thermal cyclers and temperature cycling instruments and so labeled as Authorized Thermal Cyclers for PCR.

Licensor grants to Thermal Cycler Supplier a personal, non-transferable, non-exclusive right under the Amplification System Patent Rights to convey to end-user customers, including Thermal Cycler
Supplier itself, of Thermal Cycler Suppliers Authorized Thermal Cyclers a non-exclusive license to use the same in the Fields in the Territory.

License Property

The patents include
—  describing and claiming gene amplification processes including, among others, a process known as the polymerase chain reaction (PCR) process, which are owned by Roche Molecular Systems, Inc., and amplification process claims in corresponding counterpart patents and patent applications in other countries, and,
—  automated apparatus suitable for performing the PCR process, and apparatus claims in corresponding counterpart patents and patent applications, and,
—  improvements in thermal cycling apparatus for- PCR, including a pressing heated cover, and corresponding counterpart patents and patent applications in other countries,and,
—  describing and claiming an amplification system comprising PCR reagents and a thermal cycler programmed to carry out a PCR protocol,and,
—  claim automated performance of the PCR process using certain programmed thermal cyclers.

Field of Use

Licensee has received a license from Licensor for thermal cycling limited to the fields of life sciences research, industrial testing, aspects of identity testing and forensics. Licensee will require a license for thermal cycling in additional fields, such as clinical diagnostics.

Licensee's I-CORE module is a low-cost, self-contained instrument for performing and continuously monitoring chemical reactions such as PCR. Each module can optically measure up to four separate reactions. The I-CORE module rapidly and accurately controls the heating and cooling of the sample, which allows for fast reactions and accurate results. I-CORE modules can be configured into a variety of DNA analysis instruments or can be sold to manufacturers of large clinical and research instruments for incorporation into their instrument platforms. The I-CORE module is a key component in both our Smart Cycler and GeneXpert families of products.

The discovery of PCR and other amplification techniques dramatically improved the turnaround and time sensitivity of DNA probe assays. PCR acts on a target molecule to generate a million or more copies of the target nucleic acid sequence through repeated cycles of heating and cooling. Originally, this thermal cycling was accomplished by manually moving the sample between hot and cold water baths. Detection is typically accomplished by tagging the DNA with fluorescent dyes and manually placing the amplified sample on a gel to read it. Later, thermal cyclers were developed to automate the heating and cooling functions, and fluorimeters were developed to read the fluorescent signal.

Fields shall mean research and development, quality assurance or control, environmental testing, plant diagnostics, identity testing (other than parentage testing for humans) and forensics.  The Fields specifically exclude human and veterinary diagnostics.

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

With this amended and restated agreement, Licensee desires a non-exclusive license under the patent applications, and patents that may issue therefrom, to develop and perform Assays and market Kits in one or more fields.

Licensor grants a non-exclusive immunity from suit in the Territory under Licensor Patent Rights
– to itself perform Licensed Assays;
– to make, have made, use, sell and promote Licensed Kits, and to pass on to end-user purchasers the right to use those Licensed Kits in the Licensed Fields under PHRI Patent Rights; and,
– to develop Licensed Assays and Licensed Kits, and to test Licensed Kits for quality control.

License Property

The licensed property is improvements in fluorescently labeled nucleic acid detection probes, and kits and assays employing such probes.  The patents include but are not limited to Hybridization Probes for Nucleic Acid Detection, Universal Stems, Methods and Kits, and, Detectably Labeled Dual Conformation Oligonucleotide Probes, Assays and Kits, and, Nucleic Acid Detection Probes Having Non-FRET Fluorescence Quenching and Kits and Assays Including Such Probes, and, Non-competitive Co-Amplification Methods, and, Wavelength-Shifting Probes and Primers and Their Use In Assays and Kits, and, Assays for short sequence Variants.

Field of Use

Licensed Fields shall mean the fields of Human In Vitro Diagnostics, Food Testing, and Environmental Testing.

Human In Vitro Diagnostics ( HIVD) shall mean the field of use comprising the in vitro measurement, observation or determination of one or more protein or nucleic acid targets in a sample obtained from a human being for medical management of that human being or for blood banking, bone marrow banking or similar banking of human tissues for human medical management, and pre-clinical uses and clinical trials for the foregoing uses, even if kits for such purposes are labeled Research Use Only or Investigational Use Only.

Food Testing shall mean the field of use comprising the in vitro measurement, observation, or determination of one or more protein or nucleic acid targets of an organism in a sample obtained from food and/or sources of food intended for human consumption in order to determine whether or not that food is fit for consumption.

Environmental Testing shall mean the field of use comprising the in vitro measurement, observation or determination of one or more protein or nucleic acid targets of microorganisms (including bacteria, yeast, viruses and parasites) for the purpose of detecting and/or monitoring environmental contamination in (a) materials associated with a manufacturing process, excluding samples of food intended for consumption, or (b) samples collected from air, soil, water or other liquids, particles or surfaces. Environmental Testing includes testing for the presence of microbiological agents used for bioterrorism and biowarfare.

License Grant

Licensor of Switzerland grants a non-exclusive and non-transferable license, without the right to sublicense, under the Licensed Patents in the Territory with the rights to
—  incorporate Licensed Products into Licensee’s Complete Diagnostic Kits,
—  make, offer to sell and sell such Complete Diagnostic Kits in the Licensed Field, and
—  convey with the sale of such Complete Diagnostic Kits the right to use the Complete Diagnostic Kits under the Licensed Patents in the Licensed Field. Licensee’s right to use Complete Diagnostic Kits includes the right to perform evaluations and validations of Complete Diagnostic Kits, but specifically does not include the right to use Complete Diagnostic Kits for the performance of diagnostic services or testing, except that Licensee may use Complete Diagnostic Kits as End Users.

License Property

Licensor owns or controls certain Licensed Patents relating to chemically modified thermostable DNA polymerases, also known as Hot Start Enzymes, for use in polymerase chain reaction, or PCR, technology.

Licensed Product means a chemically modified thermostable DNA polymerase, the manufacture, use or sale of which is covered by one or more Valid Claims of the Licensed Patents, sold by Licensor, directly or through its distributor, or made and sold by a supplier licensed to make and sell the same.

Complete Diagnostic Kit means a Licensee manufactured and trademarked kit covered by one or more Valid Claims of the Licensed Patents, not covered by any Licensor patents other than the Licensed Patents and dedicated for use for PCR in the Licensed Field, and which Licensee manufactured and trademarked kit is comprised of, at a minimum, the essential active reagents used in the practice of PCR for nucleic acid testing in the Licensed Field. For the avoidance of doubt and for the sake of clarification, ASRs, Analyte Specific Reagents, are not Complete Diagnostic Kits.

U.S. Patent No. 5,677,152 — Issued October 14, 1997 (process and kit claims only) Nucleic Acid Amplification Using a Reversibly Inactivated Thermostable Enzyme

U.S. Patent No. 5,773,258 — Issued June 30, 1998 (process and kit claims only) Nucleic Acid Amplification Using a Reversibly Inactivated Thermostable Enzyme

U.S. Patent No. 6,127,155—Issued October 3, 2000 (reaction mixture claims only) Stabilized Thermostable Nucleic Acid Polymerase Compositions Containing Non-Ionic Polymeric Detergents

Field of Use

The Licensed Field means the field of use consisting of products or processes for the measurement, observation or determination of a disease, disease state or genetic predisposition to a disease, by detecting, quantitating, distinguishing and/or monitoring nucleic acids in samples of material originating from a human being for the medical management for that human being, but excluding
—  human identity testing, and
—  the following human disease targets Hepatitis A Virus, Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus, Human Papilloma Virus and Parvovirus B19; provided, however, that the said exclusions for the Human Papilloma Virus and Parvovirus B19 disease targets shall be limited to 3 years from the Effective Date after which time the Human Papilloma Virus and Parvovirus B19 disease targets shall be included within the Licensed Field subject to the royalty and other terms and conditions of this Agreement.

License Grant

Swiss Licensor grants to Licensee and its Affiliates, a non-exclusive worldwide right and license under the Licensed Patents to authorize End-Users to perform Diagnostic Services using such Licensed Products in the Licensed Fields and grants a limited, non-transferable, royalty free sublicense under the Licensed Patents to Research Collaborators of the Licensee and/or its Affiliates to practice PCR under their respective contracts with the Licensee and/or its Affiliates, in accordance with the terms and conditions of this Agreement, solely for purposes of doing applied research and development, improvement, quality control and/or quality assurance for the Licensee and/or its Affiliates of Licensed Products to be Sold or otherwise commercialized in the Licensed Fields in accordance with the other terms and conditions of this Agreement; and (iii) to use PCR technology internally by Licensee or its Affiliates for the research, development, improvement and quality control and quality assurance of Licensed Products for Sale in the Licensed Fields, and to practice PCR technology solely in the United States to make Licensed Products in the DNA Manufacturing Field; and (iv) to perform Licensed Tests within the PlasmaTesting Field within the Territory for internal use only.

License Property

Animal means all animals, other than human, whether dead or alive or extinct, and specifically includes animal embryos but not human embryos.

Animal Breeding Applications means the analysis of biological specimens for the determination of genetic traits in Animals for the purpose of selective breeding of said Animals. Animal Breeding Applications specifically exclude testing for disease-related traits for the purpose of treating the test Animal for that disease.

PCR means the 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 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.

Test Process means with respect to the Plasma Testing Field (a) the polymerase chain reaction process covered by the method claims of US 4,683,195 and 4,683,202, the foreign counterparts thereof and any reissue and/or reexamination patent rights thereof, (b) the reverse transcription process covered by the method claims of US 5,407,800, US 5,322,770 and US 5,310,652, the foreign counterparts thereof and any reissue and/or reexamination patent rights thereof, or (c) the method claims of US 5,008,182, US 5,176,995 and US 5,219,727, and claims 1-4, 8, 9 and 15-18 of US 5,476,774, the foreign counterparts thereof and any reissue and/or reexamination patent rights thereof.

Field of Use

Licensee is interested in, among other things, acquiring a worldwide license from Swiss Licensor under certain of Licensor's patents for the purpose of developing and commercializing PCR-based in vitro human diagnostic products for use in clinical diagnostic testing.  Licenseeis also interested in acquiring a worldwide license from Licensor under certain of Licensor's patents for the purpose of developing and commercializing PCR-based paternity testing products for use in parentage determination.  Licensee is also interested in acquiring a worldwide license from Licensor under certain of Licensor's patents for the purpose of developing and commercializing PCR-based in vitro animal diagnostic products for use in animal testing.

Licensed Fields means the Animal Diagnostics Field, the Paternity Field, HLA Typing, the In Vitro Human Diagnostics Field, the Plasma Testing Field, and the DNA Manufacturing Field.

Plasma Testing Field means the performance of a Licensed Test solely for screening blood or blood products and/or quality control purposes at various stages in the production of blood products, and shall specifically exclude any use of a test result for diagnostic or treatment of disease in any particular individual. IGEN and its Affiliates may notify potentially infected donors of the results of Licensed Tests when either (a) such notifications required by law or governmental regulation, or (b) such potentially infected person is charged a fee by IGEN or its Affiliates for such notification. When potentially infected donors are notified in accordance with either (a) or (b) above, such notification shall not be considered as use of a test result for diagnosis or treatment of disease in any particular individual.

Animal Diagnostics Field means use of products and diagnostic processes utilizing PCR solely for analyzing specimens taken from an Animal (excluding a Human), including without limitation, blood, bodily fluid or tissue, for the purpose of testing, with respect to that Animal, for a physiological or pathological state, a congenital abnormality, or the safety and compatibility of a treatment; monitoring therapeutic measures or for detecting microorganisms or any other analyte associated with infectious and/or non-infectious diseases in Animals; Animal genetic diseases; genetic predisposition to disease in Animals, or genetic traits in Animals, including determining the sex of Animals, but specifically excluding Animal Identity Applications, Animal Breeding Applications, GMO Testing Applications, and testing performed on Animal tissue intended for use in xenotransplantation.

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 grants a non-exclusive license under the Licensed Patents in the Field in the Territory during the License Term, to make, have made, use, offer to sell, sell and import Licensed Services.  Licensee shall have the right to sublicense.

License Property

The patents and technology relate to Colorectal Cancer Assay, meaning any colorectal cancer diagnostic or monitoring test including but not limited to screening, diagnosis, staging, monitoring and pharmacogenetic testing.

Field of Use

The field shall mean colorectal cancer assays used for specialty testing.

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

For the Thermal Cycling Instrument; Algorithm; Pressing Heated Cover Patent Rights; and, Progeny Patent Rights, Licensor grants to under the Thermal Cycling Instrument Patent Rights, the Algorithm Patent Rights, Progeny Patent Rights, and the Pressing Heated Cover Patent Rights a personal, non-transferable, non-exclusive license in the Fields and in the Territory to make but not have made, to use and to sell the following to end users solely under Thermal Cycler Suppliers name and trademarks but not otherwise to manufacture for, or sell or distribute to, thermal cycler suppliers.

For the Amplification Patent Rights, Licensor grants to Thermal Cycler Supplier the following personal, nontransferable, non-exclusive rights in the Territory under the Amplification Patent Rights.

For the Amplification System Patent Rights and Automated Method Patent Rights, Licensor grants to Thermal Cycler Supplier a personal, non-transferable, non-exclusive right under the Amplification System Patent Rights and the Automated Method Patent Rights to convey to end-user customers of Thermal Cycler Suppliers Thermal Cyders and Temperature Cycling Instruments sold or distributed solely under Thermal Cycler Suppliers name and trademarks a non-exclusive license to use the same in the Fields in the Territory.

License Property

Licensor has the power to convey certain limited rights for research and in certain other fields under the now expired Patents describing and claiming gene amplification processes including, among others, a process known as the polymerase chain reaction (PCR) process.

Licensor owns Patents describing and claiming automated apparatus suitable for performing the PCR process, and apparatus claims in corresponding counterpart patents.

Licensor owns Patents describing and claiming improvements in thermal cycling apparatus for PCR, including methods comprising calculating sample temperatures ( algorithm claims) and a pressing heated cover, and corresponding counterpart patents and patent applications in other countries.

Licensor owns Patent describing and claiming an amplification system comprising PCR reagents and a thermal cycler programmed to carry out a PCR protocol.

Licensor owns patents and applications that claim automated performance of the PCR process using certain programmed thermal cyders.

Field of Use

The Fields shall mean research and development, quality assurance or control, environmental testing, food testing, plant diagnostics, identity testing ( other than parentage testing for humans) and forensics. The Fields specifically exclude human and veterinary diagnostics.

Product relates to Polymerase Chain Reaction (PCR) and instruments (thermal cycler) for performing PCR.
Polymerase chain reaction is a method widely used to rapidly make millions to billions of copies of a specific DNA sample, allowing scientists to take a very small sample of DNA and amplify it to a large enough amount to study in detail.

License Grant

Licensor hereby grants to Licensee under the Licensed Patents a personal, non-transferable, non-exclusive license in the Licensed Field and in the Territory, with no rights to sublicense, to sell directly or indirectly through distributors  and to otherwise exploit, in all cases under Licensee’s trademarks and trade names, Licensed Products in the form of complete Licensed Real-Time Thermal Cyclers as well as any add-on, substitute, repair and replacement components, including, without limitation, software or hardware, and not as a foundry or OEM manufacturer for Third Parties.

License Property

Licensed Patents shall mean the Algorithm and Heated Cover Patent Rights, the Amplification System Patent Rights, the Automated Method Patent Rights, the Real-Time Apparatus Patent Rights and the Thermal Cycling Instrument Patent Rights.

Licensor owns patent(s) that describe and claim automated thermal cycling apparatus capable of performing and detecting nucleic acid amplification in real time.  Licensor owns patent(s) describing and claiming automated apparatus suitable for performing the PCR process, and apparatus claims in corresponding counterpart patents and patent applications in other countries;  describing and claiming an amplification system comprising PCR reagents and a thermal cycler programmed to carry out a PCR protocol; and, automated performance of the PCR process using certain programmed thermal cyclers.

Licensed Product shall mean a Licensed Real-Time Thermal Cycler, including any components, replacement parts, upgrades, computer software or hardware for or in the foregoing, the Exploitation of which would, but for the rights granted under this Agreement, infringe at least one Valid Claim of the Real-Time Apparatus Patent Rights.

License refers to patents for nucleic acid sequencing and real time PCR thermalcycling in diagnostics market.

Field of Use

Licensed Field shall mean Licensed Products and processes for the use thereof, that are neither sold nor used in the Applied Markets, are certified to be compliant, on in vitro diagnostic medical devices (IVD-D), or when sold or used in other jurisdictions, satisfy the applicable regulatory requirements relating to in vitro human diagnostic products; are designed, configured, promoted arid intended for use with a menu of Licensee provided diagnostic kits that are approved, compliant or are otherwise cleared by the appropriate regulatory authority in each jurisdiction where the instrument is used or sold; and in the U.S., may also be used for Licensee provided Analyte Specific Reagents.

Applied Markets shall mean quality assurance and quality control, including, without limitation, conformance with specifications, purity and batch to batch consistency; testing and monitoring of environmental and food samples; identity testing (including, without limitation, for humans, animals, plants, organisms, microbes or their remains); epidemiology; and biosecurity.

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

This amendment updates the amendment date, territory and royalties.  The original agreement in non-exclusive.

License Property

The original license is for Licensed Real-Time Thermal Cycler shall mean an instrument, whether sold as an integrated product or as one or more components or modules, the manufacture, importation, offer for sale, sale or use of which would, but for the rights granted under this Agreement, infringe at least one Valid Claim of the Real-Time Apparatus Patent Rights.

Real-time PCR thermal cyclers/thermocyclers carry out quantitative PCR (qPCR) for experiments in gene expression, genetic variation, genotyping, and specific detection of rare targets, bacteria, and viruses.

Field of Use

The Fields shall mean research, and all applied fields, specifically including food testing. The term Fields does not include the Human In Vitro Diagnostic Field or veterinary in vitro diagnostic applications.

Product relates to Polymerase Chain Reaction (PCR) and instruments (thermal cycler) for performing PCR.
Polymerase chain reaction is a method widely used to rapidly make millions to billions of copies of a specific DNA sample, allowing scientists to take a very small sample of DNA and amplify it to a large enough amount to study in detail.

License Grant

Licensor grants an irrevocable, worldwide licenses to Licensee, a subsidiary, as follows
—  with respect to the Enabling Technology and related KnowHow
– an exclusive license in Microbes to develop, make, have made, use, import, have imported, offer for sale, sell or otherwise commercialize or distribute Products and corresponding Services in the Licensees Field; and
– a non-exclusive license in Category II Plants to develop, make, have made, use, import, have imported, offer for sale, sell or otherwise commercialize or distribute Products and Services in the Licensees Field; and,
—  with respect to the Enabling Technology and related KnowHow, a non-exclusive license to develop, make and use Expression Hosts for Internal Research Use; and
—  with respect to the Product Technology and related KnowHow, an exclusive license to develop, make, have made, use, import, have imported, offer for sale, sell or otherwise commercialize or distribute Products and corresponding Services in the Licensees Field.

Licensor grants a bailment to non-exclusively use the Materials provided by Licensor to Licensee to practice the licenses granted.

License Property

Enabling Technology includes, but is not limited to, End-Complementary Polymerase ReactIon,  Evolving Cellular DNA Uptake by Recursive Sequence Recombination,  Methods and Compositions for Polypeptide Engineering,  Methods and Compositions for Cellular and Metabolic Engineering, and,  Evolution of Whole Cells and Organisms by Recursive Sequence Recombination.

Field of Use

Licensees Field shall mean Biocatalyst Commercialization and Enzyme Commercialization, Building Block Development; and, Bulk Production.

The Detection and Research Reagent Field means making, having made, using, and selling of reagents, instruments, and services for the diagnostics and research supply markets, only as follows (1) clinical and diagnostic tests, including those conducted to identify genetic disease predisposition, genetic or other disease conditions, and infectious or pathogenic agents, as well as those conducted for other medical, agricultural or veterinary purposes; (2) tests for analytical/bioanalytical purposes, including those conducted for biomedical, chemical, or medical research or treatment purposes, for environmental purposes, and for forensic purposes, including paternity, maternity, or identity tests; and (3) sequencing and sequence analysis of nucleic acids or other biological polymers for any purpose.

License Grant

The University Licensor grants to the Licensee a nonexclusive license to make, have made on its behalf, use, offer to sell or sell, offer to lease or lease, import, or otherwise offer to dispose or dispose of Licensed Products in the Territory.

License Property

The Product is for a biomarker relating to warfarin sensitivity for use in a Warfarin Sensitivity Test.

Warfarin sensitivity testing (genotyping) may be used to help determine someone's likely sensitivity or, less commonly, resistance to warfarin and to help select appropriate doses. Warfarin is an anticoagulant, a drug that is prescribed to help prevent inappropriate blood clotting (thrombosis and thromboembolism) in people who are at risk, or to help keep an existing blood clotting condition from getting worse.

Field of Use

The use is for the Human clinical diagnostics field, including Research Use Only (RUO), lnvestigation Use Only, (IUO), Analyte Specific Reagents (ASR), and In Vitro Diagnostic (!VD) fields of use for anticoagulant dosing.

Licensee is a molecular diagnostics company focused on developing and commercializing our eSensor detection technology.

License Grant

Licensor shall (A) grant to Licensee a non-exclusive, non-transferable, royalty-free license to exploit such TAG Improvement for Licensees internal use, and (B) shall include internal use rights to use such TAG Improvement within the licenses granted to Product customers.

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. If Licensee is the Party proposing the development of a new Generic Kit or Standard Kit, and Licensor does not, within sixty (60) days after receipt of such New Kit Notice expressly agree to co-develop the new Generic Kit or Standard Kit described therein, then Licensee may pursue development of the new Generic Kit or Standard Kit independently of Licensor and the result is a combination kit then a royalty will be paid.

License Property

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.

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 Licensee or Licensees 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.

Field of Use

The first products to be commercialized by the alliance will include reagent kits for use with Licensor's new universal array designed to perform thousands of user-defined SNP analyses. The companies expect to follow this product launch with additional genotyping products that incorporate additional universal arrays and GBA reagents. Licensee will develop and manufacture GBA primer extension reagent kits that are directed to defined sets of SNPs and that can be customized by the end user. Licensor will develop and manufacture the universal GeneChip arrays.

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.

License Grant

Simultaneously with this Agreement, the Parties have settled a Litigation pursuant to a separate settlement agreement.

Licensor grants to Licensee under the Real-Time Apparatus Patent Rights a personal, non-transferable, non-exclusive license in the Fields and in the Territory, to make, but not have made, to use and to import, Licensed Real-Time Thermal Cyders, and to offer to sell, sell and distribute the same solely to end users, and solely under Licensees name and trademarks.

Licensor grants to Licensee under the Real-Time Apparatus Patent Rights a personal, non-transferable, non-exclusive license in the Fields and in the Territory, to make, but not have made, to use and to import add-on and substitute components, modules and software for Licensed Real-Time Thermal Cyclers, and to offer, sell and distribute the same solely to end-user Third-Party owners of Licensed Real-Time Thermal Cyclers purchased from Licensee.

License Property

The Existing Product shall mean the Licensed Real-Time Thermal Cyclers that as of the Effective Date were manufactured, made publicly available and identified in Licensees then current product catalogs.

Licensed Real-Time Thermal Cycler shall mean an instrument, whether sold as an integrated product or as one or more components or modules, the manufacture, importation, offer for sale, sale or use of which would, but for the rights granted under this Agreement, infringe at least one Valid Claim of the Real-Time Apparatus Patent Rights.

Thermal Cycler shall mean an instrument, whether in single or multiple modules, that is capable in itself of automatically cycling samples in the PCR process.

Field of Use

The Fields shall mean research, and all applied fields, specifically including food testing. The term Fields does not include the Human In Vitro Diagnostic Field or veterinary in vitro diagnostic applications.

Product relates to Polymerase Chain Reaction (PCR) and instruments (thermal cycler) for performing PCR.
Polymerase chain reaction is a method widely used to rapidly make millions to billions of copies of a specific DNA sample, allowing scientists to take a very small sample of DNA and amplify it to a large enough amount to study in detail.