Common use of Human In Vitro Diagnostics Field Clause in Contracts

Human In Vitro Diagnostics Field. The phrase “Human In Vitro Diagnostics Field” shall mean the field of use comprising products, technologies, services and/or processes for use in the measurement, observation or determination of attributes, characteristics, diseases, traits or other conditions of a human being: · for the medical management of a human being; and/or · for quality control or testing of human blood or tissue for transfusion or blood banking, bone marrow transplantation or banking, or tissue typing for transplantation (where “banking” refers to human samples that are stored in anticipation of future implantation into the donor or transplantation into another human recipient). Examples of activities in the HIVD Field: · Development, manufacture, or sale of anything labeled for in vitro diagnostic use or any testing products labeled for investigational use; · Development, manufacture, or sale of products designated as Analyte Specific Reagents (ASRs) by FDA or corresponding reagent products in foreign regulatory jurisdictions and general purpose reagents (GPRs) that are specifically sold for use with ASRs or such reagent products; · Development or sale of software products for the interpretation of data to provide an HIVD clinical test result; · Development, manufacture, or sale of products that convey amplification, sequencing, or other patent rights in the HIVD Field, or products that are designated specifically for use with products that convey amplification, sequencing, or other patent rights in the HIVD Field; · Genetic testing for sample tracking in a clinical laboratory; · Sale of any in vitro testing products regulated by the FDA, including products claimed to be produced under Quality System Regulation to be sold to IVD companies or clinical testing laboratories; · In- and out-licensing or other transfer of patents, technology, or know-how for HIVD use (including any accompanying contract manufacture of custom reagents for specific diagnostic customers’ homebrew testing, whether or not the reagents are produced under Quality System Regulation); · Development, manufacture, or sale of, or providing service and support for, systems (reagents, components and/or instruments) developed and manufactured for HIVD use or developed specifically for use with ASRs (or their counterparts outside the US); and · Provision of HIVD testing services. Examples of activities not in the HIVD Field: · Development, manufacture, or sale of products or services for basic and applied research, including clinical research where the medical management of a patient is not involved, unless the product or service is regulated as an in vitro diagnostic test or ASR by the FDA or its foreign counterparts; · Development, manufacture, or sale of products or services for quality assurance and quality control, including testing to determine conformance with specifications, purity and batch-to-batch consistency, but excluding human plasma or tissue-derived samples for the pharmaceutical industry; · Testing of environmental samples, including the detection of organisms, where the medical management of a human is not involved; · Identity testing applications for forensic purposes or determination of paternity, excluding genotyping or other identification testing for medical management of a human being or sample tracking in a clinical laboratory; · In vitro diagnostic testing of non-human (plant or animal) samples, including animal breeding, pedigree determination, or gender determination; · Testing for the agricultural or food industries, including the identification of genetically modified organisms (GMOs) for these industries; · Sale or service of general purpose (“open”) instrument systems or general purpose reagents, including enzymes; unless such GPRs are specifically sold for use with ASRs or other products regulated by the FDA or its foreign counterparts; · Sale of non-exclusive information products and services not regulated by FDA (such as the Celera Discovery System) to any customers, including those customers operating in the HIVD Field; · Sale of anything labeled for therapeutic or prophylactic use; · Sale of products or services that convey therapeutic or research patent rights; · In- and out- licensing or other transfer of patents, technology or know-how for use in the therapeutic, research, or applied fields; · Embryonic stem cell and recombinant cell characterization, testing, and quality control applications; and · Epidemiology testing (the screening or testing of groups of people or populations for the study of the patterns, causes, or control of disease in groups of people) and biosecurity testing (the detection of biological or chemical agents, pathogens, microorganisms or other infectious agents in the environment, agriculture, food or water), where the medical management of a human is not involved.

Human In Vitro Diagnostics Field. The phrase “Human In Vitro Diagnostics Field” shall mean the field of use comprising products, technologies, services and/or processes for use in the measurement, observation or determination of attributes, characteristics, diseases, traits or other conditions of a human being: · • for the medical management of a human being; and/or · • for quality control or testing of human blood or tissue for transfusion or blood banking, bone marrow transplantation or banking, or tissue typing for transplantation (where “banking” refers to human samples that are stored in anticipation of future implantation into the donor or transplantation into another human recipient). Examples of activities in the HIVD Field: · • Development, manufacture, or sale of anything labeled for in vitro diagnostic use or any testing products labeled for investigational use; · • Development, manufacture, or sale of products designated as Analyte Specific Reagents (ASRs) by FDA or corresponding reagent products in foreign regulatory jurisdictions and general purpose reagents (GPRs) that are specifically sold for use with ASRs or such reagent products; · • Development or sale of software products for the interpretation of data to provide an HIVD clinical test result; · • Development, manufacture, or sale of products that convey amplification, sequencing, or other patent rights in the HIVD Field, or products that are designated specifically for use with products that convey amplification, sequencing, or other patent rights in the HIVD Field; · • Genetic testing for sample tracking in a clinical laboratory; · • Sale of any in vitro testing products regulated by the FDA, including products claimed to be produced under Quality System Regulation to be sold to IVD companies or clinical testing laboratories; · • In- and out-licensing or other transfer of patents, technology, or know-how for HIVD use (including any accompanying contract manufacture of custom reagents for specific diagnostic customers’ homebrew testing, whether or not the reagents are produced under Quality System Regulation); · • Development, manufacture, or sale of, or providing service and support for, systems (reagents, components and/or instruments) developed and manufactured for HIVD use or developed specifically for use with ASRs (or their counterparts outside the US); and · • Provision of HIVD testing services. Examples of activities not in the HIVD Field: · • Development, manufacture, or sale of products or services for basic and applied research, including clinical research where the medical management of a patient is not involved, unless the product or service is regulated as an in vitro diagnostic test or ASR by the FDA or its foreign counterparts; · • Development, manufacture, or sale of products or services for quality assurance and quality control, including testing to determine conformance with specifications, purity and batch-to-batch consistency, but excluding human plasma or tissue-derived samples for the pharmaceutical industry; · • Testing of environmental samples, including the detection of organisms, where the medical management of a human is not involved; · • Identity testing applications for forensic purposes or determination of paternity, excluding genotyping or other identification testing for medical management of a human being or sample tracking in a clinical laboratory; · • In vitro diagnostic testing of non-human (plant or animal) samples, including animal breeding, pedigree determination, or gender determination; · • Testing for the agricultural or food industries, including the identification of genetically modified organisms (GMOs) for these industries; · • Sale or service of general purpose (“open”) instrument systems or general purpose reagents, including enzymes; unless such GPRs are specifically sold for use with ASRs or other products regulated by the FDA or its foreign counterparts; · • Sale of non-exclusive information products and services not regulated by FDA (such as the Celera Discovery System) to any customers, including those customers operating in the HIVD Field; · • Sale of anything labeled for therapeutic or prophylactic use; · • Sale of products or services that convey therapeutic or research patent rights; · • In- and out- licensing or other transfer of patents, technology or know-how for use in the therapeutic, research, or applied fields; · • Embryonic stem cell and recombinant cell characterization, testing, and quality control applications; and · • Epidemiology testing (the screening or testing of groups of people or populations for the study of the patterns, causes, or control of disease in groups of people) and biosecurity testing (the detection of biological or chemical agents, pathogens, microorganisms or other infectious agents in the environment, agriculture, food or water), where the medical management of a human is not involved.

Human In Vitro Diagnostics Field. The phrase “Human In Vitro Diagnostics Field” shall mean the field of use comprising products, technologies, services and/or processes for use in the measurement, observation or determination of attributes, characteristics, diseases, traits or other conditions of a human being: · for the medical management of a human being; and/or · for quality control or testing of human blood or tissue for transfusion or blood banking, bone marrow transplantation or banking, or tissue typing for transplantation (where “banking” refers to human samples that are stored in anticipation of future implantation into the donor or transplantation into another human recipient). Examples of activities in the HIVD Field: · Development, manufacture, or sale of anything labeled for in vitro diagnostic use or any testing products labeled for investigational use; · Development, manufacture, or sale of products designated as Analyte Specific Reagents (ASRs) by FDA or corresponding reagent products in foreign regulatory jurisdictions and general purpose reagents (GPRs) that are specifically sold for use with ASRs or such reagent products; · Development or sale of software products for the interpretation of data to provide an HIVD clinical test result; · Development, manufacture, or sale of products that convey amplification, sequencing, or other patent rights in the HIVD Field, or products that are designated specifically for use with products that convey amplification, sequencing, or other patent rights in the HIVD Field; · Genetic testing for sample tracking in a clinical laboratory; · Sale of any in vitro testing products regulated by the FDA, including products claimed to be produced under Quality System Regulation to be sold to IVD companies or clinical testing laboratories; · In- and out-licensing or other transfer of patents, technology, or know-how for HIVD use (including any accompanying contract manufacture of custom reagents for specific diagnostic customers’ homebrew testing, whether or not the reagents are produced under Quality System Regulation); · Development, manufacture, or sale of, or providing service and support for, systems (reagents, components and/or instruments) developed and manufactured for HIVD use or developed specifically for use with ASRs (or their counterparts outside the US); and · Provision of HIVD testing services. Examples of activities not in the HIVD Field: [***] indicates material that has been omitted pursuant to a request for confidential treatment. The omitted material has been filed separately with the Securities and Exchange Commission. · Development, manufacture, or sale of products or services for basic and applied research, including clinical research where the medical management of a patient is not involved, unless the product or service is regulated as an in vitro diagnostic test or ASR by the FDA or its foreign counterparts; · Development, manufacture, or sale of products or services for quality assurance and quality control, including testing to determine conformance with specifications, purity and batch-to-batch consistency, but excluding human plasma or tissue-derived samples for the pharmaceutical industry; · Testing of environmental samples, including the detection of organisms, where the medical management of a human is not involved; · Identity testing applications for forensic purposes or determination of paternity, excluding genotyping or other identification testing for medical management of a human being or sample tracking in a clinical laboratory; · In vitro diagnostic testing of non-human (plant or animal) samples, including animal breeding, pedigree determination, or gender determination; · Testing for the agricultural or food industries, including the identification of genetically modified organisms (GMOs) for these industries; · Sale or service of general purpose (“open”) instrument systems or general purpose reagents, including enzymes; unless such GPRs are specifically sold for use with ASRs or other products regulated by the FDA or its foreign counterparts; · Sale of non-exclusive information products and services not regulated by FDA (such as the Celera Discovery System) to any customers, including those customers operating in the HIVD Field; · Sale of anything labeled for therapeutic or prophylactic use; · Sale of products or services that convey therapeutic or research patent rights; · In- and out- licensing or other transfer of patents, technology or know-how for use in the therapeutic, research, or applied fields; · Embryonic stem cell and recombinant cell characterization, testing, and quality control applications; and · Epidemiology testing (the screening or testing of groups of people or populations for the study of the patterns, causes, or control of disease in groups of people) and biosecurity testing (the detection of biological or chemical agents, pathogens, microorganisms or other infectious agents in the environment, agriculture, food or water), where the medical management of a human is not involved. [***] indicates material that has been omitted pursuant to a request for confidential treatment. The omitted material has been filed separately with the Securities and Exchange Commission.