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In Vitro Diagnostics shall include, among other things, the use of the SELEX Process or Aptamers in the assay, testing or determination: (a) outside of a living organism, (i) of a human substance in a test material, often to identify or follow the progression of a disease or disorder or to select a patient for treatment; (ii) of a plant substance, animal substance or other substance in a test material, often to identify or follow the progression of a disease, process or disorder in a human or non-human organism; and (iii) of environmental substances (as in water quality testing); (b) of a substance on a test material such as cells (as in FACS analysis or other measurements of pathogens within biological samples); and (c) any other in vitro diagnostic use of the SELEX Process or Aptamers in drug development processes, including target identification, pre-clinical and clinical testing, and the following more specific examples of uses of Aptamer technology: (i) to observe, through protein profiling, protein levels moving up or down in diseases or models of diseases, and to evaluate whether such proteins are sensible targets for the development of therapeutic agents; (ii) to observe coordinated expression of protein pathways in a variety of biological states in various systems; (iii) to study protein or metabolite levels during pre-clinical Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company\u2019s application requesting confidential treatment under Rule 406 of the Securities Act. drug candidate evaluation in response to putative therapeutic agents during clinical trials (e.g., as markers of efficacy or response); and (iv) to study human protein or metabolite levels in response to putative therapeutic agents during clinical trials (e.g., as markers of efficacy or response). 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In Vitro Diagnostics shall include, among other things, the use of the SELEX Process or aptamers identified through the use of the SELEX Process in the assay, testing or determination: (a) outside of a living organism, (i) of a human substance in a test material, often to identify or follow the progression of a disease or disorder, or to select a patient for treatment; (ii) of a plant substance, animal substance or other substance in a test material, often to identify or follow the progression of a disease, process, or disorder in a human or non-human organism; and (iii) of environmental substances (as in water quality testing); and (b) of a substance on a test material such as cells (as in FACS analysis or other measurements of pathogens within biological samples) and (c) any other in vitro diagnostic use of the SELEX Process or aptamers identified through the use of the SELEX Process in drug development processes, including target identification, pre-clinical and clinical testing, and the following more specific examples of uses of aptamer technology: (i) to observe, through protein profiling, protein levels moving up or down in diseases or models of diseases, and to evaluate whether such proteins are sensible targets for the development of therapeutic agents; (ii) to observe coordinated expression of protein pathways in a variety of biological states in various systems; (iii) to study protein or metabolite levels during pre-clinical drug candidate evaluation in response to putative therapeutic agents during clinical trials (e.g., as markers of efficacy or response); and (iv) to study human protein or metabolite levels in response to putative therapeutic agents during clinical trials (e.g., as markers of efficacy or response). 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In Vitro Diagnostics shall include, among other things, the use of the SELEX\u00ae Process or aptamers or photoaptamers identified through the use of the SELEX\u00ae Process in the assay, testing or determination: (a) outside of a living organism, (i) of a human substance in a test material, often to identify or follow the progression of a disease or disorder, or to select a patient for treatment; (ii) of a plant substance, animal substance or other substance in a test material, often to identify or follow the progression of a disease, process, or disorder in a human or non-human organism; and (iii) of environmental substances (as in water quality testing); and (b) of a substance on a test material such as cells (as in FACS analysis or other measurements of pathogens within biological samples). 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In Vitro Diagnostics shall include, among other things, the use of the SELEX Process or aptamers or photoaptamers identified through the use of the SELEX Process in the assay, testing or determination: (a) outside of a living organism, (i) of a human substance in a test material, often to identify or follow the progression of a disease or disorder, or to select a patient for treatment; (ii) of a plant substance, animal substance or other substance in a test material, often to identify or follow the progression of a disease, process, or disorder in a human or non-human organism; and (iii) of environmental substances (as in water quality testing); and (b) of a substance on a test material such as cells (as in FACS analysis or other measurements of pathogens within biological samples).", "size": 2, "snippet_links": [{"key": "selex-process", "type": "definition", "offset": [21, 34]}, {"key": "living-organism", "type": "definition", "offset": [165, 180]}, {"key": "test-material", "type": "definition", "offset": [202, 215]}, {"key": "for-treatment", "type": "clause", "offset": [591, 604]}, {"key": "environmental-substances", "type": "clause", "offset": [815, 839]}, {"key": "quality-testing", "type": "clause", "offset": [853, 868]}, {"key": "other-measurements", "type": "definition", "offset": [951, 969]}, {"key": "biological-samples", "type": "clause", "offset": [990, 1008]}], "hash": "93e91ec1011479d951c9bc43fd55ad72", "id": 10}], "next_curs": "CmESW2oVc35sYXdpbnNpZGVyY29udHJhY3Rzcj0LEhpEZWZpbml0aW9uU25pcHBldEdyb3VwX3Y1NiIdaW4tdml0cm8tZGlhZ25vc3RpY3MjMDAwMDAwMGEMogECZW4YACAA", "definition": {"title": "In Vitro Diagnostics", "snippet": "means the use of the SELEX Process or Aptamers identified through the use of the SELEX process in the assay, testing or determination outside of a living organism, of a substance in a test material.", "size": 38, "id": "in-vitro-diagnostics", "examples": ["Diametrics shall retain records of any safety, quality and reliability related data relating to the Portal Measurement Products as well as any data necessary for &quot;Current Good Manufacturing Practices&quot; (CGMP, as required by FDA), the &quot;<strong>In Vitro Diagnostics</strong> Directive&quot; (the IVDD, as required by the European Union) and the &quot;Medical Device Directive&quot; (MDD, as required by the European Union), to the extent provided under Schedule 1, Required Quality Data.", "<strong>In Vitro Diagnostics</strong> shall mean the use of Aptamers or Aptamer Equivalents in the assay, testing or determination outside of a living organism, of a substance in a test material.", "Nothing in this Section 12.1(d) shall prohibit ROCHE from offering for sale or selling to End Users Products configured for use primarily in <strong>In Vitro Diagnostics</strong> to satisfy the bona fide requirements of such End Users for use in <strong>In Vitro Diagnostics</strong> and any Blood Screening use by such End Users of any such Products configured for use primarily in <strong>In Vitro Diagnostics</strong> shall not be deemed a breach of this Section 12.1(d).", "Company shall not use or practice the Covered Intellectual Property (a) outside the Licensed Field, (b) for any other purpose except activities that it conducts in compliance with this Agreement, (c) to make, use, sell, offer for sale, import or export any products containing any Excluded Aptamers, (d) to make, use, sell, offer for sale, import or export any Excluded Aptamers, or (e) to make, use, sell, offer for sale, import or export any Aptamers for <strong>In Vitro Diagnostics</strong>.", "For Product Purchased for Use in Human <strong>In Vitro Diagnostics</strong> or Pharmaceutical Therapeutics Research and Development The first $[*********] of Net Sales: the greater of: [***]% of Net Sales of Tests, or $[****] per Test.", "Currently, Ukraine has already taken initial steps towards the adoption of the legislation on medicines for human use that partially transposes Directive (EC) 2001/83/EC, drafted the Law of Ukraine on Medical Devices and <strong>In Vitro Diagnostics</strong> Medical Devices that is in line with Regulations (EU) 2017/745 and 2017/746 of April 05, 2017, and adopted a new technical regulation on cosmetic products that is in line with EU Regulation (EC) N 1223/2009 of November 30, 2009.", "Future shall, in performing Services, maintain internal quality processes, including without limitation design control, that are (i) International Standards Organization (ISO) 13485 registered; and (ii) in compliance with the <strong>In Vitro Diagnostics</strong> Directive (IVDD) and the FDA\u2019s Quality System Regulation (QSR) for medical devices or substantially similar registration or regulation.", "Conversely no immunity from suit shall apply to End User activities in <strong>In Vitro Diagnostics</strong>, except as provided in the HCV Diagnostics Agreement, or otherwise outside of the Field.", "During the Non-compete Period, without the Purchaser&#x27; s prior written consent, neither Chiron nor any of its Affiliates shall directly or indirectly engage in any development activities relating to <strong>In Vitro Diagnostics</strong> products, which development activities include or would require a submission to the FDA if conducted in the United States.", "Denka Seiken shall manufacture all Products under this Agreement in compliance with applicable current Good Manufacturing Practices and the Quality System Regulation for in vitro diagnostic devices, as set forth in 21 Code of Federal Regulations Part 820 et seq., all applicable requirements of Directive 98/79/EC for obtaining CE Marking of such Products, and the <strong>In Vitro Diagnostics</strong> Directive (1VDD) ISO 13485:2003."], "related": [["in-vitro-diagnostic-medical-device", "in vitro diagnostic medical device", "in vitro diagnostic medical device"], ["bioassay", "Bioassay", "Bioassay"], ["marihuana-infused-product", "Marihuana-infused product", "Marihuana-infused product"], ["marijuana-infused-products", "Marijuana-infused products", "Marijuana-infused products"], ["collaborative-drug-therapy-management", "Collaborative drug therapy management", "Collaborative drug therapy management"]], "related_snippets": [], "updated": "2025-07-06T21:58:41+00:00"}, "json": true, "cursor": ""}}