analysis of biological systems, nucleic acid detection, automated anatomic pathology systems, assays, diagnostic assay development expertise, diagnostic test kits, statistical methodologies and other formulae and analytical techniques and laboratory services that (i) have been independently developed by IVS prior to the Effective Date or during the Term and relating to the Assay or the IVD Kit and the activities performed under the Project Plan, or (ii) are independently developed by IVS after the Effective Date apart from any activities under this Agreement and without reference to or the benefit of any information or Materials provided by or on behalf of APR.
1.41 “Joint Development Committee” or “JDC” shall have the meaning set forth in Section 2.5 below.
1.42“Joint Steering Committee” or “JSC” means a group of persons established by the Parties to monitor and provide strategic oversight of the activities hereunder relating to the Development and Regulatory Approval of the Assay and IVD Kit and to facilitate communications between the Parties in relation thereto.
1.43“Know-How” means all non-patented confidential and proprietary information or biological materials, including cells, cell lines, genes, gene fragments, gene sequences, probes, DNA, RNA, cDNA libraries, proteins, peptides, polypeptides, plasmids, vectors, expression systems, organisms, biological substances, and any constituents, progeny or replications thereof or therefrom, reagents, chemical compounds, inventions, whether or not patentable, improvements, practices, formula, Trade Secrets, techniques, methods, procedures, knowledge, skill, experience, results, test data (including pharmacological, toxicological and clinical test data), analytical and quality control data and any information regarding marketing, pricing, distribution, cost, sales or manufacturing. Know-How shall not include any Patents or Product Related Data.
1.44“LDT” or “laboratory developed test” means a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory.
1.45 “Market Requirements Document” means a document prepared for the purpose of specifying customer needs and desires for a particular product or service.
1.46“Materials” means Samples, biological materials, compounds, reagents, supplies, products and other goods that one Party delivers or causes to be delivered to the other Party.
1.47“EMA” means the European Medicines Agency, or any successor to that agency.
1.48“EU” means the member states of the European Union.
1.49“NDA” means a New Drug Application, or its equivalent, and amendments thereto filed pursuant to the requirements of the FDA, for FDA approval of a product.
1.50“Pass-Through Expenses” means and is limited to the following fees and expenses to the extent actually incurred by IVS: (i) submission fees for PMA and IRB review of the clinical protocol, (ii) Class C CDx submission and review, and ethics committee review of the clinical protocol in the European Union, (iii) licensing fees to run the assay on the [***] mode, if required, (iv) out-of-pocket expenses (including contingencies, travel and other expenses), and (v) any other expenses incurred by IVS under this Agreement or any Development Plan to the extent approved