1.1.5 COMPANY Inventions means inventions, improvements, designs, programs, formulas, know-how and writings (i) supplied to EirGenix by COMPANY; and/or (ii) improvements made independently by COMPANY (including further optimization by COMPANY) to any Deliverables, Data, materials or information provided by EirGenix to COMPANY hereunder; provided, however, that COMPANY Inventions do not include EirGenix Inventions or EirGenix Methods.
1.1.6 COMPANY Materials means the materials supplied by COMPANY to EirGenix and identified as such in SOW hereto,
1.1.7 COMPANY Methods means methods or instructions provided by COMPANY to EirGenix for use in the performance of the Services.
1.1.8 Cell Line means the cell line used to produce Product, particulars of which are set out in SOW.
1.1.9 Certificate of Analysis means a certificate of analysis as to testing of Specifications of any Product in form and substance agreed to by EirGenix and COMPANY.
1.1.10 cGMP Means current Good Manufacturing Practices and General Biologics Products Standards as promulgated under the US Federal Food Drug and Cosmetic Act at 21 CFR (Chapters 210, 211, 600 and 610), the Guide to Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 91/356/EEC (with the exception that raw material lot-release testing is performed according to the USP, and the background environment air classification for drug substance manufacturing is Class C), and ICH Guidance Q7A (Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients). EirGenixs operational quality standards are defined in internal GMP policy documents.
1.1.11 cGMP Product means Product which may be required under SOW to be manufactured in accordance with cGMF.
1.1.12 Confidential Information means (a) with respect to COMPANY, all technical and non-technical information related to the Materials, COMPANY Methods, COMPANY Inventions, COMPANY- Information, Deliverables and Data, including trade secret, proprietary information, methods, formulas, processes, protocols, scale of operations, source and engineering of operations, technologies and equipment employed, information relating to quality assurance, procedures for and record keeping, medium, techniques, inventions, know-how, apparatus, and formulae, related to COMPANYs current, future and proposed media, compounds, compositions, and biological materials, and (b) with respect to EirGenix, all technical and non-technical information conveyed by EirGenix to COMPANY in any form, but specifically excluding Deliverables.
1.1.13 Data means all documentation, information, records, raw data, specimens, samples, know-how or other work product (i) supplied by COMPANY; (ii) generated by EirGenix as a result of its performance of the Services and/or under a Statement(s) of Work; (iii) relating to the composition or methods of development of