definiens: shall mean, with respect to each Product, the design, all reglJlatory filings with the FDA or any Regulatory Agency, the regular laboratory procedures, good laboratory procedures, or good manufacturing procedures ( including, but not limited to, FDA good manufacturing practices or the equivalent practices of any Regulatory Agency, EN 46000 series procedures and [COMPANY] ( or its parent company ) guidelines ), as the case may be, as well ! Js such other know - how, technical specifications, instructions, processes and other intellectual property and information [COMPANY] shall possess and as shall be necessary in order to allow [COMPANY] to own the design and the regulatory filings, and to manufacture and/or have manufactured for it the Product . The source code for any Software shall also be included in such material . Such Process & Product Description shall be suffiCiently clear and detailed that it can be readily followed and carried out by a skilled person to make the Drug Delivery System in the manner [COMPANY] considers most efficient