The Addenda will apply for particular supplies (strengths and numbers) and will apply the Quality Standards and responsibilities described in this Technical Agreement.
Such rules may be established on an organizational unit basis such as a work location, Department, Coordinate Campus, Collegiate/Administrative Unit, or University-wide and shall be the same rules for all Unit 7 (Technical Agreement) employees in an area but may vary according to what is appropriate for the work assigned to employees and shall be applied uniformly to all employees who are affected within these organizational units.
All such Products shall be fabricated, packaged, labeled, tested and stored in compliance with Chiesis quality policy, which is implemented by the relevant quality management system, such system being fully in compliance with the applicable regulatory requirements, including current Good Manufacturing Practices (cGMPs) and in accordance with the Regulatory Requirements and the Specifications as per the terms of the Technical Agreement.
Subject to the terms of the Technical Agreement, Chiesi shall share the results of any such audit with Cornerstone.
Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission Batch shall mean a specific quantity of Product that is produced according to a single manufacturing order during the same cycle of manufacture, which quantity shall be agreed in the Technical Agreement.