Pre-Campaign/Campaign Requirements. It is understood that Genentech is entering into this Agreement, the Tech Transfer Agreement and the Quality Agreement in reliance upon Lonza being fully prepared and able to conduct manufacturing of the Bulk Drug during each Campaign. In order to ensure such preparedness and ability, [*] such checklist to include without limitation, the following requirements: (i) that the Lonza Facility is compliant with all regional, national, federal, state and local regulations in the Territory; (ii) that the Lonza Facility is outfitted with all tools, equipment and utility services necessary to perform Commercial Production; (iii) that the Lonza Facility has been properly maintained and that any maintenance that is required to be performed on equipment and tools within the Lonza Facility has been performed prior to such Campaign; (iv) that the Lonza Facility is fully and adequately staffed with all supervisors, engineers, technicians, inspectors, and other dedicated personnel necessary, and with sufficient technical expertise and acceptable to Genentech, to perform Commercial Production, including any quality testing of Bulk Drug produced (in addition, the Parties shall mutually agree upon each of the primary and secondary Lonza key personnel to be assigned to perform the Commercial Production during each Campaign, and once agreed, Lonza may not change such assignment without Genentech’s mutual agreement); (v) that Lonza has adequate stock of raw materials on hand to perform all Runs required during such Campaign; and (vi) that the Lonza Facility is accessible [*]
