LONZA Facility definition
Examples of LONZA Facility in a sentence
LONZA shall be solely responsible for all scheduling related to the LONZA Facility and for the operation of such facility.
Any deliveries made pursuant to Section 18.4 shall be made FCA the LONZA Facility.
Subject to the successful completion of the development of the Manufacturing Process at the LONZA Facility as defined in the Project Plan, PROTEON retains LONZA as a manufacturer of Drug Substance.
In connection with any such transfer, the Parties shall discuss the possibility of having CLIENT Personnel stationed at the LONZA Facility where the performance of the applicable Statement of Work is being conducted.
All PROTEON personnel visiting or having access to the LONZA Facility shall agree in writing to abide by LONZA standard policies, operating procedures and security procedures as established by LONZA and communicated to PROTEON.
All Drug Substance manufactured for PROTEON hereunder shall be manufactured by LONZA at a LONZA Facility.
PROTEON hereby retains LONZA to develop the Manufacturing Process at the LONZA Facility, LONZA shall use Commercially Reasonable Efforts to develop the same, and PROTEON shall pay LONZA for such development work, all in accordance with the Project Plan and Exhibit B.
Any and all communications from and to the FDA or other Regulatory Authorities related to the Product or to the manufacture of the Drug Substance at the LONZA Facility shall be handled in accordance with the terms and conditions of the Quality Agreement, or as otherwise agreed in writing by LONZA and PROTEON.
If any PROTEON owned property (PROTEON Equipment, Drug Substance, Raw Materials, etc.) remains at the LONZA Facility for a period longer than ninety (90) days after expiration or termination of this Agreement, PROTEON shall pay for such storage as Additional Services in accordance with the applicable Project Rates.
In the event that Client desires to qualify an additional manufacturing location for the manufacture of Drug Substance (a “Second Source”), LONZA shall have the right of first refusal to qualify an additional LONZA Facility as the Second Source.