LONZA Facility Clause Samples
LONZA Facility. All Drug Substance manufactured for PROTEON hereunder shall be manufactured by LONZA at a LONZA Facility. LONZA shall be solely responsible for all scheduling related to the LONZA Facility and for the operation of such facility.
LONZA Facility. LONZA owns or lawfully controls the LONZA Facility, and that the LONZA Facility shall be maintained in accordance with cGMP and in such condition as will allow LONZA to manufacture the Drug Substance in compliance with cGMP and in conformance with the Master Production Record;
LONZA Facility. This Agreement may be terminated in its entirety by Trubion upon at least *** prior written notice to Lonza if Lonza or its Affiliates cease to own or otherwise lawfully control any Lonza Facility required to the extent necessary to perform the Services in accordance with the terms hereof.
LONZA Facility. Lonza will use Commercially Reasonable Best Efforts to ensure that the Lonza Facility shall be maintained in accordance with cGMP and in such condition as will allow Lonza to manufacture the Bulk Drug in accordance with the Bulk Drug Specifications.
LONZA Facility. Lonza hereby warrants that it owns or lawfully controls the Lonza Facility, and that, provided the Manufacturing Process is successfully implemented in accordance with the Tech Transfer Agreement, it has sufficient manufacturing capacity to enable Lonza to manufacture Bulk Drug throughout the Term in quantities sufficient to fulfill, in each calendar year, the Campaign Minimums and Campaign Minimum Runs for such year as set forth in Exhibit A hereto, in accordance with this Agreement. Lonza hereby covenants that it will use Commercially Reasonable Best Efforts to ensure that the Lonza Facility shall be maintained in accordance with cGMP and in such condition as will allow Lonza to manufacture the Bulk Drug in compliance with and conformance to cGMP and the Bulk Drug Specifications. Table of Contents