CBL Responsibilities Sample Clauses

CBL Responsibilities. CBL shall provide reasonable assistance to TKT in its efforts to obtain and maintain all necessary regulatory approvals and permits relating to the production of Product at CBL facilities. Accordingly, insofar as relating to Product and CBL’s processing thereof, CBL shall permit TKT or its designees typical and customary access to CBL’s facility, other than the filling, and packaging areas, during the formulation and filling of Product and, upon reasonable notice and during reasonable business hours and so long as TKT does not interfere with CBL’s day to day operations (i) to inspect CBL’s processing facilities, (ii) to review manufacturing and quality control records relative to production by CBL of the Product, prior to the disposition of the Product (iii) to audit CBL’s production efforts in respect of Product for compliance with FDA requirements, (iv) to review CBL’s facility master file, any correspondence, reports, or other documents from CBL to the FDA, or to any applicable foreign regulatory authority, or from the FDA, or from any applicable foreign regulatory authority, to CBL, related to the Product and/or the facility as it effects the Product, (v) to approve all Product related variances which occur during manufacture or storage of the Product, including approval of label text after receipt of labels and prior to application, and (vi) CBL will inform TKT as quickly as possible regarding facility related variances and will permit TKT onsite access to all facility related variances and information for review and those which in CBL’s judgement may affect the Product will be reviewed with TKT prior to implementation of corrective action.