Common use of Inspection Right Clause in Contracts

Inspection Right. (a) Inspection by Astellas or ROW Licensee. (i) To the extent any Regulatory Authority [… * …] requests an audit of the clinical trial sites and/or manufacturing sites in the Territory [… * …], GSK shall permit such Regulatory Authority and XenoPort [… * …] to enter the relevant clinical trial sites and, if applicable, manufacturing sites of GSK and its Affiliates during normal business hours and upon reasonable advance notice to inspect and verify compliance with applicable regulatory requirements. GSK shall, at XenoPort’s expense, provide reasonable assistance for a full and correct carrying out of the inspection. Such inspection shall not relieve GSK of any of its obligations under this Agreement.

Appears in 2 contracts

Sources: Development and Commercialization Agreement (Xenoport Inc), Development and Commercialization Agreement (Xenoport Inc)

Inspection Right. (a) Inspection by Astellas or ROW Licensee. (i) Astellas. To the extent any Regulatory Authority [... * ...] requests an audit of the clinical trial sites and/or and, if GSK supplies Compound or Product to Astellas during the Term, manufacturing sites in the Territory [... * ...], GSK shall permit such Regulatory Authority and XenoPort [... * ...] to enter the all relevant clinical trial sites and, if applicable, manufacturing sites of GSK and its Affiliates during normal business hours and upon reasonable advance notice to inspect and verify compliance with applicable regulatory requirements. GSK shall, at XenoPort’s expense, provide reasonable assistance for a full and correct carrying out of the inspection. Such inspection shall not relieve GSK of any of its obligations under this Agreement.

Appears in 1 contract

Sources: Development and Commercialization Agreement (Xenoport Inc)