Common use of Client Facility Audits Clause in Contracts

Client Facility Audits. During the Term and thereafter as required by Applicable Law, Client’s and Client Licensee’s Representatives, either together or on alternate occasions, shall be granted access upon at least [**] prior notice, at reasonable times during regular business hours, to (A) the portion of the Facility where Catalent performs Processing, Validation Services or Product Maintenance Services or which otherwise has impact on Catalent’s performance of such services, (B) relevant personnel involved in Processing, Validation Services or Product Maintenance Services and (C) Processing, Validation Services and Product Maintenance Services records described in Section 9.1, in each case solely for the purpose of verifying that Catalent is performing the Processing, Validation Services and Product Maintenance Services in accordance with Applicable Law (including cGMP), the Specifications and the Product master Batch records. Without limiting Section 4.7, Client and Client Licensee, collectively, may not conduct an audit under this Section 9.4 more than once during any [**] period; provided, that additional inspections may be conducted in the event there is a material quality or compliance issue concerning Product or its Processing or the Validation Services or Product Maintenance Services. Client’s Quality Assurance Manager will arrange Client and Client Licensee audits with Catalent Quality Management. Audits shall be designed to minimize disruption of operations at the Facility. Client’s and Client Licensee’s Representatives shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility. Such Representatives shall comply with the Facility’s rules and regulations of which they are informed. Client shall indemnify and hold harmless Catalent for any negligent or willful action or activity of such Representatives while on Catalent’s premises.