Client Facility Audits. During the Term, Client’s Representatives shall be granted access upon at least [***] days’ prior notice, at reasonable times during regular business hours, to (A) the portion of the Facility where ▇▇▇▇▇▇▇▇ performs Processing, (B) relevant personnel involved in Processing and (C) Processing records described in Section 9.1, in each case solely for the purpose of verifying that Catalent is Processing in accordance with cGMPs, the Specifications and the Product master Batch records. Client may not conduct an audit under this Section 9.4 more than once during any [***] month period; except that additional inspections may be conducted in the event there is a material quality or compliance issue concerning Product or Processing. Audits and inspections shall be designed to minimize disruption of operations at the Facility. The obligations of Client and its Representatives in Section 4.7 shall apply to all audits undertaken by Client and its Representatives pursuant to this Section 9.4.
Appears in 1 contract
Sources: Commercial Supply Agreement (Acadia Pharmaceuticals Inc)
Client Facility Audits. During the Term, Client’s Representatives shall be granted access upon at least […***…] days’ prior notice, at reasonable times during regular business hours, to (A) the portion of the Facility where ▇▇▇▇▇▇▇▇ Catalent performs Processing, (B) relevant personnel involved in Processing and (C) Processing records described in Section 9.1, in each case solely for the purpose of verifying that Catalent is Processing in accordance with cGMPs, the Specifications and the Product master Batch records. Client may not conduct an audit under this Section 9.4 more than once during any […***…] during any twelve (12) month period; except that additional inspections may be conducted in the event there is a material quality or compliance issue concerning Product or Processing. Audits and inspections shall be designed to minimize disruption of operations at the Facility. The obligations of Client and its Representatives in Section 4.7 shall apply to all audits undertaken by Client and its Representatives pursuant to this Section 9.4.
Appears in 1 contract
Sources: Commercial Supply Agreement (Acadia Pharmaceuticals Inc)