Common use of Client Facility Audits Clause in Contracts

Client Facility Audits. During the Term, Client’s Representatives shall be granted access upon at least [**] business 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 9.2, 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 [**] period; provided, that additional inspections may be conducted in the event there is a material quality or compliance issue concerning Product or its Processing. Client’s Quality Assurance will arrange Client audits with Catalent Quality Management. Audits and inspections under this Section 9.4 shall be designed to minimize disruption of operations at the Facility. Additionally, Client’s Representatives shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility, and shall comply with the Facility’s rules and regulations. Client shall indemnify and hold harmless Catalent for any negligent or wrongful action or activity of such Representatives while on Catalent’s premises.

Client Facility Audits. During the Term, Client’s Representatives shall be granted access upon at least [**] 15 business 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 9.2, 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 […**] period*…]; provided, that additional inspections may be conducted in the event there is a material quality or compliance issue concerning Product or its Processing[…***…]. Client’s Quality Assurance Manager or its designee will arrange Client audits with Catalent Quality Management. Audits and inspections under this Section 9.4 shall be designed to minimize disruption of operations at the Facility. Additionally, Client’s Representatives who are not duly authorized officers or employees shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility, and . Such Representatives shall comply with the Facility’s rules and regulations. Client shall indemnify and hold harmless Catalent for any negligent or wrongful action or activity of such Representatives while on Catalent’s premises.

Client Facility Audits. During the Term, Client’s Representatives shall be granted access upon at least [***] business 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 9.29.1, in each case solely for the purpose of verifying that Catalent is Processing in accordance with cGMPs, the Specifications and the Product master Batch recordsRecords and this Agreement. Client may not conduct an audit under this Section 9.4 more than [***] periodduring any calendar year; provided, that additional inspections may be conducted in the event there is a material quality or compliance issue concerning the Client Product or its Processing. Client’s Quality Assurance Manager will arrange Client audits with Catalent Quality Management. Audits and inspections under this Section 9.4 shall be designed to minimize disruption of operations at the Facility. Additionally, Client’s Representatives that are not employees of Client, shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility, and . Such Representatives shall comply with the Facility’s rules and regulations. Client shall indemnify and hold harmless Catalent for any negligent or wrongful action or activity of such Representatives in violation of this Section 9.4 while on Catalent’s premises.

Client Facility Audits. During the Term, Client’s Representatives shall be granted access upon at least [**] 10 business 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 9.2, 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 12-month period; provided, that additional inspections may be conducted in the event there is a material quality or compliance issue concerning Product or its Processing. Client’s Quality Assurance Manager will arrange Client audits with Catalent Quality Management. Audits and inspections under this Section 9.4 shall be designed to minimize disruption of operations at the Facility. Additionally, Client’s Representatives shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility, and . Such Representatives shall comply with the Facility’s rules and regulations. Client shall indemnify and hold harmless Catalent for any negligent or wrongful action or activity of such Representatives while on Catalent’s premises.

Client Facility Audits. During the Term, Client’s Representatives shall be granted access upon at least [**] business days’ prior notice, at reasonable times during regular business hours, 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 9.2, 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 [*] 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. Client’s Quality Assurance Manager will arrange Client audits with Catalent Quality Management. Audits and inspections under this Section 9.4 shall be designed to minimize disruption of operations at the Facility. Additionally, Client’s Representatives shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility, and . Such Representatives shall comply with the Facility’s rules and regulations. Client shall indemnify and hold harmless Catalent for any negligent or wrongful action or activity of such Representatives while on Catalent’s premises.. 9.5

Client Facility Audits. During the Term, Client’s Representatives shall be granted access upon at least [**] 10 business 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 9.2, 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 12-month period; provided, that additional inspections may be conducted in the event there is a material quality or compliance issue concerning Product or its Processing. Client’s Quality Assurance Manager will arrange Client audits with Catalent Quality Management. Audits and inspections under this Section 9.4 shall be designed to minimize disruption of operations at the Facility. AdditionallySuch Representatives shall abide by all Catalent safety rules and other applicable employee policies and procedures, and Client shall be responsible for such compliance. Client shall indemnify and hold harmless Catalent for any action, omission or other activity of its Representatives while on Catalent’s premises. Client’s Representatives shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility, and shall comply with the Facility’s rules and regulations. Client shall indemnify and hold harmless Catalent for any negligent or wrongful action or activity of such Representatives while on Catalent’s premises.

Client Facility Audits. During the Term, Client’s 's Representatives shall be granted access upon at least [**] business days’ prior noticeaccess, as mutually agreed to in advance by the parties, at reasonable times during regular business hours, to (A) the portion of the a Facility where Catalent performs Processing, (B) relevant personnel involved in Processing and (C) Processing records described in Section 9.29.1, in each case solely for the purpose of verifying that Catalent is Processing in accordance with cGMPs, the Specifications Specifications, the Quality Agreement and the Product master Batch records. Client may not conduct an audit under this Section 9.4 more than once during any [**] periodredacted]period; provided, that additional inspections may be conducted for cause or in the event there is a material quality or compliance issue concerning Product or its Processing. Client’s 's Quality Assurance Manager will arrange Client audits with Catalent Quality Management. Audits and inspections under this Section 9.4 shall be designed to minimize disruption of operations at the Facility. Additionally, Any audit conducted by Client pursuant to this Section shall be conducted by no more than two (2) of Client’s 's Representatives and have a duration of no more than two (2) consecutive business days. Client's Representatives who are not employees of Client shall be required to sign Catalent’s ' s standard visitor confidentiality agreement prior to being allowed access to the Facility, and . Such Representatives shall comply with the Facility’s 's rules and regulations. Client shall indemnify and hold harmless Catalent for any negligent or wrongful action or activity of such Representatives while on Catalent’s 's premises.

Client Facility Audits. During the Term, Client’s Representatives shall be granted access upon at least [**] business days’ prior notice, at reasonable times during regular business hours, 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 9.2, 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 [*] 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. Client’s Quality Assurance Manager will arrange Client audits with Catalent Quality Management. Audits and inspections under this Section 9.4 shall be designed to minimize disruption of operations at the Facility. Additionally, Client’s Representatives shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility, and . Such Representatives shall comply with the Facility’s rules and regulations. Client shall indemnify and hold harmless Catalent for any negligent or wrongful action or activity of such Representatives while on Catalent’s premises.