Common use of Governmental Inspections and Requests Clause in Contracts

Governmental Inspections and Requests. Catalent shall promptly advise Client if an authorized agent of any Regulatory Authority notifies Catalent that it intends to or does visit the Facility for the purpose of reviewing the Processing. In the event that any such review is directed primarily at Catalent’s Processing of Products then upon Client’s reasonable prior written notice to Catalent and during regular business hours, Client’s Representative(s) may be on site in a room specifically allocated to such Representative(s) and Catalent shall confer and consult with such Representatives with respect to any material matters that arise during such review directly related to Client’s Product; provided that Client’s Representative shall not be given access to the agents of the Regulatory Authority without Catalent’s consent; and provided further that such Representatives shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to the Facility. Catalent shall provide Client with a copy of any report issued by such Regulatory Authority received by Catalent following such visit, redacted as appropriate to protect any confidential information of Catalent and Catalent’s other customers within [**] business days of Catalent’s receipt of such report. Client acknowledges that it may not direct the manner in which Catalent fulfills its obligations to permit inspection by and to communicate with Regulatory Authorities. Client shall reimburse Catalent for all reasonable and documented costs associated with inspections by Regulatory Authorities in connection with Product, and pay the fees specified in Attachment D, to the extent applicable.

Governmental Inspections and Requests. Catalent shall promptly advise Client if an authorized agent of any Regulatory Authority notifies Catalent that it intends to or does visit the Facility for the purpose of reviewing the Processing. In Processing or for the event that any such review is directed primarily at purpose of reviewing Catalent’s Processing of Products then upon Client’s reasonable prior written notice to adherence with Applicable Laws. Catalent and during regular business hours, Client’s Representative(s) agrees that a Client representative may be on site onsite at the 17 [*] = Certain confidential information contained in a room specifically allocated this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to such Representative(s) and Catalent shall confer and consult with such Representatives with respect to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. CONFIDENTIAL Facility during any material matters that arise during such review inspection directly related to Client’s Product; provided that Client’s Representative shall ADS-5102, including but not be given access limited to, any pre-approval inspections and other visits related to the agents of the Regulatory Authority without Catalent’s consent; and provided further that such Representatives Product which shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to further addressed in the FacilityQuality Agreement. Upon request, Catalent shall provide Client with a copy of any report issued by such Regulatory Authority received by Catalent following such visit, redacted as appropriate to protect any confidential information of Catalent and Catalent’s other customers within [**] business days of Catalent’s receipt of such reportand in accordance with the procedures and other terms as set forth in the Quality Agreement. Client acknowledges that it may not direct the manner in which Catalent fulfills its obligations to permit inspection by and to communicate with Regulatory Authorities; provided, however, that the foregoing should not be construed to modify or alter any obligation to Client unless directly in conflict. Client shall reimburse Catalent for all reasonable and documented costs associated with inspections by Regulatory Authorities directly attributable to Product; provided, that such inspection was not in connection with Productor as a result of Catalent’s willful misconduct, and pay the fees specified in Attachment D, to the extent applicable.negligence or non-compliance with Applicable Laws. 9.4

Governmental Inspections and Requests. Catalent shall promptly advise Client if an authorized agent of any Regulatory Authority notifies Catalent that it intends to or does visit the Facility for the purpose of reviewing the Processing. In the event that any such review is directed primarily at Processing or audit Catalent’s Processing of Products then upon Client’s reasonable prior written notice to Catalent books and during regular business hours, Client’s Representative(s) may be on site in a room specifically allocated to such Representative(s) and Catalent shall confer and consult with such Representatives records with respect to the Processing. Catalent shall promptly provide Client with a copy of any material matters that arise during written document received from such review directly related Regulatory Authority relating to Client’s Product; provided that Client’s Representative shall not be given access such notification, as well as any other request, directive or other communication of any Regulatory Authority relating to the agents Product or its Processing. Catalent shall permit authorized officials of any Regulatory Authority to inspect the Facility, including the equipment used for the Processing, shipping or receiving of Product and Client-supplied Materials and Raw Materials, as may be required or necessary for the granting or maintaining of any government approvals necessary and/or required to be granted by such Regulatory Authority for the manufacture, import, marketing, distribution and sale of the Regulatory Authority without Catalent’s consent; Product, as well as any documents relevant to the Processing of Product under this Agreement. Catalent shall permit representatives of Client and provided further that any Client Licensee to assist in the preparation for and be present at any such Representatives shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to inspection of the Facility. Upon request, Catalent shall promptly provide Client with a copy of any report issued by such Regulatory Authority received by Catalent following such visit, redacted as appropriate to protect any confidential information of Catalent and Catalent’s other customers within [**] business days customers, and notify Client of Catalent’s receipt of any actions taken by Catalent to remedy conditions cited in any such report. Prior to responding to any such report, Catalent shall provide Client acknowledges that it may not direct a copy of its proposed response for Client’s and any Client Licensee’s review and Confidential materials omitted and filed separately with the manner in which Catalent fulfills its obligations to permit inspection by Securities and to communicate with Regulatory Authorities. Client shall reimburse Catalent for all reasonable and documented costs associated with inspections by Regulatory Authorities in connection with Product, and pay the fees specified in Attachment D, to the extent applicableExchange Commission.

Governmental Inspections and Requests. Catalent shall promptly advise Client if an authorized agent of any Regulatory Authority notifies Catalent that it intends to or does visit the Facility for the purpose of reviewing the Processing. In Processing or for the event that any such review is directed primarily at purpose of reviewing Catalent’s Processing of Products then upon Client’s reasonable prior written notice to adherence with Applicable Laws. Catalent and during regular business hours, Client’s Representative(s) agrees that a Client representative may be on site onsite at the [*] = Certain confidential information contained in a room specifically allocated this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to such Representative(s) and Catalent shall confer and consult with such Representatives with respect to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Facility during any material matters that arise during such review inspection directly related to Client’s Product; provided that Client’s Representative shall ADS-5102, including but not be given access limited to, any pre-approval inspections and other visits related to the agents of the Regulatory Authority without Catalent’s consent; and provided further that such Representatives Product which shall be required to sign Catalent’s standard visitor confidentiality agreement prior to being allowed access to further addressed in the FacilityQuality Agreement. Upon request, Catalent shall provide Client with a copy of any report issued by such Regulatory Authority received by Catalent following such visit, redacted as appropriate to protect any confidential information of Catalent and Catalent’s other customers within [**] business days of Catalent’s receipt of such reportand in accordance with the procedures and other terms as set forth in the Quality Agreement. Client acknowledges that it may not direct the manner in which Catalent fulfills its obligations to permit inspection by and to communicate with Regulatory Authorities; provided, however, that the foregoing should not be construed to modify or alter any obligation to Client unless directly in conflict. Client shall reimburse Catalent for all reasonable and documented costs associated with inspections by Regulatory Authorities directly attributable to Product; provided, that such inspection was not in connection with Productor as a result of Catalent’s willful misconduct, and pay the fees specified in Attachment D, to the extent applicablenegligence or non-compliance with Applicable Laws.