Common use of Notification of Regulatory Inspections Clause in Contracts

Notification of Regulatory Inspections. Patheon shall notify Flexion by telephone within […***…], and in writing within […***…], after learning of any proposed or unannounced visit or inspection of any part of the Facility by any Regulatory Authority, including the Occupational Safety and Health Administration or any equivalent governmental agencies of the country of Manufacture, and shall permit Flexion or its agents to be present at the Facility to support Patheon during such visit or inspection if it, directly or indirectly relates to the Product or Manufacturing Suite or may reasonably be expected to adversely affect the Product or the Manufacturing Suite. For the avoidance of doubt the responsibility for conducting the inspection rests with Patheon. Flexion personnel will be permitted to take part in the inspection where this participation is directly requested either by the authorized agent of the Regulatory Authority or by Patheon. Patheon shall provide to Flexion in so far as it, directly or indirectly, affects the Product or the Manufacturing Suite or may reasonably be expected to adversely affect the Product or the ***Confidential Treatment Requested Manufacturing Suite, either a copy of any report and other written communications received from such Regulatory Authority in connection with any visit or inspection, including the Form 483 observations and responses or any equivalent form under Applicable Law. Such copy or summary shall be provided to Flexion within […***…] business days of Patheon’s receipt thereof (and may be redacted as Patheon acting reasonably deems necessary to protect the confidentiality of matters not affecting, or not reasonably likely to affect, the Product or the Manufacturing Suite which are confidential to Patheon or to other clients of Patheon). Flexion shall have the right to review and comment on any communications with such Regulatory Authority pertaining to such inspection as set forth in Section 3.15.

Notification of Regulatory Inspections. Patheon shall notify Flexion Client by telephone within on or before […***…], and in writing within on or before […***…], after learning of any proposed or unannounced visit or inspection of any part of the Facility which relates to the Manufacture of the Product by any Regulatory Authority, including the Occupational Safety and Health Administration or any equivalent governmental agencies of the country of Manufacture, and provide all relevant information known to Patheon regarding such investigation. Patheon shall permit Flexion Client or its agents to be present at the Facility to support Patheon during such visit or inspection if it, directly or indirectly relates to it impacts the Product or Manufacturing Suite or may reasonably be expected to adversely affect the Product or affects the Manufacturing Suite. For the avoidance of doubt the The responsibility for conducting the inspection rests with Patheon. Flexion personnel will be permitted to take part in the inspection where this participation is directly requested either by the authorized agent of the Regulatory Authority or by Patheon. Patheon shall provide to Flexion Client in so far as it, directly or indirectly, it affects the Product or the Manufacturing Suite or may reasonably be expected to adversely affect the Product or the ***Confidential Treatment Requested Manufacturing Suite, either a copy of or a summary of any report and other written communications received from such Regulatory Authority in connection with any visit or inspection, including the FDA Form 483 observations and responses (or any equivalent form observations and responses from any Regulatory Authority under Applicable Law). Such copy or summary shall be provided to Flexion within *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Client on or before […***…] business days of Patheon’s receipt thereof (and may be redacted as Patheon acting reasonably deems necessary to protect the confidentiality of matters not affecting, or not reasonably likely to affect, affecting the Product or the Manufacturing Suite or which are confidential to Patheon or to other clients of Patheon). Flexion Client shall have the right to review and comment on any communications with such Regulatory Authority pertaining to such inspection as set forth in Section 3.153.17. In the event that Client is subject to an inspection by any Regulatory Authority that relates to the Products or Patheon’s performance of its obligations under this Agreement, Patheon shall provide Client and such Regulatory Authority with access to Patheon’s non-financial records, the Products and those portions of the Facility used in the Manufacture of the Products or storage, testing, handling or receiving of the Materials as required by this Agreement or otherwise by Applicable Law, in each case subject to payment by Client of the fees set out in Section 3.10(b).

Notification of Regulatory Inspections. Patheon shall will notify Flexion Client by telephone within […***…]one business day, and in writing within […***…]two business days, after learning of any proposed or unannounced visit or inspection of any part of the Facility which relates to the Manufacture of the Product by any Regulatory Authority, including the Occupational Safety and Health Administration or any equivalent governmental agencies of the country of Manufacture, and shall provide all relevant information known to Patheon regarding the investigation. Patheon will permit Flexion Client or its agents to be present at the Facility to support Patheon during such any visit or inspection if it, directly or indirectly relates to it impacts the Product or Manufacturing Suite or may reasonably be expected to adversely affect the Product or affects the Manufacturing Suite. For the avoidance of doubt the responsibility Patheon will be responsible for conducting the inspection rests with Patheon. Flexion personnel will be permitted to take part in the inspection where this participation is directly requested either by the authorized agent of the Regulatory Authority or by Patheoninspection. Patheon shall will provide to Flexion Client in so far as it, directly or indirectly, it affects the Product or the Manufacturing Suite or may reasonably be expected to adversely affect the Product or the ***Confidential Treatment Requested Manufacturing Suite, either a copy of or a summary of any report and other written communications received from such the Regulatory Authority in connection with any visit or inspection, including the FDA Form 483 observations and responses (or any equivalent form observations and responses from any Regulatory Authority under Applicable Law). Such This copy or summary shall will be provided to Flexion Client within […***…] business days of Patheon’s receipt thereof (and may be redacted as Patheon acting reasonably deems necessary to protect the confidentiality of matters not affecting, or not reasonably likely to affect, affecting the Product or the Manufacturing Suite or which are confidential to Patheon or to other clients of Patheon). Flexion shall Client will have the right to review and comment on any communications with such the Regulatory Authority pertaining to such about the inspection as set forth in Section 3.153.17. If Client is subject to an inspection by any Regulatory Authority that relates to the Products or Patheon’s performance of its obligations under this Agreement, Patheon will provide Client and the Regulatory Authority with access to Patheon’s non-financial records, the Products and those portions of the Facility used in the Manufacture of the Products or storage, testing, handling or receiving of the Materials as required by this Agreement or otherwise by Applicable Law[***]. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Notification of Regulatory Inspections. Patheon shall notify Flexion by telephone within […***…], and in writing within […***…], after learning of any proposed or unannounced visit or inspection of any part of the Facility by any Regulatory Authority, including the Occupational Safety and Health Administration or any equivalent governmental agencies of the country of Manufacture, and shall permit Flexion or its agents to be present at the Facility to support Patheon during such visit or inspection if it, directly or indirectly relates to the Product or Manufacturing Suite or may reasonably be expected to adversely affect the Product or the Manufacturing Suite. For the avoidance of doubt the responsibility for conducting the inspection rests with Patheon. Flexion personnel will be permitted to take part in the inspection where this participation is directly requested either by the authorized agent of the Regulatory Authority or by Patheon. Patheon shall provide to Flexion in so far as it, directly or indirectly, affects the Product or the Manufacturing Suite or may reasonably be expected to adversely affect the Product or the ***Confidential Treatment Requested Manufacturing Suite, either a copy of any report and other written communications received from such Regulatory Authority in connection with any visit or inspection, including the Form 483 observations and responses or any equivalent form under Applicable Law. Such copy or summary shall be provided to Flexion within […***…] business days of Patheon’s receipt thereof (and may be redacted as Patheon acting reasonably deems necessary to protect the confidentiality of matters not affecting, or not reasonably likely to affect, the Product or the Manufacturing Suite which are confidential to Patheon or to other clients of Patheon). Flexion shall have the right to review and comment on *** Certain Confidential Information Omitted - 25 - any communications with such Regulatory Authority pertaining to such inspection as set forth in Section 3.15.