Notification of Regulatory Inspections. Patheon will notify Client within one Business Day of any inspections by any governmental agency specifically involving the Products. Patheon will also notify Client of receipt of any form 483’s or warning letters or any other significant regulatory action which Patheon’s quality assurance group determines could impact the regulatory status of the Products.
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 will notify Client within […***…] of any inspections by any governmental agency specifically involving the Products. Patheon will also notify Client of receipt of any form 483’s or warning letters or any other significant regulatory action which Patheon’s quality assurance group determines could impact the regulatory status of the Products.
Notification of Regulatory Inspections. Patheon will notify Client within one Business Day of any inspection, receipt of notice of any inspection and/or any request for samples by any governmental agency specifically involving the Products. Patheon will also notify Client within three Business Days of receipt of any form 483’s or warning letters or any other significant regulatory action or finding which could directly or indirectly impact the regulatory status of the Products or Patheon’s ability to perform the Manufacturing Services. Within three Business Days of receipt, Patheon will provide Client with a reasonable description of the notifications and inspections and all supporting documentation, including, as applicable, all form 483’s and warning letters or similar warning or objection, responses and all other correspondence and discussions of the applicable Regulatory Authority, which should be redacted to protect the confidential information of Third Parties. Patheon will discuss with Client and consider in good faith any comments provided by Client on the proposed response. Additionally, Patheon will obtain Client’s prior approval of any such responses related to Product. Patheon will use commercially reasonable efforts to address and rectify any issues or problems in its manufacturing facility or procedures and any objections or warnings raised by the Regulatory Authority as soon as practicable and to continue to manufacture and supply to Client, in compliance with all Applicable Laws and the terms of this Agreement, the Products ordered by Client. After the filing of a response with the FDA or other Regulatory Authority, Patheon will notify Client of any further contacts with the Regulatory Authority relating to the subject matter of the response.
Notification of Regulatory Inspections. Impax agrees to notify Schering within thirty-six (36) hours after the initiation of any inquiries, notifications, or inspection activity by any Regulatory Authority in regard to the Product or the Approved Facility. In furtherance and not in limitation of the foregoing, Impax shall notify Schering prior to the commencement of any inspection activity by any Regulatory Authority regarding the Product or any general cGMP inspection, unless such inspection activity is an unannounced inspection. Further, Impax shall provide a reasonable description to Schering of any such governmental inquiries, notifications or inspections promptly (but in no event later than two (2) calendar days) after such visit or inquiry. Impax shall furnish to Schering, (a) within two (2) days after receipt, any report or correspondence issued by the Regulatory Authority in connection with such visit or inquiry, including but not limited to, any FDA Form 483, Establishment Inspection Report, or warning letter, or other regulatory communications and (b) copies of any and all responses or explanations to any Regulatory Authority relating to items set forth above, in each case purged only of trade secrets of Impax that are unrelated to its obligations under this Agreement and are unrelated to the Product, prior to the submission of such responses or explanations to any Regulatory Authority by Impax.
Notification of Regulatory Inspections. Patheon will notify Client within one Business Day of any inspections by any governmental agency specifically involving the Products. Patheon will also notify Client of receipt of any form 483’s or warning letters or any other significant regulatory action which Patheon’s quality assurance group determines could impact the regulatory status of the Products. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Notification of Regulatory Inspections. The parties’ rights and obligations with respect to any inspections by and Authority shall be defined by the provisions of the Quality Agreement and this Article 7. Patheon will notify Client within one Business Day of any inspections by any Authority specifically involving the Products. Patheon will also notify Client of receipt of any FDA Form 483s, Establishment Inspection Reports, warning letters or any other inspectional findings that relate to the Products. Patheon shall promptly provide copies of such inspection-related documents (to the extent related to a Product, and redacted to remove third party confidential information) to Client and grant Client a reasonable opportunity to review and comment on Patheon’s proposed responses to the same.
Notification of Regulatory Inspections. (a) Patheon will notify Client by telephone within 24 hours, and in writing within two Business Days, after learning of any proposed visit to, or inspection of, a Manufacturing Site by any Regulatory Authority, and immediately by telephone after learning of any unannounced visit to, or inspection of, a Manufacturing Site by any Regulatory Authority if the visit or inspection primarily relates to the Manufacturing Site’s compliance with cGMPs or the manufacture of the Product.
Notification of Regulatory Inspections. Patheon will notify Client within [*] of any inspections by or communications with, any governmental agency involving the Products. Patheon will furnish to Client within [*] all material information supplied to, or supplied by the governmental agency or third party supplier to the extent that the report relates to a Product or the ability of Patheon to supply a Product. Patheon will promptly correct any deficiencies noted by any governmental agency in these inspections. Patheon will also notify Client of receipt of any form 483’s or warning letters or any other significant regulatory action which Patheon’s quality assurance group determines could impact the regulatory status of the Products.
Notification of Regulatory Inspections. Flextronics’ interactions and correspondences with relevant regulatory authorities, including the U.S. Food and Drug Administration (hereinafter the “FDA”), in connection with this Agreement shall be handled in accordance with the Quality Agreement.
