Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under clause (b) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents.
Inspection by Regulatory Authorities. During the term of this Agreement, Worldwide will permit regulatory authorities to examine, (i) the facilities where the Services are being conducted; (ii) study documentation; and (iii) any other relevant information, including information that may be designated by Worldwide as confidential, reasonably necessary for regulatory authorities to confirm that the Services are being conducted in compliance with Applicable Laws and regulations. Worldwide will immediately notify Sponsor if any regulatory authority schedules, or without scheduling, begins an inspection that relates to the Services, and, unless expressly prohibited by such regulatory authority, permit Sponsor to attend such inspection.
Inspection by Regulatory Authorities. Upon the request of the FDA or any other Regulatory Authority, Arena shall (i) provide the FDA or such other Regulatory Authority reasonable access to observe and inspect (including pre-approval inspections) the Facility and the procedures used for the manufacture, release and stability testing, or warehousing of Finished Product and to audit the Facility for compliance with GMP or other applicable Regulatory Standards and (ii) cause any Third Party that manufactures any active pharmaceutical agent contained in Finished Product to provide the FDA or such other Regulatory Authority reasonable access to observe and inspect (including pre-approval inspections) the facility at which such Third Party manufactures such active pharmaceutical agent and the procedures used for the manufacture, release and stability testing, or warehousing of such active pharmaceutical agent and to audit such facility for compliance with GMP and all other applicable Regulatory Standards. Arena specifically agrees to cooperate with any inspection by the FDA or other Regulatory Authority, whether prior to or after Regulatory Approval of the applicable Finished Product, and to provide Eisai a copy of any inspection or audit report resulting from any such inspection (subject to reasonable confidentiality restrictions imposed by any Third Party that manufactures active pharmaceutical agent).
Inspection by Regulatory Authorities. During the term of this Agreement, WCT will permit regulatory authorities to examine, (i) the facilities where the Services are being conducted; (ii) study documentation; and (iii) any other relevant information, including information that may be designated by WCT as confidential, reasonably necessary for regulatory authorities to confirm that the Services are being conducted in compliance with Applicable Laws and regulations. WCT will immediately notify Sponsor if any regulatory authority schedules, or without scheduling, begins an inspection that relates to the Services, and, unless expressly prohibited by such regulatory authority, permit Sponsor to attend such inspection.
Inspection by Regulatory Authorities. ALLERGAN shall permit representatives of appropriate Regulatory Authorities from the Territory or country of Manufacture to inspect the Manufacturing Facilities to verify the Product and API is being manufactured and supplied in accordance with cGMPs, GQPs, GVPs and Product Specifications, API specifications and in accordance with the Manufacturing Authorizations and Marketing Authorizations. ALLERGAN shall provide GSK with a copy of any report or deficiency notice arising from such inspections conducted by Regulatory Authorities from the Territory or country of Manufacture, appropriately redacted to maintain confidentiality of ALLERGAN's proprietary trade secrets, however, for the avoidance of doubt, any major or critical observations of the Regulatory Authority will be disclosed in un-redacted form. GSK shall have the right to make recommendations to ALLERGAN regarding corrective action provided that ALLERGAN shall make the final determination with respect to the corrective action taken. ALLERGAN shall promptly remedy or cause the remedy of any deficiencies which may be noted in any such inspection by the Regulatory Authority.
Inspection by Regulatory Authorities. Upon the request of any Regulatory Authority having jurisdiction over the manufacture of API hereunder or Drug Product to be manufactured using such API, such Regulatory Authority shall have access to observe and inspect FFFC’s facilities and procedures used for all activities related to the manufacture and storage of the API including but not necessarily limited to the manufacture, testing and release, and/or warehousing of all API (and all Intermediates and Raw Material) and to audit such facilities for compliance with cGMP and/or other applicable Regulatory Standards. FFFC specifically agrees to cooperate with any inspection by a Regulatory Authority, whether prior to or after Regulatory Approval of a Drug Product, and to promptly provide Cempra a copy of any inspection or audit report resulting from any such inspection. If FFFC is purchasing Raw Materials from a Third Party manufacturer for use in manufacturing API, FFFC shall use commercially reasonable diligent efforts to ensure that such manufacturer’s facilities and procedures are subject to the provisions of this Section 8.14(a), or substantially similar contractual obligations, as to the manufacture of such Raw Materials, and to ensure that Cempra is provided copies of any inspection or audit report of such Third Party relating to such Raw Materials. For any Third Party manufacturers of Raw Materials selected by Cempra, FFFC will perform a reasonable and customary use test in accordance with relevant SOP or protocol with respect to any Raw Materials obtained from such Third Party.
Inspection by Regulatory Authorities. During the term of this Agreement, each Party will permit regulatory authorities to examine, (i) the facilities where the Services are being conducted; (ii) study documentation; and (iii) any other relevant information, including information that may be designated by one or both of the Parties as confidential, reasonably necessary for regulatory authorities to confirm that the Services are being conducted in compliance with applicable laws and regulations. Each Party will immediately notify the other if any regulatory authority schedules, or without scheduling, begins an inspection that relates to the Services or the Parties’ respective obligations hereunder. Aptiv Solutions shall provide Client with a copy of any inspection report related to the Services pursuant to this Agreement. Client shall be responsible for all costs and expenses related to Aptiv Solutions’ obligations hereunder if not otherwise included in the Project Agreement or Change Order.
Inspection by Regulatory Authorities. During the term of this Agreement, each Party will permit regulatory authorities to examine, (i) the facilities where the Services are being conducted; (ii) study documentation; and (iii) any other relevant information, including information that may be designated by one or both of the Parties as confidential, reasonably necessary for regulatory authorities to confirm that the Services are being conducted in compliance with applicable laws and regulations. Each Party will immediately notify the other if any regulatory authority schedules, or without scheduling, begins an inspection that relates to the Services or the Parties’ respective obligations hereunder. PRA shall disclose to Sponsor any finding from any regulatory authority that is directly related to the Services herein, and if permitted by the regulatory authority shall promptly provide Sponsor with a copy of the inspection report after the removal of any information of a confidential nature which is not related to the Services or to Sponsor’s activities or products, PRA shall reasonably act to contractually obtain, if PRA is responsible for contracting the Trial Sites, the cooperation of investigators and Trial Sites with respect to regulatory review. As part of PRA’s quality management procedures, PRA conducts periodical audits of its processes and systems. If such audits identify critical findings that impact the Services and/or Sponsor’s activities, PRA agrees to inform Sponsor of such findings. Horn & Co. Final, May 3, 2018
Inspection by Regulatory Authorities. During the term of this Agreement, each Party will permit regulatory authorities to examine, (i) the facilities where the Services are being conducted; (ii) study documentation; and (iii) any other relevant information, including information that may be designated by one or both of the Parties as confidential, reasonably necessary for regulatory authorities to confirm that the Services are being conducted in compliance with applicable laws and regulations. Each Party will immediately notify the other if any regulatory authority schedules, or without scheduling, begins an inspection that relates to the Services or the Parties’ respective obligations hereunder. Aptiv Solutions will allow Client to be present during any such inspection and in all instances promptly furnish to Client relevant portions of any report or correspondence issued by the regulatory authority in connection with such visit or inquiry that is directly related to Client or a Client project, including any FDA Form 483, Establishment Inspection Reports, and warning letters and any comparable documents received from any regulatory authority in any country. Upon completion of proper internal review Aptiv Solutions shall make all reasonable efforts to provide Client with copies of relevant portions of Aptiv Solutions responses or explanations directly relating to such items with a good faith effort to provide Client with sufficient time for review, in each case with only Aptiv Solutions trade secrets or other confidential information unrelated to Client's project redacted therefrom. Aptiv Solutions shall use its commercially reasonable efforts to properly address non compliance issues, and shall inform Client regarding the actions taken.
Inspection by Regulatory Authorities. Upon the request of the FDA or other Regulatory Authority, such Regulatory Authority shall have access to observe and inspect the Manufacturing Facility and procedures used for the manufacture, testing, labeling, packaging and/or warehousing of the Product and to audit such facilities for compliance with cGMP and/or other applicable regulatory standards. [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
