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. If Client does not give Patheon the documents requested under subsections (b) and (c) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized as a result, Patheon may delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents; provided, that Patheon shall perform such review within 21 days of receipt of the requested documents.
Inspection by Regulatory Authorities. If Client does not give Patheon the documents requested under subsections (b) and (c) 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; provided that such review shall take no longer than [* * *]; and until any deficiencies in the documentation relating to Patheon’s work are remedied. Any review by Patheon under this Section 7.8(f) shall be at no cost to Client.
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, 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 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.
(a) During the term of each Work Order, 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. Worldwide will notify Sponsor as soon as possible, but no later than one (1) business day if any regulatory authority schedules, or without scheduling, begins an inspection that relates to the Services or Worldwide’s obligations hereunder.
(b) Worldwide shall notify Sponsor within one (1) business day of receipt of a non-routine inquiry, correspondence, inspection or other contact by a regulatory authority in connection with a Study, or this Agreement (each a “Non-Routine Regulatory Contact”) including, but not limited to, inspections of any Sites. For avoidance of doubt, “Non-Routine Regulatory Contact” means any contact by a regulatory authority that is other than a contact that reasonable could be expected in the normal course of business.
(c) Each Party shall immediately forward to the other Party copies of any correspondence or other documentation from or to any regulatory authority relating solely to a Study or this Agreement.
(d) As to a regulatory finding, observation or other contact to which Worldwide is required or is reasonably expected to submit a written response in relation to a Study or this Agreement, Worldwide will use reasonable efforts to provide Sponsor with a reasonable opportunity to review and comment on any response (“Response”) required from Worldwide to a regulatory authority. Worldwide shall in good faith consider the inclusion of any comments from Sponsor in its Response but shall not be obligated to incorporate any such comments in a Response. In the event that Worldwide does not incorporate Sponsor comments in the Response, Worldwide shall use reasonable efforts to notify Sponsor prior to the submission of such Response in order to mutually resolve any issues. In any event Worldwide shall promptly provide to Sponsor a copy of the Response submitted by Worldwide to any regulatory authority that (i) solely relates to a Study or this Agreement; or (ii) that would have a material negative impact on the ability of Worldwide to provide the Services provided that Wo...
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.
