Inspection by Regulatory Authority. Miltenyi shall permit inspections of the Miltenyi Facility by Regulatory Authorities and shall respond to any notices or requests for information by Regulatory Authorities for any import or export license, registration or pending registration for manufacturing of Miltenyi Products during the Term of the Agreement. Miltenyi shall permit representatives of any applicable Regulatory Authority to access, at any reasonable time during normal business hours, any and all relevant records and information, personnel and facilities. To the extent that a Regulatory Authority raises any issue during or following a Regulatory Authority inspection that would prevent or hinder Autolus or its Licensees from using the Miltenyi Product for any Permitted Use, Miltenyi shall promptly advise Autolus in writing of such issue. The Parties shall promptly give written notice to each other in advance of any scheduled inspection of Miltenyi’s Facility by a Regulatory Authority.
Inspection by Regulatory Authority. Unigene agrees to inform Novartis promptly of any inspections of regulatory authorities related to any API.
Inspection by Regulatory Authority. Upon reasonable prior notice and during normal business hours, Intercept shall allow, and shall cause its Affiliates and its Third Party subcontractors to whom all or a part of the Manufacturing process of the Compound and/or the Product has been entrusted or contracted to allow, the inspection by the Regulatory Authority which is required as a condition for obtaining or maintaining Regulatory Approval for the Product in the Field in the Territory. DSP shall use its Commercially Reasonable Efforts to provide any information concerning such audit to Intercept in a timely manner. Intercept shall permit DSP or its designated representatives to be present at any audit conducted by any Regulatory Authority pursuant to this Section 6.3.4. If any issue or concerns are raised concerning the Manufacturing of the Compound or Product in connection with the audit by such Regulatory Authority, Intercept shall immediately inform DSP, including any recommendations made by the Regulatory Authority.
Inspection by Regulatory Authority. Unless prohibited by law or regulatory authority, Investigator and Institution shall notify Sponsor promptly by telephone or facsimile if the FDA or other duly authorized authority requests permission to or does inspect Institution’s facilities or research records directly related to the Protocol during the term of this Agreement and will, to the extent allowed by law, provide in writing to Sponsor copies of all materials, correspondence, statements, forms, and records which Investigator or Institution receives, obtains or generates pursuant to any such inspection. Institution, to the extent allowed by law, shall allow Sponsor to be present and provide assistance with any such inspection.
Inspection by Regulatory Authority. The Parties shall cooperate in good faith with respect to the conduct of any inspections by any Regulatory Authority of Biogen’s Drug Substance manufacturing facility and/or the Third Party Manufacturer’s Drug Product and Finished Goods manufacturing facility. Biogen shall give Bioverativ notice of, and Bioverativ shall have the right to be on site during the portion of, any such regulatory inspection conducted by a Regulatory Authority that relates to the Drug Substance or the Drug Product or Finished Goods, except to the extent (a) not permitted by applicable law of the Regulatory Authority conducting the inspection, (b) any such attendance would result in the disclosure of Confidential Information or trade secrets unrelated to the Drug Substance, Drug Product or Finished Goods (where Biogen shall have taken reasonable measures to seek to avoid disclosure of Confidential Information and such trade secrets, provided, however, that in no event shall such reasonable measures be deemed to include any measures under which Biogen would incur unreasonable additional costs), or (c) the Third Party Manufacturer’s contract with Biogen does not permit such attendance. If in Biogen’s reasonable judgment Bioverativ’s presence on site is required, Biogen will notify Bioverativ and may require Bioverativ to attend such inspection (or answer questions of the Regulatory Authority).
Inspection by Regulatory Authority i) If any Regulatory Authority notifies Tempus or an Approved Subcontractor that it will inspect Tempus’s or Approved Subcontractor’s premises, records, equipment, or procedures, in direct relation to the Activities, or otherwise take action related to this Agreement or any Task Order, then to the extent legally permissible Tempus shall notify GSK as soon as is practicable (to the extent possible, within [***] and prior to the inspection or action) and:
Inspection by Regulatory Authority. (i) Upon the request of the Regulatory Authority from whom a preapproval inspection or Regulatory Approval for a Product has been requested by Roivant, Arena shall provide such 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 applicable Regulatory Standards. Arena shall notify Roivant promptly of any inspection at the Facility by a Regulatory Authority that is scheduled in advance and shall provide Roivant with an opportunity to be present, but not participate, during such inspection. Arena specifically agrees to cooperate with any inspection by such a Regulatory Authority at the Facility, whether prior to or after Regulatory Approval of the applicable Product, and to provide Roivant a copy of any inspection or audit report resulting from any such inspection.
Inspection by Regulatory Authority. At LSC's cost and expense, Pharm-Eco agrees to permit the FDA and any other relevant regulatory authorities to inspect any facilities used by Pharm-Eco to perform its obligations under this Agreement and to cooperate fully with the FDA and such regulatory authorities in connection with LSC's conduct of any clinical trials relating to the Product and/or LSC's regulatory filings relating thereto, including furnishing information to the FDA and such regulatory authorities at LSC's, the FDA's, or the regulatory authorities' request, as the case may be. If the FDA or another relevant regulatory authority (i) gives notice to Pharm-Eco that it intends to perform an inspection of Pharm-Eco's facilities, where such inspection is directly related to the Product, or (ii) performs such an inspection directly related to the Product without notice, Pharm-Eco shall contact LSC by telephone and provide written notice to LSC immediately after receiving such notice of inspection.
Inspection by Regulatory Authority. DSP shall accept, have its Affiliate accept, and seek to have the Third Parties, who are entrusted or contracted all or a part of manufacturing process of the Compound, if any, accept, the inspection by the Regulatory Authority if it is required for Chelsea to maintain the Marketing Authorization Approval. Chelsea shall use Commercially Reasonable Efforts to obtain the information on such inspection in advance and forward it to DSP. DSP shall permit Chelsea or Chelsea’s Affiliates to be present at any inspection by the Regulatory Authority. If any issue on the manufacturing of the Compound is raised in the inspection by the Japanese, US and EU Regulatory Authorities, DSP shall inform Chelsea of the issue.
Inspection by Regulatory Authority. Miltenyi shall permit inspections of the Miltenyi Facility by Regulatory Authorities and shall respond to any notices or requests for information by Regulatory Authorities for any import or export license, registration or pending registration for manufacturing of Miltenyi Products during the Term of the Agreement. Miltenyi shall permit representatives of any applicable Regulatory Authority to access, at any reasonable time during normal business hours, any and all relevant records and information, personnel and facilities. To the extent that a Regulatory Authority raises any quality issue during or following a Regulatory Authority inspection that would Bellicumbe reasonably likely to adversely affect the suitability of the Miltenyi Products for any Permitted Use, Miltenyi shall promptly advise Bellicum in writing of such issue. The Parties will promptly give written notice to each other in advance of any scheduled inspection of Miltenyi’s Facility by a Regulatory Authority.
