Inspections by Government Agencies. With respect to any adverse findings affecting Products, Stellartech shall promptly notify Thermage of any inspections by U.S. and foreign national, federal, state, or local regulatory representatives (including, without limitation, FDA, EPA, EEOC, OSHA, and corresponding or similar foreign agencies or entities, state agencies, or building code inspectors) of any facility at which Products are being or will be manufactured, and shall provide Thermage with the results of any such inspection, including actions taken by Stellartech or any other entity to remedy conditions cited in any such inspection. Without limiting the generality of the foregoing, Stellartech shall provide copies of any written inspection reports issued by such agencies and all correspondence between Stellartech and the agency involved. Stellartech shall permit such regulatory agencies to conduct whatever inspections of the facilities at which Products are to be manufactured as such agencies may request in connection with Thermage’s obtaining approval to manufacture and market the Products, and shall cooperate fully with any such regulatory entity, domestic or foreign, as the case may be, during any such inspections. Stellartech will give Thermage prompt written notice of any inspection relating to Products and allow representatives of Thermage to be present at such facilities during any such inspection.
Inspections by Government Agencies. Without limiting the ---------------------------------- generality of Paragraph 5.1 hereof, MOVA shall permit the FDA to conduct whatever inspections of the facilities at which the Product is to be manufactured, packaged and/or stored and shall cooperate with the FDA during any such inspections.
Inspections by Government Agencies. Altana shall promptly notify Matrix of any inspections by any regulatory representatives of any facility at which the Product is being or will be distributed, to the extent such inspections pertain to the Product or the distribution thereof, and shall send Matrix copies of the results of any such inspections, including actions taken by the inspected party or any other entity to remedy conditions cited in such inspections.
Inspections by Government Agencies. (i) If any governmental agency shall inspect any facility at which any Product is manufactured or the records with respect to the Production Services or the compliance by VGX with laws and regulations applicable to the manufacturing of such Product, VGX shall notify CUSTOMER of such inspection, the results thereof and, if VGX was required, as a result of any such inspection, to take any corrective action in order to comply with any applicable law or regulation, any such action it has taken in response to such requirement.
(ii) VGX will notify CUSTOMER promptly upon receipt of any correspondence from a regulatory agency, which relates to the Production Services and promptly provide the CUSTOMER a copy thereof. CUSTOMER shall be entitled to review and approve in advance VGX’s responses and submissions, but such approval shall not be unreasonably withheld. In addition and subject to the foregoing, VGX shall provide to the regulatory agencies all documents and information requested by such authority, and shall submit to all inquiries, audits and inspections by the regulatory agencies.
(iii) VGX hereby agrees to provide (i) all information and assistance which is reasonably necessary for or useful in the preparation of comprehensive and complete regulatory submissions including without limitation applications or materials required to obtain marketing approval of Product, and (ii) access to the manufacturing facility and pertinent information to applicable regulatory agencies inspectors conducting the pre-approval inspection. CUSTOMER shall have the sole right to prepare and make any such submissions, applications or materials and shall own any and all rights and interest therein.
Inspections by Government Agencies. Distribut shall promptly notify Company of any inspections by U.S. and foreign national, federal, stat or l l regulatory agencies (including, without limitation, FDA, EPA, EEOC, OSHA, and corresponding or similar foreign agencies or entities, state agencies or building code inspe tors) of its fac ties and hall provide Company with the results of any such inspections, including ctions taken by Xx xxxxx or any other entity to remedy conditions cited in such ins . Without limiting the nerality of the foregoing, Distributor shall provide copies of a written pection reports i sued by such agencies and all correspondence between Distributor a the age y involve stributor shall cooperate fully with any such regulatory entity ing any uch i pections. Di ributor will give Company prompt written notice of any inspect ons lating to Products and allow distributors of Company to be present at such facilities during any uch inspe ions.
Inspections by Government Agencies. Prima Pharm shall promptly notify ACS of any inspections by federal or national; state, province, or regional; or local regulatory representatives (including, without limitation, FDA, EPA, EEOC, OSHA, similar state agencies or building code inspectors) of any facility at which Products are being or will be manufactured, and shall so cause the supplier(s) of Bulk Material to do the same, and shall send ACS copies of the results of any such inspections, including actions taken by Prima Pharm or any other entity to remedy conditions cited in such inspections. Without limiting the generality of the foregoing, Prima Pharm shall provide, and cause the supplier(s) of Bulk Material to provide, ACS with copies of any written inspection reports issued by such agencies and all correspondence between Prima Pharm or the Bulk Material to do the same, and the agency involved, including, but not limited to, FDA Form 483 and all correspondence relating thereto. Prima Pharm shall permit, and cause Bulk Material Suppliers to permit, the FDA to conduct whatever inspections of the facilities at which Products or Bulk Material are to be manufactured as the FDA may reasonably request in connection with ACS's obtaining and maintaining market approval for the Products, and shall cooperate fully with the FDA during any such inspections.
Inspections by Government Agencies. With respect to any ---------------------------------- adverse event or finding affecting the Products, SST shall promptly notify FMT of any inspections by U.S. and foreign national, federal, state or local regulatory agencies (including, without limitation, FDA, EPA, EEOC, OSHA, and corresponding or similar foreign agencies or entities, state agencies or building code inspectors) of its facilities and shall provide FMT with the results of any such inspections, including actions taken by SST or any other entity to remedy conditions cited in such inspections. Without limiting the generality of the foregoing, SST shall provide copies of any written inspection reports issued by such agencies and all correspondence between SST and the agency involved. SST shall cooperate fully with any such regulatory entity during any such inspections. SST will give FMT prompt written notice of any inspections relating to the Products.
Inspections by Government Agencies. Ista shall promptly notify Allergan of any inspections by federal or national; state, province, or regional; or local regulatory representatives (including, without limitation, FDA, EPA, EEOC, OSHA, similar state agencies or building code inspectors) of any facility at which Product or Finished Product is being or will be manufactured for delivery to Allergan, and shall send Allergan copies of the results of any such inspections, including actions taken by Ista, its Approved Third Party Contractor, or any other entity to remedy unsatisfactory conditions cited in such inspections.
Inspections by Government Agencies. NORAC shall promptly notify UNIMED of any inspections by federal, state or local regulatory representatives of the parties of its manufacturing facility at which the product is manufactured and the results of any such inspections, including actions taken by NORAC to remedy conditions cited in such inspections.
Inspections by Government Agencies. If any governmental agency shall inspect any facility at which any Product is manufactured or the records with respect to the compliance by VGX with laws and regulations applicable to the manufacturing of such Product, VGX shall notify CUSTOMER of such inspection, the results thereof and, if VGX was required, as a result of any such inspection, to take any corrective action in order to comply with any applicable law or regulation, any such action it has taken in response to such requirement.
