FDA Inspection. DPT shall advise COMPANY if an authorized agent of the FDA or other governmental agency visits DPT’s manufacturing facility and requests or requires information or changes which specifically pertain to the Products. FDA audit time specific to Products will be billed to COMPANY from DPT at the then-prevailing QA hourly rate.
FDA Inspection. In the event that Omnicare CR receives a Notice of Inspection (a “Notice”) from the Food and Drug Administration (“FDA”) which relates to any Project Omnicare CR shall: (a) notify Sponsor promptly of such Notice; (b) keep Sponsor informed of the progress of the inspection; and (c) provide to Sponsor a copy of any documents produced to the FDA pursuant to such Notice. Sponsor acknowledges that it is Omnicare CR’s obligation to respond to a Notice directed to Omnicare CR and that Omnicare CR must respond to the Notice without advice from, or consultation with, Sponsor concerning the contents thereof.
FDA Inspection. Unigene must advise USL promptly if Unigene receives notification that an authorized agent of the FDA or other governmental agency intends to visit the manufacturing facility, if that visit is related directly to API, Product or Vials.
FDA Inspection. In the event that PharmaForm receives a Notice of Inspection (a “Notice”) from the Food and Drug Administration (“FDA”) which relates to the Services, PharmaForm shall: (a) notify AUXILIUM ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. promptly of such Notice; (b) keep AUXILIUM informed of the progress of the inspection; and (c) provide to AUXILIUM a copy of any documents produced to the FDA pursuant to such Notice. AUXILIUM acknowledges that it is PharmaForm’s obligation to respond to a Notice directed to PharmaForm that PharmaForm must respond to the Notice without advice from, or consultation with, AUXILIUM concerning the contents thereof.
FDA Inspection. Upshxx-Xxxxx xxxll advise Ascent reasonably in advance, to the extent possible, if an authorized agent of the FDA or other governmental agency visits Upshxx-Xxxxx'x xxxufacturing facility to perform an inspection and requests or requires information or changes which directly pertain to the Products. Upshxx-Xxxxx xxxll allow Ascent to be present and assist as appropriate in the preparation for and participation in any FDA audits related to Ascent's Products. Upshxx-Xxxxx xxxll furnish to Ascent copies of all FDA forms 482 and 483 related to Ascent's Products given to Upshxx-Xxxxx xx the FDA promptly upon receipt.
FDA Inspection. Escalon will permit the FDA and corresponding drug regulatory agencies of foreign jurisdictions to inspect its manufacturing facility for finished products in accordance with applicable laws and regulations. Escalon will provide Scoxx xxth a copy of all FDA correspondence relating to finished products which is reasonably necessary to Scoxx'x xxrformance hereunder or which could adversely affect Scoxx.
FDA Inspection. DPT shall advise COMPANY if an authorized agent of the FDA or other governmental agency visits DPT’s manufacturing facility and requests or requires information or changes which directly pertain to the Products. FDA audit time specific to Products will be billed to COMPANY from DPT at the then-prevailing QA hourly rate. DPT will notify COMPANY and upon request of the COMPANY, will provide appropriately redacted copies of regulatory authority audits specifically pertaining to the Product(s) (e.g. FDA 483, Warning Letters, EMEA and local EU regulatory reports) to the COMPANY.
FDA Inspection. Eon must advise Xxxxxx-Xxxxx immediately if Eon receives notification that an authorized agent of the FDA or other governmental agency intends to visit the manufacturing facility, if that visit is related directly to the Product.
FDA Inspection. A. [ * ] hereby agrees, and any third party conducting the Bioequivalence Study shall agree, to permit representatives of [ * ] and/or of the FDA to examine at any reasonable time during normal business hours, and where applicable, make copies of relevant information and facilities necessary to confirm that the clinical trials (or studies) being conducted pursuant to this Agreement (each, a "Study") are being conducted in compliance with the protocol, this Agreement and applicable law.
FDA Inspection. In the event that AAI receives a Notice of Inspection (hereinafter "Notice") from the U.S. Food and Drug Administration (the "FDA") which relates in any way to this Service Agreement, AAI shall (a) promptly notify Esperion in writing of the Notice, (b) keep Esperion informed of the progress of the inspection, and (c) provide a copy to Esperion of any documents produced to the FDA pursuant to the Notice. Announcements: No announcement, oral presentation or publication relating to any matter described herein shall be made without the prior written approval of Esperion, which approval may be granted or withheld by Esperion in its discretion. Non Debarment: AAI warrants and represents that AAI has never been and is not currently (a) debarred by the FDA, or an employer, partner, shareholder, member, subsidiary or affiliate of any person or entity debarred by the FDA, from providing services in any capacity to a person or entity that has an approved or pending drug product application; or (b) a person or entity that has been debarred by the FDA from submitting or assisting in the submission of an abbreviated new drug application (a Debarred Entity") or an employer, partner, shareholder, member, subsidiary or affiliate of a Debarred Entity. AAI further represents and warrants to Esperion that AAI has no knowledge of any circumstances which may affect the accuracy of foregoing representations and warranties, including, but not limited to, FDA investigations of, or debarment proceedings against, AAI or any person or entity performing services or rendering assistance relating to activities taken pursuant hereto. Reports: AAI shall provide Esperion with weekly written reports describing with specificity AAI's performance of its obligations hereunder.
