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. 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. 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. Scoxx xxll permit the FDA and corresponding drug regulatory agencies of foreign jurisdictions to inspect its manufacturing facility for the Products in accordance with applicable laws and regulations. Scoxx xxll provide Escalon with a copy of all FDA correspondence relating to the Products which is reasonably necessary to Escalon's performance hereunder or which could adversely affect Escalon.
FDA Inspection. FMLP shall give APC reasonable notice under the circumstances of any impending inspection of an FMLP MG-PFH manufacturing facility by the FDA or any such governmental agency of which it has advance notice. FMLP shall advise APC promptly of any other FDA inspections of FMLP relating to or that affect MG-PFH and their results, including copies (purged of confidential or proprietary information, if any) of any FDA form 483s and other FDA communications. The parties agree that any proprietary information presented to the FDA as part of an FDA inspection may be withheld from APC or its representative. The information obtained by APC in the course of any such audit shall be considered Confidential Information.
FDA Inspection. 8 5.5 NDA's, ANDA's, & 510(k)'s..................................... 8
FDA Inspection. HARMONY shall advise SIRIUS within [c.i.] if an authorized agent of the FDA or other governmental agency visits HARMONY's manufacturing facility and requests or requires information or changes which [c.i.] or which [c.i.]. FDA audit time specific to Products will be [c.i.].
FDA Inspection. DPT shall advise COMPANY if an authorized agent of the FDA or other governmental agency schedules a visit at, or without scheduling visits, DPT’s manufacturing facility and requests or requires information or changes which specifically pertain to the Products or pertains to DPT’s ability to continue to provide Services and Product(s) under this Agreement. FDA audit time specific to Products, e.g. for cause or pre-approval inspection, will be billed to COMPANY from DPT at the then-prevailing QA hourly rate. DPT shall immediately communicate to COMPANY all communications with the FDA or other government agency, including requests for audits or that an audit has started. DPT shall allow COMPANY to be in close proximity at when there is a COMPANY specific regulatory audit.
