Government Inspections, Seizures and Recalls. If the FDA or any other federal, state or local governmental authority or EU authority makes an inspection at the contract manufacturer’s Facility which involves any Product, or seizes Product or requests a recall of Product, Eucodis shall promptly send retained samples of Products seized by such authority and duplicate reports relating to such inspections and send a copy to MDI. Eucodis shall be responsible for interacting with the EU regulators to cure any issues created by the inspection, seizure or recall and shall assist MDI in curing any issues with the FDA which are the result of the inspection, seizure and recall.
Government Inspections, Seizures and Recalls. (a) If the FDA or any other Governmental Authority conducts an inspection at Gilead's Facility pertaining to the Product, seizes any Product and/or its materials, requests a Recall of any Product, or otherwise notifies Gilead of any violation or potential violation of any Applicable Law, Eyetech shall be notified immediately, and Gilead shall take actions as may be required under the Specifications or otherwise as may be commercially reasonable way to resolve the issue to both parties' reasonable satisfaction.
(b) As applicable, Gilead shall promptly send any reports relating to such inspections, Recalls or violations or potential violations of Applicable Law to Eyetech. In the event that any such Governmental Authority requests, but does not seize, the Product in connection with any such inspection, Gilead, as the case may be (i) shall promptly notify Eyetech of such request, (ii) if possible, shall satisfy such request only after receiving Eyetech's approval (not to be unreasonably withheld, conditioned or delayed), (iii) shall follow any reasonable procedures instructed by Eyetech in responding to such request and (iv) shall promptly send any samples of the Product requested by the authority to Eyetech. In any case, Gilead will comply with all Applicable Laws.
(c) If the Product supplied by Gilead to Eyetech does not comply with the Product Warranty, other than non-compliance due to API that was non-compliant with the applicable specifications when received by Gilead in a manner that could not reasonably be detected by the required testing, Gilead shall be responsible for costs reasonably required to effect the Recall of any affected Product or other reasonably necessary corrective measures taken with respect thereto. Gilead shall be responsible for pursuing all resolutions with the applicable supplier of non-complying Product Materials.
Government Inspections, Seizures and Recalls. If any Regulatory Authority makes an inspection at Sharp's premises, seizes Products or Packaged Products or requests a recall of Packaged Products, Sharp shall promptly notify Manufacturer’s Quality Assurance Department (or such other persons or departments as Manufacturer may instruct), and Sharp shall take such actions as may be required under the Specifications or as may be reasonably requested by Manufacturer; provided, however, that Sharp shall not be required to take any actions in contravention of any Applicable Law. Sharp shall promptly send duplicate reports relating to such inspections to Manufacturer c/o Manufacturer’s Quality Assurance Department (or such other persons or departments as Manufacturer may instruct).
Government Inspections, Seizures and Recalls. If the United States Food and Drug Administration or any other Governmental Authority makes an inspection at Unipath's premises which involves any function performed by Unipath which has application to any Product, or seizes Product or requests a recall of Product, Warner-Lambert's Quality Assurance Department, or such other person xx xxxxx xx Xxxxer-Lambert may designate, shall be notified within twelve (12) hxxxx xxx Xxxxxth shall take such actions as may be required under the Specifications. Unipath shall promptly send retained samples of Product seized by such authority and duplicate reports relating to such inspections to Warner-Lambert, c/o Warner-Lambert's Quality Assurance Department.
Government Inspections, Seizures and Recalls. If any Governmental or Regulatory Authority makes an inspection at Paddock’s premises or Facility, seizes Products or Materials or requests a Recall of Products, Axcan Pharma’s Quality Assurance Department or such other person or group as Axcan Pharma may designate, shall be notified immediately and Paddock shall take such actions as may be required under the Specifications or as reasonably requested by Axcan Pharma at Axcan Pharma’s cost, subject to the provisions of paragraph 4.6 hereof. Paddock shall promptly send a portion of the retained samples of Products seized by such Governmental or Regulatory Authority and duplicate reports relating to such inspections to Axcan Pharma.
Government Inspections, Seizures and Recalls. If the FDA or any other Regulatory Authority conducts an inspection at CEPH’s premises, seizes any Products and/or its Raw Materials, requests a recall of any Products, or otherwise notifies CEPH of any violation or potential violation of any Applicable Laws relating to or affecting the Products, CEPH shall notify Advancis immediately and take such actions as may be required under the Specifications or as reasonably instructed by Advancis.
Government Inspections, Seizures and Recalls. Company shall notify Purchaser of any inspection of Company’s Facility proposed or scheduled with the FDA or any other Governmental Authority that may relate to the Products or any Facility. If the FDA or any other Governmental Authority conducts an inspection at Company’s Facility, seizes any Product and/or Product Materials, requests a Recall or Field Alert (as defined below) be issued for of any Product, or otherwise notifies Company of any violation or potential violation of any applicable Law or of any intended inspection of the Facility, Company shall notify Purchaser. For the purposes of this provision, “Field Alert” means an action taken for specific lots of US manufactured or distributed NDA/ANDA product that indicates the potential of a quality issue (e.g. bacterial contamination, significant chemical, physical degradation, adulterated or misbranded product). As applicable, Company shall promptly send any reports relating to such inspections, Recalls, Field Alerts or violations or potential violations of Law to Purchaser.
Government Inspections, Seizures and Recalls. If any Governmental or Regulatory Authority conducts an inspection at the Facility, seizes any Product and/or its Materials, requests a Recall of any Product, or otherwise notifies the Manufacturer of any violation or potential violation of any applicable Law relating to a Product or Products, or the manufacture or storage thereof, Warner shall be notified immediately by the Manufacturer and the Manufacturer shall take such actions as may be required under the Specifications or reasonably instructed by Warner. The Manufacturer shall promptly send any reports relating to such inspection, seizure, request or notification to Warner. In the event that any such Governmental or Regulatory Authority requests, but does not seize, the Product in connection with any such inspection, the Manufacturer (i) shall promptly notify Warner of such request, (ii) shall follow any reasonable procedures instructed by Warner in responding to such request, provided that such procedures do not interfere with the Manufacturer’s compliance with the Governmental or Regulatory Authority’s request, and (iii) shall promptly send any samples of the Product requested by the Authority to Warner.
Government Inspections, Seizures and Recalls. If any Governmental Body or Regulatory Authority makes an inspection of the Suite relating to the Product (including any environmental inspection, investigation, notice or inquiry), or seizes or requests a recall of the Product, GSK shall immediately notify DENDREON’s Quality Assurance department or such other person or group as DENDREON may designate in writing of the same and GSK shall take such actions as may be required under the Quality Agreement in such circumstances. GSK shall promptly send DENDREON retained samples of Products seized by such Governmental Body or Regulatory Authority (unless otherwise legally prohibited from doing so) and make reports relating to such events available to DENDREON.
Government Inspections, Seizures and Recalls. If any Regulatory Authority makes an inspection at Sharp’s Facilities, seizes Products or Packaged Products or requests a recall of Packaged Products, Sharp shall promptly notify Ascendis’ Quality Assurance Department (or such other persons or departments as Ascendis may instruct), and Sharp shall take such actions as may be required under the Specifications or as may be reasonably requested in writing by Ascendis; [***]. Sharp shall promptly send duplicate reports relating to such inspections to Ascendis care of Ascendis’ Quality Assurance Department (or such other persons or departments as Ascendis may instruct).
