FDA Proceedings Sample Clauses
The FDA Proceedings clause outlines the responsibilities and procedures that parties must follow if any product or activity under the agreement becomes subject to investigation, inquiry, or action by the U.S. Food and Drug Administration (FDA). Typically, this clause requires prompt notification to the other party if the FDA initiates any proceedings, and may specify how the parties will cooperate in responding to FDA requests or actions, such as inspections, warning letters, or recalls. Its core function is to ensure coordinated and timely responses to regulatory actions, thereby minimizing business disruption and legal risk.
FDA Proceedings. To the best of the Company’s knowledge, there are no rulemakings or similar proceedings before the FDA or any similar entity in any other jurisdiction which involve the Company or any of its subsidiaries or any of the processes or products which the Disclosure Package or the Prospectus discloses the Company or any of its subsidiaries has developed, is developing or proposes to develop, or uses or proposes to use which, if the subject of an action unfavorable to the Company or any of its subsidiaries, would result in a Material Adverse Change.
FDA Proceedings. To the best of ev3 LLC’s and the Company’s knowledge, there are no rulemakings or similar proceedings before the FDA or any similar entity in any other jurisdiction which involve ev3 LLC, the Company or any of their respective subsidiaries or any of the processes or products which the Prospectus discloses ev3 LLC, the Company or any of their respective subsidiaries has developed, is developing or proposes to develop, or uses or proposes to use which, if the subject of an action unfavorable to ev3 LLC, the Company or any of their subsidiaries, would result in a Material Adverse Change. Any certificate signed by an officer of the Company and delivered to the Representatives or to counsel for the Underwriters shall be deemed to be a representation and warranty by the Company to each Underwriter as to the matters set forth therein. Each of ev3 LLC and the Company acknowledge that the Underwriters and, for purposes of the opinions to be delivered pursuant to Section 5 hereof, counsel to the Company and counsel to the Underwriters, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.
FDA Proceedings. Prior to the Closing, the Company shall reasonably cooperate and consult with a representative of the Purchaser (the “Purchaser FDA Representative”) in connection with the making of all correspondence, filings, documents, communications and presentations to the FDA or members of the FDA’s staff with respect to any Primary Product prior to taking any such action, permitting the Purchaser and its advisors a reasonable time period, taking into account the date of any applicable meeting, timetable or deadline, in which to review, reasonably comment upon and consult with the Company prior to taking such action. The Company shall promptly inform the Purchaser FDA Representative upon receipt of any communication from the FDA regarding any Primary Product.
FDA Proceedings. “FDA Proceedings” shall mean any action, suit, charge, complaint, proceeding (including any civil, criminal, judicial, administrative or investigative proceeding including any such proceeding related to conduct for which debarment is mandated or permitted under Section 335(a) of Title 21 of the FDCA ), FDA inspection, FDA warning letter, FDA untitled letter, FDA notice of violation letter, FDA Form 483, inspectional observations, or any other written communication from the FDA or any state or foreign Government Body having equivalent authority over medical devices..