FDA Proceedings Sample Clauses

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.
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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.
Sample 1
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..
Sample 1
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.
Sample 1

Related to FDA Proceedings

  • Litigation; Proceedings Except as specifically disclosed in Schedule 3.1(g), there is no action, suit, notice of violation, proceeding or investigation pending or, to the best knowledge of the Company, threatened against or affecting the Company or any of its Subsidiaries or any of their respective properties before or by any court, governmental or administrative agency or regulatory authority (federal, state, county, local or foreign) which (i) relates to or challenges the legality, validity or enforceability of any of the Transaction Documents, the Shares or the Underlying Shares, (ii) could, individually or in the aggregate, have a Material Adverse Effect or (iii) could, individually or in the aggregate, materially impair the ability of the Company to perform fully on a timely basis its obligations under the Transaction Documents.

  • Actions; Proceedings There are no actions, suits or proceedings pending or, to the knowledge of the Assignor, threatened, before or by any court, administrative agency, arbitrator or governmental body (A) with respect to any of the transactions contemplated by this Assignment Agreement or (B) with respect to any other matter that in the judgment of the Assignor will be determined adversely to the Assignor and will, if determined adversely to the Assignor, materially adversely affect its ability to perform its obligations under this Assignment Agreement.

  • Pending Proceedings Borrower is not in default under any law or regulation or under any order of any court, board, commission or agency whatsoever, and there are no claims, actions, suits or proceedings pending or, to the knowledge of Borrower, threatened against or affecting Borrower or the Development, at law or in equity, before or by any court, board, commission or agency whatsoever which might, if determined adversely to Borrower, materially affect Borrower's ability to repay the Loan or impair the security to be given to the County pursuant hereto.

  • Litigation and Proceedings There are no actions, suits, proceedings, or investigations pending or, to the knowledge of the Company after reasonable investigation, threatened by or against the Company or affecting the Company or its properties, at law or in equity, before any court or other governmental agency or instrumentality, domestic or foreign, or before any arbitrator of any kind. The Company does not have any knowledge of any material default on its part with respect to any judgment, order, injunction, decree, award, rule, or regulation of any court, arbitrator, or governmental agency or instrumentality or of any circumstances which, after reasonable investigation, would result in the discovery of such a default.

  • Criminal Proceedings Any criminal complaint, indictment or criminal proceedings;

  • Suits, Actions, Proceedings If an Event of Default shall occur and be continuing, and whether or not the Agent shall have accelerated the maturity of Loans pursuant to any of the foregoing provisions of this Section 9.2, the Agent or any Bank, if owed any amount with respect to the Loans, may proceed to protect and enforce its rights by suit in equity, action at law and/or other appropriate proceeding, whether for the specific performance of any covenant or agreement contained in this Agreement or the other Loan Documents, including as permitted by applicable Law the obtaining of the ex parte appointment of a receiver, and, if such amount shall have become due, by declaration or otherwise, proceed to enforce the payment thereof or any other legal or equitable right of the Agent or such Bank; and

  • Actions and Proceedings Lender has the right to appear in and defend any action or proceeding brought with respect to the Property and to bring any action or proceeding, in the name and on behalf of Borrower, which Lender, in its discretion, decides should be brought to protect its interest in the Property.

  • Investigations and Proceedings The parties to this Agreement agree to cooperate fully in any securities regulatory investigation or proceeding or any judicial proceeding with respect to each party’s activities under this Agreement and promptly to notify the other party of any such investigation or proceeding.

  • Litigation; Governmental Proceedings There is no action, suit, proceeding, inquiry, arbitration, investigation, litigation or governmental proceeding pending or, to the Company’s knowledge, threatened against, or involving the Company or, to the Company’s knowledge, any executive officer or director which has not been disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus or in connection with the Company’s listing application for the listing of the Public Securities on the Exchange.

  • Other Proceedings No action, suit, investigation, bankruptcy or other proceeding (including, without limitation, the enactment or promulgation of a statute or rule) by or before any arbitrator or any Governmental Authority shall be threatened or pending and no preliminary or permanent injunction or order by a state or federal court shall have been entered (i) in connection with this Agreement or any transaction contemplated hereby or (ii) which, in any case, in the judgment of the Administrative Agent could reasonably be expected to result in a Material Adverse Change.

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