Actions and Investigations Sample Clauses

Actions and Investigations. There are no Claims (other than routine claims for benefits) pending or, to the Knowledge of the Company, threatened with respect to (or against the assets of) any Employee Benefit Plan, nor, to the Knowledge of the Company, is there any reasonable basis for any such Claim. No Employee Benefit Plan is currently under investigation, audit or review, directly or indirectly, by any Governmental Body, and, to the Knowledge of the Company, no such action is contemplated or under consideration by any Governmental Body.
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Actions and Investigations. To the Knowledge of the Company, the Company has not received or been subject to any notice, warning, administrative proceeding order, complaint, or other written communication of any actual or threatened Action, investigation or allegation that the Company has violated any applicable Law, including any FDA Form 483, warning letter, untitled letter, notice of violation, inspectional observation or request or requirement to recall any Company Product, and, to the Knowledge of the Company, neither the FDA, HHS, EMA, FTC, nor any other Regulatory Authority either in or outside the United States, is considering such Action, investigation or allegation. To the Knowledge of the Company, no Person has filed or has threatened to file against the Company any Action under any federal or state whistleblower statute or equivalent Law in the applicable jurisdiction, including under the federal False Claims Act, 21 U.S.C. §§ 3729-3733. To the Company’s Knowledge, neither the Company nor any officer, employee, agent or clinical investigator thereof has committed any act, made any statement or failed to make any statement that establishes a reasonable basis for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company nor, to the Company’s Knowledge, any officer, employee, agent or clinical investigator thereof has been suspended, debarred, excluded or convicted of any crime or engaged in any conduct that would reasonably be expected to result in debarment under 21 U.S.C. Section 335a, exclusion under 42 U.S.C. Section 1320a-7 or any similar Action.
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Actions and Investigations. With respect to the conduct or operation of the Business or use of the Purchased Assets, since January 1, 2008 (i) neither Seller nor any of its Subsidiaries has received any written notice, Order, complaint or other written communication of any actual or threatened enforcement Action or investigation by the FDA or any similar foreign Governmental Entity that has jurisdiction over the operation of Seller and its Subsidiaries, and (ii) to Seller’s Knowledge, neither the FDA nor any other Governmental Entity is considering such action.
Sample 1
Actions and Investigations. Since January 1, 2015, Seller has not received any written notice, warning, administrative proceeding order, complaint, or other written communication of any actual or threatened enforcement Action, adverse inspectional finding, or investigation by any Regulatory Authority or other Governmental Entity that Seller has violated any applicable Legal Requirements, including any FDA Form 483, warning letter or untitled letter, in each case, that have not been complied with or closed to the satisfaction of the relevant Regulatory Authority or other Governmental Entity. To the knowledge of Seller, neither the FDA nor any other Governmental Entity is considering such action nor do circumstances exist that would reasonably be expected to lead to any such action. Seller is not a party to, and Seller does not have any ongoing reporting obligations pursuant to, any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity.
Sample 1
Actions and Investigations. The Company has not received or been subject to (i) any notice, warning, administrative proceeding, order, complaint, or other written communication of any actual or threatened enforcement Action or investigation or allegation that the Company has violated any applicable Law by the FDA, U.S. Department of Health and Human Services (the “HHS”), European Medicines Agency (“EMA”) or other Regulatory Authority, including any FDA Form 483, warning letter or untitled letter and, to the Knowledge of the Company, neither the FDA, HHS, EMA, nor any other Regulatory Authority, is considering such Action, investigation or allegation, or (ii) any notice, correspondence or communication from any health care professional or current or former officer, director, employee, contractor or vendor asserting non-compliance with applicable Laws. To the Company’s Knowledge, no Person has filed or has threatened in writing to file against the Company any Action under any federal or state whistleblower statute or equivalent law in the applicable jurisdiction, including under the federal False Claims Act, 21 U.S.C. §§ 3729-3733. 22
Sample 1
Actions and Investigations. The Company has not received or, to the Knowledge of the Company, been subject to any notice, warning, administrative proceeding order, complaint, or other written communication of any actual or threatened enforcement Action or investigation or allegation or assertion that the Company has violated any applicable Law by the FDA, HHS, EMA, FTC or other Governmental Entity, including any FDA Form 483, warning letter or untitled letter, and, to the Knowledge of the Company, neither the FDA, HHS, EMA, FTC, nor any other Governmental Entity either in or outside the United States, is considering such Action, investigation or allegation. The Company is not a party to, and the Company does not have any ongoing reporting obligations pursuant to, any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory entity and, to the Knowledge of the Company, none of the Company’s manufacturers are operating under any such agreements. Neither the Company, nor any of its employees, officers or directors has been excluded, suspended or debarred from participation in any federal health care program or human clinical research or, to the Knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion. No Person has filed or, to the Knowledge of the Company, has threatened to file against the Company any Action under any federal or state whistleblower statute or equivalent law in the applicable jurisdiction, including under the federal False Claims Act, 21 U.S.C. §§ 3729-3733.
Sample 1
Actions and Investigations. To the Knowledge of Buyer, Buyer has not received or been subject to any notice, warning, administrative proceeding order, complaint, or other written communication of any actual or threatened enforcement Action or investigation or allegation that Buyer has violated any applicable Law by the FDA, HHS, EMA, FTC or other Governmental Entity, including any FDA Form 483, warning letter or untitled letter, and, to the Knowledge of Buyer, neither the FDA, HHS, EMA, FTC, nor any other Governmental Entity either in or outside the United States, is considering such Action, investigation or allegation. To the knowledge of Buyer, no Person has filed or has threatened to file against Buyer any Action under any federal or state whistleblower statute or equivalent law in the applicable jurisdiction, including under the federal False Claims Act, 21 U.S.C. §§ 3729-3733.
Sample 1
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Actions and Investigations. The Company has not received or been subject to (i) any written, or to the Knowledge of the Company oral, notice, warning, administrative proceeding order, complaint, or other written communication of any actual or threatened enforcement Action or investigation or allegation that the Company has violated any applicable Law by the FDA, HHS, EMA, FTC or other Regulatory Authority, including any FDA Form 483, warning letter or untitled letter, and, to the Knowledge of the Company, neither the FDA, HHS, EMA, FTC, nor any other Regulatory Authority either in or outside the United States, is considering such Action, investigation or allegation, and (ii) any written, or to the Knowledge of the Company oral, notice, correspondence, or communication from any health care professional, customer, competitor, or current or former officer, director, employee or contractor of the Company alleging or asserting noncompliance with Laws. To the Company’s Knowledge, no Person has filed or has threatened to file against the Company any Action under any federal or state whistleblower statute or equivalent law in the applicable jurisdiction, including under the federal False Claims Act, 21 U.S.C. §§ 3729-3733.
Sample 1

Related to Actions and Investigations

  • Litigation and Investigations Promptly after (i) the occurrence thereof, notice of the institution of or any material adverse development in any material action, suit or proceeding or any governmental investigation or any arbitration, before any court or arbitrator or any governmental or administrative body, agency or official, against any Consolidated Company, or any material property of any thereof, or (ii) actual knowledge thereof, notice of the threat of any such action, suit, proceeding, investigation or arbitration;

  • Complaints and Investigations Pacific Mutual, PEN, Selling Broker-Dealer and General Agent agree to cooperate fully in any insurance regulatory investigation or proceeding or judicial proceeding arising in connection with the Contracts distributed under this Agreement. Pacific Mutual, PEN, Selling Broker-Dealer and General Agent further agree to cooperate fully in any securities regulatory investigation or proceeding with respect to Pacific Mutual, PEN, Selling Broker-Dealer and General Agent, their affiliates and their agents or representatives to the extent that such investigation or proceeding is in connection with the Contracts distributed under this Agreement. Without limiting the foregoing:

  • Corporate Examinations and Investigations Prior to the Closing Date, the parties acknowledge that they have been entitled, through their employees and representatives, to make such investigation of the assets, properties, business and operations, books, records and financial condition of the other as they each may reasonably require. No investigations, by a party hereto shall, however, diminish or waive any of the representations, warranties, covenants or agreements of the party under this Agreement.

  • Access and Investigation During the Pre-Closing Period, GHX shall (and shall cause its Subsidiaries to): (a) provide the Stockholder and the Stockholder’s Representatives with reasonable access during normal business hours, upon reasonable notice to GHX, to GHX’s and its Subsidiaries’ personnel and assets and to all existing books, records, Tax Returns, work papers and other documents and information relating to GHX or its Subsidiaries; and (b) provide or make available to the Stockholder and the Stockholder’s Representatives such copies of the existing books, records, Tax Returns, work papers and other documents and information relating to GHX or its Subsidiaries as the Stockholder may reasonably request. Without limiting the generality of any of the foregoing, during the Pre-Closing Period and subject to applicable Antitrust Laws, GHX and the Stockholder shall promptly provide the other party with copies of any notice, report or other document filed with or sent to any Governmental Body on behalf of GHX or the Stockholder, as applicable, in connection with the Merger or any of the other Contemplated Transactions. The foregoing shall not require GHX to permit any inspection, or to disclose any information, that in the reasonable judgment of GHX could reasonably be expected to result in (i) the disclosure of any trade secrets of third parties or the violation of any obligations of GHX with respect to confidentiality if GHX shall have used reasonable efforts to obtain the consent of such third party to such inspection or disclosure, (ii) the waiver of any applicable attorney-client privilege so long as GHX has taken reasonable steps to permit inspection of or to disclose information described in this clause (ii) on a basis that does not compromise GHX’s privilege with respect thereto or (iii) the violation of any applicable Legal Requirement. The parties shall seek in good faith appropriate substitute disclosure arrangements under circumstances in which the immediately preceding sentence applies. No investigation by the Stockholder shall limit or otherwise affect any of the representations, warranties, covenants or obligations of GHX contained in this Agreement.

  • 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.

  • Investigations and Remediations Lessor shall retain the responsibility and pay for any investigations or remediation measures required by governmental entities having jurisdiction with respect to the existence of Hazardous Substances on the Premises prior to the Start Date, unless such remediation measure is required as a result of Lessee's use (including "Alterations", as defined in Paragraph 7.3(a) below) of the Premises, in which event Lessee shall be responsible for such payment. Lessee shall cooperate fully in any such activities at the request of Lessor, including allowing Lessor and Lessor's agents to have reasonable access to the Premises at reasonable times in order to carry out Lessor's investigative and remedial responsibilities.

  • Investigations; Litigation There is no investigation or review pending (or, to the knowledge of Parent, threatened) by any Governmental Entity with respect to Parent or any of its Subsidiaries which would have, individually or in the aggregate, a Parent Material Adverse Effect, and there are no actions, suits, inquiries, investigations or proceedings pending (or, to Parent’s knowledge, threatened) against or affecting Parent or its Subsidiaries, or any of their respective properties at law or in equity before, and there are no orders, judgments or decrees of, or before, any Governmental Entity, in each case which would have, individually or in the aggregate, a Parent Material Adverse Effect.

  • Investigations The respective representations and warranties of the Parties contained in this Agreement or in any certificate or other document delivered by any Party prior to the Closing and the rights to indemnification set forth in Article IX will not be deemed waived or otherwise affected by any investigation made by a Party to this Agreement.

  • Pending Proceedings and Examinations The Registration Statement is not the subject of a pending proceeding or examination under Section 8(d) or 8(e) of the 1933 Act, and the Company is not the subject of a pending proceeding under Section 8A of the 1933 Act in connection with the offering of the Securities.

  • Audits, Investigations or Claims To the knowledge of the Company, no deficiencies for Taxes of the Company or the Company Subsidiary have been claimed, proposed or assessed by any taxing or other governmental authority. There are no pending or, to the knowledge of the Company, threatened audits, assessments or other Actions for or relating to any Liability in respect of Taxes of the Company or the Company Subsidiary, and there are no matters under discussion with any governmental authorities, or known to the Company, with respect to Taxes that are likely to result in an additional Liability for Taxes with respect to the Company or the Company Subsidiary. Audits of federal, state, local and foreign Tax Returns by the relevant taxing authorities have been completed for the periods set forth on Disclosure Schedule 3.23(c) and, except as set forth in such Disclosure Schedule, none of the Company, the Company Subsidiary and their predecessors have been notified that any taxing authority intends to audit a Tax Return for any other period.

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