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 a basis for any such Claim. No Employee Benefit Plan is currently under investigation, audit or review, directly or indirectly, by the IRS, DOL or any other Governmental Body, and no such action is contemplated or under consideration by the IRS, DOL or any other 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.
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.
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.
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.
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
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.
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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.

Related to Actions and Investigations

  • AUDITS AND INVESTIGATIONS 27.1 Each invoice paid by UNDP shall be subject to a post-payment audit by auditors, whether internal or external, of UNDP or by other authorized and qualified agents of UNDP at any time during the term of the Contract and for a period of three (3) years following the expiration or prior termination of the Contract.

  • COMPLAINTS AND INVESTIGATIONS 1. This article applies to complaints or allegations made externally and not from normal supervisory activities.

  • 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 (a) During the period commencing on the Agreement Date and ending at such time as designees of Parent first constitute at least a majority of the Company Board pursuant to Section 1.3(a), the Company shall, and shall cause its Subsidiaries and Representatives to: (i) provide Parent and Parent’s Representatives with reasonable access, upon reasonable notice and during normal business hours, to the Company’s Representatives, properties, books, records, Tax Returns, material operating and financial reports, work papers and other documents and information relating to the Company and its Subsidiaries (including the Company Owned IP); (ii) provide Parent and Parent’s Representatives with such copies of the books, records, Tax Returns, work papers and other documents and information relating to the Company and its Subsidiaries, and with such additional financial, operating and other data and information regarding the Company and its Subsidiaries, as Parent may reasonably request; and (iii) permit Parent’s officers and other employees to meet, upon reasonable notice and during normal business hours, with the chief financial officer and other officers and managers of the Company responsible for the Company’s financial statements and the internal controls of the Company and its Subsidiaries to discuss such matters as Parent may reasonably deem necessary or appropriate in order to enable Parent to satisfy its obligations under the Xxxxxxxx-Xxxxx Act or similar act applicable thereto and the rules and regulations relating thereto or otherwise in connection with the Offer and the Merger. No information or knowledge obtained by Parent or its Representatives in any investigation conducted pursuant to this Section 5.1(a) shall affect or be deemed to modify any representation or warranty of the Company set forth herein or the conditions to the obligations of Parent and Purchaser to consummate the transactions contemplated hereby (including the Offer and the Merger), or the remedies available to the parties hereunder. Notwithstanding anything to the contrary herein, neither Company nor any of its Subsidiaries shall be required to provide access to or to disclose information to the extent such access or disclosure would jeopardize the attorney-client privilege of such Person or violate any applicable Law.

  • 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.

  • Cooperation with Investigations You agree to cooperate with us in the investigation of unusual transactions, poor quality transmissions, and resolution of customer claims, including by providing, upon request and without further cost, any originals or copies of items deposited through the Service in your possession and your records relating to such items and transmissions.

  • 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.

  • Compliance Investigations Upon City’s request, Contractor agrees to provide to City, within sixty calendar days, a truthful and complete list of the names of all subcontractors, vendors, and suppliers that Contractor has used in the past five years on any of its contracts that were undertaken within San Diego County, including the total dollar amount paid by Contractor for each subcontract or supply contract. Contractor further agrees to fully cooperate in any investigation conducted by City pursuant to City's Nondiscrimination in Contracting Ordinance. Contractor understands and agrees that violation of this clause shall be considered a material breach of the Contract and may result in Contract termination, debarment, and other sanctions.

  • Grievance Investigations Where an employee has asked or is obliged to be represented by the Institute in relation to the presentation of a grievance and an employee acting on behalf of the Institute wishes to discuss the grievance with that employee, the employee and the representative of the employee will, where operational requirements permit, be given reasonable leave with pay for this purpose when the discussion takes place in the headquarters area of such employee and leave without pay when it takes place outside the headquarters area of such employee.

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