FD&C Act Matters Sample Clauses

FD&C Act Matters. Xxxxxx represents and covenants as of the date of this Agreement and continuously during the term of this Agreement that it is not debarred pursuant to Section 335(a) or 335(b) of the FD&C Act. Xxxxxx represents that it has not been debarred under the Act in the past five (5) years. Xxxxxx will not employ or use the services of any person or entity to perform the Production of Product who is debarred under the Act or to Xxxxxx’x knowledge has engaged in activities that could lead to being debarred under the Act.
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Related to FD&C Act Matters

  • Securities Act Matters The Holder represents and warrants to the Company as of the date hereof that: (a) The Holder is acquiring this Warrant for its own account, without a view to, or sale in connection with, the distribution thereof. The Holder has no present agreement, undertaking, arrangement, commitment or obligation providing for the disposition of the Warrant or the Warrant Shares, all without prejudice, however, to the right of the Holder at any time, in accordance with this Warrant, lawfully to sell or otherwise to dispose of all or any part of the Warrant or Warrant Shares held by it; (b) The Holder is an “accredited investor” within the meaning of Regulation D under the Securities Act. The Holder has not retained, utilized or been represented by any broker or finder in connection with the transactions contemplated by this Warrant; (c) The Holder acknowledges that, subject to the Registration Rights Agreement and the DSW Registration Rights Agreement (A) the Warrants and the Warrant Shares have not been registered under the Securities Act, in reliance on the non-public offering exemption contained in Section 4(2) of the Securities Act and Regulation D thereunder; (B) because the Warrants and the Warrant Shares are not so registered, the Holder must bear the economic risk of holding this Warrant and the Warrant Shares for an indefinite period of time unless the Warrants and the Warrant Shares are subsequently registered under the Securities Act or an exemption from such registration is available with respect thereto; (C) Rule 144 under the Securities Act may or may not be available for resales of the Warrants or the Warrant Shares in the future and, if so, may only be available for sales in limited amounts; (D) there is presently no trading market for the Warrants and there is no assurance that such market will exist in the future; and (E) while there is presently a trading market for the Warrant Shares, there is no assurance that such market will be in existence in the future; and (d) If the Holder decides to dispose of this Warrant or the Warrant Shares, which it does not now contemplate, the Holder can do so only in accordance and in compliance with the Securities Act and Rule 144 or another exemption from the registration requirements of the Securities Act, as then in effect or through an effective registration statement under the Securities Act.

  • Patent Matters 4.1 Licensor shall have the right, but not the obligation, to prosecute and maintain all Patents to be issued pertaining to the Patent applications licensed in Exhibit A at its cost and expense. Licensor shall keep licensee reasonably apprised of all relevant actions regarding the status of such patents. 4.2 Each Party shall notify the other Party of any infringement of any intellectual property rights with regard to the License IP or a Licensed Product by a third party in the Field which becomes known to such Party, and of any claim of infringement by a third party that the activities of a Party infringe patent rights of such third party. Licensor shall have has sole responsibility and control of legal action relating to claims of infringement with respect to the Licensed Technology. 4.3 Licensor shall have the first right, but not an obligation, to initiate, maintain and control, at Licensor’s expense, legal action against any infringement of intellectual property rights relating to the Licensed Technology by a third party in the Field. 4.4 In any suit, proceeding or dispute involving infringement of any intellectual property rights relating to the License IP in the Field, the Parties shall provide each other with reasonable cooperation shall make available to each other , at reasonable times and under appropriate conditions, all relevant personnel, records, papers, information, samples, specimens, and the like in its possession.

  • Antitrust Matters KBR and Halliburton each agree, on behalf of itself and the members of its Group, to at all times during the term of this Agreement use reasonable best efforts to assist with the other party’s full cooperation with any Governmental Authority in its investigation of Antitrust Matters and such other party’s investigation, defense and/or settlement of any claim by any Governmental Authority relating to or arising out of the Antitrust Matters. Without limiting the foregoing, a party’s reasonable best efforts to assist with the other party’s full cooperation contemplated by the preceding sentence shall include: (a) Without limiting or qualifying the parties’ rights and obligations in Section 8.4 or Section 3.4, each of Halliburton and KBR agrees, on behalf of itself and the members of its Group, to provide, or cause to be provided, to each other as soon as reasonably practicable after written request therefor, any Information relating to the Antitrust Matters, in the possession or under the control of such party that the requesting party reasonably needs: (i) to comply with reporting, disclosure, filing or other requirements imposed on the requesting party (including under applicable securities laws) by a Governmental Authority having jurisdiction over the requesting party, (ii) for use in any Regulatory Proceeding, judicial proceeding or other proceeding or in order to satisfy audit, accounting, claims, regulatory, litigation, subpoena or other similar requirements, (iii) to allow the other party to defend or settle any claim relating to Antitrust Matters for which such party may be responsible, or (iv) to comply with its obligations under this Agreement or any Ancillary Agreement; provided, however, that neither party shall be required by this Section 8.15 to violate any Law or waive any attorney-client or other work-product privilege. In the event that any party determines that such provision of Information pursuant to this Section 8.15 could violate any Law or agreement, or waive any attorney-client or work-product privilege, the parties shall take all reasonable measures to permit the compliance with such obligations in a manner that avoids any such harm or consequence. (b) Notwithstanding Section 8.4, each party hereby undertakes, on behalf of itself and the members of its Group, to preserve, maintain and retain all documents, records and other tangible evidence related to Antitrust Matters. (c) Each party agrees, on behalf of itself and the members of its Group, to use reasonable best efforts to (i) make available any of its current and former directors, officers, employees, agents, distributors, attorneys and Affiliates who may have been involved in the Antitrust Matters and whose cooperation is requested by the other party, the DOJ or other Governmental Authority; and (ii) recommend orally and in writing that any and all such persons cooperate fully (including by appearing for interviews with Governmental Authorities or testimony, including sworn testimony before a grand jury) with any investigation conducted by a party, the DOJ or other Governmental Authority with respect to the Antitrust Matters. (d) Each party agrees to promptly inform and disclose to the other party any developments, communications or negotiations between such party or any member of its Group, on the one hand, and any Governmental Authority or third party, on the other hand, with respect to Antitrust Matters, except as prohibited by law or lawful order of a Governmental Authority. In addition, upon either party’s reasonable request, the attorneys, accountants, consultants or other advisors of the Board of Directors or any committee thereof of a requested party shall brief the Board of Directors or any committee thereof of the requesting party concerning the status of or issues arising under or relating to the Antitrust Matters.

  • Regulatory Requirements and Governing Law 43 14.1 Regulatory Requirements. 43 14.2 Governing Law 44 ARTICLE 15. NOTICES 44 15.1 General. 44 15.2 Xxxxxxxx and Payments. 44 15.3 Alternative Forms of Notice 44 15.4 Operations and Maintenance Notice 44 ARTICLE 16. FORCE MAJEURE 45 16.1 Force Majeure 45 ARTICLE 17. DEFAULT 45 17.1 Default. 45 ARTICLE 18. INDEMNITY, CONSEQUENTIAL DAMAGES AND INSURANCE 46 18.1 Indemnity. 46 18.2 No Consequential Damages. 47 18.3 Insurance 47 ARTICLE 19. ASSIGNMENT 49 19.1 Assignment. 49 ARTICLE 20. SEVERABILITY 49 20.1 Severability. 49 ARTICLE 21. COMPARABILITY 50 21.1 Comparability. 50 ARTICLE 22. CONFIDENTIALITY 50 22.1 Confidentiality. 50 ARTICLE 23. ENVIRONMENTAL RELEASES 53 23.1 Developer and Connecting Transmission Owner Notice 53 ARTICLE 24. INFORMATION REQUIREMENT 53 24.1 Information Acquisition. 53 24.2 Information Submission by Connecting Transmission Owner 54 24.3 Updated Information Submission by Developer 54 24.4 Information Supplementation 54 ARTICLE 25. INFORMATION ACCESS AND AUDIT RIGHTS 55 25.1 Information Access. 55 25.2 Reporting of Non-Force Majeure Events. 55 25.3 Audit Rights. 56 25.4 Audit Rights Periods. 56 25.5 Audit Results. 56 ARTICLE 26. SUBCONTRACTORS 56 26.1 General. 56 26.2 Responsibility of Principal. 57 26.3 No Limitation by Insurance 57 ARTICLE 27. DISPUTES 57 27.1 Submission 57 27.2 External Arbitration Procedures. 57 27.3 Arbitration Decisions. 58 27.4 Costs. 58 27.5 Termination 58 ARTICLE 28. REPRESENTATIONS, WARRANTIES AND COVENANTS 58 28.1 General. 58 ARTICLE 29. MISCELLANEOUS 59 29.1 Binding Effect. 59 29.2 Conflicts. 59 29.3 Rules of Interpretation 59 29.4 Compliance 60 29.5 Joint and Several Obligations. 60 29.6 Entire Agreement. 60 29.7 No Third Party Beneficiaries. 60 29.8 Waiver 60 29.9 Headings. 61 29.10 Multiple Counterparts. 61 29.11 Amendment. 61 29.12 Modification by the Parties. 61 29.13 Reservation of Rights. 61 29.14 No Partnership 62 29.15 Other Transmission Rights. 62 Appendices STANDARD LARGE GENERATOR INTERCONNECTION AGREEMENT THIS STANDARD LARGE GENERATOR INTERCONNECTION AGREEMENT

  • FDA Matters (a) The Corporation has (i) complied in all material respects with all applicable laws, regulations and specifications with respect to the manufacture, design, sale, storing, labeling, testing, distribution, inspection, promotion and marketing of all of the Corporation’s products and product candidates and the operation of manufacturing facilities promulgated by the U.S. Food and Drug Administration (the “FDA”) or any corollary entity in any other jurisdiction and (ii) conducted, and in the case of any clinical trials conducted on its behalf, caused to be conducted, all of its clinical trials with reasonable care and in compliance in all material respects with all applicable laws and the stated protocols for such clinical trials. (b) All of the Corporation’s submissions to the FDA and any corollary entity in any other jurisdiction, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and remain true, accurate and complete in all material respects and do not misstate any of the statements or information included therein, or omit to state a fact necessary to make the statements therein not materially misleading. (c) The Corporation has not committed any act, made any statement or failed to make any statement that would breach the FDA’s policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar laws, rules or regulations, whether under the jurisdiction of the FDA or a corollary entity in any other jurisdiction, and any amendments or other modifications thereto. Neither the Corporation nor, to the Corporation’s Knowledge, any officer, employee or agent of the Corporation has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar state or foreign law or regulation or (ii) exclusion under 42 U.S.C. Section 1320a 7 or any similar state or foreign law or regulation, and neither the Corporation nor, to the Corporation’s Knowledge, any such person has been so debarred or excluded. (d) The Corporation has not sold or marketed any products prior to receiving any required or necessary approvals or consents from any federal or state governmental authority, including but not limited to the FDA under the Food, Drug & Cosmetics Act of 1976, as amended, and the regulations promulgated thereunder, or any corollary entity in any jurisdiction. The Corporation has not received any notice of, nor is the Corporation aware of any, actions, citations, warning letters or Section 305 notices from the FDA or any corollary entity.

  • Regulatory References A reference in this Agreement to a section in the HIPAA Rules means the section as in effect or as amended.

  • Laws Applicable to Construction; Consent to Jurisdiction The interpretation, performance and enforcement of this Agreement shall be governed by the laws of the State of Delaware without reference to principles of conflict of laws, as applied to contracts executed in and performed wholly within the State of Delaware. In addition to the terms and conditions set forth in this Agreement, the Restricted Stock Units are subject to the terms and conditions of the Plan, which is hereby incorporated by reference.

  • Litigation; Observance of Agreements, Statutes and Orders (a) Except as disclosed in Schedule 5.8, there are no actions, suits or proceedings pending or, to the knowledge of the Company, threatened against or affecting the Company or any Subsidiary or any property of the Company or any Subsidiary in any court or before any arbitrator of any kind or before or by any Governmental Authority that, individually or in the aggregate, could reasonably be expected to have a Material Adverse Effect. (b) Neither the Company nor any Subsidiary is in default under any term of any agreement or instrument to which it is a party or by which it is bound, or any order, judgment, decree or ruling of any court, arbitrator or Governmental Authority or is in violation of any applicable law, ordinance, rule or regulation (including without limitation Environmental Laws) of any Governmental Authority, which default or violation, individually or in the aggregate, could reasonably be expected to have a Material Adverse Effect.

  • Disputes and Governing Law This Agreement shall be construed in accordance with the laws of the PRC. Any disputes that arise in connection with this Agreement shall be litigated in courts located within the Pudong New Area, Shanghai, the PRC.

  • Sanctions Concerns and Anti Corruption Laws (a) No Loan Party, nor any Subsidiary, nor, to the knowledge of the Loan Parties, any director, officer, employee, agent, affiliate or representative thereof, is an individual or entity that is, or is owned or controlled by any individual or entity that is (i) currently the subject or target of any Sanctions, (ii) included on OFAC’s List of Specially Designated Nationals, HMT’s Consolidated List of Financial Sanctions Targets and the Investment Ban List, or any similar list enforced by any other relevant sanctions authority or (iii) located, organized or resident in a Designated Jurisdiction. (b) The Loan Parties and their Subsidiaries have conducted their business in compliance with the United States Foreign Corrupt Practices Act of 1977, the UK Bxxxxxx Xxx 0000 and other similar anti-corruption legislation in other jurisdictions, and have instituted and maintained policies and procedures designed to promote and achieve compliance with such laws and applicable Sanctions, and to the knowledge of the Borrower, the Loan Parties and their Subsidiaries are in compliance with such anti-corruption laws and applicable Sanctions in all material respects.

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