Compliance With Government Regulations and Other Responsibilities Sample Clauses

Compliance With Government Regulations and Other Responsibilities. Duties and Responsibilities. COMPANY will perform the Services in accordance with all applicable government laws and regulatory requirements, including those relating to current Good Manufacturing Practices (“cGMP”), as required by regulatory authorities, including, but not limited, to the United States Food and Drug Administration (“FDA”), the Chinese Food and Drug Administration (“SFDA”), and the European Agency for the Evaluation of Medicinal Products, (“EMEA”) which apply to the Services. COMPANY represents and warrants to Avedro that it has and will maintain during the Term, all government permits, including without limitation health, safety and environmental permits, necessary for the conduct of the actions and procedures that it undertakes pursuant to this Agreement. a) In assuming responsibility for undertaking this Agreement, COMPANY will: 1) Perform chemistry research, process evaluation and development, and manufacturing of specialty chemicals as defined by Avedro for any project entered pursuant to a Contract under this Agreement (each, a “Project”); 2) Perform technical and chemistry consultation, technical assistance and product development, and CMC regulatory assistance as defined in the Contracts or as necessary throughout the product development process, for any Project; and if necessary, develop analytical methods for profiling end product, intermediates, impurities, or degradation products; 3) Develop or utilize existing analytical methods, which will allow determination of the identity and quantification of the purity of each end product compound that Avedro requests COMPANY to manufacture (each, a “Avedro Compound”) or any intermediate synthesized or manufactured by COMPANY in connection with the manufacture of Avedro Compounds;
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Related to Compliance With Government Regulations and Other Responsibilities

  • Compliance with Government Regulations The Company covenants that if any share of Common Stock required to be reserved for purposes of exercise or conversion of Warrants require, under any federal or state law or applicable governing rule or regulation of any national securities exchange, registration with or approval of any governmental authority, or listing on any such national securities exchange, before such shares may be issued upon exercise, the Company will use its commercially reasonable efforts to cause such shares to be duly registered, approved or listed on the relevant national securities exchange, as the case may be.

  • Compliance with Governmental Rules and Regulations Except as otherwise provided in the Agreement and except for the accuracy of information furnished to the Fund by Price Services, each Fund assumes full responsibility for the preparation, contents and distribution of its prospectuses and compliance with all applicable requirements of the ’40 Act, the ‘34 Act, the ‘33 Act, and any other laws, rules and regulations of governmental authorities having jurisdiction over the Fund. Price Services shall be responsible for complying with all laws, rules and regulations of governmental authorities having jurisdiction over transfer agents and their activities and cooperating with respect to examinations and requests from such governmental authorities.

  • COMPLIANCE WITH GOVERNMENTAL RULES AND REGULATIONS; RECORDS The Trust assumes full responsibility for its compliance with all securities, tax, commodities and other laws, rules and regulations applicable to it.

  • Authority; Compliance With Other Agreements and Instruments and Government Regulations The execution, delivery and performance by Borrower and the Subsidiary Guarantors of the Loan Documents to which it is a Party have been duly authorized by all necessary corporate action, and do not and will not: (a) Require any consent or approval not heretofore obtained of any partner, director, stockholder, security holder or creditor of such Party; (b) Violate or conflict with any provision of such Party's charter, articles of incorporation or bylaws, as applicable; (c) Result in or require the creation or imposition of any Lien (other than pursuant to the Loan Documents) or Right of Others upon or with respect to any Property now owned or leased or hereafter acquired by such Party; (d) Violate any Requirement of Law applicable to such Party; (e) Result in a breach of or constitute a default under, or cause or permit the acceleration of any obligation owed under, any material indenture or loan or credit agreement or any other Contractual Obligation to which such Party is a party or by which such Party or any of its Property is bound or affected; and such Party is not in violation of, or default under, any Requirement of Law or Contractual Obligation, or any material indenture, loan or credit agreement described in Section 4.2(e), in any respect that constitutes a Material Adverse Effect.

  • Compliance with OFAC Rules and Regulations None of the Credit Parties or their Subsidiaries or their respective Affiliates (a) is a Sanctioned Person, (b) has more than 15% of its assets in Sanctioned Countries, or (c) derives more than 15% of its operating income from investments in, or transactions with Sanctioned Persons or Sanctioned Countries. No part of the proceeds of any Extension of Credit hereunder will be used directly or indirectly to fund any operations in, finance any investments or activities in or make any payments to, a Sanctioned Person or a Sanctioned Country.

  • Compliance with Securities Regulations and Commission Requests The Company, subject to Section 3(b), will comply with the requirements of Rule 430B of the 1933 Act Regulations and will notify the Representatives immediately, and confirm the notice in writing, of (i) the effectiveness of any post-effective amendment to the Registration Statement or any new registration statement relating to the Securities or the filing of any supplement or amendment to the Prospectus, (ii) the receipt of any comments from the Commission with respect to the Registration Statement, (iii) any request by the Commission for any amendment to the Registration Statement or any amendment or supplement to the Prospectus or for additional information, (iv) the issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement or such new registration statement or of any order preventing or suspending the use of any preliminary prospectus relating to the Securities, or of the suspension of the qualification of the Securities for offering or sale in any jurisdiction, or of the initiation or threatening of any proceedings for any of such purposes or of any examination pursuant to Section 8(e) of the 1933 Act concerning the Registration Statement and (v) if the Company becomes the subject of a proceeding under Section 8A of the 1933 Act in connection with the offering of the Securities. The Company will promptly effect the filings required under Rule 424(b), in the manner and within the time period required by Rule 424(b) (without reliance on Rule 424(b)(8)), and will take such steps as it deems necessary to ascertain promptly whether the Prospectus transmitted for filing under Rule 424 was received for filing by the Commission and, in the event that it was not, it will promptly file the Prospectus. The Company will make every reasonable effort to prevent the issuance of any stop order and, if any stop order is issued, to obtain the lifting thereof at the earliest possible moment.

  • Compliance with Rules and Regulations PFPC undertakes to comply with all applicable requirements of the Securities Laws and any laws, rules and regulations of governmental authorities having jurisdiction with respect to the duties to be performed by PFPC hereunder. Except as specifically set forth herein, PFPC assumes no responsibility for such compliance by the Fund or any other entity.

  • COMPLIANCE WITH NEW YORK STATE INFORMATION SECURITY BREACH AND NOTIFICATION ACT Contractor shall comply with the provisions of the New York State Information Security Breach and Notification Act (General Business Law Section 899-aa; State Technology Law Section 208).

  • Compliance with Governmental Regulations Landlord and Tenant shall comply with all rules, regulations and requirements promulgated by national, state or local governmental agencies or utility suppliers concerning the use of utility services, including any rationing, limitation or other control. Tenant shall not be entitled to terminate this Lease nor to any abatement in rent by reason of such compliance.

  • 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

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