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 ▇▇▇▇▇▇▇▇ 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
Compliance with Healthcare Laws The tests, studies, and trials conducted by or on behalf of or sponsored by the Company or any of its subsidiaries were and, if still pending, are being conducted in all material respects in accordance with all applicable Health Care Laws (as defined below) and standard medical and scientific research protocols, procedures, and controls; none of the Company or any of its subsidiaries has received any written notice, correspondence, or other written communication from any regulatory agency or any institutional review board or comparable body requiring or threatening the termination, suspension, or material modification of any tests, studies, or trials, or commercial distribution, and to the knowledge of the Company and its subsidiaries, there are no reasonable grounds for the same. Each of the Company and its Subsidiaries has obtained (or caused to be obtained) the informed consent of each human subject who participated in a test, study, or trial. None of the tests, studies, or trials involved any investigator who has been disqualified as a clinical investigator. The Company and its directors, officers, employees, and agents are, and at all times prior hereto have been, in material compliance with, all health care laws and regulations applicable to the Company or any of its product candidates or activities, including development and testing of pharmaceutical products, kickbacks, recordkeeping, documentation requirements, the hiring of employees (to the extent governed by Health Care Laws), quality, safety, privacy, security, licensure, accreditation or any other aspect of developing and testing health care or pharmaceutical products (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the United States Food and Drug Administration, the Drug Enforcement Agency, the Centers for Medicare & Medicaid Services, and the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws. To the Company’s knowledge, there are no facts or circumstances that would reasonably be expected to give rise to liability of the Company under any Health Care Laws, except that would not individually or in the aggregate have a Material Adverse Effect.
Compliance with Federal and State Work Authorization and Immigration Laws The Contractor and all subcontractors, suppliers and consultants must comply with all federal and state work authorization and immigration laws, and must certify compliance using the form set forth in Section 7 (“Georgia Security and Immigration Compliance Act Affidavits”). The required certificates must be filed with the Owner and copied maintained by the Contractor as of the beginning date of this contract and each subcontract, supplier contract, or consultant contract, and upon final payment to the subcontractor or consultant. State officials, including officials of the Georgia Department of Audits and Accounts, officials of the Owner, retain the right to inspect and audit the Project Site and employment records of the Contractor, subcontractors and consultants without notice during normal working hours until Final Completion, and as otherwise specified by law and by Rules and Regulations of the Georgia Department of Audits and Accounts.
Compliance with Health Care Laws Each of the Company and its Subsidiaries is, and at all times has been, in compliance in all material respects with all applicable Health Care Laws, and has not engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal health care program. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the Public Health Service Act (42 U.S.C. §§ 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated pursuant to such statutes; (iii) Medicare (Title XVIII of the Social Security Act); (iv) Medicaid (Title XIX of the Social Security Act); (v) the Controlled Substances Act (21 U.S.C. §§ 801 et seq.) and the regulations promulgated thereunder; and (vi) any and all other applicable health care laws and regulations. Neither the Company nor, to the knowledge of the Company, any subsidiary has received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor, to the knowledge of the Company, any subsidiary is a party to or has 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 authority. Additionally, neither the Company, its Subsidiaries nor any of its respective employees, officers or directors has been excluded, suspended or debarred from participation in any U.S. 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.
Compliance with Laws and Rules Applicant shall comply with all statutes, regulations, and ordinances of all local, state and federal jurisdictions concerning the use of the Property. In addition, the City shall have the right to adopt reasonable rules concerning the use of the Property and Applicant shall comply with the rules.