CGMP and Ecgmp Standards
CGMP and Ecgmp Standards Sample Clauses
Related to CGMP and Ecgmp Standards
OMB Standards Unless specified otherwise within this agreement, the Subrecipient shall procure all materials, property, or services in accordance with the requirements of 24 CFR 84.40−48.
Ethical Standards 7.8.1 Within ninety (90) days after the Effective Date, Developer shall adopt written policies establishing ethical standards of conduct for all Developer-Related Entities, including Developer’s supervisory and management personnel, in dealing with (a) IFA and the Department and (b) employment relations. Such policy shall be subject to review and comment by IFA prior to adoption. Such policy shall include standards of ethical conduct concerning the following: 7.8.1.1 Restrictions on gifts and contributions to, and lobbying of, IFA, the Department and any of their respective members, commissioners, directors, officers and employees, and elected State officials; 7.8.1.2 Protection of employees from unethical practices in selection, use, hiring, compensation or other terms and conditions of employment, or in firing, promotion and termination of employees; 7.8.1.3 Protection of employees from retaliatory actions (including discharge, demotion, suspension, threat, harassment, pay reduction or other discrimination in the terms and conditions of employment) in response to reporting of illegal (including the making of a false claim), unethical or unsafe actions or failures to act by any Developer-Related Entity; 7.8.1.4 Restrictions on directors, members, officers or supervisory or management personnel of any Developer-Related Entity engaging in any transaction or activity, including receiving or offering a financial incentive, benefit, loan or other financial interest, that is, or to a reasonable person appears to be, in conflict with or incompatible with the proper discharge of duties or independence of judgment or action in the performance of duties, or adverse to the interests of the Project or employees; 7.8.1.5 Restrictions on use of office or job position for a purpose that is, or would to a reasonable person appear to be, primarily for the private benefit of a director, member, officer or supervisory or management person, rather than primarily for the benefit of Developer or the Project, or primarily to achieve a private gain or an exemption from duty or responsibility for a director, member, officer or supervisory or management person; and 7.8.1.6 Restrictions on directors, members, officers or employees of any Developer-Related Entity performing any of the Work if the performance of such services would be prohibited under IFA’s conflict of interest rules and policies. 7.8.2 Developer shall cause its directors, members, officers and supervisory and management personnel, and require those of all other Developer-Related Entities, to adhere to and enforce the adopted policy on ethical standards of conduct. Developer shall establish reasonable systems and procedures to promote and monitor compliance with the policy. 7.8.3 Notwithstanding the foregoing in this Section 7.8, Developer has an affirmative obligation under this Agreement to disclose to IFA and to the Indiana State Ethics Commission when an interested party is or becomes an employee of IFA or the State. This obligation extends only to those facts that Developer knows or reasonably could know. For purposes of this Section 7.8.3, “interested party” means (a) the individual executing this Agreement, (b) an individual who has an interest of three percent (3%) or more of Developer, (c) any member of the immediate family of an individual specified in clause (a) or (b). For purposes of the preceding sentence, “immediate family” means the spouse and the unemancipated children of an individual.
Safety Standards Performance of the Contract for all commodities or contractual services must comply with requirements of the Occupational Safety and Health Act and other applicable State of Florida and federal requirements.
Data Practices The parties acknowledge that this Agreement is subject to the requirements of Minnesota’s Government Data Practices Act, Minnesota Statutes, Section 13.01 et seq.
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
Policies, Guidelines, Directives and Standards Either the Funder or the Ministry will give the HSP Notice of any amendments to the manuals, guidelines or policies identified in Schedule C. An amendment will be effective in accordance with the terms of the amendment. By signing a copy of this Agreement the HSP acknowledges that it has a copy of the documents identified in Schedule C.
Quality Standards Each Party agrees that the nature and quality of its products and services supplied in connection with the other Party's Marks will conform to quality standards set by the other Party. Each Party agrees to supply the other Party, upon request, with a reasonable number of samples of any Materials publicly disseminated by such Party which utilize the other Party's Marks. Each Party will comply with all applicable laws, regulations, and customs and obtain any required government approvals pertaining to use of the other Party's marks.
Contractor Standards Contractor shall comply with Contractor Standards provisions codified in the SDMC. Contractor understands and agrees that violation of Contractor Standards may be considered a material breach of the Contract and may result in Contract termination, debarment, and other sanctions.
Compliance with Standards Although the standards for workmanship, material, and equipment have been selected in these specifications as a basis of reference, standards and specifications of the other bank member countries and recommendations of standards international organizations will be acceptable provided they are substantially equivalent to the designated standards and provided furthermore that the contractor submits for approval detailed specifications which he proposes to use. Reference to brand names or catalog numbers if any in these specifications have been made only for that equipment for which it has been determined that a degree of standardization is necessary to maintain certain essential features. And in certain cases such references have also been made for purposes of convenience to specify the requirements, in either case offers of alternative goods, which have similar characteristics and provide performance and quality at lease equal to those specified are acceptable. If the contractor offers materials, equipment, design calculations or tests, which conform to standards other than those specified, full details of the differences between the proposed standards and that specified in so far as they affect the design or purpose of the equipment, are to be supplied by the contractor if called upon to do so by the engineer, where required by the engineer for approval purposes, the contractor shall supply, without charge, duplicate copies of the proposed standards with English translations of the relevant portions. The contractor shall have available in his place of business (or in his supplier’s works) the relevant copies of standards or codes used for the use of the Engineer.
Standards Any additions, modifications, or replacements made to a Party’s facilities shall be designed, constructed and operated in accordance with this Agreement, NYISO requirements and Good Utility Practice.
