Product Regulatory Requirements Sample Clauses

Product Regulatory Requirements. For the purpose of clarity, and without limiting any other limitation or exclusion of Supplier’s obligations or liability hereunder, Supplier Parties shall not be responsible under this Agreement for any Regulatory Requirements (except as may be required as part of the Specifications). If Recipient requests information reasonably required for, and related to, Regulatory Requirements, Supplier Parties shall cooperate in good faith by providing Recipient relevant Product information reasonably available to Supplier.
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Product Regulatory Requirements. (a) The Company and the Company Subsidiaries have not manufactured for commercial supply, marketed, sold or supplied any product which was at the time not fully compliant with (i) the requirements of all applicable laws and the laws of any territory in which any product has been placed on the market; (ii) the terms of any applicable recognized national or international product standards; and (iii) any representation or warranty (whether express or implied) given in respect of any product. (b) At no time has the Company or any Company Subsidiary had knowledge of or received any notice, claim, governmental enforcement action or other communication from any person alleging any defect in any product manufactured for commercial supply, marketed, sold or supplied by the Company or any Company Subsidiary or any contravention of any applicable law or standard relating to any such product.
Product Regulatory Requirements. (a) Parent and the Parent Subsidiaries have not manufactured for commercial supply, marketed, sold or supplied any product which was at the time not fully compliant with (i) the requirements of all applicable laws and the laws of any territory in which any product has been placed on the market; (ii) the terms of any applicable recognized national or international product standards; and (iii) any representation or warranty (whether express or implied) given in respect of any product. (b) At no time has Parent or any Parent Subsidiary had knowledge of or received any notice, claim, governmental enforcement action or other communication from any person alleging any defect in any product manufactured for commercial supply, marketed, sold or supplied by Parent or any Parent Subsidiary or any contravention of any applicable law or standard relating to any such product.

Related to Product Regulatory Requirements

  • Regulatory Requirements Each Party’s obligations under this Agreement shall be subject to its receipt of any required approval or certificate from one or more Governmental Authorities in the form and substance satisfactory to the applying Party, or the Party making any required filings with, or providing notice to, such Governmental Authorities, and the expiration of any time period associated therewith. Each Party shall in good faith seek and use its Reasonable Efforts to obtain such other approvals. Nothing in this Agreement shall require Developer to take any action that could result in its inability to obtain, or its loss of, status or exemption under the Federal Power Act or the Public Utility Holding Company Act of 2005 or the Public Utility Regulatory Policies Act of 1978, as amended.

  • Compliance with Regulatory Requirements Upon demand by Lender, Borrower shall reimburse Lender for Lender’s additional costs and/or reductions in the amount of principal or interest received or receivable by Lender if at any time after the date of this Agreement any law, treaty or regulation or any change in any law, treaty or regulation or the interpretation thereof by any Governmental Authority charged with the administration thereof or any other authority having jurisdiction over Lender or the Loans, whether or not having the force of law, shall impose, modify or deem applicable any reserve and/or special deposit requirement against or in respect of assets held by or deposits in or for the account of the Loans by Lender or impose on Lender any other condition with respect to this Agreement or the Loans, the result of which is to either increase the cost to Lender of making or maintaining the Loans or to reduce the amount of principal or interest received or receivable by Lender with respect to such Loans. Said additional costs and/or reductions will be those which directly result from the imposition of such requirement or condition on the making or maintaining of such Loans.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • Regulatory Reporting Ultimus agrees to provide reports to the federal and applicable state authorities, including the SEC, and to the Funds’ Auditors. Applicable state authorities are those governmental agencies located in states in which the Fund is registered to sell shares.

  • 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

  • Statutory Requirements This Agreement is subject to the requirements of Chapter 2.2 of Division 2 of the California Health and Safety Code and Title 28 of the California Code of Regulations. Any provision required to be in this Agreement by reason of such laws shall be binding upon Blue Shield whether or not such provision is actually included in this Agreement. In addition, this Agreement is subject to applica- ble state and federal statutes and regulations. Any provision required to be in this Agreement by rea- son of such state and federal statutes shall bind the Subscriber and Blue Shield whether or not such provision is actually included in this Agree- ment.

  • CHILD ABUSE REPORTING CONTRACTOR hereby agrees to annually train all staff members, including volunteers, so that they are familiar with and agree to adhere to its own child and dependent adult abuse reporting obligations and procedures as specified in California Penal Code section 11164 et seq. and Education Code 44691. To protect the privacy rights of all parties involved (i.e., reporter, child and alleged abuser), reports will remain confidential as required by law and professional ethical mandates. A written statement acknowledging the legal requirements of such reporting and verification of staff adherence to such reporting shall be submitted to the LEA.

  • Health Requirements A. Provider shall remain in compliance with all applicable federal, state, county, and municipal, statutes, laws, ordinances, regulations, and guidelines, as well as any Board guidelines, policies, and rules in effect now or later, and as amended from time to time related to COVID-19. B. Provider shall comply with evolving requirements to protect the health and safety of Student Participants and staff, as expressed in local, and state guidance from various government agencies. This includes, but is not limited to, adhering to all health and safety guidelines issued by CPS, IDPH, and CDPH related to COVID-19. Provider acknowledges these health and safety guidelines are subject to change. C. Required health and safety practices may vary across age groups and settings. Provider shall comply, at a minimum, with all health and safety mandates issued by the State of Illinois and the City of Chicago and guidance from the Illinois State Board of Education (“ISBE”). D. Under Chicago’s March 19 Public Health Order, congregate facilities (such as long-term care facilities, childcare settings, correctional facilities, etc.) must immediately report to CDPH clusters of COVID-19 patients, defined as two or more confirmed cases of COVID-19 occurring within 14 calendar days of each other at a facility. To report positive cases, Provider must complete the COVID-19 Online Case Report Form found at the following website: xxxxx://xxxxxx.xxx.xxxxxxxx.xxx/surveys/?s=FR7MAJAY84. A copy of the current COVID-19 Online Case Report Form is attached and incorporated into this Supplemental Scope as Attachment A. Provider must also comply with additional operational, reporting and tracing requirements established by CPS. E. As of July 13, 2020, interim guidance issued by CDPH encourages notification for every COVID-19 case. For more information, see CDPH Interim Guidance on Management of COVID 19 Cases in Childcare Settings (“CDPH Guidance”) at the following link: https://xxx.xxxxxxx.xxx/content/dam/city/depts/cdph/HealthProtectionandResponse/Interim% 20Guidance%20on%20Management%20of%20COVID 19%20Cases%20in%20Childcare%20Settings%2007.13.

  • Program Requirements The parties shall comply with the Disadvantaged Business Enterprise Program requirements established in 49 CFR Part 26.

  • Regulatory Authorities Except as described in the Registration Statement, the General Disclosure Package or the Prospectus, each of the Company and its subsidiaries: (a) is and at all times has been in material compliance with all statutes, rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”); (b) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (c) possesses all Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (d) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (e) has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge that any such Governmental Authority is considering such action; and (f) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission). The studies, tests and preclinical and clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each of its subsidiaries, were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package or the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its subsidiaries has received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its subsidiaries that are material to the Company and its subsidiaries taken as a whole.

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