Regulatory Compliance And Related Matters Sample Clauses

Regulatory Compliance And Related Matters. Within ninety (90) days after the Effective Date, quality/regulatory representatives from both Parties will meet to define and document processes for exchange of customer complaints, trends or other information concerning Alliance Products necessary to be shared between the Parties to ensure compliance with the Quality System Regulation provisions of the applicable Regulatory Authorities or other international agencies for conformity to QSR Standard, ISO and other applicable regulatory requirements. The document prepared pursuant to this Section 5.7 and subject to Section 5.8, also will define how notices, corrective actions or recall of Alliance Products will be handled. The recommendations of the quality/regulatory representatives will become effective when approved by the JRB. These processes may be modified from time to time in writing by the JRB.
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Regulatory Compliance And Related Matters. 1 NDA ......................................................................
Regulatory Compliance And Related Matters. 11.1 NDA. Praecis shall be responsible for obtaining all FDA approvals relating to registration of the Product, shall pay any applicable user fee for such registration, and shall own the NDA. Praecis shall have similar responsibilities for obtaining all foreign registrations and approvals to market the Product in all countries outside of the US.
Regulatory Compliance And Related Matters. 10.1 Supplier represents and warrants that the design and manufacturing process for the Products follows the principles of the International Organization for Standardization standard on quality management systems for medical devices (ISO 13485:2003). 10.2 Supplier acknowledges that some of Purchaser’s products which incorporate the Products are subject to regulations which do not allow changes to process and Product characteristics unless properly validated and timely submitted for approval to the relevant Regulatory Agency. Any material change in the manufacturing process, storing conditions of any Product will not be allowed unless a written agreement is reached by the Parties and a written approval is submitted by Purchaser to Supplier. 10.3 Supplier acknowledges that between-lot consistency of physical-chemical characteristics and immunoreactivity of the Products will be critical to Purchaser in order to comply with the FDA Quality System Regulation (21 C.F.R. Part 820) in place. Therefore, Supplier will use commercially reasonable efforts to ensure consistency of physical-chemical characteristics and immunoreactivity of the Products as defined in the Specifications. 10.4 Purchaser acknowledges that Supplier will have no means to verify the performance of the Products in any products manufactured by Purchaser. Therefore, Purchaser is obligated to share with Supplier experimental evidence showing unusual/suboptimal performances. Supplier is obligated to take into consideration functional quality control data provided by Purchaser and to entertain joint analysis and effort with Purchaser representatives to interpret results and troubleshoot any problems. 10.5 Supplier acknowledges that Purchaser must perform, under the FDA Quality System Regulation (21 C.F.R. Part 820), regular audits and quality inspections of its critical suppliers. In such consideration, Supplier will allow Purchaser’s quality assurance representatives to enter its premises and perform standard quality audits according to ISO 13485:2003 once annually. Purchaser must notify Supplier at [***] prior to the audit and such audit shall be scheduled at [***]. Supplier will make its personnel and quality documents available to Purchaser’s representatives. Such audits will be subject to the confidentiality obligations set forth below in Section 13. Supplier acknowledges that a Regulatory Agency may request to perform audits and quality inspections of Purchaser’s critical suppliers. In such con...
Regulatory Compliance And Related Matters 

Related to Regulatory Compliance And Related Matters

  • Regulatory Compliance Neither Borrower nor any of its Subsidiaries is an “investment company” or a company “controlled” by an “investment company” under the Investment Company Act of 1940, as amended. Neither Borrower nor any of its Subsidiaries is engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and U of the Federal Reserve Board of Governors). Borrower and each of its Subsidiaries has complied in all material respects with the Federal Fair Labor Standards Act. Neither Borrower nor any of its Subsidiaries is a “holding company” or an “affiliate” of a “holding company” or a “subsidiary company” of a “holding company” as each term is defined and used in the Public Utility Holding Company Act of 2005. Neither Borrower nor any of its Subsidiaries has violated any laws, ordinances or rules, the violation of which could reasonably be expected to have a Material Adverse Change. Neither Borrower’s nor any of its Subsidiaries’ properties or assets has been used by Borrower or such Subsidiary or, to Borrower’s knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than in material compliance with applicable laws. Borrower and each of its Subsidiaries has obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all Governmental Authorities that are necessary to continue their respective businesses as currently conducted. None of Borrower, any of its Subsidiaries, or any of Borrower’s or its Subsidiaries’ Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engaging in or conspiring to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person. None of Borrower, any of its Subsidiaries, or to the knowledge of Borrower and any of their Affiliates or agents, acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or engages in making or receiving any contribution of funds, goods or services to or for the benefit of any Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any property or interest in property blocked pursuant to Executive Order No. 13224, any similar executive order or other Anti-Terrorism Law.

  • Legal and Regulatory Compliance ‌ 4.22.1 During the term of this Contract, Contractor must comply with all local, state, and federal licensing, accreditation and registration requirements/standards, necessary for the performance of this Contract and all other applicable federal, state and local laws, rules, and regulations. 4.22.2 While on the HCA premises, Contractor must comply with HCA operations and process standards and policies (e.g., ethics, Internet / email usage, data, network and building security, harassment, as applicable). HCA will make an electronic copy of all such policies available to Contractor. 4.22.3 Failure to comply with any provisions of this section may result in Contract termination.

  • Environmental Compliance and Reports Borrower shall comply in all respects with any and all Environmental Laws; not cause or permit to exist, as a result of an intentional or unintentional action or omission on Borrower’s part or on the part of any third party, on property owned and/or occupied by Borrower, any environmental activity where damage may result to the environment, unless such environmental activity is pursuant to and in compliance with the conditions of a permit issued by the appropriate federal, state or local governmental authorities; shall furnish to Lender promptly and in any event within thirty (30) days after receipt thereof a copy of any notice, summons, lien, citation, directive, letter or other communication from any governmental agency or instrumentality concerning any intentional or unintentional action or omission on Borrower’s part in connection with any environmental activity whether or not there is damage to the environment and/or other natural resources. Additional Assurances. Make, execute and deliver to Lender such promissory notes, mortgages, deeds of trust, security agreements, assignments, financing statements, instruments, documents and other agreements as Lender or its attorneys may reasonably request to evidence and secure the Loans and to perfect all Security Interests.

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • Financial Viability and Regulatory Compliance 2.6.1 Contractor warrants and represents that its corporate entity is in good standing with all applicable federal, state, and local licensing authorities and that it possesses all requisite licenses to perform the services required by this contract. Contractor further warrants and represents that it owes no outstanding delinquent federal, state or local taxes or business assessments. 2.6.2 Contractor agrees to promptly disclose to the MPHA any IRS liens or licensure suspension or revocation that may adversely affect its capacity to perform the services outlined within this contract. The failure by Contractor to disclose such issue to the MPHA in writing within 5 days of such notification received will constitute a material breach of this contract. 2.6.3 Contractor further agrees to promptly disclose to the MPHA any change of more than 50% of its ownership and/or any declaration of bankruptcy that Contractor may undergo during the term(s) of this contract. The failure of Contractor to disclose any change of more than 50% of its ownership and/or its declaration of bankruptcy within 5 days of said actions shall constitute a material breach of this contract. 2.6.4 All disclosures made pursuant to this section of the contract shall be made in writing and submitted to MPHA within the time periods required herein.

  • 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.

  • Policy Compliance Violations The Requester and Approved Users acknowledge that the NIH may terminate the DAR, including this Agreement and immediately revoke or suspend access to all controlled-access datasets subject to the NIH GDS Policy at any time if the Requester is found to be no longer in agreement with the principles outlined in the NIH GDS Policy, the terms described in this Agreement, or the Genomic Data User Code of Conduct. The Requester and PI agree to notify the NIH of any violations of the NIH GDS Policy, this Agreement, or the Genomic Data User Code of Conduct data within 24 hours of when the incident is identified. Repeated violations or unresponsiveness to NIH requests may result in further compliance measures affecting the Requester. The Requester and PI agree to notify the appropriate DAC(s) of any unauthorized data sharing, breaches of data security, or inadvertent data releases that may compromise data confidentiality within 24 hours of when the incident is identified. As permitted by law, notifications should include any known information regarding the incident and a general description of the activities or process in place to define and remediate the situation fully. Within 3 business days of the DAC notification(s), the Requester agrees to submit to the DAC(s) a detailed written report including the date and nature of the event, actions taken or to be taken to remediate the issue(s), and plans or processes developed to prevent further problems, including specific information on timelines anticipated for action. The Requester agrees to provide documentation verifying that the remediation plans have been implemented. Repeated violations or unresponsiveness to NIH requests may result in further compliance measures affecting the Requester. NIH, or another entity designated by NIH may, as permitted by law, also investigate any data security incident or policy violation. Approved Users and their associates agree to support such investigations and provide information, within the limits of applicable local, state, tribal, and federal laws and regulations. In addition, Requester and Approved Users agree to work with the NIH to assure that plans and procedures that are developed to address identified problems are mutually acceptable and consistent with applicable law.

  • Public safety compliance The Hirer shall comply with all conditions and regulations made in respect of the premises by the Fire Authority, Local Authority, the Licensing Authority or otherwise, particularly in connection with any event which constitutes regulated entertainment, at which alcohol is sold or provided or which is attended by children. (a) The Hirer acknowledges that they have received information in the following matters: (b) In advance of an entertainment or play the Hirer shall check the following items:

  • Compliance with U.S. Securities Laws; Regulatory Compliance Notwithstanding any provisions in this Receipt or the Deposit Agreement to the contrary, the withdrawal or delivery of Deposited Securities will not be suspended by the Company or the Depositary except as would be permitted by Instruction I.A.(1) of the General Instructions to the Form F-6 Registration Statement, as amended from time to time, under the Securities Act.

  • Notification of Breach / Compliance Reports The Adviser shall notify the Trust immediately upon detection of (i) any material failure to manage any Fund in accordance with its investment objectives and policies or any applicable law; or (ii) any material breach of any of the Funds’ or the Adviser’s policies, guidelines or procedures. In addition, the Adviser shall provide a quarterly report regarding each Fund’s compliance with its investment objectives and policies, applicable law, including, but not limited to the 1940 Act and Subchapter M of the Code, as applicable, and the Fund’s policies, guidelines or procedures as applicable to the Adviser’s obligations under this Agreement. The Adviser agrees to correct any such failure promptly and to take any action that the Board may reasonably request in connection with any such breach. Upon request, the Adviser shall also provide the officers of the Trust with supporting certifications in connection with such certifications of Fund financial statements and disclosure controls pursuant to the Xxxxxxxx-Xxxxx Act. The Adviser will promptly notify the Trust in the event (i) the Adviser is served or otherwise receives notice of any action, suit, proceeding, inquiry or investigation, at law or in equity, before or by any court, public board, or body, involving the affairs of the Trust (excluding class action suits in which a Fund is a member of the plaintiff class by reason of the Fund’s ownership of shares in the defendant) or the compliance by the Adviser with the federal or state securities laws or (ii) an actual change in control of the Adviser resulting in an “assignment” (as defined in the 0000 Xxx) has occurred or is otherwise proposed to occur.

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