Regulatory Reporting Requirements. During the Term, for no additional fee, FIS agrees to modify those FIS developed programs installed for Client so that such programs will comply with the mandatory data processing output requirements specified by federal regulatory authorities applicable to assist Client in achieving compliance. Resident Staff will provide program modifications necessary to meet state and local regulatory requirements at Client’s request. Client acknowledges and agrees that certain state or local regulatory changes may require modifications to the Base Processing Software that cannot be made by Resident Staff. In these situations, the FIS RPS procedures will be utilized to determine the scope of work required to make such modifications. By mutual agreement of the parties, Client will fund such modifications or use Pre-funded Development hours to make the modifications. Client agrees to make FIS aware of any local or state regulatory requirements not included in the requirements established by federal regulatory authorities.
Regulatory Reporting Requirements. COMPANY and DISTRIBUTOR each will be responsible for regulatory reporting and for responding to regulatory inquiries within their respective territories. DISTRIBUTOR and COMPANY each shall use their best efforts to notify the other, by telephone, facsimile or email within forty-eight (48) hours (but in any event such notification shall occur within seventy-two (72) hours) after either Party becomes aware of any matter which must be reported to the MHLW or FDA. The Party which becomes aware of any such matter will use its best efforts to provide to the other Party within five (5) calendar days of first becoming aware of such matter (but in any event no later than within five (5) business days), with a detailed written report, by facsimile regarding the event. COMPANY shall supply DISTRIBUTOR with a copy of its medical device report filed with the FDA in accordance with the Medical Device Reporting Regulation (21 C.F.R. § 803 (2001) within twenty-four (24) hours of supplying such a report to FDA. DISTRIBUTOR shall supply COMPANY with a copy of its report filed with the MHLW within twenty-four (24) hours of supplying such a report to the MHLW. Follow-up reports to the initial report will be submitted using the same procedures and timelines.
Regulatory Reporting Requirements. UTOPIA will provide Service Provider all information and documents, within UTOPIA’s control, as necessary to permit Service Provider to comply with regulatory reporting requirements.
Regulatory Reporting Requirements. The investigator must promptly report all SAEs to GW in accordance with the procedures detailed in Section 7.8, “Prompt Reporting of SAEs to Glaxo Wellcome”. GW has a legal responsibility to notify both the local regulatory authority and other regulatory agencies about the safety of a drug under clinical investigation. Prompt notification of SAEs by the investigator to the appropriate project contact for SAE receipt is essential so that legal obligations and ethical responsibilities towards the safety of other subjects are met. The investigator, or responsible person according to local requirements, must comply with the applicable local regulatory requirements related to the reporting of SAEs to regulatory authorities and the IRB/IEC.
Regulatory Reporting Requirements. Network Owner will provide Service Provider all information and documents, within Network Owner’s control, as necessary to permit Service Provider to comply with regulatory reporting requirements. Pursuant to Section 4.a, Network Owner may assign these obligations to its Network Operator.
Regulatory Reporting Requirements. Oxford and PA HRM shall be jointly responsible for compliance with all regulatory reporting requirements, including, but not limited to, those of DOI, DPW and DOH.
Regulatory Reporting Requirements. Anesta and Elan each will be responsible for regulatory reporting and for responding to regulatory inquiries within their respective territories. Anesta will generate the required data base output for such responses from the safety database for OT-fentanyl Products.
Regulatory Reporting Requirements. 9 6. EDUCATION..................................................................................................... 9 7. STAFFING; COMPUTER USE........................................................................................ 9
Regulatory Reporting Requirements. During the Term, for no additional fee, Fidelity agrees to modify those Fidelity-developed programs installed for Client so that such programs will comply with the mandatory data processing output requirements specified by federal regulatory authorities applicable to assist Client in achieving compliance. Resident Staff will provide program modifications necessary to meet state and local regulatory requirements at Client's request. Client acknowledges and agrees that certain state or local regulatory changes may require modifications to the Base Processing Software that cannot be made by Resident Staff. In these situations, the SRO procedures described above will be utilized to determine the scope of work required to make such modifications. By mutual agreement of the parties, Dedicated Resources may be used to make the modifications or Client will fund such modifications. Client agrees to make Fidelity aware of any local or state regulatory requirements not included in the requirements established by federal regulatory authorities.
Regulatory Reporting Requirements. During the term of this Agreement, SI agrees to modify those SI-developed programs installed for Client so that such programs will comply with the mandatory data processing output requirements specified by federal regulatory authorities applicable to Client. Program modifications necessary to meet state and local regulatory requirements will be provided at Client's request by the Resident Staff. Client agrees to make SI aware of any local or state regulatory requirements not included in the requirements established by federal regulatory authorities.
