Regulatory Services. X.X. Xxxxxx will perform the following services subject to the review and approval of the Customer and its legal counsel.
Regulatory Services. Critical Start does not operate as a provider of services regulated by the Federal Communications Commission (FCC) or state regulatory authorities and does not intend to provide any services that are regulated by either. If the FCC or any state regulatory authorities imposes regulatory requirements or obligations on any services provided by Critical Start hereunder, Critical Start may (a) modify, replace, or substitute products at Customer's expense, and/or (b) change the way in which such services are provided to Customer to avoid the application of such requirements or obligations to Critical Start (for example, by acting as Customer’s agent for acquiring such services from a third-party common carrier).
Regulatory Services. ° CRF Filing and Reconciliation (actuals will be billed) Pages **** **** **** **** **** ° Regulatory Site Drug Release Approval # Sites **** **** **** **** **** Sub-Total Regulatory Services $ **** $ **** $ ****
Regulatory Services. The Regulatory services involve elements needed to complete the relevant sections of the BLA as well as other documentation, and appropriate support for the various filings. This includes, but is not limited to:
Regulatory Services. The Company will advise and assist Client in all regulatory and rate matters, including the design and preparation of schedules and tariffs, the analysis of rate filings, the preparation and presentation of testimony and exhibits to regulatory authorities, and other regulatory activities.
Regulatory Services. 2.7.1 In the event Seller, in the course of performing the Services, is required to submit any Regulatory Documentation to a Governmental Entity, Seller shall provide the Company a draft of such Regulatory Documentation as far in advance of the intended date of submission as reasonably possible and shall incorporate any comments thereto provided by the Company. Seller shall promptly notify the Company of any other Regulatory Documentation received from or to be submitted to any Governmental Entity, including correspondence, meeting minutes and summaries received by Seller from, or to be submitted by Seller to, any Governmental Entities, and shall provide the Company with copies thereof within five (5) Business Days after receipt thereof or, if such documents are prepared by Seller for submission to Governmental Entities, sufficiently in advance of such submission so as to allow the Company to review and finalize the content of such submission with Seller. Notwithstanding the foregoing, Seller shall not be required to delay a regulatory submission to any Governmental Entity or incorporate any comments of the Company to the extent doing so would cause Seller to violate the requirements of a Governmental Entity or Applicable Laws. For clarity, the terms of this Section 2.7.1 do not apply to correspondence with or reporting to Governmental Entities regarding adverse events or other safety information pertaining to the Compound or Products, which correspondence and reporting are governed by the terms of Section 2.8.
Regulatory Services. The Parties shall consult and collaborate on the most effective and expeditious plan for obtaining regulatory clearance for investigational use and commercial marketing of the Assay.
Regulatory Services. Filing and Reconciliation of CRFs in the Study Master File After logging in Clinical Data Management, completed CRFs are transferred to the Study Master File. Fees reflect time required to verify CRF and ancillary pages received against the Clinical Data Management tracking log and filing of CRFs. The Sponsor will be billed for the actual number of pages filed. Study Master File and CRF Return Omnicare CR will return the Study Master File in hard copy format in accordance with Omnicare CR’s SOPs, within three (3) months of final study deliverable. A final review of the study wide and individual investigator files is completed by Project Management for completeness and accuracy. Sponsor will be billed for the actual number of sites returned. Compilation of Appendices to Clinical Study Report Omnicare CR has included cost to compile and collate the Clinical Study Report electronic to hard-copy appendices in accordance with ICH guidelines. It is assumed that the Clinical Study Report appendices without hyper links will be prepared. Deliverables include electronic-to-paper publishing, with all required formatting, utilizing a validated environment and formatting check. Hardcopies requested by the Sponsor can be provided for an additional charge. PostScript files will allow for subsequent printing needs of Sponsor (one CD-ROM). Publishing of the appendices with hyper links applied is available for an additional charge.
Regulatory Services. Company is required to conduct the Business in accordance with all applicable regulatory requirements. Accordingly, in the event Company is obligated to meet a regulatory requirement arising from Services delivered or to be delivered by a Provider, Company may, at its option, request a Provider to perform Services pursuant to the issuance of a Work Order. Such Work Order must be signed by both the Company and the Provider and must be approved in writing by both AWS and MTN to become effective. Services for regulatory requirements under this Section 1.4 will also be deemed Additional Services.
Regulatory Services. 4.8.1 In connection with the Regulatory Services, Sunovion shall provide the necessary number of FTEs as agreed upon in writing by the Parties from time to time at the FTE Rate for Regulatory Services (the “Regulatory Service Charge”).
