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. (Optional Services)
a) Review existing investor accounts including collection, review and validation of investor information including tax withholding certificates (W8s and W9s) and self-certifications and GIIN numbers to comply with the requirements of U.S. FATCA, U.K. CDOT or any other Model 1 Intergovernmental agreements
b) Onboard new investors including collection, review and validation of investor information including tax withholding certificates (W8s and W9s) and self-certifications and GIIN numbers to comply with the requirements of U.S. FATCA, U.K. CDOT or any other Model 1 Intergovernmental agreements
c) Provide ongoing investor monitoring including changes in circumstance, tax withholding certificates and GIIN numbers
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 **** **** **** **** ****
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:
2.2.1. preparation of the CMC update for the Phase 3 FDA package including a Rehovot-Beer Tuvia bridging document;
2.2.2. development and preparation of the requisite assays;
2.2.3. analytical method validation;
2.2.4. preparation of process validation documents;
2.2.5. annual report preparation (CMC, stability, process updates);
2.2.6. preparation of the CMC chapter of the BLA (process, methods, validations, specifications);
2.2.7. participation in meetings and calls with Savient (e.g. preparation for the end of Phase 2 [EOP21 meeting);
2.2.8. participation in meetings with regulatory authorities (e.g. the EOP2 meeting); and
2.2.9. support for any and all regulatory activities required for worldwide registrations.
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.
2.7.2 Seller shall provide the Company with reasonable advance notice of all meetings, conferences and discussions scheduled with any Governmental Entity concerning the Compound or Product, and shall incorporate any input from the Company in preparing for such meetings, conferences or discussions; provided, that Seller shall not be required to incorporate any input from the Company to the extent doing so would cause Seller to violate the requirements of a Governmental Entity or Applicable Laws. One or more representatives of the Company shall have the right to attend and participate in all such meetings, conferences, and discussions to the extent not prohibited by Applicable Law or the applicable Governmental Entity, and Seller shall facilitate such participation. If the Company elects not to participate in such meetings, conferences or discussions, Seller shall provide the Company with written summaries of such meetings, conferences or discussions ...
Regulatory Services. Filing and Reconciliation of CRFs in the Study Master File Study Master File and CRF Return Compilation of Appendices to Clinical Study Report
Regulatory Services. Lonza shall provide, and Customer shall pay for, the regulatory services referred to in the applicable Project Plan. These shall be paid for on a per person per day basis.
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.
