Regulatory Process. If the Durham Planning Department or other regulatory agency delays or does not grant promptly an application for a permit or site plan approval made by the Company, then each of the deadlines contained herein may be extended by the length of such delay, subject to discussion by the Parties.
Regulatory Process. Not later than 90 days after the date of enactment of the SAFETEA–LU, the Secretary shall issue re- vised regulations under section 1307(c) of the Transportation Equity Act for 21st Century (23 U.S.C. 112 note; 112 Stat. 230) that—
Regulatory Process. SMI shall provide Aspect with an advance copy of any regulatory filing relating to the Modules and Aspect shall have the right to make comments and suggestions on any such regulatory filing, provided that SMI shall only be required to provide portions of such filings describing or relating to the Bispectral Index. Any comments or suggestions made by Aspect shall be given due consideration by SMI in its discretion and changes to the regulatory filings specifically requested by Aspect shall not be unreasonably refused. Aspect agrees to promptly provide such comments (in any event within thirty (30) days of its receipt of the proposed filing), and agrees that such filings shall be the Proprietary Information of SMI.
Regulatory Process. Subject to the terms of any collaboration agreement entered into by the Parties in accordance with Section 2.6 (Collaboration Option), AMT shall have sole and full control, authority, discretion and right to conduct (by itself, through its Affiliates or via a Third Party) and make all decisions regarding all development and regulatory matters (including interaction with all Governmental Authorities and preparation of any Regulatory Filings) with respect to GDNF Products. From time to time upon the written request of Amgen (but not more than [**] in any Calendar Year), AMT shall deliver to Amgen a written summary of development and regulatory activities conducted hereunder by it since the last such report. Amgen shall grant a right of reference to AMT to all Regulatory Approvals and Regulatory Filings owned by Amgen as of the Effective Date, if any, relating to GDNF Products in the Licensed Field. All Regulatory Approvals and Regulatory Filings obtained by AMT relating to GDNF Products in the Licensed Field shall be solely owned by AMT and held in the name of AMT or its respective designated Affiliates or Sublicensee(s).
Regulatory Process. 13 5.01 Not a Development Order or Permit 13
Regulatory Process. (a) The requirements of this Clause 24.37 shall only apply to the extent that a BXC Lender is a Lender under this Agreement. 143 (b) The Parent undertakes to each BXC Lender that (and shall procure that the Group implements and maintains proper systems, policies and procedures, including maintaining a roster of appropriate regulatory and legal advisers, to ensure that):
Regulatory Process. Drug Master File The Drug Master File (DMF) outlines how the Mo-99 is produced. There are existing DMFs for HEU Mo-99. For a Mo-99 producer to start using LEU-produced material, they would need to write a new DMF, or modify the existing DMF to detail the new process used for the different target material. The typical contents of a DMF are as follows: • Component Specifications • Master Batch Record
Regulatory Process. Following a process of consultation with representative stakeholders of ANCBC in November 2003 (the “Stakeholder Consultations”)1, Fortis Pacific filed an application on December 1, 2003 (the “Application”) pursuant to the provisions of section 54 of the Act seeking an Order of the Commission approving the proposed acquisition by Fortis Pacific of a reviewable interest in ANCBC. Fortis Pacific believes the Application addresses all the issues relevant to the exercise by the Commission of its jurisdiction under section 54 of the Act2. In addition, pursuant to Order G-18-04, the Commission 1 See details in the Application, Schedule A. 2 See, for example, Commission Order G-71-03 re Tricor Acquisition (STP) Inc. acquisition of Pacific Northern Gas Ltd. and Pacific Northern Gas (N.E.) Ltd. and Commission Order G-8-02 approving BC Gas Inc. acquisition of Centra Gas British Columbia Inc. and Centra Gas Whistler Inc. 604050.2 directed that notice of the Application be published and established an interrogatory procedure culminating in written submissions from registered Intervenors. Fortis Pacific provided prompt and complete responses to all Information Requests filed by registered Intervenors. Ultimately, only three Intervenors filed written submissions.
Regulatory Process. TGC, with appropriate assistance from IAVI and funding from IAVI as and to the extent provided under the appropriate Work Plan and Budget, will use Reasonable Commercial Efforts to assemble all Approval Applications relating to the manufacture of any Clinical Vaccine developed or to be developed under the Agreement or supplied or to be supplied to IAVI under the Supply Agreement. TGC shall have the right to reference any relevant regulatory documents filed by IAVI, including Approval Applications and Regulatory Approvals, if required by TGC for the development of a vaccine outside of the Program Field. IAVI, with appropriate assistance from TGC as and to the extent provided under the appropriate Work Plan and Budget, will use Reasonable Commercial Efforts to assemble all Approval Applications needed to conduct clinical trials with any Clinical Vaccine developed or to be developed under the Agreement or supplied or to be supplied to IAVI under the Supply Agreement. In connection with any Approval Application, IAVI will have the right to reference any relevant regulatory documents of TGC.
Regulatory Process. The Province, in a manner consistent with the public interest and its legal and fiduciary obligations under the Laws, will consult or reasonably cooperate with the Proponent where it deems appropriate in respect of authorizations and permitting. The Province is committed to a timely efficient regulatory process with opportunities to deepen cooperntion between regulatory agencies (Environmental Assessment Office (EAO), Canadian Environmental Assessment Agency (CEAA) and the Oil and Gas Commission (OGC) and to streamline the regulatory regime. The EAO has created a single team dedicated to LNG projects to provide consistency to reviews. They are also are working with CEAA to coordinate environmental assessments for a streamlined approach where projects trigger both federal and provincial requirements. The BAO and OGC have signed a memorandum of understanding to endeavour to provide a seamless approach to pennitting if an Environmental Assessment Certificate were to be issued. This includes eliminating duplication between environmental assessment and pennitting; providing opportunity for Proponents to apply for permits while in the environmental assessment process; coordinating consultetion with First Nations; and bolstering compliance and enforcement.