Regulatory Process Sample Clauses

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— (i) do not preclude a State transpor- tation department or local transportation agency, prior to compliance with section 102 of the National Environmental Policy Act of 1969 (42 U.S.C. 4332), from— (I) issuing requests for proposals; (II) proceeding with awards of design- build contracts; or (III) issuing notices to proceed with preliminary design work under design- build contracts; (ii) require that the State transportation department or local transportation agency receive concurrence from the Secretary be- fore carrying out an activity under clause (i); and (iii) preclude the design-build contractor from proceeding with final design or con- struction of any permanent improvement prior to completion of the process under such section 102.

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. 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— (i) do not preclude a State transpor- tation department or local transportation agency, prior to compliance with section 102 of the National Environmental Policy Act of 1969 (42 U.S.C. 4332), from— (I) issuing requests for proposals; (II) proceeding with awards of design- build contracts; or (III) issuing notices to proceed with preliminary design work under design- build contracts; (ii) require that the State transportation department or local transportation agency receive concurrence from the Secretary be- fore carrying out an activity under clause (i); and lations for 1-year applicable accounting peri- ods by a cognizant Federal or State govern- 1 So in original. (iii) preclude the design-build contractor from proceeding with final design or con- struction of any permanent improvement prior to completion of the process under such section 102.

Regulatory Process. Drug Master File

Regulatory Process. ‌ On May 1, 2023, BC Hydro filed an application with the BCUC pursuant to section 71 of the UCA to accept the Sechelt Creek and Brown Lake EPA renewals for filing. After the BCUC established a regulatory timetable7 to review the filing, BC Hydro submitted a letter requesting that the ▇▇▇▇▇▇▇▇ Creek, ▇▇▇▇▇▇ Creek, ▇▇▇▇▇▇▇▇▇▇ Creek and ▇▇▇▇▇ Creek EPA renewals also be reviewed in the same proceeding.8 The BCUC accepted BC Hydro’s request and amended the regulatory timetable to include one round of BCUC and intervener information requests (IR) and allow time for BC Hydro to submit an amended Filing.9 On July 6, 2023, BC Hydro filed the amended consolidated Filing including the six EPA renewals described in Section 1.1 above. Two parties intervened and actively participated in the proceeding: • British Columbia Old Age Pensioners’ Organization et al (BCOAPO); and • the Commercial Energy Consumers Association of British Columbia (CEC). The following parties also intervened in the proceeding but did not actively participate: • ▇▇▇▇▇ Lake Indian Band; • Splats’in; and • Little Shushwap Lake First Nation. On August 9, 2023, the BCUC issued IR No. 1 to BC Hydro and on August 16, 2023, registered interveners BCOAPO and CEC issued Intervener IR No. 1 to BC Hydro. BC Hydro submitted its responses to both the BCUC’s and Intervener’s IR No. 1 on September 27, 2023. On October 19, 2023, the BCUC issued Order G-282-23 establishing a further regulatory timetable and setting deadlines for final arguments from BC Hydro and registered interveners. By letter dated October 27, 2023, BC Hydro requested an extension to the deadline to file its final argument from November 2, 2023, to November 9, 2023, due to resource constraints of key personnel and on October 30, 2023, the BCUC issued Order G-295-23 amending the regulatory timetable. Between November 9 and November 23, 2023, BC Hydro and the registered interveners submitted their final arguments to the BCUC and on December 7, 2023, BC Hydro submitted its reply argument.

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.

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): (i) the Group complies with all applicable laws and applicable guidelines published by the relevant regulator and maintains and complies with all licenses, consents and authorisations whatsoever which are reasonably required or necessary to carry on the business from time to time; (ii) prior to entering into a new market (including allowing access to the online business from a new jurisdiction or territory) (a “New Market Entry”), the board of directors (or any committee thereof duly authorized to act on behalf of such board) of the Parent (the “Board”) has all information necessary and reasonably in advance to allow it to make an informed decision on entering such market (including information relating to the regulatory environment, enforcement and disclosure requirements); and (iii) the Group actively monitors, with the assistance of its regulatory counsels, being internationally reputable law firms with experience in the gambling sector in the relevant jurisdictions (“Regulatory Counsel”), and its other legal and regulatory advisers (as necessary), and at least quarterly asks its Regulatory Counsel to notify it of any significant changes/developments in the regulatory environment, enforcement or other adverse indications that would suggest the Matrix (as such term is defined in paragraph (d) below) findings for that market (or legal opinion, if requested) are no longer Clean (as such term is defined in paragraph (l) below), or it is not legal to continue to operate in, or (as applicable) provide services in, such market or that the Group should change the manner in which it operates or (as applicable) provides services (“Adverse Findings”). The Board must be kept promptly and regularly appraised of Adverse Findings and shall promptly determine whether any changes in the business, the manner in which it operates, or the jurisdictions in which it is present or from which its online business is accessible are required.

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.