General Regulatory Matters. (a) The Members acknowledge that either the Company will be a “natural gas company” as defined in Section 2(6) of the NGA or the assets of the Company will be operated by a “natural gas company” as defined in Section 2(6) of the NGA in accordance with the certificate of authority granted by the FERC.
(b) Each Member shall (i) cooperate fully with the Company, any Management Committee, USG, EQT, and the applicable Operator in securing the Necessary Regulatory Approvals, including supporting all ATF FERC Applications, and in connection with any reports prescribed by the FERC and any other Governmental Authority having jurisdiction over the Company; (ii) join in any eminent domain takings by the Company, to the extent, if any, required by Law; and (iii) without limiting or modifying Section 6.04 or 6.05, devote such efforts as shall be reasonable and necessary to develop and promote the Facilities for the benefit of the Company, taking into account such Member’s Sharing Ratio(s), resources, and expertise.
General Regulatory Matters. Each Partner shall:
(a) cooperate fully with the Partnership and the Management Committee in securing appropriate Authorizations for the development, construction and operation of the Facilities, including supporting all applications submitted to the FERC by or on behalf of the Partnership, and in connection with any reports prescribed by any other Governmental Authority having jurisdiction over the Partnership;
(b) join in any eminent domain takings by the Partnership, to the extent, if any, required by Law;
(c) devote such efforts as shall be reasonable and necessary to develop and promote the Facilities for the benefit of the Partnership, taking into account the Partner’s Percentage Interest, resources and expertise; and
(d) cooperate fully with the Partnership and the Management Committee to ensure compliance with FERC Standards of Conduct, if applicable.
General Regulatory Matters. (a) Subject to Micrologix’s obligations under Section 6.7(b) and Applicable Laws during the period in which it is the IND holder, Strata shall have all regulatory responsibility with respect to and relative to the Product and has the sole right and decision making authority with respect to all such regulatory matters, including without limitation reaching agreement on all regulatory matters with the FDA and/or any other Competent Authority.
(b) The Parties acknowledge that Micrologix, as of the Effective Date, owns and holds certain Governmental Approvals in connection with the research and development of the Product, including without limitation the IND listed in Exhibit “D”. Micrologix shall be responsible for the filing and maintenance in good standing of all such Governmental Approvals, with costs and expenses associated therewith to be included in Reimbursable Costs. During the time that Micrologix is the holder of the IND, Micrologix shall comply with all Applicable Laws applicable to the holder of the IND, including, without limitation, process, track and report all IND Safety Reports (as defined by the FDA). Upon Strata’s request, such request to be made as soon as reasonably possible, Micrologix shall transfer to Strata, without any additional consideration, those Governmental Approvals (including without limitation the IND) requested by Strata.
(c) During the time that Micrologix is the holder of such Governmental Approvals, Strata shall be entitled to attend any and all meetings and participate in telephone calls with the Competent Authorities, including without limitation any meeting preparation, meeting co-ordination, preparation of minutes and pre-NDA meeting with the FDA. During such time as Micrologix is the holder of such Governmental Approvals, subject to Micrologix’s obligations under Section 6.7(b) and Applicable Laws during the period of time in which it is the IND holder:
(i) Strata has the sole right and decision making authority for all regulatory matters with respect to or relative to the Product.
(ii) While it is still the holder of the IND in the United States, Micrologix shall give Strata no less than three (3) business days notice following the scheduling of any such meeting and/or telephone call with the FDA and/or other Competent Authority (or such shorter period of time, if the meeting and/or telephone call is scheduled within such three (3) business days and in such event such notice shall be in sufficient time so that Stra...
General Regulatory Matters. Each Member shall:
a) cooperate fully with the Company and the Management Committee in securing appropriate Authorizations for the development, construction and operation of the Facilities, including supporting all applications submitted to the FERC by or on behalf of the Company, and in connection with any reports prescribed by any other Governmental Authority having jurisdiction over the Company;
b) join in any eminent domain takings by the Company, to the extent, if any, required by Law;
c) devote such efforts as shall be reasonable and necessary to develop and promote the Facilities for the benefit of the Company, taking into account the Member’s Percentage Interest, resources and expertise; and
d) cooperate fully with the Company and the Management Committee to ensure compliance with FERC Standards of Conduct, if applicable.
General Regulatory Matters. In addition to the specific requirements of this Article 6 and the Quality Assurance Agreement, Schering shall (i) be responsible for obtaining and maintaining in good order all site licenses and current registrations granted by the FDA and any other applicable Regulatory Authority for the Manufacture of the Clinical Supplies and Finished Product at the Schering Facility(ies) as contemplated hereunder and will make copies of such registrations and all related documents available to Indevus and its designee for inspection during audits upon Indevus’ reasonable request; and (ii) take all steps necessary to be obtain and maintain FDA approval as a manufacturer of Finished Product under Indevus’ NDA, and comply with regulations promulgated by the FDA and any other applicable Regulatory Authority in connection with Schering’s Manufacture of the Clinical Supplies and Finished Product hereunder. In addition, Sections 3.4 and 3.5 of the License Agreement are hereby incorporated by reference, as if stated in their entirety, herein.
General Regulatory Matters. (a) The Members acknowledge that the Company will be a “natural gas company” as defined in Section 2.(6) of the NGA.
(b) Each Member shall (i) cooperate fully with the Company, the Management Committee and GMOS in securing the Necessary Regulatory Approvals, including supporting all FERC Applications, and in connection with any reports prescribed by the FERC and any other Governmental Authority having jurisdiction over the Company; (ii) join in any eminent domain takings by the Company, to the extent, if any, required by Law; and (iii) devote such efforts as shall be reasonable and necessary to develop and promote the Facilities for the benefit of the Company, taking into account such Member’s Sharing Ratio, resources and expertise.
General Regulatory Matters. With respect to the Fentanyl Product, Arius shall provide Arius Two with copies of any materials relating to any regulatory matter in the Territory and, when reasonably practicable, shall provide copies of any documents to be presented to any Competent Authority in the Territory prior to their presentation thereto, so that Arius Two shall have an opportunity to review and comment thereon. All interactions with any Competent Authority in the Territory related to the Fentanyl Product shall be disclosed to Arius Two, provided that such requirement shall not limit Arius’ discretion in interacting with such Competent Authorities in any way.
General Regulatory Matters. (a) . Each Partner shall:
(a) cooperate fully with the Partnership, the Management Committee and the Operator in securing appropriate Authorizations for the development, construction and operation of the Facilities, including supporting all applications to the FERC, and in connection with any reports prescribed by any other Governmental Authority having jurisdiction over the Partnership;
(b) join in any eminent domain takings by the Partnership, to the extent, if any, required by Law;
(c) devote such efforts as shall be reasonable and necessary to develop and promote the Facilities for the benefit of the Partnership, taking into account the Partner’s Sharing Ratio, resources and expertise; and
(d) cooperate fully with the Partnership, the Management Committee and the Operator to ensure compliance with FERC Standards of Conduct, if applicable.
General Regulatory Matters. The Members acknowledge that either the Company will be a “natural gas company” as defined in Section 2(6) of the NGA or the assets of the Company will be operated by a “natural gas company” as defined in Section 2(6) of the NGA in accordance with the certificate of authority granted by the FERC.
General Regulatory Matters. (i) Neither AHB, any Affiliate, nor any of their respective properties is a party to or is subject to any order, decree, agreement, memorandum of understanding or similar arrangement with, or a commitment letter or similar submission to, or extraordinary supervisory letter from, any Bank Regulatory Authority or any federal or state governmental agency or authority charged with the supervision or regulation of issuers of securities or the supervision or regulation of it (collectively, the “AHB Regulatory Authorities”). AHB has paid all assessments made or imposed by any AHB Regulatory Authority.
(ii) No member of the AHB Group has been advised by, nor has any Knowledge of facts that could give rise to an advisory notice by, any AHB Regulatory Authority that such AHB Regulatory Authority is contemplating issuing or requesting, or is considering the appropriateness of issuing or requesting, any such order, decree, agreement, memorandum of understanding, commitment letter, supervisory letter or similar submission.
(iii) AHB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that they were required to file since January 1, 2002 with (A) the Federal Reserve Board, (B) the OCC, (C) and any other AHB Regulatory Authority, and all other reports and statements required to be filed by them since January 1, 2002, and have paid all fees and assessments due and payable in connection therewith. Except as set forth in Schedule 5.3(j)(iii) of the AHB Disclosure Schedule and except for normal examinations conducted by Bank Regulatory Authorities, (A) no Bank Regulatory Authority has initiated or has pending any proceeding or, to the Knowledge of AHB, investigation into the business or operations of AHB since January 1, 2002, and (B) there is no unresolved violation, criticism or exception by any AHB Regulatory Authority with respect to the business, operations, policies or procedures of AHB since January 1, 2002.
