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.
General Regulatory Matters. Each Partner shall:
General Regulatory Matters. Each Member shall:
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) 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.
General Regulatory Matters. With respect to the Fentanyl Product, Arius shall provide Arius Two with copies of any materials relating to any regulatory matter and, when reasonably practicable, shall provide copies of any documents to be presented to any Competent Authority prior to their presentation thereto, so that Arius Two shall have a reasonable opportunity to review and comment thereon, provided that such requirement shall not limit Arius’ discretion in interacting with such Competent Authorities in any way.
General Regulatory Matters. (a) During the Development, the JDMC shall have all regulatory responsibility with respect to and relative to the Product or RSD1235 in the Field in the Territory and has the sole right and decision making authority with respect to all such regulatory matters, including reaching agreement on all regulatory matters with the FDA and any other Competent Authority. Subject to the foregoing, from and after the IND Transfer Date, Fujisawa, under the oversight of the JDMC, shall have primary regulatory responsibility for the Indication in the Field in the Territory. From and after Fujisawa’s receipt of the applicable Approval Letter from a particular country in the Territory for the Indication, the JDMC shall no longer have any regulatory responsibility or oversight with respect to the Indication in such country. From and after Fujisawa’s receipt of any such Approval Letter, Fujisawa shall have sole right and decision making authority with respect to all regulatory matters for the Indication, as well as other indications, in such country.
General Regulatory Matters. 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. 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. 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: Strata has the sole right and decision making authority for all regulatory matters with respect to or relative to the Product. 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 Strata shall be able to a...
General Regulatory Matters. Fujisawa shall be entitled []** including without limitation []** provided that []** Atrix shall use Commercially Reasonable Efforts []** that is []** and shall []** and provided further that []** Atrix shall make all reasonable efforts to provide Fujisawa copies of any materials relating to any regulatory matter prior to their -------- ** Confidential Treatment Requested 35 presentation to the FDA or any other Competent Authority, so that Fujisawa shall have an opportunity to review and comment thereon and Atrix shall []** Notwithstanding the foregoing and in addition to Fujisawa's rights set forth in this Section 9.06, in the event any []** the Parties agree that []** Atrix agrees that []** Any interaction with the FDA needs to be promptly documented and a copy sent to the other Party within three business days.
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.
