Other Regulatory Obligations. (a) Auxilium shall comply with all pharmacovigilance obligations imposed by Applicable Law in relation to the Product. Each Party shall keep the other informed in a timely manner of any Information that such Party receives (directly or indirectly) that (i) raises any material concerns regarding the safety or efficacy of the Product; (ii) reasonably indicates or suggests a potential material liability of either Party to Third Parties in connection with the Product; (iii) is reasonably likely to lead to a recall or market withdrawal of the Product in any jurisdiction; or (iv) relates to the Product and is reasonably likely to have a material impact on a Regulatory Approval, Pricing Approval, or the Commercialization of the Product in the Field in the Auxilium Territory.
Other Regulatory Obligations. Once it enters service, KBPL, as the successor to the Four Pipelines, will assume and be bound by all applicable obligations of the Four Pipelines under the Alaska Pipeline Act.
Other Regulatory Obligations. 1. GammaTile LLC will grant cross-reference rights to IsoRay with respect to the Product DMR to the extent necessary to perform IsoRay’s obligations under this Agreement.
Other Regulatory Obligations. Licensor shall receive and coordinate reports from B&L and other sources and promptly report to the FDA and/or Regional Regulatory Authority any and all of the following events or experiences: adverse events; "serious adverse drug experience", "unexpected adverse drug experience", "life-threatening adverse drug experience", or fatal events that may be experienced by any subject in a clinical study designated to support regulatory approval of the Products or components thereof, where any such event or experience is "associated with the use" of the Products as those terms are defined in 21 C.F.R. 314.80, 314.81, and 803, or as otherwise required by any other applicable FDA regulations or the similar regulations and requirements in jurisdictions outside the United States. Licensor will comply with other requirements for the submission of reports and notices to the FDA or Regional Regulatory Authority, including reports and notices to the FDA as required under 21 CFR Sections 202, 203 and 207 and the similar regulations and requirements in jurisdictions outside the United States. Within the one (1)-year period before the reasonably anticipated First Commercial Sale, and from time to time thereafter at either party's request, the parties will discuss and seek to establish standard operating procedures for the collection, monitoring and reporting of all product complaints, and the prompt exchange of information as contemplated by this paragraph and Section 5.5, and Licensor shall also thereafter comply with all such mutually agreed standard operating procedures.
Other Regulatory Obligations. (a) Menarini shall comply with all pharmacovigilance obligations imposed by the Applicable Law in relation to the Product. Menarini shall keep VIVUS informed, in a timely manner consistent with Applicable Laws governing adverse event reporting obligations and the pharmacovigilance reporting requirements to Regulatory Authorities in the Menarini Territory, of any Information that Menarini receives (directly or indirectly) that (i) raises any material concerns regarding the safety or efficacy of the Product; (ii) indicates or suggests a potential material liability of either Party to Third Parties in connection with the Product; (iii) is reasonably likely to lead to a recall or market withdrawal of the Product; or (iv) relates to the Product and is reasonably likely to have a material impact on a Regulatory Approval, Pricing Approval, or the Commercialization of the Product. Menarini shall provide VIVUS with drafts of all pharmacovigilance reports to the Regulatory Authorities and shall not submit such reports before VIVUS has reviewed and been provided a reasonably opportunity to comment on such reports and discuss such reports with Menarini. Failure by Menarini to comply with the provisions of this Section shall be deemed to be a material breach of this Agreement, giving rise to VIVUS’s right to terminate this Agreement pursuant to Section 12.2(a).
Other Regulatory Obligations. Noise Perform monitoring to document compliance with the FEIS and SFEIS. Primary None As Required Environmental Protection Plan (COL Appendix B) - EIE for non-evaluated environmental impacts or changes to evaluated impacts Perform notifications and prepare environmental impact evaluations to support compliance. Primary Support As Required Department of Army Permit SAS-2007-01837 Support compliance with permit obligations. Support Primary As Required XxXXX Observe and support required signs. Sign replacement as required. Support Primary NHPA Ensure compliance with NHPA requirements prior to any new land disturbing activities and support new discovery (if applicable)] Primary Support As Required Bulk Gas Impact Perform Periodic Monitoring of Bulk Gas Shipments, storage locations, and management to comply with obligations for Vogtle 1&2. Primary Support As Required Federal Aviation Administration (FAA) Determinations. Various contractors and Owners make notifications. Ensure applicable structures have determinations and are lit accordingly. Report lighting outages to the FAA as required. Support Primary As Required CONFIDENTIAL AND PROPRIETARY Exhibit A – Scope of Work / Division of Responsibilities Table 2. Environmental Compliance Division of Responsibility (Notes 1, 2) Title Purpose Owners Responsibility ContractorResponsibility Agency/Frequency/Dates
