Regulatory Interface Clause Samples

Regulatory Interface. Insulet shall exercise commercially reasonable efforts to obtain and Maintain any Product Registrations in the countries of the Territory as set forth in Section II of Exhibit II during the Term. As used in this Section 5.4, the term “Maintain” means that: (a) Insulet shall exercise commercially reasonable efforts to maintain the Product Registrations as valid and in force with the appropriate Governmental Authorities, (b) Insulet shall use commercially reasonable efforts to the extent possible to minimize the number and extent of any changes to the Product Registrations, and (c) Insulet shall notify Distributor of any change to any of the Product Registrations during the Term and any such change requested or required by appropriate Governmental Authorities in the Territory. As between the Parties hereto, it is agreed that the Product Registrations shall be held in the name of Insulet, who shall be the beneficial owner of all Product Registrations and Distributor may not use the Product Registrations, or any of them, on or in respect of any product other than the Products or use any authorization other than one or more of the Product Registrations on or in respect of the Products, except as may be approved in writing by Insulet. Distributor agrees to use its commercially reasonable efforts to assist Insulet, [***] in obtaining and Maintaining the Product Registrations. [***] If any Governmental Authority gives notice to Insulet that its Product Registration may be invalid or may be revoked, limited, or conditioned, Insulet shall promptly inform Distributor, but in any case [***]

Regulatory Interface. Distributor shall be responsible for obtaining Registration of the Product in the Territory and shall exercise commercially reasonable efforts to obtain and Maintain any Product Registrations in the Territory during the Term. As between the Parties hereto, it is agreed that the Product Registrations shall be held in the name of Distributor, who shall be the beneficial owner of all Product Registrations and Ampio may not use the Product Registrations, or any of them, on or in respect of any product other than the Product or use any authorization other than one or more of the Product Registrations on or in respect of the Product, except as may be approved in writing by Distributor. Ampio agrees to use its commercially reasonable efforts to assist Distributor, at Distributor’s costs, in obtaining and Maintaining the Product Registrations. All costs to obtain or Maintain the Product Registrations shall be borne by Distributor. If any Governmental Authority gives notice to Distributor that its Product Registration may be invalid or may be revoked, limited, or conditioned, Distributor shall promptly inform Ampio, but in any case not more than 5 Business Days following Distributor’s receipt of such notice. In support of Distributor’s Registration of the Product, Ampio will (a) shall supply to Distributor efficacy, quality and safety data as specified by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), (b) perform or cause to be performed and will supply to Distributor data from Zone 4 stability testing of the Product, and (c) will provide suitable evidence that the site at which the Product is manufactured complies with the Agency requirements (ANVISA), including, if required, inspection by the Brazilian Regulatory Authorities at manufacturing site.

Regulatory Interface. PHNSY&IMF (Code 106) will be the point of contact for interface with regulatory agencies and will coordinate inspections with the required parties. Code 106.3 will be notified of any regulatory inspections, meetings, inquiries, issues or requests for information specific to the operations being conducted by its Contractors. Contractors shall immediately investigate all practices cited in Notices of Violations (NOVs)/Notices of Noncompliance (NONs)/enforcement actions and take immediate actions to remedy infractions to return to compliance. Contractors shall provide to Code 106.3 a written response identifying the alleged violation, investigation results, reasons for a response, remedial actions taken and preventative actions to prevent a recurrence. Contractors shall not enter into any agreement with a regulatory agency without notifying and obtaining concurrence from the Navy. Contractors shall reimburse the Navy for any monetary fines and penalties assessed against the Navy as a result of non-compliant actions.

Regulatory Interface. The Contractor may be required to assist in the application of regulatory requirements that pertain to projects and keep current with changing Federal, State, and local laws and regulations. Specific duties may include: assisting in administrative or judicial proceedings related to the project; assisting in technical review or analysis to integrate comments from Federal, State, and local governments on programs and related studies; assisting in meetings with regulators; assisting in interpretation of new regulatory and statutory requirements; and providing recommendations for environmental policy integration as it applies to the TO. The Contractor shall provide properly qualified representatives with the technical expertise to support the Government in technical meetings pursuant to the requirements of each TO. The Contractor shall provide support for meeting agendas, meeting minutes, audiovisual equipment, facilitation, and technical presentations. Details regarding anticipated meetings will be provided under each TO.

Regulatory Interface. Always subject to Section 5.2.2 [**], the Parties agree to cooperate in good faith as follows in regulatory issues:

Regulatory Interface. 12.1 Save where prohibited by applicable law, including any Regulatory Requirements, and subject to Clauses 11.1.4 (Project Management) and 13 (Confidentiality) and Clause 12.3 below, the PCO shall, after the Investment Date, promptly notify the MoE, for and on behalf of the RoL, in writing of any material action by a Regulator (including any suspension notices, enforcement notices and/or material amendments required to relevant procedures) in relation to the Project. 12.2 Save where prohibited by applicable law, including any Regulatory Requirements, and subject to Clauses 11.1.4 (Project Management) and 13 (Confidentiality) and Clause 12.3 below, the MoE, for and on behalf of the RoL, shall, after the Investment Date, be entitled to require discussions with the PCO, whether by way of meetings or otherwise, to understand the circumstances that have prompted such action from any Regulator. 12.3 For the purposes of this Clause 12 (Regulatory Interface), references to "Regulator" shall mean only those Lithuanian Regulators who have statutory authority to oversee and regulate the undertaking of any of the design, construction, testing, commissioning, operation, maintenance and/or decommissioning of the NNPP.

Regulatory Interface. The Contractor shall assist in the application of general and site-specific regulatory requirements that pertain to assigned AFCEC projects and maintain currency with changing DoD regulations and federal, state, and local statutes and regulations. The Contractor is not an employee of the Government and shall not represent the Government in an official or unofficial capacity without the express prior written permission from the CO. This notwithstanding, in the event that any regulatory representative approaches the Contractor with a stated intent to inspect the activities of the Contractor without the previous direction of the CO, the Contractor shall respectfully inform the regulatory representative and the COR that requested inspection must be delayed until the CO is properly notified and a duly appointed COR is present or other direction is issued by the CO. If this is not possible, due to project constraints, the Contractor shall notify the CO, COR, and the AF base point of contact (POC) at the earliest possible time following the inspection.