Regulatory Interface Sample Clauses

Regulatory Interface. Both parties agree to subject themselves to the Regulatory Interface with OERC for approval of Planned Investments as specified in this Agreement as specified in this agreement, as may be required in any Financial Year.
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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.
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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.
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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.
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Regulatory Interface. Always subject to Section 5.2.2 [**], the Parties agree to cooperate in good faith as follows in regulatory issues:
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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 not more than [***] Business Days following Insulet’s receipt of such notice.
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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.
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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.
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Related to Regulatory Interface

  • Regulatory Investigations It shall be the Administrator’s duty and responsibility, and not the Owner Trustee’s duty and responsibility, to cause the Trust to respond to, defend, participate in or otherwise act in connection with any regulatory, administrative, governmental, investigative or other proceeding or inquiry relating in any way to the Trust, its assets or the conduct of its business.

  • Regulatory Inspections Manufacturer will permit Rhythm or its agents to be present and participate in any visit or inspection by any Authority of the Facility (to the extent it relates in any way to any Product) or the Manufacturing Process. Manufacturer will give as much advance notice as reasonably possible to Rhythm of any such visit or inspection. Manufacturer will provide Rhythm with a copy of any report or other written communication * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. received from such Authority in connection with such visit or inspection, and any written communication received from any Authority relating to any Product, the Facility (if it relates to or affects the Development and/or Manufacture of Product) or the Manufacturing Process, within two (2) business days after receipt, and will consult with, and require approval from, Rhythm before responding to each such communication. Manufacturer will provide Rhythm with a copy of its final responses within five (5) business days after submission.

  • Regulatory Information (a) All the notaries at De Pinna LLP are regulated through the Faculty Office of the Archbishop of Canterbury. Its address is The Faculty Office, 0 Xxx Xxxxxxxxx, Xxxxxxxxxxx, Xxxxxx XX0X 0XX, its telephone: 000 0000 0000, and it can be reached by email at xxxxxxx.xxxxxx@0xxxxxxxxxxxx.xxx. It also has a website at xxx.xxxxxxxxxxxxx.xxx.xx.

  • Regulatory Issues 3.3.1 The Licensee shall be solely responsible for determining which jurisdictions they choose to market to and receive xxxxxx from.

  • Regulatory Materials (a) Alvogen shall have the sole right to control filing or submission of Regulatory Materials with the Regulatory Agencies in the Territory with respect to Product including the MAA Approval for Product and Regulatory Approvals in the Territory, subject to Section 3.2 and the oversight of and in consultation with the Executive Steering Committee, and [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. shall be responsible for managing all communications and interactions with the Regulatory Agencies in the Territory with respect to Product in the Territory. In all cases, prior to the filing of any Regulatory Materials (including the MAA for Product) for Product with the applicable Regulatory Agency, Alvogen shall provide a copy thereof to Pfenex (through the Executive Steering Committee) for its review and comment. Pfenex shall have fifteen (15) Business Days from the date it receives a copy of any Regulatory Materials with respect to the Product to provide Alvogen with comments regarding such Regulatory Materials, unless the Regulatory Agencies in the Territory or Applicable Law requires that such Regulatory Material(s) be filed on a timeline that does not reasonably permit such advanced notice, in which case Pfenex shall have as much time as is reasonably practicable to provide Alvogen with comments. Alvogen shall consider all such comments in good faith. Alvogen shall, to the extent permitted by Applicable Law, provide Pfenex with (i) reasonable advanced notice (and in no event less than fifteen (15) Business Days’ advance notice whenever feasible) of substantive meetings with any Regulatory Agency in the Territory that are either scheduled with or initiated by or on behalf of Alvogen or its Affiliates, (ii) an opportunity to have a reasonable number (but at least two (2)) representatives participate in all substantive meetings with the Regulatory Agencies in the Territory with respect to Product, and in any case keep Pfenex informed as to all material interactions with the Regulatory Agencies in the Territory with respect to Product, and (iii) a copy of any material documents, information and correspondence submitted to or received from the Regulatory Agencies in the Territory with respect to Product as soon as reasonably practicable.

  • Regulatory Applications (a) Sky and SBI and their respective Subsidiaries shall cooperate and use their respective reasonable best efforts to prepare, within 45 days of the execution of this Agreement, all documentation and requests for regulatory approval, to timely effect all filings and to obtain all permits, consents, approvals and authorizations of all third parties and Governmental Authorities and Regulatory Authorities necessary to consummate the transactions contemplated by this Agreement. Each of Sky and SBI shall have the right to review in advance, and to the extent practicable each will consult with the other, in each case subject to applicable laws relating to the exchange of information, with respect to, and shall be provided in advance so as to reasonably exercise its right to review in advance, all material written information submitted to any third party or any Governmental Authority or Regulatory Authority in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the parties hereto agrees to act reasonably and as promptly as practicable. Each party hereto agrees that it will consult with the other party hereto with respect to the obtaining of all material permits, consents, approvals and authorizations of all third parties and Governmental Authorities or Regulatory Authorities necessary or advisable to consummate the transactions contemplated by this Agreement and each party will keep the other party apprised of the status of material matters relating to completion of the transactions contemplated hereby.

  • Regulatory Filings NYISO and Connecting Transmission Owner shall file this Agreement (and any amendment hereto) with the appropriate Governmental Authority, if required. Any information related to studies for interconnection asserted by Developer to contain Confidential Information shall be treated in accordance with Article 22 of this Agreement and Attachment F to the ISO OATT. If the Developer has executed this Agreement, or any amendment thereto, the Developer shall reasonably cooperate with NYISO and Connecting Transmission Owner with respect to such filing and to provide any information reasonably requested by NYISO and Connecting Transmission Owner needed to comply with Applicable Laws and Regulations.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, Registration Statement, the Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

  • Communications Regulatory Matters (A) Schedule 5.13(A) sets forth a true and complete list of the following information for each License issued to each Loan Party or its Subsidiaries: the name of the licensee, the type of service, the expiration date and the geographic area covered by such License.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

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