Responsible Regulatory Party Sample Clauses

The Responsible Regulatory Party clause designates which party in an agreement is accountable for obtaining, maintaining, and complying with all necessary regulatory approvals and permits related to the contract's subject matter. Typically, this clause specifies whether the buyer, seller, or another party must handle interactions with government agencies, submit required documentation, and ensure ongoing compliance with applicable laws. By clearly assigning regulatory responsibilities, the clause helps prevent confusion, delays, or legal issues arising from unmet regulatory obligations.
Responsible Regulatory Party. Subject to the roles of the various Committees described in Article 2, the allocation of Responsible Regulatory Party for Collaboration Products under this Agreement is as follows: (a) [****] will be the Responsible Regulatory Party in the [****] and the [****] for all Collaboration Products; and (b) [****] will be the Responsible Regulatory Party in the [****] for all Collaboration Products during the Development of such Collaboration Product. At the time of receipt of first Regulatory Approval for the [****].
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Responsible Regulatory Party. Unless to the extent otherwise provided in the Global Development Plan and subject to Section 2.5, (a) Clovis will be solely responsible and have the final authority with respect to regulatory activities to obtain Regulatory Approval for Products in the Licensed Territory and (b) 3BP will be solely responsible and have the final authority with respect to all regulatory activities to obtain Regulatory Approval for Products in the Retained Territory. [***].
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Responsible Regulatory Party. Unless to the extent otherwise provided in the Global Development Plan and subject to Section 2.8, (i) Servier shall be solely responsible and have the final authority with respect to regulatory activities regarding the Product in the Licensed Territory in the Field and (ii) EOS shall be responsible and have the final authority with respect to all regulatory activities regarding the Product in the Retained Territory in the Field. Except for those clinical studies commenced prior to the Effective Date and unless otherwise provided in Section 3.2 (a) or agreed by the Parties, Servier shall be the sponsor of all clinical studies of the Product performed in the Licensed Territory, and EOS (or its designee) shall be the sponsor of all clinical studies performed in the Retained Territory.
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Related to Responsible Regulatory Party

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.

  • Regulatory Compliance Neither Borrower nor any of its Subsidiaries is an “investment company” or a company “controlled” by an “investment company” under the Investment Company Act of 1940, as amended. Neither Borrower nor any of its Subsidiaries is engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and U of the Federal Reserve Board of Governors). Borrower and each of its Subsidiaries has complied in all material respects with the Federal Fair Labor Standards Act. Neither Borrower nor any of its Subsidiaries is a “holding company” or an “affiliate” of a “holding company” or a “subsidiary company” of a “holding company” as each term is defined and used in the Public Utility Holding Company Act of 2005. Neither Borrower nor any of its Subsidiaries has violated any laws, ordinances or rules, the violation of which could reasonably be expected to have a Material Adverse Change. Neither Borrower’s nor any of its Subsidiaries’ properties or assets has been used by Borrower or such Subsidiary or, to Borrower’s knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than in material compliance with applicable laws. Borrower and each of its Subsidiaries has obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all Governmental Authorities that are necessary to continue their respective businesses as currently conducted. None of Borrower, any of its Subsidiaries, or any of Borrower’s or its Subsidiaries’ Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engaging in or conspiring to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person. None of Borrower, any of its Subsidiaries, or to the knowledge of Borrower and any of their Affiliates or agents, acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or engages in making or receiving any contribution of funds, goods or services to or for the benefit of any Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any property or interest in property blocked pursuant to Executive Order No. 13224, any similar executive order or other Anti-Terrorism Law.

  • Governmental Compliance The Tenant Improvements shall comply in all respects with the following: (i) the Code and other state, federal, city or quasi-governmental laws, codes, ordinances and regulations, as each may apply according to the rulings of the controlling public official, agent or other person; (ii) applicable standards of the American Insurance Association (formerly, the National Board of Fire Underwriters) and the National Electrical Code; and (iii) building material manufacturer’s specifications.

  • Regulatory Cooperation In connection with any foreclosure, collection, sale or other enforcement of Liens granted to the Administrative Agent in the Collateral Documents, Parent will, and will cause its Restricted Subsidiaries to, reasonably cooperate in good faith with the Administrative Agent or its designee in obtaining all regulatory licenses, consents and other governmental approvals necessary or (in the reasonable opinion of the Administrative Agent or its designee) reasonably advisable to conduct all aviation operations with respect to the Collateral and will, at the reasonable request of the Administrative Agent and in good faith, continue to operate and manage the Collateral and maintain all applicable regulatory licenses with respect to the Collateral until such time as the Administrative Agent or its designee obtain such licenses, consents and approvals, and at such time Parent will, and will cause its Restricted Subsidiaries to, cooperate in good faith with the transition of the aviation operations with respect to the Collateral to any new aviation operator (including, without limitation, the Administrative Agent or its designee).