Obtaining and Maintaining Regulatory Approvals Clause Samples

The "Obtaining and Maintaining Regulatory Approvals" clause requires one or more parties to secure and uphold all necessary permits, licenses, or authorizations from relevant government authorities to legally conduct the activities outlined in the agreement. In practice, this means the responsible party must apply for, receive, and keep current any regulatory approvals needed for operations, such as environmental permits, business licenses, or product certifications. This clause ensures that the parties remain compliant with applicable laws and regulations, thereby reducing legal risks and preventing interruptions to business activities due to regulatory non-compliance.
Obtaining and Maintaining Regulatory Approvals. Through its reports submitted to the JDC, Partner will keep Kiniksa informed of regulatory developments related to the Licensed Product in each country and region in the Territory and will promptly notify ​ Kiniksa in writing of any decision by any Regulatory Authority in the Territory regarding the Licensed Product. Subject to this Section 6.2.1 (Obtaining and Maintaining Regulatory Approvals), for each Indication that is included in the Territory Development Plan or Global Development Plan for the Licensed Product, Partner will be the marketing authorization holder and will be responsible for all regulatory activities leading up to and including obtaining, and thereafter maintaining, Regulatory Approvals and any Reimbursement Approvals in all countries and regions of the Territory, in its own name or in the name of its Affiliate, Sublicensee, or Third Party Distributor. If it is not feasible for Partner to own any such Regulatory Submissions, Regulatory Approvals, or Reimbursement Approvals in its own name according to the relevant Applicable Laws in the Territory, then (a) Kiniksa will hold such Regulatory Submissions, Regulatory Approvals, or Reimbursement Approvals in its own name for the benefit of and on behalf of Partner (in such case, Kiniksa will be the “Marketing Authorization Holder”, which means the Party in whose name the Regulatory Approvals and Reimbursement Approvals for the Licensed Product in the Territory are held) and will appoint Partner as its legal agent in the Territory; (b) without the prior written consent of Kiniksa, Partner will not conduct any activities or initiate any procedures that would affect the validity or change the information of such Regulatory Submissions, Regulatory Approvals, or Reimbursement Approvals; (c) Kiniksa will reasonably cooperate with Partner and execute such documents and make such submissions on behalf of Partner as may be reasonably necessary or to the extent Kiniksa is required to do so as owner of such Regulatory Submissions, Regulatory Approvals, or Reimbursement Approvals under Applicable Law in the Territory; provided that Kiniksa will assume no liability as a result of being the Marketing Authorization Holder or otherwise holding such Regulatory Submissions (unless Kiniksa is grossly negligent or willfully breaches its obligations as the Marketing Authorization Holder), Regulatory Approvals, or Reimbursement Approvals on behalf of Partner; (d) Partner will reimburse Kiniksa for Kiniksa’s costs...
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Obtaining and Maintaining Regulatory Approvals. Through its reports submitted to the JDC, Partner will keep ImmunoGen reasonably informed of regulatory developments related to the Licensed Products in each country and region in the Territory and will [***] notify ImmunoGen in writing of any decision by any Regulatory Authority in the Territory regarding any Licensed Product. (a) [***]. No earlier than [***] and no later than [***], at Partner’s request, the Parties will discuss, through the JMC and JSC, a reasonably detailed plan to be submitted by Partner, whether it may be advantageous for Partner to [***] the Licensed Products ([***]) in the Territory and accordingly whether to grant Partner the right to so [***] the Licensed Product ([***]) in the Territory for use in the Territory in accordance with this Agreement. If the Parties so elect to have Partner [***] the Licensed Products (or any component thereof) in the Territory, then following completion of the [***] for the Licensed Products ([***]) and receipt of all approvals and authorizations necessary for Partner or its Affiliate or their respective CMOs to [***] the Licensed Products ([***]) in the Territory (including after validation and qualification of Partner’s or such Affiliate’s or CMO’s applicable facilities in the Territory) (“[***]”), Partner or one of its Affiliates will be responsible for all regulatory activities and interactions with Regulatory Authorities in the Territory leading up to and including obtaining (to the extent not already obtained) and thereafter maintaining [***] for such [***] Licensed Product (or any component thereof) in the Territory in Partner’s or its Affiliate’s own name in accordance with the applicable regulatory strategy approved by the JSC.
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Obtaining and Maintaining Regulatory Approvals. Each Party will keep the other Party informed of regulatory developments related to the Collaboration Products in each region in the Territory and will promptly notify the other Party in writing of any decision by any Regulatory Authority in the Territory regarding any Collaboration Product.
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Obtaining and Maintaining Regulatory Approvals. Through its reports submitted to the JDC, Partner will keep Kiniksa informed of regulatory developments related to the Licensed Product in each country and region in the Territory and will promptly notify Kiniksa in writing of any decision by any Regulatory Authority in the Territory regarding the Licensed Product.
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Related to Obtaining and Maintaining Regulatory Approvals

  • Requisite Regulatory Approvals All Consents required to be obtained from or made with any Governmental Authority in order to consummate the transactions contemplated by this Agreement shall have been obtained or made.

  • Regulatory Approvals (a) Each Party shall, and shall cause its ultimate parent entity (as such term is defined in the HSR Act) to, use reasonable best efforts to file or otherwise submit, as soon as practicable after the date of this Agreement, all applications, notices, reports, filings and other documents reasonably required to be filed by such Party or its ultimate parent entity with or otherwise submitted by such Party or its ultimate parent entity to any Governmental Body with respect to the Contemplated Transactions, and shall file no later than ten (10) Business Days thereafter the Notification and Report Forms required by the HSR Act. Each Party shall (i) promptly supply the other with any information which may be required in order to effectuate such filings, (ii) submit promptly any additional information which may be reasonably requested by any such Governmental Body, and (iii) coordinate with the other Party in making any such filings or information submissions pursuant to and in connection with the foregoing that may be necessary, proper, or advisable in order to consummate and make effective the Contemplated Transactions. (b) Without limiting the generality of anything contained in this Section 5.4, in connection with its efforts to obtain all requisite approvals and authorizations, and the expiration or termination of all applicable waiting periods for the Contemplated Transactions under any Antitrust Law, each Party hereto shall use its reasonable best efforts to (i) cooperate with the other with respect to any investigation or other inquiry; (ii) promptly provide to the other a copy of all communications received by such Party from, or given by such Party to, any Governmental Body, in each case regarding the Contemplated Transactions; and (iii) to the extent not prohibited under applicable Antitrust Law, permit the other to review in advance any communication given by it to any Governmental Body concerning the Contemplated Transactions, consider in good faith the views of the other in connection with any proposed written communications by such Party to any Governmental Body concerning the Contemplated Transactions, and consult with each other in advance of any meeting or telephone or video conference with, any Governmental Body, and give the other or its outside counsel the opportunity to attend and participate in such meetings and conferences unless prohibited by the applicable Governmental Body; provided, that materials required to be provided pursuant to this Section 5.4(b) may be restricted to outside counsel and redacted to (A) remove references concerning the valuation of either Party, (B) comply with contractual arrangements, and (C) preserve attorney-client privilege. Neither Party shall commit to or agree with any Governmental Body to stay, toll or extend any applicable waiting period under applicable Antitrust Law, or pull and refile under the HSR Act, without the prior written consent of the other. Parent and the Company shall each pay one-half of the filing fee under the HSR Act relating to the HSR filing required for the Merger; provided, however, that each Party shall bear its own legal fees. (c) Except as required by this Agreement, prior to Closing, neither the Company nor Parent shall, and shall cause its Affiliates not to, acquire or agree to acquire by merging or consolidating with, or by purchasing a substantial portion of the assets of or equity in, or by any other manner, any Person or portion thereof, or otherwise acquire or agree to acquire any assets, if the entering into of an agreement relating to or the consummation of such acquisition, merger or consolidation would reasonably be expected to (i) impose any delay in the obtaining of, or significantly increase the risk of not obtaining, any authorizations, consents, orders, declarations or approvals of any Governmental Body necessary to consummate the Contemplated Transactions or the expiration or termination of any applicable waiting period, or (ii) increase the risk of any Governmental Body entering an order prohibiting the consummation of the Contemplated Transactions.

  • Other Regulatory Approvals All necessary approvals, authorizations and consents of any governmental or regulatory entity required to consummate the Merger shall have been obtained and remain in full force and effect, and all waiting periods relating to such approvals, authorizations and consents shall have expired or been terminated.

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • Governmental and Regulatory Approvals Other than the filing provided for under Section 1.3 and filings pursuant to the HSR Act (which are addressed in Section 6.1(c)), all consents, approvals and actions of, filings with and notices to any Governmental Entity required of AHP, Monsanto or any of their Subsidiaries to consummate the Merger, the Share Issuance and the other transactions contemplated hereby, the failure of which to be obtained or taken would reasonably be expected to have a Material Adverse Effect on Newco and its Subsidiaries (including the Surviving Corporation and its Subsidiaries), taken together after giving effect to the Merger, shall have been obtained; provided however, that the provisions of this Section 6.1(d) shall not be available to any party whose failure to fulfill its obligations pursuant to Section 5.4 shall have been the cause of, or shall have resulted in, the failure to obtain such consent or approval.