Regulatory Approval in the Territory Sample Clauses

Regulatory Approval in the Territory. 3.1 Licensee shall use Commercially Reasonable Efforts to obtain all required Regulatory Approvals for the Product for the Initial Indication as soon as reasonably possible following the Effective Date.
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Regulatory Approval in the Territory. Asahi shall (i) file an IND for the Product for the indication of Dupuytren’s Contracture in the Territory no later than the [**] anniversary of the Effective Date, (ii) use Commercially Reasonable Efforts, to file a MAA for the Product for the indication of Dupuytren’s Contracture in the Territory no later than the [**] anniversary of the Effective Date and (iii) use Commercially Reasonable Efforts to obtain Regulatory Approval for the Product for the indication of Dupuytren’s Contracture in the Territory by the [**] anniversary of the Effective Date. Without limitation of Auxilium’s remedies hereunder or at Law, should Asahi determine it may not to be able to satisfy the foregoing obligations within the period indicated after consultations with the Regulatory Authority in the Territory or fail to satisfy the foregoing obligations within the period indicated, Asahi shall promptly consult with the JSC regarding the reason for such failure.
Sample 1
Regulatory Approval in the Territory. 3.1 Licensee shall use Commercially Reasonable Efforts to obtain all required Regulatory Approvals for the Product for the Initial Indication as soon as reasonably possible following the Effective Date. Quoin shall be the applicant and owner of Regulatory Approvals in the Territory in the mainland China due to the restriction of the Applicable Laws and the Licensee shall serve as the domestic legal representative for the Product. Whenever and wherever Licensee or its Affiliate is allowed to hold the Regulatory Approval including the marketing authorization holder of the Product by Applicable Laws, Quoin shall support or transfer such holder of the Regulatory Approval, no matter in the application stage or being approved, to Licensee or its designated Affiliate. Notwithstanding above, in the regions where Licensee or its Affiliate is permitted to directly serve as the holder for the Regulatory Approval, including the marketing authorization holder, Quoin shall support Licensee to apply and hold such Regulatory Approval directly.
Sample 1
Regulatory Approval in the Territory. Actelion shall (i) file for Regulatory Approval for the Finished Product in each of the countries in the Territory no later than the [**] anniversary of the Effective Date and (ii) use Commercially Reasonable Efforts to obtain Regulatory Approval for the Finished Product in each of the countries in the Territory no later than the [**] anniversary of the Effective Date. Actelion’s failure to comply with either of the foregoing clauses (i) or (ii) for any country in the Territory shall constitute a material breach of this Agreement by Actelion with respect to such country, unless the Parties agree otherwise in writing (and at each Party’s sole discretion) or Actelion’s failure is due to Auxilium’s breach of its obligations hereunder to provide Actelion with necessary assistance in connection with Regulatory Approvals.
Sample 1
Regulatory Approval in the Territory. If at any time after eighteen (18) months from (x) the Effective Date, with respect to Dupuytren’s Contracture, (y) the date of Regulatory Approval in the EU for Peyronie’s Disease or (z) the date agreed to by the Parties, with respect to any New Indication, Sobi (i) has not filed for Regulatory Approval for the Finished Product and (ii) is not using Commercially Reasonable Efforts to obtain Regulatory Approval for the Finished Product, including performing Development Activities required for obtaining the Regulatory Approval, then Auxilium shall be entitled to terminate the Agreement with respect to such indication and country by providing written notice to Sobi. *** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
Sample 1

Related to Regulatory Approval in the Territory

  • 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.

  • Regulatory Approvals All Requisite Regulatory Approvals shall have been obtained and shall remain in full force and effect and all statutory waiting periods in respect thereof shall have expired, and no such Requisite Regulatory Approval shall have resulted in the imposition of any Materially Burdensome Regulatory Condition.

  • No Regulatory Approval By CenterState or Charter, if either of their respective boards of directors so determines by a vote of a majority of the members of its entire board, in the event any Regulatory Approval required for consummation of the transactions contemplated by this Agreement shall have been denied by final, non-appealable action by such Governmental Authority or an application therefor shall have been permanently withdrawn at the request of a Governmental Authority.

  • Regulatory Applications (a) Sky and Metropolitan 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 Metropolitan 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.

  • 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.

  • Required Regulatory Approvals Certain transactions required, permitted or otherwise contemplated by this Agreement may under certain circumstances require prior filings with and approvals, or non-disapprovals, from the Indiana Department of Insurance or the Indiana Insurance Commissioner. Such transactions include: (a) issuance or purchase of any additional capital stock of the Company or other securities convertible into or exchangeable or exercisable for capital stock of the Company pursuant to Sections 1.2 or 3.4; (b) transfer of Shares to a wholly owned subsidiary of a Shareholder, to another Shareholder or to a wholly owned subsidiary of another Shareholder pursuant to Sections 3.1(a) or 3.4; (c) exercise of preemptive rights by a Shareholder pursuant to Section 3.2; and (d) exercise of call rights by the Company or a Shareholder pursuant to Section 3.3 (including pursuant to the two provisos in Section 3.1(b)). Notwithstanding anything to the contrary contained in this Agreement, any such transactions requiring filings with and approvals, or non-disapprovals, from the Indiana Department of Insurance or the Indiana Insurance Commissioner shall not, to the extent within the control of a party hereto, be entered into or consummated unless and until the required filings have been made and the required approvals (or non-disapprovals) have been obtained, and to the extent not within the control of an applicable party hereto, such party shall use best efforts to cause such transactions not to be entered into or consummated unless and until the required filings have been made and the required approvals (or non-disapprovals) have been obtained.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Territory 43.1 This Agreement applies to the territory in which Verizon operates as an Incumbent Local Exchange Carrier in the Commonwealth of Pennsylvania. Verizon shall be obligated to provide Services under this Agreement only within this territory.

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • Other Regulatory Approvals Each party hereto shall cooperate and use its reasonable best efforts to promptly prepare and file all necessary documentation to effect all necessary applications, notices, petitions, filings and other documents, and use all reasonable efforts to obtain (and will cooperate with each other in obtaining) any consent, acquiescence, authorization, order or approval of, or any exemption or nonopposition by, any Governmental Entity required to be obtained or made by Parent or the Company or any of their respective Subsidiaries in connection with the Offer and the Merger or the taking of any other action contemplated by this Agreement.

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