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. 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. 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. 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 Any waiting period applicable to the Transactions under the HSR Act shall have been terminated or shall have expired.

  • 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.

  • Regulatory Approvals; Efforts (a) Prior to the Closing, Parent, Merger Sub and the Company shall use their respective reasonable best efforts to take, or cause to be taken, all actions, and to do, or cause to be done, all things necessary, proper or advisable under any applicable Laws to consummate and make effective the Merger including (i) the preparation and filing of all forms, registrations and notices required to be filed to consummate the Merger, (ii) the satisfaction of the conditions to consummating the Merger, (iii) taking all reasonable actions necessary to obtain (and cooperating with each other in obtaining) any consent, authorization, Order or approval of, or any exemption by, any third party, including any Governmental Entity (which actions shall include furnishing all information and documentary material required under the HSR Act) required to be obtained or made by Parent, Merger Sub, the Company or any of their respective Subsidiaries in connection with the Merger or the taking of any action contemplated by this Agreement, and (iv) the execution and delivery of any additional instruments necessary to consummate the Merger and to fully carry out the purposes of this Agreement. Additionally, each of Parent, Merger Sub and the Company shall use reasonable best efforts to fulfill all conditions precedent to the Merger and shall not take any action after the date of this Agreement that would reasonably be expected to materially delay the obtaining of, or result in not obtaining, any permission, approval or consent from any such Governmental Entity necessary to be obtained prior to Closing. To the extent that transfers of any permits issued by any Governmental Entity are required as a result of the execution of this Agreement or the consummation of the Merger, the parties hereto shall use reasonable best efforts to effect such transfers.

  • No Regulatory Approval By the Company or Parent, if its Board of Directors so determines by a vote of a majority of the members of its entire Board, in the event any Requisite Regulatory Approval shall have been denied by final, nonappealable action by such Governmental Authority or a Governmental Authority shall have requested the permanent withdrawal of an application therefor.

  • Licensed Territory Worldwide NIH Patent License Agreement—Exclusive APPENDIX C – ROYALTIES Royalties:

  • 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 The territorial limits of this Agreement shall be identical with those of the Reinsured Contracts.

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