Assignment of Marketing Approvals Sample Clauses

Assignment of Marketing Approvals. On a territory-by-territory basis (each of the EU and Canada being considered a separate ‘territory’ for this purpose), within *** days following the initial grant of Marketing Approval for a Licensed Product in that territory (an “Assigned Territory”), as applicable, or earlier if requested by CSL, BioCryst shall assign the BioCryst-filed application for Regulatory Approval in the Assigned Territory (each, an “Ex-US BioCryst Filed NDA”) and any related Regulatory Filings made with, and Marketing Approvals from, Health Canada and the EMA in the name of BioCryst to CSL, in which case, CSL agrees within such *** day period to accept any such transfer of the Ex-US BioCryst Filed NDA and such related Regulatory Filings and Marketing Approvals. Following any such transfer of an Ex-US BioCryst Filed NDA or any such Regulatory Filings: (i) CSL shall thereafter be responsible for all Regulatory Filings and Marketing Approvals in such Assigned Territory and leading all interactions with the applicable Regulatory Authorities in the Assigned Territory with respect to all regulatory matters relating to the sale of Licensed Products in the Assigned Territory, (ii) BioCryst shall reasonably cooperate with CSL in CSL’s preparation of all Regulatory Filings and correspondence with the applicable Regulatory Authorities relating to Licensed Products in the Assigned Territory, (iii) CSL may invite BioCryst to attend and/or actively participate in meetings, conferences or discussions with Regulatory Authorities in the Assigned Territory with respect to the sale of Licensed Products for the Field in such territory, and (iv) CSL shall keep BioCryst reasonably informed of all material regulatory developments relating to Licensed Products in each Assigned Territory through regular reports at the JSC meetings.
Sample 1
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Related to Assignment of Marketing Approvals

  • 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.

  • 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 Filings and Approvals Copies of all necessary governmental and third party approvals, registrations, and filings in respect of the transactions contemplated by this Agreement;

  • Statutory Approvals No declaration, filing or registration with, or notice to or authorization, consent or approval of, any federal, state, local or foreign government, any instrumentality, subdivision, court, administrative agency or commission or authority thereof, or any quasi-governmental or private body exercising any regulatory, taxing, importing or other governmental or quasi-governmental authority or regulatory body (including a stock exchange or other self-regulatory body) or any other authority (each, a "Governmental Authority") is necessary for the execution and delivery of this Agreement by ITI or the consummation by ITI of the transactions contemplated hereby, except for those required under or in relation to (A) state securities or "blue sky" laws (the "Blue Sky Laws"), (B) the Securities Act, (C) the Exchange Act of 1934, as amended (the "Exchange Act"), (D) the DGCL with respect to the filing of the Certificate of Merger, (E) the ITI Stockholders' Consent, and (F) such consents, approvals, order, authorizations, registrations, declarations and filings the failure to obtain, make or give which would reasonably be expected to have, in the aggregate, an ITI Material Adverse Effect (the "ITI Required Statutory Approvals"), it being understood that references in this Agreement to "obtaining" such ITI Required Statutory Approvals shall mean making such declarations, filings or registrations; giving such notice; obtaining such consents or approvals; and having such waiting periods expire as are necessary to avoid a violation of law.

  • Regulatory Matters and Approvals Each of the Parties will give any notices to, make any filings with, and use its reasonable best efforts to obtain any necessary authorizations, consents, and approvals of governments and governmental agencies in connection with the transactions contemplated by this Agreement. Without limiting the generality of the foregoing:

  • Regulatory Consents and Approvals All consents, approvals and actions of, filings with and notices to any Governmental or Regulatory Authority necessary to permit the parties to this Agreement to perform their obligations under it and to consummate the transactions contemplated hereby, (a) shall have been duly obtained, made or given, (b) shall be in form and substance reasonably satisfactory to EPI, (c) shall not be subject to the satisfaction of any condition that has not been satisfied or waived and (d) shall be in full force and effect, and all terminations or expirations of waiting periods imposed by any Governmental or Regulatory Authority necessary for the consummation of the transactions contemplated by this Agreement, including under competition laws, shall have occurred.

  • Necessary Approvals Tenant shall proceed with all due diligence and exercise reasonable efforts to obtain and maintain, or cause to be obtained and maintained, all approvals necessary to use and operate, for its Permitted Use, each Property and the Facility located thereon under applicable law and, without limiting the foregoing, shall exercise reasonable efforts to maintain (or cause to be maintained) appropriate certifications for reimbursement and licensure.

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

  • Third Party Approvals (a) Subject to the terms and conditions of this Agreement, Parent and the Partnership and their respective Subsidiaries will cooperate and use their respective commercially reasonable efforts to prepare all documentation, to effect all filings, to obtain all permits, consents, approvals and authorizations of all Governmental Authorities and third parties necessary to consummate the transactions contemplated by this Agreement and to comply with the terms and conditions of such permits, consents, approvals and authorizations and to cause the Merger to be consummated as expeditiously as practicable. Each of Parent and the Partnership has 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, all material written information submitted to any third party or any Governmental Authorities in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the Parties agrees to act reasonably and promptly. Each Party agrees that it will consult with the Other Parties with respect to the obtaining of all material permits, consents, approvals and authorizations of all third parties and Governmental Authorities necessary or advisable to consummate the transactions contemplated by this Agreement, and each Party will keep the Other Parties apprised of the status of material matters relating to completion of the transactions contemplated hereby.

  • Governmental and Regulatory Approvals Other than the filing of the Articles of Merger provided for under Section 1.3, all consents, approvals and actions of, filings with and notices to any Governmental Entity required by the Company, Parent or any of their subsidiaries under applicable law or regulation to consummate the Merger and the transactions contemplated by this Agreement, the failure of which to be obtained or made would result in a material adverse effect on Parent’s ability to conduct the business of the Company in substantially the same manner as presently conducted, shall have been obtained or made (all such approvals and the expiration of all such waiting periods, the “Requisite Regulatory Approvals”).

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