Transfer of Regulatory Approvals. At the Closing, Seller shall transfer the exclusive benefit of the Regulatory Approvals to Purchaser free of all Encumbrances, other than Permitted Encumbrances, on the terms and conditions set forth in this Section 6.10. As soon as practicable following the Closing Date but in any event no later than 20 days after the Closing Date, Seller shall make such notifications or filings with applicable Regulatory Authorities as may be necessary to effect the transfer of each of the Regulatory Approvals to Purchaser.
Transfer of Regulatory Approvals. (a) Promptly after the Closing Date (and in any event within five (5) business days after receiving written notice from Millennium under Section 3.1 of this Agreement) Schering shall provide each of Millennium and the New Commercial Licensee with appropriate documentation to grant each of them the right to access and cross-reference any applicable drug master file for the active pharmaceutical ingredient in the INTEGRILIN Products in each country in the Transferring Territory where Schering holds a Regulatory Approval, in the format required by the applicable Regulatory Authority, to enable each of Millennium and the New Commercial Licensee to perform each of their respective obligations under the New Commercial Agreement.
(b) During the Transition Period, Schering, Millennium and the New Commercial Licensee shall coordinate the Transfer of all Regulatory Approvals of INTEGRILIN Products in the Transferring Territory to the New Commercial Licensee, including, without limitation, the current [**] for the Transferring Territory. For purposes of clarity, it is anticipated that meetings with the Regulatory Authorities pursuant to Section 3.2(c) will include discussions with, and agreement of, the Regulatory Authorities concerning the Transfer review process and timing of such review process and approval of the various filings, and that such meetings will take place ahead of initiating the Transfer. Each of Schering and Millennium shall use, and Millennium shall procure that the New Commercial Licensee uses, commercially reasonable efforts to complete the Transfer of Regulatory Approvals for INTEGRILIN Products in each country in the Transferring Territory where Schering holds such Regulatory Approvals as soon as practicable after the Closing Date. The Parties acknowledge and agree that Millennium or New Commercial Licensee, as applicable, will have final decision making with regard to the plans, actions, filings and timing thereof required to complete the Transfer subject to the requirement that such decisions shall not delay the Marketing Authorization Transfer filings for the Territory [**] beyond the Closing Date. Commercially reasonable efforts by Schering pursuant to this Section 5.1(b) shall include, without limitation, promptly performing any actions reasonably necessary to effect the Transfer of all Regulatory Approvals existing as of the Effective Date in the Transferring Territory to Millennium or the New Commercial Licensee pursuant to this 5.1(b) i...
Transfer of Regulatory Approvals. On or as promptly as practical after the Closing, Seller shall deliver the Regulatory Documentation to Buyer and Buyer shall confirm receipt thereof, Within seven (7) Business Days Seller shall file the Seller FDA Letter with the FDA and shall provide notice to Buyer of such filing. Within seven (7) Business Days after receiving notice from the Seller of the filing of the Seller FDA Letter, Buyer shall file the Buyer FDA Letter with the FDA. Seller and Buyer shall take all other actions reasonably necessary to notify the FDA that the Regulatory Approvals have been transferred from Seller to Buyer and to affect the transfer of such Regulatory Approvals from Seller to Buyer.
Transfer of Regulatory Approvals. Upon termination of this Agreement by Ampio under Section 13.2, Daewoong shall, and shall cause its Affiliates and any Terminated Sublicensees to, upon Ampio’s request, transfer to Ampio and/or its Affiliates and/or any Third Party appointed by Ampio (hereinafter referred to as “Transferee”) with reasonable assistance, excluding financial assistance, to the extent permissible under the Laws of the Territory, the Regulatory Approvals which Daewoong or its Affiliates or Terminated Sublicensees have with respect to the Products in the Territory, in each case subject to all licenses granted by any of them (whether or not in effect) to any Surviving Sublicensees and further subject to the royalty obligations (if any) set forth in Section 14.2. Such assistance shall include, among others, an authorization by Daewoong or its Affiliates or Terminated Sublicensees given to the Transferee to access to the Regulatory Approvals filed by Daewoong or its Affiliates or Terminated Sublicensees with the Regulatory Authorities with respect to the Products in the Territory (e.g., Regulatory Filings), the provision by Daewoong, if necessary, to the Transferee of the Daewoong Know-How and such other acts which the Transferee may reasonably request Daewoong in order to transfer such Regulatory Approvals with respect to the Products in the Territory, subject in all cases to such licenses held by the Surviving Sublicensees.
Transfer of Regulatory Approvals. On the Closing Date, the Seller shall transfer to the Purchaser or its designee the Regulatory Approvals set forth in SCHEDULE 2.2(E) hereto. Following such transfer, the Purchaser shall be solely responsible for obtaining all Regulatory Approvals regarding the
Transfer of Regulatory Approvals. Promptly after receipt of Regulatory Approval for the Vivelle-Dot(TM) Product in the Netherlands, the parties will work together to transfer such Regulatory Approvals to Novartis at Novartis' expense.
Transfer of Regulatory Approvals. Upon expiration or termination of the Agreement, Elan shall transfer or cause to be transferred to Anesta all Regulatory Approvals, or applications therefor, that are in the name of Elan at Anesta's cost.
Transfer of Regulatory Approvals. Parent and the Company shall use commercially reasonable efforts to file, as soon as practicable after the date of this Agreement, all notices, reports and other documents required to be filed with any Governmental Body and described on Schedule 6.2 with respect to the Merger and the other transactions contemplated by this Agreement and each Related Agreement, and to submit promptly any additional information requested by any such Governmental Body.
Transfer of Regulatory Approvals. Effective immediately as of the Repurchase Date, Elan shall to the extent permissible under applicable law transfer or cause to be transferred to Anesta all Regulatory Approvals, or applications therefor, that are in the name of Elan at Anesta's cost. Elan agrees to promptly execute all documents and take any other actions reasonably requested by Anesta in connection with such transfer, including the taking of any actions necessary (with Anesta's cooperation and at Anesta's cost) to obtain publication of the marketing authorization therefor in the Gazetta Ufficiale in Italy. Anesta agrees to use commercially reasonable efforts to assist in the transfer to Anesta of all such Regulatory Approvals or applications therefor as expeditiously as possible."
25. Section 10.6 of the Agreement is hereby deleted in its entirety, and is replaced as follows:
Transfer of Regulatory Approvals. According to the process or procedures recommended or required by the relevant Regulatory Authority, Seller shall initiate transfer, effective as of the Closing, of ownership or holdership of EUAs issued by FDA, foreign equivalents or similar Regulatory Approvals issued by Health Canada, and any Regulatory Approval issued by the TGA, including those listed in Schedule 9.14.
