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. 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. 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."
Transfer of Regulatory Approvals. 2.1. Schering, in coordination with, and with the cooperation of GSK, will use commercially reasonable efforts to complete the Transfer of the Central Marketing Authorization in the Territory for the Licensed Product to GSK, including, without limitation, [**].
Transfer of Regulatory Approvals for the First-Gen COVID Vaccine Products. Upon the effective date of Option Exercise, CureVac shall (or shall cause the Affiliate or Third Party holding the Regulatory Approvals to) assign and transfer to GSK the Regulatory Approvals granted for the First-Gen COVID Vaccine Products, subject to GSK’s diligence obligations under Section 4.10 and the rights granted to CureVac with respect to the Regulatory Approvals relevant for the CureVac Territory under Section 6 and the respective Distribution Agreement. Any costs incurred in connection with this transfer shall be borne by the Parties in equal shares as part of the Development Costs in accordance with Section 4.3.
Transfer of Regulatory Approvals. In connection with this Agreement and the transactions contemplated hereby, PLC shall, to the extent permitted by applicable Legal Requirements, transfer to Xxxxxxx within thirty (30) days of the date hereof, all regulatory approvals held by PLC for Laser Power Sources, including without limitation, all approvals and supporting documentation for the sale of Laser Powers Sources in the United States and, to the extent existing, Canada, Europe and any other jurisdictions, including all of the following: (i) all documentation in support of 510(k) Pre-Market Notification regulatory clearance(s) under 21 C.F.R. 807, and (ii) all documentation in support of CE Xxxx(s) for the Laser Power Sources, including, without limitation, in the case of (i) and (ii): all (A) submissions and related correspondence with the FDA or applicable notified body, (B) technical files, (C) justifications to file, (D) documentation to file, (E) engineering supporting documentation, (F) engineering change requests, (G) laser product reports, laser supplemental reports, laser abbreviated reports and laser annual reports, and (H) and any other relevant documentation in support of these regulatory clearances. Except as set forth on Schedule 3.12 hereto, PLC hereby represents and warrants that the approvals and documentation with respect to the 510(k) Pre-Market Notification are current with respect to the Model 3 Laser Power Source through the specifications set forth in Exhibit A. PLC hereby covenants to perform its obligations described on Schedule 3.12 within thirty days after the date hereof.
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.
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.
