Protocol Amendment Sample Clauses

Protocol Amendment. ▇▇▇▇▇▇▇ shall conduct the ▇▇▇▇▇▇▇ Study in accordance with the amended protocol set forth on Schedule 1 attached hereto (the “Amended Protocol”). ▇▇▇▇▇▇▇ shall submit the Amended Protocol to the FDA, other applicable Regulatory Authorities and applicable Institutional Review Boards (IRBs), and shall not amend or modify the Amended Protocol without the prior written consent of Actavis; provided, however, that Actavis’ consent shall not be required with respect to any amendment to the Amended Protocol that, if ▇▇▇▇▇▇▇ is the current holder of the IND with respect to the ▇▇▇▇▇▇▇ Study, is explicitly (i) required in writing by the EMA or FDA or (ii) recommended in writing by the DSMB to address a safety concern with respect to the Lead Product (but, for clarity, not to address a concern regarding efficacy of the Lead Product).

Protocol Amendment. Effective as of date of last signature, the Protocol has been amended to version 6 Amendment 4 dated 4th October 2023. Appendix 2 attached to the Agreement is hereby updated and replaced in its entirety with Appendix 2- 1 Budget , included in this Amendment as Appendix 1 . 2.1 Změna protokolu. S platností od data posledního podpisu byl Protokol změněn na verzi 6 Dodatek 4 ze dne 4. října 2023. Příloha 2 připojená ke Smlouvě se tímto aktualizuje a v plném rozsahu nahrazuje „Přílohou 2 Rozpočet“, která je součástí tohoto Dodatku jako příloha č. 1. /

Protocol Amendment. Effective as 1 December 2023, the Protocol has been amended to Protocol v3.0. 2 ZMĚNY 2.1 Dodatek protokolu. S účinností od 1. prosince 2023 byl Protokol upraven Dodatkem na Protokol v3.0. Effective as 1 December 2023 Appendix 1 attached to the Agreement is hereby updated and replaced in its entirety with Appendix 1-1, attached hereto and incorporated herein by reference. The parties have agreed to follow this change retroactively from December 1, 2023 Příloha 1 „Rozpočet a harmonogram plateb“ připojená ke Smlouvě se tímto aktualizuje a nahrazuje se v celém svém rozsahu přílohou 1-1, která je připojena na konci tohoto Dodatku. Strany se dohodly, že se touto změnou budou řídit zpětně od 1. prosince 2023

Protocol Amendment. If, at a future date, changes in the Protocol ------------------ appear desirable or become necessary due to governmental regulatory requirements, such changes shall be made through prior written agreement (protocol amendment) between the Sponsor and CTBR. If such changes can be expected to affect the timing of the delivery of the Draft or Final Report(s), then CTBR shall submit amended delivery dates for the Sponsor's written approval. If such changes can be expected to affect the price for the Study, CTBR shall submit a written estimate; however, CTBR shall, in each case, recover the additional charges arising out of the performance of such work. No deviation from the Protocol may be made without specific written authorization and approval of the Sponsor.