The sponsor will notify the Principal Investigator of these events. For studies conducted outside the United States under a U.S. IND, the Principal Investigator must comply with U.S. FDA IND regulations and with the record retention policies of the relevant national and local health authorities. 6.10 Publications The investigator must agree to send to the Sponsor/Investigator or Sponsor/Investigator’s representative, for review all manuscripts, abstracts and presentations using data from this study prior to their submission. The Sponsor/Investigator or Sponsor/Investigator’s representative reserves the right to delete from such materials any part or parts deemed to be confidential or proprietary. 6.11 Changes to protocol The protocol may not be modified without written approval of the Sponsor/Investigator or Sponsor/Investigator’s representative, or the study director. All changes to the protocol must be submitted to the FDA, the overseeing IRB, and local IRB/IEC. Additionally, changes must be approved by overseeing IRB prior to their implementation. Documentation of IRB/IEC approval must be sent to the Sponsor/Investigator or Sponsor/Investigator’s representative, and the Study Director immediately upon receipt. Any changes 44 Protocol: 2014-0443 Version 2.1 Version Date: 11 April 2016 and modifications to the informed consent language must be reviewed and approved by the Sponsor/Investigator or Sponsor/Investigator’s representative, and the Study Director prior to submission to the local IRB. 45 Protocol: 2014-0443 Version 2.1 Version Date: 11 April 2016 REFERENCES 1.