Upon the subject’s permission, medical information may be given to his or her personal physician or other appropriate medical personnel responsible for his or her welfare. Data generated by this study must be available for inspection upon request by representatives of the U.S. FDA, national and local health authorities, Genentech, Galena Biopharma, and the IRB for each study site, if appropriate. 6.9 RETENTION OF RECORDS U.S. FDA regulations (21 CFR §312.62[c]) require that records and documents pertaining to the conduct of this study and the distribution of investigational drug, including CRFs, consent forms, laboratory test results, and medication inventory records, must be retained by the Principal Investigator for two years after marketing application approval. If no application is filed, these records must be kept two years after the investigation is discontinued and the U.S. FDA and the applicable national and local health authorities are notified. 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 CONFIDENTIAL Page 50 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 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 THE 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 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. CONFIDENTIAL Page 51 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 REFERENCES Akerley W, Sikov WM, Cummings F, et al. Weekly high-dose paclitaxel in metastatic and locally advanced breast cancer: a preliminary report. Semin Oncol 1997;24 (5 Suppl 17):87-90.