summary letter). 6.0 INVESTIGATOR REQUIREMENTS 6.1 Study initiation Before the start of this study, the following documents must be on file with the sponsor, Galena Biopharma, or a representative: • Original U.S. FDA Form 1572 for each site (for all studies conducted under U.S. Investigational New Drug [IND] regulations), signed by the Principal Investigator. The names of any sub-investigators must appear on this form. Investigators must also complete all regulatory documentation as required by local and national regulations. • Current curriculum vitae of the Principal Investigator • Written documentation of IRB approval of protocol and informed consent document • A copy of the IRB-approved informed consent document • A signed Clinical Research Agreement 6.2 Study completion The following materials are requested by Galena Biopharma when a study is considered complete or terminated: • A summary, prepared by the Principal Investigator, of the study, and/or a study manuscript, and/or a study abstract submitted to scientific conferences. 6.3 Informed consent 41 Protocol: 2014-0443 Version 2.1 Version Date: 11 April 2016 An informed consent template will be provided, and the final IRB-approved document must be provided to the sponsor for regulatory purposes. The informed consent document must be signed by the patient or the patient’s legally authorized representative before his or her participation in the study. The case history for each patient shall document that informed consent was obtained prior to participation in the study. A copy of the informed consent document must be provided to the patient or the patient's legally authorized representative. If applicable, it will be provided in a certified translation of the local language. Signed consent forms must remain in each patient’s study file and must be available for verification by study monitors at any time. 6.4 Institutional review board or ethics committee approval This protocol, the informed consent document, and relevant supporting information must be submitted to the IRB for review and must be approved before the study is initiated. The study will be conducted in accordance with U.S.