Reconciliation The Sponsor agrees to conduct reconciliation for the product. Genentech and the Sponsor will agree to the reconciliation periodicity and format, but agree at minimum to exchange monthly line listings of cases received by the other party. If discrepancies are identified, the Sponsor and Genentech will cooperate in resolving the discrepancies. The responsible individuals for each party shall handle the matter on a case-by-case basis until satisfactory resolution. CONFIDENTIAL Page 98 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 h. AEs of Special Interest (AESIs) AEs of Special Interest are defined as a potential safety problem, identified as a result of safety monitoring of the Product The Adverse Events of Special Interest are: SAE Reporting Investigators must report all SAEs to both Genentech and Galena within the timelines described below. The completed Medwatch/case report should be faxed immediately upon completion to Genentech Drug Safety at: (650) 225-4682 OR (650) 225-5288 AND drugsafety@galenabiopoharma.com Relevant follow-up information should be submitted to both Genentech and Galena Drug Safety as soon as it becomes available. Serious AE reports that are related to the study drugs and AEs of Special Interest (regardless of causality) will be transmitted to both Genentech and Galena within fifteen (15) calendar days of the Awareness Date. Serious AE reports that are unrelated to the study drugs will be transmitted to Genentech within thirty (30) calendar days of the Awareness Date. Additional Reporting Requirements to both Genentech and Galena include the following: Any reports of pregnancy following the start of administration with the study drugs will be transmitted to Genentech within thirty (30) calendar days of the Awareness Date. All Non-serious Adverse Events originating from the Study will be forwarded in an annual report to both Genentech and Galena. Note: Investigators should also report events to their IRB as required. MedWatch 3500A Reporting Guidelines In addition to completing appropriate patient demographic and suspect medication information, the report should include the following information within the Event Description (section 5) of the MedWatch 3500A form: Protocol description (and number, if assigned) Description of event, severity, treatment, and outcome if known Supportive laboratory results and diagnostics Investigator’s assessment of the relationship of the adverse event to each investigational product and suspect medication Follow-up Information Additional information may be added to a previously submitted report by any of the following methods: Adding to the original MedWatch 3500A report and submitting it as follow-up Adding supplemental summary information and submitting it as follow-up with the original MedWatch 3500A form Summarizing new information and faxing it with a cover letter including patient identifiers (i.e. D.O.B. initial, patient number), protocol description and number, if assigned, brief adverse event description, and notation that additional or follow-up information is being submitted (The patient identifiers are important so that the new information is added to the correct initial report) Occasionally Genentech may contact the reporter for additional information, clarification, or current status of the patient for whom and adverse event was reported. For questions regarding SAE reporting, you may contact the Genentech Drug Safety representative noted above or the MSL assigned to the study. Relevant CONFIDENTIAL Page 99 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 follow-up information should be submitted to Genentech Drug Safety as soon as it becomes available and/or upon request. MedWatch 3500A (Mandatory Reporting) form is available at http://www.fda.gov/medwatch/getforms.html Additional Reporting Requirements for IND Holders For Investigator-Sponsored IND Studies, some additional reporting requirements for the FDA apply in accordance with the guidance set forth in 21 CFR § 600.80. Events meeting the following criteria need to be submitted to the Food and Drug Administration (FDA) as expedited IND Safety Reports according to the following guidance and timelines: 7 Calendar Day Telephone or Fax Report: The Investigator is required to notify the FDA of any fatal or life-threatening adverse event that is unexpected and assessed by the investigator to be possibly related to the use of study drugs. An unexpected adverse event is one that is not already described in the study drugs Investigator Brochure. Such reports are to be telephoned or faxed to the FDA and Genentech within 7 calendar days of first learning of the event. 15 Calendar Day Written Report The Investigator is also required to notify the FDA and all participating investigators, in a written IND Safety Report, of any serious, unexpected AE that is considered reasonably or possibly related to the use of study drugs. An unexpected adverse event is one that is not already described in the study drugs investigator brochure. Written IND Safety reports should include an Analysis of Similar Events in accordance with regulation 21 CFR § 312.32. All safety reports previously filed by the investigator with the IND concerning similar events should be analyzed and the significance of the new report in light of the previous, similar reports commented on. Written IND safety reports with Analysis of Similar Events are to be submitted to the FDA, Genentech, and all participating investigators within 15 calendar days of first learning of the event. The FDA prefers these reports on a Medwatch 3500 form, but alternative formats are acceptable (e.g., summary letter). FDA fax number for IND Safety Reports: Fax: 1 (800) FDA 0178 All written IND Safety Reports submitted to the FDA by the Investigator must also be faxed to Genentech Drug Safety: Fax: (650) 225-4682 or (650) 225-5288 And will be submitted to the Site IRBs. For questions related to safety reporting, please contact Genentech Drug Safety: Tel: (888) 835-2555 Fax: (650) 225-4682 or (650) 225-5288 CONFIDENTIAL Page 100 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 IND Annual Reports Copies to Genentech: All IND annual reports submitted to the FDA by the Sponsor-Investigator should be copied to Genentech. Copies of such reports should be faxed to Genentech Drug Safety: Fax: (650) 225-4682 or (650) 225-5288 STUDY CLOSE-OUT Any study report submitted to the FDA by the Sponsor-Investigator should be copied to Genentech. This includes all IND annual reports and the Clinical Study Report (final study report). Additionally, any literature articles that are a result of the study should be sent to Genentech.