9.2. Financial Disclosure and Obligations Investigators are required to provide financial disclosure information to allow the sponsor to submit the complete and accurate certification or disclosure statements required under 21 CFR 54. In addition, the investigator must provide to the sponsor a commitment to promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following the completion of the study. Neither the Sponsor (SELLAS) nor CRO (Cancer Insight, LLC) is financially responsible for further testing or treatment of any medical condition that may be detected during the screening process. In addition, in the absence of specific arrangements, neither the Sponsor nor CRO is financially responsible for further treatment of the patient’s disease. 9.3. Investigator Documentation Prior to beginning the study, the investigator will be asked to comply with ICH E6(R 2) 8.2 and Title 21 of the CFR by providing the following essential documents, including but not limited to: • IRB approval • Original investigator-sig ned investigator agreement page of the protocol • Form FDA 1572, fully executed, and all updates on a new fully executed Form FDA 1572 • Curriculum vitae for the investigator and each subinvestigator listed on Form FDA 1572 SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/ MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 225 • Financial disclosure information to allow the sponsor to submit complete and accurate certification or disclosure statements required under 21 CFR 54. In addition, the investigators must provide to the sponsor a commitment to promptly update this information if any relevant changes occur dur ing the course of the investigation and for 1 year after the completion of the study • IRB -approved informed consent, samples of site advertisements for recruitment for this study, and any other written information regarding this study that is to be provided to the patient or legal guardian 9.4. Study Conduct The investigator agrees that the study will be conducted according to the principles of ICH E6(R2). The investigator will conduct all aspects of this study in accordance with all national, state, and local laws or regulations. Study information from this protocol will be posted on publicly available clinical trial registers before enrollment of patients begins. 9.5. Adherence to Protocol The investigator agrees to conduct the study as outlined in this protocol in accordance with ICH E6(R2) and all applicable guidelines and regulations. 9.6. Adverse Events and Study Report Requirements By participating in this study, the investigator agrees to submit reports of SAEs according to the timeline and method outlined in the protocol. In addition, the investigator agrees to submit annual reports to the study site IRB as appropriate. In accordance with the regulation 21 CFR 312.32, the sponsor shall within 60 days of the anniversary date that the investigational new drug application went into effect to submit a brief report of the progress of the investigation. SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/ MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 226 9.7. Investigator’s Final Report Upon completion of the study, the investigator, where applicable, shou ld inform the institution; the investigator/institution should provide the IRB with a summary of the study’s outcome and the sponsor and regulatory authority(ies) with any reports required. 9.8. Records Retention For countries falling within the scope of the ICH guidelines, the sponsor-specific essential documents should be retained until at least 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product. The following documents will be maintained for 2 years beyond product FDA and European Union full approval of the combination of galinpepimut-S plus pembrolizumab (if such is granted in the future based on the results of this study or other studies) or until SELLAS notifies the site in writing with permission to either send the documents to another location or locally destroy these documents: • eCRFs - a copy of each patient’s full eCRF must be kept. • Patient files/signed informed consent - which substantiates the data entered on the eCRFs for all required test and evaluation procedures and verifies that the patient has signed an informed consent to enter the study. • Patient exclusion record - which should reflect the reason any patient was screened and found ineligible for the study. • Monitoring log - listing dates of monitor visits. • Regulatory documents - including protocol and all versions, investigator brochure and all versions, FDA Form 1572, curricula vitae, IRB correspondence, IRB SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/ MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 227 approval/renewals and IRB approved consent form, copy of all investigators and subinvestigator curricula vitae, financial disclosure forms each year filed with their IRB of record, current medical license during duration of the study , and other documents as requested by SELLAS or any regulatory agency. • AE eCRF - which should explain any serious or unexpected adverse experiences. This also includes all SAE reports, MedWatch forms, and/or Council for International Organizations of Medical Sciences forms. All correspondence with the site’s IRB/IEC of record, regulatory authority(ies), and SELLAS . These documents should be retained for a longer period, however, if required by the applicable regulatory requirement(s) or if needed by the Sponsor. SELLAS Life Sciences Group requires that it be notified in writing if the investigator wishes to relinquish ownership of the data so that mutually agreed -upon arrangements can be made for transfer of ownership to a suitably qualified, responsible person. 9.9. Publications SELLAS Life Sciences Group, as the Sponsor, has proprietary interest in this study. Data are the property of the Sponsor and cannot be published without prior authorization from the sponsor. After completion of the study, the data may be considered for reporting at a scientific meeting and/or for publication in a scientific journal. Authorship and manuscript composition of any publication will reflect joint cooperation between multiple investigators and sites and SELLAS personnel. SELLAS will work with the investigators to determine how the manuscript is written and edited, the number and order of authors, the publication to which it will be submitted, and other related issues. Authorship will be established by site enrollment. The first author will be from the highest enrolling site. The last author will be from the site that contributes the most to the development of the protocol, data analysis , and drafting of the article for publication. The sponsor has final approval authority over all such issues. No individual publications will be allowed before completion of the final report of the multicenter study except as agreed by SELLAS , but data and publication thereof will not be unduly withheld. SELLAS Life Sciences Group Galinpepimut -S Protocol : SLS17 -201/ MK3475 -770 Protocol v1.1 (Amendment 1.0) 12 April 2019 Page 228 10. Study Managemen t and Monitoring 10.1.