10.2 Ethics Committee and Regulatory Authorities Before patients participate in this study, the protocol, informed consent form, any promotional material/advertisements, and any other written information will be re viewed and approved/given favorable opinion by the Ethics Committee (EC) and applicable regulatory authorities. The Investigator’s Brochure will be provided for review. The EC’s composition or a statement that the EC’s composition meets applicable regulatory criteria will be documented. The study will commence only upon the sponsor’s receipt of approval/favorable opinion from the EC and, if required, upon the sponsor’s notification of applicable regulatory authority(s) approval, as described in the Clinical Trial Agreement. If the protocol or any other information given to the subject is amended, the revised documents will be reviewed and approved/given favorable opinion by the EC and applicable regulatory authorities, where applicable. The protocol amendme nt will only be implemented upon the sponsor’s receipt of approval and, if required, upon the sponsor’s notification of applicable regulatory authority(s) approval. 10.3 Informed Consent and Human Subject Protection Investigators will choose patients for participation while considering the study eligibility criteria. The investigator will exercise no selectivity so that no bias is introduced from this source. All patients and/or their legally authorized representative must sign an informed consent form before e ntering into the study according to applicable national and local regulatory requirements and ICH GCP. An assent form may be provided and should be signed by Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 70 of 81 CONFIDENTIAL patients less than 18 years of age. Before use, the informed consent form will be reviewed by the sponsor and approved by the EC and regulatory authority(s), where applicable, (see Section 10.2). The informed consent form will include a comprehensive explanation of the proposed treatment without any exculpatory statements, in accordance with the elements required by ICH GCP and applicable national and local regulatory requirements. Patients or their legally authorized representative(s) will be allowed sufficient time to consider participation in the study. By signing the informed consent form, patients/healthy volunteers or their legally authorized representative(s) agree that they will complete all evaluations required by the study, unless they withdraw voluntarily or are terminated from the study for any reason. The sponsor will provide to the investigator in written form any new information that significantly bears on the subjects’ risks associated with IP exposure. The informed consent will be updated, if necessary. This new information and/or revised informed consent form, which has been approved by the applicable EC and regulatory authorities, where applicable, will be provided by the investigator to the subjects who consented to participate in the study. Four out of ten subjects have already been accrued under the original single-dose Study Design, the first one being accrued in May 2017. These subjects will be asked to sign a new informed consent for multiple dosing. 10.4 Confidentiality The investigator will comply with the confidentiality policy as described in the Clinical Trial Agreement. Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 71 of 81 CONFIDENTIAL 11 ADMINISTRATIVE CONSIDERATION 11.1 Investigator’s Responsibilities The investigator will comply with the protocol (which has been approved/given favorable opinion by the EC), ICH GCP, and applicable national and local regulatory requirements as described in the Clinical Trial Agreement. The investigator is ultimately responsible for the conduct of all aspects of the study at the study site and verifies by signature the int egrity of all data transmitted to the sponsor.