Such audits/inspections can occur at any time during or after completion of the study. If an audit or inspection occurs, the investigator and inst itution agree to allow the auditor/inspector direct access to all relevant documents and to allocate his/her time and the time of his/her staff to the auditor/inspector to discuss findings and any relevant issues. 13.5 Study and Site Closure Upon completion or premature discontinuation of the study, the monitor will conduct site closure activities with the investigator or site staff, as appropriate, in accordance with applicable regulations, GCP, and Heat Biologics procedures. In addition, Heat Biologics reserve s the right to temporarily suspend or prematurely discontinue this study at any time for reasons including, but not limited to, safety or ethical issues or severe non -compliance. For this multicenter study, this can occur at one or more sites. If Heat Bi ologics determines such action is needed, Heat Biologics will discuss this with the investigator, including the reasons for taking such action, at that time. When feasible, Heat Biologics will provide advance notification to the investigator, where applic able, of the impending action prior to it taking effect. Heat Biologics will promptly inform all other investigators, and/or institutions conducting the study if the study is suspended or prematurely discontinued for safety reasons. Heat Biologics will al so promptly inform the regulatory authorities of the suspension or premature discontinuation of the study and the reason(s) for the action. If required by applicable regulations, the investigator must inform the IEC/IRB promptly and provide the reason for the suspension or premature discontinuation. 13.6 Records Retention Following closure of the study, the investigator must maintain all site study records, except for those required by local regulations to be maintained by someone else, in a safe and secure loc ation. The records must be maintained to allow easy and timely retrieval, when needed (e.g., audit or inspection), and, whenever feasible, to allow any subsequent review of data in conjunction with assessment of the facility, supporting systems, and staff . Where permitted by local laws/regulations or institutional policy, some or all of these records can be maintained in a format other than hard copy (e.g., microfiche, scanned, electronic); however, caution needs to be exercised before such action is take n. The investigator must assure that all reproductions are legible and are a true and accurate copy of the original and meet Heat Biologics, Inc. Investigational Product: Vesigenurtacel -L Protocol HS410 -101 CONFIDENTIAL Version 8.0; 03 Feb 2016 Page 71 of 86 accessibility and retrieval standards, including re -generating a hard copy, if required. Furthermore, the investigator must ensur e there is an acceptable back up of these reproductions and that an acceptable quality control process exists for making these reproductions. Heat Biologics will inform the investigator of the time period for retaining these records to comply with all applicable regulatory requirements. The minimum retention time will meet the strictest standard applicable to that site for the study, as dictated by any institutional requirements or local laws or regulations, or Heat Biologics standards/procedures; otherwis e, the retention period will default to 15 years. The investigator must notify Heat Biologics of any changes in the archival arrangements, including, but not limited to, the following: archival at an off -site facility, transfer of ownership of the records in the event the investigator leaves the site. 13.7 Provision of Study Results and Information to Investigators When required by applicable regulations, the investigator signatory for the clinical study report will be determined at the time the report is written. When the clinical study report is completed, Heat Biologics will provide the investigator with a full summary of the study results. The investigator is encouraged to share the summary results with the patients, as appropriate. In addition the i nvestigator will be give n reasonable access to review the relevant statistical tables, figures, and reports and will be able to review the results for the entire study at the Heat Biologics site or other mutually agreeable location. 13.8 Data Management The dat a collection tool for this study will be Heat Biologics -defined ECRF . Patient data necessary for analysis and reporting will be entered/transmitted into a validated database or data system. Clinical data management will be performed in accordance with ap plicable Heat Biologics standards and data cleaning procedures. Heat Biologics, Inc. Investigational Product: Vesigenurtacel -L Protocol HS410 -101 CONFIDENTIAL Version 8.0; 03 Feb 2016 Page 72 of 86 APPENDIX 1: BLADDER CANCER STAGING Based on AJCC staging , which can be found at the following URL: http://www.cancer.gov/cancertopics/pdq/treatment/bladder/HealthProfessional/page3 These T categories for bladder cancer refer to the primary tumor.  TX: primary tumor cannot be assessed; information not known  TO: no evidence of primary tumor  Ta: noninvasive papillary carcinoma  Tis: noninvasive flat carcinoma, also called flat carcinoma in situ. This means that the disease is still localized, or contained within the urothelium layer of the bladder wall. Cancer cells have not invaded the deeper layers of bladder wall tissue.  T1: the tumor has grown from the layer of cells lining the bladd er into the connective tissue below. It has not grown into the muscle layer of the bladder.  T2: tumor has grown into the muscle layer o T2a: the tumor is in the inner half of the muscle layer o T2b: the tumor is in the outer half of the muscle layer  T3: tumor has grown through the muscle layer and into the surrounding fatty tissue o T3a: this spread into the fatty tissue can only be seen with a microscope o T3b: this spread into the fatty tissue is large enough to be seen on imaging test or to be seen/felt b y the surgeon  T4: tumor has spread into nearby organs or structures. It may be growing in the stroma (main tissue) of the prostate, the seminal vesicles, uterus, vagina, pelvic wall , or abdominal wall Histologic Features of Urothelial Papillary Lesions Papilloma Papillary Neoplasm of Low Malignant Potential Low-grade Papillary Carcinoma High -grade Papillary Carcinoma Architecture: Papillae Organization of cells Delicate Identical to Normal Delicate. Occasional fused Polarity identical to normal.