1995;15(3- 4):235- 253. Relevant Guidelines • United States Pharmacopoeia • European Pharmacopoeia • United States Requirements for Drugs and Biologics (21CFR Parts 200 (Drugs) & 21CFR Parts 600 (Biologics), 2008). • Guidance on the Development of Vaccinia Virus Based Vaccines Against Smallpox (EMEA/CPMP/1100/02), 2002. • Recommendations for the Production and Quality Control of Smallpox Vaccine, Revised 2003 (WHO Technical Report Series. No 926), 2004. • Safet y Reporting Requirements for INDs and BA/BE Studies, December 2012 Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 80 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. 14.0 APPENDICES 14.1 Schedule of Events All Treatment V isits have a ± 3 day window LTFU Visits have a +14 day window Screening Treatment Long -Term Follow -Up Week 1 3 5 9 13 17 21 25 1st visit (6 mos after EoT) Every subsequent 6 mos16* Day –28 – –1 EoT Dosing: PROSTVAC -V or placebo1 X Dosing: PROSTVAC -F or placebo1 X X X X X X GM-CSF or placebo2 X X X X X X X Immune Monitoring ** Immune/Biomarker Status X X X Peripheral Blood RNA X X X Tumor CTC (US sites only) X X X Immune function (US sites only) X X X Procedures Informed Consent X Medical History X Prostate Cancer History X Prostate Cancer Treatment Update X X Complete Physical Exam3 X X Abbreviated Physical Exam4 X X X X X X X X13 X13 Vital Signs5 X X X X X X X X X X Autoimmune Disease Status X14 X14 ECOG X X X X X X X X X Adverse Events X X X X X X X X X Concomitant Medications X X X X X X X X X X15 ECG X X Quality of Life Questionnaire*** X X X Laboratory Assessments HLA-A2 typing X PSA and PAP X X8 X X X X X X X Testosterone X Hematology6 X X8 X X X X X X Serum Chemistry7 X X8 X X X X X X Cardiac Markers9 X HIV, HBsAg, HepC10 X PT(INR)/PTT X X C-Reactive Protein X X Urinalysis X X Protocol BNIT -PRV- 301; Amendment 7 PROSTVAC -V/F Version 2. 7, 08 February 2017 CONFIDENTIAL AND RESTRICTED 81 Amend 7 Disclosure requires written consent from Bavarian Nordic , Inc. 14.1 Schedule of Events (Continued) All Treatment V isits have a ± 3 day window LTFU Visits have a +14 day window Screening Treatment Long -Term Follow -Up Week 1 3 5 9 13 17 21 25 1st visit (6 mo s after EoT) Every subsequent 6 mos16* Radiology Assessments Bone Scan X11 X X X CT Scan with contrast (pelvis and abdomen) **** X11 X12 X X * Until 12 months after the projected number of events is realized or death, whichever is first. ** Immune monitoring samples should be collected only after a patient is eligible by all other criteria and prior to the first dose of study drug (US Only). *** QOLs include: FACT -P, BPI -SF, and EQ -5D-3L to be performed at Week 1 and Week 25 during the Treatment Phase and at Month 6 during the LTFU Phase. **** For subjects enrolled in Germany, MRI must be used as the primary imaging modality 1. Subject should remain in the clinic for at least 30 minutes following administration of PROSTVAC -V/F/ placebo for observation of adverse reaction. 2. GM-CSF or placebo will be administered the day of vaccination and following 3 consecutive days. 3. A Complete Physical Examination will include, at a minimum, the general appearance of the subject, height (screening only) and weight, and examination of the skin, eyes, ears, nose, throat, lung, heart, abdomen, extremities, musculoskeletal system, genitourinary system, nervous system, and lymphatic system 4. Abbreviated physical examinations will be driven by problems or issues identified during the Treatment Phase and during the LTFU Phase that have changed since Screening 5. Vital signs will include including sitting BP, heart rate, RR, temperature, and weight 6. Hematology: CBC with differential, RBC with indices, platelets 7. Serum chemistry: BUN, creatinine, ALT, AST, alkaline phosphatase, total bilirubin, LDH, sodium potassium, chloride, bicarbonate, calcium and glucose 8. Blood samples do not need to be repeated at Day 1, if screening samples were run within 7 days of the visit 9. Cardiac Markers (CK, CK- MB, Troponins T and I) 10. Virology testing required unless known negative within the previous 2 months 11. Baseline Bone Scan and CT Scan of the abdomen and pelvis (if not performed within 3 months of the start of S creening); for subjects with allergies to contrast agents, MRIs for abdomen and pelvis may be performed. Only in cases where MRI is unavailable may a non- contrast CT be performed. 12.