If any physical activity is undertaken, discomfort is increased. CONFIDENTIAL Page 83 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 Appendix D.2 Glossary of Clinical Trials AVID Antiarrhythmics Versus Implantable Defibrillators BEST Beta-blocker Evaluation of Survival Trial CAMIAT Canadian Amiodarone Myocardial Infarction Arrhythmia Trial CAPRIE Clopidogrel vs Aspirin in Patients at Risk of Ischemic Events CASH Cardiac Arrest Study HamburgCHF-STAT Congestive Heart Failure-Survival Trial of Antiarrhythmic Therapy CHARM Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity CIBIS Cardiac Insufficiency BIsoprolol Study CIBIS II Cardiac Insufficiency Bisoprolol Study II CIDS Canadian Implantable Defibrillator Study COMET Carvedilol or Metoprolol European Trial CONSENSUS Cooperative North Scandinavian Enalapril Survival Study CONSENSUS II Cooperative New Scandinavian Enalapril Survival Study II COPERNICUS Carvedilol Prospective Randomized Cumulative Survival Trial DEFINITE Defibrillators in Nonischemic Cardiomyopathy Treatment Evaluation DIAMOND Danish Investigation of Arrhythmia and Mortality on Dofetilide DIG Digitalis Investigation Group ELITE Evaluation of Losartan In The Elderly ELITE II Losartan Heart Failure Survival Study - ELITE II EMIAT Infarction Amiodarone TrialGESICA Grupo de Estudio de Sobrevida en Insuficiencia Cardiaca en Argentina GUSTO 1 Global Utilization of Streptokinase and TPA for Occluded coronary arteriesMADIT Multicenter Automatic Defibrillator Implantation Trial MADITII Multicenter Automatic Defibrillator Implantation Trial II MDC Metoprolol in Dilated Cardiomyopathy trial MERIT-HF Metoprolol CR/XL Randomized Intervention Trial in Heart Failure MOCHA Multicenter Oral Carvedilol in Heart-failure Assessment MTT Myocarditis Treatment Trial OPTIMALL Optimal Therapy in Myocardial Infarction with the Angiotensin II Antagonist Losartan PRECISE Prospective Randomized Evaluation of Carvedilol In Symptoms and Exercise PROVED Prospective Randomized study Of Ventricular failure and the Efficacy of Digoxin RADIANCE Randomized Assessment of Digoxin on Inhibitors of the Angiotensin Converting Enzyme RALES Randomized Aldactone Evaluation Study RESOLVD Randomized Evaluation of Strategies for Left Ventricular Dysfunction SAVE Survival And Ventricular Enlargement SCD-HeFT Sudden Cardiac Death in Heart Failure: Trial of prophylactic amiodarone versus implantable defibrillator therapy SOLVD Studies Of Left Ventricular Dysfunction SWORD Survival With Oral D-sotalol ValHeFT Valsartan Heart Failure Trial CONFIDENTIAL Page 84 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 VALIANT Valsartan in Acute Myocardial Infarction APPENDIX E NCCN Guidelines for Adjuvant Breast Cancer Treatment http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf For hormone receptor positive, NP breast cancer see BINV-6 or BINV-9 For hormone receptor negative, NP breast cancer see BINV-8 or BINV-9 For hormone receptor negative, NN breast cancer see BINV-8 or BINV-9 CONFIDENTIAL Page 85 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 APPENDIX F Study Randomization and Stratification Schema CONFIDENTIAL Page 86 of 102 Protocol: HERCEPTIN® + E75/GM-CSF Version 3.1 ML25749 05 March 2017 APPENDIX G E75 + GM-CSF Formulation Plan ML25749 Combination immunotherapy with Herceptin® and the HER2 vaccine E75 in low and intermediate HER2 expressing breast cancer patients to prevent recurrence Dosing Preparation Instructions Dosing Summary: The study treatment is 1000 mcg of E75 peptide (nelipepimut-S) mixed with 250 mcg of lyophilized Leukine® (sargramostim, GM-CSF) or placebo (water for injection) mixed with Leukine, administered in four separate 0.4 mL intradermal injections. The E75 peptide is provided as 1.5 mg/mL of E75 acetate (contains a 1.42 mg/mL solution of the E75 peptide).