1 . 10 Returns and Reconciliation N/A 8.2 GV AX Pancreas Vaccine 8. 2 .1 Agent Accountability The IND S ponsor or the IND Sponsor’s representative shall take responsibility for and shall take all steps to maintain appropriate records and ensure appropriate supply, storage, handling, distribution and usage of investigational product in accordance with the protocol and any applicable laws and regulations. 8. 2 .2 Mode of Action GM - CSF - secreting , irradiated, whole cell vaccines recruit and activate tumor - specific T cells and induce a cytotoxic response t hrough two mechanisms: 1. they deliver a range of peptide antigens (without the need for specific knowledge of the relevant target antigens), and 2. GM - CSF is an important growth and differentiation factor for dendritic cells, which are potent antigen - pres enting cells. 8.