3 .2 Mode of Action J1790 / Version 7.0 / December 10, 2020 49 8. 3 .3 Description 8. 3 .4 Packaging and Labeling Information - 8. 3 .5 Preparation - 8. 3 .6 Storage 8. 3 .7 Stability J1790 / Version 7.0 / December 10, 2020 50 8. 3 .8 Route of Administration 8. 3 .9 Subject Care Implications - - - - J1790 / Version 7.0 / December 10, 2020 51 - - 8. 3 . 10 Returns and Reconciliation The investigator is responsible for keeping accurate records of the clinical supplies, the amount dispensed to, and returned by the subjects and the amount remaining at the conclusion of the trial. Upon co m pletion or ter m ination of the study, all unused and/or partially used investigational product will be destroyed at the site per institutional policy. It is the Investigat o r ’s respon s ibility to arrange for disposal of all empty containers, provided that procedures for proper disposal have been established according to applicable federal, state, local and institutional guidelines and procedures, and provided that appropriate records of disposal are kept. 8.4 Nivolumab 8 . 4 .1 Agent Accountability The IND sponsor 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. At the end of the study period, Bristol - Myers Squibb Company will not continue to supply study drug to subjects/investigators unless the Sponsor - Investigator chooses to exten d their study. The investigator is responsible to ensure that the subject receives appropriate standard of care or other appropriate treatment in the independent medical judgement of the Investigator to treat the condition under study .