94(7): p. 2217 -24 64. Herceptin, Package Insert. Genentech, Inc., 2015 V11.2 (1/9/20 ) Page 47 of 50 APPENDIX A ADXS11 -001 Drug Ordering Drug Ordering and Distribution : ADXS11 -001 will be supplied by Advaxis and distributed by Almac Clinical Services LLC. No supplies will be shipped to any site until regulatory approval has been obtained. There will NOT be an initial drug supply forwarded to all investigational sites until initial regulatory approval . Initial and Subsequent Requests : The designated person(s) from each participating hospital will complete the Drug Order Request Form and email the completed form to Almac. Study drug is not patient specific and you may order multiple vials of study drug to accommodate more than one patient depending upon the enrollment expectations at your site and storage capacity at -80 ± 10°C . ADXS11 -001 will be shipped from Almac Clinical Services directly to the institution. Shipments will be made Monday through Thursday for Tuesday through Friday delivery per the table below. To ensure ample time for delivery, drug requests must be received by Almac before 12:00 pm Eastern Standard Time (EST) Monday through Wednesday. If the drug request is received prior to 12 noon, that will be considered Day 1. Study drug will be shipped Day 2 to arrive on site Day 3 before 10:30 am local time. Receipt and dispensing of trial medication must be recorded by an authorized person at the trial site. Orders in (by 12 PM EST) Shipment Out Expected Delivery Monday Tuesday Wednesday Tuesday Wednesday Thursday Wednesday Thursday Friday Thursday Monday Tuesday Friday Monday Tuesday EST = Eastern Standard Time Complete and email the Drug Reorder Request Form to: ATTN: palogistics.clinicalservices@almacgroup.com CC: Larry.haines@almacgroup.com logistics@advaxis.com Cold Chain Verification: Cold chain verification must be completed immediately before unpacking the shipper, by carefully following the instructions below: V11.2 (1/9/20 ) Page 48 of 50 TempTale USB4 Temperature Recorder Review Instructions Stopping the Monitor: On receipt of the shipment, the TempTale USB4 temperature recorder should be stopped. For this the RED stop button is held down firmly for 3 seconds .