A hexagonal “STOP” icon appears in the upper right hand corner of the display. Alarm: A small blinking “BELL” icon is on the display after the device has been stopped. This means that during the transport a significant temperature excursion occurred. Please follow steps 1 -6. 1) Plug the USB cable into your computer. 2) Copy both files from the USB device into an email. 3) Specify the subject header with Protocol Name, Site Name/No. and Shipment No. 4) Please send an e- mail with both attachments to Almac and Advaxis via the following e- mail addresses: • coldchainteampa@almacgroup.com • logistics@advaxis.com 5) The medication contained in this shipment must not be dispensed to patients until a positive written feedback from Advaxis is available. 6) Please store the affected medication separately and wait until confirmation of supply usability is received. No Alarm: If the device has been stopped and no blinking “BELL” icon is visible, verification that the medication was shipped under good conditions is complete. No further actions from your side are necessary. Please discard the temperature logger. You can use the medication immediately. Display Stop Button USB Adapter & Cable V 1 1. 2 (1/ 9/ 2 0 ) P a g e 4 9 of 5 0 N o st u d y dr u g s h o ul d b e a d mi ni st er e d t o a n y p ati e nt s u nl e s s t h e T e m p T al e U S B 4 h a s b e e n r e vi e w e d a n d t h e s hi p m e nt h a s b e e n v erifi e d or a ut h ori z e d f or cli ni c al u s e. F or q u e sti o n s a b o ut T e m p T al e U S B 4 a n d dr u g s hi p m e nt s, pl e a s e e -m ail t h e f oll o wi n g: Al m ac: pal o gistics.cli nicalser vices @al mac gr o u p.c o m C C: larr y. hai nes @al mac gr o u p.c o m l o gistics @a d va xis.c o m Dr u g A c c o u nt a bilit y : All st u d y dr u g m u st b e a c c o u nt e d f or b y u si n g t h e N CI Dr u g A c c o u nt a bilit y F or m d uri n g t h e c o ur s e of t hi s st u d y. T h e p h ar m a ci st or q u alifi e d r e s e ar c h st aff m e m b er will m ai nt ai n i n v e nt or y r e c or d s. T h e r e c or d s will i n cl u d e d et ail s of m at eri al s r e c ei v e d, t h e d at e di s p e n s e d, t h e p ati e nt i d e ntifi c ati o n n u m b er a n d i niti al s of p ati e nt r e c ei vi n g t h e d o s e , a n d d o c u m e nt ati o n of dr u g d e str u cti o n f oll o wi n g n otifi c ati o n fr o m t h e S p o n s or or c o m pl eti o n/t er mi n ati o n of t h e st u d y. R e c ei pt a n d di s p e n si n g of tri al m e di c ati o n m u st b e r ec or d e d b y a n a ut h ori z e d p er s o n at t h e tri al sit e. It i s t h e I n v e sti g at or’ s r e s p o n si bilit y t o arr a n g e f or di s p o s al of all e m pt y c o nt ai n er s, pr o vi d e d t h at pr o c e d ur e s f or pr o p er di s p o s al h a v e b e e n e st a bli s h e d a c c or di n g t o a p pli c a bl e f e d er al, st at e, l o c al a n d i n stit uti o n al g ui d eli n e s a n d pr o c e d ur e s, a n d pr o vi d e d t h at a p pr o pri at e r e c or d s of di s p o s al ar e k e pt. Dr u g D e str u cti o n a n d R et ur n : O p e n e d a n d u n o p e n e d vi al s c a n b e d e str o y e d a c c or di n g t o t h e sit e’ s g ui d eli n e s f or Bi o h a z ar d W a st e Di s p o s al or b y u si n g t h e st e p s s h o w n b el o w f or A D X S 1 1 - 0 0 1 d e str u cti o n. T h e u s e d or u n u s e d vi al s of A D X S 1 1 -0 0 1 c a n b e tr e at e d wit h a 1 0 % bl e a c h s ol uti o n f or di si nf e cti o n. U s e a 1 0 % s ol uti o n of Cl or o x  ( or a n y si milar c o m m ercial c hlorin e ble a c h s olutio n c o nt ai ni n g 5. 2 5 % s o di u m h y p o c hl orit e ( N a Cl O) f or di si nf e cti o n . 1. Tr e at u n o p e n e d or o p e n e d vi al s( s) wit h a mi ni m u m v ol u m e of 0. 2 5 m L of bl e a c h s ol uti o n t o st erili z e it s c o nt e nt s. 2. E m pt y t h e di si nf e ct e d c h e mi c al s ol uti o n i n dr ai n, r u n w at er t o r e m o v e r e si d u al m at eri al s fr o m dr ai n a n d di s c ar d e m pt y vi al s i nt o d e si g n at e d bi o h a z ar d o u s w a st e c o nt ai n er, a s a p pli c a bl e. 3. T h e r e si d u al I V b a g s or ot h er c o m p o n e nt s u s e d f or pr e p ari n g t h e dr u g pr o d u ct s h o ul d al s o b e i n a cti v at e d wit h bl e a c h a n d di s c ar d e d i n si mil ar m a n n er a s e x pl ai n e d i n st e p s 1 a n d 2. If A D X S 1 1-0 0 1 i s d e str o y e d at t h e sit e, it will b e t h e i n v e sti g at or’ s r e s p o n si bilit y t o e n s ur e t h at pr o c e d ur e s f or pr o p er di s p o s al h a v e b e e n e st a bli s h e d a c c or di n g t o a p pli c a bl e r e g ul ati o n s, g ui d eli n e s, a n d i n stit uti o n al pr o c e d ur e s a n d t h at: • Br U O G h a s b e e n al ert e d t o dr u g d e str u cti o n a n d h a s b e e n s e nt h o s pit al d e str u cti o n p oli c y • writt e n a ut h ori z ati o n f or di s p o s al/ d e str u cti o n h a s b e e n gr a nt e d b y A d v a xi s • arr a n g e m e nt s h a v e b e e n m a d e f or t h e di s p o s al • a p pr o pri at e r e c or d s of t h e di s p o s al h a v e b e e n d o c u m e nt e d A s e p ar at e N CI Dr u g A c c o u nt a bilit y F or m m u st b e c o m pl et e d f or Dr u g D e str u cti o n . V11.2 (1/9/20 ) Page 50 of 50 Accidental Spills: All accidental spills shall be handled in compliance with applicable sit e safety procedures or following the guidance below: 1. In the event there is an accidental spill of ADXS11- 001, isolate the area and notify others in the vicinity. 2. Put on appropriate personal protective equipment (PPE) if not already worn (e.g. gown or lab coat, gloves and loose fitting mask with eye shield or goggles). 3. Remove any broken glass or sharps and place them into sharps container. 4. Place paper tower over the spill. 5. Saturate the paper -towel(s) with bleach starting at the outside of the spill and worki ng towards the center. Allow the 10% bleach solution to remain on area for approximately 10 min. 6. Dispose the paper towel(s) in a biohazardous waste container. 7. Clean the remaining disinfectant with additional paper towels, as needed. 8. Discard all materials including PPEs, in the designated biohazardous waste container(s). 9. Inform the Principal Investigator (PI) and other appropriate personnel, e.g. Research Manager, Pharmacy Manager. Exposure to ADXS11- 001: All exposure incidences shall be handled in compliance with applicable site safety procedures or following the guidance below: 1. In the event of an accidental exposure, remove and dispose of contaminated PPEs or clothing into the designated biohazardous waste containers. a. For skin contamination: thoroughly wash the affected area immediately with soap and water. b. For needle stick injury: wash the affected area thoroughly with soap and water and cover the area with a sterile gauze dressing. Notify the PI who will determine appropriate medical actions to be ta ken. 2. For eye contamination: immediately and thoroughly rinse the affected area for up to 15 minutes using an eyewash; making the water flow across the affected eye from the nose to the outer corner of the eye. If only one eye is contaminated, avoid contami nating the other eye (position your head so the affected eye must be below the other eye). Notify PI who will determine appropriate medical actions to be taken. It will be the investigator’s responsibility to ensure that procedures for proper disposal hav e been established according to applicable regulations, guidelines, and institutional procedures and that: • the coordinating institution has been alerted to drug destruction and has been sent hospital destruction policy, if applicable • arrangements have been made for the disposal • appropriate records of the disposal have been documented A separate (NCI) Drug Accountability Form must be completed for drug destruction.