Common use of Outline of study procedures Clause in Contracts

Outline of study procedures. All study procedures are outlined in the Schedule of Assessments below (Table 6.1). A more detailed description of the study procedures performed at each study stage/visit is given in the following sections. Table 6.1 Schedule of Events Hospitalization Post discharge follow-up Visits/Week Study days Screening Day (-7) to Day (-1) Day 1 Day of application(1) Daily during hospitalization(2) Day of discharge Telephone Contact Day 8 (+ 1 day) Day 30 (+ 5 days) Day 90 (+ 5 days) Day 180 (+ 7 days) End of Study Visit Follow-up Safety Visits (Months 12, 24, 36, 48 60, + 30 days) AM1 X Hospitalization X Coronary angiography, PCI, stent(1) X Informed consent X Inclusion/exclusion criteria X Pregnancy test X Demography medical history; concurrent illnesses X Physical examination X X X X X X X X Xxxxx xxxxx (temperature, arterial BP. weight) X X X X X X X X 12-lead ECG X X (4) X X X X X X Laboratory safety parameters X (5) X (6) X (6) X X X X Total CK/CK MB X X (7) NT-proBNP X X (8) X (6) X X X Echocardiography/MRI X X X X X Continuous ECG monitoring X (9) Cardiac catheterization; application of BL- 1040; coronary angiography X PTT or ACT measurements X (10) 24-hour ambulatory Xxxxxx monitoring X X X X X Safety contact for discharged patients X Minnesota Living with Heart Failure® X X X X Serious/Adverse events and concomitant medication X X X X X X X X X

Outline of study procedures. All study procedures are outlined in the Schedule of Assessments below (Table 6.1). A more detailed description of the study procedures performed at each study stage/visit is given in the following sections. Annotated Protocol incorporating Amendment 1, Amendment 2, Amendment 3, and Amendment 4 01 December 2008 Protocol BL-1040.01, Version 5.00 Safety and Feasibility study of BL-1040 Final CONFIDENTIAL Table 6.1 Schedule of Events Visits/Week Hospitalization Post discharge follow-up Visits/Week Study days Screening Day (-7) to Day (-1) Day 1 Day of application(1) application1 Daily during hospitalization(2) hospitalization2 Day of discharge Telephone Contact Day 8 (+ ± 1 day) Day 30 (+ ± 5 days) Day 90 (+ ± 5 days) Day 180 (+ ± 7 days) End of Study Visit Follow-up Safety Visits (Months 12, 24, 36, 48 60, + ± 30 days) AM1 AMI X Hospitalization X <-----------------------X----------------------------------> Coronary angiography, PCI, stent(1) stent3 X Informed consent X Inclusion/exclusion criteria X Pregnancy test X Demography Demography; medical history; concurrent illnesses X Physical examination X X X X X X X X Xxxxx xxxxx (temperature, arterial BP. , weight) X X X X X X X X 12-lead ECG X X (4) X4 X X X X X X Laboratory safety parameters X (5) X (6) X (6) X5 X6 X6 X X X X Total CK/CK MB X X (7) X7 NT-proBNP X X (8) X (6) X6 X6 X X X Echocardiography/MRI MRI8 X X X X X Continuous ECG monitoring X (9) X9 Cardiac catheterization; application of BL- 1040BL-1040; coronary angiography X PTT or ACT measurements X (10) X10 24-hour ambulatory Xxxxxx monitoring X X X X X Safety contact for discharged patients X Minnesota Living with Heart Failure® FailureÒ X X X X Serious/Adverse events and concomitant medication X X X X X X X X X