Astrazeneca? October 22, 2003 Stephen Olson, MD. University of Minnesota University of Minnesota Dept. of Psychiatry Office of Sponsored Projects Admin. 2450 Riverside Avenue 430 University Gateway Minneapolis, MN 55455 200 Oak Street SE Attention: Dr. Stephen Olson Minneapolis, MN 55455-2070 Re: Eiicacy nd Tolerability of Olanzapine, Quetapine and Risperidone io the Treatment of First Episode Peychosis:A Randomized Docble Blind 52 Week Compesion- Protocol Number SO77HLZO114 Dear Dr, Olson: ‘This letter will serve to amend the agreement dated May 20, 2002 arnongst AstraZeneca Pharmaceuticals LP (“AstraZeneca”), The Regents of the University of Minnesota (“Institution”) and Stephen Olson, MD (“Principal Investigatos”) ("Agreement") ‘The Exhibit A within the Agreement is hereby amended due to the elimination of Phase I (visits 20, 21, 22 and 23), and for the supplementation of the budget for additional work ‘expended toward the successful enrollment of the study during an extended enrollment period of 6 months beginning September 1, 2003. The following revisions have been made to Exhibit A: U. _ PER SUBJECT PAYMENT 315,648 Pes Subject Payment shal be made for evaluable, eligible Subjects only, An eligible Subjet is one who meets the inclusionfenclsion requirements of th Protocol, who was earalled by Inston and from whom Informed Consent has been obtsned. An evaluable Subject i one for whom all CRFshave been completed in ceordance withthe Protocol, and who has completed the appropriate study procedures 2s set forth the Protech, ad undergone the evaluations required bythe Protocol for assessment ofefracy and safety. The pr subjet coat includes subjoct related coss aswell s noirsubjoc core such a ovesbead expences, ECG preparation & review, laboratory specimen preparation & analysis, Mow pressure monitoring, peyehiatrc ratings, completion of case report forms, administrative costs, cous for subject eave, ete and equipment costs. Per Susject Payments shal become du for each evaluable, eligible Subject ypom AstraZeneea’s satisfactory review of ll Sty Dectmentation,ieluding completed CRFs ang close-out audits. No payments wil be made for Subjects with unsatisfactory CRF scr ‘unresolved dats deficiencies i he Study Documentation, A completed CRF i one that i ign by Principal Davesigaor when sequired and contin ll complete veried infarmation ia accavdance withthe procekres 0d scheduled sésessmentsn stated inthe Protocol Perio Baus AstazeneeaPhismacetcals LP see bul See ee oe wonsct Goes UM SPA 0004‘AenZeosi soya tIsion he Per Stet Paya ccenting ote mien Payment se forth below: Completion of Visit 3: 34452 s1aK 2.352 Completion of Visi 12: 821136 Completion of Visi 15 1,890 Completion of Visit19 and $3,336 ‘p00 Salstictory completion and Sat tte Pe $10 co Inston for Peyho-EtaescalImeremon that re completed for visits 1,3, ‘5, 8.amd 10 foreach poten. i reneetin fr subjes wo dont compete he Sy wl be ekused on rorated basis acconting othe following sched pa T Completion of Visit 1; $3,222 Completion of Vist 12: * srajaza Completionof Visit 2: $3,990 Completion of Visit 3: $11,052 Completion of Visit 3; $4,452 Completion of Visit14: $11,682 Completion of Visit ¢: $5,082 Completion of Vise 15: $12,312 Completion Visit 5: 35,368 Completion of Visit 16; 512.942 Completion of Visi 6: $5,934 Completion of Vise 17: $13,572 Completion of Visit7: 56,564 Completion of Visi 1: $14,200 Completion of Visit &: $2,134 Completion of Visi 19; $15,648 Compleinn of Visits: 58.286 Compleionot Vist 10: 38.916 Completion Visit 11: $9,546 ‘MTethertems and conditions ofthe Agreement shall main in ful force and effect If the above amendment is acceptable to you, please so indicate by signing the enclosed wo Cabics ofthis leter and returning one fully-executed copy to me, Savinder K. Saini at; 1800 ‘Concord Pike, FOC2-CE2-704, ‘Wilmington DE 19850, Very tly yours, Cyrene qian Savinder K. Suni, Bog, Investigator Agreements Specialist “AGREED AND ACCEPTED: By. dtu Livrahle ‘The Regents of the-{niversity of Minnesota NOY 1.3 2003 _ ae Woo By, Principal Investigator UM SPA 0005