Trial Exhibits

The following documents have been presented as evidence in trial and are available as part of the public record:

Risperdal Label (PX 0002)


August 1996 -- Letter to FDA Requesting Risperdal Label Change to Include Pediatric Use (PX 0006)


July 1996 -- Safety of Risperidone in Neonates, Infants, Children, and Adolescents (PX 0007)


September 1997 -- Department of Health & Human Services Rejecting Risperdal Label Change (PX 0008)


March 2000 -- Record of FDA Contact Regarding Request for Pediatric Market Exclusivity (PX 0009)


November 2000 -- Janssen Clinic Research Report on Long-term Safety and Efficacy of Risperdal in Children (PX 0010)


August 2001 -- Topline Results on Long-term Safety and Efficacy of Risperdal in Children (PX 0011)


July 2002 -- Clinical Research Report (PX 0012)


January 2005 -- Risperidone in Children With Disruptive Behavior Disorders and Subaverage Intelligence: A 1-Year, Open-Label Study of 504 Patients (PX 0013)


September 2002 -- Topline Results on Long-term Safety and Efficacy of Risperdal in Children (PX 0014)


Chart: Rate of Gynecomastia (PX 0017)


Chart: Rate of Gynecomastia (PX 0017a)


Chart: Rate of Gynecomastia (PX 0017b)


Chart: Rate of Gynecomastia (PX 0017c)


Chart: Submitted to FDA (PX 0017d)


August 2000 -- Risperdal Pediatric Market Opportunity (PX 0018)


July 2002 -- Child and Adolescent & Other New Business (PX 0019)


July 2001 -- Risperdal Child and Adolescent Market Business Plan (PX 0020)


January 2002 -- Revised Prolactin Analysis (PX 0022)


May 2002 -- Prolactin Statistical Tables (PX 0023)


May 2002 -- Prolactin Statistical Tables (PX 0023a)


July 2002 -- Prolactin Levels in Children and Adolescents With Long -Term Risperidone Use (PX 0025)


August 2002 -- Email About Prolactin Concerns (PX 0027)


September 2002 -- Statistical Documentation Long -Term Risperidone Treatment vs Pro!actin Pooled Analysis (PX 0028)


September 2002 -- Document on Prolactin Connection and Gynecomastia (PX 0029)


September 2002 -- Prolactin Statistic Table 20 (PX 0029a)


November 2002 -- Risperdal Child and Adolescent Psychiatry Advisory Board Meeting (PX 0031)


November 2001 -- Prolactin Presentation Given at Advisory Board Meeting (PX 0032)


Prolactin Levels During Long-Term Risperdone Treatment in Children and Adolescents (PX 0037)


October 2004 -- Use of Risperdal in Children Aged 5 to 17 Years A Response to FDA (PX 0044)


2001 Business Plan Summary (PX 0045)


October 2001 --Strategic Plan Children and Adolescents (PX 0046)


Sales Training Presentation (PX 0047)


August 2003 --Child and Adolescent Regional Advisory Board Meeting (PX 0048)


Jan 2006 -- Department of Health and Human Services Application (PX 0055)


February 2002 -- Statistics for Prolactin Report (PX 0056)


February 2002 --Statistics Documentation for Manuscript (PX 0057)


December 1994 -- Ivo Caers Document Showing High Prolactin Levels (PX 0058)


October 1994 -- Ivo Caers Risperdal Report Suggests Market Is Too Small (PX 0059)


September 2002 -- Prolactin Statistics (PX 0061)


September 2002 -- Shap B Chart (PX 0062)


September 2003 -- Integrated Project Plan (PX 0065)


Physiologic Effects of Prolactin (PX 0066)


Prolactin Label (PX 5059)


Prolactin Label (PX 5127)