1. Gubbs Inc. Creator of software tools that provide data processing and reporting solutions www.gubbsinc.com GuWu ® – PK/PD Study Design and Reporting Solution Thermo Watson™ is an industry standard LIMS system used by laboratories that conduct protocol-driven bioanalytical studies. Until recently, Watson has had limited tools for generating final reports, especially reports (Method Validation, Sample Analysis) generated in support of GLP studies. Most users resort to exporting Watson tables to Microsoft® Excel or Word for further statistical processing and/or Word formatting. The task of generating a complete report containing sufficient information requires more information and functionality than is currently available in Watson tools. Final Reports (especially Method Validation) can typically take days to weeks to prepare and require a high level of QC and QA events to ensure all data is correct and accurate. GuWu allows users to manage the report writing process and generate completely formatted Watson data-derived GLP study reports with the click of a button. Entering table information into a GLP study report is not the most time-intensive step The following steps are the most time-intensive and error prone steps:  Formatting Entering page content specific table legends Entering table titles Configuring non-breaking spaces and non-breaking hyphens  Entering compound specific data in report body section Analytical Reference Standard information Summary Precision and Accuracy statements/tables Method Validation Summary information Sample receipt information  Hyperlinking References to tables, appendices and figures to must be hyperlinked to actual table, appendix and figure.  Method Validation Summary Table Sample Analysis reports are expected to contain a table summarizing information determined in the Method Validation study/report.

2. Formatting Features HyperlinkingGuWu automatically configures Table, Appendix, and Figure hyperlinks when referenced in the Body Text. Non-breaking spaces (NBSP) and Non-breaking hyphens (NBH) GuWu automatically configures NBSPs and NBHs in compound names and table/appendix/figure reference hyperlinks in order to prevent unwanted word-wrap occurances. Extensive field code options GuWu allows users to place several pieces of information in the report based on field codes configured by the user. Signature BlocksAutomatically generates several types of signature blocks based on Contributing Personnel information and Role assignments. Table title generationAutomatically generates user defined table names complete with analyte and time/temperature variables. Automatic generation of multi-analyte reports GuWu automatically generates sentences and tables for multi-analyte studies. There is no need to maintain separate templates for two-, three-, etc. analyte studies. Automatic generation of legends Automatically generates page content-specific legends for multi-page tables Functionality Features Multi-analyte reportsOnly one report template is needed for single or multi-analyte reports. GuWu automatically modifies body text content and generated tables for all analytes. Complete Inventory of Method Validation Reports GuWu contains a complete inventory of tables expected of a GLP Method Validation Report, including Recovery Tables Storing non-Watson information GuWu has it’s own database to store information needed to generate a report, but which is not present in the Watson database. Most of this information is restricted to dropdown box choices (rather than free-form text as in Watson) – which allows administrators to enforce consistency when reporting some information (e.g. High Performance Liquid Chromatography – Mass Spectrometry). Expanded table statistics functions Allows users to configure an expanded statistics sections to include or not include outlier or rejected data points. Outlier determination tool (Eval Outlier) Eval Outlier automatically inspect Method Development QC tables for outliers and displays or prints outlier information. Using this information, users may determine whether or not to exclude data within Watson. Incurred sample feature (TBR) New recommendations by the FDA will require that Incurred Sample repeats be performed. GuWu will contain an intuitive simple Incurred Sample Assignment feature. Automatic Method Validation information retrieval In a Sample Analysis study report, GuWu will automatically retrieve and report either Watson or GuWu information from the Method Validation study associated with the Sample Analysis study. This eliminates the need for users to have to manually retrieve information located in electronic or hardcopy Method Validation reports or documents. Generate Report SectionsGuWu allows users to generate portions of the report (i.e. a single table, all tables without report body, just the report body). Method Validation Summary Sample Analysis reports are expected to contain a table or section that summarizes information from the Method Validation study upon which the assay was validated. GuWu will automatically retrieve this information from the appropriate Watson study (as assigned by the user). HooksGuWu can (as a custom modification to GuWu) retrieve data from additional company data stores that contain information needed in a report. For example, Analytical Reference Standard information may be stored in a separate database system. GuWu can retrieve this information to include in a report. TBR = To Be Released Gubbs Inc. Creator of software tools that provide data processing and reporting solutions www.gubbsinc.com GuWu features that make life easier for users

3. Time Benefits of GuWu Report Preparation  Sample Analysis Report preparation can take days  Method Validation Report preparation can take weeks Report QC  Report QC processes are not eliminated  Report QC completion times are reduced Most format/accuracy items are performed automatically  QC accuracy is enhanced Reports are delivered more quickly to QA Report QA  Report QA processes are not eliminated  Report QA completion times are reduced QA is allowed to focus on SOP items rather than formatting Value accuracy checks proceed much more quickly since accuracy issues should be eliminated at the QC step Gubbs Inc. Creator of software tools that provide data processing and reporting solutions

4. Cost Benefits of GuWu Gubbs Inc. Creator of software tools that provide data processing and reporting solutions

5. Gubbs Inc. Creator of software tools that provide data processing and reporting solutions www.gubbsinc.com Insert Field Code feature Eval Outlier feature Optional Extended Table Statistics feature Page Content Specific Table Legends feature Method Validation Summary feature Automatic Multiple Analyte in Body Text feature Note non-breaking space format in Analyte Name to prevent unwanted word-wrap Note automatic hyperlinks to actual table Note page content specific legend on page 5 does not appear on page 6