Schedule of Changes. Sponsor and Omnicare to the following changes and additional work pursuant to the general terms and conditions set forth in the Agreement: [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Pursuant to Exhibit F, Omnicare CR will provide additional services to support the Sponsor’s Study of PEP005 Topical Gel, Protocol # PEP005-008, Final Version 3, Dated 8 th May 2006 Biometrics: • Additional Statistical Analysis — • The following will be performed: • End of Study clinical response of the Day **** vs Day **** subjects and all subjects • End of Study histological response of the Day **** vs Day **** subjects and all subjects • Baseline vs End of Study Erythema LSR • Baseline vs End of Study Desquamation LSR • Baseline vs End of Study Swelling LSR • Baseline vs End of Study Vesiculation/Pustulation LSR • Baseline vs End of Study Erosion/ Ulceration LSR • Baseline vs End of Study Pigmentation LSR • Baseline vs End of Study Scarring LSR • Final delivery would be statistical output and a short description of methology used • Provided to Sponsor by end of **** • Fees: • **** hours Statistician (India) @ A$****/hr **** • **** hours Team Leader @ A$****/hr **** • Data Entry: Original Units ****; Actual Units **** = **** units @ $****/unit **** • Data Review: Original Units ****; Actual Units **** = **** units @ $****/unit **** • QC Full: Original Units ****; Actual Units **** = **** units @ $****/unit **** • CRF Tracking: Original Units ****; Actual Units **** = **** units @ $****/unit **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Pursuant to Exhibit F, Omnicare CR will provide additional services to support the Sponsor’s Study of PEP005 Topical Gel, Protocol # PEP005-008, Final Version 3, Dated 8 th May 2006 Clinical Data Management: (continued) • Dictionary Coding of AEs: Original Units ****; Actual Units **** = **** **** units @ $****/unit • Dictionary Coding of Meds: Original Units ****; Actual Units **** = **** **** units @ $****/unit. • SAE Reconciliation: Original Units ****; Actual Units **** = **** **** units @ $****/unit • New i...
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes to the budget based on the final reconciliation pursuant to the general terms and conditions set forth in the Agreement: • Estimated Data Entry (actuals will be billed) >Pages in Int’l Pages **** **** **** **** **** • Data Review and Query Resolution > CRF Pages Page **** **** **** **** **** • Quality Control Check of critical variables Patient **** **** **** **** **** • Edit Development (actuals will be billed) Edits **** **** **** **** **** • CRF and Query Tracking (includes all ancillary pages; actuals will be billed) Page **** **** **** **** **** • Dictionary Coding of Adverse Event terms to MedDRA (estimated to be per patient; actuals will be billed) Term **** **** **** **** **** • Dictionary Coding of Medication terms (estimated to be per patient; actuals will be billed) Term **** **** **** **** **** Lab Visit Verification Visits **** **** **** **** **** • Reconciliation of the, Safety and Clinical Database (actuals will be billed) SAE **** **** **** **** **** * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work pursuant to the general terms and conditions set forth in the Agreement: [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Pursuant to Exhibit D, Omnicare CR will provide clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP005-003 Upon the conduct of the final reconciliation of tasks performed for Sponsor and comparing estimates with Exhibit D and change Order # 01 to Exhibit D, the following additional Clinical Data Management activities were performed: Data Entry **** **** **** pages @ A$****/page **** Data Review **** **** **** pages @ A$****/page **** QC Critical Variables **** **** ****patients @ $****/patient **** Edit Development **** **** **** edits @ A$****/edit **** CRF Tracking **** **** **** pages @ A$****/page **** AE Dictionary Coding **** **** **** terms @ A$****/term **** Meds Dictionary Coding **** **** **** terms @ A$****/term **** Lab Load-Subsequent **** **** **** load @A$****/load **** Lab Visit Verification **** **** **** visits @ A$****/visit **** SAE reconciliation **** **** **** SAE @ A$****/SAE **** Protocol deviation log load **** **** **** load @ A$****/load **** For Biometrics, the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** **** x unique table @ A$****/table **** x repeat table @ A$****/table **** x unique listing @ A$****/listing Total Estimated Service Fees **** * Total Estimated Pass Through Expenses **** ** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project.
Schedule of Changes. If the recalculation results in an increase or decrease to the Grid Charges, Transpower will forward to the Customer a revised Grid Charges Schedule not less than 20 Business Days prior to the replacement, enhancement, removal or reconfiguration;
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work pursuant to the general terms and conditions set forth in the Agreement: [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Pursuant to Exhibit D, Omnicare CR will provide clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-002 Revised costing for tables and listings presented in Statistical Analysis Plan. The original proposal was costed at a discounted rate which will be maintained in this Change Order #1. The original estimate of Tables (**** repeat), Listings (**** repeat) and figures (**** repeat). Following on from design of data displays and reporting requirements there has been an increase in the number of Tables and Listings presented in the Statistical Analysis Plan. The updated count of Tables is **** repeat Listings is **** repeat and **** repeat Figures. * **** repeat tables @ $****/table = $**** **** * **** repeat listings@ $****/listing = $**** * **** repeat figures @ $****/figure = $**** **** Actuals will be billed. * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project.
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work pursuant to the general terms and conditions set forth in the Agreement: [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Pursuant to Exhibit D, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-003 In order of evaluate confounding study effects of **** (****) site, additional tables are to be produced and analysis performed at the request of the Sponsor, with **** (****) site excluded. This revision requires the following additional tables: **** **** x unique table @ A$****/table **** x repeat table @ A$****/table Biometrics Team Leader time. **** **** hours @ A$****/ hour Total Estimated Pass Through Expenses **** ** * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project.
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work pursuant to the general terms and conditions set forth in the Agreement: [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Pursuant lo Exhibit B, Omnicare CR will provide statistical support for the Sponsor’s Study of PEP005 Topical Gel, Protocol # PEP005-001 Sponsor has requested the production of **** (****) additional tables (**** unique and **** repeat tables) and the provision of a short flash report (up to **** (****) page) to accompany delivery of tables. These additional tables and flash report are to be delivered by 28 February 2006. The estimated cost to produce the additional tables and flash report are: * **** unique tables @ $****/table = $**** **** * **** repeat table @ $****/table = $**** **** * **** flash report (**** hours Biostatistician time @ $****/hour) = $**** **** Actuals will be billed. Total Estimated Pass Through Expenses **** ** * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project.
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work pursuant to the general terms and conditions set forth in the Agreement: [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Pursuant to Exhibit I, Omnicare CR will provide additional statistical services for Sponsor’s requirements Additional data displays presented within the Data Monitoring Committee Statistical Analysis Plan: • Data Tables (original contract included 10 unique and 5 repeat; actual displays were 17 unique and 8 repeat tables): - 7 unique tables @ US$****/table US$**** - 3 repeat tables @ US$****/table US$**** • Data Listings (original contract included 2 unique and 0 repeat; actual displays were 12 unique and 4 repeat listings): - 10 unique listings @ US$****/table US$**** - 4 repeat listings @ US$****/table US$**** * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project.
Schedule of Changes. Sponsor and Omnicare CR agree to the following additional work services pursuant to the general terms and conditions set forth in the Agreement: Pursuant to Exhibit B, Omnicare CR will load Sponsor’s log of protocol deviations from monitoring of PEP005-001 into the clinical database Development of an additional DCM/DCI module, loading the spreadsheet data and QC of received data. $**** * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project.
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work pursuant to the general terms and conditions set forth in the Agreement: [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Pursuant to Exhibit D, Omnicare CR will provide Biometrics support for the Sponsor’s Study of PEP005 Topical Gel, Protocol # PEP005-003 Additional analysis requested for **** (****) repeat tables to be developed @ $****/table **** Total Estimated Pass Through Expenses **** ** * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project.
