Schedule of Changes. Sponsor and Omnicare CR agree to the following additional work and reduced services pursuant to the general terms and conditions set forth in the Agreement: **** 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 B, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5-001, Version 2 Unique Tables: * Estimated number of unique tables in original budget = **** * Actual number of unique tables = **** * Variance = **** unique tables @ AUS$**** **** Repeat Tables: **** * Estimated number of repeat tables in original budget = **** * Actual number of repeat tables = **** * Variance = **** repeat table @ AUS$**** Unique Listings: **** * Estimated number of unique listings in original budget = **** * Actual number of unique listings = **** * Variance = **** unique listings @ AUS$**** Repeat Listings: **** * Estimated number of repeat listings in original budget = **** * Actual number of repeat listings = **** * Variance = **** repeat listings @ AUS$**** Pursuant to Exhibit B, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-001, Version 2 Unique Figures: * Estimated number of unique figures in original budget = **** * Actual number of unique figures = **** * variance = **** unique figure @ AUS$**** **** Repeat Figures: **** * Estimated number of repeat figures in original budget = **** * Actual number of repeat figures = **** * Variance = **** repeat figure @ AUS$**** Total Estimated Service Fees to be Billed **** * Total Estimated Service Fees Not to be Billed **** 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.
Appears in 1 contract
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work and reduced services 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 BF, Omnicare CR will provide biometrics additional services to support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5-001, Version 2 Unique Tables: * Estimated number of unique tables in original budget = **** * Actual number of unique tables = **** * Variance = **** unique tables @ AUS$**** **** Repeat Tables: **** * Estimated number of repeat tables in original budget = **** * Actual number of repeat tables = **** * Variance = **** repeat table @ AUS$**** Unique Listings: **** * Estimated number of unique listings in original budget = **** * Actual number of unique listings = **** * Variance = **** unique listings @ AUS$**** Repeat Listings: **** * Estimated number of repeat listings in original budget = **** * Actual number of repeat listings = **** * Variance = **** repeat listings @ AUS$**** Pursuant to Exhibit B, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-001008, Final Version 2 Unique Figures3, Dated 8 th May 2006 Biometrics: • Additional Statistical Analysis — • The following will be performed: • End of Study clinical response of the Day **** Estimated number vs Day **** subjects and all subjects • End of unique figures in original budget 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 number of unique figures Units **** = **** units @ $****/unit **** variance • QC Full: Original Units ****; Actual Units **** = **** unique figure units @ AUS$$****/unit **** • CRF Tracking: Original Units ****; Actual Units **** Repeat Figures: **** * Estimated number of repeat figures in original budget = **** * Actual number of repeat figures = units @ $**** * Variance = */unit **** repeat figure @ AUS$**** Total Estimated Service Fees to be Billed **** * Total Estimated Service Fees Not to be Billed **** 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. 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 item not covered in original contract — Protocol Deviation Log Load: **** units @ $****/unit **** * 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.
Appears in 1 contract
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work and reduced services 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 24b-2 of the Securities Exchange Act of 19331934, as amended. Pursuant to Exhibit BF, Omnicare CR will provide biometrics additional services to support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5-001, Version 2 Unique Tables: * Estimated number of unique tables in original budget = **** * Actual number of unique tables = **** * Variance = **** unique tables @ AUS$**** **** Repeat Tables: **** * Estimated number of repeat tables in original budget = **** * Actual number of repeat tables = **** * Variance = **** repeat table @ AUS$**** Unique Listings: **** * Estimated number of unique listings in original budget = **** * Actual number of unique listings = **** * Variance = **** unique listings @ AUS$**** Repeat Listings: **** * Estimated number of repeat listings in original budget = **** * Actual number of repeat listings = **** * Variance = **** repeat listings @ AUS$**** Pursuant to Exhibit B, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-001008, Final Version 2 Unique Figures3, Dated 8 th May 2006 Biometrics: • Additional Statistical Analysis — • The following will be performed: • End of Study clinical response of the Day **** Estimated number vs Day **** subjects and all subjects • End of unique figures in original budget 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 number of unique figures Units **** = **** units @ $****/unit **** variance • QC Full: Original Units ****; Actual Units **** = **** unique figure units @ AUS$$****/unit **** • CRF Tracking: Original Units ****; Actual Units **** Repeat Figures: **** * Estimated number of repeat figures in original budget = **** * Actual number of repeat figures = units @ $**** * Variance = */unit **** repeat figure @ AUS$**** Total Estimated Service Fees to be Billed **** * Total Estimated Service Fees Not to be Billed **** 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 24b-2 of the Securities Exchange Act of 19331934, 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 item not covered in original contract — Protocol Deviation Log Load: **** units @ $****/unit **** * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project.
Appears in 1 contract
Schedule of Changes. Sponsor and Omnicare CR agree to the following additional work and reduced services pursuant to the general terms and conditions set forth in the Agreement: **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 24b-2 of the Securities Exchange Act of 19331934, as amended. Pursuant to Exhibit B, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5-001, Version 2 Unique Tables: * Estimated number of unique tables in original budget = **** * Actual number of unique tables = **** * Variance = **** unique tables @ AUS$**** **** Repeat Tables: **** * Estimated number of repeat tables in original budget = **** * Actual number of repeat tables = **** * Variance = **** repeat table @ AUS$**** Unique Listings: **** * Estimated number of unique listings in original budget = **** * Actual number of unique listings = **** * Variance = **** unique listings @ AUS$**** Repeat Listings: **** * Estimated number of repeat listings in original budget = **** * Actual number of repeat listings = **** * Variance = **** repeat listings @ AUS$**** Pursuant to Exhibit B, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-001, Version 2 Unique Figures: * Estimated number of unique figures in original budget = **** * Actual number of unique figures = **** * variance = **** unique figure @ AUS$**** **** Repeat Figures: **** * Estimated number of repeat figures in original budget = **** * Actual number of repeat figures = **** * Variance = **** repeat figure @ AUS$**** Total Estimated Service Fees to be Billed **** * Total Estimated Service Fees Not to be Billed **** Total Estimated Pass Through Expenses **** ** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 24b-2 of the Securities Exchange Act of 19331934, as amended. * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project.
Appears in 1 contract
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work and reduced services pursuant to the general terms and conditions set forth in the Agreement: [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Pursuant to Exhibit BD, Omnicare CR will provide biometrics clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5-001PEP005- 003 Upon the conduct of the final reconciliation of tasks performed for Sponsor and comparing estimates with Exhibit D and change Order # 01 to Exhibit D, Version 2 Unique Tablesthe following additional Clinical Data Management activities were performed: * Estimated number of unique tables in original budget = **** * Actual number of unique tables = **** * Variance = **** unique tables @ AUS$Data Entry **** **** Repeat Tables: **** * Estimated number of repeat tables in original budget = pages @ A$****/page **** * Actual number of repeat tables = **** * Variance = **** repeat table @ AUS$**** Unique Listings: **** * Estimated number of unique listings in original budget = **** * Actual number of unique listings = **** * Variance = **** unique listings @ AUS$**** Repeat Listings: **** * Estimated number of repeat listings in original budget = **** * Actual number of repeat listings = **** * Variance = **** repeat listings @ AUS$**** Pursuant to Exhibit B, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-001, Version 2 Unique Figures: * Estimated number of unique figures in original budget = **** * Actual number of unique figures = **** * variance = **** unique figure @ AUS$Data Review **** **** Repeat Figures**** pages @ A$****/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$****/load **** For Biometrics , the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** * Estimated number of repeat figures in original budget = **** * Actual number of repeat figures = x unique table @ A$****/table **** * Variance = x repeat table @ A$****/table **** repeat figure x unique listing @ AUS$A$****/listing Total Estimated Service Fees **** Total Estimated Service Fees to be Billed **** * Total Estimated Service Fees Not to be Billed **** Total Estimated Pass Through Expenses **** ** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project.
Appears in 1 contract
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work and reduced services pursuant to the general terms and conditions set forth in the Agreement: [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Pursuant to Exhibit BD, Omnicare CR will provide biometrics clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5PEP005-001003 Upon the conduct of the final reconciliation of tasks performed for Sponsor and comparing estimates with Exhibit D and change Order # 01 to Exhibit D, Version 2 Unique Tablesthe following additional Clinical Data Management activities were performed: * Estimated number of unique tables in original budget = **** * Actual number of unique tables = **** * Variance = **** unique tables @ AUS$Data Entry **** **** Repeat Tables: **** * Estimated number of repeat tables in original budget = pages @ A$****/page **** * Actual number of repeat tables = **** * Variance = **** repeat table @ AUS$**** Unique Listings: **** * Estimated number of unique listings in original budget = **** * Actual number of unique listings = **** * Variance = **** unique listings @ AUS$**** Repeat Listings: **** * Estimated number of repeat listings in original budget = **** * Actual number of repeat listings = **** * Variance = **** repeat listings @ AUS$**** Pursuant to Exhibit B, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-001, Version 2 Unique Figures: * Estimated number of unique figures in original budget = **** * Actual number of unique figures = **** * variance = **** unique figure @ AUS$Data Review **** **** Repeat Figures**** pages @ A$****/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$****/load **** For Biometrics, the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** * Estimated number of repeat figures in original budget = **** * Actual number of repeat figures = x unique table @ A$****/table **** * Variance = x repeat table @ A$****/table **** repeat figure x unique listing @ AUS$A$****/listing Total Estimated Service Fees **** Total Estimated Service Fees to be Billed **** * Total Estimated Service Fees Not to be Billed **** Total Estimated Pass Through Expenses **** ** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project.
Appears in 1 contract
Schedule of Changes. Sponsor and Omnicare Ominicare CR agree to the following changes and additional work and reduced services pursuant to the general terms and conditions set forth in the Agreement: [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Pursuant to Exhibit BC, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5-001, Version 2 Unique Tables: * Estimated number of unique tables in original budget = **** * Actual number of unique tables = **** * Variance = **** unique tables @ AUS$**** **** Repeat Tables: **** * Estimated number of repeat tables in original budget = **** * Actual number of repeat tables = **** * Variance = **** repeat table @ AUS$**** Unique Listings: **** * Estimated number of unique listings in original budget = **** * Actual number of unique listings = **** * Variance = **** unique listings @ AUS$**** Repeat Listings: **** * Estimated number of repeat listings in original budget = **** * Actual number of repeat listings = **** * Variance = **** repeat listings @ AUS$**** Pursuant to Exhibit B, Omnicare CR will provide biometrics clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005PEPO05-001O03 Revised costing for tables and listings presented in Statistical Analysis Plan. The original proposal had an estimate of Tables (**** unique/ **** repeat), Version 2 Unique Figures: Listings (**** Estimated unique/ **** repeat) and Figures (**** unique/ **** repeat). Following on from design of data displays and reporting requirements there has been an increase in the number of unique figures Tables and Listings presented in original budget = the Statistical Analysis Plan. The updated count of Tables is **** unique/ **** repeat, Listings is **** unique/ **** repeat and **** unique/ **** repeat Figure. Service Fees to be Invoiced **** * Actual number of **** unique figures tables @ $****/table = $ **** * variance **** repeat table @ $****/table = $**** * **** unique listings @ $****/listing = $**** * **** repeat listings @ $****/listing = $**** Service Fees not to be Invoiced **** * **** unique figure @ AUS$$**** */figure = ($ ****) * Repeat Figures: **** * Estimated number of repeat figures in original budget = **** * Actual number of repeat figures = **** * Variance = **** repeat figure @ AUS$$**** Total Estimated Service Fees to be Billed */figure = ($**** * Total Estimated Service Fees Not to *) Actuals will be Billed **** Total Estimated Pass Through Expenses **** ** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amendedbilled. * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Appears in 1 contract
Schedule of Changes. Sponsor and Omnicare Ominicare CR agree to the following changes and additional work and reduced services pursuant to the general terms and conditions set forth in the Agreement: [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Pursuant to Exhibit BC, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5-001, Version 2 Unique Tables: * Estimated number of unique tables in original budget = **** * Actual number of unique tables = **** * Variance = **** unique tables @ AUS$**** **** Repeat Tables: **** * Estimated number of repeat tables in original budget = **** * Actual number of repeat tables = **** * Variance = **** repeat table @ AUS$**** Unique Listings: **** * Estimated number of unique listings in original budget = **** * Actual number of unique listings = **** * Variance = **** unique listings @ AUS$**** Repeat Listings: **** * Estimated number of repeat listings in original budget = **** * Actual number of repeat listings = **** * Variance = **** repeat listings @ AUS$**** Pursuant to Exhibit B, Omnicare CR will provide biometrics clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005PEPO05-001O03 Revised costing for tables and listings presented in Statistical Analysis Plan. The original proposal had an estimate of Tables (**** unique/ **** repeat), Version 2 Unique Figures: Listings (**** Estimated unique/ **** repeat) and Figures (**** unique/ **** repeat). Following on from design of data displays and reporting requirements there has been an increase in the number of unique figures Tables and Listings presented in original budget = the Statistical Analysis Plan. The updated count of Tables is **** unique/ **** repeat, Listings is **** unique/ **** repeat and **** unique/ **** repeat Figure. Service Fees to be Invoiced **** * Actual number of **** unique figures tables @ $****/table = $**** * variance **** repeat table @ $****/table = $**** * **** unique listings @ $****/listing = $**** * **** repeat listings @ $****/listing = $**** Service Fees not to be Invoiced **** * **** unique figure @ AUS$$**** */figure = ($ ****) * Repeat Figures: **** * Estimated number of repeat figures in original budget = **** * Actual number of repeat figures = **** * Variance = **** repeat figure @ AUS$$**** Total Estimated Service Fees to be Billed */figure = ($**** * Total Estimated Service Fees Not to *) Actuals will be Billed **** 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 amendedbilled. * 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.
Appears in 1 contract
Schedule of Changes. Sponsor and Omnicare CR agree to the following additional work and reduced services pursuant to the general terms and conditions set forth in the Agreement: **** 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 24b-2 of the Securities Exchange Act of 19331934, as amended. Pursuant to Exhibit BA, Omnicare CR will provide additional biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5# PEP005-001004, Version 2 3 Unique Tables: * Estimated number of unique tables in original budget = **** $ **** * Actual number of unique tables = **** * Variance = **** unique tables @ AUS$**** **** Repeat Tables: **** * Estimated number of repeat tables in original budget = **** * Actual number of repeat tables = **** * Variance = **** repeat table @ AUS$**** Unique Listings: $ **** * Estimated number of unique listings in original budget = **** * Actual number of unique listings = **** * Variance = **** unique listings @ AUS$**** Pursuant to Exhibit A, Omnicare CR will provide additional biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-004, Version 3 Repeat Tables: * Estimated number of repeat tables in original budget = **** $ **** * Actual number of repeat tables = **** * Variance = **** repeat tables @ AUS$**** Repeat Listings: $ **** * Estimated number of repeat listings in original budget = **** * Actual number of repeat listings = **** * Variance = **** repeat listings @ AUS$**** Pursuant to Exhibit B, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-001, Version 2 Unique Figures: * Estimated number of unique figures in original budget = **** * Actual number of unique figures = **** * variance = **** unique figure @ AUS$**** **** Repeat Figures: **** * Estimated number of repeat figures in original budget = **** * Actual number of repeat figures = **** * Variance = **** repeat figure @ AUS$**** Total Estimated Service Fees to be Billed **** * Total Estimated Service Fees Not to be Billed **** Total Estimated Pass Through Expenses **** ** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Appears in 1 contract
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work and reduced services pursuant to the general terms and conditions set forth in the Agreement: [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Pursuant to Exhibit BA, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5-001, Version 2 Unique Tables: * Estimated number of unique tables in original budget = **** * Actual number of unique tables = **** * Variance = **** unique tables @ AUS$**** **** Repeat Tables: **** * Estimated number of repeat tables in original budget = **** * Actual number of repeat tables = **** * Variance = **** repeat table @ AUS$**** Unique Listings: **** * Estimated number of unique listings in original budget = **** * Actual number of unique listings = **** * Variance = **** unique listings @ AUS$**** Repeat Listings: **** * Estimated number of repeat listings in original budget = **** * Actual number of repeat listings = **** * Variance = **** repeat listings @ AUS$**** Pursuant to Exhibit B, Omnicare CR will provide biometrics additional Biometrics and Clinical Data Management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-001004, Version 2 3 Additional Analysis: Tables produced for time to resolution and summary of mild and moderate local skin reactions: • 1 Unique Figures: * Estimated number of unique figures in original budget = Table @ $**** * Actual number of unique figures = • 2 Repeat Tables @ $**** * variance = **** unique figure @ AUS$Clinical Data Management Final Reconciliation: $ $ **** **** Repeat Figures: • Data Entry — Contracted units **** * Estimated number of repeat figures in original budget = *, Actual **** * Actual number of repeat figures = **** * , Variance = **** repeat figure @ AUS$$****/unit $ **** Total Estimated Service Fees to be Billed • QC Data Review — Contracted units ****, Actual ****, Variance = **** * Total Estimated Service Fees Not to be Billed @ $****/unit $ **** Total Estimated Pass Through Expenses • Query Resolution — Contracted units ****, Actual ****, Variance = **** @ $** ***/unit $ **** Certain confidential information contained in this document• Dictionary Coding of AEs — Contracted units ****, marked with four asterisksActual ****, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 Variance = **** @ $****/unit $ **** • Dictionary Coding of the Securities Act of 1933Meds — Contracted units ****, as amended. Actual ****, Variance = **** @ $****/unit $ **** • PK Lab Load (Subsequent) — Contracted units ****, Actual ****, Variance = **** @ $****/unit **** • PK Lab Visit Verification — Contracted units ****, Actual ****, Variance = **** @ $****/unit **** • Local Lab (Initial) — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Local Lab (Subsequent) — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** * 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.
Appears in 1 contract
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work and reduced services 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 BA, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5-001, Version 2 Unique Tables: * Estimated number of unique tables in original budget = **** * Actual number of unique tables = **** * Variance = **** unique tables @ AUS$**** **** Repeat Tables: **** * Estimated number of repeat tables in original budget = **** * Actual number of repeat tables = **** * Variance = **** repeat table @ AUS$**** Unique Listings: **** * Estimated number of unique listings in original budget = **** * Actual number of unique listings = **** * Variance = **** unique listings @ AUS$**** Repeat Listings: **** * Estimated number of repeat listings in original budget = **** * Actual number of repeat listings = **** * Variance = **** repeat listings @ AUS$**** Pursuant to Exhibit B, Omnicare CR will provide biometrics additional Biometrics and Clinical Data Management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-001PEP005- 004, Version 2 3 Additional Analysis: Tables produced for time to resolution and summary of mild and moderate local skin reactions: • 1 Unique Figures: * Estimated number of unique figures in original budget = Table @ $**** * Actual number of unique figures = $ **** * variance = • 2 Repeat Tables @ $**** unique figure @ AUS$$ **** • Data Entry — Contracted units **** Repeat Figures: *, Actual **** * Estimated number of repeat figures in original budget = **** * Actual number of repeat figures = **** * , Variance = **** repeat figure @ AUS$$****/unit $ **** • QC Data Review — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Query Resolution — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Dictionary Coding of AEs — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Dictionary Coding of Meds — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • PK Lab Load (Subsequent) — Contracted units ****, Actual ****, Variance = **** @ $****/unit **** • PK Lab Visit Verification — Contracted units ****, Actual ****, Variance = **** @ $****/unit **** • Local Lab (Initial) — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Local Lab (Subsequent) — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** Total Estimated Service Fees to be Billed $ **** * Total Estimated Service Fees Not to be Billed **** Total Estimated Pass Through Expenses **** ** Total Estimated Budget $ **** 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. **** 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.
Appears in 1 contract
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work and reduced services 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 24b-2 of the Securities Exchange Act of 19331934, as amended. Pursuant to Exhibit BD, Omnicare CR will provide biometrics clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5-001PEP005- 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, Version 2 Unique Tablesthe following additional Clinical Data Management activities were performed: * Estimated number of unique tables in original budget = **** * Actual number of unique tables = **** * Variance = **** unique tables @ AUS$Data Entry **** **** Repeat Tables: **** * Estimated number of repeat tables in original budget = pages @ A$****/page **** * Actual number of repeat tables = **** * Variance = **** repeat table @ AUS$**** Unique Listings: **** * Estimated number of unique listings in original budget = **** * Actual number of unique listings = **** * Variance = **** unique listings @ AUS$**** Repeat Listings: **** * Estimated number of repeat listings in original budget = **** * Actual number of repeat listings = **** * Variance = **** repeat listings @ AUS$**** Pursuant to Exhibit B, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-001, Version 2 Unique Figures: * Estimated number of unique figures in original budget = **** * Actual number of unique figures = **** * variance = **** unique figure @ AUS$Data Review **** **** Repeat Figures**** 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: **** * Estimated number of repeat figures in original budget = **** * Actual number of repeat figures = x unique table @ A$****/table **** * Variance = x repeat table @ A$****/table **** repeat figure x unique listing @ AUS$A$****/listing Total Estimated Service Fees **** Total Estimated Service Fees to be Billed **** * Total Estimated Service Fees Not to be Billed **** 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 24b-2 of the Securities Exchange Act of 19331934, 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.
Appears in 1 contract
Schedule of Changes. Sponsor and Omnicare CR agree to the following additional work and reduced services pursuant to the general terms and conditions set forth in the Agreement: **** 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 BA, Omnicare CR will provide additional biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5# PEP005-001004, Version 2 3 Unique Tables: * Estimated number of unique tables in original budget = **** $ **** * Actual number of unique tables = **** * Variance = **** unique tables @ AUS$**** **** Repeat Tables: **** * Estimated number of repeat tables in original budget = **** * Actual number of repeat tables = **** * Variance = **** repeat table @ AUS$**** Unique Listings: $ **** * Estimated number of unique listings in original budget = **** * Actual number of unique listings = **** * Variance = **** unique listings @ AUS$**** Pursuant to Exhibit A, Omnicare CR will provide additional biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-004, Version 3 Repeat Tables: * Estimated number of repeat tables in original budget = **** $ **** * Actual number of repeat tables = **** * Variance = **** repeat tables @ AUS$**** Repeat Listings: $ **** * Estimated number of repeat listings in original budget = **** * Actual number of repeat listings = **** * Variance = **** repeat listings @ AUS$**** Pursuant to Exhibit B, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-001, Version 2 Unique Figures: * Estimated number of unique figures in original budget = **** * Actual number of unique figures = **** * variance = **** unique figure @ AUS$**** **** Repeat Figures: **** * Estimated number of repeat figures in original budget = **** * Actual number of repeat figures = **** * Variance = **** repeat figure @ AUS$**** Total Estimated Service Fees to be Billed **** * Total Estimated Service Fees Not to be Billed **** 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. **** 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.
Appears in 1 contract
Schedule of Changes. Sponsor and Omnicare CR agree to the following additional work and reduced services pursuant to the general terms and conditions set forth in the Agreement: **** 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 BA, Omnicare CR will provide additional biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5# PEP005-001004, Version 2 3 Unique Tables: * Estimated number of unique tables in original budget = **** * Actual number of unique tables = **** $ **** * Variance = **** unique tables @ AUS$**** **** Repeat Tables: **** * Estimated number of repeat tables in original budget = **** * Actual number of repeat tables = **** * Variance = **** repeat table @ AUS$**** Unique Listings: $ **** * Estimated number of unique listings in original budget = **** * Actual number of unique listings = **** * Variance = **** unique listings @ AUS$**** Pursuant to Exhibit A, Omnicare CR will provide additional biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-004, Version 3 Repeat Tables: * Estimated number of repeat tables in original budget = **** * Actual number of repeat tables = **** $ **** * Variance = **** repeat tables @ AUS$**** Repeat Listings: $ **** * Estimated number of repeat listings in original budget = **** * Actual number of repeat listings = **** * Variance = **** repeat listings @ AUS$**** Pursuant to Exhibit B, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-001, Version 2 Unique Figures: * Estimated number of unique figures in original budget = **** * Actual number of unique figures = **** * variance = **** unique figure @ AUS$**** **** Repeat Figures: **** * Estimated number of repeat figures in original budget = **** * Actual number of repeat figures = **** * Variance = **** repeat figure @ AUS$**** Total Estimated Service Fees to be Billed **** * Total Estimated Service Fees Not to be Billed **** 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. **** 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.
Appears in 1 contract
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work and reduced services 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 BF, Omnicare CR will provide biometrics additional services to support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5-001, Version 2 Unique Tables: * Estimated number of unique tables in original budget = **** * Actual number of unique tables = **** * Variance = **** unique tables @ AUS$**** **** Repeat Tables: **** * Estimated number of repeat tables in original budget = **** * Actual number of repeat tables = **** * Variance = **** repeat table @ AUS$**** Unique Listings: **** * Estimated number of unique listings in original budget = **** * Actual number of unique listings = **** * Variance = **** unique listings @ AUS$**** Repeat Listings: **** * Estimated number of repeat listings in original budget = **** * Actual number of repeat listings = **** * Variance = **** repeat listings @ AUS$**** Pursuant to Exhibit B, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-001008, Final Version 2 Unique Figures3, Dated 8th May 2006 Biometrics: • Additional Statistical Analysis — • The following will be performed: • End of Study clinical response of the Day **** Estimated number vs Day **** subjects and all subjects • End of unique figures in original budget 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 number of unique figures Units **** = **** units @ $****/unit **** variance • QC Full: Original Units ****; Actual Units **** = **** unique figure units @ AUS$$****/unit **** • CRF Tracking: Original Units ****; Actual Units **** Repeat Figures: **** * Estimated number of repeat figures in original budget = **** * Actual number of repeat figures = units @ $**** * Variance = */unit **** repeat figure @ AUS$**** Total Estimated Service Fees to be Billed **** * Total Estimated Service Fees Not to be Billed **** 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. 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 8th 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 item not covered in original contract — Protocol Deviation Log Load: **** units @ $****/unit **** * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project.
Appears in 1 contract
Schedule of Changes. Sponsor and Omnicare CR agree to the following additional work and reduced services pursuant to the general terms and conditions set forth in the Agreement: **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Pursuant to Exhibit B, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5-001, Version 2 Unique Tables: * Estimated number of unique tables in original budget = **** **** * Actual number of unique tables = **** * Variance = **** unique tables @ AUS$**** **** Repeat Tables: **** * Estimated number of repeat tables in original budget = **** * Actual number of repeat tables = **** * Variance = **** repeat table @ AUS$**** Unique Listings: **** * Estimated number of unique listings in original budget = **** * Actual number of unique listings = **** * Variance = **** unique listings @ AUS$**** Repeat Listings: **** * Estimated number of repeat listings in original budget = **** * Actual number of repeat listings = **** * Variance = **** repeat listings @ AUS$**** Pursuant to Exhibit B, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-001, Version 2 Unique Figures: * Estimated number of unique figures in original budget = **** * Actual number of unique figures = **** * variance = **** unique figure @ AUS$**** **** Repeat Figures: **** * Estimated number of repeat figures in original budget = **** * Actual number of repeat figures = **** * Variance = **** repeat figure @ AUS$**** Total Estimated Service Fees to be Billed **** * Total Estimated Service Fees Not to be Billed **** Total Estimated Pass Through Expenses **** ** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project.
Appears in 1 contract
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work and reduced services pursuant to the general terms and conditions set forth in the Agreement: [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 24b-2 of the Securities Exchange Act of 19331934, as amended. Pursuant to Exhibit BA, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5-001, Version 2 Unique Tables: * Estimated number of unique tables in original budget = **** * Actual number of unique tables = **** * Variance = **** unique tables @ AUS$**** **** Repeat Tables: **** * Estimated number of repeat tables in original budget = **** * Actual number of repeat tables = **** * Variance = **** repeat table @ AUS$**** Unique Listings: **** * Estimated number of unique listings in original budget = **** * Actual number of unique listings = **** * Variance = **** unique listings @ AUS$**** Repeat Listings: **** * Estimated number of repeat listings in original budget = **** * Actual number of repeat listings = **** * Variance = **** repeat listings @ AUS$**** Pursuant to Exhibit B, Omnicare CR will provide biometrics additional Biometrics and Clinical Data Management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-001PEP005- 004, Version 2 3 Additional Analysis: Tables produced for time to resolution and summary of mild and moderate local skin reactions: • 1 Unique Figures: * Estimated number of unique figures in original budget = Table @ $**** * Actual number of unique figures = $ **** * variance = • 2 Repeat Tables @ $**** unique figure @ AUS$$ **** • Data Entry — Contracted units **** Repeat Figures: *, Actual **** * Estimated number of repeat figures in original budget = **** * Actual number of repeat figures = **** * , Variance = **** repeat figure @ AUS$$****/unit $ **** • QC Data Review — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Query Resolution — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Dictionary Coding of AEs — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Dictionary Coding of Meds — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • PK Lab Load (Subsequent) — Contracted units ****, Actual ****, Variance = **** @ $****/unit **** • PK Lab Visit Verification — Contracted units ****, Actual ****, Variance = **** @ $****/unit **** • Local Lab (Initial) — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Local Lab (Subsequent) — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** Total Estimated Service Fees to be Billed $ **** * Total Estimated Service Fees Not to be Billed **** Total Estimated Pass Through Expenses **** ** Total Estimated Budget $ **** 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. **** 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 24b-2 of the Securities Exchange Act of 1934, as amended.
Appears in 1 contract