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 A, Omnicare CR will provide additional Biometrics and Clinical Data Management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-004, Version 3 Additional Analysis: Tables produced for time to resolution and summary of mild and moderate local skin reactions: • 1 Unique Table @ $**** • 2 Repeat Tables @ $**** Clinical Data Management Final Reconciliation: $ $ **** **** • Data Entry — Contracted units ****, Actual ****, Variance = **** @ $****/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 $ **** * 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 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 AF, Omnicare CR will provide additional Biometrics and Clinical Data Management services to support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-004008, Final Version 3 Additional Analysis: Tables produced for time to resolution and summary of mild and moderate local skin reactions3, Dated 8 th May 2006 Biometrics: • 1 Unique Table @ $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 **** • 2 Repeat Tables @ $Fees: • **** Clinical Data Management Final Reconciliation: $ $ hours Statistician (India) @ A$****/hr **** • **** hours Team Leader @ A$****/hr **** • Data Entry — Contracted units Entry: Original Units ****, ; Actual Units ****, Variance * = **** @ $****/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 Data Review: Original Units ****, ; Actual Units ****, Variance * = **** units @ $****/unit **** • Local Lab (Initial) — Contracted units QC Full: Original Units ****, ; Actual Units ****, Variance * = **** units @ $****/unit $ **** • Local Lab (Subsequent) — Contracted units CRF Tracking: Original Units ****, ; Actual Units ****, Variance * = **** 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 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. **** 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 A, Omnicare CR will provide additional Biometrics and Clinical Data Management biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-004, Version 3 Additional AnalysisUnique Tables: Tables produced for time to resolution and summary * Estimated number of mild and moderate local skin reactions: • 1 Unique Table @ $unique tables in original budget = **** • 2 Repeat Tables @ $* Actual number of unique tables = **** Clinical Data Management Final Reconciliation: $ $ **** **** • Data Entry — Contracted units ****, Actual ****, Variance = **** unique tables @ $AUS$****/unit * Unique Listings: $ **** • QC Data Review — Contracted units * 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 = */unit *** * Actual number of repeat tables = **** $ **** • Query Resolution — Contracted units ****, Actual ****, * Variance = **** repeat tables @ $AUS$****/unit * Repeat Listings: $ **** • Dictionary Coding * Estimated number of AEs — Contracted units repeat listings in original budget = ****, * * Actual number of repeat listings = ****, * * Variance = **** repeat listings @ $****/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 $ AUS$**** * 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 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 AD, Omnicare CR will provide additional Biometrics and Clinical Data Management 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 # PEP005-00401 to Exhibit D, Version 3 Additional Analysis: Tables produced for time to resolution and summary of mild and moderate local skin reactions: • 1 Unique Table @ $**** • 2 Repeat Tables @ $**** the following additional Clinical Data Management Final Reconciliationactivities were performed: $ $ Data Entry **** **** • Data Entry — Contracted units **** pages @ A$****, Actual /page **** Data Review **** **** **** pages @ A$****, Variance = /page **** QC Critical Variables **** **** ****patients @ $****/unit $ /patient **** • QC Data Review — Contracted units Edit Development **** **** **** edits @ A$****, Actual /edit **** CRF Tracking **** **** **** pages @ A$****, Variance = /page **** AE Dictionary Coding **** **** **** terms @ $A$****/unit $ /term **** • Query Resolution — Contracted units Meds Dictionary Coding **** **** **** terms @ A$****, Actual /term **** Lab Load-Subsequent **** **** **** load @A$****/load **** Lab Visit Verification **** **** **** visits @ A$****, Variance = /visit **** SAE reconciliation **** **** **** SAE @ $A$****/unit $ /SAE **** • Dictionary Coding of AEs — Contracted units Protocol deviation log load **** **** **** load @ A$****/load **** For Biometrics , Actual the production of the final tables and listings included **** (****) additional unique table (****), Variance = **** @ $(****/unit $ ) additional repeat table (****) and **** • Dictionary Coding of Meds — Contracted units (****, Actual ) additional unique listing (****), Variance = at the request of the Sponsor: **** **** x unique table @ $A$****/unit $ /table **** • PK Lab Load (Subsequent) — Contracted units x repeat table @ A$****, Actual /table **** x unique listing @ A$****, Variance = /listing Total Estimated Service Fees **** @ $****/unit * Total Estimated Pass Through Expenses **** • PK Lab Visit Verification — Contracted units ****, Actual ****, Variance = * **** @ $****/unit **** • Local Lab (Initial) — Contracted units ****Certain confidential information contained in this document, Actual ****marked with four asterisks, Variance = **** @ $****/unit $ **** • Local Lab (Subsequent) — Contracted units ****has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, Actual ****, Variance = **** @ $****/unit $ **** 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 AB, Omnicare CR will provide additional Biometrics and Clinical Data Management 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 # PEP005-004001, Version 3 Additional Analysis2 Unique Figures: Tables produced for time to resolution and summary * Estimated number of mild and moderate local skin reactions: • 1 Unique Table @ $unique figures in original budget = **** • 2 Repeat Tables @ $* Actual number of unique figures = **** Clinical Data Management Final Reconciliation: $ $ * variance = **** 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 @ $****/unit $ AUS$**** • QC Data Review — Contracted units ****, Actual ****, Variance = Total Estimated Service Fees to be Billed **** @ $****/unit $ * Total Estimated Service Fees Not to be Billed **** • Query Resolution — Contracted units ****, Actual ****, Variance = Total Estimated Pass Through Expenses **** @ $****/unit $ * **** • Dictionary Coding 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 AEs — Contracted units ****the Securities Act of 1933, 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 $ **** 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 AB, Omnicare CR will provide additional Biometrics and Clinical Data Management 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 # PEP005-004001, Version 3 Additional Analysis2 Unique Figures: Tables produced for time to resolution and summary * Estimated number of mild and moderate local skin reactions: • 1 Unique Table @ $unique figures in original budget = **** • 2 Repeat Tables @ $* Actual number of unique figures = **** Clinical Data Management Final Reconciliation: $ $ * variance = **** 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 @ $****/unit $ AUS$**** • QC Data Review — Contracted units ****, Actual ****, Variance = Total Estimated Service Fees to be Billed **** @ $****/unit $ * Total Estimated Service Fees Not to be Billed **** • Query Resolution — Contracted units ****, Actual ****, Variance = Total Estimated Pass Through Expenses **** @ $****/unit $ * **** • Dictionary Coding 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 AEs — Contracted units ****the Securities Exchange Act of 1934, 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 $ **** 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 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 AF, Omnicare CR will provide additional Biometrics and Clinical Data Management services to support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-004008, Final Version 3 Additional Analysis: Tables produced for time to resolution and summary of mild and moderate local skin reactions3, Dated 8 th May 2006 Biometrics: • 1 Unique Table @ $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 **** • 2 Repeat Tables @ $Fees: • **** Clinical Data Management Final Reconciliation: $ $ hours Statistician (India) @ A$****/hr **** • **** hours Team Leader @ A$****/hr **** • Data Entry — Contracted units Entry: Original Units ****, ; Actual Units ****, Variance * = **** @ $****/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 Data Review: Original Units ****, ; Actual Units ****, Variance * = **** units @ $****/unit **** • Local Lab (Initial) — Contracted units QC Full: Original Units ****, ; Actual Units ****, Variance * = **** units @ $****/unit $ **** • Local Lab (Subsequent) — Contracted units CRF Tracking: Original Units ****, ; Actual Units ****, Variance * = **** 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 24b-2 of the Securities Exchange Act of 1934, 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. **** 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.
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Schedule of Changes. Sponsor and Omnicare Ominicare 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 AC, Omnicare CR will provide additional Biometrics and Clinical Data Management clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005PEPO05-004, Version 3 Additional Analysis: O03 Revised costing for tables and listings presented in Statistical Analysis Plan. The original proposal had an estimate of Tables produced for time to resolution and summary of mild and moderate local skin reactions: • 1 Unique Table @ $(**** • 2 Repeat Tables @ $unique/ **** Clinical Data Management Final Reconciliation: $ $ repeat), Listings (**** 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 Tables and Listings presented in 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 **** * **** • Data Entry — Contracted units ****, Actual ****, Variance = **** unique tables @ $****/unit $ /table = $**** • QC Data Review — Contracted units ****, Actual ****, Variance = * **** repeat table @ $****/unit $ /table = $**** • Query Resolution — Contracted units ****, Actual ****, Variance = * **** unique listings @ $****/unit $ /listing = $**** • Dictionary Coding of AEs — Contracted units ****, Actual ****, Variance = * **** repeat listings @ $****/unit $ /listing = $**** • Dictionary Coding of Meds — Contracted units ****, Actual ****, Variance = Service Fees not to be Invoiced **** * **** unique figure @ $****/unit /figure = ($ ****) * • PK Lab Load (Subsequent) — Contracted units ****, Actual ****, Variance = **** repeat figure @ $****/unit **** • PK Lab Visit Verification — Contracted units ****, Actual ****, Variance /figure = **** @ ($****/unit **** • Local Lab (Initial) — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Local Lab (Subsequent) — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** 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. **** 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 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 AF, Omnicare CR will provide additional Biometrics and Clinical Data Management services to support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-004008, Final Version 3 Additional Analysis: Tables produced for time to resolution and summary of mild and moderate local skin reactions3, Dated 8th May 2006 Biometrics: • 1 Unique Table @ $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 **** • 2 Repeat Tables @ $Fees: • **** Clinical Data Management Final Reconciliation: $ $ hours Statistician (India) @ A$****/hr **** • **** hours Team Leader @ A$****/hr **** • Data Entry — Contracted units Entry: Original Units ****, ; Actual Units ****, Variance * = **** @ $****/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 Data Review: Original Units ****, ; Actual Units ****, Variance * = **** units @ $****/unit **** • Local Lab (Initial) — Contracted units QC Full: Original Units ****, ; Actual Units ****, Variance * = **** units @ $****/unit $ **** • Local Lab (Subsequent) — Contracted units CRF Tracking: Original Units ****, ; Actual Units ****, Variance * = **** 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 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. **** 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 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 AD, Omnicare CR will provide additional Biometrics and Clinical Data Management clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # #PEP005-004003 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 3 Additional Analysis: Tables produced for time to resolution and summary of mild and moderate local skin reactions: • 1 Unique Table @ $**** • 2 Repeat Tables @ $**** the following additional Clinical Data Management Final Reconciliationactivities were performed: $ $ Data Entry **** **** • Data Entry — Contracted units **** pages @ A$****, Actual /page **** Data Review **** **** **** pages @ A$****, Variance = /page **** QC Critical Variables **** **** ****patients @ $****/unit $ /patient **** • QC Data Review — Contracted units Edit Development **** **** **** edits @ A$****, Actual /edit **** CRF Tracking **** **** **** pages @ A$****, Variance = /page **** AE Dictionary Coding **** **** **** terms @ $A$****/unit $ /term **** • Query Resolution — Contracted units Meds Dictionary Coding **** **** **** terms @ A$****, Actual /term **** Lab Load-Subsequent **** **** **** load @A$****/load **** Lab Visit Verification **** **** **** visits @ A$****, Variance = /visit **** SAE reconciliation **** **** **** SAE @ $A$****/unit $ /SAE **** • Dictionary Coding of AEs — Contracted units Protocol deviation log load **** **** **** load @ A$****/load **** For Biometrics, Actual the production of the final tables and listings included **** (****) additional unique table (****), Variance = **** @ $(****/unit $ ) additional repeat table (****) and **** • Dictionary Coding of Meds — Contracted units (****, Actual ) additional unique listing (****), Variance = at the request of the Sponsor: **** **** x unique table @ $A$****/unit $ /table **** • PK Lab Load (Subsequent) — Contracted units x repeat table @ A$****, Actual /table **** x unique listing @ A$****, Variance = /listing Total Estimated Service Fees **** @ $****/unit * Total Estimated Pass Through Expenses **** • PK Lab Visit Verification — Contracted units ****, Actual ****, Variance = * **** @ $****/unit **** • Local Lab (Initial) — Contracted units ****Certain confidential information contained in this document, Actual ****marked with four asterisks, Variance = **** @ $****/unit $ **** • Local Lab (Subsequent) — Contracted units ****has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, Actual ****, Variance = **** @ $****/unit $ **** 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.
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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 24b-2 of the Securities Exchange Act of 19331934, as amended. Pursuant to Exhibit AD, Omnicare CR will provide additional Biometrics and Clinical Data Management 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 # PEP005-00401 to Exhibit D, Version 3 Additional Analysis: Tables produced for time to resolution and summary of mild and moderate local skin reactions: • 1 Unique Table @ $**** • 2 Repeat Tables @ $**** the following additional Clinical Data Management Final Reconciliationactivities were performed: $ $ Data Entry **** **** • Data Entry — Contracted units **** pages @ A$****, Actual /page **** Data Review **** **** **** pages @ A$****, Variance = /page **** QC Critical Variables **** **** ****patients @ $****/unit $ /patient **** • QC Data Review — Contracted units Edit Development **** **** **** edits @ A$****, Actual /edit **** CRF Tracking **** **** **** pages @ A$****, Variance = /page **** AE Dictionary Coding **** **** **** terms @ $A$****/unit $ /term **** • Query Resolution — Contracted units Meds Dictionary Coding **** **** **** terms @ A$****, Actual /term **** Lab Load-Subsequent **** **** **** load @A$****/load **** Lab Visit Verification **** **** **** visits @ A$****, Variance = /visit **** SAE reconciliation **** **** **** SAE @ $A$****/unit $ /SAE **** • Dictionary Coding of AEs — Contracted units Protocol deviation log load **** **** **** load @ A$****/load **** For Biometrics , Actual the production of the final tables and listings included **** (****) additional unique table (****), Variance = **** @ $(****/unit $ ) additional repeat table (****) and **** • Dictionary Coding of Meds — Contracted units (****, Actual ) additional unique listing (****), Variance = at the request of the Sponsor: **** **** x unique table @ $A$****/unit $ /table **** • PK Lab Load (Subsequent) — Contracted units x repeat table @ A$****, Actual /table **** x unique listing @ A$****, Variance = /listing Total Estimated Service Fees **** @ $****/unit * Total Estimated Pass Through Expenses **** • PK Lab Visit Verification — Contracted units ****, Actual ****, Variance = * **** @ $****/unit **** • Local Lab (Initial) — Contracted units ****Certain confidential information contained in this document, Actual ****marked with four asterisks, Variance = **** @ $****/unit $ **** • Local Lab (Subsequent) — Contracted units ****has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, Actual ****, Variance = **** @ $****/unit $ **** 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.
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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 24b-2 of the Securities Exchange Act of 19331934, as amended. Pursuant to Exhibit A, Omnicare CR will provide additional Biometrics and Clinical Data Management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-PEP005- 004, Version 3 Additional Analysis: Tables produced for time to resolution and summary of mild and moderate local skin reactions: • 1 Unique Table @ $**** $ **** • 2 Repeat Tables @ $**** Clinical Data Management Final Reconciliation: $ $ **** **** • Data Entry — Contracted units ****, Actual ****, Variance = **** @ $****/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 $ **** * Total Estimated Pass Through Expenses **** ** Total Estimated Budget $ **** * 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 24b-2 of the Securities Exchange Act of 19331934, as amended.
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Schedule of Changes. Sponsor and Omnicare Ominicare 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 AC, Omnicare CR will provide additional Biometrics and Clinical Data Management clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005PEPO05-004, Version 3 Additional Analysis: O03 Revised costing for tables and listings presented in Statistical Analysis Plan. The original proposal had an estimate of Tables produced for time to resolution and summary of mild and moderate local skin reactions: • 1 Unique Table @ $(**** • 2 Repeat Tables @ $unique/ **** Clinical Data Management Final Reconciliation: $ $ repeat), Listings (**** 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 Tables and Listings presented in 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 **** * **** • Data Entry — Contracted units ****, Actual ****, Variance = **** unique tables @ $****/unit /table = $ **** • QC Data Review — Contracted units ****, Actual ****, Variance = * **** repeat table @ $****/unit $ /table = $**** • Query Resolution — Contracted units ****, Actual ****, Variance = * **** unique listings @ $****/unit $ /listing = $**** • Dictionary Coding of AEs — Contracted units ****, Actual ****, Variance = * **** repeat listings @ $****/unit $ /listing = $**** • Dictionary Coding of Meds — Contracted units ****, Actual ****, Variance = Service Fees not to be Invoiced **** * **** unique figure @ $****/unit /figure = ($ ****) * • PK Lab Load (Subsequent) — Contracted units ****, Actual ****, Variance = **** repeat figure @ $****/unit **** • PK Lab Visit Verification — Contracted units ****, Actual ****, Variance /figure = **** @ ($****/unit **** • Local Lab (Initial) — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Local Lab (Subsequent) — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** 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. **** 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.
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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 A, Omnicare CR will provide additional Biometrics and Clinical Data Management biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-004, Version 3 Additional AnalysisUnique Tables: Tables produced for time to resolution and summary * Estimated number of mild and moderate local skin reactions: • 1 Unique Table @ $unique tables in original budget = **** • 2 Repeat Tables @ $**** Clinical Data Management Final Reconciliation: $ $ **** * Actual number of unique tables = **** • Data Entry — Contracted units ****, Actual ****, * Variance = **** unique tables @ $AUS$****/unit * Unique Listings: $ **** • QC Data Review — Contracted units * 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 = */unit *** $ **** • Query Resolution — Contracted units * Actual number of repeat tables = ****, Actual ****, * * Variance = **** repeat tables @ $AUS$****/unit * Repeat Listings: $ **** • Dictionary Coding * Estimated number of AEs — Contracted units repeat listings in original budget = ****, * * Actual number of repeat listings = ****, * * Variance = **** repeat listings @ $****/unit $ AUS$**** • Dictionary Coding of Meds — Contracted units ****, Actual ****, Variance = Total Estimated Service Fees to be Billed **** @ $****/unit $ * Total Estimated Service Fees Not to be Billed **** • PK Lab Load (Subsequent) — Contracted units ****, Actual ****, Variance = Total Estimated Pass Through Expenses **** @ $****/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.
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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 A, Omnicare CR will provide additional Biometrics and Clinical Data Management biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-004, Version 3 Additional AnalysisUnique Tables: Tables produced for time to resolution and summary * Estimated number of mild and moderate local skin reactions: • 1 Unique Table @ $unique tables in original budget = **** • 2 Repeat Tables @ $**** Clinical Data Management Final Reconciliation: $ $ **** * Actual number of unique tables = **** • Data Entry — Contracted units ****, Actual ****, * Variance = **** unique tables @ $AUS$****/unit * Unique Listings: $ **** • QC Data Review — Contracted units * 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 = */unit *** $ **** • Query Resolution — Contracted units * Actual number of repeat tables = ****, Actual ****, * * Variance = **** repeat tables @ $AUS$****/unit * Repeat Listings: $ **** • Dictionary Coding * Estimated number of AEs — Contracted units repeat listings in original budget = ****, * * Actual number of repeat listings = ****, * * Variance = **** repeat listings @ $****/unit $ AUS$**** • Dictionary Coding of Meds — Contracted units ****, Actual ****, Variance = Total Estimated Service Fees to be Billed **** @ $****/unit $ * Total Estimated Service Fees Not to be Billed **** • PK Lab Load (Subsequent) — Contracted units ****, Actual ****, Variance = Total Estimated Pass Through Expenses **** @ $****/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 24b-2 of the Securities Exchange Act of 19331934, as amended.
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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 AB, Omnicare CR will provide additional Biometrics and Clinical Data Management 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 # PEP005-004001, Version 3 Additional Analysis2 Unique Figures: Tables produced for time to resolution and summary * Estimated number of mild and moderate local skin reactions: • 1 Unique Table @ $unique figures in original budget = **** • 2 Repeat Tables @ $* Actual number of unique figures = **** Clinical Data Management Final Reconciliation: $ $ * variance = **** 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 @ $****/unit $ AUS$**** • QC Data Review — Contracted units ****, Actual ****, Variance = Total Estimated Service Fees to be Billed **** @ $****/unit $ * Total Estimated Service Fees Not to be Billed **** • Query Resolution — Contracted units ****, Actual ****, Variance = Total Estimated Pass Through Expenses **** @ $****/unit $ * **** • Dictionary Coding 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 AEs — Contracted units ****the Securities Act of 1933, 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 $ **** 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 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 A, Omnicare CR will provide additional Biometrics and Clinical Data Management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-PEP005- 004, Version 3 Additional Analysis: Tables produced for time to resolution and summary of mild and moderate local skin reactions: • 1 Unique Table @ $**** $ **** • 2 Repeat Tables @ $**** Clinical Data Management Final Reconciliation: $ $ **** **** • Data Entry — Contracted units ****, Actual ****, Variance = **** @ $****/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 $ **** * Total Estimated Pass Through Expenses **** ** Total Estimated Budget $ **** * 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 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 AC, Omnicare CR will provide additional Biometrics and Clinical Data Management clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005PEPO05-004, Version 3 Additional Analysis: O03 Revised costing for tables and listings presented in Statistical Analysis Plan. The original proposal had an estimate of Tables produced for time to resolution and summary of mild and moderate local skin reactions: • 1 Unique Table @ $(**** • 2 Repeat Tables @ $unique/ **** Clinical Data Management Final Reconciliation: $ $ repeat), Listings (**** 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 Tables and Listings presented in 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 **** * **** • Data Entry — Contracted units ****, Actual ****, Variance = **** unique tables @ $****/unit /table = $ **** • QC Data Review — Contracted units ****, Actual ****, Variance = * **** repeat table @ $****/unit $ /table = $**** • Query Resolution — Contracted units ****, Actual ****, Variance = * **** unique listings @ $****/unit $ /listing = $**** • Dictionary Coding of AEs — Contracted units ****, Actual ****, Variance = * **** repeat listings @ $****/unit $ /listing = $**** • Dictionary Coding of Meds — Contracted units ****, Actual ****, Variance = Service Fees not to be Invoiced **** * **** unique figure @ $****/unit /figure = ($ ****) * • PK Lab Load (Subsequent) — Contracted units ****, Actual ****, Variance = **** repeat figure @ $****/unit **** • PK Lab Visit Verification — Contracted units ****, Actual ****, Variance /figure = **** @ ($****/unit **** • Local Lab (Initial) — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Local Lab (Subsequent) — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** 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. **** 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.
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