Common use of Schedule of Changes Clause in Contracts

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. References Changes and/or Additions Estimated Service Fee (AS) Pursuant to Exhibit D, Omnicare CR will provide clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP005- 003 Upon the conduct of the final reconciliation of tasks performed for Sponsor and comparing estimates with Exhibit D and change Order # 01 to Exhibit D, the following additional Clinical Data Management activities were performed: Activity Contracted Units Actual Units Difference Data Entry **** **** **** pages @ A$****/page **** Data Review **** **** **** pages @ A$****/page **** QC Critical Variables **** **** ****patients @ $****/patient **** Edit Development **** **** **** edits @ A$****/edit **** CRF Tracking **** **** **** pages @ A$****/page **** AE Dictionary Coding **** **** **** terms @ A$****/term **** Meds Dictionary Coding **** **** **** terms @ A$****/term **** Lab Load-Subsequent **** **** **** load @A$****/load **** Lab Visit Verification **** **** **** visits @ A$****/visit **** SAE reconciliation **** **** **** SAE @ A$****/SAE **** Protocol deviation log load **** **** **** load @ A$****/load **** For Biometrics , the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** **** x unique table @ A$****/table **** x repeat table @ A$****/table **** x unique listing @ A$****/listing Total Estimated Service Fees **** * Total Estimated Pass Through Expenses **** ** 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.

Appears in 1 contract

Samples: Change (Peplin Inc)

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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. References Reference Changes and/or Additions Estimated Service Fee (ASAUS$) Pursuant to Exhibit D, C Omnicare CR will provide additional clinical data Reconciliation of final clinical data management and biometrics activities. management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, . Protocol #PEP005- 003 Upon PEP005-002 For biometrics, the conduct of the final reconciliation of tasks additional work performed for Sponsor and comparing estimates with Exhibit D and change Order # 01 to Exhibit D, the following additional Clinical Data Management activities were performedfinal efficacy analysis includes: Activity Contracted Units Actual Units Difference Data Entry **** **** unique table @ $**** unique table **** * **** unique listing @ $**** unique listings **** * **** repeat tables @ $**** repeat table **** Biometrics Total **** For clinical data management support: Not covered in the original contract, an additional Protocol Deviation Log Load = **** loads @ $****/load **** The increase in cost for additional units processed will be as follows: * Data Entry: from **** pages to **** pages. = Additional **** pages @ A$$**** / page **** * Data Review: from **** pages to **** pages = Additional **** pages @ $****/page **** Data Review * QC Full: from **** patients to **** patients = Additional **** pages @ A$****/page **** QC Critical Variables **** **** ****patients @ $****/patient **** Edit Development * QC Critical Variables: from **** to **** patients = Additional **** patients @ $****/patient **** * Edit Development: from **** to **** edits = Additional **** edits @ A$$****/edit **** * CRF Tracking Tracking: from **** to **** pages = Additional **** pages @ A$$****/page **** AE Dictionary Coding **** **** **** terms @ A$****/term **** Meds Dictionary Coding **** **** **** terms @ A$****/term **** Lab Load-Subsequent **** **** **** load @A$****/load **** Lab Visit Verification **** **** **** visits @ A$****/visit **** SAE reconciliation **** **** **** SAE @ A$****/SAE **** Protocol deviation log load **** **** **** load @ A$****/load **** For Biometrics , the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** **** x unique table @ A$****/table **** x repeat table @ A$****/table **** x unique listing @ A$****/listing Total Estimated Service Fees **** * Total Estimated Pass Through Expenses **** ** Total Estimated budget **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 24b-2 of the Securities Exchange Act of 19331934, as amended. Estimated Service Reference Changes and/or Additions Fee (AUS$) * Dictionary coding of meds: from **** terms to **** terms = Additional **** terms @ $****/term **** * Lab load- subsequent: from **** loads to **** loads = Additional **** load @ $****/load **** * Lab visit verification: from **** to **** visits = Additional **** visits @ $****/visit **** Decrease in cost will be as follows: * Dictionary coding of AEs: from **** terms to **** terms = decrease **** terms @ $****/term **** * SAE Reconciliation: **** SAEs to ****SAEs = decrease **** SAE @ $****/SAE **** Clinical Date Management Total **** Total Estimated Service Fees to be Provided **** * Total Estimated Service Fees not to be provided **** Total Estimated Pass Through Expanses **** ** 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.

Appears in 1 contract

Samples: Change (Peplin Inc)

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. References Reference Changes and/or Additions Estimated Service Fee (ASAUS$) Pursuant to Exhibit DA, Omnicare CR will provide clinical data management additional Biometrics and Clinical Data Management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol ## PEP005- 003 Upon the conduct 004, Version 3 Additional Analysis: Tables produced for time to resolution and summary of the final reconciliation of tasks performed for Sponsor mild and comparing estimates with Exhibit D and change Order # 01 to Exhibit D, the following additional Clinical Data Management activities were performedmoderate local skin reactions: Activity Contracted Units Actual Units Difference Data Entry • 1 Unique Table @ $**** $ **** • 2 Repeat Tables @ $**** pages @ A$$ **** Clinical Data Management Final Reconciliation: • Data Entry — Contracted units ****/page , Actual ****, Variance = **** Data Review **** **** **** pages @ A$****/page **** QC Critical Variables **** **** ****patients @ $****/patient /unit $ **** Edit Development • QC Data Review — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Query Resolution — Contracted units ****, Actual ****, Variance = **** edits @ A$$****/edit /unit $ **** CRF Tracking • Dictionary Coding of AEs — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Dictionary Coding of Meds — Contracted units ****, Actual ****, Variance = **** pages @ A$$****/page /unit $ **** AE Dictionary Coding • PK Lab Load (Subsequent) — Contracted units ****, Actual ****, Variance = **** @ $****/unit **** • PK Lab Visit Verification — Contracted units ****, Actual ****, Variance = **** terms @ A$$****/term /unit **** Meds Dictionary Coding • Local Lab (Initial) — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Local Lab (Subsequent) — Contracted units ****, Actual ****, Variance = **** terms @ A$$****/term /unit $ **** Lab Load-Subsequent **** **** **** load @A$****/load **** Lab Visit Verification **** **** **** visits @ A$****/visit **** SAE reconciliation **** **** **** SAE @ A$****/SAE **** Protocol deviation log load **** **** **** load @ A$****/load **** For Biometrics , the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** **** x unique table @ A$****/table **** x repeat table @ A$****/table **** x unique listing @ A$****/listing Total Estimated Service Fees $ **** * Total Estimated Pass Through Expenses **** ** Total Estimated budget 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

Samples: Change (Peplin Inc)

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. References Reference Changes and/or Additions Estimated Service Fee (ASAUS$) Pursuant to Exhibit DA, Omnicare CR will provide clinical data management additional Biometrics and Clinical Data Management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP005- 003 Upon the conduct # PEP005-004, Version 3 Additional Analysis: Tables produced for time to resolution and summary of the final reconciliation of tasks performed for Sponsor mild and comparing estimates with Exhibit D and change Order # 01 to Exhibit D, the following additional moderate local skin reactions: • 1 Unique Table @ $**** • 2 Repeat Tables @ $**** Clinical Data Management activities were performedFinal Reconciliation: Activity Contracted Units Actual Units Difference Data Entry $ $ **** **** • Data Entry — Contracted units ****, Actual ****, Variance = **** pages @ A$****/page **** Data Review **** **** **** pages @ A$****/page **** QC Critical Variables **** **** ****patients @ $****/patient /unit $ **** Edit Development • QC Data Review — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Query Resolution — Contracted units ****, Actual ****, Variance = **** edits @ A$$****/edit /unit $ **** CRF Tracking • Dictionary Coding of AEs — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Dictionary Coding of Meds — Contracted units ****, Actual ****, Variance = **** pages @ A$$****/page /unit $ **** AE Dictionary Coding • PK Lab Load (Subsequent) — Contracted units ****, Actual ****, Variance = **** @ $****/unit **** • PK Lab Visit Verification — Contracted units ****, Actual ****, Variance = **** terms @ A$$****/term /unit **** Meds Dictionary Coding • Local Lab (Initial) — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Local Lab (Subsequent) — Contracted units ****, Actual ****, Variance = **** terms @ A$$****/term /unit $ **** Lab Load-Subsequent **** **** **** load @A$****/load **** Lab Visit Verification **** **** **** visits @ A$****/visit **** SAE reconciliation **** **** **** SAE @ A$****/SAE **** Protocol deviation log load **** **** **** load @ A$****/load **** For Biometrics , the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** **** x unique table @ A$****/table **** x repeat table @ A$****/table **** x unique listing @ A$****/listing Total Estimated Service Fees $ **** * Total Estimated Pass Through Expenses **** ** Total Estimated budget 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

Samples: Change (Peplin Inc)

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. References Changes and/or Additions Estimated Service Fee (AS) Pursuant to Exhibit D, Omnicare CR will provide clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP005- 003 Upon the conduct of the final reconciliation of tasks performed for Sponsor and comparing estimates with Exhibit D and change Order # 01 to Exhibit D, the following additional Clinical Data Management activities were performed: Activity Contracted Units Actual Units Difference Data Entry **** **** **** pages @ A$****/page **** Data Review **** **** **** pages @ A$****/page **** QC Critical Variables **** **** ****patients @ $****/patient **** Edit Development **** **** **** edits @ A$****/edit **** CRF Tracking **** **** **** pages @ A$****/page **** AE Dictionary Coding **** **** **** terms @ A$****/term **** Meds Dictionary Coding **** **** **** terms @ A$****/term **** Lab Load-Subsequent **** **** **** load @A$****/load **** Lab Visit Verification **** **** **** visits @ A$****/visit **** SAE reconciliation **** **** **** SAE @ A$****/SAE **** Protocol deviation log load **** **** **** load @ A$****/load **** For Biometrics , the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** **** x unique table @ A$****/table **** x repeat table @ A$****/table **** x unique listing @ A$****/listing Total Estimated Service Fees **** * Total Estimated Pass Through Expenses **** ** 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 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

Samples: Change (Peplin Inc)

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. References Reference Changes and/or Additions Estimated Service Fee (ASA$) Pursuant to Exhibit DF, Omnicare CR will provide clinical data management additional services to support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP005- 003 Upon the conduct # PEP005-008, Final Version 3, Dated 8 th May 2006 Biometrics: • Additional Statistical Analysis — • The following will be performed: • End of Study clinical response of the final reconciliation of tasks performed for Sponsor and comparing estimates with Exhibit D and change Order # 01 to Exhibit D, the following additional Clinical Data Management activities were performed: Activity Contracted Units Actual Units Difference Data Entry Day **** vs Day **** subjects and all subjects • End of Study histological response of the Day **** pages vs Day **** subjects and all subjects • Baseline vs End of Study Erythema LSR • Baseline vs End of Study Desquamation LSR • Baseline vs End of Study Swelling LSR • Baseline vs End of Study Vesiculation/Pustulation LSR • Baseline vs End of Study Erosion/ Ulceration LSR • Baseline vs End of Study Pigmentation LSR • Baseline vs End of Study Scarring LSR • Final delivery would be statistical output and a short description of methology used • Provided to Sponsor by end of **** • Fees: • **** hours Statistician (India) @ A$****/page /hr **** Data Review **** **** **** pages hours Team Leader @ A$****/page /hr **** QC Critical Variables Clinical Data Management: • Data Entry: Original Units ****; Actual Units **** = **** ****patients units @ $****/patient /unit **** Edit Development • Data Review: Original Units ****; Actual Units **** = **** units @ $****/unit **** edits @ A$• QC Full: Original Units ****/edit ; Actual Units **** CRF Tracking = **** units @ $****/unit **** • CRF Tracking: Original Units ****; Actual Units **** pages = **** units @ A$$****/page **** AE Dictionary Coding **** **** **** terms @ A$****/term **** Meds Dictionary Coding **** **** **** terms @ A$****/term **** Lab Load-Subsequent **** **** **** load @A$****/load **** Lab Visit Verification **** **** **** visits @ A$****/visit **** SAE reconciliation **** **** **** SAE @ A$****/SAE **** Protocol deviation log load **** **** **** load @ A$****/load **** For Biometrics , the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** **** x unique table @ A$****/table **** x repeat table @ A$****/table **** x unique listing @ A$****/listing Total Estimated Service Fees **** * Total Estimated Pass Through Expenses **** ** Total Estimated budget /unit **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Reference Changes and/or Additions Estimated Service Fee (A$) 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 **** 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.

Appears in 1 contract

Samples: Change (Peplin Inc)

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. References Reference Changes and/or Additions Estimated Service Fee (ASAUS$) Pursuant to Exhibit DA, Omnicare CR will provide clinical data management additional Biometrics and Clinical Data Management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol ## PEP005- 003 Upon the conduct 004, Version 3 Additional Analysis: Tables produced for time to resolution and summary of the final reconciliation of tasks performed for Sponsor mild and comparing estimates with Exhibit D and change Order # 01 to Exhibit D, the following additional Clinical Data Management activities were performedmoderate local skin reactions: Activity Contracted Units Actual Units Difference Data Entry • 1 Unique Table @ $**** $ **** • 2 Repeat Tables @ $**** pages @ A$$ **** Clinical Data Management Final Reconciliation: • Data Entry — Contracted units ****/page , Actual ****, Variance = **** Data Review **** **** **** pages @ A$****/page **** QC Critical Variables **** **** ****patients @ $****/patient /unit $ **** Edit Development • QC Data Review — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Query Resolution — Contracted units ****, Actual ****, Variance = **** edits @ A$$****/edit /unit $ **** CRF Tracking • Dictionary Coding of AEs — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Dictionary Coding of Meds — Contracted units ****, Actual ****, Variance = **** pages @ A$$****/page /unit $ **** AE Dictionary Coding • PK Lab Load (Subsequent) — Contracted units ****, Actual ****, Variance = **** @ $****/unit **** • PK Lab Visit Verification — Contracted units ****, Actual ****, Variance = **** terms @ A$$****/term /unit **** Meds Dictionary Coding • Local Lab (Initial) — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • Local Lab (Subsequent) — Contracted units ****, Actual ****, Variance = **** terms @ A$$****/term /unit $ **** Lab Load-Subsequent **** **** **** load @A$****/load **** Lab Visit Verification **** **** **** visits @ A$****/visit **** SAE reconciliation **** **** **** SAE @ A$****/SAE **** Protocol deviation log load **** **** **** load @ A$****/load **** For Biometrics , the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** **** x unique table @ A$****/table **** x repeat table @ A$****/table **** x unique listing @ A$****/listing Total Estimated Service Fees $ **** * Total Estimated Pass Through Expenses **** ** Total Estimated budget 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

Samples: Change (Peplin Inc)

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. References Changes and/or Additions Estimated Service Fee Reference Changes aud/or Additions (ASA$) Pursuant to Exhibit DF, Omnicare CR will provide clinical data management additional services to support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP005- 003 Upon the conduct # PEP005-008, Final Version 3, Dated 8th May 2006 Biometrics: • Additional Statistical Analysis — • The following will be performed: • End of Study clinical response of the final reconciliation of tasks performed for Sponsor and comparing estimates with Exhibit D and change Order # 01 to Exhibit D, the following additional Clinical Data Management activities were performed: Activity Contracted Units Actual Units Difference Data Entry Day **** vs Day **** subjects and all subjects • End of Study histological response of the Day **** pages vs Day **** subjects and all subjects • Baseline vs End of Study Erythema LSR • Baseline vs End of Study Desquamation LSR • Baseline vs End of Study Swelling LSR • Baseline vs End of Study Vesiculation/Pustulation LSR • Baseline vs End of Study Erosion/ Ulceration LSR • Baseline vs End of Study Pigmentation LSR • Baseline vs End of Study Scarring LSR • Final delivery would be statistical output and a short description of methology used • Provided to Sponsor by end of **** • Fees: • **** hours Statistician (India) @ A$****/page /hr **** Data Review **** **** **** pages hours Team Leader @ A$****/page /hr **** QC Critical Variables Clinical Data Management: • Data Entry: Original Units ****; Actual Units **** = **** ****patients units @ $****/patient /unit **** Edit Development • Data Review: Original Units ****; Actual Units **** = **** units @ $****/unit **** edits @ A$• QC Full: Original Units ****/edit ; Actual Units **** CRF Tracking = **** units @ $****/unit **** • CRF Tracking: Original Units ****; Actual Units **** pages = **** units @ A$$****/page **** AE Dictionary Coding **** **** **** terms @ A$****/term **** Meds Dictionary Coding **** **** **** terms @ A$****/term **** Lab Load-Subsequent **** **** **** load @A$****/load **** Lab Visit Verification **** **** **** visits @ A$****/visit **** SAE reconciliation **** **** **** SAE @ A$****/SAE **** Protocol deviation log load **** **** **** load @ A$****/load **** For Biometrics , the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** **** x unique table @ A$****/table **** x repeat table @ A$****/table **** x unique listing @ A$****/listing Total Estimated Service Fees **** * Total Estimated Pass Through Expenses **** ** Total Estimated budget /unit **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Estimated Service Fee Reference Changes and/or Additions (A$) 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 **** 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.

Appears in 1 contract

Samples: Change (Peplin Inc)

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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 of the Securities Act of 1933, as amended. Estimated Service References Changes and/or Additions Estimated Service Fee (AS) Pursuant to Exhibit D, Omnicare CR will provide clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP005- PEP005-003 Upon the conduct of the final reconciliation of tasks performed for Sponsor and comparing estimates with Exhibit D and change Order # 01 to Exhibit D, the following additional Clinical Data Management activities were performed: Activity Contracted Units Actual Units Difference Data Entry **** **** **** pages @ A$****/page **** Data Review **** **** **** pages @ A$****/page **** QC Critical Variables **** **** ****patients @ $****/patient **** Edit Development **** **** **** edits @ A$****/edit **** CRF Tracking **** **** **** pages @ A$****/page **** AE Dictionary Coding **** **** **** terms @ A$****/term **** Meds Dictionary Coding **** **** **** terms @ A$****/term **** Lab Load-Subsequent **** **** **** load @A$****/load **** Lab Visit Verification **** **** **** visits @ A$****/visit **** SAE reconciliation **** **** **** SAE @ A$****/SAE **** Protocol deviation log load **** **** **** load @ A$****/load **** For Biometrics Biometrics, the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** **** x unique table @ A$****/table **** x repeat table @ A$****/table **** x unique listing @ A$****/listing Total Estimated Service Fees **** * Total Estimated Pass Through Expenses **** ** 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.

Appears in 1 contract

Samples: Change (Peplin Inc)

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. References Reference Changes and/or Additions Estimated Service Fee (ASAUS$) Pursuant to Exhibit D, C Omnicare CR will provide additional clinical data Reconciliation of final clinical data management and biometrics activities. management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, . Protocol #PEP005- 003 Upon PEP005-002 For biometrics, the conduct of the final reconciliation of tasks additional work performed for Sponsor and comparing estimates with Exhibit D and change Order # 01 to Exhibit D, the following additional Clinical Data Management activities were performedfinal efficacy analysis includes: Activity Contracted Units Actual Units Difference Data Entry **** **** unique table @ $**** unique table **** * **** unique listing @ $**** unique listings **** * **** repeat tables @ $**** repeat table **** Biometrics Total **** For clinical data management support: Not covered in the original contract, an additional Protocol Deviation Log Load = **** loads @ $****/load **** The increase in cost for additional units processed will be as follows: * Data Entry: from **** pages to **** pages. = Additional **** pages @ A$$**** / page **** * Data Review: from **** pages to **** pages = Additional **** pages @ $****/page **** Data Review * QC Full: from **** patients to **** patients = Additional **** pages @ A$****/page **** QC Critical Variables **** **** ****patients @ $****/patient **** Edit Development * QC Critical Variables: from **** to **** patients = Additional **** patients @ $****/patient **** * Edit Development: from **** to **** edits = Additional **** edits @ A$$****/edit **** * CRF Tracking Tracking: from **** to **** pages = Additional **** pages @ A$$****/page **** AE Dictionary Coding **** **** **** terms @ A$****/term **** Meds Dictionary Coding **** **** **** terms @ A$****/term **** Lab Load-Subsequent **** **** **** load @A$****/load **** Lab Visit Verification **** **** **** visits @ A$****/visit **** SAE reconciliation **** **** **** SAE @ A$****/SAE **** Protocol deviation log load **** **** **** load @ A$****/load **** For Biometrics , the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** **** x unique table @ A$****/table **** x repeat table @ A$****/table **** x unique listing @ A$****/listing Total Estimated Service Fees **** * Total Estimated Pass Through Expenses **** ** Total Estimated budget **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Estimated Service Reference Changes and/or Additions Fee (AUS$) * Dictionary coding of meds: from **** terms to **** terms = Additional **** terms @ $****/term **** * Lab load- subsequent: from **** loads to **** loads = Additional **** load @ $****/load **** * Lab visit verification: from **** to **** visits = Additional **** visits @ $****/visit **** Decrease in cost will be as follows: * Dictionary coding of AEs: from **** terms to **** terms = decrease **** terms @ $****/term **** * SAE Reconciliation: **** SAEs to ****SAEs = decrease **** SAE @ $****/SAE **** Clinical Date Management Total **** Total Estimated Service Fees to be Provided **** * Total Estimated Service Fees not to be provided **** Total Estimated Pass Through Expanses **** ** 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.

Appears in 1 contract

Samples: Change (Peplin Inc)

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. References Estimated Service Reference Changes and/or Additions Estimated Service Fee (ASAUS$) Pursuant to Exhibit D, C Omnicare CR will provide additional clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, . Protocol #PEP005- 003 Upon PEP005-002 Reconciliation of final clinical data management and biometrics activities. For biometrics, the conduct of the final reconciliation of tasks additional work performed for Sponsor and comparing estimates with Exhibit D and change Order # 01 to Exhibit D, the following additional Clinical Data Management activities were performedfinal efficacy analysis includes: Activity Contracted Units Actual Units Difference Data Entry **** **** unique table @ $**** unique table **** * **** unique listing @ $**** unique listings **** * **** repeat tables @ $**** repeat table **** Biometrics Total **** For clinical data management support: Not covered in the original contract, an additional Protocol Deviation Log Load = **** loads @ $****/load **** The increase in cost for additional units processed will be as follows: * Data Entry: from **** pages to **** pages. = Additional **** pages @ A$$****/page **** * Data Review Review: from **** pages to **** pages = Additional **** pages @ A$$****/page **** * QC Critical Variables Full: from **** patients to **** patients = Additional ***** patients @ $****/patient **** Edit Development * QC Critical Variables: from **** to **** patients = Additional **** patients @ $****/patient **** * Edit Development: from **** to **** edits = Additional **** edits @ A$$****/edit **** * CRF Tracking Tracking: from **** to **** pages = Additional **** pages @ A$$****/page **** AE Dictionary Coding **** **** **** terms @ A$****/term **** Meds Dictionary Coding **** **** **** terms @ A$****/term **** Lab Load-Subsequent **** **** **** load @A$****/load **** Lab Visit Verification **** **** **** visits @ A$****/visit **** SAE reconciliation **** **** **** SAE @ A$****/SAE **** Protocol deviation log load **** **** **** load @ A$****/load **** For Biometrics , the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** **** x unique table @ A$****/table **** x repeat table @ A$****/table **** x unique listing @ A$****/listing Total Estimated Service Fees **** * Total Estimated Pass Through Expenses **** ** Total Estimated budget **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Estimated Service Reference Changes and/or Additions Fee (AUS$) * Dictionary coding of meds: from **** terms to **** terms = Additional **** terms @ $****/term **** * Lab load- subsequent: from **** loads to **** loads = Additional **** load @ $****/load **** * Lab visit verification: from **** to **** visits = Additional **** visits @ $****/visit **** Decrease in cost will be as follows: * Dictionary coding of AEs: from **** terms to **** terms = decrease **** terms @ $****/term **** * SAE Reconciliation: **** SAEs to ****SAEs = decrease **** SAE @ $****/SAE **** Clinical Date Management Total **** Total Estimated Service Fees to be Provided **** * Total Estimated Service Fees not to be provided **** Total Estimated Pass Through Expanses **** ** 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.

Appears in 1 contract

Samples: Change (Peplin Inc)

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. References Reference Changes and/or Additions Estimated Service Fee (ASA$) Pursuant to Exhibit DF, Omnicare CR will provide clinical data management additional services to support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP005- 003 Upon the conduct # PEP005-008, Final Version 3, Dated 8 th May 2006 Biometrics: • Additional Statistical Analysis — • The following will be performed: • End of Study clinical response of the final reconciliation of tasks performed for Sponsor and comparing estimates with Exhibit D and change Order # 01 to Exhibit D, the following additional Clinical Data Management activities were performed: Activity Contracted Units Actual Units Difference Data Entry Day **** vs Day **** subjects and all subjects • End of Study histological response of the Day **** pages vs Day **** subjects and all subjects • Baseline vs End of Study Erythema LSR • Baseline vs End of Study Desquamation LSR • Baseline vs End of Study Swelling LSR • Baseline vs End of Study Vesiculation/Pustulation LSR • Baseline vs End of Study Erosion/ Ulceration LSR • Baseline vs End of Study Pigmentation LSR • Baseline vs End of Study Scarring LSR • Final delivery would be statistical output and a short description of methology used • Provided to Sponsor by end of **** • Fees: • **** hours Statistician (India) @ A$****/page /hr **** Data Review **** **** **** pages hours Team Leader @ A$****/page /hr **** QC Critical Variables Clinical Data Management: • Data Entry: Original Units ****; Actual Units **** = **** ****patients units @ $****/patient /unit **** Edit Development • Data Review: Original Units ****; Actual Units **** = **** units @ $****/unit **** edits @ A$• QC Full: Original Units ****/edit ; Actual Units **** CRF Tracking = **** units @ $****/unit **** • CRF Tracking: Original Units ****; Actual Units **** pages = **** units @ A$$****/page **** AE Dictionary Coding **** **** **** terms @ A$****/term **** Meds Dictionary Coding **** **** **** terms @ A$****/term **** Lab Load-Subsequent **** **** **** load @A$****/load **** Lab Visit Verification **** **** **** visits @ A$****/visit **** SAE reconciliation **** **** **** SAE @ A$****/SAE **** Protocol deviation log load **** **** **** load @ A$****/load **** For Biometrics , the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** **** x unique table @ A$****/table **** x repeat table @ A$****/table **** x unique listing @ A$****/listing Total Estimated Service Fees **** * Total Estimated Pass Through Expenses **** ** Total Estimated budget /unit **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 24b-2 of the Securities Exchange Act of 19331934, as amended. Reference Changes and/or Additions Estimated Service Fee (A$) 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 **** 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.

Appears in 1 contract

Samples: Change (Peplin Inc)

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