Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work pursuant to the general terms and conditions set forth in the Agreement: [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Pursuant to Exhibit D, Omnicare CR will provide clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP005-003 Upon the conduct of the final reconciliation of tasks performed for Sponsor and comparing estimates with Exhibit D and change Order # 01 to Exhibit D, the following additional Clinical Data Management activities were performed: Data Entry **** **** **** pages @ A$****/page **** Data Review **** **** **** pages @ A$****/page **** QC Critical Variables **** **** ****patients @ $****/patient **** Edit Development **** **** **** edits @ A$****/edit **** CRF Tracking **** **** **** pages @ A$****/page **** AE Dictionary Coding **** **** **** terms @ A$****/term **** Meds Dictionary Coding **** **** **** terms @ A$****/term **** Lab Load-Subsequent **** **** **** load @A$****/load **** Lab Visit Verification **** **** **** visits @ A$****/visit **** SAE reconciliation **** **** **** SAE @ A$****/SAE **** Protocol deviation log load **** **** **** load @ A$****/load **** For Biometrics, the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** **** x unique table @ A$****/table **** x repeat table @ A$****/table **** x unique listing @ A$****/listing Total Estimated Service Fees **** * Total Estimated Pass Through Expenses **** ** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project.
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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. 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 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: Data Entry **** **** unique table @ $**** unique table **** * **** unique listing @ $**** unique listings **** * **** repeat tables @ $**** repeat table **** 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 **** ** **** 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. * 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 **** Total Estimated Service Fees to be Provided **** * Total Estimated Pass Through Expanses **** ** * 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.
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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. 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 moderate local skin reactions: • 1 Unique Table @ $**** • 2 Repeat Tables @ $**** Clinical Data Management activities were performedFinal Reconciliation: 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$****/listing Total Estimated Service Fees **** * Total Estimated Pass Through Expenses **** ** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work pursuant to the general terms and conditions set forth in the Agreement: [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK] **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Pursuant to Exhibit D, Omnicare CR will provide clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP005-PEP005- 003 Upon the conduct of the final reconciliation of tasks performed for Sponsor and comparing estimates with Exhibit D and change Order # 01 to Exhibit D, the following additional Clinical Data Management activities were performed: Data Entry **** **** **** pages @ A$****/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$****/load **** For BiometricsBiometrics , the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** **** x unique table @ A$****/table **** x repeat table @ A$****/table **** x unique listing @ A$****/listing Total Estimated Service Fees **** * Total Estimated Pass Through Expenses **** ** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project.
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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 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: 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$****/load **** For BiometricsBiometrics , the production of the final tables and listings included **** (****) additional unique table (****), **** (****) additional repeat table (****) and **** (****) additional unique listing (****), at the request of the Sponsor: **** **** x unique table @ A$****/table **** x repeat table @ A$****/table **** x unique listing @ A$****/listing Total Estimated Service Fees **** * Total Estimated Pass Through Expenses **** ** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 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.
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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 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 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: Data Entry **** **** unique table @ $**** unique table **** * **** unique listing @ $**** unique listings **** * **** repeat tables @ $**** repeat table **** 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 **** ** **** 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. * 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 **** * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project.
Appears in 1 contract
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes and additional work 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 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 Clinical Data Management activities were performedmoderate local skin reactions: Data Entry • 1 Unique Table @ $**** $ **** • 2 Repeat Tables @ $**** pages @ A$$ **** • 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 $ **** 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.
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