Schedule of Changes. Sponsor and Omnicare CR agree to the following changes to the budget based on the final reconciliation pursuant to the general terms and conditions set forth in the Agreement: • Estimated Data Entry (actuals will be billed) >Pages in Int’l Pages **** **** **** **** **** • Data Review and Query Resolution > CRF Pages Page **** **** **** **** **** • Quality Control Check of critical variables Patient **** **** **** **** **** • Edit Development (actuals will be billed) Edits **** **** **** **** **** • CRF and Query Tracking (includes all ancillary pages; actuals will be billed) Page **** **** **** **** **** • Dictionary Coding of Adverse Event terms to MedDRA (estimated to be per patient; actuals will be billed) Term **** **** **** **** **** • Dictionary Coding of Medication terms (estimated to be per patient; actuals will be billed) Term **** **** **** **** **** Lab Visit Verification Visits **** **** **** **** **** • Reconciliation of the, Safety and Clinical Database (actuals will be billed) SAE **** **** **** **** **** * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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Samples: Clinical Services Master Agreement (Peplin Inc), Clinical Services Master Agreement (Peplin Inc)
Schedule of Changes. Sponsor and Omnicare CR agree to the following changes to the budget based on the final reconciliation pursuant to the general terms and conditions set forth in the Agreement: • Estimated Data Entry (actuals will be billed) >Pages in Int’l Pages **** **** **** **** **** • Data Review and Query Resolution > CRF Pages Page **** **** **** **** **** • Quality Control Check of critical variables Patient **** **** **** **** **** • Edit Development (actuals will be billed) Edits **** **** **** **** **** • CRF and Query Tracking (includes all ancillary pages; actuals will be billed) Page **** **** **** **** **** • Dictionary Coding of Adverse Event terms to MedDRA (estimated to be per patient; actuals will be billed) Term **** **** **** **** **** • Dictionary Coding of Medication terms (estimated to be per patient; actuals will be billed) Term **** **** **** **** **** Lab Visit Verification Visits **** **** **** **** **** • Reconciliation of the, Safety and Clinical Database (actuals will be billed) SAE **** **** **** **** **** * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 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 to the budget based on the final reconciliation and additional work pursuant to the general terms and conditions set forth in the Agreement: • Estimated Data Entry (actuals [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 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 #PEP005-002 For biometrics, the additional work performed for final efficacy analysis includes: * **** 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 billed) >Pages in Int’l Pages as follows: * Data Entry: from **** pages to **** pages. = Additional **** pages @ $**** / page **** * Data Review: from **** pages to **** pages = Additional **** pages @ $****/page **** * QC Full: from **** patients to **** patients = Additional **** patients @ $****/patient **** * QC Critical Variables: from **** to **** patients = Additional **** patients @ $****/patient **** * Edit Development: from **** to **** edits = Additional **** edits @ $****/edit **** * CRF Tracking: from **** to **** pages = Additional **** pages @ $****/page **** **** 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 **** • Data Review and Query Resolution > CRF Pages Page terms @ $****/term **** * Lab load- subsequent: from **** loads to **** loads = Additional **** load @ $****/load **** • Quality Control Check of critical variables Patient * Lab visit verification: from **** to **** visits = Additional **** visits @ $****/visit **** Decrease in cost will be as follows: * Dictionary coding of AEs: from **** • Edit Development (actuals will be billed) Edits terms to **** terms = decrease **** terms @ $****/term **** * SAE Reconciliation: **** SAEs to ****SAEs = decrease **** • CRF and Query Tracking (includes all ancillary pages; actuals will be billed) Page SAE @ $**** **** **** **** **** • Dictionary Coding of Adverse Event terms to MedDRA (estimated to be per patient; actuals will be billed) Term **** **** **** **** **** • Dictionary Coding of Medication terms (estimated to be per patient; actuals will be billed) Term **** **** **** **** **** Lab Visit Verification Visits **** **** **** **** **** • Reconciliation of the, Safety and Clinical Database (actuals will be billed) SAE **** **** **** **** /SAE **** * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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Schedule of Changes. Sponsor and Omnicare CR agree to the following changes to the budget based on the final reconciliation pursuant to the general terms and conditions set forth in the Agreement: Clinical Data Management • Estimated Data Entry (actuals will be billed) >> Pages in Int’l Pages **** **** **** **** **** • Data Review and Query Resolution > CRF Pages Page Pages **** **** **** **** **** • Quality Control Check of critical variables Patient **** **** **** **** **** • Edit Development (actuals will be billed) Edits **** **** **** **** **** • CRF and Query Tracking (includes all ancillary pages; actuals will be billed) Page **** **** **** **** **** • Dictionary Coding of Adverse Event terms to MedDRA (estimated to be per patient; actuals will be billed) Term **** **** **** **** **** • Dictionary Coding of Medication terms Terms (estimated to be per patient; actuals will be billed) Term **** **** **** **** **** Lab Visit Verification Visits **** **** **** **** **** • Reconciliation of the, the Safety and Clinical Database (actuals will be billed) SAE **** **** **** **** **** * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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Schedule of Changes. Sponsor and Omnicare CR agree to the following changes to the budget based on the final reconciliation pursuant to the general terms and conditions set forth in the Agreement: Sponsor: Pxxxxx PCN: KO1503.03 Clinical Data Management • Estimated Data Entry (actuals will be billed) >Pages in Int’l Pages **** **** **** **** **** • Data Review and Query Resolution > CRF Pages Page Pages **** **** **** **** **** • Quality Control Check of critical variables Patient **** **** **** **** **** • Edit Development (actuals will be billed) Edits **** **** **** **** **** • CRF and Query Tracking (includes all ancillary pages; actuals will be billed) Page **** **** **** **** **** • Dictionary Coding of Adverse Event terms to MedDRA (estimated to be per patient; actuals will be billed) Term **** **** **** **** **** • Dictionary Coding of Medication terms Terms (estimated to be per patient; actuals will be billed) Term **** **** **** **** **** Lab Visit Verification Visits **** **** **** **** **** • Reconciliation of the, the Safety and Clinical Database (actuals will be billed) SAE **** **** **** **** **** * The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original unit costs. ** Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project. **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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Schedule of Changes. Sponsor and Omnicare CR agree to the following changes to the budget based on the final reconciliation and additional work pursuant to the general terms and conditions set forth in the Agreement: • Estimated Data Entry (actuals will be billed) >Pages in Int’l Pages [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 @ $**** $ **** • Data Review and Query Resolution > CRF Pages Page Entry — Contracted units ****, Actual ****, Variance = **** @ $**** **** **** /unit $ **** • Quality Control Check of critical variables Patient QC Data Review — Contracted units ****, Actual ****, Variance = **** @ $**** **** **** /unit $ **** • Edit Development (actuals will be billed) Edits Query Resolution — Contracted units ****, Actual ****, Variance = **** @ $**** **** **** **** • CRF and Query Tracking (includes all ancillary pages; actuals will be billed) Page **** **** **** **** /unit $ **** • Dictionary Coding of Adverse Event terms to MedDRA (estimated to be per patient; actuals will be billed) Term AEs — Contracted units ****, Actual ****, Variance = **** @ $**** **** **** /unit $ **** • Dictionary Coding of Medication terms Meds — Contracted units ****, Actual ****, Variance = **** @ $****/unit $ **** • PK Lab Load (estimated to be per patient; actuals will be billedSubsequent) Term — 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 **** **** **** **** **** Lab Visit Verification Visits **** **** **** **** **** • Reconciliation of the, Safety and Clinical Database (actuals will be billed) SAE **** **** **** **** 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.
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