Common use of BY AND BETWEEN Clause in Contracts

BY AND BETWEEN. Xxxxxx Operations Pty Ltd. Omnicare CR, Inc. By: /s/ Xxxxx Xxxxxxx By: /s/ XXXXX X. XXXXX Name: Xxxxx Xxxxxxx Name: XXXXX X. XXXXX Title: Chief Scientific Officer and Vice President, Research & Development Title: EXECUTIVE VICE PRESIDENT GLOBAL BUSINESS DEVELOPMENT CHIEF RELATIONS OFFICER Dated: 9/8/06 Dated: 8/23/06 **** 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. Initial Sponsor Notification Form Change in Project Scope Protocol Number: PEP005-002 Date of Request: 13JUL2006 Omnicare PCN: KO1504 Omnicare Project Director: Omnicare Account Director: Sponsor Study Manager: **** **** Xxxxx Xxxxxxx Individual and Department making request: ****, Biometrics ****, Clinical Data Management Brief Description of Project Scope Change: Reconciliation of final clinical data management and biometrics activities for the PEP005-002 study. For clinical data management the final study reconciliation is attached. The estimate cost for this work is $**** For biometrics the additional work includes **** additional tables [**** (unique) and **** (repeat)] and **** additional listing (**** [unique]) requested from the round table data review. In addition it was discussed and agreed to present the efficacy data as both safety and an efficacy evaluable population due to large numbers of major protocol deviations. This work has been costed as a repeat table rate and consists of the following **** repeat tables (****, ****, ****, ****, ****, ****, ****, and ****. The estimated cost for biometrics work is $****. The overall increase for the study reconciliation is $**** Implementation of this request will affect the budget as follows (provide estimate of anticipated costs associated with change, if available) þ Increase ¨ Decrease ¨ Other (specify) The above information briefly outlines a description of the additional/changed services, which relate to the referenced study/protocol. Costs above are estimates. OCR and Sponsor will discuss in detail the budgetary and/or timeline impact of the additional/changed services within five (5) business days of receipt of acknowledgment received at OCR. þ OCR may proceed with the additional/changed services. It is understood that detail and full cost estimate will be xxxxxxxx.xx OCR. ¨ OCR may not proceed with additional/changed services. Sponsor Comments: Please acknowledge approval/refusal to proceed with the additional/changed services by sending written confirmation to the OCR Project Leader by one of the following methods: 1) signing and returning this document via fax to , or 2) sending a confirming email to the Project Leader. Sponsor Acknowledgment /s/ Xxxxx Xxxxxxx 9\8\06 Sponsor Signature Date * Notification only — not legally binding **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. PEP005-002 Final CDM Contract Reconcillation Contract Item unit unit cost A$ # units per contract contract cost actual # units actual cost difference comment Oversight — CDM manager days **** **** **** **** **** **** Oversight — Lead CDA days **** **** **** **** **** **** DMP days **** **** **** **** **** **** database development project **** **** **** **** **** **** data entry page **** **** **** **** **** **** data review page **** **** **** **** **** **** QC full patient **** **** **** **** **** **** QC critical variables patient **** **** **** **** **** **** Edit development edit **** **** **** **** **** **** includes **** lab edits CRF tracking page **** **** **** **** **** **** dictionary coding of AEs term **** **** **** **** **** **** dictionary coding of meds term **** **** **** **** **** **** lab load — initial load **** **** **** **** **** **** lab load — subsequent load **** **** **** **** **** **** lab visit verification visit **** **** **** **** **** **** SAE reconciliation SAE **** **** **** **** **** **** Protocol deviation log load load **** **** **** **** **** **** Not covered in original contract Total **** **** **** **** 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. Exhibit D to the Clinical Services Master Agreement between Xxxxxx Operations Pty Ltd. and Omnicare CR, Inc., dated 24-08-05. THIS EXHIBIT D is entered into this 24 th day of August, 2005 (“Effective Date”), by and between Xxxxxx Operations Pty Ltd. (hereinafter “Sponsor” ) and Omnicare CR, Inc. (hereinafter “Omnicare CR”).

Appears in 1 contract

Samples: Change (Peplin Inc)

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BY AND BETWEEN. Xxxxxx Operations Pty Ltd. Omnicare CR, Inc. By: /s/ Xxxxx Xxxxxxx By: /s/ XXXXX X. XXXXX Xxxxxxx Xxxxxxxxx Name: Xxxxx Xxxxxxx Name: XXXXX X. XXXXX Xxxxxxx Xxxxxxxxx Title: Chief Scientific Officer and Vice PresidentDirector, Research & Drug Development Title: EXECUTIVE VICE PRESIDENT GLOBAL BUSINESS DEVELOPMENT CHIEF RELATIONS OFFICER Pres. & Global Chief Operating Officer Dated: 9/8/06 10 February 2006 Dated: 8/23/06 2-22-06 **** 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. Initial Sponsor Notification Form Change in Project Scope Protocol Number: PEP005-002 003 Date of Request: 13JUL2006 18JAN2005 Omnicare PCN: KO1504 KO1505 Omnicare Project Director: Omnicare Account Director: Sponsor Study Manager: Sponsor Outsourcing Manager: **** **** Xxxxx Xxxxxxx Individual and Department making request: ****, Biometrics ****, Clinical Data Management Brief Description of Project Scope Change: Reconciliation of final clinical data management Revised costing for tables and biometrics activities for the PEP005-002 study. For clinical data management the final study reconciliation is attachedlistings presented in Statistical Analysis Plan. The original proposal was costed a discounted rate which will be maintained in this change of scope. The original estimate cost for this work is $**** For biometrics the additional work includes **** additional tables [**** (unique) and **** (repeat)] and **** additional listing of Tables (**** [unique]repeat), Listings (**** repeat) requested and Figures (**** repeat). Following on from the round table design of data review. In addition it was discussed displays and agreed to present the efficacy data as both safety and an efficacy evaluable population due to large numbers of major protocol deviations. This work reporting requirements there has been costed as a repeat an increase in the number of Table and Listing presented in the Statistical Analysis Plan (please see attached table rate of contents for flagging of Unique (P) and consists Repeat (S) displays). The updated count of the following Tables is **** repeat tables (and Listings is ****, ****, ****, ****, ****, ****, ****, and * repeat. The increase in cost to produce these data displays as set out in the Statistical Analysis Plan will be ****. The estimated cost for biometrics work is $****. The overall increase for the study reconciliation is $**** Implementation of this request will affect the budget as follows (provide estimate of anticipated costs associated with change, if available) þ Increase ¨ Decrease ¨ Other (specifySpecify) The above information briefly outlines a description of the additional/changed services, which relate to the referenced study/protocol. Costs above are estimates. OCR and Sponsor will discuss in detail the budgetary and/or timeline impact of the additional/changed services within five (5) business days of receipt of acknowledgment received at OCR. þ OCR may proceed with the additional/changed services. It is understood that detail and full cost estimate will be xxxxxxxx.xx OCR. ¨ OCR may not proceed with additional/changed services. Sponsor Comments: **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Initial Sponsor Notification Form Please acknowledge approval/refusal to proceed with the additional/changed services by sending written confirmation to the OCR Project Leader by one of the following methods: 1) signing and returning this document via fax to , or 2) sending a confirming email to the Project Leader. Sponsor Acknowledgment /s/ Xxxxx Xxxxxxx 9\8\06 30\1\06 Sponsor Signature Date * Notification only — not legally binding **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. PEP005-002 Final CDM Contract Reconcillation Contract Item unit unit cost A$ # units per contract contract cost actual # units actual cost difference comment Oversight — CDM manager days **** **** **** **** **** **** Oversight — Lead CDA days **** **** **** **** **** **** DMP days **** **** **** **** **** **** database development project **** **** **** **** **** **** data entry page **** **** **** **** **** **** data review page **** **** **** **** **** **** QC full patient **** **** **** **** **** **** QC critical variables patient **** **** **** **** **** **** Edit development edit **** **** **** **** **** **** includes **** lab edits CRF tracking page **** **** **** **** **** **** dictionary coding of AEs term **** **** **** **** **** **** dictionary coding of meds term **** **** **** **** **** **** lab load — initial load **** **** **** **** **** **** lab load — subsequent load **** **** **** **** **** **** lab visit verification visit **** **** **** **** **** **** SAE reconciliation SAE **** **** **** **** **** **** Protocol deviation log load load **** **** **** **** **** **** Not covered in original contract Total **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant Change Order #02 to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Exhibit D to the Clinical Services Master Agreement between Xxxxxx Operations Pty Ltd. and Omnicare CR, Inc., dated 24-08-0524 th August 2005. THIS EXHIBIT D CHANGE ORDER is entered into this 24 th 3 rd day of AugustMay, 2005 2006 (“Effective Date”), ) by and between Xxxxxx Operations Pty Ltd. (hereinafter “Sponsor” ) and Omnicare CR, Inc. (hereinafter Inc.(hereinafter “Omnicare CR”).

Appears in 1 contract

Samples: Change (Peplin Inc)

BY AND BETWEEN. Xxxxxx Operations Pty Ltd. Omnicare CR, Inc. By: /s/ Xxxxx Xxxxxxx Xxxxxxxx By: /s/ XXXXX X. XXXXX Xxxx Xxxxx Name: Xxxxx Xxxxxxx Xxxxxxxx Name: XXXXX X. XXXXX Xxxx Xxxxx Title: Chief Scientific Officer and Vice President, Research & Development Director Clinical Dev. Title: EXECUTIVE VICE PRESIDENT GLOBAL BUSINESS DEVELOPMENT CHIEF RELATIONS OFFICER CEO Dated: 9/8/06 27 November 06 Dated: 8/23/06 12/06/06 **** 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. Initial Sponsor Notification Form Change in Project Scope Protocol Number: PEP005-002 006 Date of Request: 13JUL2006 ; 16NOV2006 Omnicare PCN: KO1504 KO1605.01 Omnicare Project Director: Omnicare Account Director: Sponsor Study Manager: **** Omnicare Account Director: **** Xxxxx Sponsor Study Manager: Xxxxxxx Xxxxxxxx Sponsor Outsourcing Manager: Individual and Department making request: ****, Biometrics ****, Clinical Data Management Brief Description of Project Scope Change: Reconciliation The number of final clinical data management displays presented within the Data Monitoring Committee Statistical Analysis Plan and biometrics activities reviewed by the DMC exceeds that presented within Exhibit I. Exhibit I has 10 unique/5 repeat tables and 2 unique/0 repeat listings for the PEP005-002 study. For clinical data management the final study reconciliation is attachedDSMB SAP. The estimate current DMC SAP has 17 unique/8 repeat tables and 12 unique/4 repeat listings. This represents an increase of 7 unique tables, 3 repeat tables, 10 unique listings and 4 repeat listings with an estimated additional cost for this work is of $**** For biometrics the additional work includes **** additional tables [**** (unique) and **** (repeat)] and **** additional listing (**** [unique]) requested from the round table data reviewUSD. In addition it was discussed and agreed to present the efficacy data as both safety and an efficacy evaluable population due to large numbers of major protocol deviations. This work has been costed as a repeat table rate and consists of the following **** repeat tables (****, ****, ****, ****, ****, ****, ****, and ****. The estimated cost for biometrics work is $****. The overall increase for the study reconciliation is $**** Implementation of this request will affect þ Increase the budget as follows (provide estimate of ¨ Decrease anticipated costs associated with change, if available) þ Increase ¨ Decrease ): ¨ Other (specify) The above information briefly outlines a description of the additional/changed services, which relate to the referenced study/protocol. Costs above are estimates. OCR and Sponsor will discuss in detail the budgetary and/or timeline impact of the additional/changed services within five (5) business days of receipt of acknowledgment acknowledgement received at OCR. þ OCR may proceed with the additional/changed services. It is understood that detail and full cost estimate will be xxxxxxxx.xx provided by OCR. ¨ OCR may not proceed with additional/changed services. Sponsor Comments: Please acknowledge approval/refusal to proceed with the additional/changed services by sending written confirmation to the OCR Project Leader by one of the following methods: 1) signing and returning this document via fax to , or 2) sending a confirming email to the Project Leader. Sponsor Acknowledgment /s/ Xxxxx Xxxxxxx 9\8\06 Xxxxxxxx 17/11/06 Sponsor Signature Date * Notification only — not legally binding **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. PEP005-002 Final CDM Contract Reconcillation Contract Item unit unit cost A$ # units per contract contract cost actual # units actual cost difference comment Oversight — CDM manager days **** **** **** **** **** **** Oversight — Lead CDA days **** **** **** **** **** **** DMP days **** **** **** **** **** **** database development project **** **** **** **** **** **** data entry page **** **** **** **** **** **** data review page **** **** **** **** **** **** QC full patient **** **** **** **** **** **** QC critical variables patient **** **** **** **** **** **** Edit development edit **** **** **** **** **** **** includes **** lab edits CRF tracking page **** **** **** **** **** **** dictionary coding of AEs term **** **** **** **** **** **** dictionary coding of meds term **** **** **** **** **** **** lab load — initial load **** **** **** **** **** **** lab load — subsequent load **** **** **** **** **** **** lab visit verification visit **** **** **** **** **** **** SAE reconciliation SAE **** **** **** **** **** **** Protocol deviation log load load **** **** **** **** **** **** Not covered in original contract Total **** **** **** **** 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. Exhibit D J to the Clinical Services Master Agreement between Xxxxxx Operations Pty Ltd. Ltd and Omnicare CR, Inc., dated 24-08-05. June 1, 2005 THIS EXHIBIT D J is entered into this 24 th 5th day of AugustDecember, 2005 2006 (“Effective Date”), by and between Xxxxxx Operations Pty Ltd. Ltd (hereinafter “Sponsor) and Omnicare CR, Inc. (hereinafter “Omnicare CR”).

Appears in 1 contract

Samples: Change (Peplin Inc)

BY AND BETWEEN. Xxxxxx Pxxxxx Operations Pty Ltd. Omnicare CR, Inc. By: /s/ Xxxxx Pxxxx Xxxxxxx By: /s/ XXXXX X. XXXXX Lxxxxxx Xxxxxxxxx Name: Xxxxx Pxxxx Xxxxxxx Name: XXXXX X. XXXXX Lxxxxxx Xxxxxxxxx Title: Chief Scientific Officer and Vice PresidentDirector, Research & Drug Development Title: EXECUTIVE VICE PRESIDENT GLOBAL BUSINESS DEVELOPMENT CHIEF RELATIONS OFFICER Pres. & Global Chief Operating Officer Dated: 9/8/06 10 February 2006 Dated: 8/23/06 2-22-06 **** 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-2 406 of the Securities Exchange Act of 19341933, as amended. Initial Sponsor Notification Form Change in Project Scope Protocol Number: PEP005-002 003 Date of Request: 13JUL2006 18JAN2005 Omnicare PCN: KO1504 KO1505 Omnicare Project Director: Omnicare Account Director: Sponsor Study Manager: Sponsor Outsourcing Manager: **** **** Xxxxx Pxxxx Xxxxxxx Individual and Department making request: ****, Biometrics ****, Clinical Data Management Brief Description of Project Scope Change: Reconciliation of final clinical data management Revised costing for tables and biometrics activities for the PEP005-002 study. For clinical data management the final study reconciliation is attachedlistings presented in Statistical Analysis Plan. The original proposal was costed a discounted rate which will be maintained in this change of scope. The original estimate cost for this work is $**** For biometrics the additional work includes **** additional tables [**** (unique) and **** (repeat)] and **** additional listing of Tables (**** [unique]repeat), Listings (**** repeat) requested and Figures (**** repeat). Following on from the round table design of data review. In addition it was discussed displays and agreed to present the efficacy data as both safety and an efficacy evaluable population due to large numbers of major protocol deviations. This work reporting requirements there has been costed as a repeat an increase in the number of Table and Listing presented in the Statistical Analysis Plan (please see attached table rate of contents for flagging of Unique (P) and consists Repeat (S) displays). The updated count of the following Tables is **** repeat tables (and Listings is ****, ****, ****, ****, ****, ****, ****, and * repeat. The increase in cost to produce these data displays as set out in the Statistical Analysis Plan will be ****. The estimated cost for biometrics work is $****. The overall increase for the study reconciliation is $**** Implementation of this request will affect the budget as follows (provide estimate of anticipated costs associated with change, if available) þ Increase ¨ o Decrease ¨ o Other (specifySpecify) The above information briefly outlines a description of the additional/changed services, which relate to the referenced study/protocol. Costs above are estimates. OCR and Sponsor will discuss in detail the budgetary and/or timeline impact of the additional/changed services within five (5) business days of receipt of acknowledgment received at OCR. þ OCR may proceed with the additional/changed services. It is understood that detail and full cost estimate will be xxxxxxxx.xx pxxxxxxx.xx OCR. ¨ o OCR may not proceed with additional/changed services. Sponsor Comments: **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Initial Sponsor Notification Form Please acknowledge approval/refusal to proceed with the additional/changed services by sending written confirmation to the OCR Project Leader by one of the following methods: 1) signing and returning this document via fax to , or 2) sending a confirming email to the Project Leader. Sponsor Acknowledgment /s/ Xxxxx Pxxxx Xxxxxxx 9\8\06 30\1\06 Sponsor Signature Date * Notification only — not legally binding **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 406 of the Securities Exchange Act of 19341933, as amended. PEP005-002 Final CDM Contract Reconcillation Contract Item unit unit cost A$ # units per contract contract cost actual # units actual cost difference comment Oversight — CDM manager days **** **** **** **** **** **** Oversight — Lead CDA days **** **** **** **** **** **** DMP days **** **** **** **** **** **** database development project **** **** **** **** **** **** data entry page **** **** **** **** **** **** data review page **** **** **** **** **** **** QC full patient **** **** **** **** **** **** QC critical variables patient **** **** **** **** **** **** Edit development edit **** **** **** **** **** **** includes **** lab edits CRF tracking page **** **** **** **** **** **** dictionary coding of AEs term **** **** **** **** **** **** dictionary coding of meds term **** **** **** **** **** **** lab load — initial load **** **** **** **** **** **** lab load — subsequent load **** **** **** **** **** **** lab visit verification visit **** **** **** **** **** **** SAE reconciliation SAE **** **** **** **** **** **** Protocol deviation log load load **** **** **** **** **** **** Not covered in original contract Total **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant Change Order #02 to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Exhibit D to the Clinical Services Master Agreement between Xxxxxx Pxxxxx Operations Pty Ltd. and Omnicare CR, Inc., dated 24-08-0524th August 2005. THIS EXHIBIT D CHANGE ORDER is entered into this 24 th 3rd day of AugustMay, 2005 2006 (“Effective Date”), ) by and between Xxxxxx Pxxxxx Operations Pty Ltd. (hereinafter “Sponsor) and Omnicare CR, Inc. (hereinafter Inc.(hereinafter “Omnicare CR”).

Appears in 1 contract

Samples: Change (Peplin Inc)

BY AND BETWEEN. Xxxxxx Pxxxxx Operations Pty Ltd. Omnicare CR, Inc. By: /s/ Xxxxx Xxxxxxx JXXXXXX XXXXXXXX By: /s/ XXXXX KXXXX X. XXXXX Name: Xxxxx Xxxxxxx JXXXXXX XXXXXXXX Name: XXXXX KXXXX X. XXXXX Title: Chief Scientific Officer and Vice President, Research & Development CLINICAL RESEARCH MGR Title: EXECUTIVE VICE PRESIDENT GLOBAL BUSINESS DEVELOPMENT CHIEF RELATIONS OFFICER Dated: 9/8/06 21 February 2006 Dated: 8/23/06 3/7/06 **** 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-2 406 of the Securities Exchange Act of 19341933, as amended. Initial Sponsor Notification Form Change in Project Scope Protocol Number: PEP005-002 001 Date of Request: 13JUL2006 19OCT2005 Omnicare PCN: KO1504 KO1503 Omnicare Project Director: Omnicare Account Director: Sponsor Study Manager: Sponsor Outsourcing Manager: **** **** Xxxxx Pxxxx Xxxxxxx Individual and Department making request: ****, Biometrics ****, Clinical Data Management Brief Description of Project Scope Change: Reconciliation In order to load Pxxxxx’x log of final clinical data management and biometrics activities for the protocol deviations from monitoring of PEP005-002 study001 into the clinical database an additional Oracle Clinical module is required to be built to receive this data. For clinical data management the final study reconciliation is attached. The estimate cost for this work is $This will take as estimated **** For biometrics hours to complete and would include building the additional work includes **** additional tables [**** (unique) DCM/DCL module, loading the spreadsheet data and **** (repeat)] and **** additional listing (**** [unique]) requested from the round table data review. In addition it was discussed and agreed to present the efficacy data as both safety and an efficacy evaluable population due to large numbers QC of major protocol deviations. This work has been costed as a repeat table rate and consists of the following **** repeat tables (****, ****, ****, ****, ****, ****, ****, and ****received data. The estimated proposed cost for biometrics work is $****. The overall increase for the study reconciliation is $**** Implementation of this request will affect the budget as follows (provide estimate of anticipated costs associated with change, if available) ): þ Increase ¨ o Decrease ¨ o Other (specify) The above information briefly outlines a description of the additional/changed services, which relate to the referenced study/protocol. Costs above are estimates. OCR and Sponsor will discuss in detail the budgetary and/or timeline impact of the additional/changed services within five (5) business days of receipt of acknowledgment acknowledgement received at OCR. þ OCR may proceed with the additional/changed services. It is understood that detail and full cost estimate estimated will be xxxxxxxx.xx provided by OCR. ¨ o OCR may not proceed with additional/changed services. Sponsor Comments: Please acknowledge approval/refusal to proceed with the additional/changed services by sending written confirmation to the OCR Project Leader by one of the following methods: 1) signing and returning this document via via-fax to , or 2) sending a confirming email to the Project Leader. Sponsor Acknowledgment /s/ Xxxxx Xxxxxxx 9\8\06 JXXXXXX XXXXXXXX 25 Oct 05 Sponsor Signature Date * Notification only — not legally binding **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 406 of the Securities Exchange Act of 19341933, as amended. PEP005-002 Final CDM Contract Reconcillation Contract Item unit unit cost A$ # units per contract contract cost actual # units actual cost difference comment Oversight — CDM manager days **** **** **** **** **** **** Oversight — Lead CDA days **** **** **** **** **** **** DMP days **** **** **** **** **** **** database development project **** **** **** **** **** **** data entry page **** **** **** **** **** **** data review page **** **** **** **** **** **** QC full patient **** **** **** **** **** **** QC critical variables patient **** **** **** **** **** **** Edit development edit **** **** **** **** **** **** includes **** lab edits CRF tracking page **** **** **** **** **** **** dictionary coding of AEs term **** **** **** **** **** **** dictionary coding of meds term **** **** **** **** **** **** lab load — initial load **** **** **** **** **** **** lab load — subsequent load **** **** **** **** **** **** lab visit verification visit **** **** **** **** **** **** SAE reconciliation SAE **** **** **** **** **** **** Protocol deviation log load load **** **** **** **** **** **** Not covered in original contract Total **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant Change Order #03 to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Exhibit D B to the Clinical Services Master Agreement between Xxxxxx Pxxxxx Operations Pty Ltd. and Omnicare CR, Inc., dated 24-08-0524th Aug 2005. THIS EXHIBIT D CHANGE ORDER is entered into this 24 th 15th day of AugustDecember, 2005 (“Effective Date”), by and between Xxxxxx Pxxxxx Operations Pty Ltd. (hereinafter “Sponsor) and Omnicare CR, Inc. (hereinafter “Omnicare CR”).

Appears in 1 contract

Samples: Change (Peplin Inc)

BY AND BETWEEN. Xxxxxx Pxxxxx Operations Pty Ltd. Omnicare CR, Inc. By: /s/ Xxxxx Pxxxx Xxxxxxx By: /s/ XXXXX X. XXXXX Kxxxx Xxxxx Name: Xxxxx Pxxxx Xxxxxxx Name: XXXXX X. XXXXX Kxxxx Xxxxx Title: Chief Scientific Officer and Director, Drug Development Title: Senior Vice President, Research Global Marketing & Business Development Title: EXECUTIVE VICE PRESIDENT GLOBAL BUSINESS DEVELOPMENT CHIEF RELATIONS OFFICER Dated: 9/8/06 20/12/05 Dated: 8/23/06 1/26/06 **** 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-2 406 of the Securities Exchange Act of 19341933, as amended. Initial Sponsor Notification Form Change in Project Scope Protocol Number: PEP005-002 001 Date of Request: 13JUL2006 20XXX0000 Omnicare PCN: KO1504 KO1503 Omnicare Project Director: Omnicare Account Director: Sponsor Study Manager: Sponsor Outsourcing Manager: **** **** Xxxxx Pxxxx Xxxxxxx Individual and Department making request: ****, Biometrics ****, Clinical Data Management Writing Brief Description of Project Scope Change: Reconciliation The final number of final clinical data management tables and biometrics activities for listings represents a significant increase compared to the PEP005-002 studycontracted number of TLs (**** tables and **** listings versus **** tables and **** listings). For clinical data management More time will be required to draft the final study reconciliation is attachedClinical Study Report based on the increased number of tables and listings. The estimate cost for this This additional work is represents an additional $**** For biometrics the additional work includes **** additional tables [**** (unique) and **** (repeat)] and **** additional listing (**** [unique]) requested from the round table data review. In addition it was discussed and agreed to present the efficacy data as both safety and an efficacy evaluable population due to large numbers of major protocol deviations. This work has been costed as a repeat table rate and consists for production of the following **** repeat tables (****, ****, ****, ****, ****, ****, ****, and ****CSR. The estimated cost for biometrics work is $****. The overall increase for the study reconciliation is $**** Implementation of this request will affect the budget as follows (provide estimate of anticipated costs associated with change, if available) þ Increase ¨ o Decrease ¨ o Other (specifySpecify) The above information briefly outlines a description of the additional/changed services, which relate to the referenced study/protocol. Costs above are estimates. OCR and Sponsor will discuss in detail the budgetary and/or timeline impact of the additional/changed services within five (5) business days of receipt of acknowledgment received at OCR. þ OCR may proceed with the additional/changed services. It is understood that detail and full cost estimate will be xxxxxxxx.xx pxxxxxxx.xx OCR. ¨ o OCR may not proceed with additional/changed services. Sponsor Comments: Please acknowledge approval/refusal to proceed with the additional/changed services by sending written confirmation to the OCR Project Leader by one of the following methods: 1) signing and returning this document via fax to , or 2) sending a confirming email to the Project Leader. Sponsor Acknowledgment /s/ Xxxxx Pxxxx Xxxxxxx 9\8\06 Sponsor 30 December 2005 Sponor Signature Date * Notification only — not legally binding **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 406 of the Securities Exchange Act of 19341933, as amended. PEP005-002 Final CDM Contract Reconcillation Contract Item unit unit cost A$ Change Order # units per contract contract cost actual # units actual cost difference comment Oversight — CDM manager days **** **** **** **** **** **** Oversight — Lead CDA days **** **** **** **** **** **** DMP days **** **** **** **** **** **** database development project **** **** **** **** **** **** data entry page **** **** **** **** **** **** data review page **** **** **** **** **** **** QC full patient **** **** **** **** **** **** QC critical variables patient **** **** **** **** **** **** Edit development edit **** **** **** **** **** **** includes **** lab edits CRF tracking page **** **** **** **** **** **** dictionary coding of AEs term **** **** **** **** **** **** dictionary coding of meds term **** **** **** **** **** **** lab load — initial load **** **** **** **** **** **** lab load — subsequent load **** **** **** **** **** **** lab visit verification visit **** **** **** **** **** **** SAE reconciliation SAE **** **** **** **** **** **** Protocol deviation log load load **** **** **** **** **** **** Not covered in original contract Total **** **** **** **** 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. 4 To Exhibit D to the B To The Clinical Services Master Agreement between Xxxxxx Between Pxxxxx Operations Pty Ltd. and And Omnicare CR, Inc., dated 24-08-05Dated 24thAugust 2005. THIS EXHIBIT D CHANGE ORDER is entered into this 24 th 10th day of AugustJanuary, 2005 (“Effective Date”)2006, by and between Xxxxxx Pxxxxx Operations Pty Ltd. (hereinafter “Sponsor) and Omnicare CR, Inc. (hereinafter “Omnicare hereinafter“Omnicare CR”).

Appears in 1 contract

Samples: Change (Peplin Inc)

BY AND BETWEEN. Xxxxxx Operations Pty Ltd. Omnicare CR, Inc. By: /s/ Xxxxx Xxxxxxx Xxxxxxxx By: /s/ XXXXX X. XXXXX Xxxx Xxxxx Name: Xxxxx Xxxxxxx Xxxxxxxx Name: XXXXX X. XXXXX Xxxx Xxxxx Title: Chief Scientific Officer and Vice President, Research & Development Director Clinical Dev. Title: EXECUTIVE VICE PRESIDENT GLOBAL BUSINESS DEVELOPMENT CHIEF RELATIONS OFFICER CEO Dated: 9/8/06 27 November 06 Dated: 8/23/06 12/06/06 **** 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-2 406 of the Securities Exchange Act of 19341933, as amended. Initial Sponsor Notification Form Change in Project Scope Protocol Number: PEP005-002 006 Date of Request: 13JUL2006 ; 16NOV2006 Omnicare PCN: KO1504 KO1605.01 Omnicare Project Director: Omnicare Account Director: Sponsor Study Manager: **** Omnicare Account Director: **** Xxxxx Sponsor Study Manager: Xxxxxxx Xxxxxxxx Sponsor Outsourcing Manager: Individual and Department making request: ****, Biometrics ****, Clinical Data Management Brief Description of Project Scope Change: Reconciliation The number of final clinical data management displays presented within the Data Monitoring Committee Statistical Analysis Plan and biometrics activities reviewed by the DMC exceeds that presented within Exhibit I. Exhibit I has 10 unique/5 repeat tables and 2 unique/0 repeat listings for the PEP005-002 study. For clinical data management the final study reconciliation is attachedDSMB SAP. The estimate current DMC SAP has 17 unique/8 repeat tables and 12 unique/4 repeat listings. This represents an increase of 7 unique tables, 3 repeat tables, 10 unique listings and 4 repeat listings with an estimated additional cost for this work is of $**** For biometrics the additional work includes **** additional tables [**** (unique) and **** (repeat)] and **** additional listing (**** [unique]) requested from the round table data reviewUSD. In addition it was discussed and agreed to present the efficacy data as both safety and an efficacy evaluable population due to large numbers of major protocol deviations. This work has been costed as a repeat table rate and consists of the following **** repeat tables (****, ****, ****, ****, ****, ****, ****, and ****. The estimated cost for biometrics work is $****. The overall increase for the study reconciliation is $**** Implementation of this request will affect þ Increase the budget as follows (provide estimate of ¨ Decrease anticipated costs associated with change, if available) þ Increase ¨ Decrease ): ¨ Other (specify) The above information briefly outlines a description of the additional/changed services, which relate to the referenced study/protocol. Costs above are estimates. OCR and Sponsor will discuss in detail the budgetary and/or timeline impact of the additional/changed services within five (5) business days of receipt of acknowledgment acknowledgement received at OCR. þ OCR may proceed with the additional/changed services. It is understood that detail and full cost estimate will be xxxxxxxx.xx provided by OCR. ¨ OCR may not proceed with additional/changed services. Sponsor Comments: Please acknowledge approval/refusal to proceed with the additional/changed services by sending written confirmation to the OCR Project Leader by one of the following methods: 1) signing and returning this document via fax to , or 2) sending a confirming email to the Project Leader. Sponsor Acknowledgment /s/ Xxxxx Xxxxxxx 9\8\06 Xxxxxxxx 17/11/06 Sponsor Signature Date * Notification only — not legally binding **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 406 of the Securities Exchange Act of 1934, as amended. PEP005-002 Final CDM Contract Reconcillation Contract Item unit unit cost A$ # units per contract contract cost actual # units actual cost difference comment Oversight — CDM manager days **** **** **** **** **** **** Oversight — Lead CDA days **** **** **** **** **** **** DMP days **** **** **** **** **** **** database development project **** **** **** **** **** **** data entry page **** **** **** **** **** **** data review page **** **** **** **** **** **** QC full patient **** **** **** **** **** **** QC critical variables patient **** **** **** **** **** **** Edit development edit **** **** **** **** **** **** includes **** lab edits CRF tracking page **** **** **** **** **** **** dictionary coding of AEs term **** **** **** **** **** **** dictionary coding of meds term **** **** **** **** **** **** lab load — initial load **** **** **** **** **** **** lab load — subsequent load **** **** **** **** **** **** lab visit verification visit **** **** **** **** **** **** SAE reconciliation SAE **** **** **** **** **** **** Protocol deviation log load load **** **** **** **** **** **** Not covered in original contract Total **** **** **** **** 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 19341933, as amended. Exhibit D J to the Clinical Services Master Agreement between Xxxxxx Operations Pty Ltd. Ltd and Omnicare CR, Inc., dated 24-08-05. June 1, 2005 THIS EXHIBIT D J is entered into this 24 th 5th day of AugustDecember, 2005 2006 (“Effective Date”), by and between Xxxxxx Operations Pty Ltd. Ltd (hereinafter “Sponsor) and Omnicare CR, Inc. (hereinafter “Omnicare CR”).

Appears in 1 contract

Samples: Change (Peplin Inc)

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BY AND BETWEEN. Xxxxxx Operations Pty Ltd. Omnicare CR, Inc. By: /s/ Xxxxx Xxxxxxx Kalsamas By: /s/ XXXXX X. XXXXX NameName : Xxxxx Xxxxxxx Kalsamas Name: XXXXX X. XXXXX Title: Chief Scientific Officer and Vice President, Research & Dated: Director Clinical Development 25 June 2006 Title: EXECUTIVE VICE PRESIDENT GLOBAL BUSINESS DEVELOPMENT CHIEF RELATIONS OFFICER Dated: 9/8/06 Dated: 8/23/06 7/12/06 **** 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. Initial Sponsor Notification Form Change in Project Scope Protocol Number: PEP005-002 003 Date of Request: 13JUL2006 16JUN2006 Omnicare PCN: KO1504 KO1505 Omnicare Project Director: Omnicare Account Director: Sponsor Study Manager: **** **** Xxxxx Xxxxxxx Individual and Department making request: ****, Biometrics ****, Clinical Data Management Brief Description of Project Scope Change: Reconciliation of final clinical data management Revised tables and biometrics activities for the PEP005-002 studyanalysis to provide additional information in forthcoming study design. For clinical data management the final study reconciliation is attached. The estimate cost for this work is $**** For biometrics the additional work includes **** additional tables [**** (unique) and **** (repeat)] and **** additional listing (**** [unique]) requested from the round table data review. In addition it was discussed and agreed to present the efficacy data as both safety and an efficacy evaluable population due to large numbers of major protocol deviations. This work has been costed as a repeat table rate and consists of the following Estimated changes would include **** repeat tables (****, ****, ****, ****, ****, ****, ****, and ****. The estimated * unique table with a total cost for biometrics work is $****. The overall increase for the study reconciliation is of $**** Implementation of this request will affect the budget as follows (provide estimate of anticipated costs associated with change, if available) ): þ Increase ¨ Decrease ¨ Other (specify) The above information briefly outlines a description of the additional/changed services, which relate to the referenced study/protocol. Costs above are estimates. OCR and Sponsor will discuss in detail the budgetary and/or timeline impact of the additional/changed services within five (5) business days of receipt of acknowledgment received at OCR. þ OCR may proceed with the additional/changed services. It is understood that detail and full cost estimate estimated will be xxxxxxxx.xx provided by OCR. ¨ OCR may not proceed with additional/changed services. Sponsor Comments: Please acknowledge approval/refusal to proceed with the additional/changed services by sending written confirmation to the OCR Project Leader by one of the following methods: 1) signing and returning this document via fax to , or 2) sending a confirming email to the Project Leader. Sponsor Acknowledgment /s/ Xxxxx Xxxxxxx 9\8\06 XXXXXXX XXXXXXXX 16/6/06 Sponsor Signature Date * Notification only — not legally binding **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. PEP005-002 Final CDM Contract Reconcillation Contract Item unit unit cost A$ # units per contract contract cost actual # units actual cost difference comment Oversight — CDM manager days **** **** **** **** **** **** Oversight — Lead CDA days **** **** **** **** **** **** DMP days **** **** **** **** **** **** database development project **** **** **** **** **** **** data entry page **** **** **** **** **** **** data review page **** **** **** **** **** **** QC full patient **** **** **** **** **** **** QC critical variables patient **** **** **** **** **** **** Edit development edit **** **** **** **** **** **** includes **** lab edits CRF tracking page **** **** **** **** **** **** dictionary coding of AEs term **** **** **** **** **** **** dictionary coding of meds term **** **** **** **** **** **** lab load — initial load **** **** **** **** **** **** lab load — subsequent load **** **** **** **** **** **** lab visit verification visit **** **** **** **** **** **** SAE reconciliation SAE **** **** **** **** **** **** Protocol deviation log load load **** **** **** **** **** **** Not covered in original contract Total **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant Change Order #04 to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Exhibit D to the Clinical Services Master Agreement between Xxxxxx Operations Pty Ltd. and Omnicare CR, Inc., dated 24-08-0524 th August 2005. THIS EXHIBIT D CHANGE ORDER is entered into this 24 th 22 nd day of AugustSeptember, 2005 2006 (“Effective Date”), by and between Xxxxxx Operations Pty Ltd. (hereinafter “Sponsor” ) and Omnicare CR, Inc. (hereinafter “Omnicare CR”).

Appears in 1 contract

Samples: Change (Peplin Inc)

BY AND BETWEEN. Xxxxxx Pxxxxx Operations Pty Ltd. Omnicare CR, Inc. By: /s/ Xxxxx Pxxxx Xxxxxxx By: /s/ XXXXX X. XXXXX Lxxxxxx Xxxxxxxxx Name: Xxxxx Pxxxx Xxxxxxx Name: XXXXX X. XXXXX Lxxxxxx Xxxxxxxxx Title: Chief Scientific Officer and Vice PresidentDirector, Research & Drug Development Title: EXECUTIVE VICE PRESIDENT GLOBAL BUSINESS DEVELOPMENT CHIEF RELATIONS OFFICER Pres. & Global Chief Operating Officer Dated: 9/8/06 10 February 2006 Dated: 8/23/06 2/22/06 **** 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-2 406 of the Securities Exchange Act of 19341933, as amended. Initial Sponsor Notification Form Change in Project Scope Protocol Number: PEP005-002 Date of Request: 13JUL2006 18JAN2005 Omnicare PCN: KO1504 Omnicare Project Director: Omnicare Account Director: Sponsor Study Manager: Sponsor Outsourcing Manager: **** **** Xxxxx Pxxxx Xxxxxxx Individual and Department making request: ****, Biometrics ****, Clinical Data Management Brief Description of Project Scope Change: Reconciliation of final clinical data management Revised costing for tables and biometrics activities for the PEP005-002 study. For clinical data management the final study reconciliation is attachedlistings presented in Statistical Analysis Plan. The original proposal had an estimate cost for this work is $**** For biometrics the additional work includes **** additional tables [**** (unique) and **** (repeat)] and **** additional listing of Tables (**** [unique]unique/**** repeat), Listings (**** unique/**** repeat) requested from the round table and Figures (**** unique/**** repeat). Following on form design of data review. In addition it was discussed displays and agreed to present the efficacy data as both safety and an efficacy evaluable population due to large numbers of major protocol deviations. This work reporting requirements there has been costed as a repeat an increase in the number of Tables and Listings presented in the Statistical Analysis Plan (please see attached table rate of contents for flagging of Unique (P) and consists Repeat (S) displays). The updated count of the following Tables is **** unique/**** repeat tables (and Listings is ****, * unique/****, ****, ****, ****, ****, ****, and ***** repeat. The estimated increase in cost for biometrics work is to produce these data displays as set out in the Statistical Analysis Plan will be $****. The overall increase for the study reconciliation is $**** Implementation of this request will affect the budget as follows (provide estimate of anticipated costs associated with change, if available) ): þ Increase ¨ o Decrease ¨ o Other (specify) The above information briefly outlines a description of the additional/changed services, which relate to the referenced study/protocol. Costs above are estimates. OCR and Sponsor will discuss in detail the budgetary and/or timeline impact of the additional/changed services within five (5) business days of receipt of acknowledgment received at OCR. þ OCR may proceed with the additional/changed services. It is understood that detail and full cost estimate will be xxxxxxxx.xx provided by OCR. ¨ o OCR may not proceed with additional/changed services. Sponsor Comments: Comments **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Initial Sponsor Notification Form Please acknowledge approval/refusal to proceed with the additional/changed services by sending written confirmation to the OCR Project Leader by one of the following methods: 1) signing and returning this document via fax viafax to , or 2) sending a confirming email to the Project Leader. Sponsor Acknowledgment /s/ Xxxxx Pxxxx Xxxxxxx 9\8\06 30/1/06 Sponsor Signature Date * Notification only — not legally binding **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 406 of the Securities Exchange Act of 19341933, as amended. PEP005-002 Final CDM Contract Reconcillation Contract Item unit unit cost A$ # units per contract contract cost actual # units actual cost difference comment Oversight — CDM manager days **** **** **** **** **** **** Oversight — Lead CDA days **** **** **** **** **** **** DMP days **** **** **** **** **** **** database development project **** **** **** **** **** **** data entry page **** **** **** **** **** **** data review page **** **** **** **** **** **** QC full patient **** **** **** **** **** **** QC critical variables patient **** **** **** **** **** **** Edit development edit **** **** **** **** **** **** includes **** lab edits CRF tracking page **** **** **** **** **** **** dictionary coding of AEs term **** **** **** **** **** **** dictionary coding of meds term **** **** **** **** **** **** lab load — initial load **** **** **** **** **** **** lab load — subsequent load **** **** **** **** **** **** lab visit verification visit **** **** **** **** **** **** SAE reconciliation SAE **** **** **** **** **** **** Protocol deviation log load load **** **** **** **** **** **** Not covered in original contract Total **** **** **** **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant Change Order #02 to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Exhibit D C to the Clinical Services Master Agreement between Xxxxxx Pxxxxx Operations Pty Ltd. and Omnicare CR, Inc., dated 24-08-0520 July 2006. THIS EXHIBIT D CHANGE ORDER is entered into this 24 th day of August20th July, 2005 2006 (“Effective Date”), by and between Xxxxxx Pxxxxx Operations Pty Ltd. (hereinafter “Sponsor) and Omnicare CR, Inc. (hereinafter “Omnicare CR”).

Appears in 1 contract

Samples: Change (Peplin Inc)

BY AND BETWEEN. Xxxxxx Pxxxxx Operations Pty Ltd. Omnicare CR, Inc. By: /s/ Xxxxx Pxxxx Xxxxxxx By: /s/ XXXXX KXXXX X. XXXXX Name: Xxxxx Pxxxx Xxxxxxx Name: XXXXX KXXXX X. XXXXX Title: Chief Scientific Officer and Vice President, Research & Development Title: EXECUTIVE VICE PRESIDENT GLOBAL BUSINESS DEVELOPMENT CHIEF RELATIONS OFFICER Dated: 9/8/06 Dated: 8/23/06 **** 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-2 406 of the Securities Exchange Act of 19341933, as amended. Initial Sponsor Notification Form Change in Project Scope Protocol Number: PEP005-002 Date of Request: 13JUL2006 Omnicare PCN: KO1504 Omnicare Project Director: Omnicare Account Director: Sponsor Study Manager: **** **** Xxxxx Pxxxx Xxxxxxx Individual and Department making request: ****, Biometrics ****, Clinical Data Management Brief Description of Project Scope Change: Reconciliation of final clinical data management and biometrics activities for the PEP005-002 study. For clinical data management the final study reconciliation is attached. The estimate cost for this work is $**** For biometrics the additional work includes **** additional tables [**** (unique) and **** (repeat)] and **** additional listing (**** [unique]) requested from the round table data review. In addition it was discussed and agreed to present the efficacy data as both safety and an efficacy evaluable population due to large numbers of major protocol deviations. This work has been costed as a repeat table rate and consists of the following **** repeat tables (****, ****, ****, ****, ****, ****, ****, and ****. The estimated cost for biometrics work is $****. The overall increase for the study reconciliation is $**** Implementation of this request will affect the budget as follows (provide estimate of anticipated costs associated with change, if available) þ Increase ¨ o Decrease ¨ o Other (specifySpecify) The above information briefly outlines a description of the additional/changed services, which relate to the referenced study/protocol. Costs above are estimates. OCR and Sponsor will discuss in detail the budgetary and/or timeline impact of the additional/changed services within five (5) business days of receipt of acknowledgment received at OCR. þ OCR may proceed with the additional/changed services. It is understood that detail and full cost estimate will be xxxxxxxx.xx pxxxxxxx.xx OCR. ¨ o OCR may not proceed with additional/changed services. Sponsor Comments: Please acknowledge approval/refusal to proceed with the additional/changed services by sending written confirmation to the OCR Project Leader by one of the following methods: 1) signing and returning this document via fax to , or 2) sending a confirming email to the Project Leader. Sponsor Acknowledgment /s/ Xxxxx Pxxxx Xxxxxxx 9\8\06 Sponsor Signature Date * Notification only — not legally binding **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 406 of the Securities Exchange Act of 19341933, as amended. PEP005-002 Final CDM Contract Reconcillation Contract Item unit unit cost A$ # units per contract actual actual Contract Item unit cost A$ contract cost actual # units actual cost difference comment Oversight — CDM manager days **** **** **** **** **** **** Oversight — Lead CDA days **** **** **** **** **** **** DMP days **** **** **** **** **** **** database development project **** **** **** **** **** **** data entry page **** **** **** **** **** **** data review page **** **** **** **** **** **** QC full patient **** **** **** **** **** **** QC critical variables patient **** **** **** **** **** **** Edit development edit **** **** **** **** **** **** includes **** lab edits CRF tracking page **** **** **** **** **** **** dictionary coding of AEs term **** **** **** **** **** **** dictionary coding of meds term **** **** **** **** **** **** lab load — initial load **** **** **** **** **** **** lab load — subsequent load **** **** **** **** **** **** lab visit verification visit **** **** **** **** **** **** SAE reconciliation SAE **** **** **** **** **** **** Protocol deviation log load load **** **** **** **** **** **** Not covered in original contract Total **** **** **** **** 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-2 406 of the Securities Exchange Act of 19341933, as amended. Exhibit D to the Clinical Services Master Agreement between Xxxxxx Pxxxxx Operations Pty Ltd. and Omnicare CR, Inc., dated 24-08-05. THIS EXHIBIT D is entered into this 24 th 24th day of August, 2005 (“Effective Date”), by and between Xxxxxx Pxxxxx Operations Pty Ltd. (hereinafter “Sponsor) and Omnicare CR, Inc. (hereinafter “Omnicare CR”).

Appears in 1 contract

Samples: Change (Peplin Inc)

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