Common use of Project Specifications Clause in Contracts

Project Specifications. Project Specifications Total # of Sites 8 Distribution of Sites Australia (1 x WA, 3 x VIC, 2 x NSW and 2 x QLD) # of Screened / Randomised Patients Patients will be randomised into one of **** PEP005 gel concentrations or vehicle gel **** treatment arms (****; ****) **** patients per arm Total of 60 to be enrolled # of CRF pages per patient (assumes **** unique pages) **** # of Total CRF Pages Processed **** # of Serious Adverse Events ****; ****% of patients Final Deliverable Clinical Study Report B. Project Management Project Management Team Project Management Team Number of Days Allocated Number of Month Project Leader (**** days per month for the first **** and last **** months; plus **** day per month for **** months) **** **** Senior Clinical Data Manager — UK (****% FTE) **** **** Lead Clinical Data Analyst — UK (****% FTE) **** **** Biometrics Team Leader (**** day per month) **** **** **** 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. The Project Leader will act as a single point of contact for Sponsor during the course of this study. The Project Leader is responsible for the generation of detailed project timelines and ensure that that these milestones are met. The Project Leader will provide on-going project status reports as agreed with Sponsor and will proactively identify and resolve critical project issues. The Project Leader is also responsible for managing the project budget and addressing all out-of-scope items with Sponsor. In addition, as the Project Leader is acting in a dual role, this person will also be responsible for usual Biometrics Team Leader activities that are discussed later in this section. SOPs All services outsources will be performed in accordance with Omnicare CR’s SOPs following review and approval by Sponsor, unless specified otherwise. Study Documents and CRF Return Omnicare CR will return all study documents in accordance with Omnicare CR’s SOP. This usually occurs within three months of study completion. The CRFs are reviewed and reconciled against the CRF tracker from Omnicare CR’s Clinical Data Management Department. Each CRF is reviewed for completeness and accuracy of filing. A CRF transfer form is completed listing the number of pages for each individual CRF returned.

Project Specifications. Project Specifications Total # of Sites 8 Distribution of Sites Australia (1 x WA, 3 x VIC, 2 x NSW and 2 x QLD) # of Screened / Screened/ Randomised Patients Patients will be randomised into one of **** PEP005 gel concentrations or vehicle gel **** Two treatment arms (****; ****) **** patients per arm Total of 60 to be enrolled # of CRF pages per patient (assumes **** unique pages) **** # of Total CRF Pages Page Processed **** # of Serious Adverse Events ****; ****% of patients Final Deliverable Clinical Study Report B. Project Management Project Management Team Project Management Team Number of Days Allocated Number of Month Months Project Leader (**** days per month for the first **** and last **** months; plus **** day per month for **** months) **** **** Senior Clinical Data Manager — UK (****% FTE) **** **** Lead Clinical Data Analyst — UK (****% FTE) **** **** Biometrics Team Leader (**** day per month) **** **** **** 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. The Project Leader will act as a single point of contact for Sponsor during the course of this study. The Project Leader is responsible for the generation of detailed project timelines and ensure that that these milestones are met. The Project Leader will provide on-going project status reports as agreed with Sponsor and will proactively identify and resolve critical project issues. The Project Leader is also responsible for managing the project budget and addressing all out-of-scope items with Sponsor. In addition, as the Project Leader is acting in a dual role, this person will also be responsible for usual Biometrics Team Leader activities that are discussed later in this section. SOPs All services outsources will be performed in accordance with Omnicare CR’s SOPs following review and approval by Sponsor, unless specified otherwise. Study Documents and CRF Return Omnicare CR will return all study documents in accordance with Omnicare CR’s SOP. This usually occurs within three months of study completion. The CRFs are reviewed and reconciled against the CRF tracker from Omnicare CR’s Clinical Data Management Department. Each CRF is reviewed for completeness and accuracy of filing. A CRF transfer form is completed listing the number of pages for each individual CRF returned.

Project Specifications. Project Specifications Total # of Sites 8 Distribution of Sites Australia (1 x WA, 3 x VIC, 2 x NSW and 2 x QLD) # of Screened / Randomised Patients Patients will be randomised into one of **** PEP005 gel concentrations or vehicle gel **** treatment arms (****; ****) **** patients per arm Total of 60 to be enrolled # of CRF pages per patient (assumes **** unique pages) **** # of Total CRF Pages Processed **** # of Serious Adverse Events ****; ****% of patients Final Deliverable Clinical Study Report B. Project Management Project Management Team Project Management Team Number of Days Allocated Number of Month Project Leader (**** days per month for the first **** and last **** months; plus **** day per month for **** months) **** **** Senior Clinical Data Manager — UK (****% FTE) **** **** Lead Clinical Data Analyst — UK (****% FTE) **** **** Biometrics Team Leader (**** day per month) **** **** **** 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. The Project Leader will act as a single point of contact for Sponsor during the course of this study. The Project Leader is responsible for the generation of detailed project timelines and ensure that that these milestones are met. The Project Leader will provide on-going project status reports as agreed with Sponsor and will proactively identify and resolve critical project issues. The Project Leader is also responsible for managing the project budget and addressing all out-of-scope items with Sponsor. In addition, as the Project Leader is acting in a dual role, this person will also be responsible for usual Biometrics Team Leader activities that are discussed later in this section. SOPs All services outsources will be performed in accordance with Omnicare CR’s SOPs following review and approval by Sponsor, unless specified otherwise. Study Documents and CRF Return Omnicare CR will return all study documents in accordance with Omnicare CR’s SOP. This usually occurs within three months of study completion. The CRFs are reviewed and reconciled against the CRF tracker from Omnicare CR’s Clinical Data Management Department. Each CRF is reviewed for completeness and accuracy of filing. A CRF transfer form is completed listing the number of pages for each individual CRF returned.

Project Specifications. Project Specifications Total # of Sites 8 Distribution of Sites Australia (1 x WA, 3 x VIC, 2 x NSW and 2 x QLD) # of Screened / Screened/ Randomised Patients Patients will be randomised into one of **** PEP005 gel concentrations or vehicle gel **** Two treatment arms (****; ****) **** patients per arm Total of 60 to be enrolled # of CRF pages per patient (assumes **** unique pages) **** # of Total CRF Pages Page Processed **** # of Serious Adverse Events ****; ****% of patients Final Deliverable Clinical Study Report B. Project Management Project Management Team Project Management Team Number of Days Allocated Number of Month Months Project Leader (**** days per month for the first **** and last **** months; plus **** day per month for **** months) **** **** Senior Clinical Data Manager — UK (****% FTE) **** **** Lead Clinical Data Analyst — UK (****% FTE) **** **** Biometrics Team Leader (**** day per month) **** **** **** 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. The Project Leader will act as a single point of contact for Sponsor during the course of this study. The Project Leader is responsible for the generation of detailed project timelines and ensure that that these milestones are met. The Project Leader will provide on-going project status reports as agreed with Sponsor and will proactively identify and resolve critical project issues. The Project Leader is also responsible for managing the project budget and addressing all out-of-scope items with Sponsor. In addition, as the Project Leader is acting in a dual role, this person will also be responsible for usual Biometrics Team Leader activities that are discussed later in this section. SOPs All services outsources will be performed in accordance with Omnicare CR’s SOPs following review and approval by Sponsor, unless specified otherwise. Study Documents and CRF Return Omnicare CR will return all study documents in accordance with Omnicare CR’s SOP. This usually occurs within three months of study completion. The CRFs are reviewed and reconciled against the CRF tracker from Omnicare CR’s Clinical Data Management Department. Each CRF is reviewed for completeness and accuracy of filing. A CRF transfer form is completed listing the number of pages for each individual CRF returned.

Project Specifications. Project Specifications Total # of Sites 8 11 Distribution of Sites Australia (1 x WA, 3 x VIC, 2 4 x NSW and 2 3 x QLD) # of Screened / Randomised Patients Patients will be randomised into one of **** PEP005 gel concentrations or vehicle gel **** treatment arms (****; ****) **** patients per arm Total of 60 to be enrolled # of CRF pages per patient (assumes **** unique pages) **** # of Total CRF Pages Processed processed **** # of Serious Adverse Events ****; ****% of patients Critical Milestone **** Final Deliverable Clinical Study Report B. Project Management Project Management Team Project Management Team Number of Days Allocated Number of Month Months Project Leader (**** days per month for the first between July-November; **** and last **** months; plus **** day days per month for **** monthsDecember & January) **** **** Senior Clinical Data Manager — UK (****% FTE) **** **** Lead Clinical Data Analyst — UK (****% FTEFTE at start up; ****% FTE for duration and ****% FTE at close out) **** **** Biometrics Team Leader (**** day per month) **** **** **** 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. The Project Leader will act as a single point of contact for Sponsor during the course of this study. The Project Leader is responsible for the generation of detailed project timelines and ensure that that these milestones are met. The Project Leader will provide on-going project status reports as agreed with Sponsor and will proactively identify and resolve critical project issues. The Project Leader is also responsible for managing the project budget and addressing all out-of-scope items with Sponsor. In addition, as the Project Leader is acting in a dual role, this person will also be responsible for usual Biometrics Team Leader activities that are discussed later in this section. SOPs All services outsources will be performed in accordance with Omnicare CR’s SOPs following review and approval by Sponsor, unless specified otherwise. Study Documents and CRF Return Omnicare CR will return all study documents in accordance with Omnicare CR’s SOP. This usually occurs within three months of study completion. The CRFs are reviewed and reconciled against the CRF tracker from Omnicare CR’s Clinical Data Management Department. Each CRF is reviewed for completeness and accuracy of filing. A CRF transfer form is completed listing the number of pages for each individual CRF returned.