Clinical Services Master Agreement



 Exhibit 10.26 
 CLINICAL SERVICES MASTER AGREEMENT 
 THIS CLINICAL SERVICES MASTER
AGREEMENT (this “Master Agreement”) is entered into as of this 1st day of June, 2005, by and between Peplin Operations Pty Ltd ACN 093 317 367
(“Sponsor”) of Level 2, 1 Breakfast Creek Road, Newstead in the state of Queensland, Australia and Omnicare CR, Inc., (“Omnicare CR”) a Delaware corporation. 
 WHEREAS, Sponsor requires various clinical research services from time to time in support of various projects (individually, a “Project,”
and collectively, the “Projects”), which shall be set forth in Exhibits to this Master Agreement; and 
 WHEREAS, Omnicare CR
and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services
designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity”; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR hereby agree as follows: 

 

	1.	Scope of Master Agreement; Obligations 

  

	 	1.1.	The specific responsibilities and obligations to be performed by Omnicare CR with respect to a Project (the “Services”), as set forth in the applicable Protocol(s), are
expressly set forth in Exhibit(s) attached to this Master Agreement, which, together with the Exhibit(s) attached hereto, are incorporated by reference herein. No Exhibit will be attached to this Master Agreement or become effective without first
being executed by duly authorized representatives of the parties hereto. To the extent any terms set forth in an Exhibit shall conflict with the terms set forth in this Master Agreement, the terms of this Master Agreement will take precedence unless
the Exhibit expressly states that a conflicting term is intended to modify a specific term in this Master Agreement. The responsibility for the Services is being transferred to Omnicare CR in accordance with 21 C.F.R. §312.52. Those
responsibilities and obligations not specifically transferred to and assumed by Omnicare CR in this Master Agreement or the Exhibit(s) as constituting part of the Services shall be and remain the sole responsibility of Sponsor.


  

	 	1.2.	Omnicare CR agrees that Omnicare CR will provide the Services in accordance with (a) all applicable federal laws and regulations, including standards of Good Clinical Practices; and
(b) the standards and practices that are generally accepted in the industry and exercised by other persons engaged in performing similar services. 

  

	 	1.3.	In the discharge of its duties, Omnicare CR shall comply with all reasonable directions of Sponsor as may be given in writing from time to time in respect of the Services.


  
  

	****	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. 









	 	1.4.	Omnicare CR shall at all times provide sufficient appropriately-trained and qualified clinical research personnel on a given Project to meet the demands of said Project.


  

	 	1.5.	In the event that Sponsor or a third-party engaged by Sponsor performs an audit of the Project, Omnicare CR will respond in writing to the audit findings within thirty (30) days of
receipt of same. 

  

	 	1.6.	Omnicare CR shall use its commercially reasonable efforts, skills and abilities to promote the interests of Sponsor and to diligently and competently perform its duties under this Master
Agreement. 

  

	2.	Payment 

  

	 	2.1.	In consideration of the Services, Sponsor shall pay to Omnicare CR: (a) the Service Fees (as defined in Section 2.2); and (b) the Pass-Through Costs (as defined in
Section 2.3). 

  

	 	2.2.	As used in this Master Agreement, the term “Service Fees” means all amounts due for the Services, exclusive of the Pass-Through Costs. The estimated Service Fees and the
payment schedule therefor are set forth in the Exhibit(s), and shall be increased to include: (a) the costs of any additional Services required as a result of Project changes by Sponsor; (b) any costs that arise out of or relate to a Force
Majeure as outlined in Section 10 below, and (c) where a Project requires more time than allotted in the Exhibit(s), and the parties agree to continue such Project beyond the expected conclusion date, any additional costs that may be
incurred in order to complete such Project, at the contractual rates set forth in the applicable Exhibit(s). All payments of Service Fees shall be made within thirty (30) days of receipt of invoice. If any payment of Service Fees is late by
more than thirty (30) days, such payment shall be subject to a liquidated damages fee of 1.5% per month of the outstanding balance. 

  

	 	2.3.	As used in this Agreement, the term “Pass-Through Costs” means all investigator, Institutional Review Board or other applicable pass-through costs actually and reasonably
incurred by Omnicare CR under this Agreement or the Exhibit(s) in order to expedite successful completion of a Project, which costs are normal and routine to studies similar to such Project (e.g., advancing an investigator’s
Institutional Review Board fee and investigator grant payments or reimbursing reasonable additional, unbudgeted patient expenses). In order to enable Omnicare CR to maintain a balance to be applied towards investigator-related Pass-Through Costs,
Omnicare CR shall invoice Sponsor for all reasonably anticipated Pass-Through Costs (the “Estimated Pass-Through Costs”) in advance of the expected payment date therefor. Except with respect to investigator-related payments, which
are payable upon receipt, all Pass-Through Costs shall be paid within thirty (30) days of receipt of invoice. If any payment Pass-Through Costs is late by more than thirty (30) days, such payment shall be subject to liquidated damages of
1.5% per month of the outstanding balance. The anticipated Pass-Through Costs and Estimated Pass-Through Costs and the payment schedule therefor are set forth in the Exhibit(s). 

  

  

	****	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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	 	2.4.	Where applicable, language pertaining to annual price increases will be included in each Exhibit. 

  

	 	2.5.	Taxes (and any penalties thereon) imposed on any payment made by Sponsor to Omnicare CR will be the responsibility of Omnicare CR. Any sales tax, usage tax, Value Added Tax (VAT), or other
similar taxes shall be the responsibility of the Sponsor. 

  

	 	2.6.	Sponsor shall make payment direct to the following bank account nominated by Omnicare CR: 

 Omnicare CR Inc. 
 First Union
National Bank 
 Philadelphia, PA 
 ABA # **** 
 Acct # **** 
  

	3.	Confidentiality 

  

	 	 3.1.
	 That certain Confidentiality Agreement by and between Omnicare CR and Sponsor dated as of 25th November 2004 (the “Confidentiality Agreement”) is hereby terminated and of no further force or effect. 


  

	 	3.2.	In connection with the performance of the Services, Sponsor shall provide to Omnicare CR, and Omnicare CR shall have access to, Sponsor’s Confidential Information. As used in this Master
Agreement, “Sponsor’s Confidential Information” means any (a) information provided by, or developed for, Sponsor within the framework of or in undertaking activity pursuant to this Master Agreement, the Exhibit(s) or the
Confidentiality Agreement; or (b) data collected during a Project. 

  

	 	3.3.	In connection with this Master Agreement, Sponsor will have access to, or become acquainted with, Omnicare CR’s Confidential Information. As used in this Master Agreement,
“Omnicare CR’s Confidential Information” means any (a) information generated or obtained in connection with Omnicare CR’s pricing, proposals or contracts (including the provisions of this Master Agreement and the
Exhibit(s)); (b) of Omnicare CR’s procedures, programs, guidelines or policies (including, without limitation, its Standard Operating Procedures); or (c) information designated in writing as “confidential.”


  

	 	3.4.	Neither Sponsor’s Confidential Information nor Omnicare CR’s Confidential Information (collectively, “Confidential Information”) shall include any information that:


  

	 	(a)	 was known by the receiving party at the time of disclosure to it by the disclosing party, or that is independently developed or discovered by the receiving party, after
disclosure by the disclosing party, without the aid, application or use of any 



  

  

	****	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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item of the disclosing party’s Confidential Information, as evidenced by written records; 


  

	 	(b)	is now or subsequently becomes, through no act or failure to act on the part of the receiving party, generally known or available; 

  

	 	(c)	is disclosed to the receiving party by a third party authorized to disclose it; or 

  

	 	(d)	is required by law or by court or administrative order to be disclosed; provided, that the receiving party shall have first given prompt notice to the other party of such
required disclosure. 

  

	 	3.5.	Each party shall exercise due care to prevent the unauthorized use or disclosure of the other party’s Confidential Information, and shall not, without the other party’s prior
written consent, (a) use the other party’s Confidential Information for any purpose other than performing its obligations under this Master Agreement and the Exhibit(s); or (b) disclose or otherwise make available, directly or
indirectly, any item of the other party’s Confidential Information to any person or entity other than those employees, independent contractors, agents or investigators of such party and/or its affiliate entities (collectively,
“Representatives”) who reasonably need to know the same in the performance of such party’s obligations under this Master Agreement (including the Exhibit(s)), or in order to make decisions or render advice in connection
therewith. For the convenience of the parties, each party acknowledges that unless precluded in writing by the other party, Confidential Information may be transmitted to a party and/or its Representatives via the Internet. Each party shall advise
its Representatives who have access to the other party’s Confidential Information of the confidential nature thereof, and agrees that such Representatives will be bound by terms of confidentiality and restrictions on use with respect thereto
that are at least as restrictive as the terms of this Section 3. 

  

	 	3.6.	The provisions of this Section 3 shall survive for a period of five (5) years from the date of any expiration or termination of this Master Agreement, however caused.


  

	 	3.7	Omnicare CR acknowledges that in accordance with Section 1043A of the Corporations Act of the Commonwealth of Australia: 

  

	 	(a)	Omnicare CR may from time to time as a consequence of the services provided hereunder possess confidential information which may have a material effect on the price or value of the securities
of Sponsor and may therefore constitute “inside information” for the purposes of the Corporations Act; and 

  

	 	(b)	as an insider one must not (whether as principal or agent in possession of such inside information): 

  

	 	•	 	 apply for, acquire or dispose of such securities, or enter into an agreement to apply for, acquire or dispose of any such securities; or 



 

	 	•	 	 procure another person to apply for, acquire or dispose of, or to enter into an agreement to apply for acquire or dispose of, any such securities.



  

  

	****	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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 and acknowledges further that: 
  

	 	(c)	once in possession of confidential information, a party may be subject to the insider trading restrictions imposed by the Corporations Act and may be prohibited from trading in the securities
(as noted above) and/or communicating the confidential information to any other person who would be likely to subscribe for, purchase or sell securities, or procure a third person to do the same until such date when this confidential information has
been made “public” in terms of the requirements of the Corporations Act; and 

  

	 	(d)	it must seek its own legal advice on its responsibilities under the Corporations Act and that neither party purports that the comments in this clause are either advice or a comprehensive
description of the provisions of the Corporations Act. 

  

	4.	Property of Sponsor 

  

	 	4.1.	All (a) of Sponsor’s Confidential Information (including, without limitation, all original Project records and reports), (b) unused clinical supplies provided by Sponsor, and
(c) complete and incomplete Case Report Forms, which in any case are in Omnicare CR’s possession, shall be and remain Sponsor’s property; provided, however, that Omnicare CR may retain one copy of Sponsor’s
Confidential Information in its files for archival purposes, as a means of determining any continuing obligations under this Master Agreement (including the Exhibit(s)). 

  

	 	4.2.	All inventions, improvements in know-how, new uses, processes and compounds involving the study drug(s) and/or product(s) covered by this Master Agreement and/or the Exhibit(s) that are
conceived or reduced to practice as a direct result of the Project(s) (“Inventions”) shall be and remain the sole property of Sponsor. Omnicare CR shall cooperate with Sponsor in obtaining, at Sponsor’s sole cost and expense,
any patent protection as may be available for the Inventions, and shall execute all documents reasonably deemed necessary by Sponsor for purposes of procuring such patent protection. Omnicare CR agrees that Omnicare CR shall endeavor to ensure
contractually the prompt disclosure to Sponsor by any investigator, employee or other individual retained by Omnicare CR for a Project of any Inventions, as well as the cooperation of such persons in securing patent protection as set forth herein.


  

	 	4.3.	 Notwithstanding the foregoing, Sponsor acknowledges that Omnicare CR and their respective professional staff currently possess certain inventions, processes, know-how, trade
secrets, methods, approaches, analyses, improvements, other intellectual properties and other assets including, but not limited to, clinical trial management analyses, analytical methods, procedures and techniques, computer technical expertise and
proprietary software, and technical and conceptual expertise in the area of conducting clinical trials, all of which have been developed independently by Omnicare CR without the benefit of any information provided by Sponsor (collectively,
“Omnicare CR Property”). Sponsor agrees that any Omnicare CR Property which is used, improved, modified or developed by Omnicare CR under or 



  

  

	****	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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during the term of this Master Agreement shall be and remain the sole and exclusive property of Omnicare CR. 


 5. Restrictions on Announcements 
 Omnicare CR shall not make any
announcement, oral presentation or publication relating to any Project without Sponsor’s prior written consent (which consent shall not be unreasonably withheld), except as required by law or by court or administrative order. Neither Omnicare
CR nor Sponsor shall employ or use the name of the other party in any publication or promotional material or in any form for public distribution, without the prior written consent of the other party, except as required by law or by court or
administrative order. 
 6. FDA Inspection 
 In the event that
Omnicare CR receives a Notice of Inspection (a “Notice”) from the Food and Drug Administration (“FDA”) which relates to any Project Omnicare CR shall: (a) notify Sponsor promptly of such Notice; (b) keep
Sponsor informed of the progress of the inspection; and (c) provide to Sponsor a copy of any documents produced to the FDA pursuant to such Notice. Sponsor acknowledges that it is Omnicare CR’s obligation to respond to a Notice directed to
Omnicare CR and that Omnicare CR must respond to the Notice without advice from, or consultation with, Sponsor concerning the contents thereof. 
 7. Access
to Facilities and Records 
  

	 	7.1.	Sponsor’s authorized representatives may visit Omnicare CR’s site and facilities at reasonable times and with reasonable frequency during normal business hours and upon reasonable
advance written notice, to observe the progress of any Services. All such visits shall be subject to Omnicare CR’s restrictions and procedures relating to safety, security and protection of Confidential Information, and in connection therewith,
Sponsor’s authorized representatives may be required to sign a confidentiality agreement, or an access agreement for special access-controlled areas. 

  


	 	7.2.	During the term of this Master Agreement, Omnicare CR shall maintain all materials and all other data obtained or generated by Omnicare CR in the course of providing the Services hereunder,
including all computerized records and files. Omnicare CR shall cooperate with any reasonable internal review or audit by Sponsor and make available to Sponsor for examination and duplication, during normal working hours and at mutually agreeable
times, all documentation, data and information relating to a Project. 

  

	 	7.3.	 Upon the expiration or termination of this Master Agreement, all materials and all other data and information obtained or generated by Omnicare CR as a direct result of
providing the Services hereunder will, at Sponsor’s option and cost and expense, be (i) delivered to Sponsor’s offices at the address provided herein in such form as is then currently in the possession of Omnicare CR,
(ii) retained by Omnicare CR for Sponsor for a period of two years, or (iii) disposed of as directed in writing by Sponsor, unless such materials are otherwise required to be stored or maintained by 



  

  

	****	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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Omnicare CR under applicable law. In no event shall Omnicare CR dispose of any materials or data or other information obtained or generated by Omnicare CR as a direct
result of providing the Services without first giving Sponsor sixty (60) days prior written notice of its intent to dispose same. Notwithstanding the foregoing, Omnicare CR may retain copies of any such materials, data and information as is
reasonably necessary for regulatory purposes or to demonstrate the satisfaction of its obligations hereunder, all subject to the confidentiality obligations set forth herein. 


 8. Indemnification 
  

	 	8.1.	Sponsor agrees to indemnify, defend and hold harmless Omnicare CR and its Affiliate Entities, and their respective officers, directors and employees from and against any and all claims,
demands, investigations, suits or actions (each a “Claim”) for any and all liabilities, losses, damages, penalties, costs or expenses of every kind whatsoever (including but not limited to court costs, legal fees, awards of
settlements) arising out of, in connection with or related to this Master Agreement and/or the Exhibit(s); provided, however, that Sponsor’s indemnity obligations under this Section 8 shall not apply to any Claim to
the extent arising directly from Omnicare CR’s negligence or willful malfeasance. 

  

	 	8.2.	Omnicare CR agrees to indemnify, defend and hold harmless Sponsor and its respective officers, directors and employees from and against any and all Claims for any and all liabilities, losses,
damages, penalties, costs or expenses of every kind whatsoever (including but not limited to court costs, legal fees, awards or settlements) arising out of, in connection with or related to any breach of this Master Agreement and/or the
Exhibit(s) by Omnicare CR, including any breach of warranties, or any willful, unlawful or negligent act or omission of Omnicare CR. 

  

	 	8.3.	Each person or entity seeking indemnification under this Section 8 (the “Indemnified Party”) shall, as a condition thereto, notify the other party within twenty
(20) days after the receipt of notice of the Claim; provided, however, that the other party shall not be released from its obligations under this Section 8 if the failure to notify that other party within twenty
(20) days does not materially prejudice the defense of such Claim. That other party shall have the right to select defense counsel and to direct the defense or, with the consent of the indemnified party (which consent shall not be unreasonably
withheld) settlement of, any Claim. In the event that representation of an Indemnified Party and the other party by the same counsel would be a conflict of interest for such counsel, the Indemnified Party may select its own independent counsel
without relieving the other party of its obligations under this Section 8. Under no circumstances shall an Indemnified Party settle or otherwise compromise any Claim without the other party’s prior written consent.


  

	 	8.4.	This clause shall survive the expiration or termination of the Master Agreement and/or the Exhibit(s). 

 9. Termination 
  

  

	****	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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	 	9.1.	Either party may terminate this Master Agreement and/or any Exhibit at any time and for any reason upon a minimum of thirty (30) days’ prior notice, provided that Omnicare CR may
only terminate under this sub-clause in the event that there are no active Exhibits, ie, all tasks under all Exhibits have been completed. 

  

	 	9.2.	Without limiting the generality of any other clause in this Master Agreement or the remedies available to either party, either party may terminate this Master Agreement immediately by notice
in writing if: 

  

	 	(a)	the other party is in material breach of any terms of this Master Agreement or any Exhibit and, where such breach is remediable, such party fails to remedy such material breach or establish a
corrective action plan to cure such material breach (which plan shall outline actions to be taken and relevant dates) acceptable to the non-breaching party within fifteen (15) days of receiving notice to do so from the non-breaching party;


  

	 	(b)	the other party is in serious and/or presistent breach of any terms of this Master Agreement or any Exhibit. Failure to perform in accordance with the corrective action plan outlined above
shall be deemed a serious breach; or 

  

	 	(c)	the other party becomes, threatens to become or is in jeopardy of becoming insolvent. 

  

	 	9.3.	Upon receipt of any notice of termination, a party shall avoid or limit, to the extent practicable, incurring any futher commitments, obligations or costs which would otherwise result in
Service Fees and Pass-Through Costs. 

  

	 	9.4.	Upon any early termination, Sponsor shall pay to Omnicare CR all Service Fees and Pass-Through Costs due and owing based upon Services completed and costs incurred through the effective date
of termination, including costs for materials and/or services previously acquired or contracted for which will not be used for the Services as a result of such termination. 

  

	 	9.5.	Any funds held by Omnicare CR which by contract definition or amendment are deemed unearned (including, without limitation, any Estimated Pass-Through Costs not used to satisfy Pass-Through
Costs) shall be returned to Sponsor within sixty (60) days after conclusion or termination of the Project(s) set forth in the applicable Exhibit(s). 

  

	 	9.6.	Following completion or termination of any Project, Omnicare CR shall forward all original Project records and reports to Sponsor (or to a repository designated by Sponsor in writing) at
Sponsor’s sole cost and expense. Thereafter, Omnicare CR shall retain any documentation related to such Project in compliance with Omnicare CR’s corporate policy on retention and destruction of records. 

 10. Force Majeure 
  

  

	****	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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 If either party’s performance of this Master Agreement or any Exhibit is prevented, restricted or delayed (either totally or
in part) by reason of any cause beyond the reasonable control of the parties, such as acts of God, explosion, disease, weather, war, insurrection, civil strike, riot or power failure, the party so affected shall, upon giving notice thereof to the
other party, be free and be excused from such performance to the extent of such prevention, restriction or delay; provided, that the affected party shall use its commercially reasonable efforts to avoid or remove such causes of
non-performance and shall continue performance with the utmost dispatch whenever such causes are removed; and provided further, that nothing herein shall relieve either party from the obligation to pay promptly in full all payments that may
be due to the other party under this Master Agreement or the Exhibit(s). In addition to the above, the affected party shall be free from any liabilities, losses, damages, penalties, costs or expenses arising out of or related to such cause beyond
the reasonable control of such affected party. If such cause for non-performance exceeds or is likely to exceed thirty (30) days, a party other than the affected party may immediately terminate the Master Agreement and/or the Exhibit(s).

 11. No Conflict 
 Each party represents and warrants that it is
authorized to enter into this Master Agreement, that it is not prevented from or impeded in carrying out its obligations under the Master Agreement and/or the Exhibit(s) by way of any agreement, arrangement or understanding that it may have with any
other person and that the terms hereof are not inconsistent with or a violation of any other legal obligation to which it is subject. 
 12. Limitations 
  

	 	12.1.	Sponsor acknowledges that the results of the Project(s) are inherently uncertain and that, accordingly, there can be no assurance, representation or warranty by Omnicare CR that the study
drug(s) and/or product(s) covered by this Master Agreement and/or the Exhibit(s) can, either during the term of this Master Agreement or thereafter, be developed successfully or, if so developed, will receive the required approval(s) from the FDA
other regulatory agency or authority. 

  

	 	12.2	Both parties acknowledge that the Services constitute research and development. Accordingly, Sponsor’s sole remedy for any breach or default hereof by Omnicare CR shall be termination of
this Master Agreement or the applicable Exhibit as herein provided or a return of any Service Fees paid to Omnicare CR for Services improperly performed or not performed. In no event shall Omnicare CR be liable for any special, indirect, incidental
or consequential damages (whether in contract or tort). 

 13. Non-Debarment 
  

	 	13.1.	Omnicare CR represents and warrants that Omnicare CR has not been nor is currently: 

  

	 	(a)	 an individual who has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) (a “Debarred Individual”) from providing services in any
capacity to a 



  

  

	****	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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person that has an approved or pending drug product application, or an employer, employee or partner of a Debarred Individual; or 


  

	 	(b)	a corporation, partnership, or association that has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) (a “Debarred Entity”) from submitting or
assisting in the submission of an abbreviated new drug application, or an employee, partner, shareholder, member, subsidiary or affiliate entity of a Debarred Entity. 

  

	 	13.2.	Omnicare CR further represents and warrants that Omnicare CR has no knowledge of any circumstances which may affect the accuracy of the representations and warranties set forth in
Section 13.1 including, but not limited to, FDA investigations of, or debarment proceedings against, Omnicare CR or any person or entity performing, or rendering assistance related to, the Services. Omnicare CR will notify Sponsor
promptly upon becoming aware of any such circumstances during the term of this Master Agreement. 

 14. Independent Contractor

 The status of the parties under this Master Agreement is that of independent contractors, and, except as specifically set forth herein, or in the Exhibit(s), neither
party has any authority to bind or act on behalf of the other party without its express written consent. 
 15. Notices 
 Any notices, requests or other communications given under this Master Agreement shall be in writing and shall be given by, personal delivery, or sent by (a) facsimile
transmission (with message confirmed during normal business hours); (b) first class mail, postage prepaid; or (c) Federal Express (or equivalent nationally recognized overnight delivery service), delivery charges prepaid. All notices shall
be given to a party at its respective address set forth below, or at such other address as such party from time to time may specify by notice in accordance with this Section 15. A notice shall be deemed given when actually received;
provided, that if any facsimile notice is received after 5:00 P.M. local time at the place of receipt, it shall be deemed to have been given as of the next following business day. 
  

					
		  	If to Omnicare CR:	  	Omnicare CR, Inc.
		  		  	630 Allendale Road
		  		  	King of Prussia, PA 19406
		  		  	Attention: Global Client Contracts
			
		  	If to Sponsor:	  	Peplin Operations Pty Ltd
		  		  	Level 2, 1 Breakfast Creek Road
		  		  	Newstead
		  		  	QLD 4006
		  		  	Australia

  

  

	****	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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 Attention: Dr Peter Welbum 
 16. Entire Agreement 
 This Master Agreement, together with all corresponding Exhibits, Amendments or Change Orders, constitutes the entire
agreement between Sponsor and Omnicare CR with respect to the subject matter hereof, and replaces and supersedes any and all prior and contemporaneous agreements and/or understandings, whether oral or written, between Sponsor and Omnicare CR with
respect to the subject matter hereof. This Master Agreement (including the Exhibit(s)) may be amended or modified only by a written instrument executed by a duly authorized officer of each party. 
 17. Construction of Agreement 
 The descriptive headings of the Sections of
this Master Agreement are for convenience only and shall not affect the meaning or construction of any of the provisions of this Master Agreement. The failure of either party to enforce any provision of this Master Agreement (including the
Exhibit(s)) shall not be construed as a waiver or limitation of that party’s subsequent rights to enforce and compel strict compliance with every provision of this Master Agreement. To the extent any provision of this Master Agreement or the
application thereof is found by a proper authority to be invalid or unenforceable, it shall be considered deleted herefrom, and the remainder of this Master Agreement shall continue in full force and effect. 
 18. Assignment and Sub-contracting 
 Neither Sponsor nor Omnicare CR may
assign this Master Agreement or any rights hereunder or delegate the performance of any duties hereunder without the prior written approval of the other party, which approval shall not be unreasonably delayed or withheld; provided, however, that
without such consent, either party may assign this Master Agreement in connection with the transfer or sale of all or substantially all of its assets, stock or business, or its merger, reorganization, consolidation or combination with or into
another entity; provided, further, however, without such consent, Omnicare CR may assign any rights hereunder to an Affiliate Entity and Sponsor may assign any rights hereunder to its parent company or a subsidiary of said parent company without the
consent of Omnicare CR. Omnicare CR shall not sub-contract any Services under an Exhibit to any legal entity other than an Affiliate Entity without the prior written consent of Sponsor, such consent not to be unreasonably withheld. Subject to the
foregoing, this Master Agreement shall be binding upon, inure to the benefit of and be enforceable by the parties and their respective successors and permitted assigns. 
 19. Timely Review 
 Sponsor acknowledges that Omnicare CR will require, among other things: (a) timely review of Omnicare CR’s
work product; and (b) timely supplies of documents, data, records, and investigational drug product(s) from Sponsor in order to properly perform the Services hereunder and that Omnicare CR are not responsible for errors, delays or other
consequences arising from the failure of Sponsor to provide such review and/or materials. Sponsor therefore agrees that it will: (a) promptly review Omnicare CR’s work product where such review is required and/or 

  

  

	****	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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necessary; and (b) provide all documents, data, records, investigational drug product(s) and other materials necessary for completion of Omnicare CR’s tasks
and Services in a timely manner and in accordance with the schedule or timeline for the applicable Project. 
 Sponsor agrees to reasonably extend all deadlines
hereunder due to delays (by Sponsor or contractors under its control) in (a) reviewing Omnicare CR’s work product; and (b) providing documents, data, records and investigational drug product(s) and other materials needed for the
completion of Omnicare CR’s tasks and Services. 
 20. Restriction 
 For the period commencing on the date of execution of the last party to sign this Master Agreement and continuing for a period of one (1) year after the termination or expiration of this Master Agreement, each party agrees that it
shall not knowingly solicit (as defined below) any of the other party’s or any of the other party’s affiliates’ then current personnel, whether employees or independent contractors under agreement with that other party. As used in
this Section 20, “solicit” means the initiation of a contact with any of the other party’s or any of the other party’s affiliates’ then current personnel for the purpose of offering employment to such personnel, but
shall not include the circumstance where any such personnel initiate a contact with the party for the purpose of obtaining employment with that party, whether in response to a general advertisement of employment placed by that party or otherwise, or
where such contact is initiated by a third party who was not instructed to contact such personnel by that party. In the event a party breaches the terms of this Section, that party agrees to pay the other party as liquidated damages and not as a
penalty a sum equal to twenty-five percent (25%) of the starting salary of such employee. 
 21. Survival 
 Any terms of this Master Agreement which by their nature extend beyond its performance, expiration or termination (including, without limitation, Sections 2 through
5, 8 through 10, 12, 20 and this Section 21) shall remain in effect indefinitely until fulfilled in accordance with their terms. 
 22. Governing Law 
 This Agreement will be governed by and construed in accordance with the laws of the State of Queensland in
Australia without giving effect to any choice of law principles that would require the application of the laws of a different jurisdiction. 
 23. Signatories 
 This Master Agreement may be executed in counterparts, each of which, when executed and delivered, shall be deemed to be
an original, and all of which, when joined, shall together constitute one and the same agreement. Any photocopy or facsimile of this Master Agreement, or of any counterpart, shall be deemed the equivalent of an original. 
  

  

	****	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. 

  12 








 IN WITNESS WHEREOF, the parties have executed this Master Agreement by their duly authorized officers as of
the date first above written. 
  

											
	Peplin Operations Pty Ltd	 		 	Omnicare CR, Inc.	 	
						
	By:	 	 /s/ Michael Aldridge
	 		 	By:	 	 /s/ Kevin D. Duffy
	 	
	Name:	 	Michael Aldridge	 		 	Name:	 	Kevin D. Duffy	 	
	Title:	 	Director	 		 	Title:	 	Senior Vice President	 	
		 		 		 		 	Global Marketing & Business Development	 	
						
		 		 		 		 	APPROVED	 	
		 		 		 		 	LEGAL DEPT.	 	
		 	29-July-05	 		 		 	28-July-05	 	

  

  

	****	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 A to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., dated 24-8-05 
 THIS EXHIBIT A is entered into this 24th day of August, 2005 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor”) and Omnicare CR, Inc. (hereinafter
“Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a Clinical Services, Master Agreement, dated 1 st Jun 05
(hereinafter the “Master Agreement”), wherein Omnicare CR agreed to provide clinical services; and 
 WHEREAS, Omnicare CR
and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform services
designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR shall provide the services set forth in this Exhibit A, subject to the terms and
conditions set forth in the Master Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY
BOUND, Sponsor and Omnicare CR agree as follows: 
 I. Project Plan 
 Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for Sponsor’s “An Open, Dose-escalation, Cohort study to determine the Safety of PEP005 Topical Gel
when applied on Day 1 and Day 2 to Actinic Keratoses on the Shoulders, Chest, Back, and/or Arms followed by Post-Treatment Follow-Up Period Lasting at Least 4 weeks.” Protocol # PEP005-004, Version 3 (hereinafter “the Project”)
and associated costs. Changes made in the Project scope, at any time during the Project, will result in a corresponding adjustment to the Project costs. 
 II. Project Roles and Responsibilities 
  

							
	 Task
	  	Peplin	  	Omnicare	  	Joint
	 CT Approvals
	  		  		  	
	 1.      Submit regulatory documents to authorities /US
	  	X	  		  	
	 2.      IEC Applications
	  		  	X	  	
				
	 Investigator’s Brochure Preparation
	  		  		  	
	 1.      Protocol development (literature review, background research)
	  	X	  		  	
	 2.      Design and write protocol
	  	X	  		  	
	 3.      Approve protocol
	  	X	  		  	
	 4.      Print and bind protocol
	  	X	  		  	

  

  

	****	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. 

  Page 1 









							
	 Task
	  	Peplin	  	Omnicare	  	Joint
	 5.      Distribute protocol to sites
	  	X	  	X	  	
	 6.      Investigator Drug Brochure Preparation
	  	X	  		  	
	 7.      Write Prototype informed consent (Template)
	  	X	  		  	
				
	 CRF Preparation
	  		  		  	
	 1.      Design and draft CRFs
	  		  	X	  	
	 2.      Approve CRFs
	  	X	  	X	  	
	 3.      Print and assemble CRFs
	  		  	X	  	
	 4.      Distribute CRFs to sites
	  		  	X	  	
	 5.      Write CRF conventions guide
	  		  	X	  	
				
	 Qualification visits
	  		  		  	
	 1.      Develop list of potential investigators
	  	X	  		  	
	 2.      Screen Investigators via surveys/telephone interviews
	  	X	  		  	
	 3.      Conduct site qualification visit
	  		  	X	  	
	 4.      Provide written site evaluation report
	  		  	X	  	
	 5.      Prepare Investigator contract
	  	X	  		  	
	 6.      Negotiate Investigator grants
	  	X	  		  	
				
	 Pre-Study Activities
	  		  		  	
	 1.      Collect all regulatory documents from each site (1572 IRB approval/informed consent, CVs
etc)
	  		  	X	  	
	 2.      Select central laboratory
	  	X	  		  	
	 3.      Select drug packaging facility
	  	X	  		  	
	 4.      Select central ethics committee (if applicable)
	  		  	X	  	
	 5.      Prepare study file notebooks for sites
	  		  	X	  	
	 6.      Generate monitoring plan
	  		  	X	  	
	 7.      Generate data entry/management plan
	  		  	X	  	
	 8.      Set up project master files
	  		  	X	  	
				
	 Investigator’s Meeting
	  	NA	  		  	
	 1.      Plan Investigator’s Meeting-include vendors, agenda, logistics
	  	NA	  		  	
	 2.      Prepare binders for the meeting
	  	NA	  		  	
	 3.      Present Investigator’s meeting
	  	NA	  		  	
	 4.      Attendance at meeting
	  	NA	  		  	
				
	 Initiation Visits
	  		  		  	
	 1.      Conduct site initiation Visits
	  		  		  	X
	 2.      Provide site initiation report in Omnicare compatible format
	  		  		  	X
				
	On-Site Monitoring	  		  		  	
	 1.      Conduct monitoring visits
	  		  	X	  	
	 2.      Provide site monitoring reports (due 10 days from visit)
	  		  	X	  	
	 3.      Verify 100% of source documentation
	  		  	X	  	
	 4.      Review drug records
	  		  	X	  	
	 5.      Review lab storage
	  		  	X	  	
	 6.      Review monitoring and data retrieval plan
	  		  	X	  	
				
	 Close-out visits
	  		  		  	
	 1.      Conduct site close-out visit
	  		  	X	  	
	 2.      Provide close-out trip report
	  		  	X	  	
				
	 Site Management
	  		  		  	
	 1.      Manage all sites questions and prepare a Q&A document
	  		  	X	  	
	 2.      Pay investigators
	  	X	  		  	

  

  

	****	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. 

  Page 2 









							
	 Task
	  	Peplin	  	Omnicare	  	Joint
	 3.      Pay drug packaging facility
	  	X	  		  	
	 4.      Pay central laboratory
	  	X	  		  	
	 5.      Maintain weekly telephone contact log with site
	  		  	X	  	
				
	 Project Management
	  		  		  	
	 1.      Regular enrollment updates (patients screened, entered, discontinued, completed)
	  		  	X	  	
	 2.      Regular update of cumulative monitoring visit schedule
	  		  	X	  	
	 3.      Regular updates of CRFs status ( received, data entered, cleaned and number of queries
outstanding)
	  		  	X	  	
	 4.      Team meetings with minutes
	  		  	X	  	
	 5.      Provision of status reports to Sponsors of performance against deliverables
	  		  	X	  	
				
	 Medical Management
	  		  		  	
	 1.      Document and manage all SAEs
	  		  	X	  	
	 2.      Cover medical emergencies after hours (pager)
	  		  	X	  	
	 3.      Develop and maintain safety database
	  		  	X	  	
	 4.      Submit SAE reports to regulatory authorities
	  	X	  		  	
	 5.      Prepare safety updates
	  	NA	  		  	
				
	 Study Drug Management
	  		  		  	
	 1.      Supply Study Drug
	  	X	  		  	
	 2.      Package Study Drug
	  	X	  		  	
	 3.      Produce Randomization Code
	  	NA	  		  	
	 4.      Label study drug
	  	X	  		  	
	 5.      Ship study drug to site
	  	X	  		  	
	 6.      Store study drug
	  	X	  		  	
	 7.      Perform post-study drug accountability
	  		  	X	  	
	 8.      Study drug disposition
	  		  	X	  	
	 9.      Update Master Drug File
	  	NA	  		  	
				
	 Data Entry
	  		  		  	
	 1.      Design/develop data collection system
	  		  	X	  	
	 2.      Validate data collection system
	  		  	X	  	
	 3.      Document control of CRFs
	  		  	X	  	
	 4.      Enter and verify data
	  		  	X	  	
				
	 Data Management
	  		  		  	
	 1.      Design/develop data cleaning system
	  		  	X	  	
	 2.      Validate cleaning system
	  		  	X	  	
	 3.      Write data management guidelines and edit specifications
	  		  	X	  	
	 4.      Review CRF and edit system
	  		  	X	  	
	 5.      Resolve edit queries
	  		  	X	  	
	 6.      Incorporate laboratory data into database
	  		  	X	  	
	 7.      Document corrections to CRFs
	  		  	X	  	
	 8.      Provide weekly patient listing of AEs
	  		  	X	  	
	 9.      Perform QC audits-electronic data compared to paper CRFs
	  		  	X	  	
	 10.    Code drug dictionary
	  		  	X	  	
	 11.    Code adverse events
	  		  	X	  	
	 12.    Code medications
	  		  	X	  	
	 13.    Test data transfer 1 standard and 1 subsequent transfer.
	  		  	X	  	
				
	 Statistical Analysis Plan
	  		  		  	
	 1.      Prepare an abbreviated analysis plan prior to CRF finalization
	  		  	X	  	
	 2.      Define efficacy tables and listings
	  		  	X	  	
	 3.      Define safety tables and listings
	  		  	X	  	

  

  

	****	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. 

  Page 3 









							
	 Task
	  	Peplin	  	Omnicare	  	Joint
	 4.      Produce efficacy tables and listings
	  		  	X	  	
	 5.      Produce safety tables and listings
	  		  	X	  	
	 6.      Provide draft report template and analysis plan
	  		  	X	  	
	 7.      Approve report template
	  		  	X	  	
	 8.      Validate efficacy tables and listings
	  		  	X	  	
	 9.      Validate safety tables and listings
	  		  	X	  	
	 10.    Perform quality assurance audit of the tables and listings
	  		  	X	  	
	 11.    Provide final tables and listings
	  		  	X	  	
	 12.    Provide statistical study report
	  		  	X	  	
				
	 Report Preparation
	  		  		  	
	 1.      Prepare draft report template
	  		  	X	  	
	 2.      Approve final report templates
	  	X	  		  	
	 3.      Draft study reports
	  		  	X	  	
	 4.      Final study reports
	  		  	X	  	
	 5.      Perform quality control verification of study reports
	  		  	X	  	
	 6.      Approval of final study reports
	  	X	  		  	
	 7.      Database transfer to Sponsor
	  		  	X	  	
				
	 Regulatory Site Audits
	  		  		  	
	 1.      Audit study sites for regulatory compliance
	  		  	X	  	
	 2.      Provide audit report
	  		  	X	  	
	 3.      Prepare annual safety report
	  	NA	  		  	

 III. Project Timeline 
 The parties acknowledge that Omnicare CR will commence performance of the Service on or about June 20, 2005. The projected timeline for this Project is as follows: 
 The following timeline is meant as a guide only. 
  

					
	 Task
	 	 	  	 Anticipated Timeline

	 Omnicare CR Activities to Commence
	 		  	June 2005
	 Drug Shipment to Site
	 		  	****
	 First Patient In
	 		  	****
	Maximum Tolerable Dose — Data Available for Sponsor to discuss with the FDA	 		  	****

  

  

	****	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. 

  Page 4 








 A detailed timeline and milestone will be developed based on the different assumptions of how the study is conducted.

 To achieve the above milestones, Omnicare Clinical Research requires the final protocol to be available no later than 20 June 2005 for Ethics
Submission. Please note Omnicare are dependent upon Sponsor providing all necessary documents in order for them to meet the above timeline. 
 IV.
Omnicare CR Services 
 A. Study Management 
 Project Leader 
 The Project Leader will act as a single point of contact for Sponsor during the course of the Project. The Project Leader is
responsible for the generation of detailed Project timelines and ensures 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 fox managing the study budget and addressing all out-of-scope items with Sponsor. 
 In addition, the
Project Leader is acting in a dual role this person will also be responsible for usual Clinical Trial Manager (CTM) activities including overseeing all site and clinical research associate (CRA) activity for the project in the US. The CTM
is also responsible for developing case report forms (CRF’s) and monitoring guidelines; overseeing regulatory document management for the investigational site and for reviewing and tracking the Project CRA activities which include the
scheduling of site visits, site visit reports, monitoring logs and follow-up correspondence. 
 Project Administrative Support/Coordination

 The Project Coordinator provides the necessary administrative support for all functional areas with administrative related tasks. 
 B. Clinical Trial Initiation 
 Setup & Maintenance of
Study Master File 
 Omnicare CR will establish and maintain the Study Master file in accordance with Omnicare CR’s Standard Operating Procedure
(SOP). The individual investigator file, and patient CRFs will be maintained in a locked, limited access, area. In addition, it is the responsibility of all Omnicare CR Project team members to ensure that the documents related to the study are
forwarded on a regular and frequent basis to the Study Master File. A transmittal sheet accompanies all documents forwarded to the Study Master File. The transmittal sheet clearly identifies the documents being submitted to the Study Master File.
Upon receipt, the file room verifies that the documents noted on the transmittal sheet have been received, signs and dates the 

  

  

	****	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. 

  Page 5 








 
transmittal sheet, and forwards a copy of the transmittal sheet back to the sender to confirm receipt. 
 Regulatory Document Collection 
 Document collection will cover all
criteria required under the principles of Good Clinical Practices (GCP) and International Committee for Harmonization (ICH) guidelines, as well as Omnicare CR Standard Operating Procedures (SOPs). 
 Omnicare CR will track the retrieval of documents on an ongoing basis and provide updates to Sponsor as requested. The fee for document collection, processing, and
tracking is based upon the number of sites required for the Project. 
 Protocol Amendments and IND Safety Reports and Investigator Brochure Updates 

 Protocol amendments will be billed at an additional processing fee (see budget). IND safety reports and revised Investigator Brochures will be sent to
sites at an additional fee (see budget). 
 Site Qualification 
 Omnicare CR’s site management and monitoring procedure will be performed in accordance with ICH-GCP to ensure each investigative site’s compliance with regulations and protocol requirements, and to enhance expeditious enrollment
of appropriate patients into the clinical study. Regulatory documents will be reviewed by the CRA on an ongoing basis during the study conduct phase, including verification of signed informed consent forms and investigator IRB notifications.

 The Ominicare CR CRA will review the following information at the pre-study site visit: 
  

	 	•	 	 Latest version of the Protocol for this study 


  

	 	•	 	 Consent form process 


  

	 	•	 	 AE and SAE reporting procedures and contact information 


  

	 	•	 	 Case report form completion and maintenance 


  

	 	•	 	 Source documentation requirements 


  

	 	•	 	 Drug accountability requirements 


 Sites that have
recently had a pre-study site visit performed by Sponsor or have worked with Omnicare CR in the preceding six months may be exempt from a pre-study site visit. Sponsor will provide Omnicare CR with a list of any exempt investigators for this study.

 Site Initiation 
 Once all regulatory documents and
approvals are received, a site initiation visit will be scheduled. During this visit, the CRA will review the following with the principal investigator and his/her staff as appropriate and the CTM will provide training: 
  

	 	•	 	 Study goals and obligations 


  

	 	•	 	 Investigator brochure 


  

	 	•	 	 Protocol procedures (with particular attention to inclusion/exclusion criteria, enrollment goals, adverse events, primary efficacy variables and GCP compliance)



  

  

	****	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. 

  Page 6 









	 	•	 	 Informed consent procedure 


  

	 	•	 	 dose escalation request procedure 


  

	 	•	 	 AE/SAE reporting 


  

	 	•	 	 CRF completion and error correction/need for adequate source documentation 


  

	 	•	 	 Maintenance of the investigator binder and site visit log 


  

	 	•	 	 Laboratory sample handling procedures and results reporting procedures 


  

	 	•	 	 Clinical supply dispensation, accountability and storage procedures 


 Site Interim Visits 
 Omnicare CR CRAs will perform ****% source document verification of CRF data for accuracy and
completeness. They will also review source data for appropriate identification, documentation, and reporting of both serious and non-serious adverse event for the first **** patients enrolled at the investigational site and source documentation for
****% of all subjects enrolled at the investigational site after the first **** patients Omnicare CR will supply to Sponsor weekly the monitoring schedule with at least **** weeks notice of anticipated visits. CRFs will be retrieved during each
monitoring visit, as well as pages for completed subject courses, running log pages and one-year follow-up pages. Pages and information for patients who fail screening will be reviewed and monitored. 
 The following issues are addressed at each interim visit as appropriate: 
  

	 	•	 	 Source document verification 


  

	 	•	 	 CRF completion 


  

	 	•	 	 Expedient data retrieval and query resolution 


  

	 	•	 	 Drug accountability 


  

	 	•	 	 Check and review of the regulatory binder and its contents 


  

	 	•	 	 Clinical supply inventory 


  

	 	•	 	 SAE reporting 


  

	 	•	 	 Enrollment issues and targets 


  

	 	•	 	 Protocol amendments 


  

	 	•	 	 Significant protocol deviations 


  

	 	•	 	 Acceptability of facilities 


  

	 	•	 	 Personnel changes 


  

	 	•	 	 Updated regulatory documentation 


  

	 	•	 	 Laboratory sample handling 


 Following each monitoring
visit, Omnicare CR will complete follow-up letters and site visit reports within two weeks of each visit. These follow-up letters and monitoring reports will be forwarded to Sponsor on a monthly basis. 
 Site Closeouts 
 At the conclusion of the study, after all completed
CRFs have been returned to Omnicare CR for logging and tracking, and after all unused CRF binders have been returned to Omnicare CR for destruction, the Omnicare CR CRA will perform a close-out visit. 
  

  

	****	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. 

  Page 7 








 The following issues are evaluated and/or reviewed with the investigator and his/her staff at the close-out visit:

  

	 	•	 	 Reason for termination (if study is not complete) 


  

	 	•	 	 Reconciliation and removal of clinical supplies per Sponsor’s requirements (including hazardous materials) 


  

	 	•	 	 All original CRFs retrieved from the site at the previous visit 


  

	 	•	 	 Signed informed consents retained by investigator 


  

	 	•	 	 Record retention requirements 


  

	 	•	 	 Notification to IRB or ethics committee of study termination 


  

	 	•	 	 Collection of randomization codes for return to Sponsor 


  

	 	•	 	 Resolution of all data queries 


  

	 	•	 	 Investigator binder contents (complete and updated) 


  

	 	•	 	 Informed consent log 


  

	 	•	 	 Financial agreements and disclosure (filed separately) 


  

	 	•	 	 Signature log and screening log 


  

	 	•	 	 Site visit and subject enrollment log 


  

	 	•	 	 Laboratory certification and renewals 


  

	 	•	 	 Summary/discussion of study from investigator and/or staff 


 Site Maintenance 
 Omnicare CR maintains a minimum of bi-weekly contact with investigational sites via telephone, facsimile, e-mail and/or
mail correspondence, based on the requirements of each investigational site. 
 Activities that are performed in-house between monitoring visits include, but
are not limited to: 
  

	 	•	 	 Discussion of study protocol and any amendments to the protocol 


  

	 	•	 	 Inclusion/exclusion questions or issues 


  

	 	•	 	 Review of clinical laboratory results 


  

	 	•	 	 New staff or team member orientation 


  

	 	•	 	 Additional site training 


  

	 	•	 	 Clinical supply activities or issues 


  

	 	•	 	 Enrollment updates (via weekly fax updates) 


  

	 	•	 	 AE and SAE updates 


  

	 	•	 	 Data query resolution 


  

	 	•	 	 Scheduling activities 


 Included in Site Maintenance
activities, Omnicare CR CRAs will assist Sponsor in resolving data queries for data from the investigational site, which are unclear, conflicting or incomplete. The status of all queries resolved by Omnicare CR will be communicated to Sponsor. The
CTM will provide Sponsor with an up-to-date report on the status of queries on an as-needed basis. The fee for resolution of data queries is included in the CRA site maintenance estimate. 
 Project Team Training 
 Omnicare CR will rely on Sponsor and internal
experts to provide specific therapeutic area training and orientation to the protocol and the CRF prior to study initiation and on an ongoing 

  

  

	****	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. 

  Page 8 








 
basis. This training will be designed to ensure that various team members are familiar with the Project requirements and their role within the team. Items
discussed at these meetings will include, but will not be limited to: 
  

	 	•	 	 Therapeutic area and clinical development background 


  

	 	•	 	 Protocol and CRF 


  

	 	•	 	 Discussion of therapeutic implications for this study 


  

	 	•	 	 Monitoring guidelines 


 Sponsor Meeting Attendance

 Omnicare CR assigned Project team will attend face-to-face meetings with Sponsor’s clinical team at assigned times throughout the Project.

 C. Medical and Safety 
 Medical Monitoring
(during business hours) 
 The Medical Advisor will be responsible for the following: 
  

	 	•	 	 Participation in team training and/or team meetings if required 


  

	 	•	 	 Monitoring of dose limiting toxicity for each cohort and making decision in relation to dose escalation, cohort expansion or maximum tolerated dose (MTD)



  

	 	•	 	 Availability for receipt of calls mainly during business hours 


  

	 	•	 	 Answering protocol specific questions from investigators, Clinical Research Associates (CRAs) or other members of the project team 


  

	 	•	 	 Answering patient specific questions (e.g. patient eligibility, evaluability etc.) from investigators, CRAs, or other members of the project team



  

	 	•	 	 Serious Adverse Event (SAE) medical review 


  

	 	•	 	 The maintenance of the full records of all communications regarding medical monitoring of the study 


  

	 	•	 	 Communication of medical monitoring matters to the client as appropriate 


 Any out of hours requests, will be billed at the out of hours rate, presented in the budget. 
 Global Safety Coordinator

 The Global Safety Coordinator is responsible for the coordination of all activities relating to safety. They will also be responsible for the
generation of, and any required revisions to, the Study Safety Plan, a comprehensive document, which defines the process and flow for contracted safety services. Safety coordination also includes assistance with the SAE reconciliation process, and
completion of sponsor derived queries of the sites. 
 The Global Safety Coordinator will be based in the US and will be responsible for receiving SAE
reports, preparing narratives, arranging medical review and reviewing reportability. 
  

  

	****	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. 

  Page 9 








 SAE Reporting — Initial Descriptive Narratives 
 Omnicare CR assumes that the descriptive summaries will be written from information provided by the investigator on the SAE report forwarded to Omnicare CR at the time of the event. If significant follow-up
information becomes available, the narrative will be updated accordingly. Omnicare CR will be responsible for notifying Sponsor and relevant regulatory agencies (FDA) of expedited events. Omnicare CR will fax to Sponsor all initial and follow-up SAE
reports received from site personnel or Omnicare CR’s CRAs within one business day. 
 The Safety Coordinator assigned to the project will coordinate all
activities relating to safety. These activities include attendance of internal and external team meetings, safety training of project staff or sites, communication of safety information to Omnicare CR project management and data management
departments as well as to Sponsor, and tracking the flow of safety information for the life of the project. The Safety Coordinator will also generate and update, the Study Safety Plan, which defines the process and flow for contracted safety
services. Safety coordination also includes assistance with the SAE reconciliation process and completion of sponsor derived queries of the sites. 
 D.
Clinical Data Management 
 Data Management Project Team 
 Due to the nature of the deliverables for this study, Omnicare CR has assumed a Clinical Data Leader (CDL) will be assigned to the Project for almost **** days per month for just over **** months. The LCDM will provide oversight
of the management team as well as ensure that all deliverables are achieved. 
 On a continual basis, the Omnicare CR team, CRAs, Project Leader/CTM and the
CDL will work in concert, will evaluate number and type of queries being generated by Clinical Data Management, in order to proactively manage the retrieval of quality data for both the studies and site release status. Plans will be implemented to
inspect the data for trends and issues in order to provide focused training at both the project team and the site levels. This will commence as soon as the first CRF pages are submitted in order to proactively resolve data issues. 
 It is Omnicare CR’s policy to perform a quality control (QC) of the final database to ensure the error rate is within an acceptable range. Each CRF will be
printed as a data listing with 100% QC of pre-defined critical data fields against the hard-copy CRF. In addition, a sampling of the patient data will undergo quality control for 100% of the data fields, prior to declaration of a clean database. The
processes and outcomes of these QC audits will be documented, with audit findings corrected within the timeframe identified with the Data Management Plan. Omnicare CR supports the plan for transfer of clean data to give both Sponsor and the Omnicare
CR Biometrics Group an opportunity to review clean data periodically, ensuring that guidelines are complete and accurate, and that the data is represented correctly in preparation for the analysis. 
 Omnicare CR believes that these strategies will ensure: 
  

	 	•	 	 Cleaner cases and data. 


  

	 	•	 	 Minimises queries — assumption of one query every **** CRF pages. 


  

	 	•	 	 Timely resolution of study and site issues. 


  

	 	•	 	 Cohesiveness between Sponsor, Omnicare CR and the study site. 


  

  

	****	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. 

  Page 10 









	 	•	 	 On-time delivery of final clean clinical study database. 


  

	 	•	 	 No surprises when preparing for data analysis. 


 Data Management Plan (DMP) 
 The DMP will include descriptions to the following Data Management activities: 
  

	 	•	 	 Project data flow 


  

	 	•	 	 Database development overview 


  

	 	•	 	 Edit specifications 


  

	 	•	 	 Data entry guidelines 


  

	 	•	 	 Data handling guidelines 


  

	 	•	 	 Study assumptions (Level 1) 


  

	 	•	 	 SAE reconciliation process 


  

	 	•	 	 External data load procedures / External Data Cleaning parameters / Discrepancy identification flow 


  

	 	•	 	 Dictionary coding guidelines and processes 


  

	 	•	 	 Database closure procedures 


 Prior to the start of
Data Management activities, the DMP and edit specifications must be agreed to and signed by the Omnicare CR designee and Sponsor representative. The agreement to all data handling rules will ensure an accurate and timely final database lock leading
to a successful data analysis. It is assumed that all portions of the DMP related to any specific task will be agreed upon prior to the start of those activities. 
 Review of Data Management Plan 
 Omnicare CR assumes **** Sponsor review cycles including up to **** major and **** minor revision in order
to finalize the DMP. 
 CRF Design and CRF Completion Guidelines 
 Omnicare CR assumes work on the CRF design will commence once the protocol is finalized. Upon receipt of the final draft comments, the final printable version of the CRF is prepared and provided to Sponsor for approval signature. The cost
associated with this task will comprise of **** Sponsor review cycles with **** major and **** minor revision. The CRF completion guidelines will follow the same process as the CRF and will need to be finalized prior to commencement of study
monitoring. 
 Database Development 
 Omnicare CR’s
Data Management Department uses Oracle Clinical for a standardized, validated approach to database design, edit development, data collection and storage. 
 Edit Checks 
 The edit specifications identified in the DMP require Sponsor approval prior to the initiation of the programming of the edit
checks (budget includes **** edits). It is Omnicare CR’s goal and in the project’s best interest to have all edits programmed and tested prior to any CRF data being 

  

  

	****	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. 

  Page 11 








 
submitted to Data Management. This will ensure there are no delays in reviewing and querying the data. Omnicare CR suggests a periodic review of the edit
specifications and data review guidelines to ensure that the rules and edit checks meet the project needs. 
 Data Entry 
 Omnicare CR assumes the CRFs for screen failure patients will not be received in-house, unless otherwise specified. All CRF and ancillary data received from the
investigative Site are logged into a tracking database on a page-by-page basis. Each page is identified by type of page and date received. Working copies will be maintained in CDM and used for any annotations during processing and cleaning. All
original (white) CRF and query pages will be immediately sent for filing in the Project Master File. 
 Data Review and Query Processing

 Omnicare CR assumes that the study data will be received in TBD retrieval / retrievals per subject. Data review includes **** (****) manual review
data checks and the application of **** (****) study assumptions for every **** (****) pages of the CRF per subject. Omnicare CR assumes that the manual review checks are not expected to exceed **** checks comparing **** datapoints.

 Quality Control Check of the Database 
 It is Omnicare
CR’s policy to perform a QC of the final database ensuring the error rate is within an acceptable range. Each CRF will be printed as a data listing with 100% QC of adverse events and the protocol identified primary efficacy parameters against
the hard-copy CRF. Also, a random sample subset of the patients will under go a 100% QC of all data points vs. the CRFs, to ensure the estimate of the error rate for the database is within acceptable limits prior to declaration of clean database.
The processes and outcomes of these QC procedures will be documented, with the findings, corrected within the timeframe identified within the DMP. Omnicare CR believes that these strategies will ensure the following results with respect to these
studies: 
  

	 	•	 	 Quality data 


  

	 	•	 	 On-time delivery of Final Clean Clinical Study Databases 


  

	 	•	 	 NO surprises when preparing for data analysis 


 Dictionary Coding 
 Omnicare CR is proficient in coding to both MedDRA and the WHO-Drug dictionaries. Additional dictionaries can also be
accommodated. 
 Sponsor is required to have a current MedDRA license in good standing prior to receipt of any MedDRA coded terms. It is assumed under this
Exhibit that Sponsor has a current MedDRA license in good standing and that such will be maintained throughout the course of the Project. 
 Reconciliation of the Safety and Clinical Database 
 Omnicare CR assumes a total of **** SAE for this project. A total of ****
(****) Adverse Event (AE) qualifiers will be reconciled. Omnicare CR’s Clinical Data Leader will update Omnicare CR’s Safety group with the DCF responses and the Safety group will update Sponsor of the changes. 
  

  

	****	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. 

  Page 12 








 E. Biometrics Analysis 
 Statistical Analysis Plan 
 Omnicare CR will develop a statistical analysis plan, including operational definition of endpoints to be
analysed, definition of patient subsets (evaluable and intent-to-treat), visit windows, rules for data handling, and a detailed description of statistical methodology. 
 If Sponsor has a standard statistical analysis plan template then this can be used instead. Omnicare CR has budgeted for one Sponsor review and one revision. 
 Design of Table Shells (Mocks) 
 The statistical plan will include a
set of formatted shells for all data displays (data listings, summary tables and graphics) planned for each study. If formatted data displays are not required, a detailed table of contents of SAS generated data displays will be included. 

Tables, Listings and Graph Programming 
 Omnicare CR will perform
the programming and will validate the following tables, listings and figures/graphs: 
  

							
	  	  	Unique	 	Repeat	 	Total
	 Tables
	  	****	 	****	 	****
	 Listings
	  	****	 	****	 	****
	 Figures/Graphs
	  	****	 	****	 	****

 Database Transfer 
 Omnicare CR assumes **** standard and **** subsequent database transfers which will be submitted to Sponsor in the form of SAS datasets. 
 Statistical Report 
 A statistical report will be developed in accordance with Sponsor’s requirements and will summarise the results of
the study, including findings that may not be appropriate for the body of the clinical report (tests for interaction, data distribution issues, etc.), deviations from the planned analyses, and additional exploratory analyses. 
 F. Clinical Writing 
 Clinical Study Report 
 Omnicare CR will draft the integrated clinical and statistical summary in accordance with ICH guidelines on the “Structure and Content of Clinical Study
Reports”, appropriate agency regulations, and Omnicare CR SOPs and clinical study report format. A draft clinical report will 

  

  

	****	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. 

  Page 13 








 
be generated within **** (****) weeks after receipt of source material and final summary tables and patient data listings. 
 Biometrics will produce up to **** tables and **** listings that will be summarised in the clinical study report. Sponsor will provide **** set of collated comments.
Omnicare CR’s cost estimate includes **** major (up to **** days) and **** minor (up to **** day) revision. This fee does not include the compilation or collation of clinical study report appendices. 
 G. Regulatory 
 Filing and Reconciliation of CRFs in the Study
Master File 
 CRFs tracked in clinical data management (CDM) are transferred to the Study Master File. CRFs and ancillary pages are verified against
the CDM tracking log and then filed. Sponsor will be billed for the actual number of pages filed. 
 CRF Return 
 Omnicare CR will return the CRFs in accordance with Omnicare’s SOPs within **** (****) months of final study deliverable. The CRFs are reviewed and reconciled
against the CRF tracker from Omnicare’s CDM department. Sponsor will be billed for the actual number of pages returned. 
 Return Study Master Files
— Hard Copy 
 Omnicare will return the Study Master File in hard copy format in accordance with Omnicare’s SOPs within **** (****) months
of final study deliverable. A final review of the study wide and individual investigator files is completed by Project Management for completeness and accuracy. Sponsor will be billed for the actual number of sites returned. 
 H. Clinical Quality Assurance and Validation 
 Quality Plan 
 Omnicare will develop a customised project-specific Quality Plan in partnership with Sponsor. The plan will include details
such as the percentages of sites/patients/data to be audited, the timeline of audits, and the plan for generation of individual Audit Reports and Certificates. Sponsor will be requested to review and sign off on the plan and any necessary amendments
to the original plan, prior to implementation. 
 CQA Site Audit 
 Omnicare will conduct **** site audit. The site audit will include ****% review of essential documents, including all informed consent documents and serious adverse event reporting compliance. In addition, for
approximately ****% (with a minimum of ****) of subjects at the study site, CRF data will be audited against source documents with an emphasis on critical efficacy and safety data; drug accountability will also be verified for these subjects. The
associated cost budgeted includes preparation and travel time, audit time, audit follow-up, and Audit Report and Audit Certificate generation. 
  

  

	****	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. 

  Page 14 








 V. Budget 
 A.
Estimated Project Budget 
  

													
	 Services
	  	        Unit        	 	#
        Units        	 	Unit
        Cost        
AUD	 	Service
      Fees      
AUD	 	Estimated
    Pass-Thru    
AUD	 	Estimated
    Total Cost    
AUD
	 STUDY MANAGEMENT
	  		 		 		 		 		 	
	 •   Project Leader / Clinical Trial Manager — Australia (assumes **** days per month for **** months)

	  	Days	 	****	 	****	 	****	 	****	 	****
	 •   Project Administrative Support/Coordination —Australia (includes support for all functional
areas)
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Subtotal — Study Management 
	  		 		 		 	****	 	****	 	****
	 CLINICAL TRIAL INITIATION
	  		 		 		 		 		 	
	 •   Study Master File (America; **** site for **** months)
	  	Site Months	 	****	 	****	 	****	 	****	 	****
	 •   Regulatory Document Collection (US)
	  	Site	 	****	 	****	 	****	 	****	 	****
	 Local IRB (pass-throughs are estimates only; actual fees will be billed based on specific IRB fees)
	  	Site	 	****	 	****	 	****	 	****	 	****
	 •   Protocol Amendments excluding ICF change (US)
	  	Amendments/
site	 	****	 	****	 	****	 	****	 	****
	 •   Protocol Amendments including ICF change (US)
	  	Amendments/
site	 	****	 	****	 	****	 	****	 	****
	 •   IND Safety Report (US)
	  	Reports/Site	 	****	 	****	 	****	 	****	 	****
	 •   Investigator Brochure Updates (US)
	  	IB Updates/
Site	 	****	 	****	 	****	 	****	 	****
	 •   CRA Training
	  	Hours	 	****	 	****	 	****	 	****	 	****
	 Subtotal — Clinical Trial Initiation 
	  		 		 		 	****	 	****	 	****
	 CLINICAL TRIAL MANAGEMENT
	  		 		 		 		 		 	
	 •   Clinical Monitoring
	  		 		 		 		 		 	
	 >Site Qualification Visit (US): **** hrs on-site, **** hrs for prep, follow-up, and reports, and **** hrs for travel — IF REQUIRED (actual units
provided will be billed)
	  	Visit	 	****	 	****	 	****	 	****	 	****

  

  

	****	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. 

  Page 15 









													
	 Services
	  	        Unit        	 	#
        Units        	 	Unit
        Cost        
AUD	 	Service
      Fees      
AUD	 	Estimated
    Pass-Thru    
AUD	 	Estimated
    Total Cost    
AUD
	 >Site Initiation Visit (US): **** hrs on-site, **** hrs for prep follow-up, and reports, and **** hrs for travel 
	  	Visit	 	****	 	****	 	****	 	****	 	****
	 > Clinical Trial Manager Training at Site Initiation Visit 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 >Site Interim Visits (US): assume **** visits/site, **** hrs on-site, **** hrs for prep, follow-up, and reports, and **** hrs for travel: ****-weekly
visits 
	  	Visits	 	****	 	****	 	****	 	****	 	****
	 >Additional Day Interim Visits (IF REQUIRED; based on **** hours per day) 
	  	Visit	 	****	 	****	 	****	 	****	 	****
	 >Site Close-Out Visit (US): **** hrs on-site, **** hrs for prep, follow-up, and reports, and **** hrs for travel 
	  	Visits	 	****	 	****	 	****	 	****	 	****
	 •   Site Maintenance for **** hrs/month/site (**** site in the US x **** months)
	  	Site Months	 	****	 	****	 	****	 	****	 	****
	 •   Project Team Training (to be held in Omnicare CR’s Sydney offices)
	  		 		 		 		 		 	
	 >CTM — Australia 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 > Medical Monitor—Australia 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 >Safety Officers — US (Via teleconference) 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Statistician: Australia 
	  		 	****	 	****	 	****	 	****	 	****
	 •   Sponsor Meeting Attendance (billed on actuals) by Project Leader/clinical Trial Manager (professional fees included
in Study Management; pass-through expenses are included as it assumes some travel to Queensland for face-to-face meetings)
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Subtotal — Clinical Trial Management
	  		 		 		 	****	 	****	 	****
	 MEDICAL AND SAFETY
	  		 		 		 		 		 	
	 •   Medical Monitoring, including does escalation, availability during business hours in Australia (actual hours
expended will be billed)
	  	Hours	 	****	 	****	 	****	 	****	 	****

  

  

	****	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. 

  Page 16 









													
	 Services
	  	        Unit        	 	#
        Units        	 	Unit
        Cost        
AUD	 	Service
      Fees      
AUD	 	Estimated
    Pass-Thru    
AUD	 	Estimated
    Total Cost    
AUD
	 •   Medical Monitoring availability out of business hours, between 6pm and 8am in Australia (actual hours expended will
be billed)
	  	Hours	 	****	 	****	 	****	 	****	 	****
	 •   Protocol Review by Medical Monitor plus project specific forms/ plan completed etc.(Australia)
	  	Project	 	****	 	****	 	****	 	****	 	****
	 •   Medical Consulting requested in Australia
	  	Hours	 	****	 	****	 	****	 	****	 	****
	 •   Safety Plan and Master File Set Up
	  	Site	 	****	 	****	 	****	 	****	 	****
	 •   Safety Phone Cover (actuals months will be billed)
	  	Months	 	****	 	****	 	****	 	****	 	****
	 •   Global Safety Coordinator in the US (assumes **** day per month for **** months)
	  	Days	 	****	 	****	 	****	 	****	 	****
	 •   SAE Reporting (with narratives) Billed on actuals 
	  	Reports	 	****	 	****	 	****	 	****	 	****
	 •   Dear Dr Letters reporting Pls who report to IEC, tracking of IRB acknowledgement letter
	  	Letter	 	****	 	****	 	****	 	****	 	****
	 •   SAE Reporting (Follow-up/Revision Reports >****) Billed on actuals 
	  	Report	 	****	 	****	 	****	 	****	 	****
	 Subtotal — Medical and Safety 
	  		 		 		 	****	 	****	 	****
	 CLINICAL DATA MANAGEMENT
	  		 		 		 		 		 	
	 •   Lead CDA — Americas (assumes ****% FTE x **** months Startup, ****% FTE x **** months, and ****% FTE x
**** months Close-out)
	  	Days	 	****	 	****	 	****	 	****	 	****
	 •   Development of Data Management Plan (includes **** major and **** minor revision; add **** revisions will be billed
at per diem rates)
	  	Days	 	****	 	****	 	****	 	****	 	****
	 •   CRF Design (assumes **** page CRF, **** unique CRF pages); includes **** major and **** minor
revision
	  	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. 

  Page 17 









													
	 Services
	  	        Unit        	 	#
        Units        	 	Unit
        Cost        
AUD	 	Service
      Fees      
AUD	 	Estimated
    Pass-Thru    
AUD	 	Estimated
    Total Cost    
AUD
	 •   Database Development, Testing and Maintenance (assumes **** page CRF, **** unique CRF pages)
	  	Project	 	****	 	****	 	****	 	****	 	****
	 •   Estimated Data Entry (actuals will be billed) — Pages in US
	  	Pages	 	****	 	****	 	****	 	****	 	****
	 •   Estimated Data Review and Query Resolution (assumes **** issue per **** CRF pages, **** manual checks and the
application of **** study assumption for **** CRF pages); assumes **** CRF pages per enrolled patient. Queries will be billed on actuals (Based on issues)
	  	Issue	 	****	 	****	 	****	 	****	 	****
	 •   Quality Control Check of Database versus CRF (assumes **** CRF pages per patient)
	  	Page	 	****	 	****	 	****	 	****	 	****
	 •   Edit Development (actuals Will be billed)
	  	Edits	 	****	 	****	 	****	 	****	 	****
	 •   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	 	****	 	****	 	****	 	****	 	****
	 •   Dictionary Coding of Medical History (estimated to be **** per patient; actuals will be billed)
	  	Term	 	****	 	****	 	****	 	****	 	****
	 •   PK Laboratory Data
	  		 		 		 		 		 	
	 >Initial Load
	  	Project	 	****	 	****	 	****	 		 	****
	 >Subsequent Loading (actuals will be billed)
	  	Load	 	****	 	****	 	****	 		 	****
	 >Lab Header Visit Verification (**** visits x **** patients; actuals will be billed)
	  	Visits	 	****	 	****	 	****	 		 	****
	 •   Reconciliation of the Safety and Clinical Database (actuals will be billed)
	  	SAE	 	****	 	****	 	****	 		 	****
	 Subtotal — Clinical Data Management
	  		 		 		 	****	 	****	 	****

  

  

	****	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. 

  Page 18 









													
	 Services
	  	        Unit        	 	#
        Units        	 	Unit
        Cost        
AUD	 	Service
      Fees      
AUD	 	Estimated
    Pass-Thru    
AUD	 	Estimated
    Total Cost    
AUD
	 BIOMETRICS ANALYSIS
	  		 		 		 		 		 	
	 •   Biometrics Team Leader
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Statistical Consultation as requested
	  	Hours	 	****	 	****	 	****	 	****	 	****
	 •   Statistical Plan + Mocks
	  	Project	 	****	 	****	 	****	 	****	 	****
	 •   Programming/QC of Data Displays (actuals will be billed).
	  		 		 		 		 		 	
	 > Unique Tables
	  	Table	 	****	 	****	 	****	 	****	 	****
	 >Repeat Tables
	  	Table	 	****	 	****	 	****	 	****	 	****
	 > Unique Listings
	  	Listing	 	****	 	****	 	****	 	****	 	****
	 >Repeat Listings
	  	Listing	 	****	 	****	 	****	 	****	 	****
	 •   Statistical Analysis (Reg.)
	  	Project	 	****	 	****	 	****	 	****	 	****
	 Statistical Report (Regular)
	  	Project	 	****	 	****	 	****	 	****	 	****
	 Standard Data Transfer
	  		 		 		 		 		 	
	 >Initial
	  	Transfer	 	****	 	****	 	****	 	****	 	****
	 >Subsequent (if required)
	  	Transfer	 	****	 	****	 	****	 	****	 	****
	 Add’l Stats consulting, meeting attendance, etc. , will be charged at per diem rates as
follows:

	 Team Leader
	  	Days	 		 	****	 		 		 	
	 Statistician
	  	Days	 		 	****	 		 		 	
	 Programmer
	  	Days	 		 	****	 		 		 	
	 Subtotal — Biometrics Analysis
	  		 		 		 	****	 	****	 	****
	 CLINICAL WRITING
	  		 		 		 		 		 	
	 •   Clinical Study Report
> includes **** major revision (up to **** days) and **** minor (up to
**** day) revision >Per Omnicare CR’s SOPS
>Fee does not include CSR appendices
	  	Report	 	****	 	****	 	****	 	****	 	****
	 •   Narrative (actuals will be billed)
	  	Narrative	 	****	 	****	 	****	 	****	 	****
	 •   Clinical Writing Input to SAP
	  	Project	 	****	 	****	 	****	 	****	 	****
	 •   Sponsor Meeting Attendance (Senior Writer; actuals will be billed)
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Attendance at Sponsor Requested Meetings:

	Attendance at Sponsor requested meetings (teleconferences/video conferences or Sponsor review/planning meetings at Sponsor/Omnicare CR, Inc.) will be billed to Sponsor
according to the following per diem rates:
	 Director:
	  	****	 		 		 		 		 	
	 Senior Writer:
	  	****	 		 		 		 		 	
	 Clinical Writer:
	  	****	 		 		 		 		 	
	 Sponsor will be billed for actual time expended 

	 Subtotal — Clinical Writing
	  		 		 		 	****	 	****	 	****
	 REGULATORY SERVICES
	  		 		 		 		 		 	

  

  

	****	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. 

  Page 19 









													
	 Services
	  	        Unit        	 	#
        Units        	 	Unit
        Cost        
AUD	 	Service
      Fees      
AUD	 	Estimated
    Pass-Thru    
AUD	 	Estimated
    Total Cost    
AUD
	 •   CRF Filing and Reconciliation (bill on actuals)
	  	Pages	 	****	 	****	 	****	 	****	 	****
	 •   Return of CRF (hard copy); bill on actuals
	  	Pages	 	****	 	****	 	****	 	****	 	****
	 •   Return of Investigator and Study-Wide Documents (paper)
	  	Sites	 	****	 	****	 	****	 	****	 	****
	 Subtotal — Regulatory Services 
	  		 		 		 	****	 	****	 	****
	 CLINICAL QUALITY ASSURANCE
	  		 		 		 		 		 	
	 •   Quality Plan
	  	Days	 	****	 	****	 	****	 	****	 	****
	 •   CQA Site Audits — includes preparation and travel time, audit time, audit follow-up, and Audit Report and
Audit Certificate generation at **** site in the US
	  	Sites	 	****	 	****	 	****	 	****	 	****
	 Subtotal — Clinical Quality Assurance
	  		 		 		 	****	 	****	 	****
	 MISCELLANEOUS PASS-THROUGH EXPENSES
	  		 		 		 		 		 	
	 •   CRF Printing (bill on actuals)
	  	Pages	 	****	 		 		 	****	 	****
	 Subtotal — Miscellaneous PT Expenses
	  		 		 		 		 	****	 	****
	 Estimated Services Budget 
	  		 		 		 	****	 		 	
	 Estimated Pass Through 
	  		 		 		 		 	****	 	
	 Total Estimated Budget 
	  		 		 		 		 		 	****

 B. Payment Schedules 
 1. Invoicing Process for Service Fees 
 Omnicare CR maintains a project accounting system, whereby all direct project
costs (Service Fees or Pass-through Expenses) are coded by project. 
 An initial payment of AUD$****, representing approximately **** percent (****%) of the
estimated Service Fees, is due and payable upon execution of this Exhibit A. Subsequent payments shall be made monthly, based on Project progress and upon submission of an invoice to Sponsor by Omnicare CR. The subsequent invoices shall be
reduced by a prorated portion from the initial payment such that the initial payment is applied evenly over the term of the Project. All payments shall be processed within **** days. If any payment of Service Fees or Pass-Through Expenses is
late by more than **** (****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
 2. Pass-Through Expense Invoicing 
  

  

	****	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. 

  Page 20 








 Omnicare CR’s project accounting system is able to capture and categorize in summary the following key Pass-Through
Expenses related to a project: 
  

	•	 	 Travel 


  

	•	 	 Delivery costs 


  

	•	 	 CRT and other printing or copying costs 


  

	•	 	 Investigator Meeting costs 


  

	•	 	 Telecommunication costs (which may include telephone, fax, pager, conference calls, or PC connectivity charges) 


  

	•	 	 All other project related expenses that are not related to Service Fees and any additional detail to support Pass-Through Expenses will be provided on a fee basis.



 3. Payments 
 Sponsor shall
make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. Westpac Banking Corporation, Maquarie
Shopping Centre, North Ryde, NSW 2113 SWIFT ID: **** BSB/Account Number: **** 
 4. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary, the estimated Service Fees set forth in this Exhibit A shall remain in effect until ****. Thereafter,
Omnicare CR reserves the right to increase the price of the remaining Services under this Exhibit A as of each ****; such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period.

 ACCEPTANCE 
 The terms and conditions of the Master
Agreement govern this Exhibit A and such document is incorporated herein by reference as if fully set forth herein. 
 BY AND BETWEEN: 

 

									
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.
					
	By:	 	 /s/ Michael Aldridge
	 		 	By:	 	 /s/ Kevin D. Duffy

	Name:	 	Michael Aldridge	 		 	Name:	 	Kevin D. Duffy
	Title:	 	Director	 		 	Title:	 	 Senior Vice President
 Global Marketing & Business
Development

	Dated:	 	24-Aug-05	 		 	Dated:	 	9/6/05

  

  

	****	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. 

  Page 21 








 Change Order #01 to Exhibit A to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 24th August 2005. 
 THIS CHANGE ORDER is entered into
this 24th day of October, 2005 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “ Sponsor
“) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS , Sponsor and Omnicare CR entered into a certain
Clinical Service Master Agreement, dated 1 st June 2005 (collectively, with the Exhibit thereto, as they same may have been amended or supplemented as of the date hereof, the “Agreement”) the terms of which are incorporated herein by
reference; and 
 WHEREAS , Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect
beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment any references to
“Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS , Sponsor and
Omnicare CR agree that Omnicare CR desire to amend Exhibit A to the Agreement to provide for certain additional tasks or changes in the scope of the work provided under the Agreement; 
 NOW, THEREFORE , for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND , Sponsor and Omnicare CR agree as follows:

 1. 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 1 









						
	 Reference
	  	 Changes and/or Additions
	  	Estimated Service
Fee (AUS$)
			
	Pursuant to Exhibit A, Omnicare CR will provide additional clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-004,
Version 3	  	1.  CRF design (increase in CRF size):	  		
	  	 a.    Assumption used in the original contract was a ****-page CRF with **** unique pages. Actual CRF page was
**** pages with **** unique and **** repeat pages per patient. Additional cost = AUS$****/ unique page (x **** pages) and AUS$****/ repeat page (x **** pages).
	  	$	****
			
		  	 b.  Additional work associated with revisions requested by Sponsor on CRF design.
	  	$	****
			
		  	2.  Database development (increase in CRF size):	  	$	****
			
		  	 Assumption and actual as noted in (1a) above, Additional cost = AUS$****/ unique page (x **** pages) and AUS$****/ repeat page (x ****
pages)
	  		
		  		  	 	 
	Total Estimated Service Fees	  	$	*****
		  		  	 	 
	Total Estimated Pass Through Expenses	  	 	******
		  		  	 	 
	Total Estimated Budget	  	$	 ****
		  		  	 	 

  
  

	*	The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original
unit costs. 

  

	**	Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project. 

 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR
agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set forth in this Change Order #01. 
  


  

	****	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. 

  Page 2 








 3. Payment 
 The full payment of AUS$**** representing **** percent (****%) of the estimated Service Fees, shall be due and payable to Omnicare CR upon execution of this Change Order #01. The payment of service fees and pass through expenses shall be
made by Sponsor within **** (****) days of receipt of invoice. If the payment of service fees or pass through expenses is late by more than **** (****) days, such payment shall be subject to a penalty fee of ****% per month of the
outstanding balance. 
 Sponsor shall make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking
Corporation, 
 Macquarie Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 4. Annual Price
Increase 
 Notwithstanding anything contained herein to the contrary and subject to any previous annual price increase(s), the estimated Service
Fees, Set forth in this Change Order #01 shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change Order #01 as of each ****; such increases shall not exceed the
percentage change of the Medical Services Price Index for the corresponding period. 
 5. No Other Changes 
 Except as expressly provided to the contrary in this Change Order #01, all other terms and conditions of the Agreement shall continue in force and effect. 
 ACCEPTANCE 
 BY AND BETWEEN: 
  

									
	Peplin Operations Pty Ltd.	  		 	Omnicare CR, Inc.
					
	By:	 	 /s/ Peter Welburn
	  		 	By:	 	 /s/ Kevin D. Duffy

	Name:	 	Peter Welburn	  		 	Name:	 	Kevin D. Duffy
	Title:	 	Director, Drug Development	  		 	Title:	 	 Senior Vice President
 Marketing & Business
Development

	Dated:	 	October 3, 2005	  		 	Dated:	 	10/24/05

  

  

	****	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. 

  Page 3 








 Change Order #02 to Exhibit A to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 24th August 2005. 
 THIS CHANGE ORDER is entered into this
24th day of October, 2005 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter
“Sponsor”) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a certain Clinical Services Master Agreement, dated 1st June 2005 (collectively,
with the Exhibit thereto as the same may have been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as
Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be
deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR
desire to amend Exhibit A to the Agreement to provide for certain additional tasks or changes in the scope of the work provided under the Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 1. Schedule of Changes 
 Sponsor and Omicare CR agree to the following changes and additional work pursuant to
the general terms and conditions set forth in the Agreement: 
  

									
	 Reference
	  	 Changes and/or Additions
	  	 Estimated Service
 Fee (AUS$)

	Pursuant to Exhibit A, Omnicare CR will provide additional clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-004, Version
3	 		  	 Edit Development:
 * Estimated number of edit checks in original budget = ****.
 * Actual number of edit checks =
****.
 * Variance = **** edit checks @ AUS$****
	  	****
		 		  		  	 
	 Total Estimated Service Fees
	  		  	****
		  		  	 
	 Total Estimated Pass-Through Expense
	  		  	****
		  		  	 
	 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 1 








  

	*	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, 

 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR
agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set forth in this Change Order #02. 
 3. Payment 
 The full payment of AUS$**** representing **** percent (****%) of the estimated Service Fees,
shall be due and payable to Omnicare CR upon execution of this Change Order #01. The payment of service fees and pass through expenses shall be made by Sponsor within **** (****) days of receipt of invoice. If the payment of service fees or
pass through expenses is late by more than **** (****) days, such payment shall be subject to a penalty fee of ****% per month of the outstanding balance. 
 Sponsor shall make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Macquarie
Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 4. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary and subject to any previous annual price
increase(s), the estimated Service Fees set forth in this Change Order #02 shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change Order #02 as of each ****;
such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 5. No Other Changes

 Except as expressly provided to the contrary in this Change Order #02, all other terms and conditions of the Agreement shall continue in force and effect.

  

  

	****	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. 

  Page 2 








 ACCEPTANCE 
 BY AND
BETWEEN: 
  

											
	Peplin Operations Pty Ltd.	 	Omnicare CR, Inc.	 	
						
	By:	 	 /s/ Peter Welburn
	 		 	By:	 	 /s/ Kevin D. Duffy
	 	
	Name:	 	Peter Welburn	 		 	Name:	 	Kevin D. Duffy	 	
	Title:	 	Director, Drug Development	 		 	Title:	 	 Senior Vice President
 Global Marketing & Business
Development
	 	
	Dated:	 	October 3, 2005	 		 	Dated:	 	10/24/05	 	

  

  

	****	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. 

  Page 3 








 Change Order #03 to Exhibit A to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 24th Aug 2005. 
 THIS CHANGE ORDER is entered into this
23rd day of Dec, 2005 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor”) and
Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and
Omnicare CR entered into a certain Clinical Services Master Agreement, dated 1st June 2005 (collectively, with the Exhibit as the same may have
been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing
and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR desire to amend Exhibit A to the Agreement to provide for certain additional tasks or
changes in the scope of the work provided under the Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING
TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
  

	1.	Schedule of Changes 

 Sponsor and Omnicare CR agree to the
following additional work and reduced services pursuant to the general terms and conditions set forth in the Agreement: 
  

  

	****	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. 

  Page 1 









										
	 Reference
	 	 Services to be Billed
	 	Estimated Additional
Service Fee (AUS$)
	 Pursuant to Exhibit A, Omnicare CR will provide
 additional biometrics support for the Sponsor’s Cohort
 Study of PEP005 Topical Gel, Protocol # PEP005-004,

 Version 3
	 	 Unique Tables:
  
 *  Estimated number of unique tables in original budget = ****
	 		 	$  ****	 	 	
					
		 	 *  Actual number of unique tables = ****
	 		 			 	
		 	 *  Variance = **** unique tables @ AUS$****
	 		 			 	
					
		 	Unique Listings:	 		 	$  ****	 	 	
					
		 	 *  Estimated number of unique listings in original budget = ****
	 		 			 	
					
		 	 *  Actual number of unique listings = ****
	 		 			 	
					
		 	 *  Variance = **** unique listings @ AUS$****
	 		 			 	
			
	 Reference
	 	 Services to be Billed
	 	Estimated Reduced
Service Fee (AUS$)
	 Pursuant to Exhibit A, Omnicare CR will provide
 additional biometrics support for the Sponsor’s Cohort
 Study of PEP005 Topical Gel, Protocol # PEP005-004,

 Version 3
	 	 Repeat Tables:
  
 *  Estimated number of repeat tables in original budget = ****
	 		 	$  ****	 	 	
					
		 	 *  Actual number of repeat tables = ****
	 		 			 	
					
		 	 *  Variance = **** repeat tables @ AUS$****
	 		 			 	
					
		 	Repeat Listings:	 		 	$    ****	 	 	
					
		 	 *  Estimated number of repeat listings in original budget = ****
	 		 			 	
					
		 	 *  Actual number of repeat listings = ****
	 		 			 	
					
		 	 *  Variance = **** repeat listings @ AUS$****
	 		 			 	
		 		 		 	 	 	 	
	Total Estimated Service Fees to be Billed	 		 	****	*	 	
		 		 		 	 	 	 	
	Total Estimated Service Fees Not to be Billed	 		 	****	 	 	
		 		 		 	 	 	 	
	Total Estimated Pass Through Expenses	 		 	****	**	 	
		 		 		 	 	 	 	

  

  

	*	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. 

  Page 2 









	2.	Term 

 Notwithstanding any language to the contrary set forth
in the Agreement, Sponsor and Omnicare CR agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set forth in this Change Order #03. 
  

	3.	Payment 

 The full payment of AUS$**** of the estimated
Service Fees, shall be due and payable to Omnicare CR upon execution of this Change Order #03. The payment of Service Fees and Pass-Through Expenses shall be made by Sponsor within **** (****) days of receipt of invoice. If the payment of
Service Fees or Pass-Through Expenses is late by more than **** (****) days, such payment shall be subject to a penalty fee of ****% per month of the outstanding balance. 
 Sponsor shall make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR
Inc. 
 Westpac Banking Corporation, 
 Macquarie Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
  

	4.	Annual Price Increase 

 Notwithstanding anything contained
herein to the contrary and subject to any previous annual price increase(s), the estimated Service Fees set forth in this Change Order #03 shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the
remaining Services under this Change Order #03 as of each ****; such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
  

	5.	No Other Changes 

 Except as expressly provided to the
contrary in this Change Order #03, all other terms and conditions of the Agreement shall continue in force and effect. 
  

  

	****	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. 

  Page 3 








 ACCEPTANCE 
 BY AND
BETWEEN: 
  

											
	Peplin Operations Pty Ltd.	 	Omnicare CR, Inc.	 	
						
	By:	 	 /s/ Michael Aldridge
	 		 	By:	 	 /s/ Leonard Stigliano
	 	
	Name:	 	Michael Aldridge	 		 	Name:	 	Leonard Stigliano	 	
	Title:	 	Managing Director & CEO	 		 	Title:	 	Pres. & Global Chief Operating Officer	 	
	Dated:	 	12-Dec-05	 		 	Dated:	 	12-23-05	 	

  

  

	****	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. 

  Page 4 








 Change Order #04 to Exhibit A to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 24th August 2005. 
 THIS CHANGE ORDER is entered into this 22nd day of September, 2006 (“Effective
Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor” ) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a certain Clinical Services Master Agreement,
dated 1st June 2005 (collectively, with the Exhibit thereto, as the same may have been amended or supplemented as of the date hereof, the
“Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity
(such entity being defined as an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except
for any references to invoicing or payment, any reference to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR desire to amend Exhibit A to the Agreement to provide for certain additional tasks or changes in the scope of the work provided under the Agreement;

 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as
follows: 
 1. 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 1 









							
	 Reference
	 	 Changes and/or Additions
	 	Estimated Service
Fee (AUS$)	 
	  
 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 @ $****
	 	$	****	 
	 		 			
	 	Clinical Data Management Final Reconciliation:	 			
	 		 			
	 		 			
	 		 			
			
		 	 •   Data Entry — Contracted units ****, Actual
 ****, Variance = **** @ $****/unit
	 	$	****	 
			
		 	 •   QC Data Review — Contracted units ****,
 Actual ****, Variance = **** @ $****/unit
	 	$	****	 
			
		 	 •   Query Resolution — Contracted units
 ****, Actual ****, Variance = **** @ $****/unit
	 	$	****	 
			
		 	 •   Dictionary Coding of AEs — Contracted units
 ****, Actual ****, Variance = **** @ $****/unit
	 	$	****	 
			
		 	 •   Dictionary Coding of Meds — Contracted units
 ****, Actual ****, Variance = **** @ $****/unit
	 	$	****	 
			
		 	 •   PK Lab Load (Subsequent) — 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	 	 	****	**
		 		 	 	 	 
	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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 2 








 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set
forth in this Change Order #04. 
 3. Payment 
 The
full payment of AUS$**** representing **** percent (****%) of the estimated Service Fees, shall be due and payable to Omnicare CR upon execution of this Change Order #04. The payment of service fees and pass through expenses shall be made by Sponsor
within **** (****) days of receipt of invoice. If payment of service fees or pass through expenses is late by more than **** (****) days, such payment shall be subject to a penalty fee of ****% per month of the outstanding balance.

 Sponsor shall make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking
Corporation, 
 Macquarie Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 4. Annual Price
Increase 
 Notwithstanding anything contained herein to the contrary and subject to any previous annual price increase(s), the, estimated Service
Fees set forth in this Change Order #04 shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change Order #04 as of each ****; such increases shall not exceed the
percentage change of the Medical Services Price Index for the corresponding period. 
 5. No Other Changes 
 Except as Expressly provided to the contrary in this Change Order #04, all other terms and conditions of the Agreement shall continue in force and effect. 
  

  

	****	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. 

  Page 3 








 ACCEPTANCE 
 BY AND
BETWEEN: 
  

									
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.
					
	By: 	 	 /s/ Michael Aldridge
	 		 	By:	 	 /s/ Dale Evans

	Name:	 	Michael Aldridge	 		 	Name:	 	Dale Evans
	Title:	 	Director	 		 	Title:	 	CEO
	Dated:	 	4-Oct-06	 		 	Dated:	 	10/10/06

  

  

	****	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. 

  Page 4 








 Change Order #05 to Exhibit A to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 24th August 2005. 
 THIS CHANGE ORDER is entered into this
18th Day of January, 2007 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor”)
and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor
and Omnicare CR entered into a certain Clinical Services Master Agreement, dated 1st June 2005 (collectively, with the Exhibit thereto, as the
same may have been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate
Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate
Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR desire to amend Exhibit A to the Agreement to provide
for certain additional tasks or changes in the scope of the work provided under the Agreement; 
 NOW, THEREFORE, for good and valuable
consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 1. 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 1 









							
	 Reference
	  	 Changes and/or Additions
	  	Estimated Service
Fee (AUS$)	 
	Pursuant to Exhibit A, Omnicare CR will provide additional services to support the Sponsor’s Cohort Study of PEP005 Topical Gel. Protocol # PEP005-004. Version
3	  	Appendices to final Clinical Study report:	  			
	  	  
 •        Set-up and Management @ A$****/ project
	  	$	****	 
	  	  
 •        Estimated Hyperlinks = **** units @ A$**** unit
	  	$	****	 
			
		  	 •        Estimated Scanned and Cleaned Pages units = **** units @ A$****/ unit
	  	$	****	 
			
		  	 •        Estimated Volumes = **** units @ A$****/ unit
	  	$	****	 
			
		  	 •        Project Coordinator (Australia) = **** hours @ A$****/hour
	  	$	****	 
		  		  	 	 	 
	 Total Estimated Service Fees
	  		  	$	****	*
		  		  	 	 	 
	 Total Estimated Pass Through Expenses
	  		  	$	****	**
		  		  	 	 	 
	 Total Estimated Budget
	  		  	$	****	 
		  		  	 	 	 

  

	*	The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original
unit costs. 

  

	**	Sponsor will be billed for actual Pass Through Expenses incurred in support of the Project. 

 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR
agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set forth in this Change Order #05. 
 3. Payment 
 An initial payment of A$****, representing **** percent (****%) of the estimated Service Fees,
shall be due and payable to Omnicare CR upon execution of this Change Order #05. The remaining balance of A$**** shall be due and payable upon completion of the above-mentioned activities. The payment of service fees and pass through expenses shall
be made by Sponsor within **** (****) days of receipt of invoice. If payment of service fees or pass through expenses is late by more than **** (****) days, such payment shall be subject to a penalty fee of ****% per month of the outstanding
balance. 
  

  

	****	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. 

  Page 2 








 Sponsor shall make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking
Corporation, 
 Macquarie Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 4. Annual Price
Increase 
 Notwithstanding anything contained herein to the contrary and subject to any previous annual price increase(s), the estimated Service Fees
set forth in this Change Order #05 shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change Order #05 as of each ****; such increases shall not exceed the
percentage change of the Medical Services Price Index for the corresponding period. 
 5. No Other Changes 
 Except as expressly provided to the contrary in this Change Order #05, all other terms and conditions of the Agreement shall continue in force and effect. 
 ACCEPTANCE 
 BY AND BETWEEN: 
  

									
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.
					
	By:	 	 /s/ Peter Welburn
	 		 	By:	 	 /s/ Dale Evans

	Name:	 	Peter Welburn	 		 	Name:	 	Dale Evans
	Title:	 	General Manager, Aus	 		 	Title:	 	Chief Executive Officer
	Dated:	 	24\1\07	 		 	Dated:	 	02\09\07

  

  

	****	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. 

  Page 3 









			
	Initial Sponsor Notification Form	  	



 Change in Project Scope 
  

							
	Protocol Number: PEP004	 	 	  	Date of Request:	  	 Omnicare
PCN:
 K01502

	Omnicare Project Director:	 	 	  	****	  	 
	Omnicare Account Director:	 	 	  	****	  	 
	Sponsor Study Manager:	 	 	  	Janelle Katsamas	  	 
	 Sponsor Outsourcing Manager:
  
	 	 	  	 	  	 
	Individual and Department making
request:	 	 	  	****, Project management	  	 
	  
 Brief
Description of Project Scope Change: Appendix to final CSR.
	  	 
	  
 Setup and
Management: US$ ****
	  	 
	  
 Est.
Hyper-links ($****/link): U$****
	  	 
	  
 Est. Scanned
and Cleaned Pages ($****/page): US$****
	  	 
	  
 Est. Volumes
($****/Volume): US$****
	  	 
	  
 Project
coordinator (Australia): AUD****
	  	 
	  
 Exchange rate: 1USD = 1.2683AUD
	 	 	  	Total: $**** 	  	 
	  
 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. 
  

	 ̈	OCR may proceed with the additional/changed services. It is understood that detail and full cost estimate will be 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/ Janelle Katsamas
	 		 	20/12/06	 	
	Sponsor Signature	 		 	Date       	 	

  

  

	****	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. 

   

					
	14 OCT 2005	  	Omnicare Clinical Research	  	Page 1 of 1
	(Replaces version 01JUL2004)	  	CONFIDENTIAL 	  	









 Exhibit B to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., dated 24-8-05. 
 THIS EXHIBIT B is entered into this 24th day of August, 2005 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor”) and Omnicare CR, Inc. (hereinafter
“Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a
Clinical Services Master Agreement, dated 1st June 05 (hereinafter the “Master Agreement”), wherein Omnicare CR agreed to provide
clinical services; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or
indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references
to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity”, and 
 WHEREAS, Sponsor and
Omnicare CR agree that Omnicare CR shall provide the services set forth in this Exhibit B, subject to the terms and conditions set forth in the Master Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor CR agree as follows: 
 I. Project Plan 
 Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for Sponsor’s
“A multi-center, randomised, double-blind, parallel-group, vehicle-controlled study to determine the safety of PEP005 0.0025%, 0.01% and 0.05% gel with two treatment schedules, Day 1 and Day 2 or Day 1 and Day 8 applications to actinic
keratoses”. Protocol #PEP005-001 dated 28 February 2005 Version 2 (hereinafter “the Project”) and associated costs, Changes made in the Project scope, at any time during the Project, will result in a corresponding adjustment to
the Project costs. 
 II. Project Roles and Responsibilities 
  

					
	 Task
	  	     Peplin    
	  	     Omnicare    

	 Project Management
	  		  	
	 1. Regular updates of CRFs status (received, data entered, cleaned and number of queries outstanding)
	  		  	X
	 2. Team meetings with minutes
	  		  	X
	 3. Provision of status reports to Sponsor of performance against deliverables
	  		  	X

  

  

	****	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. 

  Page 1 









					
	 Task
	  	    Peplin    	  	    Omnicare    
	 Data Entry
	  		  	
	 1. Design/develop data collection system
	  		  	X
	 2. Validate data collection system
	  		  	X
	 3. Document control of CRFs
	  		  	X
	 4. Enter and verify data
	  		  	X
	 Data Management
	  		  	
	 1. Design/develop data cleaning system
	  		  	X
	 2. Validate cleaning system
	  		  	X
	 3. Write data management guidelines and edit specifications
	  		  	X
	 4. Review CRF and edit system
	  		  	X
	 5. Resolve edit queries
	  		  	X
	 6. Incorporate laboratory data into database
	  		  	X
	 7. Document corrections to CRFs
	  		  	X
	 8. Provide weekly patient listing of AEs
	  		  	X
	 9. Perform QC audits-electronic data compared to paper CRFs
	  		  	X
	 10. Code drug dictionary
	  		  	X
	 11. Code adverse events
	  		  	X
	 12. Code medications
	  		  	X
	 13. Test data transfer after 25% amount of patients completed
	  		  	X
	 14. Test data transfer after 75% amount of patients completed
	  		  	X
	 Statistical Analysis Plan
	  		  	
	 1. Prepare an abbreviated analysis plan prior to CRF finalisation
	  		  	X
	 2. Define efficacy tables and listings
	  		  	X
	 3. Define safety tables and listings
	  		  	X
	 4. Produce efficacy tables and listings
	  		  	X
	 5. Produce safety tables and listings
	  		  	X
	 6. Provide draft report template and analysis plan
	  		  	X
	 7. Approve report template
	  	X	  	
	 8. Validate efficacy tables and listings
	  		  	X
	 9. Validate safety tables and listings
	  		  	X
	 10. Perform quality assurance audit of the tables and listings
	  		  	X
	 11. Provide final tables and listings
	  		  	X
	 12. Provide top line statistical summary report / statistical study report
	  		  	X

  

  

	****	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. 

  Page 2 









							
	 Task
	 	 	  	         Peplin        
	  	         Omnicare        

	 Report Preparation
	 		  		  	
	 1. Prepare draft report template
	 		  		  	X
	 2. Approve final report template
	 		  	X	  	
	 3. Draft study report
	 		  		  	X
	 4. Final study report
	 		  		  	X
	 5. Perform quality assurance of study report
	 		  		  	X
	 6. Approval of final study report
	 		  	X	  	
	 7. Database transfer to Sponsor
	 		  		  	X

 III. Project Timeline 
 The parties acknowledge that Omnicare CR will commence performance of the Service on or about 12 July 2005. The projected timeline for this Project is as follows: 
 The following timeline is meant as a guide only. 
  

			
	 Activities
	    	                     Anticipated Timeline               
     

	Start Database Set Up	    	w/c 11 July 2005
	Complete Database Build	    	****
	Commence Data Entry	    	****
	Complete Validation	    	****
	First Batch of DCFs Issued	    	****
	Last Patient Out	    	****
	Last CRF to Omnicare CR	    	****
	Last DCF Issued	    	****
	Soft Lock	    	****
	Hard Lock	    	****
	Top Line Summary Statistical Results	    	****
	Final Statistical Analysis Complete	    	****
	Clinical Study Report Available (following 7 weeks)	    	****

 A detailed timeline and milestones will be developed based on the different assumptions of how the project is
conducted. 
  

  

	****	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. 

  Page 3 








 To achieve the above milestones, Omnicare CR requires the data specifications to be available no later than mid
July 2005 for development of the database. In addition, collection of the last DCF is critical to achieving Top Line Summary Statistical Report. Please note Omnicare CR are dependent upon Sponsor providing all necessary documents in order for
them to meet the above timeline. 
 IV. Omnicare CR Services 
 Services provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the project specifications provided by Sponsor, and are outlined below. It should be noted, however, that the costs presented in
this budget for these services are estimated pending review of the final specifications, protocol and CRF. 
 A. Project Specifications 
 Project Specifications 
  

			
	 Total # of Sites
	  	11
	 Distribution of Sites
	  	Australia (1 x WA, 3 x VIC, 4 x NSW and 3 x QLD)
	 # of Screened / Randomised Patients
	  	60
	 # of CRF pages per patient (assumes **** unique pages)
	  	****
	 # of Total CRF Pages 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    
Months

	 Project Leader (**** days per month between July-November; **** days per month December & January)
	  	****	  	****
	 Senior Clinical Data Manager — UK (****% FTE)
	  	****	  	****
	 Lead Clinical Data Analyst — UK (****% FTE at start up; ****% FTE for duration and ****% FTE at close out)
	  	****	  	****
	 Biometrics Team Leader
	  	****	  	****

  

  

	****	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. 

  Page 4 








 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 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. 
 C. Clinical Data Management 
  

			
	 Activity
	  	     Number    

	 # Unique CRF Pages
	  	****
	 # Repeat CRF Pages
	  	****
	 Total CRF Pages
	  	****
	 # of Edit Checks
	  	****
	 # of Adverse Events per Patient — MedDRA
	  	****
	 # of Concomitant Medications per Patient — WHODrug
	  	****
	 # of Transfers (including initial)
	  	****

 Data Management Project Team 
 A data management team will be assigned to this project to carry out all of the activities defined in the specifications. The team will consist of a Clinical Data Manager, Lead Clinical Data Analyst, Database
Programming staff, Dictionary Manager, Data Technicians and Clinical Data Analysts. Team resources for the project will be developed by the Data Manager and will be based on the Case Report Form retrieval plan. Adjustments can be made as needed as
the study progresses. 
  

  

	****	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. 

  Page 5 








 Due to the nature of the deliverables for this Project, Omnicare CR has assumed a Clinical Data Manager (CDM) will
be assigned to this project for almost **** days per month for just over **** months. The CDM will provide oversight of the data management team as well as ensure that all deliverables are achieved. 
 On a continual basis, the Omnicare CR team, Project Leader/Biostatistics Team Leader; the Clinical Data Manager and the Lead Clinical Data Analyst will work in concert,
will evaluate the number and type of queries being generated by Clinical Data Management, in order to proactively manage the retrieval of quality data and site release status Plans will be implemented to inspect the data for trends and issues in
order to suggest focused training at both the project team and the site levels. This will commence as soon as the first CRF pages are submitted in order to proactively resolve data issues. 
 It is Omnicare CR’s policy to perform a quality control (QC) of the final database to ensure the error rate is within an acceptable range. Each CRF will be
printed as a data listing with 100% QC of pre-defined critical data fields against the hard-copy CRF. In addition, a ****% sampling of the patient data will undergo quality control for 100% of the data fields, prior to declaration of a clean
database. The processes and outcomes of these QC audits will be documented, with audit findings corrected within the timeframe identified with Data Management Plan. Omnicare CR supports the plan for transfer of clean data to give both Sponsor and
the Omnicare Biometrics Group an opportunity to review clean data periodically, ensuring that guidelines are complete and accurate, and that the data is represented Correctly in preparation for the analysis. 
 Omnicare CR believes that these strategies will ensure: 
  

	•	 	 Cleaner cases and data. 


  

	•	 	 Minimises queries. 


  

	•	 	 Timely resolution of study and site issues. 


  

	•	 	 Cohesiveness between Sponsor, Omnicare CR and the study site. 


  

	•	 	 On-time delivery of final clean clinical study database. 


  

	•	 	 No surprises when preparing for data analysis. 


 Clinical Data Manager 
 The Clinical Data Manager assigned to this project will oversee all Data Management activities throughout the life of
the project. This dedicated Clinical Data Manager will act as the primary liaison for all Data Management activities. Many of the Clinical Data Manager’s activities are listed below: 
  

	•	 	 Overseeing the completion of setup and maintenance of all data management activities 


  

	•	 	 Creation and implementation of the Data Management Plans 


  

	•	 	 Supporting the development of the CRF completion guidelines 


  

	•	 	 Liaise with monitoring team to ensure expectations for recording data accurately are communicated to the project team and the study site



  

	•	 	 Managing the query generation 


  

  

	****	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. 

  Page 6 









	•	 	 Proactively addressing data quality issues to reduce query generation 


  

	•	 	 Ensuring high quality and timely data management deliverables 


  

	•	 	 Maintain ongoing communication with Sponsor team members and Omnicare CR’s project team members 


  

	•	 	 Oversee project training for Clinical Data Management team members 


  

	•	 	 Provide status updates to both the Omnicare CR internal Project team and the Sponsor team members 


  

	•	 	 Clinical Data Management Project resource plan to ensure proper staffing throughout the study 


 Lead Clinical Data Analyst (CDA) 
 Omnicare CR has assigning a lead
CDA. The Lead CDA will provide additional team oversight for the project Data Technicians and CDAs. The Lead CDA will assist the Clinical Data Manager with the following activities in relation to the page-related staff: 
  

	•	 	 Prioritisation of Clinical Data Management tasks 


  

	•	 	 Directing the daily task Clinical Data Management team task assignments 


  

	•	 	 Monitoring the status of task and work load 


  

	•	 	 Ongoing project training within Data Management 


  

	•	 	 Providing feedback to the Clinical Monitoring staff on query trends 


  

	•	 	 Providing backup support to the Clinical Data Manager 


  

	•	 	 Ensure a cohesive team that maintains high quality and data consistency 


  

	•	 	 Generating metrics reports 


 Data Management Plan

 Omnicare CR assumes **** (****) Sponsor review cycles including up to **** major and **** minor revision in order to finalise the data management
plan. 
 Database Development 
 Omnicare CR will develop
the study clinical database utilising Oracle Clinical with Omnicare CR standard specifications. 
 Edit Specifications 
 Edit programming will begin after receiving Sponsor’s signoff of the edit specifications. The budget includes **** edits. 
 MedDRA Dictionary 
 Sponsor is required to have a current MedDRA
license in good standing prior to receipt of any MedDRA coded terms. It is assumed under this Exhibit that Sponsor has a current MedDRA license in good standing and that such will be maintained throughout the course of the Services. 
  

  

	****	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. 

  Page 7 








 Data Management Plan 
 The Clinical Data Manager will develop the Data Management Plan. The Data Management Plan will include descriptions of the following Data Management activities: 
  

	•	 	 Project data flow 


  

	•	 	 Database development overview 


  

	•	 	 Edit specifications 


  

	•	 	 Data entry guidelines 


  

	•	 	 Data handling guidelines 


  

	•	 	 Study assumptions (Level 1) 


  

	•	 	 SAE reconciliation process 


  

	•	 	 External data load procedures / External Data Cleaning parameters / Discrepancy identification flow 


  

	•	 	 Dictionary coding guidelines and processes 


  

	•	 	 Database closure procedures 


 Prior to the start of
Data Management activities, the Data Management Plan and edit specifications must be agreed to and signed by the Omnicare CR designee and Sponsor representative. The agreement to all data handling rules will ensure an accurate and timely final
database lock leading to a successful data analysis. It is assumed that all portions of the Data Management Plan related to any specific task will be agreed upon prior to the start of those activities. 
 Data Tracking and Data Entry 
 The dual data entry strategy will be
utilised for numeric and/or text fields. Data will be entered by one member of the data entry staff and re-entered on-line by a second member of the staff. CRF data for screen failure patients will be tracked and entered into the database but will
not be cleaned. 
 All CRF and ancillary data received from the investigative sites are logged into a tracking database on a page-by-page basis. Each page is
identified by type of page and date received. Working copies will be maintained in Clinical Data Management and used for any annotations during processing and cleaning. All original (white) CRF pages will be archived by the Sponsor prior to the
working Copies being sent to Omnicare CR. 
 Data Review and Query Processing 
 Following the data handling rules and edits specifications listed in the Data Management Plan, the Lead CDA will be responsible for: 
  

	•	 	 Reviewing the CRF data for obvious corrections and potential queries via the electronic Edit checks and the Manual review checks listed in the Data Management Plan



  

	•	 	 Applying any agreed upon self evident corrections or study assumptions 


  

	•	 	 Transmitting queries to investigative sites via monitors 


  

  

	****	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. 

  Page 8 









	•	 	 Tracking queries (issued and resolved) into Oracle Clinical Discrepancy Management System 


  

	•	 	 Working with the Clinical Data Manager to ensure all Data Clarification Forms (DCFs) are signed by the investigator and received in house via fax or mail.



 On a continual basis, the Clinical Data Manager will evaluate the number and type of queries being generated by Clinical Data Management,
in order to proactively manage the retrieval of quality data on these studies. The team will frequently inspect the data for trends and identification of issues, providing feedback to both the project team and the site. This will begin as soon as
sufficient CRF pages are received to identify the trends. 
 Reconciliation of Safety and Clinical Database 
 Omnicare CR assumes a total of **** SAEs for this project. A total of **** (****) Adverse Event (AE) qualifiers will be reconciled. Omnicare CR’s Clinical
Data Manager will update with the DCF responses and inform Sponsor of the changes. 
 D. Biometrics 
 Statistical Analysis Plan 
 Omnicare CR will develop a statistical
analysis plan, including operational definition of endpoints to be analysed, definition of patient subsets (evaluable and intent-to-treat), visit windows, rules for data handling, and a detailed description of statistical methodology. 
 If Sponsor has a standard statistical analysis plan template then this can be used instead. Omnicare CR has budgeted for one Sponsor review and one revision. 

Design of Table Shells (Mocks) 
 The statistical plan will include
a set of formatted shells for all data displays (data listings, summary tables and graphics) planned for each study. If formatted data displays are not required, a detailed table of contents of SAS generated data displays will be included.

 Tables, Listings and Graph Programming 
 Omnicare CR
will perform the programming and will validate the following tables, listings and figures/ graphs: 
  

							
	 	  	    Unique    	 	    Repeat    	 	    Total    
	 Tables
	  	****	 	****	 	****
	 Listings
	  	****	 	****	 	****
	 Figures/Graphs
	  	****	 	****	 	****

  

  

	****	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. 

  Page 9 








 Database Transfer 
 Omnicare CR assumes **** standard database transfer that will be submitted to Sponsor in the form of SAS datasets. 
 Top Line Statistics Summary
Report / Statistical Report 
 A report will be developed in accordance with Sponsor’s requirements and will summarise the results of the study,
including findings that may not be appropriate for the body of the clinical report (tests for interaction, data distribution issues, etc.), deviations from the planned analyses, and additional exploratory analyses. 
 It has been assumed that the Top Line Statistics Summary Report will include a small number of safety and efficacy tables with a brief overview of the document that is
sufficient for inclusion in a Press Release to be organised by Sponsor. 
 Lab Samples 
 Lab samples are being analysed centrally at QML in Australia. 
 E. Clinical Writing 
 Clinical Study Report 
 The integrated clinical and statistical summary
will be prepared in accordance with ICH guidelines on the “Structure and Content of Clinical Study Reports”, appropriate agency regulations, and Omnicare CR’s SOI’s and clinical study report format. A draft clinical report will
be generated within **** (****) weeks after receipt of source material and final summary tables and patient data listings. 
 The designated Omnicare CR
clinical writers will liaise closely with the statistician and other team members. All clinical documents will receive two levels of quality control reviews before they are released. There will be a QC review by an independent clinical writer for
accuracy and consistency, and a review by the writing manager for accuracy, client format consistency, and appropriate regulatory and clinical perspective. The first draft will then be provided to the Sponsor for review. 
 The second draft clinical study report will be produced after receipt of one set of collated comments from the Sponsor. It is our experience at Omnicare CR that this can
be facilitated, more speedily, by ****. The second draft will be reviewed within the Clinical Writing Department at Omnicare CR to ensure that all Sponsor comments are addressed and that all changes are consistent with the supporting data. Following
the Sponsor’s second review, minor revisions will be made and the report finalised. 
 Omnicare CR Biometrics will provide up to **** tables, ****
listings and **** figures that will be summarised in the clinical study report. 
  

  

	****	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. 

  Page 10 








 This fee includes **** major and **** minor revision. One major revision of the draft report is considered to be up to
**** (****) days of requested changes and a minor revision is up to **** (****) day of requested changes. Patient narratives will be drafted from final patient data listings. Omnicare CR Clinical Writing will prepare patient narratives for
SAEs and discontinuations due to adverse events based upon a $**** per narrative fee. This fee does not include the collation or compilation of clinical study report appendices. 
 Clinical Writing Input to SAP 
 Omnicare CR Clinical Writing will review the draft statistical analysis plan and mock
summary tables and data listings for consistency with the protocol and ICH guidelines. Clinical Writing will provide feedback on the table design and format to facilitate the use of the data in the clinical study report. 
 V. Budget 
 A. Estimated Project Budget 
  

															
	 Services
	  	        Unit        	  	#
        Units        	  	Unit
        Cost        
(A$)	  	      Fees (A$)      	  	Estimated
    Pass-Thru    
(A$)	  	Estimated
    Total Cost    
(A$)
	 CLINICAL DATA MANAGEMENT 
	  		  		  		  		  		  	
	 •
	 	Clinical Data Management Oversight — Int’l (CDM Manager assumes ****% FTE x **** month for Start-up, ****% FTE for **** months for Duration, and ****% FTE for **** months for
Close-out)	  	Days	  	****	  	****	  	****	  	****	  	****
	 •
	 	Lead CDA Int’l (assumes ****% FTE x **** month for Start-up, ****% FTE for **** months for Duration and ****% FTE for **** months for Close-out) —Actual days will be billed
	  	Days	  	****	  	****	  	****	  	****	  	****
	 •
	 	Development of Data Management Plan (includes **** major and **** minor revision; add’l revisions will be billed at per diem rates)	  	Days	  	****	  	****	  	****	  	****	  	****
	 •
	 	Database Development, Testing and Maintenance (assumes **** page CRF, **** unique CRF pages)	  	Project	  	****	  	****	  	****	  	****	  	****
	 •
	 	 Estimated Data Entry
 (actuals will be
billed)
	  	Pages	  	****	  	****	  	****	  	****	  	****

  

  

	****	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. 

  Page 11 









															
	 Services
	  	        Unit        	  	#
        Units        	  	Unit
        Cost        
(A$)	  	      Fees (A$)      	  	Estimated
    Pass-Thru    
(A$)	  	Estimated
    Total Cost    
(A$)
	 CLINICAL DATA MANAGEMENT (continued)
	  		  		  		  	
	 •
	 	Estimated Data Review and Query Resolution (assumes **** issue per **** CRF pages, **** manual checks and the application of **** study assumption for **** CRF pages); assumes **** CRF pages
per enrolled patient, **** pages per screen failure patient, and **** pages per drop out patient. Based on number of CRF Pages, actuals will be billed	  	Page	  	****	  	****	  	****	  	****	  	****
	 •
	 	Quality Control Check of Database versus CRF (assumes **** CRF pages per patient)	  	Patient	  	****	  	****	  	****	  	****	  	****
	 •
	 	Quality Control Check of Database versus CRF critical variables (**** minutes/patient)	  	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	  	****	  	****	  	****	  	****	  	****
	 •
	 	External Vendor) — Initial Load (actuals will be billed)	  		  		  		  		  		  	****
		 	Initial Load	  	Load	  	****	  	****	  	****	  	****	  	****
		 	> Subsequent Load (actuals will be billed)	  	Monthly	  	****	  	****	  	****	  	****	  	****
		 	Lab Visit Verification (**** visits x 60 patient’s: actuals will be billed)	  	Visits	  	****	  	****	  	****	  	****	  	****
	 •
	 	Reconciliation of the Safety and Clinical Database (actuals will be billed)	  	SAE	  	****	  	****	  	****	  	****	  	****
		 	 Subtotal — Clinical Data Management
	  		  		  		  	****	  	****	  	****

  

  

	****	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. 

  Page 12 









															
	 Services
	  	        Unit        	  	#
        Units        	  	Unit
        Cost        
(A$)	  	      Fees (A$)      	  	Estimated
    Pass-Thru    
(A$)	  	Estimated
    Total Cost    
(A$)
	BIOMETRICS	  		  		  		  		  		  	
	 •
	 	Biometrics Team Manager (includes Project Management)	  	Days	  	****	  	****	  	****	  	****	  	****
	 •
	 	Project Data Setup	  	Project	  	****	  	****	  	****	  	****	  	****
	 •
	 	Statistical Plan	  	Project	  	****	  	****	  	****	  	****	  	****
	 •
	 	Design of Table Shells (Mocks)	  	Project	  	****	  	****	  	****	  	****	  	****
	 •
	 	Programming/QC of Data Displays (actuals will be billed).	  		  		  		  		  		  	
		 	Unique Tables	  	Table	  	****	  	****	  	****	  	****	  	****
		 	Repeat Tables	  	Table	  	****	  	****	  	****	  	****	  	****
		 	Unique Listings	  	Listing	  	****	  	****	  	****	  	****	  	****
		 	Repeat Listings	  	Listing	  	****	  	****	  	****	  	****	  	****
		 	Unique Figures	  	Figure	  	****	  	****	  	****	  	****	  	****
		 	Repeat Figures	  	Figure	  	****	  	****	  	****	  	****	  	****
	 •
	 	Programmatic Evaluability/Outcome	  	Project	  	****	  	****	  	****	  	****	  	****
	 •
	 	Statistical Analysis	  	Project	  	****	  	****	  	****	  	****	  	****
	 •
	 	Statistical Report (Top Line Stats Summary Report)	  	Project	  	****	  	****	  	****	  	****	  	****
	 •
	 	FDA Item 11 (if required)	  	Project	  	****	  	****	  	****	  	****	  	****
	 •
	 	Standard Data Transfer	  		  		  		  		  		  	
		 	> Initial	  	Transfer	  	****	  	****	  	****	  	****	  	****
		 	> Subsequent	  	Transfer	  	****	  	****	  	****	  	****	  	****
	 Add’l Stats consulting, meeting attendance, etc., will be charged at per diem rates as
follows:

		 	Team Leader	  	Days	  		  	****	  		  		  	
		 	Statistician	  	Days	  		  	****	  		  		  	
		 	Programmer	  	Days	  		  	****	  		  		  	
		 	Subtotal — Biometrics	  		  		  		  	****	  	****	  	****
	 CLINICAL WRITING 
	  		  		  		  		  		  	
	 •
	 	Clinical Study Report - Phase II; includes **** major (up to **** days), and **** minor (up to **** day) revision: does not include compilation of Clinical Study Report Appendices;
per Omnicare CR SOPs)	  	Report	  	****	  	****	  	****	  	****	  	****
	 •
	 	Narratives (actuals will be billed)	  	Narrative	  	****	  	****	  	****	  	****	  	****
	 •
	 	Clinical Writing Input to SAP	  	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. 

  Page 13 









															
	 Services
	  	        Unit        	  	#
        Units        	  	Unit
        Cost        
(A$)	  	  Fees (A$)  	  	Estimated
Pass-Thru
(A$)	  	Estimated
Total Cost
(A$)
	 CLINICAL WRITING (continued) 
	  		  		  		  		  		  	
		 	Attendance at Sponsor Requested Meetings:	  		  		  		  		  		  	
		 	Sponsor will be billed for actual time expended. Attendance at Sponsor requested meetings (teleconferences/video conferences or client review/planning meetings at
Sponsor/Omnicare CR) will be billed to Sponsor according to the following per diem rates:
		 	Director	  		  		  	****	  		  		  	
		 	Senior Writer	  	Days	  		  	****	  		  		  	
		 	Clinical Writer	  	Days	  		  	****	  		  		  	
		 	 Subtotal — Clinical Writing
	  		  		  		  	****	  	****	  	****
	 MISCELLANEOUS 
	  		  		  		  		  		  	
	 •
	 	Return of CRF (hard copy); bill on actuals	  	Pages	  	****	  	****	  	****	  	****	  	****
	 Subtotal — Miscellaneous 
	  		  		  		  	****	  	****	  	****
		 		  		  		  		  	 	  	 	  	 
	 Estimated Services Budget 
	  		  		  		  	****	  		  	
		 		  		  		  		  	 	  		  	
	 Estimated Pass Through 
	  		  		  		  		  	****	  	
		 		  		  		  		  		  	 	  	
	 Total Estimated Budget 
	  		  		  		  		  		  	****
		 		  		  		  		  		  		  	 

 B. Payment Schedules 
 1. Invoicing Process for Service Fees 
 Omnicare CR maintains a project accounting system, whereby all direct project costs (Service Fees or
Pass-Through Expenses) are coded by project. 
 An initial payment of AUD$****, representing approximately **** percent (****%) of the estimated Service
Fees, is due and payable upon execution of this Exhibit B. Subsequent payments shall be made monthly, based on Project progress and upon submission of an invoice to Sponsor by Omnicare CR. The subsequent invoices shall be reduced by a prorated
portion form the initial payment such that the initial payment is applied evenly over the term of the Project. All payments shall be processed within **** days. If any payment of Service Fees or Pass-Through Expenses is late by more than ****
(****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
 2. Pass-Through Expense
Invoicing 
 Omnicare CR’s project accounting system is able to capture and categorize in summary the following key Pass-Through Expenses related to
a project: 
  

	•	 	 Travel 


  

	•	 	 Delivery costs 


  

	•	 	 CRF and other printing or copying costs 


  

  

	****	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. 

  Page 14 









	•	 	 Investigator Meeting costs 


  

	•	 	 Telecommunication costs (which may include telephone, fax, pager, conference calls, or PC connectivity charges) 


 All other project related expenses that are not related to Service Fees and any additional detail to support Pass-Through Expenses will be provided on a fee basis.

 3. Payments 
 Sponsor shall make payment directly to
the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Maquarie
Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 4. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary, the estimated Service Fees set forth in this
Exhibit B shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Exhibit B as of each ****; such increases shall not exceed the percentage change of the
Medical Services Price Index for the corresponding period. 
 ACCEPTANCE 
 The terms and conditions of the Master Agreement govern this Exhibit B and such document is incorporated herein by reference as if fully set forth herein. 
 BY AND BETWEEN: 
  

									
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.
					
	BY:	 	 /s/ Michael Aldridge
	 		 	BY:	 	 /s/ Kevin D. Duffy

	Name:	 	Michael Aldridge	 		 	Name:	 	Kevin D. Duffy
	Title:	 	Director	 		 	Title:	 	 Senior Vice President
 Global Marketing & Business
Development

	Date:	 	24-8-05	 		 	Date:	 	9-6-05

  

  

	****	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. 

  Page 15 








 Change Order #01 to Exhibit B to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 24th Aug 2005. 
 THIS CHANGE ORDER is entered into this 23
rd day of Dec, 2005 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor”) and
Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor
and Omnicare CR entered into a certain Clinical Services Master Agreement, dated 1 st June 2005 (collectively, with the Exhibit thereto, as the
same may have been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership, as Omnicare CR’s; hereinafter referred to as “Affiliate
Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate
Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR desire to amend Exhibit B to the Agreement to
provide for certain additional tasks or changes in the scope of the work provided under the Agreement. 
 NOW, THEREFORE, for good and
valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 1. Schedule of Changes

 Sponsor and Omnicare CR agree to the following additional work and reduced services pursuant to the general terms and conditions set forth in the
Agreement: 
  

  

	****	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. 

  Page 1 









						
	 Reference
	 	 Services to be Billed
	 	Estimated
Additional
Service Fee (AUS$)	 
	Pursuant to Exhibit B, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol #PEP0O5-001, Version 2	 	 Unique Tables: 
  
 *       Estimated number of unique tables in original budget = ****
  
 *       Actual number of
unique tables = ****
  
 *       Variance = **** unique tables @ AUS$****
	 	****	 
			
		 	Repeat Tables:	 	****	 
			
		 	 *       Estimated number of repeat tables in original budget = ****
	 		
			
		 	 *       Actual number of repeat tables = ****
	 		
			
		 	 *       Variance = **** repeat table @ AUS$****
	 		
			
		 	Unique Listings:	 	****	 
			
		 	 *       Estimated number of unique listings in original budget = ****
	 		
			
		 	 *       Actual number of unique listings = ****
	 		
			
		 	 *       Variance = **** unique listings @ AUS$****
	 		
			
		 	Repeat Listings:	 	****	 
			
		 	 *       Estimated number of repeat listings in original budget = ****
	 		
			
		 	 *       Actual number of repeat listings = ****
	 		
			
		 	 *       Variance = **** repeat listings @ AUS$****
	 		
			
	 Reference
	 	 Services Not to be Billed
	 	Estimated
Reduced
Service Fee (AUS$)	 
	Pursuant to Exhibit B, Omnicare CR will provide biometrics support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEP005-001, Version 2	 	 Unique Figures:
  
 *       Estimated number of unique figures in original budget = ****
  
 *       Actual number of
unique figures = ****
  
 *       variance = **** unique figure @ AUS$****
	 	****	 
			
		 	Repeat Figures:	 	****	 
			
		 	 *       Estimated number of repeat figures in original budget = ****
	 		
			
		 	 *       Actual number of repeat figures = ****
	 		
			
		 	 *       Variance = **** repeat figure @ AUS$****
	 		
		 		 	 	 
	Total Estimated Service Fees to be Billed	 	****	*
		 		 	 	 
	Total Estimated Service Fees Not to be Billed	 	****	 
		 		 	 	 
	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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 2 








  

	*	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. 

 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR
agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set forth in this Change Order #01. 
 3. Payment 
 The full payment of AUS$**** of the estimated Service Fees, shall be due and payable to Omnicare
CR upon execution of this Change Order #01. The payment of Service Fees and Pass-Through Expenses shall be made by Sponsor within **** (****) days of receipt of invoice. If the payment of Service Fees or Pass-Through Expenses is late by more
than **** (****) days, such payment shall be subject to a penalty fee of ****% per month of the outstanding balance. 
 Sponsor shall make payment
directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Macquarie
Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 4. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary and subject to any previous annual price
increase(s), the estimated Service Fees set forth in this Change Order #01 shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change Order #01 as of each ****;
such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 5. No Other Changes

 Except as expressly provided to the contrary in this Change Order #01, all other terms and conditions of the Agreement shall continue in force and effect.

  

  

	****	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. 

  Page 3 








 ACCEPTANCE 
 BY
AND BETWEEN: 
  

									
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.
					
	By:	 	 /s/ Michael Aldridge
	 		 	By:	 	 /s/ Leonard Stigliano

	Name:	 	Michael Aldridge	 		 	Name:	 	Leonard Stigliano
	Title:	 	CEO & Managing Director	 		 	Title:	 	Pres. & Global Chief Operating Officer
	Dated:	 	12-Dec-05	 		 	Dated:	 	12-23-05

  

  

	****	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. 

  Page 4 









			
	  
 Initial
Sponsor Notification Form
  
	  	



 Change in Project Scope 
  

					
	 Protocol Number: PEP005-001
  
	 	     Date of Request:
04OCT2005
  
	 	     Omnicare PCN: KO1503
  

	 Omnicare
Project Director:      
 Omnicare Account Director:      
 Sponsor Study Manager:      
 Sponsor Outsourcing Manager:      
  
	 	     ****
     ****
     Peter
Welburn

	 Individual and Department making      
 request:      
	 	    ****, Biometrics
	 Brief Description of Project Scope Change:
  
 Revised costing for tables and
listings presented in Statistical Analysis Plan. The original proposal had an estimate of Tables (**** unique/**** repeat), Listings (**** unique/**** repeat) and Figures (**** unique/**** repeat). Due to reporting requirements and providing
comprehensive efficacy analysis there has been an increase in the number of Tables and Listings designed and presented in the Statistical Analysis Plan (please see attached table of contents for flagging of Unique (P) and Repeat
(S) displays.
  
 The updated count of Tables is **** unique/**** repeat and Listings
is **** unique/**** repeat.
  
 The increase in cost to produce these data displays as set
out in the Statistical Analysis Plan will be $****
  

	 	 
	 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 provided by 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. 

   


					
	01JUL2004 (Initial Version)	 	 Omnicare Clinical Research
 CONFIDENTIAL
	 	Page 1 of 1










			
	  
 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/ Peter Welburn
	 		 		  	 7/10/05

	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 of the Securities Exchange Act of 1934, as amended. 

   


					
	01JUL2004 (Initial Version)	 	 Omnicare Clinical Research
 CONFIDENTIAL
	 	Page 2 of 1









 Change Order #02 to Exhibit B to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 24th Aug 2005. 
 THIS CHANGE ORDER is entered into this 18
th day of October, 2005 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor”) and
Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a certain Clinical Services
Master Agreement, dated 1 st June 2005 (collectively, with the Exhibit thereto, as the same may have been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are incorporated herein by reference; and

 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common
ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment any references to “Omnicare CR”
shall be deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that
Omnicare CR desire to amend Exhibit B to the Agreement to provide for certain additional tasks or changes in the scope of the work provided under the Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
  

  

	****	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. 

  Page 1 








 1. Schedule of Changes 
 Sponsor and Omnicare CR agree to the following additional work services pursuant to the general terms and conditions set forth in the Agreement: 
  

					
	 Reference
	  	 Services to be Billed
	  	Estimated
        Additional Service        
Fee (AUS$)
	Pursuant to Exhibit B, Omnicare CR will load Sponsor’s log of protocol deviations from monitoring of PEP005-001 into the clinical database	  	Development of an additional DCM/DCI module, loading the spreadsheet data and QC of received data.	  	$****


  
  

	*	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. 

 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement Sponsor and Omnicare CR
agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set forth in this Change Order #02. 
 3. Payment 
 The full payment of AUS$**** of the estimated Service Fees, shall be due and payable to Omnicare
CR upon execution of this Change Order #02. The payment of Service Fees and Pass-Through Expenses shall be made by Sponsor within **** (****) days of receipt of invoice. If the payment of Service Fees or Pass-Through Expenses is late by more
than **** (****) days, such payment shall be subject to a penalty fee of ****% per month of the outstanding balance. 
 Sponsor shall make payment
directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Macquarie
Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
  

  

	****	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. 

  Page 2 








 4. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary, the estimated Service Fees set forth in this Change Order #02 shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the
price of the remaining Services under this Change Order #02 as of each ****; such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 5. No Other Changes 
 Except as expressly provided to the
contrary in this Change Order #01, all other terms and conditions of the Agreement shall continue in force and effect. 
  

  

	****	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. 

  Page 3 









											
	ACCEPTANCE 	 		 		 		 	
					
	BY AND BETWEEN: 	 		 		 		 	
			
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.
						
	By:	 	 /s/ JANELLE KATSAMAS
	 		 	By: 	 	 /s/ KEVIN D. DUFFY
	 	
	Name:	 	JANELLE KATSAMAS	 		 	Name: 	 	KEVIN D. DUFFY	 	
	Title:	 	CLINICAL RESEARCH MGR	 		 	Title: 	 	EXECUTIVE VICE PRESIDENT	 	
		 		 		 		 	GLOBAL BUSINESS DEVELOPMENT	 	
		 		 		 		 	CHIEF RELATIONS OFFICER	 	
	Dated:	 	21 February 2006	 		 	Dated:	 	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 of the Securities Exchange Act of 1934, as amended. 

  Page 4 









			
	  
 Initial
Sponsor Notification Form
  
	 	



 Change in Project Scope 
  

					
	 Protocol Number: PEP005-001
  
	 	     Date of Request:
19OCT2005
  
	 	     Omnicare PCN: KO1503
  

	 Omnicare
Project Director:      
 Omnicare Account Director:      
 Sponsor Study Manager:      
 Sponsor Outsourcing Manager:      
  
	 	     ****
     ****
     Peter
Welburn

	 Individual and Department making      
 request:      
	 	    ****, Clinical Data Management
	 Brief Description of Project Scope Change:
  
 In order to load Peplin’s log
of protocol deviations from monitoring of PEP005-001 into the clinical database an additional Oracle Clinical module is required to be built to receive this data. This will take as estimated **** hours to complete and would include building the
DCM/DCL module, loading the spreadsheet data and QC of received data. The proposed cost 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 acknowledgement received at
OCR. 
  

	þ	OCR may proceed with the additional/changed services. It is understood that detail and full cost estimated will be 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/ JANELLE KATSAMAS
	 		  	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 of the Securities Exchange Act of 1934, as amended.

   


					
	01JUL2004 (Initial Version)	 	 Omnicare Clinical Research
 CONFIDENTIAL
	 	Page 1 of 1









 Change Order #03 to Exhibit B to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 24th Aug 2005. 
 THIS CHANGE ORDER is entered into this
15th day of December, 2005 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor”)
and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor
and Omnicare CR entered into a certain Clinical Service Master Agreement, dated 1 st June 2005 (collectively, with the Exhibit thereto, as the
same may have been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity, (such entity being defined as an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate
Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate
Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR desire to amend Exhibit B to the Agreement to provide
for certain additional tasks or changes in the scope of the work provided under the Agreement; 
 NOW, THEREFORE, for good and valuable
consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 Following database close, data management reconciliation
to CRF pages received, queries raised, QC performed SAE reconciliation has taken place. 
  

  

	****	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. 

  Page 1 








 1. 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: 
  

													
	 Omnicare CR, Inc.
 Clinical Budget for:
 Sponsor:
 PCN:
 Services
	 	 Peplin
 KO1503.03
 Unit
	 	# Units    	 	Unit Cost	 	Fees    	 	 Estimated
 Pass-Thru
	 	 Estimated
 Total Cost

							
	 •   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	 	****	 	****	 	****	 	****	 	****
	 Sub-Total Clinical Data Management
	 		 		 		 	****	 	****	 	****
		 		 		 		 	 	 	 	 	 
	 Estimated Services Budget
	 		 		 		 	****	 		 	
		 		 		 		 	 	 		 	
	 Estimated Pass Through
	 		 		 		 		 	****	 	
		 		 		 		 		 	 	 	
	 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 2 








 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set
forth in this Change Order #03. 
 3. Payment 
 The
full payment of AUS$**** of the estimated Service Fees, shall be due and payable to Omnicare CR upon execution of this Change Order #03. The payment of Service Fees and Pass-Through Expenses shall be made by Sponsor within **** (****) days of
receipt of invoice. If the payment of Service Fees or Pass-Through Expenses is late by more than **** (****) days, such payment shall be subject to a penalty fee of ****% per month of the outstanding balance. 
 Sponsor shall make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking
Corporation, 
 Macquarie Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 4. Annual Price
Increase 
 Notwithstanding anything contained herein to the contrary, the estimated Service Fees set forth in this Change Order #03 shall remain in
effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change Order #03 as of each ****; such increases shall not exceed the percentage change of the Medical Services Price Index for
the corresponding period. 
 5. No Other Changes 
 Except as expressly provided to the contrary in this Change Order #01, all other terms and conditions of the Agreement shall continue in force and effect. 
  

  

	****	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. 

  Page 3 









											
	ACCEPTANCE	 		 		 		 	
					
	BY AND BETWEEN:	 		 		 		 	
			
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.
						
	By:	 	 /s/ JANELLE KATSAMAS
	 		 	By: 	 	 /s/ KEVIN D. DUFFY
	 	
	Name:	 	JANELLE KATSAMAS	 		 	Name: 	 	KEVIN D. DUFFY	 	
	Title:	 	CLINICAL RESEARCH MGR	 		 	Title: 	 	EXECUTIVE VICE PRESIDENT	 	
		 		 		 		 	GLOBAL BUSINESS DEVELOPMENT	 	
		 		 		 		 	CHIEF RELATIONS OFFICER	 	
	Dated:	 	20 December 2005	 		 	Dated:	 	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 of the Securities Exchange Act of 1934, as amended. 

  Page 4 









			
	  
 Initial
Sponsor Notification Form
  
	 	



 Change in Project Scope 
  

					
	 Protocol Number: PEP005-001
  
	 	     Date of Request:
21NOV2005
  
	 	     Omnicare PCN: KO1503
  

	 Omnicare
Project Director:      
 Omnicare Account Director:      
 Sponsor Study Manager:      
 Sponsor Outsourcing Manager:      
  
	 	     ****
     ****
     Peter
Welburn

	 Individual and Department making      
 request:      
	 	    ****, Clinical Data Management
	 Brief Description of Project Scope Change:
  
 Following database close, data
management reconciliation of CRE pages received, queries raised, QC performed and SAE reconciliation has taken Place. These tasks are billed as actuals as per the contract and the final reconciliation of tasks is attached. This represents an overall
increase of $**** in the clinical data management budget.
  

	 	 
	 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 acknowledgement received at
OCR. 
  

	þ	OCR may proceed with the additional/changed services. It is understood that detail and full cost estimate will be 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/ Michael Aldridge
	 		  	 12-De-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 of the Securities Exchange Act of 1934, as amended.

   


					
	01JUL2004 (Initial Version)	 	 Omnicare Clinical Research
 CONFIDENTIAL
	 	Page 1 of 1









 PEP005-001 (KO1503) 
  

															
	 Contract item
	  	 unit
	  	 unit cost A$
	  	 # units per
 contract
	  	 contract
 cost
	  	 actual # units
	  	 actual cost
	  	 difference

	 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	  	****	  	****	  	****	  	****	  	****	  	****
	 CRF tracking
	  	page	  	****	  	****	  	****	  	****	  	****	  	****
	 dictionary coding of AEs
	  	term	  	****	  	****	  	****	  	****	  	****	  	****
	 dictionary coding of meds
	  	term	  	****	  	****	  	****	  	****	  	****	  	****
	 lab load — initial
	  	load	  	****	  	****	  	****	  	****	  	****	  	****
	 lab visit verification
	  	visit	  	****	  	****	  	****	  	****	  	****	  	****
	 SAE reconciliation
	  	SAE	  	****	  	****	  	****	  	****	  	****	  	****
		  		  		  		  	 	  		  	 	  	 
	 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. 









 Change Order #03 to Exhibit B to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 18th October 2005. 
 THIS CHANGE ORDER is entered into
this 15th day of December, 2005 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter
“Sponsor” ) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a certain Clinical Services Master Agreement, dated 1st June 2005 (collectively,
with the Exhibit thereto, as the same may have been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as
Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be
deemed to include “Omnicare CR and/or Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR
desire to amend Exhibit B to the Agreement to provide for certain additional tasks or changes in the scope of the work provided under the Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 Following database close, data management reconciliation of CRF pages received, queries raised, QC performed and SAE reconciliation has taken place. 
  

  

	****	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. 

  Page 1 








 1. 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: 
  

													
	 Omnicare CR, Inc.
	  	Peplin	  		  		  		  		  	
	 Clinical Budget for:
	  	KO1503.03	  		  		  		  		  	
	 Sponsor:
	  		  		  		  		  		  	
	 PCN:
	  		  		  		  		  		  	
	 Services
	  	 Unit
	  	 # Units
	  	 Unit Cost
	  	 Fees
	  	 Estimated
 Pass-Thru
	  	 Estimated
 Total Cost

	 Clinical Data Management
	  		  		  		  		  		  	
	 •   Estimated Data Entry (actuals will be billed)
 > Pages in Int’l 
	  	Pages	  	****	  	****	  	****	  	****	  	****
	 •   Data Review and Query Resolution
 > CRF Pages 
	  	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 (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	  	****	  	****	  	****	  	****	  	****
		  		  		  		  	 	  	 	  	 
	 Sub-Total Clinical Data Management 
	  		  		  		  	**** 	  	**** 	  	**** 
		  		  		  		  	 	  		  	
	 Estimated Services Budget 
	  		  		  		  	**** 	  		  	
		  		  		  		  	 	  	 	  	
	 Estimated Pass Through 
	  		  		  		  		  	**** 	  	
		  		  		  		  		  	 	  	 
	 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 2 








 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set
forth in this Change Order #03. 
 3. Payment 
 The
full payment of AUS $**** of the estimated Service Fees, shall be due and payable to Omnicare CR upon execution of this Change Order #03. The payment of Service Fees and Pass-Through Expenses shall be made by Sponsor within **** (****) days of
receipt of invoice. If the payment of Service Fees or Pass-Through Expenses is late by more than **** (****) days, such payment shall be subject to a penalty fee of ****% per month of the outstanding balance. 
 Sponsor shall make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking
Corporation, 
 Macquarie Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 4. Annual Price
Increase 
 Notwithstanding anything contained herein to the contrary, the estimated Service Fees set forth in this Change Order #03 shall remain in
effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change Order #03 as of each ****; such increases shall not exceed the percentage change of the Medical Services Price Index for
the Corresponding period. 
 5. No Other Changes 
 Except as expressly provided to the contrary in this Change Order #01, all other terms and conditions of the Agreement shall continue in force and effect. 
  

  

	****	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. 

  Page 3 









											
	ACCEPTANCE 	 		 		 		 	
					
	BY AND BETWEEN: 	 		 		 		 	
			
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.
						
	By:	 	 /s/ Peter Welburn
	 		 	By: 	 	 /s/ Kevin Duffy
	 	
	Name:	 	Peter Welburn	 		 	Name: 	 	 Kevin Duffy
	 	
	Title:	 	Director, Drug Development	 		 	Title: 	 	Senior Vice President, Global Marketing	 	
		 		 		 		 	 & Business Development
	 	
	Dated:	 	20/12/05	 		 	Dated:	 	 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 of the Securities Exchange Act of 1934, as amended. 

  Page 4 









			
	  
 Initial
Sponsor Notification Form
  
	 	



 Change in Project Scope 
  

					
	 Protocol Number: PEP005-001
  
	 	     Date of Request:
21DEC2005
  
	 	     Omnicare PCN: KO1503
  

	 Omnicare
Project Director:      
 Omnicare Account Director:      
 Sponsor Study Manager:      
 Sponsor Outsourcing Manager:       
  
	 	     ****
     ****
     Peter
Welburn

	 Individual and Department making      
 request:      
	 	    ****, Clinical Writing
	 Brief Description of Project Scope Change:
  
 The final number of tables and
listings represents a significant increase compared to the contracted number of TLs (**** tables and **** listings versus **** tables and **** listings). More time will be required to draft the Clinical Study Report based on the increased number of
tables and listings. This additional work represents an additional $**** for production of the CSR.
  

	 	 
	 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 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/ Peter Welburn
	 		 	30 December 2005
	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.

   


					
	01JUL2004 (Initial Version)	 	 Omnicare Clinical Research
 CONFIDENTIAL
	 	Page 1 of 1









 Change Order # 4 To Exhibit B To The Clinical Services Master Agreement 
 Between Peplin Operations Pty Ltd. And Omnicare CR, Inc., 
 Dated 24th August 2005. 
 THIS CHANGE ORDER is entered into
this 10 th day of January, 2006, by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor”) and Omnicare
CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS,
Sponsor and Omnicare CR have entered into certain Clinical Services Master Agreement, dated 1st June 2005 (collectively, with the
Exhibit thereto, as the same may have been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as
Omnicare ,CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be
deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR desire to amend
Exhibit B to the Agreement to provide for certain additional tasks or changes in the scope of the work provided under the Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR hereby agree as follows: 
 1. Schedule of Changes 
 Sponsor and Omnicare CR agree to the following additional work pursuant to the general terms and conditions
set forth in the Agreement: 
  

						
	 Reference
	  	 Services to be Billed
	  	Estimated
Additional Service
Fee (AUS$)
	 Pursuant to Exhibit B,
 Omnicare CR will provide

 Clinical Writing Services for the
 Sponsor’s Cohort Study
of
 PEP005 Topical Gel, Protocol #PEP005-001, Version 2
	  	 More time will be required to draft the Clinical Study Report based on the increased number of tables and listings: 
  
 •        **** tables and **** listings were produced versus **** tables and **** listings originally contracted. 
  
 •        Estimated additional time:
 **** days of a Senior Writer @
$****/day = $****
 **** day of a Director CW @ $****/day = $****
	  	 	****
		  		  		
		  		  	 	 
	Total Estimated Additional 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  1 








  

	*	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. 

 In the event of any conflict between the provisions of this Change Order #4 and the Agreement, the terms of this Change Order #4 shall govern. 
 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR
agree that the term of the Agreement shall be extended as set forth above to permit completion of the additional work set forth in this Change Order #4. 
 3. Payment 
 The full payment of AUS$**** of the estimated additional Service Fees shall be due and payable to Omnicare CR upon
execution of this Changes #4. The payment of Service Fees and pass through expenses shall be made by Sponsor within **** (****) days of receipt of invoice. If any payment of service fees or pass through expenses is late by more than **** (****)
days, such payment shall be subject to a penalty fee of ****% per month of the outstanding balance. 
 Sponsor shall make payment directly to the following
bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation 
 Macqarie Shopping Centre 
 North Ryde, NSW 2114 
 Swift ID: **** 
 BSB/Account
Number: **** 
 4. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary, the estimated service fees set forth in this Change Order #4 shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining
services under this Change Order #4 as of each ****; such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 5. No Other Changes 
 Except as expressly provided to the contrary in this Change Order #4, all other terms and
conditions of the Agreement shall continue in full force and effect. 
  

  

	****	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. 

  2 








 ACCEPTED AND APPROVED BY AND BETWEEN: 
  

											
	Peplin Operations Pty Ltd.	 	Omnicare CR, Inc.	 	
						
	22By:	 	 /s/ Peter Welburn
	 		 	By:	 	/s/ KEVIN D.
DUFFY                              	 	
	Name:	 	Peter Welburn	 		 	Name:	 	KEVIN D. DUFFY	 	
	Title:	 	Director, Drug Development	 		 	Title:	 	 EXECUTIVE VICE PRESIDENT
 GLOBAL BUSINESS DEVELOPMENT
  
 CHIEF RELATIONS OFFICER
	 	
	Date: 30\1\06.	 	Date: 2-13-06	 	

  

  

	****	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. 

  3 








 Change Order #05 to Exhibit B to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 24 August 2005. 
 THIS CHANGE
ORDER is entered into this 13th day of February, 2006 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter
“Sponsor”) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a certain Clinical Services Master Agreement, dated 1 st June 2005 (collectively,
with the Exhibit thereto, as the same may have been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as
Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be
deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR
desire to amend Exhibit B to the Agreement to provide for certain additional tasks or changes in the scope of the work provided under the Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 1. 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 1 









						
	 Reference
	  	 Changes and/or Additions
	  	Estimated Service
Fee (AUS$)	 
			
	Pursuant lo Exhibit B, Omnicare CR will provide statistical support for the Sponsor’s Study of PEP005 Topical Gel, Protocol # PEP005-001	  	Sponsor has requested the production of **** (****) additional tables (**** unique and **** repeat tables) and the provision of a short flash report (up to **** (****) page) to
accompany delivery of tables. These additional tables and flash report are to be delivered by 28 February 2006.	  		
			
		  	The estimated cost to produce the additional tables and flash report are:	  		
			
		  	* **** unique tables @ $****/table = $****	  	****	 
		  	* **** repeat table @ $****/table = $****	  	****	 
		  	* **** flash report (**** hours Biostatistician time @ $****/hour) = $****	  	****	 
			
		  	Actuals will be billed.	  		
		  		  	 	 
	Total Estimated Service Fees to be Invoiced	  	****	 
		  		  	 	 
	Total Estimated Pass Through Expenses	  	****	**
		  		  	 	 

  
  

	*	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. 

 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR
agree that the term of the Agreement shall be extended to 28 February 2006 to permit the completion of the additional work set forth in this Change Order #05. 
 3. Payment 
 The full payment of AUS$**** for Service Fees, shall be due and payable to Omnicare CR upon execution of this Change
Order #05. The payment of service fees and pass through expenses shall be made by Sponsor within **** (****) days of receipt of invoice. If the payment of service fees or pass through expenses is late by more than **** (****) days, such
payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
  

  

	****	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. 

  Page 2 








 Sponsor shall make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking
Corporation, 
 Macquarie Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 4. Annual Price
Increase 
 Notwithstanding anything contained herein to the contrary and subject to any previous annual price increase(s), the estimated Service Fees
set forth in this Change Order #05 shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change Order #05 as of each ****; such increases shall not exceed the
percentage change of the Medical Services Price Index for the corresponding period. 
 5. No Other Changes 
 Except as expressly provided to the contrary in this Change Order #05, all other terms and conditions of the Agreement shall continue in force and effect. 
  

											
	ACCEPTANCE	 		 		 		 	
					
	BY AN BETWEEN:	 		 		 		 	
			
	Peplin Operations Pty Ltd.	 	Omnicare CR, Inc.	 	
						
	By:	 	 /s/ Peter Welburn
	 		 	By:	 	 /s/ KEVIN D. DUFFY
	 	
	Name:	 	Peter Welburn	 		 	Name:	 	KEVIN D. DUFFY	 	
	Title:	 	Director, Drug Development	 		 	Title:	 	 EXECUTIVE VICE PRESIDENT
 GLOBAL BUSINESS DEVELOPMENT
 CHIEF RELATIONS OFFICER
	 	
	Dated:	 	21 February 2006	 		 	Dated:	 	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 of the Securities Exchange Act of 1934, as amended. 

  Page 3 









			
	  
 Initial
Sponsor Notification Form
  
	  	



 Change in Project Scope 
  

					
	 Protocol Number: PEP005-001
  
	 	     Date of Request:
10FEB2006
  
	 	     Omnicare PCN: KO1503
  

	 Omnicare
Project Director:      
 Omnicare Account Director:      
 Sponsor Study Manager:      
 Sponsor Outsourcing Manager:      
  
	 	     ****
     ****
     Peter
Welburn

	 Individual and Department making      
 request:      
	 	    ****, Biometrics
	 Brief Description of Project Scope Change:
  
 The sponsor has requested the
production of **** additional tables (**** unique and **** repeat tables) and the provision of a short flash report (up to **** page) to accompany delivery of tables. These additional tables and flash report are to be delivered by
28FEB2006.
  
 The estimate cost to produce **** unique tables (@ $**** each, is $****,
**** repeat table (@ $**** each) is $**** and the flash report (**** hours @ $**** each) is $****. The Total estimated cost 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 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/ Peter Welburn
	 		 	16\2\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.

   


					
	01JUL2004 (Initial Version)	 	 Omnicare Clinical Research
 CONFIDENTIAL
	 	Page 1 of 1









 Change Order #06 to Exhibit B to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 24 August 2005. 
 THIS CHANGE ORDER is entered into this 22nd day of September,
2006 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor”) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a certain Clinical Services Master Agreement,
dated 1 st June 2005 (collectively, with the Exhibit thereto, as the same may have been amended or supplemented as of the date hereof, the
“Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity
(such entity being defined as an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except
for any references to invoicing or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR desire to amend Exhibit B to the Agreement to provide for certain additional tasks or changes in the scope of the work provided under the Agreement;

 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as
follows: 
 1. 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 1 









						
	 Reference
	  	 Changes and/or Additions
	  	Estimated Service
Fee (AUS$)	 
	Pursuant to Exhibit B, Omnicare CR will provide Statistical and Clinical Writing support for the Sponsor’s Study of PEP005 Topical Gel, Protocol # PEP005-001	  	Sponsor has requested the additional production of tables and a graph as well as clinical writing additions.	  		
	  	  
 The cost to produce the additional tables and graph are:
	  		
	  	  
 *       **** unique tables @ $****/table
	  	****	 
	  	  
 *       **** repeat tables @ $****/table
	  	****	 
	  	  
 *       **** unique graph @ $****/graph
	  	****	 
	  	  
 The cost for the additional clinical writing are:
	  		
	  	  
 *       Senior Clinical Writer — ****days@ $****/day
	  	****	 
	  	  
 *       Clinical Writing Director — **** day @ $****/day
  
	  	****  
	  

		  		  	 	 
	Total Estimated Service Fees	  	****	*
		  		  	 	 
	Total Estimated Pass Through Expenses	  	****	**
		  		  	 	 
	Total Estimated Budget 	  	****	 
		  		  	 	 

  
  

	*	The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original
unit costs. 

  

	**	Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project. 

  

	2.	Term 

 Notwithstanding any language to the contrary set forth
in the Agreement, Sponsor and Omnicare CR agree that the term of the Agreement shall be extended to permit the completion of the additional work set forth in this Change Order #06. 
  

	3.	Payment 

 The full payment of AUS$**** representing ****
percent (****%) of the estimated Service Fees, shall be due and payable to Omnicare CR upon execution of this Change Order #06. The payment of service fees and pass through expenses shall be made by Sponsor within **** (****) days of receipt of
invoice. If payment of service fees or pass through expenses is late by more than **** (****) days, such payment shall be subject to a penalty fee of ****% per month of the outstanding balance. 
  

  

	****	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. 

  Page 2 








 Sponsor shall make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking
Corporation, 
 Macquarie Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
  

	4.	Annual Price Increase 

 Notwithstanding anything contained
herein to the contrary and subject to any previous annual price increase(s), the estimated Service Fees set forth in this Change Order #06 shall remain in effect until ****. Thereafter, Omnicare CR reserves the right increase the price of the
remaining Services under this Change Order #06 as of each ****; such increases shall not exceed the percentage change of the Medical Services Index for the corresponding period. 
  

	5.	No Other Changes 

 Except as expressly provided to the
contrary in this Change Order #06, all other terms and conditions of the Agreement shall continue in force and effect. 
  

											
	ACCEPTANCE	 		 		 	
				
	BY AND BETWEEN: 	 		 		 	
				
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.	 	
						
	By:	 	 /s/ Michael Aldridge
	 		 	By:	 	 /s/ Dale Evans
	 	
	Name:	 	Michael Aldridge	 		 	Name:	 	Dale Evans	 	
	Title:	 	Managing Director & CEO	 		 	Title:	 	CEO	 	
	Dated:	 	4-oct-06	 		 	Dated:	 	10/10/06	 	

  

  

	****	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. 

  Page 3 








 Exhibit C to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., dated 24-08-05. 
 THIS EXHIBIT C is entered into this 24th day of August, 2005 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor”) and Omnicare CR, Inc. (hereinafter
“Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a
Clinical Services Master Agreement, dated 1 st June 05 (hereinafter the “Master Agreement”), wherein Omnicare CR agreed to provide
clinical services; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or
indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references
to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and
Omnicare CR agree that Omnicare CR shall provide the services set forth in this Exhibit C, subject to the terms and conditions set forth in the Master Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 I. Project Plan 
 Based on the Project Specifications, Omnicare CR has provided a description of services to be
performed for Sponsor’s “A multi-centre, randomised, double-blind, parallel-group, vehicle-controlled study to determine the safety of PEP005 0.0025%, 0.01% and 0.05% gel with two treatment schedules, Day 1 and Day 2 or Day 1 and Day 8
applications to nodular basal cell carcinoma”. Protocol #PEP005-002 dated 28 February 2005 Version 2 Amendment #1 dated 9 June 2005 (hereinafter “the Project”) and associated costs. Changes made in the Project scope, at any
time during the Project, will result in a corresponding adjustment to the Project costs. 
 II. Project Roles and Responsibilities 
  

									
	 Task
	 	 	  	         Peplin        
	 	 	  	       Omnicare      

	 Project Management
	 		  		 		  	
	 1. Regular updates of CRFs status (received, data entered, cleaned and number of queries outstanding)
	 		  		 		  	X
	 2. Team meetings with minutes
	 		  		 		  	X
	 3. Provision of status reports to Sponsor of performance against deliverables
	 		  		 		  	X

  

  

	****	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. 

  Page 1 









									
	 Task
	 	 	  	         Peplin        
	 	 	  	      Omnicare      
	 Data Entry
	 		  		 		  	
	 1. Design/develop data collection system
	 		  		 		  	X
	 2. Validate data collection system
	 		  		 		  	X
	 3. Document control of CRFs
	 		  		 		  	X
	 4. Enter and verify data
	 		  		 		  	X
	 Data Management
	 		  		 		  	
	 1. Design/develop data cleaning system
	 		  		 		  	X
	 2. Validate cleaning system
	 		  		 		  	X
	 3. Write data management guidelines and edit specifications
	 		  		 		  	X
	 4. Review CRF and edit system
	 		  		 		  	X
	 5. Resolve edit queries
	 		  		 		  	X
	 6. Incorporate laboratory data into database
	 		  		 		  	X
	 7. Document corrections to CRFs
	 		  		 		  	X
	 8. Provide weekly patient listing of AEs
	 		  		 		  	X
	 9. Perform QC audits-electronic data compared to paper CRFs
	 		  		 		  	X
	 10. Code drug dictionary
	 		  		 		  	X
	 11. Code adverse events
	 		  		 		  	X
	 12. Code medications
	 		  		 		  	X
	 13. Test data transfer after 25% amount of patients completed
	 		  		 		  	X
	 14. Test data transfer after 75% amount of patients completed
	 		  		 		  	X
	 Statistical Analysis Plan
	 		  		 		  	
	 1. Prepare an abbreviated analysis plan prior to CRF finalisation
	 		  		 		  	X
	 2. Define efficacy tables and listings
	 		  		 		  	X
	 3. Define safety tables and listings
	 		  		 		  	X
	 4. Produce efficacy tables and listings
	 		  		 		  	X
	 5. Produce safety tables and listings
	 		  		 		  	X
	 6. Provide draft report template and analysis plan
	 		  		 		  	X
	 7. Approve report template
	 		  	X	 		  	
	 8. Validate efficacy tables and listings
	 		  		 		  	X
	 9. Validate safety tables and listings
	 		  		 		  	X
	 10. Perform quality assurance audit of the tables and listings
	 		  		 		  	X
	 11. Provide final tables and listings
	 		  		 		  	X
	 12. Provide statistical analysis
	 		  		 		  	X
	 13. Database transfer to Sponsor
	 		  		 		  	X

  

  

	****	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. 

  Page 2 









									
	 Task
	 	 	  	        Peplin        	 	 	  	      Omnicare      
	 Report Preparation
	 		  		 		  	
	 1. Prepare draft report template
	 		  		 		  	X
	 2. Approve final report template
	 		  	X	 		  	
	 3. Draft study report
	 		  		 		  	X
	 4. Final study report
	 		  		 		  	X
	 5. Perform quality control of study report
	 		  		 		  	X
	 6. Approval of final study report
	 		  	X	 		  	

 III. Project Timeline 
 The parties acknowledge that Omnicare CR will commence performance of the Service on or about 15 September 2005. The projected timeline for this Project is as follows: 
 The following timeline is meant as a guide only. 
  

			
	 Activities
	  	Anticipated Timeline
	 Start Database Set Up
	  	Mid September
 2005

	 Complete Database Build
	  	****
	 Commence Data Entry
	  	****
	 Complete Validation Programming
	  	****
	 First Batch of DCFs Issued
	  	****
	 Last Patient In
	  	****
	 Treatment and Follow Up Period
	  	****
	 Last Patient Out
	  	****
	 Lasr CRF to Omnicare CR
	  	****
	 Last DCF Issued
	  	****
	 Soft Lock
	  	****
	 Hard Lock
	  	****
	 Final Statistical Analysis Complete
	  	****
	 Clinical Study Report Available (following 7 weeks)
	  	****

 A detailed timeline and milestones will be developed based on the different assumptions of how the project is
conducted. 
  

  

	****	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. 

  Page 3 








 IV. Omnicare CR Services 
 Services provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the project specifications provided by Sponsor, and are outlined below. It should be noted, however, that the costs presented in
this budget for these services are estimated pending review of the final specifications, protocol and CRF. 
 A. 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. 

  Page 4 








 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. 
 C. Clinical Data Management 
  

			
	 Activity
	    	 Number

	# Unique CRF Pages	    	****
	# Repeat CRF Pages	    	****
	Total CRF Pages	    	****
	# of Edit Checks	    	****
	# of Adverse Events per Patient — MedDRA	    	****
	# of Concomitant Medications per Patient — WHODrug	    	****
	# of Transfers (including initial)	    	****

 Data Management Project Team 
 A data management team will be assigned to this project to carry out all of the activities defined in the specifications. The team will consist of a Clinical Data Manager, Lead Clinical Data Analyst, Database
Programming staff, Dictionary Manager, Data Technicians and Clinical Data Analysts. Team resources for the project will be developed by the Data Manager and will be based on the Case Report Form retrieval plan. Adjustments can be made as needed as
the study progresses. 
  

  

	****	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. 

  Page 5 








 Due to the nature of the deliverables for this Project, Omnicare CR has assumed a Clinical Data Manager (CDM) will
be assigned to this project for almost **** days per month for just over **** months. The CDM will provide oversight of the data management team as well as ensure that all deliverables are achieved. 
 On a continual basis, the Omnicare CR team, Project Leader/Biostatistics Team Leader, the Clinical Data Manager and the Lead Clinical Data Analyst will work in concert,
will evaluate the number and type of queries being generated by Clinical Data Management, in order to proactively manage the retrieval of quality data and site release status. Plans Will be implemented to inspect the data for trends and issues in
order to suggest focused training at both the project team and the site levels. This will commence as soon as the first CRF pages are submitted in order to proactively resolve data issues. 
 It is Omnicare CR’s policy to perform a quality control (QC) of the final database to ensure the error rate is within an acceptable range. Each CRF will be printed
as a data listing with 100% QC of pre-defined critical data fields against the hard copy CRF in addition, a ****% sampling of the patient data will undergo quality control for l00% of the data fields, prior to declaration of a clean database. The
processes and outcomes of these QC audits will be documented, with audit findings corrected within the timeframe identified with the Data Management Plan. Omnicare CR supports the plan for transfer of clean data to give both Sponsor and the Omnicare
Biometrics Group an opportunity to review clean data periodically, ensuring that guidelines are complete and accurate, and that the data is represented correctly in preparation for the analysis. 
 Omnicare CR believes that these, strategies will ensure; 
  

	•	 	 Cleaner cases and data. 


  

	•	 	 Minimises queries. 


  

	•	 	 Timely resolution of study and site issues. 


  

	•	 	 Cohesiveness between Sponsor Omnicare CR and the study site. 


  

	•	 	 On-time delivery of final clean clinical study database. 


  

	•	 	 No surprises when preparing for data analysis. 


 Clinical Data Manager 
 The Clinical Data Manager assigned to this project will oversee all Data Management activities throughout the life of
the project. This dedicated Clinical Data Manager will act as the primary liaison for all Data Management activities. Many of the Clinical Data Manager’s activities are listed below: 
  

	•	 	 Overseeing the completion of setup and maintenance of all data management activities 


  

	•	 	 Creation and implementation of the Data Management Plans 


  

	•	 	 Supporting the development of the CRF completion guidelines 


  

	•	 	 Liaise with monitoring team to ensure expectations for recording data accurately are communicated to the project team and the study site



  

  

	****	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. 

  Page 6 









	•	 	 Managing the query generation 


  

	•	 	 Proactively addressing data quality issues to reduce query generation 


  

	•	 	 Ensuring high quality and timely data management deliverables 


  

	•	 	 Maintain ongoing communication with Sponsor team members and Omnicare CR’s project team members 


  

	•	 	 Oversee project training for Clinical Data Management team members 


  

	•	 	 Provide status updates to both the Omnicare CR internal Project team and the Sponsor team members 


  

	•	 	 Clinical Data Management Project resource plan to ensure proper staffing throughout the study 


 Lead Clinical Data Analyst (CDA) 
 Omnicare CR has assigning a lead
CDA. The Lead CDA will provide additional team oversight for the project Data Technicians and CDAs. The Lead CDA will assist the Clinical Data Manager with the following activities in relation to the page-related staff: 
  

	•	 	 Prioritisation of Clinical Data Management tasks 


  

	•	 	 Directing the daily task Clinical Data Management team task assignments 


  

	•	 	 Monitoring the status of task and work load 


  

	•	 	 Ongoing project training within Data Management 


  

	•	 	 Providing feedback to the Clinical Monitoring staff on query trends 


  

	•	 	 Providing backup support to the Clinical Data Manager 


  

	•	 	 Ensure a cohesive team that maintains high quality and data consistency 


  

	•	 	 Generating metrics reports 


 Data
Management Plan 
 Omnicare CR assumes **** (****) Sponsor review cycles including up to **** major and **** minor revision in order to finalise the data
management plan. 
 Database Development 
 Omnicare CR
will develop the study clinical database utilising Oracle Clinical with Omnicare CR standard specifications. 
 Edit Specifications 
 Edit programming will begin after receiving Sponsor’s signoff of the edit specifications. The budget includes **** edits. 
 MedDRA Dictionary 
 Sponsor is required to have a current MedDRA
license in good standing prior to receipt of any MedDRA coded terms. It is assumed under this Exhibit that Sponsor has a current MedDRA license in good standing and that such will be maintained throughout the course of the Services. 
  

  

	****	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. 

  Page 7 








 Data Management Plan 
 The Clinical Data Manager will develop the Data Management Plan. The Data Management Plan will include descriptions of the following Data Management activities: 
  

	•	 	 Project data flow 


  

	•	 	 Database development overview 


  

	•	 	 Edit specifications 


  

	•	 	 Data entry guidelines 


  

	•	 	 Data handling guidelines 


  

	•	 	 Study assumptions (Level 1) 


  

	•	 	 SAE reconciliation process 


  

	•	 	 External data load procedures / External Data Cleaning parameters / Discrepancy identification flow 


  

	•	 	 Dictionary coding guidelines and processes 


  

	•	 	 Database closure procedures 


 Prior to the
start of Data Management activities, the Data Management Plan and edit specifications must be agreed to and signed by the Omnicare CR designee and Sponsor representative. The agreement to all data handling rules will ensure an accurate and timely
final database lock leading to a successful data analysis. It is assumed that all portions of the Data Management Plan related to any specific task will be agreed upon prior to the start of those activities. 
 Data Tracking and Data Entry 
 The dual data entry strategy will be
utilised for numeric and/or text fields. Data will be entered by one member of the data entry staff and re-entered on-line by a second member of the staff CRF data for screen failure patients will be tracked and entered into the database but will
not be cleaned. 
 All CRF and ancillary data received from the investigative sites are logged into a tracking database on a page-by-page basis. Each page is
identified by type of page and date received. Working copies will be maintained in Clinical Data Management and used for any annotations during processing and cleaning. All original (white) CRF pages will be archived by the Sponsor prior to the
working copies being sent to Omnicare CR. 
 Data review and Query Processing 
 Following the data handling rules and edits specifications listed in the Data Management Plan, the Lead CDA will be responsible for: 
  

	•	 	 Reviewing the CRF data for obvious corrections and potential queries via the electronic Edit checks and the Manual review checks listed in the Data
Management Plan 


  

	•	 	 Applying any agreed upon self evident corrections or study assumptions 


  

	•	 	 Transmitting queries to investigative sites via monitors 


  

  

	****	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. 

  Page 8 









	•	 	 Tracking queries (issued and resolved) into Oracle Clinical Discrepancy Management System 


  

	•	 	 Working with the Clinical Data Manager to ensure all Data Clarification Forms (DCFs) are signed by the investigator and received in house via fax or mail.



 On a continual basis, the Clinical Data Manager will evaluate the number and type of queries being generated by Clinical Data Management,
in order to proactively manage the retrieval of quality data on these studies. The team will frequently inspect the data for trends and identification of issues, providing feedback to both the project team and the site. This will begin as soon as
sufficient CRF pages are received to identify the trends. 
 Reconciliation of Safety and Clinical Database 
 Omnicare CR assumes a total of **** SAEs for this project. A total of **** (****) Adverse Event (AE) qualifiers will be reconciled. Omnicare CR’s Clinical Data
Manager will update with the DCF responses and inform Sponsor of the changes. 
 D. Biometrics 
 Statistical Analysis Plan 
 Omnicare CR will develop a statistical
analysis plan, including operational definition of endpoints to be analysed, definition of patient subsets (evaluable and intent-to-treat), visit windows, rules for data handling and a detailed description of statistical methodology. 
 If Sponsor has a standard statistical analysis plan template then this can be used instead. Omnicare CR has budgeted for one Sponsor review and one revision. 

Design of Table Shells (Mocks) 
 The statistical plan will include
a set of formatted shells for all data displays (data listings, summary tables and graphics) planned for each study. If formatted data displays are not required, a detailed table of contents of SAS generated data displays will be included.

 Tables, Listings and Graph Programming 
 Omnicare CR
will perform the programming and will validate the following tables, listings and figures/ graphs: 
  

							
	 	  	    Unique    	 	    Repeat    	 	    Total    
	 Tables
	  	****	 	****	 	****
	 Listings
	  	****	 	****	 	****
	 Figures/Graphs
	  	****	 	****	 	****

  

  

	****	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. 

  Page 9 








 Database Transfer 
 Omnicare CR assumes **** standard database transfer that will be submitted to Sponsor in the form of SAS datasets. 
 Lab Samples 

Lab samples are being analysed centrally at QML in Australia. 
 E.
Clinical Writing 
 Clinical Study Report 
 The
integrated clinical and statistical summary will be prepared in accordance with ICH guidelines on the “Structure and Content of Clinical study Reports”, appropriate agency regulations, and Omnicare CR’s SOPs and clinical study report
format. A draft clinical report will be generated within **** (****) weeks after receipt of source material and final summary tables and patient data listings. 
 The designated Omnicare CR clinical writers will liaise closely with the statistician and other team members. All clinical documents will receive two levels of quality control reviews before they are released. There will be an independent
clinical writer for accuracy and consistency, and a review by the writing manager for accuracy, client format consistency, and appropriate regulatory and clinical perspective. The first draft will then be provided to the Sponsor for review.

 The second draft clinical study report will be produced after receipt of one set of collated comments from the Sponsor. It is our experience at Omnicare CR
that this can be facilitated, more speedily, by ****. The second draft will be reviewed within the Clinical Writing Department at Omnicare CR to ensure that all Sponsor comments are addressed and that all changes are consistent with the supporting
data. Following the Sponsor’s second review, minor revisions will be made and the report finalised. 
 Omnicare CR Biometrics will provide up to ****
tables, **** listings and **** figures that will be summarised in the clinical study report. 
 This fee includes **** major and **** minor revision. One
major revision of the draft report is considered to be up to **** (****) days of requested changes and a minor revision is up to **** (****) day of requested changes. Patient narratives will be drafted from final patient data listings. Omnicare
CR Clinical Writing will prepare patient narratives for SAEs and discontinuations due to adverse events based upon a $**** per narrative fee. This fee does not include the collation or compilation of clinical study report appendices. 
  

  

	****	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. 

  Page 10 








 Clinical Writing Input to SAP 
 Omnicare CR Clinical Writing will review the draft statistical analysis plan and mock summary tables and data listing for consistency with the protocol and ICH guidelines. Clinical Writing will provide feedback on the table design and
format to facilitate the use of the data in the clinical study report. 
 V. Budget 
 A. Estimated Project Budget 
  

													
	 Services
	  	        Unit        	  	#
    Units    	 	Unit
Cost
    (A$)    	 	Fees
    (A$)    	 	Estimated
    Pass-Thru (A$)    	 	Estimated
    Total Cost (A$)    
	 CLINICAL DATA MANAGEMENT
	  		  		 		 		 		 	
	 •   Clinical Data Management Oversight — Int’l
(CDM Manager assumes ****% FTE)
	  	Days	  	****	 	****	 	****	 	****	 	****
	 •   Lead CDA — Int’l (assumes ****% FTE for **** months)
	  	Days	  	****	 	****	 	****	 	****	 	****
	 •   Development of Data Management Plan
(includes **** major and **** minor revision; add’l revisions, will be
billed at per diem rates)
	  	Days	  	****	 	****	 	****	 	****	 	****
	 •   Database Development, Testing and Maintenance
(assumes **** page CRF, ****) unique
CRF-pages
	  	Project	  	****	 	****	 	****	 	****	 	****
	 •   Estimated Data Entry
(actual will be billed)
	  	Pages	  	****	 	****	 	****	 	****	 	****
	 •   Estimated Data Review and Query Resolution
(assumes **** issue per **** CRF pages, **** manual checks and the
application of **** study assumption for **** CRF pages); assumes **** CRF pages per enrolled patient, **** pages per screen failure patient, and **** pages per drop out patient. Queries will be billed on actuals.
	  	Page	  	****	 	****	 	****	 	****	 	****
	 •   Quality Control Check of Database versus CRF
(assumes **** CRF pages per patient)
	  	Patient	  	****	 	****	 	****	 	****	 	****

  

  

	****	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. 

  Page 11 









													
	 Services
	  	        Unit        	  	#
    Units    	 	Unit Cost
    (A$)    	 	Fees
    (A$)    	 	Estimated
    Pass-Thru (A$)    	 	Estimated
    Total Cost (A$)    
	 CLINICAL DATA MANAGEMENT (continued)
	  		  		 		 		 		 	
	 •   Quality Control Check of Database versus CRF 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	  	****	 	****	 	****	 	****	 	****
	 •   External Vendor — Initial Load
(actuals will be billed)
	  		  		 		 		 		 	****
	 >Initial Load
	  	Load	  	****	 	****	 	****	 	****	 	****
	 >Subsequent Load
(actuals will be billed)
	  	Monthly	  	****	 	****	 	****	 	****	 	****
	 >Lab Visit Verification
(**** visits x 60 patients; actuals will be billed)
	  	Visits	  	****	 	****	 	****	 	****	 	****
	 •   Reconciliation of the safety and Clinical Database
(assumes ****% SAEs; actuals will be billed)
	  	SAE	  	****	 	****	 	****	 		 	****
	 Subtotal – Clinical Data Management
	  		  		 		 	****	 	****	 	****
	 BIOMETRICS
	  		  		 		 		 		 	
	 •   Biometrics Team Manager
	  	Days	  	****	 	****	 	****	 	****	 	****
	 •   Project Data Setup
	  	Project	  	****	 	****	 	****	 	****	 	****
	 •   Statistical Plan
	  	Project	  	****	 	****	 	****	 	****	 	****
	 •   Design of Table Shells
(Mocks)
	  	Project	  	****	 	****	 	****	 	****	 	****
	 •   Programming/QC of Data Displays
(actuals will be billed)
	  		  		 		 		 		 	
	 Unique Tables
	  	Table	  	****	 	****	 	****	 	****	 	****
	 Repeat Tables
	  	Table	  	****	 	****	 	****	 	****	 	****
	 Unique Listings
	  	Listing	  	****	 	****	 	****	 	****	 	****
	 Repeat Listings
	  	Listing	  	****	 	****	 	****	 	****	 	****
	 Unique Figures
	  	Figure	  	****	 	****	 	****	 	****	 	****
	 Repeat Figures
	  	Figure	  	****	 	****	 	****	 	****	 	****

  

  

	****	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. 

  Page 12 









													
	 Services
	  	        Unit        	  	#
    Units    	 	Unit Cost
    (A$)    	 	Fees
    (A$)    	 	Estimated
    Pass-Thru (A$)    	 	Estimated
    Total Cost (A$)    
	 BIOMETRICS (continued)
	  		  		 		 		 		 	
	 •   Programmatic Evaluability/Outcome
	  	Project	  	****	 	****	 	****	 	****	 	****
	 •   Statistical Analysis
	  	Project	  	****	 	****	 	****	 	****	 	****
	 •   FDA Item 11 (if required)
	  	Project	  	****	 	****	 	****	 	****	 	****
	 •   Standard Data Transfer
	  		  		 		 		 		 	
	 > Initial
	  	Transfer	  	****	 	****	 	****	 	****	 	****
	 > Subsequent
	  	Transfer	  	****	 	****	 	****	 	****	 	****
	Add’l Stats consulting, meeting attendance, etc., will be charged at per diem rates as follows:
	 Team Leader
	  	Days	  		 	****	 		 		 	
	 Statistician
	  	Days	  		 	****	 		 		 	
	 Programmer
	  	Days	  		 	****	 		 		 	
	 Subtotal — Biometrics
	  		  		 		 	****	 	****	 	****
	CLINICAL WRITING	  		  		 		 		 		 	
	 •   Clinical Study Report Phase 11 (Report includes **** major (up to **** days) and **** minor (up to **** day)
revision; does not include compilation of Clinical Study Report Appendices; per Omnicare SOPs)
	  	Report	  	****	 	****	 	****	 	****	 	****
	 •   Narratives (actuals will be billed)
	  	Narrative	  	****	 	****	 	****	 	****	 	****
	 •   Clinical Writing Input to SAP
	  	Project	  	****	 	****	 	****	 	****	 	****
	 •   Sponsor Meeting Attendance
(billed on actuals; Senior Writer International)
	  	Days	  	****	 	****	 	****	 	****	 	****
	Attendance at Sponsor Requested Meetings:	 		 		 		 	
	Attendances Sponsor requested meetings (teleconferences/video conferences or client review/planning meeting at Sponsor/Omnicare CR, Inc.) will be billed to Sponsor according to
the following per diem rates:
	 Director
	  	Days	  		 	****	 		 		 	
	 Senior Writer
	  	Days	  		 	****	 		 		 	
	 Clinical Writer
	  	Days	  		 	****	 		 		 	
	Sponsor will be billed for actual time expended.	  		  		 		 		 		 	
	 Subtotal — Clinical Writing
	  		  		 		 	****	 	****	 	****
	MISCELLANEOUS	  		  		 		 		 		 	
	 •   Return of CRF (hard copy); bill on actuals
	  	Pages	  	****	 	****	 	****	 	****	 	****
	 Subtotal - Miscellaneous
	  		  		 		 	****
	 	****
	 	****

	 Estimated Services Budget 
	  		  		 		 	****	 		 	
	 Estimated Pass Through 
	  		  		 		 		 	****	 	
	 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 13 








 B. Payment Schedules 
 1. Invoicing Process for Service Fees 
 Omnicare CR maintains a project accounting system, whereby all direct project costs (Service Fees or
Pass-Through Expenses) are coded by project. 
 An initial payment of AUD****, representing approximately **** percent (****%) of the estimated Service Fees,
is due and payable upon execution of this Exhibit C. Subsequent payments shall be made monthly, based on Project progress and upon submission of an invoice to Sponsor by Omnicare CR. The subsequent invoices shall be reduced by a prorated
portion from the initial payment such that the initial payment is applied evenly over the term of the Project. All payments shall be processed within **** days. If any payment of Service Fees or Pass-Through Expenses is late by more than ****
(****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
 2. Pass-Through Expense
Invoicing 
 Omnicare CR’s project accounting system is able to capture and categorize in summary the following key Pass-Through Expenses related to
a project: 
  

	•	 	 Travel 


  

	•	 	 Delivery costs 


  

	•	 	 CRF and other printing or copying costs 


  

	•	 	 Investigator Meeting costs 


  

	•	 	 Telecommunication costs (which may include telephone, fax, pager, conference calls, or PC connectivity charges) 


 All other project related expenses that are not related to Service Fees and any additional detail to support Pass-Through Expenses will be provided on a fee basis.

 3. Payments 
 Sponsor shall make payment directly to
the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Maquarie
Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
  

  

	****	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. 

  Page 14 








 4. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary, the estimated Service Fees set forth in this Exhibit C shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining
Services under this Exhibit C as of each ****; such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 ACCEPTANCE 
 The terms and conditions of the Master Agreement govern this Exhibit C and such document is
incorporated herein by reference as if fully set forth herein. 
 BY AND BETWEEN:  
  

									
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.
					
	BY:	 	 /s/ Michael Aldridge
	 		 	BY:	 	 /s/ Kevin D. Duffy

	Name:	 	Michael Aldridge	 		 	Name:	 	Kevin D. Duffy
	Title:	 	Director	 		 	Title:	 	 Senior Vice President
 Global Marketing & Business
Development

	Date:	 	24-08-05	 		 	Date:	 	9/6/05

  

  

	****	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. 

  Page 15 








 Change Order #01 to Exhibit C to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 24 August 2005. 
 THIS CHANGE ORDER is entered into this 3rd day of February, 2006
(“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor” ) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a certain Clinical Services Master Agreement,
dated 1 st June 2005 (collectively, with the Exhibit thereto, as the same may have been amended or supplemented as of the date hereof, the
“Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity
(such entity being defined as an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except
for any references to invoicing or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR desire to amend Exhibit C to the Agreement to provide for certain additional tasks or changes in the scope of the work provided under the Agreement;

 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as
follows: 
 1. Schedule of Changes 
 Sponsor and
Ominicare 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 1 









					
			
	 Reference
	 	 Changes and/or Additions
	 	 Estimated Service Fee (AUS$)

	Pursuant to Exhibit C, Omnicare CR will provide clinical data management support for the Sponsor’s Cohort Study of PEP005 Topical Gel, Protocol # PEPO05-O03	 	Revised costing for tables and listings presented in Statistical Analysis Plan. The original proposal had an estimate of Tables (**** unique/ **** repeat), Listings (**** unique/ **** repeat)
and Figures (**** unique/ **** repeat). Following on from design of data displays and reporting requirements there has been an increase in the number of Tables and Listings presented in the Statistical Analysis Plan.	 	
			
		 	The updated count of Tables is **** unique/ **** repeat, Listings is **** unique/ **** repeat and **** unique/ **** repeat Figure.	 	
			
		 	Service Fees to be Invoiced 	 	****
			
		 	*   **** unique tables @ $****/table = $ ****	 	
			
		 	*   **** repeat table @ $****/table = $****	 	
			
		 	*   **** unique listings @ $****/listing = $****	 	
			
		 	*   **** repeat listings @ $****/listing = $****	 	
			
		 	Service Fees not to be Invoiced 	 	****
			
		 	*   **** unique figure @ $****/figure = ($ ****)	 	
			
		 	*   **** repeat figure @ $****/figure = ($****)	 	
			
		 	Actuals will be billed.	 	

  

  

	*	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. 

  Page 2 








 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set
forth in this Change Order #01. 
 3. Payment 
 The
full payment of AUS$**** for Service Fees, shall be due and payable to Omnicare CR upon execution of this Change Order #01. The payment of service fees and pass through expenses shall be made by Sponsor within **** (****) days of receipt of
invoice. If the payment of service fees or pass through expenses is late by more than **** (****) days such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
 Sponsor shall make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Macquarie Shopping Centre, 
 North Ryde, NSW
2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 4. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary and subject to any previous annual price increase(s), the estimated Service Fees set forth in this Change Order #01 shall remain in effect until ****.
Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change Order #01 as of each ****; such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding
period. 
 5. No Other Changes 
 Except as
expressly provided to the contrary in this Change Order #01, all other terms and conditions of the Agreement shall continue in force and effect. 
  

  

	****	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. 

  Page 3 









											
	ACCEPTANCE	 		 		 		 	
					
	BY AND BETWEEN:	 		 		 		 	
			
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.
						
	By:	 	 /s/ Peter Welburn
	 		 	By: 	 	 /s/ Leonard Stigliano
	 	
	Name:	 	Peter Welburn	 		 	Name: 	 	Leonard Stigliano	 	
	Title:	 	Director, Drug Development	 		 	Title: 	 	Pres. & Global Chief Operating Officer	 	
	Dated:	 	10 February 2006	 		 	Dated:	 	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. 

  Page 4 









			
	  
 Initial
Sponsor Notification Form
  
	 	



 Change in Project Scope 
  

					
	 Protocol Number: PEP005-002
  
	 	     Date of Request:
18JAN2005
  
	 	     Omnicare PCN: KO1504
  

	 	 
	 Omnicare
Project Director:      
 Omnicare Account Director:      
 Sponsor Study Manager:      
 Sponsor Outsourcing Manager:      
  
	 	     ****
     ****
     Peter
Welburn

	 Individual and Department making      
 request:      
	 	    ****, Biometrics
	  
 Brief Description of Project Scope Change:
  
 Revised costing for tables and listings presented in Statistical Analysis Plan. The original proposal had an estimate of Tables (**** unique/**** repeat), Listings (****
unique/**** repeat) and Figures (**** unique/**** repeat). Following on form design of data displays and reporting requirements there has been an increase in the number of Tables and Listings presented in the Statistical Analysis Plan (please see
attached table of contents for flagging of Unique (P) and Repeat (S) displays).
  
 The
updated count of Tables is **** unique/**** repeat and Listings is **** unique/**** repeat.
  
 The increase in cost to produce these data displays as set out in the Statistical Analysis Plan will be $****.

	  
 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 provided by 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. 

   


					
	01JUL2004 (Initial Version)	 	 Omnicare Clinical Research
 CONFIDENTIAL
	 	Page 1 of 1










			
	  
 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 viafax to                     , or 2)
sending a confirming email to the Project Leader. 
 Sponsor Acknowledgment 
  

									
	/s/ Peter Welburn	 	 	 		  	 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. 

   


					
	01JUL2004 (Initial Version)	 	 Omnicare Clinical Research
 CONFIDENTIAL
	 	Page 2 of 1









 Change Order #02 to Exhibit C to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 20 July 2006. 
 THIS CHANGE ORDER is entered into this 20th July, 2006
(“Effective Date”), by and between Peplin Operations Pty Ltd . (hereinafter “Sponsor” ) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a certain Clinical Services Master Agreement, dated 1 June 2005 (collectively, with the Exhibit
thereto, as the same may have been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity such entity being defined as an entity under direct or indirect beneficial common ownership as (Omnicare CR’s; hereinafter referred to as “Affiliate
Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate
Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR desire to amend Exhibit C to the Agreement to provide
for certain additional tasks or changes in the scope of the work provided under the Agreement; 
 NOW, THEREFORE, for good and valuable
consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 1. 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 1 









									
	 Reference
	 	 	 	 Changes and/or Additions
	 	 	  	         Estimated Service        
Fee (AUS$)

	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	 	 	  	****
		 		 	Biometrics Total 	 	 	  	****
					
		 		 	For clinical data management support:	 		  	
					
		 		 	 Not covered in the original contract, an additional Protocol Deviation Log Load
 = **** loads @ $****/load
	 		  	****
					
		 		 	The increase in cost for additional units processed will be as follows:	 		  	
					
		 		 	 *   Data Entry: from **** pages to **** pages.
       = Additional **** pages @ $**** / 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 2 









							
	 	  	 	 	Estimated Service
	 Reference
	  	 Changes and/or Additions
	 	 Fee (AUS$)

		  	 *   Dictionary coding of meds: from **** terms to **** terms
       = Additional **** terms @ $****/term
	 	****	 	
				
		  	 *   Lab load- subsequent: from **** loads to **** loads
       = Additional **** load @ $****/load
	 	****	 	
				
		  	 *   Lab visit verification: from **** to **** visits
       = Additional **** visits @ $****/visit
	 	****	 	
				
		  	Decrease in cost will be as follows:	 		 	
				
		  	 *   Dictionary coding of AEs: from **** terms to **** terms
       = decrease **** terms @ $****/term
	 	****	 	
				
		  	 *   SAE Reconciliation: **** SAEs to ****SAEs
       = decrease **** SAE @ $****/SAE
	 	****	 	
		  		 		 	
		  		 	 	 	
				
		  	Clinical Date Management Total	 	****	 	
		  		 	 	 	
		
	Total Estimated Service Fees to be Provided	 	**** *  
		  		 	 	 	
			
	Total Estimated Service Fees not to be provided	 	****	 	
		  		 	 	 	
		
	Total Estimated Pass Through Expanses	 	**** **
		  		 	 	 	
			
	Total Estimated Budget	 	****	 	
		  		 	 	 	

  
  

	*	The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original
unit costs. 

  

	**	Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project. 

 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR
agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set forth in this Change Order #02. 
 3. Payment 
 Full payment of AUS$**** for Service Fees shall be due and payable to Omnicare CR upon execution
of this Change Order #02. The payment of service fees and pass through 

  

  

	****	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. 

  Page 3 








 
expenses shall be made by Sponsor within **** (****) days of receipt of invoice. If the payment of service fees or pass through expenses is late by more
than **** (****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
 Sponsor shall make
payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Macquarie
Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB Account Number: **** 
 4. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary and subject to any previous annual price
increase(s), the estimated Service Fees set forth in this Change Order #02 shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change Order #02 as of each ****;
such increase shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 5. No Other Changes

 Except as expressly provided to contrary in this Change Order #02, all other terms and conditions of the Agreement shall continue in force and effect.

 ACCEPTANCE 
 BY AND BETWEEN: 
  

											
	Peplin Operations Pty Ltd.	  		 	Omnicare CR, Inc.	 	
						
	By:	 	 /s/ Peter Welburn
	  		 	By:	 	 /s/ KEVIN D. DUFFY
	 	
	Name:	 	Peter Welburn	  		 	Name:	 	KEVIN D. DUFFY	 	
	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. 

  Page 4 









			
	  
 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:      
	 	     ****
     ****
     Peter
Welburn

	 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 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/ Peter Welburn
	 		 	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.

   


					
	01JUL2004 (Initial Version)	 	 Omnicare Clinical Research
 CONFIDENTIAL
	 	Page 1 of 1









 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 Peplin 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 Peplin Operations Pty Ltd. (hereinafter “Sponsor” ) and Omnicare CR, Inc. (hereinafter “Omnicare
CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a Clinical Services
Master Agreement, dated 1 st June 05 (hereinafter the “Master Agreement”), wherein Omnicare CR agreed to provide clinical services;
and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial
common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment any references to “Omnicare
CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree
that Omnicare CR shall provide the services set forth in this Exhibit D, subject to the terms and conditions set forth in the Master Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 I. Project Plan 
 Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for Sponsor’s
“A multi-centre, randomised, double-blind, parallel-group, vehicle-controlled study to determine the safety of PEP005 0.0025%, 0.01% and 0.05% gel with two treatment schedules, Day 1 and Day 2 or Day 1 and Day 8 applications to superficial
basal cell carcinoma”. Protocol #PEP005-003 dated 28 February 2005 Version 2 Amendment #1 dated 9 June 2005 (hereinafter “the Project”) and associated costs. Changes made in the Project scope, at any time during the Project,
will result in a corresponding adjustment to the Project costs. 
 II. Project Roles and Responsibilities 
  

									
	 Task
	 	 	  	         Peplin        
	 	 	  	       Omnicare      

	 Project Management
	 		  		 		  	
	 1. Regular updates of CRFs status (received, data entered, cleaned and number of queries outstanding)
	 		  		 		  	X
	 2. Team meetings with minutes
	 		  		 		  	X
	 3. Provision of status reports to Sponsor of performance against deliverables
	 		  		 		  	X

  

  

	****	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. 

  Page 1 









									
	 Task
	 	 	  	         Peplin        
	 	 	  	      Omnicare      
	 Data Entry
	 		  		 		  	
	 1. Design/develop data collection system
	 		  		 		  	X
	 2. Validate data collection system
	 		  		 		  	X
	 3. Document control of CRFs
	 		  		 		  	X
	 4. Enter and verify data
	 		  		 		  	X
	 Data Management
	 		  		 		  	
	 1. Design/develop data cleaning system
	 		  		 		  	X
	 2. Validate cleaning system
	 		  		 		  	X
	 3. Write data management guidelines and edit specifications
	 		  		 		  	X
	 4. Review CRF and edit system
	 		  		 		  	X
	 5. Resolve edit queries
	 		  		 		  	X
	 6. Incorporate laboratory data into database
	 		  		 		  	X
	 7. Document corrections to CRFs
	 		  		 		  	X
	 8. Provide weekly patient listing of AEs
	 		  		 		  	X
	 9. Perform QC audits-electronic data compared to paper CRFs
	 		  		 		  	X
	 10. Code drug dictionary
	 		  		 		  	X
	 11. Code adverse events
	 		  		 		  	X
	 12. Code medications
	 		  		 		  	X
	 13. Test data transfer after 25% amount of patients completed
	 		  		 		  	X
	 14. Test data transfer after 75% amount of patients completed
	 		  		 		  	X
	 Statistical Analysis Plan
	 		  		 		  	
	 1. Prepare an abbreviated analysis plan prior to CRF finalisation
	 		  		 		  	X
	 2. Define efficacy tables and listings
	 		  		 		  	X
	 3. Define safety tables and listings
	 		  		 		  	X
	 4. Produce efficacy tables and listings
	 		  		 		  	X
	 5. Produce safety tables and listings
	 		  		 		  	X
	 6. Provide draft report template and analysis plan
	 		  		 		  	X
	 7. Approve report template
	 		  	X	 		  	
	 8. Validate efficacy tables and listings
	 		  		 		  	X
	 9. Validate safety tables and listings
	 		  		 		  	X
	 10. Perform quality assurance audit of the tables and listings
	 		  		 		  	X
	 11. Provide final tables and listings
	 		  		 		  	X
	 12. Provide statistical analysis
	 		  		 		  	X
	 13. Database transfer to Sponsor
	 		  		 		  	X

  

  

	****	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. 

  Page 2 









					
	 Task
	 	        Peplin        	 	      Omnicare      
	 Report Preparation
	 		 	
	 1. Prepare draft report template
	 		 	X
	 2. Approve final report template
	 	X	 	
	 3. Draft study report
	 		 	X
	 4. Final study report
	 		 	X
	 5. Perform quality assurance of study report
	 		 	X
	 6. Approval of final study report
	 	X	 	

 III. Project Timeline 
 The parties acknowledge that Omnicare CR will commence performance of the Service on or about 15 September 2005. The projected timeline for this Project is as follows: 
 The following timeline is meant as a guide only. 
  

									
	  	 	Activities	 	 	  	Anticipated Timeline	 	  
		 	Start Database Set Up	 		  	Mid September 2005	 	
		 	Complete Database Build	 		  	****	 	
		 	Commence Data Entry	 		  	****	 	
		 	Complete Validation Programming	 		  	****	 	
		 	First Batch of DCFs Issued	 		  	****	 	
		 	Last Patient In	 		  	****	 	
		 	Treatment and Follow Up Period	 		  	****	 	
		 	Last Patient Out	 		  	****	 	
		 	Last CRF to Omnicare CR	 		  	****	 	
		 	Last DCF Issued	 		  	****	 	
		 	Soft Lock	 		  	****	 	
		 	Hard Lock	 		  	****	 	
		 	Final Statistical Analysis Complete	 		  	****	 	
		 	Clinical Study Report Available (following 7 weeks)	 		  	****	 	

 A detailed timeline and milestones will be developed based on the different assumptions of how the project is
conducted. 
  

  

	****	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. 

  Page 3 








 IV. Omnicare CR Services 
 Services provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the project specifications provided by Sponsor, and are outlined below. It should be noted, however, that the costs presented in
this budget for these services are estimated pending review of the final specifications, protocol and CRF. 
 A. 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

		
		  	Two treatment arms (****)
		
		  	**** patients per arm
		  	Total of 60 to be enrolled
	 # of CRF pages per patient (assumes **** unique pages)
	  	****
	 # of Total CRF 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    
     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. 

  Page 4 








 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. 
 C. Clinical Data Management 
  

			
	 Activity
	  	 Number

	# Unique CRF Pages	  	****
	# Repeat CRF Pages	  	****
	Total CRF Pages	  	****
	# of Edit Checks	  	****
	# of Adverse Events per Patient — MedDRA	  	****
	# of Concomitant Medications per Patient — WHODrug	  	****
	# of Transfers (including initial)	  	****

 Data Management Project Team 
 A data management team will be assigned to this project to carry out all of the activities defined in the specifications. The team will consist of a Clinical Data Manager, Lead Clinical Data Analyst, Database
Programming staff, Dictionary Manager, Data Technicians and Clinical Data Analysts. Team resources for the project will be developed by the Data Manager and will be based on the Case Report Form retrieval plan. Adjustments can be made as needed as
the study progresses. 
  

  

	****	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. 

  Page 5 








 Due to the nature of the deliverables for this Project, Omnicare CR has assumed a Clinical Data Manager (CDM) will
be assigned to this project for almost **** days per month for just over **** months. The CDM will provide oversight of the data management team as well as ensure that all deliverables are achieved. 
 On a continual basis, the Omnicare CR team, Project Leader/Biostatistics Team Leader, the Clinical Data Manager and the Lead Clinical Data Analyst will work in concert,
will evaluate the number and type of queries being generated by Clinical Data Management, in order to proactively manage the retrieval of quality data and site release status. Plans will be implemented to inspect the data for trends and issues in
order to suggest focused training at both the project team and the site levels. This will commence as soon as the first CRF pages are submitted in order to proactively resolve data issues. 
 It is Omnicare CR’s policy to perform a quality control (QC) of the final database to ensure the error rate is within an acceptable range. Each CRF will be
printed as a data listing with 100% QC of pre-defined critical data fields against the hard-copy CRF. In addition, a ****% sampling of the patient data will undergo quality control for 100% of the data fields, prior to declaration of a clean
database. The processes and outcomes of these QC audits will be documented, with audit findings corrected within the timeframe identified with the Data Management Plan. Omnicare CR supports the plan for transfer of clean data to give both Sponsor
and the Omnicare Biometrics Group an opportunity to review clean data periodically, ensuring that guidelines are complete and accurate, and that the data is represented correctly in preparation for the analysis. 
 Omnicare CR believes that these strategies will ensure: 
  

	•	 	 Cleaner cases and data. 


  

	•	 	 Minimises queries. 


  

	•	 	 Timely resolution of study and site issues. 


  

	•	 	 Cohesiveness between Sponsor, Omnicare CR and the study site. 


  

	•	 	 On-time delivery of final clean clinical study database. 


  

	•	 	 No surprises when preparing for data analysis. 


 Clinical Data Manager 
 The Clinical Data Manager assigned to this project will oversee all Data Management activities throughout the life of
the project. This dedicated Clinical Data Manager will act as the primary liaison for all Data Management activities. Many of the Clinical Data Manager’s activities are listed below: 
  

	•	 	 Overseeing the completion of setup and maintenance of all data management activities 


  

	•	 	 Creation and implementation of the Data Management Plans 


  

	•	 	 Supporting the development of the CRF completion guidelines 


  

	•	 	 Liaise with monitoring team to ensure expectations for recording data accurately are communicated to the project team and the study site



  

  

	****	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. 

  Page 6 









	•	 	 Managing the query generation 


  

	•	 	 Proactively addressing data quality issues to reduce query generation 


  

	•	 	 Ensuring high quality and timely data management deliverables 


  

	•	 	 Maintain ongoing communication with Sponsor team members and Omnicare CR’s project team members 


  

	•	 	 Oversee project training for Clinical Data Management team members 


  

	•	 	 Provide status updates to both the Omnicare CR internal Project team and the Sponsor team members 


  

	•	 	 Clinical Data Management Project resource plan to ensure proper staffing throughout the study 


 Lead Clinical Data Analyst (CDA) 
 Omnicare CR has assigning a lead
CDA. The Lead CDA will provide additional team oversight for the project Data Technicians and CDAs. The Lead CDA will assist the Clinical Data Manager with the following activities in relation to the page-related staff: 
  

	•	 	 Prioritisation of Clinical Data Management tasks 


  

	•	 	 Directing the daily task Clinical Data Management team task assignments 


  

	•	 	 Monitoring the status of task and work load 


  

	•	 	 Ongoing project training within Data Management 


  

	•	 	 Providing feedback to the Clinical Monitoring staff on query trends 


  

	•	 	 Providing backup support to the Clinical Data Manager 


  

	•	 	 Ensure a cohesive team that maintains high quality and data consistency 


  

	•	 	 Generating metrics reports 


 Data
Management Plan 
 Omnicare CR assumes **** (****) Sponsor review cycles including up to **** major and **** minor revision in order to finalise the data
management plan. 
 Database Development 
 Omnicare CR
will develop the study clinical database utilising Oracle Clinical with Omnicare CR standard specifications. 
 Edit Specifications 
 Edit programming will begin after receiving Sponsor’s signoff of the edit specifications. The budget includes **** edits. 
 MedDRA Dictionary 
 Sponsor is required to have a current MedDRA
license in good standing prior to receipt of any MedDRA coded terms. It is assumed under this Exhibit that Sponsor has a current MedDRA license in good standing and that such will be maintained throughout the course of the Services. 
  

  

	****	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. 

  Page 7 








 Data Management Plan 
 The Clinical Data Manager will develop the Data Management Plan. The Data Management Plan will include descriptions of the following Data Management activities: 
  

	•	 	 Project data flow 


  

	•	 	 Database development overview 


  

	•	 	 Edit specifications 


  

	•	 	 Data entry guidelines 


  

	•	 	 Data handling guidelines 


  

	•	 	 Study assumptions (Level 1) 


  

	•	 	 SAE reconciliation process 


  

	•	 	 External data load procedures / External Data Cleaning parameters / Discrepancy identification flow 


  

	•	 	 Dictionary coding guidelines and processes 


  

	•	 	 Database closure procedures 


 Prior to the
start of Data Management activities, the Data Management Plan and edit specifications must be agreed to and signed by the Omnicare CR designee and Sponsor representative. The agreement to all data handling rules will ensure an accurate and timely
final database lock leading to a successful data analysis. It is assumed that all portions of the Data Management Plan related to any specific task will be agreed upon prior to the start of those activities. 
 Data Tracking and Data Entry 
 The dual data entry strategy will be
utilised for numeric and/or text fields. Data will be entered by one member of the data entry staff and re-entered on-line by a second member of the staff. CRF data for screen failure patients will be tracked and entered into the database but will
not be cleaned. 
 All CRF and ancillary data received from the investigative sites are logged into a tracking database on a page-by-page basis. Each page is
identified by type of page and date received. Working copies will be maintained in Clinical Data Management and used for any annotations during processing and cleaning. All original (white) CRF pages will be archived by the Sponsor prior to the
working copies being sent to Omnicare CR. 
 Data Review and Query Processing 
 Following the data handling rules and edits specifications listed in the Data Management Plan, the Lead CDA will be responsible for: 
  

	•	 	 Reviewing the CRF data for obvious corrections and potential queries via the electronic Edit checks and the Manual review checks listed in the Data
Management Plan 


  

	•	 	 Applying any agreed upon self evident corrections or study assumptions 


  

	•	 	 Transmitting queries to investigative sites via monitors 


  

  

	****	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. 

  Page 8 









	•	 	 Tracking queries (issued and resolved) into Oracle Clinical Discrepancy Management System 


  

	•	 	 Working with the Clinical Data Manager to ensure all Data Clarification Forms (DCFs) are signed by the investigator and received in house via fax or mail.



 On a continual basis, the Clinical Data Manager will evaluate the number and type of queries being generated by Clinical Data
Management, in order to proactively manage the retrieval of quality data on these studies. The team will frequently inspect the data for trends and identification of issues, providing feedback to both the project team and the site. This will begin
as soon as sufficient CRF pages are received to identify the trends. 
 Reconciliation of Safety and Clinical Database 
 Omnicare CR assumes a total of **** SAEs for this project. A total of **** (****) Adverse Event (AE) qualifiers will be reconciled. Omnicare CR’s Clinical Data
Manager will update with the DCF responses and inform Sponsor of the changes. 
 D. Biometrics 
 Statistical Analysis Plan 
 Omnicare CR will develop a statistical
analysis plan, including operational definition of endpoints to be analysed, definition of patient subsets (evaluable and intent-to-treat), visit windows, rules for data handling, and a detailed description of statistical methodology. 
 If Sponsor has a standard statistical analysis plan template then this can be used instead. Omnicare CR has budgeted for one Sponsor review and one revision. 

Design of Table Shells (Mocks) 
 The statistical plan will include
a set of formatted shells for all data displays (data listings, summary tables and graphics) planned for each study. If formatted data displays are not required, a detailed table of contents of SAS generated data displays will be included.

 Tables, Listings and Graph Programming 
 Omnicare CR
will perform the programming and will validate the following tables, listings and figures/ graphs: 
  

							
	 	  	    Unique    	 	    Repeat    	 	    Total    
	 Tables
	  	****	 	****	 	****
	 Listings
	  	****	 	****	 	****
	 Figures/Graphs
	  	****	 	****	 	****

  

  

	****	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. 

  Page 9 








 Database Transfer 
 Omnicare CR assumes **** standard database transfer that will be submitted to Sponsor in the form of SAS datasets. 
 Lab Samples 

Lab samples are being analysed centrally at QML in Australia. 
 E.
Clinical Writing 
 Clinical Study Report 
 The
integrated clinical and statistical summary will be prepared in accordance with ICH guidelines on the “Structure and Content of Clinical Study Reports”, appropriate agency regulations, and Omnicare CR’s SOPs and clinical study report
format. A draft clinical report will be generated within **** (****) weeks after receipt of source material and final summary tables and patient data listings. 
 The designated Omnicare CR clinical writers will liaise closely with the statistician and other team members. All clinical documents will receive two levels of quality control reviews before they are released. There will be a QC review by
an independent clinical writer for accuracy and consistency, and a review by the writing manager for accuracy, client format consistency, and appropriate regulatory and clinical perspective. The first draft will then be provided to the Sponsor for
review. 
 The second draft clinical study report will be produced after receipt of one set of collated comments from the Sponsor. It is our experience at
Omnicare CR that this can be facilitated, more speedily, by ****. The second draft will be reviewed within the Clinical Writing Department at Omnicare CR to ensure that all Sponsor comments are addressed and that all changes are consistent with the
supporting data. Following the Sponsor’s second review, minor revisions will be made and the report finalised. 
 Omnicare CR Biometrics will provide up
to **** tables, **** listings and **** figures that will be summarised in the clinical study report. 
 This fee includes **** major and **** minor revision.
One major revision of the draft report is considered to be up to **** (****) days of requested changes and a minor revision is up to **** (****) day of requested changes. Patient narratives will be drafted from final patient data listings.
Omnicare CR Clinical Writing will prepare patient narratives for SAEs and discontinuations due to adverse events based upon a $**** per narrative fee. This fee does not include the collation or compilation of clinical study report appendices.

  

  

	****	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. 

  Page 10 








 Clinical Writing Input to SAP 
 Omnicare CR Clinical Writing will review the draft statistical analysis plan and mock summary tables and data listings for consistency with the protocol and ICH guidelines. Clinical Writing will provide feedback on the table design and
format to facilitate the use of the data in the clinical study report. 
 V.Budget 
 A. Estimated Project Budget 
  

															
	 Services
	  	    Unit    	  	# Units	 	Unit Cost
    (A$)    	 	Fees (A$)	 	Estimated
    Pass-Thru    
    (A$)    	 	Estimated
Total Cost
(A$)
	 CLINICAL DATA MANAGEMENT
	  		  		 		 		 		 	
	 •
	 	 Clinical Data Management Oversight — Int’l (CDM Manager assumes ****% FTE for **** months)
	  	Days	  	****	 	****	 	****	 	****	 	****
	 •
	 	 Lead CDA — Int’l (assumes ****% FTE for **** months)
	  	Days	  	****	 	****	 	****	 	****	 	****
	 •   
	 	 Development of Data Management Plan
(includes **** major and **** minor revision; add’ l revisions will be billed at per diem
rates)
	  	Days	  	****	 	****	 	****	 	****	 	****
	 •   
	 	 Database Development, Testing and Maintenance
(assumes **** page CRF, **** unique CRF pages)
	  	Project	  	****	 	****	 	****	 	****	 	****
	 •   
	 	 Estimated Data Entry (actuals will be billed)
	  	Pages	  	****	 	****	 	****	 	****	 	****
	 •   
	 	 Estimated Data Review and Query Resolution
(assumes **** issue per **** CRF pages, **** manual checks and the application of **** study
assumption for **** CRT pages); assumes **** CRT pages per enrolled patient, **** pages per screen failure patient, and **** pages per drop out patient. Queries will be billed on actuals.
	  	Page	  	****	 	****	 	****	 	****	 	****
	 •   
	 	 Quality Control Check of Database versus CRF
(assumes **** CRF pages per patient)
	  	Patient	  	****	 	****	 	****	 	****	 	****

  

  

	****	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. 

  Page 11 









															
	 Services
	    	     Unit    
	    	 # Units
	    	 Unit Cost
(A$)
	    	 Fees (A$)
	    	 Estimated
Pass-Thru
(A$)
	    	 Estimated
Total Cost
(A$)

	 CLINICAL DATA MANAGEMENT (continued) 
	    		    		    		    		    		    	
	 •        
	 	 Quality Control Check of Database versus CRF 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	    	****	    	****	    	****	    	****	    	****
	 •        
	 	 External Vendor — Initial Load (actuals will be billed)
	    		    		    		    		    		    	
		 	 > Initial Load 
	    	Load	    	****	    	****	    	****	    	****	    	****
		 	 > Subsequent Load (actuals will be billed) 
	    	Monthly	    	****	    	****	    	****	    	****	    	****
		 	 >Lab Visit Verification (**** visits x 60 patients; actuals will be billed) 
	    	Visits	    	****	    	****	    	****	    	****	    	****
	 •        
	 	 Reconciliation of the Safety and Clinical Database (actuals will be billed)
	    	SAE	    	****	    	****	    	****	    		    	****
		 		    		    		    		    	 	    	 	    	 
		 	Subtotal — Clinical Data Management 	    		    		    		    	*****	    	****	    	****
		 		    		    		    		    	 	    	 	    	 
	 BIOMETRICS
	    		    		    		    		    		    	
	 •
	 	 Biometrics Team Manager
	    	Days	    	****	    	****	    	****	    	****	    	****
	 •
	 	 Project Data Setup
	    	Project	    	****	    	****	    	****	    	****	    	****
	 •
	 	 Statistical Plan
	    	Project	    	****	    	****	    	****	    	****	    	****
	 •
	 	 Design of Table Shells (Mocks)
	    	Project	    	****	    	****	    	****	    	****	    	****
	 •
	 	 Programming/QC of Data Displays (actuals will be billed).
	    		    		    		    		    		    	
		 	 Unique Tables 
	    	Table	    	****	    	****	    	****	    	****	    	****
		 	 Repeat Tables 
	    	Table	    	****	    	****	    	****	    	****	    	****
		 	 Unique Listings 
	    	Listing	    	****	    	****	    	****	    	****	    	****
		 	 Repeat Listings 
	    	Listing	    	****	    	****	    	****	    	****	    	****
		 	 Unique Figures 
	    	Figure	    	****	    	****	    	****	    	****	    	****
		 	 Repeat Figures 
	    	Figure	    	****	    	****	    	****	    	****	    	****

  

  

	****	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. 

  Page 12 









													
	 Services
	  	Unit	  	# Units	  	Unit Cost
(A$)	  	Fees (A$)	  	Estimated
Pass-Thru
(A$)	  	Estimated
Total
Cost (A$)
	 BIOMETRICS (continued)
	  		  		  		  		  		  	
	 •   Programmatic Evaluability/ Outcome
	  	Project	  	****	  	****	  	****	  	****	  	****
	 •   Statistical Analysis
	  	Project	  	****	  	****	  	****	  	****	  	****
	 •   FDA Item 11 (if required)
	  	Project	  	****	  	****	  	****	  	****	  	****
	 •   Standard Data Transfer
	  		  		  		  		  		  	
	 > Initial 
	  	Transfer	  	****	  	****	  	****	  	****	  	****
	 >Subsequent 
	  	Transfer	  	****	  	****	  	****	  	****	  	****
	 Add’l Stats consulting, meeting attendance, etc., will be charged at per dient rates as follows:

	  		  		  	
	 Team Leader 
	  	Days	  		  	****	  		  		  	
	 Statistician 
	  	Days	  		  	****	  		  		  	
	 Programmer 
	  	Days	  		  	****	  		  		  	
		  		  		  		  	 	  	 	  	 
	 Subtotal — Biometrics 
	  		  		  		  	****	  	****	  	****
		  		  		  		  	 	  	 	  	 
	 CLINICAL WRITING 
	  		  		  		  		  		  	
	 •   Clinical Study Report Phase II (Report includes ****
major (up to **** days) and **** minor (up
to
**** day) revision; does not include compilation of
Clinical Study Report Appendices; per Omnicare
SOPs; assumes awarded both sBCC and nBCC
studies)
	  	Report	  	****	  	****	  	****	  	****	  	****
	 •   Narratives (actuals will be billed) 
	  	Narrative	  	****	  	****	  	****	  	****	  	****
	 •   Clinical Writing Input to SAP
	  	Project	  	****	  	****	  	****	  	****	  	****
	 •   Sponsor Meeting Attendance (billed on actuals:
    Senior Writer International) 

	  	Days	  	****	  	****	  	****	  	****	  	****
	 Attendance at Sponsor Requested Meetings:
	  		  		  		  		  		  	
	Attendance at Sponsor requested meetings (teleconferences/video conferences or client review/planning meetings at Sponsor/Omnicare CR, Inc.) will be billed to Sponsor
according to the following per diem rates:
	 Director 
	  	Days	  		  	****	  		  		  	
	 Senior Writer 
	  	Days	  		  	****	  		  		  	
	 Clinical Writer 
	  	Days	  		  	****	  		  		  	
	 Sponsor will be billed for actual time expended. 
	  		  		  		  		  		  	
		  		  		  		  	 	  	 	  	 
	 Subtotal — Clinical Writing 
	  		  		  		  	****	  	****	  	****
		  		  		  		  	 	  	 	  	 
	 MISCELLANEOUS
	  		  		  		  		  		  	
	 •   Return of CRF (hard copy); bill on actuals
	  	Pages	  	****	  	****	  	****	  	****	  	****
	 Subtotal — Miscellaneous 
	  		  		  		  	****	  	****	  	****
		  		  		  		  	 	  		  	
	 Estimated Services Budget
	  		  		  		  	****	  		  	
		  		  		  		  	 	  	 	  	
	 Estimated Pass Through
	  		  		  		  		  	****	  	
		  		  		  		  		  	 	  	 
	 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 13 









	B.	Payment Schedules 

  

	1.	Invoicing Process for Service Fees 

 Omnicare CR maintains a project
accounting system, whereby all direct project costs (Service Fees or Pass-Through Expenses) are coded by project. 
 An initial payment of AUD****,
representing approximately **** percent (****%) of the estimated Service Fees, is due and payable upon execution of this Exhibit D. Subsequent payments shall be made monthly, based on Project progress and upon submission of an invoice to
Sponsor by Omnicare CR. The subsequent invoices shall be reduced by a prorated portion from the initial payment such that the initial payment is applied evenly over the term of the Project. All payments shall be processed within **** days. If
any payment of Service Fees or Pass-Through Expenses is late by more than **** (****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
  

	2.	Pass-Through Expense Invoicing 

 Omnicare CR’s project
accounting system is able to capture and categorize in summary the following key Pass-Through Expenses related to a project: 
  

	•	 	 Travel 


  

	•	 	 Delivery costs 


  

	•	 	 CRF and other printing copying costs 


  

	•	 	 Investigator Meeting costs 


  

	•	 	 Telecommunication costs (which may include telephone, fax, pager, conference calls, or PC connectivity charges) 


 All other project related expenses that are not related to Service Fees and any additional detail to support Pass-Through Expenses will be provided on a fee basis.

  

	3.	Payments 

 Sponsor shall make payment directly to the
following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Maquarie
Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
  

  

	****	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. 

  Page 14 









	4.	Annual Price Increase 

 Notwithstanding anything contained
herein to the contrary, the estimated Service Fees set forth in this Exhibit D shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Exhibit D as of each
****; such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 ACCEPTANCE

 The terms and conditions of the Master Agreement govern this Exhibit D and such document is incorporated herein by reference as if fully set forth
herein. 
 BY AND BETWEEN: 
  

											
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.	 	
						
	BY :	 	 /s/ Michael Aldridge
	 		 	BY :	 	 /s/ Kevin D. Duffy
	 	
	Name :	 	Michael Aldridge	 		 	Name :	 	Kevin D. Duffy	 	
	Title :	 	Director	 		 	Title :	 	Senior Vice President
Global Marketing & Business Development	 	
	Date :	 	24-08-05	 		 	Date :	 	9/6/05	 	

  

  

	****	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. 

  Page 15 








 Change Order #01 to Exhibit D to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 24 August 2005. 
 THIS CHANGE ORDER is entered into this 3rd day of February, 2006
(“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor”) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a certain Clinical Services Master Agreement,
dated 1 st June 2005 (collectively, with the Exhibit thereto, as the same may have been amended or supplemented as of the date hereof, the
“Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity
(such entity being defined as an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except
for any references to invoicing or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR desire to amend Exhibit D to the Agreement to provide for certain additional tasks or changes in the scope of the work provided under the Agreement;

 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as
follows: 
 1. 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 1 









					
	 Reference
	  	 Changes and/or Additions
	  	         Estimated Service Fee (AS$)        

			
	Pursuant to Exhibit D, Omnicare
CR will provide clinical data
management support for
the
Sponsor’s Cohort Study of PEP005
Topical Gel, Protocol # PEP005-002	  	Revised costing for tables and listings presented in Statistical Analysis Plan. The original proposal was costed at a discounted rate which will be maintained in this Change Order #1. The
original estimate of Tables (**** repeat), Listings (**** repeat) and figures (**** repeat). Following on from design of data displays and reporting requirements there has been an increase in the number of Tables and Listings presented in the
Statistical Analysis Plan.	  	
			
		  	The updated count of Tables is **** repeat Listings is **** repeat and **** repeat Figures.	  	
			
		  	Estimated Service Fees to be Invoiced 	  	
			
		  	* **** repeat tables @ $****/table = $****	  	****
			
		  	* **** repeat listings@ $****/listing = $****	  	
			
		  	Services Fees not to be Invoiced 	  	
			
		  	* **** repeat figures @ $****/figure = $****	  	****
			
		  	Actuals will be billed.	  	

  

	*	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. 

 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR
agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set forth in this Change Order #01. 
  


  

	****	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. 

  Page 2 








 3. Payment 
 The full payment of AUS$**** for Service Fees, shall be due and payable to Omnicare CR upon execution of this Change Order #01. The payment of service fees and pass through expenses shall be made by Sponsor within **** (****) days of
receipt of invoice. If the payment of service fees or pass through expenses is late by more than **** (****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balanced. 
 Sponsor shall make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Macquarie Shopping Centre, 
 North Ryde, NSW
2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 4. Annual Price Increase 
 Notwithstanding anything contained herein to the Contrary and subject to any previous annual price increase(s), the estimated Service Fees set forth in this Change Order #01 shall remain in effect until ****.
Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change Order #01 as of each ****; such increases shall not exceed the percentage change of the Medical Services Price index for the corresponding
period. 
 5. No Other Changes 
 Except as
expressly provided to the contrary in this Change Order #01, all other terms and conditions of the agreement shall continue in force and effect. 
 ACCEPTANCE 
 BY AND BETWEEN: 
  

											
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.	 	
						
	By:	 	 /s/ Peter Welburn
	 		 	By: 	 	 /s/ Leonard Stigliano
	 	
	Name:	 	Peter Welburn	 		 	Name:	 	Leonard Stigliano	 	
	Title:	 	Director, Drug Development	 		 	Title:	 	Pres. & Global Chief Operating Officer	 	
	Dated:	 	10 February 2006	 		 	Dated:	 	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. 

  Page 3 









			
	  
 Initial
Sponsor Notification Form
  
	  	



 Change in Project Scope 
  

					
	Protocol Number: PEP005-003	  	Date of Request: 18JAN2005	 	 Omnicare PCN: KO1505
  

	 Omnicare Project Director:      
 Omnicare Account
Director:      
 Sponsor Study Manager:      
 Sponsor Outsourcing Manager:      
	  	 ****
 ****
 Peter Welburn

	 Individual and Department making      
 request:      
	  	****, Biometrics
	 Brief Description of Project Scope Change:
  
 Revised costing for tables and
listings 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 of Tables (**** repeat), Listings (**** repeat) and Figures (**** repeat).
Following on from design of data displays and reporting requirements there has been an increase in the number of Table and Listing presented in the Statistical Analysis Plan (please see attached table of contents for flagging of Unique (P) and
Repeat (S) displays).
  
 The updated count of Tables is **** repeat and Listings is
**** repeat.
  
 The increase in cost to produce these data displays as set out in the
Statistical Analysis Plan will be ****.

	  
 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 provided.by 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. 

   

					
	01JUL2004 (Initial Version)	 	Omnicare Clinical Research	 	Page 1 of 1
		 	CONFIDENTIAL	 	










			
	  
 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/ Peter Welburn
	 		 	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. 

   

					
	01JUL2004 (Initial Version)	 	Omnicare Clinical Research	 	Page 2 of 1
		 	CONFIDENTIAL	 	









 Change Order #02 to Exhibit D to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 24 th August 2005. 
 THIS CHANGE ORDER is entered into this
3 rd day of May, 2006 (“Effective Date”) by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor” ) and
Omnicare CR, Inc.(hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and
Omnicare CR entered into a certain Clinical Services Master Agreement, dated 1 st June 2005 (collectively, with the Exhibit thereto, as the
same may have been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate
Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate
Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR desire to amend Exhibit D to the Agreement to provide
for certain additional tasks or changes in the scope of the work provided under the Agreement; 
 NOW, THEREFORE, for good and valuable
consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 1. 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 1 









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

  

  

	****	Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant
to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 2 








  

	*	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. 

 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR
agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set forth in this Change Order #02. 
 3. Payment 
 The full payment of A$**** representing **** percent (****%) of the estimated Service Fees, shall
be due and payable to Omnicare CR upon execution of this Change Order #02. The payment of service fees and pass through expenses shall be made by Sponsor within **** (****) days of receipt of invoice. If the payment of service fees or pass
through expenses is late by more than **** (****) days, such payment shall be subject to a penalty fee of ****% per month of the outstanding balanced. 
 Sponsor shall make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Macquarie
Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 4. Annual Price Increase 
 Notwithstanding anything contained herein to the Contrary and subject to any previous annual price
increase(s), the estimated Service Fees set forth in this Change Order #02 shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change Order #02 as of each ****;
such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 5. No Other Changes

 Except as expressly provided to the contrary in this Change Order #02, all other terms and conditions of the Agreement shall continue in force and effect.

  

  

	****	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. 

  Page 3 








 ACCEPTANCE 
 BY AND
BETWEEN: 
  

											
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.	 	
						
	By:	 	 /s/ JANELLE KATSAMAS
	 		 	By: 	 	 /s/ KEVIN D. DUFFY
	 	
	Name:	 	JANELLE KATSAMAS	 		 	Name:	 	KEVIN D. DUFFY	 	
	Title:	 	DIRECTOR, CLINICAL DEVELOP.	 		 	Title: 	 	EXECUTIVE VICE PRESIDENT
GLOBAL BUSINESS DEVELOPMENT
CHIEF RELATIONS OFFICER	 	
	Dated:	 	8 May 2006	 		 	Dated:	 	  
	 	

  

  

	****	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. 

  Page 4 









			
	  
 Initial
Sponsor Notification Form
  
	  	



 Change in Project Scope 
  

					
	 Protocol Number: PEP005-003
  
	  	 Date of Request: 24APR2006
  
	  	 Omnicare PCN:
KO1505
  

	 Omnicare Project Director:      
 Omnicare Account
Director:      
 Sponsor Study Manager:      
	  	 ****
 ****
 Peter Welburn

	 Individual and Department making      
 request:      
	  	 ****, Clinical Data Management

****, Biometrics

	 Brief Description
of Project Scope Change:
  
 Following database close, data management reconciliation of
CRF pages received, data entry performed, edit checks programmed, queries raised, QC performed and SAE reconciliation has taken place. These tasks are billed as actuals as per the contract and the final reconciliation of tasks is attached. This
represents an overall estimated increase of $**** in the clinical data management budget.
  
 For Biometrics the production of the final tables and listings included an extra **** unique table (****), **** repeat table (****) and **** unique listing (****) that were requested by the sponsor during the course of the study. This
represents an estimated increase of $****.
  
 The total increase in the budget from the
reconciliation of data management and biometrics services is estimated to be $****.



	  
 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 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/ Janelle Katsamas
	 		 	26\4\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. 

   

					
	01JUL2004 (Initial Version)	 	Omnicare Clinical Research	 	Page 1 of 1
		 	CONFIDENTIAL	 	









 PEP005-003 Final CDM Contract Reconciliation 
  

																	
	 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	 	****	 	****	 	****	 	****	 	****	 	****	 	 **** rand plus ****screen
 failures

	 Edit development
	 	edit	 	****	 	****	 	****	 	****	 	****	 	****	 	
	 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
	 		 		 		 	****	 		 	****	 	****	 	
		 		 		 		 	 	 		 	 	 	 	 	

 Prepared by ****, 18 th April 2006 
  

  

	****	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. 









 Change Order #03 to Exhibit D to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 24 th August 2005. 
 THIS CHANGE ORDER is entered into this
19 th day of June, 2006 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter
“Sponsor”) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a certain Clinical Services Master Agreement, dated 1 st June 2005 (collectively, with the Exhibit thereto, as the same may have been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are
incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such equity being defined as an entity
under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or
payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR desire to amend Exhibit D to the Agreement to provide for certain additional tasks or changes in the scope of the work provided under the Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows:

 1. 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 1 









									
	 Reference
	    	 Changes and/or Additions
	    	 Estimated
Service Fee
(AS)

					
	Pursuant to Exhibit D, Omnicare CR will
provide biometrics support for the
Sponsor’s Cohort Study of PEP005
Topical Gel, Protocol #
PEP005-003	    	In order of evaluate confounding study effects of **** (****) site, additional tables are to be produced and analysis performed at the request of the Sponsor, with **** (****) site excluded.
This revision requires the following additional tables:	    		    	****	 	
					
		    	**** x unique table @ A$****/table	    		    		 	
		    	**** x repeat table @ A$****/table	    		    		 	
					
		    	Biometrics Team Leader time.	    		    	****	 	
		    	**** hours @ A$****/ hour	    		    		 	
		    		    		    		 	
		    		    	 	 	
	Total Estimated Service Fees	    		    		    	****	 	
		    		    	 	 	
		    		    		    		 	
		    		    	 	 	
	Total Estimated Pass Through Expenses	    		    		    	****	 	**
		    		    	 	 	
		    		    		    		 	
		    		    	 	 	
	Total Estimated Budget	    		    		    	****	 	
		    		    	 	 	

  
  

	*	The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original
unit costs. 

  

	**	Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project. 

 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR
agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set forth in this Change Order #03. 
 3. Payment 
 The full payment of A$**** representing **** percent (****%) of the estimated Service Fees, shall
be due and payable to Omnicare CR upon execution of this Change Order #03. The payment of service fees and pass through expenses shall be made by Sponsor within **** (****) days of receipt of invoice. If the payment of service fees or pass through
expenses is late by more than **** (****) days, such payment shall be subject to a penalty fee of ****% per month of the outstanding balance. 
  

  

	****	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. 

  Page 2 








 Sponsor shall make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking
Corporation, 
 Macquarie Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 4. Annual Price
Increase 
 Notwithstanding anything contained herein to the contrary and subject to any previous annual price increase(s), the estimated Service Fees
set forth in this Change Order #03 shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change Order #03 as of each ****; such increases shall not exceed the
percentage change of the Medical Services Price Index for the corresponding period. 
 5. No Other Changes 
 Except as expressly provided to the contrary in this Change Order #03, all other terms and conditions of the Agreement shall continue in force and effect. 
 ACCEPTANCE 
 BY AND BETWEEN: 
  

											
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.	 	
						
	By:	 	 /s/ Janelle Kalsamas
	 		 	By:	 	 /s/ KEVIN D. DUFFY
	 	
	Name :	 	Janelle Kalsamas	 		 	Name:	 	KEVIN D. DUFFY	 	
	 Title:
 Dated:
	 	 Director Clinical Development
 25
June 2006
	 		 	Title:	 	EXECUTIVE VICE PRESIDENT
GLOBAL BUSINESS DEVELOPMENT
CHIEF RELATIONS OFFICER	 	
		 		 		 	Dated:	 	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. 

  Page 3 









			
	  
 Initial Sponsor Notification Form
  
	  	



 Change in Project Scope 
  

					
	 Protocol Number: PEP005-003
  
	  	Date of Request: 16JUN2006	  	Omnicare PCN: KO1505
	 		 
	 Omnicare
Project Director:      
 Omnicare Account Director:      
 Sponsor Study Manager:      
  
	  	 ****
 ****

 Peter Welburn
  
	  	 
	 Individual and Department making      
 request:      
	  	****, Biometrics	  	 
	 Brief Description of Project Scope Change:
  
 Revised tables and analysis to
provide additional information in forthcoming study design. Estimated changes would include **** repeat tables and **** unique table with a total cost 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 estimated will be 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/ JANELLE KATSAMAS
	 		 	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. 

   

					
	01JUL2004 (Initial Version)	 	Omnicare Clinical Research	 	Page 1 of 1
		 	CONFIDENTIAL	 	









 Change Order #04 to Exhibit D to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 24 th August 2005. 
 THIS CHANGE ORDER is entered into this
22 nd day of September, 2006 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor”
) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS,
Sponsor and Omnicare CR entered into a certain Clinical Services Master Agreement, dated 1 st June 2005 (collectively, with the Exhibit
thereto, as the same may have been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate
Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or Affiliate Entity”;
and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR desire to amend Exhibit D to the Agreement to provide for certain
additional tasks or changes in the scope of the work provided under the Agreement; 
 NOW, THEREFORE, for good and valuable
consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 1. 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 1 









							
	 Reference
	    	 Changes and/or Additions
	    	 Estimated
Service Fee
(A$)
	 	 
	Pursuant to Exhibit D, Omnicare CR will provide Biometrics support for the Sponsor’s Study of PEP005 Topical Gel, Protocol # PEP005-003	    	Additional analysis requested for **** (****) repeat tables to be developed @ $****/table	    	****	 	
		    		    		 	
		    		    	 	 	
	Total Estimated Service Fees 	    		    	****	 	
		    		    	 	 	
	Total Estimated Pass Through Expenses	    		    	****	 	**
		    		    	 	 	
	Total Estimated Budget 	    		    	****	 	
		    		    	 	 	

  
  

	*	The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original
unit costs. 

  

	**	Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project. 

 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR
agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set forth in this Change Order #04. 
 3. Payment 
 The full payment of AUS$**** representing **** percent (****%) of the estimated Service Fees,
shall be due and payable to Omnicare CR upon execution of this Change Order #04. The payment of service fees and pass through expenses shall be made by Sponsor within **** (****) days of receipt of invoice. If payment of service fees or pass through
expenses is late by more than **** (****) days, such payment shall be subject to a penalty fee of ****% per month of the outstanding balance. 
 Sponsor
shall make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Macquarie
Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
  

  

	****	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. 

  Page 2 








 4. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary and subject to any previous annual price increase(s), the estimated Service Fees set forth in this Change Order #04 shall remain in effect until ****.
Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change Order #04 as of each ****; such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding
period. 
 5. No Other Changes 
 Except as
expressly provided to the contrary in this Change Order #04, all other terms and conditions of the Agreement shall continue in force and effect. 
 ACCEPTANCE 
 BY AND BETWEEN 
  

											
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.	 	
						
	By:	 	 /s/ Michael Aldridge
	 		 	By: 	 	 /s/ Dale Evans
	 	
	Name:	 	Michael Aldridge	 		 	Name:	 	Dale Evans	 	
	Title:	 	Director	 		 	Title:	 	CEO	 	
	Dated:	 	4-Oct-06	 		 	Dated:	 	10/11/06	 	

  

  

	****	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. 

  Page 3 








 Exhibit E to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc.,dated 19 
 December, 2005. 
 THIS EXHIBIT E is
entered into this 19 th day of December, 2005 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter
“Sponsor”) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a
Clinical Services Master Agreement, dated 1 June 2005 (hereinafter the “Master Agreement”), wherein Omnicare CR agreed to provide clinical services; and 
 WHEREAS , Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate
Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate
Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR shall provide the services set forth in this
Exhibit E, subject to the terms and conditions set forth in the Master Agreement; 
 NOW, THEREFORE, for good and valuable
consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 I. Project Plan 
 Based on the Project Assumptions, Omnicare CR has provided a description of services to be performed for statistical consulting services in support of Sponsor’s
pivotal study design for studies in Australia/New Zealand and the USA. Changes made in the Project assumptions or Omnicare CR services, at any time during the Project, will result in a corresponding adjustment to the Project costs. 
 II. Omnicare CR Services and Project Assumptions 
 Omnicare CR will be
actively involved in providing statistical consulting services on Sponsor’s projects in and relating to Australia/New Zealand and the USA. The services will include but are not limited to: 
  

	•	 	 Pivotal study design 


  

	•	 	 Sample size calculation for pivotal studies 


  

	•	 	 Writing of Statistical section of protocol 


  

	•	 	 Review of protocol 


  

  

	****	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. 

  Page 1 








 III. Project Timeline 
 It is assumed that Omnicare CR commenced performance of the services in support of the Project **** and shall continue until ****. 
 IV. Budget

 A. Estimated Project Budget 
 The hourly rate for
the services to be conducted will be A$****/hour. 
  

													
	 Services
	    	    Unit    	    	#
    Units    	    	Unit
Cost
    AUD    	    	Service
Fees
    AUD    	    	Estimated
Pass-Thru
AUD	    	Estimated
Total
Cost AUD
	BIOMETRICS	    		    		    		    		    		    	
	 Statistical Consultation as requested
	    	Hours	    	****	    	****	    	****	    	****	    	****
	Subtotal — Biometrics	    		    		    		    	****	    	****	    	****
		    		    		    		    	 	    		    	
	 Estimated Services Budget
	    		    		    		    	****	    		    	
		    		    		    		    		    	 	    	
	 Estimated Pass Through
	    		    		    		    		    	****	    	
		    		    		    		    		    		    	 
	 Total Estimated Budget
	    		    		    		    		    		    	****

 The quoted price does not include GST. Where applicable, these tax amounts will be added to relevant invoiced
items. All project related pass-through costs (expenses for travel, accommodation, shipments, courier services, scanning, regulatory authority submission fees, etc) reasonably incurred by Omnicare CR will be passed through at cost to Sponsor.

 B. Payment Schedules 
 1. Invoicing Process for
Service Fees 
 Omnicare CR maintains a project accounting system, whereby all direct project costs (Service Fees or Pass-Through Expenses) are coded by
project. 
 An initial payment of AUD****, representing approximately **** percent (****%) of the estimated Service Fees, is due and payable upon execution of
this Exhibit E. Subsequent payments shall be made monthly, based on Project progress and upon submission of an invoice to Sponsor by Omnicare CR. The subsequent invoices shall be reduced by a prorated portion 

  

  

	****	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. 

  Page 2 








 
from the initial payment such that the initial payment is applied evenly over the term of the Project. All payments shall be processed within **** days.
If any payment of Service Fees or Pass-Through Expenses is late by more than **** (****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
 2. Pass-Through Expense Invoicing 
 Omnicare CR’s project
accounting system is able to capture and categorize in summary the following key Pass-Through Expenses related to a project: 
  

	•	 	 Travel 


  

	•	 	 Delivery costs 


  

	•	 	 CRF and other printing or copying costs 


  

	•	 	 Investigator Meeting costs 


  

	•	 	 Telecommunication costs (which may include telephone, fax, pager, conference calls, or PC connectivity charges) 


 All other project related expenses that are not related to Service Fees and any additional detail to support Pass-Through Expenses will be provided on a fee basis.

 3. Payments 
 Sponsor shall make payment directly to
the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Maquarie
Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID **** 
 BSB/Account Number: **** 
  

  

	****	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. 

  Page 3 








 4. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary, the estimated Service Fees set forth in this Exhibit E shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining
Services under this Exhibit E as of each ****; such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 ACCEPTANCE 
 The terms and conditions of the Master Agreement govern this Exhibit E and such document is
incorporated herein by reference as if fully set forth herein. 
 BY AND BETWEEN: 
  

											
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.	 	
						
	BY:	 	 /s/ Peter Welburn
	 		 	BY: 	 	 /s/ Kevin D. Duffy
	 	
	Name:	 	Peter Welburn	 		 	Name:	 	Kevin D. Duffy	 	
	Title:	 	Director, Drug Development	 		 	Title:	 	Executive Vice President
Global Bus. Dev./Chief Relations Officer	 	
	Date:	 	January 10, 2006	 		 	Date:	 	January 6, 2006	 	

  

  

	****	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. 

  Page 4 








 Change Order #01 to Exhibit E to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 19 th December 2005. 
 THIS CHANGE
ORDER is entered into this 23 rd day of May 2006 (“Effective Date”), by and between Peplin Operations Pty Ltd.
(hereinafter “Sponsor”) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a certain Clinical Services Master Agreement, dated 1 st
June 2005 (collectively, with the Exhibit thereto as the same may have been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as
Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be
deemed to include “Omnicare CR and/or an Affiliate Entity”, and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR
desire to amend Exhibit E to the Agreement to provide for certain additional tasks or changes in the scope of the work provided under the Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 1. 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: 
  

										
	 Reference
	    	 Changes and/or Additions
	 	Estimated Service
Fee (AUS$)
	Pursuant to Exhibit E,	    	Additional Statistical Consultation:	 		 			 	
	Omnicare CR will provide	    		 		 			 	
	biometrics support for the	    	 •   Australian Statistician
	 		 	****	 	 	
	Sponsor’s statistical	    	 **** hours @ A$**** per hour
	 		 			 	
	consultation requirements in	    		 		 			 	
	Australia, New Zealand and	    	 •   US Statistician
	 		 	****	 	 	
	the US	    	 **** hours @ A$**** per hour
	 		 			 	
		    	 (US$****/hour exchanged at
	 		 			 	
		    	 1.2934 = AUS$****/hour)
	 		 			 	
		    		 		 	 	 	 	
	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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 1 








  

	*	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. 

 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR
agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set forth in this Change Order #01. 
 3. Payment 
 The full payment of AUS$**** of the Service Fees shall be due and payable to Omnicare CR upon
execution of this Change Order #01. The payment of service fees and pass through expenses shall be made by Sponsor within **** (****) days of receipt of invoice. If any payment of service fees or pass through expenses is late by more than ****
(****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
 Sponsor shall make payment
directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Macquarie
Shopping Center, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 4. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary and subject to any previous annual price
increase(s), the estimated Service Fees set forth in this Change Order #01 shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change Order #01 as of each ****;
such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 5. No Other Changes

 Except as expressly provided to the contrary in this Change Order #01, all other terms and conditions of the Agreement shall continue in force and effect.

  

  

	****	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. 

  Page 2 








 ACCEPTANCE 
 BY
AND BETWEEN:  
  

											
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.	 	
						
	By:	 	 /s/ Peter Welburn
	 		 	By:	 	 /s/ KEVIN D. DUFFY
	 	
	Name:	 	Peter Welburn	 		 	Name:	 	KEVIN D. DUFFY	 	
	Title:	 	 Chief Scientific Officer and Vice President,
 Research
& Development
	 		 	Title:	 	 EXECUTIVE VICE PRESIDENT
 GLOBAL BUSINESS DEVELOPMENT
CHIEF RELATIONS OFFICER
	 	
	Dated:	 	25/5/06	 		 	Dated:	 	6/6/06	 	

  

  

	****	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. 

  Page 3 








 Change Order #02 to Exhibit E to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 19 th December 2005. 
 THIS CHANGE
ORDER is entered into this 1 st day of November 2006 (“Effective Date”), by and between Peplin Operations Pty Ltd.
(hereinafter “Sponsor” ) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a certain Clinical Service Master Agreement, dated 1 st
June 2005 (collectively, with the Exhibit thereto, as the same may have been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as
Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be
deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare; CR agree that Omnicare CR
desire to amend Exhibit E to the Agreement to provide for, certain, additional tasks or changes in the scope of the work provided under the Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 1. 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: 
  

								
	 Reference
	    	 Changes and/or Additions
	 	Estimated Service
Fee (AUS$)
	Pursuant to Exhibit E, Omnicare CR will provide, ad-hoc statistical consulting for Sponsor’s requirements in Australia, New Zealand and the US	    	Additional Statistical Consultation in relation to sample size, protocol review, discussion on study design that are not covered by previous Exhibits:	 			 	
		    	 •   Australian Statistician
 **** hours @ A$**** per hour
	 	****	 	 	
				
		    	 •   US Statistician
 **** hours @ A$**** per hour (US$****/hour exchanged at 1.3382 = ****/ hour)
	 	****	 	 	
		    		 	 	 	 	
	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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 1 








  

	*	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, 

 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR
agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set forth in this Change Order #02. 
 3. Payment 
 The full payment of AUS$**** of the Service Fees shall be due and payable to Omnicare CR upon
execution of this Change Order #02. The payment of Service fees and pass through expenses shall be made by Sponsor within **** (****) days of receipt of invoice. If any payment of service fees or pass through expenses is late by more than ****
(****)days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
 Sponsor shall make payment directly to
the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Macquarie
Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: ***** 
 4. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary and subject to any previous annual price
increase(s), the estimated Service Fees set forth in this Change Order #02 shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change Order #02 as of each ****;
such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 5. No Other Changes

 Except as expressly provided to the contrary in this Change Order #02, all other terms and conditions of the Agreement shall continue in force and effect.

  

  

	****	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. 

  Page 2 








 ACCEPTANCE 
 BY
AND BETWEEN: 
  

											
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.	 	
						
	By:	 	 /s/ Peter Welburn
	 		 	By:	 	 /s/ Dale Evans
	 	
	Name:	 	Peter Welburn	 		 	Name:	 	Dale Evans	 	
	Title:	 	 Chief Scientific Officer and Vice President,
 Research
& Development
	 		 	Title:	 	CEO	 	
	Dated:	 	9/11/06	 		 	Dated:	 	11/21/06	 	

  

  

	****	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. 

  Page 3 








 Exhibit F to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 1 st June 2005 
 THIS EXHIBIT F is
entered into this 1 st day of May, 2006 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter
“Sponsor”) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a Clinical, Services Master Agreement, dated 1 st June 2005 (hereinafter the
“Master Agreement”), wherein Omnicare CR agreed to provide clinical services; and 
 WHEREAS, Omnicare CR and/or an affiliate
entity (such entity being defined as an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor.
Except for any references to invoicing or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity” and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR shall provide the services set forth in this Exhibit F, subject to the terms and
conditions set forth in the Master Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY
BOUND, Sponsor an Omnicare CR agree as follows: 
 I. Project Plan 
 Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for Sponsor’s, Multi-Center, open-label study to determine the efficacy of PEP005 0.05% topical gel in
patients with Cutaneous Squamous Cell Carcinoma in situ (SCCIS, Bowen’s Disease)” . The Protocol Reference Number is PEP005-008, Protocol Final Version 3, Dated 8 th May 2006 (hereinafter “the project”) and associated
costs. Changes made in the Project scope, at any time during the Project, will result in a corresponding adjustment to the Project costs. 
 [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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 1 








 II. Project Roles and Responsibilities 
  

					
	 Roles and Responsibilities
	  	 Sponsor
	  	 Omnicare CR

	CRF Preparation	  		  	
	1. Design and draft CRF	  		  	ü
	2. Approve CRF	  	ü	  	
	3. Print and assemble CRF	  	ü	  	
	4. Distribute CRFs to site	  	ü	  	
	5. Write CRF conventions guide	  	ü	  	
	Data Entry	  		  	
	1. Design/develop data collection system	  		  	ü
	2. Validate data collection system	  		  	ü
	3. Document control of CRFs	  		  	ü
	4. Enter and verify data	  		  	ü
	Medical and Safety	  		  	
	1. Document and manage all SAEs	  		  	ü
	2. Cover medical emergencies after hours (pager)	  	ü	  	
	3. Develop and maintain safety database (Using existing database set up of KO1601 and KO1602)	  		  	ü
	4. Submit SAE reports to regulatory authorities	  	ü	  	
	5. Prepare safety updates	  		  	ü
	6. Medical Monitor — Review of SAEs	  	ü	  	
	Data Management	  		  	
	1. Design/develop data cleaning system	  		  	ü
	2. Validate cleaning system	  		  	ü
	3. Write data management guidelines and edit specifications	  		  	ü
	4.Review CRF and edit system	  		  	ü
	5.Resolve edit queries	  		  	ü
	6.Incorporate laboratory data into database	  	N/A	  	
	7. Document corrections to CRFs	  		  	ü
	8. Provide weekly patient listing of AEs	  	N/A	  	
	9. Perform QC audits-electronic data compared to paper CRFs	  		  	ü
	10. Code drug dictionary	  	N/A	  	
	11. Code adverse events	  		  	ü
	12. Code medications	  		  	ü
	13. Test data transfer	  		  	ü

  

  

	****	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. 

  Page 2 









					
	 Roles and Responsibilities
	  	 Sponsor
	  	 Omnicare CR

	Abbreviated Statistical Analysis Plan	  		  	
	1. Prepare an abbreviated statistical analysis plan prior to database lock	  		  	ü
	2. Approve abbreviated statistical analysis plan and mock listing displays	  	ü	  	
	3. Define efficacy tables and listings	  	ü    (tables)	  	ü    (listings)
	4. Define safety tables and listings	  	ü    (tables)	  	ü    (listings)
	5. Produce efficacy tables and listings	  	ü    (tables)	  	ü    (listings)
	6. Produce safety tables and listings	  	ü    (tables)	  	ü    (listings)
	7. Provide draft report template and analysis plan	  	N/A	  	
	8. Approve report template	  	N/A	  	
	9. Validate efficacy tables and listings	  	ü    (tables)	  	ü    (listings)
	10. Validate safety tables and listings	  	ü    (tables)	  	ü    (listings)
	11. Perform quality assurance audit of the tables and listing	  	ü    (tables)	  	ü    (listings)
	12. Provide final tables and listings	  	ü    (tables)	  	ü    (listings)
	Report Preparation	  		  	
	1. Prepare draft report template	  	ü	  	
	2. Approve final report template	  	ü	  	
	3. Draft study report	  	ü	  	
	4. Final study report	  	ü	  	
	5. Perform quality control verification of study report	  	ü	  	
	6. Approval of final study report	  	ü	  	
	Project Management	  		  	
	1. Regular progress updates to Sponsor	  		  	ü
	 2. Regular updates of CRF and DCF status (received, data entered, cleaned and number of queries
     outstanding)
	  		  	ü
	3. Team meetings with minutes (if applicable)	  		  	ü

 III. Project Timeline 
 The parties acknowledge that Omnicare CR will commence performance of the Service on or about 1 May 2006. The projected timeline for this Project is as follows: 
  

  

	****	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. 

  Page 3 









			
	Activities	  	Anticipated Timeline
		
	Project Start	  	1 May 2006
		
	Final Protocol Available (Sponsor’s responsibility)	  	****
		
	Final CRF Available	  	****
		
	First Patient First Visit	  	****
		
	Recruitment Period (~ 3 months)	  	****
		
	Treatment Period	  	****
		
	Last Patient Last Visit	  	****
		
	Submission of Last CRF to Data Management	  	****
		
	Database Close	  	****
		
	Statistical Analysis — Draft Listings	  	****
		
	Statistical Analysis — Final Listings	  	****
		
	Database Transferred to Sponsor	  	****
		
	Study Duration	  	****

 A detailed timeline and milestones will be developed based on the different assumptions of how the project is
conducted. 
 IV. Omnicare CR Services 
 Services provided
by Omnicare CR and the assumptions upon which associated costs were determined are based on the project specifications provided by Sponsor, and are outlined below. It should be noted, however, that the costs presented in this budget for these
services are estimated pending review of the final specifications, protocol and CRF. 
 [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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 4 








 A. Project Specifications 
 Project Specifications 
  

			
	Total number of sites	 	3
		
	Distribution of sites	 	Australia: 2 x Qld and 1 x NSW
		
	No. of patients	 	24 evaluable patients (excludes screening failure)
		
	Enrolment period	 	Late **** to **** (**** months)
		
	Study Duration	 	Up to **** weeks screening plus **** weeks treatment period
		 	(from first treatment application to last follow-up
		 	visit)
		
		 	**** months used in budget
		
	No. of CRF pages	 	For the 24 evaluable patients:
		 	 Estimated at **** pages per patient (**** unique and **** repeat
 pages, assuming unique pages to be ****% similar to those
 used for PEP005-006- Maximum number used in
budget)

		
		 	For the estimated **** screening failure patients:
		 	Estimated at **** pages per patient
		
	Total CRF pages	 	**** pages (maximum number used in budget)
		
	Data Entry QC	 	Because of the small number of patients, Omnicare CR
		 	would recommend ****% of CRF pages
		
	Edit developments	 	 ****% manual review using programmed data listings, ****
 edit checks to be programmed, but time costed for
 programming of data listings

		
	No. of AEs	 	**** per patient = **** AEs
		
	No. of SAEs	 	**** per 12 patient = **** SAEs (maximum)
		
	# Coding of AEs (MedDRA)	 	**** per patient = **** codes
		
	# Coding of Meds (WHODrug)	 	**** per patient = **** codes
		
	Data displays	 	Tables = **** unique / **** repeat
		 	Listings = **** unique / **** repeat
		 	Graphics = **** unique / **** repeat
		
	Final deliverable	 	Final statistical listings

  

  

	****	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. 

  Page 5 








 B. Project Management 
 The Project Lead will act as a single point of contact during the course of this study. The Project Lead is responsible for: 
  

	•	 	 The generation of detailed project timelines and ensuring that the milestones are met 


  

	•	 	 Providing ongoing status reports as agreed with the Sponsor 


  

	•	 	 Identifying and resolving critical project issues 


  

	•	 	 Managing the study budget and addressing any out-of-scope items with the Sponsor as they arise 


 C. Medical and Safety 
 Safety Coordinator 
 The Safety Coordinator is responsible for the coordination of all activities relating to safety and will be based in Sydney. The Safety Coordinator will also be
responsible for the generation of, and any required revisions to, the Study Safety Plan, a comprehensive document, which defines the process and flow for contracted safety services. In addition, a Safety Master File will be set up. Safety
coordination also includes assistance with the SAE reconciliation process, and completion of sponsor derived queries of the sites. 
 Safety Database 

 Omnicare CR will utilise the safety database developed for other on-going Sponsor projects (PCN KO1601 and KO1602 Actinic Keratoses studies). A Safety
Officer will be appointed in the US to provide monthly database maintenance and enter the data into the **** database. 
 SAE Reporting — Initial
Descriptive Narratives 
 The number of SAEs anticipated for this study is no more than **** (****). Omnicare CR assumes that the descriptive summaries
will be written from information provided by the investigator on the SAE report forwarded to Omnicare CR at the time of the event. 
 If significant follow-up
information becomes available, the narrative will be updated accordingly. The fee for SAE reporting included in the project budget includes costs for providing up to ***** (****) follow-ups for the study and to update SAE information. Any
additional follow-ups will be charged at a rate of A$**** per additional follow up. 
  

  

	****	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. 

  Page 6 








 D. Clinical Data Management 
 Lead Clinical Data Analyst 
 Due to the nature of the deliverables for this study, Omnicare CR has assumed a Lead Clinical Data Analyst will
be assigned to this project. The Lead Clinical Data Analyst will oversee the data management team as well as ensuring that all deliverables are achieved, with the support of the Data Manager. 
 Data Management Plan 
 Omnicare CR assumes **** (****) Sponsor
review cycles including up to **** (****) major and **** (****) minor revision in order to finalise the data management plan. 
 If Sponsor requests
Omnicare CR to begin work prior to a signed data management plan, the Clinical Data Manager will work with Sponsor’s representative. Changes to the data management plan (signed or unsigned) after the start of any work will incur a fee for
rework and for any work going forward. 
 CRF Design 
 Omnicare CR assumes work on the CRF design will commence once the protocol is finalised. The cost associated with this task is comprised **** (****) Sponsor review cycles with **** (****) major and **** (****) minor revision. If
additional requests are made for modifications to the final approved CRF, Sponsor will be charged accordingly. 
 The CRF completion guidelines will be
prepared by Sponsor and will need to be finalised prior to commencement of study monitoring. 
 Database Development 
 Omnicare CR will develop the study clinical database utilising Oracle Clinical with Omnicare CR standard specifications. Should Sponsor request any changes to the
post-production database structure, additional fees will be incurred. 
 Edit Specifications 
 Data review will be performed manually utilizing programmed data listings so no edits will be programmed. 
 MedDRA and WHO-Drug Dictionaries 
 Sponsor is required to have a current MedDRA and WHO-Drug license in good standing
prior to receipt of any MedDRA or WHO-Drug coded terms. It is assumed under this Proposal that Sponsor has a current MedDRA and WHO-Drug license in good standing and that such will be maintained throughout the course of the study. 
  

  

	****	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. 

  Page 7 








 Data Review and Query Processing 
 Review includes **** manual review data checks and the application of **** (****) study assumptions for every **** pages of the CRF per subject. Omnicare CR assumes that the manual review checks are not expected
to exceed **** checks comparing **** datapoints. Should the manual review checks exceed **** checks, Sponsor will be billed for actuals. 
 Data
Management Reports 
 Omnicare CR will provide Sponsor its standard CRF and DCF reports on a monthly basis.The standard reports consist of cumulative
CRF/DCF status; cumulative CRF by site; outstanding DCFs by site; resolved DCFs by site and weekly metrics (data processing). Custom metrics and data reports are available for an additional fee. 
 Protocol Deviation Log Load 
 Omnicare CR will develop an additional
Oracle Clinical module in order to load Sponsor’s log of protocol deviations into the clinical database. This includes development of the DCM/DCI module, loading the spreadsheet database, and quality control of received data. 
 E. Biometrics 
 Abbreviated Statistical Analysis Plan

 Omnicare CR will develop an abbreviated statistical analysis plan, including operational definition of endpoints to be analysed, definition of patient
subsets (evaluable and intent-to-treat), visit windows rules for data handling, and a detailed description of statistical methodology. If Sponsor has a standard statistical analysis plan template then this can be used instead. Omnicare CR has
budgeted for **** (****) Sponsor review and **** (****) revision. Additional revisions will be charged to Sponsor. 
 Design of Listing Shells
(Mocks) 
 The abbreviated statistical plan will include a set of formatted shells for all data listings planned for the study. If formatted data displays
are not required, a detailed table of contents of SAS generated data displays will be included. 
 Tables, Listings and Graph Programming 

Omnicare CR will perform the programming and will validate the following tables, listings and figures/graphs: 
  

  

	****	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. 

  Page 8 









							
	 	  	 Unique
	  	 Repeat
	  	 Total

	Tables	  	****	  	****	  	****
	Listings	  	****	  	****	  	****
	Figures/Graphs	  	****	  	****	  	****

 Should the actual number of tables, listings or figures/graphs exceed this estimate; a revised cost estimate will
be presented to Sponsor. 
 Programmatic Evaluability/Outcome 
 Omnicare CR will develop patient evaluability criteria and relevant algorithms and will present these to Sponsor for review and approval. These algorithms will be programmed using SAS to identify evaluable patients. 
 Statistical Analysis 
 Omnicare CR will not perform a statistical
analysis. 
 Database Transfer 
 Omnicare CR assumes ****
(****) standard database transfer which will be submitted to Sponsor in the form of SAS datasets. 
 V. Budget 
 A. Estimated Project Budget 
  

													
	 Services
	  	       Unit      
	  	 #
      Units      
	  	 Unit
 Cost
      (A$)      
	  	 Fees
      (A$)      
	  	 Estimated
Pass-Thru
    (A$)    
	  	 Estimated
Total
  Cost (A$)  


	A. Project Management	  		  		  		  		  		  	
	 •     Biometrics Team Manager—Australia
	  	Days	  	****	  	****	  	****	  	****	  	****
	 •     Project Administrative Support/Coordination —Int’l
 (includes
support for all functional areas)
	  	Days	  	****	  	****	  	****	  	****	  	****
	 Sub-Total Project Management 
	  		  		  		  	****	  	****	  	****

  

  

	****	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. 

  Page 9 









													
	 Services
	  	       Unit      
	  	 #
      Units      
	  	 Unit
 Cost
      (A$)      
	  	 Fees
      (A$)      
	  	 Estimated
Pass-Thru
    (A$)    
	  	 Estimated
Total
  Cost (A$)  


	B. Clinical Data Management	  		  		  		  		  		  	
	 •     Lead CDA—UK (assumes ****% FTE x **** month, ****% FTE x **** months, and ****% FTE
for **** months)
	  	Days	  	****	  	****	  	****	  	****	  	****
	 •     Development of Data Management Plan (includes **** major and **** minor revision; add’l revisions
will be billed at per diem rates)
	  	Days	  	****	  	****	  	****	  	****	  	****
	 •     CRF Design (assumes **** page CRF, **** unique CRF pages); includes **** major and **** minor
revision
	  	Project	  	****	  	****	  	****	  	****	  	****
	 •     Database Development, Testing and Maintenance (assumes **** page CRF, **** unique CRF
pages)
	  	Project	  	****	  	****	  	****	  	****	  	****
	 •     Estimated Data Entry — UK (actuals will be billed)
	  	Pages	  	****	  	****	  	****	  	****	  	****
	 •     Estimated Data Review and Query Resolution (assumes **** issue per **** CRF pages, **** manual checks and
the application of **** study assumption for **** CRF pages); assumes **** CRF pages per enrolled patient, **** pages per screen failure patient, and **** pages per drop out patient. Queries will be billed on actuals.
	  	Pages	  	****	  	****	  	****	  	****	  	****
	 •     Quality Control Check of Database versus CRF (assumes **** CRF pages per patient)
	  	Pages	  	****	  	****	  	****	  	****	  	****

  
  
  

  

	****	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. 

  Page 10 









													
	 Services
	  	       Unit      
	  	 #
      Units      
	  	 Unit
 Cost
      (A$)      
	  	 Fees
      (A$)      
	  	 Estimated
Pass-Thru
    (A$)    
	  	 Estimated
Total
  Cost (A$)  


	B. Clinical Data Management (continued)	  		  		  		  		  		  	
	 •     Programming of data listings for manual review process
	  	Project	  	****	  	****	  	****	  	****	  	****
	 •     CRF and Query Tracking (includes all ancillary pages; actuals will be billed)
	  	Pages	  	****	  	****	  	****	  	****	  	****
	 •     Dictionary Coding of Adverse Event terms to MedDRA (estimated to be **** per patient; actuals will be
billed)
	  	Terms	  	****	  	****	  	****	  	****	  	****
	 •     Dictionary Coding of Medication Terms (estimated to be **** per patient; actuals will be
billed)
	  	Terms	  	****	  	****	  	****	  	****	  	****
	 •     Reconciliation of the Safety and Clinical Database (actuals will be billed)
	  	SAEs	  		  	****	  	****	  	****	  	****
	 Sub-Total Clinical Data Management 
	  		  		  		  	****	  	****	  	****
	C. Biometrics Analysis	  		  		  		  		  		  	
	 •     Project Data Setup
	  	Project	  	****	  	****	  	****	  	****	  	****
	 •     Abbreviated Statistical Plan
	  	Project	  	****	  	****	  	****	  	****	  	****
	 •     Design of Listing Shell (Mocks)
	  	Project	  	****	  	****	  	****	  	****	  	****
	 •     Programming/QC of Data Displays (actuals will be billed).
	  		  		  		  		  		  	
	 > Unique Tables 
	  	Tables	  	****	  	****	  	****	  	****	  	****
	 > Repeat Tables 
	  	Tables	  	****	  	****	  	****	  	****	  	****
	 > Unique Listings 
	  	Listings	  	****	  	****	  	****	  	****	  	****
	 > Repeat Listings 
	  	Listings	  	****	  	****	  	****	  	****	  	****
	 > Unique Figures 
	  	Figures	  	****	  	****	  	****	  	****	  	****
	 > Repeat Figures 
	  	Figures	  	****	  	****	  	****	  	****	  	****
	 •     Programmatic
 Evaluability/Outcome
	  	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. 

  Page 11 









													
	 Services
	  	       Unit      
	  	 #
      Units      
	  	 Unit
 Cost
      (A$)      
	  	 Fees
      (A$)      
	  	 Estimated
Pass-Thru
    (A$)    
	  	 Estimated
Total
  Cost (A$)  


	C. Biometrics Analysis (continued)	  		  		  		  		  		  	
	 •     Statistical Analysis
	  	Project	  	****	  	****	  	****	  	****	  	****
	 •     Standard Data Transfer
	  	Transfer	  	****	  	****	  	****	  	****	  	****
	 •     Return of CRF (hard copy); billed on actuals
	  	Pages	  	****	  	****	  	****	  	****	  	****
	 Add’l Stats consulting, meeting attendance, etc., will be charged at per diem rates as
follows:

	 > Team Leader 
	  	Days	  	**** 	  		  		  		  	
	 > Statistician 
	  	Days	  	**** 	  		  		  		  	
	 > Programmer 
	  	Days	  	**** 	  		  		  		  	
	 Sub-Total Biometrics 
	  		  		  		  	****	  	****	  	****
	D. Safety Services	  		  		  		  		  		  	
	 •     Safety Plan and Master File Set Up (also includes protocol familiarisation)
	  	Project	  	****	  	****	  	****	  	****	  	****
	 •     Safety Phone Cover (actual months will be billed)
	  	Months	  	****	  	****	  	****	  	****	  	****
	 •     SAE Reporting (with initial descriptive summary); billed on actuals
	  	Reports	  	****	  	****	  	****	  	****	  	****
	 •     ****
	  		  		  		  		  		  	
	 > Project Set-Up (set up costs included in PCN KO1601) 
	  	Project	  	****	  	****	  	****	  	****	  	****
	 > Monthly Database Maintenance (first patient in to database close; performed in the US) 
	  	Months	  	****	  	****	  	****	  	****	  	****
	 > Data Entry into **** (actuals will be billed; performed in the US) 
	  	SAEs	  	****	  	****	  	****	  	****	  	****
	 Sub-Total Safety Services 
	  		  		  		  	****	  	****	  	****
	 Estimated Services Budget 
	  		  		  		  	****	  		  	
	 Estimated Pass Through 
	  		  		  		  		  	****	  	


									
		  	 	  		  	 	  	


																	
	 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 12 








 B. Payment Schedules 
 1. Invoicing Process for Service Fees 
 Omnicare CR maintains a project accounting system, whereby all direct project costs (Service Fees or
Pass-Through Expenses) are coded by project. 
 An initial payment of A$****, representing approximately **** percent (****%) of the estimated Service Fees,
is due and payable upon execution of this Exhibit F. Subsequent payments shall be made monthly, based on Project progress and upon submission of an invoice to Sponsor by Omnicare CR. After receipt of the initial payment, the subsequent invoices
shall be reduced by a prorated portion from the initial payment such that the initial payment is applied evenly over the remaining term of the Project. All payments shall be processed within **** days. If any payment of Service Fees or
Pass-Through Expenses is late by more than **** (****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
 2. Exchange Rates 
 The pricing is based on the following exchange rates assumptions: 
 One (1) A$ = US Dollars (US$) 0.7395 
 One (1) A$ = Euro 0.6178 
 This Exhibit F involves services provided in regions with currencies other than the budget currency, which is
Australian Dollars (A$). In the event the exchange rate moves three percent (3%) or more positively or negatively within a six-month timeframe, the parties agree to meet in good faith to discuss and negotiate new rates based on the new exchange
rate. 
 In addition, at the time Omnicare CR processes any pass through expenses in currencies other than A$, such expenses shall be converted to AS using
the exchange rate for the corresponding period as published by oanda.com. 
 3. Pass Through Expense Invoicing 
 Omnicare CR’s project accounting system is able to capture and categorise in summary the following Key pass-through expenses related to your project: 
  

	 	•	 	 Travel 


  

	 	•	 	 Delivery Costs 


  

	 	•	 	 Printing or copying costs 


  

	 	•	 	 Meeting costs 


  

	 	•	 	 Telecommunication Costs (which may include telephone, fax, paper, conference calls, or PC connectivity charges) 


  

	 	•	 	 All other Project related expenses that are not related to service fees 


  

  

	****	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. 

  Page 13 








 4. Payments 
 Sponsor
shall make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Maquarie
Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: ***** 
 5. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary, the estimated Service Fees set forth in this
Exhibit F shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Exhibit F as of each ****; such increases shall not exceed the percentage change of the
Medical Services Price Index for the corresponding period. 
 ACCEPTANCE 
 The terms and conditions of the Master Agreement govern this Exhibit F and such document is incorporated herein by reference as if fully set forth herein. 
 BY AND BETWEEN; 
  

											
	Peplin Operation Pty Ltd.	 		 	Omnicare GR, Inc.	 	
						
	BY:	 	 /s/ Michael Aldridge
	 		 	BY:	 	 /s/ KEVIN D. DUFFY
	 	
	Name:	 	Michael Aldridge	 		 	Name:	 	KEVIN D. DUFFY	 	
	Title:	 	Managing Director & CEO	 		 	Title:	 	EXECUTIVE VICE PRESIDENT GLOBAL BUSINESS DEVELOPMENT CHIEF RELATIONS OFFICER	 	
	Date:	 	25-May-06	 		 	Date:	 	6/6/06	 	

  

  

	****	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. 

  Page 14 








 Change Order #01 to Exhibit F to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 1 st June 2005. 
 THIS CHANGE ORDER
is entered into this 27 th Day of February, 2007 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter
“Sponsor”) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a certain Clinical Services Master Agreement, dated 1 st June 2005
(collectively, with the Exhibit thereto, as the same may have been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership
Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment any references to “Omnicare CR” shall be
deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR
desire to amend Exhibit F to the Agreement to provide for certain additional tasks or changes in the scope of the work provided under the Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 1. Schedule of Changes 
 Sponsor and Omnicare 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 1 









					
	 Reference
	  	 Changes and/or Additions
	  	 Estimated
 Service Fee
 (A$)

	Pursuant to Exhibit F, Omnicare CR will provide additional services to support the Sponsor’s Study of PEP005 Topical Gel, Protocol #
PEP005-008, Final Version 3, Dated 8 th May 2006	  	 Biometrics:
  
 •   Additional Statistical Analysis —
  
 •   The following will be performed:

  
 •      End of Study clinical response of the Day **** vs Day **** subjects
 and all
subjects
  
 •      End of Study histological response of the Day **** vs Day ****
 subjects and
all subjects
  
 •      Baseline vs End of Study Erythema LSR
  
 •      Baseline vs End of Study Desquamation LSR
  
 •      Baseline
vs End of Study Swelling LSR
  
 •      Baseline vs End of Study Vesiculation/Pustulation LSR
  
 •      Baseline vs End of Study Erosion/ Ulceration LSR
  
 •      Baseline
vs End of Study Pigmentation LSR
  
 •      Baseline vs End of Study Scarring LSR
  
 •     Final delivery would be statistical output and a short description of
 methology used
	  	
			
		  	 •     Provided to Sponsor by end of ****
	  	
			
		  	 •     Fees:
	  	
			
		  	 •      **** hours Statistician (India) @ A$****/hr
	  	****
			
		  	 •      **** hours Team Leader @ A$****/hr
	  	****
			
		  	Clinical Data Management: 	  	
			
		  	 •     Data Entry: Original Units ****; Actual Units **** = ****
units @
 $****/unit
	  	****
			
		  	 •     Data Review: Original Units ****; Actual Units **** = ****
units @
 $****/unit
	  	****
			
		  	 •     QC Full: Original Units ****; Actual Units **** = **** units @ $****/unit
	  	****
			
		  	 •     CRF Tracking: Original Units ****; Actual Units **** = **** units @ $****/unit
	  	****

  

  

	****	Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant
to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 2 









								
	 Reference
	  	 Changes and/or Additions
	  	  Estimated
    Service Fee  
(A$)
				
	 Pursuant to Exhibit F, Omnicare CR will provide additional services to support the Sponsor’s Study of PEP005 Topical Gel,
Protocol # PEP005-008, Final Version 3,
 Dated 8 th May 2006
	  	Clinical Data Management: (continued) 	  			 	
	  		  			 	
	  	 •     Dictionary Coding of AEs: Original Units ****; Actual Units **** =
	  	****	 	 	
	  	 **** units @ $****/unit
	  			 	
	  		  			 	
	  	 •     Dictionary Coding of Meds: Original Units ****; Actual Units **** =
	  	****	 	 	
	  	 **** units @ $****/unit.
	  			 	
	  		  			 	
	  	 •     SAE Reconciliation: Original Units ****; Actual Units **** = ****
	  	****	 	 	
	  	 units @ $****/unit
	  			 	
	  		  			 	
		  	 •     New item not covered in original contract — Protocol
Deviation Log
 Load: **** units @ $****/unit
	  	****	 	 	
		  	  			 	
		  		  	 	 	 	 
	Total Estimated Service Fees 	  	****	*	 	
		  		  	 	 	 	 
	Total Estimated Pass Through Expenses 	  	****	**	 	
		  		  	 	 	 	 
	Total Estimated Budget 	  	****	 	 	
		  		  	 	 	 	 

  
  

	*	The Estimated Service Fees set forth above represent the original unit costs set forth in the Agreement and are subject to any annual price increase(s) applied against the original
unit costs. 

  

	**	Sponsor will be billed for actual Pass-Through Expenses incurred in support of the Project. 

 2.  Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and
Omnicare CR agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set forth in this Change Order #01. 
 3.  Payment 
 An initial payment of A$****, representing **** percent (****%) of the estimated
Service Fees, shall be due and payable to Omnicare CR upon execution of this Change Order #01. The payment of service fees and pass through expenses shall be made by Sponsor within **** (****) days of receipt of invoice. If payment of service
fees or pass through expenses is late by more than **** (****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
  

  

	****	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. 

  Page 3 








 Sponsor shall make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Macquarie Shopping Centre, 
 North Ryde, NSW 2113 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 4.  Annual Price Increase 
 Notwithstanding anything contained herein to the contrary and subject to
any previous annual price increase(s), the estimated Service Fees set forth in this Change Order #01 shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change
Order #01 as of each ****; such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 5.  No Other Changes 
 Except as expressly provided to the contrary in this Change Order #01, all other terms and conditions
of the Agreement shall continue in force-and effect. 
 ACCEPTANCE 
 BY AND BETWEEN: 
  

											
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.	 	
						
	By:	 	 /s/ Peter Welburn
	 		 	By:	 	 /s/ Dale Evans
	 	
	Name:	 	Peter Welburn	 		 	Name:	 	Dale Evans	 	
	Title:	 	General Manager	 		 	Title:	 	Chief Executive Officer	 	
	Date:	 	7/3/07	 		 	Date:	 	27/2/07	 	

  

  

	****	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. 

  Page 4 








 Exhibit G to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., dated June 1, 
 2005. 
 THIS EXHIBIT G is entered into this 12 th day of May 2006, by
and between Peplin Operations Pty Ltd. (hereinafter “Sponsor”) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a Clinical Services Master Agreement, dated June 1, 2005 (hereinafter the “Master Agreement”), wherein Omnicare CR agreed to provide clinical
services; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect
beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to
“Omnicare CR” shall be deemed to include “Omnicare CR and/or on Affiliate Entity;” and 
 WHEREAS, Sponsor and
Omnicare CR agree that Omnicare CR shall provide the services set forth in this Exhibit G, subject to the terms and conditions set forth in the Master Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 I. Project Plan 
 Based on the Project Specifications, Omnicare CR has provided a description of services to be
performed for Sponsor’s Integrated **** Safety Database. (hereinafter “the Project”) and associated costs. Changes made in the Project scope, at any time during the Project, will result in a corresponding adjustment to the Project
costs. 
 II. Project Timeline 
 The projected timeline
for this Project is as follows: 
  

					
	 Major Milestones
	 	 	  	 Projected Timeline

	Develop and maintain **** Database	 		  	**** months
	Total Study Duration	 		  	**** months

  

  

	****	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. 

  Page 1 








 III. Omnicare CR Services 
 Services provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the Project specifications provided by Sponsor, and are outlined below. It should be noted, however, that the timeline and costs
presented in this budget for these services are estimated pending review of the final specifications, protocol and case report form (CRF). 
 A. Safety
and Medical 
 Safety Database 
 Omnicare CR will
develop the safety database for the Project. The database platform is the current version of the **** safety surveillance system. The system is fully validated and complaint with all regulatory requirements for electronic storage of adverse event
data. Additionally, the system is capable of generating adverse event files in electronic format according to the definitions set in ICH E2B. Omnicare CR is able to perform electronic submission of serious, unexpected, suspected adverse reactions
(‘SUSARs’) to regulatory authorities as mandated by the European Clinical Trials Directive. 
 IV. Budget 
 A. Estimated Project Budget 
  

			
	Omnicare CR, lnc. Clinical Budget for:
	Sponsor:	  	Peplin
	Compound:	  	N/A
	Study:	  	Integrated **** Safety Database
	PCN:	  	KO1604

  

													
	 Services
	  	Unit	  	# Units	  	Unit Cost	  	Fees (US$)	  	Estimated
Pass-Thru
(US$)	  	Estimated Total
Cost (US$)
	 A. Safety and Medical 
	  		  		  		  		  		  	
	 •   Sponsor Requested Follow Up 
	  	Report	  	****	  	****	  	****	  	****	  	****
	 •   ****
	  		  		  		  		  		  	
	 Project Set-Up 
	  	Project	  	****	  	****	  	****	  	****	  	****
	 Monthly Database Maintenance (billed on actuals) 
	  	Month	  	****	  	****	  	****	  	****	  	****
	 Data Entry into **** (actuals will be billed) 
	  	SAE	  	****	  	****	  	****	  	****	  	****
		  		  		  		  	 	  	 	  	 
	 Sub-Total Safety and Medical 
	  		  		  		  	****	  	****	  	****
		  		  		  		  	 	  	 	  	 
	 Estimated Services Budget 
	  		  		  		  	****	  		  	
		  		  		  		  	 	  		  	
	 Estimated Pass Through 
	  		  		  		  		  	****	  	
	 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 2 








 B. Payment Schedules 
 1. Invoicing Process for Service Fees 
 Omnicare CR maintains a project accounting system, whereby all direct project costs (Service Fees or
Pass-Through Expenses) are coded by project. 
 An initial payment of US $**** representing approximately **** percent (****%) of the estimated Service Fees,
is due and payable upon execution of this Exhibit G. Subsequent payments shall be made monthly, based on Project progress and upon submission of an invoice to Sponsor by Omnicare CR. After receipt of the initial payment, the subsequent invoices
shall be reduced by a prorated portion from the initial payment such that the initial payment is applied evenly over the remaining term of the Project. All payments shall be processed within **** days. If any payment of Service Fees or
Pass-Through Expenses is late by more than **** (****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
 2. Pass-Through Expense Invoicing 
 Omnicare CR’s project accounting system is able to capture and categorize in
summary the following key Pass-Through Expenses related to a project: 
  

	•	 	 Travel 


  

	•	 	 Delivery costs 


  

	•	 	 CRF and other Printing copying costs 


  

	•	 	 Investigator Meeting costs 


  

	•	 	 Telecommunication costs (which may include telephone, fax, pager, conference calls, or PC connectivity charges) 


 All other project related expenses that are not related to Service Fees and any additional detail to support Pass-Through Expenses will be provided on a fee basis.

 3. Payments 
 Sponsor shall make payment directly to
the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 First Union National Bank 
 Philadelphia, PA 
 ABA #
**** 
 Acct # **** 
  

  

	****	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. 

  Page 3 








 4. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary, the estimated Service Fees set forth in this Exhibit G shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining
Services under this Exhibit G as of each ****; such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 ACCEPTANCE 
 The terms and conditions of the Master Agreement govern this Exhibit G and such document is
incorporated herein by reference as if fully set forth herein. 
 BY AND BETWEEN : 
  

											
	Peplin Operations Pty Ltd.	 	Omnicare CR, Inc.	 	
						
	BY :	 	 /s/ Peter Welburn
	 		 	BY :	 	 /s/ KEVIN D. DUFFY
	 	
	Name :	 	Peter Welburn	 		 	Name :	 	KEVIN D. DUFFY	 	
	Title:	 	 Chief Scientific Officer and Vice President,
 Research
& Development
	 		 	Title:	 	 EXECUTIVE VICE PRESIDENT
 GLOBAL BUSINESS DEVELOPMENT

 CHIEF RELATIONS OFFICER
	 	
	Date:	 	10, May 2006	 		 	Date:	 	6/5/06	 	

  

  

	****	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. 

  Page 4 








 Exhibit H to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated June 1, 2005. 
 THIS EXHIBIT H is entered into this 16th day of June 2006 by
and between Peplin Operations Pty Ltd. (hereinafter “ Sponsor “) and Omnicare CR, Inc. (hereinafter Omnicare CR). 
 WHEREAS, Sponsor and Omnicare CR entered into a, Clinical Services Master Agreement, dated June 1, 2005 (hereinafter the “Master Agreement), wherein Omnicare CR agreed to provide clinical services; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity begin defined as an entity under direct or indirect beneficial common ownership as
Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment any references to “Omnicare CR” shall be
deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR
shall provide the services set forth in this Exhibit H, subject to the terms and conditions set forth in the Master Agreement; 
 NOW,
THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 I. Project Plan

 Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for Sponsor’s “Multi-center,
randomized, double-blind, double-dummy, parallel-group, vehicle-controlled comparison study to determine the efficacy of PEP005 0.025% and 0.05% gel in patients with AK lesions” (hereinafter “the Project”) and associated costs.
Changes made in the Project scope, at any time during the Project, will result in a corresponding adjustment to the Project costs. 
 II. Project Timeline

 The parties acknowledge and agree that Omnicare CR commenced performance of the Services under the letter of intent dated January 16, 2006. The
projected timeline for this Project is as follows: 
  

  

	****	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. 

  Page 1 









			
	 Major Milestones
	  	 Projected Timeline

	Study Start	  	February 1, 2006
	Work Stopped Due to FDA Request for Redesign	  	****
	Total Study Duration	  	****

 All service areas initiated start-up associated tasks until notice that the protocol required redesign. Future work
on this protocol beginning on **** will be contracted under a separate Exhibit (KO1605) 
 III. Omnicare CR Services 
 Services provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the Project specifications provided by Sponsor, and are
outlined below. It should be noted, however, that the timeline and costs presented in this budget for these services are estimated pending review of the final specification, protocol and case report form (CRF). 
 A. Study Management 
 Project Director

 The Project Director will act as a single point of contact for the Sponsor during the course of this study. The Project Director is responsible for the
generation of detailed project timelines and ensures that these milestones are met. The Project Director will provide on-going project status reports as directed by the Sponsor and will proactively identify and resolve critical project issues. The
Project Director as also responsible for managing the study budget and addresses all out-of-scope items with the Sponsor. 
 Clinical Trial
Manager 
 The Clinical Trial Manager will be dedicated to managing the day-to-day clinical trial activity. The Clinical Trial Manager is responsible for
overseeing all site and clinical research associate (CRA) activity for the Project. The Clinical Trial Manager is also responsible for developing case report form completion and monitoring guidelines; overseeing regulatory document management for
each investigational site and for reviewing and tracking the Project CRA activities which include the scheduling of site visits, site visit reports, monitoring logs and follow-up correspondence. 
 Project Administrative Coordination 
 The Project
Coordinator provides the necessary administrative support to the Project Director and to the rest of the Project Team with all administrative related tasks. 
  

  

	****	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. 

  Page 2 








 Draft Informed Consent Review 
 The Omnicare CR Project Management Team will review the draft of the Informed Consent and will evaluate whether it is in accordance with IRB and Ethic committee requirements. The Project Management Team will provide
feedback to Sponsor as required. 
 B. Clinical Trial Initiation 
 Investigator Document Plan 
 An Investigator Document Plan will be developed for the Sponsor. The purpose of the
Investigator Document Plan is to define the project-specific review criteria for essential documents, the investigational product shipment approval procedure, the investigator site binder content and essential document file maintenance. 

Investigator Essential Document Management–Regulatory Document Collection 
 Once Sponsor has signed the Investigator Documentation Plan, essential document packages, with letters of instruction, will be mailed to qualified investigative sites. Document collection will cover all criteria
required under the principles of Good Clinical Practices (GCP) and International Committee for Harmonization (ICH) guidelines as well as Omnicare CR SOPs. 
 Omnicare CR will track the retrieval of documents on an ongoing basis and provide updates to Sponsor as requested. The fee for essential document collection, processing, and tracking is based upon the number of sites required for the
Project. All sites that drop from the study for any reason will be billed based on percentage of work completed prior to notification of the drop. A submission-ready regulatory document package for each investigator will be forwarded to Omnicare CR
Regulatory prior to drug shipment and site initiations. Omnicare CR Regulatory will review the packages. 
 Once all essential documents and approvals are
received, the essential documents are copied and an Investigator Site File is created. An Investigator Site File Binder will be sent to each investigator. 
 Investigator’s Meeting Coordination 
 Omnicare CR’s Meetings Coordinator will coordinate arrangements
associated with the investigators’ meetings(s) for the Project. Omnicare CR’s Meetings’ Coordinator has extensive experience in conducting investigators’ meetings, including but not limited to, organizing and scheduling the
meeting, making cost-effective travel arrangements for participants, and providing on-site coordination services. 
 The Meeting Coordinator will manage all
logistics of the meeting including: 
  

	 	•	 	 Identify appropriate location(s) for the meeting 


  

	 	•	 	 Negotiate, organize, and make hotel arrangements (e.g. meeting space and lodging) 


  

	 	•	 	 Secure discounted travel arrangements and issue tickets to investigators and study coordinators 


  

	 	•	 	 Prepare meeting materials (e.g. Welcome letters/packets, and name badges) 


  

	 	•	 	 Arrange meal functions and off-site events 


  

	 	•	 	 Manage administrative aspects associated with the meeting 


  


  

	****	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. 

  Page 3 









	 	•	 	 Provide on-site assistance at the meeting (the coordinator will arrive at the location prior to the meeting and will stay after the meeting to manage any
outstanding arrangements such as shipping meeting materials 


  

	 	•	 	 Provide post meeting service including reconciliation of outstanding meeting bills 


 C. Clinical Trial Management 
 CRA activities and Site Responsibilities 
 Omnicare CR CRAs perform comprehensive site management and monitoring activities to include the following types of monitoring visits: 
  

	 	•	 	 Pre study selection visits 


  

	 	•	 	 Initiation visits 


  

	 	•	 	 Interim monitoring visits 


  

	 	•	 	 Close out visits 


 All activities are performed in
accordance with ICH- GCP guidelines to ensure all investigational sites are compliant with all applicable regulations and protocol requirements. 
 The
paramount responsibility of Omnicare CR CRAs is to ensure patient rights, safety and data integrity. This is accomplished through ongoing review of the following: 
  

	 	•	 	 Informed consent process 


  

	 	•	 	 IRB/IEC approval 


  

	 	•	 	 Ensuring proper AE and SAE reporting and documented follow up 


  

	 	•	 	 Adherence the protocol 


  

	 	•	 	 100% source documentation verification and data query clarification 


  

	 	•	 	 Investigational product administration and accountability 


  

	 	•	 	 Protocol Compliance 


  

	 	•	 	 Site training and support 


 Omnicare CR CRAs ensure
ongoing site compliance via the continual review of the following: 
  

	 	•	 	 Site staff qualifications and experience 


  

	 	•	 	 Site staffing, facilities, storage and equipment 


  

	 	•	 	 Accessibility and eligibility of subjects 


  

	 	•	 	 Review and retrieval of regulatory documents (i.e. FDA 1572, protocol signature page, curricula vitae, medical licenses, certification of investigators’
financial disclosure, etc.) 


  

	 	•	 	 Accurate and timely completion of all CRF and source data 


 In addition to on-site responsibilities, each CRA is responsible for site management documentation and follow-up activities to ensure that site staff remains motivated and focused. These activities include the following: 
  

	 	•	 	 Site Visit Report and follow-up letters 


  

	 	•	 	 Providing site training and support through communications 


  

	 	•	 	 Generation of status reports 


  

	 	•	 	 Maintenance of tracking tools/logs 


  

	 	•	 	 Facilitation of DCF resolution 


  

  

	****	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. 

  Page 4 








 Omnicare CR CRAs complete comprehensive site visit reports and follow-up letters which are provided to the Omnicare CR
Project Management Team within 10 working days of the visit however all urgent issues are immediately reported to Project Management. The visit reports provided by the CRAs include detailed action plans for all issues identified and all issues are
tracked through to resolution. 
 Site Qualification (Pre-Study Visits and Phone Calls) 
 Omnicare CR’s site management and monitoring procedures will be performed in accordance with ICH-GCP guidelines to ensure each investigative site’s compliance
with regulations and protocol requirements, and to enhance expeditious enrollment of appropriate patients into the clinical study. Regulatory documents will be reviewed by the CRA on an ongoing basis during the study conduct phase, including
verification of signed informed consent forms and investigator IRB notifications. 
 The Omnicare CR CRA will review the following information at the
pre-study site visit: 
  

	 	•	 	 Latest version of the Protocol for this study 


  

	 	•	 	 Consent form process 


  

	 	•	 	 AE and SAE reporting procedures and contact information 


  

	 	•	 	 Case report form completion and maintenance 


  

	 	•	 	 Source documentation requirements 


  

	 	•	 	 Drug accountability requirements 


 In addition, to
ascertain that an identified investigational site is qualified to perform this study to Omnicare CR’s expectations, the CRA will review the following issues at the study site and report this “study profile” in a site visit report to
Omnicare CR and the Sponsor: 
  

	 	•	 	 Principal investigator qualifications and experience 


  

	 	•	 	 Site staffing, facilities, storage and equipment 


  

	 	•	 	 Adequacy of and accessibility to subject population 


  

	 	•	 	 Access to source documentation 


  

	 	•	 	 Status of regulatory documentation (i.e. FDA 1572, protocol sign-off page, curricula vitae, medical licenses, certification of investigators’ financial
disclosure, etc.) 


  

	 	•	 	 IRB and ethics committee issues 


  

	 	•	 	 Laboratory and pharmacy certifications and normal ranges (if applicable) 


  

	 	•	 	 Investigator agreement and indemnification issues 


  

	 	•	 	 Recommendations for investigational site approval or exclusion from the study 


 Sites that have recently had a pre-study site visit performed by the Sponsor or have worked with Omnicare CR in the preceding six (6) months may be exempt from a pre-study site visit. The Sponsor will provide
Omnicare CR with a list of any exempt investigators for this study. 
 Sponsor Meeting Attendance 
 Omnicare CR assigned Project Team will attend face-to-face meetings with the Sponsor’s clinical team throughout 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. 

  Page 5 








 Clinical Grants Administration 
 Omnicare CR’s Investigator Grant staff will administer the clinical grant payments to the site. Included in their responsibilities are following: 
  

	 	•	 	 Processing financials records for all of the patients in the study 


  

	 	•	 	 Issue initial and interim payments for each investigator 


  

	 	•	 	 Reconciling all payments to each of the investigators prior to final payments 


  

	 	•	 	 Tracking account administration with Omnicare CR’s finance group 


  

	 	•	 	 Maintaining IRS W-9 forms and all relevant and government reports 


  


	 	•	 	 Reporting excess grants from sites at study end 


 Activities included in Clinical Grants Administration include the following: 
 Investigator Grant Start-Up Administration 

 Investigator Grant Start up Administration includes two activities: Contract Review which includes protocol/contract evaluation, investigator/site budget
drafting, and telephone contact with the investigator and Grant Set-up which involves evaluating and entering site specific information. Confirm with the site representative(s) the correct name of the payee and that the site representative(s)
understand how payments will be made. Identify correct payee by verifying contract information with IRS W-9 and site profile, follow-up calls and correspondence may be needed to clarify discrepancies. Set-up directories, site, and study specific
spreadsheets to perform the tracking payments/invoices to the sites. Set up binders/files for hard copy files of site profiles and order checks (i.e. in addition to setting up an account for each payee). 
 Grant Management 
 Grant Management includes review-and
verification of source payment tracking data, data entry, and tracking and follow-up clarification with the Project Management staff and site contacts/site communications, managing ongoing investigator inquiries regarding payments and follow-up.
Grant Management occurs after the site “set up” until **** days after final payment (note: actuals will be billed). Grant Management also includes determining when grant payments are due per contract (i.e. site payment status),
re-designing tracking spreadsheets as study parameters change, reconciling tracking logs with general ledger, and making adjustments from previous payment cycle and at study completion. Also includes re-issuing checks as needed (due to sites not
cashing or lost checks), completing Sponsor specific reconciliation (as needed) and completing a final reconciliation of all payments made throughout the study. 
 The following are the types of ongoing payments which are required/performed during the course of a clinical trial: multiple IRB payments/fees (for initial & amendment submissions), patient enrollments (i.e. payments based on
completed CRFs, visits or procedures performed and may include, coordinator fees, and investigator fees). Other types of separate payments include screen failure payments, incentive fee payments, specialized equipment payments, specialized study
specific supply payments, and sub-study payments. 
 In addition, participating sites will be analyzed with Project Managers for the future enrollment to
determine grant payment projections. Time will be allocated to complete the grant payment reconciliation process with Omnicare CR’s business administration office 
  


  

	****	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. 

  Page 6 








 D. Safety and Medical 
 Medical Monitoring (during business hours) 
 The medical aspects of The Sponsor’s clinical program will be
overseen by one of Omnicare CR’s staff physicians who will be assigned to the study during business hours as the Project’s Medical Monitor. In addition to acting as medical advisor to the Project Team, the Medical Monitor is responsible
for the following: 
  

	 	•	 	 Addressing medical inquiries, internal or external 


  

	 	•	 	 Reviewing of clinical documentation (protocol, draft CRF, samle informed consent form) 


  

	 	•	 	 Project-specific medical training 


  

	 	•	 	 Evaluating patient eligibility (in conjunction with the Medical Director of the Sponsor) 


  

	 	•	 	 Participating in team meetings 


  

	 	•	 	 Review of Safety Data, such as laboratory results, ECGs, SAEs, AE Listings 


  

	 	•	 	 Reviewing study reports, regulatory submissions and study manuscripts 


 Safety Coordinator 
 The Coordinating Safety Officer
assigned to the Project will coordinate all activities relating to safety. These activities include attendance of internal and external team meetings, safety training of Project staff or sites, communication of safety information to Omnicare CR
Project Management and Data Management departments as well as the sponsor, and tracking the flow of safety information for the life of the Project. The Coordinating Safety officer will also be responsible for the generation of, and any required
revisions to, the Study Safety Plan, a comprehensive documents, which defines the process and flow for contracted safety services. Safety coordination also includes assistance with the SAE reconciliation process, and completion of sponsor derived
queries of the sites. 
 E. Clinical Data Management 
 A
Data Management team will be assigned to this project to carry out all of the activities defined in the bid specifications. The team will consist of a Lead Data Manager, Database Programming staff, Dictionary Manager and specialists, Clinical Data
Analysts and Data Technicians. Team resources for the project will be developed by the Data Manager and will be based on the patient enrollment plan along with the Case Report Form retrieval plan. Adjustments will be made as needed as the study
progress. 
 The Data Management team will work together under the leadership of the Lead Clinical Data Manager to ensure the meeting of all project quality
deliverables along with a successful and timely database closure. 
  

  

	****	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. 

  Page 7 








 Data Manager 
 The Clinical Data Manager assigned to this project will oversee all Data Management activities throughout the life of the project. This dedicated Clinical Data Management will act as the primary liaison for all Data Management activities.
Many of the Clinical Data Management’s activities are listed bellow: 
  

	 	•	 	 Overseeing the completion of setup and maintenance of all data management activities 


  

	 	•	 	 Creation and implementation of the Data Management Plans. The Data Manager will assure the receipt of the Sponsor’s approval prior to the initiation of any
tasks outlined in this plan 


  

	 	•	 	 Supporting the development of the CRF completion guidelines 


  

	 	•	 	 Liaise with Clinical Trial Managers to ensure expectations for recording data accurately are communicated to the Project Team and the study site



  

	 	•	 	 Managing the query generation and final resolution 


  

	 	•	 	 Proactively addressing data quality issues to reduce query generation 


  

	 	•	 	 Liaise with the Clinical Trial Managers for timely query resolution 


  

	 	•	 	 Ensuring high quality and timely data management deliverables 


  

	 	•	 	 Maintain ongoing communication with Sponsor team members and Omnicare CR’s Project Team Members 


  

	 	•	 	 Oversee Project training for Clinical Data Management team members 


  

	 	•	 	 Provide status updates to both the Omnicare CR internal Project Team and the Sponsor team members 


  

	 	•	 	 Clinical Data Management Project resource plan to ensure proper staffing throughout the study 


 Lead Clinical Data Analyst 
 Based on the deliverables
for the Project, Omnicare CR has assigned a Lead Clinical Data Analyst. The Lead Clinical Data Analyst will provide additional team oversight for the Project Data Technicians and Clinical Data Analysts. The Lead Clinical Data Analyst will assist the
Clinical Data Manager with the following activities in relation to the page-related staff: 
  

	 	•	 	 Prioritization of Clinical Data Management tasks 


  

	 	•	 	 Directing the daily Clinical Data Management team task assignments 


  

	 	•	 	 Monitoring the status of task and work load 


  

	 	•	 	 Ongoing Project training within Data Management 


  

	 	•	 	 Providing feedback to the Clinical Monitoring staff on query trends 


  

	 	•	 	 Providing backup support to the Clinical Data Manager 


  

	 	•	 	 Ensure a cohesive team that maintains high quality and data consistency 


  

	 	•	 	 Generating metrics reports 


  

  

	****	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. 

  Page 8 








 F. Biometrics Analysis 
 Biometrics Team Manager 
 Omnicare CR recognizes that statistical and programmatic services are critical to Sponsor
achieving timelines and objectives for the Project. All of Omnicare CR’s biostatisticians are Master’s or Ph.D. level prepared, with an average of **** (****) years of **** experience. Both the biostatistician and lead programmer assigned
to Sponsor’s Project will meet with you during Project initiation and throughout the clinical phase, and will serve as Sponsor’s main point of contact for technical communications for the duration of the study. The frequency of
communication will be determined at the kick off meeting, at a minimum communication should be scheduled for every other or every week depending on the complexity of the deliverables. In addition Omnicare CR Biometrics Senior Management meet
together on a weekly basis to review staffing needs and forecasting. At this weekly meeting management communicates with individual Project Team leaders to monitor the success factor of the team. 
  

  

	****	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. 

  Page 9 








 IV. Budget 
 A.
Estimated Project Budget 
  

			
	Omnicare CR, Inc. Clinical Budget for:	 	
	Sponsor:	 	Peplin
	Compound:	 	PEP005 0.025%, and 0.05% get
	Study:	 	Multi-centre, randomised, double-blind, double-dummy, parallel-group, vehicle-controlled comparison study to determine the efficacy of PEP005 0.25% and 0.5% get in patients with AK
lesions.
	PCN:	 	KO1601

  

													
	 Services
	  	 Unit
	  	 # Units
	  	 Unit Cost
	  	 Fees (US $)
	  	 Actual Units
Worked
	  	 Actual Revenue
(US$)

	A. Study Management	  		  		  		  		  		  	
	 o Project Director — Americas (assumes ****% FTE)
	  	Days	  	****	  	****	  	****	  	****	  	****
	 o Project Administrative Support/Coordination — Americas (includes support o for all functional areas) (assumes ****%
FTE)
	  	Days	  	****	  	****	  	****	  	****	  	****
	 o Draft Informed Consent Review
	  	Review	  	****	  	****	  	****	  	****	  	****
	   Sub-Total Study Management	  		  		  		  	****	  		  	****
							
	B. Clinical Trial Initiation	  		  		  		  		  		  	
	 o Site Screening and Identification (assumes Peplin will perform this task)
	  		  		  		  		  		  	
	> Zone 1	  	Site	  	****	  	****	  	****	  	****	  	****
	 o Site Recruitment (assumes Peplin will perform this task)
	  		  		  		  		  		  	
	> Zone 1	  	Site	  	****	  	****	  	****	  	****	  	****
	 o Study Master File
	  		  		  		  		  		  	
	 > Americas: **** sites for
 **** months
	  	Site Months	  	****	  	****	  	****	  	****	  	****
	 o Regulatory Document Collection
	  		  		  		  		  		  	

  

  

	****	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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	> Zone1	  	Site	  	****	  	****	  	****	  	****	  	****
	    Central IRB (pass-throughs are estimates only; actual fees will be billed based on specific IRB fees)
	  	Site	  	****	  	****	  	****	  	****	  	****
	    Local IRB (pass-throughs are estimates only; actual fees will be billed based on specific IRB fees)
	  	Site	  	****	  	****	  	****	  	****	  	****
	 o Protocol Amendment — excluding ICF change
	  		  		  		  		  		  	
	> Zone 1	  	Amendments/site	  	****	  	****	  	****	  	****	  	****
	 o Protocol Amendments — including ICF chage
	  		  		  		  		  		  	
	> Zone1	  	Amendments/site	  	****	  	****	  	****	  	****	  	****
	 o Investigator Agreement Negotiation — Standard (actuals will be billed)
	  		  		  		  		  		  	
	> Americas	  	Site	  	****	  	****	  	****	  	****	  	****
	 o Investigator Agreement Negotiation — Complex (actuals will be billed)
	  		  		  		  		  		  	
	> Americas	  	Site	  	****	  	****	  	****	  	****	  	****
	 o Investigator Agreement Amendment — Simple
	  		  		  		  		  		  	
	> Americas	  	Amendments/site	  	****	  	****	  	****	  	****	  	****
	 o Investigator Agreement Amendment — Standard
	  		  		  		  		  		  	
	> Americas	  	Amendments/site	  	****	  	****	  	****	  	****	  	****
	 o Investigator Agreement Amendment — Complex
	  		  		  		  		  		  	
	> Americas	  	Amendments/site	  	****	  	****	  	****	  	****	  	****
	 o Letters of Indemnification (Us sites only)
	  	Site	  	****	  	****	  	****	  	****	  	****
	 o Facility Letters
	  		  		  		  		  		  	
	># Complex Facility Letters	  	Site	  	****	  	****	  	****	  	****	  	****
	># Complex Facility Letters	  	Site	  	****	  	****	  	****	  	****	  	****
	 o Notice Letters
	  	Site	  	****	  	****	  	****	  	****	  	****
	 o IND Safety Report
	  		  		  		  		  		  	
	> Zone 1	  	Reports/Site	  	****	  	****	  	****	  	****	  	****
	 o Investigator Brochure Updates
	  		  		  		  		  		  	
	> Zone 1	  	IB Updates/Site	  	****	  	****	  	****	  	****	  	****

  

  

	****	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. 

  Page 11 









													
	 o   Collect Financial Disclosure at Site Closeout
	  		  		  		  		  		  	
	>Zone 1	  	Site	  	****	  	****	  	****	  	****	  	****
	 o   Vendor/Lab Service Agreements - Americas
	  	Project	  	****	  	****	  	****	  	****	  	****
	 o   Investigators’ Meeting Coordination (pass-through is for investigator travel only-other pass-throughs are indicated below)

	  		  		  		  		  		  	
	      > Coordination, Meeting 1 North America
	  	Meeting	  	****	  	****	  	****	  	Partial	  	****
	      >Per Attendee, Meeting 1 North America
	  	Attendee	  	****	  	****	  	****	  	****	  	****
	 o   Investigators’ Meeting Preparation
	  	Days	  	****	  	****	  	****	  	****	  	****
	 o   Investigators’ Meeting Attendance (OCR attendees x days)
	  		  		  		  		  		  	
							
	Project Director - Americas	  	Days	  	****	  	****	  	****	  	****	  	****
	CTM - Americas	  	Days	  	****	  	****	  	****	  	****	  	****
	Data Manager - Int’l	  	Days	  	****	  	****	  	****	  	****	  	****
	Medical Monitor - Americas	  	Days	  	****	  	****	  	****	  	****	  	****
	Safety Officer - Americas	  	Days	  	****	  	****	  	****	  	****	  	****
	CQA Manager - Americas	  	Days	  	****	  	****	  	****	  	****	  	****
	Project Coordinator	  	Days	  	****	  	****	  	****	  	****	  	****
	Study Initiation Manager	  	Days	  	****	  	****	  	****	  	****	  	****
	Contract Negotiator.	  	Days	  	****	  	****	  	****	  	****	  	****
	Clinical Data Analyst	  	Days	  	****	  	****	  	****	  	****	  	****
	CRA Attendees	  		  		  		  		  		  	
	>Zone 1.**** CRAs	  	Days	  	****	  	****	  	****	  	****	  	****
	Client Attendee Travel	  	Attendee	  	****	  	****	  	****	  	****	  	****
	      Sub-Total Clinical Trial Initiation 
	  		  		  		  	**** 	  		  	**** 

  

  

	****	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. 

  Page 12 









													
	C. Clinical Trial Management	  		  		  		  		  		  	
	  o     Clinical Trial Manager – Americas (assumes ****% FTE)
	  	Days	  	****	  	****	  	****	  	****	  	****
	  o     Clinical Monitoring
	  		  		  		  		  		  	
	>Site Qualification Visit 	  		  		  		  		  	****
	 >Zone 1: **** hrs on-site, **** hrs for prep,
 follow-up, and reports, and **** hrs for travel
	  	Visits	  	****	  	****	  	****	  	****	  	****
	>Site Qualification Phone Screen 	  		  		  		  	****
	 >Zone 1: **** hour phone call: **** hrs for
 prep, follow-up, end report
	  	Call	  	****	  	****	  	****	  	****	  	****
	>Site Initiation Visit         	  		  		  		  		  	****
	 >Zone 1: **** hrs on-site, **** hrs for prep,
 follow-up, and reports, and **** hrs for travel
	  	Visits	  	****	  	****	  	****	  	****	  	****
	>Site Interims Visit         	  		  		  		  		  	****
	 >Zone 1: assume **** visits/site, **** hrs on-
 site, **** hrs for prep, follow-up, and reports,
 and **** hrs for travel

	  	Visits	  	****	  	****	  	****	  	****	  	****
	> Additional Day Interim Visits (based on **** hour day; visits are total per zone; actuals will be billed)
							
	 >Zone 1: assume **** days for Zone pool of
 visits
	  	Visits	  	****	  	****	  	****	  	****	  	****
	>Site Close-out Visit      	  		  		  		  		  	
	 >Zone 1: **** hrs on-site, **** hrs for prep,
 follow-up, and reports and **** hrs for travel
	  	Visits	  	****	  	****	  	****	  	****	  	****
	  o     Site Maintenance for **** hrs/month/site (**** sites x **** enrollment and treatment
months)
	  	
							
	>Zone 1:**** sites	  	Site Months	  	****	  	****	  	****	  	****	  	****
	  o     CRA Monthly Teleconferences
	  		  		  		  		  		  	
	>Zone 1:**** CRAS	  	Months	  	****	  	****	  	****	  	****	  	****

  

  

	****	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. 

  Page 13 









													
	  o      Project Team Training (To be held in conjunction with Investigator
Meeting)
	  		  		  		  		  	
							
	Project Director – Americas 	  	Days	  	****	  	****	  	****	  	****	  	****
	CTM – Americas 	  	Days	  	****	  	****	  	****	  	****	  	****
	Data Manager – Int’l                 	  		  	****	  	****	  	****	  	****	  	****
	Medical Monitor-Americas 	  	Days	  	****	  	****	  	****	  	****	  	****
	Safety Officer – Americas 	  	Days	  	****	  	****	  	****	  	****	  	****
	Project Coordinator 	  	Days	  	****	  	****	  	****	  	****	  	****
	CRA Attendees 	  	Days	  		  		  		  		  	****
	>Zone 1 CRAs:**** CRAs 	  	Days	  	****	  	****	  	****	  	****	  	****
	  o      Sponsor Meeting Attendance (assumes **** face-to-face meeting and **** one-hour
teleconferences, not all positions participate in all meetings; bill on actuals)

							
	Project Director –Americas 	  	Days	  	****	  	****	  	****	  	****	  	****
	CTM-Americas 	  	Days	  	****	  	****	  	****	  	****	  	****
	Data Manager-Int’l 	  	Days	  	****	  	****	  	****	  	****	  	****
	Statistician-Int’l 	  	Days	  	****	  	****	  	****	  	****	  	****
	Sr.Writer-Americas 	  	Days	  	****	  	****	  	****	  	****	  	****
	Project Coordinator 	  	Days	  	****	  	****	  	****	  	****	  	****
	Clinical Data Analyst 	  	Days	  	****	  	****	  	****	  	****	  	****
	Programmer 	  	Days	  	****	  	****	  	****	  	****	  	****
	  o      Project-Kick Off Meeting and **** Internal Team Teleconference Attendance (not all
positions participate in all meetings: bill on actuals)

							
	Project Director –Americas 	  	Days	  	****	  	****	  	****	  	****	  	****
	CTM-Americas 	  	Days	  	****	  	****	  	****	  	****	  	****
	Data Manager-Int’l 	  	Days	  	****	  	****	  	****	  	****	  	****
	Medical Monitor-Americas 	  	Days	  	****	  	****	  	****	  	****	  	****
	Safety Officer – Americas 	  	Days	  	****	  	****	  	****	  	****	  	****
	Statistician – Americas 	  	Days	  		  	****	  	****	  	****	  	****
	Statistician – Int’l 	  	Days	  	****	  	****	  	****	  	****	  	****
	Sr.Writer – Americas 	  	Days	  	****	  	****	  	****	  	****	  	****
	CQA Manager – Americas 	  	Days	  	****	  	****	  	****	  	****	  	****
	Study Initiation Manager 	  	Days	  	****	  	****	  	****	  	****	  	****
	Project Coordinator 	  	Days	  	****	  	****	  	****	  		  	****

  

  

	****	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. 

  Page 14 









													
	Clinical Data Analyst	  	Days	  	****	  	****	  	****	  	****	  	****
	Contract Negotiator	  	Days	  	****	  	****	  	****	  		  	****
	Programmer	  	Days	  	****	  	****	  	****	  		  	****
	 o       Clinical Grants Administration
	  		  		  		  		  		  	
	>Grant Payment Set-up	  		  		  		  		  		  	****
	>Zone 1	  	Sites	  	****	  	****	  	****	  	****	  	****
	 >Grant Management (takes place for active sites from site set-up through **** days after site close out; estimated
amounts; actuals will be billed based on number of active sites set up )

	> Zone 1	  	Site Quarters	  	****	  	****	  	****	  		  	
	 >Payment Processing (estimated based on **** payments/site; actuals, including investigator and site related payment and
any miscellaneous payments. actuals will be billed; pass through costs are related to photocopying and postage)

	>Zone 1:**** sites	  	Payments	  	****	  	****	  	****	  		  	****
	>Estimated Investigator Grants (includes Administrative, Study Coordinator, and Investigator fees; excludes tests in the synopsis that will be performed by the central
laboratory; estimate based upon draft synopsis provided and may change upon review of the final protocol)	  	Patient	  	****	  	****	  	****	  	****	  	
	 o             Refund Checks (if needed; actuals will be
billed)
	  	Refund	  	****	  	****	  	****	  	****	  	****
	 Sub Total Clinical Trial Management
	  		  		  		  	**** 	  		  	**** 
	D. Safety and Medical	  		  		  		  		  		  	
	 o       Medical Monitoring availability during business hours (flat fee of **** hours per
month from first patient in through last patient out)

	>Americas	  	Months	  	****	  	****	  	****	  	****	  	****
	 Greater than **** hours per month will be billed at hourly rate (from first patient in through last patient out); Billed on actuals


	>Americas	  	Hours	  	****	  	****	  	****	  	****	  	****

  

  

	****	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. 

  Page 15 









													
	 o Medical Monitoring during Study Start Up and Study Close-out (Billed on actuals)
	> America 	  	Hours	  	****	  	****	  	****	  	****	  	****
							
	  o      Safety Coordinator
	  		  		  		  		  		  	
	 >Americas — assumes ****day per
 month for **** months 
	  	Days	  	****	  	****	  	****	  	****	  	****
	  o      SAE Reporting (with initial descriptive summary) Billed on actuals 
	  	Report	  	****	  	****	  	****	  	****	  	****
	  o      Sponsor Requested Follow Up
	  	Report	  	****	  	****	  	****	  	****	  	****
	  o      ****
	  		  		  		  		  		  	
	>Project Set-up 	  	Project	  	****	  	****	  	****	  	****	  	****
	 >Monthly Database Maintenance
 (first patient in to database
 close) 
	  	Month	  	****	  	****	  	****	  	****	  	****
	>Data Entry into **** (actuals will be billed) 	  	SAE	  	****	  	****	  	****	  	****	  	****
	  o      Medical Review of Protocol (bill on actuals)
	  	Days	  	****	  	****	  	****	  	****	  	****
	  o      Sub-Total Safety and Medical 
	  		  		  		  	**** 	  		  	**** 
							
	 E. Clinical Data Management 
	  		  		  		  		  		  	
	  o     Clinical Data Management Oversight — Int’l ( CDM Manager assumes ****% FTE x **** months for
Start-up, ****% FTE for **** months for Duration, and ****% FTE for **** months for close-out)
	  	Days	  	****	  	****	  	****	  	****	  	****
	  o     Lead CDA — Int’l (assumes ****% FTE x **** months, ****% FTE x **** months, and ****% FTE for ****
months)
	  	Days	  	****	  	****	  	****	  	****	  	****
	  o     Development of Data Management Plan (includes **** major and **** minor revision; add’l revisions will be
billed at per diem rates)
	  	Days	  	****	  	****	  	****	  	****	  	****

  

  

	****	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. 

  Page 16 









													
	 o CRF Design (assumes **** page CRF, **** unique CRF pages); includes **** major and **** minor revision
	  	Project	  	****	  	****	  	****	  	****	  	****
	 o Database Development, Testing and Maintenance (assumes **** page CRF, **** unique CRF pages)
	  	Project	  	****	  	****	  	****	  	****	  	****
	 o Estimated Data Entry (actuals will be billed)
	  		  		  		  		  		  	
							
	>Pages in Int’l	  	Pages	  	****	  	****	  	****	  	****	  	****
	 o Estimated Data Review and Query resolution (assumes **** issue per **** CRF pages, **** manual checks and the application of
**** study assumption for **** CRF pages); assumes **** CRF pages per enrolled patient, **** pages per screen failure patient and **** pages per drop out patient. Pages will be billed on actuals

	>CRF Pages	  	Page	  	****	  	****	  	****	  	****	  	****
	 o Quality control check — critical items
	  	Patient	  	****	  	****	  	****	  	****	  	****
	 o Quality control check — full case
	  	Patient	  	****	  	****	  	****	  	****	  	****
	 o Edit Development (actuals will be billed
	  	Edits	  	****	  	****	  	****	  	****	  	****
	 o CRF Tracking (includes all ancillary pages; actuals will be billed)
	  	Page	  	****	  	****	  	****	  	****	  	****
	 o Dictionary Med remapping — ATC Meds (actuals will be billed)
	  	Term	  	****	  	****	  	****	  	****	  	****
	 o Dictionary Coding of Adverse Event terms to MedDRA (estimated to be **** per patient; actuals will be billed)
	  	Term	  	****	  	****	  	****	  	****	  	****
	 o Dictionary Coding of Medication Terms (estimated to be **** per patient; actuals will be billed)
	  	Term	  	****	  	****	  	****	  	****	  	****
	 o External Vendor — Initial Load (actuals will be billed)
	  		  		  		  		  	
	Initial Load	  	Load	  	****	  	****	  	****	  	****	  	****
	>Subsequent Load (actuals will be billed)	  	Loads	  	****	  	****	  	****	  	****	  	****

  

  

	****	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. 

  Page 17 









													
	Lab visit Verification (****	  	                Visits	  	****	  	****	  	****	  	****	  	****
	visits x **** patients;	  		  		  		  		  		  	
	actuals will be billed)	  		  		  		  		  		  	
	 o          Reconciliation of the Safety
	  	SAE	  	****	  	****	  	****	  	****	  	****
	 and Clinical Database
	  		  		  		  		  		  	
	 (actuals will be billed)
	  		  		  		  		  		  	
	 o          Protocol Deviation Log Load
	  	Project	  	****	  	****	  	****	  	****	  	****
	 Sub-Total Clinical Data Management 
	  		  		  		  	**** 	  		  	****
	 F. Biometrics Analysis 
	  		  		  		  		  		  	
	 o          Biometrics Team Manager
	  	Days	  	****	  	****	  	****	  	****	  	****
	 o          Project Data Setup
	  	Project	  	****	  	****	  	****	  	****	  	****
	 o          Statistical Plan
	  	Project	  	****	  	****	  	****	  	****	  	****
	 o          Randomization Schedule
	  	Project	  	****	  	****	  	****	  	****	  	****
	 o          Design of Table Shells (Mocks)
	  	Project	  	****	  	****	  	****	  	****	  	****
	 o          Programming/QC of Data Displays (actuals will be
billed).
	  		  		  		  		  	
	Unique Tables 	  	Table	  	****	  	****	  	****	  	****	  	****
	Repeat Tables 	  	Table	  	****	  	****	  	****	  	****	  	****
	Unique Listings 	  	Listing	  	****	  	****	  	****	  	****	  	****
	Repeat Listings 	  	Listing	  	****	  	****	  	****	  	****	  	****
	 o          Programmatic Evaluability / Outcome
	  		  		  		  		  		  	
	 o
                                         
        >Regular or Advanced 
	  	Project	  	****	  	****	  	****	  	****	  	****
	 o          Statistical Analysis
	  		  		  		  		  		  	
	 o                                        
                                 >Regular 
	  	Project	  	****	  	****	  	****	  	****	  	****
	 o          FDA Item 11
	  	Project	  	****	  	****	  	****	  	****	  	****
	 o          Standard Data Transfer
	  		  		  		  		  		  	
	>Initial 	  	Transfer	  	****	  	****	  	****	  	****	  	****
	>Add’l datasets will be billed @ $**** Euro per dataset 	  		  		  	
	Add’l Stats consulting, meeting attendance, etc., will be charged at per diem rates as follows:	  		  		  	
	Team Leader 	  	Days	  		  	****	  		  		  	
	Statistician 	  	Days	  		  	****	  		  		  	
	Programmer 	  	Days	  		  	****	  		  		  	
	 Sub-Total Biometrics 
	  		  		  		  	**** 	  		  	**** 

  

  

	****	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. 

  Page 18 









													
	G. Clinical Writing	  	All assumes using OCR SOPs. If using Sponsor SOPs/templates, all CW is custom priced
	 o       Clinical Study Report
	  		  		  		  		  		  	****
	Phase ll/lll Report 	  	Report	  	****	  	****	  	****	  	****	  	****
	> includes **** major (up to **** 	  		  		  		  		  		  	
	days) and **** minor (up to **** 	  		  		  		  		  		  	
	day) revision 	  		  		  		  		  		  	
	> assumes up to **** tables and 	  		  		  		  		  		  	
	**** listing provided for 	  		  		  		  		  		  	
	summarization> assumes OCR 	  		  		  		  		  		  	
	SOPs and CSR template 	  		  		  		  		  		  	
	> fee does not include CSR 	  		  		  		  		  		  	
	appendices (including TLs) 	  		  		  		  		  		  	
							
	>Tables (greater than ****) 	  	Report	  	****	  	****	  	****	  	****	  	****
	 o       Narratives (actuals will be billed) 
	  	Narrative	  	****	  	****	  	****	  	****	  	****
	 o       Clinical Writing Input to SAP
	  	Project	  	****	  	****	  	****	  	****	  	****
	 Attendance at Sponsor Requested Meetings:
	  		  		  		  		  		  	
	 Attendance at Sponsor requested meetings (teleconferences/video conferences or client review/planning meetings at
Sponsor/Omnicare CR, Inc.) will be billed to Sponsor according to the following per diem rates:
	  		  	
	 Director 
	  	****	  		  		  		  		  	
	 Senior Writer 
	  	****	  		  		  		  		  	
	 Clinical Writer 
	  	****	  		  		  		  		  	
	 Sponsor will be billed for actual time expended.
	  		  		  		  		  		  	
	 Sub-Total Clinical Writing 
	  		  		  		  	**** 	  		  	****
							
	H. Technology	  		  		  		  		  		  	
	 o       OmnieView
	  		  		  		  		  		  	
	>Set-up 	  	Site	  	****	  	****	  	****	  	****	  	****
	>Monthly Maintenance 	  	Months	  	****	  	****	  	****	  	****	  	****
	 Sub-Total Technology 
	  		  		  		  	**** 	  		  	****
	I. Regulatory Services	  		  		  		  		  		  	
	 o       CRF Filing and Reconciliation (bill on actuals)
	  	Pages	  	****	  	****	  	****	  	****	  	****
	 o       Return of CRF (hard copy): bill on actuals
	  	Pages	  	****	  	****	  	****	  	****	  	****
	 o       Return of Investigator and Study-Wide Documents (paper)
	  	Sites	  	****	  	****	  	****	  	****	  	****

  

  

	****	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. 

  Page 19 









													
	 o       Regulatory Site Drug Release Approval
	  	# Sites	  	****	  	****	  	****	  	****	  	****
	 o       Compilation of Clinical Study Report Appendices (electronic copy)
	  		  		  		  		  	
	>Setup and Management Fee	  	Report	  	****	  	****	  	****	  	****	  	****
	 >Scanning (without cleaning); actuals will
 be billed
	  	Pages	  	****	  	****	  	****	  	****	  	****
	>Scanning and cleaning; actuals will be billed	  	Pages	  	****	  	****	  	****	  	****	  	****
	 >Volumes (fee does not include hyper-linking);
 actuals will be billed
	  	Volume	  	****	  	****	  	****	  	****	  	****
	 Sub-Total Regulatory Services
	  		  		  		  	**** 	  		  	****
							
	J. Clinical Quality Assurance	  		  		  		  		  		  	
	 o       Quality Plan
	  	Days	  	****	  	****	  	****	  	****	  	****
	 o       CQA Site Audits — includes preparation and travel time, audit time, audit follow-up, and Audit
Report and Audit Certificate generation
	  		  		  		  		  		  	
	>Assumes **** sites in Americas	  	Sites	  	****	  	****	  	****	  	****	  	****
	 o       Contract Provider Audits
	  	Site	  	****	  	****	  	****	  	****	  	****
	 o       Pre-Regulatory inspection Audits
	  	Audit 	  	****	  	****	  	****	  		  	****
	 Sub-Total Clinical Quality Assurance
	  		  		  		  	**** 	  		  	****
							
	K. Clinical Supplies management	  		  		  		  		  		  	
	 o       Receipt and Inventory of Study Drug (Americas)
	  	Per **** patients	  	****	  	****	  	****	  	****	  	****
	 o       Receipt and Inventory of Study Drug (Americas)
	  	Batch	  	****	  	****	  	****	  	****	  	****
	 o       Storage of study drug (Americas) storage conditions refrigerated (2 ° C-8 ° C)
	  	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. 

  Page 20 









													
	  o Shipment Preparation and shipping of Study Drug to sites in Americas. Shipping conditions: refrigerated (2 o C-8 o C), **** sites,
**** shipments per site (Pass through includes insulated shipping container and temperature recorder. Peplin must supply a qualified shipping container or a qualification can be done at an extra fee.)
	  	Shipment	  	****	  	****	  	****	  	****	  	****
	  o Manage general Study drug Issues (Americas) **** days per month
	  	Month	  	****	  	****	  	****	  	****	  	****
	  o Project meetings with Pharmacist’s attendance
	  	Day	  	****	  	****	  	****	  	****	  	****
	  o Receipt of Returned Drug Americas (x receipts per site, x sites)
	  	Receipt	  	****	  	****	  	****	  	****	  	****
	  o Storage of returned drug at room temperature (Americas)
	  	Month	  	****	  	****	  	****	  	****	  	****
	  o Return of study drug to Sponsor or Certified Destructor (incl. provision of Certificate of destruction)
	  	Destruction run	  	****	  	****	  	****	  	****	  	****
	  o Final reconciliation (Americas)
	  	Day	  	****	  	****	  	****	  	****	  	****
	    Sub-Total Clinical Supplies Management 
	  		  		  		  	**** 	  		  	**** 
							
	 L. Miscellaneous Pass-Through Expenses 
	  		  		  		  		  		  	
	    Sub-Total Miscellaneous Pass Through Expenses 
	  		  		  		  		  		  	**** 
							
	 Estimated Services Budget 
	  		  		  		  	**** 	  		  	**** 
	 Estimated Pass Through 
	  		  		  		  		  		  	**** 
	 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 21 








 B. Payment Schedules 
 1. Invoicing Process for Service Fees 
 Omnicare CR maintains a project accounting system, whereby all direct project costs (Service Fees or
Pass-Through Expenses) are coded by project. 
 Payments for actual Service Fees provided as outlined in the above budget (minus any Service Fee payments made
under the letter of intent dated January 16, 2006) shall be due and payable in US Dollars upon execution of this Exhibit H and upon submission of an invoice to Sponsor by Omnicare CR. Subsequent payments shall be made monthly, based on
Project progress and upon submission of an invoice to Sponsor by Omnicare CR. All payments shall be processed within **** days. If any payment of Service Fees or Pass-Through Expenses is late by more than **** (****) days, such payment
shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
 2. Pass-Through Expense Invoicing 
 Omnicare CR’s project accounting system is able to capture and categorize in summary the following key Pass-Through Expenses related to a project: 
  

	•	 	 Travel 


  

	•	 	 Delivery costs 


  

	•	 	 CRF and other printing or copying costs 


  

	•	 	 Investigator Meeting costs 


  

	•	 	 Telecommunication costs (which may include telephone, fax, pager, conference calls, or PC connectivity charges) 


 All other project related expenses that are not related to Service Fees and any additional detail to support Pass-Through Expenses will be provided on a fee basis.

 Payments for Pass-through expenses incurred (minus any Pass-through expense payments made under the letter of intent dated January 16, 2006) shall be
due and payable upon execution of this Exhibit H and upon submission of an invoice to Sponsor by Omnicare CR. Subsequent payments shall be made monthly, based on Project progress and upon submission of an invoice to Sponsor by Omnicare CR

 3. Payments 
 Sponsor shall make payment directly to the
following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Wachovia Bank 
 ABA # **** 
 Acct # **** 
  

  

	****	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. 

  Page 22 








 4. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary, the estimated Service Fees set forth in this Exhibit H shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining
Services under this Exhibit H as of each ****; such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 V. Signatory Authority 
 The parties acknowledge and agree that Sponsor has authorized Omnicare CR to execute Clinical
Study Agreement with investigators in the Project on the behalf of Sponsor. Sponsor understands and acknowledges that it will be bound by the terms of the investigator agreements. 
 ACCEPTANCE 
 The terms and conditions of the Master Agreement govern this Exhibit H and such document is
incorporated herein by reference as if fully set forth herein. 
 BY AND BETWEEN: 
  

											
	 Peplin Operations Pty Ltd.
	 		 	 Omnicare CR, Inc.
	 	
						
	 BY:
	 	 /s/ Michael Aldridge
	 		 	BY:	 	 /s/ Dale Evans
	 	


											
						
	 Name:
	 	Michael Aldridge	 		 	Name:	 	Dale Evans	 	


											
						
	 Title:
	 	Director	 		 	Title:	 	CEO	 	


											
						
	 Date:
	 	10 Oct 06	 		 	Date:	 	10/24/06	 	

 (SEAL) 
  

  

	****	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. 

  Page 23 








 Exhibit I to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated June 1, 2005. 
 THIS EXHIBIT
I is entered into this 21st day of June 2006, by and between Peplin Operations Pty Ltd. (hereinafter “ Sponsor “)
and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a Clinical Services
Master Agreement, dated June 1, 2005 (hereinafter the “Master Agreement”), wherein Omnicare CR agreed to provide clinical services; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate
Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate
Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR shall provide the services set forth in this
Exhibit I, subject to the terms and conditions set forth in the Master Agreement; 
 NOW, THEREFORE, for good and valuable
consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 I. Project Plan 
 Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for Sponsor’s “A multi-center, randomized, double-blind,
double-dummy, vehicle-controlled sequential cohort study to determine the safety of PEP005 0.025% and 0.05% topical gel in patients with actinic keratoses” (hereinafter “the Project”) and associated costs. Changes made in the Project
scope, at any time during the Project, will result in a corresponding adjustment to the Project costs. 
 II. Project Timeline 
 The parties acknowledge and agree that Omnicare CR commenced performance of the Services under the letter of intent dated May 25, 2006. The projected timeline for
this Project is as follows: 
  

  

	****	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. 

  Page 1 









					
	 Major Milestones
	 	 	  	 Projected Timeline

	 Study Start
	 		  	****
	 First Patient In
	 		  	****
	 Last Patient In
	 		  	****
	 Last Patient End of Treatment
	 		  	****
	 Last CRF to Data Management
	 		  	****
	 Database Close
	 		  	****
	 Statistical Analysis
	 		  	****
	 Study Close/Report
	 		  	****
	 Total Study Duration
	 		  	****

 III. Omnicare CR Services 
 Services provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the Project specifications provided by Sponsor, and are outlined below. It should be noted, however, that
the timeline and costs presented in this budget for these services are estimated pending review of the final specifications, protocol and case report form (CRF). 
 A. Study Management 
 Project Director 
 The Project Director will act as a single point of contact for the Sponsor during the course of this study. The Project Director is responsible for the generation of detailed project timelines and ensures that these
milestones are met. The Project Director will provide on-going project status reports as directed by the Sponsor and will proactively identify and resolve critical project issues. The Project Director is also responsible for managing the study
budget and addresses all out-of-scope items with the Sponsor. 
 Clinical Trial Manager 
 The Clinical Trial Manager will be dedicated to managing the day-to-day clinical trial activity. The Clinical Trial Manager is responsible for overseeing all site and
clinical research associate (CRA) activity for the Project. The Clinical Trial Manager is also responsible for developing case report form completion and monitoring guidelines; overseeing regulatory document management for each investigational
site and for reviewing and tracking the Project CRA activities which include the scheduling of site visits, site visit reports, monitoring logs and follow-up correspondence. 
 Project Administrative Coordination 
 The Project
Coordinator provides the necessary administrative support to the Project Director and to the rest of the Project Team with all administrative related tasks. 
  

  

	****	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. 

  Page 2 








 Draft Informed Consent Review 
 The Omnicare CR Project Management Team will review the draft of the Informed Consent and will evaluate whether it is in accordance with IRB and Ethic committee requirements. The Project Management Team will provide
feedback to Sponsor as required. 
 B. Clinical Trial Initiation 
 Setup & Maintenance of Study Master File 
 Omnicare CR will establish and maintain the Study Master File in
accordance with Omnicare CR’s Standard Operating Procedure (SOP). The study wide, individual investigator files, and patient CRFs will be maintained in a locked, limited access, controlled file room. 
 Investigator Document Plan 
 An Investigator Document
Plan will be developed for the Sponsor. The purpose of the Investigator Document Plan is to define the project-specific review criteria for essential documents, the investigational product shipment approval procedure, the investigator site binder
content and essential document file maintenance. 
 Investigator Essential Document Management-Regulatory Document Collection

 Once Sponsor has signed the Investigator Documentation Plan, essential document packages, with letters of instruction, will be mailed to qualified
investigative sites. Document collection will cover all criteria required under the principles of Good Clinical Practices (GCP) and International Committee for Harmonization (ICH) guidelines, as well as Omnicare CR SOPs. 
 Omnicare CR will track the retrieval of documents on an ongoing basis and provide updates to Sponsor as requested. The fee for essential document collection, processing,
and tracking is based upon the number of sites required for the Project. All sites that drop from the study for any reason will be billed based on percentage of work completed prior to notification of the drop. A submission ready regulatory document
package for each investigator will be forwarded to Omnicare CR Regulatory prior to drug shipment and site initiations. Omnicare CR Regulatory will review the packages. 
 Once all essential documents and approvals are received, the essential documents are copied and an Investigator Site File is created. An Investigator Site File Binder will be sent to each investigator. 
 IRB Submissions 
 Omnicare CR will work with
investigational sites, Sponsor and the IRBs to obtain regulatory approval for sites participating in this study. Omnicare CR will submit to the Central IRB on behalf of those sites using the Central IRB. 
  

  

	****	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. 

  Page 3 








 Protocol Amendments and IND Safety Reports and Investigator Brochure Updates 
 Protocol amendments will be billed at an additional processing fee. IND safety reports and revised Investigator Brochures will be sent to sites at an additional fee.

 Regulatory Document Renewals and Updates — Annual Site Maintenance 
 Throughout the study, Omnicare CR will collect updated essential documents. The updating of essential documents (medical licenses, lab certifications, and changes to FDA
form 1572 fee will be based on the site’s date of drug shipment through the site’s first IRB re-approval date. For studies lasting greater than one year, the annual renewal and update fee will be charged based on the site’s subsequent
IRB re-approval dates. 
 Investigator Agreement Negotiation 
 Omnicare CR will be responsible for the following activities related to negotiating the investigator agreements: 
  

	 	•	 	 Create all investigator agreement templates and patients budget template with the Sponsor 


  

	 	•	 	 When possible, set up pre approved alternative language and budget parameters in anticipation of site negotiation 


  

	 	•	 	 Negotiate all investigator agreements that satisfy Sponsor requirements on behalf of the Sponsor 


  

	 	•	 	 Incorporate changes using pre-approved alternative parameters and if changes are outside parameters and secure approval by the Sponsor



  

	 	•	 	 Obtain signatures from investigators, institutions, facilities, site management organizations on all investigator agreements as needed



  

	 	•	 	 Collect IRS Form W9 and payment information sheets from sites 


  

	 	•	 	 Track documentation and communication between the sites, Omnicare CR Project Management and the Sponsor. 


 Agreement Negotiation for Institutional Sites 
 Omnicare CR will also be responsible for the above activities related to negotiating the investigator agreements for academic medical centers and large hospitals. Negotiation of investigator agreements for these types of sites tends to be
very involved due to legal staff at these institutional sites reviewing and negotiating the investigator agreements. 
 Investigator
Agreement Amendments 
 Protocol and study amendments, which require investigator agreement revisions, amendments and/or re-negotiation, will be billed as
needed at an additional processing fee per unit. (See budget.) 
 Facility Letters and other Investigator Notices 
 Facility letters are shortened versions of the investigator agreements intended to apprise the facilities where study procedures are going to be performed that a study is
taking place on their premises. A facility letter also outlines duties and obligations of the facility during the course of the study. Facility letters are used when investigators have privileges at one Institution where 

  

  

	****	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. 

  Page 4 








 
most of the study procedures are performed and grant payments are sent but some other procedures will occur at another facility. Facility letters are also
common when investigators are affiliated with SMOs. If an SMO is involved and the Institution refuses to be apart of the main agreement, the facility where the study will be performed will accept and sign the facility letter. Facility letters are
billed as noted in the budget. Facility letters are created, negotiated, and tracked like investigator agreements. 
 Examples of miscellaneous investigator
notices and documentation are: termination letters, transfer letters, or any notices related to the Protocol that affects the agreements. Notices without any negotiation and without site signature involved will be billed as noted in the budget.
These notices involve drafting the template, tailoring the templates for each site, preparing them for delivery, and sending to the sites. If additional work is required such as follow-up or negotiation these will be billed at the amendment letter
rate per unit. 
 Letters of Indemnification 
 Letters of Indemnification are often required by sites to be on Sponsor letterhead and signed by the Sponsor outlining how they will be indemnified and what they are indemnifying for during the course of a study. The letters of
indemnification are negotiated and issued as needed and site and Sponsor signature is obtained. Letters of Indemnification are created, negotiated and tracked like investigator agreements. 
 Vendor Service Agreements 
 Vendor Agreements are
separate agreements between a vendor and Omnicare CR on behalf of the Sponsor. Vendor agreement terms and conditions are negotiated separately from investigator agreements and related documents. 
 Project Team Training 
 Omnicare CR, in conjunction
with the Sponsor, will provide specific therapeutic area training and orientation to the protocol and the CRF prior to study initiation and on an ongoing basis. This training will be designed to ensure that all Team members are familiar with the
Project requirements and their role within the Team. Items discussed at these meetings will include, but will not be limited to: 
  

	 	•	 	 Therapeutic are and clinical development background 


  

	 	•	 	 Protocol and CRF 


  

	 	•	 	 Discussion of therapeutic implications for this study 


  

	 	•	 	 Monitoring guidelines 


  

	 	•	 	 Data handling rules from Data Management Plan 


 Investigator’s Meeting Coordination 
 Omnicare CR’s Meetings Coordinator will coordinate arrangements
associated with the investigators’ meeting(s) for the Project. Omnicare CR’s Meetings’ Coordinator has extensive experience in conducting investigators’ meetings, including but not limited to, organizing and scheduling the
meeting, making cost-effective travel arrangements for participants, and providing on-site coordination services. 
  

  

	****	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. 

  Page 5 








 The Meeting Coordinator will manage all logistics of the meeting including: 
  

	 	•	 	 Identify appropriate location(s) for the meeting 


  

	 	•	 	 Negotiate, organize, and make hotel arrangements (e.g. meeting space and lodging) 


  

	 	•	 	 Secure discounted travel arrangements and issue tickets to investigators and study coordinators 


  

	 	•	 	 Prepare meeting materials (e.g. Welcome letters/packets, and name badges) 


  

	 	•	 	 Arrange meal functions and off-site events 


  

	 	•	 	 Manage administrative aspects associated with the meeting 


  

	 	•	 	 Provide on-site assistance at the meeting (the coordinator will arrive at the location prior to the meeting and will stay after the meeting to manage any
outstanding arrangements such as shipping meeting materials 


  

	 	•	 	 Provide post meeting service including reconciliation of outstanding meeting bills 


 Investigators’ Meeting Preparation 
 The Omnicare
CR Project Team will prepare slides, educational handouts, meeting materials, etc. according to Omnicare CR’s plan for training investigators to successfully conduct this study. 
  

	 	•	 	 Assist in defining meeting requirements and outlining a meeting agenda 


  

	 	•	 	 Preparing necessary meeting materials (e.g., annotated CRFs, presentation materials, etc.) 


  

	 	•	 	 Coordinating presentations 


  

	 	•	 	 Conducting presentations and/or workshops on protocol, CRF, study conduct issues, and reporting of serious adverse events 


 Investigators’ Meeting Attendance 
 Omnicare
CR’s clinical trial management staff assigned to the Project will be available on-site to assist during the meeting. They will arrive at the location prior to the meeting to assist Omnicare CR and/or attendees with any last minute details that
may arise. 
 C. Clinical Trial Management 
 CRA activities and Site Responsibilities 
 Omnicare CR CRAs perform comprehensive site management and monitoring activities to include the
following types of monitoring visits: 
  

	 	•	 	 Pre study selection visits 


  

	 	•	 	 Initiation visits 


  

	 	•	 	 Interim monitoring visits 


  

	 	•	 	 Close out visits 


 All activities are
performed in accordance with ICH-GCP guidelines to ensure all investigational sites are compliant with all applicable regulations and protocol requirements. 
  

  

	****	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. 

  Page 6 








 The paramount responsibility of Omnicare CR CRAs is to ensure patient rights, safety and data integrity. This is
accomplished through ongoing review of the following: 
  

	 	•	 	 Informed consent process 


  

	 	•	 	 IRB/IEC approval 


  

	 	•	 	 Ensuring proper AE and SAE reporting and documented follow up 


  

	 	•	 	 Adherence the protocol 


  

	 	•	 	 100% source documentation verification and data query clarification 


  

	 	•	 	 Investigational product administration and accountability 


  

	 	•	 	 Protocol Compliance 


  

	 	•	 	 Site training and support 


 Omnicare CR CRAs
ensure ongoing site compliance via the continual review of the following: 
  

	 	•	 	 Site staff qualifications and experience 


  

	 	•	 	 Site staffing, facilities, storage and equipment 


  

	 	•	 	 Accessibility and eligibility of subjects 


  

	 	•	 	 Review and retrieval of regulatory documents (i.e. FDA 1572, protocol signature page, curricula vitae, medical licenses, certification of investigators’
financial disclosure, etc.) 


  

	 	•	 	 Accurate and timely completion of all CRF and source data 


 In addition to on-site responsibilities, each CRA is responsible for site management documentation and follow-up activities to ensure that site staff remains motivated and focused. These activities include the
following: 
  

	 	•	 	 Site Visit Report and follow-up letters 


  

	 	•	 	 Providing site training and support through communications 


  


	 	•	 	 Generation of status reports 


  

	 	•	 	 Maintenance of tracking tools/logs 


  

	 	•	 	 Facilitation of DCF resolution 


 Omnicare CR
CRAs complete comprehensive site visit reports and follow-up letters which are provided to the Omnicare CR Project Management Team within 10 working days of the visit however all urgent issues are immediately reported to Project Management. The
visit reports provided by the CRAs include detailed action plans for all issues identified and all issues are tracked through to resolution. 
 Site Qualification (Pre-Study Visits and Phone Calls) 
 Omnicare CR’s site management and monitoring procedures will be performed in
accordance with ICH-GCP guidelines to ensure each investigative site’s compliance with regulations and protocol requirements, and to enhance expeditious enrollment of appropriate patients into the clinical study. Regulatory documents will be
reviewed by the CRA on an ongoing basis during the study conduct phase, including verification of signed informed consent forms and investigator IRB notifications. 
 The Omnicare CR CRA will review the following information at the pre-study site visit: 
  

	 	•	 	 Latest version of the Protocol for this study 


  

	 	•	 	 Consent form process 


  

	 	•	 	 AE and SAE reporting procedures and contact information 


  

  

	****	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. 

  Page 7 









	 	•	 	 Case report form completion and maintenance 


  

	 	•	 	 Source documentation requirements 


  

	 	•	 	 Drug accountability requirements 


 In
addition, to ascertain that an identified investigational site is qualified to perform this study to Omnicare CR’s expectations, the CRA will review the following issues at the study site and report this “study profile” in a site
visit report to Omnicare CR and the Sponsor: 
  

	 	•	 	 Principal investigator qualifications and experience 


  

	 	•	 	 Site staffing, facilities, storage and equipment 


  

	 	•	 	 Adequacy of and accessibility to subject population 


  

	 	•	 	 Access to source documentation 


  

	 	•	 	 Status of regulatory documentation (i.e. FDA 1572, protocol sign-off page, curricula vitae, medical licenses, certification of investigators’ financial
disclosure, etc.) 


  

	 	•	 	 IRB and ethics committee issues 


  

	 	•	 	 Laboratory and pharmacy certifications and normal ranges (if applicable) 


  

	 	•	 	 Investigator agreement and indemnification issues 


  

	 	•	 	 Recommendations for investigational site approval or exclusion from the study 


 Sites that have recently had a pre-study site visit performed by the Sponsor or have worked with Omnicare CR in the preceding 12 months may be exempt from a
pre-study site visit. The Sponsor will provide Omnicare CR with a list of any exempt investigators for this study. 
 Site Initiation 

 Once all regulatory documents and approvals are received, a site initiation visit will be scheduled. During this visit, the CRA will review the following
with the principal investigator and his/her staff as appropriate: 
  

	 	•	 	 Study goals and obligations 


  

	 	•	 	 Investigator brochure 


  

	 	•	 	 Protocol procedures with particular attention to inclusion/exclusion criteria, enrollment goals, adverse events, primary efficacy variables and GCP
compliance) 


  

	 	•	 	 Informed consent procedure 


  

	 	•	 	 Randomization procedure 


  

	 	•	 	 AE/SAE reporting 


  

	 	•	 	 CRF completion and error correction/need for adequate source documentation 


  

	 	•	 	 Maintenance of the investigator binder and site visit log 


  

	 	•	 	 Laboratory sample/photography sample handling procedures and results reporting procedures 


  

	 	•	 	 Clinical supply dispensation, accountability and storage procedures 


 Site Interim Visits 
 Omnicare CR CRAs will perform
100% source document verification of CRF data for accuracy and completeness. CRFs will be retrieved during each monitoring visit. Pages and information for patients who fail screening will be reviewed and monitored. 
  

  

	****	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. 

  Page 8 








 The following issues are addressed at each interim visit as appropriate: 
  

	 	•	 	 Source document verification 


  

	 	•	 	 CRF completion 


  

	 	•	 	 Expedient data retrieval and query resolution 


  

	 	•	 	 Drug accountability 


  

	 	•	 	 Check and review of the regulatory binder and its contents 


  


	 	•	 	 Clinical supply inventory 


  

	 	•	 	 SAE reporting 


  

	 	•	 	 Enrollment issues and targets 


  

	 	•	 	 Protocol amendments 


  

	 	•	 	 Significant protocol deviations 


  

	 	•	 	 Acceptability of facilities 


  

	 	•	 	 Personnel changes 


  

	 	•	 	 Updated regulatory documentation 


  

	 	•	 	 Laboratory sample/photography sample handling 


 Following each monitoring visit, Omnicare CR will complete follow-up letters and site visit reports within two weeks of each visit. These follow-up letters and monitoring reports will be available to the Sponsor via Omnieview. 

Site Closeouts 
 At the conclusion of the study,
after all completed CRFs have been returned to Omnicare CR for logging and tracking, and after all unused CRF binders have been returned to Omnicare CR for destruction, the Omnicare CR CRA will perform a close-out visit. 
 The following issues are evaluated and/or reviewed with the investigator and his/her staff at the close-out visit: 
  

	 	•	 	 Reason for termination (if study is not complete) 


  

	 	•	 	 Reconciliation and removal of clinical supplies per The Sponsor’s requirements (including hazardous materials) 


  

	 	•	 	 All original CRFs retrieved from the site at the previous visit 


  

	 	•	 	 Signed informed consents retained by investigator 


  

	 	•	 	 Record retention requirements 


  

	 	•	 	 Notification to IRB or ethics committee of study termination 


  

	 	•	 	 Collection of randomization codes for return to The Sponsor 


  

	 	•	 	 Resolution of all data queries 


  

	 	•	 	 Investigator binder contents (complete and updated) 


  

	 	•	 	 Informed consent log 


  

	 	•	 	 Financial agreements and disclosure (filed separately) 


  

	 	•	 	 Signature log and screening log 


  

	 	•	 	 Site visit and subject enrollment log 


  

	 	•	 	 Laboratory certification and renewals 


  

	 	•	 	 Summary/discussion of study from investigator and/or staff 


  


  

	****	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. 

  Page 9 








 Site Maintenance 
 Omnicare CR maintains a minimum of bi-weekly contact with investigational sites via telephone, facsimile, e-mail and/or mail correspondence, based on the requirements of each investigational site. 
 Activities that are performed in-house between monitoring visits include, but are not limited to: 
  

	 	•	 	 Discussion of study protocol and any amendments to the protocol 


  

	 	•	 	 Inclusion/exclusion questions or issues 


  

	 	•	 	 Review of clinical laboratory results 


  

	 	•	 	 New staff or team member orientation 


  

	 	•	 	 Additional site training 


  

	 	•	 	 Clinical supply activities or issues 


  

	 	•	 	 Enrollment updates (via weekly fax updates) 


  

	 	•	 	 AE and SAE updates 


  

	 	•	 	 Data query resolution 


  

	 	•	 	 Scheduling activities 


 Included in Site
Maintenance activities, Omnicare CR CRAs will assist the Sponsor in resolving data queries for data from investigational sites, which are unclear, conflicting or incomplete. 
 CRA Teleconferences 
 Omnicare CR’s CRAs will
participate in conference calls with the Sponsor as warranted by the Project. 
 Sponsor Meeting Attendance 
 Omnicare CR assigned Project Team will attend face-to-face meetings with the Sponsor’s clinical team throughout the Project. 
 Clinical Grants Administration 
 Omnicare CR’s
Investigator Grant staff will administer the clinical grant payments to the site. Included in their responsibilities are following: 
  

	 	•	 	 Processing financials records for all of the patients in the study 


  

	 	•	 	 Issue initial and interim payments for each investigator 


  

	 	•	 	 Reconciling all payments to each of the investigators prior to final payments 


  

	 	•	 	 Tracking account administration with Omnicare CR’s finance group 


  

	 	•	 	 Maintaining IRS W-9 forms and all relevant and government reports 


  

	 	•	 	 Reporting excess grants from sites at study end 


 Activities included in Clinical Grants Administration include the following: 
  

  

	****	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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 Investigator Grant Start-up Administration 
 Investigator Grant Start up Administration includes two activities: Contract Review which includes protocol/contract evaluation, investigator/site budget drafting, and
telephone contact with the investigator and Grant Set-up which involves evaluating and entering site specific information. Confirm with the site representative(s) the correct name of the payee and that the site representative(s) understand how
payments will be made. Identify correct payee by verifying contract information with IRS W-9 and site profile; follow-up calls and correspondence may be needed to clarify discrepancies. Set-up directories, site, and study specific spreadsheets to
perform the tracking payments/invoices to the sites. Set up binders/files for hard copy files of site profiles and order checks (i.e. in addition to setting up an account for each payee). 
 Grant Management 
 Grant Management includes review
and verification of source payment tracking data, data entry, and tracking and follow-up clarification with the Project Management staff and site contacts/site communications, managing ongoing investigator inquiries regarding payments and follow-up.
Grant Management occurs after the site “set up” until 60 days after final payment (note: actuals will be billed). Grant Management also includes determining when grant payments are due per contract (i.e. site payment status),
re-designing tracking spreadsheets as study parameters change, reconciling tracking logs with general ledger, and making adjustments from previous payment cycle and at study completion. Also includes re-issuing checks as needed (due to sites not
cashing or lost checks), completing Sponsor specific reconciliation (as needed) and completing a final reconciliation of all payments made throughout the study. 
 The following are the types of ongoing payments which are required/performed during the course of a clinical trial: multiple IRD payments/fees (for initial & amendment submissions), patient enrollments (i.e. payments based on
completed CRFs, visits or procedures performed and may include, coordinator fees, and investigator fees). Other types of separate payments include screen failure payments, incentive fee payments, specialized equipment payments, specialized study
specific supply payments, and sub-study payments. 
 In addition, participating sites will be analyzed with Project Managers for the future enrollment to
determine grant payment projections. Time will be allocated to complete the grant payment reconciliation process with Omnicare CR’s business administration office. 
 Payments 
 As payments are processed the following are generated: payment/check request form, payment detail and
letters (by Sponsor request) to accompany checks. In addition, Omnicare CR will update site-specific logs and study-specific summary logs as well as the log for tracking payments sent to sites. The payment process includes mailing and photocopying
expenses. 
 Investigator grants, with parameters defined by the Sponsor, will be passed through at cost. Invoices submitted for payment to Sponsor for
estimated grant funds will be payable upon the receipt of the invoice. Any remaining funds will be carried forward to the next payment cycle and additional invoices will be generated as needed. A grant administration fee will be applied, based on
the number of sites and payments to be managed throughout the duration of the study. 
  

  

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 Site Refund Checks 
 Additional costs may be incurred if the Sponsor requests site refunds. Letter will be sent to sites that do not enroll patients in a study, etc. A letter from Investigator Grants is generated to the site requesting
the return of funds for a stated reason. This is sent via preferred carrier or by certified mail. Follow up with the site contact will occur up to three times. Regardless of the outcome, the service will be considered rendered if either of the
following occurs. (1) A refund is received, (2) a letter and 3 follow up calls have been completed or (3) an agreement is reached between the Sponsor and the principal investigator. 
 If the site objects to refunding the monies, the site sends a detailed letter stating reasonable start up costs. A copy of the letter is forwarded to the Project Manager
and or Sponsor to determine the outcome and action needed. Otherwise, the site returns a check payable to Omnicare CR for the amount stated in the refund letter. The check is returned to Investigator Grants and then is forwarded to Account
Receivable Department to be deposited and credited to the study. Refund service fees are not calculated in advance as part of any grant administration budget item. 
 D. Safety and Medical 
 Medical Monitoring (during business hours) 
 The medical aspects of The Sponsor’s clinical program will be overseen by one of Omnicare CR’s staff physicians who will be assigned to the study during
business hours as the Project’s Medical Monitor. In addition to acting as medical advisor to the Project Team, the Medical Monitor is responsible for the following: 
  

	 	•	 	 Addressing medical inquiries, internal or external 


  

	 	•	 	 Reviewing of clinical documentation (protocol, draft CRF, sample informed consent form) 


  

	 	•	 	 Project-specific medical training 


  

	 	•	 	 Evaluating patient eligibility (in conjunction with the Medical Director of the Sponsor) 


  

	 	•	 	 Participating in team meetings 


  

	 	•	 	 Review of Safety Data, such as laboratory results, ECGs, SAEs, AE Listings 


  

	 	•	 	 Reviewing study reports, regulatory submissions and study manuscripts 


 Safety Coordinator 
 The Coordinating Safety Officer
assigned to the Project will coordinate all activities relating to safety. These activities include attendance of internal and external team meetings, safety training of Project staff or sites, communication of safety information to Omnicare CR
Project Management and Data Management departments as well as the sponsor, and tracking the flow of safety information for the life of the Project. The Coordinating Safety officer will also be responsible for the generation of, and any required
revisions to, the Study Safety Plan, a comprehensive document, which defines the process and flow for contracted safety services. Safety coordination also includes assistance with the SAE reconciliation process, and completion of sponsor derived
queries of the sites. 
  

  

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 SAE Reporting- (with initial descriptive summaries) 
 Omnicare CR can provide initial descriptive summaries for all identified serious adverse events. The descriptive summaries will be written from information provided by
the investigator on the SAE report forwarded to Omnicare CR at the time of the event. If significant follow-up information becomes available, the narrative will be updated accordingly. 
 SAE Reporting (Follow-up/Revision Reports>2) 
 Updates or revisions to an initial SAE report greater than two (2) will be billed per unit based upon the actual number of additional reports required. The Coordinating Safety Officer tracks all initial and follow-up reports.

 Safety Database 
 Omnicare CR will
develop the safety database for the Project. The database platform is the current version of the **** system. The system is fully validated and compliant with all regulatory requirements for electronic storage of adverse event data. Additionally,
the system is capable of generating adverse event files in electronic format according to the definitions set in ICH E2B. Omnicare CR is able to perform electronic submission of serious, unexpected, suspected adverse reactions (‘SUSARs’)
to regulatory authorities as mandated by the European Clinical Trials Directive. 
 E. Clinical Data Management 
 A Data Management team will be assigned to this project to carry out all of the activities defined in the bid specifications. The team will consist of a Lead Data
Manager, Lead CDA, Database Programming staff, Dictionary Manager and specialists, Clinical Data Analysts and Data Technicians. Team recourses for the project will be developed by the Data Manager and will be based on the patient enrollment plan
along with the Case Report Form retrieval plan. Adjustments will be-made as needed as the study progress. 
 The Data Management team will work together
under the leadership of the Lead Clinical Data Manager to ensure the meeting of all project quality deliverables along with a successful and timely database closure. 
 Data Manager 
 The Clinical Data Manager assigned to this project will oversee all Data Management activities
throughout the life of the project. This dedicated Clinical Data Manager will act as the primary liaison for all Data Management activities. Some of the Clinical Data Manager’s activities are listed below: 
  

	 	•	 	 Overseeing and supporting the Lead CDA throughout the completion of setup and completion of all data management activities 


  

	 	•	 	 Review and approval of the Data Management Plan. The Data Manager will assure the receipt of the Sponsor’s approval prior to the initiation of any tasks
outlined in this plan 


  

	 	•	 	 Supporting the development of the CRF completion guidelines 


  


  

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	 	•	 	 Maintain ongoing communication with Sponsor team members and Omnicare CR’s Project Team Members 


  

	 	•	 	 Development of resource and contingency plans to ensure appropriate project staffing throughout the study, based on the Data Retrieval Plan provided by the
CTM. 


 Lead Clinical Data Analyst 
 Based on the deliverables for the Project, Omnicare CR has assigned a Lead Clinical Data Analyst. The Lead Clinical Data Analyst will provide additional team oversight for the Project Data Technicians and Clinical
Data Analysts. The Lead Clinical Data Analyst will assist the Clinical Data Manager with the following activities in relation to the page-related staff: 
  

	 	•	 	 Prioritize of Clinical Data Management tasks 


  

	 	•	 	 Direct the daily Clinical Data Management team task assignments 


  

	 	•	 	 Monitor the status of task and work load 


  

	 	•	 	 Oversee Project training for Clinical Data Management team members. 


  

	 	•	 	 Liaise with Clinical Trial Managers to ensure expectations for recording data accurately are communicated to the Project Team and the study site



  

	 	•	 	 Manage the query generation and final resolution 


  

	 	•	 	 Proactively address data quality issues to reduce query generation 


  

	 	•	 	 Liaise with the Clinical Trial Managers for timely query resolution 


  

	 	•	 	 Ensure high quality and timely data management deliverables 


  

	 	•	 	 Provide feedback to the Clinical Monitoring staff on query trends 


  

	 	•	 	 Provide backup support to the Clinical Data Manager 


  

	 	•	 	 Ensure a cohesive team that maintains high quality and data consistency 


  

	 	•	 	 Provide status updates to both the Omnicare CR internal Project Team and the Sponsor team members 


 Data Management Plan 
 The Lead CDA will develop the
Data Management Plan. The Data Management Plan will include descriptions of the following Data Management activities: 
  

	 	•	 	 Project data flow 


  

	 	•	 	 Database development overview 


  

	 	•	 	 Edit specifications 


  

	 	•	 	 Data entry guidelines 


  

	 	•	 	 Data handling guidelines 


  

	 	•	 	 Study assumptions (Level 1) 


  

	 	•	 	 SAE reconciliation process 


  

	 	•	 	 External data load procedures / External Data Cleaning parameters / Discrepancy identification flow 


  

	 	•	 	 Dictionary coding guidelines and processes 


  

	 	•	 	 Database closure procedures 


  

  

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 Prior to the start of Data Management activities, the Data Management Plan and edit specifications must be agreed to and
signed by the Omnicare CR designee and Sponsor representative. It is expected that the Sponsor will respond to requests for comments (on draft documents) or approval (on final documents) within two (2) weeks of receipt of document. The
agreement to all data handling rules will ensure an accurate and timely final database lock leading to a successful data analysis. It is assumed that all portions of the Data Management Plan related to any specific task will be agreed upon prior to
the start of those activities. 
 CRF Design and CRF Completion Guidelines 
 Upon approval of a final protocol by the Sponsor, a draft CRF to record pertinent study data will be prepared with input from Omnicare CR’s Data Management, Project
Management, and Biometrics. A draft document / CRF is provided to Sponsor for review. It is expected that the Sponsor will respond to requests for comments (on drafts documents) or approval (on final documents) within two (2) weeks of receipt
of documents. Upon receipt of the final draft comments, the final printable version of the CRF is prepared and provided to Sponsor for approval signature. Sponsor will be provided with either “camera-ready” CRFs for printing or with
ready-to-use multicopy carbonless forms. 
 Any requests for Clinical Data Management to supply the CRF Completion Guidelines will follow the same process.
These guidelines need to be finalized prior to the start of monitoring, preferably prior to the investigator meeting. 
 Database Creation
and Testing 
 Omnicare CR’s Data Management Department uses Oracle Clinical for a
standardized, validated approach to database design, edit development, data collection and storage. Several benefits for using this approach include an integrated query system directly linked to the clinical database. Omnicare CR’s Programming
group will develop data entry screens using Oracle Clinical® version 4.5 software running on Solaris Unix. The data entry screens (i.e. CRF data module designs) will mimic the flow of the
CRF, thereby improving the ease and integrity of the data entry process. 
 Database creation will be initiated upon the receipt of the final Case Report
Form. 
 A series of standard metric reports will be provided to the Project Team and the Sponsor. These standard CRF and query status reports are listed in
Section “Reports.” Omnicare CR provides flexible and a ‘can do’ customer service approach to all aspects of Omnicare CR’s work and can create customized Sponsor reports if requested. 
 Data Tracking and Data Entry 
 The dual data entry
strategy will be utilized for numeric and/or text fields. Data will be entered by one member of the data entry staff and re-entered on-line by a second member of the staff. Omnicare CR assumes the CRFs for screen failure patients will not be
received in-house, unless otherwise specified. 
  

  

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 All CRF and ancillary data received from the investigative sites are logged into a tracking database on a page-by-page
basis. Each page is identified by type of page and date received. Working copies will be maintained in Clinical Data Management and used for any annotations during processing and cleaning as appropriate. All original (white) CRF and query pages
will be immediately sent for filing in the Project Master File. 
 Data Review and Query Processing 
 Following the data handling rules and edits specifications listed in the Data Management Plan, the Clinical Data Analyst team will be responsible for: 
  

	 	•	 	 Reviewing the CRF data for obvious corrections and potential queries via the electronic Edit checks and the Manual review checks listed in the Data
Management Plan 


  

	 	•	 	 Applying any agreed upon self evident corrections or study assumptions 


  

	 	•	 	 Transmitting queries to investigative sites with a copy forwarded to Project Management 


  

	 	•	 	 Logging queries (issued and resolved) into Oracle Clinical Discrepancy Management System 


  

	 	•	 	 Working with the Clinical Trials Manager to ensure all Data Clarification Forms (DCFs) are signed by the investigator and received in house via fax or mail.



 On a continual basis, Clinical Trial Manager and the Clinical Data Manager working together will evaluate the number and type of queries
being generated by Clinical Data Management, in order to proactively manage the retrieval of quality data on these studies. The team will frequently inspect the data for trends and identification of issues, providing feedback to both the Project
Team and the site. This will begin as soon as sufficient CRF pages are received to identify the trends. 
 Quality Control Review of the
Database 
 It is Omnicare CR’s policy to perform a QC of the final database ensuring the error rate is within an acceptable range. Each CRF will be
printed as a data listing with 100% QC of adverse events and the protocol identified primary efficacy parameters against the hard-copy CRF. Also, a random sample subset of the patients will under go a 100% QC of all data points vs. the CRFs, to
ensure the estimate of the error rate for the database is within acceptable limits prior to declaration of clean database. The processes and outcomes of these QC procedures will be documented, with the findings corrected within the timeframe
identified within the Data Management Plan. Omnicare CR believes that these strategies will ensure the following results with respect to these studies: 
  

	 	•	 	 Quality data 


  

	 	•	 	 On-time delivery of Final Clean Clinical Study Databases 


  

	 	•	 	 No surprises when preparing for data analysis 


 Edit Checks 
 The edit specifications identified in the Data Management Plan require Sponsor approval prior to the
initiation of the programming of the edit checks. It is Omnicare CR’s goal and in the Project’s best interest to have all edits programmed and tested prior to any CRF data being submitted to Data Management. This will ensure there are no
delays in reviewing and querying 
  

  

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 the data. Omnicare CR suggests a periodic review of the edit specifications and data review guidelines to ensure that the
rules and edit checks meet the Project needs. It is expected that the Sponsor will respond to requests for comments (on draft documents) or approval (on final documents) within two (2) weeks of receipt of documents. The Sponsor will be billed
on the actual number of edit checks defined and approved by the Sponsor. 
 Dictionary Coding 
 Omnicare CR is proficient in coding to both MedDRA and the WHO-Drug dictionaries. Additional dictionaries can also be accommodated. 
 Omnicare CR Clinical Data Management will: 
  

	 	•	 	 Design and maintain the clinical database with Omnicare CR’s current version (at time of database build) of MedDRA for coding Adverse Events and Medical
History terms, and WHO-Drug for coding Medications 


  

	 	•	 	 Utilize standard coding conventions as listed in the Data Management Plan for the mapping procedures. If Sponsor requires specific coding guidelines they
must be provided prior to the start of the coding work and will be included in the Data Management Plan 


  

	 	•	 	 Utilize an automated process using Oracle TMS to map literal text to the corresponding term in the dictionary 


  

	 	•	 	 Research, code and review unmapped terms with a dedicated team 


 The Dictionary team will provide standard reports of all automated and manually coded terms/medications for periodic review and to Sponsor at soft lock of the database. Sponsor feedback and final approval is requested
prior to hard lock of the database. 
 Sponsor is required to have a MedDRA license prior to receipt of any MedDRA coded terms. 
 Sponsor is required to have a WHO-Drug license prior to receipt of any WHO-Drug coded medications. 
 Dictionary Mapping of the WHO-Drug ATC Level 
 Omnicare CR will map all medications to the WHO-Drug ATC level to the matching medication indication reported on the CRF, utilizing both the medication indication and medication route. 
 Reconciliation of the Safety and Clinical Database 
 On a monthly basis (weekly during final month), Omnicare CR will receive a cumulative SAE listing of the Omnicare CR Safety database to compare against the clinical database. The qualifiers identified in the Data Management Plan will be
reconciled, and a site query will be generated in order to resolve discrepancies. Clinical Data Management will update Omnicare CR’s Safety department with the DCF responses and Safety will update Sponsor on the changes. 
  

  

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 Reports 
 The standard Omnicare CR CRF and DCF reports will be provided to Sponsor and Omnicare CR’s Clinical Trial Manager on a monthly basis and more frequently approaching a database lock. 
 The standard reports are as follows: 
  

	 	•	 	 Cumulative CRF / DCF Status 


  

	 	•	 	 Cumulative CRFs by Site 


  

	 	•	 	 Outstanding DCFs by Site 


  

	 	•	 	 Resolved DCFs by Site 


  

	 	•	 	 Weekly Metrics: Data Processing 


 Nonstandard
reports can be accommodated at an additional per diem cost. This would include reports for data metrics, data quality, and ad hoc data reports requested by the Sponsor. 
 Standard Data Transfers 
 At the conclusion of the study, Omnicare CR will transfer the Project database to Sponsor in
standard Omnicare CR SAS data sets using Omnicare CR standard naming conventions and format. Omnicare CR recommends an initial test transfer, an interim transfer when 50% of patients are entered, and a final transfer when 100% of patients have been
entered and the database is soft locked and then again at hard-lock. 
 Customized data transfers, or interim data closures and transfers can be accommodated
on request at an additional fee. 
 Protocol Deviation Log Load 
 Omnicare CR will develop an additional Oracle Clinical module in order to load Sponsor’s log of protocol deviations into the clinical database. This includes development of the DCM/DCI module, loading the
spreadsheet database, and quality control of received data. 
 F. Biometrics Analysis 
 Biometrics Team Manager 
 Omnicare CR recognizes that
statistical and programmatic services are critical to Sponsor achieving timelines and objectives for the Project. All of Omnicare CR’s biostatisticians are Master’s or Ph.D. level prepared, with an average of **** (****) years of
****, ****, or **** experience. Both the biostatistician and lead programmer assigned to Sponsor’s Project will meet with you during Project initiation and throughout the clinical phase, and will serve as Sponsor’s main point of contact
for technical communications for the duration of the study. The frequency of communication will be determined at the kick off meeting, at a minimum communication should be scheduled for every other or every week depending on the complexity of the
deliverables. In addition Omnicare CR Biometrics Senior Management meet together on a weekly basis to review staffing needs and forecasting. At this weekly meeting 
  

  

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 management communicates with individual Project Team leaders to monitor the success factor of the team. 
 In addition, the Biometrics Team Leader will serve as local liaison to the Sponsor for technical issues, as the main point of contact for both clinical data management
and biometrics services. 
 Project Data Setup 
 The primary software product used for statistical analysis is SAS Version 8 or higher. SAS version 6 is available as a prior version. Omnicare CR’s standard SAS macros are globally accessible, validated according to current software
development practices and Omnicare CR SOPs, and are compliant with FDA industry guidance documents. Every programming project environment is created with both a development and production area. Version control software tracks all changes made to
production files once files are ‘checked in’ from the development environment. Prior to programming actual data displays (data listings, summary tables and graphics), Omnicare CR will perform the following: 
  

	 	•	 	 Initialize an internal Quality Control project tracking system which tracks the status of the program, the validation of the program output, the owners of
the files and the dates that the events were completed 


  

	 	•	 	 Customize project specific macros and header files for program development 


  

	 	•	 	 Create a cross reference file for data displays to SAS program files 


  

	 	•	 	 Review of client programming style guidelines if applicable and incorporate into programming specifications if applicable 


  

	 	•	 	 Hold at least one internal kick-off meeting for the Biometrics team members 


 After approval of the prototype data display formats by Sponsor and the Omnicare CR Project Team, the programming staff will develop the programs required to generate each data display. Any changes to data display
formats after approval and programming initiation could result in additional charges. 
 Statistical Plan 
 A statistical analysis plan, including operational definition of endpoints to be analyzed, definition of patient subsets (evaluable and intent-to-treat), visit windows,
rules for data handling, and a detailed description of statistical methodology, will be prepared for each study. By default the plan follows Omnicare CR SOP’s which incorporate all ICH and FDA guidance. If the Sponsor has a standard statistical
analysis plan template then this can be used instead. This plan will be submitted to Sponsor for review and approval prior to closing the database for analysis or after receiving the final protocol and CRF if Sponsor is providing the database. It is
expected that the Sponsor will respond to requests for comments (on draft documents) or approval (on final documents) within two (2) weeks of receipt of documents. 
  


  

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 Sample Size/Power Determination 
 Omnicare CR will estimate the required sample size according to the study design specified in the protocol and clinical assumptions of effect size and variability provided by Sponsor. In cases where clinical
assumptions are not available or are not considered reliable, power curves will be provided for various scenarios for review by Sponsor. 
 Randomization Schedule 
 The Project statistician will generate a randomization schedule according to the study design specified in the
protocol. Electronic copies of the randomization will be created for loading into the clinical database at the time of database closure. Electronic and paper copies of the randomization are stored in a secured location in accordance with Omnicare CR
SOPs. Fees include verification and review by a senior biostatistician. 
 Design of Table Shells (Mocks) 
 The statistical plan will include a set of formatted shells for all data displays (data listings, summary tables and graphics) planned for the study, which will be
prepared with input from the Clinical Writing Department. If formatted data displays are not required, a detailed table of contents of SAS generated data displays will be included. 
 Programming/QC of Data Displays 
 The process to
programming actual data displays (data listings, summary tables and graphics) at Omnicare CR is methodical and stepwise in description. 
 

 
  

  

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 The process begins with the rules and requirements stated in the Protocol, Statistical Analysis Plan and Mock Data
Displays. The annotated mocks drive the specifications for derived datasets definitions document, the programming of those datasets and the development and production of the data displays. The derived dataset specifications document follows the
format presented by the FDA guidance concerning regulatory submissions in electronic format. Derived dataset structures can be created to client specifications. If specifications are not provided then programming defaults to CDISC standard
structures in SAS transport file format. As the mocks is the specification for all programming output, any changes to data display formats or raw database after approval and programming initiation could result in additional charges. 
 The biometrics staff will use a combination of independent programming, hand tabulations from supporting listings, and programming verification to ensure the accuracy and
completeness of tables, listings, and statistical results. Products developed in SAS are validated for accuracy through a double programming process and these processes are outlined in the departmental SOPs and guidelines. The status of a SAS
program’s development is monitored through an internal tracking system which stores the individuals involved with a given product, comments for program and output issues, when the programmed files are ready for QC and when the person validating
the results states that the product has passed QC. All report data displays will be verified for accuracy and internal consistency among data displays. A quality control binder, including the quality control strategy for each data display and audit
trail, will be included in the Project file. 
 Programmatic Evaluability/Outcome 
 Patient evaluability criteria and relevant algorithms will be developed for the study by Omnicare CR and presented to Sponsor for review and approval. These algorithms
will be programmed using SAS to identify evaluable patients. Biostatisticians will verify the accuracy of the output with independent programming and review of individual patient data. Final decisions regarding patient evaluability will require
approval by the Sponsor; patient evaluability is performed once for each patient in the study. 
 Data listings for each patient’s evaluability status
and supporting data will be prepared and submitted to Sponsor for classification prior to breaking the blind. Data classification meetings may be held either in person or via teleconference. 
 Statistical Analysis 
 Omnicare CR staff
biostatisticians will perform statistical analysis, in accordance with the approved statistical analysis plan. The analysis includes verification of assumptions needed for statistical inference, determination of investigator-by-treatment
interaction, and examination of outlying data points. 
 Statistical findings which may not be appropriate for the body of the clinical report (e.g., tests
for interaction, data distribution issues, etc.), deviations from the planned analyses, and additional exploratory analyses will be included in a statistical appendix to the clinical report. 
  

  

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 The Project statistician will also review the clinical report to ensure appropriate representation of statistical
methodology and inference. 
 FDA Item 11 
 Additional data definition documentation for all derived datasets can be provided to support the FDA requirements for submitting to the agency. The file produced would be named define pdf matching the guidance titled Regulatory Submissions
in Electronic Format; New Drug Applications. Datasets are provided in SAS version 5-transport format. 
 Standard Data Transfer

 At the conclusion of the study, Omnicare CR will transfer, the Project database to Sponsor in standard Omnicare CR SAS data sets using Omnicare CR
standard naming conventions and format. Customized data transfers, or interim database closes and transfers, can be accommodated on request at an additional fee. 
 Data Safety Monitoring Board 
 A Data Safety Monitoring Board (DSMB) will be formed according to Omnicare
CR’s operating procedures and will be solely responsible for evaluating the interim results of the study. One (1) organizational meeting and one (1) interim analysis evaluation meeting are planned. 
 Omnicare CR and Sponsor will jointly develop guidelines for membership of the DSMB, and for conduct of DSMB meeting to be documented in the DSMB Charter. The DSMB members
will be recruited by Omnicare/Sponsor. Members of the DSMB will neither have previous involvement with Sponsor’s studies in this area, nor be currently involved in clinical trials of competing therapies. 
 The DSMB will have a written charter that will be produced by a Project Director which will define the responsibilities and will maintain records of all meetings. The
written charter will also include a statistical appendix that will document the requirements and guidelines for analyzing and interpreting the interim safety results. 
 Omnicare CR’s biometrics team will prepare mock data displays specific to the DSMB charter. A senior statistician, otherwise unrelated to the study, will be responsible for the development of the data displays
defined by the DSMB to ensure interim data accuracy and summaries are produced. These data displays will be programmed and validated by biometrics staff. The validation will be performed through a combination of individual patient data review and
independent programming. 
 When the blind is ready to be broken, the DSMB statistician will perform the final run of the DSMB data displays and prepare for
the DSMB. 
 For each DSMB meeting, the database will be extracted and the data listings and summary tables will be rerun. If the DSMB requests data
clarification or further information, Omnicare CR will re-extract the data and rerun the listings and tables on the new data. 
  

  

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 G. Clinical Writing 
 Clinical Study Report — Phase II/III 
 The Clinical Writing Department has experience in the production of
integrated statistical and clinical study reports covering a wide range of therapeutic areas. It will be the responsibility of the assigned Clinical Writer to ensure delivery of an integrated statistical and clinical study report for this program.
The integrated clinical and statistical summary will be prepared in accordance with ICH guidelines on the “Structure and Content of Clinical Study Reports”, appropriate agency regulations, and Omnicare CR’s SOPs and clinical study
report format. A draft clinical report will be generated within **** (****) weeks after receipt of source material and final summary tables and patient data listings. 
 The designated Omnicare CR clinical writers will liaise closely with the statistician and other team members. All clinical documents will receive, two levels of quality control reviews before they are released. There
will be a QC review by an independent clinical writer for accuracy and consistency, and a review by the writing manager for accuracy, client format consistency, and appropriate regulatory and clinical perspective. The first draft will then be
provided to the Sponsor for review. 
 The second draft clinical study report will be produced after receipt of one set of collated comments from the Sponsor.
It is Omnicare CR’s experience at Omnicare CR that this can be facilitated, more speedily, by holding a draft review meeting (optional) between a Sponsor representative and the Omnicare CR clinical writer. The second draft will be reviewed
within the Clinical Writing Department at Omnicare CR to ensure that all Sponsor comments are addressed and that all changes are consistent with the supporting data. Following the Sponsor’s second review, minor revisions will be made and the
report finalized. 
 Omnicare CR Biometrics will provide up to **** tables and **** listings that will be summarized in the clinical study report. This fee
includes **** major and **** minor revision. **** major revision of the draft report is considered to be up to **** (****) days of requested changes and a minor revision is up to **** (****) day of requested changes. Patient narratives
will be drafted from final patient data listings. Omnicare CR Writing will prepare patient narratives for SAEs and, discontinuations due to adverse events based upon a $**** per narrative fee. The fee for the study report does not include study
report appendices (including TLs). 
 Clinical Writing Input to Statistical Analysis Plan 
 Omnicare CR’s Clinical Writing will review the draft statistical analysis plan and mock summary tables and data listings for consistency with the protocol and ICH
guidelines for clinical study reports. Clinical Writing will provide feedback on the table design and format to facilitate the use of the data in the clinical study report. 
  

  

	****	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. 

  Page 23 








 H. Technology 
 Omnicare CR recognizes the importance of accurately tracking clinical study data and processes throughout the life of a study. Our secure clinical trial portal, OmnieView and OmnieTrack our clinical trial management system, allow study
teams to communicate via a secure internet site, 24 hours a day, 7 days a week from anywhere. Sponsors can view the progress of their study by going to one centralized location. Because all team members have access to the same portal,
communications can be more-timely, trial progress is known more quickly, and centralization allows everyone to see the same current information. Examples of information available on OmnieView include trial progress reports and metrics., reference
and training materials, newsletters and other communications, contact listings, templates/forms and lots more. 
 OmnieTrack is Omnicare CR’s global
Clinical Trial Management System (CTMS), which provides the ability for study personnel to plan, track and control all aspects of the clinical trial process for the duration of a study. OmnieTrack utilizes “web-enabled” technology to
enable dispersed sites and Omnicare CR locations to communicate in real time through a central “hub”, transcending time zones worldwide. 
 OmnieTrack includes process and workflow automation, which includes task notification, issues escalation, and comparative analysis between actual and projected data. It also has enhanced capabilities including electronic trip reports and
automated study projections. Key features and functionality of OmnieTrack are, 
  

	 	•	 	 Investigator Recruitment / Essential Document Tracking 


  

	 	•	 	 Patient Enrollment (patient accrual) by site and by trial projected and actual 


  

	 	•	 	 Monitoring Statue and Monitor Visit Scheduling 


  

	 	•	 	 CRF pages ready for review at site (projected/actual), CRF pages collected as related to patient and monitoring visit schedules 



 

	 	•	 	 Trip Reporting — electronic trip reports 


 OmnieTrack is able to provide you with ongoing, reliable and accurate information regarding specific studies via OmnieView and can deliver information to you in real time, summarized or detailed deliveries from the modules listed above.
Status reports and trip report formats can be customized to meet your requirements (fees apply). 
 Omnicare CR works with each study team to assess what
technologies and features should be used on a clinical trial to maximize the benefit of the solutions. Omnicare CR also works with sponsors to identify other technical requirements such as interfaces, secure connections, and customized reports. Fees
are determined after the full requirements are known. 
  

  

	****	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. 

  Page 24 








 I. Regulatory Services 
 Filing and Reconciliation of CRFs in the Study Master File 
 After logging in Clinical Data Management, completed CRFs
are transferred to the Study Master File. Fees reflect time required to verify CRF and ancillary pages received against the Clinical Data Management tracking log and filing of CRFs. The Sponsor will be billed for the actual number of pages filed.

 Study Master File and CRF Return 
 Omnicare CR will return the Study Master File in hard copy format in accordance with Omnicare CR’s SOPs, within three (3) months of final study deliverable. A final review of the study wide and individual investigator files is
completed by Project Management for completeness and accuracy. Sponsor will be billed for the actual number of sites returned. 
 Compilation of Appendices to Clinical Study Report 
 Omnicare CR has included cost to compile and collate the Clinical Study Report
electronic to hard-copy appendices in accordance with ICH guidelines. It is assumed that the Clinical Study Report appendices without hyper links will be prepared. Deliverables include electronic-to-paper publishing, with all required formatting,
utilizing a validated environment and formatting check. Hardcopies requested by the Sponsor can be provided for an additional charge. PostScript files will allow for subsequent printing needs of Sponsor (one CD-ROM). Publishing of the appendices
with hyper links applied is available for an additional charge. 
 J. Clinical Quality Assurance 
 Independent CQA audits provide additional verification to Sponsor that all contracted processes and procedures have been followed. As part of Omnicare CR’s
contracted service, a CQA Project Leader will attend Omnicare CR and Sponsor Project Team meetings, conduct and manage the audit program, and proactively address any issues that may arise during the clinical development program. 
 In addition to contracted audits, CQA may, at its discretion, audit any aspect of a clinical trial. As these are internal audits intended to support the overall quality
of Omnicare CR’s work, reports generated as a result of the audits are submitted to the management of Omnicare CR. Although the audit report is not provided to the Sponsor, CQA will inform Sponsor of any observations that affect the integrity
of the study. CQA also provides an Audit Certificate for inclusion in the Project Master File. 
 An Executive Summary will be generated at the end of each
study, documenting the quality status over the complete duration of the study. The Executive Summary will summarize all of the pertinent issues for all audits conducted in a concise, easy-to-read format. The findings will be listed by audit types
and by categories and will be evaluated for their impact on the GCP compliance of the study. The Executive Summary also will document the corrective actions taken to achieve resolution of the findings. 
  

  

	****	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. 

  Page 25 








 Together with the Executive Summary, a Summary Audit Certificate will be issued for each audit conducted during the
study. 
 Quality Plan 
 The CQA Project
Leader will develop a customized Project-specific Quality Plan in partnership with Sponsor. Ideally this contact person will be a CQA representative within Sponsor. The Quality Plan describes the approaches and methodology for the audits and as
such, is a component of the Global Project Management Process (GPMP). The plan will include details such as the percentages of sites/patients/data to be audited, the timeline of audits, and the plan for generation of individual Audit Reports and
Certificates. Sponsor will be requested to review and sign off on the plan and any necessary amendments to the original plan, prior to implementation. 
 Investigator Site Audits 
 Typically, **** percent (****%) of the sites in a project are selected for audit. In the
case of multinational trials, one site should be audited in each country. Audits will typically be performed at sites with high enrollment of subjects to identify whether study site performance, site documentation and facilities are in compliance
with regulatory obligations and the requirements of the protocol, SOPs and ICH GCP. Typically more than one site will be selected for audit in countries with larger numbers of sites. Other criteria may also be used for selection of sites to be
audited, e.g. issues identified by monitors or other members of the Project Team. 
 Study site audits will include an audit of the “in-house”
investigator files for each site to be visited, as well as the audit at the study site itself. On-site auditing activities include 100% review of essential documents, including all informed consent documents and serious adverse event reporting
compliance. In addition, for approximately ****% of subjects at each study site, CRF data will be audited against source documents with an emphasis on critical efficacy and safety data; drug accountability will also be verified for these subjects.

 Each audit will conclude with a debriefing session with the site’s study personnel. Critical or urgent issues will be discussed at this time and
recommendations for improved compliance will be offered. Should any observations arise that affect the integrity of the study, the CQA auditor will immediately alert Sponsor’s representative and the Omnicare CR Project Leader. 
 Specifics will be defined in the Quality Plan. An Audit Report, which documents the audit results as well as suggestions for corrective actions, will be generated. Upon
receipt and acceptance of the responses, the Audit Report along with written responses will be sent to Sponsor. The Audit Report will summarize all of the pertinent issues in a concise, easy-to-read format, and will also list the findings by
categories. In addition, an Audit Certificate will be provided. 
  

  

	****	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. 

  Page 26 








 K. Clinical Supplies Management 
 General Service Description 
 Sponsor will provide study drug to Omnicare CR’s central dispensing pharmacy
located in Perrysburg (Ohio). Sponsor will provide Omnicare CR with a MSDS and any special handling procedures for storage and distribution. 
 Upon approval
of the proposal by Sponsor, Omnicare CR will assign a Study Drug Coordinator. The role of this Coordinator is to oversee the study drug management aspects of the project. The Coordinator’s responsibilities are to ensure that all cGMP/GCP
requirements and all relevant local guidelines are followed for storage and distribution activities associated with the project. 
 Omnicare CR will be
responsible for central storage, distribution to sites and Returned Drug Management, including drug destruction, of study drugs from all sites. Storage (assumed 4 months) and distribution of study drug to sites will be performed at cold store.
Omnicare CR assumes up to **** shipments per site and an overall number of **** sites. 
 Ordering, Receipt and Inventory Setup

 Clinical supplies and other project related supplies/material would be ordered and/or received by Omnicare CR. Upon receipt, all items will be
inspected and transferred to Omnicare CR’s “Quarantine” area until released. Upon a visual inspection and paperwork release, drug product will be placed into inventory. 
 Storage for Distribution 
 Until shipment, clinical
supplies will be stored in a segregated limited access area. Temperature and humidity are continuously monitored and recorded for the storage area. Products for this study will be stored in dedicated storage units or on designated shelves. The
current inventory status of clinical supplies can be provided to Sponsor upon request during the study. 
 Distribution 
 A written request (i.e. fax) for shipment to clinical sties will be received from Sponsor or designee. Study Drug will be shipped to investigational sites by overnight
courier. It is assumed that each investigational site will require up to **** shipments throughout the duration of the trial. It is Omnicare CR’s assumption that supplies to be distributed to investigational sites will be stored pre-kitted,
require no additional preparation or assembly prior to shipment and that **** hour shipping notice will be given by Sponsor. A Shipping Note including an acknowledgement of receipt section will accompany each clinical supply shipment. Prior to
distribution, each shipment will be QC checked and inventory records will be adjusted. 
  

  

	****	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. 

  Page 27 








 Returned Drug Management 
 Each site will return study drug back to Omnicare CR’s distribution facility. Upon receipt (assume one receipt per site), the returned study drug will be inspected and transferred to Omnicare CR’s rejected
material area until released for destruction. Omnicare CR, will notify Sponsor before and after destruction of returned drug. Omnicare CR will document the receipt of each shipment from investigational sites. Returns from each site will be tracked
and stored separately (at room temperature). The current inventory status of returned Study Drug can be provided to Sponsor, upon request, during the study. 
 Documentation/Quality Assurance and Project Management/General Study Drug Issues 
 Omnicare CR will generate, review
and approve documentation to ensure compliance with cGMP/GCPs. All documentation will be filed in a project-specific pharmacy file. Upon Project completion, Omnicare CR will provide all original Study Drug Management Documentation associated with
the receipt, storage, shipping and returns to Sponsor, unless arrangements are made with Sponsor to archive originals at Omnicare CR. 
  

  

	****	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. 

  Page 28 








 IV. Budget 
 A.
Estimated Project Budget 
 Omnicare CR, Inc. Clinical Budget for: 
  

			
	Sponsor:	  	Peplin
		
	Compound:	  	PEP005 Topical Gel
		
	Study:	  	A multi-center, randomized, double-blind, double-dummy, vehicle-controlled sequential cohort study to determine the safety of PEP005 0.025% and 0.05% topical gel in patients with actinic
keratoses
		
	PCN:	  	KO1605

  

													
	 Services
	  	        Unit        	 	    # Units    	 	Unit
        Cost        	 	      Fees      	 	Estimated
    Pass-Thru    	 	Estimated
    Total Cost    
	 A. Study Management 
	  		 		 		 		 		 	
	 •        Project Director — Americas (assumes
****% FTE)
	  	Days	 	****	 	****	 	****	 	****	 	****
	 •        Project Administrative
Support/Coordination - Americas
(includes
support for all functional
areas) (assumes ****% FTE)
	  	Days	 	****	 	****	 	****	 	****	 	****
	 •        Draft Informed Consent Review
	  	Review	 	****	 	****	 	****	 	****	 	****
	 Sub-Total Study Management 
	  		 		 		 	****	 	****	 	****
	 B. Clinical Trial Initiation 
	  		 		 		 		 		 	
	 •        Site Screening and Identification (assumes Peplin will perform this task)

	 		 		 	
	 > Zone 1 
	  	Site	 	****	 	****	 	****	 	****	 	****
	 •        Site Recruitment (assumes Peplin will perform this task)
	 		 		 	
	 > Zone 1 
	  	Site	 	****	 	****	 	****	 	****	 	****
	 •        Study Master File
	  		 		 		 		 		 	
	 > Americas: **** sites for **** months 
	  	Site Months	 	****	 	****	 	****	 	****	 	****
	 •        Regulatory Document Collection
	 		 		 		 	
	 > Zone 1 
	  	Site	 	****	 	****	 	****	 		 	****
	 Central IRB (pass-throughs are
estimates only; actual fees will be billed
based on specific IRB fees)

	  	Site	 	****	 	****	 	****	 	****	 	****
	 Local IRB (pass-throughs are estimates
only; actual fees will be billed based on
specific IRB fees) 

	  	Site	 	****	 	****	 	****	 	****	 	****
	 •        Protocol Amendments — excluding ICF change
	 		 		 		 	
	 > Zone 1 
	  	Amendments/site	 	****	 	****	 	****	 	****	 	****
	 •        Protocol Amendments — including ICF change
	 		 		 		 	
	 > Zone 1 
	  	Amendments/site	 	****	 	****	 	****	 	****	 	****

  

  

	****	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. 

  Page 29 









															
	 Services
	  	         Unit        
	 	     # Units    
	 	 Unit
        Cost        
	 	       Fees      
	 	 Estimated
    Pass-Thru    
	 	 Estimated
    Total Cost    

	 •        
	  	Investigator Agreement Negotiation — Standard (actuals will be billed)	 		 	
		  	 > Americas 
	  	Site	 	****	 	****	 	****	 	****	 	****
	 •        
	  	Investigator Agreement Negotiation — Complex (actuals will be billed)	 		 	
		  	 > Americas 
	  	Site	 	****	 	****	 	****	 	****	 	****
	 •        
	  	Investigator Agreement Amendments — Standard	 		 		 	
		  	 > Americas 
	  	Amendments/site	 	****	 	****	 	****	 	****	 	****
	 •        
	  	Letters of Indemnification (US sites
only)	  	Site	 	****	 	****	 	****	 	****	 	****
	 •        
	  	Facility Letters	  		 		 		 		 		 	
		  	># Standard Facility Letters 	  	Site	 	****	 	****	 	****	 	****	 	****
		  	># Complex Facility Letters 	  	Site	 	****	 	****	 	****	 	****	 	****
	 •        
	  	Notice Letters	  	Site	 	****	 	****	 	****	 	****	 	****
	 •        
	  	IND Safety Report	  		 		 		 		 		 	
		  	 >Zone 1 
	  	Reports/Site	 	****	 	****	 	****	 		 	****
	 •        
	  	Investigator Brochure Updates	  		 		 		 		 		 	
		  	 >Zone 1 
	  	IB Updates/Site	 	****	 	****	 	****	 	****	 	****
	 •        
	  	Collect Financial Disclosure at Site Closeout	 		 		 	
		  	 >Zone 1 
	  	Site	 	****	 	****	 	****	 	****	 	****
	 •        
	  	Vendor/Lab Service Agreements —
Americas	  	Project	 	****	 	****	 	****	 	****	 	****
	 •        
	  	Investigators’ Meeting Coordination (pass-through is for investigator travel only-other pass-throughs are indicated below)
		  	 > Coordination, Meeting 1 North
America 
	  	Meeting	 	****	 	****	 	****	 	****	 	****
		  	 > Per Attendee, Meeting 1 North
America 
	  	Attendee	 	****	 	****	 	****	 	****	 	****
	 •        
	  	Investigators Meeting Preparation	  	Days	 	****	 	****	 	****	 	****	 	****
	 •        
	  	Investigators’ Meeting Attendance (OCR attendees x days)	 		 		 	
		  	 Project Director — Americas 
	  	Days	 	****	 	****	 	****	 	****	 	****
		  	 CTM — Americas 
	  	Days	 	****	 	****	 	****	 	****	 	****
		  	 Medical Monitor —
Americas 
	  	Days	 	****	 	****	 	****	 	****	 	****
		  	 Project Coordinator 
	  	Days	 	****	 	****	 	****	 	****	 	****
		  	 CRA Attendees 
	  		 		 		 		 		 	
		  	 >Zone 1: ****
CRAs 
	  	Days	 	****	 	****	 	****	 	****	 	****
		  	 Client Attendee Travel 
	  	Attendee	 	****	 	****	 	****	 	****	 	****
		  	 Meeting Coordinators
	  	Attendee	 	****	 	****	 	****	 	****	 	****
		  	Sub-Total Clinical Trial Initiation	  		 		 		 	****	 	****	 	****

  

  

	****	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. 

  Page 30 









													
	C. Clinical Trial Management	  		 		 		 		 		 	
	 •        Clinical Trial Manager
-
Americas (assumes ****%
FTE)
	  	Days	 	****	 	****	 	****	 	****	 	****
	 •        Clinical Monitoring
	  		 		 		 		 		 	
	 >Site Qualification Visit 
	 		 		 		 		 	
	 >Zone 1: **** hrs on-site, ****
hrs for prep, follow-up,
and
reports, and **** hrs for travel 
	  	Visits	 	****	 	****	 	****	 	****	 	****
	 >Site Initiation Visit 
	  		 		 		 		 		 	
	 >Zone 1: **** hrs on-site, ****
hrs for prep, follow-up, and
reports, and **** hrs
for travel 
	  	Visits	 	****	 	****	 	****	 	****	 	****
	 >Site Interims Visit 
	  		 		 		 		 		 	
	 >Zone 1: assume **** visits/site,
**** hrs on- site, **** hrs for
prep, follow-up, and
reports, and
**** hrs for travel 
	  	Visits	 	****	 	****	 	****	 	****	 	****
		  	 >Additional Day Interim Visits (based on **** hour day; visits are total per zone; actuals will be
billed)

	 >Zone 1: assume **** days for
Zone pool of visits 
	  	Visits	 	****	 	****	 	****	 	****	 	****
		  		 		 		 		 	 >Site Close-out Visit 

	 >Zone 1: **** hrs on- site, ****
hrs for prep, follow-up, and
reports, and **** hrs
for travel 
	  	Visits	 	****	 	****	 	****	 	****	 	****
	 •        Site Maintenance for **** hrs/month/site (**** sites x ****
enrollment and treatment months)
	 		 	
	 >Zone 1: **** sites 
	  	Site Months	 	****	 	****	 	****	 	****	 	****
	 •        CRA Monthly Teleconferences
	  		 		 		 		 		 	
	 >Zone 1: **** CRAS 
	  	Months	 	****	 	****	 	****	 	****	 	****
	 •        Project Team Training (To be held in conjunction with Investigator
Meeting)
	 		 		 		 	
	 Project Director -
Americas 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 CTM — Americas 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Medical Monitor -
Americas 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Project Coordinator 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 CRA Attendees 
	  	Days	 		 		 		 		 	
	 >Zone 1 CRAs: **** CRAs 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 •        Sponsor Meeting Attendance (assumes **** face-to-face meetings and
**** one-hour teleconferences, not all positions participate in all meetings; bill on actuals)

	 Project Director -
Americas 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 CTM — Americas 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Data Manager — Int’l 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Statistician — Int’l 
	  		 	****	 	****	 	****	 	****	 	****
	 Sr. Writer — Americas 
	  	Days	 	****	 	****	 	****	 	****	 	****

  

  

	****	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. 

  Page 31 









													
	 Project Coordinator
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Clinical Data Analyst
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Programmer
	  	Days	 	****	 	****	 	****	 	****	 	****
	 •        Project Team Teleconference Attendance (assumes **** meetings; not
all positions participate in all meetings; bill on actuals)
	 	
	 Project Director -
Americas 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 CTM — Americas 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Data Manager — Int’l 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Medical Monitor -
Americas 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Safety Officer -
Americas 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Statistician — Int’l 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Sr. Writer — Americas 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 CQA Manager- Americas 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Study Initiation
Manager 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Project Coordinator 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Clinical Data Analyst 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Contract Negotiator 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Programmer 
	  	Days	 	****	 	****	 	****	 	****	 	****
	 •        Clinical Grants Administration
	 	
	 >Grant Payment Set-up         
	 		 		 		 		 	
	 >Zone 1 
	  	Sites	 	****	 	****	 	****	 		 	****
	 > Grant Management (takes place for active sites from site set-up through **** days after
site close-out; estimated
amounts; actuals will be billed based on number of active sites set up)

	 >Zone 1 
	  	Site Quarters	 	****	 	****	 	****	 		 	****
	 >Payment Processing (estimated based on **** payments/site; actuals, including investigator and
site related
payment and any miscellaneous payments, actuals will be billed; pass through costs are related to photocopying
and postage)

	 >Zone 1: **** sites 
	  	Payments	 	****	 	****	 	****	 	****	 	****
	 >Estimated Investigator Grants
(Includes Administrative, Study
Coordinator, and Investigator
fees;
excludes tests in the synopsis that
will be performed by the central
laboratory; estimate based upon
draft synopsis provided and may
change upon review of the final
protocol) 
	  	Patient	 	****	 	****	 	****	 	****	 	****
		  	Screen Fail Patient
- Americas	 	****	 	****	 		 	****	 	****

  

  

	****	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. 

  Page 32 









													
		  	Enrolled
Patient
—
Americas	 	****	 	****	 		 	****	 	****
	 •        Refund Checks (if needed;
    actuals will be
billed)
	  	Refund	 	****	 	****	 	****	 	****	 	****
	 •        Central Laboratory Services
    (****
passthroughs)
	  	Project	 	****	 	****	 		 	****	 	****
	 •        **** (based upon **** Sites)
	  	Project	 	****	 		 		 	****	 	****
	 Sub Total Clinical Trial Management
	  		 		 		 	****	 	****	 	****
	D. Safety and Medical	  		 		 		 		 		 	
	
	 •        Medical Monitoring availability during business hours (flat fee of ****
hours per month from first patient in through last patient out)

	 > Americas
	  	Months	 	****	 	****	 	****	 	****	 	****
	 Greater than **** hours per month will be billed at hourly rate (from first patient in through
last patient out); Billed on actuals

	 > Americas
	  	Hours	 	****	 	****	 	****	 	****	 	****
	 •        Medical Monitoring during Study Start Up and Study Close-out (Billed on
actuals)
	 		 		 	
	 > Americas
	  	Hours	 	****	 	****	 	****	 	****	 	****
	 •        Safety Coordinator
	 		 		 	
	 > Americas — assumes
**** day per month for ****
months
	  	Days	 	****	 	****	 	****	 	****	 	****
	 •        SAE Reporting (with initial
    descriptive summary)
Billed
    on actuals
	  	Report	 	****	 	****	 	****	 	****	 	****
	 •        SAE Reporting (Follow-
    up/Revision Reports
>****)
    Billed on actuals
	  	Report	 	****	 	****	 	****	 	****	 	****
	 > Data Entry into ****
(actuals
                        will be billed)
	  	SAE	 	****	 	****	 	****	 	****	 	****
							
	 •        Medical Review of Protocol (bill
    on actuals)
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Sub-Total Safety and Medical
	  		 		 		 	****	 	****	 	****
	E. Clinical Data Management	  		 		 		 		 		 	
							
	 •        Clinical Data Management
    Oversight — Int’l
(CDM
    Manager assumes ****%
    FTE x **** months for Start-
    up, ****% FTE for
    **** months for Duration,
    and
****% FTE for
    **** months for Close-out)
	  	Days	 	****	 	****	 	****	 	****	 	****

  

  

	****	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. 

  Page 33 









													
							
	 •        Lead CDA — Int’l (assumes
    ****% FTE x
**** months,
    ****% FTE x **** months,
    and ****% FTE for
    **** months)
	  	Days	 	****	 	****	 	****	 	****	 	****
	 •        Development of Data
    Management Plan
(includes
    **** major and **** minor
    revision; add’l revisions will
    be billed at per diem rates)
	  	Days	 	****	 	****	 	****	 	****	 	****
	 •        CRF Design (assumes ****
    page CRF, **** unique
CRF
    pages); includes **** major
    and **** minor revision
	  	Project	 	****	 	****	 	****	 	****	 	****
	 •        Database Development, Testing
    and Maintenance
(assumes
    **** page CRF, **** unique
    CRF pages)
	  	Project	 	****	 	****	 	****	 	****	 	****
	 •        Estimated Data Entry (actuals will be billed)
	 		 		 		 		 	
	 > Pages in Int’l
	  	Pages	 	****	 	****	 	****	 	****	 	****
	 •        Estimated Data Review and Query Resolution (assumes **** issue per **** CRF
pages, **** manual checks and the application of **** study assumption for **** CRF pages); assumes **** CRF pages per enrolled patient, **** pages per screen failure patient and **** pages per drop out patient. Pages will be billed on
actuals.

	 > CRF Pages
	  	Page	 	****	 	****	 	****	 	****	 	****
	 •        Quality control check — critical
    items
	  	Patient	 	****	 	****	 	****	 	****	 	****
	 •        Quality control check — full
    case
	  	Patient	 	****	 	****	 	****	 	****	 	****
	 •        Edit Development (actuals will
    be billed)
	  	Edits	 	****	 	****	 	****	 	****	 	****
	 •        CRF Tracking (includes all
    ancillary pages; actuals
will
    be billed)
	  	Page	 	****	 	****	 	****	 	****	 	****
	 •        Dictionary Med remapping —
    ATC Meds (actuals will
be
    billed)
	  	Term	 	****	 	****	 	****	 	****	 	****
	 •        Dictionary Coding of Adverse
    Event terms to
MedDRA
    (estimated to be **** per
    patient; actuals will be billed)
	  	Term	 	****	 	****	 	****	 	****	 	****

  

  

	****	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. 

  Page 34 









													
	 •        Dictionary Coding of
	  	Term	 	****	 	****	 	****	 	****	 	****
	 Medication Terms (estimated to be ****
per patient; actuals will be billed)
	  		 		 		 		 		 	
	 •        External Vendor — Initial Load (actuals will be billed)
	 		 		 		 		 	
	 Initial Load
	  	Load	 	****	 	****	 	****	 	****	 	****
	 >Subsequent Load
	  	Loads	 	****	 	****	 	****	 	****	 	****
	 (actuals will be billed) 
	  		 		 		 		 		 	
	 Lab Visit Verification
	  	Visits	 	****	 	****	 	****	 	****	 	****
	 (**** visits x **** patients; actuals will be
billed) 
	  		 		 		 		 		 	
	 •        Reconciliation of the
	  	SAE	 	****	 	****	 	****	 		 	****
	 Safety and Clinical Database (actuals will
be billed)
	  		 		 		 		 		 	
	 •        Interim Database Close (assumes clean database; based on # patients in
close — actuals will be billed)
	 	
	 •                >1st Interim Close

	  	Patients	 	****	 	****	 	****	 	****	 	****
	 •        Protocol Deviation Log
	  	Project	 	****	 	****	 	****	 	****	 	****
	 Load
	  		 		 		 		 		 	
	 Sub-Total Clinical Data Management
	  		 		 		 	****	 	****	 	****
	 F. Biometrics Analysis 
	  		 		 		 		 		 	
	 •            Biometrics Team Manager
	  	Days	 	****	 	****	 	****	 	****	 	****
	 •            Biometrics CRF Review
	  	Days	 	****	 	****	 	****	 	****	 	****
	 •            Statistical Input into
	  	Days	 	****	 	****	 	****	 	****	 	****
	     Protocol
	  		 		 		 		 		 	
	 •            Project Data Setup
	  	Project	 	****	 	****	 	****	 	****	 	****
	 •            Statistical Plan
	  	Project	 	****	 	****	 	****	 	****	 	****
	 •            Sample Size/Power
	  	Days	 	****	 	****	 	****	 	****	 	****
	     Determination
	  		 		 		 		 		 	
	 •            Randomization Schedule
	  	Project	 	****	 	****	 	****	 	****	 	****
	 •            Design of Table Shells
	  	Project	 	****	 	****	 	****	 	****	 	****
	     (Mocks)
	  		 		 		 		 		 	
	 •        Programming/QC of Data Displays (actuals will be billed).
	 		 		 		 		 	
	Unique Tables	  	Table	 	****	 	****	 	****	 	****	 	****
	Repeat Tables	  	Table	 	****	 	****	 	****	 	****	 	****
	Unique Listings	  	Listing	 	****	 	****	 	****	 	****	 	****
	Repeat Listings	  	Listing	 	****	 	****	 	****	 	****	 	****
	Unique Figures	  	Figure/Graph	 	****	 	****	 	****	 	****	 	****
	Repeat Figures	  	Figure/Graph	 	****	 	****	 	****	 	****	 	****
	 •            Custom Derived Data Sets
	  		 		 		 		 		 	
	     >Initial (Assumes **** 
	  	Project	 	****	 	****	 	****	 	****	 	****
	     datasets) 
	  		 		 		 		 		 	
	     >Subsequent
	  	Dataset	 	****	 	****	 	****	 	****	 	****
	     (Assumes **** datasets) 
	  		 		 		 		 		 	
	 •            Programmatic Evaluability/Outcome
	  		 		 		 		 		 	
	     >Regular or Advanced 
	  	Project	 	****	 	****	 	****	 	****	 	****
	 •            Statistical Analysis
	  		 		 		 		 		 	
	>Regular 	  	Project	 	****	 	****	 	****	 	****	 	****
	 •            FDA Item 11
	  	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. 

  Page 35 









													
	 •                                       
     Standard Data Transfer
	  	Transfer	 	****	 	****	 	****	 	****	 	****
	>Initial        	  	Transfer	 	****	 	****	 	****	 	****	 	****
	>Subsequent	  	Transfer	 	****	 	****	 	****	 	****	 	****
	Add’l Stats consulting, meeting attendance, etc., will be charged at per diem rates as follows:
	 Team Leader
	  	Days	 		 	****	 		 		 	
	 Statistician
	  	Days	 		 	****	 		 		 	
	 Programmer
	  	Days	 		 	****	 		 		 	
	 •                DSMB Contracts
	  	Days	 	****	 	****	 	****	 	****	 	****
	         (assumes Peplin will recruit
        participants)
	  		 		 		 		 		 	
	 •        DSMB Orientation Meeting (organize, attend, and follow
up)
	 		 		 		 	
	 Project Director
	  	Days	 	****	 	****	 	****	 	****	 	****
	 Project Coordinator
	  	Days	 	****	 	****	 	****	 	****	 	****
	 •                DSMB Meeting
	  	Days	 	****	 	****	 	****	 	****	 	****
	         (Project Director
Attendance,
        Preparation, and Follow Up)
	  		 		 		 		 		 	
	 •                DSMB Meeting
	  	Days	 	****	 	****	 	****	 	****	 	****
	         (Project Coordinator Support)
	  		 		 		 		 		 	
	 •                DSMB Meeting
	  	Days	 	****	 	****	 	****	 	****	 	****
	         (Statistician Attendance
and
        Preparation)
	  		 		 		 		 		 	
	 •                Safety DSMB Data
	  	 Unique
 Tables
	 	****	 	****	 	****	 	****	 	****
	         Displays
	  		 		 		 		 		 	
		  	 Repeat
 Tables
	 	****	 	****	 	****	 	****	 	****
		  	 Unique
 Listings
	 	****	 	****	 	****	 	****	 	****
		  	 Derived
 Datasets
	 	****	 	****	 	****	 	****	 	****
	 •                Write DSMB
Charter
	  		 		 		 		 		 	
	Clinical Writer    	  	Days	 	****	 	****	 	****	 	****	 	****
	Statistician	  	Days	 	****	 	****	 	****	 	****	 	****
	 •                Statistical
	  	Project	 	****	 	****	 	****	 	****	 	****
	 •                Appendix document to
chapter
	  		 		 		 		 		 	
	 •                DSMB Contractor
	  	Project	 	****	 		 		 	****	 	****
	         Sub-Total Biometrics 
	  		 		 		 	****	 	****	 	****
	G. Clinical Writing 	  	All assumes using OCR SOPs. If using Sponsor SOPs/templates, all CW is custom priced
	 •                 Clinical Study
Report:
	  		 		 		 		 		 	
	     Phase II/III Report
	  	Report	 	****	 	****	 	****	 	****	 	****
	 > includes **** major (up to ****
days) and **** minor (up to ****

 day) revision > assumes up to ****

 tables and **** listing provided for
summarization> assumes OCR
SOPs and CSR template > fee does
not include CSR appendices
(including TLs) 
	  		 		 		 		 		 	
	 > Tables
	  	Report	 	****	 	****	 	****	 		 	****
	 (greater than ****)
	  		 		 		 		 		 	

  

  

	****	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. 

  Page 36 









													
	 •        Narratives (actuals
will be billed)
	  	Narrative	 	****	 	****	 	****	 	****	 	****
	 •        Clinical writing
Input to SAP
	  	Project	 	****	 	****	 	****	 	****	 	****
	Attendance at Sponsor Requested Meetings:	  		 		 		 		 		 	
	Attendance at Sponsor requested meetings (teleconferences/video conferences or client review/planning meetings at Sponsor/Omnicare CR, Inc.) will be billed to Sponsor according
to the following per diem rates:
	 Director:
	  		 	$ ****	 		 		 		 	
	 Senior Writer:
	  		 	$ ****	 		 		 		 	
	 Clinical Writer:
	  		 	$ ****	 		 		 		 	
	Sponsor will be billed for actual time expended.	  		 		 		 		 		 	
	 Sub-Total Clinical Writing 
	  		 		 		 	****	 	****	 	****
	H. Technology 	  		 		 		 		 		 	
	 •        OmnieView
	  		 		 		 		 		 	
	 >Monthly Maintenance
	  	Months	 	****	 	****	 	****	 	****	 	****
	 Sub-Total Technology 
	  		 		 		 	****	 	****	 	****
	I. Regulatory Services 	  		 		 		 		 		 	
	 •        CRF Filing and Reconciliation
(bill
on actuals)
	  	Pages	 	****	 	****	 	****	 	****	 	****
	 •        Return of CRF (hard copy); bill
on
actuals
	  	Pages	 	****	 	****	 	****	 	****	 	****
	 •        Return of Investigator and
Study-Wide
Documents (paper)
	  	Sites	 	****	 	****	 	****	 	****	 	****
	 •        Regulatory Site Drug Release
Approval
	  	# Sites	 	****	 	****	 	****	 		 	****
	 •        Compilation of Clinical Study Report Appendices (electronic
copy)
	 		 		 		 	
	 >Setup and Management Fee 
	  	Report	 	****	 	****	 	****	 	****	 	****
	 >Scanning (without cleaning); 
	  	Pages	 	****	 	****	 	****	 	****	 	****
	 actuals will be billed 
	  		 		 		 		 		 	
	 >Scanning and cleaning;
actuals 
	  	Pages	 	****	 	****	 	****	 	****	 	****
	 will be billed 
	  		 		 		 		 		 	
	 >Volumes (fee does not include 
	  	Volume	 	****	 	****	 	****	 	****	 	****
	 hyper-linking); actuals will be
billed 
	  		 		 		 		 		 	
	 •        Regulatory Consulting
	  	Days	 	****	 	****	 	****	 		 	****
	 (Vice President Americas)
	  		 		 		 		 		 	
	 Sub-Total Regulatory Services 
	  		 		 		 	****	 	****	 	****
	J. Clinical Quality Assurance 	 		 		 		 		 	
	 •        Quality Plan
	  	Days	 	****	 	****	 	****	 	****	 	****
	 •        CQA Site Audits — includes preparation and travel time, audit time,
audit follow-up, and Audit Report and Audit Certificate generation

	 >Assumes **** sites in 
	  	Sites	 		 		 		 		 	
	 Americas 
	  		 	****	 	****	 	****	 	****	 	****
	 •        Pre-Regulatory
Inspection Audits
	  	Audit	 	****	 	****	 	****	 	****	 	****
	 Sub-Total Clinical Quality
Assurance 
	  		 		 		 	****	 	****	 	****

  

  

	****	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. 

  Page 37 









													
	K. Clinical Supplies Management	  		 		 		 		 		 	
	 •            Receipt and Inventory of
    Study Drug
(Americas)
	  	 Per 100
 patients
	 	****	 	****	 	****	 		 	****
	 •            Receipt and Inventory of
    Study Drug
(Americas)
	  	Batch	 	****	 	****	 	****	 		 	****
	 •            Storage of study drug
    (Americas)
storage
    conditions:
    refrigerated (2°C-8°C)
	  	Month	 	****	 	****	 	****	 		 	****
	 •            Shipment Preparation and
    shipping of
Study Drug to
    sites in Americas. Shipping
    conditions:
    refrigerated (2°C-8°C), ****
    sites, **** shipments per
site
    (Pass through includes
    insulated shipping container
    and temperature recorder.
    Peplin must supply a
    qualified
shipping container
    or a qualification can be done
    at an extra fee.)
	  	Shipment	 	****	 	****	 	****	 	****	 	****
	 •            Manage General Study drug
    Issues
(Americas) **** days
    per month
	  	Month	 	****	 	****	 	****	 		 	****
	 •            Project meetings
with
    Pharmacist’s attendance
	  	Day	 	****	 	****	 	****	 		 	****
	 •            Receipt of Returned Drug
    Americas
(**** receipt per
    site, **** sites)
	  	Receipt	 	****	 	****	 	****	 	****	 	****
	 •            Storage of returned drug at
    room
temperature (Americas)
	  	Month	 	****	 	****	 	****	 		 	****
	 •            Return of study drug to
    Sponsor or
Certified
    Destructor (Incl. provision of
    Certificate of destruction)
	  	 Destruction
 run
	 	****	 	****	 	****	 	****	 	****
	 •            Final
reconciliation
    (Americas)
	  	Day	 	****	 	****	 	****	 		 	****
	     Sub-Total Clinical Supplies Management
	 		 		 	****	 	****	 	****

  

  

	****	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. 

  Page 38 









													
	L. Miscellaneous Pass-Through Expenses	  		 		 		 		 		 	
	 •            CRF Printing (bill on actuals)
	  	Pages	 	****	 	****	 		 	****	 	****
	 •            Investigator Binders
(includes
    printing, copying and shipping;
    bill on actuals)
	  	Binder	 	****	 	****	 		 	****	 	****
	 •            Shipment of Start-up Packet
    (bill on
actuals)
	  	Sites	 	****	 		 		 	****	 	****
	 •            Courier Cost for Drug
    Shipments to
Sites (bill on
    actuals)
	  	Shipment	 	****	 	****	 		 	****	 	****
	 •            Ship CRFs (bill on actuals)
	  	Box	 	****	 	****	 		 	****	 	****
	 •            Ship CRF from OCR back to
    Sites (bill
on actuals)
	  	Box	 	****	 	****	 		 	****	 	****
	 •            Copying (bill on actuals)
	  	Pages	 	****	 	****	 		 	****	 	****
	 •            Investigator Brochure Printing
    (bill
on actuals)
	  	Pages	 	****	 	****	 		 	****	 	****
	 •            Protocol Printing (bill on
    actuals)

	  	Pages	 	****	 	****	 		 	****	 	****
	 •            Informed Consent Printing (bill
on
    actuals)
	  	Pages	 	****	 	****	 		 	****	 	****
	     Sub-Total Miscellaneous Pass Through Expenses
	 	****	 	****	 		 	****	 	****
	Estimated Services Budget	  		 		 		 	****	 		 	
	Estimated Pass Through	  		 		 		 		 	****	 	
	Total Estimated Budget	  		 		 		 		 		 	****
	Optional Services	  		 		 		 		 		 	
	Total Optional Services	  		 		 		 		 		 	

  

  

	****	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. 

  Page 39 








 B. Payment Schedules 
 1. Invoicing Process for Service Fees 
 Omnicare CR maintains a project accounting system, whereby all direct project costs (Service Fees or
Pass-Through Expenses) are coded by project. 
 An initial payment of US $**** (minus any Service Fee payments made under the letter of intent dated
May 25, 2006) representing approximately **** percent (****%) of the estimated Service Fees, is due and payable upon execution of this Exhibit I. Subsequent payments shall be made monthly, based on Project progress and upon submission of
an invoice to Sponsor by Omnicare CR. After receipt of the initial payment, the subsequent invoices shall be reduced by a prorated portion from the initial payment such that the initial payment is applied evenly over the remaining term of the
Project. All payment shall be processed within **** days. If any payment of Service Fees or Pass-Through Expenses is late by more than **** (****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the
outstanding balance. 
 2. Pass-Through Expense Invoicing 
 Grant Payments — In order to ensure timely processing of investigator grant payments, Omnicare CR requires Sponsor to provide an up front initial payment representing ****% of the total study grant estimate or an amount that is
sufficient to pay all initial site fees, whichever is greater. Site start up payments and fees are based on an estimate of the study specific contractual obligations to be negotiated with the sites and may include: advances, funds for advertising,
pharmacy set up charges, local IRB fees and any other site related administrative start up fees. Payment of Sponsor funds is due upon execution of this Exhibit I. From that point forward, Omnicare CR will invoice **** (****) days in
advance of grant payments due investigators based on Patient enrollment estimates. 
 Omnicare CR payment from Sponsor at least **** (****) days in
advance of the actual payment to investigators. Payments to investigators will not be released until payments are received by Omnicare CR from Sponsor. Omnicare CR will to deposit payments from Sponsor into a bank account and shall draw upon such
account to make the investigator payments. Any remaining funds in the account will be returned to the sponsor after the termination of the study, as soon as all contracted obligations to the investigators have been satisfied. 
 In the event payments from Sponsor are insufficient to cover the payments to investigators, Sponsor will promptly advance funds to Omnicare CR for the amount of grant
payments required. 
  

  

	****	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. 

  Page 40 








 Omnicare CR’s project accounting system is able to capture and categorize in summary the following key Pass-Through
Expenses related to a project: 
  

	•	 	 Travel 


  

	•	 	 Delivery costs 


  

	•	 	 CRF and other printing or copying costs 


  

	•	 	 Investigator Meeting costs 


  

	•	 	 Telecommunication costs (which may include telephone, fax, pager, conference calls, or PC connectivity charges) 


 All other project related expenses that are not related to Service Fees and any additional detail to support Pass-Through Expenses will be provided on a fee basis.

 3. Payments 
 Sponsor shall make payment via wire
transfer directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Wachovia Bank 
 ABA # **** 
 Acct
# **** 
 4. Annual Price Increase 
 Notwithstanding
anything contained herein to the contrary, the estimated Service Fees set forth in this Exhibit I shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this
Exhibit I as of each ****; such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
  

  

	****	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. 

  Page 41 








 V. Signatory Authority 
 The parties acknowledge and agree that Sponsor has authorized Omnicare CR, subject to the terms of the Power of
Attorney executed between the Sponsor and Omnicare CR on 24th July 2006, to execute Clinical Study Agreements with investigators in the Project
on behalf of Sponsor. Sponsor understands and acknowledges that provided Omnicare CR has exercised its power within and in accordance with the terms of the Power of Attorney it will be bound by the terms of the investigator agreements. 

ACCEPTANCE 
 The terms and conditions of the Master Agreement
govern this Exhibit I and such document is incorporated herein by reference as if fully set forth herein. 
 Section Intentional Left Blank 
  

													
	BY AND BETWEEN:	 		 	
			
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.
					
	By:	 	 /s/ Peter Welburn
	 		 	By:	 	 /s/ Dale Evans

		 	Name:	 	 Peter Welburn Chief Scientific Officer
 and Vice
President,
	 		 		 	Name:	 	 Dale Evans
 CEO

		 		 		 		 		 	Title:	 	
		 	Title:	 	Research & Development	 		 		 		 	
			
	Date: 17 October 2006	 		 	Date: 10/24/06

 [SEAL] 
  

  

	****	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. 

  Page 42 








 Change Order #01 to Exhibit I to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 1st June 2005. 
 THIS CHANGE ORDER is entered into this
20th day of November 2006 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter
“Sponsor”) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a certain Clinical Services Master Agreement, dated 1st June 2005 (collectively,
with the Exhibit thereto, as the same may have been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are incorporated herein by reference; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as
Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be
deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR
desire to amend Exhibit I to the Agreement to provide for certain additional tasks or changes in the scope of the work provided under the Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 1. 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

   

			
	Page 1	 	Peplin Operations Pty Ltd










					
	 Reference
	  	 Changes and/or Additions
	  	Estimated Service
Fee (US$)
	Pursuant to Exhibit I, Omnicare CR will provide additional statistical services for Sponsor’s requirements	  	Additional data displays presented within the Data Monitoring Committee Statistical Analysis Plan:	  	
		  	 •        Data Tables (original contract included 10 unique and 5 repeat; actual
displays were 17 unique and 8 repeat tables):
	  	
			
		  	 -     7 unique tables @ US$****/table
	  	US$****
			
		  	 -     3 repeat tables @ US$****/table
	  	US$****
			
		  	 •        Data Listings (original contract included 2 unique and 0 repeat; actual displays were
12 unique and 4 repeat listings):
	  	
			
		  	 -     10 unique listings @ US$****/table
	  	US$****
			
		  	 -     4 repeat listings @ US$****/table
	  	US$****
	 Total Estimated Service Fees 
	  		  	US$*****
	 Total Estimated Pass Through Expenses
	  		  	******
	 Total Estimated Budget 
	  		  	US$****

  
  

	*	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. 

 2. Term 
 Notwithstanding any language to the contrary set forth in the Agreement, Sponsor and Omnicare CR
agree that the term of the Agreement shall be extended for a reasonable period of time to permit the completion of the additional work set forth in this Change Order #01. 
 3. Payment 
 The full payment of US$**** of the Service Fees shall be due and payable to Omnicare CR upon
execution of this Change Order #01. The payment of service fees and pass through expenses shall be made by Sponsor within **** (****) days of receipt of invoice. If any payment of service fees or pass through expenses is late by more than ****
(****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
 Sponsor shall make payment
directly to the following bank account nominated by Omnicare CR: 
  

  

	****	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. 

   

			
	Page 2	 	Peplin Operations Pty Ltd









 Beneficiary: Omnicare CR Inc. 
 Bank Name: Wachovia Bank ABA 
 Number: ****

 Account Number: **** 
 4. Annual Price
Increase 
 Notwithstanding anything contained herein to the contrary and subject to any previous annual price increase(s), the estimated Service Fees
set forth in this Change Order #01 shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Change Order #01 as of each ****, such increases shall not exceed the
percentage change of the Medical Services Price Index for the corresponding period. 
 5. No Other Changes 
 Except as expressly provided to the contrary in this Change Order #01, all other terms and conditions of the Agreement shall continue in force and effect. 
 ACCEPTANCE  
 BY AND BETWEEN:  
  

															
	 Peplin Operations Pty Ltd.
	 		 	Omnicare CR, Inc.
					
	By:	 	 /s/ Janelle Katsamas
	 		 	By:	 	 /s/ Dale Evans

		 	Name:	 	Janelle Katsamas	 		 		 	Name: 	 	Dale Evans
		 	Title:	 	Director Clinical Dev.	 		 		 	Title: 	 	CEO	 	
			
	Dated: 27 November 06	 		 	Dated: 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. 

   

			
	Page 3	 	Peplin Operations Pty Ltd









 Initial Sponsor Notification Form 

			
	 	  	



 Change in Project Scope 
  

					
	 Protocol Number: PEP005-006
	    	Date of Request; 16NOV2006	  	Omnicare PCN: KO1605.01
			
	 Omnicare Project Director:
	    	****	  	
	 Omnicare Account Director:
	    	****	  	
	 Sponsor Study Manager:
	    	Janelle Katsamas	  	
	 Sponsor Outsourcing Manager:
	    		  	
			
	Individual and Department making request:	    	****, Biometrics	  	
			
	Brief Description of Project Scope Change:	    		  	

 The number of data displays presented within the Data Monitoring Committee Statistical Analysis Plan and 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 DSMB SAP. The
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 of $**** USD. 
  

					
	 Implementation of this request will affect
	  	þ	    	Increase
	 the budget as follows (provide estimate of
	  	 ̈	    	Decrease
	 anticipated costs associated with change, if

 available):
	  		    	
		  	 ̈	    	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 acknowledgement received at
OCR. 
  

	þ	OCR may proceed with the additional/changed services. It is understood that detail and full cost estimate will be 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/ Janelle Katsamas
	 		 	 17/11/06

	 Sponsor Signature
	 		 	Date

  

  

	****	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. 

   

					
		 	 Omnicare Clinical Research
 CONFIDENTIAL
	 	Page 1 of 1









 Exhibit J to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd and Omnicare CR, Inc., 
 dated June 1, 2005 
 THIS EXHIBIT J
is entered into this 5th day of December, 2006 (“Effective Date”), by and between Peplin Operations Pty Ltd (hereinafter
“Sponsor”) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered
into a Clinical Services Master Agreement, dated June 1, 2005 (hereinafter the “Master Agreement”) wherein Omnicare CR agreed to provide clinical services; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as
Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be
deemed to include “Omnicare CR and/or an Affiliate Entity”, and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR
shall provide the services set forth in this Exhibit J, subject to the terms and conditions set forth in the Master Agreement; 
 NOW,
THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 I. Project Plan

 Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for Sponsor’s project, 
 Protocol No. PEP005-009- 
 An open-label, multi-center,
dose-escalation, cohort study to determine the maximum tolerated dose and safety of PEP005 Topical Gel given as either a single application (on Day 1) or two applications (on Day 1 and Day 8) to a superficial Basal Cell
Carcinoma (sBCC) on the trunk (hereinafter “the Project”) and associated costs. Changes made in the Project scope, at any time during the Project, will result in a corresponding adjustment to the Project costs. 
  

  

	****	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. 

  Page 40 








 II. Project Assumptions 
 The following Project assumptions and services were assembled from information provided in the request for proposal received on September 6, 2006, the Distribution of Tasks list received on September 7, 2006 and in accordance with
the revised Protocol PEP005-009, dated 12 November 2006, and additional information obtained during follow-up conversations with Sponsor personnel. The budget provided herein has been based upon the following revised Project assumptions.

  

			
	 GENERAL STUDY INFORMATION

		
	 Compound
	  	PEP005 Topical Gel
	 Therapeutic Area / Indication
	  	Superficial basal cell carcinoma
	 Study Phase
	  	IIa
	 Bid Currency
	  	USD $
	
	STUDY SITES
		
	 Number of Investigative Sites
	  	6
	 Number of Back-up Investigative Sites
	  	—
	 Number of Sites per Country
	  	
	 • US
	  	6
	
	PATIENTS
		
	 Number of Screened Patients
	  	116 (58 per treatment arm)
	 Number of Enrolled Patients
	  	58 per treatment arm (2 treatment arms) Budget based on total 116
	 Number of Completed Patients
	  	116 (58 per treatment arm) (assumed maximum # of patients for budget purposes)
	
	PROJECT MANAGEMENT
		
	 Project Director — Americas
	  	****% FTE for **** months; **** Days
	 Clinical Trial Manager — Americas
	  	****% FTE for **** months; **** Days
	 Project Coordinator — Americas
	  	****% FTE for **** months; **** Days
	
	STUDY START-UP ACTIVITIES
		
	 Number of Investigator Sites Screened / Recruited
	  	6 sites, pre-selected by Sponsor
	 Submission to Ethics Committees / IRB
	  	1 Central IRB
	 Submission to Regulatory Authority
	  	Sponsor
	 IMPD Preparation (Type)
	  	No Omnicare involvement
	
	MONITORING AND SITE MANAGEMENT
		
	 Number of CRAs
	  	2
	 Number of Qualification Visits
	  	Not required
	 Number of Initiation Visits
	  	**** visits; assumes **** hours on-site; **** hours travel; **** preparation, report and follow-up
	 Frequency of interim Visits
	  	Assumes every **** weeks

  

  

	****	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. 

  Page 2 









			
	
	MONITORING AND SITE MANAGEMENT
		
	 Number of Interim Visits
	  	**** visits; assumes **** hours on-site; **** hours travel; **** preparation, report and follow-up
	 Pool of Additional One-Day Visits
	  	TBD if required
	 Number of Close Out Visits
	  	**** visits; assumes **** hours on-site, **** hours travel; **** preparation, report and follow-up
	 Site Maintenance
	  	**** hours per site, for **** sites for **** months
	
	SPONSOR MEETINGS
		
	 Number and Location of Investigator Meeting
	  	One in the U.S.
	 Omnicare Investigator Meeting Attendees
	  	See budget
	 Project Team Training
	  	One in the U.S, in combination with investigators’ Meeting
	 Kick-off Meeting
	  	NA
	 Number of Team Teleconferences and Attendees
	  	Monthly CRA TCs
	
	DATA MANAGEMENT
		
	 Lead Data Manager — International
	  	****% FTE for **** months; **** Days
	 Lead CDA — International
	  	****% FTE for **** months; **** Days
	 Number of CRF Pages — Enrolled Patient
	  	50 pages per patient (25 Unique/25 Repeat)
	 Number of Adverse Event Terms per Patient
	  	3
	 Number of Con Med Terms per Patient
	  	7
	 Number of Medical Histories per Patient
	  	n/a
	 Number of Edits
	  	200
	 Number/Type of Laboratory
	  	1 Central Lab 12 data imports (monthly)
	 Number of Queries per Patient
	  	**** per **** CRF pages
	
	BIOMETRICS
		
	 Biometrics Team Lead — International
	  	**** Days per Month **** Days in total
	 Number of Tables
	  	50 Unique/35 Repeat
	 Number of Listings
	  	22 Unique / 5 Repeat
	 Number of Figures
	  	0 Unique / 0 Repeat
	 Number of Interim Analysis
	  	n/a
	 Number of Transfers
	  	0
	
	SAFETY/MEDICAL
		
	 Medical Monitor — Americas
	  	**** Days per Month
	 Number of SAEs (with narratives)
	  	4
	 Number of Days Safety Coordinator — Americas
	  	**** Days
	 Number of Months **** Maintenance
	  	12

  

  

	****	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. 

  Page 3 









			
	
	MEDICAL WRITING
		
	 Study Protocol Development
	  	Provided by Sponsor
	 Clinical Study Report
	  	 Assuming using Omnicare SOPs, includes **** major (****
 days) revision and **** minor (**** day) revision

	 Number of Patient Narratives
	  	4
	
	QUALITY ASSURANCE
		
	 Number of Site Audits and Location
	  	US, Audit by Sponsor
	 Number and Type of Additional Audits
	  	n/a
	
	TECHNOLOGY
		
	 OmniView / OmniTrack
	  	**** months
	
	CLINICAL SUPPLIES MANAGEMENT
		
	 Supply, Package, Label, Ship and Store Study Drug
	  	Sponsor
	 Provide Randomisation Code
	  	Sponsor
	 Drug Accountability
	  	Sponsor and OMNICARE CR
	 Study Drug Disposition, update Master Drug File
	  	OMNlCARE CR

  

  

	****	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. 

  Page 4 








 III. Project Timeline 
 The parties acknowledge that Omnicare CR commenced performance of the Service at beginning of October 2006. The projected timeline for the Project is **** months. 
  

			
	 PROJECT TIMELINE

	 Protocol Synopsis Finalized
	  	****
	 Final Protocol available and submitted to FDA
	  	****
	 Commencement of Omnicare Work (Start Date)
	  	****
	 FDA Approval
	  	****
	 Site Initiation
	  	****
	 First Patient Enrolled — cohort 1
	  	****
	Last Patient Enrolled — cohort 1 (assumes excluding 21 screening days of final expanded cohort)	  	****
	 Last CRF to Data Management Unit.
	  	****
	 Database Lock
	  	****
	 Draft Statistical Analysis
	  	****
	 Final Statistical Analysis
	  	****
	 Draft Clinical Study Report
	  	****
	 Final Clinical Study Report
	  	****
	 Study Completion — End of Omnicare Involvement
	  	****
	 Total Omnicare Involvement
	  	****

 Maximum Timelines Cohorts 
 The timing of this cohort study is such that patients are recruited in a cohort of three and a decision to go to the next cohort is made on Day ****, and not at the end of each cohort on Day **** (**** treatment +
**** follow-up days per subject till wound healing = **** days). So the following timelines apply if the study runs for the whole duration, through to the assumed maximum number of patients: 
  

			
	 Day - **** to day - ****
	  	 •        screening for 1st dose cohort

	 Day **** (Baseline)
	  	 •        treatment start of 1st dose cohort of treatment arm 1 (single dose application)

	 Day ****
	  	 •        DESC (Dose Escalation Steering Committee) evaluation prior to approval to escalate to
next dosage concentration

		  	 •     Treatment start of 2nd dose cohort of treatment arm 1

		  	 •     Treatment start of 1st dose cohort of treatment arm 2 (two dose application)


 Assumed cohort evaluation periods: 
  

  

	****	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. 

  Page 5 









	•	 	 7 escalations × 2 dose groups of 3 patients × **** days for each DESC review, assumes maximum of **** days.



  

	•	 	 Final Expanded Cohort: 


 **** days screening 
 **** days treatment 
 **** days wound evaluation 
 = assumes maximum of **** days. 
 Various iterations may apply, moving through cohorts. 
 It is expected however
that the study would not go beyond 2/3 of this total time before the maximum tolerated dose is determined. 
 Please note that Omnicare CR’s and
External Vendor (****) budgets are calculated based on the maximum length and maximum number of patients. 
  

  

	****	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. 

  Page 6 








 IV. Omnicare CR Services 
 A. Study Management 
 1. Project Resources 
 Omnicare’s goal of providing outstanding customer service, technical leadership and drug development expertise is accomplished by committing a highly experienced team of professionals to Sponsor’s Project.
The team members highlighted below are being proposed based upon their relevant therapeutic experience and areas of expertise, as well as on their previous cooperation with Sponsor. We would like to propose Sponsor the highest possible degree of
Consistency in the Project team. 
 2. Core Project Team Members 
 Listed below are the members of the Project Team along with a brief description of their relevant experience and
respective responsibilities. Curricula Vitae of this project team have been provided to Sponsor under an Appendix to the proposal for these studies, dated 15th September 2006. 
 ****, Project Director 
 Knowing that the cooperation between **** and the Sponsor Project team on a previous study has been a success for both sides, we would like to propose to assign her to this trial, too. **** will be responsible for
general project oversight and be the main contact for Sponsor for all project-related questions and issues. 
 **** has **** years of clinical research
experience having started at Omnicare Clinical Research (formerly Bio-Pharm/IBAH) as a Clinical Research Associate. **** has participated in many large, International trials for such complicated indications as sepsis, nosocomial pneumonia and
oncology trials, as both a monitor and manager. She obtained a Bachelor of Science in **** from the State University of ****. 
 **** has received her Masters
of Science in **** from ****. Combined with her extensive clinical experience, **** education enables both a strong clinical and management approach to clinical research. 
 ****, Clinical Trial Manager 
 **** will be the Clinical Trial Manager for the study. She will be managing the
day-to-day clinical trial activities and be responsible for overseeing all site and CRA activity, developing case report forms and monitoring guidelines, overseeing regulatory document management for each investigational site, as well as reviewing
and tracking CRA activities which include the scheduling of site visits, site visit reports, monitoring logs, and follow-up correspondence. 
 **** has joined
Omnicare in ****, bringing with her a wealth of experience in the pharmaceutical and CRO industry where she has held various positions of increasing responsibility. Her long track record of almost 20 studies includes projects from phase I to phase
IV, and therapeutic areas such as cardiovascular diseases, endocrinology, neurology, and 
  

  

	****	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. 

  Page 7 








 respiratory disorders. She also has gained experience in oncology projects and has monitored a dermatology trial.

 **** is a registered nurse and has been involved in various trials as a nurse, which makes her especially qualified due to her knowledge of both the CRO
and site staff side of the project. 
 ****, Lead Data Manager 
 As the Data Management Lead, **** will be based in the UK and coordinate all clinical data management activities from there. She will be supported by a Clinical Data Analyst on the study. 
 **** has been with Omnicare for over **** years and has gained experience in a data management role since ****. Her previous therapeutic area experience includes a
dermatology project in sun burns, and oncology studies in lung cancer, breast cancer, and skin malignancies. 
 ****, Lead Biostatistician 

**** will manage and coordinate all internal functional technical service activities, and also be available as a primary point of contact regarding brostatistics
issues for Sponsor. He will be an integral member of the project management team within Omnicare and will ensure that consistent information is relayed between Sponsor and the Biometrics team in Australia and the US. **** is based in Sydney and will
be available to discuss or provide immediate assistance on issues arising in relation to Statistics, and will also be available to attend teleconferences with Sponsor. 
 **** has been working in the healthcare industry for eight years, and has held statistician and data management roles for the same period. Most notably, **** has worked in the CRO industry since 2001 both in the UK as
well as Australia. 
 He brings advanced skills in the data management and statistical analyses of clinical trials from study set-up to database close and
reporting of results. **** is experienced in database design, build and management, data validation, medical coding, query resolution, statistical analyses and study design. He has been involved in planning; coordinating and execution of clinical
data solutions for many local and global studies. **** is experienced in various database software packages including SAS and Oracle Clinical used in the budgets for the studies to be conducted. 
 He received First Class honors for a Bachelor of Applied Science (****) from the University of **** in **** and also achieved a Bachelor of Applied Science
(****) from the same university in ****. 
 ****, Biostatistics US 
 As Biostatistics services will be provided from the US and Australia for this project, we propose **** as the Senior Project Statistician in the US. She will cooperate closely with ****. 
 **** has joined Omnicare in **** as a Statistician and has been involved in over ten projects. Her therapeutic experience relevant to the planned Project includes a phase
II trial in skin 
  

  

	****	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. 

  Page 8 








 malignancies and a phase III trial in malignant melanoma. **** holds an M.S. degree in **** from the University of ****,
****. 
 ****, Clinical Writing Lead 
 **** will be the
Director of Clinical Writing for this project. **** will supervise, and direct the clinical writers who will be assigned to the completion of the clinical study report is responsible for approving the final report and ensuring that the clinical
writing deliverable of the study are completed in an efficient and timely fashion. 
 Before joining Omnicare CR, **** was a member of the research faculty in
the **** and **** at another CRO involving oversight of the data management, biostatistics, and scientific writing departments. 
 **** is a graduate of both
the University of **** (B. S. ****) and **** University (M.S., ****, Ph.D., ****). He has a ****, and earned a **** degree from the University of ****. 
 3. Core Project Team Structure 
 **** 
  

  

	****	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. 

  Page 9 








 B. Project Tracking and Management Tools 
 1. Web-based Project Tracking 
 Omnicare CR recognizes
the importance of accurately tracking clinical study data and processes, throughout the life of a study. As a result, Omnicare CR has continued to enhance its capabilities around managing clinical studies by building upon our existing solutions and
is proud to present our most advanced clinical trial management solutions, including our secure clinical trial portal, Omni® View & Omni® Track, our clinical trial management system. 
 Omni® View allows study teams to communicate via a secure internet, site 24 hours a day, 7 days a week from anywhere on the globe. Sponsors can view the
progress of their clinical trial by going to one centralized location. Because all team members have access to the same portal, communications can be more-timely, trial progress is known more quickly, and centralization allows everyone to see the
same current information. This avoids having to wait for the compilation of hard-copy information to distribute to a global audience or for deliveries in the mail. The amount of email communication will be significantly reduced. 
 Omnicare CR works with each study team to assess what technologies and features should be used on a clinical trial to maximize the benefit of the solutions. Omnicare CR
also works with sponsors to identify other technical requirements such as interfaces, secure connections, and customized reports. Fees are determined after the full requirements are known. 
 Service fees were based on the assumption that only Sponsor will access Omni® View for the trials. Additional fees apply, if the sites should also access the
system. 
 C. Project Meetings 
 Sponsor plans to have an
Investigator Meeting, and it is assumed that there will be a project team training (in conjunction with the Investigator Meeting) meeting. 
 1. Project Team Training 
 Omnicare CR will rely on internal experts to provide specific therapeutic area training and orientation to the
protocol and the CRF prior to study initiation and on an ongoing basis. This training will be designed to ensure that all Project Team members are familiar with the Project requirements and their role within the Project Team. It is anticipated that
this meeting will be combined with the Investigator Meeting (see below) 
 Items discussed at these meetings will include, but will not be limited to:

  

	•	 	 Therapeutic area and clinical development background 


  

	•	 	 Protocol and CRF 


  

	•	 	 Discussion of therapeutic implications for the Project 


  

	•	 	 Monitoring guidelines 


  

	•	 	 Data handling rules from Data Management Plan 


  

  

	****	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. 

  Page 10 








 2.      Investigator Meeting 
       Coordination 
 It
is assumed that one investigator meeting will be held in US. Omnicare CR’s Meeting Manager will coordinate arrangements associated with the investigators’ meeting for this Project. Our Meeting Manager has extensive experience in conducting
investigators’ meeting, including but not limited to, organizing and scheduling the meeting, making cost-effective travel arrangements for participants, and providing on-site coordination services. 
 The Meeting Manager will participate on the weekly Project Team teleconference in addition to managing all logistics of the meeting. 
       Preparation 
 The
Omnicare CR Project Team will prepare slides, educational handouts, meeting materials, etc. according to Omnicare CR’s plan for training investigators to successfully conduct the Project. 
       Attendance 
 The
Omnicare CR Project Director and Meeting Manager will be available on site, to assist during the meeting, if requested. The Meeting Coordinator will arrive at the location prior to the meeting to assist attendees with any last minute details that
may arise. 
 A representative of **** will also attend the meeting, to provide photographic training to investigators. 
 3.      Project Team Meetings 
 The Project Director will conduct team meetings to disseminate information and address study related issues, Omnicare CR has assumed **** monthly teleconferences at **** hours duration per call will be held to review the study status.
Attendees will include the following: Sponsor team. Project Director, Clinical Trial Manager, additional functional team members may attend, as required. Attendance will be billed at the relevant daily rate plus at cost 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 11 








 D. Clinical Trial Initiation 
 1.      Site Selection/ Patient Recruitment Plan 
 It is assumed, that Peplin will be
responsible for Site Screening and Identification, as well as for Site Recruitment. 
 Based on Omnicare CR’s previous experience with the type of sites
enrolled in the planned study, no issues are expected to occur with subject recruitment and retention. 
 At the site initiation visit, Omnicare recommends
that the CRA, in conjunction with the site staff, develop a patient recruitment plan detailing the recruitment strategies the site will use and the number of patients they feel will be enrolled at their site. The site will be held accountable for
the success of this plan and the CRA will work with the site to modify and enhance the plan as necessary. 
 2.      Central Laboratory 
 As discussed with Sponsor, **** has been identified as suitable lab
for the present Project. Estimated total pass-through costs have been added within the budget for PEP005-009. 
 3.      Photography of sBCC Lesions 
 According to the protocol synopses at least four pictures of the selected
sBCC lesion will be taken at each scheduled and unscheduled patients visit. The investigative sites therefore need to be equipped with cameras and web cast facilities. 
 Omnicare CR has identified a suitable provider, **** Estimated total pass-through costs have been added within the budget for PEP005-009. 
 4.      Dermatopathology Laboratory 
 Pre-study lesion biopsy slides from patients in the screening phase will be sent to the central Dermatopathology laboratory for review and histological confirmation as part of the inclusion requirements. On Day 85 of
the treatment the patient’s sBCC lesion will be excised and sent to a central dermatopathology laboratory for histological examination. In cooperation with Sponsor, Omnicare CR has identified a suitable lab, **** Estimated total
pass-through costs have been added within the budget for PEP005-009. 
 Omnicare CR will perform an assessment visit of this lab prior to project start, as
further discussed under Section J. Clinical Quality Assurance, herein. 
 5.      Setup and Maintenance
of Project Master File 
 Omnicare CR will establish and maintain the Project Master File in accordance with Omnicare CR’s Standard Operating
Procedure (SOP). The study wide, individual investigator flies, and patient CRFs will be maintained in a locked, limited access, controlled file room. Ultimate 
  

  

	****	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. 

  Page 12 








 responsibility for ensuring the accuracy and completeness of the Project Master File lies with the Head of the Regulatory
File Room in US. In addition, it is the responsibility of all Omnicare CR Project Team members to ensure that the documents related to the Project are forwarded on a regular and frequent basis to the PMF. A transmittal sheet accompanies all
documents forwarded to the Project Master File. The transmittal sheet clearly identifies the documents being submitted to the Project Master File. Upon receipt, the file room verifies that the documents noted on the transmittal sheet have been
received, signs and dates the transmittal sheet, and forwards a copy of the transmittal sheet back to the sender to confirm receipt. 
 6.      Investigator Document Plan 
 An Investigator Document Plan will be developed for the Sponsor. The
purpose of Investigator Document Plan is to list the essential documents required for investigational product shipment release, identify the Project-specific completion and review criteria for essential investigator documents, to detail the
investigational product shipment approval procedure, detail the content of the Investigator Site File/Regulatory Binder, the Project Master File location, the procedure for submitting documents to the Project Master File return of documents to the
Sponsor and the ongoing maintenance and review criteria for essential documents. The Investigator Document Plan also contains any translation requirements and Omnicare CR essential document templates and/or Sponsor-specific templates as required.

 7.      Investigator Essential Document Management 
 Once Sponsor has signed the Investigator Documentation Plan, essential document packages, with letters of instruction, will mailed to qualified sites. Document collection
will cover all criteria required under the principles of Good Clinical Practices (GCP) and International Committee for Harmonization (ICH) guidelines, as Omnicare CR SOPs. 
 Omnicare CR will track the retrieval of documents on an ongoing basis and provide updates to Sponsor as requested. The fee for essential document collection, processing, and tracking is based upon the number of sites
required for the Project. All sites that drop from the Project for any reason will be billed based on percentage of work completed prior to notification of the drop. A submission-ready regulatory document package for each investigator will be
forwarded to Sponsor or to Omnicare CR regulatory prior to drug shipment and site initiations. There will be an additional fee for this service if Omnicare CR Regulatory reviews the packages. 
 Once all essential documents and approvals are received, the essential documents are copied and an investigator site file is created. An investigator site file binder
will be sent to each investigator. 
  

  

	****	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. 

  Page 13 








 8.      Regulatory and Ethics Committee Submission 
 Omnicare understands that rapid start-up and timelines in general are crucial to Sponsor for this study. 
 Sponsor will submit the study to the FDA. Omnicare CR’s budget is based on a **** month start-up period (****) to include ****: In order to enroll the first patient ****, sites will have to be initiated in ****.
To keep that timeline the final protocol will need to be submitted to the FDA at beginning of ****, and approval given by ****. 
 Omnicare CR will be
responsible for submission to IRBs/Ethics Committees. Based on the list of pre-selected sites and the previous Sponsor trial we assume that all sites will have central IRBs. Upon review of the protocol synopsis, there appeared to be no major issues
that are foreseen to arise from the Ethics Committee application. This is a standard dose escalation, cohort study. 
 The estimated **** months start-up time
take into account that December/January is a holiday season. 
 9.      Country Specific ICF Adaptations

 Omnicare CR will be responsible for liaising with the Ethics committees and regulatory authorities in providing modifications, and translations to the
template ICF. 
 10.    Facility Letters and other Investigator Notices 
 Omnicare CR can prepare and submit facility letters, notice letters and other Investigator Notices as required during the course of the Project. Unit costs have been
provided within the budget. 
 11.    Letters of Indemnification 
 The letters of indemnifications are negotiated and issued as needed and site and Sponsor signature is obtained. Letters of indemnifications are created, negotiated, and
tracked like clinical study agreements. 
 For all agreements activities, if the Project ends, if a site is terminated, or if any site drops from the Project
for any reason, that site’s documents will be billed based on percentage of work completed on each document prior to notification of the termination or drop. 
 12.    Protocol Amendments and IND Safety Reports and Investigator Brochure Updates 
 Protocol
amendments will be billed at an additional processing fee. IND safety reports and revised Investigator Brochures will be sent to sites at an additional fee. 
 13.    Essential Document Renewals and Updates — Annual Site Maintenance 
 Throughout the
Project, Omnicare CR will collect updated essential documents. The updating of essential documents (medical licenses, lab certifications, etc.) fee will be based on the site’s date of drug shipment through the site’s first IRB/Ethics
re-approval date. For studies lasting greater than 
  

  

	****	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. 

  Page 14 








 one year, the annual renewal and update fee will be charged based on the site’s subsequent IRB/Ethics re-approval
dates. 
 14.    Clinical Trial Agreements 
 For sites who have participated in the previous study these agreements will be used as the basis for the new study agreement, decreasing the need for negotiation, which will facilitate the execution process. If new
sites will be initiated these agreements will serve as a template for the new agreements. 
 Activities include: 
  

	•	 	 Create all clinical study agreements templates and patient budget template with the Sponsor 


  

	•	 	 When possible, set up pre-approved alternative language and budget parameters in anticipation of negotiation 


  

	•	 	 Negotiate all clinical study agreements that satisfy Sponsor requirements on behalf of the Sponsor 


  

	•	 	 Incorporate changes using pre-approved alternative parameters and if changes are outside parameters, secure approval by the Sponsor



  

	•	 	 Obtain signatures from investigators, institutions, facilities, on all clinical study agreements as needed 


  

	•	 	 Collect IRS Form W9 and payment information forms from sites 


  

	•	 	 Track documentation and communication with the sites, Omnicare CR Project Management and the Sponsor. 


 15.    Clinical Study Agreements Amendments 
 Protocol modifications and/or changes at the site level which require CSA revisions, amendments and/or re-negotiation, will be billed as needed at an additional processing fee per unit. (See budget) 
 16.    Vendor/Lab Service Agreements 
 Omnicare CR will be responsible for handling agreements between all Laboratories involved in both Project and Omnicare CR on behalf of the Sponsor. The lab agreements’ terms and conditions are negotiated separately from clinical study
agreements and related documents. 
  

  

	****	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. 

  Page 15 








 E. Clinical Trial Conduct 
 1.      Clinical Monitoring 
 Omnicare CR will provide initiation, interim and closeout
visits in accordance with Sponsor’s specifications. It is assumed that Sponsor will perform qualification visits. 
 Interim site monitoring visits will
begin once a site has enrolled its first patient and each site will receive one interim visit at that stage. 100% Source Data Verification will be performed during each visit. It is important however to maintain flexibility and responsiveness to
changing workloads, particularly where a site is involved in more than one study. 
 Omnicare CR’s site management and monitoring procedures will be
performed in accordance with ICH/ GCP to ensure each investigative site’s compliance with regulations and protocol requirements, and to enhance expeditious enrollment of appropriate patients into the clinical study. Regulatory documents will be
reviewed by the CRAs on an ongoing basis during the study conduct phase, including verification of signed informed consent forms and investigators IRB notifications. 
 Following each site visit, the CRAs complete comprehensive site visit reports and follow-up letters, which are provided to Sponsor within ten (10) working days of the visit however all urgent issues are
immediately reported to Sponsor’s Clinical Trial Manager. The monitoring visit reports provided by the CRAs include detailed action plans for all issues identified and all issues are tracked through to resolution. These follow-up letters and
monitoring reports will be forwarded to the Sponsor on a monthly basis or as defined by Sponsor. 
 2.      Clinical Monitoring Scheme 
 Omnicare CR has based the budget on separate monitoring visits according
to the following time and frequency assumptions: 
  

											
	 Type of Visit
	 	    Visits per site    	 	    Total number of    
visits	 	    Time onsite in hours    	 	Preparation,
follow-up and
    reporting in hours    	 	    Travel time in hours    
	Qualification Visits	 	****	 	****	 	****	 	****	 	****
	Initiation Visits	 	****	 	****	 	****	 	****	 	****
	Interim Monitoring Visits (frequency ever 4 weeks)	 	****	 	****	 	****	 	****	 	****
	Close-out Visits	 	****	 	****	 	****	 	****	 	****

 Any additional monitoring visits required will be invoiced Sponsor at the relevant daily rate, plus associated
pass-through costs. 
 3.      Site Maintenance 
 During the interim period between each on-site visit it is essential that the CRAs maintain regular contact with the Investigative sites to ensure that the site remains
focused on the Project and is actively screening potential subject enrollment. 
  

  

	****	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. 

  Page 16 








 The fee for site maintenance is estimated at **** hours per month per site for **** enrolment and treatment months. The
associated cost for site maintenance also includes the resolution of data queries by the study CRA. Also, the assigned CRAs will assist the Sponsor in resolving data queries for data from investigational sites, which are unclear, conflicting or
incomplete. The status of all queries resolved by Omnicare CR will be communicated to the Sponsor on an as-needed basis. The fee for resolution of data queries is included in the CRAs site maintenance. 
 F. Safety and Pharmacovigilance Services 
 1.      Safety Coordinator 
 The Safety Coordinator is responsible for the coordination of all activities
relating to safety. They will also be responsible for the generation of, and any required revisions to the Study, Safety Plan, a comprehensive document, which defines the process and flow contracted safety services. Safety coordination also includes
assistance with the SAE reconciliation process, and completion of sponsor derived queries of the sites. 
 2.      Availability for Receipt of SAEs 
 During business hours Omnicare CR has, a dedicated direct line to
the Safety Surveillance Department for receipt of SAE information. During evening hours, weekends and holidays, a designated member of the Safety Surveillance Department will be on call via mobile telephone where contracted. All return calls to the
sites will be made immediately to obtain the necessary SAE information and to determining the necessity of an SAE report. 
 3.      SAE Reporting and Initial Descriptive Narratives 
 Omnicare CR can be the primary contact for SAE
reports originating from investigative sites or from other healthcare professionals and assume responsibility for the subsequent querying and receipt of follow-up information. The present budgets include service fees for SAE reporting without
narratives. If required by Sponsor, Omnicare CR can prepare descriptive summaries based on the information provided in the SAE report form and supporting documentation. If significant follow-up information available, the narrative will be updated
accordingly. Additional fees apply. 
 4.      Safety Database 
 It is assumed, that there is an existing database platform, the ****, within Omnicare CR for Sponsor. Therefore the present budgets include no Project set-up fees but
only monthly database maintenance and date entry costs. 
 The system is fully validated and compliant with all regulatory requirements for electronic storage
of adverse event data. Additionally, the system is capable of generating adverse event files in electronic format according to the definitions set in ICH E2B. 
 The pricing structure for the use of **** has been developed to be highly competitive for both **** SAE volume. 
  

  

	****	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. 

  Page 17 








 5.      Report SAEs to FDA Agency 
 As discussed, Sponsor will assume responsibility to report SAE reactions that are associated with a drug or medical device to the FDA. 
 G. Clinical Data Management 
 Omnicare CR’s Clinical Data
Management group is excited to have another opportunity to partner with Sponsor. This provides an opportunity for Omnicare CR to build on our working knowledge of Sponsor’s Project and utilize efficiencies from our best practices and process
improvements instituted from previous projects. 
 Omnicare CR will assign Ms. **** as the Lead Clinical Data Manager for this project, who is very
familiar with Sponsors processes and requirement. 
 This previous experience will enhance our study start-up and management activities, and will ensure that
an experienced, knowledgeable team is partnering with the Sponsor team members. The experiences previously gained will benefit the new study in the following areas: 
  

	•	 	 Status reports 


  

	•	 	 Creation of the Data Management Plan 


  

	•	 	 Database Development 


  

	•	 	 Set-up of processes 


  

	•	 	 Training of staff 


  

	•	 	 Communication between Sponsor and Omnicare 


  

	•	 	 Working knowledge of all processes 


  

	•	 	 Central Laboratory Management and Data Loads 


 A Data Management will be assigned to this project to complete the activities defined in the bid specifications. The team will report into the Clinical Data Manager, and will consist of a Dictionary and Laboratory Managers and specialists,
Clinical Data Analysts and Data Technicians. Team resources for the project will be developed by the Clinical Data Manager and will be based on the patient enrolment plan along with the Case Report Form retrieval plan. Adjustments will be made as
needed as the studies progress. The Data Management team will work together under the leadership of the Clinical Data Manager, to insure the meeting of all project quality targets along with a timely database closure. 
 Dose Escalation Steering Committee (DESC) Reports 
 Omnicare’s Clinical Data Management department will support the DESC. Reports will be produced by Clinical Data Management Programmers, upon receipt of listings of the appropriate safety data for DESC review. 
  

  

	****	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. 

  Page 18 








 H. Biometrics Services 
 Omnicare CR will assign **** (Australia) as the Lead Biostatistician and **** (US) as Biostatistician for this project. Both have gained previous experience with Sponsor-specific processes and are excited to continue expanding their
working relationship with Sponsor during the conduct of the present new Project. These experiences, especially expectations of SAP writing, the programming of Tables, Listings and Graphs, and communication will be carried forward to the new project.
Thus a familiarity with Sponsor procedures is guaranteed. 
 Using the same Biometrics team will facilitate the whole statistical analysis process as,
valuable previous experience and ‘lessons learned’ will be applied to this new project. 
 FDA Item 11 
 FDA Item 11 represents the definition documentation provided for all derived datasets according to CDISC requirements. Essentially this documentation support the FDA
requirements for submission and accompanies the standard data transfer. 
 This was initially requested by Sponsor on Sponsor’s earlier studies and
Omnicare CR is providing this additional data definition documentation also for the present project, in order to be consistent throughout the development program. The file contains the structure and contents of the derived datasets as per CDISC SDTM
(study data tabulation model) v3.1.1: 
 The file produced would be named define.pdf matching the guidance titled Regulatory Submissions in Electronic Format
New Drug Applications. Datasets are provided in SAS version 5-transport format. 
 I. Clinical Writing 
 1.      Clinical Study Report — Phase III 
 It will be the responsibility of the assigned Director Clinical Writing to ensure delivery of integrated statistical and clinical study report for this Project. The integrated clinical and statistical summary will be
prepared in accordance with ICH-GCP Guidelines on the “Structure and Content of Clinical Study Reports” appropriate agency regulations, and Omnicare’s SOPs and clinical study report format. A draft clinical report will be generated
within **** (****) weeks after receipt of source material and final summary tables and patient data listings. 
 The designated Omnicare CR clinical
writers will liaise closely with the statistician and other Project Team members. All clinical documents will receive two levels of quality control reviews before they are released. There will be a QC review by an independent clinical writer for
accuracy and consistency, and a review by the writing manager for accuracy, client format consistency, and appropriate regulatory and clinical perspective. The first draft will then be provided to the Sponsor for review. 
 The second draft clinical study report will be produced after receipt of one set of collated comments from the Sponsor. It is our experience at Omnicare CR that this can
be facilitated, more speedily, by **** 
  

  

	****	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. 

  Page 19 








 ****. The second draft will be reviewed within the Clinical Writing Department at Omnicare to ensure that all Sponsor
comments are addressed and that all changes are consistent with the supporting data. Following the Sponsor’s second review, minor revisions will be made and the report finalized. 
 The fee for this report includes the drafting of the methodology sections in advance of the results section of the study report, as requested by the Sponsor. The methods section will contain the full methodology and
planned analyses details (ICH-GCP Guidelines Sections 1-9). The methods sections will be drafted after receipt of the final statistical analysis plan. An internal clinical writing review for consistency with the ICH-GCP Guidelines and for
accuracy with the source documentation will be completed. The draft methodology section will be provided to the Sponsor. 
 The writing fee estimates are based on receipt of final data. If database Changes occur which require a substantial amount of time (> 1/2
 day overall) for rework or repeat quality control, additional fees will be agreed upon with Sponsor before proceeding. 
 2.       Narratives 
 Patient narratives will be drafted from final patient data listings. Omnicare clinical writing can prepare patient narratives for SAEs and discontinuations due to AEs. 
 3.      Clinical Writing Input to Statistical Analysis Plan 
 Omnicare’s Clinical Writing will review the draft statistical analysis plan and mock summary tables and data listings for consistency with the protocol and ICH-GCP
Guidelines for clinical study reports. Clinical Writing will provide feedback on the table design and format to facilitate the use of the data in the clinical study report. 
 4.      Compilation of Appendices to Clinical Study Report 
 Omnicare CR’s Regulatory department (US) will compile and collate the Clinical Study Report electronic appendices in accordance with ICH-GCP Guidelines.
Clinical Study Report appendices without hyperlinks will be prepared. Agreement will be reached with Sponsor prior to initiating the Project regarding the table of contents detail. Deliverables include electronic publishing, with all required
formatting, utilizing a validated environment and 100% formatting check. Hardcopies requested by the Sponsor can be provided for ****. PostScript files will allow for subsequent printing needs of the Sponsor (one CD-ROM). Publishing of the
appendices with hyperlinks applied is available for an additional charge. 
  

  

	****	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. 

  Page 20 








 J. Clinical Quality Assurance 
 Independent Clinical Quality Assurance (CQA) audits provide additional verification to Sponsor that all contracted processes and procedures have been followed. As part of our contracted service, a CQA Project Leader will attend conduct
and manage the audit program, and proactively address any issues that may arise during the clinical development program. 
 In addition to contracted audits,
CQA may, at its discretion, audit any aspect of a Project. As these are internal audits intended to support the overall quality of Omnicare’s work, reports generated as a result of the audits are submitted to the management of Omnicare Although
the audit report is not provided to the Sponsor, CQA will inform Sponsor of any observations that affect the integrity of the Project. CQA also provides an Audit Certificate for inclusion in the PMF. 
 An Executive Summary will be generated at the end of each Project, documenting the quality status over the complete duration of the Project. The Executive summary will
summarize all of the pertinent issues for all audits conducted in a concise, easy-to-read format. The findings will be listed by audit types and by categories and will be evaluated for their impact on the GCP compliance of the Project. The Executive
Summary also will document the corrective actions taken to achieve resolution of the findings. 
 Together with the Executive Summary, a Summary Audit
Certificate will be issued for each audit conducted during the Project. 
 1.      Quality Plan

 The CQA Project Leader will develop a customized Project-specific Quality Plan in partnership with Sponsor. Ideally this contact person will be a CQA
representative within Sponsor. The Quality Plan describes the approaches and methodology for the audits and as such, is a component of the Global Project Management Process (GPMP). The plan will include details such as the percentages of
sites/patients/data be audited, the timeline of audits, and the plan for generation of individual Audit Report and Certificates. Sponsor will be requested to review and sign off on the plan and any necessary amendments to the original plan, prior to
implementation. 
 2.      Dermatophatology Laboratory Audit 
 CQA will conduct an audit of the selected Dermatopathology Laboratory to provide additional verification that all contracted processes and procedures can be followed. The
audit will be conducted to identify whether laboratory performance, laboratory documentation and facilities are in compliance with regulatory obligations, the requirements of the protocol, SOPs and ICH-GCP Guidelines, and GLP Guidelines. 

On-site auditing activities will include review of SOPs, laboratory documentation, including accreditation and proficiency testing records, processes for laboratory
receipt, handling, analysis, quality control and reporting of results, including standards for re-test and approval of laboratory results. 
 The audit will
conclude with a debriefing session with the laboratory’s personnel. Critical or urgent issues will be discussed at this time and recommendations for improved compliance will be offered. Should any observations arise that affect the integrity of
the Project or the analysis of the 
  

  

	****	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. 

  Page 21 








 samples, the CQA auditor will immediately alert Sponsor’s representative and the Omnicare Project Leader.

 An Audit Report will be generated, documenting the results of the audit as well as suggestions for corrective actions. The report will be sent to the
Sponsor’s representative for attention and potential resolution of findings and to the Omnicare Project Leader for information., the Audit Report will summarize all of the pertinent issues in a concise, easy-to-read format, and will also list
the findings by categories. An Audit Certificate will also be provided. 
  

  

	****	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. 

  Page 22 








 V. Budget 
 A.
Estimated Project Budget in USD 
 Omnicare CR, Inc. Clinical Budget for: 
  

			
	Sponsor:	  	Peplin Ltd.
		
	Compound:	  	PEP005 topical gel
		
		  	An open-label, multi-center, dose-escalation, cohort study to determine the maximum tolerated dose and safety of PEP005 Topical Gel given as either a single application (on Day 1 = or two
applications (on Day 1 and Day 8) to a superficial Basal cell carcinoma
	Study:	  	(sBCC) on the truck
		
	PCN:	  	KO1607 (6 sites, 1 protocol only)

  

															
	 Services
	  	Unit	  	    # Units    	  	Unit Cost
    (USD $)    	  	Fess
    (USD $)    	  	Estimated
Pass—
Through
Costs
    (USD $)    	  	Estimated
Total Cost
    (USD $)    
	A. Study Management	  		  		  		  		  		  	
	•	 	Project Director — Americas Assumes
****% FTE (**** days per month) for
entire project duration. **** months	  	Days	  	****	  	****	  	****	  	****	  	****
	•	 	Project Administrative
Support/Coordination —Americas (includes
support for all functional areas) Assumes
****% FTE (**** days per month) for
entire project duration,
**** months	  	Days	  	****	  	****	  	****	  	****	  	****
		 	Sub-Total Study Management	  		  		  		  	****	  	****	  	****
	B. Clinical Trial Initiation	  		  		  		  		  		  	
	 •
	 	Site Screening and Identification Assume to
be done by Peplin	  		  		  		  		  		  	
		 	> USA	  	Site	  	****	  	****	  	****	  	****	  	****
	•	 	Site Recruitment Assume to be done by
Peplin	  		  		  		  		  		  	
		 	> USA	  	Site	  	****	  	****	  	****	  	****	  	****
	•	 	Study Master File	  	All assumes using Omnicare SOPs.
		 	>Americas: 6 sites for **** months	  	Site Months	  	****	  	****	  	****	  	****	  	****
	•	 	Regulatory Document Collection	  		  		  		  		  		  	
		 	>USA	  	Site	  	****	  	****	  	****	  		  	****
		 	Central IRB (pass-throughs are estimates
only: actual fees will be billed based on
specific IRB fees)	  	Site	  	****	  	****	  	****	  	****	  	****
	•	 	Protocol Amendments - excluding ICF
change	  		  		  		  		  		  	
		 	> USA	  	Amendments/site	  	****	  	****	  	****	  	****	  	****
	•	 	Protocol Amendments — including ICF
change	  		  		  		  		  		  	

  

  

	****	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. 

   

			
	KO1607 Study PEP005-009	  	Page 23










			
	Omnicare CR, Inc. Clinical Budget for:
		
	Sponsor:	  	Peplin Ltd.
		
	Compound:	  	PEP005 topical gel
		
		  	An open-label, multi-center, dose-escalation, cohort study to determine the maximum tolerated dose and safety of PEP005 Topical Gel given as either a single application (on Day 1= or two
applications (on Day 1 and Day 8) to a superficial Basal Cell Carcinoma
	Study:	  	(sBCC) on the trunk
		
	PCN:	  	KO1607 (6 sites, 1 protocol only)

  

															
	 Services
	 	    Unit    	 	    # Units    	 	Unit Cost
    (USD $)    	 	Fees
    (USD $)    	 	Estimated
Pass-
Through
Costs
    (USD $)    	 	Estimated
Total Cost
    (USD $)    
		 	> USA	 	Amendments/site	 	****	 	****	 	****	 	****	 	****
	 •
	 	 Investigator Agreement
 Negotiation — Standard
	 		 		 		 		 		 	
		 	> Americas 	 	Site	 	****	 	****	 	****	 	****	 	****
	 •
	 	 Investigator Agreement Negotiation—
 Complex
	 		 		 		 		 		 	
		 	> Americas 	 	Site	 	****	 	****	 	****	 	****	 	****
	 •
	 	 Investigator Agreement Amendments —
 Standard
	 		 		 		 		 		 	
		 	> Americas 	 	Amendments/site	 	****	 	****	 	****	 	****	 	****
	 •
	 	 Letters of Indemnification (US sites only)
	 	Site	 	****	 	****	 	****	 	****	 	****
	 •
	 	 Facility Letters
	 		 		 		 		 		 	
		 	># Standard Facility Letters 	 	Site	 	****	 	****	 	****	 	****	 	****
		 	># Complex Facility Letters 	 	Site	 	****	 	****	 	****	 	****	 	****
	 •
	 	 Notice Letters
	 	Site	 	****	 	****	 	****	 	****	 	****
	 •
	 	 IND Safety Report
	 		 		 		 		 		 	
		 	> USA 	 	Reports/Site	 	****	 	****	 	****	 	****	 	****
	 •
	 	 Investigator Brochure Updates
	 		 		 		 		 		 	
		 	> USA 	 	IB Updates/Site	 	****	 	****	 	****	 	****	 	****
	 •
	 	 Vendor/Lab Service
 Agreements Americas
	 	Agreements	 	****	 	****	 	****	 	****	 	****
	 •
	 	 Investigators Meeting Coordination (pass-
 through is
for investigator travel only-other
 pass-throughs are indicated below)
	 		 		 		 		 		 	
		 	> Coordination Meeting /US 	 	Meeting	 	****	 	****	 	****	 	****	 	****
		 	>Per Attendee, Meeting / US 	 	Attendee	 	****	 	****	 	****	 	****	 	****
	 •
	 	 Investigators’ Meeting Preparation
	 	Days	 	****	 	****	 	****	 		 	****
	 •
	 	 Investigators’ Meeting Attendance (OCR
 attendees
x days)
	 		 		 		 		 		 	
		 	Project Director — Americas 	 	Days	 	****	 	****	 	****	 	****	 	****
		 	CTM — Americas 	 	Days	 	****	 	****	 	****	 	****	 	****
		 	Data Manager — Int’l 	 	Days	 	****	 	****	 	****	 	****	 	****
		 	Medical Monitor — Americas 	 	Days	 	****	 	****	 	****	 	****	 	****
		 	Safety Officer — Americas 	 	Days	 	****	 	****	 	****	 	****	 	****

  

  

	****	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. 

   

			
	KO1607 Study PEP005-009	  	Page 24









 Omnicare CR, Inc. Clinical Budget for: 
  

			
	 Sponsor:
	  	Peplin Ltd.
	 Compound:
	  	PEP005 topical gel
		  	An open-label, multi-center, dose-escalation, cohort study to determine the maximum tolerated dose and safety of PEP005 Topical Gel given as either a single application (on Day 1= or two
applications (on Day 1 and Day 8) to a superficial Basal Cell Carcinoma
	 Study:
	  	(sBCC) on the trunk
	 PCN:
	  	KO1607 (6 sites. 1 protocol only)

  

																	
	  	 	  	 	 Services
	  	Unit	  	    # Units    	  	Unit cost
  (USD $)  	  	Fees (USD $)	  	Estimated
Past-
Through
Costs
(USD $)	  	Estimated
Total Cost
(USD $)
		 		 	 CQA Manager - Americas
 (Optional if
requeued)
	  	Days	  	****	  	****	  	****	  	****	  	****
		 		 	CRA Attendees	  		  		  		  		  		  	
		 		 	> USA: ****CRA	  	Days	  	****	  	****	  	****	  	****	  	****
		 		 	Client Attendee Travel	  	Attendee	  	****	  	****	  	****	  	****	  	****
		 		 	 Sub-Total Clinical Trial
 Initiation
	  		  		  		  	****	  	****	  	****
		 	C	 	Clinical Trial Management	  		  		  		  		  		  	
		 	 •	 	 Clinical Trial Manager -
 Americas
 Assumes ****% (**** days per
 month) for **** months
	  	Days	  	****	  	****	  	****	  	****	  	****
		 	  •
	 	Clinical Monitoring	  		  		  		  		  		  	
		 		 	 > Site Qualification Visits
 Assume not required
	  		  		  		  		  		  	
		 		 	 > USA **** hrs on-site **** hrs
 for prep, follow-up, and reports,
 and **** hrs for travel
	  	Visits	  	****	  	****	  	****	  	****	  	****
		 		 	> Site Initiation Visits	  		  		  		  		  		  	
		 		 	 > USA **** hrs on-site, ****
 hrs for prep,
follow-up, and
 reports, and **** hrs for travel
	  	Visits	  	****	  	****	  	****	  	****	  	****
		 		 	> Site Initiation Visits	  		  		  		  		  		  	
		 		 	 > USA assume **** visits/sites
 **** hrs on
site, **** hrs for
 prep, follow-up, and reports, and
 **** hrs for travel
	  	Visits	  	****	  	****	  	****	  	****	  	****
		 		 	 > Additional Day Interm Visits
 (based on **** hour day, visits
 are total per zone, actual, will be
 billed)
	  		  		  		  		  		  	
		 		 	 > USA: assume **** day for
 Zone pool of visits
TBD if
 required Visits
	  	Visits	  	****	  	****	  	****	  	****	  	****
		 		 	 > USA **** hrs on-site **** hrs
 for prep
follow-up and reports
 and **** hrs for travel
	  	Visits	  	****	  	****	  	****	  	****	  	****
		 	  •
	 	 Site Maintance for ****
 hrs/month/ site (6 sites x ****
 enrollment and treatment
 months)
	  		  		  		  		  		  	
		 		 	> USA: 6 sites	  	Site
Months	  	****	  	****	  	****	  	****	  	****
		 	  •
	 	     CRA Monthly
     Teleconferences
	  		  		  		  		  		  	
		 		 	> USA **** CRA	  	Months	  	****	  	****	  	****	  	****	  	****

  

  

	****	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. 

  Page 25 








 Omnicare CR, Inc. Clinical Budget for: 
  

			
	 Sponsor:
	  	Peplin Ltd.
		
	 Compound:
	  	PEP005 topical gel
		
	 Study:
	  	An open-label, multi-center, dose-escalation, cohort study to determine the maximum tolerated dose and safety of PEP005 Topical Gel given as either a single application (on Day 1 = or two
applications (on Day 1 and Day 8) to a superficial Basal Cell Carcinoma (sBCC) on the trunk
		
	 PCN:
	  	KO1607 (6 sites. 1 protocol only)

  

															
	 Services
	  	Unit	  	# Units	  	Unit Cost (USD $)	  	Fees (USD $)	  	Estimated Pass —
Through Costs
(USD $)	  	Estimated Total
Cost (USD $)
	 •  
	 	 Project Team Training
	  		  		  		  		  		  	
		 	Project Director — America	  	Days	  	****	  	****	  	****	  	****	  	****
		 	CTM — Americas	  	Days	  	****	  	****	  	****	  	****	  	****
		 	Data Manager — Int’l	  	Days	  	****	  	****	  	****	  	****	  	****
		 	Medical Monitor — America	  	Days	  	****	  	****	  	****	  	****	  	****
		 	Safety Officer — Americas	  	Days	  	****	  	****	  	****	  	****	  	****
		 	Statistrician — Int’l	  	Days	  	****	  	****	  	****	  	****	  	****
		 	CRA Attendees	  	Days	  		  		  		  		  	
		 	> USA CRAs; **** CRA	  	Days	  	****	  	****	  	****	  	****	  	****
	 •
	 	Sponsor Meeting Attendance (bill on
actual)	  		  		  		  		  		  	
		 	 Project Director — Americas

 Assumes **** TC , **** hours
	  	Days	  	****	  	****	  	****	  	****	  	****
		 	 CTM — Americas

 Assume, **** TC **** hours
	  	Days	  	****	  	****	  	****	  	****	  	****
		 	Data Manager — Int’l	  	Days	  	****	  	****	  	****	  	****	  	****
		 	Medical Monitor — Americas	  	Days	  	****	  	****	  	****	  	****	  	****
		 	Safety Officer — Americas	  	Days	  	****	  	****	  	****	  	****	  	****
		 	Statistrician — Int’l	  	Days	  	****	  	****	  	****	  	****	  	****
		 	St. Writer — Americas	  	Days	  	****	  	****	  	****	  	****	  	****
	 •
	 	 Clinical Grants Administration
	  		  		  		  		  		  	
		 	> Grant Payment Set-up	  		  		  		  		  		  	
		 	> USA	  	Sites	  	****	  	****	  	****	  		  	****
		 	 > Grant Management (takes place for

 active site from site set-up through

 **** days after sites close-out;

 estimated amounts, actuals will be

 billed based on number of active sites

 set up)
	  		  		  		  		  		  	
		 	> USA	  	Site Quarters	  	****	  	****	  	****	  		  	****
		 	 > Payment Processing (estimated

 based on **** payments/site; actuals,

 including investigator and site related

 payment and any miscellaneous

 payments, actuals will be billed, pass

 through costs are related to

 photocopying and postage)
	  		  		  		  		  		  	

  

  

	****	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. 

  Page 26 








 Omnicare CR, Inc. Clinical budget for: 

			
	    Sponsor:	    	Peplin Ltd.
	    Compound:	    	PEP005 topical gel
		    	An open-label, multi-center, dose-escalation, cohort study to determine the maximum tolerated dose and safety of PEP005 Topical Gel given as either a single application (on Day 1= or two
applications (on Day 1 and Day 8) to a superficial Basal Cell Carcinoma
	    Study:	    	(sBCC) on the trunk
	    PCN:	    	KO1607 (6 sites, 1 protocol only)

  

															
	 	  	 Services
	  	     Unit    
	  	    # Units    	  	Unit Cost
    (USD $)    	  	    Fees (USD $)    	  	Estimated
Pass -
Through
Costs
    (USD $)    	  	Estimated
Total Cost
    (USD $)    
		  	> USA 6 sites	  	Payments	  	****	  	****	  	****	  	****	  	****
	•	  	Estimated Investigator Grants	  		  		  		  		  		  	
		  	Assumes one follow-up visit per
patient, no Academic Medical
Centers 	  	 Enrolled
 Patient —
 Americas
	  	****	  	****	  		  	****	  	****
	 •
	  	 Refund Checks (if needed, actuals
will be billed) 
	  	Refund	  	****	  	****	  	****	  	****	  	****
		  	Sub Total clinical Trial Management	  		  		  		  	****	  	****	  	****
	 D. Safety Medical 
	  		  		  		  		  		  	
	•	  	Medical Monitoring availability
during business hours (flat fee of
**** hours per month from first
patient in through last patient out,
**** months) Covers both studies
	  		  		  		  		  		  	
		  	> Americas 	  	Month	  	****	  	****	  	****	  	****	  	****
	•	  	Medical Monstoring during Study
Start Up and Study Close-out
(Billed on actuals)	  		  		  		  		  		  	
		  	> Americas 	  	Hours	  	****	  	****	  	****	  	****	  	****
	•	  	Safety Coordinator	  		  		  		  		  		  	
		  	> Americas — assumes **** days
per month for **** months +
**** days for safety plan
generation 	  	Days	  	****	  	****	  	****	  	****	  	****
	•	  	Availability for receipt of SAEs
during non-business hours (first
patient in to last patient out plus
one month)	  		  		  		  		  		  	
		  	> Americas 	  	Months	  	****	  	****	  	****	  	****	  	****
	•	  	SAE Reporting (without narratives)
Billed on actuals 	  	Report	  	****	  	****	  	****	  	****	  	****
	•	  	SAE Reporting (with initial
descriptive summary) Billed on
actuals 	  	Report	  	****	  	****	  	****	  	****	  	****
	•	  	SAE Reporting (Follow-
up/Revision Reports > ****) Billed
on actuals 	  	Report	  	****	  	****	  	****	  	****	  	****
	•	  	 ****
	  		  		  		  		  		  	
		  	> Project Set-Up Assume not
required as database for peplin
already exists at Omnicare 
	  	Project	  	****	  	****	  	****	  	****	  	****
		  	> Monthly Database Maintenance
(first patient 	  	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. 

  Page 27 








 Omnicare CR, Inc. Clinical Budget for: 

			
	    Sponsor:	    	Peplin Ltd.
	    Compound:	    	PEP005 topical gel
		    	An open-label, multi-center, dose-escalation, cohort study to determine the maximum tolerated dose and safety of PEP005 Topical Gel given as either a single application (on Day 1 = or two
applications (on Day 1 and Day 8) to a superficial Basal Cell Carcinoma
	    Study:	    	(sBCC) on the trunk
	    PCN:	    	KO1607 (6 sites, 1 protocol only)

  

															
	 	 	 Services
	  	     Unit    
	  	    # Units    	  	Unit Cost
    (USD $)    	  	    Fees (USD $)    	  	Estimated
Pass -
Through
Costs
    (USD $)    	  	Estimated
Total Cost
    (USD $)    
		 	in to database close) Covers both
studies 	  		  		  		  		  		  	
		 	> Data Entry into **** (actuals
will be billed) 	  	SAE	  	****	  	****	  	****	  	****	  	****
		 	Sub-Total Safety and Medical 	  		  		  		  	****	  	****	  	****
	 E. Clinical Data Management 
	  		  		  		  		  		  	
	•	 	Clinical Data Management
Oversight — int’l (CDM Manager
assumes ****% FTE x ****
months for Start-up. ****% FTE
for **** months for Duration and
****% FTE for
**** months for
Close-out)	  	Days	  	****	  	****	  	****	  	****	  	****
	•	 	Lead CDA — Int’l (assumes
****% FTE x **** months,
****% FTE x **** months, and
****% FTE for **** months)	  	Days	  	****	  	****	  	****	  	****	  	****
	•	 	Development of Data Management
Plan (includes **** major and
**** minor revision; add’l
revisions will be billed at ****
rates)	  	Days	  	****	  	****	  	****	  	****	  	****
	•	 	CRF Design (assumes **** page
CRF, **** unique CRE pages);
includes **** major and ****
minor revision	  	Project	  	****	  	****	  	****	  	****	  	****
	•	 	Database Development, Testing
and Maintenance (assumes ****
page CRF, **** unique CRF
pages)	  	Project	  	****	  	****	  	****	  	****	  	****
	•	 	Estimated Data Entry
(actuals will be billed)	  		  		  		  		  		  	
		 	> Pages in Int’l 	  	Pages	  	****	  	****	  	****	  	****	  	****
	•	 	Estimated Data Review and Query
Resolution (assumes **** issue per
**** CRF pages, **** manual
checks and the application of ****
study assumption for **** CRF
pages);
assumes **** CRF pages
per enrolled patient, **** pages per
screen failure patient, and ****
pages per drop out patient. Queries
will be billed on actuals.	  		  		  		  		  		  	
		 	> CRF Pages 	  	Page	  	****	  	****	  	****	  	****	  	****
	•	 	Quality Control Check of	  	Patients	  	****	  	****	  	****	  	****	  	****

  

  

	****	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. 

  Page 28 








 Omnicare CR, Inc. Clinical Budget for: 
  

					
	 Sponsor:
	  		  	Peplin Ltd.
			
	 Compound:
	  		  	PEP005 topical gel
			
		  		  	An open-label, multi-center, dose-escalation, cohort study to determine the maximum tolerated dose and safety of PEP005 Topical Gel given as either a single application (on Day 1 = or two
applications (on Day land Day 8) to a superficial Basal Cell Carcinoma
			
	 Study:
	  		  	(sBCC) on the trunk
			
	 PCN:
	  		  	KOI607 (6 sites. 1 protocol only)

  

																	
	  	 	  	 	 Services
	  	    Unit    	  	    # Units    	  	Unit Cost
    (USD $)    	  	    Fees (USD $)    	  	Estimated
Pass
Trough
Cost
    (USD $)    	  	Estimated
Total Cost
    (USD $)    
		 		 	Database versus CRF (assumes
**** CRF pages per patient) QC
of critical variables, assume
**** min per patient, ****
patients	  		  		  		  		  		  	
		 	•	 	Quality Control Check of
Database versus CRF (assumes
**** CRF pages per patient)
Full QC check, assume ****
min per patient, **** patients	  	Patients	  	****	  	****	  	****	  	****	  	****
		 	•	 	Edit Development (actuals will
be billed)	  	Edits	  	****	  	****	  	****	  	****	  	****
		 	•	 	CRF and Query Tracking
(includes all ancillary Pages;
actuals will be billed) Assumes
**** min per page	  	Page	  	****	  	****	  	****	  	****	  	****
		 	•	 	Concomitant Medication ATC
Coding (actuals will be billed)	  	Term	  	****	  	****	  	****	  	****	  	****
		 	•	 	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	  	****	  	****	  	****	  	****	  	****
		 	•	 	Central Laboratory—Initial
Load (actual will be billed)	  		  		  		  		  		  	
		 		 	Initial Load	  	Load	  	****	  	****	  	****	  	****	  	****
		 		 	>Subsequent Load (actuals will
be billed) Assumes monthly
during **** months enrolment
+ treatment period to database
lock	  	Monthly	  	****	  	****	  	****	  	****	  	****
		 		 	Lab Visit Verification (****
visits x **** patients; actuals
will be billed)	  	Visits	  	****	  	****	  	****	  	****	  	****
		 	•	 	Reconciliation of the Safety and
Clinical Database (actuals will
be billed)	  	SAE	  	****	  	****	  	****	  		  	****
		 	•	 	Protocol deviation log Assumes
****hrs of Programmer time	  	Hours	  	****	  	****	  	****	  		  	****

  
  
  

  

	****	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. 

  Page 29 








 Omnicare CR, Inc. Clinical Budget for: 
  

					
	     Sponsor:
	  		  	Peplin Ltd.
			
	     Compound:
	  		  	PEP005 topical gel
		  		  	An open-label, multi-center, dose-escalation, cohort study to determine the maximum tolerated dose and safety of PEP005 Topical Gel given as either a single application (on Day 1 = or two
applications (on Day 1 and Day 8) to a superficial Basal Cell Carcinoma
			
	     Study:
	  		  	(sBCC) on the trunk
			
	     PCN:
	  		  	KO1607 (6 sites. 1 protocol only)

  

															
	  	 	 Services
	  	    Unit    	  	    # Units    	  	Unit Cost
    (USD $)    	  	    Fees (USD $)    	  	Estimated
Past-
Through
Cost
    (USD $)    	  	Estimated
Total Cost
    (USD $)    
	      •        	 	DESC Meeting -Customized
Reports	  	Report	  	****	  	****	  	****	  	****	  	****
		 	Sub-Total Clinical Data
Management	  		  		  		  	****	  	****	  	****
	     F .
	 	Biometrics Analysis 	  		  		  		  		  		  	
	      •	 	Biometrics Team Manager
Assumes **** days per month
for **** months 	  	Days	  	****	  	****	  	****	  	****	  	****
	      •	 	 Project Data Setup
	  	Project	  	****	  	****	  	****	  	****	  	****
	      •	 	 Statistical Analysis Plan
	  	Project	  	****	  	****	  	****	  	****	  	****
	      •	 	 Design of Table Shells (Mocks)
	  	Project	  	****	  	****	  	****	  	****	  	****
	      •	 	Programming/QC of Data
Displays (actuals will be billed).	  		  		  		  		  		  	
		 	 Unique Tables 
	  	Table	  	****	  	****	  	****	  	****	  	****
		 	 Repeat Tables 
	  	Table	  	****	  	****	  	****	  	****	  	****
		 	 Unique Listings 
	  	Listing	  	****	  	****	  	****	  	****	  	****
		 	 Repeat Listings 
	  	Listing	  	****	  	****	  	****	  	****	  	****
		 	 Unique Figures 
	  	Figure/Graph	  	****	  	****	  	****	  	****	  	****
		 	 Repeat Figures 
	  	Figure/Graph	  	****	  	****	  	****	  	****	  	****
	      •	 	 Statistical Analysis
	  		  		  		  		  		  	
		 	 > Regular 
	  	Project	  	****	  	****	  	****	  	****	  	****
	      •	 	 FDA Item 11
	  	Project	  	****	  	****	  	****	  	****	  	****
	      •	 	 Standard Data Transfer
	  		  		  		  		  		  	
		 	 >Initial 
	  	Transfer	  	****	  	****	  	****	  	****	  	****
		 	 > Subsequent 
	  	Transfer	  	****	  	****	  	****	  	****	  	****
		 	 > Add **** datasets will be
billed @ $**** Euro per
dataset 
	  		  		  		  		  		  	
	 Add 1 Stats consulting meeting attendance, etc., will be charged at **** rates as follows:

		 	 Team Leader 
	  	Days	  		  	****	  		  		  	
		 	 Statistician 
	  	Days	  		  	****	  		  		  	
		 	 Programmer 
	  	Days	  		  	****	  		  		  	
		 	 Sub-Total Biometrics 
	  		  		  		  	****	  	****	  	****
	    G.	 	 Clinical Writing 
	  	All assumes using Omnicare SOPs.
	      •	 	 Clinical Study Report
	  		  		  		  		  		  	
		 	 >Phase 11/111 Report
(includes **** major (up to
**** days) and **** minor (up
to
**** day revision) 

	  	Report	  	****	  	****	  	****	  	****	  	****
		 	 > Tables (greater than ****) 
	  	Report	  	****	  	****	  	****	  		  	****
	      •	 	Narratives (actuals will be
billed) 	  	Narrative	  	****	  	****	  	****	  	****	  	****
	      •	 	 Clinical Writing input to
	  	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. 

  Page 30 








 Omnicare CR, Inc. Clinical Budget for: 

					
	     Sponsor:
	  		  	Peplin Ltd.
	     Compound:
	  		  	PEP005 topical gel
		  		  	An open-label, multi-center, dose-escalation, cohort study to determine the maximum tolerated dose and safety of PEP005 Topical Gel given as either a single application (on Day 1 = or two
applications (on Day 1 and Day 8) to a superficial Basal Cell Carcinoma
	     Study:
	  		  	(sBCC) on the trunk
	     PCN:
	  		  	KO1607 (6 sites. 1 protocol only)

  

															
	 Services
	 	    Unit    	 	  # Units  	 	Unit Cost
    (USD $)    	 	    Fees (USD $)    	 	Estimated
Pass —
Through
costs
    (USD$)    	 	Estimated Total
    Cost (USD $)    
		 	 SAP
	 		 		 		 		 		 	
	 Attendance at Sponsor Requested Meetings:
 Attendance at Sponsor requested meetings (teleconferences/video conferences or client review/planning meetings
at
 Sponsor/Omnicare CR, Inc) will be billed to Sponsor according to the following per diem rates


								
		 	 Director:
	 	$ ****	 		 		 		 		 	
		 	 Senior Writer
	 	$ ****	 		 		 		 		 	
		 	 Clinical Writer:
	 	$ ****	 		 		 		 		 	
	 Sponsor will be billed for actual time expended
	 		 		 		 		 		 	
		 	 Sub-Total Clinical Writing
	 		 		 		 	****	 	****	 	****
	 H. Technology
	 		 		 		 		 		 	
	 •
	 	 Omni View
	 		 		 		 		 		 	
		 	 >Set-up
	 	Site	 	****	 	****	 	****	 	****	 	****
		 	 >Monthly Maintenance
	 	Months	 	****	 	****	 	****	 	****	 	****
		 	 Sub-Total Technology
	 		 		 		 	****	 	****	 	****
	 1. Regulatory Services
	 		 		 		 		 		 	
	 •   
	 	 CRF Filing and Reconciliation (bill on
actuals)
	 	Pages	 	****	 	****	 	****	 	****	 	****
	 •   
	 	 Return of CRF (hard copy.); bill on actuals
	 	Page	 	****	 	****	 	****	 	****	 	****
	 •   
	 	 Return of Investigator and Study-Wide
Documents (paper)
	 	Sites	 	****	 	****	 	****	 	****	 	****
	 •   
	 	 Report SAEs to FDA Agency
	 	# SAEs	 	****	 	****	 	****	 		 	****
	 •   
	 	 Compilation of Clinical Study Report
Appendices (electronic copy)
	 		 		 		 		 		 	
		 	 > Setup and Management Fee
	 	Report	 	****	 	****	 	****	 	****	 	****
		 	 > Scanning, actuals will be billed
	 	Pages	 	****	 	****	 	****	 	****	 	****
		 	 > Volumes (fee does not include hyper-
linking):
actuals will be billed
	 	Volume	 	****	 	****	 	****	 	****	 	****
		 	 Sub-Total Regulatory Services
	 		 		 		 	****	 	****	 	****
	 J. Clinical Quality Assurance
	 		 		 		 		 		 	
	 •   
	 	 Quality Plan
	 	Days	 	****	 	****	 	****	 	****	 	****
	 •   
	 	 Contract Provider Audits (****) (fees include
preparation, travel, on-site and reporting
time)
	 	Site	 	****	 	****	 	****	 	****	 	****
		 	 Sub-Total Clinical
	 		 		 		 	****	 	****	 	****

  

  

	****	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. 

  Page 31 









			
	Omnicare CR, Inc. Clinical Budget for:
	    Sponsor:	  	Peplin Ltd.
	    Compound:	  	 PEP005 topical gel
 An open-label,
multi-center, dose-escalation, cohort study to determine the maximum tolerated dose and safety of PEP005 Topical Gel given as either a single application (on Day 1 = or two applications (on Day 1 and Day 8) to a superficial Basal Cell Carcinoma


	    Study:	  	(sBCC) on the trunk
	    PCN:	  	KO1607 (6 sites. 1 protocol only)

  

															
	 Services
	 	    Unit    	 	#
    Units    	 	    Unit Cost (USD $)    	 	    Fees (USD $)    	 	Estimated Pass-
Through Costs
    (USD $)    	 	Estimated Total
    Cost (USD $)    
		 	 Quality Assurance 
	 		 		 		 		 		 	
	 L. Miscellaneous Pass-Through Expenses
	 		 		 		 		 		 	
	 •
	 	CRF Printing (bill on actuals) Assume
one CRF per subject + ****% extra 	 	Pages	 	****	 	****	 		 	****	 	****
	 •
	 	Investigator Binders
(includes printing, copying and
shipping)
Assume one per investigator	 	Binder	 	****	 	****	 		 	****	 	****
	 •
	 	Shipment of Start-up Packet
(**** shipment x 6 sites)	 	Sites	 	****	 	****	 		 	****	 	****
	 •
	 	 Phone Center
	 	Month	 	****	 	****	 		 	****	 	****
	 •
	 	 Beeper/Pager(# x months)
	 	Month	 	****	 	****	 		 	****	 	****
	 •
	 	 Dedicated Fax Line
	 	Month	 	****	 	****	 		 	****	 	****
	 •
	 	 Central Lab - ****
	 	Project	 	****	 	****	 		 	****	 	****
	 •
	 	Photography Lab
Assume at least one picture of
selected **** at each visit cameras
for 6 sites 	 	Project	 	****	 	****	 		 	****	 	****
	 •
	 	Dermatopathology Lab - ****
****	 	Project	 	****	 	****	 		 	****	 	****
		 	 Sub-Total Miscellaneous
	 		 		 		 		 	****	 	****
		 	 Pass Through Expenses
	 		 		 		 		 		 	
	 Estimated Services Budget
	 		 		 		 	****	 		 	
	 Estimated Pass Through
	 		 		 		 		 	****	 	
	 Total Estimated Budget
	 		 		 		 		 		 	****

 B. Payment Schedules 
   1. Invoicing Process for Service Fees 
 Omnicare CR maintains a project accounting system, whereby all
direct project costs (service or pass-through expenses) are coded by project. 
 An initial payment of $**** representing approximately **** percent (****%)
of the Estimated Service Fees is due and payable upon execution of this Exhibit J. Subsequent payments shall be made monthly, based on Project progress and upon submission of an invoice to Sponsor by Omnicare CR. After receipt of the initial
payment, the subsequent invoices shall be reduced by a prorated portion from the initial payment such that the initial payment is applied evenly over the remaining term of the Project. All payments shall be processed within **** days. If any
payment of 
  

  

	****	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. 

  Page 32 








 service fees or pass through expenses is late by more than **** (****) days, such payment shall be subject to a
penalty fee of ****% per month of the outstanding balance. 
 2. Exchange Rate 
 The pricing is based on the following exchange rates assumptions: 
 One (1) EUR € = 1.2705 USD 
 This Exhibit involves services provided in regions with currencies other than the budget currency, which is
US Dollar. At the time Omnicare CR processes any pass through expenses (including grants) in currencies other than US Dollar, such expenses shall be converted to US Dollar using the exchange rate for the corresponding period as published by
www.oanda.com 
 3. Pass through Expense Invoicing 
 Grant Payments — Omnicare CR will invoice **** (****) days in advance of grant payments due investigators based on estimates. 
 Omnicare CR requires payment from Sponsor —at least **** (****) days in advance of the actual payment to investigators. Payments to investigators will not be released until payments are received by Omnicare
CR from Sponsor. Upon Sponsor’s request, Omnicare CR agrees to deposit payments from Sponsor into a non-interest bearing bank account. Omnicare CR shall draw upon such account to make the investigator payments. Any remaining funds in the
account will be returned to Sponsor after the termination of the study, as soon as all contracted obligations to the investigators have been satisfied. 
 In
the event payments from Sponsor are insufficient to cover the payments to investigators, Sponsor will promptly advance funds to Omnicare CR for the amount of grant payments required. 
 Omnicare CR’s project accounting system is able to capture and categorize in summary the following key pass-through expenses related to a project: 
  

	 	•	 	 Travel 


  

	 	•	 	 Delivery Costs 


  

	 	•	 	 CRF and other printing or copying costs 


  

	 	•	 	 Investigator Meeting costs 


  

	 	•	 	 Telecommunication Costs (which may include telephone, fax, paper, conference calls, or PC connectivity charges) 


  

	 	•	 	 All other Project related expenses that are not related to service fees 


 Any additional detail to support pass-through costs will be provided on a fee basis. 
 All payments shall be processed within
**** days. 
  

  

	****	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. 

  Page 33 








 4. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary, the estimated Service Fees set forth in this Exhibit J shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the
price of the remaining Services under this Exhibit J as of each ****; such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 VI. Signatory Authority 
 The parties acknowledge and agree that
Sponsor has authorized Omnicare CR to execute all Clinical Study Agreements with investigators in the Project on behalf of Sponsor. Sponsor understands and acknowledges that it will be bound by the terms of the investigator agreements. 

ACCEPTANCE 
 The terms and conditions of the Master Agreement
govern this Exhibit J and such document is incorporated herein by reference as if fully set forth herein. 
  

									
	BY AND BETWEEN:	 		 		 	
				
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.	 	
				
	 BY: /s/ Peter Welburn
	 		 	 BY: /s/ Dale Evans
	 	
	Name: Peter Welburn	 		 	Name: Dale Evans	 	
	Title: General Manager	 		 	Title: CEO	 	
	Australia	 		 	Dated: 02/21/07	 	
	Dated: 15/1/07	 		 		 	

  

  

	****	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. 

  Page 34 








 Exhibit K to the Clinical Services Master Agreement 
 between Peplin Operations Pry Ltd. and Omnicare CR, Inc., 
 dated 1st June 2005 
 THIS EXHIBIT K is entered into this 4
th day of December, 2006 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor”) and
Omnicare CR, Inc, (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and
Omnicare CR entered into a Clinical Services Master Agreement, dated 1st June 2005 (hereinafter the “Master Agreement”), wherein
Omnicare CR agreed to provide clinical services; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as
an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing
or payment, references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR shall provide the services set forth in this Exhibit K, subject to the terms and conditions set forth in the Master Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows:

 I.    Project Plan 
 Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for
Sponsor’s study entitled: “An open label, multi-centre, dose-escalation, cohort study to determine the optimal tolerated regime and safety of PEP005 Topical Gel when applied to a 25 cm 2
 contiguous actinic keratoses treatment area on the face or face and scalp”. The Protocol Reference Number is PEP005-007, Draft version 0.5, dated 23
November 2006] (hereinafter “the Project”) and associated costs. Changes made in the Project scope, at any time during the Project, will result in a corresponding adjustment to the Project costs. 
 II.    Project Roles and Responsibilities 
 Sponsor has requested assistance from Omnicare CR with safety and medical, clinical data management, biometrics and clinical writing services to support 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. 

  Page 1 








 III.    Omnicare CR Services 
 Services provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the project specifications provided by Sponsor, and are outlined below. It should be noted, however, that
the costs presented in this budget for these services are estimated pending review of the final specifications, protocol and CRF. 
  

					
	 Task List (Major)
	  	        Peplin        	  	        Omnicare        
	 Investigator’s Meeting
	  		  	
	 1. Plan Investigator’s Meeting
	  	ü	  	
	 2. Prepare binders for the meeting
	  	ü	  	
	 3. Present Investigator’s meeting
	  	ü	  	
	 4. Attendance at meeting — Qld. — Biostatistician Only
	  	ü	  	ü
	 Medical Management
	  		  	
	 1. Safety Plan and Master File Set Up
	  		  	ü
	 2. Document and manage all SAEs
	  		  	ü
	 3. Cover medical emergencies after hours (pager)
	  		  	ü
	 4. Develop and maintain safety database
	  		  	ü
	 5. Submit SAE reports to regulatory authorities
	  		  	ü
	 6. Prepare safety updates
	  		  	ü
	 7. Medical Monitor- Review of SAEs
	  		  	ü
	 Data Entry
	  		  	
	 1. Design/develop data collection system
	  		  	ü
	 2. Validate data collection system
	  		  	ü
	 3. Document control of CRFs
	  		  	ü
	 4. Enter and verify data
	  		  	ü
	 Data Management
	  		  	
	 1. Design/develop data cleaning system
	  		  	ü
	 2 Validate cleaning system
	  		  	ü
	 3. Write data management guidelines and edit specifications
	  		  	ü
	 4. Write CRF completion guidelines
	  	ü	  	
	 5. Review CRF and run edit system
	  		  	ü
	 6. Resolve edit queries
	  		  	ü
	 7. Incorporate laboratory data into database
	  		  	ü
	 8. Document corrections to CRFs
	  		  	ü

  

  

	****	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. 

  Page 2 









					
	 Task List (Major)
	  	        Peplin        	  	        Omnicare        
	 Date Management (continued)
	  		  	
	 9. Perform QC audits — electronic data vs paper CRFs
	  		  	ü
	 10. Code adverse events
	  		  	ü
	 11. Code medications (terms and ATC)
	  		  	ü
	 12. Test data transfer after 25% of patients completed
	  		  	ü
	 13. Test data transfer after 75% of patients completed
	  		  	ü
	 14. Produce protocol deviation logs
	  		  	ü
	 15. Provide DESC data listings
	  		  	ü
	 Biometrics
	  		  	
	 1. Prepare a statistical analysis plan prior to database lock
	  		  	ü
	 2. CRF development and statistical review
	  		  	ü
	 3. Define efficacy tables and listings
	  		  	ü
	 4. Define safety tables and listings
	  		  	ü
	 5. Produce efficacy tables and listings
	  		  	ü
	 6. Produce safety tables and listings
	  		  	ü
	 7. Provide draft report template and analysis plan
	  		  	ü
	 8. Approve report template
	  	ü	  	
	 9. Validate efficacy tables and listings
	  		  	ü
	 10. Validate safety tables and listings
	  		  	ü
	 11. Perform quality assurance audit of the tables and listings
	  		  	ü
	 12. Provide final tables and listings
	  		  	ü
	 13. Provide statistical analysis
	  		  	ü
	 Report Preparation
	  		  	
	 1. Prepare draft report template
	  		  	ü
	 2. Approve final report template
	  		  	ü
	 3. Draft study report
	  		  	ü
	 4. Final study report
	  		  	ü
	 5. Perform quality assurance of study report
	  		  	ü
	 6. Approval of final study report
	  	ü	  	
	 7. Database transfer to Client
	  		  	ü

  

  

	****	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. 

  Page 3 








 IV. Project Timeline 
 The parties acknowledge that Omnicare CR will commence performance of the Services on or about ****. The projected timeline for this Project is as follows: 
  

			
	 Activities
	  	Anticipated Timeline
	 Project Start Up
	  	****
	 First Patient In
	  	****
	 Last Patient In (assumes **** months recruitment period)
	  	****
	 Last Patient Out (assumes **** months treatment time)
	  	****
	 Last CRF to Data Management
	  	****
	 Database Close
	  	****
	 Statistical Analysis Available
	  	****
	 Clinical Study Report provided to Peplin
	  	****
	 Project Close-out
	  	****
	 Total Project Duration
	  	****

 A detailed timeline and milestones will be developed based on the different assumptions of how the project is
conducted. 
 V. Budget 
 A. Estimated Project Budget

 The following budget is presented to Peplin in Australian Dollars (A$): 
  

													
	 Services
	 	    Unit    	 	#
    Units    	 	    Unit Cost    	 	    Fees    	 	Estimated
    Pass-Thru    	 	Estimated
    Total Cost    
	 A. Study Management and Investigator Meeting Attendance

	 •     Project Administrative
Support/Coordination — Int’l (incl.
support for all functional
areas) for project
duration of **** months
	 	Days	 	****	 	****	 	****	 	****	 	****
	 •     Investigators’ Meeting Attendance
(Statistician — Australia)
	 	Days	 	****	 	****	 	****	 	****	 	****
	 Sub-Total Study Management and Investigator Meeting Attendance
	 	****	 	****	 	****

  
  
  

  

	****	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. 

  Page 4 









													
	 Services
	 	    Unit    	 	#
    Units    	 	    Unit Cost    	 	    Fees    	 	Estimated
    Pass-Thru    	 	Estimated
    Total Cost    
	 B. Safety and Medical
	 		 		 		 		 		 	
	 •     Medical Monitoring availability during
business hours (flat fee of **** hours per
month from first
patient in through last
patient out)
	 	Months	 	****	 	****	 	****	 	****	 	****
	 •     Medical Monitoring availability during
non-business hours (from first patient in
through last
patient out; billed on actuals)
	 	Hours	 	****	 	****	 	****	 	****	 	****
	 •     Safety Coordinator
(assumes ****
day/month for ****
months
	 	Days	 	****	 	****	 	****	 	****	 	****
	 •     SAE Reporting (with
initial descriptive
summary) Billed on
actuals 
	 	Report	 	****	 	****	 	****	 	****	 	****
	 •     SAE Reporting
(Follow-up/Revision
Report >****)
Billed on actuals 
	 	Report	 	****	 	****	 	****	 	****	 	****
	 •     ****
	 		 		 		 		 		 	
	 >Monthly Database Maintenance (first
patient in to database close) 
	 	Month	 	****	 	****	 	****	 	****	 	****
	 >Data Entry into
**** (actuals will
be billed) 
	 	SAE	 	****	 	****	 	****	 	****	 	****
	 •     Safety Reporting to Regulatory Authorities
— Int’l (assumes **** estimated ****
hours
per reportable SAE (‘SUSAR’);
actuals will be billed 
	 	Hours	 	****	 	****	 	****	 	****	 	****

  
  
  

  

	****	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. 

  Page 5 









													
	 Services
	 	    Unit    	 	#
    Units    	 	    Unit Cost    	 	    Fees    	 	Estimated
    Pass-Thru    	 	Estimated
    Total Cost    
	 •     Safety Reporting of SAEs to Investigator
Sites — Int’l (estimated **** hours
per
reportable SAE (‘SUSAR’); actuals will be
billed)
	 	Hours	 	****	 	****	 	****	 	****	 	****
	 •     Safety Plan and Master File Set Up (also
includes protocol familiarisation)
	 	Project	 	****	 	****	 	****	 	****	 	****
	 Sub-Total Safety and Medical
	 		 		 		 	****	 	****	 	****
	 C. Clinical Data Management
	 		 		 		 		 		 	
	 •     Clinical Data Management Oversight —
Int’l (CDM Manager assumes ****% FTE
x
**** months for Start- up, ****% FTE
for **** months for Duration, and ****%
FTE for **** months for Close-out)
	 	Days	 	****	 	****	 	****	 	****	 	****
	 •     Lead CDA — Int’l (assumes ****% FTE
x **** months. ****% FTE x
**** months, and
****% FTE for
**** months
	 	Days	 	****	 	****	 	****	 	****	 	****
	 •     Development of Data Management Plan
(includes **** major and **** minor
revision; add’l
revisions will be billed at
per diem rates)
	 	Days	 	****	 	****	 	****	 	****	 	****
	 •     CRF Design (assumes **** page CRF,
**** unique CRF pages); includes ****
major and **** minor
revision
	 	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. 

  Page 6 









													
	 Services
	 	    Units    	 	#
    Units    	 	    Unit Cost    	 	    Fees    	 	Estimated
    Pass-Thru    	 	Estimated
    Total Cost    
	 •     Database Development, Testing and
Maintenance (assumes **** page CRF,
**** unique
CRF
	 	Project	 	****	 	****	 	****	 	****	 	****
	 •     Estimated Data Entry (actuals will be
billed)
	 	Pages	 	****	 	****	 	****	 	****	 	****
	 •     Estimated Data Review and Query
Resolution (assumes **** issue per ****
CRF pages, **** manual
checks and the
application of **** study assumption for:
**** CRF pages); assumes **** CRF
pages per enrolled patient, **** pages per
screen failure patient, and **** pages per
drop out patient. Queries will be billed on
actuals.

	 	Pages	 	****	 	****	 	****	 	****	 	****
	 •     Quality Control Check of Database versus
CRF (QC of critical variables)
	 	Patients	 	****	 	****	 	****	 	****	 	****
	 •     Quality Control Check of Database versus
CRF (assumes **** CRF pages per
patient); Full QC check)

	 	Patients	 	****	 	****	 	****	 	****	 	****
	 •     Edit, Development
(actuals will be
billed)
	 	Edits	 	****	 	****	 	****	 	****	 	****
	 •     CRF and Query Tracking (includes all
ancillary pages; actuals will be billed)
	 	Pages	 	****	 	****	 	****	 	****	 	****
	 •     Dictionary Med remapping — ATC Meds
(actuals will be billed)
	 	Term	 	****	 	****	 	****	 	****	 	****

  
  
  

  

	****	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. 

  Page 7 









													
	 Services
	 	    Units    	 	#
    Units    	 	    Unit Cost    	 	    Fees    	 	Estimated
    Pass-Thru    	 	Estimated
    Total Cost    
	 •   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	 	****	 	****	 	****	 	****	 	****
	 •   External Vendor — Initial Load (actuals
will be billed)
	 		 		 		 		 		 	
	 > Initial Load 
	 	Load	 	****	 	****	 	****	 	****	 	****
	 >Subsequent Load (actuals will be billed) 
	 	Load	 	****	 	****	 	****	 	****	 	****
	 >Lab Visit Verification (**** visits x **** patients; actuals will be billed) 
	 	Visits	 	****	 	****	 	****	 	****	 	****
	 •   Reconciliation of the Safety and Clinical
Database (actuals will be billed)
	 	SAE	 	****	 	****	 	****	 	****	 	****
	 •   Protocol Deviation Log Load
	 	Load	 	****	 	****	 	****	 	****	 	****
	 •   DESC data listings (**** DESC reports at
**** hours programmer time per report)
	 	Report	 	****	 	****	 	****	 	****	 	****
	 •   CRF Filing and Reconciliation (bill on
actuals)
	 	Pages	 	****	 	****	 	****	 	****	 	****
	 •   Return of CRF (hard copy); bill on actuals
	 	Pages	 	****	 	****	 	****	 	****	 	****
	 Sub-Total Clinical Data Management 
	 		 	****	 	****	 	****

  

  
  
  

	****	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. 

  Page 8 









													
	 Services
	 	    Units    	 	#
    Units    	 	    Unit Cost    	 	    Fees    	 	Estimated
    Pass-Thru    	 	Estimated
    Total Cost    
	 D. Biometrics Analysis
	 		 		 		 		 		 	
	 •   Biometrics Team Manager
	 	Days	 	****	 	****	 	****	 	****	 	****
	 •   Project Data Setup
	 	Project	 	****	 	****	 	****	 	****	 	****
	 •   Statistical Plan
	 	Project	 	****	 	****	 	****	 	****	 	****
	 •   Randomisation Schedule
	 	Project	 	****	 	****	 	****	 	****	 	****
	 •   Design of Table Shells (Mocks)
	 	Project	 	****	 	****	 	****	 	****	 	****
	 > Unique Tables 
	 	Table	 	****	 	****	 	****	 	****	 	****
	 > Repeat Tables 
	 	Table	 	****	 	****	 	****	 	****	 	****
	 > Unique Listings 
	 	Listing	 	****	 	****	 	****	 	****	 	****
	 > Repeat Listings 
	 	Listing	 	****	 	****	 	****	 	****	 	****
	 •   Programmatic Evaluability/Outcome
	 	Project	 	****	 	****	 	****	 	****	 	****
	 •   Statistical Analysis
	 	Project	 	****	 	****	 	****	 	****	 	****
	 •   FDA Item 11
	 	Project	 	****	 	****	 	****	 	****	 	****
	 •   Standard Data Transfer (initial only)
	 	Transfer	 	****	 	****	 	****	 	****	 	****
	 •   Biometrics review of CRF
	 	Hours	 	****	 	****	 	****	 	****	 	****
	 Sub-Total Biometrics Analysis
	 		 		 		 	****	 	****	 	****
	 E. Clinical Writing
	 		 		 		 		 		 	
	 •   Clinical Study Report
	 		 		 		 		 		 	
	 > Phase II/III Report (includes ****
major (up to **** days) and **** minor
(up to **** day) revision) 
	 	Report	 	****	 	****	 	****	 	****	 	****
	 >Tables (greater
than ****) 
	 	Report	 	****	 	****	 	****	 	****	 	****
	 •   Narratives (actuals
will be billed) 
	 	Narrative	 	****	 	****	 	****	 	****	 	****
	 •   Clinical Writing Input to SAP
	 	Project	 	****	 	****	 	****	 	****	 	****
	 Sub-Total Clinical Writing
	 		 		 		 	****	 	****	 	****

  

  
  
  

	****	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. 

  Page 9 









													
	 Services
	  	    Units    	  	#
    Units    	  	    Unit Cost    	  	    Fees    	 	Estimated
    Pass-Thru    	 	Estimated
    Total Cost    
	 Estimated Services Budget
	  		  		  		  	****	 		 	
	 Estimated Pass Through
	  		  		  		  		 	****	 	
	 Total Estimated Budget
	  		  		  		  		 		 	****

 B. Payment Schedules 
 1. Invoicing Process for Service Fees 
 Omnicare CR maintains a project accounting system, whereby all direct project costs (Service Fees or
Pass-Through Expenses) are coded by project 
 An initial payment of A$****, representing approximately **** percent (****%) of the estimated Service Fees,
is due and payable upon execution of this Exhibit K. Subsequent payments shall be made monthly, based on Project progress and upon submission of an invoice to Sponsor by Omnicare CR. After receipt of the initial payment, the subsequent invoices
shall be reduced by a prorated portion from the initial payment such that the initial payment is applied evenly over the remaining term of the Project. All payments shall be processed within **** days. If any payment of Service Fees or
Pass-Through Expenses is late by more than **** (****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
 2. Exchange Rates 
 The pricing is based on the following exchange rates assumptions: 
 One (1) A$ = US Dollars (US$) 0.7675 
 This
Exhibit K involves services provided in regions with currencies other than the budget currency, which is Australian Dollars (A$). In the event the exchange rate moves three percent (3%) or more positively or negatively within a six-month
timeframe, the parties agree to meet in good faith to discuss and negotiate new rates based on the new exchange rate. 
 In addition, at the time Omnicare CR
processes any pass through expenses in currencies other than A$, such expenses shall be converted to A$ using the exchange rate for the corresponding period as published by oanda.com. 
 3. Pass-Through Expense Invoicing 
 Omnicare CR’s project accounting system is able to capture and categorise in
summary the following key pass-through expenses related to your 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. 

  Page 10 









	 	•	 	 Travel 


  

	 	•	 	 Delivery Costs 


  

	 	•	 	 Printing or copying costs 


  

	 	•	 	 Meeting costs 


  

	 	•	 	 Telecommunication Costs (which may include telephone, fax, paper, conference calls, or PC connectivity charges) 


  

	 	•	 	 All other Project related expenses that are not related to service fees 


 4. Payments 
 Sponsor shall make payment directly to the following bank account nominated by Omnicare CR: 

Omnicare CR Inc. 
 Westpac Banking
Corporation, 
 Maquarie Shopping Centre, 
 North Ryde, NSW 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 5. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary, the estimated Service Fees set forth in this Exhibit K shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the
price of the remaining Services under this Exhibit K as of each ****, such increase shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 ACCEPTANCE 
 The terms and conditions of the Master Agreement govern
this Exhibit K and such document is incorporated herein by reference as if fully set forth herein. 
  

													
	BY AND BETWEEN:	  		  	
			
	Peplin Operations Pty Ltd.	  		  	Omnicare CR, Inc.
					
	BY:	 	 /s/ PETER WELBURN
	  		  	BY:	 	 /s/ Dale Evans

		 	Name:	 	PETER WELBURN	  		  		 	Name:	 	Dale Evans
		 	Title:	 	GENERAL MANAGER, AUS.	  		  		 	Title:	 	CEO
		 	Date:	 	14 FEBRUARY 2007	  		  		 	Date:	 	03/05/07

  

  

	****	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. 

  Page 11 








 Exhibit L to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 1st June 2005 
 THIS EXHIBIT L is entered into this 11
th day of July, 2007 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor” ) and
Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a Clinical Services Master
Agreement, dated 1st June 2005 (hereinafter the “Master Agreement”), wherein Omnicare CR agreed to provide clinical services; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing
and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS , Sponsor and Omnicare CR agree that Omnicare CR shall provide the services set forth in this Exhibit L, subject to the terms and
conditions set forth in the Master Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY
BOUND, Sponsor and Omnicare CR agree as follows: 
 I. Project Plan 
 Following Sponsor’s request for the production of ad hoc efficacy tables, Omnicare CR will provide new “As Treated” patient population tables to be run. These tables involve three study protocols:
PEP005-001 (six (6) tables), PEP005-002 (nine (9) tables) and PEP005-003 (nine (9) tables) (hereinafter “the Project”). Changes made in the Project scope, at any time during the Project, will result in a
corresponding adjustment to the Project costs. 
 II. Project Roles and Responsibilities 
 Sponsor has requested assistance from Omnicare CR with the production of ad hoc efficacy tables to be run under a new “As Treated” patient population to
support the Project. 
 III. Omnicare CR Services 
 Services provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the project specifications provided by Sponsor, and are outlined below: 
  

  

	****	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. 

  Page 1 









					
	 Task List (Major)
	  	    Peplin    	  	    Omnicare    
	 Biometrics
	  		  	
	 1. Define “As Treated” tables
	  		  	ü
	 2. Approve “As Treated” tables
	  	ü	  	
	 3. Produce “As Treated” tables
	  		  	ü
	 4. Validate “As Treated” tables
	  		  	ü
	 5. Perform quality assurance audit of the “As Treated” tables
	  		  	ü
	 6. Provide final “As Treated” tables
	  		  	ü

 IV. Project Timeline 
 The parties acknowledge that Omnicare CR will commence performance of the Services during July 2007. The projected timeline for this Project is as follows: 
  

			
	 Activities
	  	Anticipated Timeline
	 Project Start Up
	  	2 July 2007
	 Final “As Treated” Tables provided to Sponsor
	  	****

 A detailed timeline and milestones will be developed based on the different assumptions of how the project is
conducted. 
 V. Budget 
 A. Estimated Project Budget

 The following budget is presented to Peplin in Australian Dollars (A$): 
  

																		
	 Services
	  	    Unit    	  	#
    Units    	 	 	    Unit Cost    	 	 	    Fees    	 	 	Estimated
    Pass-Thru    	 	 	Estimated
    Total Cost    	 
	 o  Design of Table
Shells (Mocks);
assumes **** repeat tables
	  	Tables	  	*	***	 	*	***	 	*	***	 	*	***	 	*	***
	 Estimated Services Budget
	  		  			 			 	****	 	 			 		
	 Estimated Pass Through 
	  		  			 			 			 	****	 	 		
	 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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 2 








 B. Payment Schedules 
 1. Invoicing Process for Service Fees 
 Omnicare CR maintains a project accounting system, whereby all direct project costs (Service Fees or
Pass-Through Expenses) are coded by project. 
 An initial payment of A$****, representing approximately **** percent (****%) of the estimated Service Fees,
is due and payable upon execution of this Exhibit L. Subsequent payments shall be made monthly, based on Project progress and upon submission of an invoice to Sponsor by Omnicare CR. After receipt of the initial payment, the subsequent invoices
shall be reduced by a prorated portion from the initial payment such that the initial payment is applied evenly over the remaining term of the Project. All payments shall be processed within **** days. If any payment of Service Fees or
Pass-Through Expenses is late by more than **** (****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
 2. Exchange Rates 
 The pricing is based on the following exchange rates assumptions: 
 One (1) A$ = US Dollars (US$) 0.8375 
 This
Exhibit L involves services provided in regions with currencies other than the budget currency, which is Australian Dollars (A$). In the event the exchange rate moves three percent (3%) or more positively or negatively within a six-month
timeframe, the parties agree to meet in good faith to discuss and negotiate new rates based on the new exchange rate. 
 In addition, at the time Omnicare CR
processes any pass through expenses in currencies other than A$, such expenses shall be converted to A$ using the exchange rate for the corresponding period as published by oanda.com. 
 3. Pass-Through Expense Invoicing 
 Omnicare CR’s project accounting system is able to capture and categorise in
summary the following key pass-through expenses related to your project: 
  

	 	•	 	 Travel 


  

	 	•	 	 Delivery Costs 


  

	 	•	 	 Printing or copying costs 


  

	 	•	 	 Meeting costs 


  

	 	•	 	 Telecommunication Costs (which may include telephone, fax, paper, conference calls, or PC connectivity charges) 


  

	 	•	 	 All other Project related expenses that are not related to service fees 


  

  

	****	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. 

  Page 3 








 4. Payments 
 Sponsor
shall make payment directly to the following bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Maquarie
Shopping Centre, 
 North Ryde, NSW 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 5. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary, the estimated Service Fees set forth in this
Exhibit L shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Exhibit L as of each ****, such increases shall not exceed the percentage change of the
Medical Services Price Index for the corresponding period. 
 ACCEPTANCE 
 The terms and conditions of the Master Agreement govern this Exhibit L and such document is incorporated herein by reference as if fully set forth herein. 
  

											
	BY AND BETWEEN:	  		  		 	
				
	Peplin Operations Pty Ltd.	  		  	Omnicare CR, Inc.	 	
						
	BY:	 	 /s/ Peter Welburn
	  		  	BY:	 	 /s/ Dale Evans, PhD
	 	
	Name:	 	Peter Welburn	  		  	Name:	 	Dale Evans, PhD	 	
	Title:	 	 General Manager
 Chief Scientific Officer
and
 Vice President, Research & Development
	  		  	Title:	 	Chief Executive Officer	 	
	Date:	 	19/4/07	  		  	Date:	 	August 7, 2007	 	

 

 
  

  

	****	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. 

  Page 4 








 Exhibit M to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 1st June 2005 
 THIS EXHIBIT M is entered into this 29
th day of August, 2007 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor”) and
Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor
and Omnicare CR entered into a Clinical Services Master Agreement, dated 1st June 2005 (hereinafter the “Master Agreement”), wherein
Omnicare CR agreed to provide clinical services; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as
an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing
or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR shall provide the services set forth in this Exhibit M, subject to the terms and conditions set forth in the Master Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows:

 I. Project Plan 
 Based on the Project Specifications,
Omnicare CR has provided a description of services to be performed for Sponsor’s study entitled: “A Phase I, Single-Centre, Open-Label, Fixed-Dose Study of the Safety and Efficacy of a Two- or Three-Day Application of PEP005 Topical Gel
in the Treatment of Patients with a Common Wart (Verruca Vulgaris) on the Dorsal Hand”. The Protocol Reference Number is PEP005-019, Draft version 0.2, dated 10 July 2007 (hereinafter “the Project”) and associated costs.
Changes made in the Project scope, at any time during the Project, will result in a corresponding adjustment to the Project costs. 
 II. Project Roles
and Responsibilities 
 Sponsor has requested assistance from Omnicare CR with safety and medical, clinical data management, biometrics and clinical
writing services to support 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. 

  Page 1 








 III. Omnicare CR Services 
 Services provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the project specifications provided by Sponsor, and are outlined below. It should be noted, however, that the costs presented in
this budget for these services are estimated pending review of the final specifications, protocol and CRF. 
  

					
	 Task List (Major)
	  	    Peplin    	  	    Omnicare    
	 CT Approvals
	  		  	
	 1. Submit regulatory documents to relevant authorities
	  	ü	  	
	 2. Prepare and submit Ethics Committee Applications
	  	ü	  	
	 Investigator’s Brochure Preparation
	  	ü	  	
	 1. Protocol development (literature review, background)
	  	ü	  	
	 2. Design and write protocol
	  	ü	  	
	 3. Approve protocol
	  	ü	  	
	 4. Print and bind protocol
	  	ü	  	
	 5. Distribute protocol to sites
	  	ü	  	
	 6. Investigator Drug Brochure Preparation
	  	ü	  	
	 7. Draft prototype informed consent
	  	ü	  	
	 8. Approve prototype informed consent
	  	ü	  	
	 CRF Preparation
	  		  	
	 1. Design and draft CRFs
	  		  	ü
	 2. Provide input into the development of the CRF, as reqd
	  		  	ü
	 3. Approve CRFs
	  	ü	  	
	 4. Print and assemble CRFs
	  	ü	  	
	 5. Distribute CRFs to sites
	  	ü	  	
	 6. Write CRF conventions guide
	  	ü	  	
	 Project Management
	  		  	
	 1. Provide weekly enrolment updates
	  	ü	  	
	 2. Regular update of cumulative monitoring visit schedule
	  	ü	  	
	 3. Provide weekly updates of CRFs status (received, data entered, cleaned and number of queries outstanding)
	  		  	ü
	 4. Team meetings with minutes
	  	ü	  	
	 5. Provision of status reports to clients of performance against deliverables
	  	ü	  	
	 Qualification Visits
	  		  	
	 1. Develop list of potential investigators
	  	ü	  	
	 2. Screen Investigators via surveys/telephone interviews
	  	ü	  	
	 3. Conduct site qualification visit
	  	ü	  	
	 4. Provide written site evaluation report
	  	ü	  	
	 5. Prepare Investigator contract
	  	ü	  	
	 6. Negotiate Investigator grants
	  	ü	  	

  

  

	****	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. 

  Page 2 









					
	 Task List (Major)
	  	    Peplin    	  	    Omnicare    
	 Pre-Study Activities
	  		  	
	 1. Collect all regulatory documents from each site
	  	ü	  	
	 2. Select central laboratory
	  	N/A	  	
	 3. Select drug packaging facility
	  	N/A	  	
	 4. Select central ethics committee (if applicable)
	  	N/A	  	
	 5. Prepare study file notebooks for sites
	  	ü	  	
	 6. Generate monitoring plan
	  	ü	  	
	 7. Generate data entry/management plan
	  	ü	  	
	 8. Set up project master files
	  	ü	  	
	 Investigator’s Meeting (If applicable)
	  		  	
	 1. Plan Investigator’s Meeting
	  	N/A	  	
	 2. Prepare binders for the meeting
	  	N/A	  	
	 3. Present Investigator’s meeting
	  	N/A	  	
	 4. Attendance at meeting
	  	N/A	  	
	 Initiation Visits
	  		  	
	 1. Conduct site initiation visits
	  	ü	  	
	 2. Provide site initiation report
	  	ü	  	
	 On-Site Monitoring
	  		  	
	 1. Conduct monitoring visits
	  	ü	  	
	 2. Provide site monitoring reports
	  	ü	  	
	 3. Verify 100% of source documentation
	  	ü	  	
	 4. Review drug records
	  	ü	  	
	 5. Review lab storage
	  	N/A	  	
	 6. Review monitoring and data retrieval plan
	  	ü	  	
	 7. Resolve data queries as they arise
	  	ü	  	
	 Close-out visits
	  		  	
	 1. Conduct site close-out visit
	  	ü	  	
	 2. Provide close-out trip report
	  	ü	  	
	 3. Prepare study documents for archiving
	  	ü	  	
	 Site Management
	  		  	
	 1. Manage all site questions and prepare a Q&A document
	  	ü	  	
	 2. Pay investigators (excludes PTCs for grant payments)
	  	ü	  	
	 3. Pay drug packaging facility
	  	ü	  	
	 4. Pay central laboratory
	  	N/A	  	
	 5. Maintain weekly telephone contact log with site
	  	ü	  	

  

  

	****	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. 

  Page 3 









					
	 Task List (Major)
	  	    Peplin    	  	    Omnicare    
	 Interactive Voice Response System (IVRS)
	  		  	
	 1. Provision of IVRS randomisation and blinding/unblinding
	  	N/A	  	
	 Medical Management
	  		  	
	 1. Document and manage all SAEs
	  		  	ü
	 2. Cover medical emergencies after hours (pager)
	  	ü 	  	
	 3. Develop/ maintain safety database
	  		  	ü
	 4. Submit SAE reports to regulatory authorities
	  		  	ü
	 5. Prepare safety updates
	  		  	ü
	 6. Medical Monitor — Review of SAEs
	  		  	ü
	 Study Drug Management
	  	ü	  	
	 Data-Entry
	  		  	
	 1. Design/develop data collection system
	  		  	ü
	 2. Validate data collection system
	  		  	ü
	 3. Document control of CRFs
	  		  	ü
	 4. Enter and verify data
	  		  	ü
	 Data Management
	  		  	
	 1. Design/develop data cleaning system
	  		  	ü
	 2. Validate cleaning system
	  		  	ü
	 3. Write data management guidelines and edit specifications
	  		  	ü
	 4. Review CRF and run edit system
	  		  	ü
	 5. Resolve edit queries
	  		  	ü
	 6. Incorporate laboratory data into database
	  		  	ü
	 7. Document corrections to CRFs
	  		  	ü
	 8. Perform QC audits — electronic data compared to paper CRFs
	  	N/A	  	
	 9. Code adverse events
	  		  	ü
	 10. Code medications
	  		  	ü

  

  

	****	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. 

  Page 4 









					
	 Task List (Major)
	  	    Peplin    	  	    Omnicare    
	 Statistical Analysis
	  		  	
	 1. Prepare a statistical analysis plan prior to CRF finalisation
	  		  	ü
	 2. Review of protocol statistical methods
	  		  	ü
	 3. CRF development and statistical review
	  		  	ü
	 4. Define efficacy tables and listings
	  		  	ü
	 5. Define safety tables and listings
	  		  	ü
	 6. Produce efficacy tables and listings
	  		  	ü
	 7. Produce safety tables and listings
	  		  	ü
	 8. Provide draft report template and analysis plan
	  		  	ü
	 9. Approve report template
	  	ü	  	
	 10. Validate efficacy tables and listings
	  		  	ü
	 11. Validate safety tables and listings
	  		  	ü
	 12. Perform quality assurance audit of the tables and listings
	  		  	ü
	 13. Provide final tables and listings
	  		  	ü
	 14. Provide statistical study report
	  		  	ü
	 Report Preparation
	  		  	
	 1. Prepare draft study report template
	  	N/A	  	
	 2. Approve final study report template
	  	N/A	  	
	 3. Draft study report
	  	N/A	  	
	 4. Final study report
	  	N/A	  	
	 5. Perform quality assurance of study report
	  	N/A	  	
	 6. Approval of final status report
	  	ü	  	
	 7. Database transfer to Client
	  		  	ü
	 Regulatory Site Audits
	  	ü	  	

 IV. Project Timeline 
 The parties acknowledge that Omnicare CR will commence performance of the Services on or about 1 September 2007. The projected timeline for this Project is as follows: 
  

  

	****	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. 

  Page 5 









			
	 Activities
	  	 Anticipated Timeline

	Commencement of Work (Start Date)	  	1 September 2007
		
	Protocol Finalised	  	****
		
	First Patient Enrolled	  	****
		
	Recruitment Period	  	****
		
	Last Patient Enrolled	  	****
		
	Treatment Period	  	****
		
	Last Patient End of Treatment	  	****
		
	Last CRF to Data Management	  	****
		
	Database Lock	  	****
		
	Statistical Analysis	  	****
		
	Final Clinical Study Report	  	****
		
	Study Completion — End Omnicare Involvement	  	****

 A detailed timeline and milestones will be developed based on the different assumptions of how the project is
conducted. 
 V. Budget 
 A. Estimated Project Budget

 The following budget is presented to Peplin in Australian Dollars (A$): 
  

													
	 Services
	  	    Unit    	  	    # Units    	 	    Unit Cost    
(A$)	 	    Fees (A$)    	 	Estimated
    Pass-Thru    
(A$)	 	Estimated
    Total Cost    
(A$)
	 A. Study Management
	  		  		 		 		 		 	
							
	 •    ProjectAdministrative
Support/Coordination - Int’l (includes
support for all functional areas
-
**** day per month for **** months)
	  	Days	  	****	 	****	 	****	 	****	 	****
							
	 Sub Total Study Management 
	  		  		 		 	****	 	****	 	****

  

  

	****	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. 

  Page 6 









															
	 Services
	 	    Unit    	 	    # Units    	 	    Unit Cost    
(A$)	 	    Fees (A$)    	 	Estimated
    Pass-Thru    
(A$)	 	Estimated
    Total Cost    
(A$)
	 B. Safety and Medical 
	 		 		 		 		 		 	
								
	 •
	 	Medical Monitoring availability
during business hours (flat fee of **** hours
per month from first patient in through
last patient out)	 	Months	 	****	 	****	 	****	 	****	 	****
								
	 •
	 	Medical Monitoring during Study Start
Up and Study Close- out (actuals
will be billed)	 	Hours	 	****	 	****	 	****	 	****	 	****
								
	 •
	 	Medical Consulting (if required)	 	Days	 	****	 	****	 	****	 	****	 	****
								
	 •
	 	Safety Coordinator - (assumes
**** day per month for **** months
plus **** additional days for Safety
Plan development)	 	Days	 	****	 	****	 	****	 	****	 	****
								
	 •
	 	SAE Reporting To Sponsor (with
initial descriptive summary); actuals
will be billed	 	Report	 	****	 	****	 	****	 	****	 	****
								
	 •
	 	**** (majority of costs are already
covered under separate PCN, exl.
SAEs)	 		 		 		 		 		 	
								
		 	> Project Set-Up	 	Project	 	****	 	****	 	****	 	****	 	****
								
		 	> Monthly Database Maintenance (first
patient in to database close)	 	Month	 	****	 	****	 	****	 	****	 	****
								
		 	> Data Entry into **** (actuals will be
billed)	 	SAE	 	****	 	****	 	****	 	****	 	****

  

  

	****	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. 

  Page 7 









															
	 Services
	  	    Unit    	  	    # Units    	 	    Unit Cost    
(A$)	 	    Fees (A$)    	 	Estimated
    Pass-Thru    
(A$)	 	Estimated
    Total Cost    
(A$)
	 •
	 	Safety Reporting of SAEs to
Investigator Sites — Int’l (estimated
**** mins per reportable SAE
(‘SUSAR’) per site; actuals will be
billed)	  	SUSAR	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Safety Reporting to Regulatory
Authorities — Int’l (assumes
generation of CIOMS forms; estimated
**** hours per reportable SAE
(‘SUSAR’); actuals will be
billed)	  	SUSAR	  	****	 	****	 	****	 	****	 	****
								
		 	Sub Total Safety and Medical	  		  		 		 	****	 	****	 	****
							
	C. Clinical Data Management	  		  		 		 		 		 	
								
	 •
	 	Clinical Data Management Oversight
— Int’l (assumes ****% FTE x
**** months for Start- up, ****% FTE
for **** months for Duration, and
****% FTE for **** months
for
Close-out)	  	Days	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Development of Data Management
Plan (includes **** major and ****
minor revision; add’l revisions will be
billed at per diem rates)	  	Days	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	CRF Design (assumes **** page CRF,
**** unique CRF pages; includes ****
review cycles)	  	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. 

  Page 8 









															
	 Services
	  	    Unit    	  	    # Units    	 	    Unit Cost    
(A$)	 	    Fees (A$)    	 	Estimated
    Pass-Thru    
(A$)	 	Estimated
    Total Cost    
(A$)
	 •
	 	Database Development, Testing
(assumes **** page CRF, **** unique
CRF pages)	  	Project	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Database Maintenance	  	Months	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Estimated Data Entry (actuals will be
billed)	  	Pages	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Estimated Data Review and Query
Resolution (assumes **** issue per
**** CRF pages, **** study
assumption for **** CRF pages);
assumes **** CRF pages per enrolled
patient, ****
pages per screen failure
patient, and **** pages per drop out
patient Queries will be billed on
actuals.	  		  		 		 		 		 	
								
		 	> CRF Pages + Electronic data visits
(eg labs, ABPM)	  	Page	  	****	 	****	 	****	 	****	 	****
								
		 	> Issues	  	Issue	  	****	 	****	 	****	 	****	 	****
								
		 	> Manual Checks	  	Check	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Quality Control Check of Database
versus CRF (assumes **** CRF pages per
patient) ****% of of pages	  	Page	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Quality Control Check of Database
versus CRF - ****% CRF data for
square root of patients (assumes ****
CRF pages ) - **** patients	  	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 24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 9 









															
	 Services
	 	    Unit    	 	    # Units    	 	    Unit Cost    
(A$)	 	    Fees (A$)    	 	Estimated
    Pass-Thru    
(A$)	 	Estimated
    Total Cost    
(A$)
	 •
	 	Edit Development (actuals will be
billed) 	 	Edits	 	****	 	****	 	****	 	****	 	****
								
	 •
	 	CRF Tracking and Filing
(includes all ancillary pages;
actuals will be billed) 	 	Page	 	****	 	****	 	****	 	****	 	****
								
	 •
	 	Dictionary — ATC Coding of
Medications (actuals will be
billed) 	 	Term	 	****	 	****	 	****	 	****	 	****
								
	 •
	 	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	 	****	 	****	 	****	 	****	 	****
								
	 •
	 	External Vendor - Data Loads
(actuals will be billed) 	 		 		 		 		 		 	
								
		 	> Initial Load 	 	Load	 	****	 	****	 	****	 	****	 	****
								
		 	> Subsequent Loads (actuals will
be billed) 	 	Monthly	 	****	 	****	 	****	 	****	 	****
								
	 •
	 	Local Laboratory Data	 		 		 		 		 		 	
								
		 	> Database Setup 	 	Project	 	****	 	****	 	****	 	****	 	****
								
		 	> Local Normal Ranges
Processed (actuals will be billed) 	 	Sets	 	****	 	****	 	****	 	****	 	****

  

  

	****	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. 

  Page 10 









															
	 Services
	  	    Unit    	  	    # Units    	 	    Unit Cost    
(A$)	 	    Fees (A$)    	 	Estimated
    Pass-Thru    
(A$)	 	Estimated
    Total Cost    
(A$)
	 •
	 	PK Laboratory Data	  		  		 		 		 		 	
								
		 	> Initial Load 	  	Project	  	****	 	****	 	****	 	****	 	****
								
		 	> Subsequent Loading (actuals will be billed) 	  	Load	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Reconciliation of the Safety and Clinical Database (actuals will be billed) 	  	SAE	  	****	 	****	 	****	 	****	 	****
								
		 	Sub Total Clinical Data Management 	  		  		 		 	****	 	****	 	****
							
	 D. Biometrics 
	  		  		 		 		 		 	
								
	 •
	 	Biometrics Team Manager	  	Days	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Project Data Setup	  	Project	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Statistical Plan	  	Project	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Design of Table Shells (Mocks)	  	Project	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Mock Annotation	  	Project	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Programming of Data Displays (actuals will be billed)	  		  		 		 		 		 	
								
		 	> Unique Tables	  	Table	  	****	 	****	 	****	 	****	 	****
								
		 	> Repeat Tables	  	Table	  	****	 	****	 	****	 	****	 	****
								
		 	> Unique Listings	  	Listing	  	****	 	****	 	****	 	****	 	****
								
		 	> Repeat Listings	  	Listing	  	****	 	****	 	****	 	****	 	****
								
		 	> Unique Figures	  	Figure/Graph	  	****	 	****	 	****	 	****	 	****
								
		 	> Repeat Figures	  	Figure/Graph	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Custom Derived Data Sets (Initial; assumes **** datasets)	  	Project	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Programmatic Evaluability/ Outcome	  	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. 

  Page 11 









															
	 Services
	  	    Unit    	  	    # Units    	 	    Unit Cost    
(A$)	 	    Fees (A$)    	 	Estimated
    Pass-Thru    
(A$)	 	Estimated
    Total Cost    
(A$)
	 •
	 	Statistical Analysis	  	Project	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Statistical Report	  	Project	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Standard Data Transfer	  		  		 		 		 		 	
								
		 	> Initial	  	Transfer	  	****	 	****	 	****	 	****	 	****
								
		 	> Subsequent	  	Transfer	  	****	 	****	 	****	 	****	 	****
								
		 	Sub Total Biometrics	  		  		 		 	****	 	****	 	****
							
	E. Regulatory Services	  		  		 		 		 		 	
								
	 •
	 	CRF Filing and Reconciliation
(actuals will be billed)	  	Pages	  	****	 	****	 	****	 	****	 	****
								
	 •
	 	Return of CRF (hard copy)
(actuals will be billed)	  	Pages	  	****	 	****	 	****	 	****	 	****
								
		 	Sub Total Regulatory Services	  		  		 	****	 	****	 	****	 	
							
	 Estimated Services Budget 
	  		  		 		 	****	 		 	
							
	 Estimated Pass Through 
	  		  		 		 		 	****	 	
							
	 Total Estimated Budget 
	  		  		 		 		 		 	****

 B. Payment Schedules 
 1. Invoicing Process for Service Fees 
 Omnicare CR maintains a project accounting system, whereby all direct project costs (Service Fees or
Pass-Through Expenses) are coded by project. 
 An initial payment of A$****, representing approximately **** percent (****%) of the estimated Service Fees,
is due and payable upon execution of this Exhibit M. Subsequent payments shall be made monthly, based on Project progress and upon submission of an invoice to Sponsor by Omnicare CR. After receipt of the initial payment, the subsequent invoices
shall be reduced by a prorated portion from the initial payment such that the initial payment is applied evenly over the remaining term of the Project. All payments shall be processed within **** days. If any payment of Service Fees or
Pass-Through Expenses is late by more than **** (****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
  


  

	****	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. 

  Page 12 








 2. Exchange Rates 
 The pricing is based on the following exchange rates assumptions: 
 One (1) A$ = US Dollars (US$) 0.8375 
 This Exhibit M involves services provided in regions with currencies other than the budget currency, which is Australian Dollars (A$). In the event the exchange
rate moves three percent (3%) or more positively or negatively within a six-month timeframe, the parties agree to meet in good faith to discuss and negotiate new rates based on the new exchange rate. 
 In addition, at the time Omnicare CR processes any pass through expenses in currencies other than A$, such expenses shall be converted to A$ using the exchange rate for
the corresponding period as published by oanda.com. 
 3. Pass-Through Expense Invoicing 
 Omnicare CR’s project accounting system is able to capture and categorise in summary the following key pass-through expenses related to your project: 
  

	 	•	 	 Travel 


  

	 	•	 	 Delivery Costs 


  

	 	•	 	 Printing or copying costs 


  

	 	•	 	 Meeting costs 


  

	 	•	 	 Telecommunication Costs (which may include telephone, fax, paper, conference calls, or PC connectivity charges) 


  

	 	•	 	 All other Project related expenses that are not related to service fees 


 4. Payments 
 Sponsor shall make payment directly to the following bank account nominated by Omnicare CR: 

Omnicare CR Inc. 
 Westpac Banking
Corporation, 
 Maquarie Shopping Centre, 
 North Ryde, NSW 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 5. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary, the estimated Service Fees set forth in this Exhibit M shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the
price of the remaining Services under this Exhibit M as of each ****, such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
  

  

	****	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. 

  Page 13 








 ACCEPTANCE 
 The
terms and conditions of the Master Agreement govern this Exhibit M and such document is incorporated herein by reference as if fully set forth herein. 
  

											
	BY AND BETWEEN:	    		    	
			
	Peplin Operations Pty Ltd.	    		    	Omnicare CR, Inc.
						
	BY:	 	 /s/ Peter Welburn
	    		    	BY:	 	 /s/ Dale Evans, PhD
	 	
	Name:	 	Peter Welburn	    		    	Name:	 	Dale Evans, PhD	 	
	Title:	 	 General Manager, Australia
 Chief Scientific Officer
and
 Vice President, Research & Development
	    		    	Title:	 	Chief Executive Officer	 	
	Date:	 	6/2/07	    		    	Date:	 	21 Sept 2007	 	

 

 
  

  

	****	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. 

  Page 14 








 Exhibit N to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 1st June 2005 
 THIS EXHIBIT N is entered into this 20
th day of September, 2007 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor”)
and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS,
Sponsor and Omnicare CR entered into a Clinical Services Master Agreement, dated 1st June 2005 (hereinafter the “Master Agreement”),
wherein Omnicare CR agreed to provide clinical services; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being
defined as an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to
invoicing or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR shall provide the services set forth in this Exhibit N, subject to the terms and conditions set forth in the Master Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows:

 I. Project Plan 
 Based on the Project Specifications,
Omnicare CR has provided a description of services to be performed for Sponsor’s study entitled: “A Phase I, pharmacokinetic study to evaluate the extent of systemic absorption of PEP005, when applied as 0.05% PEP005 Topical Gel to a
100 cm2 (5cm x 20cm) contiguous AK treatment area on the dorsal fore-arm” — Protocol # PEP005-013, Draft Version 0.1 dated 23 August 2007 (hereinafter “the Project”) and associated costs. Changes made in the Project
scope, at any time during the Project, will result in a corresponding adjustment to the Project costs. 
 II. Project Roles and Responsibilities

 Sponsor has requested assistance from Omnicare CR with safety and medical, clinical data management, biometrics and clinical writing services to
support the Project. 
  

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 III. Omnicare CR Services 
 Services provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the project specifications provided by Sponsor, and are outlined below. It should be noted, however, that the costs presented in
this budget for these services are estimated pending review of the final specifications, protocol and CRF. 
  

					
	Task List (Major)	  	Peplin	  	Omnicare
	 CT Approvals
	  	 	  	 
	 1. Submit regulatory documents to relevant authorities
	  	ü	  	
	 2. Prepare and submit Ethics Committee Applications
	  	ü	  	
	 Investigator’s Brochure Preparation
	  	ü	  	 
	 1. Protocol development (literature review, background)
	  	ü	  	
	 2. Design and write protocol
	  	ü	  	
	 3. Approve protocol
	  	ü	  	
	 4. Print and bind protocol
	  	ü	  	
	 5. Distribute protocol to sites
	  	ü	  	
	 6. Investigator Drug Brochure Preparation
	  	ü	  	
	 7. Draft prototype informed consent
	  	ü	  	
	 8. Approve prototype informed consent
	  	ü	  	
	 CRF Preparation
	  	 	  	 
	 1. Design and draft CRFs
	  		  	ü
	 2. Provide input into the development of the CRF, as reqd
	  		  	ü
	 3. Approve CRFs
	  	ü	  	
	 4. Print and assemble CRFs
	  	ü	  	
	 5. Distribute CRFs to sites
	  	ü	  	
	 6. Write CRF conventions guide
	  	ü	  	
	 Project Management
	  	 	  	 
	 1. Provide weekly enrolment updates
	  	ü	  	
	 2. Regular update of cumulative monitoring visit schedule
	  	ü	  	
	 3. Provide weekly updates of CRFs status (received, data entered, cleaned and number of queries outstanding)
	  		  	ü
	 4. Team meetings with minutes
	  	ü	  	
	 5. Provision of status reports to clients of performance against deliverables.
	  	N/A	  	

  

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	Task List (Major)	  	Peplin	  	Omnicare
	 Qualification visits
	  	 	  	 
	 1. Develop list of potential investigators
	  	ü	  	
	 2. Screen Investigators via surveys/telephone interviews
	  	ü	  	
	 3. Conduct site qualification visit
	  	ü	  	
	 4. Provide written site evaluation report
	  	ü	  	
	 5. Prepare Investigator contract
	  	ü	  	
	 6. Negotiate Investigator grants
	  	ü	  	
	 Pre-Study Activities
	  	 	  	 
	 1. Collect all regulatory documents from each site
	  	ü	  	
	 2. Select central laboratory
	  	ü	  	
	 3. Select drug packaging facility
	  	ü	  	
	 4. Select central ethics committee (if applicable)
	  	ü	  	
	 5. Prepare study file notebooks for sites
	  	ü	  	
	 6. Generate monitoring plan
	  	ü	  	
	 7. Generate data entry/management plan
	  		  	ü
	 8. Set up project master files
	  	ü	  	ü
	 Investigator’s Meeting (if applicable)
	  	 	  	 
	 1. Plan Investigator’s Meeting
	  	N/A	  	
	 2. Prepare binders for the meeting
	  	N/A	  	
	 3. Present Investigator’s meeting
	  	N/A	  	
	 4. Attendance at meeting
	  	N/A	  	
	 Initiation Visits
	  	 	  	 
	 1. Conduct site initiation visits
	  	ü	  	
	 2. Provide site initiation report
	  	ü	  	
	 On-Site Monitoring
	  	 	  	 
	 1. Conduct monitoring visits
	  	ü	  	
	 2. Provide site monitoring reports
	  	ü	  	
	 3. Verify 100% of source documentation
	  	ü	  	
	 4. Review drug records
	  	ü	  	
	 5. Review lab storage
	  	ü	  	
	 6. Review monitoring and data retrieval plan
	  	ü	  	
	 7. Resolve data queries as they arise
	  	ü	  	
	 Close-out visits
	  	 	  	 
	 1. Conduct site close-out visit
	  	ü	  	
	 2. Provide close-out trip report
	  	ü	  	
	 3. Prepare study documents for archiving
	  	ü	  	

  

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  **** Certain confidential information contained in
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	Task List (Major)	  	Peplin	  	Omnicare
	 Site Management
	  	 	  	 
	 1. Manage all site questions and prepare a Q&A document
	  	ü	  	
	 2. Pay investigators (excludes PTCs for grant payments)
	  	ü	  	
	 3. Pay drug packaging facility
	  	ü	  	
	 4. Pay central laboratory
	  	ü	  	
	 5. Maintain weekly telephone contact log with site
	  	ü	  	 
	 Interactive Voice Response System (IVRS)
	  	 	  	 
	 1. Provision of IVRS randomisation and blinding/ unblinding
	  	N/A	  	 
	 Medical Management
	  	 	  	 
	 1. Document and manage all SAEs
	  		  	ü
	 2. Cover medical emergencies after hours (pager)
	  	ü	  	
	 3. Develop/ maintain safety database
	  		  	ü
	 4. Submit SAE reports to regulatory authorities
	  		  	ü
	 5. Prepare safety updates
	  		  	ü
	 6. Medical Monitor — Review of SAEs
	  	 	  	ü
	 Study Drug Management
	  	ü	  	 
	 Data Entry
	  	 	  	 
	 1. Design/develop data collection system
	  		  	ü
	 2. Validate data collection system
	  		  	ü
	 3. Document control of CRFs
	  		  	ü
	 4. Enter and verify data
	  	 	  	ü
	 Data Management
	  	 	  	 
	 1. Design/develop data cleaning system
	  		  	ü
	 2. Validate cleaning system
	  		  	ü
	 3. Write data management guidelines and edit specifications
	  		  	ü
	 4. Review CRF and run edit system
	  		  	ü
	 5. Resolve edit queries
	  		  	ü
	 6. Incorporate laboratory data into database
	  		  	ü
	 7. Document corrections to CRFs
	  		  	ü
	 8. Perform QC audits — electronic data compared to paper CRFs
	  	N/A	  	
	 9. Code adverse events
	  		  	ü
	 10. Code medications
	  		  	ü
	 11. Loading of Protocol Deviations Log
	  		  	ü

  

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  **** Certain confidential information contained in
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	Task List (Major)	  	Peplin	  	Omnicare
	 Statistical Analysis
	  	 	  	 
	 1. Prepare a statistical analysis plan prior to CRF finalisation
	  		  	ü
	 2. Review of protocol statistical methods
	  		  	ü
	 3. CRF development and statistical review
	  		  	ü
	 4. Define efficacy tables and listings
	  		  	ü
	 5. Define safety tables and listings
	  		  	ü
	 6. Produce efficacy tables and listings
	  		  	ü
	 7. Produce safety tables and listings
	  		  	ü
	 8. Provide draft report template and analysis plan
	  		  	ü
	 9. Approve report template
	  	ü	  	
	 10. Validate efficacy tables and listings
	  		  	ü
	 11. Validate safety tables and listings
	  		  	ü
	 12. Perform quality assurance audit of the tables and listings
	  		  	ü
	 13. Provide final tables and listings
	  		  	ü
	 14. Provide statistical study report
	  	N/A	  	 
	 Report Preparation
	  	 	  	 
	 1. Prepare draft report template
	  	ü	  	
	 2. Approve final report template
	  	ü	  	
	 3. Draft study report
	  	ü	  	
	 4. Final study report
	  	ü	  	
	 5. Perform quality assurance of study report
	  	ü	  	
	 6. Approval of final study report
	  	ü	  	
	 7. Prepare draft Top Line Report template
	  		  	ü
	 8. Draft Top Line Report
	  		  	ü
	 9. Final Top Line Report
	  		  	ü
	 10. Provide relevant appendice documents
	  		  	ü
	 7. Database transfer to Client
	  	 	  	ü
	 Regulatory Site Audits
	  	ü	  	 

 IV. Project Timeline 
 The parties acknowledge that Omnicare CR will commence performance of the Services on or about 1 September 2007. The projected timeline for this Project is as follows: 
  

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	 Activities
	  	                 Anticipated Timeline                


	 Commencement of Work (Start Date)
	  	1 September 2007
	 Protocol Finalised
	  	****
	 First Patient Enrolled
	  	****
	 Last Patient Enrolled
	  	****
	 Last Patient End of Treatment
	  	****
	 Last CRF to Data Management
	  	****
	 Database Lock
	  	****
	 Statistical Analysis
	  	****
	 Final Top Line Report
	  	****
	 Study Completion — End Omnicare Involvement
	  	****

 A detailed timeline and milestones will be developed based on the different assumptions of how the project is
conducted. 
 V. Budget 
 A. Estimated Project Budget

 The following budget is presented to Peplin in Australian Dollars (A$): 
  

															
	 	 	Services	  	    Unit    	  	    # Units    	 	    Unit Cost    
(A$)	 	    Fees (A$)    	 	Estimated
    Pass-Thru    
(A$)	 	Estimated
    Total Cost    
(A$)
	A.	 	Study Management 	  	 	  	 	 	 	 	 	 	 	 	 
	•	 	Project Administrative
Support/Coordination - Int’l (includes
support for all functional areas)	  	Days	  	****	 	****	 	****	 	****	 	****
	 	 	Sub Total Study Management	  	 	  	 	 	 	 	****	 	****	 	****
	C.	 	Safety and Medical 	  	 	  	 	 	 	 	 	 	 	 	 
	•	 	Medical Monitoring availability during
business hours (flat fee of **** hours per
month from first patient in through last
patient out)	  	Months	  	****	 	****	 	****	 	****	 	****

  

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	 	  	Services	  	    Unit    	  	    # Units    	 	    Unit Cost    
(A$)	 	    Fees (A$)    	 	Estimated
    Pass-Thru    
(A$)	 	Estimated
    Total Cost    
(A$)
		  	 > Greater than ****
hours per month will
be billed at hourly
rate (from first
patient in
through
last patient out)
(actuals will be
billed) 
	  	Hours	  	****	 	****	 	****	 	****	 	****
	•	  	Medical Monitoring during Study Start Up
and Study Close-out (actuals will be
billed) 	  	Hours	  	****	 	****	 	****	 	****	 	****
	•	  	Safety Coordinator - assumes **** day per
month for **** months plus ****
additional day for Safety Plan
development	  	Days	  	****	 	****	 	****	 	****	 	****
	•	  	Safety Review of CRFs and Queries	  	Case	  	****	 	****	 	****	 	****	 	****
	•	  	SAE Reporting To Sponsor (with initial
descriptive summary); actuals will be
billed 	  	Report	  	****	 	****	 	****	 	****	 	****
	•	  	****	  		  		 		 		 		 	
		  	 > Project Set-Up
(costs included in
KO1504) 
	  	Project	  	****	 	****	 	****	 	****	 	****
		  	 > Monthly Database
Maintenance (first
patient in to database
close; included in
KO1504) 

	  	Month	  	****	 	****	 	****	 	****	 	****
		  	 > Data Entry into
**** (actuals will be
billed) 
	  	SAE	  	****	 	****	 	****	 	****	 	****

  

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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. 









															
	 	  	Services	  	    Unit    	  	    # Units    	 	    Unit Cost    
(A$)	 	    Fees (A$)    	 	Estimated
    Pass-Thru    
(A$)	 	Estimated
    Total Cost    
(A$)
	 •   
	  	Safety Reporting of SAEs to Investigator
Sites —Int’l (estimated **** mins per
reportable SAE (‘SUSAR’) per
site;
actuals will be billed) 	  	SUSAR	  	****	 	****	 	****	 	****	 	****
	 •   
	  	Safety Reporting to Regulatory Authorities
— Int’l (assumes generation of CIOMS
forms; estimated **** hours
per
reportable SAE (‘SUSAR’); actuals will be
billed) 	  	SUSAR	  	****	 	****	 	****	 	****	 	****
	 	  	Sub Total Safety and Medical 	  	 	  	 	 	 	 	**** 	 	**** 	 	**** 
	D.	  	Clinical Data Management 	  	 	  	 	 	 	 	 	 	 	 	 
	 •   
	  	Clinical Data Management Oversight
—
Int’l (assumes ****% FTE x **** months
for Start-up, ****% FTE for **** months
for Duration, and ****% FTE for
**** months for Close-out)	  	Days	  	****	 	****	 	****	 	****	 	****
	 •   
	  	Development of Data Management Plan
(includes **** major and **** minor
revision; add’l revisions will be billed at
per diem rates)
	  	Days	  	****	 	****	 	****	 	****	 	****
	 •   
	  	CRF Design (assumes **** page CRF,
**** unique CRF pages; includes ****
review cycles)	  	Project	  	****	 	****	 	****	 	****	 	****

  

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	 	 	Services	  	    Unit    	  	    # Units    	 	    Unit Cost    
(A$)	 	    Fees (A$)    	 	Estimated
    Pass-Thru    
(A$)	 	Estimated
    Total Cost    
(A$)
	•	 	Database Development, Testing (assumes
**** page CRF, **** unique CRF pages)	  	Project	  	****	 	****	 	****	 	****	 	****
	•	 	Database Maintenance	  	Months	  	****	 	****	 	****	 	****	 	****
	•	 	Estimated Data Entry (actuals will be
billed)	  	Pages	  	****	 	****	 	****	 	****	 	****
	•	 	Estimated Data Review and Query
Resolution (assumes **** issue per ****
CRF pages, **** study assumption for
**** CRF pages); assumes ****
CRF
pages per enrolled patient, **** pages per
screen failure patient, and **** pages per
drop out patient. Queries will be billed on
actuals.	  		  		 		 		 		 	
		 	> CRF Pages +
Electronic data visits
(eg labs, ABPM) 	  	Page	  	****	 	****	 	****	 	****	 	****
		 	> Issues 	  	Issue	  	****	 	****	 	****	 	****	 	****
		 	> Manual Checks 	  	Check	  	****	 	****	 	****	 	****	 	****
	•	 	Quality Control Check of Database versus CRF of Safety & Efficacy Data for all Subjects (assumes **** CRF pages per patient) ****% of pages	  	Page	  	****	 	****	 	****	 	****	 	****

  

 Page 9 
  
  
  **** 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. 









															
	 	 	Services	  	    Unit    	  	    # Units    	 	    Unit Cost    
(A$)	 	    Fees (A$)    	 	Estimated
    Pass-Thru    
(A$)	 	Estimated
    Total Cost    
(A$)
	 •
	 	Quality Control Check of Database versus
CRF — ****% CRF data for square root
of patients (assumes **** CRF pages per
patient) — ****
patients	  	Page	  	****	 	****	 	****	 	****	 	****
	 •
	 	Edit Development (actuals will be billed)	  	Edits	  	****	 	****	 	****	 	****	 	****
	 •
	 	CRF Tracking and Filing (includes all
ancillary pages; actuals will be billed)	  	Page	  	****	 	****	 	****	 	****	 	****
	 •
	 	Dictionary — ATC Coding of Medications
(actuals will be billed)	  	Term	  	****	 	****	 	****	 	****	 	****
	 •
	 	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	  	****	 	****	 	****	 	****	 	****
	 •
	 	External Vendor — Data Loads (actuals
will be billed) 	  		  		 		 		 		 	
		 	> Initial Load 	  	Load	  	****	 	****	 	****	 	****	 	****
		 	> Subsequent Loads
(actuals will be
billed) 	  	Monthly	  	****	 	****	 	****	 	****	 	****

  

 Page 10 
  
  
  **** 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. 









															
	 	 	Services	  	    Unit    	  	    # Units    	 	    Unit Cost    
(A$)	 	    Fees (A$)    	 	Estimated
    Pass-Thru    
(A$)	 	Estimated
    Total Cost    
(A$)
	 •
	 	 PK Laboratory Data
	  		  		 		 		 		 	
		 	 > Initial Load 
	  	Project	  	****	 	****	 	****	 	****	 	****
		 	 > Subsequent
Loading
(actuals will be
billed)
	  	Load	  	****	 	****	 	****	 	****	 	****
	 •
	 	Reconciliation of the Safety and Clinical
Database
(actuals will be billed) 	  	SAE	  	****	 	****	 	****	 	****	 	****
	 •
	 	 Loading of protocol deviations log
	  	Hours	  	****	 	****	 	****	 	****	 	****
	 	 	 Sub Total Clinical Data Management 
	  	 	  	 	 	 	 	****	 	****	 	****
	 E.
	 	 Biometrics 
	  	 	  	 	 	 	 	 	 	 	 	 
	 •
	 	 Biometrics Team Manager
	  	Days	  	****	 	****	 	****	 	****	 	****
	 •
	 	 Project Data Setup
	  	Project	  	****	 	****	 	****	 	****	 	****
	 •
	 	 Statistical Plan
	  	Project	  	****	 	****	 	****	 	****	 	****
	 •
	 	 Design of Table Shells (Mocks)
	  	Project	  	****	 	****	 	****	 	****	 	****
	 •
	 	 Mock Annotation
	  	Project	  	****	 	****	 	****	 	****	 	****
	 •
	 	Programming of Data Displays (actuals will be
billed) 	  		  		 		 		 		 	
		 	 > Unique Tables 
	  	Table	  	****	 	****	 	****	 	****	 	****
		 	 > Repeat Tables 
	  	Table	  	****	 	****	 	****	 	****	 	****
		 	 > Unique Listings 
	  	Listing	  	****	 	****	 	****	 	****	 	****
		 	 > Repeat Listings 
	  	Listing	  	****	 	****	 	****	 	****	 	****
	 •
	 	Custom Derived Data Sets (Initial;
assumes **** datasets)	  	Project	  	****	 	****	 	****	 	****	 	****
	 •
	 	 Statistical Analysis
	  	Project	  	****	 	****	 	****	 	****	 	****
	 •
	 	 Standard Data Transfer (Initial only)
	  	Transfer	  	****	 	****	 	****	 	****	 	****

  

 Page 11 
  
  
  **** 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. 









															
	 	 	Services	  	    Unit    	  	    # Units    	 	    Unit Cost    
(A$)	 	    Fees (A$)    	 	Estimated
    Pass-Thru    
(A$)	 	Estimated
    Total Cost    
(A$)
	 •
	 	Biometrics Review of CRF	  	Hours	  	****	 	****	 	****	 	****	 	****
	 	 	Sub Total Biometrics	  	 	  	 	 	 	 	****	 	****	 	****
	 F.
	 	Clinical Writing (All assumes using OCR SOPs) 
	 •
	 	Clinical Study Report	  		  		 		 		 		 	
		 	Phase I Report
> includes **** major
revision (up to ****
days) and **** minor
(up to **** day)
revision
> per OCR SOPs and
CSR template
>
fee does not
include CSR
appendices
(including TLs) 	  	Report	  	****	 	****	 	****	 	****	 	****
	 •
	 	Narratives (actuals will be billed) 	  	Narrative	  	****	 	****	 	****	 	****	 	****
	 •
	 	Clinical Writing Input to SAP	  	Project	  	****	 	****	 	****	 	****	 	****
	 •
	 	Top Line Report	  	Report	  	****	 	****	 	****	 	****	 	****
	 	 	Sub Total Clinical Writing 	  	 	  	 	 	 	 	****	 	****	 	****
	 G.
	 	Regulatory Services 	  	 	  	 	 	 	 	 	 	 	 	 
	 •
	 	CRF Filing and Reconciliation (actuals
will be billed) 	  	Pages	  	****	 	****	 	****	 	****	 	****
	 •
	 	Return of CRF (hard copy) (actuals will
be billed) 	  	Pages	  	****	 	****	 	****	 	****	 	****
	 •
	 	Return of Investigator and Study-Wide
Documents (paper)	  	Sites	  	****	 	****	 	****	 	****	 	****

  

 Page 12 
  
  
  **** 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. 









															
	 	 	Services	  	    Unit    	  	    # Units    	 	    Unit Cost    
(A$)	 	    Fees (A$)    	 	Estimated
    Pass-Thru    
(A$)	 	Estimated
    Total Cost    
(A$)
	 •
	 	Upload of Clinical Study Report
Appendices Content	  		  		 		 		 		 	
		 	 > Management Fee 
	  	Report	  	****	 	****	 	****	 	****	 	****
		 	 > Additional
Footers; actuals
will be billed
	  	Pages	  	****	 	****	 	****	 	****	 	****
		 	 > Scanning with cleaning; actuals will be
billed 
	  	Pages	  	****	 	****	 	****	 	****	 	****
	 	 	 > Upload (fee does not include
hyperlinking)
	  	Upload	  	****	 	****	 	****	 	****	 	****
	 	 	 Sub Total Regulatory Services 
	  	 	  	 	 	 	 	****	 	****	 	****
	 Estimated Services Budget 
	  	 	  	 	 	 	 	****	 	 	 	 
	 Estimated Pass Through 
	  	 	  	 	 	 	 	 	 	****	 	 
	 Total Estimated Budget 
	  	 	  	 	 	 	 	 	 	 	 	****

 B. Payment Schedules 
 1. Invoicing Process for Service Fees 
 Omnicare CR maintains a project accounting system, whereby all direct project costs (Service Fees or
Pass-Through Expenses) are coded by project. 
 An initial payment of A$****, representing approximately **** percent (****%) of the estimated Service
Fees, is due and payable upon execution of this Exhibit N. Subsequent payments shall be made monthly, based on Project progress and upon submission of an invoice to Sponsor by Omnicare CR. After receipt of the initial payment, the subsequent
invoices shall be reduced by a prorated portion from the initial payment such that the initial payment is applied evenly over the remaining term of the Project. All payments shall be processed within **** days. If any payment of Service Fees or
Pass-Through Expenses is late by more than **** (****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
  


 Page 13 
  **** 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. 








 2. Exchange Rates 
 The pricing is based on the following exchange rates assumptions: 
 One (1) A$ = US Dollars (US$) 0.8375 
 This Exhibit N involves services provided in regions with currencies other than the budget currency, which is Australian Dollars (A$). In the event the exchange
rate moves three percent (3%) or more positively or negatively within a six-month timeframe, the parties agree to meet in good faith to discuss and negotiate new rates based on the new exchange rate. 
 In addition, at the time Omnicare CR processes any pass through expenses in currencies other than A$, such expenses shall be converted to A$ using the exchange rate for
the corresponding period as published by oanda.com. 
 3. Pass-Through Expense Invoicing 
 Omnicare CR’s project accounting system is able to capture and categorise in summary the following key pass-through expenses related to your project: 
  

	 	•	 	 Travel 


  

	 	•	 	 Delivery Costs 


  

	 	•	 	 Printing or copying costs 


  

	 	•	 	 Meeting costs 


  

	 	•	 	 Telecommunication Costs (which may include telephone, fax, paper, conference calls, or PC connectivity charges) 


  

	 	•	 	 All other Project related expenses that are not related to service fees 


 4. Payments 
 Sponsor shall make payment directly to the following bank account nominated by Omnicare CR: 

Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Maquarie Shopping Centre, 
 North Ryde, NSW 
 SWIFT ID: **** 
 BSB/Account Number: **** 
 5. Annual Price Increase 
 Notwithstanding anything contained herein to the contrary, the estimated Service Fees set
forth in this Exhibit N shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Exhibit N as of each ****, such increases shall not exceed the percentage
change of the Medical Services Price Index for the corresponding period. 
  

 Page 14 
  **** 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. 








 ACCEPTANCE 
 The
terms and conditions of the Master Agreement govern this Exhibit N and such document is incorporated herein by reference as if fully set forth herein. 
 BY AND BETWEEN: 
  

													
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.
					
	BY:	 	 /s/ Michael Aldridge
	 		 	BY:	 	 /s/ Dale Evans

		 	Name: 	 	 Michael Aldridge
	 		 		 	Name: 	 	 Dale Evans, Ph.D.

		 	Title: 	 	 CEO
	 		 		 	Title: 	 	 Chief Executive Officer

		 	Date: 	 	 19-Dec-07
	 		 		 	Date: 	 	 12/21/07


  

 Page 15 
  
  
  **** 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 O to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 1st June 2005

 THIS EXHIBIT O is entered into this 30th October, 2007 (“Effective Date”), by and between Peplin Operations Pty
Ltd. (hereinafter “Sponsor”) and Omnicare CR, Inc. (hereinafter “Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered into a Clinical Services Master Agreement, dated
1st June 2005 (hereinafter the “Master Agreement”), wherein Omnicare CR agreed to provide clinical services; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as Omnicare
CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be deemed to
include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR shall provide the
services set forth in this Exhibit O, subject to the terms and conditions set forth in the Master Agreement; 
 NOW, THEREFORE, for good
and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows: 
 I. Project Plan 
 Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for Sponsor’s study entitled: “Efficacy and tolerability Study
of PEP005 (0.05%) Topical Gel for Treatment of Contiguous Actinic Keratosis Lesions on the back of the hand” . The Protocol Reference Number is PEP005-018, (hereinafter “the Project”). Changes made in the Project scope, at any
time during the Project, will result in a corresponding adjustment to the Project costs. 
 II. Project Roles and Responsibilities 
 Sponsor has requested assistance from Omnicare CR with Project Management, Clinical Monitoring, Clinical Trial Initiation, Safety and Medical, Clinical Data Management, Biometrics
and Clinical Writing services to support 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. 

  Page 1 
  
  









 III. Omnicare CR Services 
 Services
provided by Omnicare CR and the assumptions upon which associated costs were determined are based on the project specifications provided by Sponsor, and are outlined below. It should be noted, however, that the costs presented in this budget for
these services are estimated pending review of the final specifications, protocol and CRF. 
  

					
	 	  	         Scenario 1 -
US        

	 Task List (Major)
	  	     Peplin    
	  	    Omnicare    
	 CT Approvals
	  		  	
	 1. Submit regulatory documents to relevant authorities
	  	ü	  	
	 2. Prepare and submit Ethics Committee Applications
	  		  	ü
			
	 Investigator’s Brochure Preparation — to be ready 10 September
	  	ü	  	
	 1. Protocol development (literature review, background)
	  	ü	  	
	 2. Design and write protocol
	  	ü	  	
	 3. Approve protocol
	  	ü	  	
	 4. Print and bind protocol
	  		  	ü
	 5. Distribute protocol to sites
	  		  	ü
	 6. Investigator Drug Brochure Preparation
	  	ü	  	
	 7. Draft prototype informed consent
	  	ü	  	
	 8. Approve prototype informed consent
	  	ü	  	
			
	 CRF Preparation
	  		  	
	 1. Design and draft CRFs
	  		  	ü
	 2. Provide input into the development of the CRF, as reqd
	  		  	ü
	 3. Approve CRFs
	  	ü	  	
	 4. Print and assemble CRFs
	  		  	ü
	 5. Distribute CRFs to sites
	  		  	ü
	 6. Write CRF conventions guide
	  		  	ü
			
	 Project Management
	  		  	
	 1. Provide weekly enrolment updates
	  		  	ü
	 2. Regular update of cumulative monitoring visit schedule
	  		  	ü
	 3. Provide weekly updates of CRFs status (received, data entered, cleaned and number of queries
outstanding)
	  		  	ü
	 4. Team meetings with minutes
	  		  	ü
	 5. Provision of status reports to clients of performance against deliverables.
	  		  	ü

  
  
  
  
  

	****	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. 

  Page 2 
  
  










					
	 	  	        Scenario 1 - US        
	 Task List (Major)
	  	    Peplin    	  	    Omnicare    
	 Qualification visits
	  		  	
	 1. Develop list of potential investigators
	  		  	ü
	 2. Screen Investigators via surveys/telephone interviews
	  		  	ü
	 3. Conduct site qualification visit, if applicable
	  		  	ü
	 4. Provide written site evaluation report
	  		  	ü
	 5. Prepare Investigator contract
	  		  	ü
	 6. Negotiate Investigator grants
	  		  	ü
			
	 Pre-Study Activities
	  		  	
	 1. Collect all regulatory documents from each site
	  		  	ü
	 2. Select central laboratory
	  	N/A	  	
	 3. Select drug packaging facility
	  	N/A	  	
	 4. Select central ethics committee (if applicable)
	  	N/A	  	
	 5. Prepare study file notebooks for sites
	  		  	ü
	 6. Generate monitoring plan
	  		  	ü
	 7. Generate data entry/management plan
	  		  	ü
	 8. Set up project master files
	  		  	ü
			
	 Investigator’s Meeting (if applicable)
	  		  	
	 1. Plan Investigator’s Meeting
	  	N/A	  	
	 2. Prepare binders for the meeting
	  	N/A	  	
	 3. Present Investigator’s meeting
	  	N/A	  	
	 4. Attendance at meeting
	  	N/A	  	
			
	 Initiation Visits
	  		  	
	 1. Conduct site initiation visits
	  		  	ü
	 2. Provide site initiation report
	  		  	ü
			
	 On-Site Monitoring
	  		  	
	 1. Conduct monitoring visits
	  		  	ü
	 2. Provide site monitoring reports
	  		  	ü
	 3. Verify 100% of source documentation
	  		  	ü
	 4. Review drug records
	  		  	ü
	 5. Review lab storage
	  	N/A	  	
	 6. Review monitoring and data retrieval plan
	  		  	ü
	 7. Resolve data queries as they arise
	  		  	ü
			
	 Close-out visits
	  		  	
	 1. Conduct site close-out visit
	  		  	ü
	 2. Provide close-out trip report
	  		  	ü
	 3. Prepare study documents for archiving
	  		  	ü

  
  
  
  
  

	****	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. 

  Page 3 
  
  










					
	 	  	        Scenario 1 -
US        
	 Task List (Major)
	  	    Peplin    	  	    Omnicare    
	 Site Management
	  		  	
	 1. Manage all site questions and prepare a Q&A document
	  		  	ü
	 2. Pay investigators (excludes PTCs for grant payments)
	  		  	ü
	 3. Pay drug packaging facility
	  	ü	  	
	 4. Pay central laboratory
	  	N/A	  	
	 5. Maintain weekly telephone contact log with site
	  		  	ü
			
	 Interactive Voice Response System (IVRS)
	  		  	
	 1. Provision of IVRS randomisation and blinding/ unblinding
	  	N/A	  	
			
	 Medical Management
	  		  	
	 1. Document and manage all SAEs
	  		  	ü
	 2. Cover medical emergencies after hours (pager)
	  		  	ü
	 3. Develop/ maintain safety database
	  		  	ü
	 4. Submit SAE reports to regulatory authorities
	  		  	ü
	 5. Prepare safety updates
	  		  	ü
	 6. Medical Monitor — Review of SAEs
	  		  	ü
			
	 Study Drug Management
	  	ü	  	
			
	 Data Entry
	  		  	
	 1. Design/develop data collection system
	  		  	ü
	 2. Validate data collection system
	  		  	ü
	 3. Document control of CRFs
	  		  	ü
	 4. Enter and verify data
	  		  	ü
			
	 Data Management
	  		  	
	 1. Design/develop data cleaning system
	  		  	ü
	 2. Validate cleaning system
	  		  	ü
	 3. Write data management guidelines and edit specifications
	  		  	ü
	 4. Review CRF and run edit system
	  		  	ü
	 5. Resolve edit queries
	  		  	ü
	 6. Incorporate laboratory data into database
	  	N/A	  	
	 7. Document corrections to CRFs
	  		  	ü
	 8. Perform QC audits — electronic data compared to paper CRFs
	  	N/A	  	
	 9. Code adverse events
	  		  	ü
	 10. Code medications
	  		  	ü

  
  
  
  
  

	****	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. 

  Page 4 
  
  










					
	 	  	        Scenario 1 -
US        
	 Task List (Major)
	  	    Peplin    	  	    Omnicare    
	 Statistical Analysis
	  		  	
	 1. Prepare a statistical analysis plan prior to CRF finalisation
	  		  	ü
	 2. Review of protocol statistical methods
	  		  	ü
	 3. CRF development and statistical review
	  		  	ü
	 4. Define efficacy tables and listings
	  		  	ü
	 5. Define safety tables and listings
	  		  	ü
	 6. Produce efficacy tables and listings
	  		  	ü
	 7. Produce safety tables and listings
	  		  	ü
	 8. Provide draft report template and analysis plan
	  		  	ü
	 9. Approve report template
	  	ü	  	
	 10. Validate efficacy tables and listings
	  		  	ü
	 11. Validate safety tables and listings
	  		  	ü
	 12. Perform quality assurance audit of the tables and listings
	  		  	ü
	 13. Provide final tables and listings
	  		  	ü
	 14. Provide statistical study report
	  	N/A	  	
			
	 Report Preparation
	  		  	
	 1. Prepare draft report template
	  	ü	  	
	 2. Approve final report template
	  	ü	  	
	 3. Draft study report
	  	ü	  	
	 4. Final study report
	  	ü	  	
	 5. Perform quality assurance of study report
	  	ü	  	
	 6. Approval of final study report
	  	ü	  	
	 7. Top Line report from Day 29 information
	  		  	ü
	 8. Database transfer to Client
	  		  	ü
			
	 Regulatory Site Audits
	  	ü	  	

  
  
  
  
  

	****	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. 

  Page 5 
  
  










	IV.	Project Timeline 

 The parties acknowledge that Omnicare CR will commence performance
of the Services on or about ****. The projected timeline for this Project is as follows: 
  

			
	 PROJECT TIMELINE
	  	
	 Commencement of Work (Start Date)
	  	****        
	 Protocol Finalised
	  	****
	 First Patient Enrolled
	  	****
	 Last Patient Enrolled
	  	****
	 Last Patient End of Treatment
	  	****
	 Last CRF to Data Management
	  	****
	 Database Lock
	  	****
	 Statistical Analysis
	  	****
	 Study End
	  	****
	 Study Completion — End Omnicare Involvement
	  	****

 A detailed timeline and milestones will be developed based on the different assumptions of how the project is conducted.

  
  
  
  
  

	****	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. 

  Page 6 
  










	V.	Budget 

  

	A.	Estimated Project Budget 

 The following budget is presented to Peplin in Australian
Dollars (A$): 
  

			
	 Omnicare CR, Inc.
	  	
	 Clinical Budget for:
	  	
	 Sponsor:
	  	Peplin
	 Compound:
	  	PEP005 (0.05%)
	 Study:
	  	PEP-005-018 — US Scenario
	 PCN:
	  	KO1704

  

															
	 Services
	  	Unit	  	    # Units    	  	    Unit Cost    
(AUS $)	  	Fees
    (AUS $)    	  	    Estimated    
Pass-
Through
(AUS
$)	  	Estimated
    Total Cost    
(AUS $)
	A. Study Management	  	 	  	 	  	 	  	 	  	 	  	 
	°	 	Project Director — Americas	  	Days	  	****	  	****	  	****	  	****	  	****
	°	 	Project Administrative
Support/Coordination —
Americas (includes support
for all functional areas)	  	Days	  	****	  	****	  	****	  	****	  	****
	 	 	 Sub-Total Study
 Management
	  	 	  	 	  	 	  	$ ****	  	$ ****	  	$ ****
	Zone Legend	  	 	  	 	  	 	  	 	  	 	  	 
		 	> Zone 1: USA	  		  		  		  		  		  	
	 B. Clinical Trial Initiation
	  	 	  	 	  	 	  	 	  	 	  	 
	 °       
	 	Study Master File	  	All assumes using OCR SOPs. If using Sponsor SOPs, is custom priced
		 	 >Americas: **** sites for
   **** months
	  	Site Months	  	****	  	****	  	****	  	****	  	****
	 °       
	 	 Regulatory Document
 Collection
	  		  		  		  		  		  	
		 	   > Zone 1
	  	Site	  	****	  	****	  	****	  	****	  	****
		 	 Central IRB (pass-throughs
are estimates only; actual
fees will be billed based on
specific IRB
fees)
	  	Site	  	****	  	****	  	****	  	****	  	****
	 °       
	 	 Protocol Amendments —
 excluding ICF change
 (US sites only)
	  		  		  		  		  		  	
		 	 > Zone 1
	  	Amendments/site	  	****	  	****	  	****	  	****	  	****
	 °       
	 	 Protocol Amendments —
 including ICF change
 (US sites only)
	  		  		  		  		  		  	
		 	 > Zone 1
	  	Amendments/site	  	****	  	****	  	****	  	****	  	****

  
  
  
  
  

	****	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. 

  Page 7 
  
  










																		
	 °       
	 	Investigator Agreement
Negotiation — Standard	  		  		  		  			  			  		
		 	 >Americas 
	  	Site	  	****	  	****	  	 	****	  	 	****	  	 	****
		 	 >Int’l 
	  	Site	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °       
	 	Investigator Agreement
Negotiation — Complex	  		  		  		  			  			  		
		 	 >Americas 
	  	Site	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °       
	 	Investigator Agreement
Amendments — Simple	  		  		  		  			  			  		
		 	 >Americas 
	  	Amendments/site	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °       
	 	Investigator Agreement
Amendments — Standard	  		  		  		  			  			  		
		 	 >Americas 
	  	Amendments/site	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °       
	 	Investigator Agreement
Amendments — Complex	  		  		  		  			  			  		
		 	 >Americas 
	  	Amendments/site	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °       
	 	 Letters of Indemnification 
 (US sites only) 
	  	Site	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °       
	 	Facility Letters	  		  		  		  			  			  		
		 	 ># Standard Facility
 Letters 
	  	Site	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °       
	 	Notice Letters	  	Site	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °       
	 	IND Safety Report
(US sites only) 	  		  		  		  			  			  		
		 	 > Zone 1 
	  	Reports/Site	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °       
	 	Investigator Brochure
Updates	  		  		  		  			  			  		
		 	 > Zone 1 
	  	IB Updates/
Site	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °       
	 	Collect Financial
Disclosure at Site
Closeout	  		  		  		  			  			  		
		 	 > Zone 1 
	  	Site	  	****	  	****	  	 	****	  	 	****	  	 	****
	 	 	 Sub-Total Clinical Trial
 Initiation 
	  	 	  	 	  	 	  	$	 ****	  	$	 ****	  	$	 ****
		 	 C. Clinical Trial Management
	  		  		  		  			  			  		
	 °       
	 	Clinical Trial Manager —
Americas	  	Days	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °       
	 	Clinical Monitoring	  		  		  		  			  			  		
		 	 >Site Initiation Visit 
	  		  		  		  			  			  		
		 	 >Zone 1: **** hrs on-site,
****hrs for prep, follow-up,
and reports, and **** hrs
for travel 

	  	Visits	  	****	  	****	  	 	****	  	 	****	  	 	****
		 	 >Site Interim Visits 
	  		  		  		  			  			  		
		 	 >Zone 1: assume ****
visits/site, **** hrs on-site,
**** hrs for prep, follow-up,
and reports, and
**** hrs
for travel 
	  	Visits	  	****	  	****	  	 	****	  	 	****	  	 	****
		 	 >Site Close-Out Visit 
	  		  		  		  			  			  		
		 	 >Zone 1: **** hrs on-site,
**** hrs for prep, follow-up,
and reports, and **** hrs
for travel 

	  	Visits	  	****	  	****	  	 	****	  	 	****	  	 	****

  
  
  
  
  

	****	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. 

  Page 8 
  
  










																		
	 °
	 	 Site Maintenance for ****
hrs/month/site (**** sites x
 **** enrollment
and treatment
 months)
	  		  		  		  			  			  		
		 	>Zone 1:**** sites 	  	Site Months	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	CRA Monthly
Teleconferences	  		  		  		  			  			  		
		 	>Zone 1:**** CRAs 	  	Months	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	Project Team Training	  		  		  		  			  			  		
		 	 Project Director —
 Americas 
	  	Hours	  	****	  	****	  	 	****	  	 	****	  	 	****
		 	CTM — Americas 	  	Hours	  	****	  	****	  	 	****	  	 	****	  	 	****
		 	CRA Attendees 	  	Hours	  		  		  			  			  		
		 	> Zone 1 CRAs: **** CRAs 	  	Hours	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	Clinical Grants
Administration	  		  		  		  			  			  		
		 	>Grant Payment Set-up 	  		  		  		  			  			  		
		 	>Zone 1 	  	Sites	  	****	  	****	  	 	****	  	 	****	  	 	****
		 	 >Grant Management (takes
place for active sites from site
 set-up through **** days after
 site close-out; estimated
 amounts; actuals will be
 billed based on number
of
 active sites set up) 
	  		  		  		  			  			  		
		 	>Zone 1 	  	Site Quarters	  	****	  	****	  	 	****	  	 	****	  	 	****
		 	 >Payment Processing
 (estimated based on ****
 payments/site; actuals,
 including investigator and site
 related payment and any
 miscellaneous payments,
 actuals will be billed; pass
 through costs are related to
 photocopying and postage) 

	  		  		  		  			  			  		
		 	>Zone 1: **** sites 	  	Payments	  	****	  	****	  	 	****	  	 	****	  	 	****
		 	 >Estimated Investigator
 Grants 
	  	Enrolled Patient
- Americas	  	****	  		  			  	 	****	  	 	****
	 °
	 	 Refund Checks (if needed;
 actuals will be billed)

	  	Refund	  	****	  	****	  	 	****	  	 	****	  	 	****
	 	 	 Sub Total Clinical Trial
 Management 
	  	 	  	 	  	 	  	$	 ****	  	$	 ****	  	$	 ****
	D. Safety and Medical	  		  		  		  			  			  		
	 °
	 	 Medical Monitoring
 availability during business
 hours (flat fee of **** hours
 per month from first patient in
 through last patient out)
	  		  		  		  			  			  		
		 	>Americas 	  	Months	  	****	  	****	  	 	****	  	 	****	  	 	****

  
  
  
  
  

	****	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. 

  Page 9 
  
  










																		
		 	 > Greater than ****
 hours per month will be
 billed at hourly rate
 (from first patient in
 through last patient
 out)
 (actuals will be billed)
	  		  		  		  			  			  		
		 	>Americas 	  	Hours	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	 Medical Monitoring during
 Study Start Up and Study
 Close-out (actuals will be
 billed) 
	  		  		  		  			  			  		
		 	>Americas 	  	Hours	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	Safety Coordinator	  		  		  		  			  			  		
		 	 >Americas — assumes ****
 day per month for **** months
 plus **** additional days for
 Safety Plan development 
	  	Days	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	Safety Review of CRFs and Queries	  	Case	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	 Availability for receipt of
 SAEs during non-business
 hours (first patient in to last
 patient out plus one month)
	  		  		  		  			  			  		
		 	>Americas 	  	Month	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	 SAE Reporting To Sponsor
 (with initial descriptive
 summary);
	  		  		  		  			  			  		
		 	actuals will be billed 	  	Report	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	****	  		  		  		  			  			  		
		 	 >Monthly Database
 Maintenance (first patient in
 to database close) 
	  	Month	  	****	  	****	  	 	****	  	 	****	  	 	****
	 	 	 Sub-Total Safety and
 Medical 
	  	 	  	 	  	 	  	$	 ****	  	$	 ****	  	$	 ****
	E. Clinical Data Management 	  		  		  		  			  			  		
	 °
	 	 Clinical Data Management
 Oversight — Int’l (assumes

****% FTE x **** months for
 Start-up, ****% FTE for
 **** months for Duration, and
 ****% FTE for **** months for
 Close-out)
	  	Days	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	 Development of Data
 Management Plan (includes
 **** major and **** minor
 revision; add’l revisions will
 be billed at per diem rates) 
	  	Days	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	 CRF Design (assumes ****
 page CRF, **** unique CRF
 pages; includes **** review
 cycles)
	  	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. 

  Page 10 
  
  










															
	 °
	 	 Database Development,
 Testing
 (assumes **** page CRF, ****
  
 unique CRF pages)
	  	Project	  	****	  	****	  	****	  	****	  	****
	 °
	 	Database Maintenance	  	Months	  	****	  	****	  	****	  	****	  	****
	 °
	 	 Estimated Data Entry
 (actuals will be billed)

	  		  		  		  		  		  	
		 	>Pages in Int’l 	  	Pages	  	****	  	****	  	****	  	****	  	****
	 °
	 	 Estimated Data Review and
 Query Resolution (assumes
 **** issue per **** CRF
 pages, Queries will be billed
 on actuals.
	  		  		  		  		  		  	
		 	 > CRF Pages +
 Electronic data visits
 (eg labs, ABPM) 
	  	Page	  	****	  	****	  	****	  	****	  	****
		 	>Issues 	  	Issue	  	****	  	****	  	****	  	****	  	****
		 	>Manual Checks 	  	Check	  	****	  	****	  	****	  	****	  	****
	 °
	 	 Clinical/Medical Review
 - Overall review of each case
 to ensure clinical/medical
 integrity.
	  	Page	  	****	  	****	  	****	  	****	  	****
	 °
	 	 Quality Control Check of
 Database versus CRF of
 Safety & Efficacy Data for all
 Subjects (assumes **** CRF
 pages per patient) ****% of of
 pages
	  	Page	  	****	  	****	  	****	  	****	  	****
	 °
	 	 Quality Control Check of
 Database versus CRF - ****
 CRF data for square root of
 patients (assumes **** CRF
 pages per patient) - ****
 patients
	  	Page	  	****	  	****	  	****	  	****	  	****
	 °
	 	 CRF Tracking and Filing 
 (includes all ancillary pages;

 actuals will be billed) 
	  	Page	  	****	  	****	  	****	  	****	  	****
	 °
	 	 Dictionary - ATC Coding of
 Medications (actuals will be

billed) 
	  	Term	  	****	  	****	  	****	  	****	  	****
	 °
	 	 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	  	****	  	****	  	****	  	****	  	****
	 °
	 	Local Laboratory Data	  		  		  		  		  		  	
		 	>Database Setup 	  	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. 

  Page 11 
  
  










																		
		 	 >Local Normal Ranges
 Processed
 (actuals will be billed)
	  	Sets	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	 Reconciliation of the Safety
 and Clinical Database 
 (actuals will be billed) 
	  	SAE	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	Interim Database Lock	  	patients	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	 Loading of protocol
 deviations log
	  	hours	  	****	  	****	  	 	****	  	 	****	  	 	****
		 		  		  		  		  	 	 	  	 	 	  	 	 
	 	 	 Sub-Total Clinical Data
 Management 
	  	 	  	 	  	 	  	$	****	  	$	****	  	$	****
	F. Biometrics Analysis 	  		  		  		  			  			  		
	 °
	 	Biometrics Team Manager	  	Days	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	Project Data Setup	  	Project	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	Statistical Plan	  	Project	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	 Design of Table Shells
 (Mocks)
	  	Project	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	Mock Annotation	  	Project	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	 Programming of Data
 Displays (actuals will be
 billed) 
	  		  		  		  			  			  		
		 	Unique Tables 	  	Table	  	****	  	****	  	 	****	  	 	****	  	 	****
		 	Repeat Tables 	  	Table	  	****	  	****	  	 	****	  	 	****	  	 	****
		 	Unique Listings 	  	Listing	  	****	  	****	  	 	****	  	 	****	  	 	****
		 	Repeat Listings 	  	Listing	  	****	  	****	  	 	****	  	 	****	  	 	****
		 	Unique Figures 	  	Figure/Graph	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	 Programming of Interim Data
 Displays (actuals will be

billed) 
	  		  		  		  			  			  		
		 	Unique Tables 	  	Table	  	****	  	****	  	 	****	  	 	****	  	 	****
		 	Repeat Tables 	  	Table	  	****	  	****	  	 	****	  	 	****	  	 	****
		 	Unique Listings 	  	Listing	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	Custom Derived Data Sets	  		  		  		  			  			  		
		 	 >Initial
 (Assumes
**** datasets) 
	  	Project	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	 Programmatic
 Evaluability/Outcome
	  		  		  		  			  			  		
		 	>Regular or Advanced 	  	Project	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	Statistical Analysis	  		  		  		  			  			  		
		 		  	Project	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	Interim Analysis	  		  		  		  			  			  		
		 	>Regular 	  	Interim Analysis	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	Standard Data Transfer	  		  		  		  			  			  		
		 	>Initial 	  	Transfer	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	Biometrics CRF review	  	hours	  	****	  	****	  	 	****	  	 	****	  	 	****
		 		  		  		  		  	 	 	  	 	 	  	 	 
	 	 	Sub-Total Biometrics 	  	 	  	 	  	 	  	$	****	  	$	****	  	$	****
	G. Clinical Writing 	  	All assumes using OCR SOPs. If using Sponsor SOPs/templates, all CW is custom
 priced

	 °
	 	Day **** Top Line Report	  	Report	  	****	  	****	  	 	****	  	 	****	  	 	****
		 		  		  		  		  	 	 	  	 	 	  	 	 
	 	 	Sub-Total Clinical Writing 	  	 	  	 	  	 	  	$	****	  	$	****	  	$	****

  
  
  
  
  

	****	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. 

  Page 12 
  
  










																		
	I. Regulatory Services	  		  		  		  			  			  		
	 °
	 	 CRF Filing and Reconciliation
 (actuals will be billed)

	  	Pages	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	 Regulatory Site Drug
 Release Approval
	  	# Sites	  	****	  	****	  	 	****	  	 	****	  	 	****
		 		  		  		  		  	 	 	  	 	 	  	 	 
	 	 	 Sub-Total Regulatory
 Services 
	  	 	  	 	  	 	  	$	****	  	$	****	  	$	****
	 K. Clinical Supplies Management 
	  		  		  			  			  		
	 °
	 	 General Pharmaceutics
 project management
 (Americas)
 x hours per month
	  	Month	  	****	  	****	  	$	****	  	$	****	  	$	****
	 °
	 	 Receipt of Returned Drug
 Americas
	  	Receipt	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	 Return of study drug to
 Sponsor or Certified
 Destructor (incl. provision of
 certificate of destruction)
	  	Destruction
run	  	****	  	****	  	 	****	  	 	****	  	 	****
	 °
	 	 Final reconciliation
 (Americas)
	  	Day	  	****	  	****	  	 	****	  	 	****	  	 	****
		 		  		  		  		  	 	 	  	 	 	  	 	 
		 	 Sub-Total Clinical
 Supplies Management 
	  		  		  		  	$	****	  	$	****	  	$	****
		 		  		  		  		  	 	 	  	 	 	  	 	 
	 Estimated Services Budget 
	  		  		  		  	$	****	  			  		
	 Estimated Pass Through 
	  		  		  		  			  	$	****	  		
	 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
24b-2 of the Securities Exchange Act of 1934, as amended. 

  Page 13 
  
  










	B.	Payment Schedules 

  

	1.	Invoicing Process for Service Fees 

 Omnicare CR maintains a project accounting system,
whereby all direct project costs (Service Fees or Pass-Through Expenses) are coded by project. 
 An initial payment of A$****, representing approximately **** percent
(****%) of the estimated Service Fees, is due and payable upon execution of this Exhibit O. Subsequent payments shall be made monthly, based on Project progress and upon submission of an invoice to Sponsor by Omnicare CR. After receipt of the
initial payment, the subsequent invoices shall be reduced by a prorated portion from the initial payment such that the initial payment is applied evenly over the remaining term of the Project. All payments shall be processed within **** days.
If any payment of Service Fees or Pass-Through Expenses is late by more than **** (****) days, such payment shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
  

	2.	Exchange Rates 

 If Omnicare CR processes any pass-through expenses in a currency other
than Australian Dollars (A$), such expenses shall be converted to A$ based on the Oanda foreign currency exchange rate (Oanda.com) for the applicable period being invoiced as per provider’s standard foreign exchange rate methodology, which is
based on the provider’s revenue periods. 
  

	3.	Pass-Through Expense Invoicing 

 Omnicare CR’s project accounting system is able
to capture and categorise in summary the following key pass-through expenses related to your project: 
  

	 	•	 	 Travel 


  

	 	•	 	 Delivery Costs 


  

	 	•	 	 Printing or copying costs 


  

	 	•	 	 Meeting costs 


  

	 	•	 	 Telecommunication Costs (which may include telephone, fax, paper, conference calls, or PC connectivity charges) 


  

	 	•	 	 All other Project related expenses that are not related to service fees 


  
  
  
  
  

	****	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. 

  Page 14 
  
  










	4.	Payments 

 Sponsor shall make payment directly to the following bank account nominated
by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Maquarie Shopping Centre, 
 North Ryde, NSW 
 SWIFT ID: **** 

BSB/Account Number: **** 
  

	5.	Annual Price Increase 

 Notwithstanding anything contained herein to the contrary, the
estimated Service Fees set forth in this Exhibit O shall remain in effect until ****. Thereafter, Omnicare CR reserves the right to increase the price of the remaining Services under this Exhibit O as of each ****, such increases shall not
exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 ACCEPTANCE 
 The terms and conditions of the Master Agreement govern this Exhibit O and such document is incorporated herein by reference as if fully set forth herein. 
 BY AND BETWEEN: 
  

									
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.
					
	BY:	 	 /s/ Philip Moody
	 		 	BY: 	 	 /s/ Dale Evans, PhD

					
	Name:	 	 Philip Moody
	 		 	Name: 	 	 Dale Evans, PhD

					
	Title:	 	 CFO & VP, Finance and Operations
	 		 	Title: 	 	 Chief Executive Officer

					
	Date:	 	  
	 		 	Date: 	 	  


  
  
  
  
  
  

	****	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. 

  Page 15 
  
  









  Exhibit P to the Clinical Services Master Agreement 
 between Peplin Operations Pty Ltd. and Omnicare CR, Inc., 
 dated 1st June 2005 
 THIS EXHIBIT P is entered into this 11th day of October, 2007 (“Effective Date”), by and between Peplin Operations Pty Ltd. (hereinafter “Sponsor”) and Omnicare CR, Inc. (hereinafter
“Omnicare CR”). 
 WHEREAS, Sponsor and Omnicare CR entered
into a Clinical Services Master Agreement, dated 1st June 2005 (hereinafter the “Master Agreement”), wherein Omnicare CR agreed to
provide clinical services; and 
 WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct
or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any
references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity”; and 
 WHEREAS,
Sponsor and Omnicare CR agree that Omnicare CR shall provide the services set forth in this Exhibit P, subject to the terms and conditions set forth in the Master Agreement; 
 NOW, THEREFORE, for good and valuable consideration, AND INTENDING TO BE LEGALLY BOUND, Sponsor and Omnicare CR agree as follows:

 I. Project Plan 
 Based on the Project Specifications,
Omnicare CR has provided a description of services to be performed for Sponsor’s studies: 
  

	1.	“A multi-centre, randomised, double-blind, parallel-group, vehicle-controlled study to determine the safety of PEP005 0.0025%, 0.01% and 0.05% gel with two treatment
schedules, Day 1 and Day 2 or Day 1 and Day 8 applications to actinic keratoses”. 

 Protocol
PEP005-001 dated 28 February 2005 Version 2. 
  

	2.	“An open, Dose-escalation, Cohort study to determine the Safety of PEP005 Topical Gel when applied on Day 1 and Day 2 to Actinic Keratoses on the Shoulders, Chest, Back,
and/or Arms followed by Post-Treatment Follow-Up Period Lasting at Least 4 weeks”. 

 Protocol
PEP005-004 Version 3. 
 (hereinafter “the Project”) and associated costs. Changes made in the Project scope, at any time during the
Project, will result in a corresponding adjustment to the Project costs. 
  
  

	****	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. 








  II. Project Roles and Responsibilities 
 Sponsor has requested assistance from Omnicare CR with clinical writing services and compilation of clinical study report appendices to support the Project. 
 III. Omnicare CR Services 
 Services provided by Omnicare CR and the
assumptions upon which associated costs were determined are based on the project specifications provided by Sponsor, and are outlined below. It should be noted, however, that the costs presented in this budget for these services are estimated
pending review of the final documents. 
 The assumptions used in this estimate are based on the following: 
  

	1.	Sponsor holds all Project Study Master Files and must provide required documents to Omnicare CR. 

  

	2.	The services to be provided have been costed to assume that the Project will be conducted according to the Project Timeline detailed in Section IV. Any changes in timeline requested
by Sponsor may result in additional charges. 

  

	3.	The current format of the Clinical Study Reports is in ICHE3. 

  

	4.	Sponsor requires final documents to be provided to them in electronic PDF (distilled when possible) format. 

  

	5.	The Senior Clinical Writer will be responsible for the revisions requested by the Sponsor in both Clinical Study Reports. A first draft report will be generated within ****
(****) weeks of the provision of all documentation detailed in Section III (Point #5). All clinical documents will receive **** (****) levels of quality control reviews before they are released. There will be a QC review by an independent
(second) clinical writer for accuracy and consistency, and a review by the writing manager for accuracy, client format consistency, and appropriate regulatory and clinical perspective. The first draft will then be provided to the Sponsor for review.
At this time, the Sponsor and an outside consultant will review the Clinical Study Reports. The second draft Clinical Study Report will be produced after receipt of one (1) set of collated comments from the Sponsor. The second draft will be
reviewed within the Clinical Writing Department to ensure that all Sponsor comments are addressed and that all changes are consistent with supporting data. Following the Sponsor’s second review, minor revisions will be made and the final
finalized. An approximate timeline per Clinical Study Report is as follows: 

  
  

	****	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. 

   

 2 









			
	 Activity
	  	 Anticipated Timeframe*

	 First Draft
	  	+ **** (from provision of documentation)
		
	 Review by Sponsor and Consultant
	  	+ ****
		
	 Second Draft
	  	+ ****
		
	 Review by Sponsor and Consultant
	  	+ ****
		
	 Final Clinical Study Report Text
	  	+ ****
		
	 Final Appendices included in CSR
	  	+ ****

   * Timelines are dependent upon Sponsor responding within assigned time.

  

	6.	Hyperlinks and bookmarks (bookmarking will match the TOC) will be provided (TOCs will be in blue text with no borders, all other hyperlinks will be black text with blue borders),
and the following documentation is required as follows (responsibility shown in brackets) 

  

	 	a.	Section 14: Final Biometrics Tables—End of Text (Omnicare CR). 

  

	 	b.	Section 16.1: Final Protocol and any Amendments (Sponsor) 

  

	 	c.	Section 16.1.2: Sample Case Report Form (Omnicare CR) 

  

	 	d.	Section 16.1.3: 

 (i) List of
IRBs/IECs (Omnicare CR) 
 (ii) Sample Informed Consent (Sponsor) 
  

	 	e.	Section 16.1.4: List of Investigators (Omnicare CR) 

  

	 	f.	Section 16.1.5: Signature(s) of Principal or Coordination Investigator(s) or Sponsor’s Responsible Medical Officer — Signature Page (Omnicare CR)


  

	 	g.	Section 16.1.6: Listings of patients receiving test drug(s) or investigational product(s) from specific batches (Sponsor) 

  

	 	h.	Section 16.1.7: Randomisation scheme and codes (Omnicare CR) 

  

	 	i.	Section 16.1.8: Audit Certifications (Sponsor) 

  

	 	j.	Section 16.1.9: Documentation of statistical methods — Final Statistical Analysis Plan (Omnicare CR) 

  

	 	k.	Section 16.1.10: Documentation of Inter-Laboratory Standardisation Methods and Quality Assurance Procedures — CLIA, CAP and reference ranges for all labs listed on the
1572’s; and Quality Assurance Procedures (Sponsor) 

  

	 	l.	Section 16.1.11: Publications based on the study (Sponsor) 

  

	 	m.	Section 16.1.12: Important publications references in the report (Sponsor) 

  

	 	n.	Section 16.2: Final Biometrics listings (Omnicare CR) 

  

	 	o.	Section 16.2.2: Protocol Violations (Sponsor) 

  

	 	p.	Section 16.3.1: Case Report Forms for Deaths, Serious Adverse Events and Withdrawals for Adverse Events (Omnicare CR) 

  

	 	q.	Section 16.3.2: Other Case Report Forms submitted (Omnicare CR) 

  

	 	r.	Section 16.4: Individual patient data listings (Sponsor) 

  
  

	****	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. 

   

 3 








  Hyperlinking and bookmarking can not begin until CSR text is finalized. Completion of the above items will be
completed two weeks after CSR text finalization. 
 IV. Project Timeline 
 The parties acknowledge that Omnicare CR will commence performance of the Services on or about ****. The projected timeline for this Project is as follows: 
   

			
	 Activities
	  	 Anticipated Timeline

	 Commencement of Work (Start Date)
	  	****
	 Provision of All Documentation Detailed in Section III Omnicare CR Services Point #5
	  	 ****

	 PEP005-001 (Clinical Study Report & Appendices Completed)
	  	 ****

	 PEP005-004 (Clinical Study Report & Appendices Completed)
	  	 ****


   A detailed timeline and milestones will be developed based on the different assumptions of how the
project is conducted. 
 V. Budget 
 A. Estimated
Project Budget 
 The following budget is presented to Sponsor in Australian Dollars (A$): 
   

													
	 Services
	  	    Unit  	  	#
    Units    	  	    Unit Cost    
(A$)	  	    Fees (A$)    	  	    Estimated    
Pass-Thru
(A$)	  	    Estimated    
Total Cost
(A$)
	 Project Management
	  		  		  		  		  		  	
							
	 -   Project Director — US
	  	Days	  	****	  	****	  	****	  	****	  	****
				
	         Sub Total Project Management
	  	****	  	****	  	****
							
	 PEP005-001 (Actinic Keratoses)
	  		  		  		  		  		  	
							
	 -   Clinical Writing—Clinical Study Report
	  		  		  		  		  		  	
							
	 > Senior Clinical Writer
	  		  		  		  		  		  	
							
	 ° First Draft (Writing and QC)
	  	Days	  	****	  	****	  	****	  	****	  	****
							
	 ° Second Draft (Writing and QC)
	  	Days	  	****	  	****	  	****	  	****	  	****
							
	 ° Final CSR (Writing and QC)
	  	Days	  	****	  	****	  	****	  	****	  	****
							
	 > Director – Clinical Writing
	  	Days	  	****	  	****	  	****	  	****	  	****

   
  

	****	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 









													
	Services	  	    Unit    	  	    # Units    	  	    Unit Cost    
(A$)	  	    Fees (A$)    	  	Estimated
    Pass-Thru    
(A$)	  	Estimated
    Total Cost    
(A$)
	 Compilation of Clinical Study Report Appendices (electronic copy only; actuals will be billed)
	  		  		  		  		  		  	
	 > Set up and management
	  	Project	  	****	  	****	  	****	  	****	  	****
	 > Set up of headers & footers
	  	Project	  	****	  	****	  	****	  	****	  	****
	 > Scanned and Cleaned Pages
	  	Pages	  	****
	  	****	  	****	  	****	  	****
	 > Hyperlinks
	  	Links	  	****	  	****	  	****	  	****	  	****
	 > Volumes
	  	Volumes	  	****	  	****	  	****	  	****	  	****
	 > Headers & Footers
	  	Volumes	  	****	  	****	  	****	  	****	  	****
	 Sub Total PEP005-001
	  	 	  	 	  	 	  	****	  	****	  	****

	 PEP005-004 (Actinic Keratoses)
	  	 	  	 	  	 	  	 	  	 	  	 
	 Clinical Writing – Clinical Study Report
	  		  		  		  		  		  	
	 > Senior Clinical Writer
	  		  		  		  		  		  	
	 ° First Draft (Writing and QC)
	  	Days	  	****	  	****	  	****	  	****	  	****
	 ° Second Draft (Writing and QC)
	  	Days	  	****	  	****	  	****	  	****	  	****
	 ° Final CSR (Writing and QC)
	  	Days	  	****	  	****	  	****	  	****	  	****
	 > Director – Clinical Writing
	  	Days	  	****	  	****	  	****	  	****	  	****
	 - Compilation of Clinical Study Report Appendices (electronic copy only; actuals will be billed)
	  		  		  		  		  		  	
	 > Set up and management
	  	Project	  	****	  	****	  	****	  	****	  	****
	 > Set up of headers & footers
	  	Project	  	****	  	****	  	****	  	****	  	****
	 > Scanned and Cleaned Pages
	  	Pages	  	****	  	****	  	****	  	****	  	****
	 > Hyperlinks
	  	Links	  	****	  	****	  	****	  	****	  	****
	 > Volumes
	  	Volumes	  	****	  	****	  	****	  	****	  	****
	 > Headers & Footers
	  	Volumes	  	****	  	****	  	****	  	****	  	****
	 Sub Total PEP005-004
	  	 	  	 	  	 	  	****	  	****	  	****
	 Estimated Services Budget
	  	****	  		  	
	 Estimated Pass Through
	  		  	****	  	
	 Total Estimated Budget
	  		  		  	****

   B. Payment Schedules 
 1. Invoicing Process for Service Fees 
 Omnicare CR maintains a project accounting system, whereby all direct
project costs (Service Fees or Pass-Through Expenses) are coded by project. 
 An initial payment of $**** , representing approximately **** percent
(****%) of the estimated Service Fees, is due and payable upon execution of this Exhibit P. Subsequent payments shall be made monthly, based on Project progress and upon submission of an invoice 
  

	****	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. 

   

 5 








  
to Sponsor by Omnicare CR. After receipt of the initial payment, the subsequent invoices shall be reduced by a prorated portion from the initial payment such
that the initial payment is applied evenly over the remaining term of the Project. All payments shall be processed within **** days. If any payment of Service Fees or Pass-Through Expenses is late by more than **** (****) days, such payment
shall be subject to a liquidated damages fee of ****% per month of the outstanding balance. 
  

	2.	Exchange Rates 

 The pricing is based on the following exchange
rates assumptions: 
 One (1) A$ = US Dollars (US$) 0.8008 
 This Exhibit P involves services provided in regions with currencies other than the budget currency, which is Australian Dollars (A$). In the event the exchange rate moves three percent (3%) or more positively or
negatively within a six-month timeframe, the parties agree to meet in good faith to discuss and negotiate new rates based on the new exchange rate. 
 In
addition, at the time Omnicare CR processes any pass-through expenses in currencies other than A$, such expenses shall be converted to A$ using the exchange rate for the corresponding period as published by oanda.com. 
  

	3.	Pass-Through Expense Invoicing 

 Omnicare CR’s project
accounting system is able to capture and categorise in summary the following key pass-through expenses related to your project: 
  

	 	•	 	 Travel 


  

	 	•	 	 Delivery Costs 


  

	 	•	 	 Printing or copying costs 


  

	 	•	 	 Meeting costs 


  

	 	•	 	 Telecommunication Costs (which may include telephone, fax, paper, conference calls, or PC connectivity charges) 


  

	 	•	 	 All other Project related expenses that are not related to service fees 


  
  

	****	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. 

   

 6 









	4.	Payments 

 Sponsor shall make payment directly to the following
bank account nominated by Omnicare CR: 
 Omnicare CR Inc. 
 Westpac Banking Corporation, 
 Maquarie Shopping Centre, 
 North Ryde, NSW 
 SWIFT ID: **** 

BSB/Account Number: **** 
  

	5.	Annual Price Increase 

 Notwithstanding anything contained herein
to the contrary, the estimated Service Fees set forth in this Exhibit P shall remain in effect through the later of 1) the original timeline as outlined in Section IV or 2) ****. Thereafter, Omnicare CR reserves the right to increase the price
of the remaining Services under this Exhibit P as of each ****, such increases shall not exceed the percentage change of the Medical Services Price Index for the corresponding period. 
 ACCEPTANCE 
 The terms and conditions of the Master Agreement govern this Exhibit P and such document is incorporated
herein by reference as if fully set forth herein. 
 BY AND BETWEEN: 
   

									
	Peplin Operations Pty Ltd.	 		 	Omnicare CR, Inc.
					
	BY:	 	 /s/ Michael Aldridge
	 		 	BY: 	 	 /s/ Dale Evans

					
	Name:	 	 Michael Aldridge
	 		 	Name: 	 	 Dale Evans PhD

					
	Title:	 	 CEO
	 		 	Title: 	 	 Chief Executive Officer

					
	Date:	 	 Nov-11-07
	 		 	Date: 	 	 23 January 2008


   

	****	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. 

   

 7