exv10w22



 






Exhibit
10.22


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 sucessfully or, if so
developed, will receive the required approval(s) from the FDA orther 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.




11









 




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 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:




 




			
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asterisks, has been 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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	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.





 




			
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Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




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           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.




 




			
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asterisks, has been 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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          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





 




			
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asterisks, has been omitted 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.





 




			
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asterisks, has been 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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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.





 




			
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asterisks, has been 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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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






 




			
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Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




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	 	•	 	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.




 




			
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Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.





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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






 




			
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Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




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           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:





 




			
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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.




 




			
	****	 	Certain confidential information contained in this document, marked with four
asterisks, has been omitted 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









 








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






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






 









 






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Unit	 	 	 	 	 	Estimated	 	Estimated
	Services	 	Unit	 	# Units	 	Cost	 	Fees	 	Pass-Thru	 	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
	 	Narrative	 	****	 	 	****	 	 	 	****	 	 	 	****	 	 	 	****	 
	 	 	will be billed)
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	•	 	Clinical writing
	 	Project	 	 	****	 	 	 	****	 	 	 	****	 	 	 	****	 	 	 	****	 
	 	 	Input to 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	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	•	 	OmnieView
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	>Monthly Maintenance
	 	Months	 	 	****	 	 	 	****	 	 	 	****	 	 	 	****	 	 	 	****	 
	 	 	Sub-Total Technology
	 	 	 	 	 	 	 	 	 	 	 	 	****	 	 	 	****	 	 	 	****	 
	I. Regulatory Services	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	•	 	CRF Filing and Reconciliation (bill
	 	Pages	 	 	****	 	 	 	****	 	 	 	****	 	 	 	****	 	 	 	****	 
	 	 	on actuals)
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	•	 	Return of CRF (hard copy); bill on
	 	Pages	 	 	****	 	 	 	****	 	 	 	****	 	 	 	****	 	 	 	****	 
	 	 	actuals
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	•	 	Return of Investigator and Study-Wide
	 	Sites	 	 	****	 	 	 	****	 	 	 	****	 	 	 	****	 	 	 	****	 
	 	 	Documents (paper)
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	•	 	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 Americas
	 	Sites	 	 	****	 	 	 	****	 	 	 	****	 	 	 	****	 	 	 	****	 
	•	 	Pre-Regulatory
	 	Audit	 	 	****	 	 	 	****	 	 	 	****	 	 	 	****	 	 	 	****	 
	 	 	Inspection
Audits
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	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:
Title:
	 	Dale Evans
CEO	 	 
	 

	 	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





 









 






	 	 	 	 	 
	 	 	 	 	Estimated Service
	Reference	 	Changes and/or Additions	 	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 the budget as follows (provide
estimate of anticipated costs associated
with change, if available):

	 	þ     Increase

o     Decrease	 	 
	 

	 	o     Other (specify)	 	 





The above information briefly outlines a description of the additional/changed services, which
relate to the referenced study/protocol. Costs above are estimates. OCR and Sponsor will discuss in
detail the budgetary and/or timeline impact of the additional/changed services within five (5)
business days of receipt of 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.




o OCR may not proceed with additional/changed services.



Sponsor Comments:



Please acknowledge approval/refusal to proceed with the additional/changed services by sending
written confirmation to the OCR Project Leader by one of the following methods: 1) signing and
returning this document via fax to ___, or 2) sending a confirming email to the Project Leader.




Sponsor Acknowledgment




	 	 	 	 	 
	/s/
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.





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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.




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	•	 	7 escalations x 2 dose groups of 3 patients x **** 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.





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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.




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	 	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.




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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:




	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Preparation,	 	 
	 	 	 	 	 	 	Total number of	 	 	 	 	 	follow-up and	 	 
	Type of Visit	 	Visits per site	 	visits	 	Time onsite in hours	 	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.




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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 (>l/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
	 
	 	 
	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 truck
	 
	 	 
	PCN:

	 	KO1607 (6 sites, 1 protocol only)






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Estimated	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Pass—	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Through	 	Estimated
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Unit Cost	 	Fess	 	Costs	 	Total Cost
	Services	 	Unit	 	# Units	 	(USD $)	 	(USD $)	 	(USD $)	 	(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
	 
	 	 
	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)






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Estimated	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Pass-	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Through	 	Estimated
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Unit Cost	 	Fess	 	Costs	 	Total Cost
	Services	 	Unit	 	 #
Units	 	(USD $)	 	(USD $)	 	(USD $)	 	(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 prolocol
only)






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Estimated	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Past-	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Through	 	 	Estimated	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Unit cost	 	 	 	 	 	 	Costs	 	 	Total Cost	 
	 	 	 	 	Services	 	Unit	 	 	# Units	 	 	(USD $)	 	 	Fees
(USD $)	 	 	(USD $)	 	 	(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)






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Estimated Pass —	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Through Costs 	 	 	Estimated Total	 
	Services	 	Unit	 	 	# Units	 	 	Unit Cost (USD $)	 	 	Fees (USD $)	 	 	(USD $)	 	 	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)






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Estimated	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Pass -	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Through	 	Estimated
	 	 	 	 	 	 	 	 	 	 	Unit Cost	 	 	 	 	 	Costs	 	Total Cost
	 	 	Services	 	Unit	 	# Units	 	(USD $)	 	Fees (USD $)	 	(USD $)	 	(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.
	 

	 	Compaound:
	 	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)







	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Estimated	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Pass -	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Through	 	Estimated
	 	 	 	 	 	 	 	 	 	 	Unit Cost	 	 	 	 	 	Costs	 	Total Cost
	 	 	Services	 	Unit	 	# Units	 	(USD $)	 	Fees (USD $)	 	(USD $)	 	(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)






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Estimated	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Pass	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Trough	 	Estimated
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Unit Cost	 	 	 	 	 	Cost	 	Total Cost
	 	 	 	 	Services	 	Unit	 	# Units	 	(USD $)	 	Fees (USD $)	 	(USD $)	 	(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 Budject 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)






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Estimated	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Past-	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Through	 	Estimated
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Unit Cost	 	 	 	 	 	Cost	 	Total Cost
	 	 	 	 	Services	 	Unit	 	# Units	 	(USD
$)	 	Fees (USD $)	 	(USD $)	 	(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)






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Estimated	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Pass — 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Through	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Unit Cost	 	 	 	 	 	costs	 	Estimated Total
	Services	 	Unit	 	# Units	 	(USD $)	 	Fees (USD $)	 	(USD$)	 	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)






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Estimated Pass-	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Through Costs	 	Estimated Total
	Services	 	Unit	 	# Units	 	Unit Cost (USD $)	 	Fees (USD $)	 	(USD $)	 	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 

Title: General Manager 

Australia 

Dated: 15/1/07

	 	Name: Dale Evans

Title: CEO

Dated: 02/21/07	 	 






 




			
	****	 	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 4th 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”), wherin
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 cm2 contiguous actinic keratoses treatment area on the
face or face and scalp”. The Protocol Refrence 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 da,ta

	 	 	 	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 templat 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 projecedt 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$):




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
















 






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















 






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



















 





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





 









 






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





 









 






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





 









 






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

    Compound:

    Study:

    PCN:
	 	



Peplin

PEP005 (0.05%)

PEP-005-018 — US Scenario

KO1704






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Estimated	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Pass-	 	Estimated
	 	 	 	 	 	 	 	 	 	 	Unit Cost	 	Fees	 	Through	 	Total Cost
	Services	 	Unit	 	# Units	 	(AUS $)	 	(AUS $)	 	(AUS $)	 	(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