CLINICAL SERVICES MASTER AGREEMENT

Exhibit 10.22

CLINICAL SERVICES MASTER AGREEMENT

THIS CLINICAL SERVICES MASTER AGREEMENT (this “Master Agreement”) is entered into as of this 1^st day of June, 2005, by and between Xxxxxx Operations Pty Ltd ACN 093 317 367 (“Sponsor”) of Xxxxx 0, 0 Xxxxxxxxx Xxxxx Xxxx, 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:

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.

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.

	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 # ****

Confidentiality

	3.1.		That certain Confidentiality Agreement by and between Omnicare CR and Sponsor dated as of 25^th 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.

			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.

and acknowledges further that:

	(c)		once in possession of confidential information, a party may be subject to the xxxxxxx xxxxxxx 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.

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.

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.

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


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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


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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.

			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.
		000 Xxxxxxxxx Xxxx
		Xxxx xx Xxxxxxx, XX 00000
		Attention: Global Client Contracts

If to Sponsor:		Xxxxxx Operations Pty Ltd
		Xxxxx 0, 0 Xxxxxxxxx Xxxxx Xxxx
		Xxxxxxxx
		XXX 0000
		Xxxxxxxxx


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

Attention: Dr Xxxxx 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.

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.

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


Xxxxxx Operations Pty Ltd		Omnicare CR, Inc.

By:	/s/ Xxxxxxx Xxxxxxxx	By:	/s/ Xxxxx X. Xxxxx

Name:	Xxxxxxx Xxxxxxxx	Name:	Xxxxx X. Xxxxx
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 Xxxxxx Operations Pty Ltd. and Omnicare CR, Inc.,
dated June 1, 2005.

THIS EXHIBIT I is entered into this 21^st day of June 2006, by and between Xxxxxx 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, 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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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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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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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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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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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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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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	•		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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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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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. Electronicand paper copies of the randomization are stored in a secured location in accordance with Omnicare CR SOPs. Fees include verification and review by a senior biostatistician.

Design of Table Shells (Mocks)

The statistical plan will include a set of formatted shells for all data displays (data listings, summary tables and graphics) planned for the study, which will be prepared with input from the Clinical Writing Department. If formatted data displays are not required, a detailed table of contents of SAS generated data displays will be included.

Programming/QC of Data Displays

The process to programming actual data displays (data listings, summary tables and graphics) at Omnicare CR is methodical and stepwise in description.


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The process begins with the rules and requirements stated in the Protocol, Statistical Analysis Plan and Mock Data Displays. The annotated mocks drive the specifications for derived datasets definitions document, the programming of those datasets and the development and production of the data displays. The derived dataset specifications document follows the format presented by the FDA guidance concerning regulatory submissions in electronic format. Derived dataset structures can be created to client specifications. If specifications are not provided then programming defaults to CDISC standard structures in SAS transport file format. As the mocks is the specification for all programming output, any changes to data display formats or raw database after approval and programming initiation could result in additional charges.

The biometrics staff will use a combination of independent programming, hand tabulations from supporting listings, and programming verification to ensure the accuracy and completeness of tables, listings, and statistical results. Products developed in SAS are validated for accuracy through a double programming process and these processes are outlined in the departmental SOPs and guidelines. The status of a SAS program’s development is monitored through an internal tracking system which stores the individuals involved with a given product, comments for program and output issues, when the programmed files are ready for QC and when the person validating the results states that the product has passed QC. All report data displays will be verified for accuracy and internal consistency among data displays. A quality control binder, including the quality control strategy for each data display and audit trail, will be included in the Project file.

Programmatic Evaluability/Outcome

Patient evaluability criteria and relevant algorithms will be developed for the study by Omnicare CR and presented to Sponsor for review and approval. These algorithms will be programmed using SAS to identify evaluable patients. Biostatisticians will verify the accuracy of the output with independent programming and review of individual patient data. Final decisions regarding patient evaluability will require approval by the Sponsor; patient evaluability is performed once for each patient in the study.

Data listings for each patient’s evaluability status and supporting data will be prepared and submitted to Sponsor for classification prior to breaking the blind. Data classification meetings may be held either in person or via teleconference.

Statistical Analysis

Omnicare CR staff biostatisticians will perform statistical analysis, in accordance with the approved statistical analysis plan. The analysis includes verification of assumptions needed for statistical inference, determination of investigator-by-treatment interaction, and examination of outlying data points.

Statistical findings which may not be appropriate for the body of the clinical report (e.g., tests for interaction, data distribution issues, etc.), deviations from the planned analyses, and additional exploratory analyses will be included in a statistical appendix to the clinical report.


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The Project statistician will also review the clinical report to ensure appropriate representation of statistical methodology and inference.

FDA Item 11

Additional data definition documentation for all derived datasets can be provided to support the FDA requirements for submitting to the agency. The file produced would be named define pdf matching the guidance titled Regulatory Submissions in Electronic Format; New Drug Applications. Datasets are provided in SAS version 5-transport format.

Standard Data Transfer

At the conclusion of the study, Omnicare CR will transfer, the Project database to Sponsor in standard Omnicare CR SAS data sets using Omnicare CR standard naming conventions and format. Customized data transfers, or interim database closes and transfers, can be accommodated on request at an additional fee.

Data Safety Monitoring Board

A Data Safety Monitoring Board (DSMB) will be formed according to Omnicare CR’s operating procedures and will be solely responsible for evaluating the interim results of the study. One (1) organizational meeting and one (1) interim analysis evaluation meeting are planned.

Omnicare CR and Sponsor will jointly develop guidelines for membership of the DSMB, and for conduct of DSMB meeting to be documented in the DSMB Charter. The DSMB members will be recruited by Omnicare/Sponsor. Members of the DSMB will neither have previous involvement with Sponsor’s studies in this area, nor be currently involved in clinical trials of competing therapies.

The DSMB will have a written charter that will be produced by a Project Director which will define the responsibilities and will maintain records of all meetings. The written charter will also include a statistical appendix that will document the requirements and guidelines for analyzing and interpreting the interim safety results.

Omnicare CR’s biometrics team will prepare mock data displays specific to the DSMB charter. A senior statistician, otherwise unrelated to the study, will be responsible for the development of the data displays defined by the DSMB to ensure interim data accuracy and summaries are produced. These data displays will be programmed and validated by biometrics staff. The validation will be performed through a combination of individual patient data review and independent programming.

When the blind is ready to be broken, the DSMB statistician will perform the final run of the DSMB data displays and prepare for the DSMB.

For each DSMB meeting, the database will be extracted and the data listings and summary tables will be rerun. If the DSMB requests data clarification or further information, Omnicare CR will re-extract the data and rerun the listings and tables on the new data.


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G. Clinical Writing

Clinical Study Report — Phase II/III

The Clinical Writing Department has experience in the production of integrated statistical and clinical study reports covering a wide range of therapeutic areas. It will be the responsibility of the assigned Clinical Writer to ensure delivery of an integrated statistical and clinical study report for this program. The integrated clinical and statistical summary will be prepared in accordance with ICH guidelines on the “Structure and Content of Clinical Study Reports”, appropriate agency regulations, and Omnicare CR’s SOPs and clinical study report format. A draft clinical report will be generated within **** (****) weeks after receipt of source material and final summary tables and patient data listings.

The designated Omnicare CR clinical writers will liaise closely with the statistician and other team members. All clinical documents will receive, two levels of quality control reviews before they are released. There will be a QC review by an independent clinical writer for accuracy and consistency, and a review by the writing manager for accuracy, client format consistency, and appropriate regulatory and clinical perspective. The first draft will then be provided to the Sponsor for review.

The second draft clinical study report will be produced after receipt of one set of collated comments from the Sponsor. It is Omnicare CR’s experience at Omnicare CR that this can be facilitated, more speedily, by holding a draft review meeting (optional) between a Sponsor representative and the Omnicare CR clinical writer. The second draft will be reviewed within the Clinical Writing Department at Omnicare CR to ensure that all Sponsor comments are addressed and that all changes are consistent with the supporting data. Following the Sponsor’s second review, minor revisions will be made and the report finalized.

Omnicare CR Biometrics will provide up to **** tables and **** listings that will be summarized in the clinical study report. This fee includes **** major and **** minor revision. **** major revision of the draft report is considered to be up to **** (****) days of requested changes and a minor revision is up to **** (****) day of requested changes. Patient narratives will be drafted from final patient data listings. Omnicare CR Writing will prepare patient narratives for SAEs and, discontinuations due to adverse events based upon a $**** per narrative fee. The fee for the study report does not include study report appendices (including TLs).

Clinical Writing Input to Statistical Analysis Plan

Omnicare CR’s Clinical Writing will review the draft statistical analysis plan and mock summary tables and data listings for consistency with the protocol and ICH guidelines for clinical study reports. Clinical Writing will provide feedback on the table design and format to facilitate the use of the data in the clinical study report.


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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.


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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.


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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.


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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.


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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.


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IV. Budget

A. Estimated Project Budget


Omnicare CR, Inc. Clinical Budget for:

Sponsor:		Xxxxxx

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

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 Xxxxxx will perform this task)

> Zone 1

Site

****

•

Site Recruitment (assumes Xxxxxx 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

> Xxxx 0

Xxxxxxxxxx/xxxx

****

•

Protocol Amendments — including ICF change

> Xxxx 0

Xxxxxxxxxx/xxxx

****


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

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 0 Xxxxx Xxxxxxx

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; xxxx 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; xxxx 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 (xxxx 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 Xxxxxx 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 (xxxx

Pages

****

on actuals)

•

Return of CRF (hard copy); xxxx 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. Xxxxxx 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 (xxxx on actuals)

Pages

****

•

Investigator Binders (includes printing, copying and shipping; xxxx on actuals)

Binder

****

•

Shipment of Start-up Packet (xxxx on actuals)

Sites

****

•

Courier Cost for Drug Shipments to Sites (xxxx on actuals)

Shipment

****

•

Ship CRFs (xxxx on actuals)

Box

****

•

Ship CRF from OCR back to Sites (xxxx on actuals)

Box

****

•

Copying (xxxx on actuals)

Pages

****

•

Investigator Brochure Printing (xxxx on actuals)

Pages

****

•

Protocol Printing (xxxx on actuals)

Pages

****

•

Informed Consent Printing (xxxx 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 24^th 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:

Xxxxxx Operations Pty Ltd.

Omnicare CR, Inc.

By:

/s/ Xxxxx Xxxxxxx

By:

/s/ Xxxx Xxxxx

Name:

Xxxxx Xxxxxxx Chief Scientific Officer and Vice President,

Name:
Title:

Xxxx Xxxxx
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 Xxxxxx Operations Pty Ltd. and Omnicare CR, Inc.,
dated 1^st June 2005.

THIS CHANGE ORDER is entered into this 20^th day of November 2006 (“Effective Date”), by and between Xxxxxx Operations Pty Ltd. (hereinafter “Sponsor”) and Omnicare CR, Inc. (hereinafter “Omnicare CR”).

WHEREAS, Sponsor and Omnicare CR entered into a certain Clinical Services Master Agreement, dated 1^st June 2005 (collectively, with the Exhibit thereto, as the same may have been amended or supplemented as of the date hereof, the “Agreement”), the terms of which are incorporated herein by reference; and

WHEREAS, 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*		*Xxxxxx 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*		*Xxxxxx 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:

Xxxxxx Operations Pty Ltd.

Omnicare CR, Inc.

By:

/s/ Xxxxxxx Xxxxxxxx

By:

/s/ Xxxx Xxxxx

Name:

Xxxxxxx Xxxxxxxx

Name:

Xxxx Xxxxx

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*		*Xxxxxx 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:	Xxxxxxx Xxxxxxxx
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/ Xxxxxxx Xxxxxxxx		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 Xxxxxx Operations Pty Ltd and Omnicare CR, Inc.,
dated June 1, 2005

THIS EXHIBIT J is entered into this 5^th day of December, 2006 (“Effective Date”), by and between Xxxxxx 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, 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.

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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.

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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 1^st dose cohort
Day **** (Baseline)	•	treatment start of 1^st 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 2^nd dose cohort of treatment arm 1
		•	Treatment start of 1^st 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 15^th 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 xxxxx, 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.

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.

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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.

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.

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D. Clinical Trial Initiation

Site Selection/ Patient Recruitment Plan

It is assumed, that Xxxxxx 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.

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.

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.

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.

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.

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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.

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.

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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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.

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.

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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

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.

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.

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.


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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

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.

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.

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.

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

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

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.

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.

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.

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.

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.

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:		Xxxxxx 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 $)

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 Xxxxxx

> USA

Site

****

•

Site Recruitment Assume to be done by Xxxxxx

> 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:		Xxxxxx 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 $)

> 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:		Xxxxxx 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 $)

CQA Manager - Americas (Optional if requeued)

Days

****

CRA Attendees

> USA: ****CRA

Days

****

Client Attendee Travel

Attendee

****

Sub-Total Clinical Trial Initiation

****

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:		Xxxxxx 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 (xxxx 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:	Xxxxxx 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 $)

> 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 xxxxxx 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:	Xxxxxx 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 $)

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:		Xxxxxx 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 $)

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:		Xxxxxx 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 $)

•

DESC Meeting -Customized Reports

Report

****

Sub-Total Clinical Data Management

****

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

****

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:	Xxxxxx 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 (xxxx on actuals)

Pages

****

•

Return of CRF (hard copy.); xxxx 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:	Xxxxxx 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 (xxxx 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 xxx.xxxxx.xxx

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:

Xxxxxx Operations Pty Ltd.		Omnicare CR, Inc.

BY: /s/ Xxxxx Xxxxxxx		BY: /s/ Xxxx Xxxxx

Name: Xxxxx Xxxxxxx Title: General Manager Australia Dated: 15/1/07		Name: Xxxx Xxxxx 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 Xxxxxx Operations Pry Ltd. and Omnicare CR, Inc.,
dated 1^st June 2005

THIS EXHIBIT K is entered into this 4^th day of December, 2006 (“Effective Date”), by and between Xxxxxx Operations Pty Ltd. (hereinafter “Sponsor”) and Omnicare CR, Inc, (hereinafter “Omnicare CR”).

WHEREAS, Sponsor and Omnicare CR entered into a Clinical Services Master Agreement, dated 1^st June 2005 (hereinafter the “Master Agreement”), 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:

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)	Xxxxxx	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)	Xxxxxx	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 Xxxxxx		****
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.

Budget

Estimated Project Budget

The following budget is presented to Xxxxxx in Australian Dollars (A$):

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

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

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

Services

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

Services

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 (xxxx on actuals)

Pages

****

•

Return of CRF (hard copy); xxxx 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

Services

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

Services

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.

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 xxxxx.xxx.

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,
Xxxxxxxx Xxxxxxxx Xxxxxx,
Xxxxx Xxxx, XXX
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:

Xxxxxx Operations Pty Ltd.

Omnicare CR, Inc.

BY:

/s/ XXXXX XXXXXXX

BY:

/s/ Xxxx Xxxxx

Name:

XXXXX XXXXXXX

Name:

Xxxx Xxxxx

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 Xxxxxx Operations Pty Ltd. and Omnicare CR, Inc.,
dated 1^st June 2005

THIS EXHIBIT O is entered into this 30th October, 2007 (“Effective Date”), by and between Xxxxxx Operations Pty Ltd. (hereinafter “Sponsor”) and Omnicare CR, Inc. (hereinafter “Omnicare CR”).

WHEREAS, Sponsor and Omnicare CR entered into a Clinical Services Master Agreement, dated 1^st June 2005 (hereinafter the “Master Agreement”), wherein Omnicare CR agreed to provide clinical services; and

WHEREAS, Omnicare CR and/or an affiliate entity (such entity being defined as an entity under direct or indirect beneficial common ownership as Omnicare CR’s; hereinafter referred to as “Affiliate Entity”) is willing and able to perform the services designated by Sponsor. Except for any references to invoicing or payment, any references to “Omnicare CR” shall be deemed to include “Omnicare CR and/or an Affiliate Entity”; and

WHEREAS, Sponsor and Omnicare CR agree that Omnicare CR shall provide the services set forth in this Exhibit 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


	Scenario 1 - US
Task List (Major)	Xxxxxx	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)	Xxxxxx	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)	Xxxxxx	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)	Xxxxxx	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 Xxxxxx in Australian Dollars (A$):


		Omnicare CR, Inc. Clinical Budget for: Sponsor: Compound: Study: PCN:		Xxxxxx PEP005 (0.05%) PEP-005-018 — US Scenario KO1704

Estimated

Pass-

Estimated

Unit Cost

Fees

Through

Total Cost

Services

Unit

# Units

(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)

> Xxxx 0

Xxxxxxxxxx/xxxx

****

Protocol Amendments —
including ICF change
(US sites only)

> Xxxx 0

Xxxxxxxxxx/xxxx

****


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

> Xxxx 0

Xxxxxxx/Xxxx

****

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 (Xxxxx.xxx) 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,
Xxxxxxxx Xxxxxxxx Xxxxxx,
Xxxxx Xxxx, XXX
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:


Xxxxxx Operations Pty Ltd.		Omnicare CR, Inc.

BY:	/s/ Xxxxxx Xxxxx	BY:	/s/ Xxxx Xxxxx, PhD


Name:	Xxxxxx Xxxxx	Name:	Xxxx Xxxxx, 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

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Table of Contents

CLINICAL SERVICES MASTER AGREEMENT

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