EXHIBIT 10.36
MASTER SERVICES AGREEMENT
This Master Agreement ("Agreement") made this 29th day of July, 2002
(the "Effective Date") by and between INTRABIOTICS PHARMACEUTICALS, INC., with
its principal executive offices located at 0000 Xxxxx Xxxxx Xxxxxx, Xxxxxxxx
Xxxx, XX 00000 ("Sponsor"), and PPD DEVELOPMENT, LP, with its principal
executive offices located at 0000 Xxxxx 00xx Xxxxxx, Xxxxxxxxxx, Xxxxx Xxxxxxxx
00000, XXX, together with its affiliate company, PPD GLOBAL LTD, with offices
located at Xxxxxx Xxxx, Xxxxx Xxxxxxxx, Xxxxxxxxx, XX0 0XX, Xxxxxx Xxxxxxx
(collectively "PPD").
WHEREAS, Sponsor is engaged in the development, manufacture,
distribution, and sale of pharmaceutical products;
WHEREAS, PPD is a contract research organization engaged in the business
of managing clinical research programs;
WHEREAS, Sponsor may wish to retain the services of PPD from time to
time to perform clinical research services in connection with certain clinical
research programs Sponsor is conducting as more fully set forth in various
project specific addenda to be attached to this Agreement;
WHEREAS, PPD is willing to provide such services to Sponsor in
accordance with the terms and conditions of this Agreement and attached Project
Addenda (defined below).
NOW, THEREFORE, for good and valuable consideration contained herein,
the exchange, receipt and sufficiency of which are acknowledged, the parties
agree as follows:
1. PROJECT ADDENDA.
In the event that the parties hereto shall reach agreement with respect
to a particular clinical research program that Sponsor is conducting
(individually, "Study"), the parties shall attach to this Agreement one or more
project specific addendum for said Study (each such addendum, a "Project
Addendum" and collectively, "Project Addenda"), which Project Addenda shall be
incorporated herein by reference. The Project Addenda for a particular Study,
along with this Agreement, shall collectively, independent from other Project
Addenda, constitute the entire agreement for the specific Study. No Project
Addendum shall be attached to this Agreement without first being executed by the
parties hereto. To the extent any terms set forth in any Project Addendum shall
conflict with, or create ambiguities with, the terms set forth in this
Agreement, the terms of this Agreement shall control.
2. SERVICES.
2.1 - PPD hereby agrees to provide to Sponsor the services described in
the services section of each Project Addendum attached to this Agreement (the
"Services"). PPD shall use all reasonable efforts to perform the Services
strictly in accordance with the applicable Study protocol ("Protocol") which
shall be incorporated therein. Furthermore, in performing the Services, PPD
shall comply with this Agreement, applicable Project Addenda, any written
instructions of Sponsor, any standard operating procedures approved by Sponsor,
relevant
professional standards and all applicable supranational, national or local laws,
rules and regulations, including, but not limited to, the United States Federal
Food, Drug and Cosmetic Act, the regulations promulgated pursuant thereto, any
non-U. S. equivalents thereof, and any successor laws, rules or regulations
thereof.
2.2 - In the event that PPD is requested or required to perform services
beyond that which are specifically set forth in a Project Addendum, any such
additional services and a compensation schedule therefor must be mutually
agreed upon by the parties in writing prior to the provision of said services.
Said mutually agreed upon writing shall be an amendment to the pertinent Project
Addendum and the services set forth therein shall be deemed to be Services as
the term is used in this Agreement.
2.3. - In the event that Sponsor requests PPD to make and/or distribute
copies of copyrighted materials such as journal articles or excerpts from
publications, Sponsor agrees to pay the cost of any copyright fees incurred by
PPD that are necessary for PPD to produce such copies, unless Sponsor provides a
written representation and warranty that 1) Sponsor has paid any and all fees
and costs associated with said copying and/or distribution of the material to be
copied and or distributed; or 2) PPD is not required to pay a copyright fee to
make copies or distribute the subject material. Sponsor hereby expressly agrees
to indemnify PPD for any and all claims by third parties for damages, losses,
and costs PPD suffers as a result of making and/or distributing copyrighted
material specifically requested by Sponsor in writing.
2.4 - For the avoidance of doubt, the parties understand and agree that
enrollment rates set forth herein are good faith estimates only and PPD shall
exercise all reasonable diligence to meet enrollment expectations.
2.5 - If a change in the Study assumptions, organizational
responsibilities and/or scope of Services occurs, PPD will promptly provide
Sponsor with a written notice describing in detail the specific changes, the
reason for such changes, and the effect on the original Study budget (the
"Change Notice"). Upon, and subject to, Sponsor's written approval, the terms of
the Change Notice shall be incorporated into a written amendment to the
Agreement (the "Change Order") according to Section 19.
2.6 - PPD shall verify that informed consent documents used for a
particular Study include the human subject's express authorization for the
disclosure by the applicable site/institution and the applicable principal
investigator to Sponsor, Sponsor's employees, agents, independent contractors,
including without limit PPD, of patient-identifiable information pursuant to the
Health Insurance Portability and Accountability Act of 1996, and associated laws
regulations, and guidelines (collectively "HIPAA").
3. COMPENSATION AND PAYMENT.
3.1 - Except as otherwise expressly provided in a payment schedule
attached to an applicable Project Addendum, PPD shall submit to Sponsor an
invoice describing the Services performed and, where applicable, costs incurred
during a particular month on a monthly basis and Sponsor shall pay said invoices
within thirty (30) days of receipt.
3.2 - In the event any Project Addendum, or this Agreement, is
terminated pursuant to Section 4 of this Agreement, PPD shall be compensated for
all fees and costs due pursuant to a Project Addendum at the date of termination
as demonstrated in the applicable Project Addendum Payment Schedule.
Furthermore, the parties shall use commercially reasonable efforts to minimize
the cost of such wind-down. Additionally, PPD shall be reimbursed any and all
uncancellable obligations as regards third parties. Any funds held by PPD which
shall be shown by Sponsor to be unearned at the date of termination shall be
returned to Sponsor within forty-five (45) days of Project Addendum Termination.
Certain Services of PPD require greater utilization of resources at the outset
such that compensation based on a percentage of milestones completed prior to
PPD completing the full milestone would work to the detriment of PPD ("Special
Services"). PPD shall indicate such Special Services on each Project Addendum.
Accordingly, the Parties agree that in the event of early termination,
compensation for partially completed milestones for Special Services shall be
made on a time and materials basis.
3.3 - In the event a Study is terminated early, in addition to any and
all other compensation and reimbursement due under this Agreement, Sponsor shall
pay to PPD an amount, as determined by PPD in good faith, to represent costs and
expenses incurred as a result of said early termination, including by way of
example but not limited to, unforeseen down time and reassignment of PPD
dedicated Study personnel ("Termination Expenses"). Said Termination Expenses
shall not exceed 5% of the total fees (excluding pass through expenses) PPD
would have received pursuant to this Agreement had the Study continued full
scope until completion.
3.4 - In the event Sponsor requests PPD to begin providing Services for
any Study prior to the execution of a Project Addendum or a letter of intent,
Sponsor agrees that PPD shall be compensated on a time and material basis with
monthly invoicing for Services performed in accordance with the PPD proposal for
services which formed the basis of the award of the Study to PPD.
3.5 - Payments to PPD shall be made to:
PPD Development, LP
X.X. Xxx 00000
Xxxxxxxxx, XX 00000-0000
Tax ID# 00-0000000
3.6 - Taxes (and any penalties thereon) imposed on any payment made by
Sponsor to PPD shall be the responsibility of PPD.
4. TERM AND TERMINATION.
4.1 - The term of this Agreement shall commence as of the Effective Date
and terminate as provided for in this Section 4. Project Addenda shall commence
upon the date of complete execution by the parties and shall terminate upon the
completion of Services unless earlier terminated in accordance with this
Section 4.
4.2 - Termination
a) This Agreement or any Project Addendum may be terminated, with or
without cause, by Sponsor upon thirty (30) days prior written notice to PPD.
b) PPD may terminate this Agreement or any Project Addendum if Sponsor
commits a material breach of its obligations under this Agreement or such
Project Addendum, and Sponsor fails to remedy such breach within thirty (30)
days of its receiving written notice of such breach from PPD.
4.3 - The termination of this Agreement by either party shall
automatically terminate any and all Project Addenda, unless otherwise agreed.
4.4 - Upon termination of this Agreement or a Project Addendum pursuant
to this Section 4, PPD shall cooperate with Sponsor to provide for an orderly
wind-down of the Services provided by PPD hereunder. Furthermore, the parties
shall use commercially reasonable efforts to minimize the cost of such
wind-down.
4.5 - The obligations of the parties contained in Sections 6, 7, 8, 9,
13, 15 and 22 hereof shall survive termination of this Agreement.
5. PERSONNEL.
5.1 - The Services with respect to each Study shall be performed by PPD
under the direction of the person identified as the Project Manager in the
applicable Project Addendum or such other person acceptable to Sponsor as PPD
may from time to time designate the Project Manager, such Sponsor acceptance not
to be unreasonably withheld.
5.2 - PPD shall be obligated at all times to provide a sufficient number
of trained clinical research personnel on a given Study to meet the demands of
said Study.
5.3 - PPD shall not subcontract or assign any Services under a Project
Addendum without the prior written consent of Sponsor, such consent not to be
unreasonably withheld.
5.4 - During the period in which a particular Study is being conducted,
neither party shall recruit, hire or employ any personnel of the other who is
material to the performance of the particular Study without the prior written
consent of the other party. The foregoing shall not preclude Sponsor from
issuing and hiring individuals by general solicitations in newspaper and/or
electronic media.
6. CONFIDENTIALITY.
6.1 As used in this Agreement (and subject to the limitations of Section
6.3), "Information" shall mean any confidential or proprietary information (a)
obtained from Sponsor, (b) generated or created by PPD as a direct and sole
result of performing the Services or as a deliverable under this Agreement or
(c) relating to Sponsor's study drug, exclusive of research methodologies
developed by PPD and computer software and code developed by PPD. All
Information shall be the confidential and exclusive property of Sponsor, and
shall include without limitation any of Sponsor's Study protocols, Study data
(including all Study records), inventions, trade secrets, ideas, patent
applications, processes, formulae, compounds, cell lines,
know-how, improvements, discoveries, developments, designs and techniques,
information regarding plans for research development, present and future
products, marketing and selling, business plans, budgets and unpublished
financial statements, licenses, prices and costs, suppliers, customers,
investors and information regarding the skills and compensation of Sponsor's
employees, whether disclosed in oral, written, graphic or electronic form.
6.2 - PPD shall hold any Information in strict trust and confidence and
shall not disclose any of the Information to any third party without first
obtaining the written consent of Sponsor. PPD shall use any Information only to
provide the Services, and PPD shall not use any Information for any other
purpose without the prior written consent of Sponsor. In particular, PPD shall
not (a) use Information for any purpose or in any manner that would constitute a
violation of any laws or regulations of the United States, (b) file any patent
application containing any claim the subject matter of which is derived from
Information, or (c) retain, distribute or commercialize any Information, except
to the extent necessary to perform the Services. Additionally, PPD shall not
disclose any Information to any of its directors, officers, employees, agents,
representatives and independent contractors (the "PPD Parties"), unless such PPD
Parties have a need to know such information and, prior to any disclosure, such
PPD Parties are bound by obligations of confidentiality and non-use at least
restrictive as those found in this Agreement.
6.3 - The above provisions of confidentiality shall not apply to that
part of the Information which PPD is able to demonstrate by documentary
evidence:
a) was in PPD's possession prior to receipt from Sponsor or is developed
independently from a Study and without access to Information;
b) was in the public domain at the time of receipt from Sponsor;
c) becomes part of the public domain through no fault of PPD or any PPD
Party;
d) is lawfully received by PPD from some third party having a right of
further disclosure.
Furthermore, PPD may disclose Information to the extent, and to the persons
and/or entities, required by governmental law, rule, regulation or order;
provided, however, that PPD both (i) give prompt notice to Sponsor of the
disclosure requirement and (ii) attempt to obtain any available limitation on or
exemptions from such disclosure requirement.
6.4 - PPD agrees that upon termination or expiration of this Agreement
or, at Sponsor's request, PPD shall (and shall cause the PPD Parties to) return
to Sponsor all parts of the Information provided by Sponsor in documentary form
and return or destroy any copies thereof made by PPD or PPD Parties.
Notwithstanding the foregoing, PPD may retain one copy of any such Information
as is reasonably necessary for legal archival purposes, subject to the ongoing
obligation to maintain the confidentiality of such information.
6.5 - PPD acknowledges that disclosure or distribution of the
Information or use of the Information contrary to the terms of this Agreement
may cause irreparable harm for which damages at law may not be an adequate
remedy, and agrees that the provisions of this Agreement prohibiting disclosure
or distribution of the Information or use contrary to the provisions hereof may
be specifically enforced by a court of competent jurisdiction in addition to any
and all other remedies available at law or in equity.
6.6 - All Confidential Information containing personal data shall be
handled, to the extent applicable, in accordance with all applicable law,
including, but not limited to HIPAA and the European Data Protection Directive
[EC/95/46].
7. INTELLECTUAL PROPERTY.
7.1 - General Principles. Except to the extent necessary for the
performance of the Services and as otherwise provided in this Agreement, neither
anything contained herein nor the delivery of any information to a party shall
be deemed to grant the one party any right or licenses under any patents, patent
applications, know-how, technology, inventions or other intellectual property
rights of the other party. As used in this Agreement, "Inventions" shall mean
any and all inventions, technology, discoveries, know-how or ideas, whether or
not patentable, that are conceived, reduced to practice, made or developed as a
result of performing Services under this Agreement.
7.2 - Sponsor Inventions. PPD shall promptly notify Sponsor in writing
of any and all Inventions (other than PPD Inventions) directly relating to
Sponsor's Study drug or Protocol, including without limitation any improvement,
modification or enhancement of the foregoing ("Sponsor Inventions"). PPD shall,
and hereby does, assign to Sponsor all rights that PPD or any PPD Parties may
have in any Sponsor Inventions. In addition, PPD shall assist Sponsor, at
Sponsor's reasonable expense, in obtaining or extending protection for all
Sponsor Inventions. PPD represents that it has and will continue to have
agreements with the PPD Parties to effectuate the t s of this Section 7 and
shall enforce such agreements to provide Sponsor with the benefit of this
Section 7.
7.3 - PPD Inventions. It is acknowledged that PPD possesses certain
inventions, processes, know-how, trade secrets, improvements, other intellectual
properties and other assets, including but not limited to, data processes,
technology, means or know-how developed by PPD which relate to data collection
or data management and laboratory analyses, analytical methods, procedures and
techniques, computer technical expertise and software (including codes) which
have been independently developed without the benefit of any information
provided by Sponsor (collective, "PPD Inventions"). Sponsor and PPD agree that
any PPD Property or improvements thereto are the sole and exclusive property of
PPD, provided that, PPD hereby grants to Sponsor a worldwide, royalty-free,
non-exclusive license, sublicensable to Sponsor's affiliates and development
and/or commercialization partners (exclusive, however, of other clinical
research organizations), to use such PPD Inventions internally solely for the
purpose for which the PPD Invention was developed and on the data for which the
PPD Invention was developed in the course of developing, making, having made,
using, selling, offering for sale and importing products that are or include
Sponsor's proprietary products.
8. PUBLICATION.
PPD may not publish any articles or make any presentations relating to
the Services or referring to data, information or materials generated as part of
the Services, in whole or in part, without the prior written consent of Sponsor.
9. INDEMNIFICATION / INSURANCE.
9.1 - Sponsor shall indemnify, hold harmless and defend PPD and its
employees, directors, agents and subcontractors (exclusive of clinical sites/
investigators) (the "PPD Parties") for any and all damages (specifically
including any damages incurred by PPD as a result of indemnity obligations
imposed upon PPD by contract between PPD and third party provider to a Study
where such third party provider is approved by Sponsor), costs, expenses and
other liabilities, including reasonable attorney's fees and court costs,
incurred in connection with any claim, action or proceeding arising from this
Agreement or PPD's performance of the Services (each a "Claim"), provided
however, that Sponsor shall have no obligation hereunder with respect to any
Claim to the extent such Claim arises from: (a) the negligence or intentional
misconduct on the part of PPD or any PPD Party, (b) breach by PPD or any PPD
Party of any of its obligations under this Agreement or (c) breach by PPD or any
PPD Party of any applicable supranational, national or local law, rule or
regulation.
9.2 - PPD shall indemnify, hold harmless and defend Sponsor, its
directors, officers, employees, agents and independent contractors
(collectively, Sponsor Indemnitees") for any and all damages, costs, expenses
and other liabilities, including reasonable attorney's fees and court costs,
incurred in connection with any Claim to the extent such Claim arises from: (a)
the negligence or intentional misconduct on the part of PPD or any PPD Party,
(b) breach by PPD or any PPD Party of any of its obligations under this
Agreement or (c) breach by PPD or any PPD Party of any applicable supranational,
national or local law, rule or regulation.
9.3 - Any party liable to provide indemnification hereunder shall be
entitled, at its option, to control the defense and settlement of any claim on
which it is liable, provided that the indemnifying party shall act reasonably
and in good faith with respect to all matters relating to the settlement or
disposition of the claim as the disposition or settlement relates to the party
being indemnified, provided, however, that no settlement shall be made that
adversely affects the economic interests of the indemnified party without its
prior, written approval. The indemnified party shall reasonably cooperate in the
investigation, defense and settlement of any claim for which indemnification is
sought hereunder and shall provide prompt notice of any such claim or reasonably
expected claim to the indemnifying party. An indemnified party shall have the
right to retain its own separate legal counsel at its own expense.
PPD hereby represents that it has in place, and shall maintain for the period of
this Agreement, insurance in the following amounts:
General Liability - $1,000,000 each occurrence; $2,000,000 aggregate.
Automobile Liability - $1,000,000 combined single limit.
Excess Liability - $25,000,000 each occurrence; $25,000,000 aggregate.
Workers compensation as required by law
CRO Errors or Omissions Liability - $10,000,000 each occurrence; $10,000,000
aggregate.
10. INDEPENDENT CONTRACTOR RELATIONSHIP.
The parties hereto are independent contractors and nothing contained in
this Agreement shall be construed to place them in the relationship of partners,
principal and agent, employer/employee or joint venturer. Both parties agree
that neither party shall have power or right to bind or obligate the other
party, nor shall either hold itself out as having such authority.
11. PUBLICITY.
Except as required by law, neither party shall use the name of the other
party nor of any employee of the other party in connection with any promotion or
generation of future business without the prior written approval of the other
party.
12. FORCE MAJEURE.
In the event either party shall be delayed or hindered in or prevented
from the performance of any act required under this Agreement by reasons of acts
of terrorism, earthquake, fire, restrictive government or judicial orders or
decrees, riots, insurrection, war, Acts of God, inclement weather or other
similar reason or a cause beyond such party's control, then performance of such
act shall be excused for the period of such delay. Any timelines affected by
such force majeure shall be extended for a period equal to that of the delay and
any affected Study Budgets shall be adjusted to reflect costs increases
resulting from force majeure. Notice of the start and stop of any such force
majeure shall be provided to the other party.
13. RECORD STORAGE.
13.1 - During the term of this Agreement, PPD shall maintain all
materials and all other data obtained or generated by PPD in the course of
providing the Services hereunder, including all computerized records and files.
PPD shall cooperate with any reasonable internal review or audit by Sponsor
and/or any regulatory authority, and make available to Sponsor and/or any
regulatory authority for examination and duplication, during normal business
hours and at mutually agreeable times, all documentation, data and information
relating to a Study.
13.2 - Upon the expiration or termination of this Agreement, all
materials and all other data and information obtained or generated by PPD in the
course of providing the Services hereunder shall, at Sponsor's option, be (i)
delivered to Sponsor at its expense and risk to its offices in Mountain View,
California in such form as is then currently in the possession of PPD, (ii)
retained by PPD for Sponsor for a period of two years, or (iii) disposed of as
directed by written request of Sponsor, unless such materials are otherwise
required to be stored or maintained by PPD under applicable law. If PPD is
required by applicable law, or requested by Sponsor, to maintain and/or store
such material for a period beyond two years after the termination or expiration
of this Agreement, the parties shall mutually agree on PPD's compensation
therefore. In no event shall PPD dispose of any materials or data or other
information obtained or generated by PPD in the course of providing the Services
hereunder without first giving Sponsor sixty (60) days prior written notice of
its intent to dispose same. Notwithstanding the foregoing, PPD may retain one
copy of any such materials, data and information as is reasonably necessary for
legal archival purposes, all subject to the confidentiality obligations set
forth in Section 6.
14. DEBARMENT.
14.1 - PPD hereby certifies that neither it nor any PPD Party has been
debarred or been convicted of a crime which could lead to debarment, under the
Generic Drug Enforcement Act of 1992 (21 U.S.C. 301 et seq.), any equivalent law
or regulation outside the U.S., or any successor law or regulation to the
foregoing "Applicable Debarment Laws"). In the event that PPD or any of its
officers, directors, or employees under contract to perform services under a
Project Addendum with Sponsor becomes debarred or receives notice of action or
threat of action with respect to its debarment, PPD shall notify Sponsor
immediately.
14.2 - PPD hereby certifies that it has not utilized, and will use its
reasonable best efforts not to utilize, the services of any individual or entity
in the performance of Services under this Agreement or any Project Addendum that
has been debarred or that has been convicted of a crime which could lead to
debarment under the Applicable Debarment Laws. In the event that PPD receives
notice of the debarment or threatened debarment of any such individual or
entity, PPD shall notify Sponsor immediately.
15. NOTICES.
Any notice required or permitted to be given hereunder by either party
hereunder shall be in writing and shall be deemed given on the date received if
delivered personally, or by fax (with proof of receipt), or five (5) days after
the date postmarked if sent by registered or certified U.S. mail, return receipt
requested, postage prepaid to the following address:
If to PPD: PPD Development, LP
0000 Xxxxx 00xx Xxxxxx
Xxxxxxxxxx, Xxxxx Xxxxxxxx 00000
Attention: CEO
Tel: (000) 000-0000
Fax: (000) 000-0000
If to Sponsor: IntraBiotics Pharmaceuticals, Inc.
0000 Xxxxx Xxxxx Xxxxxx
Xxxxxxxx Xxxx, XX 00000
Attention: Xxxxx Xxxxx, M.D., President & COO
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
16. SEVERANCE.
If any one or more provisions of this Agreement shall be found to be
illegal or unenforceable in any respect by a court of competent jurisdiction,
such provision shall be interpreted to provide a legal or enforceable result,
but, if such is not possible, then such provision shall be removed, and the
parties shall meet to create a new provision that comports with the parties'
original intent. The validity, legality and enforceability of the remaining
provisions shall not in any way be affected or impaired thereby, provided the
surviving agreement materially comports with the parties' original intent.
17. WAIVER.
Waiver or forbearance by either party, or the failure by either party to
claim a breach of any provision of this Agreement or exercise any right or
remedy provided by this Agreement or applicable law, shall not be deemed to
constitute a waiver with respect to any subsequent breach of any provision
hereof.
18. CHANGES AND MODIFICATION.
No Change Orders, modifications or amendments of this Agreement, or any
Project Addendum shall be deemed effective unless in writing and executed by the
parties hereto.
19. ASSIGNMENT.
This Agreement and any Project Addendum may not be assigned by either
party without the prior written consent of the other party, provided, however,
the parties may assign this Agreement or a Project Addendum to a successor to
the party's business interests.
20. DISPUTE RESOLUTION.
In the event that any dispute arises hereunder or with respect to the
Services to be provided as set forth herein, the parties agree that the
applicable executives of each party shall promptly meet to discuss and attempt
to resolve the dispute. If the parties are unable to resolve such dispute, then
the parties are free to resolve such dispute in a court of competent
jurisdiction.
21. ENTIRE AGREEMENT.
This Agreement, along with any applicable Project Addenda, represents
the complete and entire understanding between the parties regarding the subject
matter hereof and supersedes all prior negotiations, representations or
agreements, either written or oral, regarding this subject matter.
[REMAINDER OF THIS PAGE LEFT INTENTIONALLY BLANK.]
IN WITNESS THEREOF, this Agreement has been executed by the parties
hereto through their duly authorized officers as of the Effective Date.
PPD DEVELOPMENT, LP INTRABIOTICS PHARMACEUTICAL, INC.
BY: PPD GP, LLC
ITS GENERAL PARTNER
By: /s/ Xxxx X. Xxxxxxxxx By: /s/ Xxxxxx Xxxxx
---------------------------------- ---------------------------------
Name: Xxxx X. Xxxxxxxxx, M.D. Name: Xxxxxx Xxxxx, Ph.D.
-------------------------------- -------------------------------
Title: Executive Vice President Title: Chairman & CEO
of Development ------------------------------
-------------------------------
Date: 1 August 2002 Date: July 29, 2002
-------------------------------- -------------------------------
By: /s/ Xxxxx Xxxxx
---------------------------------
Name: Xxxxx Xxxxx, M.D.
-------------------------------
Title: President & COO
------------------------------
Date: July 29, 2002
-------------------------------
