THIS Agreement is made this ___ day of _____________, 1998, between The
University of Texas M.D. Xxxxxxxx Cancer Center, 0000 Xxxxxxxx Xxxxxxxxx,
Xxxxxxx, Xxxxx 00000 ("Institution"), a component of The University of Texas
System ("System"), and Eurobiotech Corporation Limited of Xxxxxxxx Xxxxx, 0
Xxxxxx Xxxxxx, Xxxxxxxx Embankment, London, ECAY 0HA, ("Sponsor"), to conduct a
clinical and preclinical study and evaluation ("Study"). Institution and Sponsor
agree as follows:
WHEREAS, SPONSOR is the manufacturer or licensee of the Clofarabine ("Study
Drug") which has potential utilization in patient care and treatment; and
1. PROTOCOL
1.1 Institution agrees to use its best efforts to conduct the Study, as an
independent contractor, in accordance with Institutional policy, applicable
laws and regulations and the Preclinical Workscope and Protocol entitled
"Clofarabine Development Plan" ("Study"), as described in Exhibit A
attached hereto and incorporated herein. The Study will be supervised by
Xxxxxxx X. Xxxxxxx M.B., B.S. ("Principal Investigator"), at Institution,
with assistance from associates and colleagues as required.
1.2 Sponsor agrees to engage the services of Institution to conduct the Study
and further agrees to provide at no cost to Institution the Study Drug for
the conduct of the Study.
2. AWARD
In consideration for performance Study by Institution, Sponsor shall pay
Institution a total of One Million One Seventy-Seven Thousand One Hundred
Eighty-Eight and No/l00 Dollars ($1,177,188.00) for the preclinical and
clinical expenses for the Study, which is detailed by budget category in
Exhibit B. The first installment of Two Hundred Fifty Thousand and No/l00
Dollars ($250,000.00) is payable upon execution of this Agreement.
Subsequent installments will be made as outlined in Exhibit B.
3. TERM
3.1 This Agreement shall continue in force until the earlier of completion of
the Study as mutually agreed upon by the parties or Three (3) year from the
date set forth above; provided, however, that either party may terminate
the Agreement by giving thirty (30) days advance notice to the other.
3.2 Upon early termination of this Agreement, Sponsor shall be liable for all
reasonable costs incurred or obligated by Institution at the time of such
termination, subject to the maximum amount specified in Article 2. Sponsor
shall pay Institution for such costs within thirty (30) days of receipt of
an invoice for same.
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3.3 Upon termination of this Agreement, Institution shall return Sponsor's
materials and equipment to Sponsor.
4. INDEMNIFICATION
4.1 Institution shall, to the extent authorized under the Constitution and laws
of the State of Texas, indemnify and hold Sponsor harmless from liability
resulting from the negligent acts or omissions of Institution, its agents
or employees pertaining to the activities to be carried out pursuant to the
obligations of this Agreement; provided, however, that Institution shall
not hold Sponsor harmless from claims arising out of the negligence or
willful malfeasance of Sponsor, its officers, agents, or employees, or any
person or entity not subject to Institution's supervision or control.
4.2 Sponsor shall indemnify and hold harmless System, Institution, their
Regents, officers, agents and employees from any liability or loss
resulting from judgments or claims against them arising out of the
activities to be carried out pursuant to the obligations of this Agreement,
including but not limited to the use by Sponsor of the results of the
Study; provided, however, that the following is excluded from Sponsor's
obligation to indemnify and hold harmless:
a. the negligent failure of Institution to comply with any applicable
governmental requirements or to adhere to the terms of the Protocol;
or
b. the negligence or willful malfeasance by a Regent, officer, agent, or
employee of Institution or System.
5. PUBLICATION AND PUBLICITY
5.1 Institution reserves the right to publish the results of the Study.
Institution will, however, notify Sponsor and will submit a draft of the
manuscript to Sponsor for comments at least thirty (30) days prior to
submission for publication or oral presentation. Sponsor shall notify
Institution in writing within thirty (30) days of receipt of such draft
whether such draft contains information deemed to be confidential under the
provisions of Article 6, or information that if published within thirty
(30) days would have an adverse effect on a patent application in which
Sponsor owns full or part interest, or intends to obtain an interest from
Institution pursuant to this Agreement. In the latter case Sponsor has the
right to request a delay and Institution agrees to delay said publication
for a period not exceeding ninety (90) days. In any such notification,
Sponsor shall indicate with specificity to what manner and degree
Institution may disclose said information. Institution shall have the final
authority to determine the scope and content of any publication, provided
that such authority shall be exercised with reasonable regard for the
commercial interests of Sponsor. It is the intent of the parties that no
publication will contain any of confidential information disclosed by
Sponsor without Sponsor's prior written permission.
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5.2 Except as otherwise required by law or regulation, neither party shall
release or distribute any materials or information containing the name of
the other party or any of its employees without prior written approval by
an authorized representative of the non-releasing party, but such approval
shall not be unreasonably withheld.
6. CONFIDENTIAL INFORMATION
The parties may wish from time to time, in connection with work
contemplated under this Agreement, to disclose confidential information to
each other ("Confidential Information"). Each party will use reasonable
efforts to prevent the disclosure of any of the other party's Confidential
Information to third parties for a period of three (3) years from receipt
thereof, provided that the recipient party's obligation shall not apply to
information that:
a. is not disclosed in writing or reduced to writing and so marked with
an appropriate confidentiality legend within thirty (30) days of
disclosure;
b. is already in the recipient party's possession at the time of
disclosure thereof;
c. is or later becomes part of the public domain through no fault of the
recipient party;
d. is received from a third party having no obligations of
confidentiality to the disclosing party;
e. is independently developed by the recipient party; or
f. is required by law or regulation to be disclosed.
In the event that information is required to be disclosed pursuant to
subsection f, the party required to make disclosure shall notify the other
to allow that party to assert whatever exclusions or exemptions may be
available to it under such law or regulation.
7. INTELLECTUAL PROPERTY
7.1 Institution understands and acknowledges that the Study Drug which is being
provided to Institution for the purpose of conducting the Study is the
property of Sponsor and/or that the pharmaceutical compound may be subject
to certain intellectual property rights owned by or licensed to Sponsor.
This Agreement shall not be deemed or construed to convey or transfer any
of such intellectual property rights to Institution except insofar as
necessary to permit Institution to conduct the Study which is the subject
of this Agreement.
7.2 Sponsor understands and acknowledges that any new and patentable discovery,
unpatentable technology, technical know how or other intellectual property
developed solely by Institution as a result of Institution's conduct of the
Study hereunder shall be and remain the property of Institution. Sponsor
shall have an option to negotiate an exclusive, world wide license in and
to any such intellectual property developed and owned by Institution (as
well as that owned by it jointly with the Sponsor) under reasonable terms
and conditions which shall be negotiated within one hundred and eighty
(180) days following written notice to Sponsor by Institution that such
intellectual property has been developed as a result of the conduct of the
Study which is the subject of this Agreement and specifically referencing
the start of the one hundred eighty (180) day period in this
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Section 7.2. In the event that Sponsor and Institution fail to enter into a
license agreement during the time specified above, or during such extension
of time as the parties may mutually agree, then Institution's obligations
to Sponsor under this Section 7.2 shall cease.
8. GENERAL
8.1 This Agreement, including the attached Exhibit A and B, constitutes the
entire and only Agreement between the parties relating to the Study, and
all prior negotiations, representations, agreements, and understandings are
superseded hereby. No agreements altering or supplementing the terms
hereof, including the exhibits attached hereto, may be made except by a
written document signed by the duly authorized representatives of the
parties.
8.2 Any conflicts between the Protocol and this Agreement are controlled by
this Agreement.
8.3 This Agreement shall be construed and enforced in accordance with the laws
of the State of Texas.
IN WITNESS WHEREOF, Institution and Sponsor hereby enter into this
Agreement, effective as of the date first set forth above, and execute two (2)
original counterparts.
Eurobiotech Corporation Limited The University of Texas
M.D. Xxxxxxxx Cancer Center
By: /s/ [ILLEGIBLE] By: Xxxxx X. Xxxxxxx
-------------------------------- ----------------------------
Xxxxx X. Xxxxxxx, CPA
Manager, Sponsored Programs
Title CEO
Date 26/2/98 Date 2/26/98
I have read this agreement and
understand my obligations
hereunder:
By: /s/ Xxxxxxx X. Xxxxxxx
-------------------------------
Xxxxxxx X. Xxxxxxx, M.B., B.S.
Make Payment To: Principal Investigator
The University of Texas
M.D. Xxxxxxxx Cancer Center By: /s/ Xxxxx Xxxxxxxxxx
Atten: Manager, Sponsored Programs -------------------------------
P.O. Box 297402 Xxxxx Xxxxxxxxxx, M.D.,
Xxxxxxx, XX 00000 Chairman, Leukemia Dept.
Tax I.D. 74 6001118 A1
By: /s/ Xxxxxx X. Xxxx
-------------------------------
Xxxxxx X. Xxxx, Xx., M.D.
Head, Division of Medicine
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