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EXHIBIT 10.34
INSTITUTE FOR DRUG DEVELOPMENT
PROGRAM AGREEMENT
I. Agreeing Parties.
This Program Agreement is entered into by and between the CTRC
RESEARCH FOUNDATION (hereinafter referred to as "CTRC Research"), and the
UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO (hereinafter referred
to as "Health Science Center"). It is established pursuant to the authority of
the Affiliation Agreement dated June 7, 1993, by and between the Board of
Regents of the University of Texas System and the Board of Governors of the
Cancer Therapy and Research Foundation of South Texas.
II. Purpose of Agreement.
The purpose of this Program Agreement is to specify the terms under
which the agreeing parties shall collaborate in conducting research and
development of drugs for the treatment of patients with cancer under the
auspices of the Institute for Drug Development, a division of CTRC Research.
The term "research and development" as used in this agreement shall include
basic research, applied research and development, and clinical research. It is
understood that no provision of this agreement is intended to contravene any
rules, regulations, and/or bylaws which govern either of the Institutions.
Furthermore, nothing in this agreement shall limit the right of either party to
engage in such research unilaterally, or do so in collaboration with others.
III. Services To Be Performed.
A. Health Science Center will:
(1) Provide the services of a faculty member who is
acceptable to CTRC Research to serve as Director of the
Institute for Drug Development under conditions and terms to
be set forth in a specific contractual service agreement.
Those services may include drug development research under the
auspices of CTRC Research if specifically authorized in the
contractual agreement. "Faculty member" is defined as a
full-time paid employee of Health Science Center who holds a
faculty appointment through one or more Academic Departments.
If the position of Director of the Institute for Drug
Development becomes vacant, and if there are no mutually
acceptable candidates from the faculty of the Health Science
Center, Health Science Center will initiate expeditious
recruitment to employ a mutually acceptable individual for
this position. This recruitment will be conducted jointly,
with active participation by members of both institutions.
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(2) Provide the services of other mutually agreed-upon
faculty research scientists, under conditions and terms to be
set forth in specific contractual service agreements.
B. CTRC Research will:
(1) Provide access to the facilities, staff, and other
resources of the Institute for Drug Development for all
collaborative research and development activities undertaken
pursuant to this agreement. Allocations of such resources for
use by a Health Science Center faculty member will be subject
to the written concurrence of the relevant Academic Department
Chair and the Chief Operating Officer of the Institute for
Drug Development.
(2) Provide office space, secretarial support, and
laboratory facilities for use by the Director of the Institute
for Drug Development.
C. Additional services needed in the execution of this agreement
may be obtained as needed on a case-by- case basis. Contractual
agreements between the agreeing parties for such services are
required.
D. Nothing in this agreement or its execution shall be construed
so as to negate the requirement for Health Science Center faculty
members to discharge all applicable faculty responsibilities, and
provide information to academic Division and Department superiors
concerning all activities in which they are engaged.
IV. Management of Grants and Study Agreements.
A. The responsibility for soliciting, receiving, and managing any
collaborative research or clinical study project will be vested in the
institution furnishing the Principal Investigator ("managing party"),
which shall use its own system for preparing and submitting
grant/study applications and for managing awards.
B. One or more subcontracts will be established for all work or
services to be contributed by the other institution ("subcontracting
party"). Unless mutually agreed otherwise, the subcontract will
provide for the reimbursement of the subcontracting party's indirect
costs associated with the project.
C. For non-Federally supported clinical trials in which the
Principal Investigator is a Health Science Center faculty member and
the majority of the work is to be performed using CTRC Research staff
and facilities, the parties agree to the following:
(1) The Principal Investigator, with the support and
participation of CTRC Research, will have the primary
responsibility for negotiating the protocol and
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payment terms of any agreement with a sponsoring organization
("Sponsor"). Such an agreement will contain terms and
conditions acceptable to both Health Science Center and CTRC
Research, and will be processed by appropriate designated
Health Science Center staff.
(2) The clinical trials agreement will be executed by and
between Health Science Center and Sponsor. The
responsibilities of CTRC Research will be clearly delineated
in the clinical trials contract, and CTRC Research will be
provided an opportunity to review and comment on the final
draft agreement before execution by the Health Science Center.
(3) Health Science Center will subcontract with CTRC
Research for all work to be done by CTRC Research. The
subcontract will contain a budget for the work to be performed
and any specific terms for reimbursement of budgeted costs and
additional expenses incurred.
(4) The proceeds from each award will be distributed as
follows:
(a) An amount not to exceed 20% of the total
direct expenses incurred will be retained by Health
Science Center, to be shared equally by the
applicable academic Department and Division to
compensate for costs of clinical supervision and
management.
(b) In the specific instance in which all of the
work is to be performed using CTRC Research staff and
facilities, the remaining contract amount will be
devoted to the reimbursement of direct and indirect
costs incurred by CTRC Research as the subcontracting
party.
(c) In all other instances, the disposition of
the remaining contract amount will be negotiated
between the managing and subcontracting parties on a
case-by-case basis.
(5) CTRC Research will provide administrative tracking of
all research progress, and will notify Health Science Center
when a requirement occurs for billing a Sponsor in accordance
with the provisions of the clinical trial contract.
(6) CTRC Research shall invoice Health Science Center for
its portion of the costs incurred as provided for in the
subcontract between Health Science Center and CTRC Research.
D. All collaborative research and/or clinical study protocols
involving Health Science Center employees will require an approved
Certification of Proposals for Research and Other Sponsored
Activities, obtained in accordance with instructions contained in the
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Health Science Center Handbook of Operating Procedures. In addition,
protocols proposing the use of human subjects will require approval by
Health Science Center's Institutional Review Board, and those
proposing to use animal subjects will require approval by Health
Science Center's Institutional Animal Care and Use Committee.
V. Intellectual Property.
A. Under the Rules and Regulations of the University of Texas
System Board of Regents, all intellectual property created by Health
Science Center employees and/or with the support of Health Science
Center funds or facilities, whether or not collaboratively pursued, is
the property of The University of Texas System. It is agreed,
however, that when such intellectual property arises from
collaborative effort under this Program Agreement, the revenues
occurring from its license, sale or other such disposition will be
shared on a fair and reasonable basis between the collaborating
institutions as detailed in subsection C below.
B. Responsibilities for protecting intellectual property through
patent action are contingent upon the origin of the Invention or
discovery.
(1) Health Science Center is responsible at its expense
for seeking all patents for inventions or intellectual
property for which a Health Science Center employee is sole
inventor ("Health Science Center patents").
(2) CTRC Research is responsible at its expense for
seeking or arranging for all patents relative to inventions
for which CTRC Research employees are sole inventors ("CTRC
Research patents").
(3) CTRC Research is responsible at its expense for
seeking on behalf of Health Science Center, all patents
relative to inventions in which Health Science Center
employee(s) and CTRC Research employee(s) are joint or
co-inventors ("Joint Inventor Patents").
(4) If Health Science Center decides not to pursue a
patent in any country, CTRC Research will have the right to
file such patents on behalf of Health Science Center and
deduct patent filing and prosecution costs from future royalty
payments. Health Science Center is not obliged to seek patent
protection should CTRC Research opt not to seek patents for
which it has responsibility.
C. To the extent that it has the legal right to do so, Health
Science Center grants to CTRC Research during the term of this Program
Agreement an exclusive option to license, on a worldwide,
royalty-bearing basis, intellectual property created by Health Science
Center employees in the course of their drug development work
undertaken pursuant to either a grant managed by or a subcontract
awarded to Health Science
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Center, as described in Sections IV A and B. In addition, CTRC
Research shall have an exclusive option to license with the right to
sublicense Health Science Center intellectual property created by the
Director of the Institute for Drug Development directly related to any
other projects specified in the service agreement governing his/her
duties at the Institute. Beginning with the receipt by CTRC Research
of a disclosure by the Health Science Center of any creation of any
intellectual property subject to protection pursuant to Title 35 of
the United States Code, or at any earlier time mutually agreeable to
the two institutions, CTRC Research shall have four (4) months to
notify the Health Science Center of its desire to enter into a
licensing agreement. Should the Health Science Center and CTRC
Research fail to enter into a license agreement within six (6) months,
or such other time as the parties may agree, Health Science Center may
dispose of such intellectual property in accordance with Health
Science Center policy.
(1) If CTRC Research exercises its option and enters into
a license for any intellectual property, it will reimburse
Health Science Center for expenses associated with securing
the patent. CTRC Research will also pay Health Science Center
an amount equal to 50% of Net Royalties received by CTRC
Research from sublicenses for Health Science Center patents.
For Joint Inventor patents, compensation will be in an amount
equal to 25% of Net Royalties. However, if either party can
demonstrate to the other party that a different percentage
represents a more reasonable contribution by the inventing
parties, then the parties will enter into negotiation for
royalties other than that provided for herein. "Net
Royalties" is defined as the royalty payments due less
out-of-pocket expenses paid for the filing and prosecution of
patent applications.
(2) For products covered by any license, compensation
will be paid as long as CTRC Research derives income from the
patent.
(3) If CTRC Research does not exercise its option for any
intellectual property, all rights to such intellectual
property will remain with Health Science Center.
D. The parties understand that in order to obtain funding for
research including clinical trials, options and other rights relating
to intellectual property may need to be granted to the sponsor of such
research. Agreements with such sponsors shall clearly specify what
rights, if any, are to be granted in consideration for funding the
research and are to be processed in accordance with Section IV,
Management of Grants and Study Agreements. Unless otherwise provided
for in those agreements, income which results from the licensing of
intellectual property from the sponsored research agreement shall be
distributed in accordance with this article.
E. The parties recognize that a Research Collaboration Agreement
dated October 1, 1992, and an Option Agreement dated October 1, 1992,
between CTRC Research and
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Sterling Winthrop Inc. ("Sterling") provide that Sterling will fund
certain projects and programs in return in part for certain rights to
intellectual property developed as a direct result of such funding.
The parties recognize that some of the intellectual property referred
to in the agreements between Sterling and CTRC Research may be
developed in whole or in part by Health Science Center employees.
Health Science Center hereby provides to CTRC Research an exclusive
option to intellectual property developed by its employees to the
extent such intellectual property is developed pursuant to the funding
obtained from Sterling and thereby subject to the agreements between
Sterling and CTRC Research. Should CTRC Research and Sterling
exercise their respective options relating to Health Science Center
intellectual property, such intellectual property shall be treated in
accordance with the Sterling agreements and this agreement. Any
income received by CTRC Research as a result of Health Science Center
intellectual property shall be distributed in accordance with Section
V C (1) of this agreement. Any modifications to the Sterling
agreements which affect the rights of Health Science Center or its
employees shall require prior approval of Health Science Center.
VI. Reports.
A. For each of the three-month periods beginning September 1,
December 1, March 1, and June 1 of each year, CTRC Research will
provide to Health Science Center detailed progress reports describing
the scientific objectives, status, and prospects of each collaborative
research and development effort undertaken pursuant to this Program
Agreement.
B. For each patent of any type licensed or sublicensed to CTRC
Research, the License Agreement shall require that CTRC Research
provide to Health Science Center a report for each of the three-month
periods cited above, describing relevant costs, revenues, and other
financial aspects, to include a statement of Net Royalties or Net
Sales as defined in Section V C(1), and a forecast of further
commercial prospects. An annual consolidated report will be rendered
as of August 31 each year. All reports are subject to audit.
VII. Payment.
A. For services rendered pursuant to Section III A above, Health
Science Center shall furnish monthly invoices to CTRC Research for
each contract, showing current amounts due and itemizing the nature of
effort and time spent by its employees in rendering those services.
B. For compensation due pursuant to the provisions of Section V C
above, CTRC Research will make monthly payments based on the Statement
of Net Royalties or Net Sales, as appropriate, required by Section VI
B above. Any necessary adjustment in accumulated payments will be
accomplished as required.
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C. Payment shall be by check drawn against current funds of CTRC
Research, made payable to The University of Texas Health Science
Center at San Antonio and forwarded to the attention of:
Xxxxxx X. Xxxxx
Executive Vice President for Administration
and Business Affairs
The University of Texas Health Science Center at San Antonio
0000 Xxxxx Xxxx Xxxxx
Xxx Xxxxxxx, Xxxxx 00000-0000
VIII. Advisory Board.
A. An Advisory Board, consisting of three members each from CTRC
Research and Health Science Center and appointed by the President of
Health Science Center and Chairman of CTRC Research or their
designees, shall review and advise CTRC Research, Health Science
Center, and the Director of the Institute for Drug Development on all
efforts undertaken in the Institute for Drug Development pursuant to
this Program Agreement. The Advisory Board will provide special
attention to collaborative research policies and practices,
contributions to and equitable compensation arising from proposed or
ongoing collaborative ventures, maintenance of institutional integrity
and recognition, and circumstances which could result in individual or
institutional conflict of interest or the appearance thereof. The
Advisory Board Chair will be alternated annually between the agreeing
parties, with the incumbent to be selected by the Board members.
B. The President of Health Science Center or his/her designee
shall appoint one Health Science Center member of the Advisory Board
to also serve as an ex officia member of any Program Council or
similar body constituted by CTRC Research and its sublicensees to
govern the operating progress of research undertakings.
IX. Publication or Presentation.
Publication or oral presentation of results arising from research
conducted by Health Science Center faculty members shall be governed by the
Rules and Regulations of the Board of Regents of the University of Texas
System. Individuals proposing to engage in such publication or presentation
will advise CTRC Research leadership of that fact in ample time to permit any
necessary discussion and negotiations concerning content and timing.
X. Administration.
A. The President of Health Science Center or his/her designee,
and the President of the Board of Governors of the Foundation or
his/her designee, will serve as the principal points of contact for
all matters arising from this agreement.
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B. Health Science Center faculty, as defined in Section III A(a)
above, remain full-time employees even though a portion or all of
their services may be contracted to CTRC Research. Health Science
Center lenders will have ultimate supervisory responsibilities for all
full time Health Science Center faculty and resources participating in
these joint activities, whereas Foundation lenders will have similar
supervisory responsibilities for all CTRC Research employees.
XI. Term.
The primary term of this Program Agreement will be for five years
beginning with the effective date of September 20, 1994 with automatic
extensions of three years unless either party gives at least 180 days notice
before the end of the primary term or extensions thereof. Either party may
terminate this Agreement at any time with 180 days written notice to the other.
Any service agreements, contracts or other agreements entered into under the
provisions of this Program Agreement may continue in force until their
specified termination dates.
XII. Review of Agreement.
The Advisory Board shall, not less than once annually, review the
contents of this Agreement and all associated individual study agreements and
service agreements. Upon completion of their review, the Advisory Board shall
report to the Presidents of the two institutions any proposed revisions to any
of the agreements.
XIII. Amendment
All amendments to this Agreement must be in writing and signed by the
same officials authorizing the basic agreement. Amendments are effective on
the date of signature unless otherwise specified.
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EXECUTED by the parties on the day and year first written above.
SIGNATURES
THE UNIVERSITY OF TEXAS HEALTH CTRC RESEARCH FOUNDATION:
SCIENCE CENTER AT SAN ANTONIO:
/s/ /s/ XXXXXX XXXXXX
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/s/ XXXXX XXXXX /s/ XXXXXXX XXXXXXX
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