Exhibit 10.12
EXECUTION COPY
CLINICAL RESEARCH SUBCONTRACT
-----------------------------
This CLINICAL RESEARCH SUBCONTRACT, dated and effective as of March 29,
2001 (the "Agreement"), is entered into by and between THE UNIVERSITY OF NORTH
CAROLINA AT CHAPEL HILL for its School of Medicine, (hereinafter called
"UNC-CH"), and IMMTECH INTERNATIONAL, INC., a Delaware corporation with its
principal office and place of business at 000 Xxxxxxx Xxxxx, Xxxxx 000, Xxxxxx
Xxxxx, XX 00000, (hereinafter called "Immtech").
W I T N E S S E T H
WHEREAS, in pursuit of its educational purposes, which include research
and training, UNC-CH undertakes scholarly research and experimental activities
in a variety of academic disciplines; and
WHEREAS, UNC-CH has received an award from the Xxxx & Xxxxxxx Xxxxx
Foundation (the "Xxxxx Xxxxx") to fund a research and development program for
novel drug candidates for the treatment of Human African Trypanosomiasis and
Lieshmaniasis (the "Program"); and
WHEREAS, the Program contemplates that Immtech would perform certain
functions therein; and
WHEREAS, in furtherance of its scholarly research and instructional
interests, UNC-CH is willing to contract with Immtech upon the terms and
conditions set forth below; and
WHEREAS, the research program contemplated by this Agreement is of mutual
interest and benefit to Immtech and to UNC-CH, and will further UNC-CH's
instructional, research and public service objectives in a manner consistent
with its status as an educational institution; and
WHEREAS, the Research Plan (the "Research") (a copy of which is attached
hereto as Exhibit A), which will guide the performance of this Agreement, has
been written collaboratively by UNC-CH and by Immtech; and
WHEREAS, Immtech is uniquely equipped to perform the Research.
NOW THEREFORE, in consideration of the agreements and covenants contained
herein, the sufficiency of which are hereby acknowledged, the parties hereto
hereby agree as follows:
1. SCOPE OF WORK.
A. Immtech agrees it is fully able to perform the Research in a professional,
competent manner with strict adherence to its terms, and Immtech will
utilize its commercially reasonable and good faith efforts to do so.
UNC-CH and Immtech further agree that during the term of this Agreement
they will jointly prepare protocols to guide both Phase II and Phase III
clinical trials (the "Protocols").
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B. Immtech shall exercise commercially reasonable and good faith efforts to
carry out the Research in accordance with this Agreement. Immtech may
provide through subcontract for performance of portions of the Research by
other entities; provided, however, that each such subcontract to
noncommercial entities shall include payment of indirect costs not to
exceed ten percent (10%) of the total amount of such subcontract, and that
the scope of work for each such subcontract shall have been approved by
UNC-CH in writing before execution and delivery of that subcontract.
2. PERSONNEL.
Immtech's Principal Investigator is Xxxxx Xxxxx, Ph.D., together with such
additional personnel as may be assigned by Immtech. UNC-CH's Principal
Investigator shall be Xxxxxxx Xxxxxxx, Ph.D.
3. PERFORMANCE PERIOD.
The effective period of this Agreement will be from the effective date
written above through November 17, 2005, unless otherwise terminated in
accordance with Article 13. The effective period may be extended by mutual
agreement as provided in Article 14.
4. RECORDKEEPING, REPORTING AND ACCESS.
A. UNC-CH's authorized representative(s), representatives of the Xxxx &
Xxxxxxx Xxxxx Foundation, and regulatory authorities to the extent
permitted by law, may, during regular business hours, arrange in advance
with Immtech's Principal Investigator and Immtech to:
(1) examine and inspect Immtech's facilities required for performance of
the Research; and
(2) inspect and copy all data and work products relating to the Research
(such copying to be done at the expense of the requesting party if
more than one copy is requested to be made).
B. Immtech shall cooperate with any regulatory authority and allow regulators
access to applicable records and data. In performing the Research, Immtech
shall abide by the guidelines for biomedical research set forth by the
Council for International Organizations of Medical Sciences.
C. Immtech and its Principal Investigator shall perform the following record
keeping and reporting obligations in a timely fashion:
(1) preparation and maintenance of complete, accurately written records,
accounts, notes, reports and data of the Research; and
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(2) preparation and submission to UNC-CH in a timely manner of a copy of
all original case report forms ("Case Reports") for each patient or
subject participating in the Research ("Research Subject") as
provided in the Protocols.
D. All data and work products relating to the Research, including data and
work products developed by subcontractors, shall be jointly owned by
UNC-CH and Immtech; provided, however, that Immtech may use the data and
work products generated by the Research in connection with efforts to
obtain regulatory approval for Immtech products.
5. COST AND PAYMENT.
A. As consideration for performance under the terms of this Agreement, and
subject to continued availability of funds from the Xxxx & Xxxxxxx Xxxxx
Foundation, UNC-CH shall pay Immtech up to a total sum of $9.8 million
(the "Gates Funds"), as and when provided in Exhibit B attached hereto
(the "Budget And Payment Schedule") and incorporated herein by reference.
Upon the execution and delivery of this Agreement, $4.3 million of the
Gates Funds shall be paid by UNC-CH to Immtech by wire transfer of
immediately available funds to the account specified by Immtech below. The
Gates Funds includes all applicable overheads due any party or entity.
Bank Name: LaSalle Bank N.A.
Bank ABA No.: 0000-0000-0
Immtech Account Name: Immtech International, Inc.
Immtech Account No.: 5800308586
Immtech Tax I.D. No.: 00-0000000
Reference: Gates
B. Payment of all Gates Funds shall be by wire transfer to the account set
forth above and shall be made to Immtech according to the Budget And
Payment Schedule. All costs outlined in the Budget And Payment Schedule
shall remain firm for the duration of the Research, unless otherwise
agreed herein or in writing by Immtech and UNC-CH. Immtech shall deposit
Gates Funds advanced to Immtech hereunder in an interest-bearing account,
and all interest earned thereby shall be paid to UNC-CH on a quarterly
basis, with the first such payment due on or about July 1, 2001.
C. Immtech shall maintain records of receipts and expenditures under this
Agreement for a period of four (4) years following the termination or
expiration of this Agreement.
6. CONFIDENTIAL INFORMATION.
A. Neither Immtech nor UNC-CH shall disclose or use for any purpose other
than performance of the Research, any and all trade secrets, privileged
records or other confidential or proprietary information (collectively,
"Information") disclosed by one party to the other pursuant to this
Agreement. Such Information shall be disclosed in writing, or if disclosed
orally or in other than documentary form shall be reduced to writing
thirty (30) days thereafter. Information which is not in oral or written
form, such
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as but not limited to data tapes, shall be designated in writing as
confidential within thirty (30) days after disclosure. The obligation of
non-disclosure shall not apply to the following:
(1) Information at or after such time that it is or becomes publicly
available through no fault of the recipient party;
(2) Information that is already independently known to the recipient
party, as shown by its prior written records;
(3) Information at or after such time that it is disclosed on a
non-confidential basis by a third party with the legal right to do
so; or
(4) Information independently developed by personnel of the recipient
party not involved in the Research and not otherwise privy to the
Information.
B. The obligations of confidentiality under this Article shall survive and
continue for three (3) years after the expiration or termination of this
Agreement.
C. In the event that either party shall come into contact with Research
subjects' medical records, that party shall hold in confidence the
identity of the patient and shall comply with all applicable law(s)
regarding the confidentiality of such records.
D. In the event either party finds it necessary to disclose Information to a
proper authority to permit such party to defend its research against an
allegation of fraud or other misconduct in science, then such defending
party shall first notify the other party, whereupon both Immtech and
UNC-CH shall cooperate in good faith to reach an agreement with respect to
a mutually satisfactory way to disclose such Information as necessary for
this limited purpose.
7. PUBLICATIONS.
Either party shall have the right to publish the results of Research
provided such publication does not constitute a violation of Article 6. It is
anticipated that Immtech and UNC-CH will coordinate publications. However, in
the event that either party intends to publish independently of the other, prior
to submission for publication or presentation, the party seeking to publish will
provide the other party thirty (30) days for review and comment upon the
manuscript or other material for such publication. Expedited reviews for
abstracts or poster presentations may be arranged if mutually agreeable to
UNC-CH and Immtech or their respective Principal Investigator. Either party
shall be permitted to advise as to the implications of timing of the publication
if the same clinical trials set forth in Protocol are still in progress at other
sites. In addition, if requested in writing and with reasonable justification,
the party proposing to publish will withhold such publication an additional
sixty (60) days to allow for filing a patent application or taking such other
measures as the other party deems appropriate to establish and preserve its
proprietary rights. Notwithstanding the foregoing, the parties agree that if the
Research is part of a multi-center study, then the first publication of the
results of the Research shall be made in conjunction with the results from the
principal investigators at the
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other study centers. The manner in which the publication will be generated will
be negotiated between UNC-CH, Immtech and the principal investigators of other
study centers prior to initiation of the Phase II clinical trials involved in
the Research. However, in the event no publication of the multi-center study has
been made within one year of the completion of the study at all centers, then
Immtech will be free to publish its own results.
8. INTELLECTUAL PROPERTY.
A. "New Invention or Discovery" shall mean any invention or discovery
conceived or reduced to practice during and as a part of the Research or
the Program (1) performed pursuant to this Agreement by Immtech's
Principal Investigator, staff, employees, or subcontractors or jointly by
such an individual or individuals working with one or more employees of
UNC-CH, or (2) performed by any subcontractors of UNC-CH, or their
respective investigators (collectively with such subcontractors, the
"Subcontractors"), at any other study center involved in the Program, or
jointly by any such Subcontractor or Subcontractors working with one or
more employees of UNC-CH.
B. Immtech shall promptly notify UNC-CH, in writing, of any of its New
Inventions or Discoveries. The notice shall provide a full written
description of such New Invention or Discovery.
C. UNC-CH shall own all right, title and ownership in any New Invention or
Discovery; provided, however, that any such New Invention or Discovery
shall be deemed to be licensed to Immtech under and subject to the
exclusive license agreement then in effect between Immtech, UNC-CH and any
other parties thereto, as the case may be, as such license agreement may
be amended, superceded or replaced from time to time (the "Existing
License Agreement"). If the Existing License Agreement then in effect is
that certain License Agreement dated August 25, 1993 (the "1993
Agreement"), between UNC-CH and Pharm-Eco Laboratories, Inc.
("Pharm-Eco"), and which has been assigned by Pharm-Eco to Immtech, then
upon the execution by Immtech, UNC-CH, Auburn University, Duke University,
and the Georgia State University Research Foundation, Inc., of that
certain proposed License Agreement which is under negotiation as of the
date of this Agreement and is expected to be entered into shortly after
the execution of this Agreement (such executed agreement, as the same may
be amended, superceded or replaced from time to time, the "New License
Agreement"), and if so provided in the New License Agreement, the 1993
Agreement shall be superceded and replaced by the New License Agreement,
and any and all New Inventions or Discoveries which had, in accordance
with the first sentence of this Section 8(C), previously been licensed to
Immtech under the 1993 Agreement, shall then be licensed to Immtech under
the New License Agreement, and the 1993 Agreement shall no longer be in
effect. Notwithstanding any other provision of this Article 8, at such
time as the New License Agreement has not been executed and UNC-CH
concludes that further efforts to complete and execute the New License
Agreement would be futile, then upon fifteen (15) days prior written
notice to Immtech from UNC-CH, Immtech shall have no further license
rights to any New Invention or Discovery.
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D. UNC-CH represents and warrants (1) that each of those subcontractors at
the other study centers involved in the Program which are performing
"basic research" (each, a "BR Subcontractor") has granted UNC-CH an
option, for 180 days after such BR Subcontractor delivers a notice to
UNC-CH informing UNC-CH of any of its New Inventions or Discoveries, to
receive an exclusive license for such New Invention or Discovery from such
BR Subcontractor (the "License Option"), and that each such BR
Subcontractor may not license any of its New Inventions or Discoveries to
any other person or entity until either UNC-CH elects to not exercise its
License Option with respect to such New Invention or Discovery, or such
180 day option period expires without UNC-CH having exercised its License
Option with respect to such New Invention or Discovery, (2) that New
Inventions or Discoveries are not licensed to anyone other than Immtech,
and (3) that UNC-CH is not under any obligation to license any New
Inventions or Discoveries to anyone other than Immtech. UNC-CH covenants
and agrees that UNC-CH will use its best efforts to ensure that each new
BR Subcontractor or other subcontractor which UNC-CH may engage after the
date of this Agreement grants to UNC-CH a License Option substantially
similar to the License Option described in the preceding sentence.
E. UNC-CH agrees that it will not license or sublicense any New Inventions or
Discoveries to anyone other than Immtech without Immtech's express prior
written consent. UNC-CH agrees that it will (1) within ten (10) days after
its receipt by its Office of Technology Development from any BR
Subcontractor or other subcontractor of a notice of any New Invention or
Discovery, forward to Immtech a complete copy of such notice, (2) request
from such BR Subcontractor any information requested by Immtech, (3) allow
Immtech up to the 170th day of UNC-CH's 180 day License Option period (or
up to the tenth (10th) day prior to the deadline for UNC-CH set forth in
such License Option, if such License Option period is not 180 days) for
Immtech to deliver a notice to UNC-CH stating whether or not Immtech
requests UNC-CH to exercise its License Option with respect to such New
Invention or Discovery, and (4) if so requested by Immtech pursuant to the
preceding clause, duly exercise its License Option with respect to such
New Invention or Discovery, and contemporaneously with such exercise,
sublicense such New Invention or Discovery to Immtech on such terms as are
as close to the terms of the license granted to UNC-CH as is permitted by
the terms of such license granted to UNC-CH.
F. It is agreed that neither UNC-CH nor Immtech transfers to the other by
operation of this Agreement any patent right, copyright right, or other
proprietary right of either party, except as specifically set forth
herein.
9. USE OF IMMTECH'S OR UNC-CH'S NAME.
A. The use of the name, symbol or any xxxx of any party hereto, or any
contraction or combination thereof, in any manner in connection with the
Research is expressly prohibited except with prior written consent of the
party owning such name, symbol or xxxx; provided, however, that no such
consent shall be required for Immtech to identify UNC-CH and describe its
relationship and transactions with UNC-CH in connection with
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(a) communications and filings with the Securities and Exchange
Commission, the NASD, NASDAQ, the Food and Drug Administration, or other
governmental or regulatory agencies or authorities, as reasonably
advisable in connection with or required by such agencies or authorities,
(b) the inclusion of any statement previously made available to the
public, or permitted under the Existing License Agreement, in any
communications or other documentation relating to any financing or
fund-raising by Immtech, (c) the preparation of Immtech's financial
statements, and (d) communications with other study centers involved in
the Program.
10. APPLICABLE LAW.
This Agreement shall be governed by the laws of the State of North
Carolina.
11. NOTICE.
Any notice required or permitted under this Agreement shall be in writing
and shall be deemed given as of the date it is (A) delivered by hand, or (B)
delivered by courier or delivery service (including, without limitation, FedEx,
DHL, Airborne Express, UPS, Express Mail and Priority Mail) or by Registered or
Certified Mail, postage prepaid, return receipt requested, or (C) received by
facsimile, in each case addressed to the party to receive such notice at the
address or facsimile number set forth below, or such other address or facsimile
number as is subsequently specified by written notice to the parties hereto:
If to UNC-CH:
Dr. Xxxxxx Xxxxxx, Director
Office of Research Services
The University of North Carolina at Chapel Hill
000 Xxxxx Xxxx, XX#0000
Xxxxxx Xxxx, XX 00000-0000
FAX: (000) 000-0000
If to Immtech:
Immtech International, Inc.
000 Xxxxxxx Xxxxx
Xxxxx 000
Xxxxxx Xxxxx, XX 00000
FAX: (000) 000-0000
Attention: T. Xxxxxxx Xxxxxxxx
with a copy to:
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Xxxxxxxxxx, Xxxxxxxxxx & Xxxx
000 Xxxxxx Xxxx
Xxx Xxxx, Xxx Xxxx 00000-0000
FAX: (000) 000-0000
Attention: Xxxx X. Xxxxxx, Esq.
12. LIABILITY.
Immtech hereby agrees to indemnify, defend and hold harmless UNC-CH and
its schools, departments and employees from any and all liability to the extent
that such liability arises out of Immtech's performance of this Agreement or the
performance of its agents, employees or subcontractors. UNC-CH hereby agrees, to
the extent permitted by the North Carolina Tort Claims Act, to indemnify, defend
and hold harmless Immtech and its directors, officers and employees from any and
all liability to the extent that such liability arises out of UNC-CH's
performance of this Agreement or the performance of its agents, employees,
professors, researchers, students or subcontractors.
13. TERMINATION OF CLINICAL TRIALS AND/OR THIS AGREEMENT.
A. Any clinical trial under any Protocol may be terminated by either party,
upon immediate prior notice, if animal, human, and/or toxicological test
results or adverse reactions or side effects with the drug administered or
the device employed in such clinical trial is of such magnitude or
incidence to support, in the written opinion of the Scientific Advisory
Board appointed by UNC-CH to oversee the Research, the termination of such
clinical trial for the specific compound being studied. If such a
termination occurs, then the parties will evaluate other candidate
compounds for substitution and will revise the Research and Protocol
accordingly; provided, however, that if UNC-CH's Principal Investigator
and Immtech's President cannot reach an agreement on the selection of
another candidate compound for substitution within sixty (60) days after
such termination, then Xxxx Xxxxxxxx, M.D., or his successor as chairman
of the Scientific Advisory Board, shall, after consultation with both
parties and after reviewing relevant data for each candidate compound,
select the next candidate compound.
B. This Agreement may be terminated by either party upon thirty (30) days'
prior written notice if any of the following conditions occurs:
(1) If either party fails to comply with a material term of the Agreement
after receipt of written notice with reasonable opportunity to cure
from the other party.
(2) If the Xxxx & Xxxxxxx Xxxxx Foundation withdraws or terminates the
Xxxxx Xxxxx to UNC-CH through which UNC-CH is funding the Research.
C. This Agreement may be terminated in accordance with the following:
(1) If the Existing License Agreement is terminated due to any breach or
default thereunder by Immtech or if the New License Agreement is
terminated, in either case
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without any successor or replacement agreement being entered into to
which UNC-CH and Immtech are each a party, then each of Immtech and
UNC-CH shall have the right, upon written notice to the other during
the ninety (90) days following the effective date of such
termination, to terminate this Agreement. If neither Immtech nor
UNC-CH exercises such right, then this Agreement shall continue in
accordance with its terms, and any licenses or rights which were
granted by UNC-CH to Immtech under the Existing License Agreement or
the New License Agreement which are necessary or appropriate in order
for Immtech to perform its obligations under this Agreement shall
remain in effect for the duration of this Agreement, and shall be
governed by the terms and provisions of such license agreement as
though such license agreement was still in effect. Within thirty (30)
days after the execution and delivery of this Agreement by Immtech to
UNC-CH, UNC-CH shall use its best efforts to obtain the agreement of
each of Auburn University, Duke University, and the Georgia State
University Research Foundation, Inc. ("Georgia State"), to the same
terms as are set forth in the preceding sentence with respect to any
of their respective licenses or rights which are or may be granted by
either of them to Immtech under any such license agreement.
(2) If Xxxxxxx Xxxxxxx, Ph.D., were to die, become disabled, leave
UNC-CH, or otherwise be unable or unwilling to continue his
activities at UNC-CH in connection with this Agreement, and if
Immtech and UNC-CH are not able, within six (6) months after the date
of Xx. Xxxxxxx'x death, disability, departure or other cessation of
his activities, to engage a mutually agreeable successor to act as
the Principal Investigator for UNC-CH hereunder, then each of Immtech
and UNC-CH shall have the right, upon written notice to the other
during the ninety (90) days following the end of such six (6) month
period, to terminate this Agreement. If neither Immtech nor UNC-CH
exercises such right, then this Agreement shall continue in
accordance with its terms, and Immtech and UNC-CH shall continue to
cooperate in good faith to engage a mutually agreeable successor to
act as the Principal Investigator for UNC-CH hereunder.
D. Upon the effective date of termination, there shall be an accounting
conducted by Immtech, subject to verification by UNC-CH. Within thirty
(30) days after receipt of adequate documentation therefore, UNC-CH will
make payment to Immtech for:
(1) all services properly rendered and monies properly expended by
Immtech until the date of termination not yet paid for; and
(2) non-cancelable obligations properly incurred for the Research by
Immtech prior to the effective date of termination; provided,
however, that such obligations shall not exceed a period of twelve
(12) months beyond termination of the Agreement (unless UNC-CH shall
have previously approved such contract or subcontract of longer
duration) and that in no event shall UNC-CH's obligation to make
payment to Immtech exceed the amounts budgeted for the project
segment under way at the time of termination.
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E. Immtech will credit or return to UNC-CH any Gates Funds not expended or
obligated by Immtech in connection with the Research prior to the
effective termination date of the notice of termination.
F. Immediately upon receipt of a notice of termination of either this
Agreement or a clinical trial, Immtech's Principal Investigator shall stop
enrolling Research Subjects into the Protocol for such clinical trial and
shall cease conducting procedures on Research Subjects already enrolled in
the Protocol directed by UNC-CH, to the extent medically appropriate in
Immtech's discretion. If UNC-CH and Immtech cannot agree on the process
for winding down such clinical trial, then the matter shall be presented
to the Scientific Advisory Board for direction. Notwithstanding the
forgoing, if Immtech elects to take over the funding of the clinical trial
under way, then (1) Immtech may continue such clinical trial and shall
have sole discretion over such clinical trial from such point forward, and
(2) Immtech shall indemnify, defend and hold harmless UNC-CH and its
schools, departments and employees from any and all liability to the
extent that such liability arises out of Immtech's continuation of such
clinical trials from such point forward.
G. Termination of this Agreement by either party shall not affect the rights
and obligations of the parties accrued prior to the effective date of the
termination. The rights and duties under Articles 4, 6, 7, 8, 9, 10, 11,
12, 13, 14 and 21 survive the termination or expiration of this Agreement.
H. If this Agreement is terminated prior to completion, then Immtech shall
furnish UNC-CH a reasonably comprehensive Principal Investigator's report
for the Research completed.
14. AMENDMENTS.
This Agreement and the Protocol may only be extended, renewed or otherwise
amended by the mutual written consent of parties hereto.
15. ENTIRE AGREEMENT.
This Agreement represents the entire understanding of the parties with
respect to the subject matter hereof. In the event of any inconsistency between
this Agreement and the Protocols, the terms of this Agreement shall govern. In
any situation which is not covered by this Agreement or the Protocols, the
parties shall look to that certain letter agreement dated November 8, 2000,
between UNC-CH and the Xxxx & Xxxxxxx Xxxxx Foundation, for guidance as to the
intent of the parties with respect to the Program and the Research.
16. SEVERABILITY.
This invalidity or unenforceability of any term or provision of this
Agreement shall not affect the validity or enforceability of any other term or
provision hereof.
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17. INTEGRATION.
Exhibits A and B hereto are incorporated into this Agreement by reference.
18. ASSIGNMENT.
A. Neither party hereto may assign, cede or transfer any of its rights or
obligations under this Agreement without the written consent of the other
party, which consent may not be unreasonably withheld; provided, however,
that without such consent either party may assign this Agreement in
connection with the transfer or sale of all or substantially all of its
assets or business to, or its merger or consolidation with, another
company. Immtech may also assign this Agreement in whole or in part
without the consent of UNC-CH to any affiliate entity.
B. This Agreement shall insure to the benefit of and be binding upon each
party signatory hereto, its successors and permitted assigns. No
assignment shall relieve either party of the performance of any accrued
obligation which such party may then have under this Agreement.
19. INDEPENDENT CONTRACTOR.
A. In the performance of all services hereunder, Immtech shall be deemed to
be and shall be an independent contractor and, as such, shall not be
entitled to any benefits applicable to employees of UNC-CH.
B. Neither party is authorized or empowered to act as agent for the other for
any purpose and shall not on behalf of the other enter into any contract,
warranty or representation as to any matter. Neither party shall be bound
by the acts or conduct of the other.
20. CHANGES TO THE PROTOCOL.
If at a future date changes in the Research or Protocol appear desirable,
then such changes may be made through prior written agreement between UNC-CH and
Immtech. In the event that UNC-CH and Immtech disagree regarding any such
proposed change, then the Scientific Advisory Board appointed by UNC-CH to
oversee the Research shall resolve such disagreement. If in the course of
performing this Agreement, however, either of (a) generally accepted standards
of clinical research and medical practice relating to the safety of Research
Subjects, (b) a directive from the Institutional Review Board of UNC-CH with
authority over the Research, or (c) a decision of the Scientific Advisory Board
appointed by UNC-CH to oversee the Research, requires a deviation from the
Protocol, then such standards will be followed. In such case, the party aware of
the need for a deviation will immediately inform the other of the facts causing
such deviation as soon as the facts are known to the party. If the aggregate
amount of the costs of any and all required changes and/or deviations arising
pursuant to clauses (b) or (c) of this Article 20 during the term of this
Agreement, for which additional funding is not provided to Immtech by either the
Xxxx & Xxxxxxx Xxxxx Foundation, UNC-CH or any third
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party, exceed $300,000, then Immtech may terminate this Agreement upon thirty
(30) days written notice to UNC-CH.
21. CONFORMANCE WITH LAW AND ACCEPTED PRACTICE.
Immtech shall perform the Research in conformance with generally accepted
standards of good clinical practice, with the Protocol, with instructions
provided by UNC-CH's Institutional Review Board and Scientific Advisory Boards,
and with all applicable local, state and federal or national laws and
regulations governing the performance of the Protocol and Research in the
countries involved in the clinical trials, including, but not limited to, the
Swiss Tropical Institute. Immtech shall retain all records resulting from the
Research for the time required by applicable regulations, and shall allow for
inspection by UNC-CH (during normal business hours and upon reasonable advance
notice, unless an emergency medical condition exists with respect to a Research
Subject) of all such records, including the Research Subjects' medical records.
22. WAIVER.
No waiver of any term, provision or condition of this Agreement, whether
by conduct or otherwise, in any one or more instances shall be deemed to be or
construed as a further or continuing waiver of any such term, provision or
condition, or of any other term, provision or condition of this Agreement.
(REMAINDER OF PAGE INTENTIONALLY LEFT BLANK - SIGNATURE PAGE FOLLOWS)
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement in
duplicate by proper persons thereunto duly authorized, as of the date first
above written.
THE UNIVERSITY OF NORTH IMMTECH INTERNATIONAL, INC.
CAROLINA AT CHAPEL HILL
By: /s/ Xxxxx X. Xxxxxxx (acting for) By: /s/ T. Xxxxxxx Xxxxxxxx
--------------------------------- ---------------------------------
Name: Xxxxxx X. Xxxxxx, Ph.D. Name: T. Xxxxxxx Xxxxxxxx
Title: Director, Office of Research Title: President and CEO
Services
March 29, 2001 March 29, 2001
--------------------------------- ---------------------------------
Date Date
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EXHIBIT A
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TO THE
CLINICAL RESEARCH SUBCONTRACT
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(DATED AS OF MARCH 29, 2001)
RESEARCH PLAN
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(See attached)
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EXHIBIT B
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TO THE
CLINICAL RESEARCH SUBCONTRACT
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(DATED AS OF MARCH 29, 2001)
BUDGET AND PAYMENT SCHEDULE
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(See attached)
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