EXHIBIT 10.2
AMENDED AND RESTATED CLINICAL RESEARCH SUBCONTRACT
This Amended and Restated Clinical Research Subcontract, dated and
effective as of March 28, 2006 (this "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 Phamaceuticals, 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"). Capitalized terms used but not defined herein shall have the
meanings ascribed to such terms in the License Agreement (defined in Section
8(C) below).
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, a United States non-profit foundation (the "Foundation") awarded
to UNC-CH a grant on November 8, 2000 (the "2000 Foundation Grant") to fund a
research and development program for novel drug candidates for the treatment of
Human African Trypanosomiasis and Lieshmaniasis; and
WHEREAS, the Foundation 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 Foundation 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; and
WHEREAS, UNC-CH and Immtech are committed to making products resulting
from the Research available in developing countries; and
WHEREAS, the parties hereto entered into the original Clinical Research
Subcontract as of March 29, 2001 (the "Original Subcontract"); and
WHEREAS, the parties hereto are together submitting an application to the
Foundation to request additional funding to continue the Foundation Program,
particularly for the
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development of DB289 for the treatment of Human African Trypanosomiasis (the
"2006 Foundation Grant", and together with the 2000 Foundation Grant, the
"Foundation Grants"); and
WHEREAS, the parties hereto have agreed, among other things, to cooperate
and jointly prepare and submit an application for the 2005 Foundation Grant,
which, subject to the award of such 2006 Foundation Grant, would result in an
amendment and supplement to the "Budget And Payment Schedule" attached hereto on
Exhibit B to incorporate the budget and payment schedule included within the
2006 Foundation Grant, when and if awarded.
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 pursuant to the Research Plan to guide
clinical trials (the "Protocols").
B. Immtech shall exercise commercially reasonable and good faith efforts to
carry out the Research in accordance with this Agreement and in a manner
that is consistent with and in furtherance of the Grant Objectives and the
Global Access Plan. 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.
C. Immtech and UNC acknowledge that the Foundation requires that products
made from the Foundation Program funded by the Foundation Grant should be
made available to the developing countries of the world at a reasonable
price. To that end, Immtech has developed, and intends to carry out, the
Global Access Plan attached hereto as Exhibit C.
D. Research funded by, and New Inventions and Discoveries resulting from, the
Foundation Program shall be subject to the oversight of a nine member
"Steering Committee" comprised of representatives from UNC-CH, the
Foundation and Immtech, and qualified, disinterested third-parties. The
Steering Committee will be chaired by one of the disinterested third
parties. The Steering Committee will oversee the timelines and milestones
for Foundation Program activities, evaluate and recommend contingencies if
unexpected events arise, oversee compliance with ethical and regulatory
obligations and generally advise Foundation Program participants with
regard to implementation of the Global Access Plan attached at Exhibit C
hereto. A "Project Manager" will be appointed by the Steering Committee to
coordinate Steering Committee activities, facilitate communications among
committee members and Foundation Program participants and collate reports
to the Foundation.
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The Scientific Advisory Board (defined below) shall provide to Foundation
Program participants scientific and medical advice and ensure the review
of clinical trials and protocols. The Scientific Advisory Panel shall
coordinate and collaborate with the Steering Committee on any matters
directed to the Scientific Advisory Panel that would materially alter the
Foundation Program, a protocol or clinical trial.
2. PERSONNEL AND STEERING COMMITTEE
A. Immtech's Principal Investigator is Xxxxx Xxxxx, M.D., together with such
additional personnel as may be assigned by Immtech. UNC-CH's Principal
Investigator shall be Xxxxxxx Xxxxxxx, Ph.D.
B. Each of UNC-CH, the Foundation and Immtech will appoint members to the
Steering Committee in the manner set forth in the Global Access Plan.
3. PERFORMANCE PERIOD.
The effective period of this Amended and Restated Agreement will commence
on the date the last authorized representative of a party hereto signs this
Agreement (the "Effective Date") and will terminate on the date that the
Research, as the same may be amended or supplemented, is completed, unless the
Agreement is 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. Subject to the confidentiality provisions contained in Section 6 below,
UNC-CH's authorized representative(s), representatives of the 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, including labs and trial
sites 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, including records, accounts, notes,
reports and data prepared and maintained pursuant to clause 4.C below. In
performing the Research, Immtech shall abide by the guidelines for
biomedical research set forth by the Council for International
Organizations of Medical Sciences.
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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
(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 Foundation, UNC-CH
will pay Immtech, as and when received under the Foundation Grants, the
amounts set forth in the "Budget and Payment Schedule" provided in Exhibit
B attached hereto and incorporated herein by reference. The budget allows
for a permissible amount of overhead due any party or entity in compliance
with the budget approved as part of the Grant Agreements. Funds shall be
paid by UNC-CH to Immtech as provided herein by wire transfer of
immediately available funds to the account specified by Immtech below:
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Bank Name: LaSalle Bank N.A.
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Bank ABA No.: 0000-0000-0
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Immtech Account No.: 5800308586
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Immtech Tax I.D. No.: 00-0000000
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Reference: Foundation Grant
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B. Payment by UNC-CH of all funding owing to Immtech 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 funds paid to Immtech in advance of services
being rendered hereunder in an interest-bearing account, and all interest
earned thereby shall be paid to UNC-CH on a quarterly basis in arrears,
with the such payment due not later than thirty days after the end of each
such quarter in which interest is earned.
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.
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D. Funds paid to Immtech pursuant to this Agreement shall only be used for
the purposes of the Foundation Program.
6. CONFIDENTIAL INFORMATION.
A. Subject to UNC-CH's reporting obligations to the Foundation under the
Grant Agreements, 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 as but not limited to data tapes, shall be designated
in writing as confidential within thirty (30) days after disclosure. UNC
shall be permitted to disclose Information to the Foundation as necessary
to comply with the terms of the Foundation Program, however, to the extent
required by federal securities laws or other federal or state law, UNC
shall not disclose material non-public information prior to receiving
Immtech consent. 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.
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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 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
relevant 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 or UNC-CH 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 Foundation 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 Foundation
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 licensed to Immtech under and subject to that certain License
Agreement dated January 28, 2002 by and among Immtech, UNC-CH, Auburn
University, Duke University, and the Georgia State University Research
Foundation, Inc., as the same may be amended, superseded or replaced from
time-to-time (the "License Agreement").
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D. UNC-CH represents and warrants (1) that each of those subcontractors at
the other study centers involved in the Foundation 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.
G. Notwithstanding anything to the contrary herein or in the License
Agreement, Immtech hereby grants to Licensors a non-exclusive, fully paid,
royalty-free, non-revocable license (with the right to sublicense) to the
Patent Rights and University Technology for the Foundation Product to the
extent necessary to permit Licensors to (i) make or have Foundation
Product made, and (ii) use, offer for sale and sell each Foundation
Product solely for use in Developing Countries for treatment of Human
African Trypanosomiasis under the Foundation Program, provided however,
that Licensors shall not exercise such license unless and until the
occurrence of any of the following events (a "Licensing
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Event"): (i) this Agreement is terminated solely as a result of a breach
by Immtech (e.g. not due to a breach caused by the Foundation's failure to
fund the Grant or other breach predicated by or contributed to by UNC-CH
or the Foundation because of the Foundation's improperly withholding
funding (based on the terms of the Grant Agreements)) or (ii) Immtech is
unwilling or fails to fulfill the commitments set forth in Exhibit D
hereto. A Licensing Event shall not be deemed to have occurred until (x)
UNC-CH has sent a written demand to Immtech stating that one or more of
the events listed in this paragraph has occurred and (y) Immtech fails to
cure such event to the satisfaction of UNC-CH within 90 days thereafter.
Upon the occurrence of a Licensing Event, Immtech shall provide
confidentially to Licensor (with any further distribution by Licensor
subject to similar confidentiality requirements) such information, drug
product and/or data as is necessary or reasonably desirable to facilitate
Licensor's further sublicense or distribution of Foundation Products in
such Developing Countries.
USE OF NAMES IMMTECH, UNC-CH AND FOUNDATION
A. The use of the name, symbol or any xxxx of any party hereto or of the
Foundation, or any contraction or combination thereof, in any manner in
connection with the Research is expressly prohibited except with prior
written consent of the entity 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 (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 License Agreement or the license agreement
among Immtech, UNC-CH, Auburn University, Duke University, and the Georgia
State University Research Foundation, Inc. dated August 25, 1993 (the
"1993 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 Foundation 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:
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If to UNC-CH:
The University of North Carolina at Chapel Hill:
Vice Chancellor for Research and Economic Development
The University of North Carolina at Chapel Hill
000 Xxxxxxx Xxxxx, Xxxxx 0000, CB # 0000
Xxxxxx Xxxx, Xxxxx Xxxxxxxx 00000-0000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Attn: Xxxx X. Xxxxxxx
If to Immtech:
Immtech Phamaceuticals, Inc.
000 Xxxxxxx Xxxxx
Xxxxx 000
Xxxxxx Xxxxx, XX 00000
FAX: (000) 000-0000
Attention: T. Xxxxxxx Xxxxxxxx
with a copy to:
Immtech Phamaceuticals, Inc.
000 Xxxxxxx Xxxxx
Xxxxx 000
Xxxxxx Xxxxx, XX 00000
FAX: (000) 000-0000
Attention: Xxxx Xxxxxxxxx, Esq.
and
Cadwalader, Xxxxxxxxxx & Xxxx LLP
Xxx Xxxxx Xxxxxxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
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
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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 this
Agreement after receipt of written notice with reasonable opportunity
to cure from the other party; termination under this clause shall only
be effective when initiated by the non-breaching party.
(2) If the Foundation withdraws or terminates any Foundation Grant 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 License Agreement is terminated due to a breach or default
thereunder by Immtech, 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 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 the License Agreement as though such agreement was still
in effect.
(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)
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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;
provided, that all such payments are consistent with payments properly
incurred in connection with the Grant Agreements.
E. Immtech will credit or return to UNC-CH any Foundation 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.
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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.
I. Termination or cancellation of this Agreement for any reason shall not
affect the rights and obligations of the parties with respect to the
License Agreement.
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. This
Agreement is subject to and shall be implemented in a manner consistent with the
Grant Agreement documenting the Foundation Program.
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.
17. INTEGRATION.
Exhibits A, B, C and D 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.
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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
Foundation, UNC-CH or any third 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.
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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 Phamaceuticals, Inc.
CAROLINA AT CHAPEL HILL
By: /s/ Xxxxxxx X. Xxxxxxxx By: /s/ T. Xxxxxxx Xxxxxxxx
-------------------------------- -------------------------------------
(signature) (signature)
Acting for T. Xxxxxxx Xxxxxxxx
Xxxx X. Xxxxxxx President
Vice Chancellor for Research
and Economic Development
March 28, 2006 March 27, 2006
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Date Date
