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Document Preview Clinical Research Subcontract |
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Title: |
Clinical Research Subcontract |
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Entities: |
Immtech International, Inc.; LaSalle Bank, NA; Auburn University; Duke University; Georgia State University Research Foundation, Inc.; University of North Carolina, Chapel Hill; Cadwalader, Wickersham & Taft |
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Date: |
2001 |
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Size: |
Preview shows 8KB of 38KB total |
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Price: |
$35 |
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ID: |
#308302 |
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-----------------------------
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 150 Fairway Drive, Suite 150, Vernon
Hills, IL 60061, (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 Bill & Melinda Gates
Foundation (the "Gates Grant") 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").
-1-
{PAGE}
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 James Allen, Ph.D., together with such
additional personnel as may be assigned by Immtech. UNC-CH's Principal
Investigator shall be Richard Tidwell, 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 Bill &
Melinda Gates 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
-2-
{PAGE}
(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 Bill & Melinda Gates
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.: 0710-0050-5
Immtech Account Name: Immtech International, Inc.
Immtech Account No.: 5800308586
Immtech Tax I.D. No.: 39-1523370
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
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