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Testing Agreement
Testing Agreement (78K)
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TESTING AGREEMENT
AGREEMENT (this "Agreement") dated November 26, 2003 (the "Effective
Date"), by and between MEDICINES FOR MALARIA VENTURE, a not-for-profit
foundation established in Switzerland under Swiss law whose principal place of
business is International Centre Cointrin, Route de Pre-Bois 20, 1215 Geneva 15,
Switzerland ("MMV"), IMMTECH INTERNATIONAL INC., a company with offices at 150
Fairway Drive, Suite 150, Vernon Hills, Illinois, United States of America
("IMMTECH"), and THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL, a public
institution of higher education with administrative offices at Chapel Hill,
North Carolina, United States of America ("UNC");
WHEREAS, MMV has, as one of its principal objectives, the
acceleration of the discovery and development of new drugs for the treatment or
prophylaxis of malaria and to ensure the subsequent commercialization of such
drugs in a manner that facilitates their widespread use in disease endemic
countries (including price considerations);
WHEREAS, MMV has invited research proposals directed at the conduct
of a research program the objective of which is the proof of concept of
providing a new therapy for malaria, and performing subsequent drug development
activities. For the avoidance of doubt, the point of completion of drug
development is defined as the approval (such approval, "Regulatory Approval) of
marketing authorization for non-complicated malaria by at least one
internationally accepted regulatory body, such as, but not limited to, the
United States Food and Drug Administration, the U.K. Medicines and Healthcare
Products Regulatory Agency, Swissmedic, the Japanese Ministry of Health, Labour
and Welfare, or the European Agency for the Evaluation of Medical Products
(hereinafter referred to as "Regulatory Agency") and the filing of an
application seeking regulatory approval in a least one Malaria Endemic Country;
Concurrently with the execution of this Agreement, MMV and UNC have
entered into a research agreement the objective of which is the identification
of a lead compound and subsequent lead optimization studies up to the point of
identification of robust development candidates, such compounds potentially
providing new therapies or prophylactics for malaria (the "MMV/UNC Research
Agreement");
WHEREAS, the Research Program (as defined below) contemplated by
this Agreement is of mutual interest and benefit to the Collaborators (as
defined below) and to MMV, and will further the objectives of MMV;
WHEREAS, MMV and the Collaborators have agreed to undertake a
project that would first conduct a proof of concept study of a new dicationic
molecule, DB289, and would further undertake drug development activities of the
compound alone, or in combination with another antimalarial, leading to
marketing approval of a product for the treatment of malaria; and
WHEREAS, MMV has agreed to fund Immtech and UNC in accordance with
the Funding Budget for the purpose of conducting such drug development
activities.
NOW, THEREFORE, for good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the Parties hereto agree as
follows:
1. Definitions
1.1. For the purposes of this Agreement, the following terms shall have
the meanings given below: "Affiliates" means, with respect to any
Person, any other Person directly or indirectly controlling,
controlled by, or under direct or indirect common control of such
Person.
1.2. "UNC Background IPR" means patent rights and confidential
information in the Field of Use owned by UNC and developed at UNC
by Dr. Richard Tidwell or under his direct supervision and which
are not exclusively licensed to a third party, including without
limitation, Immtech.
1.3. "Immtech Background IPR" means patent rights and confidential
information in the Field of Use owned by or licensed to Immtech
and not exclusively licensed to a third party.
1.4. "Background Inventions" means any inventions that are or may be
protected as Background IPR pursuant to subparagraphs 1.2 or 1.3
above.
1.5. "Collaborators" means, collectively, UNC and Immtech.
1.6. "Control" (including "controlling," "controlled by" and "under
common control with") means the power, directly or indirectly, to
direct or cause the direction of the management and policies of a
Person whether through the ownership of voting securities or by
contract or otherwise.
1.7. "Cost of Goods" or "COGS" means the marginal cost of producing
each additional unit of the Product.
1.8. "DB289" means the aromatic diamidoxime prodrug of the dication of
DB075.
1.9. "ESAC" means the MMV Expert Scientific Advisory Committee.
1.10. "Field of Use" means the discovery, research, development, and
activities related to seeking marketing approval, manufacture, and
commercialization of drugs for the treatment and/or prophylaxis of
malaria.
1.11. "Funding Budget" means the Research Program funding budget, as set
out in Schedule 2.
1.12. "IPR" means any form of intellectual property rights including,
but not limited to, patents, copyrights, trademarks, trade
secrets, confidential information, test data, and industrial
designs.
1.13. "Malaria Endemic Countries" means the countries listed in Schedule
3 of this Agreement.
1.14. "MMV/UNC Research Agreement" means the agreement between MMV and
UNC described in the third "WHEREAS" clause above.
1.15. "Net Sales" means the actual sales receipts received by a Party,
its Affiliates, sub-licensees, permitted assignees, and other
parties acting for or on behalf of such Party ("Selling Parties")
from third parties, less any charges for (a) sales taxes, tariffs,
duties or other taxes separately stated on the invoice, (b)
shipping and insurance charges (c) third party licenses and (d)
returns, discounts rebates and the like of any Products or other
goods developed with Program funds intended for sale to patients
in other than Malaria Endemic Countries (Sales between a Party,
and any other Selling Party as aforesaid shall be excluded from
the computation of Net Sales and no royalties shall be payable on
such sales).
1.16. "Parties" means, collectively, MMV, UNC, and Immtech.
1.17. "Patents" means any and all patent applications for the use of
technology or compounds in the Field of Use and any and all
patents issuing therefrom together with any foreign equivalents,
additions, divisions, continuations, continuations-in-part,
substitutions, extensions or renewals therefor or re-issues,
registrations and re-validations, international applications under
the Patent Cooperation Treaty, and including supplementary
protection certificates or other Governmental granted exclusivity
in the nature of a patent.
1.18. "Person" means and includes natural persons, corporations, limited
liability companies, limited partnerships, limited liability
partnerships, general partnerships, joint stock companies, joint
ventures, associations, companies, trusts, banks, trust companies,
land trusts, business trusts or other organizations, whether or
not legal entities, and governments and agencies and political
subdivisions thereof and their respective successors and permitted
assigns (or in the case of a governmental person, the successor
functional equivalent of such Person).
1.19. "Principal Investigator" means the natural persons or natural
person from each Collaborator that supervise(s) the research
conducted by the Collaborator in connection with the Research
Program, pursuant to Paragraph 3.
1.20. "Product" means a pharmaceutical product that includes DB289 or a
compound developed pursuant to the MMV/UNC Research Agreement,
alone or co-packaged with a companion drug, falling within the
scope of the Field of Use.
1.21. "Program IPR" means IPR in the Field of Use that arises directly
from the activities of one or more of the Collaborators carried
out under this Agreement or the MMV/UNC Research Agreement.
1.22. "Program Inventions" means any invention that is or may be
protected as Program IPR.
1.23. "Project Team Committee" means the committee established pursuant
to subparagraph 2.2 to supervise the conduct of the Research
Program.
1.24. "Research Program" means the research program set out in
Schedule 1.
1.25. "Steering Committee" means the committee established pursuant to
subparagraph 2.3 to supervise the overall conduct of the
Agreement, particularly decisions regarding the clinical
development of DB 289.
2. Statement of Work
2.1. Each Collaborator agrees to use its reasonable efforts to perform
the activities identified in the Research Program within the time
frame specified therein and within the budget allowed in the
Funding Budget.
2.2. A Project Team Committee shall be established within sixty (60)
days after the Effective Date and shall be maintained throughout
the term of the Agreement. The Project Team Committee shall have
the following attributes and responsibilities:
(i) The Project Team Committee shall consist of up to three
(3) representatives of each Collaborator. One or more
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Immtech Int'l
As referenced in this Testing Agreement:
IMMTECH INTERNATIONAL – Switzerland under Swiss law whose principal place of
business is International Centre Cointrin, Route de Pre-Bois 20, 1215 Geneva 15,
Switzerland ("MMV"), IMMTECH INTERNATIONAL INC., a company with offices at 150
Fairway Drive, Suite 150, Vernon Hills, Illinois, United States of America
("IMMTECH"), and THE UNIVERSITY OF
_____________
Immtech International – Gallagher
Grant & Contract Administration
University of North Carolina
at Chapel Hill
C805 Brinkhouse Bullitt Bldg.
Chapel Hill, NC 27599--7525
T. Stephen Thompson
Immtech International Inc.
150 Fairway Drive
Suite 150
Vernon Hills, IL 60061
20. Assignment and Sub-Contract. This Agreement shall be binding upon and
inure
_____________
IMMTECH INTERNATIONAL – NORTH CAROLINA
By: /s/ John Gallagher for
--------------------------------------
Name: Tony G. Waldrop
Title: Vice Chancellor For Research
amd Economic Development
Date: December 3, 2003
IMMTECH INTERNATIONAL INC.
By: /s/ T. Stephen Thompson
---------------------------------
T. Stephen Thompson
President and Chief Executive
Officer
{/TEXT}
{/DOCUMENT}
_____________
dt 299794
;
Auburn
As referenced in this Testing Agreement:
Auburn University – purposes.
10.5. Subject to the terms of that certain Consortium Agreement among
Immtech, UNC, Georgia State University ("GSU"), Duke University
("Duke") and Auburn University ("Auburn," collectively with UNC,
GSU and Duke, the "Scientific Consortium"), dated as of January
15, 1997, and the License Agreement among Immtech
_____________
dt 511517
;
Duke
As referenced in this Testing Agreement:
Duke University
– internal research and educational purposes.
10.5. Subject to the terms of that certain Consortium Agreement among
Immtech, UNC, Georgia State University ("GSU"), Duke University
("Duke") and Auburn University ("Auburn," collectively with UNC,
GSU and Duke, the "Scientific Consortium"), dated as of January
15, 1997, and the
_____________
dt 290075
;
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North Carolina
As referenced in this Testing Agreement:
UNIVERSITY OF NORTH CAROLINA – IMMTECH INTERNATIONAL INC., a company with offices at 150
Fairway Drive, Suite 150, Vernon Hills, Illinois, United States of America
("IMMTECH"), and THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL, a public
institution of higher education with administrative offices at Chapel Hill,
North Carolina, United States of America ("UNC");
WHEREAS,
_____________
University of North Carolina
– Officer
Medicines for Malaria Venture
International Centre Cointrin
Route de Pre-Bois 20
CH-1215 Geneva 15
Switzerland
John Gallagher
Grant & Contract Administration
University of North Carolina
at Chapel Hill
C805 Brinkhouse Bullitt Bldg.
Chapel Hill, NC 27599--7525
T. Stephen Thompson
Immtech International Inc.
150 Fairway Drive
Suite
_____________
UNIVERSITY OF NORTH CAROLINA
– November 26, 2003
MEDICINES FOR MALARIA VENTURE
By: /s/ Lise Riopel
------------------------------------
Name: Lise Riopel
Title: Chief Scientific Officer
Date: November 26, 2003
THE UNIVERSITY OF NORTH CAROLINA
By: /s/ John Gallagher for
--------------------------------------
Name: Tony G. Waldrop
Title: Vice Chancellor For Research
amd Economic Development
Date: December 3, 2003
IMMTECH
_____________
dt 288856
;
Medicines for Malaria Venture
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