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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
308250
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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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