EXHIBIT 10.1
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
representative(s) shall be the Collaborator's Principal
Investigator or Principal Investigators, as the case may
be, as specified in Paragraph 3. The representatives
appointed by a Collaborator may be changed at the will of
that Collaborator but shall always include at least one
Principal Investigator as specified in Paragraph 3. The
chair of the Project Team Committee shall be Dr. James
Allen, or his nominee, until determined otherwise by the
unanimous vote of the Steering Committee. MMV shall
nominate a representative (project manager) to the Project
Team Committee who shall participate in meetings of the
Project Team Committee and who shall serve as a liaison
between MMV and the Project Team Committee.
(ii) The Project Team Committee shall be responsible for
regular coordination and monitoring of activities related
to the Research Program and for updates, refinements and
revisions to the Research Program which do not Materially
change its direction, scope or goal or Materially change
its cost. Such changes are not subject to the requirements
of subparagraph 23.3. Material in this context means a
substantial change in scope, direction or goal of the
Research Program (i.e. requiring an additional clinical
study) and/or a 10% increase or decrease in a yearly
budget.
(iii) The Project Team Committee may act by majority vote of its
members, either at a meeting in which all members are in
attendance in person or by other contemporaneous
electronic means (i.e. telephone or video conference) or
by a signed unanimous written consent in lieu of a
meeting. All matters related to a Material change of the
Program Budget, appointment or removal of a PI or
termination of the Program shall be referred to the
Steering Committee (defined in subparagraph 23.3) its
decision on which shall be determinative, subject to the
provisions of paragraph 23.3. The Project Team Committee
may in its discretion refer to the Steering Committee any
other matters on which it cannot reach consensus.
(iv) Meetings of the Project Team Committee will be held on a
schedule to be determined by the Project Team Committee at
its first meeting, provided that it meets at least
quarterly and conducts in-person (face-to-face) meetings
at least at six-month intervals. The in-person meetings
shall be held at dates, times, and locations agreed upon
by the Project Team Committee. Other than the in-person
meetings, meetings may be held by videoconference (where
and when such facilities are available) or a telephone
conference call. Members of the Project Team Committee
shall be responsible for making their own arrangements for
travel for such in-person meetings and MMV shall be
responsible to pay for such travel in accordance with the
Funding Budget. It shall be the responsibility of the
Chair of the Project Team Committee to prepare, or arrange
to be prepared, minutes of meetings of the Project Team
Committee and circulate them to the other members of the
said Committee at least at or before subsequent meetings
of the said Committee.
2.3. In addition to the Project Team Committee, a Steering Committee,
consisting of three (3) members, Richard Tidwell, Steve Thompson
and J Carl Craft, shall be established upon execution of the
Agreement. The Steering Committee (with input from the Project
Team Committee) shall be responsible for 1) providing guidance
regarding the overall strategy for obtaining Regulatory Approval
for DB-289, 2) deciding whether Material changes to the Research
Program or Funding Budget need to be implemented, the
implementation of such decision being subject to the provisions of
paragraph 23.3, 3) approving replacement PIs (the Steering
Committee shall have no more than 3 vetos over a Collaborator's
nominees for PI after which the Steering Committee must select the
Collaborator's forth nominee or one of the earlier three nominees,
subject to the availability of the selected prior nominee), and 4)
any other issues for which the Project Team Committee requests
assistance. The Steering Committee shall meet in face to face
meetings at least once a year to monitor progress in the
advancement of the project and to approve the yearly budget for
each ensuing year of the Agreement. All decisions of the Steering
Committee shall be unanimous.
2.4. The following reports shall be required:
(i) The Project Team Committee shall, not less than annually,
prepare a consolidated written report substantially in the
form attached hereto in Schedule 4 giving an overview in
reasonable detail of the progress by the Collaborators,
individually and collectively, on the Research Program
during the previous quarter. The Chair of the Project Team
Committee shall have responsibility for the coordination
and drafting of the annually consolidated written report.
The annually consolidated report shall be submitted to
MMV.
(ii) Each Collaborator shall provide individual annual
financial reports substantially in the form attached
hereto in Schedule 5 regarding expenditure of Program
Funds to the chair of the Project Team Committee who shall
collate and forward them to MMV. Such individual annual
financial reports shall indicate all expenditures and
financial commitments entered into pursuant to carrying
out the Research Program. Such reports shall further
include a proposed budget for the respective Collaborator
for the ensuing year.
(iii) The Project Team Committee shall annually prepare a
consolidated written scientific report substantially in
the form attached hereto in Schedule 4 concerning the
progress of research conducted under the Research Program
within sixty (60) days of the date set for the annual
presentations to the ESAC. The Chair of the Project Team
Committee shall have responsibility for the coordination
and drafting of the annual consolidated written scientific
report. The consolidated annual written scientific report
shall be sufficiently detailed to describe the work
carried out by the Collaborators, individually and
collectively, as part of the Research Program during the
previous year and results obtained (or since the
commencement of the Research Program if less than a year)
together with a suggested work program for carrying
forward the Research Program and budget for the Research
Program for the next year including priorities and goals.
Subsequent to the submission of the written report to the
ESAC, each Collaborator, as reasonably requested by and at
the expense of MMV, shall make its Principal Investigator
and its member or members of the Project Team Committee
available to the ESAC upon reasonable advance notice for
the purposes of presenting the report and discussing it.
Following such presentation, MMV shall have the reasonable
right to request changes or modifications to the Research
Program and the Funding Budget. Such changes shall, after
approval by the Project Team Committee acting pursuant to
Section 2.2(iii), thereafter be deemed to be part of the
Research Program or Funding Budget, as appropriate.
(iv) Within six (6) months after the completion of the Research
Program, each Collaborator shall provide MMV with a final
written scientific and financial report substantially in
the forms attached hereto in Schedules 4 and 5.
2.5. Any Material changes to the Research Program or Funding Budget may
only be made with the agreement of the Steering Committee and with
the express written consent of the Parties in accordance with
subparagraph 23.3.
3. Regulatory Filing
3.1. Immtech shall control the preparation, submission and prosecution
of all regulatory filings necessary for the approval of DB-289 by
a Regulatory Agency and for filing an application for regulatory
approval in at least one Malaria Endemic Country. To the extent
feasible, in Immtech's sole discretion, Immtech shall conduct the
aforementioned activities in accordance with the advice and
guidance provided by the Steering Committee. Immtech shall be the
owner and party of record for all such filings, applications and
approvals and shall be responsible for any costs associated such
filing. The Parties agree to provide assistance requested by
Immtech as reasonably necessary for preparation and prosecution of
such filings and applications. Immtech shall reimburse to the
extent funded in the Funding Budget the other Parties for any
costs and expenses incurred in such assistance.
3.2 Immtech shall promptly inform the Project Team Committee in
writing of any filing of an NDA and of any NDA approval, and shall
in connection therewith promptly provide the Project Team
Committee with a written summary of any such filing of an NDA and
NDA approval, or with a copy thereof, whichever the Project Team
Committee may elect.
4. Principal Investigator. All research conducted by the Collaborators in
connection with the Research Program will be supervised by one or more Principal
Investigators from each Collaborator. The initial Principal Investigators are:
UNC, Drs. Richard Tidwell, James Hall, Steven Meshnick; and Immtech, Dr. James
Allen. If, for any reason, a Principal Investigator is unable or unwilling to
continue to serve as Principal Investigator for the Research Program, a
successor Principal Investigator shall, upon approval by the Steering Committee,
be appointed by the Collaborator concerned within sixty (60) days from the date
the Principal Investigator ceases to serve as Principal Investigator for the
Research Program. The foregoing provisions shall apply to any replacement or
successor Principal Investigator selected in accordance with the terms of this
Agreement.
5. Payments
5.1. MMV shall pay in advance to each Collaborator the amounts
allocated for Year 1 as set forth in the Funding Budget. Promptly
upon the conclusion of Year 1 and any subsequent year, MMV on the
one hand and each Collaborator on the other hand, shall reconcile
actual expenditures to the funds advanced by MMV for such year
prior to commencement of the next year (or in the case of the last
year, promptly upon its completion). Upon such reconciliation at
the end of the respective year, the owing Party shall promptly
refund the difference. Each Collaborator shall be responsible for
paying subcontractors as provided for in the Funding Budget and
for which advance payment has been received by such Collaborator.
5.2. MMV's obligation to pay any one or more of the payments hereunder
to the Collaborators is subject to the commercially reasonable
performance of the statement of work set forth in subparagraph 2.1
or as otherwise agreed by the Parties in writing (to the
reasonable satisfaction of MMV).
5.3. Other than as set forth in this Agreement, all costs and expenses
incurred by each Collaborator in connection with the provision of
its services hereunder shall be borne exclusively by each
respective Collaborator without further reimbursement or
compensation directly or indirectly by MMV.
5.4. All dollar amounts herein refer to the currency of the United
States of America and all amounts required to be paid hereunder
shall be paid in such currency.
6. Termination
6.1. The term of this Agreement shall commence on the Effective Date
and terminate upon the Regulatory Approval by Regulatory Agency of
a Product and the filing for regulatory approval of that Product
in at least one Malaria Endemic Country unless earlier terminated
pursuant to the terms of this Paragraph or by written agreement of
the Parties and shall be subject to renewal only by mutual
agreement (in writing) of the Parties in accordance with
subparagraph 23.3.
6.2. Any Collaborator may terminate its participation in this Agreement
for any reason at any time upon ninety (90) days prior written
notice. The terminating Collaborator shall refund MMV, subject to
subparagraph 6.7, any funds remaining unexpended as of the date of
termination which have been provided by MMV.
6.3. MMV may terminate this Agreement for any reason at any time upon
ninety (90) days prior written notice if it decides not to proceed
with the Research Program.
6.4. Any Party may cancel this Agreement immediately upon written
notice to the other Parties if safety and/or efficacy
considerations regarding DB-289 arise.
6.5. In addition to the foregoing, in the event that any Party
hereunder shall breach any of the material terms, conditions and
agreements contained in this Agreement to be kept, observed or
performed by it, then any other Party may terminate this
Agreement, at its option and without prejudice to any of its other
legal and equitable rights and remedies, by giving the Party who
committed the breach ninety (90) days notice in writing,
particularly specifying the breach, unless the notified Party
within such ninety (90) day period shall have rectified the breach
or, if such breach is only reasonably capable of being rectified
within a longer time period, the notified Party has taken and
continues to take all reasonable measures to rectify it.
6.6. In the event any Party shall (i) become insolvent, (ii) suspend
its business, (iii) file a voluntary petition or an answer
admitting the jurisdiction of the court in the material
allegations of insolvency, (iv) consent to an involuntary petition
pursuant to any reorganization or insolvency law of any
jurisdiction, (v) make an assignment for the benefit of creditors,
or (vi) apply or consent to the appointment of a receiver or
trustee for a substantial part of its property, then any other
Party may thereafter immediately terminate it participation in
this Agreement by giving prior written notice of termination to
all other Parties.
6.7. If any Party withdraws its participation from this Agreement or if
this Agreement is terminated by MMV pursuant to subparagraph 6.3,
the Collaborators agree that MMV's financial obligations to them
is limited to the following:
(i) Costs accrued by Collaborator as of the effective date of
termination and any non-cancelable costs reasonably
incurred by Collaborators prior to receipt of the above
termination notice. Each Collaborator will use reasonable
diligence to limit or terminate any outstanding
commitments incurred prior to such notice. The burden
shall be on the Collaborator to demonstrate that a given
cost is "non-cancelable", absent which all costs shall be
deemed cancelable. However, for purposes of this
subparagraph, the agreed-upon cost of an on-going clinical
trial shall be considered a "non-cancelable" cost and
shall be paid by MMV unless the Agreement is terminated
under subparagraph 6.4 for safety and/or efficacy
considerations.
(ii) Expenditures due to salaries or contract obligations for
any person who is not tenured but who is retained by a
Collaborator to perform work pursuant to this Agreement.
Upon receipt of a notice from MMV pursuant to subparagraph
6.3, Collaborator must take all necessary and proper steps
to mitigate the costs associated with such salaries or
contract obligations, including but not limited to, if
possible, terminating any contractual obligations with
such person. Notwithstanding the foregoing, MMV's
financial obligation is limited to expenditures by
Collaborator due to salaries or contract obligations up to
one year from the effective date of the termination by MMV
pursuant to subparagraph 6.3 above.
6.8. The provisions of Paragraphs 2.3(iv), 5.3, 5.4, 6-13, 16 and 17
shall survive the expiration or termination of this Agreement.
7. Press Releases. Except as otherwise required by law (i.e. in the case of
Immtech, as required by securities or other regulatory laws or rules to which
its or its Affiliates are subject), no Party shall use any other Party's name or
make reference to any technology underlying another Party's IPR in any press
release without the express prior written approval of such Party, which approval
shall not be unreasonably withheld or delayed. In any such press release, MMV's
funding of the collaboration shall be acknowledged.
8. Publications. The Collaborators reserve, on behalf of their Principal
Investigators and other employees and/or students, the right to publish or
publicly disclose (hereinafter "publication") any material resulting from the
Research, subject to the following restrictions and limitations.
The Collaborators shall furnish the Project Team Committee and MMV
with a copy of any proposed publication resulting from the Research Program at
least thirty (30) days in advance of the submission of such publication to a
journal or editor or otherwise for publication.
The Project Team Committee and MMV shall have thirty (30) days after
receipt of said copies to review and recommend changes and/or deletions
necessary to protect information confidential to the Collaborators or MMV or to
identify patentable subject matter which requires protection. Collaborators or
MMV may request a delay of such publication not to exceed an additional sixty
(60) days, in order to protect confidential information or patentable subject
matter therein.
Failure to respond within the original thirty (30)-day period shall
constitute de facto agreement of the Collaborators and MMV that no revisions or
delay in publication is necessary. No provision of this Agreement shall be
interpreted to prevent or delay the defense or publication of a graduate student
thesis or dissertation.
8.1. Immtech shall be permitted, without delay from any other Party
hereto, to issue such communications and make such filings with
the Securities and Exchange Commission, the National Association
of Securities Dealers (NASD), the American Stock Exchange, the
Food and Drug Administration, or other governmental or regulatory
agencies or authorities, as (i) reasonably advisable in connection
with or required by such agencies or authorities and (ii) required
in the preparation of Immtech's financial statements. No other
Party hereto shall be permitted to make any public disclosure that
would cause Immtech to incur liability under the U.S. securities
laws or the securities laws of any other jurisdiction where its or
its Affiliates securities are registered.
9. Confidential Information
9.1. "Confidential Information" means, whether marked "confidential" or
not, all knowledge or information and any algorithms, formulae,
techniques, improvements, technical drawings, data, materials,
specifications, documents or information obtained or used in
conjunction with any business or any contract, agreement or
information directly or indirectly connected with any Party
hereto, including but not limited to trade secrets, client lists,
intellectual and industrial property, drawings, financial
information, specifications, analysis, feasibility studies,
information, data or knowledge and all other knowledge or
information whatsoever relating directly or indirectly to such
Party or the business of such Party. The obligations of this
Clause shall not apply to any information which (i) was in the
public domain at the time of disclosure or use (ii) entered the
public domain through no action of receiving Party, (iii) is
independently developed by the receiving Party's personnel not
privy to the disclosure of Confidential Information or (iv) is
disclosed in response to a valid order by a court or governmental
body; provided, however, that the receiving Party shall provide
the providing Party with prior written notice of any process
seeking such an order timely to enable the providing Party to seek
a protective order or otherwise prevent disclosure or use.
9.2. Each Party hereto shall (i) hold all Confidential Information in
confidence and take all precautions necessary to protect such
Confidential Information, (ii) not disclose the Confidential
Information to any other Person except as authorized herein, (iii)
use the Confidential Information only for the purposes of this
Agreement, (iv) not copy or reverse engineer, reverse compile or
attempt to derive the composition or underlying information of any
such Confidential Information, (v) limit the use and access to
such Confidential Information to the recipient's employees and
consultants who need to know such Confidential Information for the
purposes of this Agreement, (vi) receive, store, transmit, use and
treat such Confidential Information with at least the same degree
of care and protection as it would use with respect to its own
confidential materials and (vii) take measures to prevent creating
a premature bar to a United States or foreign patent application.
Each Party shall cause its employees, consultants, contractors or
sub-contractors or any other Person that has access to
Confidential Information to comply with the obligations set forth
herein.
10. Intellectual Property
10.1. The Parties contemplate two types of inventions in connection with
the Research Program: Background Inventions and Program
Inventions. If any IPR granted hereunder conflicts with the
Collaborators' Agreements (as defined below), the Collaborators'
Agreements shall prevail over any rights granted herein.
10.2. Each Collaborator shall disclose to the Project Team Committee and
MMV in writing, within a reasonable time, all discoveries,
inventions and improvements, patentable or unpatentable, reduced
to practice related to Program Inventions in the Field of Use by a
Collaborator in connection with the performance of the Research
Program (including, without limitation, all Background Inventions
and Program Inventions). Recipients of such information shall (i)
retain all such invention disclosures and other information
submitted by each Collaborator in accordance with the
confidentiality provisions of Paragraph 9 herein and (ii) return
all such information to the information provider upon the earliest
of (x) the termination of this Agreement, (y) the withdrawal of
the information provider from this Agreement for any reason or (z)
the withdrawal of the information recipient from this Agreement
for any reason. MMV may after reasonable notice and during regular
business hours, inspect Collaborators' Background Inventions
related to the Field of Use at Collaborators' respective places of
business. No copies of Background Inventions may be made by MMV
without such Collaborator's prior consent, which consent may be
unreasonably withheld.
10.3. Subject to any specific agreement between the Parties to the
contrary, title to any Background Invention shall remain with the
respective Collaborator.
To the extent they may legally do so, all Collaborators
agree to grant a non-exclusive, royalty-free, license without the
right to sublicense, for non-commercial, internal research
purposes to any Background Invention to other Collaborators solely
to enable the other Collaborators to carry out tasks under the
Research Program that are restricted to the Field of Use. Such
license shall be limited to the duration of the Collaborator's
participation in the Research Program. Ownership of the Background
IPR shall remain vested in the Collaborator providing such
Background IPR and no other Collaborator nor MMV shall acquire any
rights in and to another Collaborator's IPR by virtue of the
license granted in this subparagraph.
10.4. (a) Subject to any specific agreement between the Parties to the
contrary, title to each Program Invention, whether or not
patentable, that is conceived and reduced to practice in
furtherance of the Research Program will vest in Collaborator at
which the said conception and reduction to practice took place.
Where conception and reduction to practice of a given Program
Invention takes place jointly between two or more Collaborators,
title shall vest jointly in those Collaborators, unless otherwise
agreed. In the event a license is granted hereunder, the
title-holding Collaborator(s) shall retain a right to practice to
Program Inventions for 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 License Agreement among Immtech and the
Scientific Consortium dated as of January 28, 2002, UNC has
granted to Immtech an exclusive royalty-bearing, worldwide,
license to all Program Inventions in the Field of Use. This
Agreement does not amend, supplant or otherwise usurp any of the
terms, rights or agreements contained in the Consortium Agreement,
License Agreement or any other agreement between or among any of
the Collaborators (collectively, the "Collaborators' Agreements").
In the event any term, right or condition contained herein
conflicts with a term, right or condition contained in any
Collaborators' Agreement, the term, right or condition of the
Collaborators' Agreement shall prevail. Notwithstanding the above,
the Parties have reviewed the Collaborators' Agreements and do not
consider there to be any conflicts between the terms, rights or
conditions herein and the terms, rights or conditions in those
agreements.
10.6. In the event Immtech fails to commence the Regulatory Approval
process pursuant to subparagraph 3.1 above within the 12 month
period following the discovery and disclosure of a Program
Invention to Immtech (the "First Anniversary"), MMV may request
from Immtech the option (the "Option") to pursue development of
such Program Invention during the next following 12 month period
(the "Option Period"). To exercise the Option, MMV must during the
Option Period (i) deliver to Immtech written notice of MMV's
intent to commence development of such Program Invention, (ii)
disclose to Immtech the basis upon which MMV believes the Program
Invention warrant's further development, and (iii) allow Immtech
30 days to commence the Regulatory Approval process after the
receipt of such disclosure. Exercise of the Option shall be
contingent upon MMV's (i) reimbursement all of Immtech's and other
Collaborators' patent expenses incurred in conjunction with the
Program Invention not otherwise paid pursuant to subparagraph
10.8, (ii) acceptance of transfer and novation of all third party
licenses acquired in connection with the development of Program
Invention and (iii) agreement to pay a royalty to Immtech on the
Net Sales of any Product developed (the amount of such royalty to
be negotiated in good faith by MMV and Immtech and is made
expressly subject to the last sentence of paragraph 11.2)
developed pursuant to this Agreement or the MMV/UNC research
Agreement. In the event MMV exercises the Option provided herein
and fails to pursue development of the Program Invention during
the Option Period, the Option shall terminate and all IPR shall
revert to UNC.
10.7. If MMV obtains Regulatory Approval pursuant to subparagraph 10.6,
Immtech shall Grant to MMV a royalty bearing, irrevocable,
worldwide, co-exclusive, non-transferable, sub-license to all
Program Inventions (including data generated under this Agreement)
in the Field of Use. In such case, MMV shall also be granted an
irrevocable, worldwide, non-exclusive, sub-license to all required
Background Inventions in the Field of Use. Immtech is expressly
permitted to grant such a sub-license under subparagraphs 2.1 and
2.2 of the License Agreement provided that UNC consents to such
license. For the purposes of the sub-licenses granted to MMV under
this provision, UNC expressly consents to such sub-license by
signing this Agreement. Moreover, pursuant to subparagraph 5.4 of
License Agreement, if the license between Immtech and the
Consortium members is terminated (for any reason), the sub-license
provided to MMV herein shall not be terminated, but shall be
assigned to UNC and remain in full force and effect. Any license
granted hereunder shall be negotiated by MMV and Immtech (or,
pursuant to the terms of the Collaborators' Agreements, UNC) in
good faith, and upon reasonably commercial terms, including
diligence milestones.
10.8. Each Collaborator agrees to use best efforts to notify the Project
Team Committee and MMV within a reasonable amount of time of its
decision to apply for a patent or other form of intellectual
property protection in connection with the Research Program.
Collaborators shall provide MMV with the opportunity to review and
comment on all patent applications and applications for any other
legal protection for intellectual property prepared by
Collaborators as a result of the Research Program and
Collaborators shall consider MMV's comments seriously and in good
faith. Any such patent or other applications and substantive
papers prepared for filing in connection with the prosecution of
such applications shall be provided to MMV at least thirty (30)
days prior to the date they are to be filed with the relevant
office so as to afford MMV a reasonable opportunity to perform
such review and prepare such comments. Where a Program Invention
is sublicensed to MMV pursuant to subparagraph 10.7, MMV agrees to
reimburse a Collaborator for reasonable patent filing and
prosecution expenses.
10.9. If a Collaborator chooses not to file a patent application in the
U.S. or other foreign jurisdictions for a Program Invention
(whether or not it is licensed to MMV) it shall promptly notify
MMV of such decision and shall provide MMV with the opportunity to
file or to continue prosecution of, patents on any Program
Invention in the name of the Collaborator at MMV's sole cost and
expense. Collaborators shall provide MMV with sufficient notice of
a decision not to file for patent protection or other IPR in a
given jurisdiction or not to continue prosecution in order that
MMV may undertake a filing or continue prosecution, as the case
may be. Such sufficient notice shall be at least thirty (30) days
prior to the date an act to effect such filing or continuation of
prosecution is due. In the event that MMV undertakes any filing or
prosecution of a patent application by virtue of this
subparagraph, MMV shall be granted a co-exclusive license pursuant
to the terms of Paragraph 10.7 above.
10.10. No patent or other type of intellectual property protection that
is filed for or obtained in connection with the Research Program
(including without limitation Background and Program Inventions)
shall be abandoned by a Collaborator without first notifying MMV
in writing. At such time, a Collaborator shall give MMV the
opportunity to assume responsibility for the costs and maintenance
of the invention or other intellectual property thereafter
incurred at the sole cost and expense of MMV. In the event that
MMV undertakes any filing or prosecution of a patent application
by virtue of this subparagraph, MMV shall be granted a
co-exclusive license pursuant to subparagraph 10.7 above.
10.11. Notwithstanding the provisions of this Agreement to the contrary,
to the extent that the rights held by any Collaborator to
Background Inventions or Program Inventions are subject to or
limited by rights held by a government or government agency, or
have previously been licensed or otherwise obligated to a third
party, the Parties understand and agree that the rights to such
Inventions transferred or licensed to Immtech, MMV or other
entities hereunder are subject to such limitations.
10.12. In the event that third party licenses are necessary to the
progress of the Research Program, Collaborators will provide
prompt notice to the Project Team Committee and Immtech. Where the
Project Team Committee and Immtech deem it appropriate to obtain
such licenses, Immtech agrees that the cost of such licenses shall
be an expense borne by Immtech (such expense to be deducted from
Net Sales). In the event MMV undertakes any filing or prosecution
of a patent application pursuant to subparagraph 10.7 above, MMV
shall accept transfer and cause a novation of all third-party
licenses under this subparagraph 10.12.
11. License to Program Inventions.
11.1. Notwithstanding anything to the contrary herein, to the extent
they may legally do so MMV and/or UNC shall grant Immtech an
exclusive royalty-bearing, worldwide, license to all IPR Program
Inventions developed under this Agreement and the MMV/UNC Research
Agreement.
11.2. Licenses to Program Inventions granted to Immtech hereunder shall
bear Royalties (i) to UNC pursuant to the Collaborators; Agreement
and (ii) to MMV payable annually in arrears beginning on the
Effective Date and continuing until MMV receives in the aggregate
(together with amounts funded by MMV pursuant to the MMV/UNC
Research Agreement all amounts paid to the Collaborators pursuant
to this Agreement plus any amounts funded under the MMV/UNC
Research Agreement, a royalty (the "Royalty") not to exceed seven
percent (7%) of aggregate Net Sales. Notwithstanding anything else
contained in this Agreement, no Royalty shall be due or owed to
any party for sales of any Product (A) if the Product is sold for
use in a Malaria Endemic Country or (B) if no Collaborator has any
Patent Rights on (i) the structure (or "composition of matter") of
the active ingredient, (ii) the manufacturing process for the
active ingredient, or (iii) the use for which such active
ingredient is being used.
11.3. MMV shall notify Collaborators within ninety (90) days of any
determination by MMV of successful completion of the phase II
portion of the Research Program as detailed in Schedule I; such
"successful completion" is deemed to be a demonstration that DB289
alone, or in combination, is safe and efficacious for the
treatment and/or prophylaxis of non-complicated malaria. Upon
receipt of such notice, Immtech shall indicate in writing to MMV
whether it wishes to proceed with commercialization of the
Product, and if so, at the same time, Immtech shall offer terms to
MMV therefore. In such circumstances MMV and Immtech shall
negotiate, in good faith, commercially reasonable terms, including
but not limited to a percentage of annual Net Sales of Product
sold to other than Developing Nations which Immtech shall pay to
MMV as a royalty for a development and license agreement pursuant
to this Paragraph. Such terms shall recognize, in accordance with
Paragraphs 11.1 and 11.2, that the major goal for MMV in entering
into such a development and license agreement in relation to the
Product is that the Product is appropriate for use in Malaria
Endemic Countries and that it will be commercialized in such a
manner including price considerations that facilitates its
widespread use in such countries. Such negotiations shall be
carried out in a commercially reasonable period of time, failing
which shall be Immtech under no further obligation to MMV and
shall be free to enter into an agreement or agreements with a
third party or third parties for the commercialization of the
Product.
11.4. In the event of a bankruptcy of any of the Parties, all rights to
licensed patent rights granted to a Party under this Agreement to
the extent same survive prior to filing of such bankruptcy, are,
and shall be deemed to be, for purposes of Section 365(n) of the
United States Bankruptcy Code, as amended from time to time,
licenses of right to "intellectual property" as defined under
Section 101(35A) of the Bankruptcy Code. The parties agree that
any Party, as a licensee of such rights under this Agreement,
shall retain and may fully exercise all its rights and elections
under the Bankruptcy Code. In the event of insolvency, the
relevant Party shall assign to the other all of its rights, title
and interest in Program Inventions.
12. Commercialization and Pricing
12.1. The price at which the Product(s) shall be made available for
distribution within Malaria Endemic Countries shall be fixed at an
affordable level that maximizes access to the Product(s) in these
countries. The aforesaid price shall be negotiated in good faith
by MMV and Immtech pursuant to Paragraph 10.1. It being agreed,
until such time as MMV has been paid the Royalty in full, that MMV
and IMMTECH do not expect the term "affordable" to mean that
IMMTECH shall be required to make the Product(s) available for
distribution in Malaria Endemic Countries at a price lower than
the COGS plus a modest mark-up to reflect administrative overhead
costs (not to exceed 10% of COGS), cost of delivery and a modest
profit. It being further understood, that the Parties intend that
a modest profit for Product sold in Malaria Endemic Countries
shall be a percentage over COGS not to exceed the profit
percentage of other "modern" drugs sold into Malaria Endemic
Countries.
12.2. At the request and expense of MMV and upon reasonable notice,
Immtech shall present to a firm of independent auditors,
designated by MMV and acceptable by Immtech (acceptance not to be
unreasonably withheld or delayed), relevant documentation
supporting the COGS under Paragraph 11.1 (provided that such
documentation shall be subject to appropriate undertakings of
confidentiality). MMV shall not make such requests unreasonably
and shall in any event not make such requests more frequently than
once every twelve months. The aforesaid firm of auditors shall
limit their advice to MMV to a conclusion whether or not the COGS
proposed by Immtech is in accordance with the terms of Paragraph
11.1 and, if not, what adjustments to the COGS are necessary to
comply with Paragraph 11.1. In the event that the independent
auditors advise MMV that the COGS do not comply with Paragraph
11.1, Immtech will have ninety (90) days to bring its COGS
calculations into compliance failing which it will be considered
in material breach of this Agreement.
13. Indemnification
13.1. To the extent a Party is legally able to do so, each Party agrees
to indemnify, hold harmless and defend each other Party, their
trustees, officers, employees, students, and agents, against any
and all claims, suits, losses, damage, costs, fees, and expenses
asserted by third parties, both government and private, resulting
from or arising out of this Agreement, except to the extent that
any such claim, suit, loss, damage, cost, fee, or expense is
attributable to any negligence or intentional misconduct of any
Party, any inventor, or any trustee, officer, employee, student or
agent of any Party or any inventor seeking indemnification
14. Representations and Warranties
14.1. In this Agreement, any reference to a Party's "knowledge" means
(1) with respect to any natural person, the actual knowledge of
such person or (2) with respect to any corporation or other
entity, the actual knowledge of such Party's officers and
directors.
14.2. The Parties, as applicable, severally and not jointly, represent
and warrant to each other as follows:
(i) Each of the Parties has full power, authority and legal
capacity to execute and to perform its obligation(s) under
this Agreement in particular, but not limited to, to grant
MMV and Immtech the license to Program Inventions and/or
Background Inventions described in Paragraphs 10.7 and
11.1, respectively;
(ii) Each of the Parties will comply in all material respects
with all laws, statutes, rules, regulations and guidelines
promulgated by any governmental agency, instrumentality,
authority or regulatory body having jurisdiction over such
Party's conduct pursuant to any terms and conditions of
this Agreement or matters contained in the Research
Program (including, without limitation, any laws,
statutes, rules, regulations or guidelines concerning
animal or human use or testing or concerning the transfer
or export of technology) and each Party will give the
other Parties prompt written notice of any claim of
breach, violation or deviation or threatened or alleged
breach, from any such laws, statutes, rules, regulations
or guidelines or of the institution or threatened
institution of any action, suit or proceeding related
thereto. During the Research Program, each Collaborator
will comply with all biohazard or other safeguards as may
be required by any applicable law, statute, rule,
regulation or guideline;.
(iii) To the best of their knowledge and belief none of the
Parties or their Affiliates has been sued for infringement
or misappropriation of IPR or has agreed to indemnify any
other person against a charge of infringement or
misappropriation of intellectual property or has reason to
believe that their prospective performance under this
Agreement may give rise to a charge of infringement or
misappropriation of intellectual property;
(iv) Each of the Parties is covered by policies of insurance or
self-insurance and bonds of the type and in amounts that
such Party believes are adequate given its business or
assets and in light of the obligations it is assuming
under this Agreement. None of the Parties has knowledge of
any threatened termination of any of such policies; and
(v) EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT,
EACH OF THE PARTIES MAKES NO WARRANTIES, EXPRESSED OR
IMPLIED, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE OF ANYTHING DEVELOPED OR PROVIDED BY ANY PARTY
PURSUANT TO THIS AGREEMENT, INCLUDING A PRODUCT OR
RESEARCH RESULT.
15. No Agency or Joint Venture. Nothing in this Agreement shall be deemed to
create an agency relationship or joint venture between the Parties. Each
Party shall be responsible for all taxes, benefits, withholding, worker's
compensation, unemployment insurance and similar requirements of their own
employees and neither Party's employees shall be deemed agents or
employees of the other Party.
16. Quality Assurance and Record Keeping
16.1. Each Collaborator shall use reasonable efforts to keep and retain
notebooks and other written records of the research conducted by
it in accordance with good academic laboratory practice, which
shall include, in particular, extensive, thorough, and dated notes
commensurate with needs to obtain and defend patent rights.
16.2. Each Collaborator shall meet all applicable GLP (Good Laboratory
Practices), GMP (Good Manufacturing Practices) and GCP (Good
Clinical Practice) standards as per current guidelines of the
International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use
(ICH) and the regulatory requirements of internationally accepted
regulatory bodies, such as the United States Food and Drug
Administration, the European Agency for the Evaluation of
Medicinal Products, or the Japanese Ministry of Health, Labour and
Welfare. Records of quality assurance shall be available to MMV
for inspection.
16.3. Subject to the provisions of Paragraph 9, notebooks and other
written records maintained by each Party in carrying out the
Research Program shall be available to all other Parties for
inspection and copying. Such inspection shall take place after
reasonable prior written notice is given by the Party proposing to
inspect and at a mutually convenient time. Inspecting Parties
agree to use reasonable care to avoid unauthorized disclosure of
another Party's Confidential Information as mandated by Paragraph
9.2.
16.4. Notebooks and other written records maintained by each
Collaborator in carrying out the Research Program shall be
maintained for at least five years following the termination of
this Agreement.
17. Compliance with Export Control Laws. The obligations of the Parties to
transfer technology to one or more other Parties, provide technical information
and reports to one or more other Parties, and otherwise perform under this
Agreement are contingent upon compliance with applicable United States export
control laws and regulations. The transfer of certain technical data and
commodities may require a license from a cognizant agency of the United States
Government or written assurances by the Parties that the Parties shall not
export technical data, computer software, or certain commodities to specified
foreign countries without prior approval of an appropriate agency of the United
States Government. The Parties do not, alone or collectively, represent that a
license shall not be required, nor that, if required, it shall be issued.
18. Use of Names. The Parties agree not to use the name, trademark, or other
identifier of the other Parties hereto for any advertising, promotion,
publicity, or commercially related purposes unless prior written approval is
provided by the affected Party.19. Notices. Any notices required to be given or
which shall be given under this Agreement shall be in writing delivered by
recognized overnight courier service, personal delivery, telecopy (with evidence
of receipt), by certified or registered mail (with return receipt requested)
addressed to the Parties as shown below and shall be deemed to have been given
or made as of the date received:
Dr. J Carl Craft
Chief Scientific 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 150
Vernon Hills, IL 60061
20. Assignment and Sub-Contract. This Agreement shall be binding upon and
inure to the benefit of the Parties hereto and their respective successors and
permitted assigns. This Agreement shall not be transferable or assignable by any
Party, in whole or in part, without the prior written consent of all of the
Parties, which consent shall not be unreasonably withheld or delayed; any
attempted assignment in contravention of the foregoing shall be void and of no
force and effect. Moreover, no Collaborator shall have the right to sub-contract
any duties or obligations under this Agreement without the prior written
agreement of MMV, which agreement shall not be withheld unreasonably. The
sub-contracts identified in Schedule II are deemed agreed to by MMV in
accordance with the requirements of this Paragraph.
21. Counterparts. This Agreement may be executed in one or more counterparts,
each of which shall be an original copy of this Agreement and all of which when
taken together, shall constitute one and the same agreement.
22. Dispute Resolution & Governing Law.
22.1. This Agreement shall be construed and interpreted in accordance
with the laws of the State of New York, without regard to its laws
regarding conflict of laws. Any action or proceeding seeking to
enforce any provision of, or based on any right arising out of,
this Agreement may be brought against any of the Parties in the
courts of the State of New York, or, if it has or can acquire
jurisdiction, in the United States District Court for the Southern
District of New York, and each of the Parties consents to the
jurisdiction of such courts (and of the appropriate appellate
courts) in any such action or proceeding and waives any objection
to venue laid therein. Process in any action or proceeding
referred to in the preceding sentence may be served on any Party
anywhere in the world.
22.2. Any action, suit or proceeding arising out of or relating to this
Agreement may be instituted in any state or federal court located
in the State of New York, United States of America, and each Party
agrees not to assert, by way of motion, as a defense or otherwise,
in any such action, suit or proceeding, any claim that it may now
or hereafter have that it is not subject personally to the
jurisdiction of such court, that the action, suit or proceeding is
brought in an inconvenient forum, that the venue of the action,
suit or proceeding is improper or that this Agreement or the
subject matter hereof may not be enforced in or by such court.
Each Party irrevocably submits to the jurisdiction of such court
in any such action, suit or proceeding, and irrevocably agrees to
be bound by any final judgment rendered thereby in connection with
this Agreement from which no appeal has been taken or is
available. Any and all service of process and any other notice in
any such action, suit or proceeding shall be effective against any
Party if given pursuant to notice provisions of Paragraph 18.
Nothing contained herein shall be deemed to affect the right of
any Party to serve process in any manner permitted by law or to
commence legal proceedings or otherwise proceed against any other
Party in any other jurisdiction.
22.3. In addition to all other remedies available at law or in equity,
each Party shall have the right to enforce the terms of this
Agreement by a decree of specific performance, provided such Party
is not in material default hereunder and will not be required to
post bond in connection therewith. Except as otherwise provided
herein, any and all remedies herein expressly conferred upon a
Party shall be deemed cumulative with and not exclusive of any
other remedy conferred hereby, or by law or equity upon such
Party, and the exercise by a Party of any one remedy will not
preclude the exercise of any other remedy.
22.4. The validity and interpretation of this Agreement and the legal
relationship of the Parties to it shall be governed by the law of
the State of New York.
23. Rules of Construction, Amendment, and Waiver
23.1. All references to days and months in this Agreement shall be
deemed to refer to calendar days and calendar months unless
otherwise specified.
23.2. The language herein is the language chosen by all the Parties
hereto and shall not be construed against the drafter. In the
event that a translation of this Agreement is prepared and signed
by the Parties for the convenience of MMV, this English language
version shall be the official version and shall govern if there is
a conflict between the two.
23.3. Amendments to this Agreement (including Material changes to the
Research Program and Funding Budget and duration of the Agreement)
must be in writing and be signed by authorized representatives of
each Party hereto. This Agreement embodies the entire
understanding and agreement between the Collaborators and MMV with
respect to the subject matter contained herein, and any prior or
contemporaneous representations between all the Parties, either
oral or written, are hereby superseded (except as otherwise stated
herein or in the Collaborators' Agreements).
23.4. If any provision of this Agreement is held invalid or
unenforceable by any court of competent jurisdiction, the other
provisions of this Agreement shall remain in full force and
effect. Any provision of this Agreement held invalid or
unenforceable only in part or degree will remain in full force and
effect to the extent not held invalid or unenforceable.
23.5. No Party shall be responsible to any other Party for failure to
perform any of the obligations imposed by this Agreement, provided
such failure shall be occasioned by fire, flood, explosion,
lightning, windstorm, earthquake, failure or destruction, in whole
or in substantial part, of irreplaceable machinery or equipment,
major discontinuity in the supply of power, governmental
interference (not including interaction with Regulatory Agency),
civil disturbance, riot, war, strikes or other labor disturbance
or any cause beyond the reasonable control of the Party that fails
to perform its obligation(s).
23.6. The rights and remedies of the Parties to this Agreement are
cumulative and not alternative. No provision of this Agreement
shall be deemed to have been waived by any act of or acquiescence
on the part of any Parties hereto. A waiver may only occur in
writing signed by the authorized representatives of each Party
hereto, waiving the particular provision involved. No waiver of
any provision of this Agreement shall constitute waiver of any
other provision or of the same provision on any other occasion.
23.7. Each Party hereto shall pay and be responsible for the costs and
expenses, including, without limitation, attorneys' fees, incurred
by such Party in connection with the negotiation, preparation and
execution of this Agreement and the transactions contemplated
hereby.
23.8. With regard to all dates and time periods set forth or referred to
in this Agreement, time is of the essence.
Signatures start on the next page.
IN WITNESS WHEREOF, the Parties hereby indicate their agreement to
the foregoing by having this agreement to be executed by their duly authorized
representatives.
MEDICINES FOR MALARIA VENTURE
By: /s/ Christopher Hentschel
------------------------------------
Name: Christopher Hentschel
Title: Chief Scientific Officer
Date: 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 INTERNATIONAL INC.
By: /s/ T. Stephen Thompson
---------------------------------
T. Stephen Thompson
President and Chief Executive
Officer