EXHIBIT 10.2
EXECUTION COPY
================================================================================
[ ** ] = This mark indicates portions of the text which have been omitted and
filed separately with the Securities and Exchange Commission pursuant to a
request for confidential treatment of such omitted text in accordance with Rule
24b-2 of the Securities Exchange Act of 1934, as amended.
LICENSE AGREEMENT
DATED AS OF JANUARY 28, 2002
AMONG
THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL
AUBURN UNIVERSITY
DUKE UNIVERSITY
GEORGIA STATE UNIVERSITY RESEARCH FOUNDATION, INC.
AND
IMMTECH INTERNATIONAL, INC.
================================================================================
EXECUTION COPY
LICENSE AGREEMENT
THIS LICENSE AGREEMENT is made and entered into as of January 28, 2002
(the "Effective Date"), among THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL
(hereinafter referred to as "UNC"), AUBURN UNIVERSITY, DUKE University, GEORGIA
STATE UNIVERSITY RESEARCH FOUNDATION, INC. (hereinafter all of the foregoing
entities, including UNC, shall be collectively referred to as the "Licensors"),
and IMMTECH INTERNATIONAL, INC., a corporation organized and existing under the
laws of the State of Delaware (hereinafter referred to as "Licensee").
W I T N E S S E T H
WHEREAS, as anticipated by that certain Formation of Research
Collaboration Letter Agreement effective January 15, 1997, as amended by (a)
that certain Amendment to Letter Agreement effective as of October 15, 1997, (b)
that certain Second Amendment to Letter Agreement effective as of January 15,
1998, and executed in May, 1998 (the "Second Amendment"), (c) that certain Third
Amendment to Letter Agreement effective as of October 1, 1998, and executed in
January, 1999 (the "Third Amendment"), (d) that certain Fourth Amendment to
Letter Agreement effective as of October 1, 1998, and executed in March, 1999,
(e) that certain Addendum to Fourth Amendment to Letter Agreement executed in
April, 1999, and (f) that certain Second Addendum to Fourth Amendment to Letter
Agreement executed in April, 1999 (collectively with all such amendments and
addenda, the "1997 Letter Agreement"), between UNC on behalf of the Licensors,
Licensee and Pharm-Eco Laboratories, Inc. ("Pharm-Eco"), Licensee completed its
initial public offering (the "IPO"), which became effective on or about April
28, 1999.
WHEREAS, it was anticipated in the 1997 Letter Agreement that upon
completion of its IPO, Licensee and the Licensors would enter into an agreement
with respect to the licensing of the Future Compounds (as defined below).
WHEREAS, each of the Licensors has, by separate agreement, authorized UNC
to negotiate this Agreement on their behalf, and by the signature of their
authorized representatives below, hereby consent to UNC's assuming, on the
Licensors' behalf, certain duties and responsibilities as set forth herein.
NOW, THEREFORE, for and in consideration of the covenants, conditions, and
undertakings hereinafter set forth, it is agreed by and between the parties as
follows:
1. DEFINITIONS
1.1 "Affiliate" means, with respect to any particular Person, any other
Person which controls, is controlled by, or is under common control with such
particular Person. A Person shall be regarded as in control of another Person if
the first Person owns or controls, directly or indirectly, at least fifty
percent (50%) of the voting stock (or other voting equity) of the second Person.
In the case of a Non-Profit Entity, control will be deemed to exist if any
Person
-1-
EXECUTION COPY
possesses, directly or indirectly, the power to direct or cause the direction of
the management and policies of such Non-Profit Entity.
1.2 "Current Compounds" means all technology and compounds owned by one or
more of the Licensors and either licensed or optioned to Pharm-Eco as of the
date of the 1997 Letter Agreement or set forth on Exhibit A to the 1997 Letter
Agreement.
1.3 "Future Compounds" means all technology and compounds developed or
invented by one or more of the Licensors which either (a) was developed or
invented subsequent to January 15, 1997, (i) through use of Licensee-sponsored
research funding, (ii) through use of Governmental Funding made available to any
of the Licensors, (iii) through use of funds expended by Licensee or obtained
through Licensee's efforts or assistance, including, without limitation, all of
the funds provided (and to be provided) by the Bill & Melinda Gates Foundation
(pursuant to that certain grant made by that certain letter dated November 8,
2000, between the Bill & Melinda Gates Foundation and UNC (the "Gates Grant"))
and any other charitable or non-profit organization which Licensee introduces to
any of the Licensors and which funds a research program in which Licensee is a
participant, (iv) for which Licensee funded any third party research or testing
previously approved by any of the Licensors, (v) for which Licensee has funded,
or agreed or committed to fund, any patent applications or the maintenance of
any patents or patent applications, or (vi) by Dr. Richard Tidwell's or Dr.
David Boykin's laboratories at UNC and Georgia State University, respectively,
and are dications or related molecules and were not or are not developed through
the use of any funding from any governmental agency or authority, other than
Governmental Funding, and for which the Licensors have the right to include in
this Agreement, or (b) was developed or invented on or prior to January 15,
1997, through use of National Cooperative Drug Development Grants or funding and
which were not, as of such date, licensed to Pharm-Eco pursuant to that certain
License Agreement dated August 25, 1993, between UNC and Pharm-Eco, or which are
otherwise not Current Compounds.
1.4 "Governmental Funding" means (a) that certain National Cooperative
Drug Development Grant awarded to the Licensors and Pharm-Eco during the period
from 1993 to 1997, and (b) any Small Business Innovation Research grant or Small
Business Technology Transfer ("STTR") grant which was or is applied for jointly
by Licensee and any one or more of the Licensors.
1.5 "Licensed Field" means, and is limited to, the practice of the Future
Compounds (and the Current Compounds, if covered under this Agreement pursuant
to Section 26.1) for all fields of use.
1.6 "Licensed Products" means any method, procedure, product, or component
part thereof whose manufacture, use or sale includes any use of University
Technology or is covered by one or more valid and unexpired claims of the Patent
Rights.
1.7 "Licensed Territory" means the entire world.
1.8 "Net Sales" means the total Net Sales Price of Licensed Products sold
by Licensee and its Affiliates, after deducting actual allowances for returned
or defective goods, less
-2-
EXECUTION COPY
discounts. Licensed Products will be considered sold when billed out, when
delivered, or when paid for before delivery, whichever first occurs. Net Sales
shall not include sales for pre-clinical or clinical trial purposes.
1.9 "Net Sales Price" means the actual sales receipts, less any charges
for (a) sales taxes, tariffs, duties or other taxes separately stated on the
invoice, and (b) shipping and insurance charges.
1.10 "Non-Profit Entity" means (a) any entity, agency or organization that
is not an Affiliate of Licensee and that purchases any Licensed Product in bulk
for distribution or use in developing countries, or (b) any non-profit or
charitable entity, agency or organization that is not an Affiliate of Licensee.
Developing countries shall include countries which have a Per Capita GDP less
than the Per Capita GDP Threshold.
1.11 "Patent Rights" means the rights of any Licensor in (a) any U.S.
patents and/or patent applications which cover, or relate to, the Future
Compounds, and/or their use or manufacture, and which are owned, exclusively
licensed, or otherwise controlled by the Licensors, and which patents and/or
patent applications were filed prior to or are filed during the term of this
Agreement, (i) for which such Licensor has the right to grant a license
hereunder, and (ii) for which the inventions claimed therein were made in the
performance of research funded through the use of (A) Licensee-sponsored
research funding under a sponsored research agreement, (B) Governmental Funding
made available to any of the Licensors, or (C) funds expended by Licensee or
obtained through Licensee's efforts or assistance, including, without
limitation, all of the funds provided (and to be provided) by the Gates Grant
and by any other charitable or non-profit organization which funds a program in
which both Licensee and any Licensor are participants, and (b) any
continuations, continuations in part, divisionals, provisionals, continued
prosecution applications, or reissues thereof, any PCT application corresponding
to any of the foregoing, and any patents and patent applications (or their
functional equivalents) in foreign countries corresponding to any of the
foregoing, in each case subject to the statutory rights of the United States
Government in inventions which were made in the performance of research which it
funded. As of the Effective Date, the patents and patent applications included
in the Patent Rights are set forth in Exhibit A attached hereto.
1.12 "Per Capita GDP" means, for any particular country, the per capita
gross domestic product of such country, as determined by the Statistics Division
of the United Nations Secretariat and International Labour Office (or any
successor thereto), for the most recent year for which such data is then
available.
1.13 "Per Capita GDP Threshold" means, for any particular country, the
amount of $10,000; provided, however, that, for each year after 1998 for which
both the per capita gross domestic product for such country and the annual
inflation rate for such country (in each case as determined by the Statistics
Division of the United Nations Secretariat and International Labour Office (or
any successor thereto)) is then available, such threshold amount shall be
increased by the annual inflation rate for such country for each such year after
1998, such that such threshold amount is compounded on an annual basis by the
annual inflation rate for such country.
-3-
EXECUTION COPY
1.14 "Person" means any natural person or any corporation, company,
partnership, limited liability company, trust, estate, association,
unincorporated association, governmental authority, custodian, nominee, or any
other individual entity or organization in its own or any representative
capacity, or other entity.
1.15 "University Technology" means any published or unpublished research
and development information, know-how, and technical data (but excluding any
Patent Rights) which is in the possession of any of the Licensors or their
respective employees on or after the Effective Date, or which is developed by
any Licensor during the term of this Agreement, (a) for which any Licensor has
the right to grant a license hereunder, (b) which is necessary for the practice,
use or further development of the Future Compounds, and (c) which resulted,
results, was developed, or is developed through the use of (i)
Licensee-sponsored research funding under a sponsored research agreement, (ii)
Governmental Funding made available to any of the Licensors, or (iii) funds
expended by Licensee or obtained through Licensee's efforts or assistance,
including, without limitation, all of the funds provided (and to be provided) by
the Gates Grant and by any other charitable or non-profit organization which
funds a program in which both Licensee and any Licensor are participants.
1.16 "Force Majeure" means prevention or delay in the performance of a
party's obligations under this Agreement if such prevention or delay is by any
cause beyond such party's control, including, but not limited to, acts of God,
fire, explosion, disease, weather, war, insurrection, civil strife, riots,
government action, or power failure. Performance shall be excused only to the
extent of and during the reasonable continuance of such disability.
2. GRANT OF LICENSES AND TERM
2.1 The Licensors hereby grant to Licensee and to Licensee's Affiliates,
to the extent of the Licensed Territory, a non-exclusive right and license to
use University Technology in the Licensed Field and the non-exclusive right to
make, use and sell Licensed Products incorporating (or manufactured using) such
University Technology in the Licensed Field, subject to all the terms and
conditions of this Agreement (the "Technology License"). Licensee may, subject
to the prior written approval of UNC on behalf of the Licensors, which approval
shall not be unreasonably withheld or delayed, grant sublicenses of the
Technology License and its rights under this Section 2.1. Sublicensees of
Licensee may not, unless permitted by the terms of the sublicense agreement,
further sublicense the rights granted to it in such sublicense agreement without
the approval of UNC (on behalf of the Licensors), which approval may not be
unreasonably withheld or delayed.
2.2 The Licensors hereby grant to Licensee and to Licensee's Affiliates,
to the extent of the Licensed Territory, the exclusive license under and to the
Patent Rights and the exclusive right to make, use and sell Licensed Products
incorporating (or manufactured using) such Patent Rights (and not including any
University Technology) in the Licensed Field, upon the terms and conditions set
forth in this Agreement (the "Patent License", and collectively with the
Technology License, the "Licenses"). Licensee may, subject to the prior written
approval of UNC on behalf of the Licensors, which approval shall not be
unreasonably withheld or delayed, grant sublicenses of the Patent License and
its rights under this Section 2.2. Sublicensees of Licensee may not, unless
permitted by the terms of the sublicense agreement, further sublicense
-4-
EXECUTION COPY
the rights granted to it in such sublicense agreement without the approval of
UNC (on behalf of the Licensors), which approval may not be unreasonably
withheld or delayed.
2.3 Each of the Licenses granted herein is for a term beginning on the
Effective Date and, unless terminated sooner as provided in this Agreement,
ending at the expiration of the last to expire patent included in the Patent
Rights.
2.4 Licensee shall not disclose any item of unpublished University
Technology furnished by the Licensors to Licensee pursuant to Section 2.1 above
to third parties during the five (5) year period commencing on the date that
such item of unpublished University Technology is first furnished to Licensee,
provided, however, that disclosure may be made of any such item of University
Technology at any time: (a) with the prior written consent of UNC (on behalf of
the Licensors), which shall not be unreasonably withheld or delayed, or (b)
after such item shall have become public through no fault of Licensee, or (c) if
such item was known by Licensee at the time of the disclosure, as shown by
documents in existence at such time, or (d) to the Securities and Exchange
Commission, the NASD, NASDAQ, the Food and Drug Administration, and any other
U.S. or foreign governmental or regulatory agency or authority to which such
disclosure is necessary or advisable, in which case, if such disclosure is
advisable but not necessary, then Licensee shall (1) obtain the consent of UNC
on behalf of the Licensors, which consent shall not be unreasonably withheld or
delayed, and (2) to the extent practicable, request confidential treatment of
such disclosed University Technology by the receiving agency or authority, or
(e) to any sublicensees who have agreed to terms no less restrictive than those
in this Section, or (f) if required by law, a court of competent jurisdiction,
or any governmental or regulatory agency or authority.
2.5 The Licensors each represent and warrant to Licensee, as of the date
they execute and deliver this Agreement, that (a) they have the authority,
right, and power to grant to Licensee the Licenses (and the rights thereunder)
under this Agreement, (b) to the best of their knowledge, after reasonable
inquiry, there are no agreements, statutes, rules or regulations prohibiting,
restricting, or modifying such grant or limiting the Patent Rights or University
Technology covered by such Licenses, and (c) to the best of their knowledge,
after reasonable inquiry, they have not granted, sold or otherwise transferred
to any Person any licenses or other rights to any of the Patent Rights or
University Technology or Future Compounds which might reasonably be expected to
conflict with or limit the rights and Licenses granted to Licensee under this
Agreement. Notwithstanding the foregoing, any and all Licenses granted hereunder
are subject to the statutory rights of the United States Government which arise
out of its sponsorship of the research which led to the discovery or development
of Future Compounds licensed herein. Notwithstanding anything else contained in
this Agreement, each of the Licensors shall, during the term of this Agreement,
use its best efforts not to sell, grant, license, sublicense, or otherwise
transfer to any third party any rights to any Future Compounds or Patent Rights
(or to any University Technology on an exclusive basis) (or to anything that
would be a Future Compound, Patent Right or item of University Technology but
for such sale, grant, license, sublicense, or other transfer) which might
impair, limit or conflict with the rights granted to Licensee pursuant to the
Licenses (or which would have been granted to Licensee but for such sale, grant,
license, sublicense, or other transfer) and the other provisions of this
Agreement. If any Licensor becomes aware that it has entered into any
transaction described in the preceding sentence, then it shall promptly notify
Licensee of such transaction and state the other party to and the principal
-5-
EXECUTION COPY
terms of such transaction, and it shall take all reasonable efforts to negotiate
an agreement with such third party to reduce as much as practicable the
impairment, limitation or conflict with the rights granted to Licensee (or which
would have been granted to Licensee but for such transaction) under this
Agreement which such transaction has created. Licensee shall, shortly after the
execution and delivery of this Agreement, prepare a "plain English" summary of
each Licensor's obligations under this Agreement and provide each Licensor with
a copy of such summary. Each Licensor shall, within fifteen (15) days of its
receipt of such summary, distribute such summary to its scientists, professors,
appropriate students, employees, and other relevant persons, in an effort to
prevent any actions by any of such persons which might impair any of Licensee's
rights under this Agreement, as well as a copy to Licensee. The final decision
regarding the content of each summary shall be decided solely by the Licensor
receiving the summary.
2.6 Any sublicenses granted pursuant to this Article 2 shall be in
accordance with the terms and conditions of this Agreement. Licensee shall
provide UNC (on behalf of the Licensors) with a copy of all sublicense
agreements within thirty (30) days of the full execution and delivery by the
sublicensee of such sublicense agreement to Licensee. Licensee shall use
commercially reasonable efforts (which efforts may include bringing suit against
a sublicensee if economically justifiable) to enforce its rights under each
sublicense agreement. Upon the termination or expiration of this Agreement,
Licensee shall assign to the Licensors each sublicense agreement, as
contemplated by Section 5.4.
2.7 UNC shall provide to Licensee, as of June 30 and December 31 of each
year, within thirty (30) days of such dates, a revised Exhibit A to this
Agreement which shall have added to it all new Patent Rights to any Future
Compounds which were developed or obtained during each such six (6) month
period. If Licensee believes that any information on such revised Exhibit A is
incorrect, then Licensee and UNC (on behalf of the Licensors) shall cooperate in
good faith to address such belief to the reasonable satisfaction of the parties.
Each revised Exhibit A shall be accompanied by a statement of an authorized
signatory of each Licensor who has obtained any of such new Patent Rights that,
to the best of their knowledge, after reasonable inquiry, they have not granted,
sold or otherwise transferred to any Person any licenses or other rights to any
of the new Patent Rights, or to any University Technology related thereto, which
might reasonably be expected to conflict with or limit the rights and Licenses
granted to Licensee (or which would have been granted to Licensee but for such
grant, sale, or other transfer) under this Agreement.
2.8 The Licenses granted to Licensee in this Agreement shall not be
construed to confer any rights upon Licensee by implication, estoppel, or
otherwise as to any technology or intellectual property owned solely or jointly
by one or more Licensors which are not included in or part of the Patent Rights
or University Technology.
3. LICENSE FEE AND ROYALTIES
3.1 Licensee will pay to UNC on behalf of the Licensors a license fee in
the form of reimbursement of the costs (including attorney's fees) arising out
of the patenting of the Future Compounds pursuant to and in accordance with
Article 9 of this Agreement. The reimbursement of patenting costs shall be
non-refundable and shall not be a credit against any other amounts due
-6-
EXECUTION COPY
hereunder. Reimbursement of patenting costs shall be due upon monthly billings
from UNC containing invoices of such patenting costs with reasonable supporting
documentation.
3.2 (a) Beginning on the Effective Date and continuing for the term of
this Agreement, Licensee will pay the Licensors, collectively as a group, and
payable through UNC, an aggregate running royalty (the "Royalty") of five
percent (5%) of the aggregate worldwide Net Sales of any and all Licensed
Products for each fiscal year of Licensee and its Affiliates, excluding sales to
Non-Profit Entities and except as provided below in Section 3.2(b) for sales of
Licensed Products based on any Future Compounds invented by Duke University
subsequent to the date of this Agreement (the "Future Duke Licensed Products").
The Royalty for Net Sales to Non-Profit Entities shall be[ ** ], subject to the
provisions of Section 3.2(b) with respect to Future Duke Licensed Products.
Notwithstanding anything else contained in this Agreement, no Royalty shall be
due or owed under either Section 3.2(a) or Section 3.2(b) (and no amounts shall
be payable under Section 3.6 in the case of sublicense arrangements) for sales
of any Licensed Product or of any Future Duke Licensed Product if no Licensor
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. For any particular
country, if no Patent Right (covering the structure (or "composition of
matter"), the manufacture, or the use for which it is being used) for the active
ingredient of any Licensed Product or of any Future Duke Licensed Product exists
in such country, or if such Patent Right has expired in such particular country,
then no Royalty shall be payable under either Section 3.2(a) or Section 3.2(b)
(and no amounts shall be payable under Section 3.6 in the case of sublicense
arrangements) for sales in or to such country of any Licensed Product or of any
Future Duke Licensed Product incorporating, using or based on such active
ingredient.
(b) With respect to any Future Duke Licensed Products, and solely to
the extent required by applicable federal laws and regulations, Licensee and UNC
(or Duke University), understanding that certain tax ramifications exist in
regard to royalty rates, agree to negotiate in good faith all Royalty rates for
sales (such rates to be negotiated for both sales to Non-Profit Entities and for
sales to other customers) of all Future Duke Licensed Products on an annual
basis (as of the end of Licensee's fiscal year) for all of the Future Duke
Licensed Products which are to be based on Future Compounds invented by Duke
University which have become, during such twelve (12) month period, subject to
the Licenses granted to Licensee under this Agreement for Future Compounds, but,
in any event, such Royalty rates will be fairly representative of royalty rates
in the same industry for comparable technology negotiated at arms' length.
Licensee understands and acknowledges that, if such Royalty is negotiated by
UNC, then any such Royalty rate shall be subject to Duke University's approval,
which shall not be unreasonably withheld or delayed. In the event that Licensee
and UNC (or Duke University) fail to reach mutually acceptable terms within
ninety (90) days after commencement of negotiations with respect to the Royalty
rates to be paid to UNC on behalf of Duke University for any such Future Duke
Licensed Product (the "Negotiation Period"), then, unless Duke University
submits the matter to arbitration in accordance with Section 28.1 of this
Agreement, the Royalty for such Future Duke Licensed Products shall be the same
as the Royalty on Licensed Products which are not Future Duke Licensed Products.
- ----------
** Confidential Treatment Requested.
-7-
EXECUTION COPY
(c) If a third party markets or sells any product in a market in
which Licensee or any of Licensee's Affiliates markets or sells a Licensed
Product, and (i) such third party product is generically equivalent to such
Licensed Product, or (ii) such third party product has a chemical structure that
is covered by any Patent Right that Licensee has under this Agreement on any of
the Future Compounds incorporated or used in such Licensed Product, or on which
such Licensed Product is based, then the Royalty for such Licensed Product shall
be reduced by [ ** ] in such market for as long as such third party markets or
sells such third party product in such market; provided, however, that in any
event under clause (ii) above, Licensee shall take or have taken action under
Section 9.4 hereof for the purpose of stopping the marketing or sale of such
third party product.
(d) Notwithstanding anything else to the contrary contained in this
Agreement, no Royalties shall be payable on sales of any Licensed Product for [
** ] purposes. In addition, no Royalties shall be payable on any transfer of
Licensed Products between any of Licensee, its sublicensees, and any sublicensee
or Affiliate of any of them. Only one Royalty shall be paid for the sale of any
Licensed Product.
(e) Licensee shall use, and shall instruct its Affiliates to use,
commercially reasonable efforts to collect the payments that Licensee or its
Affiliates are owed for sales of Licensed Products.
3.3 (a) Licensee shall make semi-annual written reports to UNC during the
life of this Agreement (the "Summary Reports"), with each Summary Report
covering one-half of Licensee's fiscal year and stating the number, description,
and aggregate Net Sales of Licensed Products sold or otherwise disposed of
during the reporting period and upon which any Royalty is payable as provided in
Section 3.2 hereof, and the amount of any such Royalty which is due. The first
Summary Report shall include all such Licensed Products, if any, so sold or
otherwise disposed of prior to the date of such report. The Summary Report for
the first half of Licensee's fiscal year shall be due [ ** ] after the end of
the first half, and shall contain an estimate of the information required to be
set forth therein. The Summary Report for the second half of Licensee's fiscal
year shall be due [ ** ] after the end of Licensee's fiscal year, and shall
contain actual amounts for both the first half and the second half of such
fiscal year. Each Summary Report may include any adjustments that may be
necessary for any prior reporting period, including, for example, adjustments
for returns or defective goods.
(b) Until Licensee has achieved a first commercial sale of a
Licensed Product, a report shall be submitted by Licensee to UNC by the due
dates set forth in Section 3.3(a) above (a "Status Report") which will include a
full written report describing Licensee's technical and other efforts made
towards such first commercial sale for all Licensed Products then under
development.
3.4 Concurrently with the making of each Summary Report provided for in
Section 3.3(a), Licensee shall pay to UNC the Royalties specified in Section 3.2
of this Agreement which are due on the Licensed Products included in such
report.
- ----------
** Confidential Treatment Requested.
-8-
EXECUTION COPY
3.5 In the event of default in payment of any payment owing to the
Licensors under the terms of this Agreement, and if it becomes necessary for the
Licensors to undertake legal action to collect said payment, then Licensee shall
reimburse the Licensors for all reasonable legal fees and costs actually
incurred by the Licensors in connection therewith; provided, however, that if
any matter involving any payment due or alleged to be due is submitted to
arbitration in accordance with Section 28.1, then such legal fees and costs
shall be allocated as the arbitration tribunal shall determine.
3.6 (a) If Licensee sublicenses its rights with respect to the Future
Compounds or the Licensed Products pursuant to Sections 2.1 and 2.2, then
Licensee will pay to UNC, for the benefit of the Licensors, in lieu of any
Royalty due under Section 3.2, (i) [ ** ] of all signing, milestone, and other
non-royalty payments received by Licensee from each such sublicensee pursuant to
its sublicense arrangement; provided, however, that if any of such payments are
made for the reimbursement or funding of documented costs (excluding indirect
costs and expenses) incurred by Licensee for research and clinical development
of Future Compounds, then Licensee will pay to UNC, for the benefit of the
Licensors, [ ** ] of all such signing, milestone, and other non-royalty payments
received by Licensee from each such sublicensee pursuant to its sublicense
arrangement, and (ii) [ ** ] of all royalty payments received by Licensee from
each such sublicensee pursuant to its respective sublicense arrangement.
(b) With respect to Future Compounds invented by Duke University
subsequent to the Effective Date or Future Duke Licensed Products, and solely to
the extent required by applicable federal laws and regulations, Licensee and UNC
(on behalf of Duke University) will negotiate in good faith for the appropriate
percentages of signing, milestone, other non-royalty payments, and royalty
payments received by Licensee from each sublicensee of any Future Compounds
invented by Duke University subsequent to the Effective Date or any Future Duke
Licensed Products, consistent with the negotiation process described in Section
3.2 above and, if such negotiation process shall be unsuccessful during the time
period set forth therein, then, unless Duke University submits the matter to
arbitration in accordance with Section 28.1 of this Agreement, the percentages
shall be the same as set forth in Section 3.6(a) above.
3.7 (a) To the extent that Licensee uses any other proprietary technology
other than that licensed to Licensee by this Agreement (except as provided below
in Section 3.7(b) for Future Duke Licensed Products) to manufacture or sell a
Licensed Product, the amount of the Royalty will be reduced to the extent
necessary so that the sum of the total Royalties paid by Licensee to UNC on
behalf of the Licensors plus the total royalties paid by Licensee to any third
parties with respect to such Licensed Product will not, in the aggregate, exceed
[ ** ] of the worldwide Net Sales of such Licensed Product, excluding sales to
Non-Profit Entities; provided, however, that in no event will the amount of the
Royalty owed to the Licensors be less than [ ** ] of the worldwide Net Sales of
such Licensed Product, excluding sales to Non-Profit Entities.
(b) With respect to Future Duke Licensed Products, and solely to the
extent required by applicable federal laws and regulations, Licensee and UNC
will negotiate in good faith for an appropriate reduction in the Royalty due UNC
under Licensee's Licenses for each
- ----------
** Confidential Treatment Requested.
-9-
EXECUTION COPY
such Future Duke Licensed Product consistent with the negotiation process
described in Section 3.2 above and, if such negotiation process shall be
unsuccessful during the time period set forth therein, then, unless Duke
University submits the matter to arbitration in accordance with Section 28.1 of
this Agreement, the reduction in the Royalty for such Future Duke Licensed
Products shall be the same as the reduction in the Royalty on Licensed Products
which are not Future Duke Licensed Products.
3.8 UNC shall be responsible for distributing to the other Licensors any
share to which they are entitled of payments made by Licensee to UNC under this
Agreement.
3.9 If in any fiscal year of Licensee during the term of this Agreement
after Licensee has received approval from the appropriate regulatory authority
of a New Drug Application (or its equivalent elsewhere in the Licensed
Territory), the total amounts paid or payable to UNC (for the benefit of the
Licensors) under Sections 3.2 and 3.7 combined are less than [ ** ], then
Licensee shall pay to UNC (for the benefit of the Licensors) such amount that,
when combined with the amounts paid or payable by Licensee under Sections 3.2
and 3.7, shall total [ ** ].
3.10 To the extent that any of the Licensors shall have received payments
during the first or second half of Licensee's fiscal year from Licensee pursuant
to a sponsored research agreement between Licensee and any such Licensor that
relates to any Licensed Product, the amount of Royalty payable to the Licensors
under this Article 3 shall be reduced by [ ** ] by all of the Licensors combined
pursuant to such sponsored research agreement during the relevant six (6) month
period, such reduction not to exceed [ ** ] of the Royalty otherwise payable in
that period. Any remaining funds received by the Licensors pursuant to such
sponsored research agreement which have not yet been credited against the
Royalty payable in such period shall be carried forward and applied to the
Royalty payable to the Licensors in each subsequent six (6) month period,
thereby reducing the Royalty actually payable by up to [ ** ] of the Royalty
otherwise payable for each such period, until the entire amount received by the
Licensors pursuant to the sponsored research agreement has been credited against
the Royalties payable under Sections 3.2 and 3.7.
4. COMMERCIALIZATION EFFORTS
4.1 Licensee shall use its commercially reasonable efforts to proceed
diligently with the manufacture and sale of Licensed Products and shall
earnestly and diligently work to obtain regulatory approval to sell Licensed
Products and to offer and continue to offer for sale such Licensed Products
after obtaining such approvals, both under reasonable conditions, during the
term of this Agreement.
4.2 (a) Licensee shall use commercially reasonable efforts to meet a
schedule of performance milestones for each lead Future Compound. The completion
dates of each milestone with respect to any particular lead Future Compound
shall count from the date on which such lead Future Compound is selected for
clinical development by mutual agreement of Licensee and the Licensors, such
agreement not to be unreasonably delayed or withheld by any party. The schedule
of milestones for each lead Future Compound is as follows:
- ----------
** Confidential Treatment Requested.
-10-
EXECUTION COPY
Milestone# Deadline
---------- --------
(Years After Selection of
Lead Compound)
Completion of pre-clinical trials. [ ** ]
Filing of IND. [ ** ]
Completion of Phase I clinical trials. [ ** ]
Completion of Phase II clinical trials. [ ** ]
Completion of Phase III clinical trials. [ ** ]
Filing of New Drug Application. [ ** ]
# or their equivalents elsewhere in the Licensed Territory
(b) The date of selection of the lead compound known as "DB-075"
shall be the Effective Date. With respect to the lead compound known as "DB-289"
the following milestones shall apply in lieu of the milestones set forth in
Section 4.2(a):
Milestone# Deadline
---------- --------
Completion of Phase II clinical trials. [ ** ]
Completion of Phase III clinical trials. [ ** ]
Filing of New Drug Application. [ ** ]
# or their equivalents elsewhere in the Licensed Territory
(c) Failure to achieve any of the milestones for any lead compound
shall result in [ ** ] to such lead compound, such selection to be in the sole
discretion of the Licensors, but not before the (i) expiration of reasonable
grace periods to be agreed upon by Licensee and the Licensors, such agreement
not to be unreasonably delayed or withheld by any party hereto, and (ii)
exhaustion of good faith efforts on the part of the parties hereto to agree on
the appropriate adjustment of such milestones, taking into account the
conditions and results experienced by Licensee in the performance of its duties
hereunder, such agreement not to be unreasonably delayed or withheld by any
party hereto.
(d) The milestones set forth in this Section 4.2 represent
Licensee's realistic estimate of the schedule it will be able to keep in the
event that there are no unexpected technical or clinical obstacles. Adverse
results at any stage could significantly extend the periods required to meet any
or all of the milestones listed.
4.3 If this Agreement becomes effective or terminates or expires during a
calendar year, then the Minimum Royalty payable to UNC under Section 3.9 for the
portion of such year during which this Agreement is in effect shall be
determined by multiplying the Minimum
- ----------
** Confidential Treatment Requested.
-11-
EXECUTION COPY
Royalty set forth in Section 3.9 for the year in which this Agreement becomes
effective, terminates or expires, by a fraction, the numerator of which shall be
the number of days during such calendar year for which this Agreement is in
effect and the denominator of which shall be 365.
5. CANCELLATION
5.1 It is expressly agreed that, notwithstanding the provisions of any
other Section of this Agreement, if Licensee should fail to deliver to UNC any
Royalty at the time or times that the same should be due to UNC on behalf of the
Licensors where there is not a dispute between Licensee and UNC or any other
Licensor with respect to the amount of the Royalty which is due, or if Licensee
should in any material respect violate or fail to keep or perform any material
covenant, condition, or undertaking of this Agreement on its part to be kept or
performed hereunder, and there is not then occurring any material breach of this
Agreement by any Licensor, then in such event UNC shall have the right, on
behalf of the Licensors, to cancel and terminate this Agreement, and the
Licenses granted by this Agreement, upon thirty (30) days prior written notice
to Licensee if Licensee has failed to cure (unless such failure is due to Force
Majeure) such breach within forty-five (45) days of its receipt of written
notice from UNC describing such breach, or within such longer period of time as
may be reasonably necessary to cure such breach if, due to Force Majeure or
regulatory changes, such breach is not reasonably likely to be cured within such
forty-five (45) day period. If Licensee shall commit a material breach of this
Agreement as described in the first sentence of this Section 5.1 more than four
(4) times in any four (4) consecutive calendar years, then UNC shall have the
right, on behalf of the Licensors, to cancel and terminate this Agreement, and
the Licenses granted by this Agreement, upon sixty (60) days prior written
notice to Licensee, without having to permit Licensee the opportunity to cure.
If UNC does not exercise its right of termination within six (6) months of the
later of (a) the date of discovery by any Licensor of the breach which triggered
the loss of Licensee's right to cure under the preceding sentence, or (b) the
date on which the cure for the most recent prior breach was completed, then
Licensee's right to cure shall be automatically reinstated.
5.2 Alternatively, should Licensee be in breach or default as set forth in
Section 5.1 above, and should UNC be in a position where it could rightfully
terminate this Agreement in accordance with Section 5.1, then in its sole
discretion after seeking the advice of the other Licensors, which advice shall
be given due consideration by UNC, UNC may convert the exclusive Licenses to
non-exclusive Licenses upon giving fifteen (15) days notice of such decision to
Licensee.
5.3 If Licensee should be adjudged bankrupt or enter into a composition
with or assignment for the benefit of its creditors, then in such event the
Licensors shall, subject to bankruptcy law and the rulings of the bankruptcy
court, have the right to cancel and terminate this Agreement, and the Licenses
herein provided for, upon thirty (30) days prior written notice to Licensee.
5.4 Any sublicense agreements entered into by Licensee under this
Agreement which are in effect at the time of any termination (for any reason) or
expiration of this Agreement shall
-12-
EXECUTION COPY
continue in full force and effect and shall be assigned by Licensee to the
Licensors, effective as of the date of termination or expiration, as the case
may be, of this Agreement.
5.5 Any termination or cancellation under any provision of this Agreement
shall not relieve Licensee of its obligation to pay (a) any Royalty or other
fees (including attorney's fees pursuant to Section 3.1 hereof) due or owing at
the time of such cancellation or termination, or (b) any payment due to the
Licensors under Section 6.1 hereof.
5.6 Unless terminated sooner under the provisions of this Agreement, this
Agreement will continue in full force and effect until the last patent included
in the Patent Rights has expired or been finally held (by a court of competent
jurisdiction) to be invalid or unenforceable.
5.7 Licensee may, at any time, terminate this Agreement upon twelve (12)
months written notice to UNC.
5.8 Within thirty (30) days of the termination of this Agreement under
Sections 5.1 or 5.3, Licensee shall provide to the Licensors copies of all
market clearance applications associated with regulatory approval of Licensed
Products (including all data thereto) and all data related to as yet unfiled
market clearance applications associated with regulatory approval of Licensed
Products. The Licensors shall promptly reimburse Licensee for its reasonable
costs and expenses in complying with this Section 5.8. Licensee shall grant to
the Licensors a non-exclusive worldwide royalty-free right and license to use
all such applications and data for all purposes.
5.9 Upon the written request of UNC following any termination of this
Agreement under Sections 5.1 or 5.3, Licensee shall return to UNC, on behalf of
the Licensors, or destroy as directed by UNC, on behalf of the Licensors, all
information, data, and any relevant materials provided to Licensee during the
term of this Agreement which are covered by any of the Patent Rights. Licensee
shall provide UNC with a written statement signed by an authorized
representative of Licensee stating that the same has been so delivered or
destroyed, whichever is appropriate. Notwithstanding the foregoing, Licensee
shall be allowed to (a) retain one copy of such information, data and materials
provided to Licensee for purposes of documenting its obligations under this
Agreement, and (b) retain up to three (3) additional copies of such information,
data and materials in order to enable Licensee to continue with its business
operations with respect to products which are no longer covered by any Patent
Rights of the Licensors.
5.10 Notwithstanding any other provision of this Agreement, if Licensee
does not satisfy its obligations to continue to make payments to UNC (for the
benefit of the Licensors) after the Effective Date as set forth under Section
3(d) (last sentence only, as amended) of the 1997 Agreement, then UNC may (on
behalf of the Licensors) deliver to Licensee a notice stating Licensee's failure
to satisfy such obligations. Licensee shall have thirty (30) days from its
receipt of such notice to cure such failure. If Licensee shall fail to cure such
failure within such thirty (30) day period, then UNC may (on behalf of the
Licensors) deliver a notice to Licensee stating the Licensors' election to
rescind this Agreement and the 1997 Agreement effective as of a date specified
in such notice, such date to be no earlier than ten (10) days after the date of
delivery of such election notice.
-13-
EXECUTION COPY
6. DISPOSITION OF LICENSED PRODUCTS ON HAND UPON CANCELLATION OR TERMINATION
6.1 Upon cancellation or termination of this Agreement other than as
provided in Section 5.4, Licensee shall provide UNC with a written inventory of
all Licensed Products in process of manufacture, in use or in stock. Licensee
shall have the privilege of disposing of the inventory of such Licensed Products
within a period of one hundred and eighty (180) days of such termination upon
conditions most favorable to UNC that Licensee can reasonably obtain; provided,
however, that Licensee pay to UNC (for the benefit of the Licensors) a Royalty
or any other payment due thereon as calculated in accordance with Article 3.
Licensee will also have the right to complete performance of all contracts
requiring use of either University Technology, Patent Rights (except in the case
of termination pursuant to Section 5.1), Future Compounds, the Licenses, or
Licensed Products within and beyond said 180-day period; provided, however, that
Licensee pay to UNC (for the benefit of the Licensors) a Royalty or any other
payment due thereon as calculated in accordance with Article 3. If the remaining
term of any such contract exceeds one (1) year, then (a) such contract shall
continue in full force and effect, (b) the Licenses granted hereunder shall
remain in effect solely for the purpose of enabling Licensee to fulfill its
obligations under such contract, (c) Licensee shall no longer be permitted to
enter into any additional contracts requiring the use of any University
Technology, Patent Rights, Future Compounds, Licenses, or Licensed Products, and
(d) Licensee shall, after such one (1) year period, forward to UNC one hundred
percent (100%) of any receipts (other than reimbursement of Licensees expenses
or any indemnification payments) that Licensee thereafter receives under such
contract for the period after such one (1) year period. All Licensed Products
which are not disposed of as provided above shall be delivered to UNC or
otherwise disposed of, in UNC's sole discretion, and at Licensee's sole expense.
7. USE OF THE NAMES OF THE LICENSORS
7.1 The use of the name of the Licensors, or any contraction thereof, in
any manner in connection with the exercise of the Licenses is expressly
prohibited except with prior written consent of UNC (on behalf of the Licensor
whose name is requested to be used); provided, however, that no such consent
shall be required for Licensee to identify the Licensors and describe its
relationship and transactions with the Licensors in connection with (a)
communications and filings with the Securities and Exchange Commission, the
NASD, NASDAQ, the Food and Drug Administration, or other governmental or
regulatory agencies or authorities, as reasonably advisable in connection with
or required by such agencies or authorities, (b) the inclusion of the
Descriptive Statement attached hereto as Exhibit B in any communications or
other documentation relating to any financing or fund-raising by Licensee, and
(c) the preparation of Licensee's financial statements. In preparing any such
description, Licensee shall not make any claims or statements that any Licensor
has endorsed any product or product candidate of Licensee, without the prior
written consent of UNC (on behalf of such Licensor).
7.2 Duke University may, without express prior written consent of the
other parties to this Agreement, issue an announcement of the execution of this
Agreement, containing only the names of the inventors of the Patent Rights and
the name of Licensee and the names of the other Licensors, in the Duke Dialogue
and in other internal reports and publications.
-14-
EXECUTION COPY
7.3 Neither Licensee, any Affiliate or sublicensee of Licensee, nor any
Licensor (each of all of the foregoing, a "Relevant Party") shall, individually
or collectively, without the express, prior written consent of the appertaining
Relevant Party, (a) use, unless otherwise permitted in this Agreement, in either
advertising, publicity, press release, promotional activity, or other similar
activity, the name or image of (i) such appertaining Relevant Party or any of
its employees, officers, directors, students, or agents, or (ii) any
trade-names, trademarks, trade devices, service marks, symbols or any
abbreviation, contraction or simulation thereof, which is owned by such
appertaining Relevant Party, or (b) make any representations, either directly or
indirectly, about any product or service of any one or more Relevant Parties.
7.4 If any Relevant Party desires to make any use or representation which
is restricted pursuant to Section 7.3 above, then such Relevant Party shall
request the written consent of the appertaining Relevant Party and submit to
such appertaining Relevant Party a copy of the proposed use or representation.
The appertaining Relevant Party shall use its commercially reasonable efforts to
respond to the requesting Relevant Party within ten (10) days of its receipt of
the copy of such proposed use or representation from the requesting Relevant
Party.
8. LICENSORS' USE
8.1 It is expressly agreed that, notwithstanding any provisions herein,
each Licensor is free to use its University Technology, Patent Rights and
Licensed Products for its own research, public service, clinical, teaching and
educational purposes without payment of royalties; provided, however, that no
Licensor shall sell or distribute any Patent Rights or Licensed Products (or any
University Technology on an exclusive basis) for commercial use or benefit, nor
shall any Licensor donate any Licensed Products for use in any market in which
Licensee is selling such Licensed Product or any competing Licensed Product.
Furthermore, the Licensors shall be free to publish and publicly disclose at
scientific meetings University Technology, as they see fit; provided, however,
that if any such University Technology is not protected by any Patent Rights,
then any Licensor desiring to publish or disclose such University Technology
shall (a) notify Licensee in writing of its intent to so publish or disclose,
providing with such notice a copy of the proposed publication or disclosure for
Licensee's review, and (b) provide Licensee with a reasonable time period (for
which the Licensors shall use commercially reasonable efforts to provide ninety
(90) days, but which shall not be less than forty-five (45) days in any case) to
arrange for the filing, prior to any such publication or disclosure by such
Licensor, of a patent application covering such University Technology as
provided in Article 9.
9. PATENTS AND INFRINGEMENTS
9.1 Each of the Licensors and Licensee shall each cooperate in good faith
with each other to obtain, maintain and defend any and all of the Patent Rights.
Licensee shall continue to bear the cost of filing, prosecuting, maintaining and
defending all U.S. and foreign patent applications and patents included within
the Patent Rights. Licensee shall reimburse all amounts due pursuant to this
Section 9.1 within thirty (30) days of its receipt of an invoice therefor from
UNC. Such filings and prosecutions shall be (a) in the name or names of the
Licensors employing the inventors of a particular invention, as defined under
patent law, and (b) by experienced patent counsel chosen by UNC. UNC shall keep
Licensee advised on a timely basis
-15-
EXECUTION COPY
as to the prosecution of such applications and shall, shortly after the
execution and delivery of this Agreement, instruct its patent counsel in writing
to deliver to Licensee, on a timely basis, copies of all correspondence and
other documents (including, but not limited to, Applications, Office Actions,
responses, etc.) which are received by or sent by such patent counsel and which
relate to any Patent Right (including, without limitation, all patents and
patent applications included, or to be included, within the Patent Rights).
Licensee shall have the right to advise UNC as to such prosecution, and further,
shall have the right to make reasonable requests as to the conduct of such
prosecution. All final decisions pertaining to the prosecution of all patents
and patent applications included in the Patent Rights shall be at the sole
discretion of UNC, on behalf of the Licensors. Licensee shall notify UNC at
least ninety (90) days prior to any statutory deadlines for responding to office
actions, filing additional applications, and similar matters, or within
forty-five (45) days after receiving notice from UNC of any deadline if the
statutory deadline is ninety (90) days or less after receipt of such notice from
UNC, as to what steps it would like UNC to take. UNC shall, shortly after the
execution and delivery of this Agreement, instruct its patent counsel in writing
that in the event of any dispute between Licensee and either UNC or any other of
the Licensors with respect to any patent, patent application or other Patent
Right, such counsel shall deliver to Licensee, on a timely basis, upon written
request from Licensee, and at Licensee's expense, a copy of any documents
requested by Licensee which are relevant to the patent matter which is the
subject of such dispute, excluding, however, any documents protected by the
attorney-client privilege.
9.2 As regards foreign patent applications corresponding to the U.S.
patent applications described in Section 9.1 above, Licensee shall designate at
least ninety (90) days prior to any statutory deadline that country or those
countries, if any, in which Licensee desires such corresponding patent
application(s) to be filed. Licensee shall pay all costs and legal fees
associated with the preparation, filing, prosecution and maintenance of such
designated foreign patent applications and such applications shall be in the
name or names of the Licensors employing the inventors of a particular
invention, as defined under patent law. The Licensors may elect to file
corresponding patent applications in countries other than those designated by
Licensee. If the Licensors elect to do so and Licensee does not agree, within
thirty (30) days of receiving notice from UNC of such election by the Licensors,
to pay all costs and legal fees associated with the filing of such corresponding
patent applications in the non-designated countries, then the individual
Licensors exercising such right shall be responsible for all costs and legal
fees associated with the filing of such corresponding patent applications in
such non-designated countries. In such event, Licensee shall forfeit its rights
under the Licenses to the Patent Rights associated with such corresponding
patent applications in the non-designated country(ies) where the Licensors
exercise their option to file such corresponding patent applications.
9.3 If the production, sale or use of Licensed Products under this
Agreement by Licensee results in any claim for patent infringement against
Licensee, then Licensee shall promptly notify UNC thereof in writing, setting
forth the facts of such claim in reasonable detail. As between the parties to
this Agreement, Licensee shall have the first and primary right and
responsibility at its own expense to defend and control the defense of any such
claim against Licensee, by counsel of its own choice. It is understood that any
settlement of any such claim or action must be approved by each Licensor which
owns any patent or patents involved in the dispute if the validity or
enforceability of such patent or patents will be affected by the settlement
-16-
EXECUTION COPY
or if such settlement includes a grant of any rights to either any Patent Rights
with respect to such patent or patents or to any University Technology owned by
such Licensor. Such approval shall not be unreasonably withheld or delayed. The
grant of any rights to any Patent Rights or to any University Technology without
providing for commercially reasonable payments from the grantee, including
royalties on sales of product(s) based in whole or in part, manufactured or used
in accordance with any Patent Rights or University Technology, will constitute
sufficient grounds for the Licensors to withhold their approval of such
settlement. The Licensors who own the patent or patents involved shall also have
the right to review and provide input on any other settlement, which input shall
be considered in good faith by Licensee. If any settlement or other resolution
of such claim or action results in a cross-licensing arrangement between
Licensee and the complaining party, then any payments received by Licensee under
such arrangement shall be treated as if they were a non-royalty payment received
by Licensee under a sublicense agreement, and they shall be subject to the
provisions of Section 3.6. The Licensors agree to cooperate with Licensee in any
reasonable manner (including, without limitation, providing evidence and
witnesses (including the inventors) within their control) which may reasonably
be expected to be necessary or advisable in defending against any such action or
negotiating any settlement of such action. Licensee shall reimburse the
Licensors for any reasonable and actual out-of-pocket expenses incurred in
providing such assistance; provided, however, that reimbursement of any expense
of $2,500 or more shall require the submission to Licensee of third-party
invoices for such expenses.
9.4 In the event that any Patent Rights licensed to Licensee are infringed
by a third party, Licensee shall have the primary right, but not the obligation,
to institute, prosecute and control any action or proceeding with respect to
such infringement, by counsel of its choice, including any declaratory judgment
action arising from such infringement, and Licensee shall bear all expenses for
such action or proceeding and shall be entitled to the entire amount of any
settlement or judgement paid by the third party; provided, however, that if any
part of any settlement or judgement is stated to be compensation to Licensee for
lost sales of a Licensed Product, then Licensee shall pay to UNC on behalf of
the Licensors the appropriate Royalty on such part of the settlement or
judgement. The Licensors agree to cooperate with Licensee in any reasonable
manner which may reasonably be expected to be necessary or advisable in
connection with any such action or proceeding, including, without limitation,
allowing Licensee to institute and maintain the action or proceeding in the name
of the Licensor(s) who owns the patent(s) which are infringed, providing
evidence and witnesses (including the inventors) within its control, performing
such other acts as Licensee may reasonably request, and executing, verifying,
and delivering such documents as are needed or as Licensee may reasonably
request. Licensee shall reimburse the Licensors for any and all commercially
reasonable out-of-pocket expenses incurred in providing such assistance upon
submission to Licensee of third-party invoices for such expenses.
9.5 Notwithstanding the foregoing, and in the Licensors' sole discretion,
the Licensors who own the Patent Rights that are the subject of a legal action
involving the Future Compounds shall be entitled to participate in such action
through counsel of their own choosing. Nothing in the foregoing sections shall
be construed in any way which would limit the authority of the Attorney General
of North Carolina.
-17-
EXECUTION COPY
9.6 All Licensed Products (and/or their containers, labels, and/or other
packaging) sold in the United States shall be marked with all applicable United
States patent numbers. All Licensed Products (and/or their containers, labels,
and/or other packaging) shipped to or sold in other countries shall be marked in
such a manner as to conform with the patent laws and practice of the country of
manufacture or sale.
10. WAIVER
10.1 It is agreed that no waiver by any party hereto of any breach or
default of any of the covenants or agreements herein set forth shall be deemed a
waiver as to any subsequent and/or similar breach or default. Any and all
waivers must be expressly stated in writing signed by the party granting any
such waiver.
11. LICENSE RESTRICTIONS
11.1 It is agreed that the rights and privileges granted to Licensee are
each and all expressly conditioned upon the faithful performance on the part of
the Licensee of every requirement herein contained, and that each of such
conditions and requirements may be and the same are specific License
restrictions.
12. ASSIGNMENTS
12.1 This Agreement is binding upon and shall inure to the benefit of the
Licensors, their successors and assigns. However, this Agreement shall be
personal to Licensee and it is not assignable by Licensee to any other entity
without the express prior written consent of UNC, which consent shall not be
withheld or delayed unreasonably; provided, however, that Licensee may, without
such consent, assign this Agreement to (a) any of its Affiliates, and (b) any
Person acquiring all or substantially all of Licensee's assets.
13. INDEMNITY
13.1 Licensee agrees to indemnify, hold harmless and defend the Licensors,
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 the
exercise of the Licenses by Licensee, 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 Licensor, any inventor, or any trustee, officer,
employee, student or agent of any Licensor or any inventor.
14. INSURANCE
14.1 Licensee shall maintain in force at its sole cost and expense, with
reputable insurance companies, general liability insurance and products
liability insurance coverage in an amount reasonably sufficient to protect
against liability under Section 13.1, above. UNC shall have the right to request
copies of customary policy documents which evidence such coverage, in order to
ascertain from time to time that such coverage exists, such right to be
exercised in a reasonable manner.
-18-
EXECUTION COPY
15. INDEPENDENT CONTRACTOR STATUS
15.1 No party hereto is an agent of the other for any purpose except as
expressly set forth in (a) this Agreement, (b) the Patent Plan executed by the
Licensors on July 26, 1994, and (c) the Inter-Institutional Agreement dated
January 15, 1997, among the Licensors.
16. LATE PAYMENTS
16.1 In the event Royalty payments or fees are not received by UNC when
due, and there is not a dispute between Licensee and UNC or any other Licensor
with respect to the amount of the Royalty which is due, then Licensee shall pay
to UNC interest at an annual rate (the "Late Rate") equal to the prime rate (as
quoted in the Wall Street Journal) plus two percent (2%) on the amount of
Royalties or fees which are past due. The payment of such interest shall not
foreclose the Licensors from exercising any other rights they may have under
this Agreement as a consequence of the lateness of any payment.
17. WARRANTIES
17.1 The Licensors make no warranties that any patent will be issued on
University Technology or Future Compounds. To the best knowledge of each of the
Licensors, the patents comprising the Patent Rights held by such Licensor are
valid and enforceable. The Licensors further make no warranties, express or
implied, as to any matter whatsoever, including, without limitation, the
condition of any invention(s) or product(s), that are the subject of this
Agreement; or the merchantability or fitness for a particular purpose of any
such invention or product. The Licensors shall not be liable for any direct,
consequential, or other damages suffered by Licensee resulting from the use of
the Future Compounds or Licensed Products, except (a) to the extent that any
such damage is attributable to any patent infringement, negligence or
intentional misconduct of any Licensor, any inventor, or any officer, employee,
student or agent of any Licensor or any inventor, and (b) to the extent that
such Licensor may be held liable for such infringing, negligent or intentional
act.
17.2 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER
THE LICENSORS, NOR THEIR RESPECTIVE TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES,
STUDENTS AND/OR AFFILIATES MAKE ANY REPRESENTATIONS OR EXTEND ANY WARRANTIES OF
ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF PATENT RIGHTS
CLAIMS, ISSUED OR PENDING, AND THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER
OR NOT DISCOVERABLE. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A
REPRESENTATION MADE OR WARRANTY GIVEN BY THE LICENSORS THAT THE PRACTICE BY
LICENSEE, ITS AFFILIATES, AND/OR SUBLICENSEES OF THE LICENSES GRANTED HEREUNDER
SHALL NOT INFRINGE THE PATENT RIGHTS OF ANY THIRD PARTY. IN NO EVENT SHALL THE
LICENSORS, OR THEIR RESPECTIVE TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES,
STUDENTS AND/OR AFFILIATES BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF
ANY KIND, INCLUDING ECONOMIC DAMAGE OR INJURY TO PROPERTY AND LOST PROFITS,
REGARDLESS
-19-
EXECUTION COPY
OF WHETHER THE LICENSORS SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR
IN FACT SHALL KNOW OF THE POSSIBILITY OF SUCH DAMAGES.
18. ACCOUNTING AND RECORDS
18.1 Licensee will keep complete, true and accurate books of account and
records for the purpose of showing the derivation of all amounts payable to the
Licensors through UNC under this Agreement. Such books and records will be kept
at Licensee's principal place of business for at least three (3) years following
the end of the calendar quarter to which they pertain, and will be open at all
reasonable times during normal business hours for inspection by a representative
of UNC for the purpose of verifying Licensee's Royalty statements, or Licensee's
compliance in other respects with this Agreement. The representative will be
obliged to treat as confidential all relevant matters and shall, if requested by
Licensee, execute an appropriate confidentiality and non-disclosure agreement.
18.2 Such inspections shall be at the expense of the Licensors, unless a
variation or error resulting in an underpayment of Royalties of at least the
greater of (a) U.S. $10,000, or the equivalent in foreign currency, or (b) one
point five percent (1.5%) of the total amount of Royalties due for the period
during which the variation or error was in effect, is discovered in the course
of any such inspection, whereupon all costs relating thereto shall be paid by
Licensee.
18.3 Licensee will promptly pay to UNC the full amount of any Royalty
underpayment, together with interest thereon at the Late Rate; provided,
however, that such Royalty underpayment is not subject to a dispute between
Licensee and UNC or any other Licensor with respect to the amount of the Royalty
which is due.
19. COMPLIANCE WITH LAWS
19.1 In exercising its rights under the Licenses, Licensee shall fully
comply with the requirements of any and all applicable laws, regulations, rules
and orders of any governmental body having jurisdiction over the exercise of
rights under the Licenses. Licensee further agrees to indemnify and hold the
Licensors and their respective trustees, officers, employees and agents harmless
from and against any costs, expenses, attorney's fees, citations, fines,
penalties and liabilities of every kind and nature which are imposed by reason
of any established violation of any such laws, order, rules and/or regulations,
except to the extent that any of such violation or any of such costs, expenses,
attorney's fees, citations, fines, penalties or liabilities is attributable to
the negligence or intentional misconduct of any Licensor, any inventor, or any
trustee, officer, employee, student or agent of any Licensor or inventor.
20. U.S. MANUFACTURE
20.1 The parties hereto agree that any Licensed Products sold in the
United States shall be substantially manufactured in the United States.
-20-
EXECUTION COPY
21. NOTICES
21.1 Any payment or notice required or permitted to be given to the
parties hereto shall be deemed to have been properly given if (a) delivered in
person, (b) delivered by a reputable overnight delivery service which records
the name of the individual accepting delivery (such as, for example, FedEx, DHL,
Airborne Express, UPS, or USPS Express or Priority Mail), (c) mailed by
first-class certified or registered mail, return receipt requested, or (d)
delivered by successful telecopier transmission, with a hard copy of such
transmission delivered in the manner specified in the preceding clauses (a), (b)
or (c), in each case to the other party or parties at the appropriate address or
telecopier number as set forth below or to such other addresses or telecopier
numbers as may be designated by notice to each of the other parties hereto from
time to time during the term of this Agreement. Notices shall be deemed received
on the date on which they are actually delivered to the recipient (in the case
of telecopier transmission, the date of delivery shall be the date of
transmission, if transmitted prior to 5:30 P.M. in the time zone of the
recipient, else the next business day after transmission).
If to any of the Licensors, to:
The University of North Carolina at Chapel Hill
Office of Technology Development
CB #4105, 308 Bynum Hall
Chapel Hill, North Carolina 27599-4105
Telephone No.: (919) 966-3929
Telecopier No.: (919) 962-0646
Attn.: Mr. W. Mark Crowell
Associate Vice Chancellor and Director
with copies to:
Auburn University
Office of Technology Transfer
309 Samford Hall
Auburn, Alabama 36849-5176
Telephone No.: (334) 844-4977
Telecopier No.: (334) 844-5963
Attn.: Ms. Jan Thornton
Director
-21-
EXECUTION COPY
and to:
Duke University
Office of Science and Technology
454 Davison Building
Box 3664 DUMC
Durham, North Carolina 27710
Telephone No.: (919) 681-6412
Telecopier No.: (919) 684-4595
Attn.: Dr. Linda F. Abruzzini, Ph.D.
Director, Research Resources and Patent Administration
and to:
Georgia State University Research Foundation, Inc.
University Plaza
Georgia State University
Atlanta, Georgia 30303
Telephone No.: (404) 651-2569
Telecopier No.: (404) 651-2846
Attn.: Mr. John D. Marshall, Jr.
If to Licensee, to:
Immtech International, Inc.
150 Fairway Drive, Suite 150
Vernon Hills, Illinois 60061
Telephone No.: (847) 573-0033
Telecopier No.: (847) 573-8288
Attn.: Mr. T. Stephen Thompson
President & CEO
with copies to:
Immtech International, Inc.
One North End Avenue, Suite 1111
New York, New York 10282
Telephone No.: (212) 791-2888
Telecopier No.: (212) 791-2917
Attn.: Ms. Cecilia Chan
Executive Vice President
-22-
EXECUTION COPY
and to:
Cadwalader, Wickersham & Taft
100 Maiden Lane
New York, New York 10038-4892
Telephone No.: (212) 504-6000
Telecopier No.: (212) 504-6666
Attn.: John F. Fritts, Esq.
22. GOVERNING LAWS
22.1 This Agreement shall be interpreted and construed in accordance with
the laws of the State of North Carolina.
23. COMPLETE AGREEMENT
23.1 It is understood and agreed between the Licensors and Licensee that
this Agreement constitutes the entire agreement, both written and oral, between
the parties as to the licensing of the Future Compounds (and the Current
Compounds, if covered under this Agreement pursuant to Section 26.1), and that
all prior agreements relating to the Future Compounds (or the Current Compounds,
if covered under this Agreement pursuant to Section 26.1), either written or
oral, expressed or implied, shall be abrogated, canceled, and are null and void
and of no effect to the extent that they apply to the Future Compounds (and/or
the Current Compounds, if covered under this Agreement pursuant to Section
26.1). Notwithstanding the foregoing, the provisions of (a) Section 3(c),
Section 3(d) (last sentence only, as amended), and Section 5(b) of the 1997
Letter Agreement, (b) Section 1 of the Second Amendment, and (c) Section 2 of
the Third Amendment, are all incorporated by reference into this Agreement as if
fully set forth herein, except to the extent that they confer any rights,
responsibilities or obligations upon Pharm-Eco.
23.2 Notwithstanding any other provision of this Agreement, Section 6 of
the 1997 Letter Agreement is incorporated by reference into this Agreement as if
fully set forth herein, except to the extent that it confers any rights,
responsibilities or obligations upon Pharm-Eco, subject to the following
additional provisions: Should Licensee fail to execute, within ninety (90) days
of the Effective Date, a Registration Rights Agreement in accordance with
Section 6 of the 1997 Letter Agreement (the "Registration Agreement"), then the
Licensors shall have the option to require Licensee to repurchase a portion of
the Licensee Common Stock issued to the Licensors pursuant to the 1997 Letter
Agreement, with the number of shares to be repurchased to be determined by the
Licensors in their sole discretion but not to exceed ten percent (10%) of the
Licensee Common Stock issued to the Licensors pursuant to the 1997 Letter
Agreement. The Licensors shall be entitled to exercise such option at any time
up until Licensee executes the Registration Agreement, and the repurchase price
paid by Licensee shall be an average of the published NASDAQ daily trading price
for the Licensee Common Stock over the ten trading days preceding the date on
which the Licensors deliver to Licensee written notice of their exercise of the
option.
-23-
EXECUTION COPY
24. SEVERABILITY
24.1 In the event that a court of competent jurisdiction holds any
provision of this Agreement to be invalid, such holding shall have no effect on
the remaining provisions of this Agreement, and they shall continue in full
force and effect.
25. RIGHTS TO APPOINT REPRESENTATIVES
25.1 UNC is entitled, during the term of this Agreement, to designate (by
written notice to Licensee) one appropriate person as a non-voting observer (the
"Observer") of all meetings and other proceedings of Licensee's Board of
Directors. Licensee will provide to the Observer notice of all meetings of the
Board of Directors and a copy of all materials circulated among Licensee's
directors. The Observer and UNC shall be required, if requested by Licensee, to
execute an appropriate confidentiality and non-disclosure agreement covering
confidential information of Licensee; provided, however, that any such
confidentiality and non-disclosure agreement shall allow the Observer and UNC to
disclose such information to the other Licensors if such other Licensors first
agree in writing (and deliver such writing to Licensee) to become a party to
such agreement and to be bound by all of the terms and provisions of such
agreement as if they were an original party thereto.
26. APPLICABILITY TO CURRENT COMPOUNDS
26.1 This Agreement and the Licenses shall be applicable to Current
Compounds, in addition to Future Compounds, upon the execution and delivery of
this Agreement. The parties hereto acknowledge the fact that that certain
License Agreement dated August 25, 1993, between UNC and Pharm-Eco (the
"Pharm-Eco License Agreement"), has previously been assigned, in its entirety,
to Licensee by Pharm-Eco. Upon the execution and delivery of this Agreement, (a)
each occurrence of the words "Future Compounds" (excluding the definition of
Future Compounds) shall be deemed to read as "Future Compounds and/or Current
Compounds" unless the context clearly indicates otherwise, (b) the definition of
"Patent Rights" set forth in this Agreement shall also include everything
contained within the definition of "Patent Rights" set forth in the Pharm-Eco
License Agreement, (c) the definition of "University Technology" set forth in
this Agreement shall also include everything contained within the definition of
"University Technology" set forth in the Pharm-Eco License Agreement, (d) this
Agreement shall supercede and serve in lieu of the Pharm-Eco License Agreement
with respect to all Current Compounds, and (e) the Pharm-Eco License Agreement
shall be hereby terminated in all respects and shall no longer be of any effect
whatsoever, and neither party thereto shall have thereunder any obligations of
any kind to the other.
27. CONFIDENTIALITY AND NON-DISCLOSURE OF INFORMATION
27.1 Each of the Licensors, on the one hand, and Licensee, on the other
hand, agrees to accept and maintain the other's information, data, know-how,
samples and other disclosures hereunder or in connection with activities related
to this Agreement (collectively, "Information") on a confidential basis for a
period of five (5) years from the date of each such disclosure. The obligations
of this Article 27 shall survive and continue for three (3) years after the
expiration or any termination of this Agreement. Specifically excluded from such
confidential treatment shall
-24-
EXECUTION COPY
be Information which: (a) at the time of disclosure to the receiving party, was
already published, known publicly, or otherwise in the public domain; (b) after
disclosure to the receiving party, is published, becomes known publicly, or
otherwise becomes part of the public domain through no fault or breach of the
receiving party or any of its Affiliates; (c) the receiving party can establish
was in its possession prior to the time of disclosure to it; or (d) after
disclosure by the disclosing party, is made available to the receiving party in
good faith by a third party having no obligation of confidentiality to the
disclosing party.
28. ARBITRATION
28.1 If there shall arise in the future any dispute between any of the
parties hereto arising out of or relating to this Agreement, such as is
contemplated by Section 3.6(b) with respect to Future Duke Licensed Products, or
to any aspect of the Licenses granted by this Agreement, the parties hereto
agree that if the parties to such dispute agree at such future time to submit
such dispute to arbitration, then such arbitration shall be a confidential and
binding arbitration before a tribunal under the Commercial Arbitration Rules of
the American Arbitration Association, and shall be held at a site mutually
agreeable to the parties to the arbitration. If the parties are unable to agree
upon a site, then the site shall be selected by the arbitration tribunal. The
arbitration tribunal shall consist of three (3) arbitrators. The party
requesting arbitration shall name an arbitrator selected by it in its request
for arbitration. The responding party shall name an arbitrator selected by it in
its answer or response to such request for arbitration. The two arbitrators so
named shall jointly select a third arbitrator, who shall be the chairman of the
tribunal and who shall have no prior or then existing relationship or business
arrangements or financial dealings with, or interests in, either of Licensee,
UNC or any other Licensor. The decision of the arbitration tribunal shall be
final, and judgment upon the award rendered by the arbitration tribunal may be
entered in any competent court having jurisdiction thereof for judicial
acceptance of such award and an order of enforcement. Each party hereto hereby
submits itself to the courts of the place of arbitration, but only for the entry
of judgement with respect to the decision of the arbitration tribunal. The
parties hereto agree that the arbitration tribunal may, in its sole discretion,
award reasonable costs and attorney's fees to the prevailing party, and may, in
its sole discretion, assess the costs of the arbitration against the
non-prevailing party.
29. SURVIVAL OF TERMS
29.1 The provisions of Articles 6, 7, 9.3, 9.4, 9.5, 13, 14, 16, 17, 18,
19, 21, 22, 27, and 28 shall survive the expiration or termination of this
Agreement until the expiration of the appropriate statute of limitations for
such Article, except that Article 6 shall survive until eighteen (18) months
after the expiration or termination of the last contract requiring use of either
University Technology, Patent Rights, Licensed Products, Future Compounds, or
the Licenses.
30. TELECOPIER EXECUTION AND DELIVERY
30.1 A facsimile, telecopy or other reproduction of this Agreement may be
executed by one or more parties hereto, and an executed copy of this Agreement
may be delivered by one or more parties hereto by facsimile, telecopy or similar
instantaneous electronic transmission device pursuant to which the signature of
or on behalf of such party can be seen, and such execution and
-25-
EXECUTION COPY
delivery shall be considered valid, binding and effective for all purposes. At
the request of any party hereto, all parties hereto agree to execute an original
of this Agreement as well as any facsimile, telecopy, or other reproduction
hereof.
31. COUNTERPARTS
31.1 This Agreement may be executed in one or more counterparts, each of
which shall be deemed an original, but all of which, taken together, shall
constitute one and the same instrument.
32. GENERAL REPRESENTATIONS AND WARRANTIES
32.1 Each party hereto represents and warrants to the other parties hereto
that (a) the execution and delivery of this Agreement has been duly authorized
and all actions necessary for the due execution and delivery of this Agreement
have been taken, in each case to the extent necessary to make this Agreement
valid and enforceable, and (b) this Agreement constitutes the legal, valid and
binding obligation of such party, and is enforceable against it in accordance
with its terms, and (c) the person signing this Agreement on behalf of such
party has the authority to do so on behalf of such party.
33. HEADINGS
33.1 The Article and Section headings contained in this Agreement are for
reference purposes only and shall not affect in any manner the meaning or
interpretation of this Agreement.
(REMAINDER OF PAGE INTENTIONALLY LEFT BLANK - SIGNATURE PAGE FOLLOWS)
-26-
EXECUTION COPY
IN WITNESS WHEREOF, the Licensors and Licensee have each executed this
Agreement, in duplicate originals, by their respective officers hereunto duly
authorized, as of the day and year first above written.
THE UNIVERSITY OF NORTH CAROLINA IMMTECH INTERNATIONAL, INC.
AT CHAPEL HILL
By: ________________________________ By: ____________________________________
Tony G. Waldrop T. Stephen Thompson
Vice Chancellor for Research and President & CEO
Graduate Studies
GEORGIA STATE UNIVERSITY AUBURN UNIVERSITY
RESEARCH FOUNDATION, INC.
By: ________________________________ By: ____________________________________
Charles Louis Michael Moriarty
Chairman Associate Provost and Vice President
for Research
DUKE UNIVERSITY
By:__________________________________
Name:________________________________
Title:_______________________________
-27-
EXECUTION COPY
EXHIBIT A
TO THE
LICENSE AGREEMENT
(dated as of January 28, 2002)
PATENT RIGHTS
(in existence as of January 24, 2002)
UNC File # Title
1. 88-3 Use of Bis-(5-Amidino-2-Benzimidazolyl) Methane (BABIM) to
Treat Arthritis
U.S. Patent No. 4,940,723, issued 7/10/90
2. 88-4 Diamidines and Bis(imidazoles) for the Treatment of and
Prophylaxis Against Pneumocystis Carinii Pneumonia
U.S. Patent No. 4,933,347, issued 6/12/90
Korean Patent No. 164,429, issued 9/12/98
Swiss Patent No. 679857, issued 4/30/92
Venezuelan Patent Application No. 1600-89, filed 10/24/89
3. 88-4 Methods for Treating Giardia Lamblia
U.S. Patent No. 4,963,589, issued 10/16/90
4. 88-4 Methods for the Treatment of Leishmaniasis
U.S. Patent No. 5,202,320, issued 4/13/93
5. 88-4 Methods for the Treatment of Malaria
U.S. Patent No. 5,206,236, issued 4/27/93
European Patent No. 0366066, issued 3/1/95
Argentina Patent 248,011, issued 5/31/95
Australian Patent No. 626,033, issued 1/25/93
Canadian Patent No. 2,001,359, issued 5/10/97
Chinese Patent No. 89108784.2, issued 10/22/95
Danish Patent Application No. 5266/89, filed 10/24/89
Israeli Patent No. 92101, issued 2/28/96
Japanese Patent Application No. 1-278331, filed 10/25/89
Mexican Patent No. 179,371, issued 8/30/95
Philippine Patent No. 30339, issued 4/2/97
Philippine Patent No. 30360, issued 4/2/97 (divisional of '339
patent)
A-1
EXECUTION COPY
6. 93-17 Methods of Combating Pneumocystis carinii Pneumonia and
Compounds Useful Therefor
U.S. Patent No. 5,428,051, issued 6/27/95
U.S. Patent No. 5,578,631, issued 11/26/96 (divisional of '051
patent)
Canadian Patent No. 2,104,196, issued 3/27/01
Japanese Patent Application No. 6-510083, filed 10/4/93
Brazilian Patent Application No. PI9307235, filed 10/4/93
Australian Patent No. 675092, issued 5/13/97
New Zealand Patent No. 257001, issued 10/22/97
French Patent No. FR0664703, issued 12/15/99
German Patent No. P69327330.5-08, issued 12/15/99
Great Britain Patent No. GB0664703, issued 12/15/99
7. 94-34 Method for Inhibiting Retroviral Integrase
U.S. Patent Application S/N 08/185,079, filed 3/24/97
Australian Patent No. 675386, issued 5/20/97
Brazilian Patent Application No. PI9506552-0, filed 1/18/96
Canadian Patent Application No. 2179015, filed 1/18/95
Japanese Patent Application No. 519602/1995, filed 1/18/95
New Zealand Patent No. 279619, issued 7/20/00
New Zealand Patent No. 335226, issued 3/8/01 (divisional of
'619 patent)
European Patent No. 739,202, issued 3/27/98 (Issued in Germany
(No. P695066860-08), France (No. 0739202), Spain (No.
0.3902), Italy, and the U.K. (No. 073902))
Venezuelan Patent Application No. 503-96, filed 3/28/96
8. 94-34 Methods of Treating Retroviral Infections and Compounds Useful
Therefor
U.S. Patent No. 5,935,982, issued 8/10/99
European Patent Application No. 98908758.0, filed 2/27/98
Australian Patent No. 738,975, Notice of Allowance granted
10/4/01; Awaiting End of Opposition Period and Issuance of
Patent
Canadian Patent Application No. 2282552, filed 2/27/98
Japanese Patent Application No. 537870/1998, filed 2/27/98
Hong Kong Patent Application No. 00104566.6, filed 2/27/98
9. 94-43 Method of Fluorescent Detection of Nucleic Acids and
Cytoskeleton Elements using Bis-Dicationic Aryl Furans
U.S. Patent No. 5,594,138, issued 1/14/97
European Patent Application No. 95918418.5, filed 11/6/96
Australian Patent No. 699223, issued 3/11/99
Canadian Patent Application No. 2189125, filed 5/15/95
Japanese Patent No. 3098545, issued 8/11/00
A-2
EXECUTION COPY
Korean Patent Application No. 9670682, filed 11/6/96
Mexican Patent Application No. 9605421, filed 11/6/96
New Zealand Patent No. 285309, issued 5/5/95
10. 94-81 Method of Treating Pneumocystis carinii Pneumonia
U.S. Patent No. 5,521,189, issued 5/28/96
11. 94-81 Method of Treating Giardia lamblia
U.S. Patent No. 5,627,184, issued 5/6/97 (divisional of '189
patent)
12. 94-81 Compounds for the Treatment of Pneumocystis carinii, Giardia
lamblia, and Cryptosporidium parvum
U.S. Patent No. 5,606,058, issued 2/25/97 (divisional of '189
patent)
13. 94-81 Method of Treating Cryptosporidium parvum
U.S. Patent No. 5,622,955, issued 4/22/97 (divisional of '189
patent)
14. 94-81 Methods of Treating Pneumocystis carinii Pneumonia
U.S. Patent No. 5,686,456, issued 11/11/97 (divisional of '189
patent)
European Patent Application No. 95941407.9, filed 11/13/95
Canadian Patent Application No. 2204898, filed 11/13/95
South African Patent Application No. 95/9661, filed 11/14/95
Taiwanese Patent Application No. 84113375, filed 12/15/95
Japanese Patent Application No. 516327/1996, filed 11/13/95
15. 94-82 Methods of Inhibiting Pneumocystis Carinii Pneumonia, Giardia
Lamblia, and Cryptosporidium Parvum and Compounds Useful
Therefor
U.S. Patent No. 5,602,172, issued 2/11/97
Israeli Patent No. 115,875, issued 3/7/01
Australian Patent No. 692024, issued 11/5/98 Mexican Patent
No. 197564, issued 7/17/00
16. 95-48 Methods of Inhibiting Pneumocystic Carinii Pneumonia and
Compounds Useful Therefor
U.S. Patent No. 5,668,166, issued 9/16/97
European Patent Application No. 96919040.4, filed 7/3/96
Japanese Patent Application No. 501062/1997, filed 7/3/96
17. 95-48 Methods of Treating Microbial Infections
U.S. Patent No. 5,668,167, issued 9/16/97
European Patent Application No. 96918120.5, filed 7/3/96
A-3
EXECUTION COPY
Japanese Patent Application No. 501405/1997, filed 7/3/96
18. 95-49 Method of Fluorescent Detection of Nucleic Acids and
Cytoskeleton Elements Using Bis-dicationic Aryl Furans
U.S. Patent No. 5,667,975, issued 9/16/97
19. 95-50 Benzamidoxime Prodrugs as Antipneumocystic Agents
U.S. Patent No. 5,723,495, issued 3/3/98
U.S. Patent No. 5,843,980, issued 12/1/98
(continuation-in-part of the '495 patent)
U.S. Patent No. 6,025,398, issued 2/15/00 (divisional of the
'980 patent)
U.S. Patent No. 6,214,883, issued 4/10/01 (divisional of the
'398 patent)
U.S. Patent Application S/N 09/759,664, filed 1/12/01
(divisional of the '883 patent)
Australian Patent Application No. 11605/97, filed 11/15/96
Canadian Patent Application No. 2237650, filed 7/30/98
Japanese Patent Application No. 519146/1997, filed 11/15/96
European Patent Application No. 96942773.1, filed 6/11/98
20. 95-51 Methods of Combating Infectious Diseases Using Dicationic Bis-
Benzimidazoles
U.S. Patent No. 5,643,935, issued 7/1/97
U.S. Patent No. 5,639,755, issued 7/17/97 (divisional of the
'935 patent)
U.S. Patent No. 5,817,687, issued 10/6/98 (divisional of the
'935 patent)
U.S. Patent No. 5,792,782, issued 8/11/98 (divisional of the
'935 patent)
U.S. Patent No. 5,817,686, issued 10/6/98 (continuation of the
'755 patent)
U.S. Patent No. 5,939,440, issued 8/17/99 (divisional of the
'782 patent)
U.S. Patent No. 6,017,941, issued 1/25/00 (divisional of the
'687 patent)
U.S. Patent No. 5,972,969, issued 10/26/99 (divisional of the
'686 patent)
U.S. Patent No. 6,046,226, issued 4/4/00 (divisional of the
'969 patent)
U.S. Patent No. 6,156,779, issued 12/5/00 (divisional of the
'266 patent)
U.S. Patent No. 6,294,565, issued 9/25/01 (divisional of the
'779 patent)
European Patent Application No. 96916817.8, filed 6/3/96
Australia Patent No. 705261, issued 5/20/99
Canadian Patent Application No. 2,223,912, filed 6/3/96
Japanese Patent Application No. 500868/1997, filed 6/3/96
21. 98-54 2,4-bis[(4-amidino)phenyl]furans as anti-Pneumocystis carinii
agents
U.S. Patent No. 6,008,247, issued 12/28/99
U.S. Patent No. 6,127,554, issued 10/3/00 (divisional of '247
patent)
Australia Patent Application No. 77453/98, filed 7/23/98
Japanese Patent Application No. 217593/1999, filed 7/31/98
A-4
EXECUTION COPY
Canadian Patent Application No. 2242794, filed 7/10/98
European Patent Application No. 983058959, filed 7/24/98
UK Patent No. 2334716, issued 5/17/00
UK Patent No. 2343677, issued 7/18/00 (divisional of '716
patent)
22. 98-81 Antifungal Activity of Dicationic Molecules
U.S. Patent No. 6,326,395, issued 12/4/01
Japanese Patent Application No. 2000-569769, filed 3/19/01
Australian Patent Application No. 60450.99, filed 9/15/99
Canadian Patent Application No. 2,344,445, filed 9/15/99
23. 98-87 Imidazoline Receptor Binding Compounds
U.S. Patent Application S/N 09/120,584, filed 7/22/98
Japanese Patent Application No. 2000-56886, filed 1/22/01
Australian Patent Application No. 48327/99, filed 6/25/99
Canadian Patent Application No. 2,338,279, filed 6/25/99
24. 99-9 Dicationic Dibenzofuran and Dibenzithiophene Compounds and
Methods of Use Thereof
U.S. Patent No. 6,172,104, issued 1/9/01
Japanese Patent Application No. 2000-569796, filed 6/24/99
Canadian Patent Application No. 2,340,912, filed 2/16/01
25. 99-54 Methods and Formulations for the Treatment of Infectious
Bursal Disease in Avian Subjects
U.S. Patent Application S/N 09/703,804, filed 11/1/00
PCT Application No. PCT/US00/30066, filed 11/1/00 (National
Phase Due 5/1/02)
26. 99-80 Novel Prodrugs for Antimicrobial Amidines
U.S. Patent Application S/N 09/612,138, filed 7/7/00 (Notice
of Allowance Received 11/28/01)
U.S. Patent Application S/N 09/918,787, filed 7/13/01
(divisional of '138 application, Notice of Allowance
Received 10/10/01)
PCT Application No. PCT/US00/18499, filed 11/6/01 (National
Phase Filings Authorized in Canada, EPO, Australia, and
Japan)
27. 00-49 Novel Compounds that Exhibit Specific Molecular Recognition of
Mixed Nucleic Acid Sequences and Bind in the DNA Minor Groove
as a Dimer
U.S. Patent Application S/N 09/745,004, filed 12/20/00
PCT Application No. PCT/US00/34794, filed 12/20/99 (National
Phase Deadline 6/20/02)
A-5
EXECUTION COPY
28. 01-07 Diguanidino and "Reversed" Diamidino Diaryl Furans and
Thiophenes as Antimicrobial Agents
U.S. Patent Application filed 11/6/01 (S/N 10/008,535)
claiming priority to Provisional Application S/N 60/246,244,
filed 11/6/00
PCT Application filed 11/6/01, S/N to be assigned
29. 01-54 Compounds, Methods and Compositions Useful for the Treatment
of Bovine Viral Diarrhea Virus (BVDV) Infection and Hepatitis
C Virus (HCV) Infection
U.S. Patent Application filed 1/11/02 (S/N to be assigned)
claiming priority to Provisional Patent Application S/N
60/261,654, filed 1/13/01
PCT Application filed 1/11/02, S/N to be assigned
A-6
EXECUTION COPY
EXHIBIT B
TO THE
LICENSE AGREEMENT
(dated as of January 28, 2002)
DESCRIPTIVE STATEMENT
Immtech International, Inc., is a biopharmaceutical company focused on the
discovery, development and commercialization of drugs for treating infectious
diseases. The company has an exclusive worldwide license to an anti-microbial
pharmaceutical platform that is licensed from a university consortium led by The
University of North Carolina at Chapel Hill and includes Duke University, Auburn
University, and Georgia State University. The platform is based on dication and
related chemical structures that work by binding in the minor groove of an
infectious organism's DNA, blocking life-sustaining enzymes, thereby killing the
infectious organism. The company, which works with the consortium on furthering
basic research, has active programs for the development of new drugs for fungal,
parasitic, bacterial and viral diseases.
B-1