CRITICARE SYSTEMS, INC.
00000 Xxxxxxxxxx Xxxxxx
Xxxxxxxx, XX 00000
June 25, 1998
T. Xxxxxxx Xxxxxxxx, President
and CEO
Immtech International, Inc.
0000 Xxxxx Xxxxxx
Xxxxx 000
Xxxxxxxx, XX 00000
Dear Xx. Xxxxxxxx:
This Agreement states the terms and conditions whereby Criticare Systems,
Inc. ("Criticare") agrees to acquire and Immtech International, Inc. ("Immtech")
agrees to sell to Criticare certain of its intangible assets. It is Criticare's
understanding that you have the full power and authority to enter into this
Agreement.
Subject to the terms and conditions set forth herein, Criticare will pay
you, at Closing (as hereinafter defined), the sum of $150,000 for such assets.
Immtech agrees, represents and warrants and Criticare agrees as follows:
1. Criticare will acquire from Immtech at the Closing (as hereinafter
defined) the following properties, assets and rights of Immtech (collectively,
the "Purchased Assets"):
(a) All right, title and interest in U.S. Patent No. 5,484,735 to
Xxxxx et al. granted January 16, 1996 (the "735 Patent"), including any
continuations, continuations-in-part, divisionals, reissues, re-examinations,
extensions thereof, any U.S. patents or applications (including any
continuations, continuations-in-part, divisionals, reissues, re-examinations and
extensions) owned or licensed to or by Immtech which claim priority to or are
otherwise based on the 735 Patent or which otherwise establish rights which
cover, encompass or are ancillary to the "Materials," "Progeny," "Immtech
Biomaterials," "Immtech Technology" or "Immtech Improvements" thereto (as such
terms are defined in the Material Transfer and Option Agreement between Sigma
Diagnostics, Inc. and Immtech dated March 23, 1998 (a copy of which is attached
hereto as Exhibit A) (the "Sigma Agreement") and any corresponding or related
foreign applications owned or licensed by Immtech which claim priority to or are
otherwise based on the 735 Patent or which otherwise establish rights which
cover or encompass or
T. Xxxxxxx Xxxxxxxx, President
and CEO
June 25, 1998
Page 2
are ancillary to the Materials Progeny, Immtech Biomaterials, Immtech Technology
or Immtech Improvements thereto.
(b) All of Immtech's rights under the Sigma Agreement.
(c) All of Immtech's rights with respect to the License Agreement
dated March 10, 1998 between Immtech and Northwestern University (a copy of
which is attached hereto as Exhibit B (the "Northwestern NU 8403 License")).
(d) All right, title and interest in and to Patent No. 5,702,904 to
Makhlouf et at granted December 30, 1997 ("the 904 Patent"), any reissues,
re-examinations or extensions thereof, any U.S. patents or applications
(including any continuations, continuations-in-part, divisionals, reissues,
re-examinations and extensions) owned or licensed to Immtech which claim
priority to or are otherwise based on the 904 Patent and any corresponding or
related foreign applications owned or licensed by Immtech which claim priority
to or are otherwise based on the 904 Patent.
(e) All of Immtech's rights with respect to the License Agreement
dated October 27, 1994 between Immtech and Northwestern University, which is
attached hereto as Exhibit C (the "Northwestern NU 9134 License").
(f) An exclusive, royalty-free, worldwide license under Patent No.
5,405,832 to Xxxxxxx, granted on April 11, 1995 to utilize mCRP for the
treatment of septicema, as set forth in the License Agreement attached hereto as
Exhibit D (the "Sepsis License").
(g) The right, but not the obligation, to xxx for past infringement
with respect to all of the foregoing.
(h) To Immtech's knowledge, all other rights reasonably required to
make, use, sell and offer for sale products based on or related to the Purchased
Assets.
2. Immtech agrees to provide Criticare and its successors, assigns or
other legal representatives, cooperation and assistance at Criticare's request
and expense (including the execution and delivery of any and all affidavits,
declarations, oaths, exhibits, assignments, powers of attorney or other
documentation as may be reasonably required): (1) in the preparation and
T. Xxxxxxx Xxxxxxxx, President
and CEO
June 25, 1998
Page 3
prosecution of any applications for patents or registration of the intellectual
property assigned, licensed or transferred pursuant to this Agreement; (2) in
the prosecution or defense of any interference, opposition, infringement or
other proceedings that may arise in connection with any of the intellectual
property assigned, licensed or transferred pursuant to this Agreement; and (3)
in the implementation or perfection of this Agreement.
3. Criticare will not assume any of Immtech's liabilities for obligations
to Northwestern University under the Northwestern NU 8403 License and the
Northwestern NU 9134 License occurring after the Closing. Criticare is not
assuming any other liabilities or obligations of Immtech of any nature or kind.
4. To induce Criticare to enter into this Agreement, Immtech represents
and warrants that all of the statements made herein are true and correct and
that:
(a) Immtech will own at the Closing all of the Purchased Assets, and
title to the Purchased Assets will be transferred to Criticare at Closing, free
and clear of all liens or encumbrances of any nature whatsoever, including sales
taxes, if any. Immtech has obtained all necessary consents to the transfers
contemplated hereby.
(b) Between the date hereof and Closing, Immtech will utilize its
best efforts to continue its customer relationships and to preserve the value of
the Purchased Assets and their attendant goodwill for the benefit of Criticare.
(c) All corporate procedures necessary to authorize or ratify this
Agreement by Immtech have been or will be taken prior to Closing and Immtech has
the necessary power and authority to deliver this Agreement and consummate the
transactions provided for herein.
(d) Immtech is not in default, and there exist no circumstances
which would allow the other party to such agreements to allege that Immtech is
in default under the Sigma Agreement, the NU 8403 License or the NU 9134
License.
(e) There exists no fact or condition, or to your knowledge, any
threatened development not otherwise disclosed to Criticare in writing which
could reasonably be considered as adversely affecting the prospects for or value
of the Purchased Assets.
T. Xxxxxxx Xxxxxxxx, President
and CEO
June 25, 1998
Page 4
5. The representations and warranties made by Immtech herein shall be true
at and survive the Closing for a period of two years, except that in any case
where Criticare can show that a matter was concealed intentionally or failure to
disclose was as a result of gross negligence, in which case the survival period
shall be three years from the date of discovery. In addition to the other
agreements herein contained, we agree with each other that neither of us has
employed a broker or finder in connection with this transaction and that each of
us will bear our respective expenses in connection with the transaction. We
agree that any publicity or communications to third parties concerning the
transaction prior to Closing will be released only if mutually approved.
From and after the Closing, Immtech will reimburse, indemnify and
hold harmless Criticare and its officers and directors, successors and assigns,
upon demand, with respect to any damages, losses, liabilities, costs and
expenses incurred or suffered by it that result from, relate to or arise out
of (i) any liabilities or obligations of Immtech not specifically assumed by
Criticare, (ii) any breach of representation or warranty or nonfulfillment of
any agreement or covenant contained in this Agreement, and (iii) any actions,
suits, claims or proceedings, including costs and expenses incident to the
foregoing. Criticare shall be entitled, along with any other remedies it may
possess, to withhold or apply any funds which you may be entitled to receive
from it under this or any other agreement as a reserve or set-off against
amounts for which you may be liable under this Agreement.
6. Immtech covenants and agrees that for a period of three years from and
after Closing, it will make available to Criticare or its assignee the services
of Xx. Xxxxxxx to consult with and advise Criticare or its assignee regarding
research, testing, FDA compliance and approval, manufacture and
commercialization of the products or applications covered by the patents being
purchased or licensed by Criticare pursuant to this letter agreement Criticare,
at its option, may extend such agreement for all or any part of one additional
two-year period. It is expected that Xx. Xxxxxxx'x consultation will occur on a
part-time basis (no more than two days per week) for which Criticare will
reimburse Immtech for its out-of-pocket salary and employee benefit plan
expenses, pro rata, with respect to Xx. Xxxxxxx. Xx. Xxxxxxx shall also receive
bonuses based upon the completion of Phase I and II with respect to products for
which he is primarily responsible.
T. Xxxxxxx Xxxxxxxx, President
and CEO
June 25, 1998
Page 5
Immtech has discussed this engagement with Xx. Xxxxxxx and
understands that his availability is a significant inducement to Criticare to
enter into this letter agreement. Immtech and Xx. Xxxxxxx agree that they will
not enter into a consulting or advisory relationship with any person or entity
with respect to competitive products or applications during the consultancy
period and for 12 months after its conclusion.
7. Criticare or its assignee shall for a period of five years from and
after the Closing be entitled to purchase from Immtech, and Immtech or any
successor in interest to Immtech shall sell to Criticare or its assignee mCRP,
at Immtech's cost. Criticare may, at its option, manufacture mCRP, in which
event Immtech will provide all necessary know-how and expertise to enable
Criticare to manufacture the molecule in commercially viable quantities. Immtech
agrees that it will reference this commitment in any license, sublicense,
manufacturing, supply or other agreement affecting this right.
8. Criticare or, in the case of an assignment or sublicense by Criticare
to a third party, such third parry (without recourse to Criticare) shall be
responsible for any costs associated with operations during each of Phases I and
II, including without limitation the costs of conducting necessary research and
clinical studies to permit the sale of mCRP for use in the treatment of sepsis,
including salaries, fees, benefits and expenses for its employees, rent and
other corporate costs, fees associated with any and all regulatory filings,
legal and accounting fees and applications. Immtech will be responsible for all
maintenance fees related to patent protection until financing is completed.
9. Closing shall take place at Milwaukee, Wisconsin, at 2:00 p.m. on July
2, 1998 (the "Closing" or "Closing Date"). Title to the Purchased Assets shall
pass to Criticare at Closing.
10. Criticare has deposited in escrow with at its law firm, Reinhart,
Boerner, Van Deuren, Xxxxxx & Xxxxxxxxxx, s.c. (the "Law Firm"), a certified
check in the amount of $l50,000, made payable to Immtech and endorsed to Brinks,
Hofer, Xxxxxx & Lione. Immtech has, or within three days after the date of this
Agreement, will similarly deposit with such Law Firm the following: (i) the
Patent Assignment attached hereto as Exhibit E; (ii) the assignments in the
forms attached hereto as Exhibits F and G, assigning Immtech's rights under the
licenses referred to in paragraphs 3(c) and 3(e) and the Sigma Agreement; and
(iii) a copy of the agreement of Brinks, Hofer, Xxxxxx & Xxxxx ("Xxxxxx"),
agreeing to accept
T. Xxxxxxx Xxxxxxxx, President
and CEO
June 25, 1998
Page 6
$150,000 in full settlement and accord of Immtech's indebtedness to such firm,
and releasing such firm from any further liability to Immtech. The Law Firm is
authorized and directed to release such check to Brinks on July 2, 1998.
11. This letter agreement shall be binding upon and inure to the benefit
of the parties' successors and assigns, but shall not be assignable by either
party without the prior written consent of the other; provided, however, that
nothing herein shall prevent Criticare from assigning its rights and obligations
hereunder to an affiliated corporation or subsidiary corporation controlled by
or under common control with Criticare. Each of the exhibits referred to in this
letter agreement is incorporated herein by reference and made a part hereof.
It is our intent that this letter agreement set forth our entire
understanding, merging all of our prior discussions herein. If you are in
agreement with all of the foregoing, would you please execute and return a copy
of this letter to us.
Yours very truly,
CRITICARE SYSTEMS, INC.
BY: [ILLEGIBLE]
--------------------------
PRES
MW2/46716REB
Enclosures
Acknowledged and agreed to
this 29th day of June, 1998.
IMMTECH INTERNATIONAL, INC.
BY: [ILLEGIBLE]
---------------------------
Its President & CEO
Exhibits to Letter Agreement
Exhibit A Sigma Diagnostics, Inc. Agreement.
Exhibit B Northwestern NU 8403 License.
Exhibit C Northwestern NU 9134 License.
Exhibit D Sepsis License.
Exhibit E Patent Assignment.
Exhibit F Northwestern NU 8403 License Assignment.
Exhibit G Sigma Agreement Assignment.
EXHIBIT A
MATERIAL TRANSFER AND OPTION AGREEMENT
This agreement is made and entered into as of the 23rd day of March,
1998, by and between Immtech International, Inc. ("IMMTECH"), a Delaware
Corporation, maintaining an office at 0000 Xxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx, XX
00000, and Sigma Diagnostics, Inc. ("SIGMA"), a Missouri corporation maintaining
an office at 000 Xxxxx Xxxxx Xxxxxx, Xx. Xxxxx, Xxxxxxxx 00000.
WHEREAS, SIGMA desires to develop commercial diagnostic assays for
determining hemoglobin in type Alc ("Hb(Alc)") by detecting a reduced form of
Hb(Alc);
WHEREAS, SIGMA desires to obtain certain hybridoma cell lines that
produce monoclonal antibodies suitable for use in such assays from IMMTECH, and
to obtain related information known to IMMTECH in order to develop such
commercial assays;
WHEREAS, SIGMA desires to grow such cell lines and harvest
monoclonal antibodies from said cell lines for the purpose of evaluating the
suitability of the same for a commercial Hb(Alc) assay and for the purpose of
evaluating whether to exercise an option to license the exclusive, worldwide
rights associated with such cell lines, such monoclonal antibodies and such
related information known to IMMTECH, and
WHEREAS, IMMTECH is willing to provide such cell lines and such
information to SIGMA, to allow SIGMA to evaluate such cell lines and monoclonal
antibodies, and
WHEREAS, IMMTECH has, and/or will acquire as of the effective date
of this agreement, certain patent and nonpatent rights relating to such cell
lines, antibodies and information, and desires to grant SIGMA an option to
obtain such rights and a license thereto on the terms and conditions set forth
herein.
NOW THEREFORE, for and in consideration of the foregoing and the
mutual covenants and agreements contained herein, and certain other good and
valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the parties hereto agree as follows:
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1. DEFINITIONS
1.1 MATERIALS" means (1) the monoclonal antibody designated as
"MML03" having specificity to mannitol-valine-glycine-glycine (mannitol-VGG) or
a fragment, derivative, or conjugate thereof having such specificity, and (2)
hybridoma cell lines which will produce the MML03 monoclonal antibody.
1.2 "PROGENY" means all monoclonal antibodies and hybridoma cell
lines developed from the MATERIALS by IMMTECH, by SIGMA, or jointly by IMMTECH
and SIGMA.
1.3 "IMMTECH BIOMATERIALS" means all biomaterials useful in
connection with research related to the MATERIALS or in connection with PRODUCTS
involving the MATERIALS and developed or discovered by IMMTECH, independently of
SIGMA, including, without limitation, peptides, culture media, and other
biomaterials useful as calibrators, reference materials or controls.
1.4 "SIGMA BIOMATERIALS" means all biomaterials useful in connection
with research related to the MATERIALS or in connection with PRODUCTS involving
the MATERIALS or PROGENY and developed or discovered independently by SIGMA or
jointly by SIGMA and IMMTECH, including, without limitation, peptides, culture
media, and other biomaterials useful as calibrators, reference materials or
controls.
1.5 "IMMTECH TECHNOLOGY" means individually and collectively, all
designs, technical information, know-how, trade secrets, knowledge, data,
specifications, test results, manufacturing information, analytical information,
marketing information, inventions conceived and/or reduced to practice and/or
acquired, and other information relating to the MATERIALS and known to IMMTECH
on the date of this AGREEMENT or developed by IMMTECH thereafter, independently
of SIGMA, including, without limitation, all information which will allow and/or
assist SIGMA to establish commercially viable hybridoma cell lines which will
produce the MML03 monoclonal antibody in a quantity and with properties
reasonably required by SIGMA to develop a commercial Hb(Alc) assay.
1.6 "SIGMA TECHNOLOGY" means, individually and collectively, all
designs, technical information, know-how, trade secrets, knowledge, data,
specifications, test results, manufacturing information, analytical information,
marketing information, inventions conceived and/or reduced to practice and/or
acquired, and other information relating to the MATERIALS and developed
independently by SIGMA, or jointly by SIGMA and IMMTECH.
2
1.7 "SIGMA PRODUCTS" means any products which comprise MATERIALS or
PROGENY and which are developed by SIGMA or jointly by SIGMA and IMMTECH,
including, without limitation, assay kits, assay methods and assay reagents.
1.8 "EFFECTIVE DATE" means the latter of (a) the date set forth
above in the recitals to this AGREEMENT, (b) the date on which IMMTECH has
executed this AGREEMENT, (c) the date on which SIGMA has executed this AGREEMENT
or (d) the date on which SIGMA receives from IMMTECH a copy of the duly executed
IMMTECH-NORTHWESTERN LICENSE AGREEMENT.
1.9 "EVALUATION PERIOD" of this AGREEMENT means the period which
begins upon the latter of (a) the EFFECTIVE DATE of this AGREEMENT or (b) the
date of first receipt of MATERIALS by SIGMA from IMMTECH, and which ends six
months after such date.
1.10 "RESEARCH AND DEVELOPMENT PERIOD" of this AGREEMENT means the
period which begins on the last day of the EVALUATION PERIOD and which ends two
years after the last day of the EVALUATION PERIOD.
1.11 "MONOCLONALITY" means that the hybridoma cells of the MATERIALS
produce monoclonal antibodies having an antibody combining site which binds with
SPECIFICITY to mannitol-VGG.
1.12 "CELL GROWTH" means the growth of the hybridoma cells of the
MATERIALS in SIGMA bioreactors in quantities reasonably required by SIGMA for
evaluation, research and product development purposes.
1.13 "SPECIFICITY" means that the monoclonal antibodies of the
MATERIALS have are specific for mannitol-VGG in a manner consistent with that
described in U.S. Patent No. 5,484,735 to Xxxxx et al. and that such monoclonal
antibodies will not cross react with non-glucosylated hemoglobin (Hb(Ac)) or
with non-reduced glucosylated hemoglobin (Hb(Alc)).
1.14 "OPTION" means the option granted to SIGMA pursuant to P. 8.1
of this AGREEMENT.
1.15 "LICENSE" means the license to be executed in accordance with
P. 8.6 of this AGREEMENT.
1.16 "PATENT RIGHTS" means IMMTECH's patent rights associated with
the LICENSED PATENTS as set forth in Title 35 of the United States Code and in
corresponding foreign statutes and/or common law.
3
1.17 "LICENSED PATENTS" shall include U.S. Patent No. 5,484,735 to
Xxxxx et al. filed November 12, 1993 and entitled "Immunoassay of Glycosylated
Proteins Employing Antibody to Reductively Glycosylated N-Terminal Amino Acids"
(hereinafter referred to as "the `735 PATENT"), any reissues, reexaminations or
extensions thereof, any U.S. patents or applications (including divisionals and
continuation applications) owned or licensed to or by IMMTECH which claim
priority to or are otherwise based on the `735 PATENT or which otherwise
establish rights which cover, encompass or are ancillary to the MATERIALS,
PROGENY, IMMTECH BIOMATERIALS, IMMTECH TECHNOLOGY or IMMTECH IMPROVEMENTS
thereto and any corresponding or related foreign applications owned or licensed
by IMMTECH which claim priority to or are otherwise based on the `735 PATENT or
which otherwise establish rights which cover, encompass or are ancillary to the
MATERIALS, PROGENY, IMMTECH BIOMATERIALS, IMMTECH TECHNOLOGY or IMMTECH
IMPROVEMENTS thereto.
1.18 "TECHNOLOGY RIGHTS" means IMMTECH's non-patent statutory and/or
common law rights associated with the LICENSED TECHNOLOGY, including, without
limitation, trade secret rights.
l.19 "LICENSED TECHNOLOGY" means any and all non-patented MATERIALS,
PROGENY, IMMTECH BIOMATERIALS, IMMTECH TECHNOLOGY or IMPROVEMENTS thereto.
1.20 "LICENSED PRODUCT" means any PRODUCT covered by claims of the
LICENSED PATENTS or which involves LICENSED TECHNOLOGY.
1.21 "IMMTECH IMPROVEMENTS" means all modifications, variations,
revisions, new generations and new models of the MATERIALS, PROGENY, IMMTECH
BIOMATERIALS and/or IMMTECH TECHNOLOGY which relate or have consequence with
respect to the LICENSED PRODUCT in any of the following ways: (a) improves
performance of the LICENSED PRODUCT; (b) reduces the cost of materials or
components for the LICENSED PRODUCT; (c) reduces production, manufacturing or
associated costs of the LICENSED PRODUCTS; (d) increases the durability or
continuous performance characteristics of the LICENSED PRODUCTS; (e) expands the
applications to which the LICENSED PRODUCTS may be put; (f) increases or
enhances the marketability or commercial aspect of the LICENSED PRODUCT; or (g)
would, if implemented, replace or displace the LICENSED PRODUCT in one or more
materially commercial markets for LICENSED PRODUCTS. IMMTECH IMPROVEMENTS may be
patentable or unpatentable, and if patentable, need not be patented.
4
1.22 "SIGMA IMPROVEMENTS" means all modifications, variations,
revisions, new generations and new models of the SIGMA BIOMATERIALS, sigma
technology and/or SIGMA PRODUCTS which relate or have consequence with respect
to the LICENSED PRODUCT in any of the following ways: (a) improves performance
of the LICENSED PRODUCT; (b) reduces the cost of materials or components for the
LICENSED PRODUCT; (c) reduces production, manufacturing or associated costs of
the LICENSED PRODUCTS; (d) increases the durability or continuous performance
characteristics of the LICENSED PRODUCTS; (e) expands the applications to which
the LICENSED PRODUCTS may be put; (f) increases or enhances the marketability or
commercial aspect of the LICENSED PRODUCT; or (g) would, if implemented,
replace or displace the LICENSED PRODUCT in one or more materially commercial
markets for LICENSED PRODUCTS. SIGMA IMPROVEMENTS may be patentable or
unpatentable, and if patentable, need not be patented.
1.23 "TERM OF THE LICENSE" means the period commencing with the date
on which the LICENSE is executed by all parties and ending (a) for LICENSED
PRODUCTS covered by the claims of one or more LICENSED PATENTS, on the date of
expiration of the last to expire of the LICENSED PATENTS which has a claim
covering the LICENSED PRODUCTS; or alternatively, (b) for LICENSED PRODUCTS not
covered by a claim of one or more LICENSED PATENTS, on the date seven years
after the LICENSE is executed.
1.24 "NET SALES" means the gross amount invoiced for the LICENSED
PRODUCTS, less all taxes, duties, trade, quantity and cash discounts actually
allowed, and credits or allowances actually granted on account of rejections,
returns, billing errors or retroactive price reductions.
1.25 "INITIAL NET SALES" means NET SALES until the time when the
cumulative total of NET SALES equals an amount of $3,167,000.
1.26 "REMAINING NET SALES" means the NET SALES after the time when
the cumulative total of NET SALES has surpassed an amount of $3,167,000.
1.27 "AFFILIATE" means any corporation or non-corporate business
entity, which controls, is controlled by, or is under common control with a
party to this AGREEMENT. A corporation or non-corporate business entity shall be
regarded as in control of another corporation if it owns, or directly or
indirectly controls, at least forty (40%) percent of the voting stock of the
other corporation or (i) in the absence of the ownership of at least forty (40%)
percent of the voting stock of a corporation or (ii) in the case of the
5
non-corporate business entity, or non-profit corporation, if it possesses,
directly or indirectly, the power to direct or cause the direction of the
management and policies of such corporation or non-corporate business entity, as
applicable.
1.28 "IMMTECH-NORTHWESTERN LICENSE AGREEMENT" means a duly executed
agreement between IMMTECH and Northwestern University, Evanston, IL
(hereinafter, NORTHWESTERN) by which NORTHWESTERN grants IMMTECH exclusive
worldwide rights to the LICENSED PATENTS and to any LICENSED TECHNOLOGY owned by
NORTHWESTERN, with such granted rights being sufficient in scope to allow SIGMA
to develop commercial diagnostic assays for determining hemoglobin type Alc
("Hb(alc)") by detecting a reduced form of Hb (alc), and to make, have made, use
and sell such assays.
2. DELIVERY OF MATERIALS, PROGENY, IMMTECH BIOMATERIALS and IMMTECH
TECHNOLOGY
2.1 IMMTECH will deliver MATERIALS TO SIGMA within 10 days of the
EFFECTIVE DATE. The minimum quantity of delivered MATERIALS will include at
least two vials of viable hybridoma cells which will produce MMLO3 monoclonal
antibodies.
2.2 IMMTECH agrees to deliver additional quantities of MATERIALS to
SIGMA during the EVALUATION PERIOD and the RESEARCH AND DEVELOPMENT PERIOD of
this AGREEMENT upon request by SIGMA, which such additional MATERIALS are
reasonable necessary for technical evaluation, research or product development
as described in (P) 3.1, below.
2.3 IMMTECH agrees to deliver to SIGMA any and all PROGENY, IMMTECH
BIOMATERIALS, IMMTECH TECHNOLOGY and IMMTECH IMPROVEMENTS throughtout the
EVALUATION PERIOD and the RESEARCH AND DEVELOPMENT PERIOD OF THIS AGREEMENT to
allow or assist SIGMA for technical evaluation, research, or product development
as described in (P) 3.1, below.
3. USE OF MATERIALS, PROGENY, IMMTECH BIOMATERIALS and IMMTECH TECHNOLOGY
DURING EVALUATION PERIOD
3.1 SIGMA may use the MATERIOALS, PROGENY, IMMTECH BIOMATERIALS,
IMMTECH TECHNOLOGY and IMMTECH IMPROVEMENTS during the EVALUATION PERIOD for the
purpose of technical evaluation, including without limitation, evaluation of
MONOCLONALITY, CELL GROWTH and SPECIFICITY, and for the purposes of research or
product development, including,
6
without limitation, development of SIGMA BIOMATERIALS and SIGMA PRODUCTS.
3.2 None of the MATERIALS, PROGENY, IMMTECH BIOMATERIALS, IMMTECH
TECHNOLOGY or IMMTECH IMPROVEMENTS may be transferred to others outside of
SIGMA'S research facilities during the EVALUATION PERIOD of this AGREEMENT
without the written consent of IMMTECH, but such consent shall not be
unreasonably withheld.
4. PAYMENT AND REPORTS DURING THE EVALUATION PERIOD
4.1 SIGMA will pay IMMTECH an amount of twenty thousand dollars
($20,000) within ten days after the latter of (a) the EFFECTIVE DATE of this
AGREEMENT or (b) SIGMA's initial receipt of MATERIALS from IMMTECH.
4.2 SIGMA will evaluate MONOCLONALITY and CELL GROWTH within two
months after SIGMA's initial receipt of MATERIALS from IMMTECH. If MONOCLONALITY
and CELL GROWTH is acceptable to SIGMA, and if SIGMA decides, in its sole
discretion, to continue with further evaluation and/or research and/or product
development efforts, SIGMA will pay IMMTECH an additional amount of twenty-five
thousand dollars ($25,000) within two months after the latter of (a) the
EFFECTIVE DATE of this AGREEMENT or (b) SIGMA'S INITIAL receipt of MATERIALS
from IMMTECH.
4.3 SIGMA will evaluate SPECIFICITY within six months after SIGMA'S
initial receipt of MATERIALS from IMMTECH. If SPECIFICTY is acceptable to SIGMA,
and if SIGMA decides, in its sole discretion, to enter the RESEARCH AND
DEVELOPMENT PERIOD to continue with further evaluation and/or research and/or
product development efforts, SIGMA will pay IMMTECH an additional amount of
fifty thousand dollars ($50,000) within six months after the latter of (a) the
EFFECTIVE DATE of this AGREEMENT or (b) SIGMA'S INITIAL receipt of MATERIALS
from IMMTECH.
4.4 SIGMA will provide a written report to IMMTECH after the end of
the EVALUAITON PERIOD detailing the results of SIGMA'S evaluation of
MONOCLONALITY, CELL GROWTH and SPECIFICITY.
5. USE OF MATERIALS, PROGENY, IMMTECH BIOMATERIALS and IMMTECH TECHNOLOGY
DURING RESEARCH AND DEVELOPMENT PERIOD
5.1 Upon entering the RESEARCH AND DEVELOPMENT PERIOD in accordance
with (P) 4.3 above, SIGMA may use the
7
MATERIALS, PROGENY, IMMTECH BIOMATERIALS, IMMTECH TECHNOLOGY, and IMMTECH
IMPROVEMENTS during the RESEARCH AND DEVELOPMENT PERIOD for the purpose of
technical evaluation, including without limitation, evaluation of MONOCLONALITY,
CELL GROWTH and SPECIFICITY, and for the purposes of research or product
development, including, without limitation, development of SIGMA BIOMATERIALS
and SIGMA PRODUCTS.
5.2 During the RESEARCH AND DEVELOPMENT PERIOD of this AGREEMENT,
SIGMA may use the MATERIALS and PROGENY in human clinical trials.
5.3 MATERIALS, PROGENY, IMMTECH BIOMATERIALS, IMMTECH TECHNOLOGY, or
IMMTECH IMPROVEMENTS may be transferred during the RESEARCH AND DEVELOPMENT
PERIOD to appropriate regulatory authorities where such transfer is reasonably
necessary for the purpose of obtaining U.S. Food and Drug Administration (FDA)
approval of a commercial Hb(A1c) assay or for the purpose of obtaining
equivalent approval in a foreign country.
6. RETURN OF MATERIALS, PROGENY, IMMTECH BIOMATERIALS AND IMMTECH
TECHNOLOGY / PARTIAL REFUND OF PAYMENTS
6.1 If SIGMA determines, in its sole discretion, during the
EVALUATION PERIOD or the RESEARCH AND DEVELOPMENT PERIOD, that the MATERIALS or
PROGENY evaluated in accordance with (P.) 4.2 and (P.) 4.3 are not suitable for
further evaluation, research and/or product development, or that it is no longer
of commercial interest to develop a commercial Hb(A1c) assay involving the
MATERIALS or PROGENY, then SIGMA will return the MATERIALS and any PROGENY,
IMMTECH BIOMATERIALS, IMMTECH TECHNOLOGY or IMMTECH IMPROVEMENTS to IMMTECH and
provide a report to IMMTECH which explains the basis upon which the MATERIALS or
PROGENY were determined to be unsuitable or the assays were determined to be not
of commercial interest.
6.2 IMMTECH will, upon receipt of the returned MATERIALS and any
PROGENY, IMMTECH BIOMATERIALS, IMMTECH TECHNOLOGY or IMMTECH IMPROVEMENTS and
upon receipt of a report from SIGMA in accordance with (P.) 6.1, refund an
amount of twenty-five thousand dollars ($25,000) to SIGMA.
7. OWNERSHIP
7.1 The MATERIALS, PROGENY, IMMTECH MATERIALS, IMMTECH TECHNOLOGY,
IMMTECH IMPROVEMENTS and any intellectual property rights associated therewith
shall be owned by IMMTECH.
8
7.2 The SIGMA BIOMATERIALS, SIGMA TECHNOLOGY, SIGMA PRODUCTS, SIGMA
IMPROVEMENTS and any intellectual property rights associated therewith shall be
owned by SIGMA.
8. GRANT OF OPTION
8.1 IMMTECH hereby grants SIGMA an OPTION to license the PATENT
RIGHTS and the TECHNOLOGY RIGHTS under the terms set forth below.
8.2 SIGMA shall have the sole discretion as to whether or not to
exercise the OPTION.
8.3 The OPTION to license shall remain open and be exercisable by
SIGMA for an option period extending from the EFFECTIVE DATE of this AGREEMENT
until and including the date which is three months after the end of the
EVALUATION PERIOD of this AGREEMENT. If SIGMA informs IMMTECH in writing that
SIGMA does not desire to exercise its OPTION or if SIGMA fails to exercise its
OPTION with the aforementioned option period, IMMTECH shall have the right
thereafter to enter into an agreement with a third party or parties pertaining
to the MATERIALS, PROGENY, IMMTECH BIOMATERIALS, IMMTECH TECHNOLOGY or IMMTECH
IMPROVEMENTS and SIGMA shall return all such MATERIALS, PROGENY, IMMTECH
BIOMATERIALS, IMMTECH TECHNOLOGY or IMMTECH IMPROVEMENTS in SIGMA's possession
to IMMTECH.
8.4. If SIGMA decides to exercise its OPTION, no further fees beyond
those set forth under (P.) 4.1, (P.) 4.2 and (P.) 4.3 will be required at the
time of exercising the option. Additional fees and/royalties may, however, be
due, as applicable, under a LICENSE which includes the provisions of (P.) 8.7(c)
(P.) 8.7(d) and/or (P.) 8.7(g) of this AGREEMENT.
8.5 SIGMA can exercise the OPTION by (a) notifying IMMTECH that
SIGMA is exercising its option, and (b) unless previously paid by SIGMA, paying
IMMTECH the feel required under (P.) 4.3.
8.6 Upon exercise of the OPTION, the parties will negotiate in good
faith, and will, within a negotiation period of six months from the date on
which SIGMA exercised its OPTION, agree on and execute a LICENSE which includes
the terms set forth in (P.) 8.7, as well as any other terms, provisions and/or
conditions that the parties negotiate in good faith. If SIGMA and IMMTECH have
failed to execute a LICENSE having such terms within such negotiation period,
then SIGMA shall return all MATERIALS, PROGENY, IMMTECH MATERIALS, IMMTECH
TECHNOLOGY or IMMTECH IMPROVEMENTS in SIGMA's possession to IMMTECH, and IMMTECH
shall thereafter
9
have the right to enter into an agreement with a third party or parties
pertaining to the MATERIALS, PROGENY, IMMTECH BIOMATERIALS, IMMTECH TECHNOLOGY
or IMMTECH IMPROVEMENTS, provided that such third-party agreement does not
contain any terms or provisions which are more favorable to the third party than
IMMTECH had offered in writing to SIGMA during such negotiation period.
8.7 The LICENSE shall include the following terms, provisions and/or
conditions:
(a) IMMTECH shall grant SIGMA exclusive, worldwide rights under the
LICENSED PATENTS and under the LICENSED TECHNOLOGY to possess, use, make, have
made, lease, sell and have sold all MATERIALS, PROGENY, IMMTECH BIOMATERIALS,
IMMTECH TECHNOLOGY, IMMTECH IMPROVEMENTS thereto, and LICENSED PRODUCTS.
(b) SIGMA shall have the right to sublicense the LICENSED PATENTS
and LICENSED TECHNOLOGY to third parties.
(c) SIGMA shall pay IMMTECH an amount of $60,000 upon the earlier of
(i) the date of obtaining U.S. Federal Drug Administration (FDA) approval of a
LICENSED PRODUCT, or (ii) the date of the first sale of a LICENSED PRODUCT.
(d) SIGMA shall, during the TERM OF THE LICENSE, pay to IMMTECH
royalties as follows:
(i) at the rate of two percent (2%) of the INITIAL NET SALES
of LICENSED PRODUCTS; and then
(ii) at the rate of percent (5%) of the REMAINING NET SALES of
LICENSED PRODUCTS.
(e) SIGMA shall not be required to pay royalties to IMMTECH under
(P.) 8.7(d) for sales of LICENSED PRODUCTS made to AFFILIATES of SIGMA for
purposes of resale. Additionally, no multiple royalties shall be payable because
any LICENSED PRODUCT is covered by more than one patent or patent claim of the
LICENSED PATENTS. Moreover, in the event that any MATERIALS OR PROGENY become
available to third parties for commercial purposes through an act of or failure
to act by IMMTECH, the obligations of SIGMA set forth in (P.) 8.7(d) shall
terminate.
(f) For the first two year period following the date of the first
sale of a LICENSED PRODUCT, SIGMA shall meet a two-year target NET SALES amount
to be mutually agreed upon by the parties based on SIGMA's market projections,
failing which IMMTECH shall have the option, upon sixty (60) days written notice
to SIGMA, to license one other entity under the LICENSED PATENTS and LICENSED
TECHNOLOGY, with the
10
LICENSE otherwise remaining in force. However, if during such sixty (60) day
period SIGMA pays the difference in royalties due based on the above-stated
target NET SALES versus the actual NET SALES for the two-year period, then the
LICENSE will continue in effect, without any changes as to the exclusivity
thereto. Moreover, should IMMTECH license one other entity under the LICENSED
PATENTS and/or LICENSED TECHNOLOGY: (i) such third-party agreement will not
contain any terms or provisions which are more favorable to the third-party than
those contained in the LICENSE between IMMTECH and SIGMA, and (ii) SIGMA shall
be able to recover an amount of one-half of the $60,000 fee paid pursuant to
(P.) 8.7 (c) by discounting the royalty payment required under (P.) 8.7 (d) (ii)
by 3% to obtain an effective royalty rate of 2% until such amount is recovered.
(g) SIGMA will make any maintenance payments or annuities required
for any LICENSED PATENTS for countries in which the claims such patents cover
the LICENSED PRODUCTS.
(h) Notwithstanding anything in the LICENSE to the contrary:
(i) SIGMA shall have the right to terminate the LICENSE at its
sole discretion by giving written notice to IMMTECH at least ninety
(90) days prior to the effective date of termination provided that
such effective date is on or before the last day of the RESEARCH
AND DEVELOPMENT PERIOD; and
(ii) either party shall, in the event of any material default
of the LICENSE by the other party, have the right to terminate the
LICENSE by giving written notice to the other party at Least ninety
(90) days prior to the effective date of termination, unless, after
receiving written notice of such default, the default is cured or
remedied by the defaulting party within ninety (90) days.
(i) Upon expiration or termination of the LICENSE for any reason,
SIGMA shall have the right, for a period of one (1) year from the effective date
thereof, to sell all LICENSE PRODUCTS on hand and to produce and sell all
MATERIALS or PROGENY on hand, subject to the obligations of SIGMA to pay
royalties, as provided for in (P.) 8.7(d), above.
9. CONFIDENTIALITY
9.1 Any information, including information existing as IMMTECH
TECHNOLOGY or SIGMA TECHNOLOGY, that is communicated between the parties and
that is designated by the parties as being confidential information by a written
11
notice to the non-owning party within thirty (30) days after the first written
disclosure of that information by either party to the other, the non-owning
party shall, until five (5) years from the date of the expiration or termination
of this AGREEMENT: (a) take all reasonable steps to prevent disclosure of such
information to any third party and (b) not utilize any of such information for
any purpose other than the purposes provided in this AGREEMENT.
9.2 The obligations of confidentiality and non-use set forth in (P.)
9.1 shall not preclude disclosure of such information in a patent application or
in the prosecution of a patent application provided that the written consent of
the owning party is obtained prior to such disclosure.
9.3 The obligations of confidentiality and non-use set forth in (P.)
9.1 shall not extend to any of such information for which a non-owing party can
show:
(a) by the non-owning party's prior written records was already in
the non-owning party's possession prior to the date of such disclosure;
(b) such information became gennerally available to the public
through issuance or publication of a patent or application;
(c) such information is otherwise is or becomes generally available
to public through non fault of the non-owning party;
(d) such information is received by the non-owning party in good
faith from a third party on a non-confidential basis without violating any
obligation of secrecy to the owner party relating to the information disclosed;
or
(e) written consent to disclose such information was given by the
owning party.
10. PUBLICATION
10.1 If a non-patent publication results from SIGMA's work using the
MATERIALS, PROGENY, BIOMATERIALS, IMMTECH TECHNOLOGY, or IMMTECH IMPROVEMENTS,
SIGMA will acknowledge IMMTECH's provision of the same and will give credit to
IMMTECH scientists, as scientifically appropriate, based on any direct
contribution made.
12
11. WARRANTIES, DISCLAIMERS and LIMITATIONS ON LIABILITIES
11.1 SIGMA hereby represents and warrants to IMMTECH, that SIGMA is
a corporation duly organized, validly existing and in good standing under the
Laws of the State of Missouri and has all requisite corporate power and
authority to enter into this Agreement and perform its obligations hereunder.
11.2 IMMTECH hereby represents and warrants to SIGMA that the
following are true and correct as of the EFFECTIVE DATE of this AGREEMENT:
(a) IMMTECH is a corporation duly organized, validly existing and in
good standing under the laws of the State of Delaware and has the power and
authority to enter into this Agreement and perform its obligations hereunder;
(b) IMMTECH owns the LICENSE PATENTS or is the worldwide exclusive
licensee of the LICENSE PATENTS and has the right to sublicense the same to
SIGMA;
(c) There are no claims relating to patent infringement or other
matters, actions, suits, proceedings, arbitrations or investigations pending or,
to the best of knowledge, threatened, against IMMTECH which if adversely
determined, would adversely affect the MATERIALS, PROGENY, IMMTECH BIOMATERIALS,
IMMTECH TECHNOLOGY, IMMTECH IMPROVEMENTS, LICENSED PATENTS (or the patentability
thereof), LICENSED TECHNOLOGY and/or LICENSED PRODUCTS, or other related
technology practiced by IMMTECH, or IMMTECH's ability to enter into or carry out
this AGREEMENT; and
(d) As of the date hereof, IMMTECH warrants that (i) it has no
knowledge that the manufacture, use, importation or sale of any MATERIALS,
PROGENY, IMMTECH BIOMATERIALS, IMMTECH TECHNOLOGY, IMMTECH IMPROVEMENTS,
LICENSED PATENTS, LICENSED TECHNOLOGY and/ or LICENSED PRODUCTS under this
AGREEMENT either alone or in combination, nor any method of using such the same
infringes any patent or other industrial property right of a third party; and
(ii) it has not received any notification from any third party alleging or
suggesting that the manufacture, use, importation or sale of any such MATERIALS,
PROGENY, IMMTECH BIOMATERIALS, IMMTECH TECHNOLOGY, IMMTECH IMPROVEMENTS,
LICENSED PATENTS, LICENSED TECHNOLOGY and/ or LICENSED PRODUCTS does or would
infringe any patent or other industrial property. IMMTECH shall disclose to
SIGMA any information regarding adverse patent rights of which it is or becomes
aware and which relates to such MATERIALS, PROGENY, IMMTECH BIOMATERIALS,
13
IMMTECH TECHNOLOGY, IMMTECH IMPROVEMENTS, LICENSED PATENTS, LICENSED TECHNOLOGY
and/or PRODUCTS.
11.3 Notwithstanding the representations and warranties of IMMTECH
provided under (P.) 11.2, IMMTECH makes no representations or warranties as to
the suitability of the MATERIALS or PROGENY for their intended use by SIGMA.
SIGMA acknowledges that THE MATERIALS ARE EXPERIMENTAL IN NATURE AND THEY ARE
PROVIDED WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE
OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED, OF ANY KIND, except as set forth
above in (P.) 11.2.
12. MISCELLANEOUS AND GENERAL
12.1 SIGMA acknowledges that IMMTECH is subject to United States
laws and regulations controlling the export of technical data, computer
software, laboratory prototypes and other commodities and that its obligations
hereunder are contingent on compliance with all applicable United States export
and other laws and regulations. The transfer of certain technical data and
commodities may require a license from the cognizant agency of the United States
Government and/or written assurances by SIGMA that SIGMA shall not export data
or commodities to certain foreign countries without prior approval of such
agency. IMMTECH neither represents that a license shall not be required or that,
if required, it shall be issued.
12.2 SIGMA shall obtain any and all licenses, permits, approvals or
authorizations ("REQUIRED CONSENTS") required by any governmental entity or
agency having jurisdiction over the transactions contemplated by this AGREEMENT.
IMMTECH shall cooperate with, and provide reasonable assistance to, SIGMA in
obtaining the REQUIRED CONSENTS; provided, however, that SIGMA shall reimburse
IMMTECH for all IMMTECH out-of-pocket expenses incurred in providing such
assistance.
12.3 All notices, statements and reports required or contemplated
herein by one party or the other shall be in writing and shall be deemed to have
been given upon delivery in person or upon the expiration of five (5) days after
deposit in a lawful mail depository in the country of residence of the party
giving the notice, registered or certified airmail postage prepaid, and
addressed as follows:
14
If to Immtech: Attention: Mr. Xxxxx Xxxxxxxx
CEO & President
Immtech International Inc.
0000 Xxxxx Xxxxxx, Xxxxx 000
Xxxxxxxx, Xxxxxxxx 00000
Facsimile: (000) 000-0000
With a copy to: Xxxxx X. Xxxxxx, Esq. Ph.X.
Xxxxxx, Xxxxx, Xxxxxx & Xxxxx
NBC Tower - Suite 3600
000 X. Xxxxxxxxx Xxxxx Xxxxx
Xxxxxxx, XX 00000-0000
Facsimile: (000) 000-0000
If to Sigma: Attention: Xx. Xxxxxxx X. Xxxx
Vice President
Sigma Diagnostics
000 Xxxxx Xxxxx Xxxxxx
Xx. Xxxxx, Xxxxxxxx 00000
Facsimile: (314) 286-78l9
Either party hereto may change the address to which notices to such party are to
be sent by giving notice to the other party at the address and in the manner
provided above. Any notice herein required or permitted to be given, in addition
to the manner set forth above, by telex, facsimile or cable, provided that the
party giving such notice obtains acknowledge by telex, facsimile or cable that
such notice has been received by the party to be notified. Notice made in this
manner shall be deemed to have been given when such acknowledgment has been
transmitted.
12.4 SIGMA shall not grant, transfer, convey, sublicense or
otherwise assign any of its rights or delegate any of its obligations under this
AGREEMENT other than to an affiliated company without the prior written consent
of IMMTECH, and any attempt to do so shall be of no effect; however, this
AGREEMENT shall be assignable by IMMTECH. This AGREEMENT shall be binding upon
and inure to the benefit of the successors and permitted assigns of the parties
hereto.
12.5 This AGREEMENT constitutes the entire agreement between IMMTECH
and SIGMA with respect to the subject matter hereof and shall not be modified,
amended or terminated except as herein provided or except by another agreement
in writing executed by the parties hereto.
12.6 The section and paragraph headings are for convenience only and
are not a part of this AGREEMENT.
15
12.7 All rights and restrictions contained herein may be exercised
and shall be applicable and binding only to the extent that they do not violate
any applicable laws and are intended to be limited to the extent necessary so
that they will not render this AGREEMENT illegal, invalid or unenforceable. If
any provision or portion of any provision of this AGREEMENT not essential to the
commercial purpose of this AGREEMENT shall be held to be illegal, invalid or
unenforceable by a court of competent jurisdiction, it is the intention of the
parties that the remaining provisions or portions thereof shall constitute their
agreement with respect to the subject matter hereof, and all such remaining
provisions or portions hereof shall remain in full force and effect. In the
event that any provision essential to the commercial purpose of this AGREEMENT
is held to be illegal, invalid or unenforceable and cannot be replaced by a
valid provision which will implement the commercial purpose of this AGREEMENT,
this AGREEMENT and the rights granted herein shall terminate.
12.8 The term of this AGREEMENT shall begin on the EFFECTIVE DATE
and shall continue in effect through the EVALUATION PERIOD and through the
RESEARCH AND DEVELOPMENT PERIOD, unless otherwise allowed to lapse by SIGMA
pursuant to its discretion under (Paragraphs) 4.2, 4.3 and 6.1.
IN WITNESS WHEREOF, the parties have caused this AGREEMENT to be
executed by their duly authorized representatives as of day and year first above
written.
IMMTECH:
IMMTECH INTERNATIONAL INC.
By: /s/ T. Xxxxxxx Xxxxxxxx
------------------------------------
SIGMA:
SIGMA DIAGNOSTICS
By: /s/ Xxxxxxx X. Xxxx
------------------------------------
Xxxxxxx X. Xxxx
Vice President
16
LICENSE AGREEMENT
This Agreement made this tenth (10th) day of March, 1998, (the
"Effective Date"), by and between Northwestern University, an Illinois
corporation having a principal office at 000 Xxxxx Xxxxxx, Xxxxxxxx, Xxxxxxxx
00000 (hereinafter referred to as "Northwestern") and Immtech International
Inc., a Delaware corporation having a principal office at 0000 Xxxxx Xxxxxx,
Xxxxx 000, Xxxxxxxx, XX. 00000 (hereinafter referred to as "Licensee") (each a
"Party" and collectively the "Parties").
WITNESSETH
WHEREAS, Northwestern is the owner of certain patent rights and
know-how relating to Immunoassay Constructs to Quantitate
Glucosylated-Hemoglobin and other Glucosylated Serum Proteins (NU 8403) and has
the right to grant licenses hereunder, subject only to a royalty-free,
nonexclusive license heretofore granted to the United States Government;
WHEREAS, Northwestern desires to have the patent rights and know-how
developed and commercialized to benefit the public and is willing to grant a
license hereunder;
WHEREAS, Licensee has represented to Northwestern that Licensee will
commit itself to a thorough, vigorous and diligent program to develop and
subsequently manufacture, market and sell products utilizing the patent rights
and know-how;
WHEREAS, Licensee desires to obtain a license under the patent
rights and know-how upon the terms and conditions hereafter set forth;
NOW THEREFORE, in consideration of the premises and mutual covenants
contained herein, the Parties hereto agree as follows:
ARTICLE I - DEFINITIONS
1.1 "Affiliate" shall mean any corporation, firm, partnership or other
entity which controls, is controlled by or is under common control with a Party.
For the purposes of this definition, "control" shall mean any right or
collection of rights that together allow direction on any vote with respect to
any action by an entity or the direction of management and operations of that
entity. Such right or collection of rights includes without limitation (a) the
authority to act as sole member or shareholder or partner with a majority
interest in an entity; (b) a majority interest in an entity; and (c) the
authority to appoint, elect, or approve at least a majority of the governing
board of that entity.
1.2 "Field" shall mean the use of immunoassays for diagnostic purposes to
quatitate hemoglobin type A.1c.
1.3 "Know-How" shall mean any and all technical information existing as of
the Effective Date or generated during the term of this Agreement which is owned
or controlled by Northwestern and directly relates to Licensed Products and
shall include, without limitation, all biological, chemical, pharmaceutical,
pharmacological, toxological, clinical, assay control and manufacturing data and
any other information relating to the Licensed Products and useful for the
development, Regulatory Approval, commercialization or safety and effectiveness
of the Licensed Products.
1.4 "Licensed Products" shall mean diagnostic assays for determining
hemoglobin type A.1c.
1.5 "Net Sales" shall mean the gross amount invoiced by Licensee, its
Affiliates or its sublicensees, to third parties for the sale of Licensed
Products, less amounts actually invoiced or allowed with respect to trade
credits, discounts, rebates and allowances actually granted on account of price
1
adjustments, rebate programs, billing errors or the rejection or return of
goods, sales taxes, tariffs, and custom duties. If a Licensed Product is sold as
part of a combination, Net Sales for the purposes of determining royalties on
the Licensed Product(s) in the combination shall be calculated by multi plying
Net Sales by the fraction A/A+B, where A is the invoice price of the Licensed
Product(s) sold separately and B is the invoice price of the other active
ingredients in the combination.
1.6 "Patent Rights" shall mean the patents and patent applications listed
on Exhibit A attached hereto and incorporated herein by reference, and any
patents which issue from the patent applications listed on Exhibit A attached
hereto and incorporated herein by reference, and all substitutions, additions,
extensions, reissues, renewals, divisions, continuations and
continuations-in-part thereof and any foreign counterparts thereto.
1.7 "Regulatory Approval" shall mean the approval of either the Food Drug
Administration of the United States or a foreign counterpart thereto required to
commence commercial sale of a Licensed Product in such country in the Territory.
1.8 "Territory" shall mean the entire world.
ARTICLE II - GRANT
2.1 Northwestern hereby grants to Licensee and its Affiliates an exclusive
license under Patent Rights and Know-How to make, have made, use, import, offer
for sale and sell Licensed Products in the Territory in the Field.
2.2 The grant under Paragraph 2.1 shall be subject to the obligations of
Northwestern and of Licensee to the United States Government under any and all
applicable laws, regulations, and executive orders including those set forth in
35 U.S.C. ss.200, et seq.
2.3 Northwestern retains the right to utilize Patent Rights and Know-How
for noncommercial research purposes.
2.4 Northwestern hereby grants to Licensee the right to grant sublicenses
consistent with this Agreement provided that Licensee shall be responsible for
the performance of its sublicensees, including the payment of royalties.
ARTICLE III- CONFIDENTIAL INFORMATION
3.1 Northwestern and Licensee each agree that all information contained in
documents marked "Confidential" which are forwarded to one by the other shall be
received in strict confidence, used only for the purposes of this Agreement and
not disclosed by the recipient (except as required by law or court agency or
administrative order), its agents or employees to any third party without the
prior written consent of an authorized officer of the disclosing Party, unless
such information (a) was in the public domain at the time of disclosure, (b)
later became part of the public domain through no act or omission of the
recipient, its employees, agents, successors or assigns, (c) was lawfully
disclosed to the recipient by a third party having the right to disclose it, (d)
was already known by the recipient at the time of disclosure, (e) was
independently developed, (f) is required by law or court or administrative
agency order, or (g) is required to be submitted to a government agency to
obtain and maintain the approvals and clearances of Licensed Products.
Disclosure may also be made to Affiliates, distributors, customers, and agents,
to nonclinical and clinical investigators, and to consultants, where necessary
or desirable with appropriate safeguards to protect the confidential underlying
disclosure. Northwestern and Licensee also agree that confidential information
may be orally disclosed by one Party to the other Party. Such information shall
be confirmed in writing and designated "Confidential" within thirty (30) days of
disclosure for the provisions of this Article III to apply.
2
3.2 Each Party's obligation of confidence hereunder shall be fulfilled by
using at least the same degree of care with the other Party's confidential
information as it uses to protect its own confidential information. This
obligation shall exist while this Agreement is in force and for a period of two
(2) years thereafter except in the event of termination by Northwestern for
breach on the part of Licensee, in which event Licensee's obligation to maintain
the information confidential will exist for a period of ten (10) years after the
termination for breach.
3.3 This Agreement may be distributed solely (a) to those employees,
agents and independent contractors of Northwestern and Licensee who have a need
to know its contents, (b) to those persons whose knowledge of its contents will
facilitate performance of the obligations of the parties under this Agreement,
(c) to those persons, if any, whose knowledge of its contents is essential in
order to permit Licensee or Northwestern to maintain or secure the benefits
under policies of insurance, or (d) as may be required by law or regulation or
by court or administrative agency order.
ARTICLE IV - DUE DILIGENCE
4.1 Licensee shall, upon execution of this Agreement, submit to
Northwestern a preliminary development and business plan that sets forth an
outline of Licensee's intended efforts to develop and commercialize Licensed
Products. Such plan shall include a summary of personnel, expenditures and
estimated timing for the development of Licensed Products and estimates of the
market potential for Licensed Products.
4.2 Licensee agrees to devote that level of resources to the
commercialization of a Licensed Product as other companies in the industry
customarily devote to products of similar commercial potential.
ARTICLE V - PAYMENT
In consideration of the license granted by Northwestern to Licensee under
this Agreement, Licensee shall pay to Northwestern the following:
5.1 A non-creditable, non-refundable license issue fee of Twenty Thousand
Dollars ($20,000), of which the first ten thousand dollars ($10,000) shall be
paid within thirty (30) days of execution of this Agreement, and ten thousand
dollars ($10,000) shall be paid within three (3) months from the Effective Date,
but no later than August 1, 1998.
5.2 Beginning the first full calendar year after the Regulatory Approval
of a Licensed Product in a major market country, or the year 2003, whichever
comes first, Licensee shall pay to Northwestern minimum royalty payments of
$10,000 per year. Any such minimum royalty payments shall be fully creditable
against any payments required under Paragraph 5.4.
5.4 A running royalty of (a) six percent (6%) of Net Sales of Licensed
Products for the first Ten Million Dollars ($10,000,000) in sales anywhere in
the world, and (b) four percent (4%) of Net Sales of Licensed Products on sales
exceeding Ten Million Dollars anywhere in the world.
5.5 For all sublicenses granted by Licensee, a royalty at the rate of
thirty five percent (35%) of all royalties earned by Licensee under such
sublicenses.
5.5 In addition to the running royalties under Paragraph 5.4, ten percent
(10%) of any payments, including, but not limited to, sublicense issue fees or
milestones received from sublicensees as consideration for Patent Rights,
Know-How or Licensed Products.
5.6 In the event of a permitted assignment of this Agreement, five percent
(5%) of any payments received from such assignee as consideration for Patent
Rights, Know-How or Licensed Products, as defined herein.
3
ARTICLE VI - PAYMENT, REPORTS AND RECORDS
6.1 Payment Dates and Reports
Within sixty (60) days after the end of each calendar quarter of
each year during the term of this Agreement (including the last day of any
calendar quarter following the expiration of this Agreement), Licensee shall pay
to Northwestern, all royalties accruing during such calendar quarter. Such
payments shall be accompanied by a statement showing the Net Sales of each
Licensed Product by Licensee and its sublicensees in each country, the
applicable royalty rate and the calculation of the amount of royalty due.
6.2 Accounting
a. Payments in U.S. Dollars
All dollar sums referred to in this Agreement are expressed in
U.S. dollars and the Net Sales used for calculating the royalties and other sums
payable to Northwestern by Licensee pursuant to Paragraph 6.1 shall be computed
in U.S. dollars. All payments of such sums and royalties shall be made in U.S.
dollars. For purposes of determining the amount of royalties due, the amount of
Net Sales in any foreign currency shall be computed by converting such amount
into U.S. dollars at the prevailing commercial rate of exchange for purchasing
U.S. dollars with such foreign currency in question as quoted by Citibank in New
York on the last business day of the calendar quarter for which the relevant
royalty payment is to be made by Licensee.
b. Blocked Royalties
Notwithstanding the foregoing, if by reason of any restrictive
exchange laws or regulations Licensee or any Affiliate or sublicensee hereunder
shall be unable to convert to U.S. dollars an amount equivalent to the royalty
payable by Licensee hereunder in respect of Licensed Product sold for funds
other than U.S. dollars, Licensee shall notify Northwestern promptly with an
explanation of the circumstances. In such event, all royalties due hereunder in
respect of the transaction so restricted (or the balance thereof due hereunder
and not paid in funds other than U.S. dollars as hereinafter provided) shall be
deferred and paid in U.S. dollars as soon as reasonably possible after, and to
the extent that such restrictive exchange laws or regulations are lifted so as
to permit such conversion to United States dollars, of which lifting Licensee
shall promptly notify Northwestern. At its option, Northwestern shall meanwhile
have the right to request the payment (to it or to a nominee), and upon such
request Licensee shall pay, or cause to be paid, all such amounts (or such
portions thereof as are specified by Northwestern) in funds, other than U.S.
dollars, designated by Northwestern and legally available to Licensee under such
then existing restrictive exchange laws or regulations.
6.3 Records
Licensee shall keep, and shall cause its Affiliates and sublicensees
to keep, for three (3) years from the date of payment of royalties, complete and
accurate records of sales of each Licensed Product by Licensee; its Affiliates
and its sublicensees in sufficient detail to enable the accruing royalties to be
determined accurately. Northwestern shall have the right during this period of
three (3) years after receiving any report with respect to royalties due and
payable to appoint, at its expense, an independent certified public accountant
to inspect the relevant records of Licensee, its Affiliates and its sublicensees
to verify such report. Northwestern shall submit the name of said accountant to
Licensee for approval; said approval shall not be unreasonably withheld.
Licensee shall make its records and those of its Affiliates and sublicensees
available for inspection by such independent certified public accountant during
regular business hours at such place or places where such records are
customarily kept, upon reasonable notice from Northwestern, to the extent
necessary to verify the accuracy of the reports and
4
payments with not more than one (I) inspection per calendar year. Northwestern
agrees to hold in strict confidence all information concerning royalty payments
and reports, and all information learned in the course of any audit or
inspection, except to the extent necessary for Northwestern to reveal such
information in order to enforce its rights under this Agreement or as may be
required by law. If royalties are understated by ten percent (10%) or more in
LICENSEE's favor, the LICENSEE shall, within ten (10) days of receipt of the
audit report, pay the balance due Northwestern plus all reasonable costs of the
audit or inspection and interest at the prime rate as quoted by Citibank in New
York from the date at which such balance would have otherwise been due and
payable. If royalties are understated by less than ten percent (10%), Licensee
shall include such understated amount with the next scheduled payment pursuant
to Paragraph 6.1.
ARTICLE VII - PUBLICATION
Northwestern will be free to publish the results of any research related
to Patent Rights, Know-How or Licensed Products and use any information for
purposes of research, teaching, and other educationally-related matters.
ARTICLE VIII - PATENT PROSECUTION
8.1 Northwestern has granted Licensee the right to apply for, seek prompt
issuance of, and maintain during the term of this Agreement the Patent Rights in
the United States and in the foreign countries listed in Exhibit A hereto. The
prosecution, filing and maintenance of all Patent Rights shall be the primary
responsibility of Licensee; provided, however, Northwestern shall have
reasonable opportunities to advise Licensee and shall cooperate with Licensee in
such prosecution, filing and maintenance.
8.2 Payment of all fees and costs relating to the filing, prosecution, and
maintenance of Patent Rights shall be the responsibility of Licensee, whether
such fees and costs were incurred before or after the Effective Date.
ARTICLE IX - INFRINGEMENT
9.1 Licensee shall inform Northwestern promptly in writing of any alleged
infringement of the Patent Rights by a third party and of any available evidence
thereof
9.2 During the term of this Agreement, Northwestern shall have the right,
but shall not be obligated, to prosecute at its own expense all infringements of
the Patent Rights and, in furtherance of such right, Licensee hereby agrees that
Northwestern may include Licensee as a party plaintiff in such suit, without
expense to Licensee. The total cost of any such infringement action commenced or
defended solely by Northwestern shall be borne by Northwestern and Northwestern
shall keep any recovery or damages for past infringement derived therefrom.
9.3 If within six (6) months after having been notified of any alleged
infringement, Northwestern shall have been unsuccessful in persuading the
alleged infringer to desist and shall not have brought and shall not be
diligently prosecuting an infringement action, or if Northwestern shall notify
Licensee at any time prior thereto of its intention not to bring suit against
any alleged infringer, then, and in those events only, Licensee shall have the
right, but shall not be obligated, to prosecute at its own expense any
infringement of the Patent Rights, and Licensee may, for such purposes, use the
name of Northwestern as party plaintiff; provided, however, that such right to
bring such infringement action shall remain in effect only for so long as the
license ranted herein remains exclusive. No settlement, consent judgment or
other voluntary final disposition of the suit may be entered into without the
consent
5
of Northwestern, which consent shall not unreasonably be withheld. Licensee
shall indemnify Northwestern against any order for costs that may be made
against Northwestern in such proceedings. Licensee shall keep any recovery or
damages for past infringement derived therefrom; provided, however, that such
recovery, less expenses, including reasonable attorneys' fees, shall be treated
as Net Sales for the purpose of calculating running royalties under Paragraph
5.4
9.4 In the event that a declaratory judgment action alleging invalidity or
noninfringement of any of the Patent Rights shall be brought against Licensee,
Northwestern, at its option, shall have the right, within thirty (30) days after
it receives notice of the commencement of such action, to intervene and take
over the sole defense of the action at its own expense.
9.5 In any infringement suit that either Party may institute to enforce
the Patent Rights pursuant to this Agreement, the other party hereto shall, at
the request and expense of the Party initiating such suit, cooperate in all
respects and, to the extent possible, have its employees testify when requested
and make available relevant records, papers, information, samples, specimens,
and the like.
9.6 Licensee, during the term of this Agreement, shall have the sole right
in accordance with the terms and conditions herein to sublicense any alleged
infringer for future use of the Patent Rights. Any upfront fees as part of such
a sublicense shall be shared equally between Licensee and Northwestern; other
royalties shall be treated pursuant to Paragraph 5.4.
ARTICLE X - PRODUCT LIABILITY
10.1 Licensee shall at all times during the term of this Agreement and
thereafter, indemnify, defend and hold Northwestern, its trustees, directors,
officers, employees and Affiliates, harmless against all claims, proceedings,
demands and liabilities of any kind whatsoever, including legal expenses and
reasonable attorneys' fees, arising out of the death of or injury to any person
or persons or out of any damage to property, or resulting from the production,
manufacture sale, use, lease, consumption or advertisement of the Licensed
Product(s) or arising from any obligation of Licensee hereunder.
10.2 Licensee and sublicensees involved in activities described in section
10.1 shall obtain and carry in full force and effect commercial, general
liability insurance which shall protect Licensee and Northwestern with respect
to events covered by paragraph 10.1 above. Such insurance shall be written by a
reputable insurance company authorized to do business in the State of Illinois,
shall list Northwestern as an additional named insured thereunder, shall be
endorsed to include product liability coverage and shall require thirty (30)
days written notice to be given to Northwestern prior to any cancellation or
material change thereof. The limits of such insurance shall not be less than
Five Million Dollars ($5,000,000) per occurrence with an aggregate of Fifteen
Million Dollars ($15,000,000) for personal injury or death, and One Million
Dollars ($1,000,000) per occurrence with an aggregate of Three Million Dollars
($3,000,000) for property damage. Licensee shall provide Northwestern with
Certificates of Insurance evidencing the same.
10.3 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT,
NORTHWESTERN, ITS TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES, AND AFFILIATES MAKE
NO REPRESENTATIONS AND EXTEND NO 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
NORTHWESTERN THAT THE PRACTICE BY LICENSEE OF THE LICENSE GRANTED HEREUNDER
SHALL NOT
6
INFRINGE THE PATENT RIGHTS OF ANY THIRD PARTY. IN NO EVENT SHALL NORTHWESTERN,
ITS TRUSTEES, DIRECTORS. OFFICERS, EMPLOYEES AND AFFILIATES BE LIABLE FOR
INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGE OR
INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHER NORTHWESTERN SHALL BE
ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE
POSSIBILITY.
ARTICLE XI - TERM AND TERMINATION
11.1 This Agreement shall become effective on the Effective Date. Unless
sooner terminated as provided for below, this Agreement shall continue in
effect, on a county-by-country basis, until (a) the expiration of the last to
expire of any Patent Rights, or (b) ten (10) years from the date of the first
commercial sale in countries where no Patent Rights exist
11.2 Licensee shall have the right to terminate this Agreement in whole or
in part anytime after three (3) years from the Effective Date by giving
Northwestern ninety (90) days written notice.
11.3 Northwestern shall have the right to terminate or render this license
non-exclusive at any time after three (3) years from the Effective Date if, in
Northwestern's reasonable judgement, Licensee a) has not put the Licensed
Product into commercial use in the Territory in the Field, directly or through a
sublicensee, thereby not making the Licensed Product available to the public, or
b) is not demonstrably engaged in research, development, manufacturing,
marketing as appropriate, directed towards this end.
11.4 The provisions of Article III (Confidentiality), Article VI
(Payments, Reports and Records), Article X (Product Liability) and Article XIII
(Dispute Resolution) shall survive termination or expiration of this Agreement
in accordance with their terms.
11.5 If(l) either Party breaches any material obligation imposed by this
Agreement; (2) either Party makes any general assignment for the benefit of its
creditors; (3) a petition is filed by or against either Party, or any proceeding
is initiated against either Party as a debtor, under any bankruptcy or
insolvency law, unless the laws then in effect void the effectiveness of this
provision; or (4) a receiver, trustee, or any similar officer is appointed to
take possession, custody, or control of all or any part of either Party's assets
or property, then the other Party may, at its option, send a written notice that
it intends to terminate the license granted by this Agreement
11.6 If the Party in breach does not cure the breach, negate the
assignment, obtain a dismissal of the proceeding, or have the appointment
vacated and regaining its assets within ninety (90) days from the notice date,
then the other Party shall have the right to terminate the license granted
immediately upon the date of mailing of a written notice of termination to the
Party in breach.
11.7 Upon termination of this Agreement for any cause, nothing herein
shall be construed to release either Party of any obligation that has matured
prior to the effective date of such termination. Licensee may, after the date of
such termination, sell all Licensed Products that it may have on hand at the
date of termination, provided that it pays the earned royalty thereon as
provided in this Agreement
11.8 In the event of termination for breach by Licensee, Licensee agrees
to no longer use any of the Patent Rights or Know-How under which it has been
granted a license and will turn over and assign to Northwestern its Regulatory
Approvals and data and material related to price and Regulatory Approvals at no
charge with the right to sub license.
11.9 Upon termination of this Agreement, any and all existing sublicense
agreements shall be immediately assigned to Northwestern and Northwestern agrees
to keep them in force to the extent that Northwestern is capable of performing
as a licensor in place of Licensee.
7
ARTICLE XII - ASSIGNMENT
This Agreement shall not be assignable by either Party without the prior
written consent of the other, except that any Party may assign this Agreement to
any Affiliate, to a successor in interest (including the surviving company in
any consolidation or merger), or to an assignee of substantially all the
business and assets of such Party, or with respect to Licensee, to an assignee
of all or substantially all of the business to which this Agreement relates.
ARTICLE XIII - DISPUTE RESOLUTION
13.1 The Parties agree to effect all reasonable efforts to resolve any and
all disputes between them in connection with this Agreement in an amicable
manner.
13.2 The Parties agree that any dispute that arises in connection with
this Agreement and which cannot be amicably resolved by the parties shall be
resolved by binding Alternative Dispute Resolution (ADR) in the manner set forth
in Paragraph 13.3 through Paragraph 13.5.
13.3 If a Party intends to begin ADR to resolve a dispute, such Party
shall provide written notice to the other Party informing the other Party of
such intention and the issues to be resolved. Within ten (10) business days
after its receipt of such notice, the other Parry may, by written notice to the
Party initiating ADR, add additional issues to be resolved. If the Parties
cannot agree upon the selection of a neutral within twenty (20) business days
following receipt of the original ADR notice, a neutral shall be selected by the
then President of the Center for Public Resources (CPR), 000 Xxxxx Xxxxxx, Xxx
Xxxx, Xxx Xxxx 00000. The neutral shall be a single individual having experience
in the biotechnology industry who shall preside in resolution of any disputes
between the Parties. The neutral selected shall not be an employee, director or
shareholder of either Party or an Affiliate or sublicensee.
13.4 Each Party shall have ten (10) business days from the date the
neutral is selected to object in good faith to the selection of that person. If
either Party makes such an objection, the then President of the CPR shall, as
soon as possible thereafter, select another neutral under the same conditions as
set forth above. This second selection shall be final.
13.5 The ADR shall be conducted in the following manner:
(a) No later than forty-five (45) business days after selection, the
neutral shall hold a hearing to resolve each of the issues identified by the
Parties.
(b) At least five (5) days prior to the hearing, each Party must
submit to the neutral and serve on the other Party a proposed ruling on each
issue to be resolved. Such proposed ruling shall contain no argument on or
analysis of the facts or issues, and shall be limited to not more than fifty
(50) pages.
(c) The neutral shall not require or permit any discovery by any
means, including depositions, interrogatories or production of documents.
(d) Each Party shall be entitled to no more than eight (8) hours of
hearing to present testimony or documentary evidence. The testimony of both
Parties shall be presented during consecutive calendar days. Such time
limitation shall apply to any direct, cross or rebuttal testimony, but such time
limitation shall only be charged against the Party conducting such direct, cross
or rebuttal testimony. It shall be the responsibility of the neutral to
determine whether the parties have had the eight (8) hours to which each is
entitled.
(e) Each Party shall have the right to be represented by counsel.
The neutral shall have the sole discretion with regard to the admissibility of
any evidence.
8
(f) The neutral shall rule on each disputed issue within thirty (30)
days following the completion of the testimony of both Parties. Such ruling
shall adopt in its entirety the proposed ruling of one of the parties on each
disputed issue.
(g) ADR shall take place in Chicago, Illinois. All costs incurred
for a hearing room shall be shared equally between the Parties.
(h) The neutral shall be paid a reasonable fee plus expenses, which
fees and expenses shall be shared equally by the Parties.
(i) The ruling shall be binding on the Parties and may be entered as
an enforceable judgment by a state or federal court having jurisdiction of the
Parties.
13.6 This Section XIII shall survive any termination of this Agreement
ARTICLE XIV - NOTICES AND PAYMENTS
Any payment notice or other communication pursuant to this Agreement shall
be sufficiently made or given on the date of mailing if sent to such Party by
certified first class mail, postage prepaid, addressed to it at its address
below or as it shall designate by written notice given to the other Party:
In the case of Northwestern: Director
Technology Transfer Program
Northwestern University
0000 Xxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxx 00000
In the case of Licensee: Mr. Xxxxxxx Xxxxxxxx
President & CEO
Immtech International Inc.
0000 Xxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxx 00000
ARTICLE XV - GENERAL
15.1 Force Majeure. Neither party shall be liable to the other for its
failure to perform any of its obligations under this Agreement, except for
payment obligations, during any period in which such performance is delayed
because rendered impracticable or impossible due to circumstances beyond its
reasonable control, including without limitation earthquakes, governmental
regulation, fire, flood, labor difficulties, interruption of supply of key raw
materials, civil disorder, and acts of God, provided that the Party experiencing
the delay promptly notifies the other Party of the delay.
15.2 Severability. In the event any provision of this Agreement is held to
be invalid or unenforceable, the valid or enforceable portion thereof and the
remaining provisions of this Agreement will remain in full force and effect.
15.3 Applicable Law. This Agreement is made in accordance with and shall
be governed and construed under the laws of the State of Illinois, excluding its
choice of law rules.
15.4 Entire Agreement. This Agreement and the exhibits attached hereto
constitute the entire, final, complete and exclusive agreement between the
Parties and supersede all previous agreements or representations, written or
oral, with respect to the subject matter of this Agreement. This Agreement may
not be modified or amended except in a writing signed by a duly authorized
representative of each Party.
9
15.5 Headings. The headings for each article and section in this Agreement
have been inserted for convenience or reference only and are not intended to
limit or expand on the meaning of the language contained in the particular
article or section.
15.6 Independent Contractors. The Parties are not employees or legal
representatives of the other party for any purpose. Neither Party shall have the
authority to enter into any contracts in the name of or on behalf of the other
Party.
15.7 Advertising. Licensee shall not use the name of any inventor of
Northwestern University, of any institution with which the inventor has been or
is connected, nor the name of Northwestern in any advertising, promotional or
sales literature, without prior written consent obtained from Northwestern in
each case.
15.8 Waiver. Any waiver (express or implied) by either Party of any breach
of this Agreement shall not constitute a waiver of any other or subsequent
breach.
15.9 Counterparts. This Agreement may be executed in counterparts with the
same force and effect as if each of the signatories had executed the same
instrument.
15.10 Patent Marking. Licensee agrees to xxxx the Licensed Products sold
in the United States with all applicable United States patent numbers. All
Licensed Products 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.
In Witness Whereof, the Parties have executed this Agreement effective on
the date first set forth above.
LICENSEE NORTHWESTERN
By: /s/ T. Xxxxxxx Xxxxxxxx By: /s/ Xxxxx Xxxxx-Xxxxxxxx
------------------------- ---------------------------------
Name: T. Xxxxxxx Xxxxxxxx Name: XXXXX XXXXX-XXXXXXXX
Title: President and CEO Title: VICE PRESIDENT FOR RESEARCH
AND GRADUATE STUDIES
10
LICENSE AGREEMENT
This AGREEMENT made this 27th day of October, 1994 by and between
NORTHWESTERN UNIVERSITY ("NORTHWESTERN"), an Illinois corporation having a
principal office at 000 Xxxxx Xxxxxx, Xxxxxxxx, Xxxxxxxx 00000, and IMMTECH
INTERNATIONAL. INC. ("COMPANY"), a Delaware corporation having a principal
office at 0000 Xxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx, Xxxxxxxx 00000 (hereinafter
"IMMTECH").
WITNESSETH THAT:
WHEREAS, NORTHWESTERN represents that Xxxxx Xxxxxxxx, Xxxx Xxxxxx,
and Xxxxx Xxxxxxxx (the Inventors) all being employees of NORTHWESTERN at the
time of the invention, have made certain inventions in the field of "Immunoassay
for Identifying Alcoholics and Monitoring Alcohol Consumption" (NIT 9134), and
that a patent has been applied for thereon, having United States Serial Number
07/765,169 in September 1991.
WHEREAS, NORTHWESTERN, subject to U.S. government obligations has
the right to make, use, sell, and grant licenses under the INVENTION and PATENT
RIGHTS as defined herein; and NORTHWESTERN wishes to have the INVENTION, as
defined by the PATENT RIGHTS, utilized for the public interest; and
WHEREAS IMMTECH desires to obtain a license to manufacture, sell,
and use the INVENTION and PATENT RIGHTS defined herein and upon the terms and
conditions hereinafter set forth;
NOW, THEREFORE, in consideration of the promises and the faithful
Performance of the covenants contained herein, IT IS AGREED:
1.0 DEFINITIONS
For the purposes of this Agreement, and solely for that purpose, the
terms hereinafter set forth shall be defined as follows:
1.1 "INVENTION" shall mean the invention as described in EXHIBIT A,
and/or as covered in the PATENT RIGHTS and/or TECHNICAL INFORMATION
1
1.2 "PATENT RIGHTS" shall mean any United States patent for the
INVENTION together with any divisional, continuation, or other
continuation-in-part applications based thereon, and any patents resulting from
any of said applications, and any reissues or extensions based on any such
patents, and any foreign counterparts pending or issued thereof -
1.3 "LICENSED PRODUCT" shall mean any products or processes
employing any INVENTION as described in EXHIBIT A, or as described by any valid
claim in an unexpired patent, which patent application or patent is included in
the PATENT RIGHTS.
1.4 "FIELD OF USE" shall mean the exclusive use of the INVENTION and
PATENT RIGHTS for QUANTITATIVE diagnostics.
15 "NET SALES PRICE" shall mean the gross sales price of any
LICENSED PRODUCT made and sold pursuant to this Agreement, less allowances to
customers for damaged or returned products and the amounts of discounts,
transportation charges, and all sales and excise taxes and duties paid,
absorbed, or allowed -
l6 "AFFILIATE" shall mean any corporation or other legal entity (a)
owning or controlling, directly or indirectly, more than fifty percent of the
voting capital shares of IMMTECH, (b) more than fifty percent of the voting
capital shares of which are owned or controlled, directly or indirectly, by
IMMTECH; or (c) more than fifty percent of the voting capital shares of which
are owned or controlled, directly or indirectly, by a legal entity which owns or
controls, directly or indirectly more than fifty percent of the voting capital
shares of IMMTECH.
1.7 "QUANTITATIVE DIAGNOSTICS" shall mean the use of immunoassays
that yield a quantitative answer and are generally performed via enzyme-linked
antibody methodology.
1.8 "TECHNICAL INFORMATION" shall mean NORTHWESTERN's technical
information and know-how relating to the INVENTION, including technical data,
plans, specifications, and drawings.
2.0 LICENSE
2.1 NORTHWESTERN hereby grants to IMMTECH and IMMTECH hereby accepts
from NORTHWESTERN, upon the terms and
2
conditions herein specified, a worldwide, exclusive, and non-assignable (except
as herein specified) License to use the INVENTION and PATENT RIGHTS to test,
evaluate, and develop the INVENTION and LICENSED PRODUCT coveted hereby and to
make, have made, use and sell the products in the FIELD OF USE thereof during
the term of this Agreement, and during the term of any extension thereof, unless
sooner terminated as hereinafter provided -
2.2 NORTHWESTERN hereby grants to IMMTECH and IMMTECH hereby accepts
from NORTHWESTERN, upon the tents and conditions herein specified, the right to
extend the License granted hereunder to its sublicensee(s) IMMTECH shall
promptly notify NORTHWESTERN in writing that a sublicense has been wanted no
later than thirty (30) days after the effective date or the sublicense. IMMTECH
may negotiate such terms as it chooses for each sublicense, provided that
NORTHWESTERN shall receive a royalty for all sales made by sublicensee(s) at the
rate provided for in this Agreement.
2.3 If IMMTECH shall so notify NORTHWESTERN in writing as provided
in Section 2.2 of this Agreement, any sublicensee(s) to whom the License shall
have been extended pursuant to Section 2.2. hereof may make the reports and
royalty payments specified in Paragraph 3.0. hereof directly to Northwestern on
behalf of IMMTECH. For all other sublicensees, IMMTECH shall make said royalty
payments to Northwestern. For all sublicensees, Northwestern shall notify
IMMTECH and/or the sublicensee of the address to which payment should be sent.
2.4 NORTHWESTERN retains a non-exclusive, royalty-free, irrevocable
License to make, have made and use the INVENTION, PATENT RIGHTS and LICENSED
PRODUCT for its own noncommercial uses.
2.5 Outside the scope of the License between NORTHWESTERN and
IMMTECH no other, further, or different license or right, and no further power
to sublicense is hereby granted or implied.
3.0 ROYALTIES, RECORDS AND REPORTS
3.1 During the term of this Agreement, unless sooner terminated,
IMMTECH shall pay to NORTHWESTERN, in the manner hereinafter provided, earned
royalties at the rate of six percent (6%) of the NET SALES PRICE of all LICENSED
PRODUCT sold by IMMTECH, for the first Ten Million Dollars ($10,000,000) sales,
and at the rate of four percent (4%) for
3
sales exceeding Ten Million Dollars, anywhere in the world.
3.2 IMMTECH shall pay to NORTHWESTERN with respect to all
sub-licenses granted by IMMTECH hereunder, a royalty at the rate of thirty
percent (30%) of all royalties earned by IMMTECH under such sub-licenses.
3.3 LICENSED PRODUCT shall be considered sold when sold or invoiced,
and if not sold or invoiced, when delivered to a third party.
3.4 IMMTECH shall be responsible for the performance hereunder of
all obligations including payment of royalties, keeping of records, and
reporting by IMMTECH and any sublicensee(s) to whom the License shall have been
extended pursuant to this Agreement.
3.5 So long as this Agreement remains in force, IMMTECH shall
deliver to NORTHWESTERN, within sixty (60) days after the first day of January,
April, July and October of each year, a true and accurate report, giving such
particulars of the business conducted by IMMTECH and its sublicensee(s) during
the preceding three (3) months under this Agreement as are necessary to
accurately account for sales subject to royalties under this Agreement.
3.6 Simultaneously with the delivery of each report required by the
preceding paragraph 3.4, IMMTECH shall pay to NORTHWESTERN the net royalties and
any other such payment due under this Agreement for the period covered by such
report. If no royalties are due, it shall be so reported.
3.7 All payments from IMMTECH to NORTHWESTERN shall be in U.S.
dollars. Royalties for sales made by IMMTECH in foreign currencies shall be paid
to Northwestern in U.S. Dollars at a conversion rate equal to the quarter
average of daily composite closing exchange rates for the quarter in which sales
were made as published by the Wall Street Journal.
3.8 In case of any delay in payment by IMMTECH to NORTHWESTERN not
occasioned by force majeure, interest at the rate of one percent (1%) per month,
assessed from the thirty-first day after the due date of said payment, shall be
due by IMMTECH without any special notice.
3.9 Royalties shall accrue in accordance with this Agreement, upon
the first sale of LICENSED PRODUCT.
3.10 IMMTECH shall keep full, true, and accurate
4
books of account containing all particulars which may be necessary for the
purpose of showing the amount payable to NORTHWESTERN by way of royalty as
aforesaid or by way of any other provision hereunder. Said books of account
shall be sent at IMMTECH'S principal place of business. Said books and the
supporting data shall be available for inspection by Northwestern at reasonable
times upon reasonable notice to IMMTECH for three (3) years following the end of
the calendar year to which they pertain, to inspection by NORTHWESTERN for the
purpose or verifying IMMTECH'S royalty statements, or IMMTECH'S compliance in
other respects with this Agreement.
3.11 IMMTECH shall reimburse NORTHWESTERN for all out-of-pocket
costs of filing, prosecution and maintenance for all patent applications and all
patents issuing thereon filed and made at the request of IMMTECH. All such
patents and patent applications shall become part of the PATENT RIGHTS licensed
to IMMTECH hereunder. Such reimbursements shall be made to NORTHWESTERN within
sixty (60) days of receipt of invoice by IMMTECH. Any reimbursements made by
IMMTECH hereunder shall be creditable by IMMTECH in full against royalty payable
by it pursuant to Article 3.1 above.
4.0 AUDITING
4.1 NORTHWESTERN and its representatives will be entitled, upon the
provision of reasonable notice to IMMTECH, to cause a certified public
accountant ("CPA") reasonably acceptable to IMMTECH, to audit such records of
IMMTECH. Such audits shall occur during regular business hours, at the audited
party's place of business, and not more frequently than twice per year, nor more
than twice with respect to any fiscal year. Each such audit shall be designed
solely to determine correct amounts payable by one party to the other pursuant
to the terms of this Agreement, and to answer specific additional questions to
be mutually agreed upon by both parties. While such audit may disclose
information relating to the nature of goods sold and the sales price of said
goods, under no circumstances shall IMMTECH be required to disclose any
confidential information not directly relevant to the calculation of royalties.
The CPA will be under confidentiality obligations to the audited party to
disclose to the auditing party only the correct amounts payable or receivable by
the auditing party, and the answers to such specific agreed upon questions. In
the event that an audit reveals any underpayment or undercredit or royalties
and/or milestone payments by IMMTECH subject to the provisions herein, IMMTECH
will promptly pay or credit to NORTHWESTERN, as the case may be, the full
5
amount of that underpayment or undercredit, together with interest thereon at a
rate of one percent (1%) per month, assessed from the thirty-first day after
said payment was due. In the event that the audit reveals an underpayment or
undercredit of in excess of five percent (5%), IMMTECH or sublicensee, as the
case may be, will promptly pay the entire cost of that audit.
5.0 PERFORMANCE
5.1 IMMTECH shall use its commercially reasonable efforts to
commence and maintain regular commercial production and sale of LICENSED
PRODUCT.
5.2 IMMTECH shall employ its commercially reasonable efforts to
develop Licensed Products, and, consistent with prudent and reasonable business
practices: to apply for and obtain approval from the FDA for the use and sale of
Licensed Products and to market Licensed Products after such approval is
obtained.
5.3 IMMTECH shall use commercially reasonable efforts consistent
with prudent business practice to pursue any necessary studies and to seek
approvals in countries other than the United States of America to market
Licensed Products.
5.4 IMMTECH shall use commercially reasonable efforts, and shall
cause its Affiliates to use their respective commercially reasonable efforts, to
market Licensed Products after appropriate regulatory approval is obtained.
5.5 NORTHWESTERN, at its discretion, and with the consent of
IMMTECH, may utilize IMMTECH'S patent expertise by requesting advice and
assistance from IMMTECH on the preparation, filing, prosecution and maintenance
of any patent application or patent related directly to the LICENSED PRODUCT.
IMMTECH agrees to provide such patent assistance and advice to NORTHWESTERN.
IMMTECH does not warrant the results of any legal and/or patent advice offered
to NORTHWESTERN pursuant to this Agreement. All final decisions regarding the
course of preparation, filing, prosecution and maintenance shall rest with
NORTHWESTERN in its sole discretion.
6.0 TERM AND EXTENSION
6.1 This License shall continue until the expiration of the last to
expire of any patents under PATENT RIGHTS, or
6
for ten (10) years after date of execution of this Agreement in the event no
patent issues.
7.0 TERMINATION
7.1 If IMMTECH shall become bankrupt or insolvent and/or if the
business of IMMTECH shall be placed in the hands of a Receiver Assignee, or
Trustee, whether by the voluntary act of IMMTECH or otherwise, this License will
be deemed to have automatically terminated as of a date seven (7) days prior to
that event, provided, however, that such termination shall not terminate any
obligations which may have accrued prior thereto.
7.2 Notwithstanding the provisions of Article 5.1, upon any breach
or default under this Agreement by IMMTECH, NORTHWESTERN may terminate this
License by sixty (60) days written notice by registered mail to IMMTECH. Said
notice shall become effective at the end of said period, unless during said
period IMMTECH shall cure such breach or default and notify NORTHWESTERN
thereof.
7.3 IMMTECH may terminate this License at any time upon ninety (90)
days written notice by registered mail to NORTHWESTERN.
7.4 Upon termination of this License for any reason, all rights
granted hereunder shall revert to NORTHWESTERN for the sole benefit of
NORTHWESTERN.
7.5 IMMTECH's termination of this License shall not operate to
terminate any sublicenses made by IMMTECH hereunder. The rights of any and all
said sublicensee(s) shall be preserved on the condition that said sublicensee(s)
agrees to and performs all terms and conditions of IMMTECH pursuant to this
Agreement.
7.6 IMMTECH's responsibilities and obligations to report to
NORTHWESTERN and pay royalties to NORTHWESTERN as to any LICENSED PRODUCTS
produced or sold by IMMTECH or its sublicensees under this Agreement prior to
termination or expiration hereof shall survive such termination or expiration.
7.7 In the event that this Agreement is terminated by either party,
IMMTECH agrees to provide NORTHWESTERN with names and addresses of sublicensees
and copies of all Sublicense Agreements between IMMTECH and sublicensees.
7
8.0 ASSIGNMENT
8.1 This Agreement may be assigned by NORTHWESTERN. This Agreement
may be assigned by IMMTECH to the successor of its entire business, or to an
entity acquiring significant ownership interest in IMMTECH, or to any partly or
wholly-owned subsidiary, but shall not be otherwise assignable by IMMTECH
without the prior written consent of NORTHWESTERN which consent shall not be
unreasonably withheld.
9.0 INFRINGEMENT
9.1 NORTHWESTERN agrees to protect its patents within the PATENT
RIGHTS from infringement and prosecute infringers when in its reasonable
judgement such action may be proper and justified. IMMTECH shall have the right
to xxx infringers in its own name if NORTHWESTERN elects not to do so within one
hundred twenty (120) days following NORTHWESTERN's receipt of knowledge of such
infringement.
9.2 In the event either party hereto shall initiate or carry on
legal proceedings to enforce the PATENT RIGHTS against an alleged infringer, the
other party hereto shall fully cooperate with the party initiating or carrying
on such proceedings.
9.3 In the event NORTHWESTERN shall institute suit or other legal
proceedings to protect or enforce PATENT RIGHTS as provided herein, it shall
have sole control of such suit and shall retain any recovery awarded as a result
of such suit.
9.4 In the event IMMTECH shall institute suit or other legal
proceedings to protect or enforce PATENT RIGHTS as provided herein, NORTHWESTERN
shall have the option to join in such proceedings and shall be entitled to be
represented by counsel of its own choosing. From any recovery awarded as a
result of any suit or legal proceedings, IMMTECH (i) may deduct the full amount
of its expenses of prosecuting the same (including attorney's fees and court
costs); (ii) shall pay to NORTHWESTERN, to the extent possible after full
payment of (i) above, the full amount of NORTHWESTERN's costs of participating
in the same; (iii) shall pay to NORTHWESTERN, after full payment of (i) and (ii)
above, the applicable percentage determined under section 3.1 hereof, of any
remainder; and (iv) may retain the balance. IMMTECH shall not discontinue or
settle any such suit or legal proceedings brought by it without obtaining prior
concurrence of NORTHWESTERN, and giving NORTHWESTERN a timely opportunity to
continue such proceedings
8
in its own name, under its sole control, at its sole expense, and at its sole
recovery.
10.0 SEVERABILITY
10.1 Should any part or provision of this Agreement be unenforceable
or otherwise in conflict with or in violation of the law of any jurisdiction,
the remainder of this Agreement shall remain binding upon the parties.
11.0 INDEMNITY AND NEGATION OF WARRANTIES
11.1 IMMTECH agrees to indemnify, hold harmless and defend
NORTHWESTERN its officers, employees, and agents against any and all claims,
suits, losses, damages, costs, fees, and expenses resulting from or arising out
of the production or use of the LICENSED PRODUCTS by IMMTECH, its sublicensees,
and others purchasing, using and/or receiving the LICENSED PRODUCTS.
11.2 IMMTECH shall maintain, prior to sale of any LICENSED PRODUCTS,
appropriate insurance, in good standing, at least in the amount of five million
dollars ($5,000,000) the amount subject to change from time to time as
designated by NORTHWESTERN in writing, naming. NORTHWESTERN as additional
insured. IMMTECH shall deliver to NORTHWESTERN, a certificate of such insurance
providing for not less than thirty (30) days notice to NORTHWESTERN of
cancellation or material change in the terms of such insurance.
11.3 Nothing in this Agreement shall be construed as:
11.31 a warranty or representation by NORTHWESTERN as to the
validity or scope of any Patent Rights; or
11.32 a warranty or representation that anything made, used,
sold or otherwise disposed of under any license granted in
this Agreement is or will be free from infringement of patents
of third parties; or;
11.33 an obligation by NORTHWESTERN to bring or prosecute
actions or suits against third parties for infringement.
11.4 NORTHWESTERN makes no representation other than
9
those specified in this Agreement. NORTHWESTERN MAKES NO EXPRESS OR IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OF LICENSED
PRODUCT.
12.0 GENERAL
12.1 IMMTECH shall not use the name of any Inventor listed in PATENT
RIGHTS, of any institution with any Inventor has been or is connected, nor of
NORTHWESTERN, nor any adaptation of any of them, in any advertising, promotional
or sales literature, without prior written consent obtained from NORTHWESTERN in
each case. Similarly, NORTHWESTERN shall not use the name of IMMTECH or any
officer, employee or agent of IMMTECH, nor any adaptation of same, in any
advertising or promotional literature without prior consent obtained from
IMMTECH in each case.
12.2 Any notice required or permitted to be given by this Agreement
shall be given postpaid first class certified mail; unless otherwise stated:
TO LICENSEE: IMMTECH INTERNATIONAL INC.
0000 Xxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxx 00000
Attn: Mr. T. Xxxxxxx Xxxxxxxx
TO LICENSOR: NORTHWESTERN UNIVERSITY
Technology Transfer Program
0000 Xxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxx 00000-0000
Attn: Administrator
Such addresses may be altered by written notice. If no time limit is specified
for a notice required or permitted to be given under this Agreement, the time
limit therefor shall be twenty (20) full business days, not including the day of
mailing
12.3 This Agreement and its effect is subject to and shall be
construed and enforced in accordance with the internal laws of the State of
Illinois, United States of America.
12.4 The parties to this Agreement recognize and agree that each is
operating as an independent contractor and not as an agent of the other.
10
12.5 The captions herein are for convenience only and shall not be
deemed to limit or otherwise affect the construction thereof.
12.6 Any waiver by either party of the breach of any tent or
condition of this agreement will not be considered as a waiver of any subsequent
breach of the same or any other term or condition hereof.
13.0 ENTIRE AGREEMENT
13.1 This Agreement sets forth the entire agreement and
understanding between the parties as to the subject matter of this Agreement,
and merges all prior discussions between them. Neither of the parties shall be
bound by any conditions, definitions, warranties, or representations with
respect to the subject matter of this Agreement unless as duly set forth on or
subsequent to the date hereof in writing signed by a proper and duly authorized
representative of the party to be bound thereby
11
IN WITNESS WHEREOF, the parties hereto have hereunto set their hands
and duly executed this Agreement as of the day and the year first above written.
NORTHWESTERN UNIVERSITY
ATTEST: /s/ [ILLEGIBLE] By: /s/ C. Xxxxxxx Xxxx
------------------ ---------------------------
C. Xxxxxxx Xxxx, Ph.D.
Vice President for
Research
Date: November 8, 1994 Date: November 8, 1994
IMMTECH INTERNATIONAL INC.
ATTEST: /s/ Xxxx Xxxx Xxxx By: /s/ T. Xxxxxxx Xxxxxxxx
------------------ ---------------------------
Date: November 17, 1994 Date: November 17, 1994
----------------------------------
OFFICIAL XXXX
XXXX XXXX XXXX
NOTARY PUBLIC. STATE OF ILLINOIS
MY COMMISSION EXPIRES 6-25-98
----------------------------------
12
INTERNATIONAL PATENT, KNOW-HOW
AND TECHNOLOGY LICENSE AGREEMENT
THIS INTERNATIONAL PATENT, KNOW-HOW AND TECHNOLOGY LICENSE AGREEMENT
("Agreement") is made this 29th day of June, 1998 by and between IMMTECH
INTERNATIONAL, INC. ("Immtech"), a Delaware corporation, and CRITICARE SYSTEMS,
INC. ("Criticare"), a Delaware corporation.
RECITALS
Certain capitalized terms used in these recitals are defined below
in this Agreement.
A. Immtech owns the patent rights and certain Technology, including
Know-how and Technical Information necessary or useful in the design,
development, customization, manufacture, use, composition and processing of the
mCRP (modifiedC- Reactive Protein) and a recombinant form of mCRP for the
treatment of sepsis (collectively, the "mCRP Patent Rights"); and
B. Criticare desires to obtain, and Immtech is willing to grant, the
License with respect to the mCRP Patent Rights and Immtech Technology within the
Field upon the terms and conditions hereinafter set forth.
AGREEMENT
In consideration of the mutual covenants set forth herein, the
sufficiency of which is hereby acknowledged, the Parties agree to the terms and
conditions set forth below.
1. Definitions. For the purpose of this Agreement, the following
terms (when capitalized, except as otherwise noted) shall have the meanings set
forth hereinbelow.
(a) "Effective Date" means the date first stated above.
(b) "Field of the Agreement" means systems, methods,
processes, compositions, articles and apparatuses for the treatment of sepsis.
(c) "mCRP Patent Rights" means the patent rights and certain
Technology, including Know-how and Technical Information necessary or
useful in the design, development, customization, manufacture, use, composition
and processing of the mCRP (modified C- Reactive Protein) and a recombinant form
of mCRP for the treatment of sepsis owned or licensed by Immtech, including,
without limitation, the patent rights listed in Schedule A and any
continuations, continuations-in-part, divisionals, reissues, reexaminations,
extensions or other patents or applications claiming priority or based upon the
listed patents.
(d) "mCRP Technology" means Technology that is owned or
licensable by Immtech.
(e) "Improvements" means any modification or enhancement,
patentable or not, which is conceived and/or reduced to practice by Criticare or
Immtech during the term of this Agreement, related to the Field of this
Agreement.
(f) "License" is defined in Article 3.1.
(g) "Licensed Territory" means the countries listed in
Schedule B attached hereto, as that schedule may be amended from time to time by
mutual written consent of the Parties or in accordance with Articles 3.6 or 3.7.
(h) "Product" shall mean any product in the Field of the
Agreement, which is covered by any claim in the Immtech Patent Rights and/or
which is produced utilizing Technology. "Product" may also include such
additional products and/or Improvements as may be agreed upon by mutual
agreement of the Parties from time to time.
(i) "Technology" means all Know-how and Technical Information
related to the Field of this Agreement which is owned or licensable by a Party,
now and during the term of this Agreement.
(i) "Know-how" means any information, including
technical data, now, or during the term of this Agreement or any renewals
hereof, possessed by Immtech, and which are, in Immetech's or Criticare's
judgment, reasonably necessary to enable Criticare to manufacture, customize,
use, market or sell Products, and includes dimensions, materials, processes and
procedures relating thereto, and which are the secret, confidential and
proprietary information of Immtech.
(ii) "Technical Information" means any information
possessed by a Party which, although not the secret Know-how of Immtech, is
2
nevertheless in either party's reasonable judgment, useful in utilizing Know-how
or Immtech Patent Rights.
(j) The "term of this Agreement" (whether or not capitalized)
shall begin on the Effective Date hereof and unless terminated pursuant to
Article 10 shall continue for _________ years.
2. Disclosure and Support.
(a) Immtech agrees that, within thirty days after the
Effective Date of this Agreement, it will make Immtech Technology available to
Criticare for Criticare's use hereunder. As additional Immtech Technology is
developed by Immtech during the term of this Agreement, it shall promptly be
made available to Criticare hereunder at no additional cost.
(b) Immtech hereby agrees not to attempt in any manner to
license, sell or otherwise commercialize Products and/or any Improvements within
the Licensed Territory to any person or entity other than Criticare.
(c) Criticare agrees to provide to Immtech any technologically
significant data that is developed or obtained by Criticare during the term of
the Agreement. Each Party recognizes that some data may only be available in
summarized form to protect the confidentiality of customers, but Criticare shall
use reasonable efforts to secure permission, where needed, to provide such
pre-summarized information to Immtech. Representatives from Immtech are free to
contact Criticare project personnel for verbal reports, updates, or
clarification of written reports at any time during normal business hours.
3. Exclusive License Grant.
(a) Immtech hereby grants to Criticare the exclusive right and
license, with the right to sublicense others, throughout the Licensed Territory
under mCRP Technology and under the mCRP Patent Rights, to make, use, have made,
offer for sale and sell Products and to practice methods and processes utilizing
Immtech Techno1ogy in connection therewith. The foregoing right and license is
referred to herein as the "License."
(b) The right to sublicense granted Criticare in Article 3.1
specifically includes the right to sublicense others exclusively and/or
non-exclusively in the Licensed Territory under Immtech Technology and under the
Immtech Patent Rights any right granted Criticare under this Agreement,
including the right to grant exclusive and/or non-exclusive field-of-use
sublicenses.
3
(c) Criticare will advise Immtech of all sublicenses and shall
at all times keep an account of all manufacture and assembly, sales, shipments
and uses of Products by Criticare and by all sublicensees.
(d) Criticare shall be responsible for finding sublicensees
and negotiating exclusive and/or non-exclusive (including exclusive and/or
nonexclusive restricted field-of-use) sublicense agreements with said
sublicensees.
4. Payments and Accounting.
(a) In consideration of the grant of the License Criticare
shall pay to Immtech during the term of this Agreement a royalty consisting of
$100 per year.
(b) The royalties payable under this Agreement are in
consideration of the grant of rights under the Immtech Technology as well as the
grant of rights under the Immtech Patent Rights, and no additional royalty or
fee is due Immtech for Criticare's rights granted hereunder to utilize Immtech
Technology to manufacture, assemble, use, have manufactured, have assembled,
offer for sale, sell or otherwise commercialize Products or otherwise exploit
the Technology.
5. Marking and Quality.
(a) Criticare will apply, and cause each of its sublicensees
to apply, appropriate notice of patent protection on or in connection with
Products or their packages, including the numbers of relevant issued patents,
and give notice of the pendency of patent applications on Products or their
packages, such as, for example, stating "Patent Pending," such notices being
sufficient under applicable law to provide reasonable protection to the rights
of Immtech.
(b) Immtech shall at all times have the right to require that
Products manufactured or assembled by Criticare pursuant to this Agreement
satisfy reasonable standards of quality fixed by Immtech, and Immtech shall have
the right to inspect such Products, and the manufacturing process, at reasonable
times and at Immtech's expense, to confirm that such Products do conform to such
standards.
6. Confidential Status of Techno1ogy.
(a) Each Party ac1~owIedges and agrees that, subject to the
provisions of this Article 6, all Technology disclosed to it by the other Party
4
pursuant to this Agreement may constitute and comprise valuable confidential
information, and therefore the Parry agrees to hold any such Technoloy it
receives from the other Party in confidence and otherwise protect it as provided
in this Article 6.
(b) Each Party (the "receiving Party") agrees that, subject
to the provisions of this Article 6, it shall not, without the prior written
consent of the other Party (the "disclosing Party"), disclose, distribute or use
any portion of Technology disclosed to it by the disclosing Party, except to the
extent necessary for the receiving Party to exercise rights hereunder or
authorize or allow others to do so. Each receiving Parry further agrees to limit
access to such Technology to-
(i) those of its employees, or others, who have a "need
to know" of the same in order for the receiving Party to exercise said rights;
and
(ii) its sublicensees who have a "need to know" of the
same in order for sublicensees to exercise said rights; and
in either case who are under a duty to protect such Technology for the benefit
of the disclosing Party to the same extent as is the receiving Party itself.
(c) The obligations under this Article 6 shall not extend to
any information disclosed by a disclosing Party to a receiving Party which (i)
is within the public domain, or enters into the public domain through no fault
of the receiving Party, (ii) is within the possession of the receiving Party
prior to receipt from the disclosing Party as shown by appropriate records, or
(iii) is independently made available to the receiving Party by a third party
without breach by the third party of any duty owed to the disclosing Party with
respect thereto. It is understood that some Technology may, at least in part,
consist of a synthesis of information that is in the public domain; and it is,
therefore, understood that no exclusion contained in this Article 6.3 shall
operate to exclude from the obligations of this Article 6 such synthesis of
otherwise public domain information, unless it can be shown that such synthesis
is itself in the public domain.
(d) Each Party agrees that all obligations under this Article
6 with respect to any and all Technology shall survive any termination of any or
all other provisions of this Agreement and shall continue until such time as one
of the exceptions set forth in Article 6.3 becomes applicable to the Technology
in question or for a period not to exceed two years after any such termination.
(e) Neither Party shall be liable for the inadvertent or
accidental use or disclosure of Know how or Technical Information, provided such
5
use or disclosure occurs despite the Party's exercise of the same degree of care
as the Party takes to safeguard arid preserve its own proprietary information.
7. Representations and Warranties.
(a) Immtech expressly warrants
(i) that Immtech has the right to grant the License
within the Field and throughout the Licensed Territory;
(ii) that no third party has any right, title or
interest in the Immtech Patent Rights or Immtech Technology in the Field and
throughout the Licensed Territory;
(iii) that Immtech has taken no actions which adversely
affect Criticare's rights under this Agreement; and
(iv) that Immtech has the right to execute and enter
into this Agreement, to perform its obligations hereunder, and to grant the
License.
(b) Immtech warrants that, to the best of its knowledge, there
are no circumstances that would (i) render the Immtech Patent Rights invalid or
unenforceable, or (ii) render Criticare liable for patent infringement or trade
secret misappropriation as a consequence of Criticare's performing the
activities permitted by this Agreement or practice of the Immtech Patent Rights
or Immtech Technology as provided to Criticare.
(c) Immtech represents that it will timely pay all necessary
maintenance fees, annuities, taxes or other fees in order to maintain the
enforceability of the Immtech Patent Rights.
(d) Criticare and Immtech each represents that it has the
corporate power to enter into this Agreement and perform the obligations assumed
hereunder. Criticare and Immtech each represents that the person executing this
Agreement on behalf of the corporation is authorized to execute this Agreement
and legally bind the corporation.
8. Improvements.
(a) Immtech agrees that all Improvements developed by Immtech
during the term of this Agreement shall be made available on the same basis and
under the same terms as set forth in this Agreement at no additional cost to
Criticare. Immtech shall promptly notify Criticare of all such Improvements as
6
they can reasonably be made available in form sufficient to disclose such
Improvement to Criticare, and at Criticare's option such Improvements may be
included in this Agreement and/or Products.
(b) If Criticare requests Immtech, in writing, to file a
patent application in a given nation or nations within the Licensed Territory
based on the Immtech Patent Rights or a Immtech Improvement, Immtech shall
promptly initiate the filing of such application(s), using local counsel of
Criticare's choosing. Criticare shall be responsible for all out of pocket
costs, including attorney fees, of filing and prosecuting any such patent
application(s) together with all fees, taxes, assessments, and levies on said
patent application(s) and/or patent(s) obtained therefrom for so long as
Criticare desires to maintain its rights thereunder. Immtech shall cooperate
fully with the prosecution, maintenance and enforcement of said patent
application(s) and/or patent(s) obtained therefrom and shall execute all
documents reasonably necessary for these activities.
(c) Criticare agrees that all Improvements developed by
Criticare during the term of this Agreement shall be made available on a
nonexclusive basis to Immtech without cost or reduction in royalty payable to
Immtech. Criticare shall promptly notify Immtech of all such Improvements as
they can reasonably be made available in form sufficient to disclose such
Improvement to Immtech, and at Immtech's option may be included in Products
and/or may be licensed from Criticare on the same basis and under the same terms
as set forth in this Agreement.
(d) Upon termination of the term of this Agreement,
Criticare's fights to continue use of Immtech's Improvements shall be limited by
the scope of Immtech Patent Rights existing upon termination. Likewise, upon
termination of the term of this agreement Immtech's rights to continue use of
Criticare1s Improvements shall be limited by the scope of Criticare's patent
rights existing upon termination.
9. Infringement of Immtech Patent Rights.
(a) Immtech and Criticare agree to promptly notify each other
if they become aware of a probable infringement by a third party of the Immtech
Patent Rights. Immtech and Criticare further agree that, unless one Party
provides the other with written notice of the first Party's desire to not be
actively involved in a particular infringement action, actions against any third
party that may be infringing the Immtech Patent Rights in the Licensed Territory
shall be a joint effort of both Parties, and that both the costs and recovery
resulting from such actions shall be shared equally between the Parties. If
either Party notifies the other of its desire not to be actively involved in a
particular infringement action,
7
and the other chooses to go forward with such an action, the Party going forward
shall be responsible for all costs relating to such action, and shall be the
sole beneficiary of any recovery resulting from such action; and in such case
the Party desiring not to be actively involved shall render reasonable
cooperation to the Party going forward, including, if necessary, being named as
a party to the action.
(b) In the event that Criticare, and/or Criticare's customers,
successors, and assigns are held liable as an infringer of a patent or trade
secret belonging to a third parry arising from the manufacture, use and sale of
any Product and/or component element thereof licensed under this Agreement,
Immtech agrees to reimburse Criticare, and its customers, successors and assigns
for any financial loss, including attorney fees, sustained thereby.
10. Term and Termination.
(a) The Parties agree that the term of this Agreement, except
for the obligations under Article 6 hereof, may be terminated early (i) by
Criticare at any time by providing Immtech written notice of such termination;
or (ii) by either Party if the other Party breaches or defaults on any material
obligation under this Agreement and fails to cure such breach within sixty days
after receipt of written notice from the terminating Party which sets forth the
basis of such breach and the terminating Party's intent to terminate the
Agreement due to such breach.
(b) Termination of the tern of this Agreement shall terminate
all of the Parties' respective rights and obligations under this Agreement,
except that such termination shall not affect:
(i) The right of Criticare to sell any Product on hand
on the date of such termination, to fill any orders for Product received on or
before the date of such termination, and to complete any Product in the process
of manufacture at the time of such termination and to sell the same;
(ii) The rights and obligations of the Parties under
Articles 4 and 6 of this Agreement; and
(iii) The right of either Party (including all
remedies), and the obligation of the other Party, to every performance accruing
prior to such termination.
11. Funding. Criticare or its assignee agrees that it will utilize
its best efforts to raise not less than $500,000 within 12 months after the date
of this Agreement to fund the development and commercialization of a product
utilizing
8
mCRP for the treatment of sepsis. In the event that Criticare fails to complete
such financing, Immtech shall have 90 days within which to repurchase the mCRP
Patent Rights, mCRP Technology and any Improvements for their appraisal value.
Appraisal value shall be determined by a certified appraiser agreed upon by
Immtech and Criticare, or, if they cannot agree, an appraiser selected by
Criticare's then audit firm.
12. Maintenance of Immtech Patent Rights.
(a) The cost of filing, prosecuting to issuance and
maintaining the Immtech Patent Rights shall be borne by Immtech.
(b) Before permitting the Immtech Patent Rights to become
abandoned, lapsed or forfeited, Immtech shall give Criticare a reasonable notice
in writing, and Criticare may then at its option and expense, take over the
prosecution or maintenance of the Immtech Patent Rights, in which event Immtech
agrees to cooperate fully with Criticare. All costs, expenses and fees,
including attorney fees, incurred by Criticare in taking over the maintenance of
the Immtech Patent Rights shall be deducted from any royalties due Immtech
under this Agreement. Should any of the Immtech Patent Rights be abandoned,
lapsed, or forfeited due to the failure by Immtech to pay the appropriate
maintenance or other fee, then after the abandonment, Criticare shall be
permitted to sell Products covered by such abandoned patent without payment or
royalty for such sale and the obligations of Criticare under this Agreement with
respect to that abandoned Immtech Patent Right shall cease.
13. Miscellaneous.
(a) This Agreement, or any rights or obligations hereunder,
may not be assigned, in whole or in part, by either Party without the prior
written consent of the other Party, which consent shall not be unreasonably
withheld. However, nothing herein shall prevent Criticare from assigning its
rights and obligations hereunder to an affiliated corporation or subsidiary
corporation controlled by or under common control with Criticare. In the event
of such assignment, the assignee will automatically become substituted for
Criticare as to all obligations thereafter accruing hereunder and as to all
rights hereunder.
(b) The Parties agree that the sole relationship between
Immtech and Criticare hereunder will be that of licensor and licensee. Nothing
herein shall constitute or be interpreted to make either Party the agent of the
other Party, and neither Party shall in any way be authorized to obligate the
other Party in any transaction with a third party.
9
(c) All notices and other communications under or with respect
to this Agreement shall be in writing (including by telecopier and other
available communication facilities providing written copy to the recipient
party) and shall be effective when actually delivered to the party to which they
are directed or when deposited in the United States mail, postage prepaid,
addressed to the party to which they are directed at the address provided below
for that parry or at such other address as that party may designate by notice.
The initial addresses are as follows:
If to Criticare:
Criticare Systems, Inc.
00000 Xxxxxxxxxx Xxxxxx
Xxxxxxxx, XX 00000
Facsimile: 414-798-829O
Confirming telephone: 000-000-0000
With a copy to:
Reinhart, Boerner, Van Deuren,
Xxxxxx & Xxxxxxxxxx, s.c.
Attn: Xxxxxx X. Xxxxxx
0000 Xxxxx Xxxxx Xxxxxx, Xxxxx 0000
X.X. Xxx 00000
Xxxxxxxxx, XX 00000-0000
Facsimile: 414-298-8097
Confirming telephone: 000-000-0000
If to Immtech:
Immtech International Inc.
Attn: Xxxxxxx Xxxxxxxx
0000 Xxxxx Xxxxxx, Xxxxx 000
Xxxxxxxx, XX 00000
Facsimile: 000-000-0000
Confirming telephone: 000-000-0000
With a copy to:
-------------------------------------
-------------------------------------
-------------------------------------
-------------------------------------
-------------------------------------
10
(d) The Parties acknowledge and agree that this Agreement
constitutes the entire agreement and understanding relating to the subject
matter of this Agreement and supersedes all previous communications, proposals,
representations and agreements, whether oral or written and whether relating to
the subject matter of this Agreement or otherwise.
(e) The Parties acknowledge and agree that this Agreement may
only be modified by the mutual written agreement of the Parties.
(f) (i) For purposes of this Article 13.6, a "Force Majeure
Event" shall be any event or condition that [a] is not known to the Excused
Party (as defined below), as of the date of this Agreement, to exist, [b] is not
reasonably foreseeable as of such date, and [c] is not reasonably within the
control of the Excused Party. Without limiting the foregoing, any of the
following shall constitute a Force Majeure Event if the same meets the
conditions expressed in the enumerated clauses of the preceding sentence:
natural disaster, fire, explosion, epidemic, war, riot, civil disturbance,
strike, lockout, labor slow-down, acts of governmental authority, and shortage
of energy or material.
(ii) Any period of time in which a Party (the Excused
Party") must perform any obligation under this Agreement shall be extended by
the period of time that a Force Majeure Event prevents such performance in whole
or in material part or renders such performance so difficult or costly that such
performance is commercially unreasonable, and the Excused Party shall not be
liable for loss or damage incurred by the other Party by reason of any delay in
such performance during such period of extension. If the Force Majeure Event is
of such a nature that the performance of the obligation will reasonably require
an additional period of time following cessation of the Force Majeure Event,
then the period of time in which the Excused Party must perform the obligation
shall be further extended by such additional period of time, and the Excused
Party shall not be liable for loss or damage incurred by the other Party by
reason of any delay in such performance during such additional period of time.
(iii) If the period of time in which a Party must
perform any material obligation hereunder is extended for a period of more than
six consecutive months pursuant to the preceding provisions of this Article,
either Party may terminate this Agreement, without liability to the other Party
for such termination, by giving notice of termination given to the other Party
prior to the end of the period of extension.
(iv) The foregoing provisions of this Article shall not
excuse any obligation to pay any amount which becomes due under this
11
Agreement prior to termination of this Agreement, but payment for any
performance the time for which is extended pursuant to such provisions may be
suspended until such performance is rendered.
(g) The Parties agree that this Agreement will be governed and
construed in accordance with the internal laws of the State of Wisconsin.
(h) Each Party agrees that any delay or omission on the part
of the other Party to exercise any right under this Agreement will not
automatically operate as a waiver of such right or any other right, and a waiver
of any right on any one occasion will not be construed as a bar to or a waiver
of exercising the right on any other occasion.
(i) Each Party agrees that, should any provision of this
Agreement be determined by a court of competent jurisdiction to violate or
contravene any applicable law or policy, such provision may be severed and
modified by the court to the extent necessary to comply with the applicable law
or policy, and such modified provision and the remainder of the provisions
hereof will continue in full force and effect.
(j) The title, caption or heading of any provision of this
Agreement is used as a mater of convenience and is not to be used to interpret
or construe the meaning of any provision. The words "herein," "hereof," and
"hereunder," when used in this Agreement, refer to this Agreement in its
entirety. The word "include" and its derivatives mean by way of example and not
by way of exclusion or limitation. Words in the singular include the plural and
words in the plural include the singular, according to the requirements of the
context. Words importing a gender include all genders. Each Party agrees that
this Agreement is the result of extensive negotiations between the Parties and
represents the merged work product of both Parties, and so neither Party shall
be held to be the sole author of this Agreement for the purpose of contact
interpretation.
(k) This Agreement may be executed in one or more
counterparts, each of which shall be deemed to be an original, and all of which
together shall be deemed to constitute but one and the same instrument.
CRITICARE SYSTEMS, INC. IMMTECH INTERNATIONAL, INC.
BY BY
------------------------------- -----------------------------------------
Its Its
-------------------------- ------------------------------------
12
ASSIGNMENT OF INTELLECTUAL PROPERTIES
THIS ASSIGNMENT OF INTELLECTUAL PROPERTIES, effective the ___th day
of June, 1998, is between Immtech International, Inc., a Delaware corporation
("Assignor") and Criticare Systems, Inc., a Delaware corporation ("Assignee").
RECITALS
A. Assignor is the owner of all right, title and interest in and to
certain intellectual properties as specified below.
B. The Assignor desires to assign all its right, title and interest
in these properties to the Assignee and the Assignee desires to accept such
assignment.
AGREEMENTS
In consideration of the recitals and mutual agreements which follow
and other good and valuable consideration, the receipt and sufficiency of which
is hereby acknowledged, the Assignee and Assignor agree as follows:
1. Assignment of Patents and Inventions. The Assignor assigns,
transfers and contributes to the Assignee all right, title and interest in the
patents and patent applications listed on Schedule A (the "Assigned Patent
Rights"), including any continuations, continuations-in-part, divisionals,
reissues, reexaminations, extensions thereof any U.S. patents or applications
(including divisionals and continuation applications) owned or licensed to or by
Immtech which claim priority to or are otherwise based on the Assigned Patent
Rights or which otherwise establish rights which cover, encompass or are
ancillary to the "Materials," "Progeny," "Immtech Biomaterials," "Immtech
Technology" or "Immtech Improvements" thereto (as such terms are defined in the
Material Transfer and Option Agreement between Sigma Diagnostics, Inc. and
Immtech dated March 23, 1998 (a copy of which is attached hereto as Exhibit A)
(the "Sigma Agreement") and any corresponding or related foreign applications
owned or licensed by Immtech which claim priority to or are otherwise based on
the Assigned Patent Rights or which otherwise establish rights which cover or
encompass or are ancillary to the Materials Progeny, Immtech Biomaterials,
Immtech Technology or Immtech Improvements thereto.
2. Assignment of Trade Secrets. The Assignor assigns, transfers and
contributes to the Assignee all right, title and interest worldwide in and to
all trade secrets, unified patent or invention disclosures, confidential
information and know-how related to the Assigned Patent Rights.
3. Assignment of Copyrights. The Assignor assigns, transfers and
contributes to the Assignee all right, title and interest worldwide in and to
any copyrightable works, copyright registrations and applications for copyright
registration related to the Assigned Patent Rights, including without limitation
all of the exclusive rights listed in 17 U.S.C. ss. 106 and any copyright
renewal and extension terms available for any such registrations in the United
States and all foreign counties, and in and to any copyright registrations that
may result from such applications.
4. Assignment of Accrued Enforcement Rights. The Assignor assigns
and contributes to the Assignee any causes of action for infringement or
unauthorized use of any of the intellectual properties specified in Paragraphs 1
through 3 above that may have accrued prior to the execution date of this
Agreement.
5. Further Assurances. The Assignor shall provide Assignee, its
successors, assigns or other legal representatives, cooperation and assistance
at Assignee's request and expense (including the execution and delivery of any
and all affidavits, declarations, oaths, exhibits, assignments, powers of
attorney or other documentation as may be reasonably required): (1) in the
preparation and prosecution of any applications for patents or registration of
the intellectual property assigned pursuant to this Assignment; (2) in the
prosecution or defense of any interference, opposition, infringement or other
proceedings that may arise in connection with any of the intellectual property
assigned pursuant to this Assignment; and (3) in the implementation or
perfection of this Assignment.
[Signatures and notarizations on following page.]
2
IN WITNESS WHEREOF, we have hereunto set our hands and seal
For ASSIGNOR, Immtech International, Inc.:
BY
--------------------------------------
Printed Name:
Title:
State of ___________)
: SS
______________County)
On this ______ day of______________, 1998, before me appeared
__________ to me personally known, who, being by me duly sworn, did say that he
is ______ of___________________, and that said instrument was signed on behalf
of said corporation by authority of the Board of Directors.
----------------------------------------
[Seal] Notary Public, State of_________________
My commission __________________________
For ASSIGNEE, Criticare Systems, Inc.:
BY
--------------------------------------
Printed Name:
Title:
State of ___________)
: SS
______________County)
On this ______ day of______________, 1998, before me appeared
_____________________ to me personally known, who, being by me duly sworn, did
say that he is __________________ of______________, and that said instrument was
signed on behalf of said corporation by authority of the Board of Directors.
----------------------------------------
[Seal] Notary Public, State of_________________
My commission __________________________
3
SCHEDULE A
PATENTS AND PATENT APPLICATIONS
United States Patent No. 5,484,735 Issued 1/16/96
United States Patent No. 5,702,904 Issued 12/30/97
Application Ser. No. 07/397,781-CIP Filed 8/23/89
Application Ser. No. 07/765,169 Filed 9/25/91
Application Ser. No. PCT/US9O/04666 Filed 8/17/90
Application Ser. No. 90913261.5 (EPO) Filed 8/17/90
Application Ser. No. 2-512516 (Japan) Filed 8/17/90
Application Ser. No. PCT/US92/O8136 Filed 9/25/92
Application Ser. No. 08/008,126 Filed 1/22/93
Application Ser. No. 08/068,525-CIP Filed 5/27/93
Application Ser. No. 08/151,073-CIP Filed 11/12/93
Application Ser. No. 27577/92 (Australia) Filed 9/25/92
Application Ser. No. 2119651 (Canada) Filed 9/25/92
Application Ser. No. 92921176.1 (EPO) Filed 9/25/92
Application Ser. No. 5-506376 (Japan) Filed 9/25/92
Application Ser. No. 08/272,852 Filed 7/6/94
EXHIBIT F
ASSIGNMENT AGREEMENT
THIS ASSIGNMENT AGREEMENT is made and entered into as of the ___ day
of _________, 1998, by and between CRITICAIRE SYSTEMS, INC., a Delaware
corporation ("CRITICARE") and IMMTECH INTERNATIONAL, INC., a Delaware
corporation ("IMMTECH").
RECITAL
CRITICARE desires to prospectively assume all rights and obligations
of IMMTECH set forth in the Patent License Agreements between IMMTECH and
NORTHWESTERN UNIVERSITY (hereinafter referred to as "NU 9134 Licenses" and the
"NU 8403 License" (together the "LICENSES")), copies of which are attached
hereto as Exhibits A and B.
AGREEMENTS
NOW, THEREFORE, CRITICARE and IMMTECH, in consideration of the
mutual promises and agreements set forth below, the receipt and sufficiency of
which consideration hereby is acknowledged, promise and agree as follows:
1. As of the day, month and year first above written, CRITICARE will
prospectively assume all rights and obligations of IMMTECH set forth in the
LICENSES and be bound by all terms and conditions thereof continuing forward.
CRITICARE shall not be required to pay any past fees or royalties already paid
by or due from IMMTECH.
2. This ASSIGNMENT AGREEMENT embodies the entire understanding
between CRITICARE and IMMTECH relating to the LICENSE and shall supersede all
previous communications, representations or undertakings, either verbal or
written between the parties relating to the subject matter of this ASSIGNMENT
AGREEMENT.
3. This ASSIGNMENT AGREEMENT shall be governed and construed in
accordance with the internal laws of the State of Illinois.
IN WITNESS WHEREOF, CRITICARE and IMMTECH have executed this
ASSIGNMENT AGREEMENT as of the day, month and year first above written.
CRITICARE SYSTEMS, INC. IMMTECH INTERNATIONAL, INC.
BY BY
-------------------------------- ----------------------------------------
Its Its
----------------------------- -------------------------------------
NORTHWESTERN UNIVERSITY hereby consents to CRITICARE'S assumption of
IMMTECH'S rights and obligations as described above in relation to the LICENSES
and acknowledges (i) that Immtech is current with respect to all of its
obligations and is not in default under such LICENSES, and (ii) that with
respect to sublicensee activities, Immtech's sole monetary responsibility under
the NU 9134 License Agreement is 30% of royalties earned, and under the NU 8403
License Agreement is 35% of all royalties earned plus 10% of any sublicense
issue fees or milestones received from sublicensees.
NORTHWESTERN UNIVERSITY
BY
----------------------------- -----------------
Its Date
--------------------------
2
EXHIBIT G
ASSIGNMENT AGREEMENT
THIS ASSIGNMENT AGREEMENT is made and entered into as of the ___ day
of________, 1998, by and between CRITICARE SYSTEMS, INC., a Delaware corporation
("CRITICARE") and IMMTECH INTERNATIONAL, INC., a Delaware corporation
("IMMTECH").
RECITAL
CRITICARE desires to prospectively assume all rights and certain
obligations of IMMTECH set forth in a certain Material Transfer and Option
Agreement between IMMTECH and SIGMA DIAGNOSTICS, INC. (hereinafter referred to
as the "Sigma Agreement"), a copy of which is attached hereto as Exhibit A.
AGREEMENTS
NOW, THEREFORE, CRITICARE and IMMTECH, in consideration of the
mutual promises and agreements set forth below, the receipt and sufficiency of
which consideration hereby is acknowledged, promise and agree as follows:
1. As of the day, month and year first above written, CRITICARE will
prospectively assume all rights and obligations of IMMTECH set forth in the
Sigma Agreement and be bound by all terms and conditions thereof continuing
forward; provided, however, that Immtech shall retain and promptly fulfill any
obligations under such agreement to provide cultures, materials or any advice or
consultation related to the materials (as defined therein).
2. This ASSIGNMENT AGREEMENT embodies the entire understanding
between CRITICARE and IMMTECH relating to the Sigma Agreement and shall
supersede all previous communications, representations or undertakings, either
verbal or written between the parties relating to the subject matter of this
ASSIGNMENT AGREEMENT.
3. This ASSIGNMENT AGREEMENT shall be governed and construed in
accordance with the internal laws of the State of Wisconsin.
IN WITNESS WHEREOF, CRITICARE and IMMTECH have executed this
ASSIGNMENT AGREEMENT as of the day, month and year first above written.
CRITICARE SYSTEMS, INC. IMMTECH INTERNATIONAL, INC.
BY BY
------------------------------- -------------------------------------
Its Its
---------------------------- ----------------------------------
SIGMA DIAGNOSTICS, INC. hereby consents to CRITICARE'S assumption of
IMMTECH'S rights and obligations as described above in relation to the Sigma
Agreement and acknowledges that Immtech is not in default of any of its
obligations thereunder.
SIGMA DIAGNOSTICS, INC.
BY
-------------------------- -----------------
Its Date
-----------------------
2
CRITICARE SYSTEMS, INC. XXXXXXXX, XX 00000 065284
------------------------------------------------------------------------------------
OUR REFERENCE YOUR REFERENCE INVOICE INVOICE
NUMBER NUMBER DATE AMOUNT AMOUNT PAID DISCOUNT NET AMOUNT
------------------------------------------------------------------------------------
000-1610 7/1/98 $150,000.00 **$150,000.00
PURCHASE OF CERTAIN PRODUCTS RIGHTS
------------------------------------------------------------------------------------
------------------------------------------------------------------------------------
[LOGO] CRITICARE SYSTEMS, INC. NORWEST BANK MONTANA, N.A. 93-527/929 065284
00000 XXXXXXXXXX XXXXXX XXXXXXXX, XXXXXXX
XXXXXXXX, XX 00000
DATE CONTROL NO. AMOUNT
7/1/98 065284 **$150,000.00
***$150,000 DOLLARS AND 00 CENTS***
PAY IMMTECH INTERNATIONAL, INC.
TO THE 0000 XXXXX XXX [STAMP ILLEGIBLE]
ORDER XX XXXXX 000
XXXXXXXX, XX 00000 /s/ Xxxxxxx Xxxxxx
-------------------------------
/s/ [ILLEGIBLE]
-------------------------------
--------------------------------------------------------------------------------
||065284|| |:092905278|: 4990143393||
CRITICARE SYSTEMS, INC. XXXXXXXX, XX 00000 065284
------------------------------------------------------------------------------------
OUR REFERENCE YOUR REFERENCE INVOICE INVOICE
NUMBER NUMBER DATE AMOUNT AMOUNT PAID DISCOUNT NET AMOUNT
------------------------------------------------------------------------------------
000-1610 7/1/98 $150,000.00 **$150,000.00
PURCHASE OF CERTAIN PRODUCTS RIGHTS
------------------------------------------------------------------------------------
------------------------------------------------------------------------------------
[LOGO] CRITICARE SYSTEMS, INC. NORWEST BANK MONTANA, N.A. 93-527/929 065284
00000 XXXXXXXXXX XXXXXX XXXXXXXX, XXXXXXX
XXXXXXXX, XX 00000
DATE CONTROL NO. AMOUNT
7/1/98 065284 **$150,000.00
***$150,000 DOLLARS AND 00 CENTS***
PAY IMMTECH INTERNATIONAL, INC.
TO THE 0000 XXXXX XXX [STAMP ILLEGIBLE]
ORDER XX XXXXX 000
XXXXXXXX, XX 00000 /s/ Xxxxxxx Xxxxxx
-------------------------------
/s/ [ILLEGIBLE]
-------------------------------
--------------------------------------------------------------------------------
||065284|| |:092905278|: 4990143393||
Pay to the order of
Brinks, Hofer, Xxxxxx & Xxxxx:
Immtech International Inc.
by /s/ Xxxx X. Xxxxx
CFO
[LETTERHEAD OF XXXXXXXX XXXXXXX VAN DEUREN XXXXXX & RIESELBACH, S.C.]
July 1, 1998
DELIVERED BY COURIER
Xxxxxxx X. Xxxxxx, Esq.
Seyfarth, Shaw, Xxxxxxxxxxx & Xxxxxxxxx
00 X. Xxxxxx Xxxxxx
Xxxxx 0000
Xxxxxxx, XX 00000
Dear Xx. Xxxxxx:
I have enclosed with this letter a certified check in the amount of
$150,000, dated July 1, 1998, made payable to Brinks, Hofer, Xxxxxx & Xxxxx,
with regard to the Immtech matter. It is my understanding that in a conversation
with my secretary today, you orally confirmed you will hold these funds in your
possession pending notification by me to release same to Brinks, Xxxxx.
Yours very truly,
Xxxxxx X. Xxxxxx
Enc.
SETTLEMENT AGREEMENT AND RELEASE
THIS SETTLEMENT AGREEMENT AND RELEASE is between BRINKS, HOFER,
XXXXXX & XXXXX ("Xxxxxx") and IMMTECH INTERNATIONAL, INC. ("Immtech"). The
parties agree as follows:
1. Payment by Immtech. Upon execution of this Agreement, Immtech
shall cause to be deposited with Reinhart, Boerner, Van Deuren, Xxxxxx &
Rieselbach, s.c. (the "Law Firm") a check dated July 1, 1998, drawn on the
account of Criticare Systems, Inc. and made payable to Immtech in the amount of
$150,000, endorsed by Immtech to the order of Brinks and to be certified on July
1, 1998, the same to be held and released pursuant to the terms of that certain
agreement dated June 29, 1998, between Immtech and Criticare Systems, Inc. and
the Escrow Agreement attached hereto as Exhibit A.
2. Return of Property. Brinks agrees to return all files of Immtech
within 30 days from the date of this Agreement, including a current docket
report as maintained by Brinks with respect to any filing deadlines for
intellectual property matters handled by Brinks for Immtech. Brinks does not
guaranty the accuracy of such report.
3. Release. The parties hereby mutually release each other, their
parent or subsidiaries, predecessors or successors in interest, present, former
or later insurers, assigns, agents, representatives, officers, administrators,
directors, shareholders and employees from any and all claims of whatever nature
either may have against the other which arise out of or are in any manner based
upon legal services provided by Brinks to Immtech prior to the date of this
Agreement.
Date: ___________________________ BRINKS, HOFER, XXXXXX
& LIONE
BY:
-------------------------------
Its
-------------------------
Date: 6-29-98 IMMTECH INTERNATIONAL, INC.
---------------------------
BY: /s/ [ILLEGIBLE]
-------------------------------
Its President & CEO
-------------------------
SETTLEMENT AGREEMENT AND RELEASE
THIS SETTLEMENT AGREEMENT AND RELEASE is between BRINKS, HOFER,
XXXXXX & XXXXX ("Xxxxxx") and IMMTECH INTERNATIONAL, INC. ("Immtech"). The
parties agree as follows:
1. Payment by Immtech. Upon execution of this Agreement, Immtech
shall cause to be deposited with Reinhart, Boerner, Van Deuren, Xxxxxx &
Rieselbach, s.c. (the "Law Firm") a check dated July 1, 1998, drawn on the
account of Criticare Systems, Inc. and made payable to Immtech in the amount of
$150,000, endorsed by Immtech to the order of Brinks and to be certified on July
1, 1998, the same to be held and released pursuant to the terms of that certain
agreement dated June 29, 1998, between Immtech and Criticare Systems, Inc. and
the Escrow Agreement attached hereto as Exhibit A.
2. Return of Property. Brinks agrees to return all files of Immtech
within 30 days from the date of this Agreement, including a current docket
report as maintained by Brinks with respect to any filing deadlines for
intellectual property matters handled by Brinks for Immtech. Brinks does not
guaranty the accuracy of such report.
3. Release. The parties hereby mutually release each other, their
parent or subsidiaries, predecessors or successors in interest, present, former
or later insurers, assigns, agents, representatives, officers, administrators,
directors, shareholders and employees from any and all claims of whatever nature
either may have against the other which arise out of or are in any manner based
upon legal services provided by Brinks to Immtech prior to the date of this
Agreement.
Date: 6-29-98 BRINKS, HOFER, XXXXXX
-------------------------- & LIONE
BY: /s/ [ILLEGIBLE]
-------------------------------
Its Chief Operating Officer
-------------------------
Date: IMMTECH INTERNATIONAL, INC.
------------------------
BY:
-------------------------------
Its
-------------------------
EXHIBIT A
ESCROW AGREEMENT
THIS AGREEMENT by and among REINHART, BOERNER, VAN DEUREN, XXXXXX &
XXXXXXXXXX, s.c. ("Law Firm"). CRITICARE SYSTEMS, INC. ("Criticare"), IMMTECH
INTERNATIONAL, INC. ("Immtech") and BRINKS, HOFER, XXXXXX & LIONE ("Brinks").
RECITAL
Immtech, Criticare and Brinks have deposited with Law Firm certain
documents to be released at the Closing of a certain transaction on July 2,
1998.
AGREEMENTS
The parties hereby agree as follows:
1. Law Firm shall hold such documents in escrow until July 2, 1998.
Law Firm's sole responsibility shall be to determine that all documents have
been executed and provided to it prior to the close of business on June 30,
1998, and to release to Immtech and Criticare respective copies of the documents
on July 2, 1998 (including, in the case of Brinks, the certified check in the
amount of $150,000) unless enjoined by legal process.
2. The parties herein acknowledge that Law Firm regularly acts as
Criticare's legal counsel and has represented Criticare in connection with the
refinancing and sale of certain assets by Immtech to Criticare, and all parties
waive any conflict of interest.
3. The parties hereby agree to indemnify and hold harmless Law Firm
with respect to its acting as escrow agent save only damages arising out of its
intentional misconduct, including any legal fees which it may incur with respect
to the resolution of any controversy regarding this escrow.
4. This Agreement shall be governed by, construed and enforced under
Wisconsin law.
Dated: CRITICARE SYSTEMS, INC.
--------------------------
By:
------------------------------
Its
------------------------
Dated: IMMTECH INTERNATIONAL, INC.
--------------------------
By:
------------------------------
Its
------------------------
Dated: 6-29-98 BRINKS, HOFER, XXXXXX & XXXXX
--------------------------
BY: [ILLEGIBLE]
------------------------------
Accepted ___ June, 1998:
REINHART, HOFER, VAN
DEUREN, XXXXXX & RIESELBACH, s.c.
BY:
------------------------------
2
ASSIGNMENT OF INTELLECTUAL PROPERTIES
THIS ASSIGNMENT OF INTELLECTUAL PROPERTIES, effective the 29th day
of June, 1998, is between Immtech International, Inc., a Delaware corporation
("Assignor") and Criticare Systems, Inc., a Delaware corporation ("Assignee").
RECITALS
A. Assignor is the owner of all right, title and interest in and to
certain intellectual properties as specified below.
B. The Assignor desires to assign all its right, title and interest
in these properties to the Assignee and the Assignee desires to accept such
assignment.
AGREEMENTS
In consideration of the recitals and mutual agreements which follow
and other good and valuable consideration, the receipt and sufficiency of which
is hereby acknowledged, the Assignee and Assignor agree as follows:
1. Assignment of Patents and Inventions. The Assignor assigns,
transfers and contributes to the Assignee all right, title and interest in the
patents and patent applications listed on Schedule A (the "Assigned Patent
Rights"), including any continuations, continuations-in-part, divisionals,
reissues, reexaminations, extensions thereof, any U.S. patents or applications
(including divisionals and continuation applications) owned or licensed to or by
Immtech which claim priority to or are otherwise based on the Assigned Patent
Rights or which otherwise establish rights which cover, encompass or are
ancillary to the "Materials," "Progeny," "Immtech Biomaterials," "Immtech
Technology" or "Immtech Improvements" thereto (as such terms are defined in the
Material Transfer and Option Agreement between Sigma Diagnostics, Inc. and
Immtech dated March 23, 1998 (a copy of which is attached hereto as Exhibit A)
(the "Sigma Agreement") and any corresponding or related foreign applications
owned or licensed by Immtech which claim priority to or are otherwise based on
the Assigned Patent Rights or which otherwise establish rights which cover or
encompass or are ancillary to the Materials Progeny, Immtech Biomaterials,
Immtech Technology or Immtech Improvements thereto.
2. Assignment of Trade Secrets. The Assignor assigns, transfers and
contributes to the Assignee all right, title and interest worldwide in and to
all
trade secrets, unfiled patent or invention disclosures, confidential information
and know-how related to the Assigned Patent Rights.
3. Assignment of Copyrights. The Assignor assigns, transfers and
contributes to the Assignee all right, title and interest worldwide in and to
any copyrightable works, copyright registrations and applications for copyright
registration related to the Assigned Patent Rights, including without limitation
all of the exclusive rights listed in 17 U.S.C. ss. 106 and any copyright
renewal and extension terms available for any such registrations in the United
States and all foreign countries, and in and to any copyright registrations that
may result from such applications.
4. Assignment of Accrued Enforcement Rights. The Assignor assigns
and contributes to the Assignee any causes of action for infringement or
unauthorized use of any of the intellectual properties specified in Paragraphs 1
through 3 above that may have accrued prior to the execution date of this
Agreement.
5. Further Assurances. The Assignor shall provide Assignee, its
successors, assigns or other legal representatives, cooperation and assistance
at Assignee's request and expense (including the execution and delivery of any
and all affidavits, declarations, oaths, exhibits, assignments, powers of
attorney or other documentation as may be reasonably required): (1) in the
preparation and prosecution of any applications for patents or registration of
the intellectual property assigned pursuant to this Assignment; (2) in the
prosecution or defense of any interference, opposition, infringement or other
proceedings that may arise in connection with any of the intellectual property
assigned pursuant to this Assignment; and (3) in the implementation or
perfection of this Assignment.
[Signatures and notarizations on following page.]
2
IN WITNESS WHEREOF, we have hereunto set our hands and seal.
For ASSIGNOR, Immtech International, Inc.:
BY: /s/ T. Xxxxxxx Xxxxxxxx
----------------------------------
Printed name: T. Xxxxxxx Xxxxxxxx
Title: President & CEO
State of Wisconsin )
: SS
Milwaukee County )
On this 26th day of June, 1998, before me appeared T. Xxxxxxx
Xxxxxxxx to me personally known, who, being by me duly sworn, did say that he is
Pres/CEO of Immtech International, Inc., and that said instrument was signed on
behalf of said corporation by authority of the Board of Directors.
/s/ Xxxxxxxx X. Xxxxxxx
--------------------------------------
[Seal] Notary Public, State of Wisconsin
--------------
My commission 9/30/2001
------------------------
For ASSIGNEE, Criticare Systems, Inc.:
BY: /s/ Xxxxxxx xxxxxx Ruhr
----------------------------------
Printed Name: Xxxxxxx xxxxxx Ruhr
Title: President
State of Wisconsin )
: SS
Milwaukee County )
On this 29th day of June, 1998, before me appeared Xxxxxxx xxxxxx
Ruhr to me personally known, who, being by me duly sworn, did say that he is
President of Criticare Systems, Inc., and that said instrument was signed on
behalf of said corporation by authority of the Board of Directors.
/s/ [ILLEGIBLE]
--------------------------------------
[Seal] Notary Public, State of Wisconsin
--------------
My commission is permanent
------------------------
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SCHEDULE A
PATENTS AND PATENT APPLICATIONS
United States Patent No. 5,484,735 Issued 1/16/96
United States Patent No. 5,702,904 Issued 12/30/97
United States Application Ser. No. 07/397,781-CIP Filed 8/23/89
United States Application Ser. No. 07/765,169 Filed 9/25/91
Application Ser. No. PCT/US90/04666 Filed 8/17/90
Application Ser. No. 90913261.5 (EPO) Filed 8/17/90
Application Ser. No. 2-512516 (Japan) Filed 8/17/90
Application Ser. No. PCT/US92/08136 Filed 9/25/92
United States Application Ser. No. 08/008,126 Filed 1/22/93
United States Application Ser. No. 08/068,525-CIP Filed 5/27/93
United States Application Ser. No. 08/151,073-CIP Filed 11/12/93
Application Ser. No. 27577/92 (Australia) Filed 9/25/92
Application Ser. No. 2119651 (Canada) Filed 9/25/92
Application Ser. No. 92921176.1 (EPO) Filed 9/25/92
Application Ser. No. 5-506376 (Japan) Filed 9/25/92
United States Application Ser. No. 08/272,852 Filed 7/6/94
ASSIGNMENT AGREEMENT
THIS ASSIGNMENT AGREEMENT is made and entered into as of the 26th
day of June, 1998, by and between CRITICARE SYSTEMS, INC., a Delaware
corporation ("CRITICARE") and IMMTECH INTERNATIONAL, INC., a Delaware
corporation ("IMMTECH").
RECITAL
CRITICARE desires to prospectively assume all rights and obligations
of IMMTECH set forth in the Patent License Agreements between IMMTECH and
NORTHWESTERN UNIVERSITY (hereinafter referred to as "NU 9134 Licenses" and the
"NU 8403 License" (together the "LICENSES")), copies of which are attached
hereto as Exhibits A and B.
AGREEMENTS
NOW, THEREFORE, CRITICARE and IMMTECH, in consideration of the
mutual promises and agreements set forth below, the receipt and sufficiency of
which consideration hereby is acknowledged, promise and agree as follows:
1. As of the day, month and year first above written, CRITICARE will
prospectively assume all rights and obligations of IMMTECH set forth in the
LICENSES and be bound by all terms and conditions thereof continuing forward.
CRITICARE shall not be required to pay any past fees or royalties already paid
by or due from IMMTECH.
2. This ASSIGNMENT AGREEMENT embodies the entire understanding
between CRITICARE and IMMTECH relating to the LICENSE and shall supersede all
previous communications, representations or undertakings, either verbal or
written between the parties relating to the subject matter of this ASSIGNMENT
AGREEMENT.
3. This ASSIGNMENT AGREEMENT shall be governed and construed in
accordance with the internal laws of the State of Illinois.
IN WITNESS WHEREOF, CRITICARE and IMMTECH have executed this
ASSIGNMENT AGREEMENT as of the day, month and year first above written.
CRITICARE SYSTEMS, INC. IMMTECH INTERNATIONAL, INC.
BY /s/ Xxxxxxx xxxxxx Ruhr BY /s/ T. Xxxxxxx Xxxxxxxx
------------------------------ --------------------------------
Its PRES. Its President & CEO
-------------------------- ----------------------------
NORTHWESTERN UNIVERSITY hereby consents to CRITICARE'S assumption of
IMMTECH'S rights and obligations as described above in relation to the LICENSES
and acknowledges (i) that Immtech is current with respect to all of its
obligations and is not in default under such LICENSES, and (ii) that with
respect to sublicensee activities, Immtech's sole monetary responsibility under
the NU 9134 License Agreement is 30% of royalties earned, and under the NU 8403
License Agreement is 35% of all royalties earned plus 10% of any sublicense
issue fees or milestones received from sublicensees.
NORTHWESTERN UNIVERSITY
BY
------------------------------ --------------------
Its Date
--------------------------
2
LICENSE AGREEMENT
This AGREEMENT made this 27th day of October, 1994 by and between
NORTHWESTERN UNIVERSITY ("NORTHWESTERN"), an Illinois corporation having a
principal office at 000 Xxxxx Xxxxxx, Xxxxxxxx, Xxxxxxxx 00000, and IMMTECH
INTERNATIONAL INC. ("COMPANY"), a Delaware corporation having a principal office
at 0000 Xxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx, Xxxxxxxx 00000 (hereinafter
"IMMTECH").
WITNESSETH THAT:
WHEREAS, NORTHWESTERN represents that Xxxxx Xxxxxxxx, Xxxx Xxxxxx,
and Xxxxx Xxxxxxxx (the Inventors) all being employees of NORTHWESTERN at the
time of the invention, have made certain inventions in the field of "Immunoassay
for Identifying Alcoholics and Monitoring Alcohol Consumption" (NU 9134), and
that a patent has been applied for thereon, having United States Serial Number
07/765,169 in September 1991.
WHEREAS, NORTHWESTERN, subject to U.S. government obligations has
the right to make, use, sell, and grant licenses under the INVENTION and PATENT
RIGHTS as defined herein; and NORTHWESTERN wishes to have the INVENTION, as
defined by the PATENT RIGHTS, utilized for the public interest; and
WHEREAS IMMTECH desires to obtain a license to manufacture, sell,
and use the INVENTION and PATENT RIGHTS defined herein and upon the terms and
conditions hereinafter set forth;
NOW, THEREFORE, in consideration of the promises and the faithful
performance of the covenants contained herein, IT IS AGREED:
1.0 DEFINITIONS
For the purposes of this Agreement, and solely for that purpose, the
terms hereinafter set forth shall be defined as follows:
1.1 "INVENTION" shall mean the invention as described in EXHIBIT A,
and/or as covered in the PATENT RIGHTS and/or TECHNICAL INFORMATION
1
1.2 "PATENT RIGHTS" shall mean any United States patent for the
INVENTION together with any divisional, continuation, or other
continuation-in-part applications based thereon, and any patents resulting from
any of said applications, and any reissues or extensions based on any such
patents, and any foreign counterparts pending or issued thereof.
1.3 "LICENSED PRODUCT" shall mean any products or processes
employing any INVENTION as described in EXHIBIT A, or as described by any valid
claim in an unexpired patent, which patent application or patent is included in
the PATENT RIGHTS.
1.4 "FIELD OF USE" shall mean the exclusive use of the INVENTION and
PATENT RIGHTS for QUANTITATIVE diagnostics.
1.5 "NET SALES PRICE" shall mean the gross sales price of any
LICENSED PRODUCT made and sold pursuant to this Agreement, less allowances to
customers for damaged or returned products and the amounts of discounts,
transportation charges, and all sales and excise taxes and duties paid,
absorbed, or allowed.
1.6 "AFFILIATE" shall mean any corporation or other legal entity (a)
owning or controlling, directly or indirectly, more than fifty percent of the
voting capital shares of IMMTECH, (b) more than fifty percent of the voting
capital shares of which are owned or controlled, directly or indirectly, by
IMMTECH; or (c) more than fifty percent of the voting capital shares of which
are owned or controlled, directly or indirectly, by a legal entity which owns or
controls, directly or indirectly more than fifty percent of the voting capital
shares of IMMTECH.
1.7 "QUANTITATIVE DIAGNOSTICS" shall mean the use of immunoassays
that yield a quantitative answer and are generally performed via enzyme-linked
antibody methodology.
1.8 "TECHNICAL INFORMATION" shall mean NORTHWESTERN's technical
information and know-how relating to the INVENTION, including technical data,
plans, specifications, and drawings.
2.0 LICENSE
2.1 NORTHWESTERN hereby grants to IMMTECH and IMMTECH hereby accepts
from NORTHWESTERN, upon the terms and
2
conditions herein specified, a worldwide, exclusive, and non-assignable (except
as herein specified) License to use the INVENTION and PATENT RIGHTS to test,
evaluate, and develop the INVENTION and LICENSED PRODUCT covered hereby and to
make, have made, use and sell the products in the FIELD OF USE thereof during
the term of this Agreement, and during the term of any extension thereof, unless
sooner terminated as hereinafter provided.
2.2 NORTHWESTERN hereby grants to IMMTECH and IMMTECH hereby accepts
from NORTHWESTERN, upon the terms and conditions herein specified, the right to
extend the License granted hereunder to its sublicensee(s). IMMTECH shall
promptly notify NORTHWESTERN in writing that a sublicense has been granted no
later than thirty (30) days after the effective date of the sublicense. IMMTECH
may negotiate such terms as it chooses for each sublicense, provided that
NORTHWESTERN shall receive a royalty for all sales made by sublicensee(s) at the
rate provided for in this Agreement.
2.3 If IMMTECH shall so notify NORTHWESTERN in writing as provided
in Section 2.2 of this Agreement, any sublicensee(s) to whom the License shall
have been extended pursuant to Section 2.2. hereof may make the reports and
royalty payments specified in Paragraph 3.0. hereof directly to Northwestern on
behalf of IMMTECH. For all other sublicensees, IMMTECH shall make said royalty
payments to Northwestern. For all sublicensees, Northwestern shall notify
IMMTECH and/or the sublicensee of the address to which payment should be sent.
2.4 NORTHWESTERN retains a non-exclusive, royalty-free, irrevocable
License to make, have made and use the INVENTION, PATENT RIGHTS and LICENSED
PRODUCT for its own non-commercial uses.
2.5 Outside the scope of the License between NORTHWESTERN and
IMMTECH no other, further, or different license or right, and no further power
to sublicense is hereby granted or implied.
3.0 ROYALTIES, RECORDS AND REPORTS
3.1 During the term of this Agreement, unless sooner terminated,
IMMTECH shall pay to NORTHWESTERN, in the manner hereinafter provided, earned
royalties at the rate of six percent (6%) of the NET SALES PRICE of all LICENSED
PRODUCT sold by IMMTECH, for the first Ten Million Dollars ($10,000,000) sales,
and at the rate of four percent (4%) for
3
sales exceeding Ten Million Dollars, anywhere in the world.
3.2 IMMTECH shall pay to NORTHWESTERN with respect to all
sub-licenses granted by IMMTECH hereunder, a royalty at the rate of thirty
percent (30%) of all royalties earned by IMMTECH under such sub-licenses.
3.3 LICENSED PRODUCT shall be considered sold when sold or invoiced,
and if not sold or invoiced, when delivered to a third party.
3.4 IMMTECH shall be responsible for the performance hereunder of
all obligations including payment of royalties, keeping of records, and
reporting by IMMTECH and any sublicensee(s) to whom the License shall have been
extended pursuant to this Agreement.
3.5 So long as this Agreement remains in force, IMMTECH shall
deliver to NORTHWESTERN, within sixty (60) days after the first day of January,
April, July and October of each year, a true and accurate report, giving such
particulars of the business conducted by IMMTECH and its sublicensee(s) during
the preceding three (3) months under this Agreement as are necessary to
accurately account for sales subject to royalties under this Agreement.
3.6 Simultaneously with the delivery of each report required by the
preceding paragraph 3.4, IMMTECH shall pay to NORTHWESTERN the net royalties and
any other such payment due under this Agreement for the period covered by such
report. If no royalties are due, it shall be so reported.
3.7 All payments from IMMTECH to NORTHWESTERN shall be in U.S.
dollars. Royalties for sales made by IMMTECH in foreign currencies shall be paid
to Northwestern in U.S. Dollars at a conversion rate equal to the quarter
average of daily composite closing exchange rates for the quarter in which sales
were made as published by the Wall Street Journal.
3.8 In case of any delay in payment by IMMTECH to NORTHWESTERN not
occasioned by force majeure, interest at the rate of one percent (1%) per month,
assessed from the thirty-first day after the due date of said payment, shall be
due by IMMTECH without any special notice.
3.9 Royalties shall accrue in accordance with this Agreement, upon
the first sale of LICENSED PRODUCT.
3.10 IMMTECH shall keep full, true, and accurate
4
books of account containing all particulars which may be necessary for the
purpose of showing the amount payable to NORTHWESTERN by way of royalty as
aforesaid or by way of any other provision hereunder. Said books of account
shall be kept at IMMTECH'S principal place of business. Said books and the
supporting data shall be available for inspection by Northwestern at reasonable
times upon reasonable notice to IMMTECH for three (3) years following the end of
the calendar year to which they pertain, to inspection by NORTHWESTERN for the
purpose of verifying IMMTECH'S royalty statements, or IMMTECH'S compliance in
other respects with this Agreement.
3.11 IMMTECH shall reimburse NORTHWESTERN for all out-of-pocket
costs of filing, prosecution and maintenance for all patent applications and all
patents issuing thereon filed and made at the request of IMMTECH. All such
patents and patent applications shall become part of the PATENT RIGHTS licensed
to IMMTECH hereunder. Such reimbursements shall be made to NORTHWESTERN within
sixty (60) days of receipt of invoice by IMMTECH. Any reimbursements made by
IMMTECH hereunder shall be creditable by IMMTECH in full against royalty payable
by it pursuant to Article 3.1 above.
4.0 AUDITING
4.1 NORTHWESTERN and its representatives will be entitled, upon the
provision of reasonable notice to IMMTECH, to cause a certified public
accountant ("CPA") reasonably acceptable to IMMTECH, to audit such records of
IMMTECH. Such audits shall occur during regular business hours, at the audited
party's place of business, and not more frequently than twice per year, nor more
than twice with respect to any fiscal year. Each such audit shall be designed
solely to determine correct amounts payable by one party to the other pursuant
to the terms of this Agreement, and to answer specific additional questions to
be mutually agreed upon by both parties. While such audit may disclose
information relating to the nature of goods sold and the sales price of said
goods, under no circumstances shall IMMTECH be required to disclose any
confidential information not directly relevant to the calculation of royalties.
The CPA will be under confidentiality obligations to the audited party to
disclose to the auditing party only the correct amounts payable or receivable by
the auditing party, and the answers to such specific agreed upon questions. In
the event that an audit reveals any underpayment or undercredit or royalties
and/or milestone payments by IMMTECH subject to the provisions herein, IMMTECH
will promptly pay or credit to NORTHWESTERN, as the case may be, the full
5
amount of that underpayment or undercredit, together with interest thereon at a
rate of one percent (1%) per month, assessed from the thirty-first day after
said payment was due. In the event that the audit reveals an underpayment or
undercredit of in excess of five percent (5%), IMMTECH or sublicensee, as the
case may be, will promptly pay the entire cost of that audit.
5.0 PERFORMANCE
5.1 IMMTECH shall use its commercially reasonable efforts to
commence and maintain regular commercial production and sale of LICENSED
PRODUCT.
5.2 IMMTECH shall employ its commercially reasonable efforts to
develop Licensed Products, and, consistent with prudent and reasonable business
practices, to apply for and obtain approval from the FDA for the use and sale of
Licensed Products and to market Licensed Products after such approval is
obtained.
5.3 IMMTECH shall use commercially reasonable efforts consistent
with prudent business practice to pursue any necessary studies and to seek
approvals in countries other than the United States of America to market
Licensed Products.
5.4 IMMTECH shall use commercially reasonable efforts, and shall
cause its Affiliates to use their respective commercially reasonable efforts, to
market Licensed Products after appropriate regulatory approval is obtained.
5.5 NORTHWESTERN, at its discretion, and with the consent of
IMMTECH, may utilize IMMTECH'S patent expertise by requesting advice and
assistance from IMMTECH on the preparation, filing, prosecution and maintenance
of any patent application or patent related directly to the LICENSED PRODUCT.
IMMTECH agrees to provide such patent assistance and advice to NORTHWESTERN.
IMMTECH does not warrant the results of any legal and/or patent advice offered
to NORTHWESTERN pursuant to this Agreement. All final decisions regarding the
course of preparation, filing, prosecution and maintenance shall rest with
NORTHWESTERN in its sole discretion.
6.0 TERM AND EXTENSION
6.1 This License shall continue until the expiration of the last to
expire of any patents under PATENT RIGHTS, or
6
for ten (10) years after date of execution of this Agreement in the event no
patent issues.
7.0 TERMINATION
7.1 If IMMTECH shall become bankrupt or insolvent and/or if the
business of IMMTECH shall be placed in the hands of a Receiver, Assignee, or
Trustee, whether by the voluntary act of IMMTECH or otherwise, this License will
be deemed to have automatically terminated as of a date seven (7) days prior to
that event, provided, however, that such termination shall not terminate any
obligations which may have accrued prior thereto.
7.2 Notwithstanding the provisions of Article 5.1., upon any breach
or default under this Agreement by IMMTECH, NORTHWESTERN may terminate this
License by sixty (60) days written notice by registered mail to IMMTECH. Said
notice shall become effective at the end of said period, unless during said
period IMMTECH shall cure such breach or default and notify NORTHWESTERN
thereof.
7.3 IMMTECH may terminate this License at any time upon ninety (90)
days written notice by registered mail to NORTHWESTERN.
7.4 Upon termination of this License for any reason, all rights
granted hereunder shall revert to NORTHWESTERN for the sole benefit of
NORTHWESTERN.
7.5 IMMTECH's termination of this License shall not operate to
terminate any sublicenses made by IMMTECH hereunder. The rights of any and all
said sublicensee(s) shall be preserved on the condition that said sublicensee(s)
agrees to and performs all terms and conditions of IMMTECH pursuant to this
Agreement.
7.6 IMMTECH's responsibilities and obligations to report to
NORTHWESTERN and pay royalties to NORTHWESTERN as to any LICENSED PRODUCTS
produced or sold by IMMTECH or its sublicensees under this Agreement prior to
termination or expiration hereof shall survive such termination or expiration.
7.7 In the event that this Agreement is terminated by either party,
IMMTECH agrees to provide NORTHWESTERN with names and addresses of sublicensees
and copies of all Sublicense Agreements between IMMTECH and sublicensees.
7
8.0 ASSIGNMENT
8.1 This Agreement may be assigned by NORTHWESTERN. This Agreement
may be assigned by IMMTECH to the successor of its entire business, or to an
entity acquiring significant ownership interest in IMMTECH, or to any partly or
wholly-owned subsidiary, but shall not be otherwise assignable by IMMTECH
without the prior written consent of NORTHWESTERN which consent shall not be
unreasonably withheld.
9.0 INFRINGEMENT
9.1 NORTHWESTERN agrees to protect its patents within the PATENT
RIGHTS from infringement and prosecute infringers when in its reasonable
judgement such action may be proper and justified. IMMTECH shall have the right
to xxx infringers in its own name if NORTHWESTERN elects not to do so within one
hundred twenty (120) days following NORTHWESTERN's receipt of knowledge of such
infringement.
9.2 In the event either party hereto shall initiate or carry on
legal proceedings to enforce the PATENT RIGHTS against an alleged infringer, the
other party hereto shall fully cooperate with the party initiating or carrying
on such proceedings.
9.3 In the event NORTHWESTERN shall institute suit or other legal
proceedings to protect or enforce PATENT RIGHTS as provided herein, it shall
have sole control of such suit and shall retain any recovery awarded as a result
of such suit.
9.4 In the event IMMTECH shall institute suit or other legal
proceedings to protect or enforce PATENT RIGHTS as provided herein, NORTHWESTERN
shall have the option to join in such proceedings and shall be entitled to be
represented by counsel of its own choosing. From any recovery awarded as a
result of any suit or legal proceedings, IMMTECH (i) may deduct the full amount
of its expenses of prosecuting the same (including attorney's fees and court
costs); (ii) shall pay to NORTHWESTERN, to the extent possible after full
payment of (i) above, the full amount of NORTHWESTERN'S costs of participating
in the same; (iii) shall pay to NORTHWESTERN, after full payment of (i) and (ii)
above, the applicable percentage determined under section 3.1 hereof, of any
remainder; and (iv) may retain the balance. IMMTECH shall not discontinue or
settle any such suit or legal proceedings brought by it without obtaining prior
concurrence of NORTHWESTERN, and giving NORTHWESTERN a timely opportunity to
continue such proceedings
8
in its own name, under its sole control, at its sole expense, and at its sole
recovery.
10.0 SEVERABILITY
10.1 Should any part or provision of its Agreement be unenforceable
or otherwise in conflict with or in violation of the law of any jurisdiction,
the remainder of this Agreement shall remain binding upon the parties.
11.0 INDEMNITY AND NEGATION OF WARRANTIES
11.1 IMMTECH agrees to indemnify, hold harmless and defend
NORTHWESTERN, its officers, employees, and agents against any and all claims,
suits, losses, damages, costs, fees, and expenses resulting from or arising out
of the production or use of the LICENSED PRODUCTS by IMMTECH, its sublicensees,
and others purchasing, using and/or receiving the LICENSED PRODUCTS.
11.2 IMMTECH shall maintain, prior to sale of any LICENSED PRODUCTS,
appropriate insurance, in good standing, at least in the amount of five million
dollars ($5,000,000) the amount subject to change from time to time as
designated by NORTHWESTERN in writing, naming NORTHWESTERN as additional
insured. IMMTECH shall deliver to NORTHWESTERN, a certificate of such insurance
providing for not less than thirty (30) days notice to NORTHWESTERN of
cancellation or material change in the terms of such insurance.
11.3 Nothing in this Agreement shall be construed as:
11.31 a warranty or representation by NORTHWESTERN as to the
validity or scope of any Patent Rights; or
11.32 a warranty or representation that anything made, used,
sold or otherwise disposed of under any license granted in
this Agreement is or will be free from infringement of patents
of third parties; or;
11.33 an obligation by NORTHWESTERN to bring or prosecute
actions or suits against third parties for infringement.
11.4 NORTHWESTERN makes no representation other than
9
those specified in this Agreement. NORTHWESTERN MAKES NO EXPRESS OR IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OF LICENSED
PRODUCT.
12.0 GENERAL
12.1 IMMTECH shall not use the name of any Inventor listed in PATENT
RIGHTS, of any institution with any Inventor has been or is connected, nor of
NORTHWESTERN, nor any adaptation of any of them, in any advertising, promotional
or sales literature, without prior written consent obtained from NORTHWESTERN in
each case. Similarly, NORTHWESTERN shall not use the name of IMMTECH or any
officer, employee or agent of IMMTECH, nor any adaptation of same, in any
advertising or promotional literature without prior consent obtained from
IMMTECH in each case.
12.2 Any notice required or permitted to be given by this Agreement
shall be given postpaid first class certified mail; unless otherwise stated:
TO LICENSEE: IMMTECH INTERNATIONAL INC.
0000 Xxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxx 00000
Attn: Mr. T. Xxxxxxx Xxxxxxxx
TO LICENSOR: NORTHWESTERN UNIVERSITY
Technology Transfer Program
0000 Xxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxx 00000-0000
Attn: Administrator
Such addresses may be altered by written notice. If no time limit is specified
for a notice required or permitted to be given under this Agreement, the time
limit therefor shall be twenty (20) full business days, not including the day of
mailing.
12.3 This Agreement and its effect is subject to and shall be
construed and enforced in accordance with the internal laws of the State of
Illinois, United States of America.
12.4 The parties to this Agreement recognize and agree that each is
operating as an independent contractor and not as an agent of the other.
10
12.5 The captions herein are for convenience only and shall not be
deemed to limit or otherwise affect the construction thereof.
12.6 Any waiver by either party of the breach of any term or
condition of this agreement will not be considered as a waiver of any subsequent
breach of the same or any other term or condition hereof.
13.0 ENTIRE AGREEMENT
13.1 This Agreement sets forth the entire agreement and
understanding between the parties as to the subject matter of this Agreement,
and merges all prior discussions between them. Neither of the parties shall be
bound by any conditions, definitions, warranties, or representations with
respect to the subject matter of this Agreement unless as duly set forth on or
subsequent to the date hereof in writing signed by a proper and duly authorized
representative of the party to be bound thereby.
11
IN WITNESS WHEREOF, the parties hereto have hereunto set their hands
and duly executed this Agreement as of the day and the year first above written.
NORTHWESTERN UNIVERSITY
ATTEST: /s/ [ILLEGIBLE] By: /s/ XX Xxxx
-------------------------- ----------------------------
C. Xxxxxxx Xxxx, Ph.D.
Vice President for
Research
Date: November 8, 1994 Date: November 8, 1994
---------------------------- --------------------------
IMMTECH INTERNATIONAL INC.
ATTEST: /s/ Xxxx Xxxx Xxxx By: T. Xxxxxxx Xxxxxxxx
-------------------------- ----------------------------
Date: November 17, 1994 Date: November 17, 1994
---------------------------- --------------------------
--------------------------------
OFFICIAL XXXX
XXXX XXXX XXXX
NOTARY PUBLIC, STATE OF ILLINOIS
MY COMMISSION EXPIRES 6-28-98
--------------------------------
12
LICENSE AGREEMENT
This Agreement made this tenth (10th) day of March, 1998, (the
"Effective Date"), by and between Northwestern University, an Illinois
corporation having a principal office at 000 Xxxxx Xxxxxx, Xxxxxxxx, Xxxxxxxx
00000 (hereinafter referred to as "Northwestern") and Immtech International
Inc., a Delaware corporation having a principal office at 0000 Xxxxx Xxxxxx,
Xxxxx 000, Xxxxxxxx, XX. 00000 (hereinafter referred to as "Licensee") (each a
"Party" and collectively the "Parties").
WITNESSETH
WHEREAS, Northwestern is the owner of certain patent rights and
know-how relating to Immunoassay Constructs to Quantitate
Glucosylated-Hemoglobin and other Glucosylated Serum Proteins (NU 8403) and has
the right to grant licenses hereunder, subject only to a royalty-free,
nonexclusive license heretofore granted to the United States Government;
WHEREAS, Northwestern desires to have the patent rights and know-how
developed and commercialized to benefit the public and is willing to grant a
license hereunder;
WHEREAS, Licensee has represented to Northwestern that Licensee will
commit itself to a thorough, vigorous and diligent program to develop and
subsequently manufacture, market and sell products utilizing the patent rights
and know-how;
WHEREAS, Licensee desires to obtain a license under the patent
rights and know-how upon the terms and conditions hereafter set forth;
NOW THEREFORE, in consideration of the premises and mutual covenants
contained herein, the Parties hereto agree as follows:
ARTICLE 1 - DEFINITIONS
1.1 "Affiliate" shall mean any corporation, firm, partnership or other
entity which controls, is controlled by or is under common control with a Party.
For the purposes of this definition, "control" shall mean any right or
collection of rights that together allow direction on any vote with respect to
any action by an entity or the direction of management and operations of that
entity. Such right or collection of rights includes without limitation (a) the
authority to act as sole member or shareholder or partner with a majority
interest in an entity; (b) a majority interest in an entity; and (c) the
authority to appoint, elect, or approve at least a majority of the governing
board of that entity.
1.2 "Field" shall mean the use of immunoassays for diagnostic purposes to
quatitate hemoglobin type A1c..
1.3 "Know-How" shall mean any and all technical information existing as of
the Effective Date or generated during the term of this Agreement which is owned
or controlled by Northwestern and directly relates to Licensed Products and
shall include, without limitation, all biological, chemical, pharmaceutical,
pharmacological, toxological, clinical, assay control and manufacturing data and
any other information relating to the Licensed Products and useful for the
development, Regulatory Approval, commercialization or safety and effectiveness
of the Licensed Products.
1.4 "Licensed Products" shall mean diagnostic assays for determining
hemoglobin type A1c.
1.5 "Net Sales" shall mean the gross amount invoiced by Licensee, its
Affiliates or its sublicensees, to third parties for the sale of Licensed
Products, less amounts actually invoiced or allowed with respect to trade
credits, discounts, rebates and allowances actually granted on account of price
1
adjustments, rebate programs, billing errors or the rejection or return of
goods, sales taxes, tariffs, and custom duties. If a Licensed Product is sold as
part of a combination, Net Sales for the purposes of determining royalties on
the Licensed Product(s) in the combination shall be calculated by multiplying
Net Sales by the fraction A/A+B, where A is the invoice price of the Licensed
Product(s) sold separately and B is the invoice price of the other active
ingredients in the combination.
1.6 "Patent Rights" shall mean the patents and patent applications listed
on Exhibit A attached hereto and incorporated herein by reference, and any
patents which issue from the patent applications listed on Exhibit A attached
hereto and incorporated herein by reference, and all substitutions, additions,
extensions, reissues, renewals, divisions, continuations and
continuations-in-part thereof and any foreign counterparts thereto.
1.7 "Regulatory Approval" shall mean the approval of either the Food Drug
Administration of the United States or a foreign counterpart thereto required to
commence commercial sale of a Licensed Product in such country in the Territory.
1.8 "Territory" shall mean the entire world.
ARTICLE II - GRANT
2.1 Northwestern hereby grants to Licensee and its Affiliates an exclusive
license under Patent Rights and Know-How to make, have made, use, import, offer
for sale and sell Licensed Products in the Territory in the Field.
2.2 The grant under Paragraph 2.1 shall be subject to the obligations of
Northwestern and of Licensee to the United States Government under any and all
applicable laws, regulations, and executive orders including those set forth in
35 U.S.C. ss.200, et seq.
2.3 Northwestern retains the right to utilize Patent Rights and Know-How
for noncommercial research purposes.
2.4 Northwestern hereby grants to Licensee the right to grant sublicenses
consistent with this Agreement provided that Licensee shall be responsible for
the performance of its sublicensees, including the payment of royalties.
ARTICLE III - CONFIDENTIAL INFORMATION
3.1 Northwestern and Licensee each agree that all information contained in
documents marked "Confidential" which are forwarded to one by the other shall be
received in strict confidence, used only for the purposes of this Agreement, and
not disclosed by the recipient (except as required by law or court agency or
administrative order), its agents or employees to any third party without the
prior written consent of an authorized officer of the disclosing Party, unless
such information (a) was in the public domain at the time of disclosure, (b)
later became part of the public domain through no act or omission of the
recipient, its employees, agents, successors or assigns, (c) was lawfully
disclosed to the recipient by a third party having the right to disclose it, (d)
was already known by the recipient at the time of disclosure, (e) was
independently developed, (f) is required by law or court or administrative
agency order, or (g) is required to be submitted to a government agency to
obtain and maintain the approvals and clearances of Licensed Products.
Disclosure may also be made to Affiliates, distributors, customers, and agents,
to nonclinical and clinical investigators, and to consultants, where necessary
or desirable with appropriate safeguards to protect the confidential underlying
disclosure. Northwestern and Licensee also agree that confidential information
may be orally disclosed by one Party to the other Party. Such information shall
be confirmed in writing and designated "Confidential" within thirty (30) days of
disclosure for the provisions of this Article III to apply.
2
3.2 Each Party's obligation of confidence hereunder shall be fulfilled by
using at least the same degree of care with the other Party's confidential
information as it uses to protect its own confidential information. This
obligation shall exist while this Agreement is in force and for a period of two
(2) years thereafter except in the event of termination by Northwestern for
breach on the part of Licensee, in which event Licensee's obligation to maintain
the information confidential will exist for a period of ten (10) years after the
termination for breach.
3.3 This Agreement may be distributed solely (a) to those employees,
agents and independent contractors of Northwestern and Licensee who have a need
to know its contents, (b) to those persons whose knowledge of its contents will
facilitate performance of the obligations of the parties under this Agreement,
(c) to those persons, if any, whose knowledge of its contents is essential in
order to permit Licensee or Northwestern to maintain or secure the benefits
under policies of insurance, or (d) as may be required by law or regulation or
by court or administrative agency order.
ARTICLE IV - DUE DILIGENCE
4.1 Licensee shall, upon execution of this Agreement, submit to
Northwestern a preliminary development and business plan that sets forth an
outline of Licensee's intended efforts to develop and commercialize Licensed
Products. Such plan shall include a summary of personnel, expenditures and
estimated timing for the development of Licensed Products and estimates of the
market potential for Licensed Products.
4.2 Licensee agrees to devote that level of resources to the
commercialization of a Licensed Product as other companies in the industry
customarily devote to products of similar commercial potential.
ARTICLE V - PAYMENT
In consideration of the license granted by Northwestern to Licensee under
this Agreement, Licensee shall pay to Northwestern the following:
5.1 A non-creditable, non-refundable license issue fee of Twenty Thousand
Dollars ($20,000), of which the first ten thousand dollars ($10,000) shall be
paid within thirty (30) days of execution of this Agreement, and ten thousand
dollars ($10,000) shall be paid within three (3) months from the Effective Date,
but no later than August 1, 1998.
5.2 Beginning the first full calendar year after the Regulatory Approval
of a Licensed Product in a major market country, or the year 2003, whichever
comes first, Licensee shall pay to Northwestern minimum royalty payments of
$10,000 per year. Any such minimum royalty payments shall be fully creditable
against any payments required under Paragraph 5.4.
5.4 A running royalty of (a) six percent (6%) of Net Sales of Licensed
Products for the first Ten Million Dollars ($10,000,000) in sales anywhere in
the world, and (b) four percent (4%) of Net Sales of Licensed Products on sales
exceeding Ten Million Dollars anywhere in the world.
5.5 For all sublicenses granted by Licensee, a royalty at the rate of
thirty five percent (35%) of all royalties earned by Licensee under such
sublicenses.
5.5 In addition to the running royalties under Paragraph 5.4, ten percent
(10%) of any payments, including, but not limited to, sublicense issue fees or
milestones received from sublicensees as consideration for Patent Rights,
Know-How or Licensed Products.
5.6 In the event of a permitted assignment of this Agreement, five percent
(5%) of any payments received from such assignee as consideration for Patent
Rights, Know-How or Licensed Products, as defined herein.
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ARTICLE VI - PAYMENT, REPORTS AND RECORDS
6.1 Payment Dates and Reports
Within sixty (60) days after the end of each calendar quarter of
each year during the term of this Agreement (including the last day of any
calendar quarter following the expiration of this Agreement), Licensee shall pay
to Northwestern, all royalties accruing during such calendar quarter. Such
payments shall be accompanied by a statement showing the Net Sales of each
Licensed Product by Licensee and its sublicensees in each country, the
applicable royalty rate and the calculation of the amount of royalty due.
6.2 Accounting
a. Payments in U.S. Dollars
All dollar sums referred to in this Agreement are expressed in
U.S. dollars and the Net Sales used for calculating the royalties and other sums
payable to Northwestern by Licensee pursuant to Paragraph 6.1 shall be computed
in U.S. dollars. All payments of such sums and royalties shall be made in U.S.
dollars. For purposes of determining the amount of royalties due, the amount of
Net Sales in any foreign currency shall be computed by converting such amount
into U.S. dollars at the prevailing commercial rate of exchange for purchasing
U.S. dollars with such foreign currency in question as quoted by Citibank in New
York on the last business day of the calendar quarter for which the relevant
royalty payment is to be made by Licensee.
b. Blocked Royalties
Notwithstanding the foregoing, if by reason of any restrictive
exchange laws or regulations Licensee or any Affiliate or sublicensee hereunder
shall be unable to convert to U.S. dollars an amount equivalent to the royalty
payable by Licensee hereunder in respect of Licensed Product sold for funds
other than U.S. dollars, Licensee shall notify Northwestern promptly with an
explanation of the circumstances. In such event, all royalties due hereunder in
respect of the transaction so restricted (or the balance thereof due hereunder
and not paid in funds other than U.S. dollars as hereinafter provided) shall be
deferred and paid in U.S. dollars as soon as reasonably possible after, and to
the extent that such restrictive exchange laws or regulations are lifted so as
to permit such conversion to United States dollars, of which lifting Licensee
shall promptly notify Northwestern. At its option, Northwestern shall meanwhile
have the right to request the payment (to it or to a nominee), and upon such
request Licensee shall pay, or cause to be paid, all such amounts (or such
portions thereof as are specified by Northwestern) in funds, other than U.S.
dollars, designated by Northwestern and legally available to Licensee under such
then existing restrictive exchange laws or regulations.
6.3 Records
Licensee shall keep, and shall cause its Affiliates and sublicensees
to keep, for three (3) years from the date of payment of royalties, complete and
accurate records of sales of each Licensed Product by Licensee; its Affiliates
and its sublicensees in sufficient detail to enable the accruing royalties to be
determined accurately. Northwestern shall have the right during this period of
three (3) years after receiving any report with respect to royalties due and
payable to appoint, at its expense, an independent certified public accountant
to inspect the relevant records of Licensee, its Affiliates and its sublicensees
to verify such report. Northwestern shall submit the name of said accountant to
Licensee for approval; said approval shall not be unreasonably withheld.
Licensee shall make its records and those of its Affiliates and sublicensees
available for inspection by such independent certified public accountant during
regular business hours at such place or places where such records are
customarily kept, upon reasonable notice from Northwestern, to the extent
necessary to verify the accuracy of the reports and
4
payments with not more than one (1) inspection per calendar year. Northwestern
agrees to hold in strict confidence all information concerning royalty payments
and reports, and all information learned in the course of any audit or
inspection, except to the extent necessary for Northwestern to reveal such
information in order to enforce its rights under this Agreement or as may be
required by law. If royalties are understated by ten percent (10%) or more in
LICENSEE's favor, the LICENSEE shall, within ten (10) days of receipt of the
audit report, pay the balance due Northwestern plus all reasonable costs of the
audit or inspection and interest at the prime rate as quoted by Citibank in New
York from the date at which such balance would have otherwise been due and
payable. If royalties are understated by less than ten percent (10%), Licensee
shall include such understated amount with the next scheduled payment pursuant
to Paragraph 6.1.
ARTICLE VII - PUBLICATION
Northwestern will be free to publish the results of any research related
to Patent Rights, Know-How or Licensed Products and use any information for
purposes of research, teaching, and other educationally-related matters.
ARTICLE VIII - PATENT PROSECUTION
8.1 Northwestern has granted Licensee the right to apply for, seek prompt
issuance of, and maintain during the term of this Agreement the Patent Rights in
the United States and in the foreign countries listed in Exhibit A hereto. The
prosecution, filing and maintenance of all Patent Rights shall be the primary
responsibility of Licensee; provided, however, Northwestern shall have
reasonable opportunities to advise Licensee and shall cooperate with Licensee in
such prosecution, filing and maintenance.
8.2 Payment of all fees and costs relating to the filing, prosecution, and
maintenance of Patent Rights shall be the responsibility of Licensee, whether
such fees and costs were incurred before or after the Effective Date.
ARTICLE IX - INFRINGEMENT
9.1 Licensee shall inform Northwestern promptly in writing of any alleged
infringement of the Patent Rights by a third party and of any available evidence
thereof.
9.2 During the term of this Agreement, Northwestern shall have the right,
but shall not be obligated, to prosecute at its own expense all infringements of
the Patent Rights and, in furtherance of such right, Licensee hereby agrees that
Northwestern may include Licensee as a party plaintiff in such suit, without
expense to Licensee. The total cost of any such infringement action commenced or
defended solely by Northwestern shall be borne by Northwestern and Northwestern
shall keep any recovery or damages for past infringement derived therefrom.
9.3 If within six (6) months after having been notified of any alleged
infringement, Northwestern shall have been unsuccessful in persuading the
alleged infringer to desist and shall not have brought and shall not be
diligently prosecuting an infringement action, or if Northwestern shall notify
Licensee at any time prior thereto of its intention not to bring suit against
any alleged infringer, then, and in those events only, Licensee shall have the
right, but shall not be obligated, to prosecute at its own expense any
infringement of the Patent Rights, and Licensee may, for such purposes, use the
name of Northwestern as party plaintiff; provided, however, that such right to
bring such infringement action shall remain in effect only for so long as the
license granted herein remains exclusive. No settlement, consent judgment or
other voluntary final disposition of the suit may be entered into without the
consent
5
of Northwestern, which consent shall not unreasonably be withheld. Licensee
shall indemnify Northwestern against any order for costs that may be made
against Northwestern in such proceedings. Licensee shall keep any recovery or
damages for past infringement derived therefrom; provided, however, that such
recovery, less expenses, including reasonable attorneys' fees, shall be treated
as Net Sales for the purpose of calculating running royalties under Paragraph
5.4
9.4 In the event that a declaratory judgment action alleging invalidity or
noninfringement of any of the Patent Rights shall be brought against Licensee,
Northwestern, at its option, shall have the right, within thirty (30) days after
it receives notice of the commencement of such action, to intervene and take
over the sole defense of the action at its own expense.
9.5 In any infringement suit that either Party may institute to enforce
the Patent Rights pursuant to this Agreement, the other party hereto shall, at
the request and expense of the Party initiating such suit, cooperate in all
respects and, to the extent possible, have its employees testify when requested
and make available relevant records, papers, information, samples, specimens,
and the like.
9.6 Licensee, during the term of this Agreement, shall have the sole right
in accordance with the terms and conditions herein to sublicense any alleged
infringer for future use of the Patent Rights. Any upfront fees as part of such
a sublicense shall be shared equally between Licensee and Northwestern; other
royalties shall be treated pursuant to Paragraph 5.4.
ARTICLE X - PRODUCT LIABILITY
10.1 Licensee shall at all times during the term of this Agreement and
thereafter, indemnify, defend and hold Northwestern, its trustees, directors,
officers, employees and Affiliates, harmless against all claims, proceedings,
demands and liabilities of any kind whatsoever, including legal expenses and
reasonable attorneys' fees, arising out of the death of or injury to any person
or persons or out of any damage to property, or resulting from the production,
manufacture, sale, use, lease, consumption or advertisement of the Licensed
Product(s) or arising from any obligation of Licensee hereunder.
10.2 Licensee and sublicensees involved in activities described in section
10.1 shall obtain and carry in full force and effect commercial, general
liability insurance which shall protect Licensee and Northwestern with respect
to events covered by paragraph 10.1 above. Such insurance shall be written by a
reputable insurance company authorized to do business in the State of Illinois,
shall list Northwestern as an additional named insured thereunder, shall be
endorsed to include product liability coverage and shall require thirty (30)
days written notice to be given to Northwestern prior to any cancellation or
material change thereof. The limits of such insurance shall not be less than
Five Million Dollars ($5,000,000) per occurrence with an aggregate of Fifteen
Million Dollars ($15,000,000) for personal injury or death, and One Million
Dollars ($1,000,000) per occurrence with an aggregate of Three Million Dollars
($3,000,000) for property damage. Licensee shall provide Northwestern with
Certificates of Insurance evidencing the same.
10.3 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT,
NORTHWESTERN, ITS TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES, AND AFFILIATES MAKE
NO REPRESENTATIONS AND EXTEND NO 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
NORTHWESTERN THAT THE PRACTICE BY LICENSEE OF THE LICENSE GRANTED HEREUNDER
SHALL NOT
6
INFRINGE THE PATENT RIGHTS OF ANY THIRD PARTY. IN NO EVENT SHALL NORTHWESTERN,
ITS TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES AND AFFILIATES BE LIABLE FOR
INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGE OR
INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHER NORTHWESTERN SHALL BE
ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE
POSSIBILITY.
ARTICLE XI - TERM AND TERMINATION
11.1 This Agreement shall become effective on the Effective Date. Unless
sooner terminated as provided for below, this Agreement shall continue in effect
on a country-by-country basis, until (a) the expiration of the last to expire of
any Patent Rights, or (b) ten (10) years from the date of the first commercial
sale in countries where no Patent Rights exist.
11.2 Licensee shall have the right to terminate this Agreement in whole or
in part anytime after three (3) years from the Effective Date by giving
Northwestern ninety (90) days written notice.
11.3 Northwestern shall have the right to terminate or render this license
non-exclusive at any time after three (3) years from the Effective Date if, in
Northwestern's reasonable judgement, Licensee a) has not put the Licensed
Product into commercial use in the Territory in the Field, directly or through a
sublicensee, thereby not making the Licensed Product available to the public, or
b) is not demonstrably engaged in research, development, manufacturing,
marketing, as appropriate, directed towards this end.
11.4 The provisions of Article III (Confidentiality), Article VI
(Payments, Reports and Records), Article X (Product Liability) and Article XIII
(Dispute Resolution) shall survive termination or expiration of this Agreement
in accordance with their terms.
11.5 If (1) either Party breaches any material obligation imposed by this
Agreement; (2) either Party makes any general assignment for the benefit of its
creditors; (3) a petition is filed by or against either Party, or any proceeding
is initiated against either Party as a debtor, under any bankruptcy or
insolvency law, unless the laws then in effect void the effectiveness of this
provision; or (4) a receiver, trustee, or any similar officer is appointed to
take possession, custody, or control of all or any part of either Party's assets
or property, then the other Party may, at its option, send a written notice that
it intends to terminate the license granted by this Agreement.
11.6 If the Party in breach does not cure the breach, negate the
assignment, obtain a dismissal of the proceeding, or have the appointment
vacated and regaining its assets within ninety (90) days from the notice date,
then the other Party shall have the right to terminate the license granted
immediately upon the date of mailing of a written notice of termination to the
Party in breach.
11.7 Upon termination of this Agreement for any cause, nothing herein
shall be construed to release either Party of any obligation that has matured
prior to the effective date of such termination. Licensee may, after the date of
such termination, sell all Licensed Products that it may have on hand at the
date of termination, provided that it pays the earned royalty thereon as
provided in this Agreement.
11.8 In the event of termination for breach by Licensee, Licensee agrees
to no longer use any of the Patent Rights or Know-How under which it has been
granted a license and will turn over and assign to Northwestern its Regulatory
Approvals and data and material related to price and Regulatory Approvals at no
charge with the right to sublicense.
11.9 Upon termination of this Agreement, any and all existing sublicense
agreements shall be immediately assigned to Northwestern and Northwestern agrees
to keep them in force to the extent that Northwestern is capable of performing
as a licensor in place of Licensee.
7
ARTICLE XII - ASSIGNMENT
This Agreement shall not be assignable by either Party without the prior
written consent of the other, except that any Party may assign this Agreement to
any Affiliate, to a successor in interest (including the surviving company in
any consolidation or merger), or to an assignee of substantially all the
business and assets of such Party, or with respect to Licensee, to an assignee
of all or substantially all of the business to which this Agreement relates.
ARTICLE XIII - DISPUTE RESOLUTION
13.1 The Parties agree to effect all reasonable efforts to resolve any and
all disputes between them in connection with this Agreement in an amicable
manner.
13.2 The Parties agree that any dispute that arises in connection with
this Agreement and which cannot be amicably resolved by the parties shall be
resolved by binding Alternative Dispute Resolution (ADR) in the manner set forth
in Paragraph 13.3 through Paragraph 13.5.
13.3 If a Party intends to begin ADR to resolve a dispute, such Party
shall provide written notice to the other Party informing the other Party of
such intention and the issues to be resolved. Within ten (10) business days
after its receipt of such notice, the other Party may, by written notice to the
Party initiating ADR, add additional issues to be resolved. If the Parties
cannot agree upon the selection of a neutral within twenty (20) business days
following receipt of the original ADR notice, a neutral shall be selected by the
then President of the Center for Public Resources (CPR), 000 Xxxxx Xxxxxx, Xxx
Xxxx, Xxx Xxxx 00000. The neutral shall be a single individual having experience
in the biotechnology industry who shall preside in resolution of any disputes
between the Parties. The neutral selected shall not be an employee, director or
shareholder of either Party or an Affiliate or sublicensee.
13.4 Each Party shall have ten (10) business days from the date the
neutral is selected to object in good faith to the selection of that person. If
either Party makes such an objection, the then President of the CPR shall, as
soon as possible thereafter, select another neutral under the same conditions as
set forth above. This second selection shall be final.
13.5 The ADR shall be conducted in the following manner:
(a) No later than forty-five (45) business days after selection, the
neutral shall hold a hearing to resolve each of the issues identified by the
Parties.
(b) At least five (5) days prior to the hearing, each Party must
submit to the neutral and serve on the other Party a proposed ruling on each
issue to be resolved. Such proposed ruling shall contain no argument on or
analysis of the facts or issues, and shall be limited to not more than fifty
(50) pages.
(c) The neutral shall not require or permit any discovery by any
means, including depositions, interrogatories or production of documents.
(d) Each Party shall be entitled to no more than eight (8) hours of
hearing to present testimony or documentary evidence. The testimony of both
Parties shall be presented during consecutive calendar days. Such time
limitation shall apply to any direct, cross or rebuttal testimony, but such time
limitation shall only be charged against the Party conducting such direct, cross
or rebuttal testimony. It shall be the responsibility of the neutral to
determine whether the parties have had the eight (8) hours to which each is
entitled.
(e) Each Party shall have the right to be represented by counsel.
The neutral shall have the sole discretion with regard to the admissibility of
any evidence.
8
(f) The neutral shall rule on each disputed issue within thirty (30)
days following the completion of the testimony of both Parties. Such ruling
shall adopt in its entirety the proposed ruling of one of the parties on each
disputed issue.
(g) ADR shall take place in Chicago, Illinois. All costs incurred
for a hearing room shall be shared equally between the Parties.
(h) The neutral shall be paid a reasonable fee plus expenses, which
fees and expenses shall be shared equally by the Parties.
(i) The ruling shall be binding on the Parties and may be entered as
an enforceable judgment by a state or federal court having jurisdiction of the
Parties.
13.6 This Section XIII shall survive any termination of this Agreement
ARTICLE XIV - NOTICES AND PAYMENTS
Any payment, notice or other communication pursuant to this Agreement
shall be sufficiently made or given on the date of mailing if sent to such Party
by certified first class mail, postage prepaid, addressed to it at its address
below or as it shall designate by written notice given to the other Party:
In the case of Northwestern: Director
Technology Transfer Program
Northwestern University
0000 Xxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxx 00000
In the case of Licensee: Mr. Xxxxxxx Xxxxxxxx
President & CEO
Immtech International Inc.
0000 Xxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxx 00000
ARTICLE XV - GENERAL
15.1 Force Majeure. Neither party shall be liable to the other for its
failure to perform any of its obligations under this Agreement, except for
payment obligations, during any period in which such performance is delayed
because rendered impracticable or impossible due to circumstances beyond its
reasonable control, including without limitation earthquakes, governmental
regulation, fire, flood, labor difficulties, interruption of supply of key raw
materials, civil disorder, and acts of God, provided that the Party experiencing
the delay promptly notifies the other Party of the delay.
15.2 Severability. In the event any provision of this Agreement is held to
be invalid or unenforceable, the valid or enforceable portion thereof and the
remaining provisions of this Agreement will remain in full force and effect.
15.3 Applicable Law. This Agreement is made in accordance with and shall
be governed and construed under the laws of the State of Illinois, excluding its
choice of law rules.
15.4 Entire Agreement. This Agreement and the exhibits attached hereto
constitute the entire, final, complete and exclusive agreement between the
Parties and supersede all previous agreements or representations, written or
oral, with respect to the subject matter of this Agreement. This Agreement may
not be modified or amended except in a writing signed by a duly authorized
representative of each Party.
9
15.5 Headings. The headings for each article and section in this Agreement
have been inserted for convenience or reference only and are not intended to
limit or expand on the meaning of the language contained in the particular
article or section.
15.6 Independent Contractors. The Parties are not employees or legal
representatives of the other party for any purpose. Neither Party shall have the
authority to enter into any contracts in the name of or on behalf of the other
Party.
15.7 Advertising. Licensee shall not use the name of any inventor of
Northwestern University, of any institution with which the inventor has been or
is connected, nor the name of Northwestern in any advertising, promotional or
sales literature, without prior written consent obtained from Northwestern in
each case.
15.8 Waiver. Any waiver (express or implied) by either Party of any breach
of this Agreement shall not constitute a waiver of any other or subsequent
breach.
15.9 Counterparts. This Agreement may be executed in counterparts with the
same force and effect as if each of the signatories had executed the same
instrument.
15.10 Patent Marking. Licensee agrees to xxxx the Licensed Products sold
in the United States with all applicable United States patent numbers. All
Licensed Products 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.
In Witness Whereof, the Parties have executed this Agreement effective on
the date first set forth above.
LICENSEE NORTHWESTERN
By: /s/ T. Xxxxxxx Xxxxxxxx By: /s/ Xxxxx Xxxxx-Xxxxxxxx
----------------------- -------------------------------
Name: T. Xxxxxxx Xxxxxxxx Name: XXXXX XXXXX-XXXXXXXX
Title: President and CEO Title: VICE PRESIDENT FOR RESEARCH
AND GRADUATE STUDIES
10
EXHIBIT A
Immunoassay of Glycosylaed Proteins Employing Antibody
Directed to Reductively Glycosylated N-Terminal Amino Acids
Xxxxx X. Xxxxx, Xxxxx Xxxxxxxx
U.S. Patent No. 5,484,735 - Issued: January 16, 1996
INTERNATIONAL PATENT, KNOW-HOW
AND TECHNOLOGY LICENSE AGREEMENT
THIS INTERNATIONAL PATENT, KNOW-HOW AND TECHNOLOGY LICENSE AGREEMENT
("Agreement") is made this 29th day of June, 1998 by and between IMMTECH
INTERNATIONAL, INC. ("Immtech"), a Delaware corporation, and CRITICARE SYSTEMS,
INC. ("Criticare"), a Delaware corporation.
RECITALS
Certain capitalized terms used in these recitals are defined below
in this Agreement.
A. Immtech owns the patent rights and certain Technology, including
Know-how and Technical Information necessary or useful in the design,
development, customization, manufacture, use, composition and processing of the
mCRP (modifiedC- Reactive Protein) and a recombinant form of mCRP for the
treatment of sepsis (collectively, the "mCRP Patent Rights"); and
B. Criticare desires to obtain, and Immtech is willing to grant,
the License with respect to the mCRP Patent Rights and Immtech Technology within
the Field upon the terms and conditions hereinafter set forth.
AGREEMENT
In consideration of the mutual covenants set forth herein, the
sufficiency of which is hereby acknowledged, the Parties agree to the terms and
conditions set forth below.
1. Definitions. For the purpose of this Agreement, the following
terms (when capitalized, except as otherwise noted) shall have the meanings set
forth hereinbelow.
(a) "Effective Date" means the date first stated above.
(b) "Field of the Agreement" means systems, methods,
processes, compositions, articles and apparatuses for the treatment of sepsis.
(c) "mCRP Patent Rights" means the patent rights and certain
Technology, including Know-how and Technical Information necessary or
useful in the design, development, customization, manufacture, use, composition
and processing of the mCRP (modified C- Reactive Protein) and a recombinant form
of mCRP for the treatment of sepsis owned or licensed by Immtech, including,
without limitation, the patent rights listed in Schedule A and any
continuations, continuations-in-part divisionals, reissues, reexaminations,
extensions or other patents or applications claiming priority or based upon the
listed patents.
(d) "mCRP Technology" means Technology that is owned or
licensable by Immtech.
(e) "Improvements" means any modification or enhancement,
patentable or not, which is conceived and/or reduced to practice by Criticare or
Immtech during the term of this Agreement, related to the Field of this
Agreement.
(f) "License" is defined in Article 3.1.
(g) "Licensed Territory" means the countries listed in
Schedule B attached hereto, as that schedule may be amended from time to time by
mutual written consent of the Parties or in accordance with Articles 3.6 or 3.7.
(h) "Product" shall mean any product in the Field of the
Agreement, which is covered by any claim in the Immtech Patent Rights and/or
which is produced utilizing Technology. "Product" may also include such
additional products and/or Improvements as may be agreed upon by mutual
agreement of the Parties from time to time.
(i) "Technology" means all Know-how and Technical Information
related to the Field of this Agreement which is owned or licensable by a Party,
now and during the term of this Agreement.
(i) "Know-how" means any information, including
technical data, now, or during the term of this Agreement or any renewals
hereof, possessed by Immtech, and which are, in Immetech's or Criticare's
judgment, reasonably necessary to enable Criticare to manufacture, customize,
use, market or sell Products, and includes dimensions, materials, processes and
procedures relating thereto, and which are the secret, confidential and
proprietary information of Immtech.
(ii) "Technical Information" means any information
possessed by a Party which, although not the secret Know-how of Immtech, is
2
nevertheless in either party's reasonable judgment, useful in utilizing Know-how
or Immtech Patent Rights.
(j) The "term of this Agreement" (whether or not capitalized)
shall begin on the Effective Date hereof and unless terminated pursuant to
Article 10 shall continue for the term of the patent or any continuation or
extention thereof.
2. Disclosure and Support.
(a) Immtech agrees that, within thirty days after the
Effective Date of this Agreement, it will make Immtech Technology available to
Criticare for Criticare's use hereunder. As additional Immtech Technology is
developed by Immtech during the term of this Agreement, it shall promptly be
made available to Criticare hereunder at no additional cost.
(b) Immtech hereby agrees not to attempt in any manner to
license, sell or otherwise commercialize Products and/or any Improvements within
the Licensed Territory to any person or entity other than Criticare.
(c) Criticare agrees to provide to Immtech any technologically
significant data that is developed or obtained by Criticare during the term of
the Agreement. Each Party recognizes that some data may only be available in
summarized form to protect the confidentiality of customers, but Criticare shall
use reasonable efforts to secure permission, where needed, to provide such
pre-summarized information to Immtech. Representatives from Immtech are free to
contact Criticare project personnel for verbal reports, updates, or
clarification of written reports at any time during normal business hours.
3. Exclusive License Grant.
(a) Immtech hereby grants to Criticare the exclusive right and
license, with the right to sublicense others, throughout the Licensed Territory
under mCRP Technology and under the mCRP Patent Rights, to make, use, have made,
offer for sale and sell Products and to practice methods and processes utilizing
Immtech Technology in connection therewith. The foregoing right and license is
referred to herein as the "License."
(b) The right to sublicense granted Criticare in Article 3.1
specifically includes the right to sublicense others exclusively and/or
non-exclusively in the Licensed Territory under Immtech Technology and under the
Immtech Patent Rights any right granted Criticare under this Agreement,
3
including the right to grant exclusive and/or non-exclusive field-of-use
sublicenses.
(c) Criticare will advise Immtech of all sublicenses and shall
at all times keep an account of all manufacture and assembly, sales, shipments
and uses of Products by Criticare and by all sublicensees.
(d) Criticare shall be responsible for finding sublicensees
and negotiating exclusive and/or non-exclusive (including exclusive and/or
nonexclusive restricted field-of-use) sub license agreements with said sub
licensees.
4. Payments and Accounting.
(a) In consideration of the grant of the License Criticare
shall pay to Immtech during the term of this Agreement a royalty consisting of
$100 per year.
(b) The royalties payable under this Agreement are in
consideration of the grant of rights under the Immtech Technology as well as the
grant of rights under the Immtech Patent Rights, and no additional royalty or
fee is due Immtech for Criticare's rights granted hereunder to utilize Immtech
Technology to manufacture, assemble, use, have manufactured, have assembled,
offer for sale, sell or otherwise commercialize Products or otherwise exploit
the Technology.
5. Marking and Quality.
(a) Criticare will apply, and cause each of its sublicensees
to apply, appropriate notice of patent protection on or in connection with
Products or their packages, including the numbers of relevant issued patents,
and give notice of the pendency of patent applications on Products or their
packages, such as, for example, stating "Patent Pending," such notices being
sufficient under applicable law to provide reasonable protection to the rights
of Immtech.
(b) Immtech shall at all times have the right to require that
Products manufactured or assembled by Criticare pursuant to this Agreement
satisfy reasonable standards of quality fixed by Immtech, and Immtech shall have
the right to inspect such Products, and the manufacturing process, at reasonable
times and at Immtech's expense, to confirm that such Products do conform to such
standards.
4
6. Confidential Status of Technology.
(a) Each Party acknowledges and agrees that, subject to the
provisions of this Article 6, all Technology disclosed to it by the other Party
pursuant to this Agreement may constitute and comprise valuable confidential
information, and therefore the Party agrees to hold any such Technology it
receives from the other Party in confidence and otherwise protect it as provided
in this Article 6.
(b) Each Party (the "receiving Party") agrees that, subject to
the provisions of this Article 6, it shall not, without the prior written
consent of the other Party (the "disclosing Party"), disclose, distribute or use
any portion of Technology disclosed to it by the disclosing Party, except to the
extent necessary for the receiving Party to exercise rights hereunder or
authorize or allow others to do so. Each receiving Party further agrees to limit
access to such Technology to--
(i) those of its employees, or others, who have a "need
to know" of the same in order for the receiving Party to exercise said rights;
and
(ii) its sublicensees who have a "need to know" of the
same in order for sublicensees to exercise said rights; and
in either case who are under a duty to protect such Technology for the benefit
of the disclosing Party to the same extent as is the receiving Party itself.
(c) The obligations under this Article 6 shall not extend to any
information disclosed by a disclosing Party to a receiving Party which (i) is
within the public domain, or enters into the public domain through no fault of
the receiving Party, (ii) is within the possession of the receiving Party prior
to receipt from the disclosing Party as shown by appropriate records, or (iii)
is independently made available to the receiving Party by a third party without
breach by the third party of any duty owed to the disclosing Party with respect
thereto. It is understood that some Technology may, at least in part, consist of
a synthesis of information that is in the public domain; and it is, therefore,
understood that no exclusion contained in this Article 6.3 shall operate to
exclude from the obligations of this Article 6 such synthesis of otherwise
public domain information, unless it can be shown that such synthesis is itself
in the public domain.
(d) Each Party agrees that all obligations under this Article 6 with
respect to any and all Technology shall survive any termination of any or all
other provisions of this Agreement and shall continue until such time as one of
the
5
exceptions set forth in Article 6.3 becomes applicable to the Technology in
question or for a period not to exceed two years after any such termination.
(e) Neither Party shall be liable for the inadvertent or
accidental use or disclosure of Know how or Technical Information, provided such
use or disclosure occurs despite the Party's exercise of the same degree of care
as the Party takes to safeguard and preserve its own proprietary information.
7. Representations and Warranties.
(a) Immtech expressly warrants
(i) that Immtech has the right to grant the License
within the Field and throughout the Licensed Territory;
(ii) that no third party has any right, title or
interest in the Immtech Patent Rights or Immtech Technology in the Field and
throughout the Licensed Territory;
(iii) that Immtech has taken no actions which adversely
affect Criticare's rights under this Agreement; and
(iv) that Immtech has the right to execute and enter
into this Agreement, to perform its obligations hereunder, and to grant the
License.
(b) Immtech warrants that, to the best of its knowledge, there
are no circumstances that would (i) render the Immtech Patent Rights invalid or
unenforceable, or (ii) render Criticare liable for patent infringement or trade
secret misappropriation as a consequence of Criticare's performing the
activities permitted by this Agreement or practice of the Immtech Patent Rights
or Immtech Technology as provided to Criticare.
(c) Until such time as Criticare completes the financing
referred to in paragraph 11, Immtech represents that it will timely pay all
necessary maintenance fees, annuities, taxes or other fees in order to maintain
the enforceability of the Immtech Patent Rights.
(d) Criticare and Immtech each represents that it has the
corporate power to enter into this Agreement and perform the obligations assumed
hereunder. Criticare and Immtech each represents that the person executing this
Agreement on behalf of the corporation is authorized to execute this Agreement
and legally bind the corporation.
6
8. Improvements.
(a) Immtech agrees that all Improvements developed by Immtech
during the term of this Agreement shall be made available on the same basis and
under the same terms as set forth in this Agreement at no additional cost to
Criticare. Immtech shall promptly notify Criticare of all such Improvements as
they can reasonably be made available in form sufficient to disclose such
Improvement to Criticare, and at Criticare's option such Improvements may be
included in this Agreement and/or Products.
(b) If Criticare requests Immtech, in writing, to file a
patent application in a given nation or nations within the Licensed Territory
based on the Immtech Patent Rights or a Immtech Improvement, Immtech shall
promptly initiate the filing of such application(s), using local counsel of
Criticare's choosing. Criticare shall be responsible for all out of pocket
costs, including attorney fees, of filing and prosecuting any such patent
application(s) together with all fees, taxes, assessments, and levies on said
patent application(s) and/or patent(s) obtained therefrom for so long as
Criticare desires to maintain its rights thereunder. Immtech shall cooperate
fully with the prosecution, maintenance and enforcement of said patent
application(s) and/or patent(s) obtained therefrom and shall execute all
documents reasonably necessary for these activities.
(c) Criticare agrees that all Improvements developed by
Criticare during the term of this Agreement shall be made available on a
nonexclusive basis to Immtech without cost or reduction in royalty payable to
Immtech. Criticare shall promptly notify Immtech of all such Improvements as
they can reasonably be made available in form sufficient to disclose such
Improvement to Immtech, and at Immtech's option may be included in Products
and/or may be licensed from Criticare on the same basis and under the same terms
as set forth in this Agreement.
(d) Upon termination of the term of this Agreement,
Criticare's rights to continue use of Immtech's Improvements shall be limited by
the scope of Immtech Patent Rights existing upon termination. Likewise, upon
termination of the term of this agreement, Immtech's rights to continue use of
Criticare's Improvements shall be limited by the scope of Criticare's patent
rights existing upon termination.
9. Infringement of Immtech Patent Rights.
(a) Immtech and Criticare agree to promptly notify each other
if they become aware of a probable infringement by a third party of the Immtech
Patent Rights. Immtech and Criticare further agree that, unless one Party
7
provides the other with written notice of the first Party's desire to not be
actively involved in a particular infringement action, actions against any third
party that may be infringing the Immtech Patent Rights in the Licensed Territory
shall be a joint effort of both Parties, and that both the costs and recovery
resulting from such actions shall be shared equally between the Parties. If
either Party notifies the other of its desire not to be actively involved in a
particular infringement action, and the other chooses to go forward with such an
action, the Party going forward shall be responsible for all costs relating to
such action, and shall be the sole beneficiary of any recovery resulting from
such action; and in such case the Party desiring not to be actively involved
shall render reasonable cooperation to the Party going forward, including, if
necessary, being named as a party to the action.
(b) In the event that Criticare, and/or Criticare's customers,
successors, and assigns are held liable as an infringer of a patent or trade
secret belonging to a third party arising from the manufacture, use and sale of
any Product and/or component element thereof licensed under this Agreement,
Immtech agrees to reimburse Criticare, and its customers, successors and assigns
for any financial loss, including attorney fees, sustained thereby.
10. Term and Termination.
(a) The Parties agree that the term of this Agreement, except
for the obligations under Article 6 hereof, may be terminated early (i) by
Criticare at any time by providing Immtech written notice of such termination;
or (ii) by either Party if the other Party breaches or defaults on any material
obligation under this Agreement and fails to cure such breach within sixty days
after receipt of written notice from the terminating Party which sets forth the
basis of such breach and the terminating Party's intent to terminate the
Agreement due to such breach.
(b) Termination of the term of this Agreement shall terminate
all of the Parties' respective rights and obligations under this Agreement,
except that such termination shall not affect:
(i) The right of Criticare to sell any Product on hand
on the date of such termination, to fill any orders for Product received on or
before the date of such termination, and to complete any Product in the process
of manufacture at the time of such termination and to sell the same;
(ii) The rights and obligations of the Parties under
Articles 4 and 6 of this Agreement; and
8
(iii) The right of either Party (including all
remedies), and the obligation of the other Party, to every performance accruing
prior to such termination.
11. Funding. Criticare or its assignee agrees that it will utilize
its best efforts to raise not less than $500,000 within 12 months after the date
of this Agreement to fund the development and commercialization of a product
utilizing mCRP for the treatment of sepsis. In the event that Criticare fails to
complete such financing, Immtech shall have 90 days within which to repurchase
the mCRP Patent Rights, mCRP Technology and any Improvements for their appraisal
value. Appraisal value shall be determined by a certified appraiser agreed upon
by Immtech and Criticare, or, if they cannot agree, an appraiser selected by
Criticare's then audit firm.
12. Maintenance of Immtech Patent Rights.
(a) The cost of filing, prosecuting to issuance and
maintaining the Immtech Patent Rights related to a mutant protein and methods
and materials for making and using it shall be borne by Immtech.
(b) Before permitting the Immtech Patent Rights to become
abandoned, lapsed or forfeited, Immtech shall give Criticare a reasonable notice
in writing, and Criticare may then at its option and expense, take over the
prosecution or maintenance of the Immtech Patent Rights, in which event Immtech
agrees to cooperate fully with Criticare. All costs, expenses and fees,
including attorney fees, incurred by Criticare in taking over the maintenance of
the Immtech Patent Rights shall be deducted from any royalties due Immtech under
this Agreement. Should any of the Immtech Patent Rights be abandoned, lapsed, or
forfeited due to the failure by Immtech to pay the appropriate maintenance or
other fee, then after the abandonment, Criticare shall be permitted to sell
Products covered by such abandoned patent without payment or royalty for such
sale and the obligations of Criticare under this Agreement with respect to that
abandoned Immtech Patent Right shall cease.
13. Miscellaneous.
(a) This Agreement, or any rights or obligations hereunder,
may not be assigned, in whole or in part, by either Party without the prior
written consent of the other Party, which consent shall not be unreasonably
withheld. However, nothing herein shall prevent Criticare from assigning its
rights and obligations hereunder to an affiliated corporation or subsidiary
corporation controlled by or under common control with Criticare. In the event
of such
9
assignment, the assignee will automatically become substituted for Criticare as
to all obligations thereafter accruing hereunder and as to all rights hereunder.
(b) The Parties agree that the sole relationship between
Immtech and Criticare hereunder will be that of licensor and licensee. Nothing
herein shall constitute or be interpreted to make either Party the agent of the
other Party, and neither Party shall in any way be authorized to obligate the
other Party in any transaction with a third party.
(c) All notices and other communications under or with respect
to this Agreement shall be in writing (including by telecopier and other
available communication facilities providing written copy to the recipient
party) and shall be effective when actually delivered to the party to which they
are directed or when deposited in the United States mail, postage prepaid,
addressed to the party to which they are directed at the address provided below
for that party or at such other address as that party may designate by notice.
The initial addresses are as follows:
If to Critic are:
Criticare Systems, Inc.
00000 Xxxxxxxxxx Xxxxxx
Xxxxxxxx, XX 00000
Facsimile: 000-000-0000
Confirming telephone: 000-000-0000
With a copy to:
Reinhart, Boerner, Van Deuren,
Xxxxxx & Xxxxxxxxxx, s.c.
Attn: Xxxxxx X. Xxxxxx
0000 Xxxxx Xxxxx Xxxxxx, Xxxxx 0000
X.X. Xxx 00000
Xxxxxxxxx, XX 00000-0000
Facsimile: 414-298-8097
Confirming telephone: 000-000-0000
10
If to Immtech:
Immtech International Inc.
Attn: Xxxxxxx Xxxxxxxx
0000 Xxxxx Xxxxxx, Xxxxx 000
Xxxxxxxx, XX 00000
Facsimile: 000-000-0000
Confirming telephone: 000-000-0000
With a copy to:
Xxxx X. Xxxxxx, Esq.
Xxxxxxx, Carton & Xxxxxxx
000 X. Xxxxx Xxxxxx
Xxxxxxx, XX 00000-0000
Facsimile: 000-000-0000
Confirming telephone: 000-000-0000
(d) The Parties acknowledge and agree that this Agreement
constitutes the entire agreement and understanding relating to the subject
matter of this Agreement and supersedes all previous communications, proposals,
representations and agreements, whether oral or written and whether relating to
the subject matter of this Agreement or otherwise.
(e) The Parties acknowledge and agree that this Agreement may
only be modified by the mutual written agreement of the Parties.
(f) (i) For purposes of this Article 13.6, a "Force Majeure
Event" shall be any event or condition that [a] is not known to the Excused
Party (as defined below), as of the date of this Agreement, to exist, [b] is not
reasonably foreseeable as of such date, and [c] is not reasonably within the
control of the Excused Party. Without limiting the foregoing, any of the
following shall constitute a Force Majeure Event if the same meets the
conditions expressed in the enumerated clauses of the preceding sentence:
natural disaster, fire, explosion, epidemic, war, riot, civil disturbance,
strike, lockout, labor slow-down, acts of governmental authority, and shortage
of energy or material.
(ii) Any period of time in which a Party (the "Excused
Party") must perform any obligation under this Agreement shall be extended by
the period of time that a Force Majeure Event prevents such performance in whole
or in material part or renders such performance so difficult or costly that such
performance is commercially unreasonable, and the Excused Party shall not be
liable for loss or damage incurred by the other Party by reason of
11
any delay in such performance during such period of extension. If the Force
Majeure Event is of such a nature that the performance of the obligation will
reasonably require an additional period of time following cessation of the Force
Majeure Event, then the period of time in which the Excused Party must perform
the obligation shall be further extended by such additional period of time, and
the Excused Party shall not be liable for loss or damage incurred by the other
Party by reason of any delay in such performance during such additional period
of time.
(iii) If the period of time in which a Party must
perform any material obligation hereunder is extended for a period of more than
six consecutive months pursuant to the preceding provisions of this Article,
either Party may terminate this Agreement, without liability to the other Party
for such termination, by giving notice of termination given to the other Party
prior to the end of the period of extension.
(iv) The foregoing provisions of this Article shall not
excuse any obligation to pay any amount which becomes due under this Agreement
prior to termination of this Agreement, but payment for any performance the time
for which is extended pursuant to such provisions may be suspended until such
performance is rendered.
(g) The Parties agree that this Agreement will be governed and
construed in accordance with the internal laws of the State of Wisconsin.
(h) Each Party agrees that any delay or omission on the part
of the other Party to exercise any right under this Agreement will not
automatically operate as a waiver of such right or any other right, and a waiver
of any right on any one occasion will not be construed as a bar to or a waiver
of exercising the right on any other occasion.
(i) Each Party agrees that, should any provision of this
Agreement be determined by a court of competent jurisdiction to violate or
contravene any applicable law or policy, such provision may be severed and
modified by the court to the extent necessary to comply with the applicable law
or policy, and such modified provision and the remainder of the provisions
hereof will continue in full force and effect.
(j) The title, caption or heading of any provision of this
Agreement is used as a matter of convenience and is not to be used to interpret
or construe the meaning of any provision. The words "herein," "hereof," and
"hereunder," when used in this Agreement, refer to this Agreement in its
entirety. The word "include" and its derivatives mean by way of example and not
by way of exclusion or limitation. Words in the singular include the plural and
words in the
12
plural include the singular, according to the requirements of the context. Words
importing a gender include all genders. Each Party agrees that this Agreement is
the result of extensive negotiations between the Parties and represents the
merged work product of both Parties, and so neither Party shall be held to be
the sole author of this Agreement for the purpose of contract interpretation
(k) This Agreement may be executed in one or more
counterparts, each of which shall be deemed to be an original, and all of which
together shall be deemed to constitute but one and the same instrument.
CRITICARE SYSTEMS, INC. IMMTECH INTERNATIONAL, INC.
BY /s/ Xxxxxxx xxxxxx Ruhr BY /s/ T. Xxxxxxx Xxxxxxxx
-------------------------- -------------------------------
Its Pres Its President & CEO
---------------------- ---------------------------
13
ASSIGNMENT AGREEMENT
THIS ASSIGNMENT AGREEMENT is made and entered into as of the 29th
day of June, 1998, by and between CRITICARE SYSTEMS, INC., a Delaware
corporation ("CRITICARE") and IMMTECH INTERNATIONAL, INC., a Delaware
corporation ("IMMTECH").
RECITAL
CRITICARE desires to prospectively assume all rights and certain
obligations of IMMTECH set forth in a certain Material Transfer and Option
Agreement between Immtech and SIGMA DIAGNOSTICS, INC. (hereinafter referred to
as the "Sigma Agreement"), a copy of which is attached hereto as Exhibit A.
AGREEMENTS
NOW, THEREFORE, CRITICARE and IMMTECH, in consideration of the
mutual promises and agreements set forth below, the receipt and sufficiency of
which consideration hereby is acknowledged, promise and agree as follows:
1. As of the day, month and year first above written, CRITICARE will
prospectively assume all rights and obligations of IMMTECH set forth in the
Sigma Agreement and be bound by all terms and conditions thereof continuing
forward; provided, however, that Immtech shall retain and promptly fulfill any
obligations under such agreement to provide cultures, materials or any advice or
consultation related to the materials (as defined therein).
2. This ASSIGNMENT AGREEMENT embodies the entire understanding
between CRITICARE and IMMTECH relating to the Sigma Agreement and shall
supersede all previous communications, representations or undertakings, either
verbal or written between the parties relating to the subject matter of this
ASSIGNMENT AGREEMENT.
3. This ASSIGNMENT AGREEMENT shall be governed and construed in
accordance with the internal laws of the State of Wisconsin.
IN WITNESS WHEREOF, CRITICARE and IMMTECH have executed this
ASSIGNMENT AGREEMENT as of the day, month and year first above written.
CRITICARE SYSTEMS, INC. IMMTECH INTERNATIONAL, INC.
BY /s/ Xxxxxxx xxxxxx Ruhr BY
--------------------------- -------------------------------
Its Pres Its
--------------------- ---------------------------
SIGMA DIAGNOSTICS, INC. hereby consents to CRITICARE'S assumption of
IMMTECH'S rights and obligations as described above in relation to the Sigma
Agreement and acknowledges that Immtech is not in default of any of its
obligations thereunder.
SIGMA DIAGNOSTICS, INC.
BY
-------------------------- --------------
Its Date
--------------------
2
IN WITNESS WHEREOF, CRITICARE and IMMTECH have executed this
ASSIGNMENT AGREEMENT as of the day, month and year first above written.
CRITICARE SYSTEMS, INC. IMMTECH INTERNATIONAL, INC.
BY BY [ILLEGIBLE]
--------------------------- -------------------------------
Its Its CFO
--------------------- -------------------------
SIGMA DIAGNOSTICS, INC. hereby consents to CRITICARE'S assumption of
IMMTECH'S rights and obligations as described above in relation to the Sigma
Agreement and acknowledges that Immtech is not in default of any of its
obligations thereunder.
SIGMA DIAGNOSTICS, INC.
BY
---------------------------- --------------
Its Date
----------------------
2