SETTLEMENT AND LICENSE AGREEMENT
This
Settlement and License Agreement (“Agreement”) is
effective and entered into as of September 19, 2005 (the
“Effective Date”), by and between GE Healthcare Ltd.
f/k/a Amersham plc, Amersham Health, Inc., and Amersham Health AS,
(collectively “Amersham”), IMCOR Pharmaceutical Co.
f/k/a Photogen Technologies, Inc. (“IMCOR”), Alliance
Pharmaceutical Corp. (“Alliance”), and Molecular
Biosystems, Inc. (“MBI”), (Amersham, IMCOR, Alliance,
and MBI, collectively “the Parties”).
WHEREAS,
Amersham possesses intellectual property relating to the
formulation, method of preparing or use of ultrasound contrast
products;
WHEREAS,
until 2003 Alliance possessed intellectual property relating to the
formulation, method of preparing or use of ultrasound contrast
products;
WHEREAS,
on June 18, 2003, Alliance and IMCOR entered into an Asset Purchase
Agreement (the “Asset Purchase Agreement”) pursuant to
which Alliance sold, conveyed, transferred, assigned and delivered
to IMCOR all of Alliance’s right, title and interest in and
to all of Alliance’s tangible and intangible assets for all
imaging modalities, including (without limitation) (i) all rights
related to the Imagent product, (ii) all patents and other
intellectual property related to such assets, (iii) all claims and
causes of action (whether or not then asserted) related to such
products, patents or intellectual property, and (iv) all claims and
causes of action arising or related to Alliance’s business of
designing, developing, manufacturing, marketing, selling,
licensing, supporting and maintaining imaging modalities in
connection with Alliance’s imaging and diagnostic imaging
business;
WHEREAS,
the Asset Purchase Agreement granted Alliance certain rights with
respect to the Imagent business and related intellectual property
after the closing of such sale under the conditions, circumstances
and terms specified in the Asset Purchase Agreement;
WHEREAS,
IMCOR currently possesses intellectual property relating to the
formulation, method of preparing or use of ultrasound contrast
products;
WHEREAS,
there is pending in the United States District Court for the
District of New Jersey a litigation captioned IMCOR
Pharmaceutical Co. and Alliance Pharmaceutical Corp. v. Amersham
Health Inc., Amersham Health AS, and Amersham plc. v. Molecular
Biosystems Inc. , Civil Action No. 03-2853 (SRC), (the
“Action”), and;
WHEREAS,
the Parties desire to settle the Action and all existing and
potential intellectual property disputes relating to certain
products.
NOW,
THEREFORE, in consideration of the foregoing and the covenants,
acknowledgements and representations contained in this Agreement,
the Parties hereby agree as follows:
ARTICLE I. DEFINITIONS
1.1.
Definitions . For
purposes of this Agreement, the terms defined here shall have the
meanings specified below. These terms are intended to encompass
both singular and plural forms.
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1.1.1.
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“
Affiliate ” shall mean an entity that directly, or
indirectly through one or more intermediaries, controls, or is
controlled by, or is under common control with a Party. Without
limiting the generality of the foregoing, “control”
shall mean the ownership, directly or indirectly, of fifty percent
(50%) or more of the issued share capital or shares of stock
entitled to vote for the election of directors, in the case of a
corporation, or fifty percent (50%) or more of the equity interests
in the case of any other entity or the legal power to direct or
cause the direction of the general management and policies of the
entity in question.
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1.1.2.
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“
Amersham Licensed Patents ” shall mean Licensed
Patents that are owned, obtained, acquired, purchased by or
licensed to with a right to sublicense, or in any way under the
control or disposal of Amersham, including, but not limited to, all
patents asserted by Amersham in the Action, including United States
Patent Nos. 5,558,856, 5,558,857, 5,567,412, 5,567,413, 5,569,449,
5,614,169, 5,618,514, 5,637,289,, 5,648,062, 5,670,135, 5,817,291,
5,827,502, 6,106,806, 6,153,172, and 6,544,496.
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1.1.3.
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“
Field ” shall mean ultrasound diagnostic imaging in
humans and animals.
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1.1.4.
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“
Imagent ” shall mean the ultrasound contrast product
that is the subject of NDA 21-191 together with such modification
thereto as may be made in connection with such
application.
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1.1.5.
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“
IMCOR/Alliance Licensed Patents ” shall mean Licensed
Patents that are owned, obtained, acquired, purchased by or
licensed to, with a right to sublicense, or in any way under the
control or disposal of IMCOR and/or Alliance, including but not
limited to all patents asserted by IMCOR and/or Alliance in the
Action including United Sates Patent Nos. 5,540,909, 5,733,527,
6,019,960, 6,056,943, 6,280,704, 6,285,339, 6,287,539, and
6,706,253.
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1.1.6.
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“
Licensed Patents ” shall mean all present patents and
patent applications worldwide, which are issued or pending as of
the Effective Date, together with all future patents and patent
applications that claim priority (directly or indirectly through
other applications) to any patent or patent application pending as
of or before the Effective Date.
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2/11
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1.1.7.
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“
Optison ” shall mean the ultrasound contrast product
that is the subject of NDA 20-899 together with such modification
thereto as may be made in connection with such
application.
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1.1.8.
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“
Party ” shall mean Amersham, Alliance, IMCOR, and/or
MBI.
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1.1.9.
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“
Sonazoid ” shall mean any phospholipid-containing
ultrasound contrast products that include gaseous C 4 F
10 , whether or not combined or modified with any other
ingredients, elements or materials.
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1.1.10.
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“
Territor y” shall mean the entire world.
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1.1.11.
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“
Third Party ” shall mean any entity other than
Alliance, Amersham, IMCOR, MBI or their Affiliates.
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ARTICLE II. WORLDWIDE GRANT OF INTELLECTUAL
PROPERTY RIGHTS
2.1.
IMCOR hereby grants Amersham and its Affiliates a fully paid-up,
irrevocable royalty-free, nonexclusive license, with the right to
sublicense, under the IMCOR/Alliance Licensed Patents to develop,
make, have made, use, sell, offer to sell, import, or export
Optison and/or Sonazoid in the Field in the Territory.
2.2.
Alliance hereby grants
Amersham and its Affiliates a fully paid-up, irrevocable
royalty-free, nonexclusive license, with the right to sublicense,
under the IMCOR/Alliance Licensed Patents to develop, make, have
made, use, sell, offer to sell, import, or export Optison and/or
Sonazoid in the Field in the Territory.
2.3.
Amersham hereby grants
IMCOR and its Affiliates a fully paid-up, irrevocable royalty-free,
nonexclusive license, with the right to sublicense, under the
Amersham Licensed Patents to develop, make, have made, use, sell,
offer to sell, import, or export Imagent in the Field in the
Territory.
2.4.
The rights granted hereunder shall extend to IMCOR’s and
Amersham’s respective distributors, manufacturers, sales
agents, exporters, and importers with respect to activities
authorized by and for the benefit of such Party or its Affiliates
and related to the manufacture, sale, distribution, exportation or
importation of Imagent, Optison or Sonazoid (as applicable) for or
under the direction of the applicable Party or its Affiliates. The
Parties acknowledge that nothing in this Agreement shall be
construed to convey any title or ownership rights to the Licensed
Patents. With the exception of the licenses explicitly granted in
paragraphs 2.1 through 2.3, no license, release or other right,
title or interest is granted by implication, estoppel or
otherwise.
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ARTICLE III. SETTLEMENT OF INTELLECTUAL PROPERTY
DISPUTES
3.1.
It is the intention of
the Parties to settle current and potential intellectual property
disputes pertaining to the Licensed Patents therefore the Parties
have voluntarily entered into this Agreement. In that connection,
the Parties shall:
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3.1.1.
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promptly cause
their respective claims in the Action to be dismissed with
prejudice by directing their respective counsel to execute and file
a Stipulation of Dismissal with prejudice and without costs in the
form annexed as Exhibit A; and
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3.1.2.
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withdraw, to
the maximum extent allowed by the law in each specific case, all
current oppositions brought within or outside the United States
against any Licensed Patent with claims which embrace Imagent,
Optison, and/or Sonazoid in the Field;
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3.2.
Amersham hereby releases
IMCOR, its current Affiliates, and their respective current and
former officers, directors, employees, agents, and attorneys from
all claims, allegations, damages, obligations, liabilities or
expenses of any kind or nature that it may have against any of
them. This releases all claims and obligations resulting from
anything which has happened up to now, including claims of which
Amersham is not aware, and specifically including without
limitation all claims that were or could have been asserted in the
Action, including but not limited to all claims of breach of
contract, breach of duties of good faith and fair dealing, unfair
competition, fraud, conversion, unjust enrichment, misappropriation
of trade secrets, tortious interference with contract, antitrust
violations, bad faith enforcement and sham litigation, and
infringement of Amersham Licensed Patents on account of the
manufacture, use, sale, offer for sale, and importation of Imagent
up to and including the Effective Date.
3.3.
Amersham hereby releases
Alliance, its current Affiliates, and their respective current and
former officers, directors, employees, agents, and attorneys from
all claims, allegations, damages, obligations, liabilities or
expenses of any kind or nature that it may have against any of
them. This releases all claims and obligations resulting from
anything which has happened up to now, including claims of which
Amersham is not aware, and specifically including without
limitation all claims that were or could have been asserted in the
Action, including but not limited to all claims of breach of
contract, breach of duties of good faith and fair dealing, unfair
competition, fraud, conversion, unjust enrichment, misappropriation
of trade secrets, tortious interference with contract, antitrust
violations, bad faith enforcement and sham litigation, and
infringement of Amersham Licensed Pat
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