AMENDED AND RESTATED LICENSE AGREEMENT
CONFIDENTIAL
TREATMENT REQUESTED: Certain portions of this document have been omitted
pursuant to a request for confidential treatment and, where applicable, have
been marked with an asterisk [****]”)
to
denote where omissions have been made. Note that one page of this exhibit
contains omitted material pursuant to this request. The confidential material
has been filed separately with the Securities and Exchange
Commission.
AMENDED
AND RESTATED LICENSE AGREEMENT
THIS
AMENDED
AND RESTATED LICENSE AGREEMENT
(the
“Agreement”) dated the 13th day of November, 2006 (the “Effective Date”), is
made by and between Kyosei Pharmaceutical Co., Ltd. (“KYOSEI”), a Japanese
corporation having its principal place of business at 0-00-00 Xxxxxxx, Xxxxx,
Xxxxxxxx, 000-0000, Xxxxx and IMCOR Pharmaceutical Co. (“IMCOR”), a Nevada
corporation having its principal place of business at X.X. Xxx 0000, Xx Xxxxx,
Xxxxxxxxxx 00000, Xxxxxx Xxxxxx of America. (collectively the “Parties” and each
the “Party”)
R
E C I T
A L S
WHEREAS,
IMCOR
owns assets and intellectual property related to Imagent®
(perflexane lipid microspheres);
WHEREAS,
KYOSEI
and IMCOR are parties to a License Agreement dated December 16, 2003 (the
“Original License Agreement”) pursuant to which, among other things, IMCOR
licensed certain intellectual property related to Imagent
to
KYOSEI and IMCOR agreed to enter into a supply agreement to manufacture and
supply Imagent
to
KYOSEI, in each case for use only in the Territory;
WHEREAS,
IMCOR
is not in a position at this time to manufacture and supply Imagent
for
KYOSEI;
WHEREAS,
the
Parties have engaged in discussions regarding how to restructure their
relationship and now desire to amend the Original License Agreement to transfer
certain patens and trademark and to grant KYOSEI certain rights to exercise
in
the Territory and to restate their new agreement so that the terms of this
Amended and Restated License Agreement constitute the Parties’ exclusive
agreement concerning the subject hereof, making the rights and obligations
under
the Original License Agreement replaced by those under this Amended and Restated
License Agreement;
NOW,
THEREFORE,
in
consideration of the promises and covenants contained herein and intending
to be
legally bound hereby, the Parties agree as follows:
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1.
|
Definitions.
|
“Affiliate”
of an entity means a person or other Entity that controls, is controlled by
or
is under common control with such Entity, whether by stock ownership or
otherwise.
1
“Entity”
means a corporation, an association, a joint venture, a partnership, a trust,
a
business, an individual, a government or political subdivision thereof,
including an agency, or any other organization, which can exercise independent
legal standing.
“Effective
Date” means the date of signature of the Agreement.
“Field
of
Use” means echocardiology and ultrasound radiology.
“Imagent”
means
perflexane lipid microspheres used as a contrast agent in conjunction with
ultrasound, and detailed in U.S. Food and Drug Administration NDA
#21-191.
“IMCOR
Proprietary Rights” means any and all rights, licenses or interests that IMCOR
has in any technology or intellectual property other than the Patents that
are
necessary for the manufacture, sale and distribution of Products in
Japan.
“Patents”
means the following Japanese patents and patent applications, all of which
are
owned by IMCOR:
|
Issued
Patents (all of which are owned by IMCOR):
|
||
|
STABILIZED
MICROBUBBLE COMPOSITIONS FOR ULTRASOUND
|
3559849
|
Issued
6/4/2004
|
|
Pending
Patents (all application of which are made under the name of
IMCOR):
|
||
|
STABILIZED
GAS EMULSION CONTAINING PHOSPHOLIPID FOR ULTRASOUND CONTRAST
ENHANCEMENT
|
526274
|
Filed
2/15/1996 and published 9/29/2005 2005-263804
|
|
STABILIZED
GAS EMULSION CONTAINING PHOSPHOLIPID FOR ULTRASOUND CONTRAST
ENHANCEMENT
|
2005-77072
|
Filed
03/17/2005
|
|
HARMONIC
ULTRASOUND IMAGING WITH MICROBUBBLES
|
511948/1996
|
Filed
9/26/1995
|
|
HARMONIC
ULTRASOUND IMAGING WITH MICROBUBBLES
|
2005-143292
|
Filed
5/16/2005
|
|
GAS
EMULSIONS STABILIZED WITH FLUORINATED ETHERS HAVING LOW XXXXXXX
COEFFICIENTS
|
501477/1997
|
Filed
6/5/1996
|
“Products”
mean Imagent
and any
products, components or kits with which it may be packaged and sold
which practice any claim in any Patent or a claim in a patent for an improvement
to the Patents.
“Technical
Information” means research and development information, unpatented inventions,
know-how, trade secrets, manufacturing and technical data related to the
Products in the possession of IMCOR on the Effective Date of this
Agreement.
2
“Territory”
means the country of Japan.
“Trademark”
means the Japanese Trademark for IMAGENT PERFLEXANE LIPID MICROSPHERES and
DESIGN, 4691709 filed 12/17/2002 and the goodwill of the Japanese business
associated therewith, as owned by IMCOR.
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2.
|
Transfer
of Patents and Trademark and License of Rights and
Information.
|
A. In
lieu
of the license contemplated under the Original License Agreement, IMCOR shall
sell, assign, and transfer to KYOSEI all of IMCOR’s right, title and interest in
and to a) the Patents, and b) the Trademark. IMCOR shall deliver to KYOSEI
all
of executed documents necessary to the transfer of the Patents and the
Trademark. IMCOR
grants to KYOSEI for an indefinite term, whether or not this Agreement is
terminated, an exclusive right and license in the Field of Use to use the
Technical Information, IMCOR’s Proprietary Rights within the Territory solely
for the purposes set forth under Section 5.A. IMCOR specifically agrees that
it
shall provide KYOSEI with copies of the documents related to the Technical
Information and IMCOR’s Proprietary Rights IMCOR used in connection with the
manufacture of Imagent.
IMCOR
shall give KYOSEI the absolute right in the Territory, no where else. The
materials to be provided by IMCOR to KYOSEI shall include all regulatory,
manufacturing, quality, and stability documentation necessary to manufacture
Imagent
and to
register the Products with the Japanese authorities.
B. KYOSEI
shall not, by operation of this Agreement or otherwise, acquire any right,
title
or interest in or to any patent, patent application or other patent rights,
any
trademark, any Technical Information or any other item of intellectual property
or rights of IMCOR other than as expressly set forth in this Agreement. Without
limiting the foregoing, KYOSEI shall not acquire rights to manufacture, sell
or
distribute Products outside of the Territory. Except as expressly provide
herein, i) KYOSEI will not infringe any of trademark of “Imagent”
or
the
name or any similar xxxx or name owned by IMCOR or third party, and ii) KYOSEI
has no right or license with respect to any of trademark of “Imagent”
or
the
name or any similar xxxx or name owned by IMCOR or third party except for the
Trademark.
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3.
|
Payments.
|
A. In
lieu
of all and any license fees, milestones and royalties contemplated under the
Original License Agreement and in consideration of the transfer of Patents
and
the Trademark and the license of the Technical Information and IMCOR’s
Proprietary Rights, KYOSEI shall pay the sum of U.S. $1,300,000 Dollars
according to the following schedule:
$800,000
within ten (10) business days after the date of this Agreement, or on such
later
date as mutually agreed by the Parties, and;
$500,000
within five (5) business days after KYOSEI confirms in writing that KYOSEI
has
received all the documents necessary and appropriate for the transfer of the
Patents and the Trademark.
3
[****] Represents
material which has been redacted pursuant to a request for confidential
treatment pursuant to Rule 24B-2 under the Securities Exchange Act of 1934,
as
amended. The confidential materials have been filed separately with the
SEC.
|
Bank:
|
XX
Xxxxxx Chase
|
|
000
X. XxXxxxx Xx
|
|
Xxxxxxx,
XX 00000
|
Name
on
Account: Xxxxxx & Xxxxx LLC
ABA
Routing No: 000000000
Account
No.: 00000000
The
second payment of $500,000 shall be made to the following bank
account.
Bank:
[****]
Name
of
Account: [****]
ABA
Routing Number: [****]
Money
Market Account Number: [****]
C. The
payment to be made by KYOSEI under this Section shall be after deduction of
withholding tax payable, and KYOSEI shall provide the IMCOR with the
corresponding tax receipts and/or certificates evidencing payments
thereof. However, if IMCOR provides KYOSEI with all of necessary documents
for an application for relief from Japanese income tax on the payment under
this
Agreement and KYOSEI confirms that competent tax authority has duly relieved
KYOSEI from any obligations to deduct the withholding tax from payment to IMCOR
under this Agreement, Kyosei shall not deduct the withholding tax and pay IMCOR
in full.
4.
Technical
Support
A.
For
the
period of one (1) year after the Effective Date, at KYOSEI’s written request,
IMCOR shall make its commercially reasonable efforts to assist KYOSEI in
identifying, locating and/or retaining persons and entities that can assist
KYOSEI in developing, manufacturing and registering Imagent
in the
Territory. KYOSEI shall be free to engage its own third parties at no obligation
to IMCOR.
B.
IMCOR
and
KYOSEI shall cooperate with each other in all reasonable respects, including
with scheduling and by engaging and paying the service provider
directly.
C.
KYOSEI
shall grant back to IMCOR a worldwide (except for Japan), royalty-free,
exclusive, perpetual, sub-licensable license to fully exploit any modifications
or improvements made by or for KYOSEI to the Products or for processes and
manufacturing techniques for producing the Products. The foregoing shall
include, without limitation, (i) any patent covering an invention, the
manufacture, use or sale of which would be covered by or within the scope of
a
claim of a patent licensed to KYOSEI hereunder and (ii) any patent that (alone
or together with others) is based on or tends to define, describe, surround
or
improve any part of the Technical Information or any invention claimed in a
Patent and
KYOSEI shall not, except within the Territory, license to third parties the
modifications or improvements derived from or based on any of the Technical
Information.
4
5. Clinical
Development, Manufacturing and Distribution
A. KYOSEI
shall have the right (but not the obligation) in its sole discretion and without
objection from IMCOR, to develop, manufacture, market, sell and distribute
Products and use the Trademarks and Patents solely in the Territory, and to
take
all actions reasonably related thereto. KYOSEI will be in compliance with the
appropriate laws and regulations.
B.
KYOSEI
shall distribute the Products only in the Territory in the Field of Use, and
shall not distribute the Products to any third party who KYOSEI actually knows
will distribute the Product outside of the Territory.
C. If
IMCOR
establishes or has a contractual manufacturing arrangement with a facility
in
the United States that is capable of manufacturing Imagent
after
the date of this Agreement, IMCOR shall notify KYOSEI, and KYOSEI shall have
the
right for a period of six (6) months after receipt of such notice to negotiate
for mutually acceptable terms for IMCOR to perform manufacturing of Imagent
or
components for KYOSEI. Other than an agreement covering such future
manufacturing services, IMCOR shall not be responsible for any manufacturing
activities and the parties are not obligated to negotiate a manufacturing and
supply agreement as
contemplated in the Original License Agreement.
D. Each
Party shall make its reasonable commercial efforts to notify the other Party
of
Serious Adverse Events. “Serious Adverse Event” under this Section means the
serious adverse events which are defined by the International Conference on
Harmonization.
6.
Marketing
and Sales.
KYOSEI
shall make its best effort to sell and market the Products in the Territory
in
case that KYOSEI determines at its sole discretion to develop, manufacture,
and
distribute the Products in the Territory. The parties are not obligated to
negotiate a separate marketing or sales agreement as contemplated in the
Original License Agreement
7.
Currency,
Way of Payment.
All
payments to IMCOR or KYOSEI under this Agreement shall be made in United States
dollars by wire transfer.
8.
Confidentiality.
A.
The
parties agree to maintain in confidence, not to disclose to any third party
and
not to use for any purpose other than to fulfill obligations under this
Agreement, any Confidential Information of the other Party received pursuant
to
this Agreement, except in case KYOSEI disclose the Confidential Information
to
the Affiliates of KYOSEI as far as such Affiliates are obligated to the same
extent with KYOSEI under this Section. Each Party agrees to ensure that its
employees and consultants have access to Confidential Information only on a
need-to-know basis and are obligated in writing to abide by the obligations
hereunder. The foregoing obligation shall not apply to:
5
(i) Information
that is known to or independently developed by the receiving party prior to
the
time of disclosure, in each case, to the extent evidenced by written records
promptly disclosed to the disclosing party upon receipt of the confidential
information;
(ii) Information
disclosed to the receiving party by a third party that has a right to make
such
disclosure;
(iii)
Information
that becomes patented, published or otherwise part of the public domain as
a
result of acts by the disclosing party or a third person obtaining such
information as a matter of right; or
(iv)
Information
that is required to be disclosed by order of a governmental authority or a
court
of competent jurisdiction; provided that the disclosing party shall use its
best
efforts to obtain confidential treatment of such information by the agency
or
court.
B.
The
placement of a copyright notice on any confidential information shall not be
construed to mean that such information has been published and will not release
either Party from its obligation of confidence hereunder.
C. The
obligations set forth under this Section shall be effective until the
Confidential Information becomes publicly known.
9. Patent
Maintenance.
Each
Party shall
notify the other Party of any infringement claims related to or involving the
Patents or Trademark. Each Party shall use reasonable commercial efforts to
provide information to the other Party in connection with any infringement
dispute.
10
.
Representations
and Disclaimer of Warranty.
A.
IMCOR
represents and warrants to KYOSEI that:
(a) as
the
date of this Amendment, it is duly incorporated and validly existing under
the
laws of the State of Nevada;
(b) the
execution of this Agreement by IMCOR and performance of its obligations in
this
Agreement have been duly authorized by IMCOR’s Board of Directors;
6
(c) no
registration, approvals or consents are required by any person, including
governmental authorization in terms of the execution and performance of this
Agreement by IMCOR;
(d) no
pending liquidation or bankruptcy proceeding have been initiated for or against
IMCOR, and there is no such threat to the best knowledge of IMCOR’s Chairman of
the Board or Chief Operating Officer IMCOR at the time of the signature of
this
Agreement;
(e) no
litigation or other procedures which has adverse impact on this Agreement is
pending, and there is no such threat;
(f) the
execution and performance by IMCOR of its obligations hereunder do not, to
IMCOR’s knowledge, violate any law applicable to IMCOR or any contract to which
IMCOR is a party;
(g) the
Patents and Trademark listed in this Agreement are all of the patents and
trademarks issued in Japan that IMCOR owns with respect to Imagent;
(h) IMCOR
is
a lawful owner of the Patents and Trademark;
(i) use
of
the Technical Information and development, manufacture, and distribution of
the
Products by KYOSEI in the Territory does not infringe any third party’s right to
the best knowledge of IMCOR’s Chairman of the Board or Chief Operating Officer
IMCOR at the time of the signature of this Agreement;
(j) there
are
no patent, design patent, utility model patent, copyright, and trademarks,
to
the knowledge of IMCOR, which is owned by third party and is reasonably
necessary to development, manufacture and distribution of the Products to the
best knowledge of IMCOR’s Chairman of the Board or Chief Operating Officer at
the time of the signature of this Agreement;
(k) the
Patents and the Trademark are described correctly in this Agreement.
Except
as
set forth above, the Patents and Trademark sold under this Agreement are
provided on an “as is” basis and IMCOR makes no representations or warranties,
express or implied, with respect thereto.
THIS
REPRESENTATION AND WARRANTY IS IN LIEU OF ALL OTHER REPRESENTATIONS, WARRANTIES,
EXPRESS, IMPLIED OR STATUTORY, INCLUDING WITHOUT LIMITATION THE IMPLIED
WARRANTIES OF NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE AND ANY IMPLIED WARRANTIES ARISING OUT OF A COURSE OF DEALING, CUSTOM
OR
TRADE USAGE.B.
B. KYOSEI
shall notify IMCOR of any claim made against KYOSEI relating to the Products
in the Territory and shall promptly furnish IMCOR with copies of all documents
filed and held by KYOSEI in connection with such proceeding or claim when such
proceeding or claim is initiated.
7
C. In
no
event shall either Party be liable to the other, or to any person or Entity
claiming through, on behalf or against either Party, for consequential,
incidental or indirect damages (including without limitation, lost profits,
revenues, anticipated sales, business opportunities, goodwill or interruption
of
business), or punitive or exemplary damages, whether in tort or contract or
pursuant to statute, regulation or otherwise. Each Party agrees it is not
responsible for any amounts the other Party may spend in the performance of
this
Agreement unless otherwise provided in this Agreement.
11.
Indemnification.
A.
Each
Party (an “Indemnifying Party”) agrees to defend, indemnify and hold harmless
the other Party and its respective directors, trustees, officers, agents and
employees (individually, an “Indemnified Party” and collectively, the
“Indemnified Parties”), from and against any and all claims for liability, loss,
damage, action or expense suffered or incurred by the Indemnified Parties
(including reasonable attorney’s fees and expenses), which results from or
arises out of:
(i)
claims
for product liability, an serious adverse effect due to adulterated Product,
or
other claim of any kind related to the use by a third party of a Product that
was manufactured, sold or otherwise disposed by or on behalf of an Indemnifying
Party, its assignees, sublicensees, vendors or other third parties;
(ii)
claims
resulting from clinical trials or studies conducted by or on behalf of an
Indemnifying Party relating to Products, Technical Information, or any
technology transferred under this Agreement; or
(iii)
breach
of
the Indemnifying Party’s representations, warranties or covenants in this
Agreement.
B.
Each
Indemnifying Party’s obligations under this Section 11 are subject to the
limitation on damages set forth in Section 10.C. of this Agreement. An
Indemnified Party entitled to indemnification shall give written notice to
the
Indemnifying Party of any claims that may be subject to indemnification,
promptly after learning of such claim, and the Indemnifying Party shall assume
the defense of such claims with counsel reasonably satisfactory to the
Indemnified Party. If such defense is assumed by the Indemnifying Party with
counsel so selected, the Indemnifying Party will not be subject to any liability
for any settlement of such claims made by the Indemnified Party without its
consent (but such consent will not be unreasonably withheld or delayed), and
will not be obligated to pay the fees and expense of any separate counsel named
by the Indemnified Party with respect to such claims.
12.
Independent
Contractor.
Nothing
herein shall be deemed to establish a relationship of principal and agent
between IMCOR and KYOSEI, nor any of their agents or employees for any purpose
whatsoever. This Agreement shall not be construed as constituting IMCOR and
KYOSEI as partners, or as creating any other form of legal association or
arrangement, which would impose liability upon one Party for the act or failure
to act of the other Party.
8
13. Additional
Provisions.
A.
Notices,
payments, statements, reports and other communications under this Agreement
shall be in writing and shall be deemed to have been received as of the date
dispatched if sent by public overnight courier (e.g. Federal Express) and
addressed as follows:
If
for
KYOSEI:
1-25-18,
Okusawa, Otaru
Hokkaido,
047—0013, Japan
Attention:
President
If
for
IMCOR:
Chairman
of the Board
Xxxxxx
& Xxxxx XXX000 Xxxxx Xxxxxx Xxxxx
Xxxxx
0000
Xxxxxxx,
XX 00000 XXX
Attention:
Xxxxxxx X. Xxxxxx
Either
Party may change its official address upon written notice to the other
Party
B.
This
Agreement shall
be
construed and governed in accordance with the laws of Japan and subject to
exclusive jurisdiction of the courts of Japan;
provided however,
that in
the event that KYOSEI engages in any activities outside the Territory that
IMCOR
believes infringe on IMCOR proprietary rights outside of the Territory, IMCOR
shall be entitled to pursue legal recourse in any court having jurisdiction
over
the alleged violation of IMCOR rights outside the Territory.
C. In
the
event that a Party to this Agreement perceives the existence of a dispute with
the other Party concerning any right or duty provided for herein, the Parties
shall, as soon as practicable, confer in an attempt to resolve the dispute.
If
such dispute is not resolved in thirty (30) days, either Party may proceed
to
litigation.
D. Any
modification of this Agreement shall be in writing and signed by an authorized
representative of each Party. A waiver by either Party of a breach or violation
of any provision of this Agreement shall be in writing and will not constitute
or be construed as a waiver of any subsequent breach or violation of that
provision or as a waiver of any breach or violation of any other provision
of
this Agreement.
E.
Any
of
the provisions of this Agreement which are determined to be invalid or
unenforceable in any jurisdiction shall be ineffective to the extent of such
invalidity or unenforceability in such jurisdiction, without rendering invalid
or unenforceable the remaining provisions hereof or affecting the validity
or
unenforceability of any of the terms of this Agreement in any other
jurisdiction. In such event, the Parties will negotiate to modify the provision
to one that is valid and enforceable and most closely achieves their
intent.
9
F.
Nothing
in this Agreement, express or implied, is intended to confer on any person
other
than the Parties or their permitted assigns, any benefits, rights or
remedies.
G.
This
Agreement has been prepared in the English language and shall be construed
in
the English language.
H.
Immediately
following the execution of this Agreement each Party shall, if required by
applicable laws, submit this Agreement and any other necessary documents to
all
authorities of their respective government authorities whose approval may be
necessary to tender this Agreement effective and enforceable in accordance
with
its terms.
I
The
rights and obligations of the Parties under this Agreement may be assigned
or
transferred, provided that the Party which transfers such rights or obligations
shall inform the other Party in writing within fifteen (15) days of the
assignment or transfer. IMCOR
shall not enter into any
merger
or any
transaction
involving the
sale
of all
or substantially all of its assets (including Imagent)
unless
the surviving entity to such merger, or the acquirer of IMCOR’s assets, agrees
in writing to assume all of the obligations of IMCOR to KYOSEI in this
Agreement.
J.
Headings
and captions are for convenience only and are not to be used in the
interpretation of this Agreement.
K.
This
Agreement contains the entire agreement of the Parties concerning the subject
matter hereof and supersedes all proposals, oral or written, all negotiations,
conversations, or discussions between or among the Parties relating to the
subject matter of this Agreement and all past dealing or industry custom. In
particular, this Agreement (the Amended and Restated License Agreement)
supersedes and replaces the Original License Agreement in its entirety and
neither Party shall have any further rights, claims or obligations under the
Original License Agreement.
L.
Neither
Party hereto shall be responsible for any failure to perform its obligations
under this Agreement if such failure is caused by acts of God, war, strikes,
revolutions, lack or failure of transportation facilities, laws or governmental
regulations or other causes that are beyond the reasonable control of such
Party. Obligations hereunder, however, shall in no event be excused but shall
be
suspended only until the cessation of any cause of such failure. In the event
that such force majeure should obstruct performance of this Agreement for more
than six (6) months, the Parties hereto shall consult with each other to
determine whether this Agreement should be modified. The Party facing an event
of force majeure shall use its best reasonable endeavors in order to remedy
that
situation as well as to minimize its effects. A case of force majeure shall
be
notified to the other Party by telefax within five (5) days after its occurrence
and shall be confirmed by a letter.
10
M.
Each
Party shall comply with all applicable export laws, restrictions, and
regulations of the United States and Japan or any authority thereunder and
will
not export or re-export, any product, technology or information it obtains
or
learns pursuant to this Agreement (or any direct product thereof) in violation
of any such laws, restrictions or regulations.
[Signature
page follows]
11
IN
WITNESS WHEREOF the
Parties, intending to be legally bound, have caused this Agreement to be
executed by their duly authorized representatives.
|
IMCOR
Pharmaceutical
CO.
By:
/s/ Xxxx
XxXxxxxx
Name:
Xxxx XxXxxxxx
Title:
Principal Executive Officer
|
Kyosei
Pharmaceutical Co., Ltd.
By:
/s/ Xxxxxx
Xxxx
Name:
Xxxxxx Xxxx
Title:
President
|
12
