THIS AMENDED AND RESTATED LICENSE AGREEMENT is made as of April 3, 2003 between: and acknowledged and agreed to by: RECITALS:
Exhibit
10.8
THIS
AMENDED AND RESTATED LICENSE AGREEMENT is made
as of April 3, 2003
between:
(1)
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Elan
Pharmaceuticals, Inc., a Delaware corporation laving a place of business
at 000 Xxxxxxx Xxxx., Xxx Xxxxxxxxx, Xxxxxxxxxx
00000;
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(2)
|
IE
Oncology Company Limited, an international business company incorporated
under the, laws of Barbados and having its registered office at Xxxxxx'x
Court Xxxx, St. Xxxxxxx, Barbados;
and
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(3)
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Inex
Pharmaceuticals Corporation, a company duly amalgamated and validly
existing under the laws of British Columbia and having its principal
place
of business at 000,0000
Xxxxxxxx Xxxxxxx, Xxxxxxx, Xxxxxxx Xxxxxxxx,
Xxxxxx.
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and
acknowledged and agreed to by:
(1)
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Elan
Corporation, plc., a
public limited company incorporated under
the
laws of Ireland,
and having its registered office at Xxxxxxx Xxxxx, Xxxxxxx Xxxxx,
Xxxxxx
0, Xxxxxxx;
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(2)
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Elan
Pharma International ltd. incorporated
under the laws of Ireland, and -having its registered office at XXX
Xxxxx,
Xxxxxxx Xxxxxxxx Xxxx, Xxxxxxx, Xxxxxx
Xxxxx, Xxxxxxx;
and
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(3)
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Inex
International holdings Ltd., a
Bermuda exempted limited liability company established under the
laws of
Bermuda with an office at Cedar House, 41 Cedar Avenue, Hamilton,
Bermuda.
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RECITALS:
A.
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Under
that certain License Agreement dated April 27, 2001, EPIL (as defined
below), .Elan Corp (as defined below) and Elan (as defined below)
licensed
to IE Oncology (as defined below) certain intellectual property owned,
licensed or controlled by EPlf,, Elan Core or Elan (the "original
License").
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B.
|
The
Original License was issued in connection with the formation of IE
Oncology by the Original Parties (as defined below) for the purposes
of
development of certain oncology
products.
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C.
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On
or about December 28, 2001, Elan acquired TLC (as defined below),
including the intellectual property formerly owned, licensed, or
controlled by TLC and licensed to IE Oncology under the Original
License.
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D.
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The
Original Parties have agreed under a Termination Agreement, of even
date
herewith, to terminate their joint venture -relationship
and for
an Affiliate
of Inex (as defined below) to
acquire all shares of IE Oncology held by EIS (as defined below)
and
certain shareholder loans provided by EIS to IE
Oncology.
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E.
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As
part of the termination of the joint venture relationship, Elan,
EPIL,
Elan Corp, IE Oncology, Inex and IIH (as defined below) have agreed
to
amend and restate the Original
License.
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1
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DEFINITIONS;
INTERPRETATION
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1.1
|
Definitions.
In
this Agreement unless the context otherwise
requires:
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"Affiliate"
shall
mean any corporation or entity controlling, controlled or under the common
control of Elan, IE Oncology, or any third party, as the case may be, excluding,
in the case of Elan or any Affiliate of Elan, an Elan JV. For the purpose of
this definition, (i) "control" shall mean direct or indirect ownership of fifty
percent (50%) or more of the stock or shares entitled to vote for the election
of directors; and (ii) IE Oncology shall not be an Affiliate of Elan or of
any
of Elan's Affiliates.
"Agreement"
shall
mean this amended and restated license agreement (which expression shall be
deemed to include the Recitals and Schedules hereto).
"Amended
Effective Date"
shall
mean the date hereof.
"Confidential
Information"
shall
have the meaning set forth in Clause 11.
"Original
Effective Date"
shall
mean April 27, 200 1.
"EIS"
shall
mean Elan International Services, Ltd., a Bermuda exempted limited liability
company incorporated under the laws of Bermuda, and having its registered office
at Xxxxxxxxx Xxxxx, 0 Xxxxxx Xx., Xxxxxxxx, Xxxxxxx.
"Elan"
shall
mean Elan Pharmaceuticals, Inc.
"Elan
Corp"
shall
mean Elan
Corporation, plc, a public limited company incorporated under the laws of
Ireland.
"Elan
Improvements"
shall
mean any and all improvements made to the Elan Patents and/or the Elan Know-How
that are conceived, created, developed and/or otherwise invented by IE Oncology
or its permitted sublicensees at any bane after the Amended Effective
date.
"Elan
Intellectual Property"
shall
mean the Elan Know-How, the Elan Patents and the Elan Improvements.
“Elan
JV”
shall
mean an entity that Elan and a third party (i) establish or have established,
(ii) take shareholdings in or have a fight to take shareholdings in, and
(iii)
grant
certain licenses in and to certain intellectual property rights for the purpose
of implementing a strategic alliance.
"Elan
Know-How"
shall
mean the rights owned by or licensed to Elan to the specific scientific,
pharmaceutical or technical information, data, discoveries, inventions (whether
patentable or not), know-how, substances, techniques, processes, systems,
formulations, designs and expertise relating to liposome technology, which
is
not generally known to the public.
"Elan
License"
shall
have the meaning set forth in Clause 2.
"Elan
Patents" shall
mean the patents listed in Schedule 1, and any foreign counterparts thereof
and
all divisionals, continuations, continuations-in-part and all patents issuing
on
any of the foregoing and any foreign counterparts thereof, together with all
registrations, reissues, reexaminations, supplemental protection certificates,
or extensions thereof and any
foreign counterparts thereof (together, the "Supplemental Filings"), provided
that nothing herein will require Elan to make any Supplemental
Filings.
"Elan
Third Party Agreements"
shall
mean the UBC Agreement, the Regents" Agreement and the NeXstar
Agreement.
2
"EPIL"
shall
mean Elan Pharma International Limited, a private limited company incorporated
under the laws of Ireland.
"Field"
shall
mean the use of vincristine sulfate in human therapeutics by administration
of
the products.
"FDA"
shall
mean the United States Food and Drug Administration or any other successor
agency whose approval is necessary to market the products in the United States
of America.
"Force Majeure"
shall
mean causes beyond a party's reasonable control, including, without limitation,
acts of God, fires, strikes, acts of war, terrorism, or intervention of a
Governmental
Authority (including any RHA),
"Governmental
Authority" shall
mean all governmental and regulatory bodies, agencies, departments or entities
that regulate, direct or control commercial and other related activities in
a
country of the Territory.
"IE
Oncology"
shall
mean IE Oncology Company Limited, are international business company
incorporated under the laws of Barbados, and having its registered office at
Xxxxxx'x Court Xxxx, St. Xxxxxxx, Barbados, and its Affiliates.
"IIH"
shall
mean Inex International Holdings Ltd., a Bermuda exempted limited liability
company established under the laws of Bermuda with an office at Cedar House,
41
Cedar Avenue, Xxxxxxxx, Bermuda.
“Inex”
shall
mean Inex Pharmaceuticals Corporation, a corporation duly amalgamate-d and
validly existing under the laws of British Columbia and having its principal
place of business at 000-0000 Xxxxxxxx Xxxx-xxx, Xxxxxxx, Xxxxxxx Xxxxxxxx,
Xxxxxx and its Affiliates.
"Infringement
Claim"
shall
mean any claim or proceeding made against IE Oncology or Elan, as the case
may
be, alleging infringement or other unauthorized use of the proprietary rights
of
a third party arising from the exploitation of the Elan Intellectual property
relating to the. manufacture, importation, use, offer for sale, sale, or other
commercialization of the Products.
"Licensed
Method"
shall
mean any process or method that is covered by the regents' Sublicense or the
use
or practice of which would constitute, but
for
the regents' Sublicense
granted to IE Oncology herein pursuant to this Agreement, an infringement of
any
pending or issued claim within Regents' Patent Rights.
"Liposome
License"
shall
have the meaning set forth in Clause 2.1 (1).
"MHBV"
shall
mean Monksland Holdings, B.V., a Netherlands corporation and a wholly-owned
subsidiary of Xxxx, Xxxxxxxxxxx 000, Burgmeester Xxxxxxxxxxxx 00, 0000 XX
Xxxxxxxxxx, xxx Xxxxxxxxxxx.
"NeXstar
Agreement"
shall
mean that certain agreement by and between NeXstar Pharmaceuticals and TLC,
dated March 24, 1993.
“Original
License”
shall
have the meaning set forth in Recital A.
"Original
Parties"
, shall
mean Elan Corp, EPIL, TLC, EIS, Inex, IE Oncology, MHBV and IIH.
"Party"
shall
mean Elan, Inex, or IE Oncology, as the case may be, and "Parties" means Elan,
Inex and IE Oncology.
"Products"
shall
mean vincristine sulfate liposomes.
3
“Regents’
Agreement”
shall
mean that certain Exclusive License Agreement for Liposome
Technology by and
between
"FLC and The Regents of the University of California, made and effective as
of
26 June 1990.
"Regents'
Patent Rights"
means
all U.S. and foreign patents and patent applications; any reissues,
reexaminations, extensions, continuations, and divisions, and continuations-
in-part applications (to the extent that the claims in the continuation-in-part
application are adequately supported in patent application serial no.
776,826);
and any patents issuing thereon,
based on any subject
matter claimed
in or covered by the following:
(i)
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U.S.
Patent Application serial no. 220,388 entitled "Improved Method
for
Loading
Lipid-Like Vesicles with Drugs or Other Chemicals" tiled July
12, 1988
by
Xxxx Xxxxxxxx and assigned to The Regents of the University of
California,
a continuation
application of U.S. Patent Application serial no. 776,826 filed
September
17, 1985, now abandoned; and
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(ii)
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U.S.
Patent Application serial no. 547,382 entitled “Improved Method for
Loading Lipid-Like Vesicles with Drugs or Other Chemicals” filed July 3,
1990 by Xxxx Xxxxxxxx and assigned to The Regents of the University
of
California, a continuation application of U.S. Patent Application
serial
no. 220,388 f led duly 12,
1988.
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"Regents'
Sublicense"
shall
have the meaning set forth in Clause 2.1(2).
"Regulatory
Application"
shall
mean any regulatory application or any other application for Regulatory Approval
for the Products, which IE Oncology or any Affiliate or sublicensee of IE
Oncology files in the Territory, including any supplements or amendments
thereto.
“Regulatory
Approval"
shall
mean the final approval to market the Products in any country of the Territory,
including pricing and reimbursement approval and any other approval which is
required to launch the Products in the normal course of business..
"Relevant
Event"
shall
have the meaning set forth in Clause 9-3.
"RHA"
shall
mean all relevant government health authorities (or successor agency thereof)
in
each country of the Territory whose approval is necessary to market the Products
in the relevant country of the Territory.
"Term"
shall
have the meaning set forth in Clause 9.1.
"Territory"
shall
mean all the countries of the world.
"TLC"
shall
mean The Liposome Company, Inc., a corporation formerly incorporated under
the
laws of the State of Delaware, United States of America, and having its
registered office at Xxx Xxxxxxxx xxx,
Xxxxxxxxx,
xxx Xxxxxx, Xxxxxx Xxxxxx of America.
"UBC
Agreement"
shall
mean the University of British Columbia Research Project Agreement dated May
8,
1984, as amended effective May 8,1985, May 8, 1986, May 8, 1988 and May 8,
0000,
xxxxxxx Xxx Xxxxxxxxxx xx Xxxxxxx Xxxxxxxx and TLC, which was assigned to Elan
on December 28, 2001,
"United
States Dollar",
"Dollar",
"$'
and
"US$"
shall
mean the lawful currency for the time being of the United States of
America,
4
1.2
|
Interpretation.
In
this Agreement:
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(i)
|
The
singular includes the plural and vice versa, and the masculine
includes
the feminine and vice versa and the neuter includes the
masculine and
the feminine.
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(ii)
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Any
reference to a Clause or Schedule shall, unless otherwise specifically
provided, he to a Clause or Schedule of this
Agreement.
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(iii)
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The
headings of this Agreement are for ease of reference only and shall
not
affect its construction or
interpretation.
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1.3
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This
Agreement is amended and restated as of the Amended Effective Date.
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2
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LICENSES
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2.1
|
Elan
hereby grants to IE Oncology for the
Term:
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(1)
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a
paid up, exclusive license to the Elan Intellectual Property, excluding
the Regents' Patent Rights, to develop, make, have made, import,
use,
offer for sale and sell the Products in the Meld in the Territory,
subject
to any contractual obligations that Elan may have and rights of third
parties as of the Amended Effective Date with respect to the Elan
Third
Party Agreements (the "Liposome
License");
and
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(2)
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subject
to (i) a license granted to TLC in the Regents' Agreement; and (ii)
the
terms, conditions and limitations of the Regents' Agreement, a
non-exclusive sublicense to the Regents' Patent Rights to make, have
made,
use, and sell the Products in the Field in the Territory and a
non-exclusive sublicense to practice the Licensed Method, subject
to
any contractual obligations that Elan may have and rights of third
parties
as of the Amended Effective Date with respect to the Elan Third Party
Agreements ("Regents'
Sublicense")
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(collectively,
the Liposome License and Regents' Sublicense are referred to herein as the
"Elan
License"),
Notwithstanding
anything contained in this Agreement to the contrary and for the avoidance
of
doubt, no license is granted to use or otherwise exploit the Elan Intellectual
Property outside of the Field.
2.2
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Sublicensing
by IE Oncology
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(1)
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Subject
to the prior written consent of Elan, which shall not be unreasonably
withheld or delayed and any required third party consent under the
Elan
Third Party Agreements, IE Oncology shall be entitled to grant sublicenses
in respect of the Elan License to, as applicable, develop, make or
have
made, import, use, offer for sale and sell the Products in the Field
in
one or more countries of the
Territory.
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(2)
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Any
sublicense granted hereunder shall be pursuant to a written agreement,
which agreement shall be subject to the written approval of Elan,
such
approval not to be unreasonably withheld or delayed, on the same
terms
mutatis mutandis as the tees
of this Agreement insofar as they are applicable (``Sublicense
Agreement"), but excluding the tight to grant a further sublicense.,
other
than 'to Affiliates of a
sublicensee.
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5
(3)
|
Elan
shall have the right to enforce the tees of any Sublicense Agreement
relating to the intellectual property included in the Elan License
and
shall be named a third party beneficiary thereunder; provided, however
that Elan will not be a party to, any Sublicense
Agreements.
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(4)
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All
Sublicense Agreements and all rights and licenses granted thereunder
shall
automatically terminate for the country or countries covered by the
sublicense if this Agreement
terminates, howsoever terminated.
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(5)
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IE
Oncology and Inex shall remain jointly and severally liable and
responsible for all acts and omissions of any sublicensee, as if
they were
acts and omissions by IE Oncology and
Inex.
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2.3
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The
Parties intend that the Elan License shall be deemed to be "intellectual
property" as defined in Section 101(56) of the united States Bankruptcy
Code, as amended the "Code"), and that this Agreement shall be governed
by
Section 365(n) of the Code in the event a bankruptcy or similar proceeding
is commenced with respect to .Elan and that IE Oncology may elect
not to
terminate this Agreement in the event Elan or a bankruptcy trustee
rejects
this Agreement.
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3
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INTELLECTUAL
PROPERTY
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3.1
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Ownership
of Intellectual Property.
|
(1) |
Elan
owns and shall remain the owner of the Elan Intellectual Property.
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3.2
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Patent
Prosecution and
Maintenance.
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(1)
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Elan,
at its sole discretion and expense,
may:
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(i)
|
secure
the grant of any patent applications within the Elan Intellectual
Property;
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(ii)
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file
and prosecute patent applications on patentable inventions and
discoveries
relating to the same;
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(iii)
|
defend
all such applications against third party oppositions;
and
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(iv)
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maintain
in force any issued letters patent relating to the
same.
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(2)
|
IE
Oncology shall, and shall cause its permitted sublicensces to, promptly
notify Elan of any Elan Improvements. IE Oncology shall, and shall
cause
its permitted sublicensees
to, fully cooperate with Elan, at Elan's expense, in perfecting Elan's
ownership and other proprietary rights in respect of any of the Elan
Improvements and shall execute and deliver to Elan any documents
that Elan
may reasonably require with respect
thereto.
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(3)
|
Elan
will use reasonable efforts to keep IE Oncology informed of the course
of
any decision to abandon a pending or issued claim under the Elan
Patents
its any country or country in the Territory in which such Elan Patents
are
currently maintained.
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6
3.3
|
Third
Party Agreements.
|
(1)
|
During
the term of this Agreement Elan may, in its sole discretion, continue
to
maintain or terminate, in whole or in part (including any rights
or
licenses granted to Elan thereunder) the Regents' Agreement. Elan
will
keep IE Oncology informed of any anticipated material change in status
of
the Regents' Agreement: that, to Elan's knowledge, would result in
the
Regents' Agreement or any portion thereof (including any license
granted
to Elan thereunder) being
terminated.
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(2)
|
If
Elan decides, in its sole discretion, that it does not wish to continue
to
maintain the Regents' Agreement (or any portion thereof), then, ninety
(90) days prior to voluntarily surrendering its rights under or
terminating the Regents' Agreement, Elan will advise IE Oncology
in
writing of such decision and, at Elan's option, request that IE
Oncology:
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(i)
|
pursuant
to a written agreement acceptable to both Elan and IE Oncology,
undertake
to perform all of (or the relevant portion of) Man's obligations
thereunder on behalf of Elan, including payment of all amounts
due under
the Regents' Agreement, in which case the Regents' Agreement shall
continue in
full force and
effect;
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(ii)
|
pursuant
to a written agreement acceptable to Elan, IE Oncology and The
Regents of
the University of California, take assignment of, or designate
a nominee
for the assignment of, the Regents' Agreement, subject to the consent
of
IE Oncology, The Regents of the University of California and any
other
required consent and upon such terms and conditions as Elan, IE
Oncology
(or its nominee) and The Regents of the University of California
may
agree; or
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(iii)
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negotiate
in good faith with The Regents of the University of California
to obtain a
license, at IE Oncology's sole cost and expense, to the Regents'
Patent
Rights in the Field and Elan shall reasonably assist and cooperate
with IE
Oncology in obtaining such a license from The Regents of the University
of California.
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(3)
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IE
Oncology and Inex shall jointly and severally indemnify, defend and
hold
Elan and its Affiliates harmless against any and all actions, claims
and
proceedings (whether successful or otherwise), losses, responsibilities,
damages; liabilities, injuries, costs and expenses, including reasonable
attorneys' fees, arising out of the performance or breach of the
obligations undertaken by IE Oncology pursuant to Clause 3.3(2)(1)
and/or
pursuant to an assignment of the Regents' Agreement to IE Oncology
or its
nominee pursuant to 3.3(2)(ii).
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For
the
avoidance of doubt, Elan shall have no further responsibility under this Section
3.3 if, pursuant to Elan's election under Clause 3.3(2), IE Oncology (1) refuses
to undertake Elan's obligations under the Regents' Agreement pursuant to Clause
3.3(2)(1) above; (ii) refuses to take assignment of, or designate a nominee
for
the assignment of, the Regents' Agreement pursuant to Clause 3.3(2)(1i); or
(iii) is unable to negotiate a license with The Regents of the University of
California under Section 3.3(2)(iii) above. Thereafter, the obligations of
Elan
under this Section 3.3 shall be deemed null and void and this Section 3.3 shall
be of no further force and effect on the parties hereto.
7
3.4
|
Enforcement,
|
(1)
|
IE
Oncology shall. promptly notify Elan In
writing
of any actual or alleged unauthorized use of the Elan Intellectual
Property in the Field in the Territory by a third party of which
it
becomes aware and shall provide Elan with any available: evidence
of such
unauthorized use.
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(2)
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Elan
shall have the right in its discretion, but not the obligation, to
enforce
for Elan's own benefit (including by agreement or by litigation)
Elan's
intellectual property rights under the Elan Intellectual Property.
IE
Oncology and Inex shall reasonably cooperate with Elan to enforce
such
rights, provided that IE Oncology and Inex shall be reimbursed for
reasonable out-of-pocket expenses incurred in providing such cooperation.
Elan shall advise IE Oncology and Inex of any such suit or proceedings
that it may commence.
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(3)
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Should
Elan decide not to enforce its rights under the Elan Intellectual
Property
against such unauthorized use in the Field, within a reasonable period,
but in any event within 20 days after receiving written notice of
such
actual or alleged unauthorized use, IE Oncology may initiate such
proceedings in IE Oncology's name, at IE Oncology's sole cost and
expense
and for IE Oncology's sole benefit. Elan will lend its name to such
action
on IE Oncology's behalf as necessary, unless Elan believes in good
faith
that such an action may be illegal, without merit or harmful to Elan's
business strategy. IE Oncology shall advise Elan of any such suit
or
proceedings commenced by IE
Oncology.
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(4)
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The
Party bearing the cost of such action or proceeding shall be entitled
to
retain all proceeds of such action or proceeding, after reimbursement
to
the other Parties hereto of any reasonable out-of-pocket expenses
(including reasonable attorneys' fees)
that are incurred as a result of such other Party's participation
in such action or
proceeding.
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3.5
|
Defense.
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(1)
|
Each
of IE Oncology and Elan shall promptly notify the other in writing
of any
claim or proceedings made against IE Oncology or Elate, as the case
may
be, alleging infringement or other unauthorized use
of
the proprietary rights of a third party arising from the exploitation
of
the Elan Intellectual Property, including the manufacture, importation,
use, offer for sale, sale or other commercialization of the
Products.
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(2)
|
Subject
to Clause 8.6, Elan shall have the right, but not the obligation,
to take
over the conduct and control
of
any Infringement Claim brought against Elan (."Step-In Right"); provided,
however, that IE Oncology's and Inex's respective indemnify obligations
under Clause 8.4 shall continue.
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4
|
MANUFACTURING/EXPLOITATION
|
4.1
|
IE
Oncology will be solely responsible for the development, manufacture,
storage, handling, packaging, promotion, distribution., marketing
and sale
of the Products in each country of the Territory and for ensuring
that all
such activities are in strict compliance with all the legal and regulatory
requirements of each country in the Territory (including, for the
avoidance of doubt, all legal and regulatory requirements relating
to
patent marking).
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4.2
|
All
advertising, promotional materials and marketing and any costs and/or
expenses associated therewith in respect of the Products shall be
the sole
responsibility of IE Oncology.
|
8
4.3
|
IE
Oncology shall research, develop, make, have made, import, export,
use,
offer for sale and sell the Products in accordance with all statutes,
regulations and requirements of the FDA and other RDAs, including
without
limitations, cGMP, cGLP, cGMP
regulations.
|
4.4
|
For
the avoidance of doubt, Elan shall have no responsibility of any
nature
whatsoever to carry out any work or activity of the kind described
in this
Clause 4 or any other work or activity whatsoever, otherwise than
as
expressly agreed in this Agreement.
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5
|
REGULATORY
APPROVALS
|
5.1
|
For
the avoidance of doubt, IE Oncology shall have full responsibility
for its
dealings with the FDA and other RHAs relating to the Products and
Elan
shall
have no responsibility
of any nature relating thereto; provided, however, that IE Oncology
shall
promptly advise Elan of any notices or other communications relating
to
the safety of any Products.
|
5.2
|
Any
and all Regulatory Applications filed by IE Oncology or its permitted
sublicensees for the products shall be the property of IE
Oncology.
|
For
the
avoidance of doubt, the costs and expenses in relation to any filings and/or
proceedings made by IE Oncology to a Governmental Authority and the FLEA and
other RHAs, including post approval studies required by such authorities in
respect of the Products, and the maintenance of any approval relating thereto
including Regulatory Approvals, shall be paid by IE Oncology.
6
|
INSURANCE
|
During
the tern) of this Agreement and for a period of five years thereafter, IE
Oncology shall maintain and shall cause its permitted sublicensees
to maintain adequate comprehensive general liability insurance, including
product liability insurance, on the Products.
7
|
FINANCIAL
PROVISIONS
|
7.
1
|
Original
License Fee.
Elan confirms that at the Original Effective Date IE Oncology paid,
in cash, to Elan
Corp and certain of its Affiliates, a non-refundable license fee
(the
"Original License Fee"). The Parties confirm that the Original
License Fee
was not, and is not subject to future performance obligations of
Elan to
IE Oncology or Inex, and that other than the Original License Fee,
which
has been paid, no other fee, royalty or payment is payable by IE
Oncology
or any affiliate of IE Oncology to Elan or any Affiliate in respect
of
this Agreement.
|
7.2
|
Third
Party Fees.
IE
Oncology and Inex shall be jointly and severally liable and responsible
for royalties, milestones, or other payments, if any arising under
the
Elan Third Party Agreements from and after the Amended Effective
Date as a
result of the grant of rights under the Elan License hereunder
and/or from
the exercise of any of the rights granted under the Elan License,
including without limitation, the process of the commercialization
or
other exploitation of Products.
|
8
|
REPRESENTATIONS
AND WARRANTIES
|
8.1
|
Elan
represents and warrants to IE Oncology and Inex, as of the Amended
Effective Date, as follows:
|
(1)
|
with
respect to the E1an Intellectual Property as it relates to the
Products:
|
9
(i)
|
Elan
has the right to grant the Liposome
License;
|
(ii)
|
there
are no agreements between Elan and any third party that conflict
with the
Liposome License;
|
(iii)
|
the
patents and patent applications included in the Elan patents are
free and
clear of encumbrances and liens;
and
|
(iv)
|
Elan
has not received written notice of any third party claims or proceedings
of infringement of such third party's intellectual property rights
in
connection with the Elan Intellectual Property
in relation to the Field.
|
(2)
|
With
respect to the Regents' Patent Rights as it relates to the
products:
|
(i)
|
the
Regents'
Agreement is in good standing and in full force and
effect;
|
(ii)
|
Elan
has not granted any sublicenses to any third party under the Regents
Patent Rights that conflict with the Regents' Sublicense;
and
|
(iii)
|
Elan
has not received written notice of any third party claims or proceedings
of infringement
of
such third party's intellectual property rights
in connection
with the Regents' Agreement in relation to the
Field.
|
8.2
|
IE
Oncology represents and warrants to Elan as of the Amended Effective
Date,
as follows:
|
(1)
|
IE
Oncology has the right to enter into this Agreement;
and
|
(2)
|
there
are no agreements between IE Oncology and any third party that conflict
with this Agreement,
|
8.3
|
Inex
represents and warrants to Elan as of the Amended Effective date,
as
follows:
|
(1)
|
Inex
has the right to enter into this Agreement;
and
|
(2)
|
there
are no agreements between Inex and any third party that conflict
with this
Agreement.
|
8.4
|
IE
Oncology and Inex shall jointly
and
severally indemnify, defend and hold Elan and its Affiliates harmless
against any and all actions, claims and proceedings (whether successful
or
otherwise), losses, responsibilities, damages, liabilities, injuries,
costs and expenses, including reasonable attorneys' fees, arising
out
of:
|
(1)
|
the
research, testing, manufacture, transport, packaging, storage, handling,
distribution, marketing, advertising, promotion or sale of the products
by
IE Oncology, or any of its Affiliates or sublicensees on behalf of
IE
Oncology;
|
(2)
|
any
claims or proceedings made or brought against Elan on behalf of any
persons seeking damages for personal injury (including death) and/or
for
costs of medical treatment, which claims relate in any way to the
Products;
|
(3)
|
any
Infringement Claim;
|
(4)
|
any
Elan
Third Party Agreement in connection with Clause 3.3;
and
|
(5)
|
any
acts or omissions of any
sublicensees.
|
8.5
|
In
fulfilling its indemnification obligations hereunder, IE Oncology
and Inex
shall (i) reasonably and regularly consult with Elan in relation
to the
progress and status of any action, claim or proceedings; and (ii)
not make
any statements, enter into any settlement agreement or consent to
any
judgment in respect of any actions, claims and/or proceedings, without
Man's prior written consent, which consent shall not be unreasonably
withheld or delayed.
|
10
8.6
|
In
seeking an indemnity from IE Oncology or :Inex hereunder and/or in
exercising its Step-In Right under Clause 3_S(2), Elan
shall:
|
(1)
|
fully
and promptly notify IE Oncology of any claim or proceeding, or threatened
claim or proceeding of which it becomes
aware;
|
(2)
|
subject
to Clause 3.4{2}, 3.5(2) and Clause 8.5, permit IE Oncology or Inex
to
control the conduct of such claim or
proceeding;
|
(3)
|
reasonably
co-operate in the investigation and defense of such claim or proceeding,
at the reasonable cost and expense of IE Oncology and/or Inex, as
the case
may be;
|
(4)
|
not
acknowledge to the third party or to any other person the validity
of any
claims of such third party; and
|
(5)
|
not
compromise or otherwise settle any claim or proceeding without the
written
consent of IE Oncology, which consent will not be unreasonably withheld
or
delayed;
|
provided,
however, that in any event, IE Oncology's and Inex's indemnity obligations
under
Clause 8.4 shall continue to remain in full force and effect.
8.7
|
EXCEPT
AS SET FORTH IN THIS CLAUSE 8, ELAN IS GRANTING THE ELAN LICENSE
HEREUNDER
ON AN "AS IS" BASIS WITHOUT REPRESENTATION OR WARRANTY WHETHER EXPRESS
OR
IMPLIED FROM ELAN OR ANY OF ITS AFFILIATES INCLUDING WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR. PURPOSE, OR INFRINGEMENT
OF
THIRD PARTY RIGHTS, AND ALL SUCH WARRANTIES ARE EXPRESSLY
DISCLAIMED.
|
NOTWITHSTANDING
AGREEMENT, NO PARTY OR ANY OF THEIR RESPECTIVE AFFILIATES SHALL RE LIABLE TO
THE
OTHER PARTIES BY REASON OF ANY REPRESENTATION O WARRANTY, CONDITION Off. OTHER
TERM ANY DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT,
FOR
ANY CONSEQUENTIAL, SPECIAL INCIDENTAL
Off. PUNITIVE LOSS OR DAMAGE (WHETHER FOR LOSS OF CURRENT O: FUTURE PROFITS,
LOSS OF ENTERPRISE VALUE OR OTHERWISE) AND WHETHER OCCASIONED BY THE NEGLIGENCE
OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES OR AGENTS OR
OTHERWISE.
9
|
TERM
AND TERMINATION
|
9.1
|
This
Agreement supercedes and replaces the Original License and the terms
hereof are deemed-to have come into force can the Amended Effective
Date
and, subject to the rights of termination outlined in this Clause
9 and
the provisions of applicable laws, will expire on a country-by-country
basis in any country, upon the expiration of the life of the last
to
expire patent included in the Elan License in that country (the
"Term").
|
9.2
|
If
either Party commits a Relevant Event (as defined below), the other
Party
shall have, in addition to all other legal and equitable rights and
remedies hereunder, the right to terminate this
Agreement.
|
11
9.3
|
For
the purpose of this Clause 9, a "Relevant
Event"
is committed by a Party:
|
(1)
|
if
such Party commits a material breach of any of the provisions of
this Agreement,
and fails to cure the same within 60 days after receipt of a written
notice from the other Party hereto giving full particulars of the
breach
and requiring it to be remedied; provided, that i f the breaching
Party
has proposed a course of action to cure the breach and is acting
in good
faith to cure same but has not cured the breach by the 60th day,
such
period shall be extended by such period as is reasonably necessary
to
permit the breach to be cured, provided that such period shall not
be
extended by more than 90 days, unless otherwise agreed in. writing
by the
Parties;
|
(2)
|
upon
ten (10)
days prior written notice, if such Party goes into liquidation under
the
laws of any applicable jurisdiction (except for the purposes of
amalgamation or reconstruction and in such manner that the company
resulting therefrom effectively agrees to be bound by or assume the
obligations imposed on that other Party under this
Agreement);
|
(3)
|
upon
ten (10) days written notice, if a receiver, administrator, examiner,
trustee or similar officer is appointed over all or substantially
all of
assets of the other Party under the laws of any applicable jurisdiction;
and/or
|
(4)
|
Upon
ten (10) days written notice, if any proceedings are filed or commenced
by
that
other party under bankruptcy,` insolvency or debtor relief laws or
anything analogous to any of the foregoing under the laws of any
applicable jurisdiction occurs in relation to the other
party,
|
9.4
|
In
addition to rights of termination provided elsewhere in this Agreement,
Elan will be entitled forthwith to terminate this Agreement immediately
upon written notice to IE Oncology if IE Oncology, Inex indirectly,
contests or otherwise disputes the ownership, scope, or validity
of any of
the Elan Intellectual Property, or supports any such attack by a
third
party.
|
10
|
CONSEQUENCES
OF TERMINATION
|
10.1
|
Upon
exercise of those rights of termination specified in Clause 9 or
elsewhere
in this Agreement, this Agreement shall, subject to the provisions
of the
Agreement which survive the termination of the Agreement automatically
terminate forthwith and be of no further legal. force or
effect:
|
10.2
|
Consequences
of Expiration or Earlier Termination.
|
(1)
|
The
following shall be the consequences of expiration or earlier termination
of this Agreement howsoever
terminated:
|
(i)
|
any
sums that were due from
IE Oncology to Elan
howsoever prior to the termination or expiry hereof shall be paid
in full
within 30 days of termination of this
Agreement;
|
(ii)
|
all
confidentiality provisions set out herein shall remain in full force
and
effect;
|
(iii)
|
all
representations, warranties and indemnities shall remain in full
force and
effect; and
|
12
(iv)
|
subject
to Clause 10.2(2) and Clause 10.2 (3) below, all rights and licenses
granted to IE Oncology under this Agreement and/or by IE Oncology
under
any and all Sublicense Agreements shall cease for the Territory
ar for
such particular country or countries in the Territory, as the case
may be,
and neither IE Oncology nor any sublicensee may thereafter use:
(a) the
Elan Intellectual Property; and/or (b) the Regents' Patent Rights,
in any
country or countries of the
Territory.
|
(2)
|
In
the event this Agreement is terminated by Elan for a default of IE
Oncology and/or Inex (other than a termination by Elan for default
by IE
Oncology and/or Inex under Clauses 9.3(2), 9.3(3) and 9.3(4) above)
hereunder, upon the written request of IE Oncology, Elan will negotiate
with a sublicensee (other than Inex) for the survival of such
sublicensee's rights under the Elan License granted to it by IE Oncology
pursuant to a Sublicense Agreement upon terms and conditions no more
onerous or restrictive than as set forth, at Elan's option, in this
Agreement and/or the relevant Sublicense agreement for such sublicensee
and upon such other terms and conditions as Elan and such sublicensee
may
otherwise agree.
|
(3)
|
In
the event this Agreement is terminated by Elan for a default of JE
Oncology and/or Inex under Clauses 9.3(2), 9.3(3) and 9.3(4), upon
the
written request of JE Oncology, Elan will offer to each sublicensee
(other
than Inex) a license to the Elan Intellectual Property and Regents"
Patent
Rights to the extent (i} granted to IE Oncology hereunder; or (ii)
previously granted to such sublicensee under the relevant Sublicense
Agreement, upon terms and conditions no more onerous nor restrictive
than
as set forth, at Elan's option, in this Agreement and/or the relevant
Sublicense Agreement and upon such other terms and conditions as
Elan and
such sublicensee may otherwise
agree.
|
11
|
CONFIDENTIAL
INFORMATION
|
11.1
|
Confidential
Information.
|
(1)
|
The
Parties agree that it will be necessary, from time to time, to disclose
to
each other confidential and proprietary information, including without
limitation, inventions, works of authorship, trade secrets,
specifications, designs, data, know how and other proprietary information
relating to the Field, the Products, processes, services and business
of
the disclosing Party.
|
The
foregoing shall be referred to collectively as "Confidential
Information".
(2)
|
Any
Confidential Information disclosed by the disclosing Party shall
be used
by the receiving Party exclusively for the purposes of fulfilling
the
receiving Party's obligations under this Agreement and for no other
purpose.
|
(3)
|
Save
as otherwise specifically provided herein, and subject to Clause
11.2 and
Clause 11.3, each forty shall disclose Confidential Information of
the
other Party only to those employees, representatives and agents requiring
knowledge thereof in connection with fulfilling the Party's obligations
under this Agreement.
|
Each
Party further agrees to inform all such employees, representatives and agents
of
the terms and provisions of the confidentiality obligations of such Party under
this Agreement and its duties hereunder and to obtain such employees’
representatives" and agents' written agreement to abide by such confidentiality
obligations as a condition of receiving Confidential Information. Each Party
shall exercise the same standard of care as it would itself exercise in relation
to its own confidential information (but in no event less than a reasonable
standard of care) to protect and preserve the proprietary and confidential
nature of the Confidential Information disclosed to it by the other
Party.
13
Upon
termination or expiration of this Agreement, each Party shah promptly, upon
request of
the
other Party, return all documents
and any copies thereof containing Confidential Information belonging to, or
disclosed by, such other Party, save that it may retain one copy of the same
solely for the purposes of ensuring compliance with this Clause 11.
(4)
|
Any
breach of this Clause I 1 by any person informed by one of the Parties
is
considered a breach by the Party
itself.
|
(5)
|
Confidential
Information shall not to include:
|
(i)
|
information
in the public domain;
|
(ii)
|
information
made public through no breach of this
Agreement;
|
(iii)
|
information
which is independently developed by a Party, as evidenced by such
Party's
records, without the use or assistance of the other Party's Confidential
Information; and
|
(iv)
|
information
that becomes available to a receiving Party on a non- confidential
basis,
whether directly or indirectly, from a third party, which third
party did
not acquire such information on a confidential basis or otherwise
from the
disclosing Party hereto.
|
(6)
|
The
provisions relating to confidentiality in this Clause 11 shall remain
in
effect during the term of this ,Agreement, and for a period of 10
years
following the expiration or earlier termination of this
Agreement.
|
(7)
|
The
Parties agree that the obligations of this Clause 1I are necessary
and
reasonable in order to protect the Parties' respective businesses,
and
each Party agrees that monetary damages may be inadequate to compensate
a
Party for any breach by the other Party of its covenants and agreements
set forth herein. The Parties agree that any such violation or threatened
violation may cause reparable injury to a Party and that, in addition
to
any other remedies that may be available, in law and equity or otherwise,
each Party shall be entitled to seek injunctive relief against the
threatened breach of the provisions of this Clause 11, or a continuation
of any such breach by the other Party, specific performance and other
equitable relief to redress such breach together with damages and
reasonable counsel fees and expenses to enforce its rights
hereunder.
|
11.2
|
Required
Disclosures
|
(1)
|
The
receiving party will be entitled to disclose Confidential Information
which the receiving Party is required to disclose pursuant to
|
(i)
|
a
valid order of a court or other governmental body;
or
|
(ii)
|
any
other requirement of law;
|
14
provided
that if the receiving party becomes legally required to disclose any
Confidential Information hereunder, the receiving Party shall give the
disclosing Party prompt notice of such fact to enable the disclosing Party
to
seek a protective order or other appropriate remedy concerning any such
disclosure.
The
receiving Party shall fully cooperate with the disclosing Party in connection
with the disclosing Party's efforts to obtain any such order or other
remedy.
If
any
such order or other remedy does not fully preclude disclosure, the receiving,
Party shall make such disclosure only to the extent that such disclosure is
legally required.
11.3
|
Announcements
|
(1)
|
Subject
to Clause 11.2, no announcement or public statement concerning the
existence, subject matter or any term of this Agreement shall be
made by
or on behalf of a Party hereto without the prior written approval
of the
other Party.
|
(2)
|
The
terms of any such announcement shall be agreed in good faith by the
Parties.
|
(3)
|
Each
of the Parties shall be entitled to provide a copy of this Agreement
(and
any subsequent amendments hereto) to a potential third party purchaser,
assignee or licensee in connection with a potential purchase or a
potential assignment or grant of license permitted to be made under
this
Agreement; provided that the relevant purchaser, assignee or licensee
has
entered into a customary confidentiality
agreement.
|
12 CUSTOMER
COMPLAINTS AND PRODUCT RECALL
12.1
|
IE
Oncology shall establish a procedure for formal adverse event handling
and
reporting.
|
IE
Oncology and Inex shall each be jointly and severally responsible for furnishing
post marketing reports to the applicable RHAs and other relevant governmental
agencies and, at Alan's request, shall copy Elan on all such communications
with
the RHAs and other relevant regulatory agencies,
12.2
|
In
the event of any recall of the Products, as suggested or requested
by any
governmental agency, IE Oncology or Inex shall perform the recall
of the
Products in the Territory and in all events the recall costs shall
be
borne by IE Oncology or Inex, as the case may
be.
|
13
|
GENERAL
PROVISIONS
|
13.1
|
Governing
Law; Jurisdiction.
This Agreement shall be governed by and construed in accordance with
the
laws of the State of New York without regard to its conflict of laws
principles.
|
13.2
|
Impossibility
of Performance; Force Majeure.
Neither Party to this Agreement shall be
liable for failure or delay in the
performance of any of its obligations hereunder if such failure or
delay
results from Force Majeure, but any such failure or delay
shall
be remedied by such Party as soon as practicable; provided, however,
that,
no Party shall be excused for a failure or delay in the performance
of any
of its payment obligations hereunder, even if such failure or delay
results from Force Majeure.
|
15
13.3 |
Assignment.
This
Agreement may not be assigned by any Party hereto without the prior
written consent of the other Parties hereto, save that a
Party:
|
(1)
|
may
assign this Agreement in whole or in part and delegate its duties
hereunder to its Affiliate or Affiliates without such consent; provided,
however, that the assignor will remain liable and responsible for
and
subject to the terms and conditions of this Agreement;
and
|
(2)
|
may
assign its rights and obligations to a successor (whether by merger,
consolidation, reorganization or other similar event) or purchaser
of all
or,
substantially all of its assets relating to such Party's technology
related to this Agreement, provided that such successor or purchaser
has
agreed in writing to assume all of such Party's rights and obligations
hereunder and a copy of such assumption
is provided to the
other Parties.
|
13.4
|
Notices.
|
(1)
|
Any
notice to be given under this Agreement shall be sent in writing
in
English by registered or recorded delivery post or reputable overnight
courier or telefaxed to the following
addresses:
|
If
to IE
Oncology at:
Financial
Services Centre
Xxxxxx'x
Court Xxxx
St.
Xxxxxxx, Barbados
Attention:
Secretary
Telephone:
000-000-0000
Fax:
000-000-0000
with
a
copy to Inex at the address set forth below.
if
to
Inex
at:
000-0000
Xxxxxxxx
Xxxxxxx
Xxxxxxx,
Xxxxxxx Xxxxxxxx
Xxxxxx
X0X 0X0
Attn:
President and CEO
Telephone
000-000-0000
Fax:
000-000-0000
If
to
Elan
at:
c/o
Elan
International Services, Ltd.,
000
Xx.
Xxxxx Xxxxx,
Xxxxxx,
Xxxxxx
XX00,
Bermuda
Attention:
President
Telephone:
000-000-0000
Fax.
000-000-0000
or
to
such other addresses) and telefax numbers as may from time to time be notified
by either Party to the other hereunder in the manner set forth in Clause (2)
below.
16
(2)
|
Any
notice sent by mail shall be deemed to have been delivered within
7
working days after dispatch or delivery to the relevant courier and
any
notice sent by telefax shall be deemed to have been delivered upon
confirmation of receipt. Notice of change of address shall be effective
upon receipt. Notices by telefax shall also be seat by another method
permitted hereunder.
|
13.5
|
Waiver.
No
waiver of any right under this Agreement shall be deemed effective
unless
contained
in
a written document signed by the Party charged with such waiver,
and no
waiver of any breach or failure to perform shall be deemed to be
a waiver
of any other breach or failure to perform or of any other right arising
under this Agreement.
|
13.6
|
Severability.
If any provision in this Agreement is deemed to be invalid, illegal,
void
or unenforceable under any law that is applicable
hereto:
|
(1)
|
such
provision will be deemed amended to conform to applicable laws so
as to be
valid and enforceable; or
|
(2)
|
if
it cannot be so amended without materially altering the intention
of the
Parties, it will be deleted and the validity, legality and enforceability
of the remaining provisions of this Agreement shall not be impaired
or
affected in any way.
|
13.7
|
Further
Assurances.
At the request of any of the Parties, the other Party or Parties
shall
(and shall use reasonable efforts to procure that any other necessary
parties shall) execute and perform all such documents, acts and things
as
may reasonably be required subsequent
to the signing of this Agreement for assuring to or vesting in the
requesting Party the frill benefit of the terms
hereof.
|
13.8
|
Successors.
This Agreement
shall he binding upon and enure to the benefit of the Parties hereto,
their successors and permitted
assigns.
|
l3.9
|
No
Effect on Other Agreements/Conflict.
No provision of this Agreement shall be construed so as to negate,
modify or affect in any way the provisions of any other i agreement
between the Parties unless specifically referred to, and solely to
the
extent provided herein.
|
13.10
|
Amendments.
No amendment,
modification or addition hereto shall be effective or binding on
any Party
unless set forth in writing and executed by a duly authorized
representative of each Party.
|
13.11
|
Counterparts.
This Agreement
may be executed in any number of counterparts, each of which when
so
executed shall be deemed to be
an original and
all of which when taken together shall constitute this
Agreement.
|
13.12 |
Good
Faith.
Each
Party undertakes to act reasonably in giving effect to the provisions
of
this Agreement.
|
13.13
|
No
Reliance.
Each Party hereby acknowledges that in entering into this Agreement
it has
not relied on any representation or warranty save as expressly set
out
herein or in any document referred to
herein.
|
17
13.14
|
Relationship
of the Parties.
|
(1)
|
Nothing
contained in this Agreement is intended or is to be construed to
constitute Elan and IE Oncology as partners or joint venturers or
Elan as
an employee of IE Oncology,
or IE Oncology
as an employee of Elan.
|
(2)
|
Neither
Party hereto shall have any express or implied right or authority
to
assume or create any obligations
on
behalf of or in the name of the other Party or to bind the other
Party to
any contract, agreement or undertaking with any
third
|
13.15
|
Whole
Agreement. This
Agreement (including the Schedules attached hereto) sets forth all
of the
agreements and understandings between the Parties with respect to
the
subject matter hereof, and supersedes and terminates all prior agreements
and understandings between the Parties with respect to the Products
in the
Field. There are no agreements or understandings with respect to
the
subject matter hereof, either oral or written, between the Parties
other
than as set forth in this Agreement; provided, however, that nothing
contained in this Agreement shall supercede, terminate or negate
any
provision of the Termination Agreement among the Original Parties
of even
date hereof.
|
The
Remainder of This Page is Intentionally Left Blank
Signature
Page to Follow
18
IN
WITNESS WHEREOF this Agreement was executed by the parties as of the day and
year first above written.
SIGNED
By:
_________________________
for
and
on behalf of
Elan
Pharmaceuticals, Inc.
successor
to The
Liposome Company, Inc.
SIGNED
By:
_________________________
for
and
on behalf of
IE
Oncology Company Limited
SIGNED
By:
_________________________
for
and
on behalf of
Inex
Pharmaceuticals Corporation
ACKNOWLEDGED
AND AGREED TO BY:
By:
_________________________
for
and
on behalf of
Elan
Pharma International Limited
By:
_________________________
for
and
on behalf of
Elan
Corporation, plc
By:
_________________________
for
and
on behalf of
Inex
International Holdings, Ltd.
19