LICENSE AGREEMENT
BETWEEN
ELAN PHARMA INTERNATIONAL LIMITED
AND
SHEFFIELD NEWCO LIMITED
TABLE OF CONTENTS
1. DEFINITIONS
2. ELAN LICENSE TO NEWCO
3. INTELLECTUAL PROPERTY
4. NON-COMPETITION/AFTER ACQUIRED TECHNOLOGY
5. FINANCIAL PROVISIONS
6. RIGHT OF INSPECTION AND AUDIT
7. REPRESENTATIONS AND WARRANTIES
8. TERM AND TERMINATION
9. CONFIDENTIAL INFORMATION
10. GOVERNING LAW AND JURISDICTION
11. IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
12. ASSIGNMENT
13. NOTICES
14. MISCELLANEOUS
THIS AGREEMENT made this 20 October 1999
between:
(1) Elan Pharma International Limited incorporated under the laws of
Ireland, and having its registered office at XXX Xxxxx, Xxxxxxx
Xxxxxxxx Xxxx, Xxxxxxx, Xxxxxx Xxxxx, Xxxxxxx ("EPIL");
(2) Newco Limited, a private limited company incorporated under the laws of
Bermuda and having its registered office at Xxxxxxxxx Xxxxx, 0 Xxxxxx
Xxxxxx, Xxxxxxxx, Xxxxxxx ("Xxxxx"); and
(3) Sheffield Pharmaceuticals, Inc., a corporation duly incorporated and
validly existing under the laws of Delaware and having its principal
place of business at 000 X. Xxxxxxxxx Xxxx, Xxxxx 000, Xx. Xxxxx, XX
00000, USA("Sheffield").
RECITALS:
A. Simultaneously herewith, Sheffield, Elan, EIS, and Newco are entering
into the JDOA for the purpose of recording the terms and conditions of
the joint venture and of regulating their relationship with each other
and certain aspects of the affairs of, and their dealings with Newco.
B. Newco desires to enter into this Agreement with Elan so as to permit
Newco to utilize the Elan Intellectual Property in making, having made,
importing, using, offering for sale and selling the Products in Field A
and Field B and Formulations in Field C in the Territory in accordance
with the terms of this Agreement.
C. Simultaneously herewith Newco and Sheffield are entering into the
Sheffield License Agreement relating to Newco's use of the Sheffield
Intellectual Property.
1 DEFINITIONS
1.1 In this Agreement unless the context otherwise requires:
"Affiliate" shall mean any corporation or entity controlling,
controlled or under the common control of Elan or Sheffield, as the
case may be, excluding Systemic Pulmonary Delivery Ltd.. For the
purpose of this definition, "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. Newco is not an
Affiliate of Sheffield.
"Agreement" shall mean this license agreement (which expression shall
be deemed to include the Recitals and Schedules hereto).
3
"Business Plan" shall have the meaning, as such term is defined in the
JDOA.
"Change of Control of Sheffield/Newco" shall mean circumstances where:
(i) a Technological Competitor of Elan shall, directly or
indirectly, acquire [REDACTED] or more of the voting stock of
Sheffield or Newco, or otherwise control or influence in any
material respect their management or business or otherwise
have entered into any joint venture, collaboration, license or
other arrangement with Sheffield or Newco, as the case may be,
to such an extent that such a Technological Competitor of Elan
is materially engaged or involved with the business or
development of Sheffield or Newco, as the case may be; or
(ii) any person other than a Technological Competitor of Elan
shall, directly or indirectly, acquire [REDACTED] or more of
the then voting stock of Sheffield or Newco, or otherwise
merge, consolidate or enter into any similar transaction (or
binding agreement in respect thereof) with Sheffield or Newco.
"Combined Fields" shall mean Field A, Field B and Field C.
"Compounds" shall mean the Field A Compound, the Field B Compound
and/or the Field C Compound.
"Confidential Information" shall have the meaning, as such term is
defined in Clause 9.
"Definitive Documents" shall mean the definitive agreements relating to
the transaction including finance, stock purchase, research and license
agreements.
"Elan" shall mean EPIL and Affiliates and subsidiaries of Elan
Corporation, Plc. within the division of Elan Corporation, Plc.
carrying on business as Elan Pharmaceutical Technologies but shall not
include Affiliates and subsidiaries (present or future) of Elan
Corporation Plc within the division of Elan Corporation, Plc carrying
on business as Elan Pharmaceuticals which incorporates, inter alia,
Targon Corporation, Athena Neurosciences, Inc., Elan Pharmaceuticals,
Inc., Elan Diagnostics, Carnrick Laboratories, and Elan Europe Limited.
"EIS" shall mean Elan International Services, Limited, a private
limited company incorporated under the laws of Bermuda and having its
registered office at Xxxxxxxxx Xxxxx, 0 Xxxxxx Xxxxxx, Xxxxxxxx,
Xxxxxxx.
"Effective Date" shall mean the date of this Agreement.
"Elan Intellectual Property" shall mean the Elan Know-How, the Elan
Patents and the Elan Improvements.
For the avoidance of doubt, Elan Intellectual Property shall exclude
(i) Elan's patent rights and know-how relating to protein or peptide
agents or peptodomimetics, derivatives or analogs thereof, designed to
4
target a pharmaceutically active agent to a certain site or sites in
the body (targeting technology) and (ii) inventions, patents and
know-how owned, licensed or controlled by Axogen Limited and Neuralab
Limited, and by all Affiliates and subsidiaries (present or future) of
Elan Corporation, Plc. carrying on business as Elan Pharmaceuticals
which incorporates, inter alia, Targon Corporation, Athena
Neurosciences, Inc., Elan Pharmaceuticals, Inc., Elan Diagnostics,
Carnrick Laboratories, and Elan Europe Limited.
"Elan Know-How" shall mean any and all rights owned, licensed or
controlled by Elan to any discovery, invention (whether patentable or
not), know-how, substances, data, techniques, processes, systems,
formulations and designs relating to Nanocrystal(TM) Technology.
"Elan Licenses" shall have the meaning set forth in Clause 2.1.
"Elan Patents" shall mean any and all rights under any and all patents
applications and/or patents, now existing, currently pending or
hereafter filed or obtained by Elan relating to Nanocrystal(TM)
Technology as set forth in Schedule 1, and any foreign counterparts
thereof and all divisionals, continuations, continuations-in-part, any
foreign counterparts thereof and all patents issuing on, any of the
foregoing, together with all registrations, reissues, re-examinations
or extensions thereof.
"EPIL Patents" shall mean the Elan Patents owned by EPIL.
"Elan Improvements" shall mean improvements relating to the Elan
Patents and/or the Elan Know-How, developed (i) by Elan whether or not
pursuant to the Project, (ii) by Newco or Sheffield or by a third party
(under contract with Newco) whether or not pursuant to the Project,
and/or (iii) jointly by any combination of Elan, Sheffield or Newco
pursuant to the Project, except as limited by agreements with third
Parties.
Subject to third party agreements, Elan Improvements shall constitute
part of Elan Intellectual Property and be included in the license of
the Elan Intellectual Property pursuant to Clause 2.1 solely for the
purposes set forth therein. If the inclusion of an Elan Improvement in
the license of Elan Intellectual Property is restricted or limited by a
third party agreement, Elan shall use reasonable commercial efforts to
minimize any such restriction or limitation.
"Elan Trademark(s)" shall mean one or more trademarks, trade names, or
service marks that are owned or licensed by or on behalf of Elan which
Elan may nominate and approve in writing from time to time for use in
connection with the sale or promotion of the Products by Newco.
"Field A" shall mean the topical pulmonary delivery of Formulations of
the Field A Compound by means of the Field A Device.
"Field B" shall mean the topical pulmonary delivery of a Formulations
of the Field B Compound by means of the Field B Device.
5
"Field C" shall mean the topical pulmonary delivery of a Formulations
of the Field C Compound by means of the Field C Device.
"Field A Device" shall mean a third party table top unit dose nebulizer
having a reservoir capable of holding a unit dose (a device and the
compressor to nebulize a unit dose shall be deemed a device), which is
a device having any one the following characteristics:
(i) [REDACTED]
(ii) [REDACTED]
(iii) [REDACTED]
(iv) [REDACTED]
(v) [REDACTED]
For the avoidance of doubt, the Field A Device does not include
[REDACTED]
"Field B Device" shall mean the Aerosol Drug Delivery System ("ADDS"),
owned by Systemic Pulmonary Delivery Limited and exclusively licensed
to Sheffield for topical pulmonary applications.
"Field C Device" shall mean the handheld multi-dose nebulizer ("MSI")
which was licensed exclusively by Siemens to Sheffield pursuant to the
Siemens Agreements and which was subsequently sub-licensed by Sheffield
to Zambon (on an exclusive basis for delivery of various medicines for
humans in treating respiratory disease and/or other lung diseases
including, but not limited to, anti-infectives) provided that Newco,
through the Management Committee, is successful in obtaining a
sub-license from Zambon to Newco enabling the development of the Field
C Compound for use with the Field C Device, as described in more detail
in Clause 2.2.
"Field A Compound" shall mean [REDACTED]
"Field B Compound" shall mean [REDACTED] for therapeutic use to be
nominated by the Management Committee pursuant to the JDOA and with
reference to the JDOA, any Substitute Field B Compound.
"Field C Compound" shall mean [REDACTED] and with reference to the
JDOA, any Substitute Field C Compound and/or any Additional Field C
Compound.
"Financial Year" shall mean each year commencing on 1 January (or in
the case of the first Financial Year, the Effective Date) and expiring
on 31 December of each year.
"Formulations" shall mean Nanocrystal(TM) Technology formulations of
Compounds for use in Field A, Field B or Field C, as applicable.
6
"JDOA" shall mean that certain joint development and operating
agreement, of even date herewith, by and between Elan, Sheffield, EIS
and Newco.
"Licensed Technologies" shall mean the Elan Intellectual Property and
the Sheffield Intellectual Property.
"Licenses" shall mean the Elan License and the Sheffield License.
"Management Committee" shall have the meaning, as such term is defined
in the JDOA.
"Nanocrystal(TM) Technology" shall mean the Elan proprietary technology
directed to nanoparticulate formulations of compounds used in the
manufacturing and/or formulation process, and methods of making the
same.
"Newco Intellectual Property" shall mean all rights to patents,
know-how and other intellectual property arising out of the conduct of
the Project by any person, including any technology acquired by Newco
from a third party, that does not constitute Elan Intellectual Property
or Sheffield Intellectual Property.
"Newco Patents" shall mean any and all patents now existing, currently
pending or hereafter filed or obtained relating to the Newco
Intellectual Property, and any foreign counterparts thereof and all
divisionals, continuations, continuations-in-part, any foreign
counterparts thereof and all patents issuing on, any of the foregoing,
together with all registrations, reissues, re-examinations or
extensions thereof.
"Party" shall mean Elan or Newco, as the case may be, and "Parties"
shall mean Elan and Newco.
"Products" shall mean the Field A Products, the Field B Products and/or
the Field C Products, as follows:
"Field A Products" shall mean Formulations of the Field A Compound
delivered by means of any Field A Device in Field A.
"Field B Products" shall mean Formulations of the Field B Compound
delivered by means of the Field B Device in Field B.
"Field C Products" shall mean Formulations of the Field C Compound
delivered by means of the Field C Device in Field C.
"Project" shall mean all activities as undertaken by Elan, Sheffield
and Newco in order to develop the Products.
"R&D Committee" shall have the meaning, as such term is defined in the
JDOA.
7
"R&D Plan" shall have the meaning, as such term is defined in the JDOA.
"R&D Program" shall mean any research and development program commenced
by Newco pursuant to the Project.
"Sheffield" shall mean Sheffield Pharmaceuticals, Inc and its
Affiliates, excluding Newco.
"Sheffield Intellectual Property" shall mean the Sheffield Know-How,
the Sheffield Patents and the Sheffield Improvements, as such terms are
defined in the Sheffield License Agreement.
"Sheffield License" shall have the meaning set forth in Clause 2.1 of
the Sheffield License Agreement.
"Sheffield License Agreement" shall mean that certain license
agreement, of even date herewith, entered into between Sheffield and
Newco.
"Sheffield Patents" shall have the meaning as such term is defined in
the Sheffield License Agreement.
"Sheffield Improvements" shall have the meaning as such term is defined
in the Sheffield License Agreement.
"Siemens" shall mean Siemens Aktiengesellschaft.
"Siemens Agreements" shall mean the License Agreement dated 21 March
1997 and the Basic Supply Agreement dated 21 March 1997, both between
Sheffield Medical Technologies Inc. and Siemens Aktiengesellschaft.
"Technological Competitor of Elan" shall mean a company, corporation or
person listed in Schedule 2 and successors thereof or any additional
broad-based technological competitor of Elan added to such Schedule
from time to time upon mutual agreement of the Parties.
"Term" shall have the meaning set forth in Clause 8.
"Territory" shall mean all the countries of the world.
"United States Dollar" and "US$" shall mean the lawful currency for the
time being of the United States of America.
"Zambon" shall mean Inpharzam International, S.A.
8
1.2 In this Agreement:
1.2.1 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.
1.2.2 Any reference to a Clause or Schedule shall, unless otherwise
specifically provided, be to a Clause or Schedule of this
Agreement.
1.2.3 The headings of this Agreement are for ease of reference only
and shall not affect its construction or interpretation.
2. ELAN LICENSE TO NEWCO
2.1. Elan hereby grants to Newco for the Term the following licenses subject
to any contractual obligations that Elan has as of the Effective Date,
including but not limited to [REDACTED]
2.1.1 an exclusive license (including the right to grant sublicenses
subject to the limitations of Clause 2.7) of the Elan
Intellectual Property solely to make, have made, import, use,
offer for sale and sell the Field A Products in the Territory
in Field A;
2.1.2 a non-exclusive license (including the right to grant
sublicenses subject to the limitations of Clause 2.7) of the
Elan Intellectual Property solely to make, have made, import,
use, offer for sale and sell the Field B Products in the
Territory in Field B;
2.1.3 subject to the execution by Newco of a written sub-license
with Zambon as more fully described in Clause 2.2 for the
development by Newco of the Field C Formulations in accordance
with Clause 2.2, a non-exclusive license (including the right
to grant sublicenses subject to the limitations of Clause 2.7)
of the Elan Intellectual Property solely to make, have made,
import, use, offer for sale and sell the Field C Formulations
in the Territory in Field C;
(the "Elan Licenses").
2.2 On the date which is [REDACTED] days following the Effective Date, or
such extended date as may be agreed in writing by Elan and Newco, Elan
shall, at its sole discretion, be entitled forthwith to terminate the
license to Newco described in Clause 2.1.3, upon notice in writing to
Newco, in the event that Newco has not, prior to such date, executed a
written sub-license with Zambon for the development by Newco of the
Field C Formulations in Field C.
Such written sub-license will be subject to the approval of the
Management Committee and will include authority from Zambon to Newco to
9
the extent necessary for Newco to develop, make, have made and use the
Field C Formulations in the Territory, general financial terms,
development schedule, and terms governing the funding by Zambon of any
R&D Program(s) in Field C, together with such other substantive issues
as the Management Committee shall deem appropriate and customary terms.
For the avoidance of doubt, to the extent royalty or other compensation
obligations are payable to Zambon in respect of any license or
sub-license from Zambon to Newco of intellectual property rights
necessary for Newco to develop, make, have made the Field C
Formulations in the Territory, Sheffield shall be responsible for same
and shall indemnify Newco in respect of any such royalty or other
compensation obligations payable to Zambon.
2.3 Elan shall be responsible for payments related to the financial
provisions and obligations of any third party agreement with respect to
the Elan Intellectual Property to which it is a party on the Effective
Date (including amendments thereto) (the "Elan Effective Date
Agreements"), including without limitation, any royalty or other
compensation obligations triggered thereunder on the Effective Date, or
triggered thereunder after the Effective Date.
For the avoidance of doubt, royalties, milestones or other payments
which arise from the process of the commercialization or exploitation
of products under the Elan Effective Date Agreements (for example, a
milestone payment payable upon successful completion of Phase II
clinical trials, the filing of an NDA application, obtaining NDA
approval, or first commercial sale) shall be payments for which Elan
will be responsible under this Clause 2.1.
2.4 To the extent royalty or other compensation obligations that are
payable to third parties with respect to the Elan Intellectual Property
would be triggered after the Effective Date under any third party
agreement entered into by Elan after the Effective Date (the "Elan
Post-Effective Date Agreements"), by a proposed use of such Elan
Intellectual Property in connection with the Project, Elan will inform
Newco of such royalty or compensation obligations. If Newco agrees to
utilise such Elan Intellectual Property in connection with the Project,
Newco will be responsible for the payment of such royalty or other
compensation obligations relating thereto.
For the avoidance of doubt, royalties, milestones or other payments
which arise from the process of the commercialization or exploitation
of products under the Elan Post-Effective Date Agreements (for example,
a milestone payment payable upon successful completion of Phase II
clinical trials, the filing of an NDA application, obtaining NDA
approval, or first commercial sale) shall be payments for which Newco
will be responsible under this Clause 2.2.
2.5 Sheffield shall be a third party beneficiary under this Agreement and
shall have the right to cause Newco to enforce Newco's rights under
this Agreement against Elan.
2.6 Notwithstanding anything contained in this Agreement to the contrary,
Elan shall have the right outside the Field A, Field B and Field C and
10
subject to the non-competition provisions of Clause 4 to exploit and
grant licenses and sublicenses of the Elan Intellectual Property.
For the avoidance of doubt, Newco shall have no right to use the Elan
Intellectual Property outside Field A, Field B or Field C.
2.7 Newco shall not be permitted to assign or sublicense any of its rights
under the Elan Intellectual Property without the prior written consent
of Elan, which consent shall not be unreasonably withheld or delayed
provided that Elan shall in all cases, in its sole discretion, be
entitled to withhold its consent in the case of a proposed sublicense
to any Technological Competitor to Elan.
2.8 Any agreement between Newco and any permitted third party for the
development or exploitation of the Elan Intellectual Property shall
require such third party to maintain the confidentiality of all
information concerning the Elan Intellectual Property.
Insofar as the obligations owed by Newco to Elan are concerned, Newco
shall remain responsible for all acts and omissions of any permitted
sub-licensee, including Sheffield, as if they were acts and omissions
by Newco.
3 INTELLECTUAL PROPERTY
3.1 Ownership of Intellectual Property:
3.1.1 Newco shall own the Newco Intellectual Property.
3.1.2 Elan shall own the Elan Intellectual Property.
3.2 Trademarks:
3.2.1 Elan hereby grants to Newco for the Term a non-exclusive,
royalty free license in the Territory to use and display the
Elan Trademarks to promote, offer for sale and sell the
Products in Field A, Field B and the Formulations in Field C
in the Territory and the following provisions shall apply as
regards the use of the Elan Trademarks by Newco hereunder:
(1) Newco shall ensure that each reference to and use of an
Elan Trademark by Newco is in a manner approved by Elan
and accompanied by an acknowledgement, in a form
approved by Elan, that the same is a trademark (or
registered trademark) of Elan.
From time to time, upon the reasonable request of Elan,
Newco shall submit samples of the Product to Elan or
its duly appointed agent to ensure compliance with
quality standards and specifications. Elan, or its duly
appointed agent, shall have the right to inspect the
premises of Newco where the Products are manufactured,
held or stored, and Newco shall permit such inspection,
11
upon advance notice at any reasonable time, of the
methods and procedures used in the manufacture, storage
and sale of the Product. Newco shall not sell or
otherwise dispose of any Product under the Elan
Trademarks that fails to comply with the quality
standards and specifications referred to in this Clause
3.2, as determined by Elan.
(2) Newco shall not use an Elan Trademark in any way which
might materially prejudice its distinctiveness or
validity or the goodwill of Elan therein.
(3) The parties recognize that the Elan Trademarks have
considerable goodwill associated therewith. Newco shall
not use in relation to the Products any trademarks
other than the Elan Trademarks (except the Sheffield
Trademarks (as defined in the Sheffield License
Agreement) licensed to Newco under the Sheffield
License Agreement) without obtaining the prior consent
in writing of Elan, which consent may not be
unreasonably withheld. However, such use must not
conflict with the use and display of the Elan Trademark
and such use and display must be approved by Elan.
(4) Newco shall not use in the Territory any trademarks or
trade names so resembling the Elan Trademark as to be
likely to cause confusion or deception.
(5) Newco shall promptly notify Elan in writing of any
alleged infringement or unauthorised use of which it
becomes aware by a third party of the Elan Trademarks
and provide Elan with any applicable evidence of
infringement or unauthorised use.
(6) Newco shall not be permitted to assign or sublicense
any of its rights under the Elan Trademarks without the
prior written consent of Elan, which consent shall not
be unreasonably withheld or delayed.
3.2.2 Elan shall, at its expense and sole discretion, file and
prosecute applications to register and maintain registrations
of the Elan Trademarks in the Territory. Newco shall
reasonably co-operate with Elan in such efforts. In the event
Elan decides not to file or prosecute such Elan Trademark,
Newco may request Elan to do the same at Newco's expense, and
Elan shall file or prosecute such Elan Trademark at Newco's
request and expense unless Elan believes such action is
without merit.
3.2.3 Elan will be entitled to conduct all enforcement proceedings
relating to the Elan Trademarks and shall at its sole
discretion decide what action, if any, to take in respect to
any enforcement proceedings of the Elan Trademarks or any
other claim or counter-claim brought in respect to the use or
registration of the Elan Trademarks. Any such proceedings
shall be conducted at Elan's expense and for its own benefit.
Newco and Sheffield shall reasonably cooperate with Elan in
12
such efforts. In the event Elan decides not to engage in
enforcement proceedings of the Elan Trademarks, Newco may
request Elan to do the same at Newco's expense unless Elan
believes the basis for such enforcement proceedings is
without merit. In such a case, Elan shall have the sole
discretion not to engage in any such enforcement proceedings
3.2.4 Save where Newco adopts its own xxxx under Clause 3.2.4, in
the event Newco becomes aware that any Elan Trademark has
been challenged by a third party in a judicial or
administrative proceeding in a country in the Territory as
infringing on the rights of a third party Newco shall
promptly notify Elan in writing and Elan shall have the first
right to decide whether or not to defend such allegations, or
to adopt an alternative xxxx, or allow Newco to adopt an
alternative xxxx. If Elan decides not defend the Elan
Trademark, then Newco may request Elan to defend the Elan
Trademark, at Newco's expense, unless such requested defense
is reasonably believed by Elan to be unsubstantiated and
without merit. In such a case, Elan may elect not to initiate
defence proceedings.
3.2.5 Newco will have no ownership rights in respect of the Elan
Trademarks or of the goodwill associated therewith, and Newco
hereby acknowledges that, except as expressly provided in
this Agreement, it shall not acquire any rights in respect
thereof and that all such rights and goodwill are, and will
remain, vested in Elan.
3.2.6 Nothing in this Agreement shall be construed as a warranty on
the part of Elan regarding the Elan Trademarks, including
without limitation, that use of the Elan Trademarks in the
Territory will not infringe the rights of any third parties.
Accordingly, Newco acknowledges and agrees that Elan makes no
such warranty.
3.2.7 Elan assumes no liability to Newco or to any third parties
with respect to the quality, performance or characteristics
of any of the goods manufactured or sold by Newco under the
Elan Trademarks pursuant to this Agreement.
4 NON-COMPETITION/AFTER ACQUIRED TECHNOLOGY
4.1 Subject to Clause 4.2 and Clause 4.3 and Clause 8.6, during the period
during which the license described in Clause 2.1.1 has not been
terminated, Elan shall not, alone or in conjunction with a third party,
develop or commercialize any of the unit dose steroids listed in
Schedule 3 for topical pulmonary delivery using a Field A Device and
utilizing the Nanocrystal(TM)Technology, subject to written agreements
between Elan and unaffiliated third parties on the Effective Date,
including but not limited to the Development License and Supply
Agreement dated 26 July 1999 between EPIL and Merck Corporation.
For the avoidance of doubt, the non-compete obligation set forth in
this Clause 4 shall not prevent or restrict EPIL (as the owner of
intellectual property related to Nanocrystal(TM) Technology) from
entering into any agreement with any third party to license the
Nanocrystal(TM) Technology, such license being limited to compounds
13
owned, acquired, in-licensed or otherwise proprietary to such third
party but not including any of the unit dose steroids listed in
Schedule 3 for topical pulmonary delivery using a Field A Device and
utilizing the Nanocrystal(TM) Technology.
The provisions of this Clause 4.1 shall only act as a restriction upon
Affiliates and subsidiaries of Elan Corporation, Plc. within the
division of Elan Corporation, Plc. carrying on business as Elan
Pharmaceutical Technologies and shall not act as a restriction upon,
nor in any way affect, Affiliates and subsidiaries (present or future)
of Elan Corporation Plc within the division of Elan Corporation, Plc
carrying on business as Elan Pharmaceuticals which incorporates, inter
alia, Targon Corporation, Athena Neurosciences, Inc., Elan
Pharmaceuticals, Inc., Elan Diagnostics, Carnrick Laboratories, and
Elan Europe Limited.
4.2 Notwithstanding the provisions of Clause 4.1, the non-competition
obligations of Elan set forth in Clause 4.1 shall not restrict Elan
from entering into an agreement with [REDACTED] during the period of
[REDACTED] following the Effective Date, or such longer period as may
be agreed by Elan and Newco, for the development of a unit dose of
[REDACTED], for topical pulmonary delivery using a Field A Device and
utilizing the Nanocrystal(TM)Technology subject to the following
conditions:
4.2.1 if such agreement is not executed by Elan and [REDACTED] within
the period of [REDACTED] following the Effective Date, or such
longer period as may be agreed by Elan and Newco, this
exception to the non-competition obligations of Elan set forth
in Clause 4.1 shall expire and be of no further force or
effect;
4.2.2 if such agreement is agreed for execution by Elan and [REDATED]
within the period of [REDACTED] following the Effective Date,
or such longer period as may be agreed by Elan and Newco, Newco
and Sheffield shall forthwith sign an amendment to this License
Agreement (and any of the other Definitive Documents, if
necessary) terminating the non-competition obligations of Elan
set forth in Clause 4.1 insofar as such obligations relate to
[REDACTED] and the Parties shall agree in good faith and on
reasonable commercial and customary terms what portion of the
royalties payable by [REDACTED] to Elan under the agreement
proposed for execution should be payable to Newco in return for
such amendment to this License Agreement (and any of the other
Definitive Documents, if necessary).
4.3 If, after the Effective Date, Elan acquires know-how or patent rights
relating to the Field A, Field B or Field C, or acquires or merges with
a third party entity that has know-how or patent rights relating to the
Field A, Field B or Field C, Elan shall offer to license such know-how
and patent rights to Newco (subject to existing contractual
obligations), on commercially reasonable terms on an arm's length basis
for a reasonable period under the prevailing circumstances.
If Newco determines that Newco should not acquire such license, Elan
shall be free to fully exploit such know-how and patent rights with the
Elan Intellectual Property then licensed to Newco, whether inside or
outside the Field A, Field B or Field C, as applicable, and to grant to
third parties licenses and sublicenses with respect thereto.
14
5 FINANCIAL PROVISIONS
5.1 License Fee:
In consideration of the license by EPIL to Newco of the EPIL Patents
under Clause 2, Newco shall pay to EPIL a non-refundable license fee of
[REDACTED] in cash (the "License Fee"), the receipt of which is hereby
acknowledged by EPIL.
The License Fee shall not be subject to future performance obligations
of Elan to Newco or Sheffield and shall not be applicable against
future services provided by Elan to Newco or Sheffield.
For the avoidance of doubt, in the event that Elan terminates the
license to Newco described in Clause 2.1.3 pursuant to the provisions
of Clause 2.2, no part of the License Fee described in this Clause 5.1
shall become refundable to Sheffield.
5.2 Royalties:
Prior to the commercialization of the Products, the Management
Committee shall consider and if appropriate, determine reasonable
royalties with respect to the commercialization of the Products by
Newco that shall be payable by Newco to Elan and Sheffield, and shared
by Elan and Sheffield equally.
At such time, the Management Committee will agree an appropriate
definition of "Net Sales" as such term is used in this Agreement.
5.3 Payment of any royalties pursuant to Clause 5.2 shall be made quarterly
in arrears during each Financial Year within 30 days after the expiry
of the calendar quarter. The method of payment shall be by wire
transfer to an account specified by Elan. Each payment made to Elan
shall be accompanied by a true accounting of all Products sold by
Newco's permitted sublicensees, if any, during such quarter.
Such accounting shall show, on a country-by-country and
Product-by-Product basis, Net Sales (and the calculation thereof) and
each calculation of royalties with respect thereto, including the
calculation of all adjustments and currency conversions.
5.4 Newco shall maintain and keep clear, detailed, complete, accurate and
separate records for a period of 3 years:
5.4.1 to enable any royalties on Net Sales that shall have accrued
hereunder to be determined; and
5.4.2 to enable any deductions made in the Net Sales calculation to
be determined.
15
5.5 All payments due hereunder shall be made in United States Dollars.
Payments due on Net Sales of any Product for each calendar quarter made
in a currency other than United States Dollars shall first be
calculated in the foreign currency and then converted to United States
Dollars on the basis of the exchange rate in effect on the last working
day for such quarter for the purchase of United States Dollars with
such foreign currency quoted in the Wall Street Journal (or comparable
publication if not quoted in the Wall Street Journal) with respect to
the currency of the country of origin of such payment, determined by
averaging the rates so quoted on each business day of such quarter.
5.6 If, at any time, legal restrictions in the Territory prevent the prompt
payment when due of royalties or any portion thereof, the Parties shall
meet to discuss suitable and reasonable alternative methods of paying
Elan the amount of such royalties. In the event that Newco is prevented
from making any payment under this Agreement by virtue of the statutes,
laws, codes or government regulations of the country from which the
payment is to be made, then such payments may be paid by depositing
them in the currency in which they accrue to Elan's account in a bank
acceptable to Elan in the country the currency of which is involved or
as otherwise agreed by the Parties.
5.7 Elan and Newco agree to co-operate in all respects necessary to take
advantage of any double taxation agreements or similar agreements as
may, from time to time, be available.
5.8 Any taxes payable by Elan on any payment made to Elan pursuant to this
Agreement shall be for the account of Elan. If so required by
applicable law, any payment made pursuant to this Agreement shall be
made by Newco after deduction of the appropriate withholding tax, in
which event the Parties shall co-operate to obtain the appropriate tax
clearance as soon as is practicable. On receipt of such clearance,
Newco shall forthwith arrange payment to Elan of the amount so
withheld.
6 RIGHT OF INSPECTION AND AUDIT
6.1 Once during each Financial Year, or more often not to exceed quarterly
as reasonably requested by Elan, Newco shall permit Elan or its duly
authorised representatives, upon reasonable notice and at any
reasonable time during normal business hours, to have access to inspect
and audit the accounts and records of Newco and any other book, record,
voucher, receipt or invoice relating to the calculation of the royalty
payments on Net Sales submitted to Elan.
Any such inspection of Newco's records shall be at the expense of Elan,
except that if any such inspection reveals a deficiency in the amount
of the royalty actually paid to Elan hereunder in any Financial Year
quarter of [REDACTED] or more of the amount of any royalty actually due
to Elan hereunder, then the expense of such inspection shall be borne
solely by Newco. Any amount of deficiency shall be paid promptly to
Elan by Newco.
If such inspection reveals a surplus in the amount of royalties
actually paid to Elan by Newco, Elan shall reimburse Newco the surplus
within 15 days after determination.
16
6.2 In the event of any unresolved dispute regarding any alleged deficiency
or overpayment of royalty payments hereunder, the matter will be
referred to an independent firm of chartered accountants chosen by
agreement of Sheffield and Elan for a resolution of such dispute. Any
decision by the said firm of chartered accountants shall be binding on
the Parties.
7 REPRESENTATIONS AND WARRANTIES
7.1 Elan represents and warrants to Newco and Sheffield, as of the
Effective Date, as follows:
7.1.1 Elan has the right to grant the Elan Licenses;
7.1.2 there are no agreements with any third parties that conflict
with the Elan Licenses.
7.2 In addition to any other indemnities provided for herein, Elan shall
indemnify and hold harmless Newco and its Affiliates and their
respective employees, agents, officers and directors from and against
any claims, losses, liabilities or damages (including reasonable
attorney's fees and expenses) incurred or sustained by Newco arising
out of or in connection with any:
7.2.1 breach of any representation, covenant, warranty or obligation
by Elan hereunder; or
7.2.2 act or omission on the part of Elan or any of its respective
employees, agents, officers and directors in the performance
of this Agreement.
7.3 In addition to any other indemnities provided for herein, Newco shall
indemnify and hold harmless Elan and its Affiliates and their
respective employees, agents, officers and directors from and against
any claims, losses, liabilities or damages (including reasonable
attorney's fees and expenses) incurred or sustained by Elan arising out
of or in connection with any:
7.3.1 breach of any representation, covenant, warranty or obligation
by Newco hereunder; or
7.3.2 act or omission on the part of Newco or any of its agents or
employees in the performance of this Agreement.
7.4 The Party seeking an indemnity shall:
7.4.1 fully and promptly notify the other Party of any claim or
proceeding, or threatened claim or proceeding;
7.4.2 permit the indemnifying Party to take full care and control of
such claim or proceeding;
17
7.4.3 co-operate in the investigation and defence of such claim or
proceeding;
7.4.4 not compromise or otherwise settle any such claim or
proceeding without the prior written consent of the other
Party, which consent shall not be unreasonably withheld
conditioned or delayed; and
7.4.5 take all reasonable steps to mitigate any loss or liability in
respect of any such claim or proceeding.
7.5 EXCEPT AS SET FORTH IN THIS CLAUSE 7, ELAN IS GRANTING THE LICENSES
HEREUNDER ON AN "AS IS" BASIS WITHOUT REPRESENTATION OR WARRANTY
WHETHER EXPRESS OR IMPLIED INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, OR INFRINGEMENT OF THIRD PARTY
RIGHTS, AND ALL SUCH WARRANTIES ARE EXPRESSLY DISCLAIMED.
7.6 NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, ELAN AND
NEWCO SHALL NOT BE LIABLE TO THE OTHER BY REASON OF ANY REPRESENTATION
OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW, OR
UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL,
SPECIAL OR INCIDENTAL OR PUNITIVE LOSS OR DAMAGE (WHETHER FOR LOSS OF
PROFITS OR OTHERWISE) AND WHETHER OCCASIONED BY THE NEGLIGENCE OF THE
RESPECTIVE PARTIES, THEIR EMPLOYEES OR AGENTS OR OTHERWISE.
8. TERM AND TERMINATION
8.1 The term of this Agreement shall commence as of the Effective Date and
shall, subject to the rights of termination outlined in this Clauses 8,
expire on a Product-by-Product basis and on a country-by-country basis
on the last to occur of:
8.1.1 [REDACTED] years starting from the date of the first
commercial sale of the Product in the country concerned; or
8.1.2 the date of expiration of the last to expire of the patents
included in the Elan Patents and/or the Elan Improvements
and/or the Sheffield Patents and/or the Elan Improvements that
relate to the Product.
("the Term")
8.2 If either Party commits a Relevant Event, the other Party shall have,
in addition to all other legal and equitable rights and remedies
hereunder, the right to terminate this Agreement upon 30 days' prior
written notice to the defaulting Party.
18
8.3 For the purpose of this Clause 8, a "Relevant Event" is committed or
suffered by a Party if:
8.3.1 [REDACTED]
8.3.2 [REDACTED]
8.3.3 [REDACTED]
8.3.4 [REDACTED]
8.3.5 [REDACTED]
8.3.6 [REDACTED]
8.4 Elan shall be entitled to forthwith terminate this Agreement in the
event of a Change of Control of Sheffield/Newco.
As provided in Clause 8.4 of the Sheffield License Agreement, Sheffield
shall be entitled to terminate the Sheffield License Agreement if Elan
elects to terminate the Elan Licenses hereunder.
8.5 Upon expiration or termination of the Agreement:
8.5.1. any sums that were due from Newco to Elan on Net Sales in the
Territory or in such particular country or countries in the
Territory (as the case may be) prior to the expiration or
termination of this Agreement as set forth herein shall be
paid in full within 60 days after the expiration or
19
termination of this Agreement for the Territory or for such
particular country or countries in the Territory (as the case
may be);
8.5.2 any provisions that expressly survive termination or
expiration of this Agreement, including without limitation
this Clause 8, shall remain in full force and effect;
8.5.3 all representations, warranties and indemnities shall insofar
as are appropriate remain in full force and effect;
8.5.4 the rights of inspection and audit set out in Clause 6 shall
continue in force for a period of one year; and
8.5.5 all rights and licenses granted pursuant to this Agreement and
to the Elan Intellectual Property pursuant to the JDOA
(including the rights of Newco pursuant to Clause 11 of the
JDOA) shall cease for the Territory or for such particular
country or countries in the Territory (as the case may be) and
shall revert to or be transferred to Elan, and Newco shall not
thereafter use in the Territory or in such particular country
or countries in the Territory (as the case may be) any rights
covered by this Agreement;
8.5.6 subject to Clause 8.5.7 and to such license, if any, granted
by Newco to Elan pursuant to the provisions of Clause 12 of
the JDOA, all rights to Newco Intellectual Property shall be
transferred to and jointly owned by Sheffield and Elan and may
only be exploited by either Elan or Sheffield with the consent
of the other Party pursuant to a written agreement to be
negotiated in good faith;
8.5.7 the rights of permitted third party sub-licensees in and to
the Elan Intellectual Property shall survive the termination
of the license and sublicense agreements granting said
intellectual property rights to Newco; and Newco, Elan and
Sheffield shall in good faith agree upon the form most
advantageous to Elan and Sheffield in which the rights of
Newco under any such licenses and sublicenses are to be held
(which form may include continuation of Newco solely as the
holder of such licenses or assignment of such rights to a
third party or parties, including an assignment to both Elan
and Sheffield).
Any sublicense agreement between Newco and such permitted
sublicensee shall permit an assignment of rights by Newco and
shall contain appropriate confidentiality provisions.
8.6 In the event that the Parties and Sheffield mutually agree to terminate
the portion of the Project (as defined in the JDOA) which relates to
Field A, the license described in Clause 2.1.1, the provisions of
Clause 4.1 and the provisions of Clause 4.3 (insofar as the provisions
of Clause 4.3 relate to Field A) shall automatically terminate.
20
9 CONFIDENTIAL INFORMATION
9.1 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 Combined Fields, the Products, processes,
services and business of the disclosing Party.
The foregoing shall be referred to collectively as "Confidential
Information".
9.2 Any Confidential Information disclosed by one Party to another Party
shall be used by the receiving Party exclusively for the purposes of
fulfilling the receiving Party's obligations under this Agreement and
the JDOA and for no other purpose.
9.3 Each Party 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 this
Agreement and their duties hereunder and to obtain their agreement
hereto 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. Each Party shall, upon request of the other Party,
return all documents and any copies thereof containing Confidential
Information belonging to, or disclosed by, such other Party.
9.4 Any breach of this Clause 9 by any person informed by one of the
Parties is considered a breach by the Party itself.
9.5 Confidential Information shall not be deemed to include:
9.5.1 information that is in the public domain;
9.5.2 information which is made public through no breach of this
Agreement;
9.5.3 information which is independently developed by a Party as
evidenced by such Party's records;
9.5.4 information that becomes available to a Party on a
non-confidential basis, whether directly or indirectly, from a
source other than a Party, which source did not acquire this
information on a confidential basis; or
9.5.5 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;
21
provided that if the receiving Party becomes legally required
to disclose any Confidential Information, the receiving Party
shall give the disclosing Party prompt notice of such fact so
that the disclosing Party may obtain a protective order or
other appropriate remedy concerning any such disclosure. The
receiving Party shall fully co-operate 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.
9.6 The provisions relating to confidentiality in this Clause 9 shall
remain in effect during the term of this Agreement, and for a period of
7 years following the expiration or earlier termination of this
Agreement.
9.7 The Parties agree that the obligations of this Clause 9 are necessary
and reasonable in order to protect the Parties' respective businesses,
and each Party agrees that monetary damages would be inadequate to
compensate a Party for any breach by the other Party of its covenants
and agreements set forth herein.
Accordingly, the Parties agree that any such violation or threatened
violation shall cause irreparable 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 obtain injunctive relief
against the threatened breach of the provisions of this Clause 9, or a
continuation of any such breach by the other Party, specific
performance and other equitable relief to redress such breach together
with its damages and reasonable counsel fees and expenses to enforce
its rights hereunder, without the necessity of proving actual or
express damages.
9.8 For the avoidance of doubt, all Confidential Information of Newco
received by Elan hereunder shall not be disclosed by Elan to Affiliates
and/or subsidiaries (present or future) of Elan Corporation, Plc.
within the division of Elan Corporation, Plc. carrying on business as
Elan Pharmaceuticals which incorporates, inter alia, Targon
Corporation, Athena Neurosciences, Inc., Elan Pharmaceuticals, Inc.,
Elan Diagnostics, Carnrick Laboratories, and Elan Europe Limited.
10 GOVERNING LAW AND JURISDICTION
10.1 This Agreement shall be governed by and construed in accordance with
the laws of the State of New York.
10.2 The Parties will attempt in good faith to resolve any dispute arising
out of or relating to this Agreement promptly by negotiation between
executives of the Parties. In the event that such negotiations do not
result in a mutually acceptable resolution, the Parties agree to
consider other dispute resolution mechanisms including mediation.
In the event that the Parties fail to agree on a mutually acceptable
22
dispute resolution mechanism, any such dispute shall be finally settled
by the courts of competent jurisdiction. For the purposes of this
Agreement the parties submit to the non-exclusive jurisdiction of the
courts of the State of New York.
11 IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
Neither Elan nor Newco shall be liable for delay in the performance of
any of its obligations hereunder if such delay results from causes
beyond its reasonable control, including, without limitation, acts of
God, fires, strikes, acts of war, intervention of a government
authority, but any such delay or failure shall be remedied by such
Party as soon as practicable.
12 ASSIGNMENT
This Agreement may not be assigned by either Party without the prior
written consent of the other, save that either Party may assign this
Agreement to its Affiliates or subsidiaries without such prior written
consent provided that such assignment does not have any adverse tax
consequences on the other Party.
13 NOTICES
13.1 Any notice to be given under this Agreement shall be sent in writing in
English by registered airmail or telefaxed to the following addresses:
If to Newco at:
Xxxxxxxxx Xxxxx,
0 Xxxxxx Xxxxxx,
Xxxxxxxx,
Xxxxxxx
Xxxxxxxxx: Secretary
Telephone: 000 000 0000
Fax: 000 000 0000
with a copy to Elan and Sheffield at the addresses listed below:
If to Sheffield at:
Sheffield Pharmaceuticals, Inc.
000 X. Xxxxxxxxx Xxxx
Xxxxx 000
Xx Xxxxx
XX 00000
XXX.
23
Attn: Chief Executive Officer
Telephone 000 000 000 0000
Fax: 000 000 000 0000
with a copy to:
Xxxxxx Xxxxxxxxx, Esq.
Olshan, Grundman, Trome
Rosenzeig, LLP
000 Xxxx Xxxxxx
Xxx Xxxx, XX 00000
Telephone 000 000 000 0000
Fax: 000 000 000 0000
If to Elan at:
Elan Corporation, plc
Xxxxxxx Xxxxx,
Xxxxxxx Xxxxx,
Xxxxxx 0,
Xxxxxxx.
Attention: Vice President, General Counsel,
Elan Pharmaceutical Technologies,
a division of Elan Corporation, plc
Telephone: + 000 0 000 0000
Telefax: + 353 1 709 4124
or to such other address(es) and telefax numbers as may from time to
time be notified by either Party to the other hereunder.
13.2 Any notice sent by mail shall be deemed to have been delivered within
seven 7 working days after dispatch and any notice sent by telex or
telefax shall be deemed to have been delivered within twenty 24 hours
of the time of the dispatch. Notice of change of address shall be
effective upon receipt.
14 MISCELLANEOUS
14.1 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.
24
14.2 Severability:
If any provision in this Agreement is agreed by the Parties to be, or
is deemed to be, or becomes invalid, illegal, void or unenforceable
under any law that is applicable hereto:
14.2.1 such provision will be deemed amended to conform to applicable
laws so as to be valid and enforceable; or
14.2.2 if it cannot be so amended without materially altering the
intention of the Parties, it will be deleted, with effect from
the date the Parties may agree, and the validity, legality and
enforceability of the remaining provisions of this Agreement
shall not be impaired or affected in any way.
14.3 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 full
benefit of the terms hereof.
14.4 Successors:
This Agreement shall be binding upon and enure to the benefit of the
Parties hereto, their successors and permitted assigns.
14.5 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 agreement
between the Parties unless specifically referred to, and solely to the
extent provided herein.
In the event of a conflict between the provisions of this Agreement and
the provisions of the JDOA, the terms of the JDOA shall prevail unless
this Agreement specifically provides otherwise.
14.6 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
authorised representative of each Party.
14.7 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.
25
14.8 Good Faith:
Each Party undertakes to do all things reasonably within its power
which are necessary or desirable to give effect to the spirit and
intent of this Agreement.
14.9 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.
14.10 Relationship of the Parties:
Nothing contained in this Agreement is intended or is to be construed
to constitute Elan and Newco as partners, or Elan as an employee of
Newco, or Newco as an employee of Elan.
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 party.
26
SCHEDULE 1
ELAN PATENTS
[REDACTED]
SCHEDULE 2
TECHNOLOGICAL COMPETITORS OF ELAN
[REDACTED]
SCHEDULE 3
List of Steroids for Clause 4.1
[REDACTED]
IN WITNESS WHEREOF the Parties hereto have executed this Agreement.
/S/
SIGNED BY
for and on behalf of
ELAN PHARMA INTERNATIONAL LIMITED
/S/
SIGNED BY
For and on behalf of
SHEFFIELD NEWCO LIMITED
/S/
AGREED TO AND ACCEPTED BY
SHEFFIELD PHARMACEUTICALS, INC.
