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Exhibit 99.8
LICENSE AGREEMENT
BETWEEN
ELAN PHARMA INTERNATIONAL LIMITED
AND
ATRIX NEWCO, LIMITED
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TABLE OF CONTENTS
1 DEFINITIONS
2 ELAN LICENSE TO NEWCO
3 INTELLECTUAL PROPERTY
4 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
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THIS AGREEMENT made this 18 July, 2000
BETWEEN:
(1) ELAN PHARMA INTERNATIONAL LIMITED incorporated under the laws of
Ireland, and having its registered office at WIL House, Shannon
Business Park, Shannon, County Clare, Ireland ("EPIL");
(2) ATRIX NEWCO, LTD., an exempted limited liability company incorporated
under the laws of Bermuda and having its registered office at Clarendon
House, 2 Church St., Hamilton, Bermuda ("NEWCO"); and
(3) ATRIX LABORATORIES, INC., a corporation duly incorporated and validly
existing under the laws of State of Delaware and having its principal
place of business at 2579 Midpoint Drive, Fort Collins, CO 80525-4417,
United States of America.
RECITALS:
A. Simultaneously herewith, Atrix, 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 the
Field in the Territory.
C. Simultaneously herewith Newco and Atrix are entering into the Atrix
License Agreement relating to Newco's use of the Atrix 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 Atrix, as the case
may be, excluding an Elan JV. 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 Elan or EIS.
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"AGREEMENT" shall mean this license agreement (which expression shall
be deemed to include the Recitals and Schedules hereto).
"ATRIGEL(R) TECHNOLOGY" shall have the meaning as such term is defined
in the Atrix License Agreement.
"ATRIX" shall mean Atrix Laboratories, Inc. and its Affiliates.
"ATRIX INTELLECTUAL PROPERTY" shall mean the Atrix Know-How, the Atrix
Patents and the Atrix Improvements.
"ATRIX KNOW-HOW" shall have the meaning as such term is defined in the
Atrix License Agreement.
"ATRIX LICENSE" shall mean have the meaning set forth in Clause 2.1 of
the Atrix License Agreement.
"ATRIX LICENSE AGREEMENT" shall mean that certain license agreement, of
even date herewith, entered into between Atrix and Newco.
"ATRIX PATENTS" shall have the meaning as such term is defined in the
Atrix License Agreement.
"ATRIX IMPROVEMENTS" shall have the meaning as such term is defined in
the Atrix License Agreement.
"BEMA(TM) TECHNOLOGY" shall have the meaning as such term is defined in
the Atrix License Agreement.
"BUSINESS PLAN" shall have the meaning, as such term is defined in the
JDOA.
"COMPOUNDS" shall mean the compounds, up to a maximum of three, which
shall be nominated and approved by the Management Committee in
accordance with Clause 2 of the JDOA.
"CHANGE OF CONTROL OF ATRIX/NEWCO" shall mean circumstances where:
(i) a Technological Competitor of Elan shall, directly or
indirectly, acquire [**]% or more of the voting stock of Atrix
or Newco, or otherwise control or influence in any material
respect their management or business or otherwise have entered
into any joint venture, collaborative, license or other
arrangement with Atrix or Newco, as the case may be, to such
an extent that such a Technological
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Competitor of Elan is materially engaged or involved with the
business or development of Atrix or Newco, as the case may be;
or
(ii) after the date of this Agreement, any person shall, directly
or indirectly, acquire [**]% or more of the then voting stock
of Atrix or Newco, or otherwise merge, consolidate or enter
into any similar transaction (or binding agreement in respect
thereof) with Atrix or Newco.
"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.
"EFFECTIVE DATE" shall mean the date of this Agreement.
"EIS" shall mean Elan International Services, Ltd., a Bermuda exempted
limited liability company having its registered office at Clarendon
House, 2 Church St., Hamilton, Bermuda.
"ELAN" shall mean EPIL.
"ELAN IMPROVEMENTS" shall mean improvements 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 Atrix or by a third party (under contract
with Newco) pursuant to the Project, and/or (iii) jointly by any
combination of Elan, Atrix 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 a 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 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
inventions, patents and know-how owned, licensed or controlled by The
Liposome Company, Inc. and its subsidiaries, Axogen Limited and
Neuralab Limited and by all Affiliates 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, EPIL (only to the extent that it is the owner
of patents, know-how or other intellectual property or technology
invented and/or developed within the division of Elan Corporation, plc.
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carrying on business as Elan Pharmaceuticals, Athena Neurosciences,
Inc., Elan Pharmaceuticals, Inc. and Elan Europe Limited.
"ELAN JV" shall mean an entity that Elan and a third party (i)
establish or has established, (ii) take shareholdings in or have a
right 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, subject to Clause 4.1, 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, designs, expertise and information
owned by Elan relating to the NanoCrystal(TM) Technology.
"ELAN LICENSE" shall have the meaning set forth in Clause 2.1.
"ELAN PATENTS" shall, subject to Clause 4.1, mean any and all rights
under any and all patent applications and/or patents, now existing,
currently pending or hereafter filed or obtained or licensed by Elan
relating to NanoCrystal(TM) Technology, examples of which are 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.
"FIELD" shall mean the administration of the Products for pain
management or oncology indications.
"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.
"IN MARKET" shall mean the sale of the Product in the Territory by
Newco or its Affiliates, or where applicable by a permitted
sub-licensee, to an unaffiliated third party, such as (i) the end-user
consumer of the Product (ii) a wholesaler, managed care organization,
hospital or pharmacy or other third party who effects the final
commercial sale to the end-user consumer of the Product, and shall
exclude the transfer pricing of the Product(s) by Newco to an Affiliate
or a sub-licensee.
"JDOA" shall mean that certain subscription, joint development and
operating agreement, of even date herewith, by and between Elan, Atrix,
EIS and Newco.
"LICENSED TECHNOLOGIES" shall mean the Elan Intellectual Property and
the Atrix Intellectual Property.
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"LICENSES" shall mean the Elan License and the Atrix License.
"MANAGEMENT COMMITTEE" shall have the meaning, as such term is defined
in the JDOA.
"NANOCRYSTAL(TM) TECHNOLOGY" shall mean the EPIL proprietary [**].
"NEWCO INTELLECTUAL PROPERTY" shall mean all rights to patents,
know-how and other intellectual property arising during and as a direct
result of the conduct of the Project by any person, including any
technology acquired by Newco from a third party, that does not
constitute either Elan Intellectual Property or Atrix Intellectual
Property. For the avoidance of doubt, patents, know-how and other
intellectual property, including all pre-clinical and clinical trial,
on the Products, and all correspondence with and submissions to
government agencies for marketing or other regulatory approval of the
Products shall be deemed Newco Intellectual Property.
"NEWCO PATENTS" shall mean any and all patents now existing, currently
pending or hereafter filed or obtained or licensed by Newco 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 formulations of the Compounds utilizing, in no
particular order, (i) the Atrigel(R) Technology or BEMA(TM) Technology,
(ii) the NanoCrystal(TM) Technology and the BEMA(TM) Technology, or
(iii) the NanoCrystal(TM) Technology and the Atrigel(R) Technology, as
developed by or on behalf of Newco pursuant to the Project.
"PROJECT" shall mean all activities as undertaken by Elan, Atrix and
Newco in order to develop the Products.
"R&D COMMITTEE" shall have the meaning, as such term is defined in the
JDOA.
"R&D PLAN" shall have the meaning, as such term is defined in the JDOA.
"TECHNOLOGICAL COMPETITOR OF ELAN" shall mean a company, corporation or
person listed in Schedule 2 and successors thereof or [**] added to
such Schedule from time to time upon mutual agreement of the Parties
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"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.
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 [**] license (the "ELAN
LICENSE") of the Elan Intellectual Property to make, have made, import,
use, offer for sale and sell the Products in the Field in the
Territory, subject to any contractual obligations that Elan has as of
the date of nomination of the Compounds, including but not limited to
the Development License and Supply Agreement dated 26 July 1999 between
Elan Pharma International Limited and Merck Corporation.
2.2 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 2.2.
2.3 Atrix 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.
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2.4 Notwithstanding anything contained in this Agreement to the contrary,
Elan shall have the right outside the Field 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 the Field.
2.5 Except as provided in Clause 11 of the JDOA, Newco shall not be
permitted to assign, license or sublicense any of its rights under the
Elan Intellectual Property without the prior consent in writing of
Elan.
2.6 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 Atrix, 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.
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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 [**] license fee of $15
million in cash (the "LICENSE FEE"), the receipt of which is hereby
acknowledged by EPIL.
[**]
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The terms of this Clause 5.1 relating to the License Fee are
independent and distinct from the other terms of this Agreement.
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 Atrix, and [**].
At such time, the Management Committee will agree an appropriate
definition of "Net Sales" as such term is used in this Agreement.
The provisions set forth in Clauses 5.3 to 5.8 and 6 relate to the
payment of any royalties which the Management Committee may determine
to be payable by Newco to Elan under this Agreement.
5.3 Payment of 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.
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.
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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
authorized 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 [**]% 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.
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 Atrix and Elan for a resolution of such dispute. Any
decision by the said firm of chartered accountants shall be binding on
the Parties.
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7 REPRESENTATIONS AND WARRANTIES
7.1 Elan represents and warrants to Newco and Atrix, as of the Effective
Date, as follows:
7.1 Elan has the right to grant the Elan License.
7.2 There are no agreements between Elan and any third party that
conflict with the Elan License.
7.3 to the best of Elan's knowledge, there are no proceedings
pending or threatened against Elan in connection with the Elan
Intellectual Property in relation to the Field.
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 negligent 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 negligent 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;
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7.4.2 permit the indemnifying Party to take full care and control of
such claim or proceeding;
7.4.3 co-operate in the investigation and defense 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 LICENSE
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 Clause 8,
expire on a Product-by-Product basis and on a country-by-country basis
on the last to occur of:
8.1.1 [**] 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 the Elan Improvements and/or
the Atrix Patents and the Atrix Improvements
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("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.
8.3 For the purpose of this Clause 8, a "RELEVANT EVENT" is committed or
suffered by a Party if:
8.3.1 it commits a material breach of its obligations under this
Agreement or the JDOA and fails to cure it within 60 days of
being specifically required in writing to do so by the other
Party; provided, that if 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;
8.3.2 a distress, execution, sequestration or other process is
levied or enforced upon or sued out against a material part of
its property which is not discharged or challenged within 30
days;
8.3.3 it is unable to pay its debts in the normal course of
business;
8.3.4 it ceases wholly or substantially to carry on its business,
otherwise than for the purpose of a reconstruction or
amalgamation, without the prior written consent of the other
Party (such consent not to be unreasonably withheld);
8.3.5 the appointment of a liquidator, receiver, administrator,
examiner, trustee or similar officer of such Party or over all
or substantially all of its assets under the law of any
applicable jurisdiction, including without limitation, the
United States of America, Bermuda or Ireland;
8.3.6 an application or petition for bankruptcy, corporate
re-organization, composition, administration, examination,
arrangement or any other procedure similar to any of the
foregoing under the law of any applicable jurisdiction,
including without limitation, the United States of America,
Bermuda or Ireland, is filed, and is not discharged within 60
days, or a Party applies for or consents to the appointment of
a receiver, administrator, examiner or similar officer of it
or of all or a material part of its assets, rights or revenues
or the assets and/or the business of a Party are for any
reason seized, confiscated or condemned.
8.4 Elan shall be entitled to forthwith terminate this Agreement by notice
in writing to Atrix in the event of a Change of Control of Atrix/Newco.
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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
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 subject to Clause 8.5.7, all rights and licenses granted to
Newco pursuant to this Agreement and to the Elan Intellectual
Property pursuant to the JDOA (including the intellectual
property rights of Newco pursuant to Clause 10 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 Elan shall have the right to exploit and commercialize,
including the right to grant sub-licenses, the Newco
Intellectual Property [**]. Atrix shall have the right to
exploit and commercialize, including the right to grant
sub-licenses, the Newco Intellectual Property [**].
All rights to Newco Intellectual Property and any other
technology, patents and know-how belonging to Newco [**] shall
be transferred to and be jointly owned by Elan and Atrix and
may be exploited by a Party with the written consent of the
other Party such consent not to be unreasonably withheld
provided that nothing hereunder shall grant, or be construed
to grant, a license to the other party under the Elan
Intellectual Property or the Atrix Intellectual Property.
In the event of a dispute arising pursuant to this Clause
8.5.6, Elan and Atrix agree to negotiate in good faith on the
course of action to be taken with respect to determining their
respective entitlements pursuant to this Clause 8.5.6.
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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
Atrix shall in good faith agree upon the form most
advantageous to Elan and Atrix 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 Atrix).
Any sublicense agreement between Newco and such permitted
sublicensee shall permit an assignment of rights by Newco and
shall contain appropriate confidentiality provisions.
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 Field, 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 Save as otherwise specifically provided herein, 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 provided
that receiving Party may retain one complete set of Confidential
Information provided by the disclosing Party in its legal files to show
compliance with the Agreement.
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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; or
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.
9.6 The receiving Party will be entitled to disclose Confidential
Information which the receiving Party is required to disclose pursuant
to:
9.6.1 a valid order of a court or other governmental body; or
9.6.2 any other requirement of law;
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.
9.7 The provisions relating to confidentiality in this Clause 9 shall
remain in effect during the term of this Agreement, and for a period of
[**] following the expiration or earlier termination of this Agreement.
9.8 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 may 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 seek injunctive
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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.
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
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, provided that the Party whose performance is delayed or
prevented shall continue to use good faith diligent efforts to
mitigate, avoid or end such delay or failure in performance 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.
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13 NOTICES
13.1 Any notice to be given under this Agreement shall be sent in writing in
English by registered airmail, or reputable overnight courier such as
Federal Express or telefaxed to the following addresses:
If to Newco at:
Clarendon House,
2 Church St.,
Hamilton,
Bermuda
Attention: Secretary
Telephone: 441 292 9169
Fax: 441 292 2224
with a copy to Elan at:
Elan Corporation, plc
102 St. James Court
Flatts, Smiths FL04
Bermuda
Attention: President
Telephone: 441-292-9169
Fax: 441-292-2224
If to Atrix at:
Atrix Laboratories, Inc.
2579 Midpoint Drive
Fort Collins
CO 80525-4417
USA
Attn: Chief Executive Officer
Telephone 970-482-5868
Fax: 970-482-9735
with a copy to:
Morrison & Foerster LLP
5200 Republic Plaza
370 17th Street
Denver, Colorado 80202-5638
Attention: Warren L. Troupe, Esq.
Telephone: 303-592-2255
Fax: 303-592-1510
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If to Elan at:
Elan Pharma International Limited
102 St. James Court
Flatts, Smiths FL04
Bermuda
Attention: President
Telephone: 441-292-9169
Fax: 441-292-2224
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 7
working days after dispatch; any notice sent by courier shall be deemed
to have been delivered on the fourth (4th) business day following the
date of deposit with such courier service, or such earlier delivery
date as may be confirmed to the sender by such courier service and any
notice sent by telex or telefax shall be deemed to have been delivered
within 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.
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
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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 of such agreement or such earlier date as 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
authorized 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.
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.
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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.
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SCHEDULE 1
REPRESENTATIVE ELAN PATENTS
[**]
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SCHEDULE 2
TECHNOLOGICAL COMPETITORS OF ELAN
[**]
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IN WITNESS WHEREOF the Parties hereto have executed this Agreement.
SIGNED
BY: /s/ KEVIN INSLEY
--------------------
Kevin Insley
Authorized Signatory on behalf of
ELAN PHARMA INTERNATIONAL LIMITED
SIGNED
BY: /s/ DAVID R. BETHUNE
--------------------
David R. Bethune
Chairman and Chief Executive Officer
ATRIX NEWCO, LIMITED
AGREED TO AND ACCEPTED BY
ATRIX LABORATORIES, INC.
BY: /s/ DAVID R. BETHUNE
--------------------
David R. Bethune
For and on behalf of
ATRIX LABORATORIES, INC.
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