Exhibit 10.4
EXECUTION COPY (V5)
ELAN LICENSE AGREEMENT
***TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(B)(4),
200.83 AND 240.24B-2
29 June 2001
LICENSE AGREEMENT
BETWEEN
ELAN CORPORATION, PLC
AND
SAFESCIENCE NEWCO, LTD.
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TABLE OF CONTENTS
1 DEFINITIONS
2 ELAN LICENSE TO NEWCO
3 INTELLECTUAL PROPERTY
4 [...***...]
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 dated 29 June 2001, and effective as of the Effective Date (as
defined below)
between:
(1) Elan Corporation, plc., a public limited company incorporated under the
laws of Ireland, and having its registered office at Xxxxxxx Xxxxx, Xxxxxxx
Xxxxx, Xxxxxx 0, Xxxxxxx; and
(2) SafeScience Newco, Ltd., an exempted limited liability company incorporated
under the laws of Bermuda and having its registered office at Xxxxxxxxx
Xxxxx, 0 Xxxxxx Xx., Xxxxxxxx, Xxxxxxx ("Xxxxx").
RECITALS:
---------
A. Simultaneously herewith, SafeScience, 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 SafeScience are entering into the
SafeScience License Agreement relating to Newco's use of the SafeScience
Intellectual Property.
1 DEFINITIONS
1.1 In this Agreement unless the context otherwise requires:
"Affiliate" shall mean any corporation or entity controlling, controlled by
or under the common control of Elan or SafeScience or any third party, as
the case may be, excluding, in the case of Elan, an Elan JV. For the
purpose of this definition, (i)"control" shall mean direct or indirect
ownership of [...***...] or more of the stock or shares entitled to vote
for the election of directors; and (ii) Newco shall not be an Affiliate of
Elan, Elan Corp, or EIS nor shall Elan, Elan Corp, or EIS be an Affiliate
of Newco.
"After Acquired Technology" shall have the meaning as such term is defined
in Clause 4.1.
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"Agreement" shall mean this license agreement (which expression shall be
deemed to include the Recitals and Schedules hereto).
"Change of Control of SafeScience/Newco" shall mean circumstances where:
(a) a Technological Competitor of Elan shall, directly or indirectly,
(i) acquire [...***...] or more of the voting stock of
SafeScience or Newco, or otherwise control or influence in any
material respect their management or business; or (ii) otherwise
have entered into any joint venture, collaborative, license or
other arrangement with SafeScience or Newco, as the case may be,
to such an extent that such a Technological Competitor of Elan
controls or influences in any material respect the business or
management of SafeScience or Newco, as the case may be; or
(b) any person or entity shall, directly or indirectly, acquire
[...***...] or more of the then voting stock of SafeScience or
Newco, or otherwise merge, consolidate or enter into any similar
transaction (or binding agreement in respect thereof) with
SafeScience or Newco.
"Compounds" shall mean SafeScience's human therapeutic drug GBC-590, the
structure of which is described in Schedule 1, such derivatives or analogs
thereof, or other compounds which are approved in writing by the Steering
Committee, in accordance with Clause 2.4 of the JDOA.
"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 Initial Closing Date.
"EIS" shall mean Elan International Services, Ltd., a Bermudan exempted
limited liability company having its registered office at Xxxxxxxxx Xxxxx,
0 Xxxxxx Xx., Xxxxxxxx, Xxxxxxx.
"Elan" shall mean Affiliates and subsidiaries of Elan Corp within the
division of Elan Corp carrying on business as Elan Pharmaceutical
Technologies. For the avoidance of doubt, "Elan" shall exclude the
Excluded Entities.
"Elan Corp" shall mean Elan Corporation, plc., a public limited company
incorporated under the laws of Ireland.
"Elan Improvements" shall mean improvements to the Elan Patents and/or the
Elan Know-How, developed (i) by Elan outside the Project, (ii) by Elan,
SafeScience or
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Newco or by a third party (under contract with Newco) pursuant to the
Project, and/or (iii) jointly by any combination of Elan, SafeScience,
Newco or a third party (under contract with 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 Elan License pursuant
to Clause 2.1 solely for the purposes set forth therein. If the inclusion
of an Elan Improvement in the Elan License 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
Excluded Entities.
"Elan JV" shall mean an entity that Elan and a third party (i) establish or
have 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 mean, subject to Clause 4.1, any and all rights
owned, licensed or controlled by Elan to any scientific, pharmaceutical or
technical information, data, discovery, invention (whether patentable or
not), know-how, substances, techniques, processes, systems, formulations,
designs and expertise relating to Elan's proprietary [...***...] Drug
Delivery Technology, which is not generally known to the public
"Elan License" shall have the meaning set forth in Clause 2.1.
"Elan Patents" shall mean, subject to Clause 4.1, 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
Elan's proprietary [...***...] Drug Delivery Technology, as set forth in
Schedule 2, 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, and any foreign counterparts
thereof, together with all registrations, reissues, re-examinations,
supplemental protection certificates, or extensions thereof, and any
foreign counterparts thereof.
"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.
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"Excluded Entities" shall mean The Liposome Company, Inc. and its
subsidiaries; Axogen Limited; Neuralab Limited; Dura Pharmaceuticals, Inc.
and its subsidiaries; and Affiliates (present or future) of Elan Corp
within the division of Elan Corp carrying on business as Elan
Pharmaceuticals which incorporates, inter alia, Elan Pharma International,
Ltd. (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 Corp carrying on business as Elan Pharmaceuticals), Athena
Neurosciences, Inc., Elan Pharmaceuticals, Inc. and Elan Europe Limited.
"Field" shall mean the prevention and treatment of oncology indications in
humans.
"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.
"Initial Formulation" shall have the meaning as such term is defined in
Clause 2.3 of the JDOA.
"Initial Mode of Administration" shall have the meaning as such term is
defined in Clause 2.3 of the JDOA.
"Initial Closing Date" shall have the meaning as such term is defined in
Section 1(a) of the SafeScience Securities Purchase Agreement.
"JDOA" shall mean that certain subscription, joint development and
operating agreement, of even date herewith, by and between Elan,
SafeScience, EIS and Newco.
[...***...]
"NDA" shall mean New Drug Application.
"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, which does not constitute Elan Intellectual Property or SafeScience
Intellectual Property.
For the avoidance of doubt (i) any preclinical and clinical data and/or
toxicity, stability and pharmacological data generated pursuant to the
Project shall constitute Newco Intellectual Property; and (ii) any patent
application filed by Newco, or by Elan or SafeScience on behalf of Newco,
and any patent issued pursuant thereto, covering a Product shall constitute
Newco Intellectual Property.
"Party" shall mean Elan or Newco, as the case may be, and "Parties" shall
mean both parties together.
"Product" shall mean the Initial Formulation and Initial Mode of
Administration of the Compound in the Field, and such other formulations
and modes of administration of the Compound as may be agreed to by the
Steering Committee in accordance with Clause 2.4
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of the JDOA.
"[...***...] Drug Delivery Technology" shall mean Elan's proprietary
[...***...] [...***...]. For the avoidance of doubt, [...***...] Drug
Delivery Technology shall not include Elan's [...***...].
"Project" shall mean all activities as undertaken by Elan, SafeScience and
Newco in order to develop the Products.
"SafeScience" shall mean SafeScience, Inc., a Nevada corporation and its
Affiliates.
"SafeScience Improvements" shall have the meaning as such term is defined
in the SafeScience License Agreement.
"SafeScience Intellectual Property" shall mean the SafeScience Know-How,
the SafeScience Patents and the SafeScience Improvements.
"SafeScience Know-How" shall have the meaning as such term is defined in
the SafeScience License Agreement.
"SafeScience License Agreement" shall mean that certain license agreement,
of even date herewith, entered into between SafeScience and Newco.
"SafeScience Patents" shall have the meaning as such term is defined in the
SafeScience License Agreement.
"SafeScience Securities Purchase Agreement" shall mean that certain
securities purchase agreement, dated June 22, 2001, by and between
SafeScience and EIS.
"Steering Committee" shall have the meaning as such term is defined in the
JDOA.
"Technological Competitor of Elan" shall mean a person or entity listed in
Schedule 3, and divisions, subsidiaries and successors thereof, or any
additional broad-based technological competitor of Elan added to such
Schedule from time to time upon mutual agreement of SafeScience and Elan.
"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.
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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 to the Elan
Intellectual Property to make, have made, import, use, offer for sale and
sell the Product in the Field in the Territory (the "Elan License"),
subject to [...***...].
2.2 [...***...] 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 "[...***...] 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 [...***...] will be responsible under this
Clause 2.2.
2.3 SafeScience 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.
2.4 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 Newco shall not be permitted to assign, or, except as provided in Clause 11
of the JDOA, 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
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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 SafeScience, 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 [...***...] license to
use the Elan Trademarks solely to make, have made, import, use,
offer for sale and sell the Products in the Field in the Territory
and the following provisions shall apply as regards the license of
the Elan Trademarks by Elan to Newco hereunder:
3.2.1.1 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 Product is manufactured, held or stored,
and Newco shall permit such inspection, 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.
3.2.1.2 Newco shall not use an Elan Trademark in any way which
might materially prejudice its distinctiveness or validity
or the goodwill of Elan therein.
3.2.1.3 The Parties recognize that the Elan Trademarks have
considerable goodwill associated therewith. Newco shall not
use in relation to the
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Products any trademarks other than the Elan Trademarks,
except the SafeScience Trademarks (as such term is defined
in the SafeScience License Agreement) licensed to Newco
under the SafeScience License Agreement, without obtaining
the prior consent in writing of Elan, which consent may not
be unreasonably withheld. However, such use shall not
conflict with the use and display of the Elan Trademark and
such use and display shall require the prior written
approval of Elan.
3.2.1.4 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.
3.2.1.5 Newco shall promptly notify Elan in writing of any alleged
infringement or unauthorized use of which it becomes aware
by a third party of the Elan Trademarks and provide Elan
with any applicable evidence of infringement or
unauthorized use.
3.2.1.6 Newco shall favorably consider promoting and using the Elan
Trademarks in each country of the Territory and provide
proof of such use upon request by Elan.
3.2.1.7 Newco shall not be permitted to assign or sublicense any of
its rights under the Elan Trademarks without the prior
written consent of Elan.
3.2.2 Elan may, at its 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. Upon the reasonable request of Newco, Elan
shall provide registration information, including classifications,
for each country where the Elan Trademark has been registered.
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 [...***...] for
its own benefit. Newco and SafeScience shall reasonably co-operate
with Elan in such efforts.
3.2.4 Newco shall promptly notify Elan in writing in the event that any
Elan Trademark has been challenged, or is threatened to be
challenged in writing, 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 and Elan shall have the
first right to decide whether or not to defend such allegations, or
to adopt an alternative xxxx. If Elan
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decides not defend the Elan Trademark, then Newco may request Elan
to defend the Elan Trademark, [...***...] unless such requested
defense is believed by Elan to be unsubstantiated and without merit.
In such a case, Elan may elect not to initiate defense 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 Neither Elan nor Elan Corp assume liability to Newco, SafeScience,
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 [...***...]
[...***...]
5 FINANCIAL PROVISIONS
5.1 License Fee: In consideration of the license to Newco of the Elan Patents
-----------
under Clause 2.1, Newco shall pay to Elan Corp a non-refundable license fee
of $15 million in cash (the "License Fee"), the receipt of which is hereby
acknowledged by Elan Corp.
The License Fee shall not be subject to future performance obligations of
Elan to Newco or SafeScience and shall not be applicable against future
services provided by Elan to Newco or SafeScience.
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 Product, the Steering
---------
Committee shall consider and if appropriate, determine reasonable royalties
with respect to the commercialization of the Product by Newco that shall be
payable by Newco to Elan Corp and SafeScience, [...***...].
At such time, the Steering Committee will agree on an appropriate
definition of "Net
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Sales" as such term is used in this Agreement.
The provisions set forth in Clauses 5.2 to 5.8 and Clause 6 relate to the
payment of any royalties which the Steering 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 Corp. Each payment made to Elan Corp shall be
accompanied by a true accounting of all Products sold by Newco or 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 During the Term and for a period of five (5) years thereafter, Newco shall
maintain and keep clear, detailed, complete, accurate and separate records.
All costs and expenses incurred with respect to maintenance of such records
shall be borne by Newco for up to a period of three (3) years, from the
date such records are created, and thereafter, such costs and expenses
shall be borne solely by SafeScience:
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).
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
Corp 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 Corp's account in a bank acceptable
to Elan Corp in the country the currency of which is involved, or as
otherwise agreed by the Parties.
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5.7 Elan, SafeScience 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 Corp on any payment made to Elan Corp pursuant to
this Agreement shall be for the account of Elan Corp. 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 Corp 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.
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 Corp hereunder in any Financial Year
quarter of [...***...] or more of the amount of any royalty actually due to
Elan Corp hereunder, then the expense of such inspection shall be borne
solely by Newco. Newco shall promptly pay to Elan Corp any amount of
deficiency.
If such inspection reveals a surplus in the amount of royalties actually
paid to Elan Corp by Newco, Elan Corp 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
SafeScience and EIS 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 SafeScience, as of the Effective
Date, with respect to the Compound as it relates to the Elan Intellectual
Property, as follows:
7.1.1 Elan has the right to grant the Elan License;
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7.1.2 there are no agreements between Elan and any third party that
conflict with the Elan License;
7.1.3 [...***...]; and
7.1.4 [...***...].
7.2 Except to the extent Newco shall have the obligation to indemnify Elan
pursuant to Clause 7.3 hereof and SafeScience and Elan pursuant to Clause
10 of the JDOA, 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
employees, agents, officers or 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
employees, agents, officers or directors in the performance of this
Agreement.
7.4 A party to this Agreement seeking an indemnity (the "Indemnified Party"),
pursuant to this Clause 7, shall:
7.4.1 fully and promptly notify the Party responsible for indemnifying
such Indemnified Party (the "Indemnifying 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;
7.4.3 co-operate in the investigation and defense of such claim or
proceeding;
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7.4.4 not compromise or otherwise settle any such claim or proceeding
without the prior written consent of the Indemnifying Party, which
consent shall not be unreasonably withheld 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 ELAN 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 CURRENT OR
FUTURE PROFITS, LOSS OF ENTERPRISE VALUE 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 and
to the provisions of applicable laws, expire on the last to occur of:
8.1.1 the date of expiration or lapse of the last to expire or lapse of
patent rights within the Elan Intellectual Property and the
SafeScience Intellectual Property in the Territory; or
8.1.2 the date which is [...***...] years following the date of the first
commercial sale of a Product in the Territory provided, however,
that neither Elan nor SafeScience shall be obligated to license the
Elan Intellectual Property or the SafeScience Intellectual Property,
respectively, beyond any period in which Elan or SafeScience has
rights to such intellectual property pursuant to any agreement
between Elan or SafeScience and their respective licensors as such
agreements are in effect as of the Effective Date.
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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 by a
Party if:
8.3.1 such Party commits a material breach of its representations,
warranties or 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 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; or
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.
8.4 Elan shall be entitled to forthwith terminate this Agreement by notice in
writing to SafeScience in the event of a Change of Control of
SafeScience/Newco, provided that the foregoing right shall not be triggered
by the exercise by Elan of any options granted by the Definitive Documents.
16
SafeScience and Newco shall promptly notify Elan in writing of the
occurrence of a Change of Control of SafeScience/Newco.
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 any part
of the Territory shall be paid in full within 60 days;
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;
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 rights of Newco pursuant to
Clause 11 of the JDOA) shall cease for the Territory and shall
revert to or be transferred to Elan, and Newco shall not thereafter
use in the Territory any rights covered by this Agreement;
8.5.6 subject to any license granted by Newco to Elan, if any, or granted
by Newco to SafeScience, if any, pursuant to the provisions of
Clause 11.3 of the JDOA, all rights to Newco Intellectual Property
shall be assigned to and jointly owned by SafeScience and Elan and
may be exploited by both Elan and SafeScience separately provided
that Elan and SafeScience shall co-operate reasonably in the
prosecution and maintenance of patents within the Newco Intellectual
Property and provided further that nothing hereunder shall grant, or
be construed to grant, a license to Elan under the SafeScience
Intellectual Property; and
8.5.7 the rights of permitted third party sub-licensees in and to the Elan
Intellectual Property shall survive the termination of this
Agreement; and Newco, Elan and SafeScience shall in good faith agree
upon the form most advantageous to Elan and SafeScience 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
SafeScience).
Any sublicense agreement between Newco and such permitted
sublicensee shall, inter alia, permit such an assignment of rights
by Newco to Elan and shall contain appropriate confidentiality
provisions.
17
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 the disclosing Party shall be
used by the receiving Party exclusively for the purposes of fulfilling the
receiving Party's obligations under this Agreement and for no other
purpose.
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 relating to Confidential Information
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 promptly, upon request of the other Party, return all
documents and any copies thereof containing Confidential Information
belonging to, or disclosed by, such other Party.
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 be deemed not to include:
9.5.1 information which 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 receiving Party on a non-
confidential basis, whether directly or indirectly, from a source
other than another Party
18
hereto, 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 hereunder, the receiving Party shall give the
disclosing Party prompt notice of such fact to enable the disclosing Party
to seek a protective order or other appropriate remedy concerning any such
disclosure. The receiving Party shall fully 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 7 years
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.
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 seek 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 damages and reasonable counsel fees and expenses
to enforce its rights hereunder.
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
19
within 60 days of the commencement of such negotiations, 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 within 10 days of either Party's demand for
such alternative dispute resolution hereunder, or in the event that the
dispute is not resolved pursuant to any dispute resolution mechanism agreed
by the Parties within 6 months, save as otherwise agreed by the Parties,
any such dispute shall be finally settled by the courts of competent
jurisdiction. For the purposes of this Agreement the parties submit to the
exclusive jurisdiction of the courts of the State and Federal Courts
located in the State, City and County 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, 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 or recorded delivery post or reputable overnight
courier or telefaxed to the following addresses:
If to Newco at:
Xxxxxxxxx Xxxxx,
0 Xxxxxx Xx,
Xxxxxxxx,
Xxxxxxx.
Attention: Secretary
Telephone: 000 000 0000
20
Fax: 000 000 0000
with a copy to SafeScience at:
Park Square Building
00 Xx. Xxxxx Xxxxxx, 0xx Xxxxx
Xxxxxx, XX 00000
XXX
Attention: President
Telephone (000) 000-0000
Fax: (000) 000-0000
with a copy to:
XxXxxxxxx, Will & Xxxxx
00 Xxxxxxxxxxx Xxxxx
Xxx Xxxx, Xxx Xxxx 00000-0000
Attention: Xxxxxx X. Xxxxxx
Telephone (000) 000-0000
Fax: (000) 000-0000
If to Elan at:
c/o Elan International Services, Ltd.,
000 Xx. Xxxxx Xxxxx,
Xxxxxx, Xxxxxx XX00,
Bermuda.
Attention: President
Telephone: 000-000-0000
Fax: 000-000-0000
or to such other address(es) and telefax numbers as may from time to time
be notified by either Party to the other hereunder in the manner set forth
in Clause 13.2.
13.2 Any notice sent by mail shall be deemed to have been delivered within 7
working days after dispatch or delivery to the relevant courier and any
notice sent by telefax shall be deemed to have been delivered upon
confirmation of receipt. Notice of change of address shall be effective
upon receipt. Notices by telefax shall also be sent by another method
permitted hereunder.
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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 deemed to be 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 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 Party to this Agreement, the other Party 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.
22
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 act reasonably in giving effect to the provisions
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.
14.11 Whole Agreement:
----------------
This Agreement (including the Schedules attached hereto) and the
Definitive Documents set forth all of the agreements and understandings
between the Parties with respect to the subject matter hereof, and
supersede and terminate all prior agreements and understandings between
the Parties with respect to the subject matter hereof. There are no
agreements or understandings with respect to the subject matter hereof,
either oral or written, between the Parties other than as set forth in
this Agreement and the Definitive Documents.
23
Schedule 1
----------
Structure of Compound
---------------------
[...***...]
24
Schedule 2
----------
Elan Patents
------------
[...***...]
25
Schedule 3
----------
Technological Competitors of Elan
---------------------------------
[...***...]
26
IN WITNESS WHEREOF the Parties hereto have executed this Agreement.
SIGNED
BY /s/ Xxxxx Xxxxxxxxx
--------------------------
For and on behalf of
Elan Corporation, plc
SIGNED
BY /s/ Xxxxx Xxxxxx
--------------------------
For and on behalf of
SafeScience Newco, Ltd.
AGREED TO AND ACCEPTED
BY /s/ Xxxxxxx X. Xxxxxx
--------------------------
SafeScience, Inc.
27
