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Title: |
License Agreement |
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Entities: |
DOV Pharmaceutical, Inc.; Elan Corp., plc; Elan Pharmaceuticals, Inc.; Nascime Ltd. |
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Date: |
2002 |
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Size: |
Preview shows 12KB of 61KB total |
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Price: |
$49 |
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ID: |
#303456 |
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LICENSE AGREEMENT
BY AND BETWEEN
NASCIME LIMITED
AND
ELAN CORPORATION, PLC
1
{Page}
TABLE OF CONTENTS
CLAUSE PAGE
1. Definitions...........................................................3
2. Grant of Rights.......................................................8
3. (Intentionally Deleted)...............................................9
4. Trademarks............................................................9
5. (Intentionally deleted)..............................................11
6. Financial provisions.................................................11
7. Right of Audit and Inspection........................................13
8. Confidential Information.............................................13
9. Term and Termination of Agreement....................................15
10. Certain Changes of Control...........................................17
11. Representations/Warranties/Indemnities...............................18
12. Impossibility of Performance - Force Majeure.........................19
13. Settlement of Disputes ; Proper Law..................................20
14. Assignment...........................................................20
15. Notices..............................................................21
16. Miscellaneous Clauses................................................22
2
{Page}
THIS AGREEMENT made this 20th day of January 1999
AMONG:
(1) ELAN CORPORATION, PLC, a public limited company incorporated under the
laws of Ireland, and having its registered office at Lincoln House,
Lincoln Place, Dublin 2, Ireland ("ELAN"); and
(2) NASCIME LIMITED, a private limited company incorporated under the laws of
Ireland and having its registered office at 30 Herbert Street, Dublin 2
("NASCIME") and
(3) DOV PHARMACEUTICAL, INC., a corporation duly incorporated and validly
existing under the laws of New Jersey and having its principal place of
business at One Parker Plaza, Fort Lee, New Jersey 07024, United States of
America ("DOV");
WHEREAS
A. Simultaneously herewith, Elan, EIS, DOV, the Company and Nascime are
entering into the JDOA for the purpose of recording the terms and
conditions of a joint venture and of regulating their relationship with
each other and certain aspects of the affairs of and their dealings with
the Company and Nascime.
B. Elan is beneficially entitled to the use of certain patents which have
been granted or are pending in relation to drug specific dosage forms for
pharmaceutical products and Elan has developed various drug delivery
technologies and pharmaceutical products derived therefrom having improved
pharmaceutical, biopharmaceutical or other characteristics.
C. Nascime desires to enter into this Agreement with Elan so as to permit
Nascime to utilize the Elan Intellectual Property in the research,
development, manufacture, distribution and sale of the Products in the
Field.
D. Simultaneously herewith, Nascime and DOV are entering into the DOV License
Agreement relating to Nascime's use of the DOV Intellectual Property.
NOW IT IS HEREBY AGREED AS FOLLOWS:
1. DEFINITIONS
1.1 In this Agreement, including the Recitals and Schedules, the following
definitions shall prevail unless the context otherwise requires:
3
{Page}
"ACY" shall mean American Cyanamid Company.
"ACY AGREEMENT" shall mean that certain agreement between DOV and ACY
dated 29th May 1998 pursuant to which DOV licensed rights to the Compounds
for the Territory.
"AFFILIATE" of any Person (in the case of a legal entity) means any other
Person controlling, controlled or under the common control of such first
Person as the case may be. For the purposes 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 or
capital interests representing at least 50% of the equity thereof and
"controlling" and "controlled" shall be construed accordingly.
"AGREEMENT" shall mean this license agreement (which expression shall be
deemed to include the Recitals and the Schedules hereto).
"COMPANY" shall mean DOV Newco, Ltd., of which Nascime is a wholly owned
subsidiary.
"COMPOUNDS" shall mean the DOV compounds DOV 220,075 and DOV 273,547, the
rights to which were licensed by DOV pursuant to the ACY Agreement.
"CONFIDENTIAL INFORMATION" shall have the meaning set forth in Clause 8.2.
and Clause 8.6.
"CONTROLLED RELEASE" shall mean the modification of the release profile of
an orally administered drug to provide a delayed, extended, sustained,
programmed and/or pulsatile release profile and/or prolongation and/or
modification of a therapeutic effect.
"CONVERTIBLE NOTE" shall mean that certain convertible promissory note to
be issued by DOV in favour of Elan International Services, Ltd.
"DOV INTELLECTUAL PROPERTY" shall have the meaning assigned to it in the
DOV License Agreement.
"DOV LICENSE AGREEMENT" shall mean the license agreement of even date
entered into between DOV and Nascime.
"DOV PATENT RIGHTS" shall have the meaning assigned to it in the DOV
license agreement.
"EFFECTIVE DATE" means the date of this Agreement.
"EIS" means Elan International Services, Ltd., a private limited company
4
{Page}
incorporated under the laws of Bermuda and having its registered office at
Flatts, Smiths Parish, Bermuda, FL 04.
"ELAN IMPROVEMENTS" shall mean improvements to the Elan Intellectual
Property, whether made by Elan, DOV or Nascime. Subject to third party
agreements, Elan Improvements shall constitute part of Elan Intellectual
Property pursuant to Clause 2.3. solely for the purposes set forth therein
and included in the license of the Elan Intellectual Property hereunder,
insofar as such improvements relate to the Field. 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 INTELLECTUAL PROPERTY" shall mean the Elan Know-How and the Elan
Patent Rights. For the avoidance of doubt, Elan Intellectual Property
shall exclude (a) Elan's patent rights and know-how relating to [***]
and (b) inventions, patents and know-how owned, licensed or controlled by
affiliates or subsidiaries of Elan Corporation, plc, including Athena
Neurosciences, Inc., Carnrick Laboratories Inc., Elan Pharmaceuticals Inc.
(formerly Neurex Corporation) and Targon Corporation.
"ELAN KNOW-HOW" shall mean any and all rights owned, licensed or
controlled by Elan to any discovery, invention (whether or not
patentable), know-how, substances, data, techniques, processes, systems,
formulations and designs relating to pharmaceutical formulation knowledge,
expertise, information and data owned by Elan, or otherwise necessary or
useful to develop and manufacture the Products, but excluding any
discovery, invention (whether or not patentable), know-how, substances,
data, techniques, processes, systems, formulations and designs insofar as
same relates specifically to the Compounds.
"ELAN LICENSE" shall have the meaning set forth in Clause 2.1.
"ELAN PATENT RIGHTS" shall mean any and all patents now existing,
currently pending or hereafter filed or obtained relating to
pharmaceutical formulation knowledge, expertise, information and data
owned by Elan, and any foreign counterparts thereof and all divisionals,
continuations, continuations-in-part, patents of continuation, any foreign
counterparts thereof and all divisionals, continuations,
continuations-in-part, patents of addition and substitutions of, and all
patents issuing on, any of the foregoing, together with all registrations,
reissues, re-examinations or extensions of any kind with respect to any of
such patents.
"ELAN TRADEMARKS" shall mean such trademarks as may from time to time be
owned by Elan that the Parties all agree to use, which use shall be in
accordance with the terms of the License Agreements, with respect to the
sale of the Products in the Territory.
"EXCHANGEABLE NOTE" shall mean that certain convertible exchangeable
promissory note to be issued by DOV in favour of EIS.
----------
[***] Omitted pursuant to a request for confidential treatment. The omitted
material has been separately filed with the Securities and Exchange
Commission.
5
{Page}
"FDA" shall mean the United States Food and Drug Administration or any
successors or agency, the approval of which is necessary to market a
product in the United States of America.
"FIELD" shall mean the research, development and commercialization of oral
Controlled Release formulations of the Products.
"FINANCIAL YEAR" means 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.
"IND" shall mean an investigational new drug application filed with the
FDA or an ORA.
"INITIAL PERIOD" shall have the meaning set forth in Clause 9.2.
"JDOA" shall mean the joint development and operating agreement of even
date entered into between Elan, EIS, DOV, the Company and Nascime.
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