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Title: |
License Agreement |
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Date: |
2002 |
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Preview shows 11KB of 62KB total |
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$50 |
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ID: |
#303455 |
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LICENSE AGREEMENT
BY AND BETWEEN
NASCIME LIMITED
AND
DOV PHARMACEUTICAL, INC
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.....................................14
8. Confidential Information..........................................14
9. Term and Termination of Agreement.................................16
10. Certain Changes of Control........................................18
11. Representations/Warranties/Indemnities............................18
12. Impossibility of Performance - Force Majeure......................20
13. Settlement of Disputes ; Proper Law...............................20
14. Assignment........................................................21
15. Notices...........................................................21
16. Miscellaneous Clauses.............................................23
2
{Page}
THIS AGREEMENT made this 20th day of January 1999
AMONG:
(1) 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");
(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) 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").
WHEREAS
A. Simultaneously herewith, DOV, Elan, EIS, 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. DOV is beneficially entitled to the use of the Compounds.
C. Nascime desires to enter into this Agreement with DOV so as to permit
Nascime to utilize the DOV Intellectual Property in the research,
development, manufacture, distribution and sale of the Products in the
Field.
D. Simultaneously herewith Nascime and Elan are entering into the Elan
License Agreement relating to Nascime's use of the Elan 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:
"ACY" shall mean American Cyanamid Company.
3
{Page}
"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 Dove in favour of Elan International Services, Ltd.
"DOV IMPROVEMENTS" shall mean improvements relating to the Compounds per
se, whether made by DOV, Elan or Nascime. Subject to third party
agreements, DOV Improvements shall constitute part of DOV Intellectual
Property pursuant to Clause 2.3. solely for the purposes set forth therein
and included in the license of the DOV Intellectual Property hereunder,
insofar as such improvements relate to the Field. If the inclusion of a
DOV Improvement in the license of DOV Intellectual Property is restricted
or limited by a third party agreement, DOV shall use reasonable commercial
efforts to minimize any such restriction or limitation.
"DOV INTELLECTUAL PROPERTY" shall mean the DOV Know-How, the DOV Patent
Rights and the DOV Improvements.
"DOV KNOW-HOW" shall mean any and all rights owned, licensed or controlled
by DOV to any discovery, invention (whether or not patentable), know-how,
substances, data, techniques, processes, systems, formulations and designs
relating to the Compounds per se and useful or necessary to develop or
manufacture the Products
4
{Page}
including the ACY Know-How (as such term is defined in the ACY Agreement)
licensed to DOV pursuant to the ACY Agreement, but excluding any
discovery, invention (whether or not patentable), know-how, substances,
data, techniques, processes, systems, formulations and designs insofar as
same relates to the Elan Intellectual Property.
"DOV LICENSE" shall have the meaning set forth in Clause 2.1.
"DOV PATENT RIGHTS" shall mean any and all patents now existing, currently
pending or hereafter filed or obtained relating to the Compounds per se,
including the ACY Patents (as such term is defined in the ACY Agreement)
licensed to DOV pursuant to the ACY Agreement, 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.
"DOV TRADEMARKS" shall mean such trademarks as may from time to time be
owned by DOV 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.
"EFFECTIVE DATE" means the date of this Agreement.
"EIS" means Elan International Services, Ltd., a private limited company
incorporated under the laws of Bermuda and having its registered office at
Flatts, Smiths Parish, Bermuda, FL 04.
"ELAN INTELLECTUAL PROPERTY" shall have the meaning assigned to it in the
Elan License Agreement.
"ELAN LICENSE AGREEMENT" shall mean the license agreement of even date
entered into between Elan and Nascime.
"ELAN PATENT RIGHTS" shall have the meaning assigned to it in the Elan
license agreement.
"EXCHANGEABLE NOTE" shall mean that certain convertible exchangeable
promissory note to be issued by DOV in favour of EIS.
"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.
5
{Page}
"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.
"LICENSE AGREEMENTS" shall mean this Agreement and the Elan License
Agreement.
"NDA" shall mean, collectively, any New Drug Application, pre-marketing
approval, 510(k) approval or other regulatory approval application, in
relation to a Product filed by any Party with the FDA or ORA.
"NASCIME INTELLECTUAL PROPERTY" shall have the meaning assigned to such
words in the JDOA.
"NASCIME PATENT RIGHTS" shall have the meaning assigned to such words in
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