Exhibit 10.10
EXECUTION COPY
[***] TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
LICENSE AGREEMENT
BY AND BETWEEN
NASCIME LIMITED
AND
ELAN CORPORATION, PLC
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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
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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 Xxxxxxx Xxxxx,
Xxxxxxx Xxxxx, Xxxxxx 0, Xxxxxxx ("ELAN"); and
(2) NASCIME LIMITED, a private limited company incorporated under the laws of
Ireland and having its registered office at 00 Xxxxxxx Xxxxxx, Xxxxxx 0
("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 Xxx Xxxxxx Xxxxx, Xxxx Xxx, Xxx Xxxxxx 00000, Xxxxxx Xxxxxx 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:
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"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
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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.
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material has been separately filed with the Securities and Exchange
Commission.
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"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.
"LICENSE AGREEMENTS" shall mean this Agreement and the DOV 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
the JDOA.
"NET SALES" shall mean the gross amount invoiced for the Products sold by
Nascime less:
1. transportation charges or allowances, if any, included in such
price;
2. trade, quantity or cash discounts, service allowances and
broker's or agent's commissions, if any, allowed or paid;
3. credits or allowances, if any, given or made on account of [***]
and
4. any tax, excise or governmental charge upon or measured by the
sale, transportation, delivery or use of the Product;
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material has been separately filed with the Securities and Exchange
Commission.
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provided that Net Sales shall in no event be less than [***]% of such
gross amount.
"ORA" shall mean any regulatory authority outside the United States of
America, the approval of which is necessary to market a Product.
"PARTY" shall mean Elan or Nascime, as the case may be, and "Parties"
means Elan and Nascime.
"PERSON" shall mean an individual, partnership, corporation, limited
liability company, business trust, joint stock company, trust,
unincorporated association, joint venture or other entity of whatever
nature.
"PRODUCTS" shall mean the Controlled Release formulations using the Elan
Intellectual Property and incorporating the Compounds.
"PRODUCT 220,075" shall mean the [***] using the Elan Intellectual
Property and incorporating the compound DOV 220,075 (bicifadine -
analgesic) utilizing the Technologies.
"PRODUCT 273,547" shall mean the [***] using the Elan Intellectual
Property and incorporating the compound DOV 273,547 (non-benzodiazapine
anxiolytic) utilizing the Technologies.
"PROJECT" shall mean all activities as undertaken by Elan, DOV and Nascime
in order to develop the Products.
"RELEVANT EVENT" shall have the meaning set forth in Clause 9.3.
"RESEARCH COMMITTEE" shall have the meaning assigned to such words in the
JDOA.
"RESEARCH AND DEVELOPMENT PROGRAMME" shall have the meaning assigned to
such words in the JDOA.
"STRATEGIC INVESTOR" shall mean a Person investing in DOV, Elan or Nascime
for strategic purposes as evidenced by, inter alia, being engaged in one
or more pharmaceutical businesses.
"SPECIFICATIONS" shall mean the specifications for each of the Products as
approved by the FDA, as well as such other specifications which may be
agreed upon by the Parties in writing or by the Research Committee.
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[***] Omitted pursuant to a request for confidential treatment. The omitted
material has been separately filed with the Securities and Exchange
Commission.
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"STRATEGIC INVESTOR" shall mean a Person investing in DOV, Elan, the
Company or Nascime for strategic or business purposes (as opposed to
purely financial) as evidenced by, inter alia, being engaged in one or
more pharmaceutical businesses.
"TECHNOLOGIES" shall mean, collectively, the Elan Intellectual Property,
the DOV Intellectual Property and the Nascime Intellectual Property.
"TERRITORY" shall mean all the countries of the world.
"TECHNOLOGICAL COMPETITOR OF ELAN" shall mean a Person listed in SCHEDULE
1 or any additional broad-based technological competitor of Elan added to
such Schedule from time to time upon mutual agreement of Elan and DOV.
"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. GRANT OF RIGHTS
2.1. Elan shall grant a non-exclusive license (including the right to
sublicense) (the "Elan License") to Nascime of the Elan Intellectual
Property solely in the Field and in particular to make, have made, import,
use, offer for sale and sell the Products in the Territory. To Elan's
knowledge as of the Effective Date there is agreement to which Elan is a
party or by which it is bound that materially restricts the use by Nascime
of the Elan License; [***] .
2.2. To the extent a royalty or other compensation obligation is payable to
third parties with respect to the Elan Intellectual Property would be
triggered by use of such Elan Intellectual Property in connection with the
Project, [***] .
2.3. Elan Improvements shall be deemed, immediately upon development, to be
Elan Intellectual Property and included in the license of Elan
Intellectual Property granted to Nascime hereunder. Subject to third party
agreements, Elan Improvements shall constitute part of Elan Intellectual
Property pursuant to Clause 2.1. solely for the
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[***] Omitted pursuant to a request for confidential treatment. The omitted
material has been separately filed with the Securities and Exchange
Commission.
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purposes set forth therein and included in the license of the Elan
Intellectual Property hereunder, insofar as such improvements relate to
the Field. [***] .
2.4. [***]. DOV shall be a third party beneficiary under such license agreement
and consistent with the position of DOV as a shareholder in the Company
shall have the right to cause Nascime to enforce Nascime's rights against
Elan.
2.5. INTENTIONALLY DELETED
2.6. Nascime shall not be permitted to assign or sublicense any of its rights
under the Licenses without the prior written consent of Elan. Nascime
shall not enter into any agreement with any third party for development of
the Elan Intellectual Property without the prior written consent of Elan,
which may be withheld in Elan's discretion.
2.7. Any agreement between Nascime and any permitted third party for the
development or exploitation of the Elan Intellectual Property in the Field
shall require such third party to maintain the confidentiality of all
information concerning, inter alia, the Elan Intellectual Property.
Insofar as the obligations owed by Nascime to Elan are concerned, Nascime
shall remain responsible for all acts and omissions of any sub- licensee,
including DOV, as if they were acts and omissions by Nascime.
3. INTENTIONALLY DELETED
4. TRADEMARKS
4.1. Nascime represents and warrants to Elan that all Products and all
materials utilised in connection with the provision, marketing,
distribution, advertising and/or marketing thereof shall be of a
consistent and high standard of quality, commensurate with the prestige of
the Elan Trademarks and that its use of the Elan Trademarks shall conform
to such standards as Elan shall from time to time specify. Nascime shall
cooperate fully with the reasonable instructions of Elan with respect to
the maintenance of such standards.
4.2. Nascime shall:
4.2.1. favourably consider promoting and using the Elan Trademarks in
each country of the Territory and provide proof of use of the Elan
Trademarks if requested by Elan;
4.2.2. use the Elan Trademarks strictly in compliance with any applicable
trademark and other laws and regulations and use such legends,
markings and notices in connection therewith as are required by
law or otherwise reasonably required by Elan to protect Elan's
rights therein;
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[***] Omitted pursuant to a request for confidential treatment. The omitted
material has been separately filed with the Securities and Exchange
Commission.
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4.2.3. not mislead the public as to the nature or quality of any Product
on which the Elan Trademarks are affixed nor use it on advertising
or display materials which are unethical, immoral or offensive to
good taste;
4.2.4. at Elan's reasonable request supply samples of the Products and
any materials utilized in connection with the distribution,
advertising and/or marketing thereof that bear or incorporate the
Elan Trademarks for inspection by Elan;
4.2.5. not adopt or seek to register any trademark, design or logo
confusingly similar to the Elan Trademarks; and
4.2.6. promptly notify Elan in writing if any alleged infringement or
unauthorized use of the Elan Trademarks comes to Nascime's
attention.
4.3. Nascime shall use the Elan Trademarks in relation only to the Products (or
materials for advertising and promotion thereof), and in accordance with
any reasonable specifications and directions given by Elan from time to
time. In particular, but without limitation, Nascime agrees to state on
the Products or materials for the advertising or promotion thereof that
the Elan Trademarks are used under license from Elan.
4.4. Nascime shall take no action that could prejudice the validity,
re-registration or reputation of the Elan Trademarks or which could impair
the reputation, business standing or prestige of Elan.
4.5. Elan shall remain the owner of the Elan Trademarks and the goodwill
associated with the same and Nascime shall assert any ownership interest
in the Elan Trademarks or the goodwill associated therewith.
4.6. Elan shall have the first right to take such action in respect of the
registration and maintenance of the Elan Trademarks as Elan in its
reasonable business judgement deems appropriate. Nascime shall provide all
such assistance and co-operation, including the furnishing of documents
and information and the execution of registered user documentation or the
like, as may be required to give effect to any action as may be taken by
Elan. In taking any such action, Elan shall consider the legitimate
commercial interests of Nascime. At Nascime's request, Elan shall seek
protection for the Elan Trademark in a country of the Territory at the
expense of Nascime. In the event that Elan reasonably believes that the
application of the Elan trademark in the applicable country would infringe
on the rights of any third party, Elan shall not be obliged to seek such
trademark protection.
4.7. Subject to the provisions of this Agreement and any agreements entered
into between Nascime and one or more third parties, new trademarks used by
Nascime in relation to the Nascime Intellectual Property, or the Products
and all registrations thereof and applications therefor shall be owned and
registered by Nascime.
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4.8. Elan shall have the first right to enforce the Elan Trademark against any
third party in any country in the Territory. Nascime shall reasonably
co-operate with Elan in providing information and assistance to enable
Elan to conduct such enforcement. In the event Elan shall decide not to
enforce such Elan Trademark, Elan shall either (1) assign such rights in
the xxxx to Nascime to enable Nascime to enforce the xxxx in Nascime's
name and at Nascime's expense; or (2) permit Nascime to proceed with such
enforcement action in both Parties' names at Nascime's expense. Elan shall
reasonably co-operate with Nascime in providing information and assistance
to enable Nascime to conduct such enforcement. In the event of case (1) or
(2) above, Nascime shall keep Elan informed of all such enforcement
proceedings and shall reasonably consider Elan's business interests in
conducting such enforcement proceedings.
4.9. Elan shall have the first right to defend the Elan Trademark against any
allegations by any third party of any trademark infringement or other
actions in any country in the Territory. Nascime shall reasonably
co-operate with Elan in providing information and assistance to enable
Elan to conduct such defence. In the event Elan shall decide not to defend
such Elan Trademark, Elan shall either (1) assign such rights in the xxxx
to Nascime in the country at issue to enable Nascime to defend the xxxx in
Nascime's name and at Nascime's expense; or (2) permit Nascime to proceed
with such defence in both Parties' names at Nascime's expense. Elan shall
reasonably co-operate with Nascime in providing information and assistance
to enable Nascime to conduct such defence. In the event of case (1) or (2)
above, Nascime shall keep Elan informed of all such defence proceedings
and shall reasonably consider Elan's business interests in conducting such
defence proceedings.
5 INTENTIONALLY DELETED
6. FINANCIAL PROVISIONS
6.1. In consideration of the license to the Elan Patent Rights, Nascime shall
pay to Elan the following amounts:
6.1.1. ten million United States Dollars (US$10,000,000), the receipt
and adequacy of which is hereby acknowledged by Elan;
6.1.2. 8.35% of Net Sales of Product 220,075; and
6.1.3. 4.64% of Net Sales of Product 273,547.
6.2. INTENTIONALLY DELETED
6.3. Payment of royalties pursuant to Clause 6.1.2 and Clause 6.1.3. shall be
made quarterly in arrears during each Financial Year within thirty (30)
days after the expiry
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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 it, its
Affiliates and its 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.
6.4. Nascime shall maintain and keep clear, detailed, complete, accurate and
separate records for a period of three (3) years:
6.4.1. to enable any royalties on Net Sales of the Product that shall
have accrued hereunder to be determined; and
6.4.2. to enable any deductions made in the Net Sales calculation to be
determined.
6.5. 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.
6.6. 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 Nascime 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.
6.7. Elan and Nascime 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.
6.8. 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 Nascime
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, Nascime shall forthwith
arrange payment to Elan of the amount so withheld.
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7 RIGHT OF AUDIT AND INSPECTION
7.1. Once during each Financial Year, or more often not to exceed quarterly as
reasonably requested by Elan, Nascime shall permit Elan or its duly
authorised representatives, upon reasonable notice and at any reasonable
time during normal business hours, to have access to inspect and audit the
accounts and records of Nascime 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 Nascime'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 five percent (5%) or more of
the amount of any royalty actually due to Elan hereunder, then the expense
of such inspection shall be borne solely by Nascime. Any amount of
deficiency shall be paid promptly to Elan by Nascime. If such inspection
reveals a surplus in the amount of royalties actually paid to Elan by
Nascime, Elan shall reimburse Nascime the surplus within fifteen (15) days
after determination.
7.2. 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 DOV
and Elan for a resolution of such dispute. Any decision by the said firm
of chartered accountants shall be binding on the Parties.
8. CONFIDENTIAL INFORMATION
8.1. The Parties stipulate that it may 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 information relating to
the Field, the Products, processes, services and business of the
disclosing Party.
8.2. The Parties stipulate that the information to be disclosed by one Party to
the other may include trade secrets, know-how and other proprietary
information and data regarding the Products or the Technologies. The
foregoing shall be referred to collectively as "CONFIDENTIAL INFORMATION".
Any Confidential Information revealed by a 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.
8.3. Each Party agrees to disclose Confidential Information of another 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 consent hereto as a
condition of receiving Confidential Information. Each Party shall exercise
the same
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degree of care, but in no event less than a reasonable degree, and
protection to preserve the proprietary and confidential nature of the
Confidential Information disclosed by a Party, as the receiving Party
would exercise to preserve its own proprietary and confidential
information. Each Party shall, upon request of a Party, return all
documents and any copies thereof containing Confidential Information
belonging to or disclosed by such Party.
8.4. Notwithstanding the above, each Party may use or disclose Confidential
Information disclosed to it by another Party to the extent such use or
disclosure is reasonably necessary to file or prosecute patent
applications, prosecute or defend litigation, comply with patent
applications, comply with applicable governmental regulations or otherwise
submit information to tax or other governmental authorities, conduct
clinical trials, or make a permitted sublicense or otherwise exercise its
rights hereunder, provided that if a Party is required to make any such
disclosure of the other Party's Confidential Information, other than
pursuant to a written confidentiality agreement, such Party shall inform
the recipient of the terms and provisions of this Agreement and their
duties hereunder and to obtain their consent hereto as a condition of
receiving Confidential Information.
8.5. Any breach of this Clause 8 by any Person informed by one of the Parties
is considered a breach by the Party itself.
8.6. Confidential Information shall not be deemed to include:
8.6.1. information that is in the public domain;
8.6.2. information which is made public through no breach of this
Agreement;
8.6.3. information which is independently developed by a Party as
evidenced by such Party's records;
8.6.4. 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, to the best of the
Party's knowledge, did not acquire this information on a
confidential basis; or
8.6.5. information which the receiving Party is required to disclose
pursuant to:
8.6.5.1. a valid order of a court or other governmental body or
any political subdivision thereof or otherwise required
by law; or
8.6.5.2. 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
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appropriate remedy concerning any such disclosure. The receiving Party
shall fully cooperate 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.
8.7. The provisions relating to confidentiality in this Clause 8 shall remain
in effect during the term of this Agreement, and for a period of [***]
following the expiration or earlier termination of this Agreement.
8.8. The Parties agree that the obligations of this Clause 8 are necessary and
reasonable in order to protect the Parties' respective businesses, and
each Party agrees that monetary damages would be inadequate to compensate
a Party for any breach by the other Party of its covenants and agreements
set forth herein. Accordingly, the Parties agree that any such violation
or threatened violation shall cause irreparable injury to a Party and
that, in addition to any other remedies that may be available, in law and
equity or otherwise, each Party shall be entitled to obtain injunctive
relief against the threatened breach of the provisions of this Clause 8,
or a continuation of any such breach by the other Party, specific
performance and other equitable relief to redress such breach together
with its damages and reasonable counsel fees and expenses to enforce its
rights hereunder, without the necessity of proving actual or express
damages.
9. TERM AND TERMINATION OF AGREEMENT
9.1. The term of this Agreement shall commence as of the Effective Date and
expire on a Product-by-Product basis and on a country-by-country basis on
the last to occur of:
9.1.1. fifteen (15) years starting from the date of the launch of the
Product in the country concerned; or
9.1.2. the last to expire of the patents covering a Product or a method
of making or using a Product included in the Elan Patent Rights
and/or the DOV Patent Rights and/or the Nascime Intellectual
Property.
9.2. Upon expiration of the Initial Period, Elan and DOV may agree to add
successive [***] extensions to the term.
9.3. For the purpose of this Clause 9, a "Relevant Event" is committed or
suffered by Elan, Nascime or the Company if:
9.3.1. it commits a material breach of its obligations under this
Agreement or the JDOA and, in the case of a breach capable of
remedy, fails to remedy 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 rectify the
breach and is acting in good faith to rectify same but has not
cured the breach by the 60th day, such period shall be extended by
such period as is
----------
[***] Omitted pursuant to a request for confidential treatment. The omitted
material has been separately filed with the Securities and Exchange
Commission.
15
reasonably necessary to permit the breach to be rectified;
9.3.2. 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 20 days;
9.3.3. it is unable to pay its debts in the normal course of business;
9.3.4. it ceases or threatens to cease 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);
9.3.5. the appointment of a liquidator, receiver, administrator,
examiner, trustee or similar officer of such Party or over all or
a substantial part of its assets under the law of any applicable
jurisdiction, including without limit, Ireland;
9.3.6. an application or petition for bankruptcy, corporate
re-organisation, 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 30 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.
9.4. Upon termination of this Agreement, or cessation of business by Nascime or
the Company or the dissolution or winding up of Nascime or the Company, or
inability of Nascime or the Company to pay its debts as they fall due, or
the Company or Nascime otherwise becomes insolvent, or a receiver is
appointed over all or a significant part of the assets of Nascime or the
Company, or an examiner is appointed to Nascime or the Company, subject to
the provisions of Clause 9.5.6, all rights to Elan Intellectual Property
shall revert to or be transferred to Elan;
9.5. Upon expiration or termination of the Agreement:
9.5.1. any sums that were due from Nascime 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 sixty (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);
16
9.5.2. any provisions that expressly survive termination or expiration of
this Agreement, including without limitation Clause 8, shall
remain in full force and effect;
9.5.3. all representations, warranties and indemnities shall insofar as
are appropriate remain in full force and effect;
9.5.4. the rights of inspection and audit set out in Clause 7 shall
continue in force for a period of one year; and
9.5.5. except as expressly provided for under Clause 9.5.6, all rights,
licenses and sublicenses granted to this Agreement and to the Elan
Intellectual Property pursuant to the JDOA (including the rights
of Nascime pursuant to Clause 11 of the JDOA) shall cease for the
Territory or for such particular country or countries in the
Territory (as the case may be). Following such expiration or
termination, Nascime may not thereafter use in the Territory or in
such particular country or countries in the Territory (as the case
may be) and rights covered by the Elan License or the Elan
Trademarks.
9.5.6. the rights of permitted third party sublicensees in and to the
Elan Intellectual Property shall survive the termination of this
Agreement. Nascime, Elan and DOV shall in good faith agree upon
the form most advantageous to Elan and DOV in which the rights of
the sublicensor under any such sublicenses are to be held (which
form may include continuation of Nascime 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 DOV).
10. CERTAIN CHANGES OF CONTROL
10.1. In the event that:
10.1.1. a Technological Competitor of Elan directly or indirectly acquires
10% or more of the voting stock of DOV, Nascime or the Company, or
otherwise controls or influences in any material respect their
management or business or otherwise has entered into any joint
venture, collaborative, license or other arrangement with DOV,
Nascime or the Company as the case may be to such an extent that
such a Technological Competitor of Elan is materially engaged or
involved with the business or development of DOV, Nascime or the
Company as the case may be;
10.1.2. a Strategic Investor acquires [***] % or more of the voting stock
of DOV, Nascime or the Company, or otherwise controls or
influences in any material respect the management or business of
any thereof; or
----------
[***] Omitted pursuant to a request for confidential treatment. The omitted
material has been separately filed with the Securities and Exchange
Commission.
17
10.1.3. any Person other than a Strategic Investor acquires [***]% or more
of the voting stock of DOV, Nascime or the Company, or otherwise
merges, consolidates or enters into any similar transaction (or
binding agreement in respect thereof) with DOV, Nascime or the
Company;
at the option of Elan, Elan may terminate this Agreement in which case the
provisions of Clause 9.5. shall apply; provided that the foregoing shall
not apply in relation to any exercise of any options by Elan granted by
the Convertible Note or the Exchangeable Note.
11 REPRESENTATIONS/WARRANTIES/INDEMNITIES
11.1. Elan represents and warrants as of 22nd December 1998 and the Effective
Date to DOV and Nascime as follows:
11.1.1. to the best of Elan's knowledge there is no agreement to which
Elan is a party or by which it is bound that materially restricts
the use by Nascime of the Elan License;
11.1.2. the patents and patent applications included in the Elan Patent
Rights are free and clear of encumbrances and liens;
11.1.3. [***]; and
11.1.4. it has the sole, exclusive and unencumbered right to grant the
licenses and rights herein granted to Nascime pursuant to this
Agreement and that it has not granted any option, license, right
or interest in or to the Elan Intellectual Property to any third
party that would conflict with the rights granted by this
Agreement.
11.2. Elan and Nascime represent and warrant for the benefit for each other that
the execution of this Agreement by them and the full performance and
enjoyment of the rights of them under this Agreement shall not breach the
terms and conditions of any license, contract, understanding or agreement,
whether express, implied, written or oral between either of them and any
third Person.
11.3. In addition to any other indemnifications provided for herein, Elan shall
indemnify and hold harmless Nascime and its Affiliates and their
respective employees, agents, partners, officers and directors from and
against any claims, losses, liabilities or damages (including reasonable
attorney's fees and expenses) incurred or sustained by Nascime arising out
of or in connection with any (a) breach of any representation, covenant,
warranty or obligation by Elan hereunder, or (b) any act or omission on
the part of Elan or any of its respective employees, agents, partners,
officers and directors in the performance of this Agreement.
----------
[***] Omitted pursuant to a request for confidential treatment. The omitted
material has been separately filed with the Securities and Exchange
Commission.
18
11.4. In addition to any other indemnifications provided for herein, Nascime
shall indemnify and hold harmless Elan and its Affiliates and their
respective employees, agents, partners, 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 (i) breach of any representation, covenant,
warranty or obligation by Nascime hereunder, or (ii) any act or omission
on the part of Nascime or any of its agents or employees in the
performance of this Agreement.
11.5. The Party seeking an indemnity shall:
11.5.1. fully and promptly notify the other Party of any claim or
proceeding, or threatened claim or proceeding;
11.5.2. permit the indemnifying Party to take full care and control of
such claim or proceeding;
11.5.3. cooperate in the investigation and defence of such claim or
proceeding;
11.5.4. 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
11.5.5. take all reasonable steps to mitigate any loss or liability in
respect of any such claim or proceeding.
11.6. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, ELAN AND
NASCIME 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 OR INCIDENTAL
LOSS OR DAMAGE (WHETHER FOR LOSS OF PROFIT OR OTHERWISE) AND WHETHER
OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES OR
AGENTS OR OTHERWISE.
11.7. EXCEPT AS SET FORTH IN THIS CLAUSE 11, ELAN IS GRANTING THE ELAN LICENSE
HEREUNDER ON AN "AS IS" BASIS WITHOUT RECOURSE, 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.
19
12. IMPOSSIBILITY OF PERFORMANCE - FORCE MAJEURE
12.1. Neither Elan nor Nascime 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 or
non-availability of raw materials, but any such delay or failure shall be
remedied by such Party as soon as practicable.
13. SETTLEMENT OF DISPUTES; PROPER LAW
13.1. The Parties will attempt in good faith to resolve any dispute arising out
of or relating to this Agreement promptly by negotiation among executives
of the Parties. In the event that such negotiations do not result in a
resolution acceptable to the Parties, the Parties agree (except for a
dispute governed by Clause 7.2.) 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.
The Parties hereby submit to the courts of Ireland and the Parties hereby
waive any and all defences of improper venue or that the Forum is
inconvenient.
13.2. This Agreement shall be governed by and construed in accordance with the
laws of Ireland.
14. ASSIGNMENT
14.1. 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 Affiliate or other Persons with whom they have an
interest, by contract, ownership of securities or otherwise, and that are
in the nature of financing vehicles or similar entities for Elan or
Nascime as the case may be or its Affiliates without the prior written
consent of the other; provided further that such assignment does not have
any adverse tax consequences on the other Party, except that Elan may
assign its rights and obligations hereunder in connection with a sale of
all or substantially all its assets to a Person. Elan and Nascime will
discuss any assignment by either Party to an Affiliate prior to its
implementation in order to avoid or reduce any additional tax liability to
the other Party resulting solely from different tax law provisions
applying after such assignment to an Affiliate. [***].
15.1. NOTICES
15.1. Any notice to be given under this Agreement shall be sent in writing in
English by registered airmail or telefaxed to the following addresses:
----------
[***] Omitted pursuant to a request for confidential treatment. The omitted
material has been separately filed with the Securities and Exchange
Commission.
20
If to Nascime at:
Nascime Limited
00 Xxxxxxx Xxxxxx
Xxxxxx 0
Attention: Xxxx Xxxxxx/Xxxxxx Xxxxx
Telephone: + 000 0 000 0000
Telefax: + 353 1 619 9010
with a copy to DOV at:
DOV Pharmaceutical, Inc.
Xxx Xxxxxx Xxxxx
Xxxx Xxx, XX 00000
Attn: Chief Executive Officer
Telephone 000 000 0000
Fax: 000 000 0000
with a copy to:
Xxxxxxxx Xxxxxxxxxx LLP
000 Xxxx Xxxxxx
00xx Xxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attention: J. Xxxxxx Xxxxxx, Esq.
Telephone 000 000 0000
Fax: 000 000 0000
If to Elan at:
Elan Corporation, plc
Xxxxxxx Xxxxx, Xxxxxxx Xxxxx, Xxxxxx 0, Xxxxxxx
Attention: Vice President, General Counsel,
Elan Pharmaceutical Technologies,
a division of Elan Corporation, plc
Telephone: + 000 0 000 0000
Telefax: + 353 1 709 4124
If to DOV at:
DOV Pharmaceutical, Inc.
00
Xxx Xxxxxx Xxxxx
Xxxx Xxx, XX 00000
Attn: Chief Executive Officer
Telephone 000 000 0000
Fax: 000 000 0000
with a copy to:
Xxxxxxxx Xxxxxxxxxx LLP
000 Xxxx Xxxxxx
00xx Xxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attention: J. Xxxxxx Xxxxxx, Esq.
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.
15.2. Any notice sent by mail shall be deemed to have been delivered within
seven (7) working days after dispatch and any notice sent by telex or
telefax shall be deemed to have been delivered within twenty four (24)
hours of the time of the dispatch. Notice of change of address shall be
effective upon receipt.
16 MISCELLANEOUS CLAUSES
16.1. 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.
16.2. 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, (i) such provision will be deemed amended
to conform to applicable laws so as to be valid and enforceable or, 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 (ii) the validity,
legality and enforceability of the remaining provisions of this Agreement
shall not be impaired or affected in any way.
16.3. The Parties shall use their respective reasonable endeavours to ensure
that they and any necessary third party shall execute and perform all such
further deeds, documents, assurances, acts and things as either of the
Parties hereto may reasonably require by
22
notice in writing to the other Party or such third party to carry the
provisions of this Agreement.
16.4. This Agreement shall be binding upon and enure to the benefit of the
Parties hereto, their successors and permitted assigns and sub-licenses.
16.5. 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, in any such other agreement. 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.
16.6. No amendment, modification or addition hereto shall be effective or
binding on either Party unless set forth in writing and executed by a
duly authorised representative of each Party.
16.7. 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.
16.8. 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.
16.9. 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.
16.10. Nothing contained in this Agreement is intended or is to be construed to
constitute Elan and Nascime as partners, or Elan as an employee of
Nascime, or Nascime 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.
23
IN WITNESS WHEREOF the Parties hereto have executed this Agreement.
SIGNED BY
For and on behalf of
ELAN CORPORATION, PLC
/s/ Xxxxx Xxxxxx
-----------------------
SIGNED BY
For and on behalf of
NASCIME LIMITED
--------------------------
AGREED TO AND ACCEPTED
DOV PHARMACEUTICAL, INC.
--------------------------
24
IN WITNESS WHEREOF the Parties hereto have executed this Agreement.
SIGNED BY
For and on behalf of
ELAN CORPORATION, PLC
----------------------------
SIGNED BY
For and on behalf of
NASCIME LIMITED
/s/ Xxxxxx Xxxxx
----------------------------
AGREED TO AND ACCEPTED
DOV PHARMACEUTICAL, INC.
/s/ Xxxxxx Xxxxx
----------------------------
25
SCHEDULE 1
TECHNOLOGICAL COMPETITORS OF ELAN
[***]
Bioval
[***]
----------
[***] Omitted pursuant to a request for confidential treatment. The omitted
material has been separately filed with the Securities and Exchange
Commission.
26
