Exhibit 10.51
AMENDED AND RESTATED LICENSE AGREEMENT
THIS AGREEMENT (the "Agreement") is entered into on this 25th day of February,
2004 (the "Signature Date") and is effective as of May 29, 1998 (the "Effective
Date") by and between DOV PHARMACEUTICAL, INC., a corporation organized and
existing under the laws of the State of Delaware, having its registered offices
at Continental Plaza, 433 Hackensack Avenue, Hackensack, New Jersey 07601
(hereinafter "DOV") and WYETH HOLDINGS CORPORATION (formerly known as "American
Cyanamid Company"), a corporation organized under the laws of the State of
Maine, U.S.A., having its principal place of business at 5 Giralda Farms,
Madison, New Jersey 07940, U.S.A. (hereinafter "Wyeth").
WITNESSETH:
WHEREAS, DOV and Wyeth entered into that certain License Agreement dated
May 29, 1998 (as previously amended, the "Original License Agreement") pursuant
to which Wyeth granted to DOV a worldwide exclusive license under the ACY
Patents and the ACY Know-How (as such terms are defined therein) for a group of
four (4) specified compounds;
WHEREAS, DOV and Wyeth now desire (i) to amend and restate the Original
License Agreement so as to remove from such agreement the rights and licenses
granted to DOV and the other rights and obligations of each of the parties
thereunder, in each case, which rights, licenses and obligations relate to the
compound designated as CL 285,489 (also known as Indiplon) and to modify the
consideration payable by DOV to Wyeth thereunder with respect to each Product
other than CL 285,489 and (ii) at the time this Agreement is entered into by the
parties, to enter into a separate license agreement providing for the grant of a
worldwide, exclusive license to DOV under certain intellectual property rights
of Wyeth for the development and commercialization of CL 285,489 and setting
forth the rights and obligations of the parties with respect thereto;
WHEREAS, Wyeth possesses intellectual property rights relating to the
chemical compounds listed in Schedule 1 attached hereto and made a part hereof
and to pharmaceutical products to be processed from the aforesaid compounds;
1
WHEREAS, Wyeth designates Wyeth Pharmaceuticals, an Affiliate of Wyeth,
with principal offices at 500 Arcola Road, Collegeville, Pennsylvania 19426,
U.S.A., as the correspondent and contact for day-to-day business regarding the
compounds that appear in Schedule 1. All correspondence and contacts shall be
with Wyeth Pharmaceuticals.
WHEREAS, DOV is interested to develop as well as manufacture, have
manufactured , use, and sell pharmaceutical products containing Bicifadine (also
known as CL220,075), CL 216,303, and CL273,547 worldwide under licenses that
Wyeth is willing to grant.
NOW, THEREFORE, in consideration of the premises and the mutual covenants
and agreements set forth herein, the parties hereto agree as follows:
ARTICLE 1.0 DEFINITIONS
1.1 "Effective Date" means the date upon which this Agreement is executed by
both parties.
1.2 "Product" means any one, or all, of the compounds listed in Schedule 1.
1.3. "Marketed Product" means the pharmaceutical preparation in finished form
containing Product suitable for human administration, whether alone or in
combination with other active ingredients.
1.4 "Wyeth Patents" means all patents, certificates of invention, and
applications covering the Product. Such Wyeth Patents are listed in
Exhibit A of this Agreement.
1.5 "Wyeth Know-How" means all information, patentable or otherwise,
developed, applied, or acquired by Wyeth as of May 22, 1997 relating to
the production or development of the Product that is reasonably useful or
necessary to develop or manufacture Product.
1.6 "Wyeth's Place of Payment" means 500 Arcola Road, Collegeville,
Pennsylvania 19426.
2
1.7 "Affiliate" means with respect to a party, any other business entity that
directly or indirectly controls, is controlled by, or is under common
control with, such party. A business entity or party shall be regarded as
in control of another business entity if it owns, or directly or
indirectly controls, at least fifty percent (50%) of the voting stock or
other ownership interest of the other business entity, or if it directly
or indirectly possesses the power to direct or cause the direction of the
management and policies of the other business entity by any means
whatsoever.
1.8 "Net Sales" shall mean the gross amount invoiced for the Marketed Product
sold, distributed or otherwise disposed of by DOV and/or its Affiliates or
its sublicensees (including any further sublicensees), in an arm's length
transaction to an end user ("Gross Sales"), less:
(i) transportation charges or allowances, if any, included in such
price;
(ii) trade, quantity or cash discounts, service allowances and broker's
or agent's commissions, but not salaries, commissions, bonuses or
other incentive pay to in-house sales or other personnel if any,
allowed or paid;
(iii) credits or allowances, if any, given or made on account of price
adjustments, returns, bad debts, off-invoice promotional discounts,
rebates, and any all Federal, state or local government rebates
whether in existence now or enacted at any time during the term of
this Agreement (e.g., HCFA or Medicaid rebates), rejections, recalls
or destruction requested or made by an appropriate government
agency; and
(iv) any tax, excise or governmental charge upon or measured by the sale,
transportation, delivery or use of the Marketed Product;
3
provided that Net Sales shall in no event be less than eighty
percent (80%) of Gross Sales.
In the case of discounts on "bundles" of products which include the
Marketed Product, DOV, its Affiliates and its sublicensees
(including further sublicensees) may, with notice to Wyeth,
calculate Net Sales as set forth above discounting the bona fide
list price of the Marketed Product by the average percentage
discount of all products of the selling party and/or its Affiliates
or sublicensees in a particular "bundle", calculated as follows:
Average percentage
discount on a = (1-A/B) x 100
particular "bundle"
where A equals the total discounted price of a particular "bundle"
of products, and B equals the sum of the undiscounted bona fide list
prices of each unit of every product in such "bundle". DOV shall
provide Wyeth documentation, reasonably acceptable to Wyeth,
establishing such average discount with respect to each "bundle".
Where the Marketed Product is also sold other than in bundled form,
the average discount as calculated above shall be applied to the
undiscounted list price of the Marketed Products in the "bundle". If
the Marketed Product is not sold separately and no bona fide list
price exists for the Marketed Product, the parties shall negotiate
in good faith an imputed list price for the Marketed Product, and
the average discount as calculated above with respect thereto shall
be applied to such imputed list price.
For the sake of clarity, sales of Products or Marketed Products
among DOV, its Affiliates, sublicensees or Commercial Partners,
where such Product or Marketed Product is being transferred to such
Affiliate, sublicensee or Commercial Partner for purposes of resale
or further distribution, shall not be included in the calculation of
Net Sales, it being understood that Net Sales shall be calculated
based on the gross amount invoiced in connection with such resale or
further distribution. Notwithstanding, the foregoing, if Product or
Marketed Product is sold or otherwise transferred among DOV, its
Affiliates, sublicensees or Commercial Partners and DOV, such
Affiliate, such sublicensee or such Commercial Partner is the end
user of such Product or Marketed Product, then the Net Sales for
such units of Products or Marketed Products shall be calculated
based on the gross amount invoiced in connection with such sale or
transfer.
4
1.9 "Territory" means all countries of the world.
1.10 "Scheduled Payments" means those lump sums payable at the time of the
achievement of specific developmental activities during the development
period through actual commercial introduction of a Product following
regulatory approval.
1.11 "Change of Control" shall have the meaning set forth in Section 6.4 below.
1.12 "Commercial Partner" shall have the meaning set forth in Section 6.2
below.
1.13 "Partnering Agreement" shall have the meaning set forth in Section 6.2
below.
1.14 As used in this Agreement, the singular includes the plural and the plural
includes the singular, wherever appropriate by fact or by context.
ARTICLE 2.0 LICENSE GRANT
2.1 As of May 29, 1998, Wyeth hereby grants DOV an exclusive license under
Wyeth Patents and Wyeth Know-How to make, have made, use, and/or sell
Marketed Product in the Territory.
2.2 Subject to Wyeth's right of first refusal provided for in Article 4.0 and
the provisions in Article 5.0, DOV shall have the right to grant
sublicenses under the License provided for in Article 2.1.
5
ARTICLE 3.0 DEVELOPMENTAL ACTIVITIES
3.1 While this Agreement is in effect, DOV shall use reasonable efforts to
develop and commercialize the Product, either through itself or through a
third party commercial partner. Such activities include negotiating the
terms of a sublicense agreement with a third party.
3.2 DOV may disclose unpublished Wyeth Patents and Wyeth Know-How to a third
party, bound under an obligation of confidentiality that is substantially
the same as the obligation provided for in Article 7 of this Agreement, to
the extent necessary to negotiate a sublicense, and thereafter to develop
and commercialize the Product.
3.3 On a quarterly basis, DOV, upon Wyeth's request, shall provide Wyeth with
a written report outlining its developmental activities during that
quarter.
ARTICLE 4.0 WYETH RIGHT OF FIRST REFUSAL
4.1 Prior to or simultaneously with beginning discussions with any third party
regarding a potential Partnering Agreement for any Product or Marketed
Product, DOV may notify Wyeth that DOV is pursuing such discussions and
provide Wyeth with a copy of all data and information in DOV's possession
relating to such Product or Marketed Product. Prior to its entering into a
Partnering Agreement with a third party with respect to Product, DOV shall
present, in writing, to Wyeth the bona fide proposed terms and conditions
of said Partnering Agreement. Following receipt by Wyeth of said terms and
conditions, Wyeth shall have thirty (30) days to notify DOV if it intends
to enter into a development agreement with DOV, the terms of which would
exceed those proposed by a third party by ten percent (10%) relative to
Scheduled Payments and royalties, provided, however, that if DOV has not
provided Wyeth with the notification, data and information as and when
contemplated under the first sentence of this Section 4.1, the thirty (30)
day period referenced above in this sentence shall be changed to sixty
(60) days. So as to permit Wyeth to reach such decision, DOV shall provide
to Wyeth all relevant data and information regarding Product available to
DOV (which data was not previously provided to Wyeth as required under the
first sentence of this Section 4.1), simultaneously with its providing to
Wyeth the terms and conditions offered by the said third party.
6
4.2 Upon Wyeth's providing DOV with notification of its intent to enter into
an agreement with DOV pursuant to Article 4.1, the parties will promptly
negotiate said agreement embodying Wyeth's offer under Article 4.1 and
this Agreement shall terminate upon the effective date of said agreement,
solely with regard to the Product(s) elected by Wyeth under Article 4.1
and contained in said agreement.
4.3 If Wyeth does not notify DOV of its intention to enter into an agreement
with DOV pursuant to Articles 4.1 and 4.2, hereinabove, within the thirty
(30) or sixty (60) day period provided for under Section 4.1 above, as
applicable, DOV shall be free to enter into a sublicense agreement with
the third party under the terms presented to Wyeth, or better.
4.4 In the event that DOV files a New Drug Application (NDA) in the USA, or a
foreign equivalent thereof in Europe or Japan, but has not yet entered
into a license agreement with a third party for Product, DOV shall provide
Wyeth with a copy of the NDA ( or the foreign equivalent thereof as filed
together with its English translation) for evaluation by Wyeth. If Wyeth
expresses an interest in marketing the Product, then the parties shall
enter into good faith negotiations relating to the possibility of Wyeth's
obtaining marketing rights to the Product.
ARTICLE 5.0 PARTNERING AGREEMENTS
5.1 If DOV enters into a Partnering Agreement with a third party with regard
to Product under this Agreement, such Partnering Agreement shall provide
for DOV to receive Scheduled Payments and royalty payments based on Net
Sales of Marketed Product.
7
ARTICLE 6.0 PAYMENTS
6.1 Within thirty (30) days after the Effective Date of the Original License
Agreement, DOV shall pay Wyeth the fee as indicated below in this
paragraph 6.1 for exercising its Option rights with regard to each
Product. Such fee shall be non-refundable and non-creditable against any
other payments due Wyeth pursuant to this Agreement:
Bicifadine, CL 220,075 $150,000
CL 216,303 $ 50,000
CL 273,547 $ 50,000
Wyeth acknowledges that the fees provided for in this Section 6.1 have
been received.
6.2 DOV shall pay to Wyeth, on a Compound by Compound basis, each of the
Scheduled Payments set forth below within thirty (30) days after
achievement of the event corresponding to such Scheduled Payment:
Event Payment
First NDA (or equivalent) filing in the United $5,000,000
States, Europe or Japan for a product containing
Bicifadine, CL 220,075
First NDA (or equivalent) filing in the United $2,500,000
States, Europe or Japan for a product containing CL
216,303
First NDA (or equivalent) filing in the United $2,500,000
States, Europe or Japan for a Product containing CL
273,547
NDA (or equivalent) approval in the United States, $4,500,000
Europe or Japan for a Product containing any Compound
(payable one time per Compound for a potential total
of 3 payments)
8
Notwithstanding the foregoing, in the event that DOV grants to a third
party a sublicense with respect to one or more Products or otherwise
enters into an agreement (a "Partnering Agreement") with a third party (a
"Commercial Partner") relating to and where such third party has the right
to control, in whole or in part, the development or commercialization of
one or more Products in one or more countries of the Territory (including,
without limitation, any asset purchase agreement, joint venture agreement,
collaboration agreement, copromotion or comarketing agreement,
distribution agreement, or license agreement, but excluding any agreement
where the third party solely provides services to DOV in connection with
the development of the Product, e.g., a clinical trial agreement with a
clinical research organization) then, on a Product by Product basis the
Scheduled Payment set forth above that would become due with respect to
such Product(s) upon NDA (or equivalent) filing or approval, as the case
may be, but regardless of whether the relevant event actually occurs,
shall become immediately due and payable. The remaining Scheduled
Payments, if any, for such Product(s) shall remain payable upon
achievement of the relevant events as set forth above. For the sake of
clarity, only one Scheduled Payment shall be accelerated per Product.
6.3 DOV shall pay to Wyeth royalties on all Net Sales obtained by DOV or its
Affiliates, in connection with the sale, or distribution or other
disposition of any Product or Marketed Product in the Territory at the
rates set forth below:
Product/Marketed Product Royalty Rate (% of Net Sales)
Bicifadine, CL 220,075 5.0%
CL 216,303 3.5%
CL 273,547 3.5%
Notwithstanding the foregoing, if DOV sublicenses any Product or Marketed
Product or otherwise enters into a Partnering Agreement with any third
party relating to the development or commercialization of any Product or
Marketed Product in one or more countries of the Territory, DOV shall pay
to Wyeth royalties on all Net Sales obtained by DOV, its Affiliates,
sublicensees or Commercial Partners in connection with the sale,
distribution or other disposition of such Product or Marketed Product in
such country(ies), at the rates set forth below (it being understood that
for all remaining countries royalties would remain payable at the rates
set forth above):
9
Product/Marketed Product Royalty Rate (% of Net Sales)
Bicifadine, CL 220,075 5.5%
CL 216,303 4.0%
CL 273,547 4.0%
6.4 In the event that DOV at any time during the twelve (12) month period
following the Signature Date enters into any agreement or arrangement that
would result in a Change of Control (as defined below) of DOV, DOV (or
DOV's successor in interest) shall pay to Wyeth ten million dollars
($10,000,000) which payment shall become due and payable within thirty
(30) days after the date that such Change of Control becomes effective.
For purposes of this Section 6.4, "Change of Control" shall mean (i) the
acquisition, directly or indirectly, by any person or entity of securities
authorized to cast fifty percent (50%) or more of the votes in any
election of directors of DOV, (ii) the acquisition, directly or
indirectly, by any person or entity of securities authorized to cast less
than fifty percent (50%) or more of the votes in any election of directors
of DOV, where there also exists a voting agreement or other agreement that
provides such person or entity the ability to cast or cause to be cast
fifty percent 50%) or more of the votes in any election of directors of
DOV or otherwise control the management of DOV, or (iii) the sale of other
transfer of all or substantially all of the assets of DOV to another
person or entity.
6.5 DOV shall keep and shall obligate its Affiliates, sublicensees and
Commercial Partners to keep accurate and complete records of all sales of
Products and Marketed Products in accordance with generally accepted
accounting principles and practices. In any agreement between DOV and a
third party, DOV shall obligate such third party to allow routine audits
by Wyeth of such third party's records relating to the Products and
Marketed Products and shall further require such third party to likewise
obligate any additional third party that enters into an agreement with the
third party relating to the Products and Marketed
10
Products to allow routine audits by Wyeth of such additional third party's
records relating to the Marketed Product. Wyeth, no more than one time per
calendar year for each of DOV or any third party so audited, may conduct,
at its own expense, at reasonable times during normal business hours,
through an accountant designated by Wyeth and acceptable to DOV (and its
sublicensees and their sublicensees, as appropriate), an audit of the
accounts contemplated above, as well as any supporting instruments and
documents, and may make copies of and extracts from such records for the
sole purpose of ascertaining or verifying the correctness of the amounts
remitted by DOV hereunder. Such accountant shall be required by DOV or any
sublicensee to enter into a reasonably acceptable confidentiality
agreement, and in no event shall such accountants disclose to Wyeth or DOV
any information other than information relating to or supporting the
accuracy of the payments due from DOV hereunder (and, except to the extent
necessary to support sales data using bundles, in no event information
that relates to products other than the Products and Marketed Products).
Each such audit shall be limited to the records and accounts pertaining to
the year on which the audit is conducted and the immediately preceding
five (5) calendar years. Results in the form of a report of such audit
shall be made available by Wyeth to DOV and to any third party that is the
subject of the audit. Should such audit reveal any discrepancies between
reports made by DOV or its sublicensees and the audit exceeding five
percent (5%) in favor of DOV or any third party that is audited, then DOV
shall pay in full the costs of such audit requested by Wyeth; otherwise,
Wyeth shall bear the costs in full for the audit of the records of DOV,
its Affiliates, or its sublicensees. In the event DOV, its Affiliates or
sublicensees (including further sublicensees) conducts an audit of any
sublicensee selling the Marketed Product, DOV shall provide or shall cause
such Affiliate or sublicensee to provide to Wyeth a copy of each audit
report generated in connection therewith.
6.6 Royalty payments shall be due within sixty (60) days of the end of each
calendar quarter on Net Sales made in that quarter and shall be paid at
Wyeth's Place of Payment. Royalties shall accrue in the currency of the
country in which the sale of the Product or Marketed Product is made, and
if different from U. S. dollars shall be converted into such currency
using the exchange rate appearing in the Wall Street Journal applicable
for the last day of the calendar quarter during which the royalties
accrued.
11
6.7 All taxes, assessments, fees, and charges, if any, levied under income tax
laws or regulations with respect to payments due Wyeth hereunder shall be
for the account of Wyeth and if required by law to be withheld and paid to
the applicable jurisdiction, may be deducted by DOV from such payments due
to Wyeth. Receipts for all such deducted taxes, assessments, fees and
charges paid by DOV to the taxing authorities shall be secured by DOV and
sent to Wyeth.
6.8 In case of any delay in payment by DOV to Wyeth not occasioned by force
majeure, interest at the rate of 1% (one percent) per month, assessed from
the thirty-first day after the due date of the said payment, shall be due
Wyeth without any special notice.
ARTICLE 7.0 CONFIDENTIALITY
7.1 If during the performance of this Agreement, one party hereto wishes to
disclose information to another that it considers confidential, and if the
receiving party is willing to accept such information, then such
information may not be subsequently disclosed by the receiving party to a
third party, other than as provided in this Agreement, without the written
permission of the disclosing party. The parties to this Agreement agree to
hold in confidence all information and all knowledge, know-how, practices,
process or other information disclosed or submitted in writing or in other
tangible form that is considered to be confidential for a period of five
(5) years from the date of such disclosure, except:
(a) information that at the time of disclosure is in the public domain;
(b) information that after disclosure is published or otherwise becomes
part of the public domain through no fault of the receiving party;
12
(c) information that was in the possession of the receiving party at the
time of disclosure;
(d) information that is developed by or on behalf of the receiving party
independently of any disclosure to it by the disclosing party
hereunder; or
(e) information that is provided to the receiving party by a third party
with the right to so provide.
ARTICLE 8.0 ADVERSE EXPERIENCE
8.1 DOV shall keep (and DOV shall cause its sublicensees to keep under terms
and conditions equal to those set forth in this Article 8) Wyeth, during
the term of this Agreement, promptly and fully informed of all
pharmaceutical, toxicological and clinical findings relating to adverse
experience of the Product or Marketed Product.
8.2 DOV undertakes to notify Wyeth promptly with written confirmation by
immediate telecopy of any information concerning any serious adverse event
as defined by C.I.O.M.S. or the F.D.A. or by the Ministry of Health &
Welfare in Japan, as applicable, reasonably associated with clinical
studies or attributed to the use or application of the Product or Marketed
Product. In any event the above notification shall be made within two (2)
working days after DOV first learns or is advised of all relevant
information with respect to such serious adverse event.
8.3 DOV shall also forward regularly (and usually every six months unless the
parties agree on another period) to Wyeth any information on all other
adverse effects or any difficulty associated with the clinical use,
studies, investigations, tests and prescription of the Product or Marketed
Product.
13
8.4 DOV shall provide upon request the information on estimated patient days
of exposure.
8.5 DOV shall inform Wyeth, without delay, of any governmental action,
correspondence or reports to or from governmental authorities that may
affect the situation of the Product or Marketed Product and furnish Wyeth
with copies of any relevant documents relating thereto.
ARTICLE 9.0 REPRESENTATIONS AND WARRANTIES
9.1 Wyeth hereby represents and warrants that it has the right to grant DOV
the license under Article 2 of this Agreement, and that, as of the
effective date of the Original License Agreement, Wyeth was not aware of
any lawsuit, opposition or action of any kind questioning or contesting
the validity of the Wyeth Patents. Notwithstanding the foregoing, Wyeth
makes no other warranties, expressed or implied, and Wyeth does not
warrant, nor does it entitle any agent, officer, employee or
representative of Wyeth to warrant, validity, enforceability, efficacy,
merchantability, fitness for a particular purpose or otherwise with
respect to any Product, Marketed Product or Wyeth Patent as the case may
be.
9.2 DOV is fully cognizant of Good Laboratory Practices ("GLP") and Good
Manufacturing Practices ("GMP") and shall manufacture or have manufactured
Product and Marketed Product in a manner that fully complies with GLP and
GMP.
ARTICLE 10.0 INDEMNIFICATION, LIABILITY AND INSURANCE
10.1 DOV shall at all times during the term of this Agreement, and thereafter,
indemnify, defend and hold Wyeth and all its Affiliates and their
respective directors, officers, partners, employees, servants and agents
harmless from and against any and all claims and expenses, including
without limitation legal expenses, court costs, and reasonable attorney's
fees, arising out of or relating to the death of or actual or alleged
injury to any person or damage to any third party's property, and from and
against any other claim, proceeding, demand, expense, cost and liability
of any kind whatsoever (collectively "liabilities") resulting from,
arising out of or related to Product or Marketed Product.
14
10.2 DOV shall take all necessary steps, at its own costs, and shall so
obligate its sublicensee to properly maintain insurance policies to cover
all liabilities to any third party that might be incurred, directly or
indirectly, as a result of its participation in the performance of this
Agreement.
10.3 DOV shall maintain (and shall cause its sublicensee to maintain) product
liability insurance that may include funded self-insurance reserves with
respect to the development, manufacture and sale of Products and Marketed
Products in such amount as customary in the industry. DOV (and its
sublicensee) shall maintain such insurance for so long as it continues to
develop, manufacture or sell any Products and Marketed Products and
thereafter for so long as required to cover such manufacture or sales.
DOV (and its sublicensee) shall name Wyeth as an additional insured on its
insurance policy. Upon execution of the Original License Agreement DOV has
supplied, and during the term of this Agreement, upon Wyeth's request, DOV
shall supply Wyeth with evidence of such coverage, and undertakes to
communicate to Wyeth during the term of this Agreement any modifications
to such coverages.
ARTICLE 11.0 USE OF NAMES/TRADEMARKS/PUBLICITY
11.1 Neither party shall use the name of the other party in any advertising or
other form of publicity without the written permission of the other.
11.2 By virtue of this License Agreement, DOV shall not acquire any right to
use trademarks, tradedress or other indicia of origin belonging to Wyeth,
or any of its Affiliates.
11.3 The timing and content of any press release or other public communications
relating to this Agreement and the transactions contemplated herein shall,
except as otherwise required by law, be determined jointly by Wyeth and
DOV.
15
ARTICLE 12.0 PATENT INFRINGEMENTS
12.1 Wyeth shall be responsible for the filing, prosecution and maintenance of
the Wyeth Patents. Wyeth shall not allow any issued Patent included within
the Wyeth Patents and listed or Exhibit A attached hereto to lapse (by
reason of failure to pay maintenance fees or annuities or to take any
other action necessary to maintain such patent in full force and effect)
or admit the invalidity thereof prior to the mutual expiration date
thereof without DOV's prior consent.
12.2 In case any actions, claims, demands, suits or other legal proceedings are
brought or threatened to be brought against DOV by a third party for
infringement of such third party's patent(s) relating to Product per se,
by virtue of DOV's manufacture, use, sale or offer for sale of the Product
or Marketed Product hereunder, DOV shall notify Wyeth forthwith of the
threat or existence of such actions with sufficient evidence thereof to
enable the parties to prepare an appropriate defense strategy. The parties
shall consult together as to the action to be taken and as to how the
defense will be handled. DOV shall be responsible for all defense costs.
DOV undertakes not to make any admission of liability to a claimant or
plaintiff or his or her legal representative or insurer and not to sign
any agreement in respect of such proceedings without Wyeth's previous
written consent not to be unreasonably withheld.
When DOV, because of the settlement with Wyeth's consent of the claimed
infringement, or a final unappealable or non-appealed judgment of a court
of competent jurisdiction, is required to make payments to one or more
third parties to obtain a license without which the marketing of the
Marketed Product could not be made in a given country, DOV may deduct such
payments from the royalty payments due to Wyeth hereunder, provided
however that in no event shall the royalty rate be reduced by more than
fifty percent (50%) of that which would otherwise be due Wyeth.
16
12.3 DOV shall promptly inform Wyeth of any suspected infringement of any of
Wyeth Patents by a third party and provide Wyeth with any available
evidence of such suspected infringement.
Wyeth shall have the right but not the obligation to institute any claim,
suit or proceeding against an infringer or a presumed infringer to protect
and defend Wyeth Patents. Wyeth shall control the prosecution of any such
suit or claim, including without limitation the choice of counsel and
shall settle or dispose of any such suit or claim. DOV shall provide Wyeth
with all reasonable assistance (other than financial) required to
institute and maintain such proceedings. In the event Wyeth so elects,
Wyeth shall bear the entire costs of such prosecution and shall be
entitled to retain after deducting the costs and expenses borne by Wyeth
in prosecuting the claim of infringement, ninety percent (90%) of the
amount of any recovery, court award or settlement and shall pay the
remainder to DOV.
DOV shall not institute any negotiations or legal proceedings with respect
to any such infringement without prior written consent of Wyeth, but shall
have the right to institute infringement proceedings against a third party
in the event that Wyeth elects not to do so. In such event, DOV shall bear
the entire costs and expenses of such proceedings. Wyeth shall provide DOV
with all reasonable assistance (other than financial) required to
institute and maintain such proceedings. In such event, DOV shall be
entitled to retain ninety percent (90%) of the proceeds of any such
recovery, after first deducting the costs and expenses borne by DOV in
initiating and maintaining such infringement action and shall pay the
remainder to Wyeth.
ARTICLE 13.0 DURATION AND TERMINATION
13.1 This Agreement shall be binding on the parties as of the day of its
execution but shall have no force or effect until either the parties
determine that notification under Title II of the Hart-Scott-Rodino
Antitrust Improvements Act of 1976, 15 U.S.C. 18a, and the regulations
promulgated thereunder, 16 C.F.R. 801.1 et seq., is not required or if the
parties determine that such notification is required, the waiting period
shall have expired or been terminated. If a notification filing is
required, the parties shall, at their own expense, prepare and make all
appropriate filings. The parties shall cooperate in the antitrust
clearance process and hereby agree to furnish promptly to the FTC and the
Antitrust Division of the Department of Justice such additional
information reasonably requested by them in connection with such filings.
In the event that the waiting period has not expired or been terminated
within six (6) months after the date of signature of this agreement by
both parties, the parties shall revert to their status before signing and
this agreement shall be of no force and effect, except for Articles 7, 10,
and 11, which shall survive pursuant to their terms. Thereafter, the
Agreement shall continue in full force and effect in each country of the
Territory until the later of expiration of the Wyeth Patents in such
country or a period of ten (10) years following the launch of each such
Marketed Product by DOV or its sublicensee(s) in each country of the
Territory.
17
13.2 Upon expiration of this Agreement with respect to each country of the
Territory, DOV shall be deemed to have a fully-paid, royalty-free license
with the right to make or have made, use or sell Product and Marketed
Product as well as to freely utilize all data generated hereunder or
received from Wyeth by DOV without DOV's having further obligation to
Wyeth, except for maintaining confidentiality as required by Article 7.1
of this Agreement.
13.3 DOV shall be free to terminate this entire Agreement and surrender and
return to Wyeth all rights acquired by DOV hereunder in its own discretion
at any time upon 90 days' prior written notice at which time all license
rights granted hereunder shall come to an end.
13.4 In the event that a party hereto shall be presumed by the other to have
breached any material condition herein contained, the complaining party
shall be required to provide a formal written notice of such presumed
breach, requesting rectification within a sixty-day period from the date
of receipt of such notice. The party presumed to be in breach of this
Agreement shall either submit a commercially reasonable plan for
rectification within 45 days of receipt of notice (if the breach cannot be
rectified within the sixty-day period), or take appropriate steps to
remedy the breach if capable of remedy within such period. If within the
said sixty-day period neither the aforesaid plan has been submitted, nor
the breach cured, the party alleging breach shall then be entitled to
terminate this Agreement, thereby surrendering all rights granted
hereunder, by written notice to the other party, such termination having
immediate effect.
18
13.5 This Agreement may be terminated at once by Wyeth giving notice to DOV if
DOV is insolvent or has committed an act of bankruptcy or an order is made
or resolution passed for the winding up of either party.
13.6 In the event this Agreement is terminated prior to its full term pursuant
to paragraph 13.3 by DOV or pursuant to paragraphs 13.4 or 13.5 by Wyeth,
DOV shall within 30 days of such event transfer to Wyeth all information,
data and know-how of any kind relating to each Product and shall authorize
the transfer of all governmental approvals for the Products to Wyeth, in
addition to DOV's right derived from all license agreements between DOV
and its third party partners relative to Product and Marketed Product.
ARTICLE 14.0 REPORTS AND NOTICES
14.1 Upon Wyeth's request, DOV shall provide Wyeth an annual report summarizing
the stage of development relating to the Product. Such report shall be
provided within thirty (30) days of each December 31 during the term of
this Agreement.
14.2 DOV shall notify Wyeth in writing within fifteen (15) days after achieving
an event that would require that a Scheduled Payment be paid by a third
party to DOV, or by DOV to Wyeth, with respect to a Product.
14.3 Not later than sixty (60) days following the end of each quarter, DOV will
provide Wyeth with a report summarizing the Net Sales of Marketed Product
in each country in the Territory made by DOV or a third party sublicensee
of DOV. Such reporting shall begin following the first sale of Marketed
Product in the Territory.
19
14.4 Any notices or reports required or permitted to be given under this
Agreement shall be sent by certified or registered mail, or by an
equivalent service that provides verification of delivery, return receipt
requested to the respective party at the address stated below or such
address as to which the parties are subsequently appropriately notified:
If to Wyeth: Wyeth Pharmaceuticals
500 Arcola Road
Collegeville, PA 19426
Attn: Senior Vice President Global Business Development
If to DOV: DOV Pharmaceutical, Inc.
Continental Plaza
433 Hackensack Avenue
Hackensack, NJ 07601
Attn: President
ARTICLE 15.0 ASSIGNMENT
15.1 This Agreement shall be binding upon and inure to the benefit of the
parties hereto and the successors to substantially the entire business and
assets of the respective parties hereto. Notwithstanding the foregoing,
either party may void this Agreement if the Agreement is assigned for the
benefit of a creditor. This Agreement shall not be assignable by either
party, except to an Affiliate, without the prior written consent of the
other party; any other attempted assignment is void.
ARTICLE 16.0 APPLICABLE LAW
16.1 This Agreement shall be governed by and construed according to the laws of
the State of New Jersey, USA.
20
ARTICLE 17.0 FORCE MAJEURE
17.1 None of the parties shall be responsible for failure or delay in the
performance of any of its obligations hereunder due to Force Majeure.
Force Majeure shall mean any circumstance that, due to an event or a legal
position beyond the party's reasonable control, renders impossible the
fulfillment of any of the party's obligations hereunder, such as, but not
limited to, acts of God, acts, regulations, or laws of any government,
war, civil commotion, destruction of facilities or materials by fires,
earthquakes, or storms, labor disturbances, shortages of public utilities,
common carriers, or raw materials, or any other cause, or causes of
similar effects, except, however, any economic occurrence. During any such
case of Force Majeure, this Agreement shall not be terminated, but only
suspended and the party so affected shall continue to perform its
obligations as soon as such case of Force Majeure is removed or
alleviated.
ARTICLE 18.0 MISCELLANEOUS
18.1 This Agreement and the Schedules hereto constitute the full understanding
and entire Agreement between the parties and supersede and replace any and
all prior oral or written understandings and agreements with respect to
the subject matter hereof, including, without limitation, the Original
License Agreement. This Agreement shall not be effective until duly signed
by officers of both Wyeth and DOV. No terms, conditions, understandings or
Agreements purporting to modify, amend or vary this Agreement shall be
binding unless made in writing and signed by the parties hereto. It is
mutually agreed that no party has relied upon any representations or
statements of any third party except as stated herein.
18.2 The invalidity or unenforceability of an Article or any part of an Article
of this Agreement in any jurisdiction shall not cause the invalidity of
the whole Agreement as to such jurisdiction, and shall not affect the
validity or enforceability of such Article or such part of an Article in
any other jurisdiction. The parties shall replace any Article or part of
an Article found invalid or unenforceable by alternative provisions that
shall be as similar as possible in their conditions with regard to their
spirit and commercial effect. If this Agreement in any jurisdiction is
found to be invalid or unenforceable, the parties shall replace it by an
alternative agreement that shall be as similar as possible in its
conditions with regard to its spirit and commercial effect.
21
18.3 The failure of either party on any occasion to require the performance by
the other of any provision hereof shall not affect the right of such party
to enforce the same on a subsequent occasion. The waiver by either party
of any breach of any provision hereof shall not be construed to be a
waiver of any succeeding breach of that or any other provision or a waiver
of the provision itself.
18.4 This Agreement shall not constitute either party as the joint venturer,
legal representative or agent of the other party for any purpose
whatsoever. Neither party shall have any right or authority to assume or
create any obligation or responsibility for or on behalf of the other
party or to otherwise bind the other party.
18.5 The parties recognize that this is a master Agreement covering a number of
countries. If for any country in the Territory it becomes necessary to
execute a separate instrument for such country in order to satisfy local
regulatory requirements, the parties agree to execute such further
instrument that shall to the extent permitted by the laws of the country
conform to the terms and conditions of this Agreement.
18.6 This Agreement and the Schedules and Exhibits hereto are originally
prepared and signed in the English language. If any translation into any
other language is legally required for purposes of governmental filings,
the parties shall arrange for such translation, and the costs thereof
shall be borne by the party legally required to make such filing. In the
event of any question or dispute as to the meaning or interpretation of
any term, condition or provision of this Agreement, or any Schedule or
Exhibit hereto, the English language version shall in all events govern
for all purposes whatsoever.
22
18.7 Termination of this Agreement for any reason, or expiration of this
Agreement, shall not affect: (i) obligations, including the payment of any
Scheduled Payments or royalties that have accrued as of the date of
termination or expiration and (ii) rights and obligations that, from the
context thereof, are intended to survive termination or expiration of this
Agreement.
18.8 This Agreement is executed simultaneously in counterparts, each of which
shall be deemed an original, but all of which shall constitute but one and
the same instrument.
WYETH HOLDINGS CORPORATION DOV PHARMACEUTICAL, INC.
NAME: /s/ Robert A. Dougan NAME: /s/ Robert Horton
TITLE: Senior Vice President TITLE: Vice President and General Counsel
DATE: February 25, 2004 DATE: February 25, 2004
23
SCHEDULE 1
PRODUCTS
BICIFADINE, CL 220,075
CL 216,303
CL 273,547
24
EXHIBIT A
WYETH PATENTS
BICIFADINE, CL220,075
- ---------------------
United States
- -------------
U.S. 4,196,120 - expires 4/1/1997
U.S. 4,231,935 - expires 11/4/1997
U.S. 4,435,419 - expires 7/1/2001
U.S. 4.131,611 - expires 12/26/1995
U.S. 6,204,284 - expires 3/20/2018
CL 216,303
- ----------
United States
- --------------
U.S. 4,196,120 - expires 4/1/1997
U.S. 4,231,935 - expires 11/4/1997
U.S. 4,435,419 - expires 7/1/2001
U.S. 4.131,611 - expires 12/26/1995
U.S. 6,204,284 - expires 3/20/2018
CL 273,547
- ----------
United States
- -------------
U.S. 4,521,422 - expires 6/23/2003
U.S. 4,900,836 - expires 2/13/2007
25