EXHIBIT 10.3
LICENSE AGREEMENT
THIS AGREEMENT (the "Agreement') is entered into on this 25th day of
February, 2004 by and between DOV PHARMACEUTICAL, INCORPORATED, a corporation
organized and existing under the laws of the Delaware, having its registered
offices at Continental Plaza, 000 Xxxxxxxxxx Xxxxxx, Xxxxxxxxxx, Xxx Xxxxxx
00000, (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 0 Xxxxxxx
Xxxxx, Xxxxxxx, Xxx Xxxxxx 00000, 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 for a group
of four (4) specified compounds;
WHEREAS, on even date herewith DOV and Wyeth entered into an Amended
and Restated License Agreement, which agreement amends and restates 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);
WHEREAS, DOV and Wyeth now desire to enter into this license agreement
to provide 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;
WHEREAS, Wyeth possesses intellectual property rights relating to the
chemical compound listed in Schedule 1 attached hereto and made a part hereof
and to pharmaceutical products to be processed from the aforesaid compound.
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WHEREAS, Wyeth designates Wyeth Pharmaceuticals, an Affiliate of Wyeth,
with principal offices at 000 Xxxxxx Xxxx, Xxxxxxxxxxxx, Xxxxxxxxxxxx 00000,
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 by, use, and sell pharmaceutical products containing CL 285,489
worldwide under a license 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 License Agreement is
executed by both parties.
1.2 "Product" means the compound 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 License 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.
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1.6 "Wyeth's Place of Payment" means 000 Xxxxxx Xxxx, Xxxxxxxxxxxx,
Xxxxxxxxxxxx 00000.
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 by DOV and/or its Affiliates or their sublicensees
(including any further sublicensees), 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;
provided that Net Sales shall in no event be less than 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
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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.
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 As used in this e Agreement, the singular includes the plural and the
plural includes the singular, wherever appropriate by fact or by
context.
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ARTICLE 2.0 LICENSE GRANT
2.1 Effective as of May 29, 1998, Wyeth hereby grants DOV an exclusive
license under Wyeth Patents and Wyeth Know-How to make, have made, use,
import, offer for sale 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.
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 which is
substantially the same as the obligation provided for in Article 7 of
this License Agreement, to the extent necessary to negotiate a
sublicense, and thereafter to develop and commercialize the Product.
3.3 On a quarterly basis, DOV 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 its entering into a sublicense 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 sublicense agreement.
Following receipt by Wyeth of said terms and conditions, Wyeth shall
have sixty (60) 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 10% relative to Scheduled Payments and
royalties. So as to permit Wyeth to reach
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such decision, DOV shall provide to Wyeth all relevant data and
information regarding Product available to DOV, simultaneously with its
providing to Wyeth the terms and conditions offered by the said third
party.
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 License 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 agreed upon period, 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 shall express 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 SUBLICENSE AGREEMENTS
5.1 If DOV grants a sublicense to a third party with regard to Product
under this Agreement, such sublicense agreement shall provide for DOV
to receive Scheduled Payments and royalty payments based on Net Sales
of Marketed Product.
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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:
CL 285,489 $ 50,000
Wyeth acknowledges that the fee provided for in this Section 6.1 has
been received.
6.2 If DOV enters into a sublicense agreement with a third party before the
filing of an NDA (or the foreign equivalent thereof in Europe or Japan)
for a Product, DOV shall, subject to the minimum conditions set forth
in paragraph 6.4 of this Agreement, pay Wyeth during the term of this
Agreement 35% of all remuneration, excluding all adequately documented
future research and development payments, whether tangible or
intangible, including all Scheduled Payments within 30 days of receipt
by DOV from such sublicensee and one-third of all other royalties and
profits, whether tangible or intangible, within 30 days of receipt by
DOV derived from the final sale to the trade of Marketed Product by DOV
or its sublicensee, as the case may be.
6.3 If DOV enters into a sublicense agreement with a third party after the
filing of an NDA (or the foreign equivalent thereof in Europe or Japan)
for a Product, DOV shall, subject to the minimum conditions set forth
in paragraph 6.4 of this Agreement, pay Wyeth during the term of this
Agreement 25% of all remuneration, whether tangible or intangible,
including Scheduled Payments within 30 days of receipt by DOV from such
sublicensee; and 25% of all other royalties and profits; whether
tangible or intangible, within 30 days of receipt by DOV derived from
the final sale to the trade of Marketed Product by DOV or its
sublicensee, as the case may be.
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6.4 Notwithstanding any other provision of this Agreement, Wyeth shall in
no event receive Scheduled Payments and once the Product has been
commercialized, royalties on sales of Marketed Product to the trade by
DOV or its third-party sublicense with respect to each Product listed
in Schedule 1, which Scheduled Payments, in the aggregate, and
royalties are less than the amounts below indicated in this paragraph.
For the sake of clarity, in the event the portion of the first
Scheduled Payment received by DOV from a sublicensee which portion is
payable by DOV to Wyeth in accordance with Section 6.2 above, is less
than the amount indicated below in this paragraph, DOV shall pay to
Wyeth the minimum amount set forth below at such time and that portion
of such minimum amount that is in excess of the amount payable by DOV
to Wyeth pursuant to Section 6.2 above as the result of DOV's receipt
of such Scheduled Payment from its sublicensee, shall be credited
against any further Scheduled Payments due from DOV to Wyeth under this
Agreement.. The Scheduled Payments due Wyeth for the Schedule 1
compound shall be paid pursuant to the 30-day period specified in
paragraphs 6.2 and 6.3 if received by DOV from third parties; but in
the event that DOV achieves the filing of an NDA, or its equivalent in
the United States, Europe, or Japan for a Product without assistance of
a third party, DOV shall remit to Wyeth the aggregate minimum Scheduled
Payments set forth below no later than 30 days following the
achievement of such Regulatory filing.
AGGREGATE MINIMUM SCHEDULED MINIMUM ROYALTY DUE TO
PAYMENT FOR EACH PRODUCT DUE WYETH WYETH ON NET SALES
---------------------------------- ------------------
CL 285,489 $2.5 Million 2.5%
Provided however if marketing exclusivity in any country of the
Territory is lost to DOV or its sublicensee prior to the expiration of
this Agreement in such country, the parties shall meet to discuss
whether any modification to these terms is appropriate.
6.5 DOV shall keep and shall obligate its sublicensees to keep accurate and
complete records of all sales of Product and Marketed Product in
accordance with generally
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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
Product and Marketed Product 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 Product and Marketed
Product to allow routine audits by Wyeth of such additional third
party's records relating to the Product and 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 Product or Marketed Product). 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 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 Product and 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.
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6.6 Royalty payments shall be due within the shorter period of thirty (30)
days following receipt thereof by DOV or 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 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.
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 one percent (1%) 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:
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(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;
(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
and Marketed Product. In any event the above notification shall be made
within two working days after DOV should first learn or be advised of
all relevant information with respect to such 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
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associated with the clinical use, studies, investigations, tests and
prescription of the Product or Marketed Product.
8.4 DOV shall provide upon request the information on patient exposure:
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 xxxxx XXX
the license under Article 2 of this Agreement, and that, as of the
effective date of the Original License Agreement, Wyeth is 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
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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.
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 the
Product and Marketed Product 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 Product and
Marketed Product 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.
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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.
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
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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.
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.
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.
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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 Xxxx-Xxxxx-Xxxxxx
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 such Marketed Product by DOV or its
sublicensee(s) in each country of the Territory.
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.
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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.
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 Xxxxx, XXX shall within thirty (30) days of such event transfer
to Wyeth all information, data and know-how of any kind relating to the
Product and shall authorize the transfer of all governmental approvals
for the Product 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 anniversary of
the signing of this Agreement.
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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 the
Product.
14.3 Not later than sixty (60) days following the end of each quarter, DOV
shall 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.
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
000 Xxxxxx Xxxx
Xxxxxxxxxxxx, XX 00000
Attn: Senior Vice President, Global Business Development
If to DOV: DOV Pharmaceutical, Inc.
Continental Plaza
000 Xxxxxxxxxx Xxxxxx
Xxxxxxxxxx, XX 00000
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, any party may void this Agreement if the Agreement is
assigned for the benefit of a creditor. This Agreement shall not be
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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 York, USA.
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 supersedes
and replaces any and all prior oral or written understandings and
agreements with respect to the subject matter hereof including, without
limitation, the Original License Agreement. Notwithstanding the
foregoing, this Agreement shall not be deemed to have modified (i) the
Consent and Agreement entered into by Xxxxx, XXX and DOV's sublicensee,
Neurocrine Bioscience's Inc. ("Neurocrine"), on December 13, 2002, (ii)
the Consent Agreement and
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Amendment entered into by Xxxxx, XXX and Neurocrine on February __,
2004, or (iii) the Sublicense and Development Agreement entered into by
DOV and Neurocrine June 30, 1998, each of which shall remain in full
force and effect in accordance with the terms and conditions thereof as
amended from time to time. 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 which 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 which shall be
as similar as possible in its conditions with regard to its spirit and
commercial effect.
18.3 The failure of either party on any occasion to require the performance
by the other of any provision hereof shall in no manner 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 at
no time 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.
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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.
18.7 Termination of this Agreement for any reason, or expiration of this
Agreement, will 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 which, 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/ Xxxxxx X. Xxxxxx NAME: /s/ Xxxxxx Xxxxxx
TITLE: Senior Vice President TITLE: Vice President and General Counsel
DATE: 2/25/04 DATE: ________________________
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SCHEDULE 1
PRODUCTS
CL 285,489
22
EXHIBIT A
WYETH PATENTS
CL 285,489
United States
U.S. 6,399,621 expires 8/9/2020
U.S. 4,900,836 expires 2/13/2007
U.S. 4,521,422 expires 6/23/2003
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