AMENDED AND RESTATED LICENSE AGREEMENT (Bicifadine - CL220,075)
AMENDED
AND RESTATED LICENSE AGREEMENT
(Bicifadine
- CL220,075)
THIS
AGREEMENT (this “Agreement”)
is
entered into on this 7th day of December 2006 (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 ▇▇▇ ▇▇▇▇▇▇
▇▇.,
▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ (hereinafter “DOV”)
on the
one hand 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 ▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇,
▇.▇.▇. (hereinafter,
“WHC”)
and
WYETH, acting through its Wyeth Pharmaceuticals Division, a corporation
organized under the laws of the State of Delaware, U.S.A., having its principal
place of business at ▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, ▇.▇.▇.
(hereinafter “Wyeth
Pharmaceuticals”),
on
the other hand. WHC and Wyeth Pharmaceuticals may individually and collectively,
as the context requires, be referred to herein as “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 entered into that certain Amended and Restated License Agreement
dated February 25, 2004 (the “Prior
Amended and Restated License Agreement”)
pursuant to which (i) Wyeth and DOV amended and restated 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 the Prior Amended
and Restated License Agreement was entered into by the parties, the parties
also
entered 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,
DOV and Wyeth now desire to amend and restate the Prior Amended and Restated
License Agreement so as to remove from such agreement, and reflect in two
separate agreements, 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 compounds designated as CL 216,303
& CL 273,547, and to modify the rights and obligations of the parties
with respect to CL 220,075 (also known as “Bicifadine”)
contained herein;
WHEREAS,
Wyeth possesses intellectual property rights relating to the chemical compound
designated as Bicifadine and listed in Schedule
1
attached
hereto and made a part hereof and to pharmaceutical products to be processed
from the aforesaid compound;
1
WHEREAS,
Wyeth designates Wyeth Pharmaceuticals, an Affiliate of Wyeth, with principal
offices at ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, 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 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. |
“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.
|
| 1.2. |
“Control”
or “Controlled”
means, with respect to any intellectual property right, possession
of the
ability to grant the other party access, a license or sublicense
(as
applicable) as provided for herein without violating the terms of
any
agreement or other arrangement with any third party existing at the
time
such party would be first required hereunder to grant the other party
such
access, license or sublicense.
|
| 1.3. |
“DOV
Patents”
means (i) the patents and patent applications listed in Exhibit B,
all patents issuing on such patent applications, plus all other Patents
Rights that claim priority to, in whole or in part, directly or
indirectly, one or more of any such patents or patent applications,
plus
(ii) all other Patent Rights Controlled by DOV or any of its Affiliates,
as of the Effective Date or thereafter during the term of this Agreement,
that are necessary for the manufacture, use sale, offer for sale,
importation, research, development or commercialization or other
exploitation of any Product or Marketed Product solely for use in
the
Retained Rights Field,
provided, however,
that for this clause (ii) such other Patent Rights shall not
include (1) any Patent Right directed to or claiming any
manufacturing technology that is not required for the manufacture
of such
Product or Marketed Product (e.g.,
if the Product or Marketed Product is amenable to being manufactured
by a
method that is not covered by the applicable other Patent Right,
such
other Patent Right would not be considered to be a DOV Patent for
purposes
of this Agreement) or (2) any Patent Right directed to or claiming
any pharmaceutical formulation
technology.
|
| 1.4. |
“Field”
means the treatment of any diseases, disorders and conditions in
humans,
other than any disease, disorder or condition within the Retained
Rights
Field.
|
| 1.5. |
“Marketed
Product”
means a pharmaceutical preparation in finished form containing Product
suitable for human administration, whether alone or in combination
with
other active ingredients.
|
2
| 1.6. |
“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;
|
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 Product 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 Product or Marketed Product 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 Product or Marketed Product shall be calculated based on
the
gross amount invoiced in connection with such sale or transfer.
3
| 1.7. |
“Patent
Rights”
shall mean all patents and patent applications, including, without
limitation, all provisional applications, substitutions, continuations,
continuations-in-part, divisions, and renewals, all patents granted
thereon, and all patents-of-addition, reissues, reexaminations, extensions
and extended exclusivities (including, without limitation, supplementary
protection certificates and pediatric extensions) or restorations
by
existing or future extension or restoration
mechanisms.
|
| 1.8. |
“Product”
means the compound listed in Schedule 1,
plus any and all prodrugs, optical isomers, hydrates, solvates, salt
forms
and polymorphs of such compound.
|
| 1.9. |
“Retained
Rights Field”
means the treatment or amelioration of vasomotor symptoms caused
by or
occurring in relation to or connection with menopause or other female
hormonal fluctuations in the patient being
treated.
|
| 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. |
“Subject
Patent Rights”
means the patents and patent applications listed in Exhibit C,
all patents issuing on such patent applications, plus all Patents
Rights
that claim priority to, in whole or in part, directly or indirectly,
one
or more of any such patents or patent
applications.
|
| 1.12. |
“Territory”
means all countries of the world.
|
| 1.13. |
“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.
|
| 1.14. |
“Wyeth
Patents”
means the Wyeth Primary Patents and the Wyeth Secondary
Patents.
|
| 1.15. |
“Wyeth
Primary Patents”
means the (i) patents and patent applications listed in Exhibit A,
(ii) all patents issuing on such patent applications, (iii) all other
Patents Rights that claim priority to, in whole or in part, directly
or
indirectly, one or more of any of the patents or patent applications
identified in (i) or (ii) above, and (iv) those other Patent Rights
Controlled by Wyeth or any of its Affiliates, as of the Effective
Date or
thereafter during the term of this Agreement, which other Patent
Rights
relate solely to and may be used solely for the manufacture or use
of the
Product or Marketed Product in the Field, provided,
however,
that such other Patent Rights of this clause (iv) shall not include
(a) any Patent Right directed to or claiming any manufacturing technology
that is not required for the manufacture of such Product or Marketed
Product (e.g.,
if
the Product or Marketed Product is amenable to being manufactured
by a
method that is not covered by the applicable other Patent Right,
such
other Patent Right would not be considered to be a Wyeth Primary
Patent
for purposes of this Agreement) or (b) any Patent Right directed
to or
claiming any pharmaceutical formulation
technology.
|
4
| 1.16. |
“Wyeth
Secondary Patents”
means all Patent Rights (other than the Wyeth Primary Patents) Controlled
by Wyeth or any of its Affiliates, as of the Effective Date or thereafter
during the term of this Agreement, that are necessary for the manufacture,
use, sale, offer for sale, importation, research, development or
commercialization or other exploitation of any Product or Marketed
Product, provided,
however,
that such Patent Rights shall not include (i) any Patent Right directed
to
or claiming any manufacturing technology that is not required for
the
manufacture of such Product or Marketed Product (e.g.,
if the Product or Marketed Product is amenable to being manufactured
by a
method that is not covered by the applicable other Patent Right,
such
other Patent Right would not be considered to be a Wyeth Secondary
Patent
for purposes of this Agreement) or (ii) any Patent Right directed
to or
claiming any pharmaceutical formulation
technology.
|
| 1.17. |
“Wyeth’s
Place of Payment”
means ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇.
|
| 1.18. |
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
Grants
| 2.1. |
As
of May 29, 1998, Wyeth hereby grants, for itself and its Affiliates,
to
DOV and its Affiliates, an exclusive (even as to Wyeth and its Affiliates)
license under Wyeth Patents and Wyeth Know-How (a) to make, have
made and
develop (subject to Article
3.4)
Product and Marketed Product in the Territory and (b) to use, sell,
offer
to sell, import and commercialize Product and Marketed Product in
the
Field in the Territory.
For the sake of clarity, DOV shall have no right under the Wyeth
Patents
or the Wyeth Know-How to make, have made, and develop any Product
and
Market Product in the Retained Rights Field, it being understood
and
agreed that Wyeth shall have the sole right to do so, subject to
Article
3.4.
For the sake of clarity, the license granted hereunder with respect
to a
Product or Marketed Product shall encompass any metabolite of such
Product
or Marketed Product resulting from human administration of such Product
or
Marketed Product, but shall not encompass the administration of any
such
metabolite as a separate pharmaceutical
product.
|
| 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.
DOV shall provide Wyeth with a true, accurate and complete copy of
each
such sublicense granted by it promptly after granting such sublicense.
In
the event that DOV grants such a sublicense to a third party, Wyeth
agrees
to negotiate in good faith and enter into with each of DOV and such
third
party a standby license under which Wyeth would grant to such third
party
(and DOV would consent to the grant to such third party of), a direct
license of the rights granted to DOV under Article
2.1
above, which direct license (i) would become effective upon the
termination (but not expiration) of this Agreement for any reason
other
than a termination by Wyeth under Article
13.4
for an uncured material breach of this Agreement which breach is
caused in
whole or in part by the actions or omissions of such third party
(ii)
would provide for such third party to promptly cure any breach of
this
Agreement remaining uncured at such time of termination, (iii) would
be on
the terms and conditions under the sublicense agreement between DOV
and
such third party, provided,
however,
that in no event shall such terms and conditions be any less favorable
to
Wyeth than the terms and conditions of this Agreement and (iv) would
include other terms and conditions customary for agreements of such
type.
It
is understood and agreed that in consideration for entering into
any such
direct license, Wyeth would not require such sublicensee to make
any
payments to Wyeth over and above those that would be required under
clauses (ii) and (iii) above.
|
5
| 2.3. |
Without
limiting the scope of the license granted to DOV under Article
2.1(a),
Wyeth retains all rights under the Wyeth Patents and Wyeth Know-How
to
use, sell, offer to sell, import, develop and commercialize Product
and
Marketed Product in the Territory solely for use in the Retained
Rights
Field, in all events subject to Article
3.4.
On a country-by-country basis, Wyeth hereby agrees not to commercialize
Product or Marketed Product for use in the Field for the period during
which DOV is obligated to pay royalties hereunder on sales of Product
or
Marketed Product in such country.
|
| 2.4. |
As
of the Effective Date, DOV hereby grants, for itself and its Affiliates,
to Wyeth, an exclusive license under the DOV Patents to use, develop,
sell, offer to sell, import and commercialize Product and Marketed
Product
in the Territory solely for use in the Retained Rights Field, in
all
events subject to Article
3.4
remaining in full force and effect, provided,
however,
that the grant of such license shall be subject to the licenses granted
to
DOV under Article
2.1,
including, without limitation, DOV’s exclusive right under the Wyeth
Patents and to use the Wyeth Know-How to make, have made and develop
Product and Marketed Product in the
Territory.
|
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
7.0
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.
|
| 3.4. |
In
the event that either party desires either to conduct any clinical
studies
of a Product or Marketed Product for use in the Retained Rights Field
or
to seek regulatory approval to market and sell Product or Marketed
Product
for use in the Retained Rights Field, such party shall notify the
other
and the parties shall enter into negotiations for the parties to
cooperate
in the development and commercialization of Product and Marketed
Product
on mutually agreeable terms for use in the Retained Rights Field,
provided,
however,
that neither party or any of their respective Affiliates or sublicensees
shall conduct any such research or development or commercialization
of any
Product or Marketed Product for use in the Retained Rights Field
without
first reaching agreement with the other party, and provided
further,
DOV shall not be in violation of this Article
3.4
if
a patient is treated for a disease, condition or disorder falling
within
the Retained Rights Field merely incidentally as a result of
administration of Product or Marketed Product for an indication not
falling within the Retained Rights Field (provided that for this
last
provisio neither DOV, its Affiliates or sublicensees have deliberately
taken any action, directly or indirectly, to encourage such use of
a
Product or Marketed Product).
|
6
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 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
(the “Third
Party Term Sheet”).
Following receipt by Wyeth of the Third Party Term Sheet, 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
Article
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 Article
4.1),
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 Agreement shall terminate upon the effective date of 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,
within the thirty (30) or sixty (60) day period provided for under
Article
4.1,
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, provided that DOV shall
not be
required to grant by this Article
4.4
any such rights.
|
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
Article
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
|
Wyeth
acknowledges that the fees provided for in this Article
6.1
have
been received.
| 6.2. |
DOV
shall pay to Wyeth 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 States, Europe or Japan
for a
Product containing Bicifadine, CL 220,075
|
$
|
5,000,000
|
||
|
NDA
(or equivalent) approval in the United States, Europe or Japan for
a
Product containing Bicifadine,
CL 220,075
|
$
|
4,500,000
|
Notwithstanding
the foregoing, in the event that DOV grants to a third party a sublicense with
respect to Product or Marketed Product 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 Product or Marketed Product 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, 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 shall be payable by DOV within thirty (30) days. The
remaining Scheduled Payments, if any, for such Product 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 in the amount of five percent (5.0%)
of all
Net Sales obtained by DOV or its Affiliates, in connection with the
sale,
or distribution or other disposition of Product or Marketed Product
in the
Territory.
|
Notwithstanding
the foregoing, if DOV sublicenses the Product or Marketed Product or otherwise
enters into a Partnering Agreement with any third party relating to the
development or commercialization of the Product or Marketed Product in one
or
more countries of the Territory, DOV shall pay to Wyeth royalties in the amount
of five and one-half percent (5.5%) of 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) (it being understood that for all remaining countries royalties
would remain payable at the rates set forth above).
8
| 6.4. |
DOV
shall keep and shall obligate its Affiliates, sublicensees and Commercial
Partners to keep accurate and complete records of all sales of Product
and
Marketed Product 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 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 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 and 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
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.
|
| 6.5. |
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.
|
9
| 6.6. |
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.
|
| 6.7. |
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
shall
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;
|
| (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
8.0)
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.
|
10
| 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.
|
| 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 ▇▇▇▇▇ ▇▇▇
the
license under Article
2.0
of
this Agreement, and that, as of the Signature Date, Wyeth, to the
best of
its knowledge, is not a party to any lawsuit, opposition, re-examination
or interference 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 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.
|
| 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 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 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.
11
Article
11.0 Use
of Names/Trademarks/Publicity
| 11.1. |
Neither
party shall use the name or trademarks of the other party in any
advertising or other form of publicity without the written permission
of
the other party.
|
| 11.2. |
By
virtue of this License Agreement, neither party shall acquire any
right to
use trademarks, tradedress or other indicia of origin belonging to
the
other party, or any of such other party’s
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.
|
Article
12.0 Patent
Maintenance, Infringements, and Interferences
| 12.1. |
Wyeth
Patents.
|
| (i) |
Prosecution
and Maintenance.
Wyeth shall be responsible for the preparation, filing, prosecution
and
maintenance (including, without limitation, any interferences,
oppositions, reissue proceedings and reexaminations), of the Wyeth
Patents. Wyeth shall reasonably consult with DOV with respect to
the
preparation, filing, prosecution and maintenance of the Wyeth Primary
Patents and DOV agrees to reasonably cooperate with Wyeth in such
activities. Wyeth shall keep DOV advised of the status of such activities
and shall also inform DOV in a timely manner of any material
communications Wyeth receives from the relevant patent office with
respect
to such activities. Wyeth shall give notice to DOV of any desire
to cease
preparation, filing, prosecution or maintenance of any Wyeth Primary
Patent on a country-by-country basis, and in such case, DOV shall
have the
right to elect to continue preparation, filing, prosecution and
maintenance of such Wyeth Primary Patent. In the event that DOV elects
to
continue any such activities for such Wyeth Primary Patent, DOV shall
reasonably consult with Wyeth with respect thereto and shall consider
in
good ▇▇▇▇▇ ▇▇▇▇▇’▇ reasonable views with respect to such activities, and
Wyeth agrees to transfer to DOV all information reasonably requested
by
DOV for DOV to conduct such activities and to otherwise reasonably
cooperate with DOV in such actions. DOV shall keep Wyeth advised
of the
status of such actions and shall also inform Wyeth in a timely manner
of
any material communications DOV receives from the relevant patent
office
with respect to such activities. Each party shall bear its own costs
with
respect to any preparation, filing, prosecution and maintenance of
any
Wyeth Patent for which it is responsible. Upon DOV’s reasonable request,
Wyeth shall consider in good faith prosecuting in a separate Patent
application any claim(s) concerning Product or Marketed Product that
if
separated into a separate Patent would thereby qualify as a “Wyeth Primary
Patent” under clause (iv) of that definition instead of being
included in another Wyeth Patent that is a “Wyeth Secondary Patent”
hereunder, provided that (i) such separation and additional Patent
shall not adversely affect the patentability, validity or enforceability
any of the other Wyeth Patents or any other Patents owned or controlled
by
Wyeth or any of its Affiliates, and (ii) DOV shall be responsible for
any incremental out-of-pocket costs incurred by Wyeth for preparing,
filing, prosecuting and maintaining such additional
Patent.
|
12
| (ii) |
Defense.
In the event that 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 (but not relating to formulation technology or general
manufacturing technology), by virtue of DOV’s manufacture, use, sale,
offer for sale, or importation 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 up to fifty percent (50%) of such
payments from the royalty payments due to Wyeth hereunder, provided
however,
that in
no event shall any royalty payment that would otherwise be due to Wyeth be
reduced by more than fifty percent (50%).
| (iii) |
Enforcement
- Wyeth Primary Patents.
Each party shall promptly inform the other party of any suspected
infringement of any of the Wyeth Primary Patents in the Field by
a third
party and provide the other party with any available evidence of
such
suspected infringement.
|
DOV
shall
have the first right but not the obligation to institute any claim, suit or
proceeding against an infringer or a presumed infringer of the Wyeth Primary
Patents in the Field. DOV 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, provided,
however,
that
DOV shall have no right to diminish any of the rights retained by Wyeth
hereunder in settling or disposing of any such suit or claim.
Wyeth
shall provide DOV with all reasonable assistance (other than financial), at
DOV’s expense, required to institute and maintain such proceedings (including,
without limitation, being a named party to any such suit or claim). In the
event
DOV takes action against a presumed infringer of any of the Wyeth Primary
Patents, DOV shall bear the entire costs of such prosecution and, in the event
that DOV obtains payment of any recovery, court award or settlement
(a “Recovery”)
from
the third party infringer for infringement of the Wyeth Primary Patents, DOV
shall pay to Wyeth, after deducting the costs and expenses borne by DOV in
prosecuting the claim of infringement, either (a) if reasonable royalties are
recovered, the greater of (x) the royalty Wyeth would have been entitled to
receive under Article 6 hereof had such allegedly infringing product been sold
as a Product or Marketed Product under this Agreement or (y) fifty percent
(50%)
of the remainder of such Recovery or (b) if lost profits are recovered, the
greater of (x) twenty-five percent (25%) of the remainder of such Recovery
or
(y) the royalty Wyeth would have received hereunder on an amount of Net Sales
that would generate a profit for DOV in the amount of the remainder of such
Recovery, and, in the case of either (a) or (b) above, DOV shall be entitled
to
retain the remaining amount of such Recovery.
13
Wyeth
shall have the right, but not the obligation, to enforce the Wyeth Primary
Patents against any infringer or presumed infringer in the Retained Rights
Field. Wyeth shall control the prosecution of any such enforcement suit or
claim, including without limitation the choice of counsel and shall settle
or
dispose of any such suit or claim, provided,
however,
that
Wyeth shall have no right to diminish any of the rights granted to DOV hereunder
in settling or disposing of any such suit or claim.
DOV
shall provide Wyeth with all reasonable assistance (other than financial),
at
Wyeth’s expense, required to institute and maintain such proceedings (including,
without limitation, being a named party to any such suit or claim). Wyeth shall
bear the entire costs of such prosecution and shall be entitled to retain one
hundred percent (100%) of any Recovery from the third party infringer for any
such infringement.
| (iv) |
Enforcement
- Wyeth Secondary Patents.
Each party shall promptly inform the other party of any suspected
infringement of any of the Wyeth Secondary Patents in the Field by
a third
party and provide the other party with any available evidence of
such
suspected infringement.
|
Wyeth
shall have the first right, but not the obligation, to enforce the Wyeth
Secondary Patents against any infringer or presumed infringer thereof. Wyeth
shall control the prosecution of any such enforcement suit or claim, including
without limitation the choice of counsel and shall settle or dispose of any
such
suit or claim, provided,
however,
that
Wyeth shall have no right to diminish any of the rights granted to DOV hereunder
in settling or disposing of any such suit or claim.
DOV
shall provide Wyeth with all reasonable assistance (other than financial),
at
Wyeth’s expense, required to institute and maintain such proceedings (including,
without limitation, being a named party to any such suit or claim). In the
event
Wyeth so elects to enforce any of the Wyeth Secondary Patents against any
presumed third party infringer thereof, Wyeth shall bear the entire costs of
such prosecution and, in the event that Wyeth obtains payment of any Recovery
from the third party infringer for any such infringement, Wyeth shall be
entitled to retain one hundred percent (100%) of any such Recovery for any
infringement of the Wyeth Secondary Patents resulting from the manufacture,
use,
import, or sale of a product other than a Product or Marketed Product or from
the manufacture, use, import, or sale of a Product or Marketed Product in the
Retained Rights Field and, for infringement of any Wyeth Secondary Patents
as a
result of the manufacture, use, import or sale of a Product or Marketed Product
in the Field, Wyeth, after deducting the costs and expenses borne by Wyeth
in
taking action against the alleged infringer, shall be entitled to retain either
(a) if reasonable royalties are recovered, the greater of (x) the royalty Wyeth
would have been entitled to receive under Article 6 hereof had such allegedly
infringing product been sold as a Product or Marketed Product under this
Agreement or (y) fifty percent (50%) of the remainder of such Recovery or (b)
if
lost profits are recovered, the greater of (x) twenty-five percent (25%) of
the
remainder of such Recovery or (y) the royalty Wyeth would have received
hereunder on an amount of Net Sales that would generate a profit for DOV in
the
amount of the remainder of such Recovery, and, in the case of either (a) or
(b)
above, the remaining amount of such Recovery shall be payable to
DOV.
14
In
the
event that Wyeth fails to initiate action to obtain a discontinuance of the
alleged infringement of the Wyeth Secondary Patents where such infringement
is a
result of the manufacture, use, import or sale of a Product or Marketed Product
in the Field, within one hundred eighty (180) days after notice is given by
one
party to the other of such alleged infringement, DOV may, but shall not be
obligated, to request that Wyeth permit DOV to institute negotiations or legal
proceedings with respect to such infringement. Wyeth, shall notify DOV within
sixty (60) days of such request whether it will or will not permit DOV to take
such action, it being understood and agreed, that such determination may be
made
by Wyeth in its sole discretion. In the event Wyeth permits DOV to take such
action, DOV 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 (subject to the licenses and retained rights of Article
2.0).
Wyeth
shall provide DOV with all reasonable assistance (other than financial), at
DOV’s expense, required to institute and maintain such proceedings. In the event
DOV so elects to enforce the Wyeth Secondary Patents against a third party
manufacturing, using, selling or importing any Product or Marketed Product
in
the Field, DOV shall bear the entire costs of such action and, in the event
that
DOV obtains payment of any Recovery, from the third party infringer for any
such
infringement, DOV, after deducting the costs and expenses incurred in taking
such action shall pay to Wyeth either (a) if reasonable royalties are recovered,
the greater of (x) the royalty Wyeth would have been entitled to receive under
Article 6 hereof had such allegedly infringing product been sold as a Product
or
Marketed Product under this Agreement or (y) fifty percent (50%) of the
remainder of such Recovery or (b) if lost profits are recovered, the greater
of
(x) twenty-five percent (25%) of the remainder of such Recovery or (y) the
royalty Wyeth would have received hereunder on an amount of Net Sales that
would
generate a profit for DOV in the amount of the remainder of such Recovery,
and,
in the case of either (a) or (b) above, the remaining amount of such Recovery
shall be retained by DOV.
In
the
event that (i) Wyeth elects not to enforce the Wyeth Secondary Patents against
a
third party alleged to be infringing such Wyeth Secondary Patents as a result
of
the manufacture, use, import or sale of a Product or Marketed Product in the
Field, (ii) Wyeth does not permit DOV to enforce the Wyeth Secondary Patents
against such third party, (iii) neither Wyeth nor DOV (nor any of DOV’s
Affiliates, licensees or sublicensees) have taken, are taking or plan to take
action against such third party to enforce a Wyeth Primary Patent or a patent
owned or controlled by DOV or any of DOV’s Affiliates, licensees or
sublicensees, and (iv) during a given calendar quarter the units of the
allegedly infringing product being sold in the country where such infringement
is occurring amount to twenty-five percent (25%) or greater of the sum of the
units of Product, Marketed Product and such allegedly infringing product being
sold in such country, then the royalty payable by DOV to Wyeth under
Article
6.3
hereof
for sales made in such country during such calendar quarter shall be reduced
to
fifty percent (50%) of the royalty that would otherwise be payable under
Article
6.3
hereof
with respect to sales during such calendar quarter of Product or Marketed
Product in the country where such infringement is occurring.
15
| 12.2. |
DOV
Patents.
|
| (i) |
Prosecution
and Maintenance.
DOV shall be responsible, at its own expense, for the preparation,
filing,
prosecution and maintenance (including, without limitation, any
interferences, oppositions, reissue proceedings and reexaminations)
of the
DOV Patents. Wyeth shall reasonably consult with DOV with respect
to the
preparation, filing, prosecution and maintenance of the DOV Patents.
DOV
shall keep Wyeth advised of the status of such activities and shall
also
inform Wyeth in a timely manner of any material communications DOV
receives from the relevant patent office with respect to such activities.
DOV shall give notice to Wyeth of any desire to cease preparation,
filing,
prosecution or maintenance of any DOV Patent on a country-by-country
basis, and in such case, to the extent not in conflict with DOV’s
obligations under any agreement under which DOV has licensed such
DOV
Patent to a third party for use in the Field (as of the Signature
Date or
thereafter), Wyeth shall have the right to elect to continue preparation,
filing, prosecution and maintenance of such DOV Patent. In the event
that
Wyeth elects to continue any such activities for such DOV Patent,
Wyeth
shall reasonably consult with DOV with respect thereto and shall
consider
in good ▇▇▇▇▇ ▇▇▇▇▇’▇ reasonable views with respect to such activities,
and DOV agrees to transfer to Wyeth all information reasonably requested
by Wyeth for Wyeth to conduct such activities and to otherwise reasonably
cooperate with Wyeth in such actions. Wyeth shall keep DOV advised
of the
status of such actions and shall also inform DOV in a timely manner
of any
material communications Wyeth receives from the relevant patent office
with respect to such activities. Each party shall bear its own costs
with
respect to any preparation, filing, prosecution and maintenance of
any DOV
Patent for which it is responsible.
|
| (ii) |
Enforcement.
Each party shall promptly inform the other party of any suspected
infringement of any of DOV Patents by a third party and provide the
other
party with any available evidence of such suspected infringement.
DOV
shall have the sole right, but not the obligation, to institute any
claim,
suit or proceeding against an infringer or a presumed infringer of
the DOV
Patents in the Field, and the first right, but not the obligation,
to
institute any claim, suit or proceeding against an infringer or a
presumed
infringer of the DOV Patents in the Retained Rights Field. DOV, at
its
sole expense, 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, provided,
however,
that DOV shall have no right to diminish any of the rights granted
to
Wyeth hereunder in settling or disposing of any such claim. Wyeth
shall
provide DOV with all reasonable assistance (other than financial),
at
DOV’s expense, required to institute and maintain such
proceedings.
|
16
In
the
event that DOV fails to initiate action to obtain a discontinuance of the
alleged infringement of the DOV Patents as a result of the manufacture, use,
import or sale of a Product or Marketed Product in the Retained Rights Field
within one hundred eighty (180) days after notice is given by one party to
the
other of such alleged infringement, Wyeth, at its own expense, shall have the
right, but not the obligation, to institute negotiations or legal proceedings
with respect to such infringement. In such event, 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 (subject to
DOV’s involvement), provided,
however,
that
Wyeth shall have no right to diminish any of the rights retained by DOV
hereunder in settling or disposing of any such suit or claim.
DOV
shall provide Wyeth with all reasonable assistance (other than financial),
at
Wyeth’s expense, required to institute and maintain such
proceedings.
In
the
event either party enforces the DOV Patents against the manufacture, use, import
or sale of a Product or Marketed Product in the Retained Rights Field, and
obtains any Recovery from the alleged third party infringer, the enforcing
party
shall be entitled to retain from such Recovery the costs and expenses incurred
by it in taking action against such third party and the remainder of any
Recovery shall be retained by Wyeth if Wyeth is the enforcing party or paid
to
Wyeth if DOV is the enforcing party.
| 12.3. |
Subject
Patent Rights.
The parties acknowledge and agree that certain of the Subject Patent
Rights that each of them owns may be directed to the same inventions
concerning Product and thus may, during the course of prosecution
thereof,
contain conflicting and overlapping claims. In the event that an
interference proceeding is initiated between any of the U.S. patent
applications included within the Subject Patent Rights, the parties
agree
to meet to discuss a process to amicably resolve such interference
and to
cooperate in the resolution thereof, in each case, with the goal
of having
a U.S. patent issue to the assignee of the first inventor of the
invention
claimed by such conflicting claims, such patent to be subject to
the
licenses granted under Article
2.0
without payment of any additional
consideration.
|
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 ▇▇▇▇-▇▇▇▇▇-▇▇▇▇▇▇ 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 on a country by country basis until
the
later of (i) subject to Article
12.1(iii),
the last to expire of any valid and enforceable claims that are now
issued
or that issue at any time during the term of this Agreement under
the
Wyeth Patents, Subject Patent Rights and/or any DOV
Patents in
such country covering the use or sale of Marketed Product sold in
such
country, or (ii) a period of ten (10) years following the launch of
Marketed Product by DOV or any of its sublicensee(s) in such
country.
|
17
| 13.2. |
Upon
expiration of this Agreement with respect to a Marketed Product in
a
country of the Territory, the obligations of the parties under
Article
3.4
with respect to such Marketed Product in such country shall no longer
apply and DOV shall be deemed to have a fully-paid, royalty-free,
non-exclusive license with the right to make or have made, use or
sell
Product and Marketed Product in such country 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 and performing any obligations that survive expiration
of
this Agreement in accordance with Article
18.7.
|
| 13.3. |
Subject
to Article
18.7,
DOV shall be free to terminate its rights and obligations under this
Agreement and surrender and return to Wyeth all rights acquired by
DOV
hereunder at any time upon ninety (90) days’ prior written notice to Wyeth
at which time all license rights granted by Wyeth to DOV hereunder
shall
come to an end. Upon Wyeth’s request after any such termination, DOV shall
assign to Wyeth all regulatory filings and approvals pertaining to
any
Product or Marketed Product and transfer to Wyeth all data and information
in DOV’s possession in connection therewith. Such termination shall have
no affect on the licenses granted by DOV to Wyeth under
Article
2.4
(subject to Article
3.4).
|
| 13.4. |
In
the event that a party hereto breaches any material condition herein
contained, the other party may provide a formal written notice of
such
breach, requesting rectification within a sixty (60) day period from
the
date of receipt of such notice. The party alleged to be in breach
of this
Agreement shall either submit a commercially reasonable plan for
rectification within forty-five (45) days of receipt of notice (if
the
breach cannot be rectified within the sixty (60) day period), or
take
appropriate steps to remedy the breach if capable of remedy within
such
sixty (60) day period. If within the said sixty (60) 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 to it hereunder, by written
notice
to the other party, such termination having immediate effect. Upon
Wyeth’s
request after any such termination by ▇▇▇▇▇, ▇▇▇ shall assign to
Wyeth all
regulatory filings and approvals pertaining to any Product or Marketed
Product and transfer to Wyeth all data and information in DOV’s possession
in connection therewith. Any termination under this Article
13.4
shall have no affect on the licenses granted to Wyeth under
Article
2.4
(subject to Article
3.4).
|
18
| 13.5. |
This
Agreement may be terminated at once by Wyeth giving notice to DOV
if DOV
has committed an act of bankruptcy or an order is made or resolution
passed for the winding up of DOV. Upon Wyeth’s request after any such
termination by ▇▇▇▇▇, ▇▇▇ shall assign to Wyeth all regulatory filings
and
approvals pertaining to any Product or Marketed Product and transfer
to
Wyeth all data and information in DOV’s possession in connection
therewith. Any termination under this Article
13.5
shall have no affect on the licenses granted by DOV to Wyeth under
Article
2.4
(subject to Article
3.4).
|
| 13.6. |
In
the event this Agreement is terminated prior to its full term pursuant
to
Article
13.3
by
DOV or pursuant to Articles
13.4
or
13.5
by
▇▇▇▇▇, ▇▇▇ shall within thirty (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
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 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.
|
| 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
|
|
50▇
▇▇▇▇▇▇ ▇▇▇▇
|
|
|
▇▇▇▇▇▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
|
|
|
Attn:
Senior Vice President, Licensing
|
|
|
With
a copy to:
|
|
|
Wyeth
Pharmaceuticals
|
|
|
50▇
▇▇▇▇▇▇ ▇▇▇▇
|
|
|
▇▇▇▇▇▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
|
|
|
Attn:
Vice President and Chief Counsel, Global Business
Development
|
19
|
If
to DOV:
|
DOV
Pharmaceutical, Inc.
|
|
15▇
▇▇▇▇▇▇ ▇▇.
|
|
|
▇▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
|
|
|
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, or in connection with the acquisition (whether
by
merger, consolidation, sale or otherwise) of a party or that part
of such
party’s business to which this Agreement relates), 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.
|
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 Schedule and Exhibits 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 Prior Amended and Restated 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.
|
20
| 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 shall 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 Schedule 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,
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,
including, without limitation, Articles
2.2,
2.4,
3.4,
8.2
-
8.4,
12.3,
14.2
(with respect to activities occurring prior to such expiration or
termination),
14.3
(with respect to activities occurring prior to such expiration or
termination) and
14.4
and Articles 6 (with respect to any payments resulting from activities
arising prior to such expiration or termination), 7, 10, 11, 15,
16 and
18.
|
| 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.
|
[remainder
of this page intentionally left blank]
21
| WYETH HOLDINGS CORPORATION | DOV PHARMACEUTICAL, INC. | ||
| /s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇ | /s/ ▇▇▇▇▇ ▇▇▇▇▇ | ||
|
NAME:▇▇▇▇▇▇ ▇. ▇▇▇▇▇ |
NAME: ▇▇▇▇▇ ▇▇▇▇▇ |
||
|
TITLE:
Vice
President
DATE: December 7, 2006 |
TITLE:
Senior Vice President
DATE:
December 7, 2006
|
| WYETH,
acting through its
Wyeth
Pharmaceuticals Division
|
|||
| /s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇ | |||
|
NAME:
▇▇▇▇▇▇ ▇. ▇▇▇▇▇
|
|||
|
TITLE:
Vice
President
DATE:
December
7, 2006
|
SCHEDULE
1
Product
BICIFADINE,
CL 220,075
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
US
2006/0020014 A1
US
2006/0020015 A1
US
2006/0019966 A1
EXHIBIT
B
DOV
Patents
US
7,094,799B2
US
2006/0100263
US
60/702,800
EXHIBIT
C
Subject
Patent Rights
Certain
Wyeth Patents:
US
2006/0020014 A1
US
2006/0020015 A1
US
2006/0019966 A1
Certain
DOV Patents:
US
2006/0100263
US
60/702,800