EXHIBIT 10.1
***Confidential treatment has been requested for
portions of this exhibit. The
copy filed herewith omits the information subject to the confidentiality
request. Omissions are designated as [***].
A complete version of
this exhibit
has been filed separately with the
Securities and Exchange Commission.
[LOGO] Restricted Confidential
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EXECUTION COPY
EXCLUSIVE LICENSE, DEVELOPMENT AND
COMMERCIALIZATION AGREEMENT
BY AND BETWEEN
MSD WARWICK (MANUFACTURING) LTD.
AND
DOV PHARMACEUTICAL, INC.
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EXCLUSIVE LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
THIS
AGREEMENT (including
all exhibits,
schedules and other attachments,
this "Agreement"), effective as of the Closing Date
(defined below), by and
between MSD WARWICK (MANUFACTURING) LTD., a corporation organized and
existing
under the laws of Bermuda ("MERCK"), with a principal place of business at
Chesney House, 96 Pitts Bay Road, Pembroke HM 08, Bermuda and DOV
Pharmaceutical, Inc., a corporation organized and existing under the laws of
Delaware, with a principal place of business at 433 Hackensack Avenue,
Hackensack, NJ 07601 ("DOV").
RECITALS:
WHEREAS,
DOV has developed DOV
Know-How (as hereinafter defined) and has
rights to DOV Patent Rights (as hereinafter
defined); and
WHEREAS,
MERCK and DOV desire to enter into a collaboration to develop
the
Compound (as hereinafter defined) upon the terms and conditions set forth
herein; and
WHEREAS,
MERCK desires to obtain a license under the DOV Patent Rights
and
DOV Know-How, upon the terms and conditions set
forth herein and DOV desires to
grant such a license; and
WHEREAS,
MERCK desires to obtain a right of first
refusal to obtain
the
rights to develop DOV 102,677 for the
treatment and/or prevention of anxiety
and/or depression;
NOW,
THEREFORE, in
consideration of the foregoing premises and the mutual
covenants herein contained, the Parties
hereby agree as follows:
1. DEFINITIONS
Unless
specifically set forth to the contrary herein, the following
terms,
whether used in the singular or plural,
shall have the
respective meanings
set
forth below:
1.1 "ACT" shall mean, as
applicable, the United
States Federal Food, Drug and
Cosmetic
Act, 21 U.S.C. ss.ss. 301 et seq., and/or the Public Health
Service
Act, 42 U.S.C.
ss.ss. 262 et seq., as such may be amended from
time to
time.
1.2 "AFFILIATE" shall mean, in relation to a
Party, any corporation or entity
that,
directly or indirectly owns, is owned by or is under common
ownership
with such Party. For purposes of this definition, the term
"own"
(as used in the
terms "owns,"
"owned by" and "under
common ownership")
means
direct or indirect
beneficial or legal
ownership of fifty
percent
(50%) or
more of the voting interest in, or fifty percent (50%) or more
of
the equity
of or the right to appoint fifty percent (50%) or more of the
directors
or managers of that
corporation or other business entity or the
power to
direct or cause the direction of the management and policies of
such
corporation or entity,
whether pursuant to the ownership of
voting
securities, by contract or otherwise.
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1.3 "ASYMMETRIC PROCESS" shall
mean, (i) with regard to the manufacture of DOV
21,947 , a
process whereby no significant amount of DOV 102,677 is created
and (ii)
with regard to the manufacture of DOV 102,677, a process whereby
no
significant amount of DOV 21,947 is created.
1.4 "BANKRUPTCY EVENT" is
defined in Section 9.3.2.
1.5 "CALENDAR QUARTER" shall mean the respective periods of three (3)
consecutive calendar
months ending on March 31, June 30, September 30 and
December
31.
1.6 "CALENDAR YEAR" shall mean each successive period of twelve (12) months
commencing
on January 1 and ending on December 31.
1.7 "CHANGE OF CONTROL" is
defined in Section 12.2.
1.8 "CLINICAL TRIAL" shall mean a Phase I
Clinical Trial,
Phase II Clinical
Trial,
Phase III Clinical Trial and/or Phase IV Clinical Trial.
1.9 "CLOSING DATE" shall mean
the date upon which the HSR Conditions have been
met.
1.10 "COLLABORATION TERM" shall mean the duration of the Collaboration, as
described
more fully in Section 2.7.
1.11 "COLLABORATION" shall mean the
activities undertaken by the Parties hereto
as set
forth in Article 2.
1.12 "COMBINATION DRUG" shall mean a Product that
includes one or more
active
ingredients other
than Compound in combination with Compound. All
references
to Product in this Agreement shall be deemed to include
Combination Drug.
1.13 "COMMERCIALLY REASONABLE EFFORTS" shall mean with respect
to the efforts
to be
expended by a Party with respect to any objective, reasonable,
diligent,
good faith efforts to
accomplish such
objective as such
Party
would
normally use to accomplish a similar objective under similar
circumstances, it
being understood
and agreed that with
respect to the
research,
development or
commercialization of
Compound or Product,
such
efforts
shall be substantially
equivalent to those
efforts and resources
commonly
used by a Party for a similar pharmaceutical product owned by
it
or to
which it has rights,
which product is at a similar stage in its
development or product life and is of similar market potential
taking into
account
efficacy, safety, approved labeling, the competitiveness of
alternative products in the marketplace, the patent and other
proprietary
position
of the product, the
likelihood of regulatory approval given the
Regulatory
Authority involved,
the profitability of the product including
the
royalties payable to licensors of patent or other intellectual
property
rights, alternative products and other relevant factors.
Expenditures by MERCK
for development of the Product or Compound that are
comparable
to expenditures by MERCK for similar products or compounds at a
similar
commercial
value and stage of
development
shall be evidence
of
Commercially Reasonable Efforts. Commercially Reasonable Efforts
shall be
determined
on a market-by-market and Indication-by-Indication basis for a
particular
Compound or Product,
and it is anticipated
that the level of
effort
will be different for different markets, and will change over
time,
reflecting
changes in the status of the Product and the market(s)
involved.
The royalties and other payments made or required to be
made
hereunder
or under the Wyeth Agreement shall not be factors in
determining
whether
a Party has used
Commercially
Reasonable
Efforts, (that is, a
Party may
not apply lesser resources or efforts in support of a Product
or
Compound
because such Product or Compound is subject to a royalty on
sales
or to any
other payments under this Agreement or the Wyeth Agreement).
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1.14 "COMMITTEE" shall mean the joint development committee established to
facilitate
the Collaboration, as more fully described in Section 2.3.1.
1.15 "COMPOUND" shall mean DOV 21,947,
and/or DOV 216,303.
For avoidance of
doubt,
"Compound" does not include DOV 102,677.
1.16 "CONFIDENTIAL INFORMATION" shall mean any
Information disclosed by either
Party that
such Party has either marked as confidential or proprietary, or
has
identified in writing as confidential or proprietary within thirty
(30) days
of disclosure
to the other
Party ; provided, however, that
(subject
in all cases to
Article 4 below,
including without
limitation
Sections
4.2 and 4.4) information regarding the Collaboration, or a
disclosing
Party's business plans, strategies, technology, manufacturing,
research
and development, and products or services shall be deemed
Confidential
Information of the disclosing Party even if not so marked or
identified.
1.17 "CONTROL", "CONTROLS" OR "CONTROLLED
BY" shall mean, with
respect to any
item of or
right under DOV Patent
Rights, DOV Know-How, MERCK Patent
Rights,
MERCK Know-How or
MERCK Termination
Know-How, the
possession of
(whether
by ownership or license, other than pursuant to this
Agreement),
or the
ability of a Party and/or its Controlled Affiliates to grant
access
to, or a
license or sublicense
of, such item or right 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 required
hereunder
to grant the other
Party such access or license or sublicense.
For
avoidance of doubt,
intellectual property
rights that are Controlled
by a
Controlled Affiliate
of a Party shall be deemed to be Controlled by
such
Party.
1.18 "CONTROLLED AFFILIATE" shall mean,
in relation to a Party, any corporation
or entity
that, directly or
indirectly controls,
is controlled by or
is
under
common control with such Party. For purposes of this definition,
the
term
"control" (as used in the terms "controls," "controlled by" and
"under
common control") means direct or indirect beneficial or legal
ownership
of more than fifty percent (50%) of the voting interest in, or
more than
fifty percent (50%) of the equity of or the right to
appoint
more
than fifty percent (50%) of the directors or managers of that
corporation or other
business entity or the
power to direct or cause the
direction
of the management
and policies of such
corporation or
entity,
whether
pursuant to the
ownership of voting
securities,
by contract or
otherwise.
1.19 "CO-PROMOTION AGREEMENT" shall have the meaning
provided for in paragraph
2 of
Schedule 3.7.
1.20 "CRO" is defined in Section 2.2.1
hereof.
1.21 "DDMAC" shall mean the United
States Food and Drug Administration Division
of Drug
Marketing, Advertising, and Communications.
1.22 "DETAIL" shall mean a product
presentation in a face-to-face meeting in an
individual
or group practice setting between a professional sales
representative and a
Target Prescriber
in which one or more
key product
benefits
are verbally presented
in a balanced manner.
For avoidance of
doubt,
a Detail does not
include a reminder or sample drop. "Detailing"
shall mean
the act of presenting a Detail.
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1.23 "DOV 21,947" shall mean the compound having a chemical name
(+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane, including
all
solvates,
Prodrugs, salts and polymorphs thereof.
1.24 "DOV 102,677" shall mean the compound having a chemical name
(-)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane, including
all
solvates,
Prodrugs, salts and polymorphs thereof.
1.25 "DOV 216,303" shall mean the compound having a chemical name
(+)-1-(3,4-dichlorophenyl)-3-azabicyclo[3.1.0]hexane, including
all
solvates,
Prodrugs, salts and polymorphs thereof.
1.26 "DOV INFORMATION AND INVENTIONS"
shall mean all protocols, formulas, data,
Inventions, know-how and trade secrets, patentable or otherwise,
resulting
from the
Collaboration developed or invented solely by employees of DOV
or
other
persons not employed by MERCK acting on behalf of DOV.
1.27 "DOV KNOW-HOW" shall mean all
information and materials, including but not
limited
to discoveries, improvements, processes, methods, protocols,
formulas,
data (including data and results from research, preclinical
development and
Clinical Trials), inventions (including without limitation
DOV
Information
and Inventions and DOV's and/or any of its
Controlled
Affiliates' rights in
Joint Information
and Inventions), know-how and
trade
secrets, patentable or otherwise,
which (i) are
Controlled by DOV
and/or any
of its Controlled
Affiliates as of the
Closing Date or become
Controlled
by DOV and/or its Controlled Affiliates during the term of this
Agreement,
(ii) are not generally
known and (iii) are necessary or useful
to
MERCK in connection with the Collaboration or the research,
development, manufacture, marketing, use or sale of Compound or
Product in
the
Territory, excluding, however, any MERCK Know-How.
1.28 "DOV PATENT RIGHTS" shall mean any
and all Patent Rights Controlled by DOV
or its
Controlled Affiliates
as of the Closing Date or become Controlled
by DOV
and/or its Controlled
Affiliates during the term of this Agreement
that (i)
would be practiced by the manufacture, use, sale, offer for sale
or
importation
of Compound or Product; or (ii) claim or cover DOV
Information and
Inventions, including,
but not limited to,
those Patent
Rights
listed on Schedule 1.28.
1.29 "DRUG DEVELOPMENT PLAN" shall mean the preclinical and clinical
development plan for
Compound(s) and Product(s), developed in accordance
with the
Collaboration as described in Article 2.
1.30 "EMEA" shall mean the European Agency for the Evaluation of Medicinal
Products
(a cross-national Regulatory Authority in the European Union)
and
any
successor Governmental Authority having substantially the same
function.
1.31 "EXECUTION DATE" shall mean the
date of last execution by both Parties.
1.32 "FDA" shall mean the United States
Food and Drug
Administration, and
any
successor
Governmental Authority having substantially the same function.
1.33 "FIELD" shall mean (i) in the case of DOV
21,947, the use of DOV 21,947
and/or
pharmaceutical preparations in final form containing DOV 21,947
for
the
treatment and/or prevention and/or diagnosis of diseases and/or
medical
conditions in humans and/or animals; and (ii) in the case of
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DOV
216,303, the use of DOV 216,303 and/or pharmaceutical preparations in
final form
containing
DOV 216,303 for the
treatment and/or prevention
and/or
diagnosis of
depression,
anxiety or
addiction in humans
and/or
animals.
1.34 "FILING" of an NDA shall mean the
acceptance by a Regulatory Authority of
an NDA for
filing.
1.35 "FIRST COMMERCIAL SALE" shall
mean, with respect to any Product, the first
sale by
MERCK or a Related Party for end use or consumption of such
Product in
a country, excluding,
however, any sale or
other distribution
for use in
a Clinical Trial.
1.36 "FIRST POSITION DETAIL" shall mean
a Detail where key product messages and
benefits
are presented
in the first
position and at least
[***]% of the
time
available is spent on this presentation.
1.37 "GLP" or "GOOD LABORATORY
PRACTICE" shall mean the applicable then-current
standards
for laboratory activities for pharmaceuticals or biologicals,
as
set forth
in the Act and any regulations or guidance documents
promulgated
thereunder, as
amended from time to time, together with any similar
standards
of good laboratory
practice as are
required by any
Regulatory
Authority
in the Territory.
1.38 "GMP" OR "GOOD MANUFACTURING PRACTICE" shall mean the applicable
then-current standards for United States Good Manufacturing
Practices, as
specified in the United States Code of Federal Regulations and any
regulations or guidance documents promulgated thereunder,
as amended from
time to
time, together with
any similar standards
of good
manufacturing
practice
as are required by any Regulatory Authority in the Territory.
1.39 "GOVERNMENTAL AUTHORITY" means any government,
any governmental
entity,
department,
commission, board, agency or instrumentality, and any court,
tribunal
or judicial or arbitral body, whether federal, state or local,
including,
without limitation, the U.S. Federal Trade Commission.
1.40 "HSR ACT" means the
Hart-Scott-Rodino
Antitrust Improvements Act of 1974,
as
amended, 15 U.S.C. ss.18A.
1.41 "HSR CLEARANCE DATE" means the earliest date on which both Parties or
their
Controlled
Affiliates
have actual
knowledge that all applicable
waiting
periods under the HSR Act with respect to the transactions
contemplated hereunder have expired or have been terminated.
1.42 "HSR CONDITIONS" shall have the
meaning provided in Section 11.2.
1.43 "HSR FILING" means filings by
MERCK or its
Controlled Affiliates
and DOV
with the
United States Federal Trade Commission and the Antitrust
Division
of the
United States
Department of Justice of a Notification and Report
Form for
Certain Mergers and
Acquisitions (as that term is defined in the
HSR Act)
with respect to the matters set forth in this Agreement,
together
with all
required documentary attachments thereto.
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1.44 "IND" shall mean an
investigational new
drug application,
clinical study
application,
clinical trial
exemption,
or similar application or
submission
for approval to
conduct human clinical
investigations
filed
with or
submitted to a Regulatory Authority in conformance with the
requirements of such Regulatory Authority.
1.45 "INDICATION" shall mean the primary prophylactic and/or therapeutic
purpose
for which a Product is
developed specifically
directed towards
obtaining
Regulatory
Approval for use of such Product pursuant to an
approved
label claim. A single Indication shall include the primary
disease
and variants or sub-divisions or sub-classifications within such
primary
disease. For example,
for purposes of this
Agreement,
treatment
and/or
prevention
of anxiety is a single Indication; treatment of a
particular
phobia would be treated as a sub-classification within the
single
Indication
of anxiety. Treatment and prophylaxis of the same
general
psychiatric
disorder (e.g. anxiety) as defined by the DSM-IV
(i.e.,
Diagnosis and Statistical Manual) shall be treated as the same
Indication. However,
treatment of
depression shall be deemed a different
Indication
from treatment of anxiety.
1.46 "INFORMATION" shall mean any and all information and data, including
without
limitation all MERCK
Know-How, MERCK
Termination Know-How,
DOV
Know-How,
and all other
scientific,
preclinical, clinical,
regulatory,
manufacturing,
marketing, financial
and commercial
information or data,
whether
communicated in
writing or orally or by any other method, that is
provided
by one Party (or such Party's Controlled Affiliates) to the
other
Party in
connection with this Agreement.
1.47 "INITIATES" shall mean, with respect to a Clinical Trial, the
administration of the first dose to a patient in such Clinical
Trial.
1.48 "INVENTION" shall mean any
process, method, composition of matter, article
of
manufacture, discovery
or finding that is (i) conceived as a result of
the
Collaboration; or (ii) is conceived as a result of the practice of
DOV
Patent
Rights during or after the term of the Collaboration.
1.49 "JOINT INFORMATION AND INVENTIONS" shall mean all protocols,
formulas,
data,
Inventions,
know-how and trade
secrets, patentable or otherwise,
resulting
from collaborative
activities
occurring prior to the Closing
Date, or
during the
Collaboration or
resulting from the
practice of the
DOV Patent
Rights during or after the term of the Collaboration developed
or
invented jointly by employees of MERCK and DOV or others
acting on
behalf of
MERCK and DOV.
1.50 "JOINT PATENT RIGHTS" shall mean any and all
Patent Rights that claim or
cover any
Joint Information or Inventions.
1.51 "LAUNCH DATE" shall mean the date
subsequent
to receiving the
necessary
Regulatory
Approvals in the
United States when the
Parties will initiate
Detailing
activities in the
United States, as such
date is determined by
MERCK.
1.52 "MAJOR MARKET" shall mean any one of the following countries: United
States,
Japan, the United Kingdom, France, Germany, Italy or Spain.
1.53 "MARKETING AUTHORIZATION" shall mean (i) for the United States, the
approval
of an NDA, and (ii)
for any foreign
jurisdiction, the
approval
from the
relevant Regulatory Authority necessary to market and sell a
Product in
that country,
including, without
limitation,
all applicable
pricing
and government reimbursement approvals.
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1.54 "MERCK INFORMATION AND INVENTIONS" shall mean all protocols,
formulas,
data,
Inventions,
know-how and trade
secrets, patentable or otherwise,
resulting
from the Collaboration or resulting from the practice of DOV
Patent
Rights during or after the term of the Collaboration, developed or
invented
solely by employees of MERCK or other persons not employed by
DOV
acting on
behalf of MERCK.
1.55 "MERCK KNOW-HOW" shall mean all
information and materials, including but
not
limited to discoveries, improvements, processes, methods, protocols,
formulas,
data (including data and results from research, preclinical
development and Clinical Trials), inventions (including without
limitation
MERCK
Information and
Inventions and MERCK's and/or any of its Controlled
Affiliates' rights in
Joint Information
and Inventions), know-how and
trade
secrets, patentable or otherwise, which during the term of this
Agreement,
(i) are Controlled by MERCK and/or any of its Controlled
Affiliates, (ii) are not generally known and (iii) are necessary or
useful
to DOV in
connection with the Collaboration.
1.56 "MERCK PATENT RIGHTS" shall mean any and all
Patent Rights
Controlled by
MERCK
and/or any of MERCK's Controlled Affiliates, that (i) would be
practiced
by the manufacture,
use, sale, offer for sale or importation of
Compound
or Product; or (ii) claim or cover MERCK Information and
Inventions
or MERCK's rights in Joint Information and Inventions.
1.57 "MERCK TERMINATION KNOW-HOW" shall mean all information and materials,
including
but not limited to discoveries, improvements, processes,
methods,
protocols,
formulas, data (including data and results from
research,
preclinical
development
and Clinical Trials), inventions
(including
without limitation MERCK Information and Inventions and MERCK's
and/or any
of its Controlled
Affiliates' rights in
Joint Information and
Inventions), know-how
and trade secrets,
patentable or otherwise, which
during the
term of this Agreement, (i) are Controlled by MERCK and/or
any
of MERCK's
Controlled Affiliates,
(ii) are not generally known, and (iii)
are
necessary for the research, development, manufacture, marketing, use
or sale of
Compound or Product in the Territory, excluding, however, any
DOV
Know-How. The MERCK Termination Know-How shall include the
information
of the type set
forth in Schedule 1.57.
1.58 "MOTHER LIQUOR" shall mean a liquid stream (i)
containing
the negative
isomer
after recovery of the desired positive isomer, or (ii) containing
the
positive isomer after recovery of the desired negative isomer.
1.59 "NDA" shall mean a New Drug
Application or Biologics License Application
submitted
to the FDA, or a
Worldwide Marketing Application, Marketing
Authorization
Application or similar
application filed with a Regulatory
Authority
to obtain approval for marketing a biological or pharmaceutical
product in
a foreign country or group of countries.
1.60 "NET SALES" shall mean the gross
invoice price of Product sold by MERCK or
any
Related Party to the first Third Party, after deducting, if not
previously
deducted, from the amount invoiced or received:
(a) trade
and quantity
discounts actually allowed or taken other than
early pay
cash discounts;
(b)
amounts allowed or
taken by reason of returns, rebates, chargebacks
and other
allowances;
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(c)
retroactive price
reductions that are actually allowed or granted and
that are
specifically identifiable as relating to Products; and
(d) a
fixed amount equal to [***] percent ([***]%) of the amount
invoiced
to cover
bad debt, sales or
excise taxes, early
payment cash
discounts,
custom
duties, and other governmental charges, sales commissions paid to
Third
Party distributors and/or selling agents, and the cost of devices
or
delivery
systems used for dispensing or administering Product;
With
respect to sales of Combination Drugs, Net Sales shall be
calculated
on the
basis of the gross invoice price of Product(s) containing the same
strength
of Compound sold without other active ingredients. In the event
that
Product is sold only as a Combination Drug, (y) with respect to any
Combination Drug in
which Compound
is combined only with one or more
active
ingredients
the manufacture, use, sale, offer for sale or
importation of which
active ingredient(s)
would not practice any
Patent
Right
Controlled by MERCK, MERCK's Controlled Affiliates or a Third
Party,
Net Sales
shall be calculated
on the basis of the
gross invoice price of
the
Combination Drug and (z) with respect to any Combination Drug in
which
Compound
is combined only with one or more active ingredients the
manufacture, use sale,
offer for sale or importation of which active
ingredient(s) would practice any Patent Right Controlled by MERCK,
MERCK's
Controlled
Affiliates, or a Third Party, DOV and MERCK shall, prior to any
sales
of such Combination Drug, negotiate in good faith to agree in
writing on
the relative value of Compound and each other active ingredient
in such
Combination Drug,
which determination
shall be based upon
sales
prices for comparable products. Such relative value(s) shall be used in
calculating Net Sales.
The deductions set forth in paragraphs (a) through
(d) above
will be applied in calculating Net Sales for a Combination
Drug.
1.61 "PARTY" shall mean MERCK and DOV,
individually,
and "PARTIES" shall
mean
MERCK and
DOV, collectively.
1.62 "PATENT RIGHTS" shall mean patents and patent applications in the
Territory
(which for the
purposes of this
Agreement shall be deemed to
include
certificates of
invention and
applications for
certificates of
invention), including provisionals,
divisions,
continuations,
continuations-in-part, reissues, renewals, extensions, supplementary
protection
certificates,
and the like of any
such patents and patent
applications, and
foreign equivalents
thereof, and shall include patents
whose term
has been extended
by statutory patent term adjustments or
extensions
in any jurisdiction in the Territory, including but not limited
to those
patent term
adjustments and
extensions granted
under 37 C.F.R.
ss.ss.
1.701 - 1.705, 35 U.S.C. ss. 154(b), or 35 U.S.C. ss. 156.
1.63 "PIVOTAL CLINICAL TRIAL" shall mean an adequate and well-controlled
Clinical
Trial designed to demonstrate efficacy of a Product intended to
form the
basis of Filing an NDA .
1.64 "PHASE I CLINICAL TRIAL" shall mean a human clinical
trial in any country
that would
satisfy the requirements of 21 CFR 312.21(a).
1.65 "PHASE II CLINICAL TRIAL" shall
mean a human clinical trial in any country
that would
satisfy the requirements of 21 CFR 312.21(b).
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*** CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO THIS MATERIAL.
1.66 "PHASE III CLINICAL TRIAL" shall mean a human clinical trial in any
country
that would satisfy the requirements of 21 CFR 312.21(c).
1.67 "PHASE IV CLINICAL TRIAL" shall mean a human clinical
trial following the
approval
of an NDA,
including any human clinical trial in any country
consistent
with the description set forth in 21 CFR 312.85.
1.68 "PRODRUG" shall mean a compound
that, upon metabolism
within the body, is
converted
to DOV 21,947, DOV 216,303 or DOV 102,677, the in vivo
pharmacological activity of which substantially
derives from the in
vivo
presence
of the DOV 21,947, DOV 216,303 or DOV 102,677, respectively,
into
which the
compound is converted.
1.69 "PRODUCT(S)" shall mean any pharmaceutical preparation in final form,
including
without limitation any Combination Drug, containing Compound
(i)
for sale
by prescription,
over-the-counter or
any other method, or
(ii)
for
administration to human patients in a Clinical Trial.
1.70 "REGULATORY AUTHORITY" shall mean any applicable
government
regulatory
authority,
including the FDA in the United States and the EMEA in the
European
Union, involved in granting approvals for manufacturing and
marketing
a Product in the United States, or for manufacturing,
marketing,
reimbursement and/or
pricing of a Product in any other country in the
Territory.
1.71 "RELATED PARTY" shall mean each of MERCK, its Affiliates, and their
respective
sublicensees (which
term does not include distributors to whom
MERCK
sells, without
restriction,
Product or Compound),
as applicable;
provided,
however, that a manufacturer that is sublicensed by MERCK
solely
for the
purpose of
manufacturing (and not
for the purpose of developing,
marketing
or selling) Compound or Product for MERCK and whose Patent
Rights are
not Controlled by Merck shall not be deemed a "Related Party".
1.72 "SPECIALIST" shall mean a psychiatrist or neurologist, or such other
specialist
medical or health care
professional
authorized
to prescribe
Product
under the laws of the jurisdiction in which such medical or
health
care
professional
is practicing,
to the extent that
such psychiatrist,
neurologist or other specialist is approved by MERCK.
1.73 "SPECIALTY SALES REPRESENTATIVES" shall mean employees of DOV
performing
the sales
promotion of pharmaceutical products to Target Prescribers.
1.74 "SUCCESSFUL COMPLETION" of a Pivotal Clinical Trial shall mean the
achievement of a [***] and [***].
1.75 SYMMETRIC PROCESS" shall mean, (i) with
regard to the
manufacture of DOV
21,947, a
process whereby a significant amount of DOV 102,677 is made,
and
(ii) with
regard to the
manufacture of DOV 102,677, a process whereby a
significant amount of DOV 21,947 is made
1.76 "TARGET PRESCRIBER" shall mean a
Specialist identified
as a member of the
target
audience to whom DOV
shall direct a Detail as determined by MERCK
in its
marketing plans for Product.
1.77 "TERRITORY" shall mean all of the countries in the world, and their
territories and possessions.
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1.78 "THIRD PARTY" shall mean an entity other than MERCK and its Related
Parties, and DOV and its
Affiliates.
1.79 "VALID PATENT CLAIM" shall mean a claim of an issued
patent included
within the
DOV Patent Rights or Joint Patent Rights that claims the use or
composition of matter
of Compound
or Product, or a claim of an issued
patent
included within the MERCK Patent Rights
that claims a composition
of matter
of Compound or Product, the term and statutory
extensions,
if
any,
of which patent have not yet expired, which claim has not been
revoked or
held unenforceable or invalid by a decision of a court or other
governmental agency of
competent jurisdiction (which decision is not
appealable
or has not been
appealed within the
time allowed for appeal),
and which
claim has not been disclaimed, denied or admitted to be
invalid
or
unenforceable
through
reissue, re-examination or disclaimer or
otherwise.
1.80 "WYETH" shall mean Wyeth Holdings
Corporation, a Maine corporation.
1.81 "WYETH AGREEMENT" shall mean the certain
Amended and
Restated License
Agreement
between DOV and Wyeth, effective as of May 29, 1998, relating
to
the
license of DOV 216,303, as amended and restated on February 25,
2004.
2. COLLABORATION
2.1 DRUG DEVELOPMENT PLAN.
DOV and
MERCK shall engage in the Collaboration upon the terms and
conditions set forth in this Agreement. The activities to be undertaken in
the
course of the Collaboration shall be set forth in the Drug
Development Plan set
forth as Schedule 2.1 and incorporated by
reference herein. The Drug Development
Plan is subject to modification by MERCK, subject in all respects to and in
accordance with the terms and conditions of
this Agreement. MERCK
shall present
any modifications (and if timing permits proposed
modifications)
of the Drug
Development Plan to the Committee for
review and discussion,
and shall consider
in good faith DOV's input with regard to such modifications. The Drug
Development Plan shall include the preclinical
development
and pre-Marketing
Authorization Clinical Trials that MERCK plans
to conduct, and shall
include a
plan describing with specificity the
Clinical Trials to be undertaken to achieve
the Development Milestones and Product Profile
Milestones set forth in Sections
5.3 and 5.4, and the projected time frame for these Clinical Trials. For
avoidance of doubt, MERCK shall have the right to
reasonably
determine the
appropriate Clinical Trials to be performed to
achieve Development
Milestones
and Product Profile Milestones.
Notwithstanding anything herein to the contrary,
the Drug Development Plan shall provide for conducting Clinical Trials the
successful outcome of which will result in
the achievement
of the milestones
provided for in Sections 5.3(a) and 5.4 of this
Agreement,
where the Clinical
Trials are adequately designed and powered to provide data that has both
statistical and clinical significance.
2.2 CONDUCT OF
COLLABORATION.
2.2.1 MERCK shall be responsible for all
formulation,
preclinical
development,
clinical
development and
regulatory work, and
manufacturing of
clinical
supplies
pursuant
to the Drug Development Plan. Merck shall use
Commercially
Reasonable Efforts to
perform the Drug
Development
Plan.
MERCK
shall be responsible
for all regulatory
activities, both prior
to
and after
obtaining Marketing Authorization, including global safety
reporting.
MERCK shall be entitled to utilize the services of Third
Parties to
perform its Collaboration activities. To the extent MERCK
determines
to use DOV as a Contract Research Organization ("CRO"), such
activities
shall be pursuant to
an agreement
containing customary
terms
and
conditions and commercial terms negotiated in good faith between
the
Parties.
Pursuant to such an
agreement, DOV shall use only Clinical Trial
facilities
approved in advance by
MERCK, and shall be entitled to utilize
the
service of Third Parties to perform its activities as a CRO only upon
MERCK's
prior written
consent. Notwithstanding any such consent, each
Party
shall remain at all times fully liable for its respective
responsibilities under the Collaboration.
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2.2.2 DOV and MERCK shall conduct any activities that either Party performs
pursuant
to the Collaboration
in compliance
with all applicable laws,
rules and
regulations,
including,
without limitation, Good Laboratory
Practice
and Good Manufacturing Practice, to the extent applicable.
It is
not
contemplated
that DOV shall use
animals in performing its activities
under the
Collaboration.
Each Party hereby certifies that it has not
employed
or otherwise used in any capacity, and will not employ or
otherwise
use in any capacity,
the services of any person debarred under
United
States law, including
but not limited to 21 U.S.C. ss. 335(a), in
performing
any portion of the Collaboration.
2.3 JOINT DEVELOPMENT
COMMITTEE.
The Parties hereby
establish a committee to
facilitate
the Collaboration as follows:
2.3.1 COMPOSITION OF THE JOINT DEVELOPMENT
COMMITTEE. The Collaboration shall be
conducted
under the direction of a joint development committee (the
"Committee") comprised
of three representatives of MERCK and three
representatives of
DOV. Each Party may change its representatives to the
Committee from time to time, in
its sole discretion, effective upon notice
to the
other Party of such change. These representatives shall have
appropriate technical credentials, experience and knowledge,
and ongoing
familiarity with
the Collaboration. Additional representatives or
consultants may from
time to time, by mutual consent of the Parties,
be
invited to
attend Committee meetings, subject to such representative's
or
consultant's written
agreement to comply with the requirements of Article
4. The
Committee shall be chaired by a representative of MERCK, and MERCK
will have
final decision
making authority on all issues
related to the
research,
development, regulatory
approval,
manufacturing
and
commercialization of
Compounds and
Products. DOV shall have a right to
review and
provide comments on the Drug Development Plan, and in the event
DOV has a
substantive dispute in
regard to the Drug Development Plan, the
Parties'
representatives may refer the issue in dispute to the
appropriate
Executive
Vice President, MERCK
Research Laboratories,
for MERCK and the
Chief
Executive Officer for DOV. In the event that the appropriate
Executive
Vice President of MERCK Research Laboratories or the Chief
Executive
Officer of DOV requests, in writing within fifteen (15)
business
days after
the referral
of the dispute to such
parties, or within such
extended period
agreed upon by such executives, such executives shall meet
in-person
to attempt to resolve
the dispute.
If unresolved, the final
resolution
and/or course of conduct shall be determined by MERCK's
President,
MERCK
Research Laboratories, in such executive's sole
discretion. Each
Party shall bear its own expenses related to the
attendance
of such meetings by its representatives. Each Party shall
provide
Committee members with reasonable access
during regular business
hours
to all its records and documents that are related to the
Collaboration or to the development of the Product.
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2.3.2 MEETINGS. The Committee shall meet in accordance with a schedule
established by
mutual written agreement of the Parties, but no less
frequently
than once per
Calendar Quarter, with the location for such
meetings
alternating
between DOV and MERCK facilities (or such other
location
as may be determined by the Committee). Alternatively, the
Committee
may meet by means of
teleconference,
videoconference or
other
similar
communications equipment. The Committee shall confer regarding
the
status of
the Collaboration,
review relevant data and the progress of the
Drug
Development
Plan, consider and advise on any
technical issues that
arise
relating to the
Collaboration
that may be referred
to, or invited
for
referral by, the Committee. MERCK will provide DOV with copies
of any
minutes
taken of Committee meetings.
2.4 EXCHANGE OF INFORMATION. DOV shall transfer copies of all documents and
materials Controlled by DOV or DOV's
Controlled
Affiliates
embodying the DOV
Know-How and the subject matter of the DOV Patent Rights to
MERCK within thirty
(30) days after the Closing Date of this Agreement (the "Initial Transition
Period") and provide MERCK reasonable
technical support from DOV technical and
scientific personnel during this the Initial
Transition Period
relating to the
use of such DOV Know-How and the practice
of such DOV Patent
Rights, solely to
the extent permitted under the licenses
granted to MERCK
herein. Following
the
Initial Transition Period, from time to time upon MERCK's
reasonable
request,
DOV shall provide reasonable technical
support from DOV technical and scientific
personnel, relating to the use of DOV
Know-How and the practice of DOV Patent
Rights, solely to the extent permitted under the licenses granted to MERCK
herein. In furtherance of the foregoing,
DOV shall cooperate with MERCK, and
shall cause its Controlled Affiliates and
Third Party manufacturers to cooperate
with MERCK, in order to accomplish an orderly transition of manufacturing
technology for Compound to MERCK.
2.5 RECORDS AND REPORTS.
2.5.1 DOV RECORDS. If DOV is utilized as a CRO, DOV
shall maintain records, in
sufficient
detail and in good scientific manner appropriate for patent and
regulatory
purposes, which shall
fully and properly reflect all work done
and
results achieved in the performance of the Collaboration by
DOV.
2.5.2 COPIES AND INSPECTION OF RECORDS. MERCK shall have the right, during
normal
business hours and upon reasonable notice, to inspect and copy
all
such
records of DOV
referred to in Section
2.5.1. MERCK shall
maintain
such
records and the information disclosed therein in confidence in
accordance
with Section 4.1. MERCK shall have the right to arrange for its
employees
and/or consultants involved in the activities contemplated
hereunder
to visit the
offices and laboratories of DOV and any of its
Third
Party contractors
as permitted under Section 2.2 during normal
business
hours and upon reasonable notice, to discuss the Collaboration
work and
its results
in detail with the technical personnel and any
permitted
Third Party contractors of DOV. Upon request, DOV shall provide
copies of
the records described in Section 2.5.1.
2.5.3 QUARTERLY REPORTS. The Parties shall each prepare a
written report, which
shall be
delivered to the other Party at least fifteen (15) days prior to
each
quarterly meeting of the Committee, which report shall inform the
Committee
of the work performed to date on the Collaboration, evaluate
the
work
performed in relation to the goals of the Collaboration and provide
such other
information as may be reasonably requested by the Committee (a
"Collaboration
Quarterly Report").
The MERCK Collaboration Quarterly
Report
shall include
Information in sufficient detail that performance by
MERCK of
the Drug Development Plan and progress achieved in performing
the
Drug
Development Plan may be ascertained.
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2.5.4 LDRC AND EDRC REPORTS. Only to the extent applicable to Compounds and
Products,
during the Collaboration Term, MERCK shall provide to DOV
progress
reports provided in accordance
with MERCK's
regular business
practices
to MERCK's Early Development Review Committee ("EDRC") and
Late
Development Review
Committee ("LDRC"),
or the respective
successors to
such
committees,
in order to keep DOV
informed of the progress of the
conduct of
activities under the
Collaboration and the
development of the
Compounds
and Products.
2.6 INFORMATION AND INVENTIONS.
The entire right, title and interest in:
(a)
DOV Information
and Inventions shall be owned solely by DOV;
(b)
MERCK
Information and Inventions shall be owned solely by MERCK; and
(c)
Joint
Information and
Inventions shall be
owned jointly by DOV and
MERCK. Each of the
Parties, as owners of a joint and undivided
interest in the Joint
Information and
Inventions and Joint
Patent
Rights, shall have the right to exploit and to grant licenses in
and
to such Joint Information and Inventions and/or Joint Patent
Rights,
without an accounting or obligation to, or other consent required
from, the other Party, unless otherwise specified in this
Agreement.
Each Party further
agrees to execute
such documents as the other
Party may reasonably
require to give
effect to the intent
of this
Section 2.6(c).
For avoidance of
doubt, this Section
2.6(c) shall
not supersede
the licenses and other
rights granted pursuant to
Article 3.
Each Party
shall promptly
disclose to the other
Party, in writing,
the
development,
making, conception
or reduction to practice of Joint
Information and
Inventions
or, respectively, DOV Information and
Inventions
and MERCK Information and Inventions.
2.7 COLLABORATION TERM AND TERMINATION.
Except as otherwise provided herein, the
term of the Collaboration shall commence on the Closing Date
and continue until
approval of the NDA by the FDA for the
first Product.
2.8 DEVELOPMENT REPORTS FOLLOWING
TERMINATION OF COLLABORATION. Notwithstanding
any other provision of this Agreement, following the termination of the
Collaboration, MERCK shall provide a development report to DOV upon DOV's
request no more frequently than
semianually,
which report shall
include (i) an
update describing the development efforts
of MERCK and its Controlled Affiliates
pertaining to the Compound and the Product,
and (ii) a description
of clinical
studies commenced to achieve Development Milestones or Product Profile
Milestones as described in Section 5.3 or
Section 5.4, respectively.
3. LICENSE; EXCHANGE OF
INFORMATION; DEVELOPMENT AND COMMERCIALIZATION
3.1 LICENSE GRANT.
3.1.1 DOV hereby grants to MERCK an
exclusive license (even as to DOV, except as
set forth
in Section
3.1.2 below) in the Territory under DOV Patent
Rights,
DOV's and its Controlled Affiliates' rights in Joint Patent
Rights,
and DOV Know-How, with a right to sublicense, to make, have made,
use,
offer to sell,
sell or import
Compound(s)
and Product(s) in the
Field.
For the avoidance of
doubt, DOV reserves
all rights not expressly
licensed
to MERCK under this
Agreement (e.g.,
DOV reserves the right
to
make,
use, sell, offer to sell and import DOV 216,303 outside of the
Field).
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3.1.2 DOV hereby retains the right in the
Territory under DOV
Patent Rights and
DOV
Know-How, to make or have made DOV
21,947 for the
purposes of (i)
making,
having made, using,
offering for sale,
selling or importing
DOV
102,677
and/or any pharmaceutical preparation or preparations
containing
DOV
102,667 and (ii) conforming to any then-applicable requirements of a
Regulatory
Authority,
provided that DOV may not use DOV
21,947 for any
other
purposes or provide
DOV 21,947 to any other person other than for
the
purpose of having DOV 102,677 made, and any DOV 21,947 in DOV's or
any
of its
Controlled
Affiliates'
or any Third Party's possession after
completion
of the process of making DOV 102,677 shall be promptly
destroyed.
3.2. NON-EXCLUSIVE LICENSE GRANTS.
3.2.1 In the event that the making,
having made,
use, offer for sale,
sale or
import by
MERCK, or MERCK's Related Parties, of Compound(s) or Product(s)
in the
Field would infringe
during the term of
this Agreement a claim of
an issued
patent Controlled by DOV or its Controlled Affiliates and which
patent is
not covered by the grant in Section 3.1, DOV hereby grants to
MERCK,
to the extent DOV is legally able to do so, a non-exclusive,
sublicensable, royalty-free license in the Territory under any such
issued
patent for
MERCK and MERCK's
Related Parties to make, have made, use,
sell,
offer for sale or import Compound(s) and Product(s) in the
Territory.
3.2.2 DOV hereby grants to MERCK a
non-sublicenseable,
non-exclusive license to
use DOV
102,677 for the
purpose of developing
an assay relating to DOV
21,947
that quantifies the
level, if any, of DOV
102,677 present in
DOV
21,947 in
vitro or in vivo.
3.2.3 MERCK hereby grants to DOV a
non-sublicenseable,
non-exclusive license to
use DOV
21,947 for the purpose
of developing
an assay relating to DOV
102,677
that quantifies
the level,
if any, of DOV 21,947
present in DOV
102,677 in
vitro or in vivo.
3.3. SUBLICENSES.
3.3.1 MERCK may grant written sublicenses of the licenses granted it under
Sections
3.1 and 3.2 above (each, a "Sublicense Agreement"), provided,
however,
that no sublicense
granted under this
Agreement shall be
valid
unless
each sublicensee (a "MERCK Sublicensee") agrees in writing in
such
Sublicense
Agreement:
(i)
to exercise its
rights under the
sublicense in accordance with the
applicable terms of this Agreement;
(ii)
to maintain
records that Merck would be required to retain
under
this Agreement and to permit auditors of DOV to inspect such
records
on the same basis as such records could be inspected if retained
by
MERCK;
(iii) to,
in the event of a Bankruptcy Event affecting MERCK, (a)
transfer
to DOV any MERCK Termination Know-How to which such MERCK
Sublicensee has access
no later than 60 days
after the effective
date of such Bankruptcy Event, (b) transfer to DOV any
Information
or Joint Information
and Inventions to which such MERCK Sublicensee
has access and that is necessary or useful to the prosecution of
DOV
Patent Rights or Joint Patent Rights no less than 30 days before
any
application deadline
applicable
to any DOV Patent
Right or Joint
Patent Right;
(c) transfer to DOV
title to or
sponsorship of any
IND, NDA or other
regulatory filing held
in the name of such MERCK
Sublicensee pertaining
to the Compound or the
Product, or if
such
transfer is not
legally permissible or such items do not relate
solely to Compound
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or Product, to grant
DOV the right, with
right to sublicense,
to
access, use and
cross-reference
such data,
filings and
approvals
from Regulatory
Authorities,
which
right shall be exclusive
(including as to the MERCK Sublicensee) with respect to
Compound or
Product; and (d)
provide to DOV reasonable technical support from
technical and scientific personnel to effect the complete
transfer
of MERCK Termination
Know-How to which such
MERCK Sublicensee
has
access, including
Information
necessary for the use of any MERCK
Termination Know-How and the practice of any MERCK Patent Rights
and
Joint Patent
Rights in relation
to Compound or Product; and (e)
provide that all of
the provisions
of the foregoing clauses (a)
through (d)
shall survive any termination of the applicable
Sublicense Agreement;
(iv)
to observe all other
applicable terms of this Agreement; and
(v)
that (a) DOV
shall be a third party beneficiary under the applicable
Sublicense Agreement
solely for purposes of enforcing its rights in
the event of a Bankruptcy Event affecting MERCK; and (b) that in
such a Bankruptcy
Event, if the
Sublicense
Agreement by MERCK
is
rejected and the
MERCK Sublicensee does not elect to treat the
Sublicense Agreement
as terminated, then the MERCK Sublicensee
shall, at DOV's option, enter into a license agreement with DOV on
the same terms and conditions as the applicable Sublicense
Agreement.
3.3.2 (a) Contemporaneously with the
execution of a Sublicensee Agreement, MERCK
shall
obtain from each MERCK
Sublicensee a written
acknowledgement
(the
"Sublicensee
Acknowledgement")
stating that
the Sublicense Agreement
executed
between
such MERCK Sublicensee and MERCK contains those
provisions
required by Section
3.3.1 of this Agreement. During the first
twelve
months following the Closing Date, MERCK shall promptly provide
DOV
with a
copy of each
Sublicense
Acknowledgement.
Thereafter, MERCK
will
provide
DOV with copies of any additional Sublicense Acknowledgements
upon
request,
but no more frequently than once per year.
(b)
MERCK shall maintain a list of MERCK Sublicensees and a general
description of the
subject matter of each Sublicense Agreement (the
"Sublicensee List").
During
the first twelve months following the
Execution
Date, the Sublicensee
List shall be updated
contemporaneously
upon the
execution of each Sublicense Agreement and provided
promptly to
DOV
following the execution of each Sublicense Agreement. Thereafter,
MERCK will
provide DOV with a
copy of the updated
Sublicensee List
upon
request,
but no more frequently than once per year. .
3.3.3 MERCK unconditionally guarantees the
performance of all MERCK Sublicensees
in
accordance
with the terms of this Agreement, and MERCK shall be
responsible for
enforcing the provisions of any sublicense agreement to
ensure
that the MERCK Sublicensees do not breach the terms of this
Agreement.
3.3.4 In the event of a Bankruptcy Event
affecting MERCK, any and all Sublicense
Agreements
shall immediately terminate.
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3.4. RIGHT OF FIRST REFUSAL FOR DOV
102,677.
3.4.1.RIGHT OF FIRST REFUSAL. In the event
that DOV desires to commercialize DOV
102,677 or
a Product containing
it for the treatment and/or prevention of
depression
and/or anxiety in humans and/or animals, MERCK will have a
right of
first refusal with regard to obtaining exclusive rights to such
commercialization. In
such a circumstance, DOV shall present a good faith
offer for
the commercialization rights for DOV 102,677. Thereafter, after
a sixty
(60) day period of
good faith
negotiation, if it is
reasonably
apparent
that the Parties are unable to reach agreement with regard to
the
terms and
conditions
under which MERCK may obtain
exclusive rights to
commercialize
DOV 102,677
for the treatment and/or prevention of
depression
and/or anxiety in humans and/or animals, then DOV shall be free
to
commercialize
DOV 102,677
itself or to negotiate
with Third Parties
with
respect to the commercialization
of DOV 102,677 through a
collaboration or by such Third Party, provided, however, that
prior to
entering into an agreement granting rights to a Third Party for
commercializing DOV
102,677 for lesser compensation than DOV's last offer
to MERCK,
DOV shall offer the
compensation
and other relevant
material
terms to
MERCK in writing. If
MERCK does not accept such compensation and
other
relevant material in writing within thirty (30) days, it will be
deemed to
have waived its rights.
3.5. NO IMPLIED LICENSES. Except as specifically set forth
in this Agreement,
neither
Party shall
acquire any license or
other intellectual
property
interest,
by implication or otherwise, in any Information disclosed to
it
under
this Agreement or under any patents or patent applications
Controlled
by the other Party or its Controlled Affiliates.
3.6. DEVELOPMENT AND
COMMERCIALIZATION.
MERCK
shall
use Commercially Reasonable Efforts to develop and
commercialize a Product containing at least one of the Compounds at its own
expense. For avoidance of doubt, a temporary suspension, not to exceed six
months, of the development or commercialization of a Product due to MERCK's
reasonable determination that the Product
is materially unsafe for use in humans
shall not cause MERCK to be in breach of
this Section 3.6. For the avoidance of
doubt, in the event of any such
suspension,
the provisions of
Article 10 shall
apply.
3.7. OPTION FOR DOV TO CO-PROMOTE
PRODUCTS IN UNITED STATES.
3.7.1.MERCK hereby grants DOV an option to
co-promote the Product
in the United
States
only (the "Co-promotion Option") by Detailing Product to
Specialists designated
by MERCK as Target
Prescribers,
subject to the
provisions
of this Section 3.7, and conditioned on DOV and MERCK
entering
into a
Co-Promotion
Agreement on terms and
conditions
consistent
with
Schedule
3.7.
3.7.2.MERCK shall determine the Launch Date of the
Product, and shall
keep DOV
apprised
at quarterly Committee
meetings of any
changes in the projected
Launch
Date for the
Product, so that DOV has reasonable notice of the
projected
Launch Date.
DOV will notify MERCK
in writing of its intent to
exercise
the Co-Promotion Option twenty-four (24) months prior to the
projected
Launch Date as communicated by MERCK (the "Exercise Date"). If
DOV
chooses to exercise the Co-Promotion Option, MERCK and DOV will
enter
into a
Co-Promotion Agreement consistent with the terms and conditions
set
forth in
Schedule 3.7 no later than eighteen (18) months before the
Launch
Date.
3.7.3.If DOV exercises the Co-Promotion Option, DOV shall be required to
commence
Detailing on the Launch Date for the Product, and shall be
required
to deploy a sufficient number of Specialty
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*** CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED AS TO THIS MATERIAL.
Sales
Representatives
as determined by MERCK, based on the reach and
frequency
of Detailing that
MERCK determines
is desirable to the
Target
Prescribers. For
avoidance of doubt, DOV shall be required to deploy
a
minimum of
[***] and, unless otherwise agreed upon in writing,
a maximum
of [***]
Specialty Sales Representatives, with the specific number of
such
Specialty
Sales Representatives to be determined by MERCK based on
the
desired
reach and frequency of Detailing to Target Prescribers, and
communicated by MERCK
to DOV at least sixty (60) days before the Exercise
Date. In
the event that DOV has an existing sales force that is detailing
a DOV product to the same Target Prescribers and employs more
representatives than the required number of Specialty Sales
Representatives as determined by MERCK, MERCK shall consider in
good faith
utilizing
such existing DOV sales force. Compensation in any event shall
be as
described in Paragraph 2(e) of Schedule 3.7.
3.7.4. The Co-Promotion Option shall lapse
if:
(a)
DOV does not
notify MERCK in
writing of its intent to exercise the
Co-Promotion Option by the Exercise Date; or
(b)
DOV cannot
provide the number of
Specialty Sales Representatives
provided for in Section 3.7.3, unless otherwise agreed to by the
Parties; or
(c)
The Agreement is
terminated pursuant to Article 9.
3.8. SUPPLY BY MERCK TO DOV OF MOTHER
LIQUOR CONTAINING DOV 102, 677.
3.8.1.In the event that MERCK develops an Asymmetric Process for the
manufacture of DOV 21,947, MERCK shall have no obligation to supply
to DOV
Mother
Liquor containing DOV 102,677. In the event that MERCK
manufactures
DOV 21,947
using a Symmetric Process, MERCK shall, upon DOV's request
and
subject to
the terms and
conditions of this
Section 3.8,
supply to DOV
such
quantities
of the Mother
Liquor containing DOV 102,677 that are
obtained
by MERCK and its
Controlled
Affiliates
in the course of such
manufacturing process
(except such small quantities of Mother Liquor
needed by
MERCK for development
of assays, analytical
methods and other
similar
purposes).
3.8.2.Any quantities of such Mother Liquor
supplied by MERCK
shall be supplied
"where is"
and "as is", with no
warranty as to the
quality of the Mother
Liquor
or its fitness for use for any purpose. Title and risk of loss
shall
shift to DOV upon delivery by MERCK at MERCK's site of manufacture.
DOV shall
develop appropriate packaging and labeling for such Mother
Liquor,
and provide such packaging and labeling to MERCK.
3.8.3.DOV shall pay for any transportation or insurance costs associated with
the
delivery of such
quantities of Mother
Liquor, and shall reimburse
MERCK for
out of pocket costs incurred by MERCK in the recovery, storage,
packaging
and labeling of such Mother Liquor.
3.8.4.DOV shall have reasonable access to MERCK's and MERCK's Controlled
Affiliates' data in
order to support its submissions to Regulatory
Authorities relating to DOV 102,677; provided, however, that such access
shall be
limited to employees of DOV, and shall not be extended to
consultants, partners,
agents, licensees or other Third Parties,
other
than those
consultants
or independent Third Parties involved with the
analysis
of studies being conducted or data being collected for the
purpose
of gaining Marketing Authorization, or involved with the
preparation or
submission of
materials to
Regulatory
Authorities; and
provided,
further that MERCK shall be reimbursed for its and its
Controlled
Affiliates'
fully
allocated
costs for supporting such
submissions to Regulatory Authorities.
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3.8.5.Any obligation of MERCK or its
Controlled Affiliates
under this Section
3.8 to
supply Mother Liquor to DOV shall immediately cease upon any
Change
of Control
in which a Major
Pharma Entity (as
defined in Section
12.2)
obtains
control of DOV by acquiring DOV's assets or voting equity
securities
(by asset purchase,
merger, consolidation,
reorganization or
otherwise), or upon the granting by DOV to any Third Party of any
license,
promotion
rights, distribution rights or other rights relating to DOV
102,677.
3.9. ASYMMETRIC TECHNOLOGY.
(a) In the event that
MERCK develops an Asymmetric
Process
for manufacture
of DOV 21,947,
MERCK shall so notify
DOV. MERCK
shall
thereafter,
upon DOV's request, provide technical information
necessary
to permit DOV to manufacture DOV 102,677 using such
Asymmetric
Process
("MERCK Asymmetric
Technology"). To the
extent DOV utilizes such
MERCK
Asymmetric Technology,
and to the extent that
the use of the MERCK
Asymmetric
Technology
in the making or
having made of DOV 102,677 would
infringe
during the term of
this Agreement
a claim of an issued
patent
Controlled
by MERCK or its Controlled Affiliates, MERCK hereby grants to
DOV, to
the extent MERCK or its Controlled Affiliates are legally able to
do so, a
non-exclusive, fully paid-up, sublicensable, royalty-free
license
in the
Territory under the MERCK Asymmetric Technology and any such
issued
patent for DOV, DOV's
Controlled Affiliates and its and their sublicensees
to make or
have made DOV 102,677 in the Territory.
(b) In the
event that DOV develops an Asymmetric Process for manufacture
of DOV 102,677, DOV shall so notify MERCK. DOV
shall thereafter,
upon MERCK's
request, provide technical information
necessary to permit MERCK to manufacture
DOV 21,947 using such Asymmetric Process
("DOV Asymmetric
Technology"). To
the
extent MERCK or its Controlled Affiliates utilizes such DOV Asymmetric
Technology, and to the extent that the use of
the DOV Asymmetric
Technology in
the making or having made of DOV 21,947
would infringe
during the term of
this
Agreement a claim of an issued patent Controlled by DOV or its Controlled
Affiliates, DOV hereby grants to MERCK, to the extent DOV or its Controlled
Affiliates are legally able to do so, a non-exclusive, fully paid-up,
sublicensable, royalty-free license in the Territory
under the DOV
Asymmetric
Technology and any such issued pate