Exhibit 10.3
SUB-LICENSE AND DEVELOPMENT AGREEMENT
THIS AGREEMENT is effective this 30th day of June 1998, by and between
DOV Pharmaceutical, Inc., a New Jersey corporation, with offices at 1 Parker
Plaza, Suite 1500 Fort Lee, New Jersey 07024 ("DOV") and Neurocrine Biosciences,
Inc., a Delaware corporation with offices at 3050 Science Park Road, Suite 405,
San Diego, California 92121 ("Neurocrine").
WITNESSETH:
WHEREAS, DOV possesses rights to a certain chemical compound and to
pharmaceutical products to be processed from the Compound, such rights arising
from the License Agreement (defined below); and
WHEREAS, Neurocrine desires to acquire, and DOV is willing to grant to
Neurocrine, an exclusive sublicense to the patent rights and know-how, relating
to that certain chemical compound.
NOW THEREFORE, in consideration of the promises and of the mutual
covenants and obligations set forth herein, the parties hereto agree as follows:
ARTICLE 1
Definitions
1.1 "Affiliate" means with respect to a party, any other entity
which directly or indirectly controls, is controlled by, or is
under common control with, such party. An entity or party
shall be regarded as in control of another entity if it owns,
or directly or indirectly controls, at least fifty percent
(50%) of the voting stock or other ownership interest of such
entity, or if it directly or indirectly possesses the power to
direct or cause the direction of the management and policies
of the other entity by any means whatsoever.
1.2 "Compound" means the chemical compound described in Exhibit 1.
1.3 "DOV's Corporate Office" means 1 Parker Plaza, Suite 1500,
Fort Lee, New Jersey.
1.4 "FDA" means the United States Food and Drug Administration.
1.5 "IND" means an investigational new drug as defined in 21
CFR Part 312.
1.6 "Know-How" means all ideas, inventions, data, instructions,
processes, formulas, expert opinions and information,
including, without limitation, biological, chemical,
pharmacological, toxicological, pharmaceutical, physical and
analytical, clinical, safety, manufacturing and quality
control data and information, in each case, which are
necessary or useful for and are specific to the research,
design, development, testing, use, manufacture or sale of the
Compound or a Licensed Product.
1.7 "License Agreement" means the license agreement between DOV
and American Cyanamid Company ("ACY") dated May 29, 1998
attached as Exhibit 2.
1.8 "Licensed Product"means any product based upon or derived from
the Compound and approved for sale by the USFDA or its foreign
equivalent.
1.9 "NDA" means a new drug application submitted to the United
States Food and Drug Administration in accordance with Section
505 of the Federal Food, Drug and Cosmetic Act and its
implementing regulations, or a comparable filing in Japan or
within the EU.
1.10 "Net Sales" means the gross amount invoiced for the Licensed
Product sold by Neurocrine or its Affiliate or its
sublicensee, less:
(1) transportation charges or allowances, if any;
(2) 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;
(3) credits or allowances, if any, given or made on
account of price adjustments, returns, bad debts,
off-invoice promotional discounts, rebates, and any
or all federal, state or local government rebates
whether in existence now or enacted at any time
during the term of the Agreement, recalls, or
destruction requested or made by an appropriate
government agency; and
(4) Any tax, excise or governmental charge upon or
measured by the sale, transportation, delivery or use
of the Licensed Product; provided that, other than
pursuant to Section 1.5(e) below, Net Sales shall in
no event be less than 80% of Gross Sales.
(5) In the case of discounts on "bundles" of products or
services which include Licensed Products or the
Compound, the selling Party may, with notice to the
other Party, calculate Net Sales by discounting the
bona fide list price of such 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". The selling party shall provide the other party
documentation, reasonably acceptable to the other party,
establishing such average discount with respect to each
"bundle", Net Sales shall be based on the undiscounted list
price of the Licensed Products or the Compound in the
"bundle". If a Licensed Product or the Compound in a "bundle"
is not sold separately and no bona fide list price exists for
such Licensed Product or the Compound, the Parties shall
negotiate in good faith an imputed list price for such
Licensed Product or the Compound, and Net Sales with respect
thereto shall be based on such imputed list price.
1.11 "Phase I" means that portion of the FDA submission and
approval process that provides for the first introduction into
humans of the Licensed Product with the purpose of determining
human toxicity, metabolism, absorption, elimination and other
pharmacological action as more fully defined in 21 C.F.R.
ss.213.2(a).
1.12 "Phase II" means that portion of the FDA submission and
approval process that provides for the initial trials of the
Licensed Product on a limited number of patients for the
purposes of determining dose and evaluating safety and
efficacy in the proposed therapeutic indication as more fully
defined as 21 C.F.R. ss.213.21(b).
1.13 "Phase III" means that portion of the FDA submission and
approval process that provides for continued trials of the
Licensed Product on sufficient numbers of patients to
establish the safety and efficacy of the Licensed Product and
generate pharmacoeconomics date to support regulatory approval
in the proposed therapeutic indication as more fully defined
in 21 C.F.R.
ss.312.21(c).
1.14 "Pre-Phase I" means that portion of the development program
that starts with the selection of a compound for development
into the Licensed Product or the beginning of toxicological
studies relating to such compound. Pre-Phase I includes,
without limitation, toxicological, pharmacological and any
other studies, the results of which are required for filing
with an IND, as well as Licensed Product formulation and
manufacturing development necessary to obtain the permission
of regulatory authorities to begin and continue subsequent
human clinical testing. Toxicology, as used in this
definition, means full scale toxicology using "Good Laboratory
Practices" for obtaining approval from a regulatory authority
to administer the Licensed Product to humans. This toxicology
is distinguished from initial dose range finding toxicology,
which usually includes a single and repeated dose ranging
study in two species with less than half of the animals
required by the FDA, an Ames test and a related chromosome
test.
1.15 "Patent Rights" means all United States and foreign patents
(including all reissues, extensions, substitutions,
confirmations, re-registrations, re-examinations,
revalidations and patents of addition) and patent applications
(including, without limitation, all continuations,
continuations-in-part and divisions thereof) in each case,
claiming an invention which is necessary or useful for the
design, development, testing, use, manufacture or sale of the
Compound or a Licensed Product.
1.16 "Pivotal Trial" means the ***] study which is one of two
Phase III registerable trials and which is comparable to and
of the same magnitude as the trial described in Exhibit 3
hereto.
1.17 "Territory" means all countries of the world.
1.18 "Valid Claim" means a claim of a pending patent application
within the Patent Rights (provided such application has not
been pending for more than [***] from the date it was first
filed with the governmental agency with jurisdiction over
patent applications) or an issued and unexpired patent
included within the Patent Rights that has not been held
unenforceable or invalid by a court or other governmental
agency of competent jurisdiction, and that has not been
disclaimed or admitted to be invalid or unenforceable through
reissue or otherwise.
ARTICLE 2
License Grant
As of the effective date of this Agreement, DOV hereby grants
Neurocrine an exclusive sublicense to DOV's interest under the License Agreement
in the Patent Rights and Know-How to make, have made, use, import, offer for
sale and sell the Compound and the Licensed Product in the Territory, with the
right to grant sublicenses.
ARTICLE 3
Development Activities
3.1 As soon as practicable after the effective date of this
Agreement, Neurocrine shall commence, adequately fund, and
pursue a worldwide research and development program for the
development of the Licensed Product ("R & D Program") using
commercially reasonable and diligent efforts in its conduct of
the R & D Program in accordance with Neurocrine's usual and
customary practices for products of similar commercial
potential and value.
3.2 Management of the R & D Program will be provided by
Neurocrine. Arnold Lippa and Bernard Beer, upon Neurocrine's
request, will provide reasonable consultative services
pursuant to consulting agreements substantially in the form
set forth on Exhibit 4.
3.3 Neurocrine shall provide to DOV, on a [***] basis throughout
the term of this Agreement a written report setting forth the
efforts (and results of such efforts) taken by Neurocrine
pertaining to the R & D Program, including [***]. Neurocrine
shall provide such reports until the R & D Program is
terminated, or upon the first sale of the Licensed Product in
the United States, Japan or within the EU.
3.4 If Neurocrine terminates the R&D Program or halts all R&D
Program activities for a period of [***] or longer within the
United States (for reasons other than regulatory constraints),
DOV shall have the right to terminate this Agreement within
the entire Territory, or any country within the Territory,
effective upon Neurocrine's receipt of written notice of
termination from DOV. If Neurocrine terminates the R&D Program
or halts all R&D activities for a period of [***] or longer
within any other country of the Territory (for reasons other
than regulatory constraints) DOV shall have the right to
terminate this Agreement within such country, effective upon
Neurocrine's receipt of written notification from DOV. In
either such event DOV will be entitled to any payments
previously paid to, or which have accrued to DOV.
ARTICLE 4
Development Payments
4.1 In consideration of the rights granted to Neurocrine in
Article 2, herein, Neurocrine shall pay to DOV a licensing fee
of $5,000 upon the execution of this Agreement.
4.2 Neurocrine shall make scheduled payments and issue warrants
for the purchase of shares of Neurocrine's capital stock to
DOV in the amounts, and at the times, stated below:
US [***] plus warrants to purchase 75,000 shares of
Neurocrine common stock, upon [***] for the Licensed
Product. A warrant to purchase 15,000 shares of
Neurocrine common stock shall have an exercise price
equal to the Market Price, as defined herein, as of
the effective date of this Agreement. Such warrant
shall be exercisable, at any time, in whole or in
part, from the grant date through the fifth
anniversary of the grant date. A warrant to purchase
60,000 shares of Neurocrine common stock shall have
an exercise price equal to the Market Price, as
defined herein, as of the date that the first Pivotal
Trial commences. Such warrant shall be exercisable,
at any time, in whole or in part, from the grant date
through the fifth anniversary of the grant date. Upon
approval by a majority of the signatories thereto,
Neurocrine's New Registration Rights Agreement dated
March 29, 1996 shall be amended to include such
warrant in the definition of "Registrable Securities"
thereunder, those shares of Neurocrine common stock
issuable upon exercise of such warrants. The terms of
the warrants shall be substantially as set forth as
the Form of Warrant attached to this Agreement as
Exhibit 5. For purposes of this Article 4.2, "market
price" shall mean the mean of the closing price of
Neurocrine's common stock as quoted on the National
Association of Security Dealers, Inc. Automated
Quotation System or such other national securities
exchange or over-the-counter market on which such
common stock is quoted for the twenty business days
prior to the date of this Agreement, and at the date
that the first Pivotal Trial is commenced,
respectively.
[***].
[***].
ARTICLE 5
Royalties
5.1 In consideration of the rights granted in Article 2 hereof,
and in addition to the payments and issuance of warrants set
forth in Article 4 herein, Neurocrine shall pay to DOV during
the term of this Agreement, on a country-by-country basis,
royalties consisting of [***] of Net Sales of Licensed
Product.
5.2 If within any country of the Territory (I) marketing
exclusivity is lost to Neurocrine or its sublicensee prior to
the expiration of this Agreement and (ii) the manufacture, use
or sale of a Licensed Product would not infringe a Valid Claim
of a patent within the Patent Rights, then the royalty rate on
the Net Sales of such Licensed Product which would otherwise
be payable to DOV by Neurocrine will be reduced to a rate
which is equal to the [***].
5.3 All royalty payments shall be made in U.S. dollars, Net Sales
shall be converted on a country-by-country basis from the
currency used in each such country to United States Dollars.
The applicable exchange rate shall be the rate quoted in the
Wall Street Journal on the last business day of the period for
which royalties are being calculated. All royalty payments
shall be made in United States Dollars and remitted to DOV's
Corporate Office.
5.4 Within thirty (30) days after the end of [***] during the term
of this Agreement, Neurocrine shall pay to DOV the royalty
payment due for those three months.
Together with [***] royalty payment, Neurocrine shall submit
to DOV a written accounting showing its computation of
royalties due under this Agreement for such three months,
which shall set forth gross sales, Net Sales, the specific
deductions used in arriving at Net Sales, and the total
royalties due for the [***] in question. Such accounting shall
be on a country-by-country basis within the Territory.
5.5 Neurocrine shall keep full and accurate books and records
setting forth gross sales, Net Sales, the specific deductions
used in arriving at Net Sales and the amount of royalties
payable to DOV hereunder for no less than [***] after the end
of each year during the term of this Agreement. Neurocrine
shall permit DOV, to have such books and records examined by
an independent certified public accountant retained by DOV and
acceptable to Neurocrine, during regular business hours upon
reasonable advance notice. Such accountant shall keep
confidential any information obtained during such examination
and shall report to DOV, only the amounts of royalties which
he or she believes to be due and payable hereunder. In the
event of a difference of opinion between such accountant and
Neurocrine as to the amount of royalties which are due and
payable, the parties hereto shall use their best efforts to
resolve such differences. If they cannot do so, each party
will appoint one additional independent certified public
accountant, and those two individuals will jointly appoint an
additional independent certified public accountant. A majority
decision of those three accountants will be conclusive as to
the amount of royalties which are due and payable. The
expenses of this dispute resolution procedure will be borne
equally by Neurocrine and DOV.
ARTICLE 6
Confidentiality
If, during the performance of this Agreement, one party hereto
discloses information to the other which it considers
confidential, such information may not be subsequently
disclosed by the receiving party to a third party, without the
written permission of the disclosing party. The parties to
this Agreement agree to hold in confidence all information;
including, but not limited to, all information that is the
subject of this Agreement, Know-How, marketing and
manufacturing practices, processes, product information, or
financial information disclosed or submitted in writing or in
other tangible form which is considered to be confidential for
a period of five (5) years from the date of such disclosure,
except:
(1) information, which at the time of disclosure, is in
the public domain;
(2) information, which after disclosure, is published or
otherwise becomes part of the public domain through
no fault of the receiving party;
(3) information which was in the possession of the
receiving party at the time of disclosure;
(4) information which is developed by or on behalf of the
receiving party independently of any disclosure to
them by the disclosing party hereunder; or
(5) information which is provided to the receiving party
by a third party with the right to so provide.
ARTICLE 7
Adverse Experiences
7.1 During the term of this Agreement, Neurocrine shall keep, and
shall cause its sublicensees to keep DOV promptly and fully
informed of all pharmaceutical, toxicological, clinical, and
all other findings, including clinical use, studies,
investigations, tests and prescription, relating to any
adverse experiences with the Licensed Product.
7.2 Neurocrine undertakes to notify DOV, as soon as possible, of
any serious adverse event as such event is defined by the
responsible regulatory agency in the United States, Japan, or
within the EU, thought to be associated with clinical studies
of, or the use or application of, the Licensed Product. Such
notification shall be made promptly but in no event later than
five (5) working days after Neurocrine first learns of, or is
advised of, any adverse event described above.
7.3 Neurocrine shall inform DOV without delay, of any governmental
action, correspondence or reports to or from governmental
authorities which may affect the continued distribution and
sale of the Licensed Product and furnish DOV with copies of
any relevant documents relating thereto.
ARTICLE 8
Patent Infringement
8.1 In case any actions, claims, demands, suits or other legal
proceedings are brought or threatened to be brought against
Neurocrine, its Affiliates or sublicensees, by a third party
for infringement of such third party's patent(s), by virtue of
Neurocrine's manufacture, use, sale or offer for sale of the
Licensed Product, Neurocrine shall notify DOV 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.
[***].
Neurocrine undertakes not to make any admission of liability
to a claimant or plaintiff or his, her or its legal
representative or insurer and not to sign any agreement in
respect of such proceedings adversely affecting the rights of
DOV [***], which will not be unreasonably withheld.
If Neurocrine, because of any settlement 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 Licensed Product could not
be made in a given country, Neurocrine may deduct such
payments from the royalty payments due to DOV hereunder,
provided however that in no event shall the royalty rate be
reduced by more than [***] of that which would otherwise be
due to DOV.
8.2 Neurocrine shall promptly inform DOV of any suspected patent
infringement by a third party and provide DOV with any
available evidence of such suspected infringement.
DOV shall have the right but not the obligation to institute
any claim, suit or proceeding against an infringer or a
presumed infringer. DOV shall control the prosecution of any
such suit, claim or proceeding, including, without limitation,
the choice of counsel and any settlement of any such suit or
claim. Neurocrine shall provide DOV with all reasonable
assistance (other than financial) required to institute and
maintain such proceedings.
Neurocrine shall only have the right to institute any claim,
suit or proceeding against an infringer or a presumed
infringer in the event that DOV elects not to do so. In such
event, Neurocrine shall control the prosecution of any such
suit, claim or proceeding, including, without limitation, the
choice of counsel and any settlement of any such suit or
claim. DOV shall provide Neurocrine with all reasonable
assistance (other than financial) required to institute and
maintain such proceedings. During such proceedings,
Neurocrine's royalty obligations to DOV shall be reduced to
the greater of [***] of the royalty payable hereunder and the
royalty rate that DOV owes to ACY at that time. Any proceeds
from such proceedings shall first be allocated to reimburse
Neurocrine for its costs in such proceedings, second to
reimburse DOV for its lost royalty revenue during such period
and the remainder to Neurocrine. In the event that Neurocrine
is not successful in its suit, DOV shall not be reimbursed for
any lost royalty revenue.
ARTICLE 9
Indemnification, Liability and Insurance
9.1 Neurocrine, in the absence of negligence or willful misconduct
on the part of DOV, its Affiliates and sublicensees and their
respective employees, agents, officers, directors and
permitted assigns, shall at all times during the term of this
Agreement and thereafter, indemnify, defend and hold DOV and
its respective directors, officers, partners, employees, 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(s) or damage to third party property, and from and
against any other third party claim, proceeding, demand,
expense, cost and liability of any kind whatsoever
(collectively "liabilities") resulting from, arising out of or
related to product liability claims involving the Licensed
Product.
9.2 DOV, in the absence of negligence or willful misconduct on the
part of Neurocrine, its Affiliates and sublicensees and their
respective employees, agents, officers, directors and
permitted assigns shall at all times during the term of this
Agreement and thereafter, indemnify, defend and hold
Neurocrine and its respective directors, officers, partners,
employees, 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(s) or damage to third party property, and
from and against any other third-party claim, proceeding,
demand, expense, cost and liability of any kind whatsoever
resulting from, arising out of, or related to DOV's breach of
Article 10.9 herein, and any actions taken by DOV pertaining
to the Compound or Licensed Product prior to the effective
date of this Agreement.
9.3 Neurocrine shall maintain, and cause any sublicense to
maintain, a product liability insurance program which may
include funded self-insurance reserves, with additional
coverage by a nationally-recognized insurance carrier, with
respect to the development, manufacture and sale of the
Licensed Product. Coverage shall be in such amounts as are
customary within the industry. Neurocrine and any sublicensee
shall maintain such insurance program for so long as it, or
any sublicensee, continues to develop, manufacture or sell the
Licensed Product and thereafter for so long as required to
cover manufacture or sales of distributed Licensed Product.
9.4 Neurocrine (and its sublicensee) will name DOV and ACY as
additional insureds on its product liability insurance
policies. Upon execution of this Agreement, Neurocrine will
supply DOV with evidence of such coverage, and Neurocrine will
inform DOV, during the term of this Agreement, of any
modifications to such coverages.
ARTICLE 10
Warranties and Representations
10.1 Neurocrine represents and warrants that it is a corporation
duly organized, validly existing and in good standing under
the laws of Delaware.
10.2 Neurocrine represents and warrants that it has full corporate
authority to enter into, and to perform this Agreement.
10.3 Neurocrine represents and warrants that it is fully cognizant
of Good Laboratory Practices ("GLP") and Good Manufacturing
Practices ("GMP") as set forth by the FDA, and that it, and
any sublicensee, shall manufacture, or have manufactured,
Licensed Product in full compliance with GLP and GMP.
10.4 Neurocrine represents and warrants that the terms of any
sublicense it grants in accordance with Article 2 herein, will
not be inconsistent with the terms of this Agreement or the
License Agreement between DOV and ACY attached hereto as
Exhibit I.
10.5 Neurocrine represents and warrants that it has full corporate
authority to issue the warrants referred to in Article 4.2,
herein and that it shall have a sufficient amount of
authorized shares of capital stock to which the warrants
apply.
10.6 DOV represents and warrants that it is a corporation duly
organized, validly existing and in good standing under the
laws of New Jersey.
10.7 DOV represents and warrants that it has full corporate
authority to enter into, and to perform this Agreement.
10.8 DOV represents and warrants that it has the right to grant the
sub-license to Neurocrine set forth in Article 2 herein.
10.9 DOV represents and warrants that all representations made by
it to Neurocrine pertaining to Licensed Product are true to
the best of DOV's knowledge.
ARTICLE 11
Assignment
This Agreement shall be binding upon and inure to the benefit
of the parties hereto and the successors to substantially the
entire business and assets of the respective parties hereto.
Notwithstanding the foregoing, any party may void this
Agreement if the Agreement is assigned for the benefit of a
creditor. This Agreement shall not be assignable by either
party, except to an Affiliate, without the prior consent of
the other party; any other attempted assignment is void.
ARTICLE 12
Payments to ACY
DOV shall be responsible for all payments due to ACY pursuant
to the License Agreement, a true copy of which is attached
hereto as Exhibit 1.
ARTICLE 13
Applicable Law
This Agreement shall be governed by and construed according to
the laws of the State of Delaware.
ARTICLE 14
Force Majeure
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 circumstances
which, due to an event or a legal position beyond the party's
reasonable control, shall render 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 License 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 15
Term and Termination
15.1 This Agreement shall continue in full force and effect in each
country of the Territory until the later of the final
expiration of a patent covering the Compound or the Licensed
Product in such country, or a period of ten (10) years
following the first sale of Licensed Product by Neurocrine or
its sublicensee in such country.
15.2 Upon expiration of this Agreement, with respect to each
country of the Territory, Neurocrine shall be deemed to have a
full-paid, royalty-free license with the right to make or have
made, use or sell the Compound and the Licensed Product as
well as to freely utilize all data generated hereunder or
received from DOV by Neurocrine, without further obligation to
DOV, except for maintaining confidentiality as required by
Article 6 of this Agreement.
15.3 In the event that a party hereto shall be presumed by the
other to have breached any material condition herein
contained, the complaining party shall provide a written
notice of such presumed breach, requesting rectification
within a thirty (30) day period from the date of receipt of
such notice. The party presumed to be in breach of the
Agreement shall either submit a commercially reasonable plan
for rectification within 15 (fifteen) days of receipt of
notice (if the breach cannot be rectified within the thirty
(30) day period), or take appropriate steps to remedy the
breach within such period. If, within such thirty-day period,
neither the aforesaid plan shall have been submitted, nor the
breach cured, the party claiming breach shall be entitled to
[***]written notice to the other party, [***].
15.4 This Agreement may be terminated immediately by either party
by giving notice to the other party if such other party
becomes insolvent or has committed an act of bankruptcy or if
an order or resolution is made for the winding up of such
other party.
15.5 In the event that this Agreement is terminated by DOV prior to
is full term pursuant to Article 15.3, or Article 15.4,
herein, Neurocrine shall, as soon as reasonably possible,
transfer, or authorize the transfer of, [***] to DOV. Any such
transfers or transfer authorizations shall be in writing and
acceptable, in form, to DOV.
15.6 Article 6 and Section 16.9 shall survive termination of this
agreement.
ARTICLE 16
Miscellaneous
16.1 This Agreement constitutes the full understanding between the
parties and supersedes any and all prior oral or written
understandings and agreements with respect to the subject
matter hereof. 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.
16.2 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 entire Agreement as to such
jurisdiction, and shall not affect the validity or
enforceability of such Article or such part of an Article in
any other jurisdiction. The parties shall replace any Article
or part of an Article found invalid or unenforceable by
alternative provisions which shall be as similar as possible
in their conditions with regard to their spirit and commercial
effect. If this Agreement in any jurisdiction is found to be
invalid or unenforceable, the parties shall replace it by an
alternative agreement which shall be as similar as possible in
its conditions with regard to its spirit and commercial
effect.
16.3 No actual waiver of breach or default by either party hereto
of any provision of this Agreement shall be deemed or
construed to be a waiver of any succeeding breach or default
of the same or any other provision of this Agreement.
16.4 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.
16.5 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 in order to
satisfy local requirements, the parties agree to execute such
further instrument, which shall, to the extent permitted by
the laws of the particular country, conform to the terms and
conditions of this Agreement.
16.6 This Agreement has been originally written and signed in the
English language. If any translation into any other language
is 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, the English language version shall in all
events govern for all purposes, whatsoever.
16.7 Termination of this Agreement for any reason, or expiration of
this Agreement, will not affect obligations, including the
payment of any Scheduled Payments or royalties which have
accrued as of the date of termination or expiration, and
rights and obligations which, are intended to survive
termination or expiration of this Agreement.
16.8 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.
16.9 Neither party shall issue any press release or other publicity
materials, or make any oral or written presentation concerning
the Compound or Licensed Product without the 15 day prior
consent of the other party, which will not be unreasonably
withheld. This restriction shall not apply to disclosures
required by law or regulation within any country within the
Territory. However, the parties shall coordinate, to every
extent possible, as to the wording of any such disclosure.
ARTICLE 17
Notices
All notices pursuant to this Agreement will be in writing and sent by telecopy,
facsimile or other electronic means or sent by pre-paid regular, registered or
certified mail. All such notices will be delivered personally to, or addressed
as follows:
TO: Neurocrine
Neurocrine Biosciences, Inc.
3050-Science Park Road, Suite 405
San Diego, California 92121
Attn: Gary Lyons
TO: DOV
DOV Pharmaceutical, Incorporated
1-Parker Plaza, Suite 1500
Fort Lee, New Jersey 07024
Attn: Dr. Arnold Lippa
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their authorized representatives.
DOV Pharmaceutical, Inc.
By: /s/Arnold Lippa
Chief Executive Officer
Neurocrine Biosciences, Inc.
By: /s/Gary Lyons
President and
Chief Executive Officer
EXHIBIT 1
CHEMICAL COMPOUND DESCRIPTION
EXHIBIT 2
LICENSE AGREEMENT
EXHIBIT 3
[***]
EXHIBIT 4
FORM OF CONSULTING AGREEMENT
EXHBIT 5
WARRANT AGREEMENT