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EXHIBIT 10.4
[***] TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
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
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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 Market Product
sold by Neurocrine or its Affiliate or its sublicensee, less:
(a) transportation charges or allowances, if any;
(b) 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;
(c) 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
(d) Any tax, excise or governmental charge upon or measured by the
sale, transportation, delivery or use of the Market 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.
(e) 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"
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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.
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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 Marketed 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 Marketed
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.
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[***] Omitted pursuant to a request for confidential treatment. The omitted
material has been separately filed with the Securities and Exchange
Commission.
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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, [***]. Neurocrine shall provide such reports until
the R & D Program is terminated, or upon the first sale of the
Marketed 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 six months 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 six months 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 $1,300,000 plus warrants to purchase 75,000 shares of
Neurocrine common stock, upon commencement of the first
Pivotal Trial for the Marketed Product. A warrant to purchase
15,000 shares of Neurocrine common stock shall have an
exercise price equal to
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[***] Omitted pursuant to a request for confidential treatment. The omitted
material has been separately filed with the Securities and Exchange
Commission.
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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, which shall be
equal to the effective date of this Agreement, 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, which shall be equal to the
effective date of this Agreement, 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 six percent (6%) of Net Sales of
Marketed 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 [***].
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[***] Omitted pursuant to a request for confidential treatment. The omitted
material has been separately filed with the Securities and Exchange
Commission.
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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 each three months
during the term of this Agreement, Neurocrine shall pay to DOV
the royalty payment due for those three months.
Together with each three month 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 three months 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
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[***] Omitted pursuant to a request for confidential treatment. The omitted
material has been separately filed with the Securities and Exchange
Commission.
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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:
(a) information, which at the time of disclosure, is in the public
domain;
(b) information, which after disclosure, is published or otherwise
becomes part of the public domain through no fault of the
receiving party;
(c) information which was in the possession of the receiving party
at the time of disclosure;
(d) information which is developed by or on behalf of the
receiving party independently of any disclosure to them by the
disclosing party hereunder; or
(e) 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 Marketed
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 Marketed 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 Marketed Product and furnish DOV with copies of any relevant
documents relating thereto.
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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
Marketed 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
Marketed 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
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[***] Omitted pursuant to a request for confidential treatment. The omitted
material has been separately filed with the Securities and Exchange
Commission.
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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 Marketed 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 Marketed 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 Marketed 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 Marketed Product and thereafter for so long
as required to cover manufacture or sales of distributed Marketed
Product.
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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, Marketed 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 Marketed Product are true to the best of
DOV's knowledge.
ARTICLE 11
Assignment
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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 Marketed Product in such
country, or a period of ten (10) years following the first sale of
Marketed Product by Neurocrine or its sublicensee in such country.
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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 Marketed 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 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 terminate this Agreement, thereby surrendering
all rights granted hereunder, by, written notice to the other
party, such termination having immediate effect.
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, [***] 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.
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[***] Omitted pursuant to a request for confidential treatment. The omitted
material has been separately filed with the Securities and Exchange
Commission.
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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 Marketed 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
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law or regulation within any country within the Territory. However,
the parties shall coordinate, to even 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:
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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
----------------------------
Arnold Lippa, Chief Executive Officer
Neurocrine Biosciences, Inc.
By: /s/ Gary Lyons
----------------------------
Gary Lyons, President and
Chief Executive Officer
16
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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
---------------------------
Arnold Lippa, Chief Executive Officer
Neurocrine Biosciences, Inc.
By:
---------------------------
Gary Lyons, President and
Chief Executive Officer
17
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[GRAPHIC OMITTED] DOV PHARMACEUTICAL INCORPORATED
EXHIBIT 1
CHEMICAL COMPOUND DESCRIPTION
[***]
[Chemical Compound Graphic]
- ----------
[***] Omitted pursuant to a request for confidential treatment. The omitted
material has been separately filed with the Securities and Exchange
Commission.
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EXHIBIT 2
[ACY License Agreement]
19
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EXHIBIT 3
[***]
- ----------
[***] Omitted pursuant to a request for confidential treatment. The omitted
material has been separately filed with the Securities and Exchange
Commission.
20
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EXHIBIT 4
[Form of Consulting Agreement]
21
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EXHIBIT 5
[Warrant Agreement]
22
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