COLLABORATION AND LICENSE AGREEMENT
BY AND BETWEEN
GLAXO GROUP LIMITED
AND
NEUROCRINE BIOSCIENCES, INC.
COLLABORATION AND LICENSE AGREEMENT
THIS COLLABORATION AND LICENSE AGREEMENT (this "Agreement"), dated as of July
20, 2001, is made by and between Neurocrine Biosciences, Inc., 10555 Science
Center Drive, San Diego, California, U.S.A. 92121 ("Neurocrine") and Glaxo Group
Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, England,
UK UB6 0NN ("GSK").
WHEREAS, GSK is engaged in the research, development and
commercialization of human pharmaceutical products;
WHEREAS, Neurocrine is the owner or licensee of certain patent rights
and know how relating to corticotropin releasing factor, its receptors and small
molecule antagonists thereto, which may be useful in the discovery and
development of human pharmaceutical products;
WHEREAS, GSK and Neurocrine have agreed to collaborate, on the terms
and conditions set forth herein, in the research, development and
commercialization of CRF Antagonist Compounds (as defined below);
NOW, THEREFORE, in consideration of the mutual representations,
warranties and covenants contained herein and other good and valuable
consideration, the Parties agree as follows:
ARTICLE ONE
DEFINITIONS
When used in this Agreement, each of the following terms shall have the meanings
set forth in this Article One. Any terms defined elsewhere in this Agreement
should be given equal weight and importance as though set forth in this Article
One.
1.1 "AFFILIATE" shall mean a Person that, directly or indirectly, through
one or more intermediates, controls, is controlled by, or is under
common control with the Person specified. For the purposes of this
definition, control shall mean the direct or indirect ownership of, (a)
in the case of corporate entities, securities authorized to cast more
than fifty percent (50%) of the votes in any election for directors or
(b) in the case of non-corporate entities, more than fifty percent
(50%) ownership interest with the power to direct the management and
policies of such non-corporate entity. Notwithstanding the foregoing,
the term "Affiliate" shall not include subsidiaries in which a Party or
its Affiliates owns a majority of the ordinary voting power to elect a
majority of the board of directors, but is restricted from electing
such majority by contract or otherwise, until such time as such
restrictions are no longer in effect.
1.2 "COLLABORATION PRODUCTS" shall mean all CRF 1 Antagonist Compounds and
CRF 2 Antagonist Compounds [***] or which are [***] with the [***].
1.3 "COLLABORATION PATENT RIGHTS" shall mean the [***], the [***] and the
[***].
1.4 "COLLABORATION TECHNOLOGY" shall mean each and all Technology
encompassed by the [***] and specifically shall include the [***].
1.5 "COMBINATION PRODUCT" shall mean a product that contains, as active
ingredients one or more Collaboration Products and one or more other
Compounds that are not Collaboration Products.
1.6 "COMMERCIALLY REASONABLE EFFORTS" shall mean efforts and resources
[***] in the [***] for a product [***] in its [***] or [***] and is of
[***] taking into account [***] the [***] of [***] products in [***]
the [***] and other [***] of the product, the [***] given the [***]
involved, the [***] of the product including the [***] of [***], [***]
products and [***]. Commercially Reasonable Efforts shall be determined
[***] basis for [***], and it is [***] of effort will [***], reflecting
[***] of the Collaboration Product and the [***] involved.
1.7 "COMPOUND" shall mean a [***] compound or substance together with all
complexes, mixtures and other combinations, prodrugs, metabolites,
enantiomers, solid morphic forms, salt forms, racemates, and isomers
thereof.
1.8 "CONFIDENTIAL INFORMATION" shall mean with respect to each Party,
non-public proprietary data or information which belong in whole or in
part to such Party and/or information designated as Confidential
Information of such Party hereunder.
1.9 "CONTROLS" OR "CONTROLLED" shall mean with respect to Technology, the
possession of the ability to grant licenses or sublicenses without
violating the terms of any agreement or other arrangement with, or the
rights of, any Third Party.
1.10 "CO-COMMERCIALIZE" shall mean Neurocrine's option to co-commercialize
Collaboration Products in the U.S. as set forth in Section 6.3.
1.11 "CORTICOTROPIN RELEASING FACTOR" shall mean [***] referred to as [***]
as described in [***].
1.12 "CRF ANTAGONIST COMPOUND" shall mean a CRF 1 Antagonist Compound and/or
CRF 2 Antagonist Compound, as the case may be.
1.13 "CRF 1 ANTAGONIST COMPOUNDS" shall mean compounds encompassed by the
Patent Rights relating to the Collaboration Technology that are [***]
and [***]. For the avoidance of doubt, CRF 1 Antagonist Compounds shall
include any [***].
1.14 "CRF 2 ANTAGONIST COMPOUNDS" shall mean compounds encompassed by the
Patent Rights relating to the Collaboration Technology that are [***]
and [***]. For the avoidance of doubt, CRF 2 Antagonist Compounds shall
include any [***].
1.15 "CRF 1 RECEPTOR" shall mean the transmembrane receptor claimed in [***]
and all divisionals, continuations and corresponding foreign
equivalents.
1.16 "CRF 2 RECEPTOR" shall mean the transmembrane receptor claimed in [***]
and all divisionals, continuations and corresponding foreign
equivalents, including [***].
1.17 "CRF RELATED PURPOSES" shall mean purposes relating to the development
of Compounds (i) that are [***] and (ii) for [***] in which [***].
1.18 "DEFAULT" shall mean with respect to a Party that (i) any
representation or warranty of such Party set forth herein shall have
been untrue in any material respect when made or (ii) such Party shall
have failed to perform any material obligation set forth in this
Agreement.
1.19 "DEVELOP" shall mean those activities related to the pre-clinical and
clinical development of Collaboration Products including those
activities related to the obtainment of Governmental Approvals for the
clinical testing and commercial sale of Collaboration Products.
1.20 "DEVELOPMENT PATENT RIGHTS" shall mean Patent Rights arising from the
Development Program after expiration of the term of exclusivity
hereunder afforded by the Research Programs
1.21 "DEVELOPMENT PROGRAM" shall mean the development program(s) referred to
in Section 5.3 (and subject to its terms) to Develop CRF 1 Antagonist
Compounds and CRF 2 Antagonist Compounds.
1.22 "EFFECTIVE DATE" shall mean the date first written above.
1.23 "FDA" shall mean the Federal Food and Drug Administration of the United
States Department of Health and Human Services or any successor agency
thereof.
1.24 "FIELD OF USE" shall mean all [***].
1.25 "FIRST COMMERCIAL SALE" shall mean with respect to any Collaboration
Product approved for commercial sale, the first transfer by GSK, its
Affiliates and/or its sublicensees of the Collaboration Product to a
non-Affiliate Third Party in exchange for cash or some equivalent to
which value can be assigned.
1.26 "FORCE MAJEURE" shall mean any occurrence beyond the reasonable control
of a Party that prevents or substantially interferes with the
performance by the Party of any of its obligations hereunder, if such
occurs by reason of any act of God, flood, fire, explosion, earthquake,
strike, lockout, labor dispute, casualty or accident; or war,
revolution, civil commotion, acts of public enemies, blockage or
embargo; or any injunction, law, order, proclamation, regulation,
ordinance, demand or requirement of any government or of any
subdivision, authority or representative of any such government; or
breakdown of plant, inability to procure or use materials, labor,
equipment, transportation, or energy sufficient to meet manufacturing
needs without the necessity of allocation; or any other cause
whatsoever, whether similar or dissimilar to those above enumerated,
beyond the reasonable control of such Party, if and only if the Party
affected shall have used reasonable efforts to avoid such occurrence
and to remedy it promptly if it shall have occurred.
1.27 "FTE" shall mean a full time equivalent Neurocrine employee year
consisting of a minimum of a total of approximately [***] hours per
year of work on or directly related to the Research Programs. Work on
or directly related to the Research Programs can include, but is not
limited to, experimental laboratory work, recording and writing up
results, reviewing literature and references, holding scientific
discussions, managing and leading scientific staff, carrying out
management duties related to the Research Programs, and writing up
results for publications or presentation and attending or presenting
appropriate seminars and symposia.
1.28 "GENERIC COMPETITION" shall exist during a given calendar quarter with
respect to a Collaboration Product in a country if, during such
calendar quarter, one or more [***] shall be [***] in such country.
1.29 "GENERIC PRODUCTS" shall mean and include [***] (other than [***]
pursuant to this Agreement) that contain [***] the same [***] as a
[***] and which (a) [***] as a [***] and (b) can [***]or are [***] for
the [***].
1.30 "GSK CONFIDENTIAL INFORMATION" shall mean Confidential Information
owned by GSK and/or its Affiliates or otherwise designated as GSK
Confidential Information hereunder but shall not include Joint
Confidential Information.
1.31 "GSK MATERIALS" shall mean GSK proprietary research materials
including, but not limited to, assays, physical databases of chemical
structures of Compounds, reagents and materials derived therefrom. GSK
Materials will not include Program Materials or Collaboration Products.
GSK will own GSK Materials supplied by GSK to Neurocrine hereunder.
1.32 "GSK TECHNOLOGY" shall mean, all Technology and, subject to Section
1.48, (other than Program Technology) owned or Controlled by GSK and/or
its Affiliates on the Effective Date [***] (i) [***] and [***] and/or
[***] and/or (ii) [***] to the [***] of the [***] and/or [***]
including [***]. GSK Technology shall specifically include but not be
limited to the GSK Patent Rights set forth on Exhibit A.
1.33 "INDICATION" shall have the meaning ascribed to it in Article 7.
1.34 "INVERSE AGONIST" shall mean a drug which produces an effect opposite
to that of an agonist yet acts at the same receptor. A compound, which
binds to the CRF 1 Receptor or CRF 2 Receptor, as the case may be, and
in the absence of CRF or other agonist ligands, will reduce
constitutive activity. Such compound will also reduce activity at the
related CRF receptor in the presence of CRF or other agonist ligands.
Such a compound will have [***].
1.35 "JOINT CONFIDENTIAL INFORMATION" shall mean Confidential Information
owned jointly by GSK and Neurocrine or otherwise designated as Joint
Confidential Information hereunder.
1.36 "LEAD COMPOUND" shall mean [***] or such other compound [***].
1.37 "MILESTONES" shall mean the payments to be made by GSK to Neurocrine
upon occurrence of certain events as set forth in Article Eight.
1.38 "MOOD DISORDER(S)" shall mean any one or more mood disorders as such
are more particularly specified in Sections A and B of Exhibit E to
this Agreement.
1.39 "NDA" shall mean a New Drug Application covering a Collaboration
Product filed with the FDA pursuant to 21 CFR 314 or an equivalent
foreign filing required for marketing approval of a pharmaceutical
product.
1.40 "NET SALES" shall mean the [***] from sales of Collaboration Products
in the Territory by GSK, its Affiliates or sublicensees ("the Selling
Party") to Third Parties less [***] to Collaboration Product by the
Selling Party using generally accepted accounting standards for:
(i) [***] charges, including [***], for [***] Collaboration
Product;
(ii) [***] and [***] paid or allowed by the Selling Party and any
other [***] imposed upon the [***] Collaboration Product;
(iii) [***] (including [***]) [***] on Collaboration Product;
(iv) [***] to customers on account of [***] Collaboration Product;
(v) [***] to customers on account of [***] Collaboration Product;
and
(vi) Collaboration Product [***] and Collaboration Product [***]
including those [***].
Sales between GSK, its Affiliates and its or their sublicensees shall
be excluded from the computation of Net Sales and no payments will be
payable on such sales except where such Affiliates or sub-distributors
are end users but Net Sales shall include the subsequent final sales to
Third Parties by such Affiliates or sublicensees. In the event that a
Collaboration Product is sold in the form of a Combination Product, the
Net Sales for such Combination Product will be calculated as follows:
(aa) If GSK, its Affiliates and/or sublicensees separately
sells in such country, (x) each of the Collaboration Products contained
in the Combination Product and (y) other products containing as their
sole active ingredient(s) the other active component or components in
such Combination Product, the Net Sales attributable to such
Combination Product shall be calculated by [***] is GSK's (or its
Affiliates or sublicensees, as applicable) [***] during the period to
which the Net Sales calculation applies for each Collaboration Product
in the Combination Product in such country and [***] is GSK's (or its
Affiliates or sublicensees, as applicable) [***], which product(s)
contain, [***] in the Combination Product.
(bb) If GSK, its Affiliates and/or sublicensees separately
sells, in such country, each Collaboration Products contained in the
Combination Product but do not separately sell, in such country, other
products containing as their sole active ingredient(s) the other active
component or components in such Combination Product, the Net Sales
attributable to such Combination Product shall be calculated by
multiplying the Net Sales of such Combination Product by the fraction
A/C where: A is [***], and C is [***] applies for the Combination
Product in such country.
(cc) If GSK, its Affiliates and/or sublicensees do not
separately sell each Collaboration Products contained in the
Combination Product, the Net Sales attributable to such Combination
Product shall be calculated by multiplying the Net Sales of such
Combination Product by the fraction D/D+E where D is the [***] and E is
the [***] Combination Product.
1.41 "NEUROCRINE CONFIDENTIAL INFORMATION" shall mean Confidential
Information owned by Neurocrine or otherwise designated as Neurocrine
Confidential Information hereunder but shall not include Joint
Confidential Information.
1.42 "NEUROCRINE MATERIALS" shall mean Neurocrine proprietary research
materials including, but not limited to, assays, physical databases of
chemical structures of Compounds, reagents and materials derived
therefrom. Neurocrine Materials will not include Program Materials or
Collaboration Products. Neurocrine will own Neurocrine Materials
supplied by Neurocrine to GSK hereunder.
1.43 "NEUROCRINE RECEPTORS" shall mean the CRF 1 Receptor and CRF 2
Receptor.
1.44 "NEUROCRINE RECEPTOR TECHNOLOGY" shall mean, all Technology (and,
subject to Section 1.46, other than Program Technology) owned or
Controlled by Neurocrine on the Effective Date or during the [***] that
claims, describes or relates to the use [***] including Neurocrine's
[***].
1.45 "NEUROCRINE TECHNOLOGY" shall mean all Technology (other than Program
Technology or Neurocrine Receptor Technology) owned or Controlled by
Neurocrine on the Effective Date [***] and/or [***]. Neurocrine
Technology shall specifically include but not be limited to the
Neurocrine Patent Rights set forth on Exhibit B.
1.46 "NON-CRF RELATED PURPOSES" shall mean purposes relating to the
development of Compounds (i) that are [***] and (ii) are developed for
[***].
1.47 "PARTY" shall mean GSK or Neurocrine, as the case may be, and "PARTIES"
shall mean GSK and Neurocrine.
1.48 "PATENT RIGHTS" shall mean the rights and interests in and to all
issued patents and pending patent applications in any country,
including, without limitation, all provisional applications,
substitutions, continuations, continuations-in-part, divisions, and
renewals, all letters patent granted thereon, and all
patents-of-addition, reissues, reexaminations and extensions or
restorations by existing or future extension or restoration mechanisms,
including, without limitation Supplementary Protection Certificates or
the equivalent thereof.
1.49 "PERSON" shall mean any individual, firm, corporation, partnership,
limited liability company, trust, unincorporated organization or other
entity or a government agency or political subdivision thereto, and
shall include any successor by merger or otherwise) of such Person.
1.50 "PROGRAM MATERIALS" shall mean and include clones, cell lines, assays,
databases, electronic and physical databases of chemical structures,
which, in each case, are developed, by Neurocrine and/or GSK during the
course of conduct of the Research Programs. Program Materials will not
include Collaboration Products.
1.51 "PROGRAM PATENT RIGHTS" shall mean the Patent Rights arising from this
collaboration between the Parties during the period commencing on the
Effective Date and ending upon expiration of the term of exclusivity
afforded by the Research Programs (which such Program Patent Rights are
jointly owned by the Parties) "Program Patent Rights" shall include
Patent Rights [***] arising from [***] where it is determined that in
respect of [***] included in such application there are [***] as a
result of [***] during and arising from [***].
1.52 "PROGRAM TECHNOLOGY" shall mean Technology, which is discovered or
invented by Neurocrine personnel and/or GSK personnel and/or personnel
within their respective Affiliates arising from this collaboration
between the Parties during the period commencing [***] and ending upon
[***] (which such Program Technology is jointly owned by the Parties)
and specifically shall include Program Patent Rights.
1.53 "R&D PROGRAMS" shall mean the CRF 1 R&D Program and the CRF 2 R&D
Program described in Article Five.
1.54 "REGULATORY APPROVAL" shall mean the technical, medical and scientific
licenses, registrations, authorizations and approvals (including,
without limitation, approvals of Investigational Drug Applications, New
Drug Applications and equivalents, supplements and amendments, pre- and
post- approvals, pricing and third party reimbursement approvals, and
labeling approvals) of any national, supra-national, regional, state or
local regulatory agency, department, bureau, commission, council or
other governmental entity, necessary for the development, manufacture,
distribution, marketing, promotion, offer for sale, use, import, export
or sale of Collaboration Product(s) in a regulatory jurisdiction
1.55 "REGULATORY FILINGS" shall mean, collectively, Investigational New Drug
Applications, Product License Applications, Drug Master Files, NDAs
and/or any other equivalent or comparable filings as may be required by
Regulatory Authorities to obtain Regulatory Approvals.
1.56 RESEARCH PLANS" shall mean the CRF 1 research plan and the CRF 2
research plan as described in Section 5.2 (c).
1.57 "RESEARCH PROGRAMS" shall mean the CRF 1 collaborative research program
conducted by Neurocrine and GSK in accordance with the provisions of
Article Five hereof and the CRF 2 collaborative research program
conducted by Neurocrine and GSK in accordance with the provisions of
Article Five hereof.
1.58 "ROYALTIES" shall mean those royalties payable by GSK to Neurocrine
pursuant to Article Seven of this Agreement.
1.59 "[***]" shall mean the License Agreement dated [***] by and between
[***] and Neurocrine Biosciences, Inc.
1.60 "STEERING COMMITTEE" shall have the meaning set forth in Article Four
hereof.
1.61 "TECHNOLOGY" shall mean proprietary data, information and all
intellectual property, including but not limited to, trade secrets,
know-how, inventions and technology, whether patentable or not, and
Patent Rights directed to products, processes, formulations and/or
methods but which term shall specifically exclude copyright and all
registered and unregistered trademarks.
1.62 "TERRITORY" shall mean the world.
1.63 "THIRD PARTY(IES)" shall mean any Person other than Neurocrine, GSK and
their respective Affiliates.
1.64 "THIRD PARTY ROYALTIES" shall mean royalties payable by Neurocrine,
GSK, its Affiliates or sublicensees to a non-Affiliate Third Party (or
multiple non-Affiliate Third Parties) to make, have made, use, sell,
offer for sale or import Collaboration Products where the royalty
payable to such non-Affiliate Third Party [***].
1.65 "VALID CLAIM" shall mean a claim of an issued and unexpired patent or a
claim of a pending patent application which has not been held invalid
or unenforceable by a court or other government agency of competent
jurisdiction from which no appeal can be or has been taken and has not
been admitted to be invalid or unenforceable through re-examination or
disclaimer or otherwise.
ARTICLE TWO
REPRESENTATIONS AND WARRANTIES
2.1 MUTUAL REPRESENTATIONS AND WARRANTIES. Each Party hereby represents,
warrants and covenants to the other Party that:
(a) the execution, delivery to the other Party and performance by
it of this Agreement and its compliance with the terms and
provisions of this Agreement does not and will not conflict,
in any material respect, with or result in a breach of any of
the terms or provisions of (i) any other contractual
obligations of such Party, (ii) the provisions of its charter,
operating documents or bylaws, or (iii) any order, writ,
injunction or decree of any court or governmental authority
entered against it or by which it or any of its property is
bound except where such breach or conflict would not
materially impact the Party's ability to meet its obligations
hereunder,
(b) this Agreement is a legal and valid obligation binding upon
such Party and enforceable in accordance with its terms,
including Section 10.4, except as (i) enforceability may be
limited by bankruptcy, insolvency, reorganization, moratorium,
or similar laws affecting the enforcement of creditors' rights
and (ii) equitable principles of general applicability;
(c) such Party is a corporation duly organized, validly existing
and in good standing under the laws of the state or other
jurisdiction of incorporation or formation and has full
corporate power and authority to enter into this Agreement and
to carry out the provisions hereof except where failure to be
in good standing would not materially impact the Party's
ability to meet its obligations hereunder;
(d) such Party is duly authorized, by all requisite corporate
action, to execute and deliver this Agreement and the
execution, delivery and performance of this Agreement by such
Party does not require any shareholder action or approval, and
the Person executing this Agreement on behalf of such Party is
duly authorized to so by all requisite corporate action; and
(e) no consent, approval, order or authorization of, or
registration, qualification, designation, declaration or
filing with, any federal, state or local governmental
authority is required on the part of such Party in connection
with the valid execution, delivery and performance of this
Agreement, except for any filings under any applicable
securities and anti-trust laws (including but not limited to
any Hart-Scott-Rodino Act filing) and except where the failure
to obtain any of the foregoing would not have a material
adverse impact on the ability of such Party to meets its
obligations hereunder.
2.2 USE OF TECHNOLOGY. Neurocrine warrants that it will not use the GSK
Technology unless specifically licensed hereunder. GSK warrants that it
will not use the Neurocrine Technology unless specifically licensed
hereunder.
2.3 [***]. Patent Rights licensed to [***] pursuant to the [***] (the
"Sublicensed Rights") are included in the [***] licensed to [***].
[***] has reviewed and understands the terms of the [***] and, so far
as it is aware, understands the terms of this Agreement to be
consistent with it. [***] agrees that it will not [***] insofar as any
such [***] will have any [***] on any of the [***] under this Agreement
or any agreement entered into between [***], without [***] (i) may be
provided or withheld by [***] in the case of any [***] that would [***]
any such [***] or [***] of [***], including, without limitation, any
[***] to be [***], any [***] in [***], or any [***] of the Sublicensed
Rights, or (ii) will not be unreasonably withheld by [***] in the case
of any [***] that would [***] impact any such [***] further agrees that
it will promptly provide [***] with copies of any notices it receives
from or gives to [***] pertaining to any [***] of the [***].
2.4 SPECIFIC NEUROCRINE WARRANTIES Neurocrine warrants and represents to
GSK that as of the mutual date of execution of this Agreement by the
Parties:
(a) it has the full right, power and authority to grant the
licenses granted to GSK under Article Three hereof;
(b) all Patent Rights included within the Neurocrine Technology
are existing and, to its knowledge, are not invalid or
unenforceable, in whole or in part;
(c) (i) it is the sole and exclusive owner or the exclusive
licensee of the Neurocrine Technology, including, without
limitation, all Patent Rights included therein, and (ii), to
its knowledge, no Person has any right, title or interest in
or to the Neurocrine Technology;
(d) all inventors (who are known as of the date this Agreement is
signed by each of the Parties) of any inventions included
within the Neurocrine Technology have assigned their entire
right, title and interest in and to such inventions and the
corresponding Patent Rights to Neurocrine;
(e) there are no claims, judgments or settlements against or owed
by Neurocrine or, to its knowledge, pending or threatened
claims or litigation relating to the Neurocrine Technology;
(f) except as disclosed to GSK prior to the mutual date of
execution of this Agreement by the Parties, it is not aware of
any [***] which could materially adversely affect the ability
of [***] hereunder or the ability of [***] of the rights or
licenses granted to it under this Agreement;
(g) it has no knowledge of any material information, other than
information provided to GSK prior to the signing of this
Agreement, which would [***]; and
(h) it has no present knowledge of the existence of any [***]
which it has not provided to GSK prior to mutual execution by
the Parties of this Agreement and which in [***] that there
may exist [***]
2.5 [***] COLLABORATIVE EFFORT. Subject to [***] sublicensing rights
hereunder, and except where the Steering Committee shall determine
otherwise (in which event for the avoidance of doubt such work shall be
considered part of this collaboration), [***] will each work [***]; and
(ii) otherwise in contravention of the exclusive license rights granted
to [***] under [***] of this Agreement. For the avoidance of doubt,
upon expiration of the term of the Research Program:
(a) this Agreement shall remain in force and effect;
(b) the intent and effect of the license grant to [***] under
Section 3.1 is that, for the duration of this Agreement, [***]
shall have [***] or through any Affiliate and/or Third Party,
and/or otherwise [***] including [***] and/or the [***]
including [***].
2.6 COMMERCIALLY REASONABLE EFFORTS. Neurocrine and GSK shall each use
Commercially Reasonable Efforts to perform their respective obligations
under the R&D Programs and meet the goals of the R&D Programs and
Collaboration.
2.7 DISCLAIMER. EXCEPT AS EXPRESSLY PROVIDED HEREIN EACH PARTY MAKES NO
OTHER REPRESENTATION OR WARRANTY, EITHER EXPRESS OR IMPLIED, INCLUDING,
WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE WITH RESPECT TO ANY MATERIALS, INCLUDING WITHOUT
LIMITATION NEUROCRINE TECHNOLOGY AND NEUROCRINE RECEPTORS.
ADDITIONALLY, EXCEPT AS EXPRESSLY SET FORTH IN SECTION 2.4, NEUROCRINE
MAKES NO REPRESENTATION OR WARRANTY, EITHER EXPRESS OR IMPLIED, THAT
THE MANUFACTURE, USE OR SALE OF ANY COLLABORATION PRODUCT WILL NOT
INFRINGE THE INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.
ARTICLE THREE
LICENSES
3.1 LICENSE GRANT TO [***]. [***] hereby grants to [***]:
(a) the [***] right and license, [***] sublicense [***], under the
[***] Technology, including [***] Patent Rights, and [***]
interest in any Program [***], including [***] Patent Rights,
to identify, make, have made, use, sell, offer for sale, have
sold and import Collaboration Products in the Field of use in
the Territory;
(b) during the term of [***] and a period of [***], the [***] in
the Territory, with [***] sublicense [***], under the [***]
Technology, to use the [***] for [***].
3.2 [***] RIGHTS. The exclusive licenses granted to [***] in Section 3.1
above, and the provisions of Section 3.7, shall be subject to the [***]
of a [***], with [***], in each case, to the extent necessary for [***]
to solely perform its obligations [***]. Subject to the licenses
granted to [***] in Section 3.1 above, nothing herein shall be deemed
to restrict [***] right to otherwise exploit (i) the [***] for all
purposes, subject always to Section 2.5 [***]; and (ii) the [***] for
[***].
3.3 LICENSE GRANT TO [***]. [***] hereby grants to [***] under the [***]
Technology, including [***] Patent Rights, and [***] Technology,
including [***], to [***] and any other [***] conducted under the scope
and authority of this Agreement.
3.4 DISCLOSURE. During the term of this Agreement, the Parties will as
promptly as practicably possible disclose to one another all data,
information, inventions, techniques and discoveries (whether patentable
or not) arising out of the conduct of the R&D Programs and all
inventions, techniques and discoveries (whether patentable or not)
included in the Technology licensed hereunder.
3.5 DATA. All data and information arising out of the R&D Programs will be
jointly owned by the Parties and will be Joint Confidential Information
and, subject to the licenses granted by one Party to the other, as set
forth herein, may be used by the Parties for any purpose.
3.6 MATERIALS.
(a) PROGRAM MATERIALS. During the term of this Agreement, upon
request by either Party, the Party to whom the request is made
will promptly provide to the other Party such quantities of
Program Materials as shall be reasonably available in excess
of its own needs for such other Party to carry out its
respective responsibilities under this Agreement. Subject to
the licenses set forth in Article Three, each Party may use
the Program Materials created or developed by such Party for
any purpose.
(b) NEUROCRINE MATERIALS. During the term of this Agreement,
Neurocrine will supply to GSK Neurocrine Materials reasonably
both in quantity and identity) requested by GSK provided (i)
such Neurocrine Materials are reasonably and readily available
to Neurocrine in excess of Neurocrine's own requirements, and
(ii) supply of such Neurocrine Materials will not, in
Neurocrine's sole judgment, (a) conflict with Neurocrine's
internal or collaborative research programs, (b) conflict with
Neurocrine's internal policies regarding such materials or (c)
violate any agreement to which Neurocrine is a party. Any
Neurocrine Materials provided to GSK hereunder together with
materials derived therefrom thereof (i) may only be used by
GSK and GSK's permitted sublicensees in the conduct of the R&D
Programs and/or in the discovery and/or development of
Collaboration Products, (ii) may not be supplied to Third
Parties, other than Third Parties that, with the approval of
the Steering Committee, are under contract with one of the
Parties to perform services in support of the R&D Programs,
without Neurocrine's prior written consent which can be
withheld for any reason in Neurocrine's sole discretion and
(iii) will, at Neurocrine's option and at Neurocrine's request
be returned to Neurocrine or destroyed. The provision of
Neurocrine Materials hereunder will not constitute any grant,
option or license under any Neurocrine Patent Rights, except
as expressly set forth herein.
(c) GSK MATERIALS. During the term of this Agreement, GSK will
supply to Neurocrine GSK Materials reasonably both in
quantity and identity) requested by Neurocrine pursuant to the
carrying out of its obligations under the Research Program
provided (i) such GSK Materials are reasonably and readily
available to GSK in excess of GSK's own requirements, and (ii)
supply of such GSK Materials will not, in GSK's sole judgment,
(a) conflict with GSK's internal or collaborative research
programs, (b) conflict with GSK's internal policies regarding
such materials or (c) violate any agreement to which GSK is a
party. Any GSK Materials provided to Neurocrine hereunder
together with materials derived therefrom thereof (i) may only
be used by Neurocrine in the conduct of the R&D Programs, (ii)
may not be supplied to Third Parties, other than Third Parties
that, with the approval of the Steering Committee, are under
contract with one of the Parties to perform services in
support of the R&D Programs, without GSK's prior written
consent which can be withheld for any reason in GSK's sole
discretion and (iii) will, at GSK's option and at GSK's
request be returned to GSK or destroyed. The provision of GSK
Materials hereunder will not constitute any grant, option or
license under any GSK Patent Rights, except as expressly set
forth herein.
3.7 OPTION FOR [***].
(a) OPTION FOR [***]. The scope of the Collaboration between
Neurocrine and GSK set forth in this Agreement [***] research
and development of compounds that are [***]. The Parties
acknowledge that the [***] Technology may have [***]. Whilst
[***] the full and unrestricted right to use and exploit the
[***] Technology for purposes [***]and specifically to [***]
Purposes, the exercise of such rights is, and shall be, at all
times subject to the terms of Section 3.7 (b) in that, subject
to such terms, either Party shall have the option to obtain
[***] license [***] under the [***] Technology to make, have
made, use, sell, have sold and import [***] Purposes in a
particular field.
(b) EXERCISE OF THE OPTION. In order to exercise the option for
[***] Technology as referred to in Section 3.7(a), the [***]
must deliver to [***] in writing, (i) a description of [***]
of the [***] Technology with respect to which [***], (ii) a
representation by such Party that [***] has conducted [***]
which indicates that the portion of the [***] Technology with
respect to which [***] in the field [***] (which shall include
[***] etc.) and bears a reasonable relation to the [***],
(iii) a description of the [***] for which [***] which shall
be limited to a specific statement of the [***] including
[***] (for example, [***] shall not be considered sufficiently
specific while a statement of [***] shall be considered
sufficiently specific), (iv) a description of the [***] and
known and potential [***], and (v) a representation by such
Party that the Party [***] consistent with such Party's
practices with regard [***]. Upon the [***] good faith
determination that an appropriate demonstration to [***] of
(i)-(v) above has been made by the requesting Party, the other
Party shall [***] right and license [***] under [***]
Technology with respect to which [***] for such [***] Purpose
[***] and the requesting Party shall [***] in respect of same
for so long as [***] Technology for such [***] Purpose in such
particular [***]. For the avoidance of doubt [***] of this
Agreement for any reason.
3.8 INVENTION ASSIGNMENT AGREEMENTS. All Neurocrine and GSK personnel
conducting the R&D Programs will have executed Neurocrine's or GSK's,
as the case may be, standard non-disclosure and invention assignment
agreement.
ARTICLE FOUR
STEERING COMMITTEE
4.1 CREATION; AUTHORITY. Within sixty (60) days of the Effective Date,
Neurocrine and GSK will form a Steering Committee to oversee the
research, development and commercialization of Collaboration Products
by reviewing all recommendations and issues arising from the R&D
Program and Project Teams, who shall be responsible to the Steering
Committee. The Steering Committee shall be comprised of an equal number
(maximum four (4) per party) of representatives appointed by Neurocrine
and GSK. GSK representatives on the Steering Committee will be at VP
level and will include representatives who can address all the
potential Indications for Collaboration Products arising from the
Collaboration.
4.2 SECRETARY. A secretary to the Steering Committee shall be appointed on
an annual basis and will rotate between GSK and Neurocrine, with GSK
providing the first such secretary. The secretary shall be responsible
for scheduling quarterly meetings, distributing meeting materials in
advance of meetings and meeting minutes following meetings. The
secretary shall also be empowered to call special meetings on request
of any Steering Committee member. The Party convening a special meeting
shall send notices and agenda for such meetings to the other Party and
to each Steering Committee member.
4.3 MEETINGS. The Steering Committee shall meet no less frequently than
quarterly. Steering Committee meetings may be by teleconference or by
videoconference as well as in person, with at least one face-to-face
meeting per annum. Either Party may call a special meeting of the
Steering Committee two (2) times per year, on fifteen (15) days written
notice to the other Party. Meetings will alternate between the offices
of the Parties, unless otherwise agreed. Each Party shall have one vote
only. Members of the Committee shall have the right to participate in
meetings by telephone. Each Party shall be responsible for expenses
incurred by its employees and its members of the Steering Committee
incurred in attending or otherwise participating in Steering Committee
meetings.
4.4 DECISIONS OF THE COMMITTEE. All decisions of the Steering Committee
shall be made in good faith in the best interests of the Collaboration
to further the goals of the Collaboration and shall be unanimous. In
the event the Steering Committee shall be unable to reach a decision on
any matter, the matter shall be submitted to the [***] Neurocrine [***]
of GSK for [***] based on [***] and if they can not agree within [***]
of the matter having been referred to them [***].
4.5 REPORTING AND DISCLOSURE.
(a) REPORTS. Prior to each quarterly meeting of the Steering
Committee, the Parties will distribute to each other written
copies of all materials intended to be submitted at the
Steering Committee meeting plus, to the extent not set forth
in the Steering Committee materials, a written report from the
CRF Research Project Team and, where applicable, the CRF
Development Project Team(s) both more particularly referred
to in Article 5) summarizing any other material data and
information arising out of the conduct of the R&D Program. In
the event that after receipt of any such report, either Party
shall request additional data or information relating to the
R&D Program data or Technology licensed hereunder, the Party
to whom such request is made shall promptly provide to the
other Party such data or information that such Party
reasonably believes is necessary for the continued conduct of
the R&D Program.
(b) MEETINGS. At the meetings of the Steering Committee, GSK and
Neurocrine will review in reasonable detail (i) all data and
information generated in the conduct of the R&D Programs by
each Party and (ii) all Program Technology licensed hereunder
developed by the Parties.
4.6 GOALS OF THE COLLABORATION. The goals of the Collaboration, expressed
herein as an intent (rather than creating any express or implied
liability on the part of either Party) shall be:
(a) to establish [***] for [***];
(b) to establish [***] for [***];
(c) to identify [***] to the [***];
(d) to identify [***] to the [***];
(e) to identify [***]; and
(f) to [***] for all [***] in this context shall have the same
meaning as in Section [***].
ARTICLE FIVE
CRF R&D PROGRAM
5.1 CRF R&D PROGRAM. Under the terms and conditions set forth herein, GSK
and Neurocrine will collaborate in the conduct of a collaborative
research and development program to [***] (the "CRF R&D Program"). The
CRF R&D Program will be comprised of two (2) main components: the CRF
Research Program and the CRF Development Program.
5.2 CRF RESEARCH PROGRAM.
(a) TERM. The initial term of the CRF Research Program will be
[***] from the Effective Date, extendable by a further [***],
to [***] from the Effective Date, upon the mutual agreement of
both Parties. To give effect to the foregoing, on or around
[***] before expiration of the initial [***] term of the CRF
Research Program, the Parties shall meet to consider and agree
upon the appropriateness, or not, of extending such CRF
Research Program for a further [***]. If the Parties do not
agree mutually to extend the CRF Research Program for a
further [***] in accordance with the foregoing provisions, GSK
and Neurocrine shall nevertheless continue into [***] of the
CRF Research Program to allow for an orderly winding down, and
transition, of activities carried out during the initial
[***].
(b) GOALS.
(i) [***] Antagonist Compounds. The goal of the CRF
Research Program as such relates to [***]Antagonist
Compounds, will be to [***] and [***] to the [***] as
Development Compounds for [***] and [***] other [***]
and to identify [***] for future research and
development. It is expected that the [***] for [***]
Receptor Antagonists will be [***] and [***] or
another [***] for which the therapeutic benefit is
not directly related to [***]. It is a further goal
of the CRF Research Program to continue basic [***]
biology research including development of [***],
[***] and [***] to further study [***] of the [***]
and to explore [***] as it relates to development
[***]. (ii) [***]Antagonist Compounds. The goal of
the CRF Research Program, as such relates to [***]
Antagonist Compounds, will be to [***] for [***] to
evaluate [***] and [***] and to identify [***] that
can be optimized for [***].
For the purposes of this Agreement, the following terms shall
have the meanings assigned below:
"Development Compound" shall mean a Collaboration Product with
respect to which [***].
"Back-up Compound" shall mean a series of one (1) or more
Compounds that are included within the [***] and that may exhibit an
improved pharmacokinetic profile with an acceptable safety profile.
"Follow-On Compound" shall mean a series of one (1) or more
Compounds that belong to [***] and that exhibit an improved
pharmacokinetic profile and an acceptable safety profile.
"Second Generation Compound" shall mean Compounds that when
compared to the [***] interact with a [***] and which have distinct
pharmacophore properties and improved profile with an acceptable safety
profile.
(c) CRF RESEARCH PLAN. The initial [***] CRF research plan is
attached hereto as Exhibit C and such plan also incorporates a
detailed research plan for the first year of the CRF Research
Program. The [***] plan will be updated on an annual basis by
the CRF Research Project Team and will specifically include
detailed plans for the following year including staffing
levels and activities as well as a more general plan for the
remaining term of the program. Each annual plan shall be
prepared jointly by the Parties through the CRF Research
Project Team and submitted to the Steering Committee for
review and approval. The CRF Research Plan may only be
modified or amended upon the written approval of the Steering
Committee. If the Parties agree, pursuant to Section 5.2 (a),
to extend the initial [***] term of the CRF Research Program
by a further [***], to [***] from the Effective Date, the
Parties shall as soon as practicably thereafter, through the
CRF Research Project Team, commence the drafting of a suitable
supplement to the then existing CRF Research Plan which such
supplement the CRF Research Project Team shall then use all
reasonable endeavors to have submitted to, and approved by,
the Steering Committee, in writing, before the commencement of
such further period of [***]. Such newly supplemented CRF
Research Plan will then also be updated by the CRF Research
Project Team on an annual basis for the remaining period of
[***] and will specifically include detailed plans for the
following year including staffing levels, activities and
estimated expenditures as well as more general plan for the
remaining term of the program. Such annual plan shall also be
prepared jointly by the CRF Research Project Team and
submitted to the Steering Committee for review and approval.
If the Parties have not mutually agreed to extend the CRF
Research Program for a further [***] and, pursuant to Section
5.2 (a), the Parties continue into a [***] of the CRF Research
Program (to allow for the orderly winding down and transition
of activities carried out during the [***]), the Parties
shall, as soon as practicable after determining such course of
action, and through the CRF Research Project Team, set out the
terms of such [***] program of research before submitting such
[***] plan to, and for approval by, the Steering Committee
before the commencement of [***].
(d) FUNDING OF THE RESEARCH PROGRAM.
(i) Internal Costs. [***] shall fund [***] costs arising
out of the conduct of the CRF Research Program,
provided however that Neurocrine shall not be
obligated to devote more than [***] full time
equivalent Neurocrine personnel ("FTE") to the
conduct of the CRF Research Program in [***] and
[***] FTEs in [***] (provided that the Parties have
mutually agreed to extend the CRF Research Program
for a [***] as contemplated by Section 5.2 (a) and
not for the avoidance of doubt where such [***]
activity relates to the orderly winding down and
transition of activities carried out during the [***]
as also contemplated by Section 5.2 (a)). In the
event the Steering Committee shall elect to request
that Neurocrine devote more than the above number of
FTEs to the conduct of the CRF Research Program in
any year, GSK will provide such funding for each
additional Neurocrine FTE at a rate of [***] per FTE
per year.
(ii) External and Third Party Costs. GSK will be
responsible for all GSK and Neurocrine Third Party
and external costs and expenses approved by the
Steering Committee. Third Party contractors will be
used whenever GSK's and/or Neurocrine's internally
dedicated FTEs are insufficient to meet the timelines
established by the Steering Committee or when Third
Party contractors will best meet the goals of the
Collaboration. In some instances, the Steering
Committee may elect to request that Neurocrine act as
a Third Party contractor to the CRF Research Program
and in such event, Neurocrine will be compensated
accordingly by GSK as agreed between Neurocrine and
the Steering Committee.
5.3 CRF DEVELOPMENT PROGRAM.
(a) GOAL. The goal of the Development Program as it relates to
[***] Antagonist Compounds will be to [***] for [***] and
[***] plus other [***] for like or different [***]. It is the
ultimate goal of the CRF Development Program as such relates
to [***], although no obligation and/or liability is hereby
created or implied, to [***] on a Collaboration Product for at
least [***] by [***]. The goal of the Development Program as
it relates to [***] Antagonist Compounds shall be [***] and
reflected at the time the [***] to incorporate detailed
reference to the development of [***] Antagonist Compounds
pursuant to Section 5.3(b).
(b) CRF DEVELOPMENT PLAN. The CRF Development Program will be
conducted in accordance with the CRF Development Plan attached
hereto as Exhibit D. The CRF Development Plan will be updated
by each of the CRF Development Project Teams at least on an
annual basis. Where a plan for a particular Collaboration
Product does not already form part of the CRF Development
Plan, the relevant CRF Development Project Team shall draft
such plan for the particular Collaboration Product for which
it has responsibility, with a view to same being incorporated
into and forming part of the CRF Development Plan In both
cases, such updates and/or amendments shall be submitted each
time by the relevant CRF Development Project Team to the
Steering Committee for review and approval. As of the
Effective Date, the CRF Development Plan attached hereto as
Exhibit D [***].
(c) CONDUCT AND FUNDING. GSK will be responsible for the conduct
and funding of all aspects of the CRF Development Program
which will include; scale-up, GLP toxicology, GSK's preferred
animal models and any other analyses or models requested by
GSK, GMP manufacturing, and clinical development including
regulatory affairs matters relating to same. In addition, GSK
will fund the completion of all Transition Activities for
[***]. For the purposes of the foregoing, "Transition
Activities" shall mean and include all [***] ongoing on [***]
which will be completed [***] and specifically includes the
activities and expenses set forth on Exhibit F.
5.4 CRF RESEARCH AND CRF DEVELOPMENT PROJECT TEAMS.
(a) ESTABLISHMENT. Within sixty (60) days of the Effective Date,
the Parties will establish a CRF Research Project Team and at
least one CRF Development Project Team (collectively, the
"Project Teams"). It is acknowledged that there is likely to
be a different Development Project Team for each Collaboration
Product (except in the case of certain Back-Up Compounds), and
references to "CRF Development Project Team" and "Project
Teams" shall be interpreted accordingly.
(b) COMPOSITION AND MEETINGS.
(i) The CRF Research Project Team shall be composed of
equal representatives from both Parties. The Parties
shall each designate a Project Team Leader so that
there will always be one Co-Project Leader from each
Party.
(ii) Each CRF Development Project Team shall be composed
of representatives of both Parties but shall consist
primarily of GSK representatives. The Project Leader
for each CRF Development Project Team shall, at all
times, be a GSK representative.
(iii) Each Project Team Leader or, in the case of the CRF
Project Research Team, the Co-Project Leaders shall
be responsible for the administration of meetings but
shall have no additional powers or rights other than
those held by virtue of being a representative, or
representatives, on the relevant Project Team.
Decisions of each Project Team shall be by unanimous
vote with each Party having one vote each. Should the
members of a Project Team become deadlocked on an
issue, then after a good faith but unsuccessful
effort to break such deadlock the issue shall be
presented to the Steering Committee for resolution.
The Project Teams shall meet at least on a monthly
basis either in person or by videoconference or
teleconference. Each Party shall be responsible for
expenses incurred by its employees incurred in
attending or otherwise participating in Project Team
meetings.
(c) CRF RESEARCH PROJECT TEAM RESPONSIBILITIES. In addition to its
general responsibility to oversee the day to day management of
the CRF Research Program, the CRF Research Project Team shall
(i) implement the CRF Research Plan; (ii) update the CRF
Research Plan on an annual basis, including preparing, on a
rolling basis, the detailed plan for the following year as
well as the more general plan for the remaining term of the
Program (ii) submit the work referred to in (i) to the
Steering Committee for its approval and (iii) provide regular
updates for, and report to, the Steering Committee on matters
relating to its area of responsibility.
(d) CRF DEVELOPMENT PROJECT TEAM(S) RESPONSIBILITIES. In addition
to its general responsibility to oversee the day to day
management of the CRF Development Program, each CRF
Development Project Team, insofar as such relates to the
particular Collaboration Product for which it has
responsibility, shall (i) where a plan does not already form
part of the CRF Development Plan, draft such plan for the
particular Collaboration Product for which it has
responsibility, with a view to same being incorporated into
and forming part of the CRF Development Plan; (ii) implement
the CRF Development Plan; (iii) update the CRF Development
Plan on an annual basis; (iv) submit the work referred to in
(i) (if applicable) and (ii) to the Steering Committee for its
approval; and (v) provide regular updates for, and report to,
the Steering Committee on matters relating to its area of
responsibility.
5.5 PERFORMANCE OBJECTIVES. GSK and Neurocrine will use Commercially
Reasonable Efforts to achieve the goals of the Collaboration, the
Research Programs and the Development Programs. In addition, GSK will
use Commercially Reasonable Efforts to [***] in order to [***].
Specifically, GSK will use Commercially Reasonable Efforts and
diligence in researching and developing Collaboration Products, and in
undertaking investigations and actions required to obtain appropriate
governmental approvals to market Collaboration Product in the
Territory. GSK shall also use Commercially Reasonable Efforts and
diligence to market and sell Collaboration Products in the Territory.
ARTICLE SIX
MANUFACTURING AND COMMERCIALIZATION
6.1 MANUFACTURING OF COLLABORATION PRODUCTS.
(a) CLINICAL AND COMMERCIAL MANUFACTURING. GSK will be responsible
for manufacturing of all clinical development and commercial
supplies of Collaboration Products. To give effect to the
foregoing, Neurocrine shall, as soon as practicably possible
after the Effective Date, [***], as GSK shall reasonably
require.
(b) RESEARCH. Manufacturing of CRF Antagonist Compounds for
research purposes shall be as set forth in the CRF Research
Plan.
6.2 COMMERCIALIZATION OF COLLABORATION PRODUCTS. GSK in its sole discretion
will make all decisions regarding the commercialization and sales and
marketing of Collaboration Products in the Territory and will book all
sales of Collaboration Products. GSK will use Commercially Reasonable
Efforts to commercialize Collaboration Products in all countries of the
Territory.
6.3 CO-COMMERCIALIZATION. For the purposes of this Agreement, and
specifically this Section 6.3, the terms "Co-Commercialization" and
Co-Commercialize" shall mean any and all activity related to the [***]
of Collaboration Product(s) sold under GSK's trademark(s) by members of
Neurocrine's [***] field sales force where such field sales force
members are [***] and otherwise subject to and in accordance with the
provisions of this Section 6.3. Subject to the provisions of this
Section 6.3, Neurocrine will have an option to Co-commercialize all
Collaboration Products [***] (the "Co-Commercialization Option").
Neurocrine may only exercise the Co-Commercialization Option if [***]
hereunder, and thereafter, [***] has or will have the [***] and the
[***] and [***]. Subject to the foregoing, and notwithstanding that
such Co-Commercialization Option [***], such Option can only be, and
must be, exercised during the period beginning on the [***] and ending
on the [***]. Neurocrine shall then be entitled to provide up to [***]
field sales force representatives in the Co-Commercialization of all
Collaboration Products. Before commencing Co-Commercialization, [***]
shall be entitled to [***] field force representatives first [***].
Thereafter, such Neurocrine field force representatives shall at all
times carry out their Co-Commercialization activities (i) under the
[***] and (ii) [***]. [***] for Co-Commercialization activities on a
[***] basis [***] and the [***] with the [***] of the particular [***]
and provided always that the [***] hereunder shall [***] for such
[***]. For the avoidance of doubt, [***].
The Parties hereby acknowledge that the foregoing principles may need
to be further set out in detail at the time the Co-Commercialization
Option is exercised by Neurocrine (and so long as any such new detailed
terms do not deviate in any way from such principles).
6.4 TRADEMARKS. All trademarks associated with Collaboration Products will
be selected and owned by GSK and maintained at GSK's expense.
Neurocrine shall be granted a license under the GSK trademarks to the
extent necessary for Neurocrine to Co-Commercialize Collaboration
Products consistent with Section 5.3 above. The terms of such license
shall be agreed by the Parties in good faith and a license executed by
same as soon as possible after the exercise of the Co-Commercialization
Option by Neurocrine pursuant to Section 5.3 and no later than the nine
(9) months anniversary of the first NDA filing by or on behalf of GSK
for the first Collaboration Product. Under no circumstances shall any
Co-Commercialization activity be undertaken by Neurocrine without such
license having already been agreed and executed by the Parties.
ARTICLE SEVEN
FEES, ROYALTIES AND MILESTONES
7.1 LICENSE FEES. In consideration for the license rights granted
hereunder, within thirty (30) days of the Effective Date, and subject
to receipt by GSK of an appropriate invoice therefore, GSK will pay to
Neurocrine [***] as a technology access fee. As additional
consideration for the license rights granted hereunder, within thirty
days of receipt by GSK of an appropriate invoice therefore, anniversary
payments of [***] each will be paid by GSK to Neurocrine on the [***]
anniversaries of the Effective Date. If the Parties have mutually
agreed to extend the Research Program for a [***] pursuant to Section
5.2 (a) then as further additional consideration for the license rights
granted hereunder, within thirty (30) days of receipt by GSK of an
appropriate invoice therefore, anniversary payments of [***] each will
be paid by GSK to Neurocrine on the [***] of the Effective Date. If the
Parties do not mutually agree to extend the CRF Research Program for a
further [***] but, pursuant to Section 5.2 (a), the Parties continue
into a [***] of the CRF Research Program (to allow for the orderly
winding down and transition of activities carried out during the
[***]), then, as further additional consideration for the license
rights granted hereunder, within thirty (30) days of receipt by GSK of
an appropriate invoice therefore, GSK will pay to Neurocrine [***] on
the [***] of the Effective Date and an additional [***] upon completion
of all such winding down and transitional activities.
7.2 ROYALTY RATES. GSK will pay to Neurocrine, incremental Royalties on a
country by country and Collaboration Product by Collaboration Product
basis, which Royalties shall be equal to:
Annual Net Sales in the Territory of
less than or equal to [***] [***]
Annual Net Sales in the Territory greater
than [***] and less than or equal to [***] [***]
Annual Net Sales in the Territory in excess of [***] [***]
For the avoidance of doubt, the thresholds referred to in this Section
7.2 are thresholds for, and determined on, [***]. GSK's royalty
obligations under this Section 7.2 shall become effective in each
country in the Territory at such time as GSK, its sublicensee or
Affiliate has commenced selling Collaboration Product in such country.
For the purposes of Royalty payments, [***] of a Collaboration Product
will be considered to be the same Collaboration Product, regardless of
the [***] for which such Collaboration Product may be used.
7.3 ROYALTY ADJUSTMENTS. Royalties on a Collaboration Product are subject
to reductions and adjustments as a result of certain events specified
in this Agreement including but not limited to those set forth below;
provided, however, in no event will Royalties on a Collaboration
Product in any country be reduced by more than [***] by reason of the
adjustments set forth below.
(a) ROYALTY ADJUSTMENT FOR GENERIC PRODUCTS. If, during a given
calendar quarter, there is Generic Competition in a particular
country then, for each such country in which there is Generic
Competition, the Royalties payable to Neurocrine for the Net
Sales of such Collaboration Product in such country during
such calendar quarter will be reduced by [***] of the royalty
rate(s) set forth in Section 7.2 above.
(b) THIRD PARTY ROYALTIES. Other than the payment by [***] of any
existing or future payments referred to and contemplated by
Section 7.4, the first [***] of royalties payable to Third
Parties for Patent Rights required to make, use or sell
Collaboration Products shall be borne by [***] and thereafter
shall be shared equally by the Parties. For the avoidance of
doubt, no license fee or milestone payments to Third Parties
shall be creditable against royalties payable to Neurocrine
under this Article Seven.
7.4 [***] ROYALTY. [***] will be responsible for all payments to the [***]
and/or any [***] and/or licensee (or any successor entity or entities
thereof,) under or in connection with the [***]. [***] will have all of
the rights set forth in that agreement to be afforded to [***] of any
technology licensed thereunder including, without limitation, in the
event of a [***] the right under [***] (as defined in Section 2.3
above), directly with [***] which [***] would be on the [***]. In the
event that [***], all payments made [***] shall in each case be [***]
from any payments [***] or thereafter becomes [***] under this
Agreement.
7.5 TERM OF ROYALTY. Royalties will be payable on a country by country and
a Collaboration Product by Collaboration Product basis until the later
of (i) the last to expire of the Patent Rights included within the
Collaboration Technology, containing a Valid Claim which would be
infringed by the sale of such Collaboration Product in such country or
(ii) 10 (ten) years following the First Commercial Sale in such
country. Upon the expiration of GSK's final remaining obligation to pay
Royalties to Neurocrine hereunder with respect to a Collaboration
Product in each such country, GSK shall have a fully paid, irrevocable,
exclusive and unrestricted license under the Neurocrine Technology to
make, have made, use, sell, and offer to sell and import such
Collaboration Product in such country.
7.6 REPORTS AND PAYMENTS.
(a) CUMULATIVE ROYALTIES. The obligation to pay Royalties under
this Article Seven shall be imposed only once (i) with respect
to any sale of the same unit of Collaboration Product and (ii)
with respect to a single unit of Collaboration Product
regardless of how many Valid Claims of Patent Rights included
in the Collaboration Technology would, but for this Agreement,
be infringed by the making, using or selling of such
Collaboration Product.
(b) STATEMENTS AND PAYMENTS. GSK shall deliver to Neurocrine
within sixty (60) days after the end of each calendar quarter,
a report certified by GSK as accurate to the best of its
ability based on information then available to GSK, setting
forth for such calendar quarter the following information on a
Collaboration Product by Collaboration Product basis: (i) Net
Sales of the Collaboration Product, (ii) the basis for any
adjustments to the Royalty payable for the sale of the
Collaboration Product and (iii) the Royalty due hereunder for
the sale of the Collaboration Product. The total Royalty due
for the sale of Collaboration Products during a calendar
quarter shall be remitted at the time such report is made.
(c) TAXES AND WITHHOLDING. All payments under this Agreement will
be made without any deduction or withholding for or on account
of any tax unless such deduction or withholding is required by
applicable law or regulations. If the paying Party is so
required to deduct or withhold such Party will (i) promptly
notify the other Party of such requirement, (ii) pay to the
relevant authorities the full amount required to be deducted
or withheld promptly upon the earlier of determining that such
deduction or withholding is required or receiving notice that
such amount has been assessed against the other Party, (iii)
promptly forward to the other Party an official receipt (or
certified copy) or other documentation reasonably acceptable
to the other Party evidencing such payment to the authorities.
In case the other Party can not take a full credit against its
tax liability for the withholding tax deducted or withheld by
the paying Party, then such other Party may propose a change
to the then current arrangement with respect to the flow of
moneys under this Agreement in order to reduce or eliminate
the extra cost for any Party and the Parties, with no
obligation as to outcome, shall discuss such proposal in good
faith.
(d) CURRENCY. All amounts payable and calculations hereunder shall
be in United States dollars. As applicable, Net Sales shall be
translated into United States dollars in accordance with GSK's
customary and usual translation procedures, consistently
applied. If governmental regulations prevent remittances from
a foreign country with respect to sales made in that country,
the royalties shall continue to accrue but the obligation of
GSK to pay royalties on sales in that country shall be delayed
until such remittances are possible. Neurocrine shall have the
right, upon giving written notice to SB, to receive payment in
that country in local currency.
(e) MAINTENANCE OF RECORDS; AUDIT. For a period of four (4) years,
GSK shall maintain and shall cause its Affiliates and
sublicensees to maintain complete and accurate books and
records in connection with the sale of Collaboration Products
hereunder, as necessary to allow the accurate calculation of
Royalties due hereunder including any records required to
calculate any Royalty adjustments hereunder. Once per calendar
year Neurocrine shall have the right to engage an independent
accounting firm reasonably acceptable to GSK, at Neurocrine's
expense, which shall have the right to examine in confidence
the relevant GSK records as may be reasonably necessary to
determine and/or verify the amount of Royalty payments due
hereunder. Such examination shall be conducted during GSK's
normal business hours, after at least fifteen (15) days prior
written notice to GSK and shall take place at the GSK facility
(ies) where such records are maintained. In the event there
was an under-payment by GSK hereunder, GSK shall promptly but
in no event later than thirty (30) days after GSK's receipt of
the independent auditor's report) make payment to Neurocrine
of any short-fall. In the event that there was an over-payment
by GSK hereunder, Neurocrine shall promptly but in no event
later than thirty (30) days after Neurocrine's receipt of the
independent auditor's report so correctly concluding) refund
to GSK the excess amount. In the event any payment by GSK
shall prove to have been incorrect by more than five percent
(5%) to Neurocrine's detriment, GSK will pay the reasonable
fees and costs of Neurocrine's independent auditor for
conducting such audit.
7.7 MILESTONES. In consideration for the license rights granted by
Neurocrine to GSK hereunder, on the first occurrence of the development
events set forth below, GSK shall make payments within thirty (30) days
of the occurrence of the following milestones and subject to receipt by
GSK, in each case, of an appropriate invoice therefore:
MILESTONE EVENT MILESTONE
Delivery to GSK of [***] CRF 1
Receptor [***] $ [***]
Development of [***] $ [***]
[***] Selection $ [***]
[***] Selection $ [***]
[***] Initiated $ [***]
The Milestones for Delivery [***] and Development of [***] shall each
be payable [***] upon the first achievement of the Milestone. The
Milestone for [***] Selection shall be payable [***]. The Milestone for
[***] Selection shall be payable [***]. The Milestone for [***]
Initiated shall be payable [***]. For the purposes of the above
Milestones, the following defined terms shall have the meanings
assigned:
"[***] Selection" shall mean selection of a Compound for [***] as
defined [***]. Approximately [***] Compounds should be at this stage at
any given time.
"[***] Selection" shall mean selection of a Compound for [***] as
defined [***]. Approximately [***] Compounds should be at this stage at
any given time.
"Development [***]" shall mean the development of a [***], provided
always, that such development meets the criteria set in the Research
Plan and has taken place subject to, and in accordance with, the
timelines set by the Steering Committee (failing which [***] shall be
deemed for this purpose not to have taken place).
"[***] Initiated" shall mean [***] but which shall specifically exclude
in this context, for the avoidance of doubt, [***].
In consideration for the license rights granted by Neurocrine to GSK
hereunder, on a [***] basis, up to a maximum of [***], and on an [***]
basis for up to [***], GSK will pay to Neurocrine the following
milestone payments within thirty (30) days following achievement of the
following events and Neurocrine shall in each case, provide GSK an
appropriate invoice therefore:
MILESTONE EVENT [***] [***] [***]
[***] Phase [***]
Study in [***] $[***] $[***] $[***]
[***]Phase [***]
Study in [***] $[***] $[***] $[***]
[***] Phase [***]
Study in [***] $[***] $[***] $[***]
Filing of [***] $[***] $[***] $[***]
Marketing Approval: [***] $[***] $[***] $[***]
Marketing Approval: [***]
[***] $[***] $[***] $[***]
Marketing Approval: [***] $[***] $[***] $[***]
In the event development of a Collaboration Product is discontinued,
only those Milestones that have not yet been paid at the time the
Collaboration Product has been discontinued will be available for
payment for future Collaboration Products achieving Milestone Events.
For the purposes of the above Milestones, the following defined terms
shall have the meanings assigned below. In addition, for the purposes
of the above Milestones, a study may be both a Phase [***] and a Phase
[***] study depending on the study design in which event both
applicable Milestones (if previously unpaid) will be payable on a
single study. Further, in the event a Phase [***] study shall be
unnecessary (as in the situation where [***] and [***]), if the
Milestone for [***] Phase [***] study has not been paid at the time of
[***], it shall be deemed payable at that time.
"Phase [***] Study" shall mean a study to [***].
"Phase [***] Study" shall mean a study to [***].
"Phase [***] Study" shall mean a [***] clinical study [***].
"Marketing Approval" shall mean the grant by the relevant regulatory
authority (ies), in the country specified, of the requisite Regulatory
Approval(s) (including pricing and/or reimbursement approval(s)) to
enable commercialization in such country of Collaboration Product.
"Indication" shall mean an individual disease or clinical condition
with respect to which [***] provided always that, notwithstanding the
foregoing, [***] shall always be deemed, for the purpose of this
Agreement and specifically this Article 7, to be [***] only and,
further, in respect of such [***] the following shall apply:
(i) achievement of a Marketing Approval for any [***] shall incur
[***] of milestone payments (dependant on whether such [***]),
for each Collaboration Product, up to [***];
(ii) if after Marketing Approval of a Collaboration Product for any
of [***] noted in Section A of Exhibit E, such Collaboration
Product also receives Marketing Approval [***] for one or more
[***] identified in Section B of Exhibit E [***], an
additional [***] milestone payment will be paid by GSK to
Neurocrine in respect of such [***] but up to maximum of [***]
for each [***] up to a maximum of [***]. The foregoing shall
be without prejudice to the general principle that all
milestone payment obligations hereunder shall be restricted to
a maximum of [***];
ARTICLE EIGHT
CONFIDENTIALITY, PUBLICATION AND
PUBLIC ANNOUNCEMENTS
8.1 CONFIDENTIALITY. Except to the extent expressly authorized by this
Agreement or otherwise agreed in writing, the Parties agree that, for
the term of this Agreement and for ten (10) years thereafter, each
Party (the "Receiving Party"), receiving hereunder any information
designated hereunder as Confidential Information of the other Party or
information of the other Party marked "Confidential" (in either case,
the "Disclosing Party"), shall keep such information confidential and
shall not publish or otherwise disclose or use for any purpose other
than as provided for in this Agreement except, to the extent that it
can be established:
(a) by the Receiving Party that the Confidential Information was
already known to the Receiving Party (other than under an
obligation of confidentiality), at the time of disclosure by
the Disclosing Party and such Receiving Party has documentary
evidence to that effect;
(b) by the Receiving Party that the Confidential Information was
generally available to the public or otherwise part of the
public domain at the time of its disclosure to the Receiving
Party;
(c) by the Receiving Party that the Confidential Information
became generally available to the public or otherwise part of
the public domain after its disclosure or development, as the
case may be, and other than through any act or omission of a
party in breach of this confidentiality obligation;
(d) by the Receiving Party that the Confidential Information was
disclosed to that Party, other than under an obligation of
confidentiality, by a Third Party who had no obligation to the
Disclosing Party not to disclose such information to others;
(e) by the Receiving Party that the Confidential Information was
independently discovered or developed by the Receiving Party
without the use of the Confidential Information belonging to
the other Party and the Receiving Party has documentary
evidence to that effect
8.2 AUTHORIZED DISCLOSURE.
(a) EACH PARTY. Each Party may disclose Confidential Information
belonging to the other Party to the extent such disclosure is
reasonably necessary to:
(i) file or prosecute patent applications claiming
inventions included within the Collaboration
Technology,
(ii) prosecute or defend litigation,
(iii) exercise rights hereunder provided such disclosure is
covered by terms of confidentiality similar to those
set forth herein, and
(iv) comply with applicable governmental laws and
regulations.
In the event a Party shall deem it necessary to disclose pursuant to
this Section 8.2 (a), Confidential Information belonging to the other
Party, the Disclosing Party shall to the extent possible give
reasonable advance notice of such disclosure to the other Party and
take reasonable measures to ensure confidential treatment of such
information.
(b) USE. GSK shall have the right to use Neurocrine Confidential
Information in the conduct of the R&D Programs and in
developing and commercializing Collaboration Products.
Neurocrine shall have the right to use GSK Confidential
Information in the conduct of the R&D Programs.
8.3 SEC FILINGS. The Parties will consult with one another with a view to
agreeing the terms of this Agreement that shall be redacted in any SEC
filing(s) that may be required to be made.
8.4 PUBLICATIONS. During the term of the Research Programs, each Party will
submit to the Steering Committee for review and approval all proposed
academic, scientific and medical publications relating to the R&D
Programs, Collaboration Products and/or Collaboration Technology for
review in connection with preservation of exclusive Patent Rights
and/or to determine whether Confidential Information should be modified
or deleted. The Steering Committee shall have no less than thirty (30)
days to review each proposed publication. The review period may be
extended for an additional thirty (30) days in the event the
nonpublishing Party can demonstrate to the Steering Committee a
reasonable need for such extension including, but not limited to, the
preparation and filing of patent applications. Such period may be
further extended by the Steering Committee. GSK and Neurocrine will
each comply with standard academic practice regarding authorship of
scientific publications and recognition of contribution of other
parties in any publications relating to R&D Programs, Collaboration
Products and/or Collaboration Technology. Notwithstanding the
foregoing, the Parties shall endeavor as far as possible, for ease and
convenience, to agree on a universal basis joint authorship in respect
of such publications.
8.5 PUBLIC ANNOUNCEMENTS.
(a) COORDINATION. The Parties agree on the importance of
coordinating their public announcements respecting this
Agreement and the subject matter thereof (other than academic,
scientific or medical publications that are subject to the
publication provision set forth above). Neurocrine and GSK
will, from time to time, and at the request of the other Party
discuss and agree on the general information content relating
to this Agreement, the R&D Programs, Collaboration Products
and/or Collaboration Technology which may be publicly
disclosed.
(b) ANNOUNCEMENTS. The Parties have agreed that all events arising
out of the collaborative development of Collaboration
Products, which in Neurocrine's judgment are material to
Neurocrine, will be promptly disclosed. In addition, the
Parties have acknowledged that the progress of the
Collaboration in general is material to Neurocrine and
therefore have agreed to make regular public disclosures,
whether by press release or publication, describing the status
of the development of Collaboration Products. These releases
may be Neurocrine releases or joint Neurocrine/ GSK releases
at GSK's option. Neither Party will make any public
announcement regarding this Agreement, the R&D Programs,
Collaboration Products and/or Collaboration Technology (other
than academic, scientific or medical publications which are
subject to the publication provision set forth above) without
making good faith efforts to provide the other Party the
opportunity to review and comment prior to release unless the
specific disclosure is required by law and time does not
permit delay. Notwithstanding the foregoing, with regard to
any public announcement relating to the fact of execution of
this Agreement by the parties hereof, and the terms of such
Agreement, neither Party shall make any such announcement
without the prior consent of the other.
ARTICLE NINE
INDEMNIFICATION
9.1 INDEMNIFICATION BY GSK. GSK will indemnify, defend and hold harmless
Neurocrine, its licensees, sublicensees and Affiliates, and each of its
and their respective employees, officers, directors and agents (each, a
"Neurocrine Indemnified Party") from and against any and all liability,
loss, damage, expense (including reasonable attorneys' fees and
expenses) and cost (collectively, a "Liability") which the Neurocrine
Indemnified Party may be required to pay to one or more Third Parties
resulting from or arising out of (i) any claims of any nature (other
than claims by Third Parties relating to patent infringement) arising
out of (y) the conduct of the R&D Programs or use of Collaboration
Technology of by, on behalf of or under authority of, GSK (other than
by a Neurocrine Indemnified Party) or (z) research, development and/or
commercialization of Collaboration Products by, on behalf of or under
authority of, GSK (other than by Neurocrine Indemnified Party) and/or
(ii) any GSK representation or warranty set forth herein being untrue
in any material respect when made, except in each case, to the extent
caused by the negligence or willful misconduct of Neurocrine or any
Neurocrine Indemnified Party. Notwithstanding the foregoing, GSK shall
have no obligation to defend, indemnify or hold harmless any Neurocrine
Indemnified Party from and against any Liability arising out of or
resulting from the infringement of a Third Party Patent Right.
9.2 INDEMNIFICATION BY NEUROCRINE. Neurocrine will indemnify, defend and
hold harmless GSK, its licensees, sublicensees and Affiliates, and each
of its and their respective employees, officers, directors and agents
(each, a "GSK Indemnified Party") from and against and all Liability
which the GSK Indemnified Party may be required to pay to one or more
Third Parties arising out of (i) any claims of any nature (other than
claims by Third Parties relating to patent infringement) arising out of
(x) the conduct of the R&D Program or use of Collaboration Technology
of by, on behalf of or under authority of, Neurocrine (other than by a
GSK Indemnified Party) or (y) research, development and/or
commercialization of Collaboration Products by, on behalf of or under
authority of, Neurocrine (other than by a GSK Indemnified Party) and/or
(ii) any Neurocrine representation or warranty set forth herein being
untrue in any material respect when made, except in each case, to the
extent caused by the negligence or willful misconduct of GSK or any GSK
Indemnified Party. Notwithstanding the foregoing, Neurocrine shall have
no obligation to defend, indemnify or hold harmless any GSK Indemnified
Party from and against any Liability arising out of or resulting from
the infringement of a Third Party Patent Right.
9.3 PROCEDURE. Each Party will notify the other in the event it becomes
aware of a claim for which indemnification may be sought hereunder. In
case any proceeding (including any governmental investigation) shall be
instituted involving any Party in respect of which indemnity may be
sought pursuant to this Article Nine, such Party (the "Indemnified
Party") shall promptly notify the other Party (the "Indemnifying
Party") in writing and the Indemnifying Party and Indemnified Party
shall meet to discuss how to respond to any claims that are the subject
matter of such proceeding. The Indemnifying Party, upon request of the
Indemnified Party, shall retain counsel reasonably satisfactory to the
Indemnified Party to represent the Indemnified Party and shall pay the
fees and expenses of such counsel related to such proceeding. In any
such proceeding, the Indemnified Party shall have the right to retain
its own counsel, but the fees and expenses of such counsel shall be at
the expense of the Indemnified Party unless (i) the Indemnifying Party
and the Indemnified Party shall have mutually agreed to the retention
of such counsel or (ii) the named parties to any such proceeding
(including any impleaded parties) include both the Indemnifying Party
and the Indemnified Party and representation of both parties by the
same counsel would be inappropriate due to actual or potential
differing interests between them. All such fees and expenses shall be
reimbursed as they are incurred. The Indemnifying Party shall not be
liable for any settlement of any proceeding effected without its
written consent, but if settled with such consent or if there be a
final judgment for the plaintiff, the Indemnifying Party agrees to
indemnify the Indemnified Party from and against any loss or liability
by reason of such settlement or judgment. The Indemnifying Party shall
not, without the written consent of the Indemnified Party, effect any
settlement of any pending or threatened proceeding in respect of which
the Indemnified Party is, or arising out of the same set of facts could
have been, a party and indemnity could have been sought hereunder by
the Indemnified Party, unless such settlement includes an unconditional
release of the Indemnified Party from all liability on claims that are
the subject matter of such proceeding.
ARTICLE TEN
TERM AND TERMINATION
10.1 TERM. Unless earlier terminated by mutual agreement of the Parties or
pursuant to the provisions of this Article Ten, this Agreement will
continue in full force and effect on a Collaboration Product by
Collaboration Product basis until the final obligation to pay Royalties
with respect to the sale of such Collaboration Product in the final
country expires as provided in Section 7.5 hereof. For the avoidance of
doubt, in the event of termination of the CRF Research Program by GSK
other than by reason of expiration of one of the two terms set forth in
Section 5.2(a) such early termination of the CRF Research Program shall
also constitute an automatic termination of this Agreement in full.
10.2 GSK UNILATERAL RIGHT TO TERMINATE. GSK may terminate this Agreement at
any time for any reason upon [***] prior written notice to Neurocrine.
In addition, GSK may terminate this Agreement on a [***] basis, or
[***] basis, by giving Neurocrine at least [***] written notice thereof
at any time before [***] based on a reasonable determination by [***]
using the same standards [***] would use in assessing whether or not to
[***] does not justify [***]. After [***] Collaboration Product, GSK
may terminate this Agreement on a [***] basis, or in its entirety, or
on a [***] basis, by giving Neurocrine at least [***] prior written
notice thereof based on a reasonable determination [***], using the
same standards [***] would use in assessing whether or not to [***]
justify continued [***].
10.3 CONSEQUENCES OF TERMINATION OF AGREEMENT IN ITS ENTIRETY In the event
of termination in toto of this Agreement:
(i) other than any license(s) granted to [***], all licenses [***]
herein will [***]:
(ii) [***] will [***] to [***] specifically referred to as [***] in
respect of [***] of the Effective Date and the [***] for the
[***] and not yet [***] under Section [***]. If the Parties
have extended the initial term of the CRF Research Program by
[***] pursuant to Section 5.2 (a), [***] to [***] specifically
referred to [***] in respect of [***] and not yet [***] under
Section [***];
(iii) [***] will provide to [***] Collaboration Product [***] and
[***] to [***] R&D Program research, pre-clinical and clinical
[***] Collaboration Products [***] prior to the date of
termination of this Agreement and [***] shall thereafter have
[***];
(iv) [***] will [***] all [***] relating Collaboration Products in
the Territory;
(v) [***] will [***] to [***] license under the [***] Technology
to make, have made, use, import, market, offer for sale and
sell products in the Field of Use for [***] Purposes [***];
(vi) [***] will grant to [***] license under the [***] Patent
Rights, to make, have made, use, import, market, offer for
sale and sell products in the Field of Use for [***] Purposes
[***], provided that, [***] shall [***] retain the right to
[***] Technology other than the [***] Patent Rights for [***]
use the [***] Patent Rights [***] Purposes; and
(vi) [***] will provide to [***] any other [***] reasonably
required to allow [***] research, development and
commercialization [***].
10.4 CONSEQUENCES OF TERMINATION OF THE AGREEMENT ON A COLLABORATION PRODUCT
OR COUNTRY-BY-COUNTRY BASIS.
(a) Neurocrine shall have the right in its sole discretion at its
sole expense, for its own benefit or together with a Third
Party, to develop and commercialize in the Territory any
Collaboration Product which [***] pursuant to Section [***]
provided that [***] or any of its sublicensees is not [***],
or does not plan to [***] Product under this Agreement [***]
in this context shall mean any other Collaboration Product
[***] exhibits similar [***] and which is targeted [***]
market approval [***] as such [***].
(b) If GSK terminates [***] Neurocrine shall have the right in its
sole discretion and at its sole expense, for its own benefit
or together with a Third Party, to develop and/or
commercialize such [***] but only in those [***] in which
[***] has elected [***] develop and/or commercialize such
[***] and provided that [***] or any of its sublicensees is
not [***], or does not [***], researching, developing or
commercializing of [***] under this Agreement [***] in this
context shall have the same meaning as in Section [***].
(c) Subject to the foregoing, and if Neurocrine exercises its
rights under this Section 10.4 subject to and in accordance
with such terms, [***] shall [***] to [***] license ([***]
sublicense) in the Territory (or in the case of [***], in the
relevant countries) under the [***] Technology to make, have
made, use and sell [***] in the Field in so far as such relate
to [***] Purposes [***]. [***] shall also [***] with all such
[***] which [***], or its sublicensees reasonably have
available [***], for example [***], and shall [***] as [***]
reasonably requests, to enable [***] appropriate regulatory
approvals [***] in such country and for any other lawful
purpose related to development and commercialization of [***].
10.5 DEFAULT. Either Party may terminate this Agreement for material breach
by the other Party, which breach remains uncured for thirty (30) days
in the case of nonpayment of any amount due and sixty (60) days for all
other breaches, each measured from the date written notice of such
breach is given to the breaching Party, or, if such breach is not
capable of remedy within such sixty (60) day period and the breaching
Party uses diligent good faith efforts to cure such breach, ninety days
(90) days after written notice to the breaching Party.
10.6 BANKRUPTCY. Each party may, in addition to any other remedies available
to it by law or in equity, exercise the rights set forth below by
written notice to the other Party (the "Insolvent Party"), in the event
the Insolvent Party shall have become insolvent or bankrupt, or shall
have made an assignment for the benefit of its creditors, or there
shall have been appointed a trustee or receiver of the Insolvent Party
or for all or a substantial part of its property, or any case or
proceeding shall have been commenced or other action taken by or
against the Insolvent Party in bankruptcy or seeking reorganization,
liquidation, dissolution, winding-up arrangement, composition or
readjustment of its debts or any other relief under any bankruptcy,
insolvency, reorganization or other similar act or law of any
jurisdiction now or hereafter in effect, or there shall have been
issued a warrant of attachment, execution, distraint or similar process
against any substantial part of the property of the Insolvent Party,
and any such event shall have continued for sixty (60) days
undismissed, unbonded and undischarged. All rights and licenses granted
under or pursuant to this Agreement by Neurocrine and GSK are, and
shall otherwise be deemed to be, for purposes of Section 365 (n) of the
U.S. Bankruptcy Code, licenses of rights to "intellectual property" as
defined under Section 101 of the U.S. Bankruptcy Code. The Parties
agree that the Parties as licensees of such rights under this Agreement
shall retain and may fully exercise all of their rights and elections
under the U.S. Bankruptcy Code. The Parties further agree that, in the
event of the commencement of a bankruptcy proceeding by or against
either Party under the U.S. Bankruptcy Code, the other Party shall be
entitled to a complete duplicate of (or complete access to, as
appropriate) any such intellectual property and all embodiments of such
intellectual property, and same, if not already in the their
possession, shall be promptly delivered to them (i) upon any such
commencement of a bankruptcy proceeding upon its written request
therefore, unless the Party subject to such proceeding elects to
continue to perform all of their obligations under this Agreement or
(ii) if not delivered under (i) above, upon the rejection of this
Agreement by or on behalf of the Party subject to such proceeding upon
written request therefore by the other Party.
(a) NEUROCRINE. In the event Neurocrine shall be an Insolvent
Party, GSK may terminate the Research Programs and/or keep
this Agreement in full force and effect and retain all
licenses granted by Neurocrine to GSK herein to make, have
made, use, import, market, offer for sale and sell
Collaboration Products in the Field of use in the Territory,
subject to the payment to Neurocrine of the license fees,
milestones and royalties set forth above.
(b) GSK. In the event GSK shall be an Insolvent Party, Neurocrine
may, to the extent permitted by applicable law, terminate this
Agreement and the provision of Section 10.3. shall apply.
10.7 ACQUISITION OF NEUROCRINE. Upon the Acquisition of Neurocrine (a) such
that Neurocrine [***] or (b) such that, [***], Neurocrine [***] under
this Agreement or (c) by a Third Party who is [***] immediately
preceding the calendar quarter in which the Acquisition of Neurocrine
has taken place) , GSK shall have the right to [***]; Neurocrine's
[***] but otherwise [***]. For the purposes of the foregoing,
"Acquisition" shall mean the acquisition, directly or indirectly, by
any Third Party of (i) securities authorized to [***] or more of the
votes in any election of directors and/or (ii) the sale or other
transfer of all or substantially all of its assets. Notwithstanding the
foregoing, the sale or other transfer of substantially all of the
assets of Neurocrine to another direct or indirect wholly-owned
subsidiary of Neurocrine shall not constitute an Acquisition.
10.8 LIABILITIES. Termination of this Agreement shall not release either
Party from any obligation or liability which shall have accrued at the
time of termination, or preclude either Party from pursuing all rights
at law and in equity with respect to any Default under this Agreement.
Notwithstanding the foregoing, neither Party will be liable for
punitive, exemplary or consequential damages incurred by the other
Party arising out of any Default under this Agreement.
10.9 DISCLAIMER. WITH RESPECT TO ANY DATA, INFORMATION OR INTELLECTUAL
PROPERTY THAT EITHER PARTY BECOMES OBLIGATED TO TRANSFER TO THE OTHER
UNDER THIS ARTICLE TEN, THE TRANSFERING PARTY MAKES NO REPRESENTATIONS
AND EXPRESSLY DISCLAIMS AND MAKES NO WARRANTIES OF ANY KIND, WRITTEN OR
ORAL, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION ANY WARRANTIES
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT ANY
SUCH INFORMATION, DATA OR INTELLECTUAL PROPERTY IS ACCURATE OR COMPLETE
OR CAN BE USED BY THE RECEIVING PARTY WITHOUT INFRINGING THE
INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.
ARTICLE ELEVEN
INTELLECTUAL PROPERTY
11.1 INVENTORSHIP AND INVENTION OWNERSHIP. The inventorship of an invention
shall be determined in accordance with the patent laws of the U.S. The
ownership of an invention shall be determined in accordance with the
applicable patent laws of the country where the invention is conceived.
Notwithstanding the foregoing, the Parties shall [***] Program Patent
Rights and the Parties shall take all actions [***] necessary to [***]
and shall, subject to the terms of this Agreement including, without
limitation, [***], take all actions to provide [***] which is the
subject of such Program Patent Rights including, without limitation
[***] therein or to otherwise [***] such Program Patent Rights [***]
without [***] and without [***]. The Parties recognize the importance
of diligently determining the inventorship of a given invention and
shall co-operate as necessary in providing each other with sufficient
information to enable such a determination to be made, and shall make
all reasonable efforts to reach agreement on such determination. In the
event that the Parties cannot reach agreement as to such inventorship
determination, the matter will be passed to outside counsel acceptable
to both Parties to make a final and binding determination, the costs of
such determination to be borne jointly by the Parties.
11.2 PATENT PROSECUTION
(a) GSK PATENT RIGHTS. GSK shall [***], prepare, file, prosecute,
and maintain in countries selected by GSK, Patent Rights
relating to GSK Technology ("GSK Patent Rights").
(b) NEUROCRINE PATENT RIGHTS. Neurocrine shall select outside
counsel acceptable to both Parties to prepare, file,
prosecute, and maintain in countries selected by GSK, Patent
Rights relating to Neurocrine Technology ("Neurocrine Patent
Rights"), [***] provided however that such expense [***].
(c) STATUS UPDATE. GSK will update Appendix A twice each year or
at Neurocrine's reasonable request during the term of the
Agreement so as to reflect the most current status. of the GSK
Patent Rights. Neurocrine will update Appendix B twice each
year or at GSK's reasonable request during the term of the
Agreement so as to reflect the most current status of the
Neurocrine Patent Rights.
(d) REVIEW AND CONSULTATION. Each Party shall keep the other Party
informed of all significant steps to be taken in the
preparation and prosecution of all patent applications within
GSK Patent Rights and Neurocrine Patent Rights respectively,
and shall furnish the other Party with copies of any such
applications, amendments thereto and other related significant
correspondence to and from patent offices to allow for review
by and consultation with the other party reasonably in advance
of any submission to a patent office which could materially
affect the scope or validity of the patent coverage that may
result. Copies of all such applications filed prior to the
Effective Date shall be provided to the other Party promptly
after the Effective Date. Comments made by or on behalf of the
other Party will be taken into account in the preparation and
prosecution of such applications. Notwithstanding the
foregoing neither Party will make or allow any alteration
which would result in the reduction or loss of patent
protection for Collaboration Compounds without the consent of
the other Party, which shall not be unreasonably withheld.
(e) ABANDONMENT. GSK will not abandon any GSK Patent Rights or
permit any patent issuing therefrom to lapse without first
notifying Neurocrine and permitting them to continue the
prosecution of such patent applications and maintenance of any
patents at their expense, provided however that [***].
Neurocrine will not abandon any Neurocrine Patent Rights or
permit any patent issuing therefrom to lapse without first
notifying GSK and permitting them to continue the prosecution
of such patent applications and maintenance of any patents,
provided however that [***].
(f) ADDITIONAL COUNTRIES. In the event that [***] wish a patent
application within Neurocrine Patent Rights to be filed,
prosecuted or maintained in a particular country additional to
those countries indicated by [***], then the costs of such
filing, prosecution and maintenance in respect of that
application in that country shall be borne [***], and [***].
[***] will also have the right to indicate that it no longer
wishes to bear the costs for outside counsel to prepare, file,
prosecute, and maintain any aspect of Neurocrine Patent Rights
and shall give [***] sufficient notice and opportunity to bear
such costs, in which event [***].
(g) PROGRAM PATENT RIGHTS. GSK shall, during the term of the
Agreement, [***], prepare, file, prosecute, and maintain in
countries selected by GSK, Program Patent Rights.
(h) CONSULTATION AND REVIEW. The Parties shall promptly inform
each other of all inventions within the Program Technology,
shall also share all relevant information regarding such
inventions, and shall consult regarding the preparation of
appropriate patent applications, including in respect of the
scope and timing thereof. GSK shall keep Neurocrine informed
of all subsequent significant steps to be taken in the
prosecution of all patent applications within Program Patent
Rights, and shall furnish Neurocrine with copies of any such
applications, amendments thereto and other related significant
correspondence to and from patent offices to allow for review
by and consultation with Neurocrine reasonably in advance of
any submission to a patent office which could materially
affect the scope or validity of the patent coverage that may
result. Comments made by or on behalf of Neurocrine will be
taken into account in the preparation and prosecution of such
applications.
(i) [***] EXPENSE. In the event [***] elects not to prepare or
file a patent application in respect of inventions within the
Program Technology or to maintain any applications or patents
included in the Program Patent Rights, [***] shall give [***]
sufficient notice and opportunity to do so at [***] expense,
in which event [***].
(j) FURTHER COUNTRIES. In the event that [***] wish a patent
application within the Program Patent Rights to be filed,
prosecuted or maintained in a particular country additional to
those countries indicated by [***], then the costs of such
filing, prosecution and maintenance in respect of that
application in that country shall be borne entirely by
Neurocrine, in which event [***].
(k) STATUS REPORT. [***] will provide a report twice each year or
at [***] reasonable request during the term of the Agreement
so as to reflect the most current status of the Program Patent
Rights.
(l) DEVELOPMENT PATENT RIGHTS. The responsibility and costs for
the preparation and filing of applications relating to
Development Patent Rights, shall be borne [***], provided
however that in the case of any such inventions and Patent
Rights [***], the Parties shall have [***]. The responsibility
and costs for filing, prosecuting and maintaining the [***]
will be borne by [***] and [***] shall keep [***] informed of
all significant steps to be taken in the prosecution of all
patent applications relating thereto, and shall furnish [***]
with copies of any such applications, amendments thereto and
other related significant correspondence to and from patent
offices to allow for review by and consultation with [***]
reasonably in advance of any submission to a patent office
which could materially affect the scope or validity of the
patent coverage that may result and comments made by or on
behalf of [***] will be taken into account in the preparation
and prosecution of such applications.
11.3 EXTENSION OF PATENT RIGHTS. At the time of the [***] in respect of a
Collaboration Product, and where the Collaboration Product or the
approved use thereof is [***] shall appoint [***] or its designee as
[***]agent for the sole purpose of submitting an application to extend
the term of such patent, an application for a Supplementary Protection
Certificate, or an equivalent thereof. [***] shall co-operate with
[***] or its designee in connection with any such application.
11.4 DEFENSE OF PATENT RIGHTS. In respect of any proceeding initiated by a
Third Party which challenges the validity of, enforceability of, or
entitlement to the [***], and which proceeding does not also involve
the enforcement of such Patent Rights as set out in Section [***]
(including but not limited to pre-grant opposition, post-grant
opposition, re-examination, interference, and revocation proceedings)
the responsibilities, costs and obligations for consultation for the
Parties apply in a similar manner to those as set out in Section [***]
in respect of [***].
11.5 ENFORCEMENT OF PATENT RIGHTS.
(a) NOTIFICATION. Each Party shall promptly notify each other of
any infringement of the Patent Rights relating to [***] or
relating to [***] which may come to its attention.
(b) [***] TECHNOLOGY. Except as set forth below, [***] shall have
the first right, but not the obligation, in its own name, to
enforce Patent Rights relating to [***] Technology, against
any Third Party suspected of infringing a claim of such a
Patent Right in the Territory. In the event [***] shall not
elect to enforce any Patent Right in the Territory, [***]. The
Party [***] (the "Enforcing Party") shall have exclusive
control over the conduct of any such proceedings, including
the right to settle or compromise such proceedings consistent
with [***], provided, however, that the Enforcing Party may
not settle or compromise any such action in a manner which
diminishes the Patent Rights relating to any [***] Technology
[***], Neurocrine [***] Program [***] the [***] or which would
impose any financial obligation on the other Party without
such other Party's consent. The expenses of any proceeding the
Enforcing Party initiates, including legal fees and costs,
shall be borne by the Enforcing Party, provided however, that
the other Party (the "Non-enforcing Party") may elect to
[***]. The Non-enforcing Party will co-operate fully with the
Enforcing Party in such action upon request by the Enforcing
Party. In the event the Non-enforcing Party [***], any award
or recovery paid to the Enforcing Party by a Third Party as a
result of such patent infringement proceedings (whether by way
of settlement or otherwise) shall first be applied toward
[***], and from the remainder, if any, [***] in the event
[***] shall be the Enforcing Party shall [***] (or [***] shall
retain in the event [***] shall be the Enforcing Party) an
amount equal to the [***]. Any excess shall be for the
Enforcing Party. In the event the Non-enforcing Party has
[***], such award or recovery paid to the Enforcing Party
shall first be applied toward [***], and the remainder, if
any, shall be [***].
(c) [***]. [***] shall have the sole right but not the obligation,
in its own name and at its own expense, to enforce Patent
Rights relating to the [***] against any Third Party suspected
of infringing a claim of such a Patent Right.
11.6 INFRINGEMENT DEFENSE. [***] shall have the right, but not the
obligation, to defend and control any suit against any of [***]
Affiliates or sublicensees, alleging infringement of any patent or
other intellectual property right of a Third Party [***]. [***] shall
be responsible for the costs and expenses, including legal fees and
costs, associated with any suit or action. [***] will consult with one
another and co-operate in the defense of any such action. If [***]
finds it necessary or desirable to join [***] as a party to any such
action, [***] will execute all papers and perform such acts as shall be
reasonably required, at [***] expense. In the event the patent claim of
any Third Party is held in a final and unappealable order of a court to
be valid and infringed, or if [***] enters into a settlement of such
proceedings, [***] shall pay the full amount of any damages and/or
settlement amounts due to such Third Party.
11.7 HOLD HARMLESS. The Parties hereby agree to hold each other harmless in
respect of their good faith activities hereunder to file, prosecute,
maintain, enforce and defend Patent Rights under this Article 11.
ARTICLE TWELVE
MISCELLANEOUS
12.1 DISPUTES. Other than matters for decision by the Project Teams, for
which Section 5.4 shall apply, and/or the Steering Committee, for which
Section 4.4 shall apply, if the Parties are unable to resolve a dispute
among them informally, GSK and Neurocrine, by written notice to the
other, may have such dispute referred to their respective executive
officers designated for attempted resolution by good faith
negotiations:
FOR GSK: [***]
FOR NEUROCRINE: [***]
Any such dispute shall be submitted to the above-designated executive
officers no later than thirty (30) days following such request by
either GSK or Neurocrine. In the event the designated executive
officers are not able to resolve any such dispute within sixty (60)
days after submission of the dispute to such executive officers, GSK or
Neurocrine, as the case may be, may pursue whatever measures are
legally available to them to resolve such dispute. All negotiations
pursuant to this Section 12.1 shall be treated as compromise and
settlement negotiations. Nothing said or disclosed, nor any document
produced, in the course of such negotiations which is not otherwise
independently discoverable shall be offered or received as evidence or
used for impeachment or for any other purpose in any current or future
arbitration or litigation.
12.2 ASSIGNMENT. Neither this Agreement nor any interest hereunder shall be
assignable by either Party without the prior written consent of the
other Party, except for assignment by operation of law in connection
with a merger of a Party with or into another Person, subject at all
times to Section 10.4. This Agreement shall be binding upon the
successors and permitted assigns of the Parties and the name of a Party
appearing herein shall be deemed to include the names of such Party's
successors and permitted assigns to the extent necessary to carry out
the intent of this Agreement. Any assignment not in accordance with
this Section12.2 shall be void.
12.3 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and deliver
such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent
of the Agreement. In respect of the reporting of adverse events to
regulatory authorities in the Territory relating to Collaboration
Products, the Parties agree that such shall be performed in accordance
with appropriate pharmacovigilance terms which the Parties shall
endeavor to draft and agree in good faith, and append to this
Agreement, at the appropriate time after mutual execution by the
Parties hereof.
12.4 FORCE MAJEURE. No Party shall be liable to the other Party for loss or
damages or shall have any right to terminate this Agreement for any
default or delay attributable to any Force Majeure, if the Party
affected shall give prompt notice of any such cause to the other Party.
The Party giving such notice shall thereupon be excused from such of
its obligations hereunder as it is thereby disabled from performing for
so long as it is so disabled, provided, however, that such affected
Party commences and continues to use its Commercially Reasonable
Efforts to cure such cause.
12.5 CORRESPONDENCE AND NOTICES.
(a) ORDINARY NOTICES. Correspondence, reports, documentation, and
any other communication in writing between the Parties in the
course of ordinary implementation of this Agreement shall be
delivered by hand, sent by facsimile transmission (receipt
verified), or by airmail to the employee or representative of
the other Party who is designated by such other Party to
receive such written communication.
(b) EXTRAORDINARY NOTICES. Extraordinary notices and other
communications hereunder (including, without limitation, any
notice of force majeure, breach, termination, change of
address, exercise of rights to negotiate additional
agreements, etc.) shall be in writing and shall be deemed
given if delivered personally or by facsimile transmission
(receipt verified), mailed by registered or certified mail
(return receipt requested), postage prepaid, or sent by
nationally recognized express courier service, to the Parties
at the following addresses (or at such other address for a
Party as shall be specified by like notice, provided, however,
that notices of a change of address shall be effective only
upon receipt thereof):
All correspondence to GSK shall be addressed as follows:
Glaxo Group Limited
Glaxo Wellcome House
Berkeley Avenue, Greenford,
Middlesex
England
UK
UB6 0NN
Attention: General Counsel
with copies to:
GlaxoSmithKline plc
New Horizons Court
Brentford
Middlesex
England
UK
TW8 9EP
Attention: Corporate Law
SmithKline Beecham Corporation.
c/o GlaxoSmithKline Corporation
One Franklin Plaza
Philadelphia
PA 19101
U.S.A
Attention: Senior Vice President, WorldWide Business Development
All correspondence to Neurocrine shall be addressed as follows:
Neurocrine Biosciences, Inc.
10555 Science Center Drive
San Diego
California
U.S.A.
92121
Attention: Vice President, Business Development
Cc: General Counsel and Secretary
12.6 AMENDMENT. No amendment, modification or supplement of any provision of
this Agreement shall be valid or effective unless made in writing and
signed by a duly authorized officer of each Party.
12.7 WAIVER. No provision of the Agreement shall be waived by any act,
omission or knowledge of a Party or its agents or employees except by
an instrument in writing expressly waiving such provision and signed by
a duly authorized officer of the waiving Party.
12.8 COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which need not contain the signature of more than
one Party but all such counterparts taken together shall constitute one
and the same agreement.
12.9 DESCRIPTIVE HEADINGS. The descriptive headings of this Agreement are
for convenience only, and shall be of no force or effect in construing
or interpreting any of the provisions of this Agreement.
12.10 GOVERNING LAW. This Agreement shall be governed by and interpreted in
accordance with the substantive laws of the [***] (without regard to
conflict of law principles) and the Parties hereby submit to the [***].
12.11 SEVERABILITY. In the event that any clause or portion thereof in this
Agreement is for any reason held to be invalid, illegal or
unenforceable, the same shall not affect any other portion of this
Agreement, as it is the intent of the Parties that this Agreement shall
be construed in such fashion as to maintain its existence, validity and
enforceability to the greatest extent possible. In any such event, this
Agreement shall be construed as if such clause of portion thereof had
never been contained in this Agreement, and there shall be deemed
substituted therefore such provision as will most nearly carry out the
intent of the Parties as expressed in this Agreement to the fullest
extent permitted by applicable law unless doing so would have the
effect of materially altering the right and obligations of the Parties
in which event this Agreement shall terminate and all the rights and
obligations granted to the Parties hereunder shall cease and be of no
further force and effect.
12.12 ENTIRE AGREEMENT OF THE PARTIES. This Agreement constitutes and
contains the complete, final and exclusive understanding and agreement
of the Parties and cancels and supersedes any and all prior
negotiations, correspondence, understandings and agreements including,
without limitation, the Prior Agreement, whether oral or written, among
the Parties respecting the subject matter hereof and thereof.
12.13 INDEPENDENT CONTRACTORS. The relationship between GSK and Neurocrine
created by this Agreement is one of independent contractors and neither
Party shall have the power or authority to bind or obligate the other
except as expressly set forth in this Agreement.
12.14 NO TRADEMARK RIGHTS. Expect as otherwise provided herein, no right,
express or implied, is granted by this Agreement to use in any manner
the name "Neurocrine Biosciences" "GSK," or any other trade name or
trademark of the other Party or its Affiliates in connection with the
performance of this Agreement.
12.15 ACCRUED RIGHTS; SURVIVING OBLIGATIONS. Unless explicitly provided
otherwise in this Agreement, termination, relinquishment or expiration
of the Agreement for any reason shall be without prejudice to any
rights which shall have accrued to the benefit to any Party prior to
such termination, relinquishment or expiration, including damages
arising from any breach hereunder. Such termination, relinquishment or
expiration shall not relieve any Party from obligations which are
expressly indicated to survive termination or expiration of the
Agreement, including, without limitation, those obligations set forth
in Section 2.2, 3.7, Article 8, Article 9, Article 10 and Article 12
hereof.
12.16 EXPORT. Notwithstanding anything to the contrary set forth herein, all
obligations of Neurocrine and GSK are subject to prior compliance with
United States and foreign export regulations and such other United
States and foreign laws and regulations as may be applicable and to
obtaining all necessary approvals required by applicable agencies of
the governments of the United States and foreign jurisdictions.
Neurocrine and GSK will co-operate with one another and provide
assistance to one another as reasonably necessary to obtain any
required approvals.
IN WITNESS WHEREOF, duly authorized representatives of the Parties have
duly executed this Agreement to be effective as of the Effective Date.
NEUROCRINE BIOSCIENCES INC.
By: /s/ Gary A. Lyons
Title: Chief Executive Officer & President
GLAXO GROUP LIMITED
By: /s/ Jean Pierre Garnier
Title: Director
EXHIBITS
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