LICENSE AGREEMENT
DATED
July 21, 2000
BETWEEN
TAISHO PHARMACEUTICAL CO., LTD.
AND
NEUROCRINE BIOSCIENCES, INC.
LICENSE AGREEMENT
LICENSE AGREEMENT (this "Agreement") dated July 21, 2000 by and between Taisho
Pharmaceutical Co., Ltd., a Corporation organized under the laws of Japan with
principal offices located at 24-1, Takata 3-Chome, Toshima-ku, Tokyo 170-8633,
Japan ("Taisho") and Neurocrine Biosciences, Inc., a Delaware Corporation with
principal offices located at 10555 Science Center Drive, San Diego, California
92121 ("Neurocrine").
WITNESSETH:
WHEREAS, Taisho is engaged in the research, development, manufacture
and commercialization of human pharmaceuticals.
WHEREAS, Neurocrine is engaged in the research and development of a
proprietary altered peptide ligand product for the treatment of diabetes, and in
connection therewith has filed for and obtained patent protection for such
product and developed know-how, technology and other intellectual property
relating thereto.
WHEREAS, Taisho would like to obtain a license to Neurocrine's
technology, patents know-how and certain other intellectual property to
research, develop and commercialize Neurocrine's proprietary altered peptide
ligand product in the Licensed Territory (as defined below).
WHEREAS, Neurocrine has agreed to exclusively license to Taisho the
Licensed Technology (as defined below) in the Licensed Territory.
NOW THEREFORE, in consideration of the foregoing and the covenants
and promises contained in this Agreement, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
1.1 "Affiliate" shall mean a Person or entity that, directly or
indirectly through one or more intermediates, controls, is controlled
by, or is under common control with the Person or entity specified.
For the purposes of this definition, control shall mean with respect
to an entity, the direct or indirect ownership of (i) greater than
fifty percent (50%) of the stock shares entitled to vote for the
election of directors of the entity or (ii) greater than fifty
percent (50%) of ownership interest of the entity or (iii) the
ability to direct the management and operations of the entity.
1.2 "Agreement" shall mean this Agreement.
1.3 "Commercialize" or "Commercialization" shall mean those activities
relating to the promotion, marketing and sale of Products and shall
include Phase IV clinical trials or equivalent clinical trials
conducted following Governmental Approval to market Products.
1.4 "Commercially Reasonable Efforts" shall mean efforts and resources
commonly used in the research-based pharmaceutical industry for a
product at a similar stage in its product life of similar market
potential taking into account the competitiveness of alternative
products in the marketplace, the patent and other proprietary
position of the product, the likelihood of regulatory approval given
the regulatory structure involved, the profitability of the product
and alternative products and other relevant factors. Commercially
Reasonable Efforts shall be determined on a market by market basis
for a particular Product, and it is anticipated that the level of
effort will change over time reflecting changes in the status of the
Product and the market involved.
1.5 "Confidential Information" shall mean information designated as
confidential information belonging to either or both Parties herein
and any other information Controlled by either or both Parties,
which, if written, is marked confidential by the disclosing Party or,
if oral, is reduced to writing and marked confidential by the
disclosing Party, within thirty (30) days of the oral disclosure.
1.6 "Controls" or "Controlled" shall mean 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.
1.7 "CTX" shall mean the NBI-6024 CTX filed by Neurocrine with the
Medicines Control Agency in the United Kingdom [XXX].
1.8 "Default" shall mean with respect to either Party that (i) any
representation or warranty of such Party set forth in this Agreement
shall have been untrue in any material respect when made or (ii) such
Party shall have failed in the performance of any material obligation
of such Party set forth herein.
1.9 "Develop" or "Development" shall mean those activities related to the
pre-clinical and clinical development of Products and obtainment and
preservation of Governmental Approvals for Products.
1.10 "Development Data" shall mean preclinical and clinical data possessed
as of the Effective Date and generated after the Effective Date by or
on behalf of either Party, its Affiliates or sublicensees in the
Development of Products.
1.11 "Development Plan" shall mean [XXX] the Development of Products as
approved by the JSC.
1.12 "Effective Date" shall mean the date first written above.
1.13 "Existing Royalty Obligations" shall mean the royalty obligations set
forth in Section 5.3 and more detailed in Exhibit C. Existing Royalty
Patent Rights shall mean the Patent Rights for which the Existing
Royalty Obligations are paid.
1.14 "FDA" shall mean the Federal Food and Drug Administration of the
United States Department of Health and Human Services, and successor
agencies.
1.15 "Field of Use" shall mean with respect to a pharmaceutical product,
all human therapeutic and prophylactic uses of that product. [XXX]
1.16 "Five Year Plan" shall mean the five-year plan and budget adopted by
the Parties for the Development of Products in Asia, Europe and the
United States as set forth on Exhibit E.
1.17 "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, breakdown
of plant, 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, 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.
1.18 "Governmental Approvals" shall mean any approvals, licenses,
registrations, authorizations, or equivalents, of any foreign or
United States federal, state or local regulatory agency, department,
bureau or other government entity, including the FDA, necessary for
the manufacture, use, storage, transport, export, import, clinical
testing and/or sale of a Product in a country.
1.19 "Governmental Authorities" shall mean all governmental entities,
agencies and bureaus, including the FDA and comparable foreign
governmental and/or regulatory agencies which control the
manufacture, use, storage, transport, export, import, clinical
testing and/or sale of pharmaceutical products.
1.20 "JSC" shall mean the Joint Steering Committee established with the
authorities set forth in Article 4.
1.21 "Licensed Patent Rights" shall mean the patents and patent
applications listed on Exhibit B and any Patent Rights based thereon.
1.22 "Licensed Technology" shall mean any technology, trade secrets,
know-how and other intellectual property (other than Trademarks)
directed to products, processes, formulations and/or methods and any
biological materials owned or Controlled on the Effective Date or to
be owned or Controlled thereafter by Neurocrine or its Affiliates
which are necessary to research, develop, formulate, make, use or
sell NBI-6024 and shall include the Licensed Patent Rights,
Neurocrine Data and Manufacturing Technology.
1.23 "Licensed Territory" shall mean Asian and European countries listed
on Exhibit D.
1.24 "Manufacturing Technology" shall mean technology and know-how owned
or Controlled by Neurocrine or its Affiliates which relate to the
manufacture of NBI-6024 as set forth in the CTX and any other
technology, know-how or standard operating procedures implemented by
Neurocrine or its Affiliates which are actually being used by
Neurocrine or its Affiliates to manufacture Products during the term
of this Agreement.
1.25 "Milestone Payments" shall mean the payments to be made by Taisho to
Neurocrine upon occurrence of certain events as set forth in Section
5.1.
1.26 "NBI-6024" shall mean altered peptide ligand [XXX].
1.27 "Net Price Per Unit" shall mean the price per unit of Products or, in
the case of multi active components Products, NBI-6024 contributed
portion thereof (as determined by a method approved by both Parties),
for the sale of Products by Taisho or Affiliates or sublicensees of
Taisho to a Third Party other than Affiliates or sublicensees of
Taisho, less the amount expected to be incurred per unit such as
returns and allowances ( including, but not limited to, prompt
payment and volume discounts, chargebacks from wholesalers and other
allowances granted to customers or wholesalers of Products, whether
in cash or trade), freight, shipping, packing, insurance, rebates,
and sales and other taxes based on sales price when included in gross
sales, but not including taxes when assessed on income derived from
such sales.
1.28 "Neurocrine Data" shall mean the pre-clinical and clinical data
collected by Neurocrine or its Affiliates in support of the CTX.
1.29 "Neurocrine Territory" shall mean worldwide excluding the Licensed
Territory.
1.30 "Party" shall mean Neurocrine or Taisho, as the case may be, and
"Parties" shall mean Neurocrine and Taisho.
1.31 "Patent Right" shall mean patent applications, patents issuing
thereon and any extensions or restorations by existing or future
extension or restoration mechanisms including Supplementary
Protection Certificates or the equivalent thereof, renewals,
continuations, continuations-in-part, divisions, patents-of-addition,
and/or reissues of any patent, which have not lapsed, been canceled
or become abandoned and have not been declared invalid or
unenforceable by an unreversed and unappealable decision or judgement
of a court or other appropriate body of competent jurisdiction.
1.32 "Person" shall mean an individual, a partnership, a joint venture, a
corporation, a trust, an estate, an unincorporated organization, or
any other entity, or a government or any department or agency
thereof.
1.33 "Pediatric Phase II" shall mean a Phase II clinical trial in patients
[XXX].
1.34 "Phase II" shall mean a clinical trial designed to provide
preliminary indications of safety and efficacy of a Product in the
intended patient population.
1.35 "Phase III" shall mean a clinical trial, which if the pre-defined
end-points are met, is intended to be submitted in an application for
marketing approval as statistically significant data in support of a
Product's safety and efficacy for the intended indication.
1.36 "Product(s)" shall mean pharmaceutical products [XXX] as an active
component.
1.37 "Regulatory Filings" shall mean, collectively, Investigational New
Drug Applications, Biologics License Applications, Drug Master Files,
New Drug Approvals and/or any other comparable filings as may be
required by Governmental Authorities to obtain Governmental
Approvals.
1.38 "Taisho Technology" shall mean any technology, trade secrets,
know-how and other intellectual property (other than Trademarks)
directed to products, processes, formulations and/or methods and any
biological materials owned or Controlled on the Effective Date or to
be owned or Controlled thereafter by Taisho or its Affiliates which
are necessary to research, develop, formulate, make, use [XXX].
1.39 "Third Party (ies)" shall mean any Person other than Taisho and/or
Neurocrine.
1.40 "Trademark" shall mean any trade name, logo or trademark (whether or
not registered) together with all goodwill associated therewith.
ARTICLE 2
REPRESENTATIONS, WARRANTIES AND COVENANTS
2.1 Representations and Warranties of Taisho.
(a) Corporate Power. Taisho is duly organized and validly existing
under the laws of Japan and has full corporate power and authority to
enter into this Agreement and to carry out the provisions hereof.
(b) Due Authorization. Taisho is duly authorized to execute and
deliver this Agreement and to perform its obligations hereunder. The
Person executing this Agreement on Taisho's behalf has been duly
authorized to do so by all requisite corporate action.
(c) Binding Agreement. This Agreement is a legal and valid obligation
binding upon Taisho and enforceable in accordance with its terms. The
execution, delivery and performance of this Agreement by Taisho does
not conflict with any agreement, instrument or understanding, oral or
written, to which it is a party or by which it may be bound, nor
violate any material law or regulation of any court, governmental
body or administrative or other agency having jurisdiction over it.
(d) Validity. Taisho is aware of no action, suit or inquiry or
investigation instituted by any federal, state or country
governmental agency which questions or threatens the validity of this
Agreement.
2.2 Representations and Warranties of Neurocrine.
(a) Corporate Power. Neurocrine is duly organized and validly
existing under the laws of Delaware and has full corporate power and
authority to enter into this Agreement and carry out the provisions
hereof.
(b) Due Authorization. Neurocrine is duly authorized to execute and
deliver this Agreement and to perform its obligations hereunder. The
Person executing this Agreement on Neurocrine's behalf has been duly
authorized to do so by all requisite corporate action. (c) Binding
Agreement. This Agreement is a legal and valid obligation binding
upon Neurocrine, and enforceable in accordance with its terms. The
execution, delivery and performance of this Agreement by Neurocrine
does not conflict with any agreement, instrument or understanding,
oral or written, to which it is a party or by which it may be bound,
nor violate any material law or regulation of any court, governmental
body or administrative or other agency having jurisdiction over it.
(d) Validity. Neurocrine is aware of no action, suit or inquiry or
investigation instituted by any federal, state or country
governmental agency which questions or threatens the validity of this
Agreement.
2.3 Covenants of Taisho.
(a) Development and Commercialization. Taisho covenants to use
Commercially Reasonable Efforts to Develop and Commercialize Products
in the Licensed Territory.
(b) Indications. Taisho will use Commercially Reasonable Efforts to
obtain Governmental Approvals to Develop and Commercialize NBI-6024
in the Licensed Territory for all indications for which Neurocrine
shall have obtained Governmental Approvals to Commercialize NBI-6024
in the Neurocrine Territory to the extent regulatively and
practically appropriate taking into consideration the circumstances
of markets in the Licensed Territory.
(c) Compliance by Taisho. Taisho covenants to comply with all
applicable statutes, regulations and guidance of any Governmental
Authorities relating to the Development and/or Commercialization of
Products in the Licensed Territory.
2.4 Covenants of Neurocrine.
(a) Development and Commercialization. Neurocrine covenants to use
Commercially Reasonable Efforts to Develop and Commercialize Products
in the United States.
(b) Indications. Neurocrine will use Commercially Reasonable Efforts
to obtain Governmental Approvals to Develop and Commercialize
NBI-6024 in the United States for all indications outlined in the
Five-Year Plan.
(c) Compliance by Neurocrine. Neurocrine covenants to comply with all
applicable statutes, regulations and guidance of any Governmental
Authorities relating to the Development and/or Commercialization of
Products in the Neurocrine Territory.
ARTICLE 3
LICENSE GRANT; TECHNOLOGY TRANSFER
3.1 Technology Ownership. Neurocrine shall retain sole right and title,
subject only to the licenses and any other rights granted to Taisho
hereunder, with respect to the Licensed Technology.
3.2 License Grants.
(a) Neurocrine hereby grants to Taisho an exclusive license with
sublicensing rights under Licensed Technology, to research, develop,
formulate, make, have made, use, sell, offer for sale, import and
export Products in the Field of Use in the Licensed Territory.
(b) Taisho hereby grants to Neurocrine an exclusive license with
sublicensing rights under Taisho Technology, to research, develop,
formulate, make, have made, use, sell, offer for sale, import and
export Products in the Field of Use in the Neurocrine Territory
3.3 Sublicenses. Taisho and Neurocrine shall each have the right to grant
sublicenses to Licensed Technology and Taisho Technology,
respectively, to Third Parties in their respective territories,
provided, however, that the sublicensing Party shall remain
responsible for the full and complete performance of all of
obligations hereunder. Each Party shall provide the other with copies
of all agreements sublicensing the Licensed Technology in the case of
Taisho or Taisho Technology, in the case of Neurocrine, which copies
may be redacted but in any event will contain such information as
shall be required to calculate payments and any other information
reasonably necessary to the other Party to meet reporting or
corporate obligations.
3.4 Transfer of Licensed Technology. Neurocrine agrees to use reasonable
efforts to assist Taisho in the transfer of the Licensed Technology
by instructing and/or assisting Taisho's supervisory employees in the
use of such technology at Taisho's facilities or some other location
mutually agreed between the Parties. Taisho will pay to Neurocrine
per diem fees based upon [XXX] per Neurocrine person-year plus travel
and related expenses devoted to the transfer of the Licensed
Technology for any assistance given to Taisho by Neurocrine at
Taisho's request.
3.5 Option. Following the execution of this Agreement, the Parties will
discuss the terms under which Neurocrine [XXX]. In no event will
Neurocrine be obligated to grant the Option to Taisho if the Parties
are unable to agree on mutually acceptable terms, or if Neurocrine
determines it is not in Neurocrine's business interests to grant such
an Option.
ARTICLE 4
DEVELOPMENT AND COMMERCIALIZATION
4.1 Joint Steering Committee. The Parties shall form a joint steering
committee (the "JSC") consisting of at least three (3) members from
each of Neurocrine and Taisho (with Neurocrine and Taisho having
equal representation). The JSC shall have the following
responsibilities: (i) to establish policies for the Development and
Commercialization of Products, (ii) to establish policies for and
co-ordinate the formulation activities for Products, (iii) to review
and approve and monitor annual Development Plans for each of the
Parties, (iv) to co-ordinate data exchange and preparation of
Regulatory Filings, (v) to monitor the Commercialization of Products
in Asia, Europe and the United States and (vi) such other activities
as the Parties shall agree are appropriately decided by the JSC.
4.2 Meetings and Decision of the Joint Steering Committee. The
chairperson of the JSC will be designated annually by Taisho and
Neurocrine on an alternating basis starting with Neurocrine. A
secretary will be appointed for each meeting and shall be responsible
for the minutes of the meeting. The JSC shall meet no less frequently
than twice per year. Decisions of the JSC shall be made by unanimous
vote. In the event the JSC is unable to reach agreement on any issue,
the issue shall be referred to the Senior Vice President, Development
of Neurocrine and Head of Development of Taisho for resolution. All
decisions of the JSC shall be consistent with the Five Year Plan and
will be reached in good faith.
4.3 Development Plan. Prior to the Effective Date the Parties worked
together to coordinate the each Party's development plan for its
territory to develop a global five year plan (the "Five Year Plan" as
set forth on Exhibit E). The goal of the FiveYear Plan is to minimize
duplicate efforts and maximize Product potential through coordinated,
efficient and cost effective Development and Commercialization. The
FiveYear Plan includes outline timelines for pre-clinical and
clinical studies and Regulatory Filings. The Five Year Plan will be
updated on an annual basis and, when necessary in consideration of
the progress of the Development, from time to time additionally by
mutual agreement of the Parties. On or before September 15 of each
year each Party will submit to the JSC a plan for the Development of
Products for the Party's territory in the next following year (the
"Development Plans"). The Development Plans will be consistent with
the then valid Five Year Plan.
4.4 Data. On each meeting of the JSC, and upon written request at any
other time, the Parties will exchange written summaries of all
Development Data obtained to the date. Upon request, each Party will
provide the other Party with access to Development Data in such
detail as shall be reasonably necessary to allow the other Party to
use the Development Data in support of its Development and
Commercialization of Products in its territory. In case the cost of
such a requested portion of Development Data other than Neurocrine
Data has been borne by only one Party according to Section 4.8 below
and requesting Party uses it as the basis for Regulatory Filing (i.e.
relies upon it to demonstrate safety and/or efficacy) of New Drug
Approval in its territory, requesting Party shall give written notice
of such use in advance [XXX]. All Development Data shall be
considered Confidential Information of the disclosing Party. The
Parties shall maintain all Development Data, related records,
documents and raw data in sufficient detail and in good scientific
manner as will properly reflect all works done and results achieved
in the performance of the Development.
4.5 Territories. Taisho will conduct Development of Products in the
Licensed Territory and Neurocrine will conduct Development of
Products in the Neurocrine Territory. In their Development of
Products, each Party may collaborate or consult with researchers and
investigators and contract for pre-clinical studies without regard to
territory restrictions but in no event will Neurocrine or Taisho
conduct clinical trials outside of the Neurocrine Territory or
Licensed Territory, respectively, without the prior written approval
of the other Party. Notwithstanding the foregoing, Neurocrine will
have the right to complete any clinical trials in progress on the
Effective Date regardless of where the clinical trials are being
conducted.
4.6 Development Assistance. Taisho may request that Neurocrine conduct on
Taisho's behalf certain research and/or pre-clinical studies on
Products set forth in Taisho's Development Plan. In the event
Neurocrine has adequate personnel available, Neurocrine will
undertake to conduct such research and/or pre-clinical studies on
Taisho's behalf. Taisho will compensate Neurocrine for per diem fees
which will be calculated on the basis of the amount of [XXX] per
Neurocrine personnel full time equivalent devoted to such research
and/or pre-clinical studies.
4.7 Taisho Research and Development. If Taisho desires, Taisho may send
at its expense and Neurocrine agrees to accept Taisho's employees to
Neurocrine at Neurocrine's San Diego facilities for Development of
Products. Neurocrine and Taisho shall discuss how best to accomplish
such arrangement.
4.8 Development Cost. Each Party shall [XXX] be responsible for
conducting any pre-clinical and/or clinical studies and any other
activities required only for the Development, Regulatory Filing of
New Drug Approval and/or Commercialization of Product in its
territory ("Independent Studies"). The outside costs of all studies
and activities and in-house study costs approved by the JSC based
upon the Five Year Plan and the Development Plan other than
Independent Studies [XXX] in accordance with the cost sharing methods
to be agreed by the Parties. Additionally, Taisho shall reimburse
Neurocrine [XXX] of all development expenses for the Licensed
Territory that occurred [XXX]. Such reimbursement will be due within
thirty (30) days of the execution of this Agreement.
4.9 Commercialization. The JSC shall monitor the Commercialization of
Products in Asia, Europe and the United States. All matters relating
solely to local issues of promotion, advertising, reimbursement or
other issues relating solely to Commercialization of Products in the
Licensed Territory shall be decided by Taisho in Taisho's sole
business judgment. All matters relating solely to local issues of
promotion, selling, advertising, reimbursement or other issues
relating solely to Commercialization of Products in the Neurocrine
Territory shall be decided by Neurocrine in Neurocrine's sole
business judgment.
4.10 Reporting. Neurocrine and Taisho shall each promptly notify the other
of any events that occurred in their respective territories which
shall be reported to any Governmental Authorities in respective
Parties' territories under any laws and regulations including 21 CFR
314.80, 600.12, 600.14 and 600.80 of the United States (as such
requirements may be amended from time to time) and any similar or
equivalent reporting requirements to other Governmental Authorities.
As for the events that occur in the context of clinical trials, both
Parties shall comply with provisions of Exhibit F.
ARTICLE 5
LICENSE FEES AND MILESTONE PAYMENTS
5.1 Data Purchase. On execution of this Agreement, Taisho shall purchase
from Neurocrine rights to the Neurocrine CTX filing for NBI-6024 and
all supporting data and information for use in exploitation of the
Asian rights granted hereunder for a one-time payment of [XXX] and
rights to the Neurocrine CTX filing for NBI-6024 and all supporting
data and information for use in exploitation of the European rights
granted hereunder for a one-time payment of [XXX]. The above payments
shall be made within thirty (30) days of execution of this Agreement.
5.2 Milestone Payments. At the first occurrence of the events as to the
Product first applicable to the events set forth below, within thirty
(30) days after Taisho becomes aware of it, Taisho shall pay the
corresponding amounts as the Milestone Payments for all the rights to
Products granted to it as long as this Agreement is in force and
effect, provided, however, as to the events which occurred before the
execution of this Agreement, Taisho shall pay the corresponding
amount within thirty (30) days of the execution of this Agreement:
a) for the rights in Japan/Asia total [XXX]
o [XXX] Phase II [XXX] [XXX]
o [XXX] Pediatric Phase II [XXX] [XXX]
o [XXX] Phase III [XXX] [XXX]
o Regulatory Filings of New Drug Approval
or any other comparable filing [XXX] [XXX]
o Governmental Approval for [XXX] [XXX]
b) for the rights in Europe total [XXX]
o [XXX] Phase II [XXX] [XXX]
o [XXX] Pediatric Phase II [XXX] [XXX]
o [XXX] Phase III [XXX] [XXX]
o Regulatory Filings of New Drug Approval
or any other comparable filing [XXX] [XXX]
o Governmental Approval for Commercialization [XXX] [XXX]
Each Milestone Payment shall be made only once[XXX]
upon Regulatory Filing of New Drug Approval or any
other comparable filing [XXX].
5.3 Third Party Royalties. [XXX] shall bear any payments (license fees,
milestone payments and royalties and so on) owed or to be owed to the
Third Parties with respect to Existing Royalty Obligations in the
Licensed Territory and Neurocrine Territory. [XXX] any other payments
(license fees, milestone payments and royalties and so on) owed or to
be owed to Third Parties other than their Affiliates with respect to
patents or patent applications in the Licensed Territory, that are
owned or controlled by such Third Parties and that would prohibit
Taisho, and/or its sublicensees from Commercializing Products on the
basis of claims directed to a composition comprising NBI-6024 and/or
use, making and/or sale thereof in the Licensed Territory. [XXX] bear
any payments (license fees, milestone payments and royalties and so
on) owed or to be owed to Third Parties other than Neurocrine's
Affiliates with respect to such Third Parties' patents or patent
applications in the Licensed Territory other than those described in
above two cases.
5.4 Sublicense Fee. Within thirty (30) days of the date upon which [XXX]
or its Affiliate shall grant a [XXX] to the [XXX] to any Third Party
other than [XXX] Affiliates, [XXX] shall pay to [XXX] per each of
such Third Parties as executing parties of sublicense agreement with
[XXX]. In the event a sublicensee of [XXX] (other than an Affiliate
of [XXX]) shall further sublicense the Licensed Technology, no
additional sublicense fee will be payable for such further sublicense
unless under the circumstances, it was a sublicense that would more
appropriately been granted by [XXX].
MANUFACTURING
6.1 Pre-clinical and Early Clinical Supply. [XXX] shall supply NBI-6024
for the pre-clinical, Phase I and Phase II clinical studies other
than Independent Studies set forth in the Five-Year Plan (i.e. for
both of Licensed Territory and Neurocrine Territory) in the vial
sizes and quantities set forth in the Five-Year Plan. [XXX] may elect
to contract with [XXX] for such manufacture and supply. [XXX] shall
use reasonable best efforts to manufacture and supply reasonable
quantities of NBI-6024 for any Independent Studies upon [XXX]
request.
6.2 Phase III Clinical Supply and Commercial Supply. [XXX] shall
manufacture and supply NBI-6024 for Phase III clinical studies and
Commercialization unless
(a) the Parties agree otherwise,
(b) [XXX] is unable to manufacture and supply NBI-6024 or
(c) [XXX] requests that [XXX] manufacture and supply NBI-6024, in
whole or in part, for Phase III clinical studies and/or
Commercialization.
6.3 Costs Prior to Commercialization. All costs incurred in providing
supply of NBI-6024 for pre-clinical and clinical studies, other than
Independent Studies, set forth in the Five-Year Plan will be [XXX] by
the Parties as set forth in Section 4.8. All costs incurred in
providing supply of NBI-6024 for pre-clinical and clinical studies
that are Independent Studies will be costs paid by the Party
conducting the Independent Study as set forth in Section 4.8.
6.4 Supply. Taisho and Neurocrine will agree on a mechanism whereby
Taisho will submit to Neurocrine rolling forecasts of its
requirements for NBI-6024 followed by firm orders at such times and
frequencies as shall be reasonably necessary to enable [XXX] to plan
its manufacturing activities in order to maximize efficiency and
reduce costs. In the event [XXX] supplies NBI-6024 for
Commercialization by [XXX] under Section 6.2 above, the price for
supply shall [XXX] of the Net Price Per Unit until
(a) for all Asian countries in the Licensed Territory, the expiration
of Patent Right last to expire of the Licensed Patent Rights in
Japan, and
(b) for all European countries in the Licensed Territory, the
expiration of Patent Right last to expire of the Licensed Patent
Rights in Great Britain, Germany, France or Italy.
Net Price Per Unit for the calculation of the supply price shall be
decided as follows: i) As to the supply price for Taisho's firm
orders made by the end of [XXX] calendar quarters commencing with the
one during which Product is launched for the first time in the
Licensed Territory, Net Price Per Unit shall be [XXX]. ii) As to the
supply price for Taisho's firm orders made after the period set forth
in Section 6.4 i) above, Net Price Per Unit shall be [XXX].
6.5 Intermediary. In the event both Taisho and Neurocrine shall
manufacture NBI-6024, Neurocrine and Taisho will each act at purchase
of materials of NBI-6024 as intermediaries for one another to achieve
quantity discounts and the lowest price on manufacturing and
supplies.
6.6 Payments.
(a) Payments. Taisho shall pay all payments for supply of NBI-6024 by
Neurocrine to Taisho in each case within sixty (60) days from receipt
of NBI-6024 and invoice.
(b) Currency. If Net Price Per Unit is in a currency other than
United States Dollars, the Net Price Per Unit for the purpose of
calculating payments hereunder shall be determined in the applicable
foreign currency and then converted into its equivalent in United
States Dollars at the average rate of exchange for medium of buying
funds and selling funds and as published by the Wall Street Journal
for the calendar quarter.
(c) Legal Restrictions. If at any time legal restrictions prevent the
prompt remittance by Taisho of all or any part of payments for supply
of NBI-6024 in any country in the Licensed Territory, Taisho shall
have the right and option to make such payment by depositing the
amount thereof in local currency to an interest bearing account in
the name of Neurocrine in a bank or other depository in such country.
Taisho will consult with Neurocrine and promptly advise Neurocrine of
any such arrangements.
6.7 Manufacturing by Taisho. To the extent of not conflicting with
Sections 6.1 and 6.2 above or after the expiration of Patent Right
last to expire of Licensed Patent Rights in the Licensed Territory,
Taisho shall have the right to manufacture NBI-6024 for the Licensed
Territory and/or have NBI-6024 manufactured on its behalf, which
shall be subject to the terms and conditions [XXX]. In such cases,
Taisho shall pay in consideration of the license of Manufacturing
Technology
(a) the royalty not less than [XXX] of Net Sales in all Asian
countries in the Licensed Territory until the time set forth in
Section 6.4 (a) and
(b) the royalty not less than [XXX] of Net Sales in all European
countries in the Licensed Territory until the time set forth in
Section 6.4 (b), provided however that if a situation occurs in which
the terms and conditions are [XXX]. In case the manufacturing cost
incurred by Taisho or its subcontractor is too high to meet the above
requirements, both Parties shall seek for any appropriate
arrangements including a joint manufacturing agreement with one or
more Third Parties.
6.8 Statements. Taisho shall deliver to Neurocrine within sixty (60) days
after the end of each calendar quarter, a statement certified by
Taisho as accurate to the best of its ability, setting forth the Net
Sales of all Products and the number of units of such Products in
each country in the Licensed Territory during the previous quarter.
ARTICLE 7
RECORDS; AUDIT
7.1 Record Retention. Each Party shall keep complete and accurate records
in sufficient detail to permit the other Party to confirm the
accuracy of calculations of all payments and all costs and expenses
hereunder. Such records shall be retained for no less than a four-(4)
year period following the year in which any such payments were made
hereunder.
7.2 Audit. Once per calendar year, each Party shall have the option to
engage at its own expense, an independent certified public accountant
reasonably acceptable to the other Party, to examine, in confidence,
the records of the other Party as may be necessary to determine, with
respect to any calendar year, the correctness of any budget,
calculation or payment hereunder. The report of such accountant shall
be limited to a certificate verifying any report made or payment
submitted by the audited Party during such period but may include, in
the event the accountant shall be unable to verify the correctness of
any such payment, information relating to why such payment is
unverifiable. All information contained in any such certificate shall
be deemed to be Confidential Information hereunder. If any audit
performed under this Section 7.2 shall indicate that any payment or
reported expense hereunder was in error by more than ten percent
(10%), the audited Party shall pay the cost of the audit.
7.3 Survival. This Article 7 shall survive any termination of this
Agreement for a period of four (4) years.
ARTICLE 8
INTELLECTUAL PROPERTY
8.1 Trademarks. Each Party will market Products under its own Trademarks.
8.2 Patent Prosecution of the Licensed Patent Rights.
(a) Direction. During the term of this Agreement, Neurocrine shall
direct outside counsel reasonably acceptable to Taisho to prosecute
and maintain worldwide all patents and/or patent applications
included within the Licensed Patent Rights. Neurocrine will regularly
consult with Taisho and will keep Taisho and/or its designated patent
officers and counsel advised of the status of patent matters in the
Licensed Territory. Taisho shall have the right to comment upon all
patent filings relating to the Licensed Patent Rights. Neurocrine
shall furnish copies of relevant patent-related documents for the
Licensed Territory to Taisho in a timely fashion to enable Taisho to
review and comment.
(b) Expenses. All expenses in connection with prosecution and
maintenance of the Licensed Patent Rights will be borne by
Neurocrine, provided, however, Taisho shall bear all expenses
incurred after the execution of this Agreement in connection with
prosecution and maintenance of the Licensed Patent Rights in the
Licensed Territory to the extent this Agreement is in force and
effect.
8.3 Patent Enforcement of the Licensed Patent Rights. Neurocrine may, but
shall not be obligated to, elect to enforce the Licensed Patent
Rights against Third Parties and to defend the Licensed Patent Rights
against any challenges worldwide. In the event Neurocrine shall so
elect, Neurocrine shall determine the worldwide strategy and Taisho
shall assist and co-operate with Neurocrine in any such enforcement
or defense. Neurocrine shall bear all associated costs and expenses
(including attorneys' fees) and retain any damages or recoveries with
respect to the Neurocrine Territory. Taisho shall reimburse
Neurocrine for all costs and expenses (including attorneys' fees)
incurred by Neurocrine after the execution of this Agreement in the
enforcement and/or defense of such action with respect to the
Licensed Territory, and shall retain any damages or recoveries with
respect to the Licensed Territory subject to the payment to
Neurocrine of [XXX] of any such damages or recoveries after deduction
of the amount equal to the above reimbursement. In the event
Neurocrine shall not elect to undertake such enforcement and/or
defense in the Licensed Territory, Taisho may, but shall not be
obligated to, do so at its own expense. In such event, Taisho shall
retain any damages or recoveries obtained from such action.
8.4 Third Party Actions.
(a) Neurocrine as Named Party. Neurocrine shall defend any action
naming Neurocrine or Neurocrine and Taisho and claiming the
infringement of any Third Party Patent Right through the making,
having made, using, selling or having sold NBI-6024. The Parties
shall confer with each other and cooperate during the defense of any
action in which both Neurocrine and Taisho are named parties. Taisho
shall assist and co-operate with Neurocrine in the defense of any
such action and if Neurocrine finds it necessary or desirable to have
Taisho join as a party, Taisho shall execute all papers or perform
such other acts as may reasonably be required by Neurocrine. Taisho
shall, at its own expense, be entitled to participate in and have
counsel selected by it participate in any action in which Taisho is a
named party. Neurocrine shall bear all associated costs and expenses
(including attorneys' fees) and pay all damages and settlement
amounts with respect to the making, having made, using, selling or
having sold NBI-6024 in the Neurocrine Territory. Taisho shall bear
all associated costs and expenses (including attorneys' fees)
incurred after the execution of this Agreement and pay all damages
and settlement amounts with respect to the making, having made,
using, selling or having sold NBI-6024 in the Licensed Territory
other than those with respect to Existing Royalty Obligation Patent
Rights by the holders of those rights, which shall be borne by
Neurocrine.
(b) Taisho as Named Party. Taisho shall defend any action which names
Taisho but does not name Neurocrine and which claims the infringement
of any Third Party Patent Right through the making, having made,
using, selling or having sold NBI-6024 in the Licensed Territory. If
necessary and at Taisho's expense, Neurocrine will assist and
co-operate with Taisho in any such defense. Taisho shall bear all
costs and expenses (including attorneys' fees) and all damages and
settlement amounts arising out of or in connection with any such
action other than those arising out of or in connection with any
action with respect to Existing Royalty Obligation Patent Rights by
the holders of those rights, which shall be borne by Neurocrine.
8.5 New Inventions.
(a) Intellectual property rights regarding any invention made by
either Party during the term of this Agreement shall be solely owned
by such Party, and the other Party shall have no rights in or to such
invention other than those rights specifically granted to such other
Party hereunder. The Party who made the invention shall have the
right to prosecute and maintain, in its sole discretion and at its
own expenses, all patent application or patent regarding such
invention in any country in the world. The other Party, its
Affiliates and its sublicensees shall have a non-exclusive right to
exercise such invention free of charge only for the purpose of
Development and Commercialization of Products in its territory.
(b) Intellectual property rights regarding any invention made jointly
by the Parties in the course of Development shall be jointly owned by
the Parties. The Parties shall cooperate with the prosecution and the
maintenance of patent application and patent regarding such invention
and the expenses therefor shall be equally borne by the Parties. Each
Party shall be free to exercise or license to Third Parties its
interest of such rights for any purpose not conflicting with this
Agreement in the world.
(c) Each Party may at its discretion determine not to maintain its
intellectual property rights set forth in this Section 8.5, and in
such case shall notify the other Party in writing of its
determination not to maintain and enable the other Party to maintain
such rights in the other Party's name without any consideration to
discontinuing Party and at the other Party's expenses, and after such
notice shall be exempted from obligations to bear any and all
expenses regarding such rights. In such event and if the other Party
maintains such intellectual property rights, the Party who determines
not to maintain shall have no right to such intellectual property
rights.
8.6 Notice. Each Party will promptly notify the other upon becoming aware
of (i) any Third Party claim or action against Taisho and/or
Neurocrine for infringement of Third Party Patent Rights through the
making, having made, using, selling or having sold NBI-6024 or (ii)
any Third Party infringement of the Licensed Patent Rights.
ARTICLE 9
TAXES
All figures of any payment under this Agreement, including Data Purchase Fee,
Milestone Payments and payment for supplying of NBI-6024, are net of any taxes
and duties, except withholding tax if levied in Japan on any of the payment. Any
withholding taxes levied shall be borne by Neurocrine and deducted by Taisho
from the payment for tax payment to appropriate tax authorities and Taisho shall
obtain and deliver to Neurocrine the original copies of all official receipts
for such withholding tax payment.
ARTICLE 10
CONFIDENTIALITY
10.1 Confidentiality. Except to the extent expressly authorized by this
Agreement or otherwise agreed in writing by the Parties, the Parties
agree that, for the term of this Agreement and for five (5) years
thereafter, the receiving Party shall keep confidential and shall not
publish or otherwise disclose to any Third Parties other than its
employees, directors, sublicensees or Affiliates who are under the
confidentiality obligation equivalent to that of the receiving Party
and shall not use for any purpose other than as provided for in this
Agreement any Confidential Information furnished to it by the other
Party pursuant to this Agreement, except to the extent that it can be
established by the receiving Party by competent proof that such
Confidential Information:
(a) was already known to the receiving Party, other than under an
obligation of confidentiality, at the time of disclosure by the other
Party;
(b) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving Party;
(c) became generally available to the public or otherwise part of the
public domain after its disclosure and other than through any act or
omission of the receiving Party in breach of this Agreement;
(d) was disclosed to the receiving Party, other than under an
obligation of confidentiality to a Third Party, by a Third Party who
had no obligation to the disclosing Party not to disclose such
information to others; or
(e) was independently discovered or developed by the receiving Party
without the reference to Confidential Information belonging to the
disclosing Party.
10.2 This Agreement.
(a) Material Terms. The Parties agree that the material terms of this
Agreement shall be considered Confidential Information of both
Parties. Each Party shall have the right to disclose in confidence
the material terms of this Agreement to parties retained by such
Party to perform legal, accounting or similar services and who have a
need to know such terms in order to provide such services.
(b) Filings. The Parties will consult with one another and agree on
the provisions of this Agreement to be redacted in any filings made
by either Party with the United States Securities and Exchange
Commission or as otherwise required by law or regulation.
Notwithstanding the foregoing, each Party may disclose the terms of
this Agreement to the extent necessary to comply with the United
States Securities and Exchange Commission requirements or those
required by applicable laws or regulations.
10.3 Authorized Disclosure. Each Party may disclose Confidential
Information belonging to the other Party to the extent such
disclosure is reasonably necessary in the following:
(a) filing, prosecuting or maintaining Patent Rights included in the
Licensed Patent Rights or other Patent Rights to be acquired
hereunder;
(b) Regulatory Filings;
(c) prosecuting or defending litigation set forth in Article 8;
(d) complying with applicable regulations of Governmental
Authorities;
(e) Product Development; and
(f) Product Commercialization.
Notwithstanding the foregoing, in the event a Party intends or is
required to make a disclosure of the other Party's Confidential
Information pursuant to this Section 10.3, it will, except where
impracticable, give reasonable advance notice to the other Party of
such disclosure and use best efforts to secure confidential treatment
of such information.
10.4 Publications. Prior to oral or written presentation or submission for
publication of any data or information arising out of a Party's
Development of Products, each Party will provide a copy of the
proposed presentation or publication to the other Party for review.
The reviewing Party will have a minimum of thirty (30) days to review
any proposed presentation or publication for its Confidential
Information. Upon request, the presenting or publishing Party will
remove any Confidential Information belonging to the other Party from
any presentation or publication.
ARTICLE 11
INSURANCE; INDEMNIFICATION
11.1 Indemnification.
(a) Non-Patent. Each Party shall indemnify and hold the other Party
harmless from and against any and all liability, damage, loss, cost
(including reasonable attorneys' fees) and expense arising out of the
Development and/or Commercialization of Products by the Party, its
Affiliates and/or its sublicensees other than those arising out of
the infringement of a Patent Right of a Third Party through the
making, using or selling of Products by the Party, its Affiliates
and/or its sublicensees, provided, however, in case the indemnified
Party receives notice of a claim for which indemnification may be
sought, the indemnified Party shall promptly inform the indemnifying
Party of such notice. Notwithstanding the foregoing, the other Party
shall not be entitled to indemnification under this subsection (a),
against any claim of personal injury or property damage to the extent
resulting from such other Party's negligence or misconduct.
(b) Patent. Subject to Section 5.3 and Article 8, each Party will
indemnify the other Party and hold the other Party harmless from and
against any and all liability, damage, loss, cost (including
reasonable attorneys' fees) and expense arising out of any claim of
infringement of a Patent Right of a Third Party through the making,
having made, using, selling or having sold Products by or on behalf
of the Party which is brought by a Third Party, provided, however, in
case the indemnified Party receives notice of a claim for which
indemnification may be sought, the indemnified Party shall promptly
inform the indemnifying Party of such notice.
11.2 Indemnification Procedure. In the event the indemnified Party shall
inform the indemnifying Party of the notice set forth in Section 11.1
above, the Parties shall, subject to the provisions of Article 8 with
respect to patent related claims, decide how to respond to the claim
and how to handle the claim in an efficient manner.
ARTICLE 12
TERM AND TERMINATION
12.1 Term of this Agreement. This Agreement shall become effective as of
the Effective Date and, unless earlier terminated pursuant to other
provisions of this Article 12, shall continue in full force and
effect until the expiration date of Patent Right last to expire of
Licensed Patent Rights in the Licensed Territory. After expiration of
this Agreement, each Party may continue to exercise rights vested
hereunder regarding Products without further payment to the other
Party.
12.2 Termination of Product Development. Should Taisho completely abandon
all efforts towards its Development for a period of more than [XXX]
for any reason other than Force Majeure according to the reasonable
judgement by the Parties or should Taisho terminate at its discretion
Development of Products in the Licensed Territory by giving
Neurocrine [XXX] prior written notice, rights of Taisho to Products
(including all data, information, physical manifestations and
Regulatory Filings) in the Licensed Territory shall revert and be
delivered to Neurocrine, and Taisho shall be free from any and all
monetary or developmental obligations thereafter. In addition,
Neurocrine shall be granted a royalty-free worldwide non-exclusive
license with sublicensing rights under the Taisho Technology to make,
have made, use and sell Products.
12.3 Default by Taisho. Upon the Default by Taisho under this Agreement,
Neurocrine shall notify Taisho of such Default and, in the event such
Default shall be a payment Default, require that Taisho cure such
Default [XXX] or in the event such Default shall be a Default other
than a payment Default, require that Taisho cure such Default within
[XXX]. In the event Taisho shall not have cured the Default at the
end of the applicable grace period, Neurocrine may terminate this
Agreement and all licenses to the Licensed Technology will revert to
Neurocrine. Upon termination of this Agreement pursuant to this
Section 12.3, rights of Taisho to Products (including all data,
information, physical manifestations and Regulatory Filings) in the
Licensed Territory shall revert and Taisho will return to Neurocrine
all physical manifestations of the Licensed Technology. In addition,
Neurocrine shall be granted a royalty-free worldwide non-exclusive
license with sublicensing rights under the Taisho Technology to make,
have made, use and sell Products.
12.4 Default by Neurocrine. Upon the Default by Neurocrine under this
Agreement, Taisho shall notify Neurocrine of such Default and require
that Neurocrine cure such Default within [XXX]. In the event
Neurocrine shall not have cured the Default at the end of the [XXX]
grace period, Taisho shall be relieved, without losing the license or
any other right granted to Taisho under or pursuant to this
Agreement, of any and all payment obligations other than those for
supply of NBI-6024 by Neurocrine to Taisho hereunder until such time
as Neurocrine shall cure such Default.
12.5 Insolvency or Bankruptcy.
(a) Insolvent Party. Either Party may, in addition to any other
remedies available to it by law or in equity, terminate this
Agreement, in whole or in part, by written notice to the other Party
in the event the other 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 other
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 other 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 other
Party, and any such event shall have continued for [XXX] undismissed,
unbonded and undischarged.
(b) Rights in Bankruptcy. All rights and licenses granted under or
pursuant to this Agreement, 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 or other applicable laws. The Parties further agree
that, in the event of the commencement of a bankruptcy proceeding by
or against Taisho under the U.S. Bankruptcy Code or other applicable
laws, Neurocrine shall to the extent legally possible 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 its possession, shall be
promptly delivered to it (i) upon any such commencement of a
bankruptcy proceeding upon its written request therefor, unless
Taisho elects to continue to perform all of its obligations under
this Agreement or (ii) if not delivered under (i) above, upon the
rejection of this Agreement by or on behalf of Taisho upon written
request therefor by Neurocrine.
(c) Licenses Upon Bankruptcy. Upon the termination of this Agreement
by Neurocrine pursuant to this Section 12.5, all licenses to the
Licensed Technology will revert to Neurocrine.
(d) In case of a commencement of bankruptcy proceeding by or against
Neurocrine, Taisho shall be entitled to the rights permitted by
applicable laws.
12.6 Accrued Rights, Surviving Obligations. With the exception explicitly
provided otherwise herein, termination, relinquishment or expiration
of this Agreement for any reason shall be without prejudice to any
rights, which shall have accrued to the benefit of either Party prior
to such termination, relinquishment or expiration.
12.7 Damages. In no event shall either Party be responsible for any
consequential damages incurred by the other Party in connection with
this Agreement, including, without limitation, lost profits or
opportunities or injury to Person or property resulting from the
termination of this Agreement.
ARTICLE 13
MISCELLANEOUS PROVISIONS
13.1 Assignment. Neither this Agreement nor any interest hereunder shall
be assignable by either Party without the prior written consent of
the other Party unless such assignment is accompanied by the sale of
essentially all of the assigning company's assets. 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 Section shall be void.
13.2 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 this Agreement.
13.3 Force Majeure. Neither Party shall be liable to the other 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 take reasonable and
diligent actions to cure such cause.
13.4 No Trademark Rights. Except as otherwise provided herein, no right,
express or implied, is granted by this Agreement to use in any manner
the name "Neurocrine" or "Taisho" or any other Trademark, service
mark or trade name of the other Party in connection with the
performance or termination of this Agreement.
13.5 Notices. All notices and other communications hereunder shall be in
writing and shall be deemed given if delivered personally or by
facsimile transmission (receipt verified), telexed, mailed by
registered or certified air mail (return receipt requested), postage
prepaid, or sent by 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):
If to Neurocrine, addressed to:
Neurocrine Biosciences, Inc.
10555 Science Center Drive
San Diego, California 92121
Attention: Chief Executive Officer
Facsimile: 858-658-7605
With a copy to: Secretary
Facsimile: 858-658-7605
If to Taisho, addressed to:
Taisho Pharmaceutical Co., Ltd.
24-1, Takata 3-chome, Toshimaku,
Tokyo 170-8633, Japan
Attention: Group Manager, Business Development Group,
Ethical Business Strategy Division
Facsimile: 3-3985-0716
13.6 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.
13.7 Waiver. No provision of this Agreement shall be waived by any act,
omission or knowledge of any 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.
13.8 Counterparts. This Agreement shall be executed in two counterparts,
each of which shall contain the signature of the Parties and all such
counterparts shall constitute one and the same agreement.
13.9 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.
13.10 Governing Law. This Agreement shall be governed by and interpreted in
accordance with the substantive laws of the State of California.
13.11 Severability. Whenever possible, each provision of this Agreement
will be interpreted in such manner as to be effective and valid under
applicable law, but if any provision of this Agreement is held to be
prohibited by or invalid under applicable law, such provision will be
ineffective only to the extent of such prohibition or invalidity,
without invalidating the remainder of this Agreement.
13.12 Entire Agreement of the Parties. This Agreement will constitute and
contain the complete, final and exclusive understanding and agreement
of the Parties and cancels and supersedes any and all prior
negotiations, correspondence, understandings and agreements, whether
oral or written, between the Parties respecting the subject matter
hereof.
13.13 Dispute Resolution. The Parties agree that in the event of a dispute
between them arising from, concerning or in any way relating to this
Agreement, the Parties shall undertake good faith efforts to resolve
any such dispute in good faith. In the event the Parties shall be
unable to resolve any such dispute, the matter shall be referred to
the Chief Executive Officer of Neurocrine and the President of Taisho
for further review and resolution. In the event that they shall be
unable to resolve the dispute, then the dispute shall be finally
settled by arbitration, in San Francisco, California, under the Rules
of Conciliation and Arbitration of the International Chamber of
Commerce. The award of arbitration shall be final and binding upon
both Parties.
13.14 Independent Contractors. The relationship between Neurocrine and
Taisho 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.
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the
date first above written.
NEUROCRINE BIOSCIENCES, INC.
/s/Gary A. Lyons
- -----------------------------
By: Gary Lyons
Title: Chief Executive Officer
TAISHO PHARMACEUTICAL CO., LTD.
/s/Akira Uehara
- ------------------------------
By: Akira Uehara
Title: President
EXHIBIT A
NBI-6024
[XXX]
EXHIBIT B
LICENSED PATENT RIGHTS
[XXX]
EXHIBIT C
EXISTING ROYALTY OBLIGATIONS
[XXX]
EXHIBIT D
Asian countries
[XXX]
European countries
[XXX]
EXHIBIT E
FIVE YEAR PLAN
(see attached)
EXHIBIT F
Neurocrine and Taisho will exchange the information described in this Exhibit F
in English, in the time frames specified below, for NBI-6024.
[XXX]