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EXHIBIT 99.2
AMENDMENT NUMBER ONE
DATED
November 30, 2000
To the
LICENSE AGREEMENT
DATED
July 21, 2000
BETWEEN
TAISHO PHARMACEUTICAL CO., LTD.
AND
NEUROCRINE BIOSCIENCES, INC.
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AMENDMENT NUMBER ONE TO THE LICENSE AGREEMENT
AMENDMENT NUMBER ONE (this "Amendment") dated November 30, 2000 to the
LICENSE AGREEMENT (the "License 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").
W I T N E S S E T H:
WHEREAS, Taisho and Neurocrine entered into the License Agreement pursuant
to which Neurocrine licensed to Taisho exclusive rights to Neurocrine's
proprietary altered peptide ligand, NBI-6024, in the Field of Use in Asian and
European countries (each as defined in the License Agreement).
WHEREAS, Taisho and Neurocrine now wish to amend the License Agreement to
provide for collaboration between Neurocrine and Taisho in the development of
NBI-6024 and to provide to Taisho exclusive commercialization rights to NBI-6024
in the Neurocrine Territory (as defined in the License Agreement) as an
additional option set forth in Section 3.5 of the License Agreement.
NOW THEREFORE, in consideration of the foregoing and the covenants and
promises contained in this Amendment, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
Unless otherwise defined herein, capitalized terms used in this Amendment and in
the License Agreement amended by this Amendment shall have the meanings assigned
to such terms in the License Agreement.
1.1 "Collaboration" shall mean the collaboration between Taisho and Neurocrine
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to Develop Licensed Products under the terms set forth herein.
1.2 "Development Plan" shall mean the annual worldwide plan for the Development
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of Products as approved by the JSC.
1.3 "Licensed Territory" shall mean all the world.
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1.4 "Milestone Payments" shall mean the payments to be made by Taisho to
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Neurocrine upon occurrence of certain events as set forth in Sections 5.1B and
5.2B or 5.5B.
1.5 "Net Sales" shall mean the sales of Products or, in the case of multi
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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 incurred 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 when included in gross sales,
but not including taxes when assessed on income derived from such sales.
1.6 "Rest of World" shall mean all the world other than Asian and European
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countries listed on Exhibit D.
ARTICLE 2
AMENDEMENTS
2.1 Amendment of Section 1.29. Section 1,29 of the License Agreement
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("Neurocrine Territory") is hereby deleted.
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2.2 Amendment of Section 2.3. Section 2.3(b) of the License Agreement is hereby
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amended to read as set forth below.
(b) Indications. Taisho will use Commercially Reasonable Efforts to
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obtain Governmental Approvals to Develop and Commercialize NBI-6024 in the
Licensed Territory for all reasonable indications to the extent
regulatively and practically appropriate taking into consideration the
circumstances of markets in the Licensed Territory.
2.3 Amendment of Section 2.4. Section 2.4 of the License Agreement is hereby
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amended to read as set forth below.
(a) Development and Commercialization. Neurocrine covenants to use
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Commercially Reasonable Efforts to collaborate with Taisho to Develop and
Commercialize Products in the Licensed Territory.
(b) Compliance by Neurocrine. Neurocrine covenants that all activities
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undertaken by Neurocrine in collaborating with Taisho hereunder will
comply with all applicable statutes, regulations and guidance of any
Governmental
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Authorities relating to the Development and/or Commercialization of
Products.
2.4 Amendment of Section 3.2 (b). Section 3.2(b) of the License Agreement is
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hereby amended to read as set forth below.
(b) Taisho hereby grants to Neurocrine ***** license ***** under Licensed
Technology and Taisho Technology, ***** as set forth in this
Agreement.
2.5 Amendment of Section 3.3. Section 3.3 of the License Agreement is hereby
------------------------
amended to read as set forth below.
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3.3 Sublicenses. Taisho shall have the right to grant sublicenses to
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Licensed Technology to Third Parties, provided, however, that Taisho shall
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remain responsible for the full and complete performance of all
obligations hereunder. Taisho shall provide Neurocrine with copies of all
agreements sublicensing the Licensed Technology, *****.
2.6 Amendment of Section 3.5. Section 3.5 of the License Agreement is hereby
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deleted.
2.7 Amendment of Section 4.1. Section 4.1 of the License Agreement is hereby
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amended to delete "for each of the Parties" in Subsection (iii).
2.8 Amendment of Section 4.2. Section 4.2 of the License Agreement is hereby
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amended to read as set forth below.
4.2 Meetings and Decision of the Joint Steering Committee. The
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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. In the event these two
persons are unable to reach agreement on the issue, the issue shall be
finally decided by Head of Development of Taisho. All decisions of the JSC
shall be consistent with the Five Year Plan and will be reached in good
faith.
2.9 Amendment of Section 4.3. Section 4.3 of the License Agreement is amended
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to read as set forth below.
4.3 Development Plan. Prior to the Effective Date the Parties worked
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together to coordinate a development plan for a global five year plan (the
"Five Year Plan" as set forth on Exhibit E). The goal of the Five Year
Plan is to maximize Product potential through coordinated, efficient and
cost effective
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Development and Commercialization. The Five Year 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 the JSC will adopt a plan for the Development of Products for
the Licensed Territory in the next following year (the "Development
Plans"). The Development Plans will be consistent with the then valid Five
Year Plan.
2.10 Amendment of Section 4.4. Section 4.4 of the License Agreement is hereby
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amended to read as set forth below.
4.4 Data. On each meeting of the JSC, and upon written request at any
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other time, the Parties will exchange written summaries of all Development
Data obtained to the date. 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.
2.11 Amendment of Section 4.5. Section 4.5 of the License Agreement is hereby
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deleted.
2.12 Amendment of Section 4.6. Section 4.6 of the License Agreement is hereby
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amended to read as set forth below.
4.6 Collaboration.
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(a) Taisho will fund conduct of the Collaboration by no less than *****
Neurocrine FTEs (full time equivalents equal to ***** hours per year)
for a period of *****. Taisho will compensate Neurocrine for the
Neurocrine FTEs at a rate of ***** per FTE per *****. The Neurocrine
FTEs will be devoted *****. The number of Neurocrine FTEs may be
increased or decreased and/or extended beyond the initial ***** term
upon mutual agreement of the Parties.
(b) Taisho may request that Neurocrine conduct on Taisho's behalf certain
research, pre-clinical studies, and/or clinical studies on Products
set forth in Development Plan as a part of the Collaboration. In the
event such research, pre-clinical studies, and/or clinical studies
shall not be covered by the Neurocrine FTEs set forth in (a) above,
Taisho will compensate Neurocrine for additional Neurocrine FTEs
devoted to such research, pre-clinical studies, and/or clinical
studies at a rate of *****.
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2.13 Amendment of Section 4.8. Section 4.8 of the License Agreement is hereby
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amended to read as set forth below.
4.8 Development Cost. ***** of all studies and activities and in-house
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study costs approved by the JSC based upon the Five Year Plan and the
Development Plan, which are conducted after (effective date of this
Amendment), *****. The outside costs of all studies and activities *****
approved by the JSC based upon the Five Year Plan and the Development
Plan, which are conducted from the execution of this Agreement until
(effective date of this Amendment), shall be ***** in accordance with
***** to be agreed by the Parties. Additionally, Taisho shall reimburse
Neurocrine ***** of all development expenses for the Licensed Territory
that occurred from December 25, 1999 to the execution of this Agreement.
Such reimbursement will be due within thirty (30) days of the execution of
this Agreement.
2.14 Amendment of Section 4.9. Section 4.9 of the License Agreement is hereby
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amended to read as set forth below.
4.9 Commercialization. The JSC shall monitor the Commercialization of
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Products. All matters relating to Commercialization of Products in the
Licensed Territory shall be decided by Taisho in Taisho's sole business
judgment.
2.15 Amendment of Section 4.10. Section 4.10 of the License Agreement is
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hereby amended to read as set forth below.
4.10 Reporting. Neurocrine and Taisho shall each promptly notify the
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other of any events that come to their attention which shall be reported
to any Governmental Authorities 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.
2.16 Amendment of Article 5. Article 5 of the License Agreement is hereby
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amended to read as set forth below.
ARTICLE 5
LICENSE FEES AND MILESTONE PAYMENTS
5.1 LICENSE FEES AND MILESTONE PAYMENTS FOR ASIA AND EUROPE.
5.1A Data Purchase. On execution of this Agreement, Taisho shall
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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 ***** 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 *****. The above payments shall be made
within thirty (30) days of execution of this Agreement.
5.1B Milestone Payments. At the first occurrence of the events as to the
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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 the rights in Asian countries and
European countries 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 and other Asian countries total $*****
. ***** Phase II ***** $*****
. ***** Pediatric Phase II ***** $*****
. ***** Phase III ***** $*****
. Regulatory Filing of New Drug Application or any other
comparable filing ***** $*****
. Governmental Approval for Commercialization ***** $*****
b) for the rights in European countries total $*****
. ***** Phase II ***** $*****
. ***** Pediatric Phase II ***** $*****
. ***** Phase III ***** $*****
. Regulatory Filing of New Drug Application or any other
comparable filing in ***** $*****
. Governmental Approval for Commercialization ***** $*****
Each Milestone Payment shall be made only once. ***** upon Regulatory
Filing
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of New Drug Application or any other comparable filing in any country in
Asian and European countries listed on Exhibit D.
5.2 LICENSE FEES AND MILESTONE PAYMENTS FOR REST OF WORLD.
5.2A. License Issue Fee. In consideration of the licenses to the
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Licensed Technology in the Rest of World, Taisho will pay to Neurocrine a
license fee of ***** . The above payment shall be made within thirty (30)
days of execution of this Amendment.
5.2B Milestone Payments. At the first occurrence of the events as to the
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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 the rights in the Rest of World to
Products granted to it as long as this Agreement is in force and effect,
provided, however, as to the events which occurred before(effective date of
this Amendment), Taisho shall pay the corresponding amount within thirty
(30) days from (effective date of this Amendment):
. Completion of ***** Phase I ***** $ *****
. ***** Phase II ***** $ *****
. ***** Pediatric Phase II ***** $ *****
. ***** Phase III ***** $ *****
. Regulatory Filing of New Drug Application ***** $ *****
. Governmental Approval for Commercialization ***** $ *****
Each Milestone Payment shall be made only once. ***** upon
Regulatory Filing of New Drug Application in the United States.
5.3 Third Party Royalties. ***** shall bear any payments (license fees,
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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. In consideration of ***** Existing Royalty Obligations *****
will pay to *****. ***** bear 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 ***** on the basis ***** directed to
*****. ***** shall bear any payments (license fees, milestone payments
and royalties and so on) owed or to be owed to Third Parties other than
***** Affiliates with respect to such Third Parties' patents or patent
applications
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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
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***** or its Affiliates shall grant a sublicense to the ***** to any
Third Party other than ***** shall pay ***** per each of such Third
Parties as executing parties of sublicense agreement with ***** In the
event a sublicensee of ***** (other ***** ) shall further sublicense the
Licensed Technology ***** will be payable for such further sublicense
unless under the circumstances ***** that would have been more *****.
5.5 PROFIT SHARING OPTION FOR REST OF WORLD
5.5A Profit Sharing Option. At any time after ***** and before *****
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shall have the option to elect to change the agreement for Rest of World
from a royalty bearing arrangement as provided in Section 5.2, to a profit
sharing structure as set forth in this Section 5.5 (the "Option"). At the
time ***** to exercise the Option the Parties will ***** Development and
Commercialization of Products in the Rest of World. ***** completed prior
to *****, provided, however, that such ***** shall be *****.
5.5B Milestone Payments.
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In the event ***** on or before the date of the first occurrence of the
events ***** to the events ***** Section 5.2B will not apply
irrespective of its provision and the following provision will apply
instead. In the event ***** after the date of the first occurrence of the
events ***** to the events stipulated *****, Section 5.2B irrespective of
its provision shall no longer apply and the following provision will apply
instead.
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 the rights in the Rest of World to Products granted to it as
long as this Agreement is in force and effect, provided, however, as to the
events which occurred before (effective date of this Amendment), Taisho
shall pay the corresponding amount within thirty (30) days from (effective
date of this Amendment):
. Completion of ***** Phase I ***** $ *****
. ***** Phase II ***** $ *****
. ***** Pediatric Phase II ***** $ *****
. ***** Phase III ***** $ *****
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. Regulatory Filing of New Drug Application ***** $ *****
. Governmental Approval for Commercialization ***** $ *****
Each Milestone Payment shall be made only once ***** upon Regulatory Filing
of New Drug Application in the United States.
If any Milestone Payments ***** in any country in the world have been made
pursuant to Section 5.2B prior to the exercise of the Option, the amount of
each subsequent Milestone Payment under this Section 5.5B for the rights in
the Rest of World shall ***** so that the total Milestone Payments under
this Section 5.5B for the rights in the Rest of World *****. For clarity,
the license fee of ***** payable under Section 5.2A *****.
5.5C Royalties. Neurocrine shall be paid a royalty of ***** of Net Sales
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of Products in the United States and a royalty ***** of Net Sales of
Products in the Rest of World excluding the United States until the time
set forth in 6.4 (c).
5.5D Profit Sharing. Taisho and Neurocrine will ***** the net profits
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from sales of Products in the Rest of World. The net profits will be
calculated by subtracting ***** to calculate Net Sales, the royalties due
***** set forth in ***** Net Sales in the United States as Neurocrine's
Existing Royalty Obligation ***** from Net Sales of Products *****. For
clarity, any payments ***** other than ***** of Net Sales in the United
States ***** Neurocrine's Existing Royalty Obligation ***** shall not be
subtracted from Net Sales of Products in the Rest of World *****.
5.5E Third Party Royalties. In the event ***** the Option before any
*****, Section 5.3 will not apply irrespective of its provision and the
following provision will apply instead. In the event ***** on or after
*****, Section 5.3 irrespective of its provisions shall no longer apply and
the following provision will apply instead.
***** 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 ( ***** which
shall be paid as set forth *****). ***** 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 ***** ***** Products on the basis of
***** directed to *****. With respect to Third Parties patents or patent
applications in the Licensed Territory other than those described in above
two cases, ***** shall bear any payments (license fees, milestone payments
and royalties and so on) owed or to be owed to such Third Parties other
than ***** in Asian and European countries listed on Exhibit D, and
***** any payments
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(license fees, milestone payments and royalties and so on) owed or to be
owed to such Third Parties other than ***** in the Rest of World.
5.5F Supply and Manufacturing. In the event ***** the Option, the price
for supply of NBI-6024 for Commercialization in the Rest of World shall be
***** and so the provisions in Section 6.4 with regard to the price for
supply for Rest of World, irrespective of the provisions set forth in
Section 6.4, will not apply to the supply for the Rest of World and the
provisions of Section 6.4 will then apply only to the supply for Asian
countries and European countries. Similarly, in the event ***** the Option,
the provisions in Section 6.7 with regard to the royalty to be paid by
Taisho, irrespective of the provisions of Section 6.7, will not apply to
the manufacturing by Taisho or its subcontractor of NBI-6024 for the Rest
of World (Taisho shall not pay any royalty for the manufacturing by Taisho
or its subcontractor of NBI-6024 for the Rest of World) and the provisions
of Section 6.7 will then apply only to the manufacturing by Taisho or its
subcontractor of NBI-6024 for Asian countries and European countries.
2.17 Amendment of Article 6. Article 6 of the License Agreement is hereby
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amended to delete all references to Independent Studies and Neurocrine
Territory.
2.18 Amendment of Section 6.4. Section 6.4 of the License Agreement is hereby
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amended to add the following subsection (c).
(c) for Rest of World in the Licensed Territory, the expiration of Patent
Right last to expire of the Licensed Patent Rights in the United States.
2.19 Amendment of Section 6.7. Section 6.7 of the License Agreement is hereby
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amended to read as set forth below.
6.7 Manufacturing by Taisho. To the extent of not conflicting with
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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 to be agreed by the Parties *****. In such cases,
Taisho shall pay in consideration of the license of Manufacturing
Technology (a) the royalty ***** of Net Sales in all Asian countries in
the Licensed Territory until the time set forth in Section 6.4 (a), (b) the
royalty ***** of Net Sales in all European countries in the Licensed
Territory until the time set forth in Section 6.4 (b) and (c) the royalty
***** of Net Sales in Rest of World until the time set forth in 6.4(c),
provided however ***** to the case in which ***** shall manufacture
***** and supply it to ***** . In case the manufacturing cost incurred
***** is ***** to meet the above requirements, ***** shall seek for
***** including *****.
2.20 Amendment of Section 8.1. Section 8.1 of the License Agreement is hereby
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amended to read as set forth below.
8.1 Trademarks. Taisho will market Products under its own Trademarks.
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2.21 Amendment of Section 8.2 (b). Section 8.2 (b) of the License Agreement is
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hereby amended to read as set forth below.
(b) Expenses. All expenses in connection with prosecution and
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maintenance of the Licensed Patent Rights will be borne by *****,
provided, however, ***** shall bear a) all expenses incurred after the
execution of this Agreement in connection with prosecution and maintenance
of the Licensed Patent Rights in ***** to the extent this Agreement is in
force and effect until (effective date of this amendment), and b) all
expenses incurred after (effective date of this amendment) 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.
2.22 Amendment of Sections 8.3 and 8.4. Sections 8.3 and 8.4 of the License
---------------------------------
Agreement are hereby amended to delete all references to the Neurocrine
Territory and to replace all "the execution of this Agreement" in the both
Sections with (effective date of this amendment).
2.23 Amendment of Sections 8.5. Sections 8.5(a) of the License Agreement is
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hereby amended to read as set forth below.
(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. Taisho, its Affiliates and its sublicensees shall have a
non-exclusive right to exercise such invention by Neurocrine free of
charge only for the purpose of Development and Commercialization of
Products in the Licensed Territory.
2.24 Amendment of Section 11.1. Section 11.1 of the License Agreement is
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hereby amended to read as set forth below.
11.1 Indemnification.
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(a) Non-Patent. Taisho shall indemnify and hold Neurocrine harmless from
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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 Taisho, its Affiliates and/or its
sublicensees and including the conduct of the Collaboration by Neurocrine
other than those
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arising out of the infringement of a Patent Right of a Third Party through
the making, using or selling of Products by Taisho, its Affiliates and/or
its sublicensees, provided, however, in case Neurocrine receives notice of
a claim for which indemnification may be sought, Neurocrine shall promptly
inform Taisho of such notice. Notwithstanding the foregoing Neurocrine
shall not be entitled to indemnification under this subsection (a), against
any claim of personal injury or property damage to the extent resulting
from Neurocrine's negligence or misconduct.
(b) Patent. Subject to Section 5.3 and Article 8, Taisho will indemnify
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Neurocrine and hold Neurocrine 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 Taisho which is brought by a Third Party,
provided, however, in case Neurocrine receives notice of a claim for which
indemnification may be sought, Neurocrine shall promptly inform Taisho of
such notice and, provided, further, that .the foregoing shall not apply to
any Third Party licensor of Existing Royalty Patent Rights.
2.25 Amendment of Section 12.2. Section 12.2 of the License Agreement is
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hereby revised to read as set forth below.
12.2 Termination of Product Development.
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Should Taisho ***** , 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.
***** may retain its all rights of Asian and European countries
listed on Exhibit D subject to the terms and the condition of this
Agreement originally executed by the Parties (i.e. the original one
before being given any amendment).
ARTICLE 3
MISCELLANEOUS PROVISIONS
3.1 Further Actions. Each Party agrees to execute, acknowledge and deliver
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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 Amendment.
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3.2 Counterparts. This Amendment 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.
3.3 Descriptive Headings. The descriptive headings of this Amendment are for
--------------------
convenience only, and shall be of no force or effect in construing or
interpreting any of the provisions of this Amendment.
3.4 Governing Law. This Amendment shall be governed by and interpreted in
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accordance with the substantive laws of the State of California.
3.5 Severability. Whenever possible, each provision of this Amendment will be
------------
interpreted in such manner as to be effective and valid under applicable law,
but if any provision of this Amendment 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
Amendment.
3.6 Entire Agreement of the Parties. This Amendment together with the License
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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.
3.7 Dispute Resolution. The Parties agree that in the event of a dispute
------------------
between them arising from, concerning or in any way relating to this Amendment,
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.
-----------
***** Confidential treatment has been requested for omitted portions.
13
<PAGE>
IN WITNESS WHEREOF, the Parties hereto have executed this Amendment as of the
date first above written.
NEUROCRINE BIOSCIENCES, INC.
/s/ Margaret Valeur-Jensen
----------------------------
By: Margaret Valeur-Jensen
Title: Senior Vice President and General Counsel
TAISHO PHARMACEUTICAL CO., LTD.
/s/ Akira Uehara
------------------
By: Akira Uehara
Title: President
14
