Exhibit 10.34
AMENDMENT NUMBER ONE
DATED
November 30, 2000
To the
LICENSE AGREEMENT
DATED
July 21, 2000
BETWEEN
TAISHO PHARMACEUTICAL CO., LTD.
AND
NEUROCRINE BIOSCIENCES, INC.
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").
WITNESSETH:
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 to Develop Licensed Products under the terms set forth
herein.
1.2 "Development Plan" shall mean the annual worldwide plan for the
Development of Products as approved by the JSC.
1.3 "Licensed Territory" shall mean all the world.
1.4 "Milestone Payments" shall mean the payments to be made by Taisho to
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
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
countries listed on Exhibit D.
ARTICLE 2
AMENDEMENTS
2.1 Amendment of Section 1.29. Section 1,29 of the License Agreement
("Neurocrine Territory") is hereby deleted.
2.2 Amendment of Section 2.3. Section 2.3(b) of the License Agreement is
hereby amended to read as set forth below.
(b) Indications. Taisho will use Commercially Reasonable Efforts to
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 amended to read as set forth below.
(a) Development and Commercialization. Neurocrine covenants to use
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
undertaken by Neurocrine in collaborating with Taisho hereunder will
comply with all applicable statutes, regulations and guidance of any
Governmental 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 hereby amended to read as set forth below.
(b) Taisho hereby grants to Neurocrine [XXX]license[XXX] under Licensed
Technology and Taisho Technology, [XXX]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.
3.3 Sublicenses. Taisho shall have the right to grant sublicenses to
Licensed Technology to Third Parties, provided, however, that Taisho
shall 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, [XXX]
2.6 Amendment of Section 3.5. Section 3.5 of the License Agreement is
hereby deleted.
2.7 Amendment of Section 4.1. Section 4.1 of the License Agreement is
hereby 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 amended to read as set forth below.
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. 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 to read as set forth below.
4.3 Development Plan. Prior to the Effective Date the Parties worked
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
FiveYear Plan is to 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 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 FiveYear Plan.
2.10 Amendment of Section 4.4. Section 4.4 of the License Agreement is
hereby amended to read as set forth below.
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. 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 deleted.
2.12 Amendment of Section 4.6. Section 4.6 of the License Agreement is
hereby amended to read as set forth below.
4.6 Collaboration.
(a) Taisho will fund conduct of the Collaboration by no less than [XXX]
Neurocrine FTEs (full time equivalents equal to [XXX] hours per year)
for a period of [XXX]. Taisho will compensate Neurocrine for the
Neurocrine FTEs at a rate of [XXX] per FTE per [XXX]. The Neurocrine
FTEs will be devoted [XXX]. The number of Neurocrine FTEs may be
increased or decreased and/or extended beyond the initial [XXX]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 [XXX].
2.13 Amendment of Section 4.8. Section 4.8 of the License Agreement is
hereby amended to read as set forth below.
4.8 Development Cost. [XXX]of all studies and activities and in-house
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), [XXX]. The outside costs of all studies and activities
[XXX] 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 [XXX] in
accordance with [XXX] to be agreed by the Parties. Additionally, Taisho
shall reimburse Neurocrine [XXX] 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 amended to read as set forth below.
4.9 Commercialization. The JSC shall monitor the Commercialization of
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
hereby amended to read as set forth below.
4.10 Reporting. Neurocrine and Taisho shall each promptly notify the
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
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 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.
5.1B 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 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 $[XXX]
o [XXX] Phase II [XXX] $[XXX]
o [XXX] Pediatric Phase II [XXX] $[XXX]
o [XXX] Phase III [XXX] $[XXX]
o Regulatory Filing of New Drug Application or any other
comparable filing [XXX] $[XXX]
o Governmental Approval for [XXX] $[XXX]
b) for the rights in European countries total $[XXX]
o [XXX] Phase II [XXX] $[XXX]
o [XXX] Pediatric Phase II [XXX] $[XXX]
o [XXX] Phase III [XXX] $[XXX]
o Regulatory Filing of New Drug Application or any other
comparable filing in [XXX] $[XXX]
o Governmental Approval for Commercialization [XXX] $[XXX]
Each Milestone Payment shall be made only once. [XXX] upon Regulatory
Filing 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
Licensed Technology in the Rest of World, Taisho will pay to Neurocrine
a license fee of [XXX]. 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 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):
o Completion of [XXX] Phase I [XXX] $[XXX]
o [XXX] Phase II [XXX] $[XXX]
o [XXX] Pediatric Phase II [XXX] $[XXX]
o [XXX] Phase III [XXX] $[XXX]
o Regulatory Filing of New Drug Application [XXX] $[XXX]
o Governmental Approval for Commercialization [XXX] $[XXX]
Each Milestone Payment shall be made only once. [XXX] upon Regulatory
Filing of New Drug Application in the United States.
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.
In consideration of [XXX] Existing Royalty Obligations [XXX] will pay to [XXX]
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 [XXX]on the basis [XXX] directed
to [XXX]. [XXX] shall bear any payments (license fees, milestone payments and
royalties and so on) owed or to be owed to Third Parties other than [XXX]
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 sublicense to the [XXX] to any Third Party other than
[XXX] shall pay [XXX] per each of such Third Parties as executing parties of
sublicense agreement with [XXX]. In the event a sublicensee of [XXX] (other
[XXX] shall further sublicense the Licensed Technology, [XXX] will be payable
for such further sublicense unless under the circumstances [XXX] that would have
been more [XXX].
5.5 PROFIT SHARING OPTION FOR REST OF WORLD
5.5A Profit Sharing Option. At any time after [XXX] and before [XXX]
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 [XXX] to exercise the Option the Parties will
[XXX] Development and Commercialization of Products in the Rest of
World. [XXX]completed prior to [XXX], provided, however, that such
[XXX] shall be [XXX].
5.5B Milestone Payments.
In the event [XXX] on or before the date of the first occurrence of the
events [XXX] to the events [XXX], Section 5.2B will not apply
irrespective of its provision and the following provision will apply
instead. In the event [XXX] after the date of the first occurrence of
the events [XXX] to the events stipulated [XXX], 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):
o Completion of [XXX] Phase I [XXX] $[XXX]
o [XXX] Phase II [XXX] $[XXX]
o [XXX] Pediatric Phase II [XXX] $[XXX]
o [XXX] Phase III [XXX] $[XXX]
o Regulatory Filing of New Drug Application [XXX] $[XXX]
o Governmental Approval for Commercialization [XXX] $[XXX]
Each Milestone Payment shall be made only once. [XXX] upon Regulatory
Filing of New Drug Application in the United States.
If any Milestone Payments [XXX] 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 [XXX] so that the total Milestone
Payments under this Section 5.5B for the rights in the Rest of World
[XXX]. For clarity, the license fee of [XXX] payable under Section 5.2A
[XXX].
5.5C Royalties. Neurocrine shall be paid a royalty of [XXX]of Net Sales
of Products in the United States and a royalty [XXX] 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 [XXX] the net profits
from sales of Products in the Rest of World. The net profits will be
calculated by subtracting [XXX]other than those [XXX] to calculate Net
Sales, the royalties due [XXX] set forth in [XXX] Net Sales in the
United States as Neurocrine's Existing Royalty Obligation [XXX], from
Net Sales of Products [XXX]. For clarity, any payments [XXX] other than
[XXX] of Net Sales in the United States [XXX] Neurocrine's Existing
Royalty Obligation [XXX] shall not be subtracted from Net Sales of
Products in the Rest of World [XXX].
5.5E Third Party Royalties. In the event [XXX] the Option before any
[XXX], Section 5.3 will not apply irrespective of its provision and the
following provision will apply instead. In the event [XXX] on or after
[XXX], Section 5.3 irrespective of its provisions shall no longer apply
and the following provision will apply instead.
[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
([XXX] which shall be paid as set forth [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 [XXX] Products
on the basis of [XXX] directed to [XXX]. With respect to Third Parties
patents or patent applications in the Licensed Territory other than
those described in above two cases, [XXX] shall bear any payments
(license fees, milestone payments and royalties and so on) owed or to
be owed to such Third Parties other than [XXX] in Asian and European
countries listed on Exhibit D, and [XXX] any payments (license fees,
milestone payments and royalties and so on) owed or to be owed to such
Third Parties other than [XXX] in the Rest of World.
5.5F Supply and Manufacturing. In the event [XXX] the Option, the price
for supply of NBI-6024 for Commercialization in the Rest of World shall
be [XXX] 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 [XXX]
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
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 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 amended to read as set forth below.
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 to be agreed by the Parties [XXX]. In such
cases, Taisho shall pay in consideration of the license of
Manufacturing Technology (a) the royalty [XXX] of Net Sales in all
Asian countries in the Licensed Territory until the time set forth in
Section 6.4 (a), (b) the royalty [XXX] 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 [XXX] of Net Sales in Rest of World until
the time set forth in 6.4(c), provided however [XXX] to the case in
which [XXX] shall manufacture [XXX] and supply it to [XXX]. In case the
manufacturing cost incurred [XXX] is [XXX] to meet the above
requirements, [XXX] shall seek for [XXX] including [XXX].
2.20 Amendment of Section 8.1. Section 8.1 of the License Agreement is
hereby amended to read as set forth below.
8.1 Trademarks. Taisho will market Products under its own Trademarks.
2.21 Amendment of Section 8.2 (b). Section 8.2 (b) of the License Agreement
is hereby amended to read as set forth below.
(b) Expenses. All expenses in connection with prosecution and
maintenance of the Licensed Patent Rights will be borne by [XXX],
provided, however, [XXX] shall bear a) all expenses incurred after the
execution of this Agreement in connection with prosecution and
maintenance of the Licensed Patent Rights in [XXX] 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
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
hereby amended to read as set forth below.
11.1 Indemnification.
(a) Non-Patent. Taisho shall indemnify and hold Neurocrine 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 Taisho, its Affiliates and/or
its sublicensees and including the conduct of the Collaboration by
Neurocrine 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 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
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
hereby revised to read as set forth below.
12.2 Termination of Product Development.
Should Taisho [XXX], 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.
Should [XXX] 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
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.
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
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 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.
IN WITNESS WHEREOF, the Parties hereto have executed this Amendment as of the
date first above written.
NEUROCRINE BIOSCIENCES, INC.
/s/ Margaret Valeur-Jensen
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By: Margaret Valeur-Jensen
Title: Senior Vice President and General Counsel
TAISHO PHARMACEUTICAL CO., LTD.
/s/ Akira Uehara
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By: Akira Uehara
Title: President