Exhibit 10ee

*Confidential Treatment Requested

AMENDMENT TO OTSUKA-BMS ABILIFY AGREEMENTS

THIS AMENDMENT TO OTSUKA-BMS ABILIFY AGREEMENTS (“Amendment”), effective as of
October 29, 2012 (“Amendment Effective Date”), is by and between Otsuka
Pharmaceutical Co., Ltd. (“Otsuka”), a corporation organized and existing under
the laws of Japan, having a principal place of business at Shinagawa Grand
Central Tower, 2-16-4 Konan, Minato-Ku, Tokyo, 108-8242 Japan, and Bristol-Myers
Squibb Company (“BMS”), a corporation organized and existing under the laws of
Delaware, having a principal place of business at Route 206 and Province Line
Road, Princeton, New Jersey, 08540, USA. Otsuka and BMS shall be referred to
herein individually as a “Party” and collectively as the “Parties.”

RECITALS

WHEREAS, Otsuka and BMS entered into that certain Restated Development and
Commercialization Collaboration Agreement dated October 23, 2001, and an
Amendment No. 1 (dated March 28, 2003), an Amendment No. 2 (dated June 5, 2003),
an Amendment No. 3 (dated September 25, 2006), an Amendment No. 4 (dated
October 31, 2007), an Amendment No. 5 (dated April 4, 2009) (“Amendment No. 5”),
an Amendment No. 6 (dated June 1, 2010), an Amendment No. 7 (dated October
2011), and an Amendment No. 8 (dated as of January 1, 2012) (“Amendment No. 8”)
thereto (such Agreement, as amended by such Amendments, being collectively
referred to herein as the “Restated Agreement”);

WHEREAS, pursuant to Amendment No. 5, the Parties agreed, among other things, to
extend the term of the Restated Agreement in the United States until April [*],
2015 (the “U.S. Term”) and to allocate and share Operational Expenses (as
defined in Amendment No. 5) and Net Sales of Product (as such terms are defined
in the Restated Agreement) in the United States in accordance with the
applicable percentages set forth in Amendment No. 5;

WHEREAS, Otsuka and BMS entered into that certain U.S. Co-Commercialization
Agreement effective as of January 1, 2010, and an Amendment No. 1 to the U.S.
Co-Commercialization Agreement effective as of January 1, 2012 (the
“Co-Commercialization Amendment”) (such Agreement, as amended by such
Co-Commercialization Amendment, being collectively referred to herein as the
“U.S. Co-Commercialization Agreement”);

WHEREAS, as required by Amendment No. 5, the U.S. Co-Commercialization Agreement
sets forth, among other things, the number of MRs and MSLs (stated as full-time
equivalents (FTEs)) required to be deployed by the Parties and the number of
PDEs required to be provided by the Parties in the United States through [*];

WHEREAS, in part to address transitions of Product sales efforts to Otsuka and
minimize disruption to the promotion of the Product caused by such transitions,
the Parties entered into the Co-Commercialization Amendment, pursuant to which
BMS agreed (among other things) to deploy more MRs in the United States in 2012
and 2013 than it was required to deploy when the U.S. Co-Commercialization
Agreement was originally executed, and the Parties entered into that

 

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certain Europe Commercial Resources Agreement effective as of January 1, 2012
(the “Europe Commercial Resources Agreement”), pursuant to which BMS agreed
(among other things) to deploy sales representatives in the European Union (as
defined in the Restated Agreement) through [*];

WHEREAS, Otsuka and BMS now desire to further amend and supplement certain terms
and conditions of the Restated Agreement, the U.S. Co-Commercialization
Agreement, the Europe Commercial Resources Agreement and, as applicable, related
ancillary agreements between the Parties and/or their Affiliates; and

WHEREAS, Otsuka and BMS desire that all other terms and conditions of the
Restated Agreement, the U.S. Co-Commercialization Agreement, the Europe
Commercial Resources Agreement and related ancillary agreements between the
Parties and/or their Affiliates remain in full force and effect, except to the
extent amended by this Amendment;

NOW, THEREFORE, for good and valuable consideration, the receipt and adequacy of
which are hereby acknowledged, Otsuka and BMS agree as follows:

ARTICLE I

DEFINITIONS

1.1 Capitalized terms in this Amendment shall have the same meaning as those in
the Restated Agreement, unless specifically defined otherwise in this Amendment
or in the U.S. Co-Commercialization Agreement. As used throughout this
Amendment, the term “European Union” shall have the same meaning as in the
Restated Agreement, and, for clarity is defined to include Norway, Switzerland
and Iceland, in addition to the member countries of the European Union.

ARTICLE II

UNITED STATES PROVISIONS

2.1 Termination of BMS MR and MSL Obligations in the United States. Commencing
January 1, 2013, BMS shall have no further obligation under the Restated
Agreement or the U.S. Co-Commercialization to deploy MRs to Detail Product
(including, without limitation, no obligation to provide PDEs) in the United
States or to deploy MSLs to conduct medical activities relating to Product in
the United States. As of January 1, 2013, and for the remainder of the U.S.
Term, BMS shall have no obligation to diligently promote Product in the United
States, and the terms and conditions of Sections 2.3(b) and (c), 2.4 through
2.7, 2.11 and 2.12 of the U.S. Co-Commercialization Agreement shall not apply to
BMS with respect to the period beginning January 1, 2013 through to the end of
the U.S. Term, but BMS shall otherwise continue to support Product in the United
States as provided herein.

 

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2.

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2.2 Transition of Product Personnel Responsibilities in the United States.

(a) Upon execution of this Amendment and the execution of a mutually-agreed
communications plan, Otsuka shall have the right (but not the obligation) to
offer to interview and to offer to hire all of the MRs, Regional Directors
(“RDs”), District Managers (“DMs”) and MSLs in the United States who are
employed by BMS and are working in connection with Product (collectively,
“Product Personnel”) for employment by Otsuka as soon as possible. Otsuka shall
use commercially reasonable efforts to complete its hiring of Product Personnel
on or before December 31, 2012. To the extent legally permissible, BMS shall
facilitate Otsuka’s opportunity to commence to interview all Product Personnel
by no later than November 1, 2012. BMS shall inform all Product Personnel as
soon as reasonably possible of the opportunity to interview with Otsuka,
including at the time BMS extends offers (if BMS does extend offers) to any such
Product Personnel to fill other product positions within BMS and, in the event
BMS has extended such offers to any Product Personnel before Otsuka’s offer to
interview and announcement of openings, by notifying those Product Personnel to
whom BMS has made such offers of the opportunity for such Product Personnel to
interview with Otsuka for openings at Otsuka. To promote an efficient interview
process, BMS shall provide to all Product Personnel, in advance of Otsuka’s
interviews, a [*] containing the following information: (i) [*] for, (ii) [*],
and (iii) [*]. Such Product Personnel shall have the right, in their discretion,
to provide such [*] to Otsuka. Following Otsuka’s hiring of any Product
Personnel, Otsuka shall inform BMS of the identity of the hired Product
Personnel and, as soon as practicable thereafter, BMS shall certify in writing
to Otsuka that such Product Personnel have received sales certifications with
respect to Product and the date(s) of such certifications. Such Product
Personnel shall also have the right, in their discretion, to provide a summary
of their individual training records to Otsuka, and BMS shall make such
summaries of training records available to such Product Personnel prior to their
departure from BMS.

(b) Otsuka and BMS shall work closely together to promptly generate and agree
upon a communications plan relating to the transition of U.S. Product promotion
responsibilities and medical field activities from BMS to Otsuka and
communicating the opportunities for Product Personnel to be interviewed and
hired by Otsuka. This communications plan will include access by all Product
Personnel to a WebEx to be prepared by Otsuka explaining such employment
opportunities at Otsuka.

(c) In order to ensure a smooth and effective transition of Product promotion
responsibilities and medical field activities in the United States, and to
minimize disruption to the overall Product sales effort in the United States
during the transition of promotion responsibilities and medical field activities
from BMS to Otsuka, BMS shall continue to fulfill all of its existing Product
Personnel obligations and Required Resource Commitment under the Restated
Agreement and the U.S. Co-Commercialization Agreement, including relating to MRs
and PDEs, through December 31, 2012, except only to the extent of a reduction of
Product Personnel (and related PDEs) who are hired by Otsuka or, after having
been made aware of the opportunity to interview with Otsuka, voluntarily depart
BMS prior to that date. Without limiting the foregoing, through December 31,
2012, BMS shall use commercially reasonable efforts to continue to deploy the
same Product Personnel as the U.S. Co-Commercialization Agreement currently
obligates BMS to deploy, solely to Detail or otherwise work in connection with
Product, and no other products, with

 

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no layoffs, reassignments or other personnel changes or territory or field
revisions, except only to the extent such Product Personnel are hired by Otsuka
or, after having been made aware of the opportunity to interview with Otsuka,
voluntarily depart BMS. BMS shall work diligently to minimize disruption to
Product promotion and medical field activities and responsibilities in the
United States. In the event any Product Personnel, after having been made aware
of the opportunity to interview with Otsuka, are offered and elect to accept
other positions within BMS through a competitive bidding process, BMS shall not
transfer such Product Personnel to such other positions until on or after
January 1, 2013, and BMS shall use commercially reasonable efforts to ensure
that such Product Personnel continue their work in connection with Product
through December 31, 2012.

(d) In recognition of the Parties’ efforts to transition Product Personnel
responsibilities to Otsuka as soon as possible during the fourth quarter of
2012, the remedies specified in Sections 2.8, 2.9, 2.10 and 2.12 of the U.S.
Co-Commercialization Agreement shall not apply to either Party with respect to
the period beginning October 1, 2012 through to the end of the U.S. Term.

(e) Without limiting Otsuka’s right to offer to interview and offer to hire all
Product Personnel as provided and permitted in Paragraph 2.2(a) above, until
[*], neither Party shall recruit, induce or solicit for hire any former Product
Personnel employed by the other Party (i.e., Otsuka will not recruit or solicit
for hire any former Product Personnel who have accepted other positions within
BMS through a competitive bidding process after being informed of their
opportunity to interview with Otsuka, and BMS will not recruit or solicit for
hire any former Product Personnel who are hired by Otsuka).

2.3 Transition of U.S. Assumed Functions to Otsuka.

(a) The collaboration between the Parties shall continue in accordance with the
terms of the Restated Agreement, the U.S. Co-Commercialization Agreement and
ancillary Product-related agreements, except as amended hereby. BMS shall
continue to fulfill, at its sole expense (except as set forth in Paragraph 2.6
below), all of its existing obligations under the Restated Agreement and the
U.S. Co-Commercialization Agreement relating to Product promotion-related
commercial functions and medical affairs functions in the United States,
including, without limitation, relating to marketing, promotional compliance,
market access, pricing and advocacy, sales training and medical affairs, but
excluding (beginning January 1, 2013) the actual deployment of MRs and MSLs in
the United States, subject to Otsuka assuming many of such functions as provided
in Paragraph 2.3(b) below. For the avoidance of doubt, BMS shall also continue
to fulfill all of its other obligations under the Restated Agreement, the U.S.
Co-Commercialization Agreement and Product-related ancillary agreements between
the Parties and/or their Affiliates, including all obligations and functions
that are not included in the U.S. Assumed Functions (as defined below), for the
period of time as provided in such agreements.

(b) In addition to the transition of MR and MSL responsibilities to Otsuka in
the United States as provided in Paragraph 2.2 above, Otsuka shall assume
responsibility and authority for certain other Product-related functions (which
BMS is currently obligated to

 

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perform) in the United States at different times during 2013 or 2014, at
Otsuka’s sole expense. The specific Product-related functions that will be
assumed by Otsuka (as provided in this Paragraph 2.3 and in Paragraph 4.1 below)
are set forth in Exhibit A-1 and Exhibit A-2 to this Amendment (as such exhibits
may be modified in accordance with Paragraph 2.3(c) below) and shall be referred
to herein as “U.S. Assumed Functions.” Exhibit A-1 and Exhibit A-2 (as such
exhibits may be modified in accordance with Paragraph 2.3(c) below) also set
forth the anticipated timing of the transition from BMS to Otsuka of
responsibility and authority for such U.S. Assumed Functions.

(c) The U.S. Assumed Functions that Otsuka will assume as of January 1, 2013 are
set forth in Exhibit A-1 to this Amendment. Except as set forth on Exhibit A-1,
Otsuka may inform the Transition Planning Liaison of BMS on or before
November 15, 2012 of any modifications to Exhibit A-1 that Otsuka has decided
upon, which may include modifying Exhibit A-1 to add or remove functions that
Otsuka will assume and/or to change transition timelines for functions set forth
in Exhibit A-1. After November 15, 2012, the Parties must mutually agree upon
any modifications to Exhibit A-1 to this Amendment. The U.S. Assumed Functions
that Otsuka contemplates assuming by [*], or later, are set forth in Exhibit A-2
to this Amendment. Otsuka may inform the Transition Planning Liaison of BMS on
or before December 31, 2012 of any modifications to Exhibit A-2 that Otsuka has
decided upon, which may include modifying Exhibit A-2 to remove functions that
Otsuka will assume, and/or to delay transition timelines for functions set forth
in Exhibit A-2, and/or to accelerate the transition timelines for any functions
to a point on or after [*]. The Parties must mutually agree upon any
modifications to Exhibit A-2 to this Amendment (i) after December 31, 2012, or
(ii) to add any functions to those on Exhibit A-2 that Otsuka will assume, or
(iii) to accelerate the transition timelines for any functions on Exhibit A-2 to
a point prior to [*]. Upon Otsuka’s informing the Transition Planning Liaison of
BMS informing BMS of modifications to Exhibit A-1 or Exhibit A-2 within the time
period(s) specified above, or in the event that the Parties mutually agree to
modify Exhibit A-1 or Exhibit A-2 at any time, Exhibit A-1 and/or Exhibit A-2
(as applicable) shall be deemed modified. Such modified exhibit(s) shall replace
Exhibit A-1 and/or Exhibit A-2 attached to this Amendment (as applicable) and
shall delineate those Product-related functions that will be assumed by Otsuka
(U.S. Assumed Functions) and the anticipated timing for transition to Otsuka of
the U.S. Assumed Functions (on a function-by-function basis).

(d) In furtherance of a smooth and timely transition to Otsuka of the U.S.
Assumed Functions, the Parties shall discuss and use commercially reasonable
efforts to agree upon a detailed transition plan by no later than December 31,
2012. In addition, during the period the Parties are discussing such transition
plan, Otsuka or a representative of a consulting firm being retained by Otsuka,
shall have the right to meet with BMS personnel performing various functions
that Otsuka is contemplating assuming as provided in this Paragraph 2.3, to help
determine necessary capabilities, specific functions being performed, whether it
would be better for Otsuka or BMS to perform certain functions and for how long,
and to understand systems, processes, third party services, contracts,
relationships, etc., relevant to such functions that Otsuka is contemplating
assuming. BMS shall cooperate with Otsuka in this process, including (as Otsuka
and BMS deem appropriate) by establishing transition teams and e-rooms for
depositing relevant

 

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data, contracts and information. Promptly after the Amendment Effective Date,
each Party shall appoint a Transition Planning Liaison to facilitate transition
planning and shall inform the other Party of the person it has appointed.

(e) Further to facilitate the smooth and timely transition to Otsuka of the U.S.
Assumed Functions, within [*] after the Amendment Effective Date, the Parties
shall form a Transition Committee, which shall be comprised of an equal number
of representatives from each Party, each with the requisite experience,
seniority and authority to enable such representative to monitor, coordinate and
make decisions on behalf of the Parties with respect to transition issues. The
Transition Committee shall be a subcommittee of the JCC. Such Transition
Committee shall meet on a monthly basis in person or by conference call to
review, oversee, coordinate, discuss the status of, and facilitate the
transition of the U.S. Assumed Functions from BMS to Otsuka, until such time as
the transition from BMS to Otsuka of all U.S. Assumed Functions is completed in
accordance with the agreed transition plan. Employees or consultants of either
Party who are not members of the Transition Committee may attend meetings of the
Transition Committee on an ad hoc basis. In addition, given the importance of
the ongoing collaboration between the Parties and the importance to both Parties
of a smooth and timely transition, on a bi-monthly basis (i.e. once every other
month) until such time as the transition from BMS to Otsuka of all U.S. Assumed
Functions is completed in accordance with the agreed transition plan, the
President of Otsuka and a member of the Senior Management Team of BMS shall meet
in person or by telephone to discuss the transition of the U.S. Assumed
Functions from BMS to Otsuka.

(f) During the transition of the U.S. Assumed Functions from BMS to Otsuka, BMS
shall transfer or make readily available to Otsuka all commercial, medical and
other data, records and information related to Product or such U.S. Assumed
Functions, including, without limitation, the data, records and information set
forth in Exhibit B attached to this Amendment. Such transfer shall be on a
timely basis, as reasonably requested or as reasonably appropriate to effect the
timely transition of the U.S. Assumed Functions from BMS to Otsuka. In addition,
BMS shall cooperate with the transition to Otsuka of the U.S. Assumed Functions
by (among other things) offering Otsuka ([*]) reasonable access to and guidance
from BMS personnel both prior to and during the transition of various functions
and responsibilities. Following completion of the transition to Otsuka of the
various U.S. Assumed Functions, and continuing until the expiration of the U.S.
Term, BMS shall continue to provide Otsuka ([*]) with reasonable access to and
guidance from BMS personnel who have experience and knowledge relating to such
U.S. Assumed Functions

(g) Notwithstanding the transition to Otsuka of the U.S. Assumed Functions,
Otsuka anticipates the possibility that Otsuka may not, at the outset, employ
sufficient personnel to perform all such functions prior to completion of the
transition. In the event Otsuka may not be able to employ sufficient personnel
to perform any one or more U.S. Assumed Function(s) prior to completion of the
transition, Otsuka will, as soon as reasonably practicable (but in any event no
later than December 3, 2012), inform BMS of such personnel shortfall, including
the specific U.S. Assumed Function(s) (the “Specified Functions”) and the number
of personnel (or full-time equivalents) performing the Specified Functions that
Otsuka will not be able to employ prior to completing the transition; provided
that Specified Functions may not include functions that are set

 

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forth on Exhibit A-1 and are noted thereon as functions that will be transferred
to Otsuka as of January 1, 2013 unless otherwise mutually agreed (i.e. Specified
Functions may not include items on Exhibit A-1 that are asterisked). For
example, if Otsuka requires [*] employees to perform certain Product marketing
functions and, at the outset, Otsuka will only be able to hire [*] such
employees, Otsuka will inform BMS of a shortfall of [*] Product marketing
Specified Functions. From and after the date Otsuka informs BMS of the Specified
Functions and the specific shortfall in the number of personnel performing such
Specified Functions, BMS shall provide personnel (or full-time equivalents),
equal in number to the shortfall specified by Otsuka, who are knowledgeable and
competent to perform the Specified Functions, until the earlier of (i) the date
on which Otsuka employs other personnel to perform such Specified Functions or
(ii) December 31, 2013. Otsuka shall reimburse BMS’s direct costs of the BMS
personnel (or full-time equivalents) performing the Specified Functions
beginning on the date set forth in Exhibit A-1 or Exhibit A-2 (as applicable) by
which the Specified Function(s) being performed by such personnel are scheduled
to transfer to Otsuka, until the earlier of the date on which Otsuka employs
other personnel to perform such Specified Functions, or [*]. The Parties shall
agree upon a commercially reasonable cost-sharing mechanism for the BMS
personnel performing the Specified Functions.

2.4 Otsuka’s Deployment of [*] MRs in the United States.

(a) In accordance with Section 2.11(a) of the U.S. Co-Commercialization
Agreement, BMS hereby agrees that Otsuka may deploy up to [*] MRs “Additional
MRs”) to Detail Product to any HCPs appropriate to one or more approved
indications of Product (including with a focus on [*]), starting no earlier than
the Amendment Effective Date. Otsuka and BMS shall work together to promptly
generate and agree upon a communication plan relating to the deployment of the
Additional MRs and the messaging/promotional materials to be used by the
Additional MRs.

(b) As soon as reasonably practical, BMS shall provide the Additional MRs with
(i) Product promotional samples across the tablet dosing range, in quantities
reasonably requested by Otsuka, and (ii) Product promotional materials
(including package inserts and promotional aids) comparable to those being used
by MRs in the United States as of the Amendment Effective Date; provided that,
the costs of any Product promotional samples and Product promotional materials
utilized by the Additional MRs will be borne solely by Otsuka. BMS shall provide
Product promotional materials for the Additional MRs (as well as for all of
Otsuka’s Product MRs) through [*], or for such longer period as the Parties may
mutually agree upon. BMS shall provide the Additional MRs (as well as all of
Otsuka’s Product MRs) with Product promotional samples across the tablet dosing
range until the expiration of the U.S. Term and thereafter for so long as BMS
continues to manufacture Product under the Restated Agreement and related
Product supply agreements.

 

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2.5 Otsuka Freedom to Operate in the United States.

(a) In recognition of Otsuka’s assumption of the responsibility to deploy all
MRs and MSLs for Product in the United States beginning January 1, 2013, and
also to assume multiple other responsibilities and functions previously
performed by BMS (the U.S. Assumed Functions), commencing January 1, 2013,
Otsuka shall have freedom to operate in the United States with respect to
Commercialization of Product, with no further restrictions or obligations under
the Restated Agreement or the U.S. Co-Commercialization Agreement, but subject
to Paragraph 2.5(b) and Paragraph 5.1 below. Without limiting the foregoing,
beginning January 1, 2013: the terms and conditions of Sections 2.3(b) and (c),
2.4 through 2.7, 2.11 and 2.12 of the U.S. Co-Commercialization Agreement shall
not apply to Otsuka, and the obligations set forth in such Sections shall fall
solely within the discretion of Otsuka; Otsuka shall not have any obligation to
diligently promote Product in the United States; and there shall be no
restrictions or limitations on Otsuka’s right to (or the manner in which it does
so) promote Product or conduct other Product-related Commercialization
activities, either itself or with or through a third party in the United States
(except to the extent any such other Product-related Commercialization
activities are retained by BMS as provided in Paragraph 4.2 below).

(b) Commencing January 1, 2013, subject to Paragraph 5.1(b) below, Otsuka shall
have sole responsibility and authority for generating the Commercial Plan,
Marketing Plan and other plans and budgets related to Commercial Operations in
the United States, including plans relating to deployment of MRs and MSLs
(including the Target Call List) and budgets of A&P expenses and other
Operational Expenses; provided, however, that the Parties have agreed upon a
revised budget for A&P expenses and other shared Operational Expenses for
calendar years 2013, 2014 and 2015, which revised budget is attached as Exhibit
C to this Amendment (the “Shared Expense Budget”), and which replaces in its
entirety Exhibit 1 to the Co-Commercialization Amendment, and Otsuka shall have
no authority to reduce the A&P expenses set forth in the Shared Expense Budget
without the written consent of BMS. Otsuka may, however, increase such A&P
expenses, in its discretion and at it cost.

2.6 United States Operational Expenses.

(a) Through December 31, 2012, BMS and Otsuka shall share Operational Expenses,
including the MR and MSL FTE and indirect costs, A&P, distribution, R&D and
other marketing expenses, in accordance with the Restated Agreement and the U.S.
Co-Commercialization Agreement.

(b) Commencing January 1, 2013, Otsuka shall bear all Otsuka MR and MSL direct
and indirect costs. However, in exchange for Otsuka agreeing to assume MR and
MSL responsibilities for the period from January 1, 2013 through [*], BMS shall
pay Otsuka’s Affiliate, Otsuka America Pharmaceutical Inc. (“OAPI”), the total
sum of [*] which is equal to the [*] of [*] for the [*] BMS shall remit such sum
in cash to OAPI between [*] and [*].

(c) Commencing January 1, 2013, and continuing until the expiration of the U.S.
Term, notwithstanding the transition to Otsuka of the U.S. Assumed Functions as
provided in

 

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Paragraphs 2.3 and 4.1 herein, BMS and Otsuka shall continue to share the
following Operational Expenses: distribution, R&D (excluding MSL costs) and
other marketing expenses (collectively, “Other Operational Expenses”) in
accordance with the Restated Agreement and the U.S. Co-Commercialization
Agreement, up to the amount of such Other Operational Expenses budgeted in the
Shared Expense Budget attached as Exhibit C to this Amendment (or such other
mutually agreed upon budgeted amounts). For the avoidance of doubt, “Other
Operational Expenses” exclude MR and MSL FTE and indirect costs and A&P
expenses. Any Other Operational Expenses that exceed the budgeted amounts set
forth in the Shared Expense Budget attached as Exhibit C to this Amendment (or
other mutually agreed budgeted amounts) for any calendar year beginning 2013
shall be borne by Otsuka. For clarity, if actual Other Operational Expenses
incurred in a calendar year beginning 2013 are below the agreed budgeted
amounts, BMS shall pay [*] of such actual Other Operational Expenses incurred.

(d) Commencing January 1, 2013, and continuing until the expiration of the U.S.
Term, BMS and Otsuka shall share A&P expenses (excluding “other marketing
expenses” that are included in Other Operational Expenses) as follows: (a) in
calendar year 2013, [*] of all A&P expenses as incurred, up to and including
[*], and [*] of all A&P expenses that exceed [*]; (b) in calendar year 2014, [*]
of all A&P expenses as incurred, up to and including [*], and [*] of all A&P
expenses that exceed [*] as incurred; and (c) in calendar year 2015, through
April [*], 2015, [*] of all A&P expenses as incurred, up to and including [*],
and [*] of all A&P expenses that exceed [*] as incurred. The Parties agree to
spend no less than the amount of the budgeted A&P expenses set forth in the
Shared Expense Budget attached as Exhibit C to this Amendment (or other mutually
agreed budgeted amounts), except in the event of Generic Sales (as defined in
Amendment No. 5), in which event the Parties shall mutually agree on an
appropriate reduction of A&P expenses (and cost-sharing percentages associated
therewith).

2.7 Puerto Rico and other U.S. Territories. Solely for purposes of this Article
2 and the transfer of responsibilities described in this Article 2, the “United
States” means the fifty (50) states of the United States of America (and the
District of Columbia), but excludes Puerto Rico and all of the other territories
and possessions of the United States. For the avoidance of doubt, as set forth
in the Restated Agreement, Puerto Rico and all of the other territories and
possessions of the United States remain part of the United States for all other
purposes, including for purposes of revenue sharing under the Restated
Agreement.

ARTICLE III

EUROPEAN UNION/REST OF TERRITORY PROVISIONS

3.1 European Union Promotion.

(a) BMS shall deploy sales representatives in the European Union through [*] in
accordance with the Europe Commercial Resources Agreement, and shall have no
obligation to deploy sales representatives in the European Union on or after
[*]. In addition, pursuant to the Europe Commercial Resources Agreement, BMS
shall expend certain additional operational expenses in support of the sales
representatives deployed by BMS through [*], and Otsuka shall reimburse BMS up
to a specified amount of such additional operational expenses actually

 

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expended by BMS, as set forth in the Europe Commercial Resources Agreement. In
accordance with the Restated Agreement, Otsuka is currently co-promoting Product
in the European Union Co-Promotion Countries and the Nordic Countries (as
defined in Amendment No. 5) (collectively, the “G5/Nordic Countries”).
Notwithstanding anything to the contrary in the Restated Agreement, the Europe
Commercial Resources Agreement or any other Product-related agreement between
the Parties and/or their Affiliates, from and after the Amendment Effective
Date, Otsuka shall have the right to deploy its own and any contract sales
organization’s sales representatives to promote Product in any of the G5/Nordic
Countries without restriction, including no limitation on the number of sales
representatives deployed; provided that, if Otsuka (itself or using a contract
sales organization) deploys sales representatives to promote Product in any
G5/Nordics Country prior to transfer of Local Representative status from BMS to
Otsuka (or to a third party designated by Otsuka) in such country, such sales
representatives (i.e. sales representatives of Otsuka or such contract sales
organization) must use Product promotional materials approved by BMS or its
Affiliates and must comply with reasonable applicable policies of BMS or its
Affiliates in such country, until such time as Local Representative status is so
transferred in such country. For clarity, other than a contract sales
organization as described above, no third party shall have the right to promote
Product in any G5/Nordics Country prior to transfer of Local Representative
status from BMS to Otsuka (or to a third party designated by Otsuka) in such
country.

(b) At such time as BMS ceases to deploy sales representatives to actively
promote Product in any country in the European Union, on a country-by-country
basis following transfer of Local Representative status in such country to
Otsuka or a third party designated by Otsuka, Otsuka shall have unilateral
freedom to operate with respect to promotion of Product in each such country,
with no further obligations (other than revenue sharing with BMS in accordance
with the Restated Agreement) or restrictions (including, without limitation, no
restrictions on Otsuka’s right to promote Product or conduct other Product
promotion-related and medical affairs activities, itself or with or through a
third party) under the Restated Agreement, the Europe Commercial Resources
Agreement or any other Product-related agreements between the Parties and/or
their Affiliates. BMS (or its Affiliates at the European level and/or the
country level), Otsuka (or its Affiliates at the European level and/or the
country level) and any third party that will be deploying sales representatives
to promote Product in the European Union shall work together to ensure a smooth
transition of the sales representatives’ Product promotional efforts, and shall
discuss and shall use commercially reasonable efforts to agree on one or more
transition plan(s) to ensure local coordination of transitional efforts. During
the transition period, BMS or its Affiliate shall transfer or make readily
available to Otsuka or a third party designated by Otsuka all information and
records related to Product promotion in the European Union, including Product
promotion-related materials, target call lists, and HCP contact records for all
HCPs on the target call lists for calendar years 2010, 2011, 2012 and for the
first quarter of 2013. Despite the changes in this Paragraph 3.1, BMS and Otsuka
shall continue to share Net Sales in each such country in the European Union in
accordance with the Restated Agreement (including the agreed allocation set
forth therein).

3.2 Rest of Territory Promotion. At such time as BMS ceases to deploy sales
representatives to actively promote Product in any country in the Rest of
Territory, Otsuka shall

 

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have the right, on a country-by-country basis, to request to promote Product to
healthcare professionals in such country(ies), either itself or with or through
a third party. Otsuka’s request shall be subject to the consent of BMS, which
shall not be unreasonably withheld or delayed. BMS and Otsuka will discuss the
reasonable conditions under which Otsuka or a third party designated by Otsuka
may begin promoting Product in each such country, including any local regulatory
or compliance requirements in such country, and BMS policies (which shall be
provided to Otsuka) relating to Product promotional activities that must be met
(such that BMS would not bear compliance risk). For each country in the Rest of
Territory in which Otsuka requests to promote Product and BMS consents to the
same, the Parties (or their Affiliates) and any third party designated by Otsuka
shall discuss and use commercially reasonable efforts to agree upon a plan for
transitioning Product promotion responsibilities in such country to Otsuka or a
third party designated by Otsuka, including coordinating such promotion with
other commercial activities, if any, which shall remain the responsibility of
BMS in such country. During the transition period in each such country, BMS or
its Affiliate shall use commercially reasonable efforts to transfer or make
readily available to Otsuka or a third party designated by Otsuka all relevant
information and records related to Product promotion in such country in order to
facilitate such transition. For clarity, if Otsuka elects to promote in a given
country in the Rest of Territory, it will be at Otsuka’s sole expense, and there
will be no change to the sharing of Net Sales in each such country in the Rest
of Territory in accordance with the Restated Agreement (including the agreed
allocation set forth therein). In addition, the Parties will agree on a process
for communicating Product forecasts for manufacturing purposes.

3.3 Other Product-Related Obligations. On a country-by-country basis in the
European Union and the Rest of Territory, where Otsuka (or a third party
designee) is promoting Product as provided in Section 3.1 and 3.2 above, the
Parties acknowledge that Otsuka (or a third party) may desire to assume one or
more Product-related obligations (in addition to any Product promotion-related
activities that Otsuka may assume in accordance with Paragraphs 3.1 and 3.2
above) in such country prior to the expiration of the Restated Agreement,
including regulatory, distribution and/or pharmacovigilance (“PV”) obligations
(“Other Product-Related Obligations”), that BMS otherwise is and would be
required to continue to perform in accordance with the Restated Agreement and
other applicable Product-related agreements between the Parties and/or their
Affiliates, including the Post-Termination Services Agreement. In the event that
the Parties mutually agree with respect to Otsuka’s (or such third party’s)
assumption of certain Other Product-Related Obligations, the Parties shall
discuss and use commercially reasonable efforts to agree upon a plan to ensure
local coordination of the transition from BMS to Otsuka (or such third party) of
such agreed Other Product-Related Obligations, and Otsuka (or such third party)
will assume such agreed Other Product-Related Obligations, on a
country-by-country basis, as soon as reasonable (provided that any PV activities
assumed by Otsuka or such third party will be limited to collecting safety data
information and transferring such information to BMS, unless Otsuka elects to
assume global PV responsibilities).

3.4 Revenue Sharing. Notwithstanding the transition to Otsuka or a third party
designated by Otsuka of Product promotion or some other Product-related
functions in any country in the European Union or the Rest of Territory, in
accordance with Paragraphs 3.1, 3.2 or 3.3 above, BMS and Otsuka shall continue
to share Net Sales in each such country in accordance with the Restated
Agreement (including the agreed allocation set forth therein).

 

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ARTICLE IV

TERRITORY-WIDE PROVISIONS

4.1 Transition of Clinical and Certain Regulatory Functions in the Territory.
BMS shall continue to perform clinical and regulatory functions related to
Product in the Territory in accordance with the Restated Agreement. As soon as
reasonably practicable for Otsuka (currently contemplated to be by no later than
[*]), Otsuka shall assume responsibility and authority for certain clinical and
regulatory activities relating to Product in the United States (excluding PV and
CMC regulatory activities), at Otsuka’s sole expense. The Product-related
clinical and regulatory activities that Otsuka shall assume in the United States
(which are included as part of the U.S. Assumed Functions) and centralized
regulatory activities (i.e. interactions with the EMA) in the European Union,
and the anticipated timing for transition of such clinical and regulatory
activities to Otsuka, are set forth in Exhibit A-2 to this Amendment, as Exhibit
A-2 may be modified in accordance with Paragraph 2.3(c) above. In the event that
Otsuka desires to assume responsibility and authority for clinical and
regulatory activities relating to Product in other countries in the Territory
(following transfer of Local Representative status where required), Otsuka shall
inform BMS of which Product-related clinical and regulatory activities Otsuka
desires to assume outside of the United States, the countries in which Otsuka
desires to assume such activities, and the anticipated timing for Otsuka’s
capability to assume such activities. In such event, the Parties shall use
commercially reasonable efforts to agree on a plan for the transition of such
Product-related clinical and regulatory functions to be assumed by Otsuka on a
country-by-country basis. During the period of such transition planning, and
during the implementation of such transition to Otsuka of Product-related
clinical and regulatory activities (in accordance with such agreed transition
plan), and until expiration of the Restated Agreement, on a country-by-country
basis, BMS shall continue to provide Otsuka (at no cost to Otsuka) with
reasonable access to and guidance from BMS’s (and/or its Affiliates’) personnel
who have experience and knowledge relating to such transitioned Product-related
clinical and regulatory functions. The Parties agree that nothing herein shall
amend Paragraph 3 of Amendment No. 8, which paragraph shall remain in full force
and effect in accordance with its terms.

4.2 BMS’s Continuing Responsibilities. BMS shall continue to be responsible for,
and shall perform at its sole expense in accordance with all applicable
Product-related agreements between the Parties and/or their Affiliates, all
Product-related activities and functions in the Territory that are not expressly
assumed by Otsuka in accordance with Paragraphs 2.3, 3.1(b), 3.3 and 4.1 above,
including, without limitation, all Product promotion-related, medical affairs,
clinical and regulatory functions in the United States that are not assumed by
and transitioned to Otsuka as set forth in Exhibit A-1 and Exhibit A-2 to this
Amendment (as such exhibits may be modified in accordance with Paragraph 2.3(c)
above). Without limiting the foregoing, except for any functions that are
assumed by Otsuka or a third party in accordance with Paragraph 3.3 above, BMS
shall continue to be responsible for, and shall perform at its sole expense,
Product distribution, manufacture, CMC regulatory and PV activities and
responsibilities, in each case, in accordance with the Restated Agreement, the
U.S. Co-Commercialization Agreement, the Revised

 

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Pharmacovigilance Agreement Regarding Aripiprazole between the Parties
(effective March 10, 2010, and as subsequently amended), and other applicable
Product-related agreements between the Parties and/or their Affiliates,
including the Post-Termination Services Agreement and the Post-Termination
Manufacturing and Supply Agreement.

4.3 Transfer of Countries to Reserved Territory. Any country in the Territory in
which BMS has not yet commenced the sale of Product as of the Amendment
Effective Date shall be automatically and immediately deemed removed from the
Territory and transferred to and included in the Reserved Territory as of the
Amendment Effective Date. In addition, Vietnam (which, pursuant to Amendment
No. 7 to the Restated Agreement, is excluded from the Territory) shall be
automatically and immediately deemed transferred to and included in the Reserved
Territory as of the Amendment Effective Date. Upon the Amendment Effective Date,
all of BMS’s rights and obligations under the Restated Agreement shall be deemed
terminated with respect to each country transferred to the Reserved Territory in
accordance with this Paragraph 4.4, and the provisions of Section 13.1 of the
Restated Agreement shall apply to each such country (to the extent applicable in
such country). Without limiting the foregoing, BMS shall have no right to
receive any share of Net Sales in any such country or any fee in connection with
Net Sales in Vietnam, and BMS shall cooperate with Otsuka in connection with the
transition of rights and responsibilities to Otsuka in each such country that is
transferred to the Reserved Territory. Transfer of a country as provided in this
Paragraph 4.4 shall not limit or adversely affect any of BMS’s rights that
accrued in such country prior to such removal, nor release BMS from any
liability or obligation that accrued prior to such removal.

4.4 Post-Termination Services in the United States. The Parties entered into
that certain Abilify Post-Termination Services Agreement dated as of April 4,
2009, pursuant to which BMS is obligated to perform Post-Termination Services
(as defined in the Post-Termination Services Agreement), including Product
distribution and PV services, following expiration or termination of the
Restated Agreement on a Region-by-Region (as defined in the Post-Termination
Services Agreement) or country-by-country basis. With respect to
Post-Termination Services in the United States, Otsuka is contemplating assuming
responsibility for all such Post-Termination Services except for Product
distribution in the United States, prior to or at the expiration of the U.S.
Term. As soon as reasonably practicable after the Amendment Effective Date, the
Parties shall discuss in good faith, without any obligation to enter into an
agreement, an amendment to the Post-Termination Services Agreement pursuant to
which (i) Otsuka could assume all Post-Termination Services in the United States
except for Product distribution; (ii) BMS would have no obligation after the
U.S. Term to perform any Post-Termination Services in the United States except
for Product distribution; and (iii) the Parties would mutually agree on a fee to
be paid by Otsuka to BMS for BMS to perform Product distribution services in the
United States after the U.S. Term.

 

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ARTICLE V

COMMITTEE PROVISIONS

5.1 PDC and JCC.

(a) Beginning (i) January 1, 2013, with respect to the United States and
(ii) [*], with respect to the European Union, an Otsuka representative will be
the sole Chair of the JCC and the PDC, and there shall be no Co-Chair of those
committees. Beginning January 1, 2013, subject to Subparagraphs 5.1(b)(i) and
(ii) below, Otsuka shall have final decision-making authority on all JCC matters
relating to the Commercialization of Products (but not distribution,
manufacturing, delivery, supply and packaging, which functions remain under the
operational responsibility of BMS) and all PDC matters with respect to the
United States, including, without limitation, Product pricing, discounting and
key messaging. Beginning [*], Otsuka shall have final decision-making authority
on all JCC matters relating to the Commercialization of Products (but not
distribution, manufacturing, delivery, supply and packaging, which functions
remain under the operational responsibility of BMS) with respect to the European
Union, except with respect to Product pricing, discounting and key messaging.
Product pricing, discounting and key messaging in the European Union shall be
determined by mutual agreement of the Parties, subject to applicable laws and
regulations, and further, with respect to key messaging, subject to Subparagraph
5.1(b)(iii) below. Notwithstanding the above provisions, neither the Otsuka
Chair, the JCC, the PDC, nor any plan approved by the JCC may impose additional
expenses or obligations on BMS or its Affiliates beyond those specified in the
Restated Agreement, the Shared Expense Budget or the Europe Commercial Resources
Agreement, without the written consent of BMS. Further, at JCC meetings, Otsuka
will be required to discuss, and shall give BMS an opportunity to provide input
regarding, the status of Product Commercialization activities in the United
States and the European Union, including performance updates, forecasting
information pertinent to BMS’s manufacturing obligations, and other information
pertaining to BMS’s ongoing obligations related to Product Commercialization in
the United States and the European Union. In addition, the JCC shall oversee the
progress of the transition and the work of the Transition Committee.

(b) Notwithstanding Paragraph 5.1(a) above, Otsuka’s final decision-making
authority with respect to JCC matters in the United States shall be subject to
the provisions of subparagraphs (i) and (ii) below; provided that, subject to
such provisions, Product pricing and discounting decisions in the United States
in 2013, 2014 and 2015 are within Otsuka’s sole discretion. Decisions regarding
Product key messaging in the European Union shall be subject to subparagraph
(iii) below.

(i) Commencing January 1, 2013, and continuing until [*], BMS and Otsuka shall
share Discretionary Payer Discounts (as defined below), up to [*] in 2013 and up
to [*] in 2014, in proportion to the Parties’ existing revenue tier splits as
set forth in Amendment No 5. As used herein, the term “Discretionary Payer
Discounts” means discounts provided to commercial, Medicare (Part D) and
Medicaid (supplemental rebate) payers to maintain or improve formulary access.
Discretionary Payer Discounts excludes co-pay programs and non-discretionary
discounts such as FSS, PHS, Medicaid (CPI Penalty, ADAP, SDAP) and Medicare
(coverage gap). In the event that Otsuka, without the consent of BMS, grants any
Discretionary Payer Discounts in excess of [*] in 2013 and/or [*] in 2014
(“Excess Discounts”), the Excess Discounts shall be added to Net Sales at the
end of 2013 and/or 2014, respectively (the sum of the actual Net Sales and the
Excess Discounts will be referred to herein as “Adjusted Net Sales”), and the
Parties shall calculate the following: (A) the amount of BMS’s share of actual
Net

 

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Sales (after deducting from Product gross sales all discounts, including Excess
Discounts) utilizing the existing revenue sharing tiers set forth in Amendment
No 5, (B) the amount of BMS’s share of Adjusted Net Sales utilizing the existing
revenue sharing tiers set forth in Amendment No 5, and (C) the difference
between the amounts calculated in accordance with clauses (A) and (B). After
completing such calculations, the amount of the difference calculated in
accordance with clause (C) in the preceding sentence will be received by BMS as
an increase in its share of Net Sales in the United States for the year in
question; provided that, if actual Net Sales exceed [*] in 2013 and/or [*] in
2014, the preceding adjustment mechanism shall no longer apply and BMS shall not
be entitled to receive any such difference. The timing of the calculation and
settlement will be addressed based on the Parties’ existing revenue settlement
process. If Otsuka grants Discretionary Payer Discounts that exceed the Excess
Discounts threshold(s) above [*] in 2013 and/or [*] in 2014), and if BMS
consents to such increased Discretionary Payer Discounts in the interest of
Product Commercialization, then the Excess Discounts threshold(s) above shall be
increased, and the calculations set forth above shall be adjusted, accordingly.
Examples of the calculations under this Subparagraph 5.1(b)(i) are set forth in
Exhibit D attached to this Amendment.

(ii) All Product pricing decisions in the United States for 2013, 2014 and 2015
are within Otsuka’s sole discretion. However, subject to applicable laws and
regulations, if: (1) commencing January 1, 2013, and continuing until [*],
Otsuka decides to increase the wholesale list price (WLP) of Product in the
United States to a WLP that is less than [*] on an annual weighted-average
basis, above the WLP in effect as of October 1, 2012;or (2) commencing [*], and
continuing until [*], Otsuka decides to increase the wholesale list price (WLP)
of Product in the United States to a WLP that is less than [*], on an annual
weighted-average basis, above the WLP in effect as of [*]; and, (3) in either
case, (1) or (2), BMS does not consent to the lower price percentage increase(s)
that Otsuka decided to implement; then (4) the Parties shall calculate the
following: (A) the amount of Net Sales that would have been achieved in the year
in question if Otsuka had increased the price at least by the percentage stated
above (the “Predicted Net Sales”), calculated as set forth below; (B) the amount
of BMS’s share of actual Net Sales utilizing the existing revenue sharing tiers
set forth in Amendment No 5; (C) the amount of BMS’s share of Predicted Net
Sales utilizing the existing revenue sharing tiers set forth in Amendment No 5;
and (D) the difference between the amounts calculated in accordance with clauses
(B) and (C). After completing such calculations, the amount of the difference
calculated in accordance with clause (D) in the preceding sentence will be
received by BMS as an increase in its share of Net Sales in the United States
for the year in question; provided that, if Net Sales are in excess of [*] in
2013 and/or [*] in 2014, BMS shall not be entitled to receive any such
difference. The timing of the calculation and settlement will be addressed based
on the Parties’ existing revenue settlement process. If Otsuka decides to
increase the WLP in 2013 or 2014 by less than the percentages set forth above,
and if BMS consents to such lower percentage increases in the interest of
Product Commercialization, then the above formula shall not be implemented and
BMS shall receive no additional share of Net Sales as provided above. The
Parties agree that any increase of the WLP to be effective on or about
January 1, 2013, shall not be greater than [*] above the WLP in effect as of
October 1, 2012.

 

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For purposes of this Subparagraph 5.1(b)(ii), the Parties shall calculate
Predicted Net Sales as follows: (x) the Parties shall determine the difference
between the above price percentage for a given year (i.e. [*] for 2013 and [*]
for 2014) and the actual price percentage increase that Otsuka decided to
implement in such year (on an annual weighted-average basis); (y) the Parties
will multiply (I) the sum of (A) [*] plus (B) [*] and (z) [*]. For example, if
Otsuka decided to implement a [*] price increase (on an annual weighted-average
basis) in 2013, the Parties would multiply the [*] in 2013 by [*] to arrive at
the [*], and the Parties would deduct the [*] from such [*] to arrive at [*].

(iii) As of the Amendment Effective Date, the Parties are promoting Product, on
a limited basis, for the [*] in the European Union (in addition to the [*]). The
Parties hereby agree to an expanded right for Otsuka, its Affiliates and third
parties designated by Otsuka to promote Product for the [*] in the European
Union as follows:

(A) By no later than [*], Otsuka will provide to BMS (through the Europe
Alliance Committee) a business plan relating to the promotion of Product for the
[*] in the European Union. Such plan shall include, without limitation: (1) the
anticipated timing for commencing the promotion of Product for the [*] in the
European Union, on a country-by-country basis; (2) which entity (Otsuka, its
Affiliates or a third party designated by Otsuka) will promote Product for the
[*], on a country-by-country basis; (3) key messaging; (4) target audience;
(5) financial forecasts and supporting market research; (6) customer
segmentation; and (7) relative support between the [*] and [*] (such business
plan, the [*]). BMS shall have the right to provide comments and feedback on
such plan within a reasonable time after BMS receives the [*]. Otsuka shall
consider in good faith all reasonable comments and feedback from BMS.

(B) In the event Otsuka wishes to expand its existing rights, as of the
Amendment Effective Date, to promote Product (itself or through its Affiliate or
a third party in accordance with Paragraph 3.1 above) for the [*] in the
European Union at any time from [*] through [*], Otsuka shall obtain the written
consent of BMS or its Affiliate, which consent BMS or its Affiliate shall not
unreasonably withhold or delay, and may grant at any Europe Alliance meeting or
otherwise.

(C) On and after [*], with or without the consent of BMS or its Affiliates,
Otsuka, its Affiliates and any third party designated by Otsuka (in accordance
with Paragraph 3.1 above) may promote Product for the [*] in the European Union
using key messaging for [*] as Otsuka deems appropriate, subject to applicable
laws and regulations; provided that, if Otsuka fails to provide BMS with a [*]
with respect to a country in the European Union at [*] prior to [*], Otsuka
(and/or its Affiliates and any third party designated by Otsuka) may only
commence promotion of Product for the [*] in such country [*] after Otsuka has
provided a [*] with respect to such country to BMS, during which period, BMS may
provide comments and feedback on such [*] to Otsuka, which Otsuka shall consider
in good faith. The Parties contemplate that Otsuka will have provided the [*] to
BMS on or before [*], but this proviso addresses the unanticipated event that
Otsuka delays doing so.

 

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(D) In the event sales representatives of Otsuka, its Affiliate or any third
party promote both Product and some other product simultaneously, such sales
representatives shall not promote with negative messaging against Product during
the term of the Restated Agreement in the European Union.

(E) For the avoidance of doubt, BMS and Otsuka shall continue to share Net Sales
in the European Union in accordance with the Restated Agreement (including the
agreed allocation set forth therein). Further for the avoidance of doubt, the
above rights of Otsuka are in addition to, and not in limitation of, Otsuka’s
existing rights, as of the Amendment Effective Date, to promote Product in the
European Union.

(c) There shall be no change to JCC or PDC decision-making authority in the Rest
of Territory, and the terms of Section 5.1 of the Restated Agreement shall
continue to apply to JCC responsibilities, governance and decision-making with
respect to each country in the Rest of Territory during the term of the Restated
Agreement. Notwithstanding the foregoing, in those countries in the Rest of
Territory in which Otsuka requests to promote Product and BMS consents to the
same in accordance with Paragraph 3.2 above, after BMS ceases to deploy sales
representatives to actively promote Product in such countries, committee
decision-making with respect to such countries shall be the same as the
committee decision-making with respect to the European Union on and after [*],
as set forth in Paragraph 5(a) and Subparagraph 5(b)(iii) above, mutatis
mutandis, and neither the Otsuka Chair, the JCC, the PDC, nor any plan approved
by the JCC may impose additional expenses or obligations on BMS or its
Affiliates without the written consent of BMS.

(d) To preserve the status quo, beginning on October 25, 2012, and continuing
until December 31, 2012, with respect to all JCC matters in the United States
relating to the Commercialization of Products (but not distribution,
manufacturing, delivery, supply and packaging, which functions remain under the
operational responsibility of BMS) and all PDC matters in the United States, and
beginning on October 25, 2012, and continuing until [*], with respect to all JCC
matters in the European Union relating to the Commercialization of Products (but
not distribution, manufacturing, delivery, supply and packaging, which functions
remain under the operational responsibility of BMS), Otsuka and BMS shall have
equal decision-making authority on all such JCC and PDC matters, and neither
Party nor its Chair or Co-Chair of either such committee shall have tie-breaking
authority with respect to any such United States or European Union matters. In
the event the JCC or the PDC Chair and Co-Chair are unable to reach agreement on
any such JCC or PDC United States or European Union matters during the
applicable time period specified above, the unresolved matter shall be referred
to and resolved as soon as reasonably possible by the President of Otsuka and
the President, U.S. Pharmaceuticals, of BMS (or a designee thereof).

ARTICLE VI

MISCELLANEOUS PROVISIONS

6.1 Amendment. The Restated Agreement, the U.S. Co-Commercialization Agreement,
the Europe Commercial Resources Agreement and any ancillary Product-related

 

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agreements between the Parties and/or their Affiliates are hereby deemed amended
to the extent necessary to give full effect to the provisions of this Amendment;
provided that Paragraphs 4 and 5 of Amendment No. 8 shall survive in accordance
with its terms notwithstanding anything herein to the contrary.

6.2 Governing Terms. Except as modified herein, the Restated Agreement, the U.S.
Co-Commercialization Agreement, the Europe Commercial Resources Agreement and
any ancillary Product-related agreements between the Parties and/or their
Affiliates shall remain in full force and effect in accordance with their terms,
as previously amended. For the avoidance of doubt, nothing herein shall limit or
modify any transfer or transition terms of the Restated Agreement, the U.S.
Co-Commercialization Agreement or any ancillary Product-related agreements
between the Parties and/or their Affiliates, including, without limitation,
Sections 4.5.2, 4.5.3, 4.5.5, 12.7 and Article 13 of the Restated Agreement and
Paragraph 6 the Post-Termination Services Agreement, all of which shall remain
in full force and effect. To the extent that there are any inconsistencies
between this Amendment and the Restated Agreement, the U.S. Co-Commercialization
Agreement, the Europe Commercial Resources Agreement, or any ancillary
Product-related agreements between the Parties and/or their Affiliates, the
terms of this Amendment shall supersede the Restated Agreement, the U.S.
Co-Commercialization Agreement, the Europe Commercial Resources Agreement, or
such ancillary agreements, as applicable.

6.3 Counterparts; Electronic Signature. This Amendment may be executed in
counterparts, each of which shall be deemed an original and all of which
together shall constitute one and the same instrument. Each Party may execute
this Amendment by facsimile transmission or in Adobe™ Portable Document Format
(PDF) sent by electronic mail. Facsimile or PDF signatures of authorized
signatories of the Parties will be deemed to be original signatures, will be
valid and binding, and, upon delivery, will constitute due execution of this
Agreement.

[Signature Page Follows]

 

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IN WITNESS WHEREOF, Otsuka and BMS agree that this Amendment is effective as of
the Amendment Effective Date set forth above.

 

OTSUKA PHARMACEUTICAL CO., LTD.       BRISTOL-MYERS SQUIBB COMPANY By:   

/s/ Taro Iwamoto, Ph.D.

      By:   

/s/ Giovanni Caforio

   (Signature)          (Signature) Name:    Taro Iwamoto, Ph.D.       Name:   
Giovanni Caforio Title:    President and Representative Director       Title:   
President, U.S. Pharmaceuticals By:   

/s/ Tetsuya, Tachikawa

            (Signature)          Name:    Tetsuya, Tachikawa, Ph,D.         
Title:    Operating Officer, Licensing         

 

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EXHIBIT A-1

FUNCTIONS TO BE TRANSITIONED TO OTSUKA BY JANUARY 1, 2013

The following United States functions and activities (“U.S. Assumed Functions”)
shall be assumed by Otsuka and transitioned from BMS to Otsuka by January 1,
2013, all in accordance with and subject to the terms and conditions of this
Amendment, of which this Exhibit A-1 is a part (subject to modification in
accordance with Paragraph 2.3(c)):

[*] [CONTENT REDACTED]

 

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20.

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EXHIBIT A-2

FUNCTIONS TO BE TRANSITIONED TO OTSUKA BY APRIL [*], 2013 OR LATER IN 2013

The following United States functions and activities (“U.S. Assumed Functions”)
shall be assumed by Otsuka and transitioned from BMS to Otsuka by April [*],
2013 or later in 2013 or 2014 (by the dates set forth below), all in accordance
with and subject to the terms and conditions of this Amendment, of which this
Exhibit A-2 is a part (subject to modification in accordance with Paragraph
2.3(c)):

[*] [CONTENT REDACTED]

 

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EXHIBIT B

DATA, RECORDS AND INFORMATION

The following is a list of data, records and information related to Product or
related to U.S. Assumed Functions. The following list is illustrative of such
data, records and information that BMS must transfer or make available to Otsuka
in accordance with Paragraph 2.3(f) and Paragraph 4.1 of this Amendment, and is
not intended to limit the Product-related data, records and information that BMS
must transfer or make available to Otsuka. The Parties acknowledge that in order
to ensure a smooth transition of responsibilities to Otsuka, the Parties shall
mutually agree upon the scope and method of the transfer of the following
materials, taking into account whether such materials exist, whether Otsuka
already possesses such information, whether such materials contain information
of BMS that relates to products other than Product (in which case such
information shall be redacted or otherwise segregated), whether such materials
contain material that is governed by third-party agreements, compliance with
applicable law (e.g. privacy), and whether physical transfer of such records (as
opposed to maintenance by BMS in accordance with its record retention policies,
with Otsuka having access to such information upon reasonable request) is
necessary or desirable. The Parties also acknowledge that the following list may
not be exhaustive.

[*][CONTENT REDACTED]

 

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EXHIBIT C

SHARED EXPENSE BUDGET

 

Other Operational Expenses

   2013    2014    2015

Distribution

        

Other Marketing

        

R&D

        

Total Other Operational Expenses

        

Cost Share % (BMS/Otsuka)

        

Advertising & Promotion

              

Cost Share $ (BMS/Otsuka)

        

Notes:

“Other Marketing” includes [*]

R&D includes [*]

[*]

 

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23.

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EXHIBIT D

EXAMPLES FOR SUBPARAGRAPH 5(b)(i) RELATING TO EXCESS DISCOUNTS

This Exhibit sets forth hypothetical examples of the treatment of Excess
Discounts as described in Subparagraph 5.1(b)(i) of this Amendment.

Example 1 (Hypothetical Scenario)

If:

 

  •  

The total amount of Discretionary Payer Discounts (as defined in Subparagraph
5.1(b)(i)) in 2013 is [*]

 

  •  

The Excess Discounts (as defined in Subparagraph 5.1(b)(i)) in 2013 is [*] (i.e.
[*] – [*])

 

  •  

The actual Net Sales of Product in 2013, after deducting from gross sales all
Discretionary Payer Discounts, including the Excess Discounts [*] and other
deductions from gross sales pursuant to the Restated Agreement, is [*]

then,

 

  •  

The Adjusted Net Sales (as defined in Subparagraph 5.1(b)(i)) is [*] (i.e. [*] +
[*] of Excess Discounts);

 

  •  

The amount of BMS’s share of actual Net Sales, utilizing the existing revenue
sharing tiers set forth in Amendment No. 5, is [*] (see chart below);

 

  •  

The amount of BMS’s share of Adjusted Net Sales, utilizing the existing revenue
sharing tiers set forth in Amendment No. 5, is [*] (see chart below); and

 

  •  

The amount of the difference received by BMS as an increase in its share of Net
Sales in the United States, as provided in clause (C) of Subparagraph 5(b)(i),
is [*] (i.e., [*])

 

Annual
Net Sales Tiers ($M)

   % of Net Sales
in Tier to BMS     BMS’s share of
Actual Net Sales      BMS’s share of
Adjusted Net Sales  

   $0

   $2,700      50 %      [*]         [*]   

   $2,700

   $3,200      20 %      

   $3,200

   $3,700      7 %      

   $3,700

   $4,000      2 %      

   $4,000

   $4,200      1 %      

> $4,200

        20 %              

 

 

    

 

 

 

Total

          [*]         [*]   

 

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Example 2 (Hypothetical Scenario)

If:

 

  •  

The actual total amount of Discretionary Payer Discounts (as defined in
Subparagraph 5.1(b)(i)) in 2013 is [*]

 

  •  

The Excess Discounts (as defined in Subparagraph 5.1(b)(i)) in 2013 is [*] (i.e.
[*] – [*])

 

  •  

The actual Net Sales of Product in 2013, after deducting from gross sales all
Discretionary Payer Discounts, including the Excess Discounts ([*]) and other
deductions from gross sales pursuant to the Restated Agreement, is [*]

then,

Because actual Net Sales exceed [*], the Parties will not calculate Adjusted Net
Sales or make the other calculations set forth in Subparagraph 5.1(b)(i) and BMS
will not retain any difference pursuant to clause (C) of Subparagraph 5(b)(i),
notwithstanding that the Excess Discounts is [*] [*] in 2013.

 

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25.