Exhibit 10.52
AMENDMENT NO. 2
TO THE
LICENSE AGREEMENT

This Amendment No. 2 to the License Agreement (this “Amendment”), dated as of
June 29, 2012 (the “Amendment Effective Date”), is made by and between Amgen
Inc., a Delaware corporation having an address of One Amgen Center Drive,
Thousand Oaks, California 91320-1799 (“Amgen”), and Takeda Pharmaceutical
company Limited, a Japanese corporation having an address of 1-1, Doshomachi
4-chome, Chuo-ku, Osaka 540-8645 (“Licensee”).

WHEREAS, Amgen and Licensee entered into that certain License Agreement
(multi-product), dated as of February 1, 2008, as amended by Amendment No. 1
dated June 25, 2010 (the “Agreement”), pursuant to which the Parties entered
into a licensing arrangement for the development and commercialization by
Licensee in the Territory of Licensed Products (as that term is defined in the
Agreement);

WHEREAS, at the beginning of the Collaboration the Steering Committee delegated
certain of its responsibilities to a subcommittee referred to as the “Management
Committee” which provided oversight and coordination of the Collaboration and
functioned as the Joint Project Team under the License Agreement dated as of
February 1, 2008 between the Parties relating to AMG706 and terminated as of
June 29, 2012; and

WHEREAS, Amgen and Licensee wish to amend the Agreement to, among other things,
memorialize the establishment and role of the Management Committee under this
Agreement and set forth the terms and conditions for certain audit rights of
Licensee.

NOW, THEREFORE, in consideration of the mutual promises and covenants
hereinafter set forth, the Parties hereto agree to amend the Agreement as
follows:

ARTICLE 1 - AMENDMENT

Capitalized terms used in this Amendment and not otherwise defined herein shall
have the meanings ascribed to such terms in the Agreement.

1.1
Amendment of Section 2.3 (Governance). The first sentence of Section 2.3
(Governance) shall be deleted and replaced with the following: “The
Collaboration shall be governed by (i) a Steering Committee, which shall oversee
the activities of the Parties hereunder generally, (ii) a Management Committee,
which shall oversee and coordinate the activities of the Parties hereunder, and
(iii) a Development Committee and a Commercialization Committee for each
Licensed Product, which shall manage the development and commercialization,
respectively, of Licensed Products in the Territory. The Management Committee
shall initially be comprised of the members set forth on the Management
Committee Schedule.”

1.2
Amendment of Section 2.4 (Membership). The first sentence of Section 2.4
(Membership) shall be deleted and replaced with the following: “Unless otherwise
agreed by the Parties, each of the Development Committee and Commercialization
Committee shall be comprised of three (3) members appointed by Amgen, and three
(3) members appointed by Licensee, and the Management Committee shall be
comprised of four (4) members appointed by Amgen, and four (4) members appointed
by Licensee.”

1.3
Addition of Section 2.11 (Management Committee). The following Section 2.11
(Management Committee) shall be added immediately following Section 2.10
(Commercialization Committee) of the Agreement:

“2.11    Management Committee. The Management Committee shall be responsible for
overseeing and coordinating the overall plans of the Parties with respect to the
Licensed Products and ensuring an appropriate level of communication between the
Parties under this Agreement.

2.11.1    Meetings. The Management Committee shall meet quarterly in person, via
teleconference or videoconference or otherwise (with at least two (2) meetings
per Calendar Year being in person), or as otherwise agreed by the Parties. Any
in-person meetings shall be held on an alternating basis between Licensee's and
Amgen's facilities, unless otherwise agreed by the Parties. Each Party shall be
responsible for its own expenses relating to such meetings. As appropriate,
other employee representatives of the Parties may attend Management Committee
meetings as nonvoting participants, but no Third Party personnel may attend
unless otherwise agreed by the Parties. Each Party may also call for special
meetings as reasonably required to resolve particular matters

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requested by such Party by at least five (5) business days written notice to the
co-chair appointed by the other Party. All Management Committee meetings must
have at least one (1) member appointed by each Party in attendance.

2.11.2.    Reporting. Each Party, through the members appointed by it on the
Development Committee and the Commercialization Committee, shall keep the
Management Committee fully and promptly informed of progress and results of
activities for which each such committee is responsible and with respect to all
relevant facts and activities reasonably requested by any member thereof
regarding any Licensed Product.

2.11.3    Decision Making. The Management Committee shall make decisions by
consensus. In the event the Management Committee fails to reach consensus, and
the Management Committee determines that it is appropriate to do so, such matter
shall be escalated to the Steering Committee for resolution.”

1.4
Amendment of Section 8.13 (Audits). Section 8.13 (Audits) shall be deleted in
its entirety and replaced with the following:

“8.13    Audits. Licensee shall keep complete and accurate records pertaining to
the sale of the Licensed Products in the Territory in sufficient detail to
permit Amgen to confirm the accuracy of all payments due hereunder. Amgen shall
keep complete and accurate records pertaining to Amgen Development Costs of
Licensed Products in sufficient detail to permit Licensee to reasonably confirm
the accuracy of all payments due hereunder with respect to Licensee's obligation
to reimburse Amgen for Licensee's share of Amgen Development Costs, other than
with respect to clinical drug substance and drug product supply of Licensed
Products, pursuant to Section 8.9 (Development Cost Sharing). Such records of
Licensee and Amgen shall be open (in such form as may be available or reasonably
requested by a certified public accountant in accordance with this Section
8.13(Audits)) to inspection for five (5) years following the end of the period
to which they pertain; provided, however, such records of Amgen shall only be
available with respect to Amgen Development Costs incurred by or on behalf of
Amgen on a going forward basis from April 1, 2012. Each Party shall have the
right, at its own expense, to have an independent, certified public accountant,
selected by it to review the records of the other Party upon reasonable notice
and during regular business hours. The final report of such accountant shall be
made available to both Parties within two (2) Calendar Quarters of the audit
fieldwork having been completed unless otherwise mutually agreed by the Parties;
provided, however, that the Party being audited shall have the right to review
and comment on the final draft version of the report prior to it being
finalized. Such review and comment period shall extend for four (4) weeks after
the audited Party's receipt of such draft report. Each Party's audit rights with
respect to any Calendar Year shall expire five (5) years after the end of such
year and the books and records for any particular Calendar Year shall only be
subject to one (1) audit. During any Calendar Year period, each Party's books
and records for any particular Calendar Year shall only be subject to audit by
the other Party with respect to up to two Licensed Products. Should the
inspection lead to the discovery of a discrepancy to the auditing Party's
detriment, then the other Party shall pay to the auditing Party the amount of
the discrepancy plus interest accrued at the Contract Interest Rate, compounded
daily from the day the relevant payment(s) were due. Should the inspection lead
to the discovery of a discrepancy to the detriment of the Party being audited,
then the auditing Party shall pay to the other Party the amount of the
discrepancy without interest. The auditing Party shall pay the full cost of the
inspection unless the discrepancy is to the detriment of the auditing Party and
is greater than five percent (5%) of the amount actually paid for the audited
period, in which case the Party being audited shall pay the cost of such
inspection. Notwithstanding the foregoing, Licensee shall have no right to audit
Amgen's records under this Section 8.13 (Audits) unless Licensee has timely paid
all invoices then due under this Agreement (or timely paid any undisputed
portion and escrowed any disputed portion thereof, with a resolution of such
dispute within twelve (12) months thereafter).”

1.5
Amendment of Section 14.2.5 (Product Suspension or Product Termination). Section
14.2.5 (Product Suspension or Product Termination) shall be deleted in its
entirety and replaced with the following:

“14.2.5    Product Suspension or Product Termination. If a Product Suspension or
Product Termination occurs for a Licensed Product outside the Territory, Amgen
shall promptly notify Licensee and, at either Party's request, the Parties shall
discuss such Product Suspension or Product Termination at the Development
Committee or Commercialization Committee, as appropriate, and thereafter, at
either Party's request, at the Management Committee.

14.2.5.1    Product Suspension. In the event a Product Suspension occurs for a
Licensed Product outside the Territory, and in light of the cause of such
Product Suspension it would not be reasonable for Licensee to continue
development and commercialization of such Licensed Product in the Territory,
then Licensee shall have the right to (i) suspend its efforts to develop and
commercialize that particular Licensed Product in the Territory until such time
as Amgen, its Affiliate, and/or a licensee resumes efforts to develop or
commercialize such Licensed Product outside the Territory, and all provisions
relating to Distracting Programs under this Agreement shall

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still apply with respect to such suspended Licensed Product; or (ii) terminate
this Agreement with respect to such Licensed Product pursuant to Section
14.2.5.2 (Product Termination) below.

14.2.5.2    Product Termination. In the event a Product Termination occurs for a
Licensed Product outside the Territory, and in light of the cause of such
Product Termination, it would not be reasonable for Licensee to continue
development and commercialization of such Licensed Product in the Territory, or
if a Product Suspension occurs under Section 14.2.5.1 then, in each case,
Licensee shall have the right to terminate this Agreement with respect to such
Licensed Product, upon thirty (30) days' prior written notice to Amgen
(provided, however, that during such thirty (30) day period and such time as is
reasonably necessary thereafter, Licensee shall provide any cooperation
reasonably requested by Amgen to transition ongoing activities, and Amgen shall
reimburse all reasonable, documented, out-of-pocket expenses incurred by
Licensee in connection with the provision of such cooperation).

14.2.5.3    Certain Product Suspensions and Product Terminations.
Notwithstanding the foregoing, Licensee shall not have the right to suspend its
efforts or terminate this Agreement under this Section 14.2.5 (Product
Suspension or Product Termination) if the reason for the Product Suspension or
Product Termination, as the case may be, is specific to markets or jurisdictions
outside the Territory and does not materially apply to the development or
commercialization in the Territory. The reason for the Product Suspension or
Product Termination will be discussed at the JDC. In the event the JDC fails to
reach consensus as to whether the reason for the Product Suspension or Product
Termination materially applies to the development or commercialization in the
Territory, the committee members appointed by Licensee shall make the final
determination.”

1.6
Addition of Section 14.3.3 (Terminations by Licensee for Amgen Product
Termination). The following Section 14.3.3 (Terminations by Licensee for Amgen
Product Termination) shall be added immediately following Section 14.3.2
(Development Cost Share):

“14.3.3     Terminations by Licensee for Amgen Product Termination. For clarity,
in the event Licensee terminates this Agreement with respect to a Licensed
Product pursuant to Section 14.2.5.2 (Product Termination), then the following
provisions relating to Distracting Programs shall not survive the Termination
Date with respect to such Licensed Product: Sections 3.9 (Right of First
Discussion), 6.4 (Activities Outside the Collaboration), 6.5 (Post-Effective
Date Affiliates), 6.6 (Termination or Divestiture), 10.3.1 (Ex-Territory
Distracting Program), 10.3.2 (Ex-Territory Distracting Transaction), 10.3.3
(Protection of Amgen Information) from the words “, and the Parties shall
promptly meet to agree…” through the end of the section, and the penultimate
sentence of Section 15.1 (Change of Control).”

1.7
Addition of Management Committee Schedule. Exhibit A hereto shall be attached to
the Agreement as a new Management Committee Schedule.

1.8
Licensee's Input into Global Development Strategy.

1.8.1
Development Committee. The Parties shall hold an ad hoc Development Committee
meeting in Thousand Oaks, California as soon as reasonably practicable following
the Amendment Effective Date to discuss and establish processes and procedures
to enable Licensee to provide input into Amgen's global development for Licensed
Products (including the studies comprising such development) and the annual
budget relating thereto, and ensure that Amgen considers such input in good
faith (provided, however, that, subject to Section 1.8.2 (Escalation) below,
Amgen shall have final decision making authority with respect to such
development decisions and further provided, however, where delay is impractical
Amgen will have the right to make an interim decision pending such escalation).

1.8.2
Escalation. Licensee shall have the right to escalate to the Management
Committee any development decision that Licensee (i) determines is reasonably
likely to have a material adverse impact on the Development of the relevant
Licensed Product in the Territory, or (ii) believes that Licensee's input has
not been considered in good faith by the Development Committee in reaching a
decision, by providing written notice within five (5) business days of having
provided such input at a Development Committee meeting in accordance with the
process to be agreed upon as set forth in Section 1.8.1 (Development Committee)
above; provided, however, that Amgen shall have final decision making authority
with respect to such development decisions after discussion has taken place at
the Management Committee.

1.8.3
Process. The Parties agree to amend the Agreement to the extent necessary to
align the provisions of this Agreement with the processes established by the
Development Committee.

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1.9
Supply Terms. Promptly following the Amendment Effective Date, the Parties shall
meet and discuss in good faith whether to amend the rights and obligations of
the Parties under this Agreement on a going forward basis with respect to the
cost of clinical and commercial supply of Licensed Products in the Territory,
which may or may not include audit rights of Licensee with respect to costs
charged by Amgen for Licensee's supplies of drug substance and drug product for
Licensed Products in the Territory, fixed cost supply obligations, royalty
structure modifications or other terms and conditions as may be agreed to by the
Parties. Any agreement between the Parties with respect to the foregoing shall
be memorialized in writing and this Agreement amended accordingly.

ARTICLE 2 - REFERENCE TO AND EFFECT ON THE AGREEMENT

2.1
Reference to Agreement. Upon and after the effectiveness of this Amendment, each
reference in the Agreement to “this Agreement”, “hereunder”, “hereof” or words
of like import referring to the Agreement shall mean and be a reference to the
Agreement as modified and amended hereby.

2.2
Effectiveness of Amendment. Upon execution and delivery of this Amendment by
both Parties, the amendments set forth above shall be effective as of the
Amendment Effective Date. Except as specifically amended above, the Agreement is
and shall continue to be in full force and effect and is hereby in all respects
ratified and confirmed and shall constitute the legal, valid, binding and
enforceable obligations of the Parties.

2.3
No Waiver. The execution, delivery and effectiveness of this Amendment shall not
operate as a waiver of any right, power or remedy of either Party under the
Agreement, nor constitute a waiver of any provision of the Agreement.

ARTICLE 3 MISCELLANEOUS

3.1
Governing Law. This Amendment shall be governed by and construed in accordance
with the laws of the State of California, as applied to agreements executed and
performed entirely within the State of California, without regard to any
applicable principles of conflicts of law. Each of the Parties hereby
irrevocably and unconditionally consents to the exclusive jurisdiction of the
courts of the State of California and of the United States of America located in
the State of California for any matter arising out of or relating to this
Amendment and the transactions contemplated hereby.

3.2
Headings. The heading for each article and section in this Amendment has been
inserted for convenience of reference only and is not intended to limit or
expand on the meaning of the language contained in the particular article or
section.

3.3
Counterparts. This Amendment may be executed in two (2) or more counterparts,
each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument.

[Signature page follows]

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IN WITNESS THEREOF, duly authorized representatives of the Parties hereto have
executed this Amendment as of the date first set forth above.

Amgen Inc.
 
Takeda Pharmaceutical Company Limited
 
 
 
 
 
 
 
By: /s/ Sean E. Harper
 
By: /s/ Masato Iwasaki
Name:
Sean E. Harper
 
Name:
Masato Iwasaki
Title:
Executive Vice President,
 
Title:
Member of the Board
 
Research and Development
 
 
Senior Vice President
 
 
 
 
 
Pharmaceutical Marketing Division
 
 
 
 
 
Takeda Pharmaceutical Company Ltd.
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Exhibit A

Schedule

Management Committee

Amgen:
XXXX XXXXXXXXX (co-chair), SVP, GRAAS
XXXXXXXX XXXXXXXXXX, VP, Program Management, R&D Compliance and Strategy
Operations
XXXX XXXX, VP, Operations (CMC)
XXXXXXX XXX, VP, Business Development

Takeda:
XXXXXXXX XXXXXXXX (co-chair), President, Takeda Bio
XXXXX XXXXXXXX, Chief Medical Officer, Millennium
XXXXXX XXXX, GM CMC Center, Takeda Pharma
XXXXXXXX XXXXXXXX, Director, Oncology Marketing, Takeda Pharma

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