Exhibit 10.82

Note: Redacted portions have been marked with [*]. The redacted portions are
subject to a request for confidential treatment that has been filed with the
Securities and Exchange Commission.

License Agreement

By and Between

Amgen Inc.

and

Takeda Pharmaceutical Company Limited

Dated

February 1, 2008

CONFIDENTIAL

--------------------------------------------------------------------------------

Table of Contents

 

1       DEFINITIONS

   1

2       COLLABORATION SCOPE AND GOVERNANCE

   9

3       GRANT OF LICENSE

   13

4       DEVELOPMENT AND REGULATORY APPROVAL

   17

5       COMMERCIALIZATION

   23

6       LICENSEE AND AMGEN INDICATIONS; ACTIVITIES OUTSIDE THE COLLABORATION

   24

7       MANUFACTURE AND SUPPLY

   26

8       PAYMENT

   27

9       INTELLECTUAL PROPERTY

   32

10     CONFIDENTIALITY AND PUBLICATIONS

   34

11     REPRESENTATIONS, WARRANTIES AND COVENANTS

   38

12     LIMITATIONS OF LIABILITY; INSURANCE

   40

13     INDEMNIFICATION

   40

14     TERM AND TERMINATION

   42

15     CHANGE OF CONTROL

   43

16     MISCELLANEOUS

   43 SCHEDULES   

CONFIDENTIAL

--------------------------------------------------------------------------------

License Agreement

Preamble

This License Agreement (this “Agreement”) is entered into as of the 1st day of
February, 2008 (the “Effective Date”) by and between Amgen Inc., a Delaware
corporation having its principal place of business at One Amgen Center Drive,
Thousand Oaks, California 91320-1799, U.S.A. (“Amgen”), and Takeda
Pharmaceutical Company Limited, a Japanese corporation having its principal
place of business at 1-1, Doshomachi 4-chome, Chuo-ku, Osaka 540-8645, Japan
(“Licensee”). Amgen and Licensee are sometimes referred to herein individually
as a “Party” and collectively as the “Parties.”

Recitals

WHEREAS, Amgen is a global biotechnology company that conducts pharmaceutical
research, development, manufacturing and commercialization;

WHEREAS, Amgen is developing a number of products for the treatment of various
diseases and conditions;

WHEREAS, Amgen’s subsidiary, Amgen K.K., has previously conducted development
activities in the Territory (as defined below);

WHEREAS, concurrently with the execution of this Agreement, the Parties are
entering into the Sale and Purchase Agreement whereby Amgen shall sell, and
Licensee shall purchase, all of the outstanding capital stock of Amgen K.K.;

WHEREAS, Licensee has existing development and commercialization capabilities in
the Territory and will, subsequent to the closing of the transactions
contemplated in the Sale and Purchase Agreement, have the additional development
capabilities of Amgen K.K.;

WHEREAS, Amgen wishes to partner with Licensee, and Licensee wishes to partner
with Amgen, in each case with respect to the development and commercialization
of the Licensed Products in the Licensee Indications in the Territory (each as
defined below) in accordance with the terms and conditions hereof;

NOW, THEREFORE, in consideration of the mutual promises contained herein, and
for other good and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, and intending to be legally bound, the Parties hereto
agree as follows:

 

1. DEFINITIONS

 

1.1. “Affiliate” shall mean any corporation or other entity which directly or
indirectly controls, is controlled by or is under common control with a Party,
for so long as such control exists. For the purposes of this Section 1.1
(“Affiliate”), “control” shall mean: (i) in the case of any corporate entity,
direct or indirect ownership of more than fifty percent (50%) of the stock
having the right to vote for the election of directors thereof; or (ii) in the
case of any non-corporate entity, direct or indirect ownership of more than
fifty percent (50%) of the equity or income interest therein.

 

1.2. “Agreement” shall have the meaning set forth in the Preamble.

 

CONFIDENTIAL    Page 1   

--------------------------------------------------------------------------------

1.3. “[*] Product” shall mean a [*] for which Amgen has the exclusive rights to
develop and commercialize in North America, Europe and the Territory, and that
is being developed for [*] and as its intended therapeutic mechanism of action
targets the relevant receptor or ligand for such Distracting Product (as
described on the Distracting Products Schedule).

 

1.4. “[*]” or “[*]” shall mean, with respect to a commercial presentation of a
Licensed Product, the unit-volume-weighted average of: (a) the [*] for the [*]
presentation during the Term pursuant to the relevant [*]; (b) the [*] for such
presentation where Licensee [*] such presentation [*] in accordance with this
Agreement and the relevant [*]; and (c) the [*] by Licensee to [*] engaged by
Licensee in accordance with this Agreement that [*] to Licensee in accordance
with this Agreement and the relevant [*] is calculated without reference to any
payments associated with [*]. An example of calculation of the foregoing is set
forth on the Royalty Calculation Schedule.

 

1.5. “Amgen” shall have the meaning set forth in the Preamble.

 

1.6. “Amgen Development Costs” shall mean Amgen’s (and its Affiliates’)
fully-burdened, world-wide development costs [*] related to development of a
Licensed Product, as more specifically set forth in the Development Costs
Schedule.

 

1.7. “Amgen Development Data” shall mean the preclinical and clinical data
generated by or on the behalf of Amgen or its Affiliates (both within and
outside the Territory) in the course of its preclinical and clinical development
of a Licensed Product, both before and after[*] of this Agreement.

 

1.8. “Amgen Indemnitees” shall have the meaning set forth in Section 13.1
(Indemnity).

 

1.9. “Amgen Indication” shall have the meaning set forth in Section 6.7.2 (Amgen
Developed Indications).

 

1.10. “Amgen K.K.” shall mean Amgen Kabushiki Kaisha, a Japanese corporation.

 

1.11. “Annual Maximum” shall have the meaning set forth in Section 8.9.3
(Payment Caps).

 

1.12. “Bundle” shall mean a Licensed Product sold together with another
pharmaceutical compound for a single price.

 

1.13. “[*]Quarter” shall mean a three-month period beginning on[*].

 

1.14. “[*]Year” shall mean a one-year period beginning on [*]and ending on[*].

 

1.15. “Change of Control” shall mean, with respect to Licensee, the occurrence
of any of the following events: [*]

 

1.16. “Claims” shall have the meaning set forth in Section 13.1 (Indemnity).

 

1.17. “Collaboration” shall have the meaning set forth in Section 2.1 (Conduct
of the Collaboration).

 

1.18. “Commercialization Committee” shall mean the committee established by the
Parties to oversee and coordinate the commercialization of a particular Licensed
Product in the Territory.

 

CONFIDENTIAL    Page 2   

--------------------------------------------------------------------------------

1.19. “Confidential Information” shall have the meaning set forth in
Section 10.1 (Confidentiality; Exceptions).

 

1.20. “Contract Interest Rate” shall mean [*]%) plus the [*] rate effective for
the date [*], as published by The Wall Street Journal, Eastern U.S. Edition, on
the date [*](or, if unavailable on such date, [*]on which such rate is
available), or, if lower, the maximum rate permitted by Law.

 

1.21. “Control” shall mean, with respect to any Information or intellectual
property, that the applicable Party owns or has a license to such Information or
intellectual property and has the ability to grant to the other Party access to
and a license or sublicense (as applicable) under such Information or
intellectual property as set forth herein without violating the terms of any
agreement with any Third Party as of the time such Party would first be required
hereunder to grant such access and license or sublicense, or requiring any
payment (whether or not then due and payable) under any agreement with any Third
Party as of the time such Party would first be required hereunder to grant such
access and license or sublicense.

 

1.22. “Developed [*]” shall mean a [*] having a [*] not consisting primarily of
[*] that is either obtained through Licensee’s discovery research activities
(whether exclusively internal or in collaboration with a Third Party) or where
the rights to such [*] were controlled by a [*] at the time [*].

 

1.23. “Development Committee” shall mean the committee established by the
Parties to oversee and coordinate the development of a particular Licensed
Product in the Territory.

 

1.24. “Distracting Product”, with respect to each Licensed Product, shall have
the meaning set forth on the Distracting Products Schedule.

 

1.25. “Distracting Program” shall mean the [*] or [*], in the Territory, of any
Distracting Product. [*].

 

1.26. “Distracting Transaction” shall mean any transaction entered into by
Licensee or its Affiliate after [*] whereby a Third Party that is engaged in a
Distracting Program becomes an Affiliate of Licensee.

 

1.27. “Distracting Transaction Affiliates” shall mean those entities that are or
would become Affiliates of Licensee by virtue of a Distracting Transaction.

 

1.28. “Divest” shall mean, with respect to any Distracting Program, the sale,
exclusive license or other transfer of all of the right, title and interest in
and to such Distracting Program, including technology, Information, intellectual
property and other assets materially relating thereto, to an independent Third
Party, without the retention or reservation of any rights or interest (other
than solely an economic interest) in such Distracting Program by the relevant
Party or its Affiliates.

 

1.29. “Effective Date” shall have the meaning set forth in the Preamble.

 

1.30. “Ex-Territory Distracting Affiliates” shall mean those entities that are
or would become Affiliates of Licensee by virtue of an Ex-Territory Distracting
Transaction.

 

1.31.

“Ex-Territory Distracting Program” shall mean any development, commercialization
or manufacture of a Distracting Product intended for use or sale (or actually
used or

 

CONFIDENTIAL    Page 3   

--------------------------------------------------------------------------------

 

sold) outside the Territory or intended for import (or actually imported)
outside the Territory.

 

1.32. “Ex-Territory Distracting Transaction” shall mean any transaction entered
into by Licensee or its Affiliate after [*] whereby a Third Party that is
engaged in an Ex-Territory Distracting Program becomes an Affiliate of Licensee.

 

1.33. “Federal Court” shall have the meaning set forth in Section 16.11
(Jurisdiction and Venue).

 

1.34. “First Commercial Sale” shall mean the first sale of a Licensed Product
following Regulatory Approval by or on the behalf of Licensee, its Affiliate or
sublicensees.

 

1.35. “Force Majeure” shall have the meaning set forth in Section 16.8 (Force
Majeure).

 

1.36. “FTE” shall mean the equivalent of the work of one employee full time for
one year (consisting of at least a total of [*] weeks or [*] hours per year
(excluding vacations and holidays)). Overtime, and work on weekends, holidays
and the like shall not be counted with any multiplier (e.g., time-and-a-half or
double time) toward the number of hours that are used to calculate the FTE
contribution.

 

1.37. “FTE Rate” shall mean [*] per full-time employee per year (as of [*]),
increasing by [*]%) of the then-current FTE Rate on [*].

 

1.38. “GAAP” shall mean either Japanese or U.S. generally accepted accounting
principles, consistently applied, as used by a Party to record the relevant
transaction.

 

1.39. “Governmental Authority” shall mean any government administrative agency,
commission or other governmental authority, body or instrumentality, or any
federal, state, local, domestic or foreign governmental regulatory body.

 

1.40. “Indemnified Party” shall have the meaning set forth in Section 13.2
(Claim for Indemnification).

 

1.41. “Indemnifying Party” shall have the meaning set forth in Section 13.2
(Claim for Indemnification).

 

1.42. “Information” shall mean all tangible and intangible techniques,
information, technology, practices, trade secrets, inventions (whether
patentable or not), methods, knowledge, know-how, conclusions, skill,
experience, test data and results (including pharmacological, toxicological and
clinical test data and results), analytical and quality control data, results or
descriptions, software and algorithms.

 

1.43. “Initiation” of a clinical trial or to “Initiate” a clinical trial shall
mean the first dosing of a human subject with a Licensed Product in such trial.

 

1.44. “Joint Patents” shall mean any invention, patent or patent application
jointly owned by the Parties pursuant to Section 9.1 (Ownership).

 

1.45. “Key Event” shall have the meaning set forth in Section 6.2 (Key Event
Time Frames).

 

1.46. “Law” shall mean, individually and collectively, any and all laws,
ordinances, rules, directives, administrative circulars and regulations of any
kind whatsoever of any Governmental Authority within the applicable
jurisdiction.

 

CONFIDENTIAL    Page 4   

--------------------------------------------------------------------------------

1.47. “Licensed Amgen Know-How” shall mean Information in Amgen’s (or its
Affiliate’s) possession and Control, as of [*] or thereafter during the Term,
that is reasonably necessary for Licensee to develop or commercialize a Licensed
Product in the Licensee Indications in the Territory. Licensed Amgen Know-How
shall include Amgen Development Data that is reasonably necessary for Licensee
to develop or commercialize a Licensed Product in the Licensee Indications in
the Territory. Licensed Amgen Know-How does not include Amgen manufacturing
information. Licensed Amgen Know-How shall include Information known to the
employees of Amgen K.K. as of the date of the consummation of the transactions
contemplated in the Sale and Purchase Agreement that is reasonably necessary for
Licensee to develop or commercialize a Licensed Product in the Licensee
Indications in the Territory.

 

1.48. “Licensed Amgen Patents” shall mean those patents and patent applications
set forth on the Licensed Amgen Patents Schedule, as well as any continuation,
divisional, substitution, continuations-in-part, reissue, reexamination,
provisional and converted provisional application thereof, [*] For purposes of
determining whether a patent application falls within this definition, a patent
application shall be considered “infringed” if its pending claims would be
infringed if issued as then currently set forth in the patent application.

 

1.49. “Licensed Amgen Trademarks” shall mean any trademark rights Controlled by
Amgen in the Territory on or after [*] and corresponding to any trademarks
adopted by Amgen for use with a Licensed Product in a Licensee Indication
outside the Territory (not including any corporate or house marks, and not
including any such marks to the extent such marks would conflict with any right
of any Third Party inside the Territory).

 

1.50. “Licensed Licensee Know-How” shall mean Information in Licensee’s (or its
Affiliate’s) possession and Control, as of [*] or thereafter during the Term,
that is reasonably necessary for Amgen to develop, manufacture or commercialize
a Licensed Product within or outside the Territory in any indication. Licensed
Licensee Know-How shall include Licensee Development Data that is reasonably
necessary for Amgen to develop, manufacture or commercialize a Licensed Product
within or outside the Territory in any indication.

 

1.51. “Licensed Licensee Patents” shall mean those patents and patent
applications owned or Controlled by Licensee or its Affiliate (including an
interest in a patent or Joint Patent pursuant to Section 9.1 (Ownership))[*] For
purposes of determining whether a patent application falls within this
definition, a patent application shall be considered “infringed” if its pending
claims would be infringed if issued as then currently set forth in the patent
application.

 

1.52. “Licensed Licensee Trademarks” shall mean any trademarks adopted by
Licensee for use with a Licensed Product in the Territory in the Licensee
Indications (not including any corporate or house marks).

 

1.53. “Licensed Product” shall mean any one of the pharmaceutical products
listed on the Licensed Products Schedule.

 

1.54. “Licensee” shall have the meaning set forth in the Preamble.

 

CONFIDENTIAL    Page 5   

--------------------------------------------------------------------------------

1.55. “Licensee Assumed Item” shall have the meaning set forth in
Section 9.2.1.2 (Licensee Secondary Prosecution).

 

1.56. “Licensee Development Data” shall mean the preclinical and clinical data
generated by or on behalf of Licensee or its Affiliates in the course of its
preclinical (if any) and clinical development of a Licensed Product, on or after
[*].

 

1.57. “Licensee Indemnitees” shall have the meaning set forth in Section 13.1
(Indemnity).

 

1.58. “Licensee Indications” shall mean with respect to each Licensed Product,
the treatment, palliation, prevention or prophylaxis of disease in humans with
respect only to: (i) those specific indications (e.g., third-line metastatic
colorectal cancer) that, as of [*], are the subject of clinical development by
Amgen or for which Amgen has received Regulatory Approval with respect to such
Licensed Product outside the Territory; and (ii) any other specific indications
that are added with respect to such Licensed Product pursuant to Section 6.7
(Additional Indications). For the avoidance of doubt, Licensee Indications does
not include Amgen Indications.

 

1.59. “Licensee Product” shall have the meaning set forth in Section 3.9 (Right
of First Discussion).

 

1.60. “Losses” shall have the meaning set forth in Section 13.1 (Indemnity).

 

1.61. “MHLW” shall mean the Japanese Ministry of Health, Labour and Welfare, and
any successor agency thereto.

 

1.62. “Net Sales” shall mean with respect to a given period, the gross invoiced
sales price for a Licensed Product sold by or on behalf of Licensee, its
Affiliates or licensees hereunder to Third Parties (not including Licensee’s
Affiliates, unless and to the extent such Affiliate is the end-user of such a
Licensed Product) during such period (plus any additional consideration received
by Licensee, its Affiliates or licensees with respect to such Licensed Product
sold), less the total of the following charges or expenses, as determined in
accordance with GAAP:

 

  1.62.1. Trade, cash, prompt payment and quantity discounts;

 

  1.62.2. Returns, allowances, rebates, chargebacks and payments to government
agencies;

 

  1.62.3. Retroactive price reductions;

 

  1.62.4. Fees paid to distributors, wholesalers, selling agents (excluding any
sales representatives of a Party or any of its Affiliates), group purchasing
organizations and managed care entities;

 

  1.62.5. Credits and allowances for product replacement, whether cash or trade;
and

 

  1.62.6. Non-recoverable sales taxes, excise taxes, tariffs and duties
(excluding taxes when assessed on income derived from sales);

in each case, to the extent related to sales of a Licensed Product in a Licensee
Indication in the Territory and actually given.

 

CONFIDENTIAL    Page 6   

--------------------------------------------------------------------------------

1.63. “Ongoing Studies” shall mean those clinical studies that are being
undertaken by Amgen as of [*] utilizing Amgen K.K. in the Territory, including
those set forth on the Ongoing Studies Schedule.

 

1.64. “Party/Parties” shall have the meaning set forth in the Preamble.

 

1.65. “Patent Matters” shall have the meaning set forth in Section 9.2.1.1
(Amgen Primary Prosecution).

 

1.66. “Phase I Trial” shall mean, with respect to the United States, any human
clinical trial, the principal purpose of which is preliminary determination of
safety in healthy individuals or patients as required under 21 C.F.R.
§312.21(a), or, with respect to a jurisdiction other than the United States, an
equivalent clinical study.

 

1.67. “Phase II Trial” shall mean, with respect to the United States, any human
clinical trial conducted in the specific patient population with the disease or
condition of interest intended to be studied in a Phase III Trial for the
purposes of preliminary assessment of safety and efficacy in the indication
being studied, and selection of the dose regimen(s) to be studied in a Phase III
Trial, as described under 21 C.F.R. §312.21(b), and that, if the defined
end-points are met, is sufficient to allow the Initiation of a Phase III Trial
in the indication being studied, or, with respect to a jurisdiction other than
the United States, an equivalent clinical study.

 

1.68. “Phase III Trial” shall mean, with respect to the United States, any human
clinical trial, that, if the defined end-points are met, is intended to be a
pivotal trial for obtaining Regulatory Approval in the indication being studied
or to otherwise establish safety and efficacy in patients with the indication
being studied for purposes of filing for Regulatory Approval with the United
States Food and Drug Administration (or its successor) as required under 21
C.F.R. §312.21(c), or, with respect to a jurisdiction other than the United
States, an equivalent clinical study. In the event that a human clinical trial
that would otherwise meet the definition of a Phase II Trial would, if the
defined end-points are met, be sufficient to obtain Regulatory Approval in the
indication being studied then, for the purposes of this Agreement, such trial
shall be considered a Phase III Trial.

 

1.69. “Pricing Approval” with respect to a Licensed Product in the Territory
shall mean initial assignment, and any subsequent amendments thereto from time
to time, of a Japanese National Health Insurance drug price for such Licensed
Product.

 

1.70. “Prior Agreement” shall have the meaning set forth in Section 10.6 (Prior
Agreement).

 

1.71. “[*]” shall mean: (i) with respect to a Licensed Product for which [*]
outside the Territory, that Amgen, its Affiliates, and other licensees have [*]
related to North America and Europe for a [*]; and (ii) with respect to a
Licensed Product for which [*] outside the Territory, Amgen, its Affiliates, and
other licensees have [*] such Licensed Product outside the Territory.

 

1.72. “[*]” shall mean, with respect to a Licensed Product, that (i) a [*] has
continued for at least [*] with respect to such Licensed Product; and
(ii) Amgen, its Affiliates and licensees have not [*] such Licensed Product will
be [*].

 

CONFIDENTIAL    Page 7   

--------------------------------------------------------------------------------

1.73. “Publishing Party” shall have the meaning set forth in Section 10.7.3
(Oversight and Review).

 

1.74. “Quarterly Maximum” shall have the meaning set forth in Section 8.9.4
(Maximum Payments).

 

1.75. “Reasonably Diligent Efforts” shall mean, with respect to Licensee and a
particular Licensed Product, the application of a level of resources, efforts
and urgency to develop and commercialize such Licensed Product consistent with
Licensee’s practices in pursuing the development and commercialization of its
other high-value pharmaceutical products in light of its characteristic
features, target indication, competitiveness and sales volume, but in no event
less than the high professional standards and level commonly applied by other
pharmaceutical companies to their high-value pharmaceutical products. [*].

 

1.76. “Recall” means a “recall” (as per Article 70 of the Japanese
Pharmaceutical Affairs Law) or “market withdrawal” (as per Article 77-4-3 of the
Japanese Pharmaceutical Affairs Law) of a Licensed Product or any lots thereof.

 

1.77. “Recoveries” shall mean all cash amounts (plus the fair market value of
all non-cash consideration) received by a Party from a Third Party in connection
with the final judgment, award or settlement of any enforcement with respect to
any Licensed Amgen Patent, Licensed Amgen Trademark, Licensed Amgen Know-How,
Licensed Licensee Know-How, Licensed Licensee Trademark or Joint Patent, each of
the foregoing with respect to Licensed Products in Licensee Indications in the
Territory.

 

1.78. “Regulatory Approval” shall mean the product-specific approvals from
Governmental Authorities necessary for the distribution and sale of a Licensed
Product.

 

1.79. “Regulatory Filing” shall mean any filing with any Governmental Authority
with respect to the development, marketing, commercialization or reimbursement
of a Licensed Product.

 

1.80. “Reviewing Party” shall have the meaning set forth in Section 10.7.3
(Oversight and Review).

 

1.81. “Secondary Publication” shall have the meaning set forth in Section 10.7.1
(In Territory).

 

1.82. “Sites” shall have the meaning set forth in Section 4.15 (Transition of
Ongoing Studies).

 

1.83. “SOPs” shall have the meaning set forth in Section 4.13 (Recalls).

 

1.84. “SPC” shall mean any patent term extension or related extension of rights,
including supplementary protection certificates and similar rights.

 

1.85. “State Court” shall have the meaning set forth in Section 16.11
(Jurisdiction and Venue).

 

1.86. “Steering Committee” shall mean the committee established by the Parties
to oversee and coordinate their activities hereunder, and to ensure appropriate
communication and oversight by the Parties.

 

CONFIDENTIAL    Page 8   

--------------------------------------------------------------------------------

1.87. “Sale and Purchase Agreement” shall mean that certain Sale and Purchase
Agreement between the Parties dated as of the date hereof.

 

1.88. “Taxes” shall mean any tax, excise or duty, other than taxes upon income.

 

1.89. “Term” shall mean the period beginning on [*] and ending upon the
termination of this Agreement pursuant to Article 14 (Term and Termination).

 

1.90. “Termination Date” shall have the meaning set forth in Section 14.3.1
(General).

 

1.91. “Territory” shall mean Japan.

 

1.92. “Territory IP” shall have the meaning set forth in Section 9.4.1 (In
Territory).

 

1.93. “Territory Patents and Trademarks” shall have the meaning set forth in
Section 9.2.1.1 ([*]).

 

1.94. “Third Party” shall mean any entity other than a Party or an Affiliate of
a Party.

 

1.95. “Transition Period” shall have the meaning set forth in Section 14.5
(Transition Period).

 

1.96. “VAT” shall mean any value added tax.

 

1.97.

“Vectibix” shall mean Amgen’s proprietary anti-EGFr monoclonal antibody known in
the U.S. as Vectibix™ .

 

2. COLLABORATION SCOPE AND GOVERNANCE

 

2.1. Conduct of the Collaboration. The Parties shall cooperate to develop and
commercialize the Licensed Products in the Licensee Indications in the
Territory, in accordance with the terms and conditions of this Agreement (the
“Collaboration”).

 

2.2. Ex-Territory Activities. The Parties acknowledge that no rights are granted
hereunder to Licensee with respect to any country outside the Territory.
Licensee shall not research, develop, manufacture or commercialize any Licensed
Product outside the Territory without the express prior written consent of
Amgen. Amgen shall have the sole right to research, develop, manufacture and
commercialize the Licensed Products outside the Territory.

 

2.3. Governance. The Collaboration shall be governed by a Steering Committee,
which shall oversee the activities of the Parties hereunder generally, and by a
Development Committee and a Commercialization Committee for each Licensed
Product, which shall coordinate and oversee the development and
commercialization, respectively, of Licensed Products in the Territory. The
Steering Committee and each Development Committee shall be formed promptly
following [*]. Each Commercialization Committee shall be formed promptly
following [*] for Licensed Products which have already Initiated one or more
Phase III Trials in the Territory. For all other Licensed Products, the relevant
Commercialization Committee shall be formed promptly following Initiation of the
first Phase III Trial in the Territory for such Licensed Product.

 

2.4.

Membership. Unless otherwise agreed by the Parties, each of the Development and
Commercialization Committees shall be comprised of [*] members appointed by

 

CONFIDENTIAL    Page 9   

--------------------------------------------------------------------------------

 

Amgen, and [*] members appointed by Licensee. Each such committee shall be led
by [*] co-chairs, [*] appointed by each of the Parties. Unless otherwise
mutually agreed by the Parties, the Steering Committee shall be comprised of [*]
member appointed by Amgen and [*] member appointed by Licensee. Each of the
committees shall have the right to delegate any of its responsibilities to one
or more subcommittees as it determines appropriate.

 

2.5. Replacement of Members. Each Party shall have the right to replace its
committee members or co-chairs by written notice to the other Party. In the
event any committee member or co-chair becomes unwilling or unable to fulfill
his or her duties hereunder, the Party that appointed such member shall promptly
appoint a replacement by written notice to the other Party.

 

2.6. Input from other Personnel. Any committee member shall have the right to
solicit input or assistance from any other personnel of the Party that appointed
such member.

 

2.7. No Authority to Amend or Modify. Notwithstanding anything herein to the
contrary, no committee shall have any authority to amend, modify or waive
compliance with this Agreement.

 

2.8. Steering Committee. The Steering Committee shall be responsible for
overseeing the Parties’ conduct of the Collaboration generally, and for ensuring
an appropriate level of oversight of the Collaboration.

 

  2.8.1. Meetings. The Steering Committee shall meet [*] in person, via
teleconference or videoconference or otherwise (with at least [*] meeting per
[*] 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 Steering 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 requested by such
Party by at least [*] days written notice to the member appointed by the other
Party. All Steering Committee meetings must have the member appointed by each
Party in attendance.

 

  2.8.2. Reporting. Each Party shall keep the Steering Committee fully and
promptly informed of progress and results of activities for which it is
responsible or that it is permitted to conduct hereunder through its member on
the Steering Committee and as otherwise provided herein. Each Party shall fully
inform the Steering Committee with respect to all relevant facts and activities
regarding any Licensed Product reasonably requested by any member thereof.

 

  2.8.3. Decision Making. The Steering Committee shall make decisions by
consensus.

 

2.9.

Development Committee. With respect to each Licensed Product in the Territory,
the applicable Development Committee shall be responsible for: (i) reviewing and
approving development plans (and changes thereto) prior to adoption of such
plans (or changes) by Licensee; (ii) providing for communication and discussion
between the

 

CONFIDENTIAL    Page 10   

--------------------------------------------------------------------------------

 

Parties to optimize the efficacy and safety of the development of the applicable
Licensed Product in the Territory; (iii) reviewing and monitoring the activities
and progress against the development plans, including site enrollment, patient
enrollment, progress of trials and data received; (iv) communicating with the
applicable Commercialization Committee(s) regarding the interrelationship
between development activities and potential commercialization; and
(v) communicating with the Parties regarding all of the foregoing.

 

  2.9.1. Meetings. Each Development Committee shall meet [*] in person, via
teleconference or videoconference or otherwise (with at least [*] meetings per
[*] Year being in person), more frequently as may be required by ongoing
development activities, 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 Development 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 requested by such
Party by at least [*] days written notice to the co-chair appointed by the other
Party. All committee meetings must have at least [*] member appointed by each
Party in attendance.

 

  2.9.2. Reporting. Each Party shall keep the relevant Development Committee
fully and promptly informed of progress and results of development activities
for which it is responsible or that it is permitted to conduct hereunder through
its members on such Development Committee and as otherwise provided herein,
including by promptly providing copies of all clinical data and results for
Licensed Products as reasonably requested by the other Party. Each Party shall
fully inform the applicable Development Committee with respect to all relevant
facts and activities regarding any Licensed Product development matter
reasonably requested by any member thereof. At least [*] days prior to the first
meeting of each Development Committee of each [*] Quarter, each Party shall
deliver to such Development Committee a written summary of development
activities conducted hereunder and material clinical data and results received
by each such Party since the last such report, in each case with respect to the
applicable Licensed Product(s).

 

  2.9.3. Development Plans. At least [*] days prior to the first meeting of each
Development Committee of each [*] Year, Licensee shall provide each such
Development Committee a copy of its proposed development plan for the relevant
Licensed Product in the Territory for the next [*] for the Development
Committee’s review, comment and approval. In addition, should Licensee seek to
make material changes to an approved development plan, then at least [*] days
prior to the next meeting of the relevant Development Committee it shall provide
the Development Committee any proposed changes to the previously approved
development plan for the Development Committee’s approval.

 

CONFIDENTIAL    Page 11   

--------------------------------------------------------------------------------

  2.9.4. Decision Making. Each Development Committee shall strive to reach
consensus on decisions, taking into account the views of each committee member.
In the event the Development Committee fails to reach consensus, the committee
[*] determination unless [*] reasonably likely to [*] on Amgen’s [*] Licensed
Product [*], in which case the committee [*]determination.

 

2.10. Commercialization Committee. With respect to each Licensed Product in the
Territory, the applicable Commercialization Committee shall be responsible for:
(i) reviewing and approving commercialization plans (and changes thereto) prior
to adoption of such plans (or changes) by Licensee; (ii) communicating with the
applicable Development Committee(s) regarding the interrelationship between
development activities and potential commercialization; (iii) reviewing and
monitoring the activities and progress against the commercialization plans;
(iv) establishing appropriate processes for coordinating review of promotional
materials to ensure compliance with Law and industry best practices;
(v) overseeing the trademark and publication strategies; and (vi) communicating
with the Parties regarding all of the foregoing.

 

  2.10.1. Meetings. Each Commercialization Committee shall meet [*] in person,
via teleconference or videoconference or otherwise (with at least [*] meetings
per [*] Year being in person), more frequently as may be required by ongoing
commercialization activities, 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 Commercialization
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 requested
by such Party by at least [*] days written notice to the co-chair appointed by
the other Party. All committee meetings must have at least [*] member appointed
by each Party in attendance.

 

  2.10.2. Reporting. Each Party shall keep the relevant Commercialization
Committee fully and promptly informed of progress and results of
commercialization activities in the Territory for which it is responsible or
that it is permitted to conduct hereunder through its members on the
Commercialization Committee and as otherwise provided herein. Each Party shall
fully inform the Commercialization Committee with respect to all relevant facts
and activities regarding any Licensed Product commercialization matter
reasonably requested by any member thereof. For each Commercialization
Committee, at least [*] days prior to the first Commercialization Committee
meeting of each [*] Quarter, each Party shall deliver to the Commercialization
Committee a written summary of commercialization activities conducted hereunder
by each such Party since the last such report.

 

  2.10.3.

Commercialization Plans. At least [*] days prior to the first meeting of each
Commercialization Committee of each [*] Year, Licensee shall provide each such
Commercialization Committee a copy of its proposed commercialization

 

CONFIDENTIAL    Page 12   

--------------------------------------------------------------------------------

 

plan for the relevant Licensed Product in the Territory for the next [*] for the
Commercialization Committee’s review, comment and approval (either by indication
or for all indications for which it is responsible in the Territory). In
addition, should Licensee seek to make material changes to an approved
commercialization plan, then at least [*] days prior to the next meeting of the
relevant Commercialization Committee it shall provide the Commercialization
Committee any proposed changes to the previously approved commercialization plan
for the Commercialization Committee’s approval.

 

  2.10.4. Decision Making. Each Commercialization Committee shall strive to
reach consensus on decisions, taking into account the views of each committee
member. In the event a committee fails to reach consensus, the committee [*]
determination unless [*] reasonably likely to [*] on Amgen’s [*] of the
applicable Licensed Product [*], in which case the committee [*] determination.

 

  2.10.5. Right to Terminate Participation. Amgen shall have the right to
terminate its participation in any or all of the committees contemplated
pursuant to this Article 2 (Collaboration Scope and Governance) by [*] days
prior written notice to Licensee. In the event of such termination, matters
subject to the collaboration and oversight of the relevant Committees shall be
dealt with directly between Amgen and Licensee. All information that was to be
provided by a Party to a committee that has been terminated shall instead
provide such information (in the same time frames as previously required)
directly to the other Party. With respect to any matter under the purview of the
terminated Committee(s) that was subject to a final determination by Amgen’s or
Licensee’s committee members, such matter shall instead be subject to the final
determination of Amgen or Licensee, respectively.

 

3. GRANT OF LICENSE

 

3.1. Licensed Amgen Patents. Amgen hereby grants Licensee an exclusive right and
license under the Licensed Amgen Patents during the Term, subject to the terms
and conditions hereof, solely to develop, commercialize, use and sell Licensed
Products only in the Licensee Indications in the Territory. Such license (and
such exclusivity) is only with respect to the Licensed Products in the Licensee
Indications in the Territory. Such license shall include the right to sublicense
only as set forth in Section 3.5 (Licensee Sublicensing).

 

3.2. Licensed Amgen Know-How. Amgen hereby grants Licensee an exclusive right
and license during the Term, subject to the terms and conditions hereof, to
utilize the Licensed Amgen Know-How solely for the purpose of supporting its
development, commercialization, use and sale of Licensed Products only in the
Licensee Indications in the Territory. Such license (and such exclusivity) is
only with respect to the Licensed Products in the Licensee Indications in the
Territory. Such license shall include the right to sublicense only as set forth
in Section 3.5 (Licensee Sublicensing).

 

3.3.

[*]. In addition to the rights granted to Licensee pursuant to Sections 3.1
(Licensed Amgen Patents) and 3.2 (Licensed Amgen Know-How), Amgen hereby grants
Licensee [*] during the Term under certain [*], subject to the terms and
conditions hereof, solely

 

CONFIDENTIAL    Page 13   

--------------------------------------------------------------------------------

 

to develop, commercialize, use and sell Licensed Products only in the Licensee
Indications in the Territory. The [*] with respect to each Licensed Product are
detailed on the [*] and shall be subject to the restrictions and conditions set
forth therein. Such [*] shall include the right to [*] only as set forth in [*],
and further subject to the restrictions and conditions set forth on [*].
Specific [*] with respect to the [*] are set forth on the [*]. Licensee (and any
of its permitted sublicensees) shall comply with all such obligations. In
addition, Licensee shall take any other reasonable steps requested by Amgen to
ensure compliance with the [*] (including providing [*]. At Amgen’s request,
Licensee shall cooperate with Amgen to secure for Licensee some or all [*] from
the [*] (including by [*]), provided, however, that Licensee shall not be
required to [*] than those set forth on [*]. At such time as Licensee has [*]
with respect to any [*] hereunder, the [*] pursuant to this Agreement [*].

 

3.4. Licensed Licensee Know-How and Patents. Licensee hereby grants Amgen [*]
right and license, subject to the terms and conditions hereof, under the
Licensed Licensee Know-How and Licensed Licensee Patents solely for the purpose
of the development, commercialization, manufacture, use and sale of Licensed
Products outside the Territory (and within the Territory, in any Amgen
Indications) for all uses, and inside and outside the Territory, for performing
its obligations hereunder, including any supply obligations with respect to
Licensed Products. Such license shall include the right to sublicense [*]
provided, however, that: (i) any sublicensee shall be required to enter into a
written agreement obligating it to maintain the confidentiality of the
Confidential Information of Licensee; (ii) Amgen shall be responsible for any
disclosure of the Confidential Information of Licensee by such sublicensee in
violation of the provisions of Article 10 (Confidentiality and Publications);
(iii) no such sublicense shall operate to excuse Amgen’s compliance with its
obligations hereunder; and (iv) Amgen shall be responsible for a breach by such
sublicensee of any such obligations or prohibitions.

 

3.5. Licensee Sublicensing. Licensee shall have the right to sublicense the
rights granted it hereunder only with Amgen’s prior written consent, which Amgen
may withhold or condition in its sole discretion. Any permitted sublicensee
shall be required to enter into a written agreement obligating it to maintain
the confidentiality of the Confidential Information of Amgen and Licensee shall
be responsible for any disclosure of the Confidential Information of Amgen by
such sublicensee in violation of the provisions of Article 10 (Confidentiality
and Publications). In addition, such written agreement shall require such
sublicensee to comply with the obligations and prohibitions of this Agreement
relevant to the right(s) sublicensed, and Licensee shall be responsible for a
breach by such sublicensee of any such obligations or prohibitions. No
sublicense shall operate to excuse Licensee’s compliance with its obligations
hereunder. Licensee shall have the right to distribute a Licensed Product in the
Territory through reputable distributors.

 

3.6.

Provision of Know-How. Following [*], the Parties shall cooperate to establish
procedures for the provision of Licensed Amgen Know-How to Licensee and Licensed
Licensee Know-How to Amgen. During the Term, Amgen shall use reasonable efforts
to provide all material Licensed Amgen Know-How to Licensee, and Licensee shall
use reasonable efforts to provide all material Licensed Licensee Know-How to
Amgen. In any event, each of the Parties shall provide to the other any Licensed
Amgen Know-

 

CONFIDENTIAL    Page 14   

--------------------------------------------------------------------------------

 

How or Licensed Licensee Know-How (respectively) as the other Party shall
reasonably request. Notwithstanding the foregoing, Amgen shall have no
obligation to provide manufacturing information to Licensee and neither Party
shall have an obligation to provide information relating to any product other
than the Licensed Products.

 

3.7. Trademarks.

 

  3.7.1. Grant to Licensee. Amgen hereby grants Licensee [*] (except as
otherwise expressly set forth herein (such exception to include Amgen’s
co-promotion rights pursuant to Section 5.2 (Amgen Co-Promotion Right) and the
transition period described in Section 14.5 (Transition Period))) right and
license during the Term, subject to the terms and conditions hereof, solely to
develop, commercialize, use and sell a Licensed Product in the Territory in the
Licensee Indications under the same Licensed Amgen Trademarks as used by Amgen
for such Licensed Product in the corresponding indications outside the
Territory. Such license shall include the right to sublicense only as set forth
in Section 3.5 (Licensee Sublicensing). The Parties acknowledge that the use of
the Licensed Amgen Trademarks in the Territory may have commercial value to
Licensee, and that Licensee shall have the right to commercialize a Licensed
Product in the Licensee Indications in the Territory under the same Licensed
Amgen Trademarks as utilized for such Licensed Product in such indications by
Amgen outside the Territory. Should the Parties desire that a different
trademark be used for Licensee Indications in the Territory, or if additional
trademarks to those used outside the Territory are otherwise required, the
Parties shall consult and agree upon an additional or replacement trademark (or
trademarks). In addition, if the manufacture of Licensed Product for Licensee
for use in the Territory materially varies from the manufacture of Licensed
Product for Amgen or its Affiliates for use outside the Territory, then upon
request of Amgen the Parties shall consult and agree upon a replacement
trademark (or trademarks). Upon Amgen’s request, Licensee shall include an Amgen
trademark designated by Amgen to Licensee in writing (e.g., “Amgen”) on all
packaging, labeling, promotional and marketing materials for the applicable
Licensed Product in equal prominence to those of Licensee. Amgen hereby grants
Licensee a non-exclusive right and license, with the right to sublicense only as
set forth in Section 3.5 (Licensee Sublicensing), during the Term, subject to
the terms and conditions hereof, to use such marks solely for such purpose.

 

  3.7.2. Grant to Amgen. Licensee hereby grants Amgen [*] right and license
during the Term to use Licensed Licensee Trademarks in connection with Amgen’s
activities pursuant to Section 5.2 (Amgen Co-Promotion Right). Upon any
termination or expiration of this Agreement (in its entirety or with respect to
a particular Licensed Product in accordance with Section 14.2.3 (Specific
Product Termination)), such license shall become perpetual, and shall include
the right to use the relevant Licensed Licensee Trademarks (and the associated
goodwill) in connection with the relevant Licensed Product(s) in all indications
and both within and outside the Territory or, at Licensee’s option, Licensee
shall have the right to assign at no charge to Amgen the relevant Licensed
Licensee Trademarks (and the associated goodwill).

 

CONFIDENTIAL    Page 15   

--------------------------------------------------------------------------------

3.8. Trademark Quality Standards. Each Party shall (i) maintain such reasonable
quality standards for the Licensed Amgen Trademarks (with respect to Licensee)
or the Licensed Licensee Trademarks (with respect to Amgen) as it maintains for
its own trademarks of a similar nature and shall comply with the other Party’s
reasonable specifications and usage standards supplied to it in writing (and as
may be updated by written notice from time to time); (ii) not use any Licensed
Amgen Trademark (with respect to Licensee) or Licensed Licensee Trademark (with
respect to Amgen) in a manner that suggests any connection with any product
other than a Licensed Product or any service; and (iii) not use or display the
Licensed Amgen Trademarks (with respect to Licensee) or the Licensed Licensee
Trademarks (with respect to Amgen) in any manner that might dilute, tarnish,
disparage or reflect adversely on the other Party or such marks. Prior to using
any Licensed Amgen Trademark (with respect to Licensee) or Licensed Licensee
Trademark (with respect to Amgen), the Parties shall agree upon a guideline for
use of such trademarks, including the review procedure and timing. From time to
time, upon request by a Party, the other Party shall provide copies of the usage
of the Licensed Amgen Trademarks (with respect to Licensee) or Licensed Licensee
Trademarks (with respect to Amgen) used in the marketing or promotion of a
Licensed Product in order to review such usage. Amgen agrees that it shall not
seek to register or obtain ownership rights in any Licensed Licensee Trademark
(or confusingly similar trademark) and Licensee agrees that it shall not seek to
register or obtain ownership rights in any Licensed Amgen Trademark or any
trademark used by Amgen in connection with a Licensed Product outside the
Territory in any indication (or confusingly similar trademark to any of the
foregoing).

 

3.9. Right of First Discussion. Licensee agrees that Amgen shall have a right of
first discussion with respect to any Distracting Product contemplated to be
outlicensed by Licensee or its Affiliate, or rights to which are contemplated to
be sold or transferred to a Third Party, or for which Licensee or its Affiliate
seeks a development and/or commercialization collaborator (a “Licensee Product”)
for North America or Europe (or any portion thereof). Should Licensee determine
to seek a licensee or collaborator in such territory for a Licensee Product, it
shall give prompt written notice to Amgen thereof, and shall provide Amgen any
information reasonably requested by Amgen to allow Amgen to determine its
potential interest in such Licensee Product. Should Amgen, within [*] days of
receipt of such notice and information, notify Licensee in writing that Amgen is
interested in pursuing a potential license or collaboration, then Licensee and
Amgen shall discuss such a potential transaction in good faith, and Licensee
shall not discuss a potential license or collaboration with respect to such
Licensee Product with any Third Party until at least [*] days after initiation
of such good-faith discussions. No such license or collaboration shall be
effective or binding on either Party unless and until set forth in a definitive
written agreement duly executed by the Parties.

 

3.10.

Retained Rights and Limitations. No rights are granted to Licensee hereunder to
Licensed Amgen Patents, Licensed Amgen Know-How or Licensed Amgen Trademarks
outside the Licensee Indications, or outside the Territory. No rights are
granted to Licensee hereunder to make or have made a Licensed Product or any
other product. No rights are granted to Licensee hereunder to import or export a
Licensed Product

 

CONFIDENTIAL    Page 16   

--------------------------------------------------------------------------------

 

manufactured by Amgen or its licensee. No rights are granted herein to Licensee
to control the research, development or commercialization of a Licensed Product
outside the Territory. No rights to either Party’s patents, trademarks or other
proprietary rights are granted pursuant to this Agreement except as expressly
set forth herein, and all other rights are reserved.

 

3.11. [*]. Amgen shall have the right to [*] to the Collaboration as [*] by
written notice to Licensee, such notice to be given within [*]. As of the date
of such notice, [*] shall be considered [*] hereunder for all purposes. Promptly
following such [*], Licensee shall [*] Amgen any [*] that would have been
required hereunder [*] as a [*] (including pursuant to [*] and shall reimburse
to Amgen any reasonable costs incurred by Amgen with respect to [*] in the
Territory subsequent to [*] (including costs of [*] in the Territory). In the
event Amgen does not so [*] within the [*], then Amgen shall [*]of the [*]
Licensee pursuant to Section [*]. Any such [*] shall be [*] within [*] days of
the end of such [*] period.

 

4. DEVELOPMENT AND REGULATORY APPROVAL

 

4.1. Responsibility for Development in Licensee Indications. Licensee shall use
its Reasonably Diligent Efforts to develop each Licensed Product in each
Licensee Indication in the Territory. Such development shall be conducted in
accordance with the then-current development plan approved by the Development
Committee for such Licensed Product in such Licensee Indication. Licensee’s
responsibility with respect to Licensed Products in Licensee Indications in the
Territory shall include: (a) filing for and seeking Regulatory Approval for
Licensed Products in the Territory for a particular Licensee Indication in the
name of Licensee from the relevant Governmental Authorities; (b) identifying and
carrying out all major development tasks to be conducted prior to submission of
filings for Regulatory Approval of a Licensed Product in the Territory for a
particular Licensee Indication and any post-approval activities to be conducted
for any such Licensed Product in such Licensee Indication; (c) identifying key
development objectives, expected associated resources, risk factors, timelines,
decision points and relevant decision criteria; (d) carrying out all aspects of
all clinical trials necessary to obtain Regulatory Approval in the name of
Licensee in the Territory for each Licensed Product in each Licensee Indication
(including post-approval clinical studies) including, but not limited to,
(i) designing study protocols; (ii) establishing/contracting with clinical trial
sites, investigators and clinical research organizations, (iii) enrolling
clinical trial subjects, (iv) organizing investigator meetings, scientific
meetings, advisory panel workshops and regulatory meetings, and (v) analyzing
and summarizing clinical trial results; (e) performing any other additional
clinical research in support of the clinical development of each Licensed
Product; (f) forecasting clinical manufacturing production requirements; and
(g) reporting on study design, study outcome, other communications and
regulatory filings to the appropriate Governmental Authority. Licensee shall be
solely responsible for its costs incurred in its development of the Licensed
Products.

 

4.2.

Preclinical Development in Licensee Indications. Amgen shall have the first
option to perform (itself or through a subcontractor) any preclinical research
that is required in order to conduct development of a Licensed Product in one or
more Licensee

 

CONFIDENTIAL    Page 17   

--------------------------------------------------------------------------------

 

Indications in the Territory in accordance with this Agreement. Licensee shall
give Amgen prompt written notice upon becoming aware of any such requirement.
Amgen shall, promptly following receipt of such notice, notify Licensee of
whether or not Amgen intends to conduct such research or, instead, shall permit
Licensee to do so. Should Amgen not elect to perform such research, then
Licensee shall promptly and diligently conduct such research (itself or through
a subcontractor). [*] Such research shall be conducted in accordance with a
research plan to be agreed in writing by Amgen and Licensee. Notwithstanding the
foregoing, should [*] is reasonably likely to [*] of a Licensed Product [*] then
it shall notify [*] In such case,[*] Upon the request of either Party, the
Parties shall [*] of such research.

 

4.3. [*] Should Licensee determine to [*] of such Licensed Product for the [*]
(including with respect to [*] (e.g., [*] and including [*] Licensee shall give
Amgen prompt prior written notice thereof. The Parties shall promptly meet to
discuss [*]. Should Amgen agree in writing to permit the [*], the Parties shall
agree on a course of action with respect to such [*] prior to undertaking any
such [*] and Licensee shall conduct such [*] in accordance with any [*] by Amgen
to [*] to Amgen’s [*]. Should Amgen not so agree, then Licensee shall not [*].
Upon the request of either Party, the Parties shall meet to discuss [*]

 

4.4. Development in Combination. Licensee shall not, without Amgen’s prior
express written consent, conduct any development of a Licensed Product in
combination with any other pharmaceutical product, unless and only to the extent
that Amgen is pursuing such development outside the Territory.

 

4.5. Development in Amgen Indications and Outside the Territory. Amgen shall
have the sole right to manage and conduct the development of the Licensed
Products inside the Territory in any Amgen Indications and outside the Territory
in all indications. The foregoing is without prejudice to Licensee’s payment
obligations pursuant to Section 8.9 (Development Cost Sharing).

 

4.6. Global Development. The Parties acknowledge that it may be in their mutual
interests to integrate Licensee’s development of a Licensed Product within the
Territory into Amgen’s global development plan for such Licensed Product for a
particular Licensee Indication. The Parties agree to discuss in good faith where
it may be appropriate to so integrate such development, and the relevant
cost-sharing that will be applicable thereto. The Parties further acknowledge
the mutual desire to progress Licensed Products in an effort to provide
meaningful therapies to patients. While each Party acknowledges that the
Licensed Products are of a developmental nature and that there is no guarantee
that any or all Licensed Products will ultimately provide such benefits, the
Parties express their current desire to seek to progress the Licensed Products
as is reasonably prudent, in accordance with this Agreement, to provide data
that can inform the Parties of the development potential of the Licensed
Products.

 

4.7.

Sharing of Regulatory Filings. Licensee will disclose to Amgen a draft copy of
any Regulatory Filing in the Territory (and any regulatory filing relating to
manufacturing made by Licensee in accordance with Section 7.4 (Responsibility
for Regulatory Filings with Respect to Manufacturing)) no less than [*] days
prior to filing it with a Governmental Authority. Licensee will consider in good
faith any comments made by

 

CONFIDENTIAL    Page 18   

--------------------------------------------------------------------------------

 

Amgen with respect to such filings. Where documents are not in English, Licensee
shall also provide an English summary. Licensee shall maintain a database which
contains all clinical trial data accumulated from all clinical trials of a
Licensed Product conducted by, on behalf of, or with the support of Licensee in
the Territory (in a computer readable format as reasonably specified by Amgen).
Upon the request of either Party, the other Party shall provide a right of
reference to any requested Regulatory Filings (and any regulatory filing
relating to manufacturing made by Licensee in accordance with Section 7.4
(Responsibility for Regulatory Filings with Respect to Manufacturing)) or
Regulatory Approvals for a Licensed Product in the Territory, and Amgen shall
provide the same such right of reference to Licensee with respect to such
Regulatory Filings and Regulatory Approvals outside the Territory, in each case
as reasonably necessary for the requesting Party’s development or
commercialization of such Licensed Product as permitted hereunder (or, with
respect to Amgen, manufacture of such Licensed Product). Notwithstanding the
foregoing, Amgen shall not be required to provide to Licensee nor to allow
Licensee to access (but shall provide a right of reference as set forth in
Section 4.12.3 (Amgen Cooperation – Manufacturing Information) to the extent
necessary) Amgen’s manufacturing information with respect to a Licensed Product
or any sections of any Regulatory Filing related thereto and neither Party shall
have an obligation to provide information relating to any product other than a
Licensed Product.

 

4.8. Quality Agreement. Promptly following [*], the quality assurance
departments of Amgen and Licensee will develop and agree upon a quality
agreement governing the quality and specifications of clinical Licensed Products
(or, should Amgen so determine, separate quality agreements for each Licensed
Product or subgroups of Licensed Products) to be supplied hereunder (with
commercial product handled separately through the supply agreement to be entered
into pursuant to Section 7.3 (Supply) or one or more additional quality
agreements) including with respect to product quality and product complaints (to
the extent not covered in a separate safety agreement entered into pursuant to
Section 4.10 (Safety Agreement)) with respect to Licensed Products. The quality
agreement will be documented in writing, and routinely updated by mutual written
agreement of the Parties.

 

4.9. Transfer of Regulatory Filing. Promptly after [*], Amgen shall transfer to
Licensee all Regulatory Filings in the Territory with respect to each Licensed
Product. Licensee shall not transfer title in, fail to maintain or otherwise
attempt in any manner to dispose of any Regulatory Filings or Regulatory
Approvals or other governmental licenses, approvals or certificates for any
Licensed Product in the Territory without the prior written approval of Amgen.
Notwithstanding the foregoing, Amgen shall have no obligation to transfer any
Regulatory Filing if effectuating such transfer may give rise to any material
delay in, or make less likely, the receipt of any Regulatory Approval or might
otherwise adversely affect any such Regulatory Filing. Should any such transfer
be so delayed: (i) Amgen shall take steps reasonably necessary to provide
Licensee the necessary access to such Regulatory Filing; and (ii) Amgen shall
thereafter transfer such Regulatory Filing at such time as such delay or adverse
effect is no longer likely to occur. In particular, the Parties shall discuss
the appropriate timing for the transfer of Regulatory Filings related to
Vectibix.

 

CONFIDENTIAL    Page 19   

--------------------------------------------------------------------------------

4.10. Safety Agreement. Promptly following [*], the safety departments of Amgen
and Licensee will develop and agree upon safety data exchange procedures
governing the coordination of collection, investigation, reporting, and exchange
of information concerning adverse events with respect to the Licensed Products
sufficient to permit each Party, its Affiliates, permitted sublicensees and
licensees to comply with Law, including, to the extent applicable, those
obligations contained in U.S. Food and Drug Administration (or any successor
agency) and MHLW regulations. The safety data exchange procedures will be
documented in writing, and promptly updated if required by changes in Law or by
agreement of the Parties.

 

4.11. Adverse Event Reporting. Each Party shall be responsible for reporting to
the relevant Governmental Authorities all adverse events with respect to the
Licensed Products (whether within or outside the Territory), to the extent
required by and in accordance with Law. Each Party will ensure that its
Affiliates, permitted sublicensees and licensees, as applicable, comply with all
such reporting obligations. Each Party will designate a safety liaison to be
responsible for communicating with the other Party regarding the reporting of
adverse events with respect to a Licensed Product.

 

4.12. Communications.

 

  4.12.1.

Licensee Responsibility. Licensee shall have exclusive responsibility for all
correspondence and for any official communication (except as Amgen may be
required by Law or a Governmental Authority to communicate) regarding the
Licensed Products in Licensee Indications with applicable Governmental
Authorities in the Territory (other than with respect to manufacturing) (but
including with respect to any aspects of manufacturing for which Licensee has
assumed responsibility as expressly provided in Section 7.4 (Responsibility for
Regulatory Filings with Respect to Manufacturing)). Without prejudice to the
time periods relevant to Regulatory Filings pursuant to Section 4.7 (Sharing of
Regulatory Filings), Licensee will supply to Amgen a copy of: (i) all such
correspondence and communications to any such Governmental Authority at least
[*] days prior to provision of such correspondence or communication to such
Governmental Authority (or as promptly as possible where exigent circumstances
make such provision impractical); and (ii) all such correspondence and
communications from any such Governmental Authority within [*] days after
receipt of any such correspondence. Materials provided pursuant to Section 4.7
(Sharing of Regulatory Filings) need not be re-provided pursuant to this
subsection 4.12.1 (Licensee Responsibility) unless changed. Where correspondence
or communications are not in English, Licensee shall also provide an English
summary. Licensee shall consider in good faith any comments or suggestions made
by Amgen with respect to any such communication. Amgen shall reasonably
cooperate with Licensee in responding to any inquiry made by a Governmental
Authority in the Territory regarding a Licensed Product in Licensee Indications,
and Licensee shall reimburse all reasonable, documented, out-of-pocket expenses
incurred by Amgen in connection therewith. Amgen shall be entitled to observe
and participate in any discussions between Licensee and any Governmental
Authority relating to any Licensed Products, and Licensee shall give Amgen [*]
days prior written notice

 

CONFIDENTIAL    Page 20   

--------------------------------------------------------------------------------

 

thereof (or prompt written notice, if [*] days notice is impractical). Should
Licensee be unable to solicit Amgen’s participation in any such discussion (as,
for example, with respect to a call or visit to Licensee by such Governmental
Authority without notice), then Licensee shall provide Amgen prompt written
notice of such communication with a summary of the discussion.

 

  4.12.2. Amgen Responsibility. Amgen shall have exclusive responsibility for
all correspondence and for any official communication (except as Licensee may be
required by Law or a Governmental Authority to communicate or as expressly
provided in Section 4.12.1 (Licensee Responsibility)) regarding manufacture of
the Licensed Products and regarding the Licensed Products inside the Territory
in Amgen Indications and outside the Territory in all indications. With respect
to correspondence and communication with Governmental Authorities relating to
Licensed Products, Amgen shall use reasonable efforts to provide Licensee copies
of material written correspondence as reasonably necessary to permit Licensee to
comply with its relevant regulatory obligations (provided that Amgen shall not
be required to disclose competitively sensitive information or manufacturing
information).

 

  4.12.3. Amgen Cooperation – Manufacturing Information. Upon Licensee’s
request, Amgen will reasonably cooperate with Licensee to make and provide
copies of any direct communications by Amgen either to or from the Governmental
Authorities having jurisdiction in the Territory regarding the manufacture of
any Licensed Product by Amgen for supply to Licensee; provided, however, that
Amgen’s obligation to provide Licensee with manufacturing and process
information is limited to the circumstance where the information is reasonably
required for Licensee to carry out its development and commercialization
responsibilities, or access to such information is required by Law or a
Governmental Authority having jurisdiction in the Territory; but Licensee shall
only be entitled to use such information to the extent required by such Law or
Governmental Authority or to the extent reasonably required to carry out its
development and commercialization responsibilities hereunder. Amgen shall have
the right to instead provide any such manufacturing information directly to the
relevant Governmental Authority (including by provision of a drug master file)
if such provision will satisfy such requirement (in order to better protect the
confidentiality of such information).

 

4.13.

Recalls. The Parties shall exchange their internal standard operating procedures
as to product recalls (“SOPs”) reasonably promptly after [*] and thereafter
reasonably promptly after such SOPs are approved or modified. If either Party
becomes aware of information about quantities of a Licensed Product supplied by
Amgen to Licensee which may not conform to the specifications for such Licensed
Product then in effect, or for which there are potential adulteration,
misbranding and/or other issues regarding safety or effectiveness, or for which
a Licensed Product itself is or is likely to be the subject of a Recall in the
Territory, it shall promptly so notify the other Party and the Party having the
right to control such a Recall pursuant to Section 4.13.1 (Licensee Right) or
4.13.2 (Amgen Right) shall have the right to take immediate action with notice
to the other Party when the regulatory timeframes or public safety
considerations

 

CONFIDENTIAL    Page 21   

--------------------------------------------------------------------------------

 

so require. The Parties will meet (in person, by telephone or otherwise) to
discuss the circumstances of any potential Recall and to consider appropriate
courses of action, which courses of action with respect to a Recall shall be
consistent with the internal SOP of the Party having the right to control such
Recall pursuant to Section 4.13.1 (Licensee Right) or 4.13.2 (Amgen Right), and
the other Party shall make available to the Party having the right to control
such Recall all pertinent records which the Party having the right to control
such Recall may reasonably request to assist in effecting any Recall (provided,
however, Amgen shall be obligated to provide manufacturing information to
Licensee only to the extent necessary for Licensee to conduct such Recall, and
Amgen shall also have the right to instead provide any such manufacturing
information directly to the relevant Governmental Authority (including by
provision of a drug master file) as appropriate (in order to better protect the
confidentiality of such information). In the event of an order of a Governmental
Authority having jurisdiction in the Territory mandating a Recall, the Party
having the right to control such a Recall pursuant to subsection 4.13.1
(Licensee Right) or 4.13.2 (Amgen Right) shall promptly comply with such order
with written notice to the other Party.

 

  4.13.1. Licensee Right. Licensee shall have the sole right to control a Recall
of a Licensed Product in the Licensee Indications in the Territory. Licensee
shall maintain complete and accurate records of any Recall it has the right to
control pursuant to this Section 4.13 (Recalls) for such periods as may be
required by Law, but in any event for no less than [*]

 

  4.13.2. Amgen Right. Amgen shall have the sole right to control a Recall of a
Licensed Product inside the Territory in any Amgen Indication and outside the
Territory in all indications. Amgen shall maintain complete and accurate records
of any Recall it has the right to control pursuant to this Section 4.13
(Recalls) for such periods as may be required by Law, but in any event for no
less than [*]

 

4.14. Cooperation Generally. Subject to the oversight of the Development
Committee, the Parties shall provide each other with any cooperation reasonably
requested by the other with respect to the development of a Licensed Product in
the Territory.

 

4.15. [*].

 

4.16. [*]. The Parties acknowledge that Amgen has ongoing [*] in the Territory
with respect to certain [*] other than [*] which it may have previously
performed through [*]. Licensee agrees that it shall provide Amgen any [*]
reasonably requested by Amgen to [*] of such [*] to Amgen or its designee and to
enable [*] with such [*]. Amgen shall [*] any [*] Licensee in providing [*].

 

4.17. [*]. Amgen will seek to promptly inform Licensee of any [*] and Amgen’s
[*], to the extent practicable. Upon request of Licensee, during the [*] day
period following notice to Licensee of [*]:

 

  4.17.1. Discuss [*]. Amgen will engage with Licensee in good faith discussion
with respect to [*] necessary to [*] of the applicable [*]; and

 

  4.17.2.

Discuss [*]. In addition to the discussions set forth in Section 4.17.1 (Discuss
[*]), in the event: (a) Amgen [*] develop a Licensed Product in [*]; (b) Amgen
causes a [*] with respect to such Licensed Product due to [*] of an [*] that

 

CONFIDENTIAL    Page 22   

--------------------------------------------------------------------------------

 

Amgen intends to [*]; and (c) the applicable [*] is, as of the date of notice of
[*] Licensed Product was [*] prior to the date of notice of [*], then, during
such [*] day period, upon request of Licensee, the Parties shall also [*] with
respect to [*] such [*] in the Territory.

Any [*] the Parties with respect to any of the foregoing shall be [*], and
neither Party shall [*]. Notwithstanding the foregoing, if a [*] is initiated
for [*] prior to [*] for such [*], then the rights set forth in [*] shall not
apply, and if [*] the Agreement, neither the provisions of [*] or [*] shall
apply.

 

4.18. Provision of Development Information. If Amgen [*] with [*] whereby Amgen
[*] with respect to a Licensed Product in [*], such [*] will [*] whereby such
[*] will [*] with [*] hereunder.

 

5. COMMERCIALIZATION

 

5.1. Operational Control in Licensee Indications. Licensee shall have
operational responsibility for commercialization of the Licensed Products in the
Territory in the Licensee Indications. Licensee shall commercialize the Licensed
Products in all Licensee Indications in the Territory. Such commercialization
shall be conducted in accordance with the then-current commercialization plan
approved by the Commercialization Committee. Licensee shall promote and
commercialize the Licensed Products using only professional and well-trained
employees of Licensee, and shall not utilize a contract sales organization in
connection with a Licensed Product without Amgen’s prior written approval.
Subject to the foregoing, with respect to Licensee Indications in the Territory,
Licensee’s responsibilities shall include: (a) determination of commercial
strategies (e.g., strategies for branding, product positioning, pre-launch
activities (e.g., market research), launch and post-launch marketing and
promotion, pricing and reimbursement and field sales force optimization);
(b) determination of packaging and labeling (provided, however, that Amgen shall
have the right to participate in any discussions with Governmental Authorities
with respect to labeling in accordance with Section 4.12.1 (Licensee
Responsibility)); (c) creation of promotional materials regarding the Licensed
Products which are intended for distribution to Third Parties (including medical
professionals) and to Licensee’s sales force (subject to Section 3.8 (Trademark
Quality Standards)); (d) determining and conducting promotion activities; and
(e) conducting sales, distribution and medical affairs activities, including
booking sales (i.e., recognizing all revenues), taking orders and distributing,
contracting, handling of returns, handling all aspects of order processing,
invoicing and collecting, warehousing, documenting inventory and receivables,
call reporting, handling data regarding sales to hospitals and other end users
and handling all other customer service-related functions. Licensee shall be
solely responsible for its costs incurred in its commercialization of the
Licensed Products.

 

5.2.

Amgen Co-Promotion Right. Amgen shall have the right, on an
indication-by-indication basis, upon [*] written notice to Licensee to
co-promote each Licensed Product in one or more Licensee Indications in the
Territory, from and [*] in the Territory. Licensee shall provide Amgen any
information reasonably requested by

 

CONFIDENTIAL    Page 23   

--------------------------------------------------------------------------------

 

Amgen to allow Amgen to consider whether to exercise such right. Should Amgen
elect to co-promote a Licensed Product in one or more Licensee Indications in
the Territory, it may elect to provide up to [*]%) of the details for such
indication, and Amgen’s notice of exercise of its option shall specify the
percentage of total details (up to such maximum) that Amgen desires to perform
for such indication. The Parties shall cooperate to allocate details between
them on an equitable basis in good faith, taking into account geography,
settings, provider category and detailing position, as well as Amgen’s sales
force composition and strategic focus in the Territory so as not to unreasonably
interfere with Licensee’s commercialization activities hereunder. Licensee shall
pay Amgen [*] (but not less than [*]. Amgen shall have the right to terminate
its co-promotion activities by [*] days notice to Licensee, and the Parties
shall cooperate to transition such activities to Licensee with a minimum of
disruption. At the request of either Party, the Parties shall enter into a
written agreement detailing the terms and conditions of such co-promotion
effort.

 

5.3. Commercialization in Amgen Indications and Outside the Territory. Amgen
shall be solely responsible for the commercialization of the Licensed Products
inside the Territory in Amgen Indications and outside the Territory in all
indications and, in each case, the costs thereof. Licensee shall have no rights
with respect thereto.

 

5.4. Compliance with Laws, Regulations and Guidelines. Each Party agrees to
comply with Law with respect to the development and commercialization of the
Licensed Products in the Licensee Indications in the Territory. Neither Party
shall be required to undertake any activity relating to the commercialization of
a Licensed Product in the Territory that it believes, in good faith, may violate
any Law.

 

5.5. Cooperation Generally. Subject to the oversight of the Commercialization
Committee, the Parties shall cooperate generally with respect to the
commercialization of the Licensed Products in the Licensee Indications in the
Territory.

 

6. LICENSEE AND AMGEN INDICATIONS; ACTIVITIES OUTSIDE THE COLLABORATION

 

6.1. Reasonably Diligent Efforts. Licensee shall use Reasonably Diligent Efforts
to develop, obtain Regulatory Approval for and commercialize each Licensed
Product in each Licensee Indication in the Territory.

 

6.2. [*]. With respect to each of the [*], there shall be a [*] with respect to
a particular Licensed Product in a given Licensee Indication would result in
such [*] being [*] in the Territory no later than [*] with regard to the [*];
and, [*] with regard to the [*] and the [*], as the case may be, after the
corresponding [*] (or its Affiliate or licensee) [*] with respect to the [*].
Should Licensee [*] with respect to a particular [*] during such time period,
there shall [*] that Licensee [*] with respect to such Licensed Product, which
[*] Licensee may [*] by [*] the [*] to [*] within: [*] with regard to [*]; and,
[*] with regard to the [*] and the [*], as the case may be, of [*]. For the
purposes of this Section 6.2 [*] achieved by [*] prior to [*] shall be [*]. For
the purposes of this Section 6.2 [*] achieved by Amgen outside the Territory
with respect to [*] prior to [*] provided by Amgen pursuant to [*] shall be
deemed to have been [*].

 

CONFIDENTIAL    Page 24   

--------------------------------------------------------------------------------

[*]

[*]

[*]

[*]

[*]

 

6.3. [*]. If Licensee [*] in accordance with Section [*] or [*] with respect to
a Licensed Product, then Amgen [*]. If Licensee [*], then Amgen shall [*] with
respect to such [*]. Should Amgen provide [*] to Licensee with respect to such
Licensed Product, [*] with respect to such Licensed Product upon [*], or upon
such earlier point as Amgen has specified by no less than [*] days written
notice to Licensee. During such [*], Licensee shall [*] with respect to such
Licensed Product [*].

 

6.4. [*].

 

6.5. [*].

 

6.6. [*].

 

6.7. Additional Indications.

 

  6.7.1. Licensee Proposed Indications. Licensee shall develop and commercialize
Licensed Products only in Licensee Indications. Should Licensee wish to develop
or commercialize a Licensed Product in the Territory in an indication other than
a Licensee Indication, it shall request Amgen’s written approval thereof and the
Parties shall discuss in good faith expansion of the definition of Licensee
Indications to include such indication. Licensee shall provide Amgen any
information reasonably requested by Amgen in order to allow Amgen to understand
the circumstances and relevant factors with respect to such request. Amgen shall
have the right to approve or reject the expansion of such definition in its sole
discretion. Should Amgen agree in writing to expand the definition of Licensee
Indication to include the newly proposed indication, then such indication shall,
from such point forward, be a Licensee Indication. Should Amgen not so agree,
then Licensee shall not develop or commercialize such Licensed Product in the
indication so proposed. Any such approved development shall be subject to [*]

 

  6.7.2.

Amgen Developed Indications. Within [*] days after Amgen’s written request with
respect to a Licensed Product in a particular indication (other than a Licensee
Indication) which is then subject to actual or planned clinical development by
Amgen outside the Territory, Licensee shall inform Amgen in writing of whether
or not it intends to develop and commercialize such Licensed Product in the
Territory in such indication. Amgen shall provide Licensee with all information
reasonably requested by Licensee reasonably necessary to enable

 

CONFIDENTIAL    Page 25   

--------------------------------------------------------------------------------

 

Licensee to make such determination. Should Licensee elect in writing to do so
during such [*] day period, then such indication shall, from that point forward,
be a Licensee Indication. Should Licensee notify Amgen that it does not intend
to so develop and commercialize such Licensed Product for such indication (or
fail to timely respond to Amgen’s request), then such indication in the
Territory shall become an “Amgen Indication” with respect to such Licensed
Product, and Licensee shall have no rights hereunder with respect thereto. Amgen
shall have the right to develop and commercialize, itself or through one or more
Third Parties, the Licensed Products in the Territory in Amgen Indications,
without restriction and without payment or obligation to Licensee.

 

7. MANUFACTURE AND SUPPLY

 

7.1. Manufacturing Rights. No rights are granted to Licensee hereunder to
manufacture a Licensed Product or to obtain a Licensed Product from any entity
other than Amgen or its designee. Licensee shall not manufacture a Licensed
Product or obtain a Licensed Product from any entity other than Amgen or its
designee, except as expressly provided in the Clinical Supply Schedule or a
supply agreement separately entered into between the Parties.

 

7.2. Clinical Supply. Licensee shall obtain its requirements of Licensed
Products (except for Vectibix, clinical supply for which is the subject of
Section 7.3 (Supply)) for use in clinical development solely from Amgen or its
designee, except to the extent expressly set forth on the Clinical Supply
Schedule attached hereto. The terms for providing such clinical supply are set
forth on the Clinical Supply Schedule. The Parties may determine to include in
one or more commercial supply agreements to be entered into in accordance with
Section 7.3 (Supply) with respect to Licensed Products provisions for clinical
supply of such Licensed Products.

 

7.3. Supply. The Parties (or their Affiliates) will enter into a supply
agreement for the clinical and commercial supply of Vectibix. The supply
agreement is attached hereto as the Vectibix Supply Agreement Schedule and shall
be entered into by the Parties concurrently with the execution of this
Agreement. Following the initiation of the first Phase III Trial for a Licensed
Product in the Territory, upon the request of either Party, the Parties shall
negotiate in good faith a commercial supply agreement for commercial supply of
such Licensed Product to Licensee for use in the Territory. The terms of such
commercial supply agreement shall be materially consistent with the Supply
Agreement Term Sheet Schedule attached hereto.

 

7.4.

Responsibility for Regulatory Filings with Respect to Manufacturing. Amgen shall
be solely responsible for the preparation and submission of all regulatory
filings required to be filed with any Governmental Authority in the Territory
with respect to the manufacture of a Licensed Product provided to Licensee by
Amgen (including with respect to the use of any contract manufacturer to produce
such Licensed Product on Amgen’s behalf) (the foregoing “Manufacturing Filing
Responsibilities”), except to the extent that either: (i) Licensee has assumed
responsibility for aspects of manufacturing pursuant to the Clinical Supply
Schedule, a supply agreement between the Parties or other agreement between the
Parties; or (ii) Amgen has maintained manufacturing

 

CONFIDENTIAL    Page 26   

--------------------------------------------------------------------------------

 

responsibility but notifies Licensee that it wishes to transition Manufacturing
Filing Responsibilities with respect to one or more Licensed Products to
Licensee. In any of the foregoing cases, the Parties shall cooperate to
transition the relevant Manufacturing Filing Responsibilities to Licensee and
Licensee thereafter shall be solely responsible for the relevant Manufacturing
Filing Responsibilities. Licensee shall provide Amgen any cooperation reasonably
requested by Amgen in connection with any such filings, and Amgen shall
reimburse all reasonable, documented, out-of-pocket expenses incurred by
Licensee in connection with such cooperation.

 

8. PAYMENT

 

8.1. License Payments by Licensee. In consideration of the rights granted by
Amgen to Licensee hereunder, Licensee shall make the following payments to
Amgen;

 

  8.1.1. License Fee. Licensee shall pay Amgen a non-refundable, non-creditable
license fee in the amount of $200,000,000, within [*] days after [*].

 

  8.1.2. Development Milestone Payments. Licensee shall pay Amgen the
non-refundable, non-creditable development milestone payments as set forth on
the Milestone Payments Schedule attached hereto, in each case within [*] days
after the occurrence of the corresponding event with respect to each Licensed
Product. Such milestone payments shall be payable for each Licensed Product. If
a milestone payment becomes due for occurrence of a milestone event with respect
to a given Licensed Product and Licensee has not paid a milestone payment listed
prior in order to the milestone payment then due for such Licensed Product, then
Licensee shall pay all such previously listed and unpaid milestone payments
concurrently with payment of the milestone payment then due (regardless of
whether or not the milestone event(s) corresponding to the previously unpaid
milestone payment(s) has/have occurred with respect to such Licensed Product);
provided that no milestone payments shall be due for milestone events that
occurred prior to [*].

 

8.2. Royalty Payments. Licensee shall pay Amgen a royalty on Net Sales during
the Term for each Licensed Product. Such royalty shall be equal to the greater
of the following: (a) [*]%) of Net Sales, [*]; and (b) [*]%) of Net Sales. An
example of calculation of the foregoing is set forth on the Royalty Calculation
Schedule.

 

8.3. [*]. At such time as Licensee receives Pricing Approval in the Territory
for a Licensed Product or from time-to-time thereafter as the Pricing Approval
is amended, [*], given the Parties’ [*] such Licensed Product for the Territory
and the relevant [*] the Territory, that: (i) the [*] Licensed Product hereunder
would be predominantly [*] (i.e. the [*] of Section [*]); and (ii) due to such
[*] such Licensed Product by Licensee in the Territory would [*], then it shall
have the right to [*] will provide [*] all reasonable supporting information
requested by [*] to enable [*] to confirm [*] Licensed Product. Such [*] shall
specify the total [*] and [*] at which [*] such Licensed Product [*] and [*]
shall notify [*] in writing within [*] days of [*] as to whether [*] shall
either: (a) [*] such Licensed Product to [*] set forth in [*]; or (b) [*] with
respect to such Licensed Product, such [*] days following [*] of [*] providing
for [*].

 

CONFIDENTIAL    Page 27   

--------------------------------------------------------------------------------

8.4. [*] Not Included. The payments to be made pursuant to Section 8.2 (Royalty
Payments) do not include any amounts payable pursuant to Section 8.10 ([*])
hereof or pursuant to any section of the relevant supply agreement that provides
for a pass-through of third-party payment obligations similar to Section 8.10
([*]), each of which are separately due and payable without reference to amounts
paid pursuant to such Section 8.2 (Royalty Payments).

 

8.5. Appropriate Measure of Value. Each of the Parties acknowledges that the
value provided by the other hereunder is comprised of many related items,
including intellectual property of various types, access to development and
commercial expertise, clinical data and other financial and non-financial
consideration and that the royalties set forth in Section 8.2 (Royalty Payments)
are intended to capture such value as an aggregate. Therefore the increase,
decrease or lapse of any particular items or rights shall not affect the amount
of such royalty, and the Parties agree that both the amount and duration of the
royalties set forth in this Article are reasonable.

 

8.6. Calculation of Net Sales. In calculating Net Sales:

 

  8.6.1. Free Products. Any disposal of a Licensed Product at no charge for, or
use of a Licensed Product without charge in, clinical or preclinical trials,
given as free samples, or distributed at no charge to patients unable to
purchase the same shall not be included in Net Sales.

 

  8.6.2. Bundled Products. Where a Licensed Product is sold in a Bundle, then
for the purposes of calculating the Net Sales under this Agreement, such
Licensed Product shall be deemed to be sold for an amount equal to (X÷Y) × Z,
where: X is the average sales price during the applicable reporting period
generally achieved for such Licensed Product (or, should more than one Licensed
Product be included in a Bundle with a product other than a Licensed Product,
the sum of such average sales prices for the included Licensed Products) in the
Territory; Y is the sum of the average sales price during the applicable
reporting period generally achieved in the Territory, when sold alone, by each
pharmaceutical product included in the Bundle; and Z equals the price at which
the Bundle was actually sold. In the event that a Licensed Product or one or
more of the other pharmaceutical products in the Bundle are not sold separately,
the Parties shall confer in good faith to determine an equitable fair market
price to apply to such bundled Licensed Product.

 

8.7.

Reports. Beginning with the [*] Quarter after the First Commercial Sale of a
Licensed Product in the Territory and thereafter for each [*] Quarter until the
expiration of Licensee’s obligation to pay royalties hereunder, royalty payments
and reports of the sale of each Licensed Product for each [*] Quarter will be
calculated and delivered by Licensee to Amgen under this Agreement within [*]
days after the end of each such [*] Quarter. Each payment of royalties will be
accompanied by a report of Net Sales of each Licensed Product stating: (a) Net
Sales of each Licensed Product (on a Licensed Product-by-Licensed Product basis)
by or on behalf of Licensee, its Affiliates or licensees during the applicable
[*] Quarter (detailed with gross invoiced amounts, deductions and Net Sales);
and (b) a calculation of the royalty payment due from Licensee hereunder for
such [*] Quarter. [*]. Reports will contain additional

 

CONFIDENTIAL    Page 28   

--------------------------------------------------------------------------------

 

information as reasonably requested by Amgen to enable it to comply with its
obligations to its licensors.

 

8.8. No Wrongful Reductions. Licensee shall not attempt to reduce compensation
rightly due to Amgen hereunder by shifting compensation otherwise payable to
Licensee from a Third Party with respect to a Licensed Product to another
product or service for which no royalties are payable by it hereunder.

 

8.9. Development Cost Sharing. In addition to the other payments referenced
herein, Licensee shall pay to Amgen a share of Amgen Development Costs for [*]:

 

  8.9.1. Amounts. Licensee’s share of Amgen Development Costs shall be as set
forth in the below table, subject in each case to the maximum amounts described
in Section 8.9.3 (Payment Caps):

 

[*] Year

   Licensee Share  

[*]

   [ *]%

 

  8.9.2. [*]. From and after [*], Licensee shall pay to Amgen a share equal to
[*]%) of Amgen Development Costs relating to [*].

 

  8.9.3. Payment Caps. Licensee’s payment obligations pursuant to this
Section 8.9 (Development Cost Sharing) (such payment obligations “Development
Cost Payments”), shall be subject to a maximum payment as set forth below for
each [*] Year (each, an “Annual Maximum”). In the event that payment of a
Development Cost Payment would result in payments to Amgen pursuant to such
sections in excess of the Annual Maximum for the relevant [*] Year, then such
Development Cost Payment shall be reduced so that the total Development Cost
Payment to be paid by Licensee for such [*] Year shall equal the Annual Maximum
for such [*] Year. Once the Annual Maximum is met for a given [*] Year, no
further Development Cost Payment shall be payable by Licensee for such [*] Year.
For the purposes of this Section 8.9.3 (Payment Caps), payments of Licensee’s
share of Amgen Development Costs payable pursuant to Section 8.9 (Development
Cost Sharing) shall apply against the Annual Maximum in the [*] Quarter for
which such costs are invoiced, without reference to when such payments are
actually paid or payable hereunder (but provided that such payments are
subsequently actually paid). No excess payment obligation above the Annual
Maximum for a particular [*] Year shall be carried forward to future periods.
For the avoidance of doubt, Licensee’s payment obligations pursuant to
Section 8.1.2 (Development Milestone Payments) shall not be subject to the
Annual Maximum.

 

[*] Year

   Annual
Maximum  

[*]

   [ *]

[*]

   [ *]

[*]

   [ *]

 

CONFIDENTIAL    Page 29   

--------------------------------------------------------------------------------

  8.9.4. Maximum Payments. In addition to the Annual Maximum described in
Section 8.9 (Payment Caps), Licensee’s payment obligation pursuant to this
Section 8.9 (Development Cost Sharing) shall be subject to a quarterly maximum
as described below. In the event the amount otherwise payable pursuant to this
Section 8.9 (Development Cost Sharing) with respect to a [*] Quarter (“Q1”;
“Q2”; “Q3” or “Q4”, as appropriate) would exceed: [*] (each, the “Quarterly
Maximum”), then Licensee shall pay only such Quarterly Maximum for the
applicable [*] Quarter. No excess payment obligation above the Annual Maximum
for a particular [*] Year nor above the Quarterly Maximum for a particular [*]
Quarter shall be carried forward to future periods.

 

  8.9.5. Reports. Within [*] days after the end of each [*] Quarter, Amgen shall
provide Licensee with a report specifying in reasonable detail the Amgen
Development Costs incurred or paid by Amgen in such [*] Quarter, as well as any
other costs for which Amgen is entitled reimbursement hereunder. Amgen
Development Costs may be attributed by Amgen to either the [*] Quarter in which
they are paid or incurred, but no amount shall be attributed to more than one
[*] Quarter.

 

  8.9.6. Payments. Licensee shall pay Amgen its share of Amgen Development Costs
in accordance with Section 8.12 (Payment Method) within [*] days after receiving
Amgen’s report pursuant to Section 8.9.5 (Reports).

 

  8.9.7. Example. The Development Costs Example Schedule sets forth an example
of the calculation of Licensee’s share of Amgen Development Costs.

 

8.10. [*]. In addition to the other amounts payable hereunder, Licensee shall
pay Amgen with respect to the [*] in accordance with the timing set forth
therein for such payments or, if not specified therein, in accordance with the
same time periods set forth in this Agreement for a similar type of payment.
Responsibility for amounts payable in connection with [*] hereunder shall be as
follows. With respect to [*] apply based upon [*], each [*] of such [*] shall be
calculated based upon their [*] during the applicable period. An example is set
forth as the [*] in the [*]. For [*] payable upon the [*], each Party would [*]
of such [*] equal to [*] of previously achieved [*] such [*] or a [*] of such
[*] equal to [*] of [*] in the relevant [*] to which such [*] applies (if such
[*] was based upon [*] in a given [*]). Examples are set forth as the [*]
Example in the [*]. For [*] that are [*] (e.g. [*]), Licensee shall be
responsible for [*] of [*]. For [*] based on [*] (e.g., [*]), the [*] to [*]
shall be responsible for [*] of the payment(s) associated with [*]. Upon the
other Party [*] the [*], it shall reimburse the Party that previously was
obligated to pay such [*] for either: (i) [*]) of the relevant [*], if Licensee
initially was obligated to make such [*]; or (ii) [*] of the relevant [*], if
Amgen initially was obligated to make such [*]. An example is set forth as the
[*] in the [*].

 

8.11. Cost Reimbursement. Amgen shall invoice Licensee [*] with respect to costs
to be reimbursed by Licensee hereunder including pursuant to Section 4.15 [*]
and Section 9.2.1.1 ([*]). Licensee shall pay such invoices within [*] days of
receipt.

 

8.12.

Payment Method. All payments made hereunder between the Parties shall be made in
U.S. Dollars except as set forth in Section 8.14 (Blocked Currency). Licensee
shall pay all sums due hereunder by check, wire transfer, or electronic funds
transfer (EFT) in

 

CONFIDENTIAL    Page 30   

--------------------------------------------------------------------------------

 

immediately available funds. Each Party will promptly notify the other Party of
the appropriate account information to facilitate any such payments. Regardless
of the amounts of any royalties or other payments due under this Agreement or
any other agreement between the Parties or their Affiliates, all amounts payable
under this Agreement shall be paid in full (subject to Section 8.16
(Withholding) and Section 8.17 (VAT)).

 

8.13. Audits. Licensee shall keep complete and accurate records pertaining to
the development and sale of the Licensed Products in the Territory in sufficient
detail to permit Amgen to confirm the accuracy of all payments due hereunder,
and such records 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 [*] following the end of the period to which they
pertain. Amgen shall have the right, at its own expense, to have an independent,
certified public accountant, selected by it review the records of Licensee upon
reasonable notice and during regular business hours. The report of such
accountant shall be made available to both Parties simultaneously, promptly upon
its completion. Amgen’s audit rights with respect to any [*] Year shall expire
[*] after the end of such year and the books and records for any particular [*]
Year shall only be subject to one (1) audit. Should the inspection lead to the
discovery of a discrepancy to Amgen’s detriment, then Licensee shall pay to
Amgen 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 Licensee’s
detriment, then Amgen shall pay to Licensee the amount of the discrepancy
without interest. Amgen shall pay the full cost of the inspection unless the
discrepancy is to the Amgen’s detriment and is greater than [*]%) of the amount
actually paid for the audited period, in which case Licensee shall pay the cost
of such inspection.

 

8.14. Blocked Currency. If at any time legal restrictions in the Territory
prevent the prompt remittance of any payments with respect to sales therein,
Licensee shall have the right and option to make such payments by depositing the
amount thereof in local currency to Amgen’s account in a bank or depository
designated by Amgen in the Territory.

 

8.15. Taxes. All Taxes levied on account of a payment made by Licensee to Amgen
pursuant to this Agreement will be subject to the withholding and remittance
provisions of Section 8.16 (Withholding).

 

8.16.

Withholding. In the event that Law requires Licensee to pay or withhold Taxes
with respect to any payment to be made by Licensee pursuant to this Agreement,
Licensee shall notify Amgen in writing of such payment or withholding
requirements prior to making the payment to Amgen and provide such assistance to
Amgen, including the provision of such documentation as may be required by a tax
authority, as may be reasonably necessary in Amgen’s efforts to claim an
exemption from or reduction of such Taxes. Licensee will, in accordance with
Law, withhold Taxes from the amount due, remit such Taxes to the appropriate tax
authority, and furnish Amgen with proof of payment of such Taxes within [*] days
following payment thereof. If Taxes are paid to a tax authority, Licensee shall
provide such assistance to Amgen as is reasonably

 

CONFIDENTIAL    Page 31   

--------------------------------------------------------------------------------

 

required to obtain a refund of Taxes withheld, or obtain a credit with respect
to Taxes paid.

 

8.17. VAT. All payments due Amgen from Licensee pursuant to this Agreement shall
be paid exclusive of any VAT (which, if applicable, shall be payable by Licensee
upon receipt of a valid VAT invoice).

 

8.18. Late Payment. Any payments or portions thereof due hereunder which are not
paid when due shall bear interest at the Contract Interest Rate, compounded
daily, calculated on the number of days such payment is delinquent. This
Section 8.18 (Late Payment) shall in no way limit any other remedies available
to either Party.

 

8.19. Third Party Royalties. Except as expressly set forth in Sections 8.16
(Withholding) and 8.17 (VAT), neither Party shall have the right to make any
deduction from amounts otherwise payable pursuant to this Agreement on account
of any royalty or other amount payable to any Third Party.

 

9. INTELLECTUAL PROPERTY

 

9.1. Ownership. Except to the extent expressly specified to the contrary in this
Agreement: (i) each Party shall retain and own all right, title, and interest in
and to all patent rights, trade secrets, proprietary rights and other
intellectual property rights conceived or created solely by such Party; (ii) the
Parties shall jointly own all right, title, and interest in and to all patent
rights, trade secrets, proprietary rights and other intellectual property rights
conceived or created jointly by the Parties pursuant to the Collaboration and,
subject to the provisions of this Agreement (including those licenses granted
pursuant to Article 3 (Grant of License)), neither Party shall have any duty to
account or obtain the consent of the other Party (such consent deemed given
hereunder) in order to exploit, license or assign such intellectual property
rights; and (iii) inventorship and authorship of any invention or work of
authorship conceived or created by either Party, or jointly by the Parties
pursuant to the Collaboration, shall follow the rules of the U.S. Patent and
Trademark Office and the Laws of the United States (without reference to any
conflict of law principles).

 

9.2. Prosecution and Maintenance.

 

  9.2.1. In Territory.

 

  9.2.1.1. [*] shall control, itself or through outside counsel reasonably
acceptable to [*] and directed by [*] the preparation, filing (including filing
for correction of claims or specifications), prosecution, maintenance and
defense (including responses to patent office communications, any office
actions, oppositions, interferences and challenges (whether before a patent
authority or judicial body) related thereto) (the foregoing collectively “Patent
Matters”) with respect to [*] as well as preparation and filing for any [*]

 

  9.2.1.2.

[*] it shall give [*] reasonable notice thereof [*] and continue the prosecution
or maintenance of such patent, trademark or application [*] control Patent
Matters with respect to such patent, trademark or application within the [*] in
accordance with this Section 9.2.1.2 [*] shall

 

CONFIDENTIAL    Page 32   

--------------------------------------------------------------------------------

 

control, itself or through outside counsel reasonably acceptable to [*] and
directed by [*] as well as preparation and filing for any [*].

 

  9.2.2. [*]. [*] shall control and be [*] responsible for all Patent Matters
with respect to its patent rights, trademark rights and other intellectual
property [*], at its sole cost and expense. [*] shall control and be solely
responsible for Patent Matters with respect to [*]

 

9.3. Defense and Settlement of Third Party Claims. If a [*] that a [*] by the
[*], [*] shall have the sole right to [*] at its sole cost. [*] shall reasonably
[*] at [*] request, and [*] shall [*] in connection therewith. Subject to such
[*] may [*] any [*] pursuant to this Section 9.3 (Defense and Settlement of
Third Party Claims), with [*] at its sole cost. [*] shall seek and reasonably
consider [*] before [*] for such matter. Without limiting the foregoing, [*]
shall keep [*] of all [*] regarding such [*], and shall provide [*] of and an
[*] to [*] on any such [*] and [*]. [*] (provided that, should such [*] be
reasonably necessary for [*] shall endeavor to provide such [*] to the relevant
[*] or with similar [*], or otherwise make available such [*] as reasonably
necessary to [*] shall not [*] hereunder without [*]. [*] shall keep [*] of all
[*] this Section 9.3 (Defense and Settlement of Third Party Claims). In the
event [*] becomes engaged in: [*] and, in each such case, such [*] of the other
Party: [*] use reasonable efforts to [*] in such [*] (and then so [*]).

 

9.4. Enforcement.

 

  9.4.1. In Territory. Each Party shall promptly notify the other Party in
writing if it reasonably believes that any [*] are infringed or misappropriated
by a Third Party in the Territory.

 

  9.4.1.1. [*] shall reasonably [*] at [*] request [*] in connection therewith),
and [*] shall seek and reasonably [*] before [*] within the Territory and
outside the Territory so as to[*]

 

  9.4.1.2. [*]. [*] shall seek and reasonably [*] shall keep [*] of all [*] and
shall provide [*] of and an [*] (provided that [*] shall have the [*] and any
[*]).

 

  9.4.2. [*]. [*] shall have the [*] right [*] its patent rights, trademark
rights and other intellectual properties, and the Joint Patents [*] and [*] any
such matters [*]

 

9.5. Allocation of Recoveries. All Recoveries shall [*]. Any Recoveries that are
[*] shall be allocated [*] shall have the [*] right to [*] with respect to the
[*] of any [*]. After any termination or expiration of this Agreement, [*] shall
have [*].

 

9.6. Patent Term Extensions. Each Party shall provide reasonable assistance to
the other Party in connection with obtaining SPCs for Licensed Amgen Patents
consistent with the rights of the other Party to control such matters as
specified in Section 9.2 (Prosecution and Maintenance). To the extent reasonably
and legally required in order to obtain any such SPC in a particular country,
each Party shall make available to the other a copy of the necessary
documentation to enable such other Party to use the same for the purpose of
obtaining the SPC in such country.

 

CONFIDENTIAL    Page 33   

--------------------------------------------------------------------------------

9.7. Employee Agreements. Prior to [*] relating to [*] and/or [*], each [*],
shall have [*] pursuant to which each such person [*], as appropriate,
substantially including: [*]. It is understood and agreed that any [*] and that
the [*] shall be sufficient to [*] Each Party shall [*].

 

9.8. Patent Marking. Licensed Products marketed and sold by or on the behalf of
Licensee hereunder shall be marked with appropriate patent numbers or indicia of
Licensed Amgen Patents, to the extent permitted by Law in the Territory.

 

10. CONFIDENTIALITY AND PUBLICATIONS

 

10.1. Confidentiality; Exceptions. Except to the extent expressly authorized by
this Agreement or otherwise agreed in writing, the Parties agree that, during
the Term and for [*] years thereafter, the receiving Party shall keep
confidential and shall not publish or otherwise disclose or use for any purpose
other than as provided for in this Agreement any confidential and proprietary
information and materials furnished to it by the other Party pursuant to this
Agreement (collectively, “Confidential Information”) (including information
known by the employees of Amgen KK and/or materials in the possession of Amgen
KK prior to the consummation of the transactions contemplated in the Sale and
Purchase Agreement, which shall be considered the Confidential Information of
Amgen). Licensee shall have no right to and shall not utilize any Confidential
Information of Amgen for activities outside the Territory (including, with
respect to the research, development or commercialization of any Distracting
Product outside the Territory). For clarity, Confidential Information of a Party
shall include, without limitation, all information and materials disclosed by
such Party or its designee that (i) is marked as “Confidential,” “Proprietary”
or with similar designation at the time of disclosure or (ii) by its nature can
reasonably be expected to be considered Confidential Information by the
recipient. Information disclosed orally shall not be required to be identified
as such to be considered Confidential Information. Notwithstanding the
foregoing, Confidential Information shall not include any information to the
extent that it can be established by written documentation by the receiving
Party that such information:

 

  10.1.1. was already known to the receiving Party, other than under an
obligation of confidentiality (except to the extent such obligation has expired
or an exception is applicable under the relevant agreement pursuant to which
such obligation was established), at the time of disclosure;

 

  10.1.2. was generally available to the public or otherwise part of the public
domain at the time of its disclosure to the receiving Party;

 

  10.1.3. became generally available to the public or otherwise part of the
public domain after its disclosure and other than through any act or omission of
the receiving Party in breach of this Agreement;

 

  10.1.4. was independently developed by the receiving Party (without reference
to or use of Confidential Information of the other Party) as demonstrated by
documented evidence prepared contemporaneously with such independent
development; or

 

CONFIDENTIAL    Page 34   

--------------------------------------------------------------------------------

  10.1.5. was disclosed to the receiving Party, other than under an obligation
of confidentiality (except to the extent such obligation has expired or an
exception is applicable under the relevant agreement pursuant to which such
obligation was established), by a Third Party who had no obligation to the
disclosing Party not to disclose such information to others.

 

10.2. Authorized Disclosure. Except as expressly provided otherwise in this
Agreement, each Party may use and disclose Confidential Information of the other
Party solely as follows: (i) under appropriate confidentiality provisions
substantially equivalent to those in this Agreement: (a) in connection with the
performance of its obligations or as reasonably necessary or useful in the
exercise of its rights under this Agreement, and (b) to the extent such
disclosure is reasonably necessary or useful in conducting development under
this Agreement; (ii) to the extent such disclosure is to a Governmental
Authority as reasonably necessary in filing or prosecuting patent, copyright and
trademark applications in accordance with this Agreement, prosecuting or
defending litigation in accordance with this Agreement, complying with
applicable governmental regulations with respect to performance under this
Agreement, filing Regulatory Filings, obtaining Regulatory Approval or
fulfilling post-approval regulatory obligations for a Licensed Product, or
otherwise required by Law, provided, however, that if a Party is required by Law
or the rules of any securities exchange or automated quotation system to make
any such disclosure of the other Party’s Confidential Information it shall,
except where impracticable for necessary disclosures (for example, in the event
of medical emergency), give reasonable advance notice to the other Party of such
disclosure requirement and, in the case of each of the foregoing, shall use its
reasonable efforts to secure confidential treatment of such Confidential
Information required to be disclosed; (iii) to advisors (including lawyers and
accountants) on a need to know basis, in each case under appropriate
confidentiality provisions or professional standards of confidentiality
substantially equivalent to those of this Agreement; or (iv) to the extent
mutually agreed to by the Parties.

 

10.3. Use of Confidential Information and Amgen Data with Distracting Programs.
Licensee acknowledges the value of Confidential Information and other data
provided by Amgen hereunder and agrees that it shall not utilize any such
information to benefit Licensee programs or products other than the Licensed
Products.

 

  10.3.1. Ex-Territory Distracting Program. If Licensee or its Affiliate
engages, after [*], in an Ex-Territory Distracting Program (including under a
license or collaboration agreement with a Third Party that contemplates Licensee
or its Affiliate engaging in or supporting an Ex-Territory Distracting Program),
it shall provide Amgen with prompt written notice describing in reasonable
detail, to the extent permitted by Law and without disclosing any proprietary
information of the Ex-Territory Distracting Program, the Ex-Territory
Distracting Program and its focus.

 

  10.3.2.

Ex-Territory Distracting Transaction. In the event that Licensee enters into or
agrees with a Third Party to enter into an Ex-Territory Distracting Transaction
then it shall provide prompt written notice to Amgen, specifying the identity of
the actual or potential Ex-Territory Distracting Affiliate(s) and describing in

 

CONFIDENTIAL    Page 35   

--------------------------------------------------------------------------------

 

reasonable detail, to the extent permitted by Law and without disclosing any
proprietary information of the Ex-Territory Distracting Program, the
Ex-Territory Distracting Program and its focus.

 

  10.3.3. Protection of Amgen Information. In the event that Licensee or its
Affiliate engages in an Ex-Territory Distracting Program as set forth in
Section 10.3.1 (Ex-Territory Distracting Program) or enters into an Ex-Territory
Distracting Transaction, then Licensee shall hold separate such Ex-Territory
Distracting Program (including ensuring that no personnel working on the
Collaboration work on an Ex-Territory Distracting Program (and vice versa), and
ensuring that information from the Collaboration is sequestered from personnel
working on the Ex-Territory Distracting Program (and vice versa)), and the
Parties shall promptly meet to agree upon policies and procedures to be
implemented to safeguard Amgen’s Confidential Information and data related to
the relevant Licensed Product from misuse. Until such time as the Parties have
so agreed, Amgen shall have the right to suspend provision of Confidential
Information and data (including Amgen Development Data) to Licensee hereunder
with respect to the applicable Licensed Product.

 

10.4. [*]. From time to time, upon [*] reasonable request, [*] shall [*]
relating to the foregoing, and will [*] the foregoing.

Without prejudice to the foregoing, within twenty (20) business days of the
Effective Date, Licensee shall submit to Amgen the [*] this Section 10.4 [*]. If
Amgen has any particular comments or suggestions thereon, Amgen and Licensee
will finalize the said [*] through good faith discussion.

 

10.5. Terms and Conditions Confidential. Neither Party shall disclose the terms
and conditions of this Agreement except as may be required by Law.
Notwithstanding the foregoing, with respect to complying with the disclosure
requirements of any Governmental Authority in connection with any required
filing of this Agreement, the Parties shall consult with one another concerning
which terms of this Agreement shall be requested to be redacted in any public
disclosure of the Agreement, and in any event each Party shall seek reasonable
confidential treatment for any public disclosure by any such Governmental
Authority. Notwithstanding the foregoing, the Parties shall agree upon and
release a mutual press release to announce the execution of this Agreement in
the form attached hereto as the Press Release Schedule for use in responding to
inquiries about the Agreement; thereafter, Licensee and Amgen may each disclose
to Third Parties the information contained in such press release without the
need for further approval by the other. Each Party shall additionally have the
right to issue additional press releases in regards to this Agreement and/or the
Licensed Products with the prior written agreement of the other Party or as
required to comply with any Law or by the rules of any stock exchange or
automated quotation system (in the case of such required disclosure, by
providing [*] days’ notice to the other Party and reasonably considering
comments provided by such other Party within [*] days after such notice).

 

10.6.

Prior Agreement. This Agreement supersedes the Confidential Disclosure Agreement
between the Parties dated [*] as amended and supplemented, including any written
requests thereunder, (the “Prior Agreement”) with respect to information
disclosed

 

CONFIDENTIAL    Page 36   

--------------------------------------------------------------------------------

 

thereunder relating to the Licensed Products and the research and development
related thereto. All confidential information exchanged between the Parties
under the Prior Agreement shall be deemed Confidential Information of the
disclosing Party and shall be subject to the terms of this Agreement.

 

10.7. Publications.

 

  10.7.1. In Territory. Except as set forth in Section 10.7.2 (Other
Publications), Licensee shall have the [*] right to publish with respect to
Licensed Products in Licensee Indications in publications based in the Territory
and to make scientific presentations on Licensed Products in Licensee
Indications within the Territory. Except as set forth in Section 10.7.2 (Other
Publications), Amgen shall have the [*] right to publish with respect to
Licensed Products in Amgen Indications in publications based in the Territory,
and with respect to Licensed Products in all indications in publications based
outside the Territory and to make scientific presentations on Licensed Products
in Amgen Indications inside the Territory, and with respect to Licensed Products
in all indications outside the Territory. Any proposed publication by Licensee
[*], any proposed publication by Amgen [*], any publication by Licensee [*] of
[*], and any publication by Amgen [*] (each such publication a “[*]
Publication”) shall be [*] the [*] to Sections 10.7.2 (Other Publications) and
10.7.3 (Oversight and Review).

 

  10.7.2. Other Publications. The Parties shall regularly consult and confer
with respect to a global publication plan for a Licensed Product, with the
understanding that Licensee shall have primary responsibility for shaping and
determining the publication plan with respect to the Territory, and Amgen shall
have sole responsibility for shaping and determining the publication plan
outside the Territory, but with the understanding that the Parties may agree it
is in their mutual scientific and/or commercial interest to allow a Party to
publish or present a Secondary Publication. [*]

 

  10.7.3. Oversight and Review. Except as required by Law or court order, with
respect to any publication or presentation concerning the activities to be
conducted in the Territory hereunder with respect to a Licensed Product,
including studies or clinical trials carried out by a Party under this
Agreement, or any Secondary Publication, the Party desiring to publish or
present any such publication or presentation (the “Publishing Party”): (i) shall
transmit to the other Party (the “Reviewing Party”) for review and comment a
copy of the proposed publication or presentation, at least [*] days prior to the
submission of the proposed publication or presentation to a Third Party;
(ii) shall postpone the publication or presentation for up to an additional [*]
days upon request by the Reviewing Party in order to allow the consideration of
appropriate patent applications or other protection to be filed on information
contained in the publication or presentation; (iii) upon request of the
Reviewing Party, shall remove all Confidential Information of the Reviewing
Party from the information intended to be published or presented; and (iv) shall
consider all reasonable comments made by the Reviewing Party to the proposed
publication or presentation. [*].

 

CONFIDENTIAL    Page 37   

--------------------------------------------------------------------------------

10.8. Attorney-Client Privilege. Neither Party is waiving, nor shall be deemed
to have waived or diminished, any of its attorney work product protections,
attorney-client privileges or similar protections and privileges as a result of
disclosing information pursuant to this Agreement, or any of its Confidential
Information (including Confidential Information related to pending or threatened
litigation) to the receiving Party, regardless of whether the disclosing Party
has asserted, or is or may be entitled to assert, such privileges and
protections. The Parties: (i) share a common legal and commercial interest in
such disclosure that is subject to such privileges and protections; (ii) are or
may become joint defendants in proceedings to which the information covered by
such protections and privileges relates; (iii) intend that such privileges and
protections remain intact should either Party become subject to any actual or
threatened proceeding to which the disclosing Party’s Confidential Information
covered by such protections and privileges relates; and (iv) intend that after
[*] both the receiving Party and the disclosing Party shall have the right to
assert such protections and privileges.

 

11. REPRESENTATIONS, WARRANTIES AND COVENANTS

 

11.1. Mutual Representations and Warranties. Each of the Parties hereby
represents and warrants to the other Party as follows:

 

  11.1.1. As of [*], it is duly organized and validly existing under the Laws of
its jurisdiction of incorporation and it has full corporate power and authority
and has taken all corporate action necessary to enter into and perform this
Agreement;

 

  11.1.2. As of [*], this Agreement is a legal and valid obligation binding upon
such Party and enforceable in accordance with its terms; the execution, delivery
and performance of the Agreement by such Party does not conflict with any
agreement, instrument or understanding, oral or written, by which it is bound,
nor to its knowledge as of [*] violate any Law; and the person or persons
executing this Agreement on such Party’s behalf have been duly authorized to do
so by all requisite corporate action;

 

  11.1.3. To its knowledge, as of [*] no government authorization, consent,
approval, license, exemption of or filing or registration with any court or
Governmental Authority, under Law, is or shall be necessary for, or in
connection with, the entering into of this Agreement or the transaction
contemplated by this Agreement, or (except for MHLW or other regulatory
approvals, licenses, clearances and the like necessary for the research,
development, manufacture, sales or marketing of pharmaceutical products and
except for any required filing with the United States Securities and Exchange
Commission) for the performance by it of its obligations under this Agreement;

 

  11.1.4. [*];

 

  11.1.5. As of [*], it has not been debarred or the subject of debarment
proceedings by any Governmental Authority;

 

CONFIDENTIAL    Page 38   

--------------------------------------------------------------------------------

  11.1.6. It has not granted as of [*] any right to any Third Party relating to
any patent, trademark or other proprietary right that conflicts with the rights
granted to the other Party hereunder;

 

  11.1.7. As of [*], it has not knowingly used in connection with the research,
development, manufacture or commercialization to take place pursuant to this
Agreement any employee, consultant or investigator that has been debarred or the
subject of debarment proceedings by any Governmental Authority;

 

  11.1.8. It has carried out its activities materially in accordance with Law
(including relevant Laws relating to economic sanctions and bribery); and

 

  11.1.9. It has not knowingly misappropriated any trade secret(s) of a Third
Party in connection with the performance of its activities hereunder.

 

11.2. Amgen Representations and Warranties. Amgen hereby represents that, as of
[*]:

 

  11.2.1. Amgen has provided Licensee with [*] with respect to the Licensed
Products, and has [*] information relating to [*] that are [*] relevant Licensed
Product [*] provided to Licensee;

 

  11.2.2. Amgen has disclosed to Licensee [*] as set forth on the [*] Schedule,
and has [*] Licensee with [*] that are [*] Licensed Product [*];

 

  11.2.3. The [*] Schedule sets forth a list that, to the best of Amgen’s
knowledge, is materially true and complete of all [*] with respect to the [*]
and corresponding [*] outside the Territory, and of [*] of the [*] or
corresponding [*] outside the Territory; and

 

  11.2.4. Except as referenced on the [*] Schedule, to the best of Amgen’s
knowledge Amgen has not [*] which [*] that the [*] in the Territory [*] of such
[*], or which [*] that the [*] of an [*] of [*], which [*] to an [*] in the
Territory.

 

11.3. Disclaimer of Warranties. EXCEPT AS SET FORTH IN THIS ARTICLE 11
(Representations, Warranties and Covenants), LICENSEE AND AMGEN EXPRESSLY
DISCLAIM ANY AND ALL REPRESENTATIONS AND WARRANTIES, EXPRESS, IMPLIED, STATUTORY
OR OTHERWISE, WITH RESPECT TO THE COLLABORATION, THE LICENSED AMGEN PATENTS,
LICENSED AMGEN TRADEMARKS, LICENSED AMGEN KNOW-HOW, LICENSED LICENSEE PATENTS,
LICENSED LICENSEE TRADEMARKS, LICENSED LICENSEE KNOW-HOW, THIS AGREEMENT, OR ANY
OTHER SUBJECT MATTER RELATING TO THIS AGREEMENT, INCLUDING ANY WARRANTY OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OR NONINFRINGEMENT
OF INTELLECTUAL PROPERTY RIGHTS.

 

11.4. Covenants. Each of the Parties hereby covenants to the other Party as
follows:

 

  11.4.1. It shall not knowingly use in connection with the research,
development, manufacture or commercialization to take place pursuant to this
Agreement any employee, consultant or investigator that has been debarred or the
subject of debarment proceedings by any Governmental Authority;

 

CONFIDENTIAL    Page 39   

--------------------------------------------------------------------------------

  11.4.2. It shall carry out its activities hereunder in compliance with Law
(including relevant Laws relating to economic sanctions and bribery);

 

  11.4.3. It shall not misappropriate any trade secret(s) of a Third Party in
connection with the performance of its activities hereunder; and

 

  11.4.4. It shall not grant any right to any Third Party that conflicts with
the rights granted to the other Party hereunder.

 

12. LIMITATIONS OF LIABILITY; INSURANCE

 

12.1. Limitations of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE
OTHER PARTY FOR ANY INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY OR CONSEQUENTIAL
DAMAGES OF ANY KIND ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, HOWEVER
CAUSED AND ON ANY THEORY OF LIABILITY (WHETHER IN CONTRACT, TORT (INCLUDING
NEGLIGENCE), STRICT LIABILITY OR OTHERWISE), EVEN IF SUCH PARTY WAS ADVISED OR
OTHERWISE AWARE OF THE LIKELIHOOD OF SUCH DAMAGES. The limitations set forth in
this Section 12.1 (Limitations of Liability) shall not apply with respect to
(i) either Party’s indemnification obligations under Article 13
(Indemnification), (ii) breach of Section 4.4 (Development in Combination), 10.1
(Confidentiality; Exceptions), 10.2 (Authorized Disclosure), or (iii) gross
negligence or intentional misconduct of a Party.

 

12.2. Insurance. During the Term and for [*] thereafter each Party shall obtain
and maintain comprehensive general liability insurance covering its obligations
and activities hereunder, including products liability insurance and coverage
for clinical trials, with reputable and financially secure insurance carriers in
a form and at levels as customary for a company of its size in the
pharmaceutical industry in the Territory (or reasonable self-insurance
sufficient to provide materially the same level and type of protection).

 

13. INDEMNIFICATION

 

13.1.

Indemnity. Subject to the remainder of this Article 13 (Indemnification),
Licensee shall defend, indemnify, and hold harmless Amgen, its Affiliates, and
their respective directors, officers, employees and agents (collectively, “Amgen
Indemnitees”), at Licensee’s cost and expense, from and against any and all
liabilities, losses, costs, damages, fees or expenses (including reasonable
legal expenses and attorneys’ fees incurred by any Amgen Indemnitees until such
time as Licensee has acknowledged and assumed its indemnification obligation
hereunder with respect to a claim) (collectively, “Losses”) arising out of any
claim, action, lawsuit, or other proceeding (other than a shareholder derivative
suit or like action) (collectively, “Claims”) brought against any Amgen
Indemnitee, by a Third Party to the extent such Losses result from (i) the
negligence or willful misconduct of Licensee, its Affiliates or agents in
performing under this Agreement, (ii) a breach by Licensee of this Agreement,
including any failure of Licensee’s representations or warranties in
Section 11.1 to be true, or (iii) Licensee’s, its Affiliate’s or its licensee’s
(other than Amgen, its Affiliates or its licensees) development or
commercialization of a Licensed Product but excluding such Losses to the extent
they arise from (y) or (z) below. Subject to the remainder of this Article 13

 

CONFIDENTIAL    Page 40   

--------------------------------------------------------------------------------

 

(Indemnification), Amgen shall defend, indemnify, and hold harmless Licensee,
its Affiliates, and their respective directors, officers, employees and agents
(collectively, “Licensee Indemnitees”), at Amgen’s cost and expense, from and
against any and all Losses (including reasonable legal expenses and attorneys’
fees incurred by any Licensee Indemnitees until such time as Amgen has
acknowledged and assumed its indemnification obligation hereunder with respect
to the applicable Claim) arising out of any Claim brought against any Licensee
Indemnitee, by a Third Party to the extent such Losses result from (y) the
negligence or willful misconduct of Amgen, or its Affiliates or agents in
performing under this Agreement, or (z) a breach by Amgen of this Agreement,
including any failure of Amgen’s representations or warranties in Section 11.1
(Mutual Representations and Warranties) to be true, but excluding such Losses to
the extent they arise from (i), (ii), or (iii) above. The indemnification
obligations of this Article 13 shall not apply to commercial supply obligations
or the obligations under the Vectibix supply agreement to be entered into
concurrently herewith; any indemnification obligations related to commercial
supply (or clinical supply of Vectibix) shall be handled under the supply
agreements to be entered into pursuant to Section 7.3 (Supply).

 

13.2. Claim for Indemnification. Whenever any Claim or Loss shall arise for
which a Licensee Indemnitee or an Amgen Indemnitee (the “Indemnified Party”) may
seek indemnification under this Article 13 (Indemnification), the Indemnified
Party shall promptly notify the other Party (the “Indemnifying Party”) of the
Claim or Loss and, when known, the facts constituting the basis for the Claim;
provided, however, that the failure by an Indemnified Party to give such notice
or to otherwise meet its obligations under this Section 13.2 (Claim for
Indemnification) shall not relieve the Indemnifying Party of its indemnification
obligation under this Agreement except and only to the extent that the
Indemnifying Party is actually prejudiced as a result of such failure. The
Indemnifying Party shall have exclusive control of the defense and settlement of
all Claims for which it is responsible for indemnification and shall promptly
assume defense thereof at its own expense. The Indemnified Party shall not
settle or compromise any Claim by a Third Party for which it is entitled to
indemnification without the prior written consent of the Indemnifying Party,
unless the Indemnifying Party is in breach of its obligation to defend
hereunder. In no event shall the Indemnifying Party settle any Claim without the
prior written consent of the other Party if such settlement does not include a
complete release from liability on such Claim or if such settlement would
involve undertaking an obligation other than the payment of money, would bind or
impair the other Party, or includes any admission of wrongdoing or that any
intellectual property or proprietary right of the other Party is invalid or
unenforceable. The Indemnified Party shall reasonably cooperate with the
Indemnifying Party at the Indemnifying Party’s expense and shall make available
to the Indemnifying Party reasonably requested information under the control of
the Indemnified Party, which information shall be subject to Article 10
(Confidentiality and Publications).

 

CONFIDENTIAL    Page 41   

--------------------------------------------------------------------------------

14. TERM AND TERMINATION

 

14.1. Term. This Agreement shall come into effect as of the Effective Date and
shall remain in effect until terminated in accordance with this Article 14 (Term
and Termination).

 

14.2. Termination. This Agreement may be terminated as follows:

 

  14.2.1. Termination for Breach. If either Party believes that the other Party
or its Affiliate is in material breach of this Agreement, then such Party may
deliver notice of such material breach (specifying the nature of the breach in
reasonable detail) to the other Party. In such written notice, the noticing
Party shall identify the actions or conduct that such Party would consider to be
an acceptable cure of such material breach (if curable). If the breaching Party
(or its Affiliate) fails to cure such material breach within [*] days after the
receipt of such notice (or [*] days with respect to any failure to pay amounts
due hereunder), then the other Party shall be permitted to terminate this
Agreement by written notice given within [*] days after the end of such cure
period and effective upon delivery;

 

  14.2.2. Termination for Challenge. Amgen shall have the right to terminate
this Agreement by written notice to Licensee should Licensee, its Affiliate or
its or their licensee bring or join any challenge to the validity or
enforceability of any Licensed Amgen Patent or Licensed Amgen Trademark;

 

  14.2.3. Specific Product Termination. This Agreement may terminate with
respect to a particular Licensed Product in accordance with Section 6.3
(Termination), Section 8.3 ([*]), Section 14.2.5 [*] or Section 15.1 (Change of
Control);

 

  14.2.4. All Product Termination. This Agreement shall automatically terminate
upon any termination of this Agreement with respect to all Licensed Products in
accordance with Section 6.3 [*] or Section 15.1 (Change of Control); and

 

  14.2.5. [*]. In the event a [*] Licensed Product [*] of the [*] it would [*]
Licensee to [*], then Licensee shall [*] that [*] in the Territory until such
time as [*] Licensed Product [*]. Similarly, if a [*] occurs for a Licensed
Product [*], and in [*] it would not [*], then Licensee shall [*], upon [*]
(provided, however, that during such [*]; Amgen shall [*]. For clarity, Licensee
shall not have the right to [*] under this Section 14.2.5 [*] if the reason for
the [*], as the case may be, is [*] and does not [*].

 

14.3. Effect of Termination. Expiration or termination of this Agreement
(whether as a whole, or with respect to a particular Licensed Product) shall
have the following effects with regard to the relevant Licensed Product(s):

 

  14.3.1. General. In the event of any termination or expiration of this
Agreement [*]. Any termination or expiration of this Agreement shall be without
prejudice to any other right or remedy to which a Party may be entitled. Upon
termination or expiration of this Agreement, [*]

 

  14.3.2. Development Cost Share. In the event of termination by [*] under
Sections [*] pursuant to [*] with respect to [*] shall survive. In the event of
termination by [*] or by [*] shall continue to [*] pursuant to [*] only with
respect to [*] attributable to [*]

 

CONFIDENTIAL    Page 42   

--------------------------------------------------------------------------------

14.4. Additional Surviving Provisions. In addition and without prejudice to the
provisions of Section 14.3 (Effect of Termination), in the event of any
expiration or termination of this Agreement the following provisions shall
survive: Articles 10 (Confidentiality and Publications) (except with respect to
Section 10.7 (Publications)); 12 (Limitations of Liability; Insurance); 13
(Indemnification); 14 (Term and Termination) and 16 (Miscellaneous); and
Sections 3.4 (Licensed Licensee Know-How and Patents); 6.6 ([*]) ([*]); 8.1.1
(License Fee); 8.1.2 (Development Milestone Payments) (with respect to
milestones reached prior to such expiration or termination); 8.2 (Royalty
Payments) through 8.8 (No Wrongful Reductions) (inclusive) (with respect to
sales made prior to such expiration or termination); 8.10 ([*])(with respect to
amounts incurred prior to such expiration or termination); 8.11 (Cost
Reimbursement) through 8.19 (Third Party Royalties) (inclusive); 9.1
(Ownership); 9.5 (Allocation of Recoveries) (with respect to periods prior to
termination); and 11.3 (Disclaimer of Warranties).

 

14.5. Transition Period. During the twelve (12) month period [*] pursuant to
Section [*] (Termination) or another provision of this Agreement, ([*]) (the
“Transition Period”), the Parties shall[*] and, if applicable, manufacture
of,[*] Licensee shall take all actions [*] to facilitate [*], and the Parties
shall [*] expeditiously and as reasonably necessary to [*] in the Territory. The
Parties shall each be responsible for [*] provided that, in the event of [*]
Amgen shall [*]

 

15. CHANGE OF CONTROL

 

15.1. Change of Control. Licensee shall give Amgen written notice within [*]
days after the public announcement or disclosure of any proposed Change of
Control of Licensee. In the event of the occurrence of any Change of Control of
Licensee: (i) [*]) and, (ii) Amgen shall have the right to [*]. Upon such
notice: Amgen shall have the right, by written notice to Licensee, to [*]
Licensed Products in [*]. In such case, Licensee shall [*], subject to [*]. In
particular: (a) Amgen shall [*] Licensed Products, and shall [*]; (b) Amgen
shall [*] with respect to such Licensed Products; (c) Amgen shall [*] all [*]
Licensed Products, and the sole right to [*] relating to such Licensed Products;
and (d) Amgen shall [*] Licensed Products in the Territory. In addition, should
the Change of Control of Licensee result in Licensee becoming an Affiliate of a
Party that is [*], then, without prejudice to Sections 6.4 ([*]) through 6.6
([*]) (inclusive), Amgen shall have the right to [*]. In addition, should such
Change of Control involve [*], Amgen shall have the right to [*] written notice
to Licensee, such notice to be given not later than [*].

 

16. MISCELLANEOUS

 

16.1. Affiliates. Amgen shall have the right to exercise its rights and perform
its obligations hereunder through its Affiliates (including by licensing rights
hereunder where such rights are held in the name of any such Affiliate),
provided Amgen shall be responsible for such Affiliates’ performance hereunder.

 

16.2.

Assignment. Neither this Agreement nor any rights or obligations hereunder may
be assigned or otherwise transferred (whether by operation of Law, general
succession or otherwise) by Licensee without the prior written consent of Amgen.
Amgen may assign

 

CONFIDENTIAL    Page 43   

--------------------------------------------------------------------------------

 

this Agreement, and its rights and obligations hereunder without prior written
consent to any Affiliate or, with prior notice, in connection with the transfer
or sale of all or substantially all of the business of Amgen to which this
Agreement relates. Amgen shall have the right to assign its rights and delegate
its obligations under this Agreement with respect to one or more Licensed
Products to a Party or Parties to which Amgen licenses or transfers rights with
respect to such product(s) outside the Territory. Any assignment not in
accordance with this Agreement shall be void. Subject to the foregoing, the
rights and obligations of the Parties under this Agreement shall be binding upon
and inure to the benefit of the successors and permitted assigns of the Parties.

 

16.3. Choice of Law. This Agreement shall be governed by, and enforced and
construed in accordance with, the laws of the State of California without regard
to its conflicts of law provisions.

 

16.4. Construction. The definitions of the terms herein shall apply equally to
the singular and plural forms of the terms defined. Whenever the context may
require, any pronoun shall include the corresponding masculine, feminine and
neuter forms. The words “include”, “includes” and “including” shall be deemed to
be followed by the phrase “without limitation”. The word “will” shall be
construed to have the same meaning and effect as the word “shall”. The Parties
each acknowledge that they have had the advice of counsel with respect to this
Agreement, that this Agreement has been jointly drafted, and that no rule of
strict construction shall be applied in the interpretation hereof. Unless the
context requires otherwise, (i) any definition of or reference to any agreement,
instrument or other document herein shall be construed as referring to such
agreement, instrument or other document as from time to time amended,
supplemented or otherwise modified (subject to any restrictions on such
amendments, supplements or modifications set forth herein or therein), (ii) any
reference to any Laws herein shall be construed as referring to such Laws as
from time to time enacted, repealed or amended, (iii) any reference herein to
any person shall be construed to include the person’s permitted successors and
assigns, (iv) the words “herein”, “hereof” and “hereunder”, and words of similar
import, shall be construed to refer to this Agreement in its entirety and not to
any particular provision hereof, and (v) all references herein to Articles,
Sections, Schedules or Exhibits, unless otherwise specifically provided, shall
be construed to refer to Articles, Sections, Schedules or Exhibits of this
Agreement. This Agreement has been executed in English, and the English version
of this Agreement shall control.

 

16.5. Counterparts. This Agreement may be executed in counterparts with the same
effect as if both Parties had signed the same document. All such counterparts
shall be deemed an original, shall be construed together and shall constitute
one and the same instrument. Signature pages of this Agreement may be exchanged
by facsimile or other electronic means without affecting the validity thereof.

 

16.6.

Currency. With respect to Net Sales invoiced or expenses incurred in a currency
other than U.S. Dollars, such Net Sales invoiced or expenses incurred shall be
converted into the U.S. Dollar equivalent using a rate of exchange which
corresponds to the rate used by whichever of Licensee or Amgen (or an Affiliate
of one of them) recorded such

 

CONFIDENTIAL    Page 44   

--------------------------------------------------------------------------------

 

receipt or expenditure, for the respective reporting period, related to
recording such Net Sales or expenses in its books and records that are
maintained in accordance with GAAP. If a Party is not required to perform such
currency conversion for its GAAP reporting with respect to the applicable
period, then for such period such Party shall convert its amounts received and
expenses incurred into U.S. Dollars using a rate of exchange which corresponds
to [*] buying rate as published in the Wall Street Journal, Eastern U.S. Edition
on [*] day of the [*] Quarter (or such other publication as agreed-upon by the
Parties). Any royalty amount shall be calculated based upon the U.S. Dollar
equivalent calculated in accordance with the foregoing.

 

16.7. Entire Agreement. This Agreement, including the attached Appendices,
Schedules and Exhibits constitutes the entire agreement between the Parties as
to the subject matter of this Agreement, and supersedes and merges all prior
negotiations, representations, agreements and understandings regarding the same.
The foregoing is without prejudice to the Parties’ rights and obligations
pursuant to the Sale and Purchase Agreement, License Agreement relating to
AMG706, and the Vectibix Supply Agreement, each executed concurrently herewith.

 

16.8. Force Majeure. Neither Party shall be liable for delay or failure in the
performance of any of its obligations hereunder if such delay or failure is due
to causes beyond its reasonable control, including acts of God, fires, floods,
earthquakes, labor strikes, acts of war, terrorism or civil unrest (“Force
Majeure”); provided, however, that the affected Party promptly notifies the
other Party in writing (and continues to provide monthly status updates to the
other Party for the duration of the effect) and further provided that the
affected Party shall use its commercially reasonable efforts to avoid or remove
such causes of non-performance and to mitigate the effect of such occurrence,
and shall continue performance with reasonable dispatch whenever such causes are
removed.

 

16.9. Further Assurances. Each Party agrees to do and perform all such further
acts and things and shall execute and deliver such other agreements,
certificates, instruments and documents necessary or that the other Party may
reasonably request in order to carry out the intent and accomplish the purposes
of this Agreement and to evidence, perfect or otherwise confirm its rights
hereunder.

 

16.10. Headings. Headings and captions are for convenience only and are not to
be used in the interpretation of this Agreement.

 

16.11.

Jurisdiction and Venue. Each Party hereby irrevocably submits to the exclusive
jurisdiction of the courts of the State of California (“State Court”) and the
courts of the United States of America located in the State of California
(“Federal Court”), for the purposes of any suit, action or other proceeding
arising out of or relating to this Agreement or out of any transaction
contemplated hereby. Each Party agrees that service of any process, summons,
notice or document by personal delivery, by registered mail, or by a recognized
international express delivery service to such Party’s respective address set
forth in Section 16.13 (Notices) (as such address may be changed by notice
delivered pursuant to such section) shall be effective service of process for
any action, suit or proceeding in the applicable Federal Court or State Court
with respect to any matters to which it has submitted to jurisdiction in this
Section 16.11

 

CONFIDENTIAL    Page 45   

--------------------------------------------------------------------------------

 

(Jurisdiction and Venue). Each Party irrevocably and unconditionally waives any
objection to the laying of venue of any action, suit or proceeding arising out
of this Agreement or the transactions contemplated hereby in the applicable
Federal Court or State Court, and hereby and thereby further irrevocably and
unconditionally waives and agrees not to plead or claim in any such court that
any such action, suit or proceeding brought in any such court has been brought
in an inconvenient forum. Any action brought arising out of or relating to this
Agreement or out of any transaction contemplated hereby shall be conducted in
English. Notwithstanding the foregoing, either Party shall have the right to
seek exigent, injunctive or temporary relief in any court of competent
jurisdiction. Each Party irrevocably waives any and all right to trial by jury
in any legal proceeding arising out of or relating to this Agreement or the
transactions contemplated hereby. Except as may be expressly set forth to the
contrary herein (including in Section 12.1 (Limitations of Liability) hereof),
nothing in this Agreement shall serve to limit any remedy to which a Party might
otherwise be entitled, at law or in equity.

 

16.12. No Set-Off. No Party shall have the right to deduct from amounts
otherwise payable hereunder any amounts payable to such Party (or its
Affiliates) from the other Party (or its Affiliates).

 

16.13. Notices. Any notice required or permitted to be given by this Agreement
shall be in writing, in English, and shall be delivered by hand or overnight
courier with tracking capabilities or mailed postage prepaid by registered or
certified mail addressed as set forth below unless changed by notice so given:

 

If to Amgen:

   Amgen Inc.    One Amgen Center Drive    Thousand Oaks, California 91320-1799
   Attention: Corporate Secretary    Telephone: 805-447-1000    Facsimile: [*]

 

If to Licensee:

   Takeda Pharmaceutical Company Limited    1-1, Doshomachi 4-chome, Chuo-ku   
Osaka 540-8645, Japan    Attention: General Manager, Global Licensing & Business
Development    Telephone: [*]    Facsimile: [*]

Any such notice shall be deemed given on the date delivered. A Party may add,
delete (so long as at least one person is remaining), or change the person or
address to which notices should be sent at any time upon written notice
delivered to the other Party in accordance with this Section 16.13 (Notices).

 

16.14.

Reimportation. Licensee shall undertake all steps necessary to prevent any
Licensed Product provided to or made for or on behalf of Licensee for use or
sale inside the Territory from being distributed or sold outside the Territory,
except where Amgen and Licensee agree that the exporting person or entity is in
possession of all regulatory

 

CONFIDENTIAL    Page 46   

--------------------------------------------------------------------------------

 

authorizations and intellectual property licenses necessary for such export,
import and sale. Licensee shall notify Amgen if it becomes aware of the
exportation of a Licensed Product from the Territory and discuss with Amgen the
same.

 

16.15. Relationship of the Parties. Each Party is an independent contractor
under this Agreement. Nothing contained herein is intended or is to be construed
so as to constitute Licensee and Amgen as partners, agents or joint venturers.
Neither Party shall have any express or implied right or authority to assume or
create any obligations on behalf of or in the name of the other Party or to bind
the other Party to any contract, agreement or undertaking with any Third Party.

 

16.16. Severability. If any one or more of the provisions of this Agreement is
held to be invalid or unenforceable, the provision shall be considered severed
from this Agreement and shall not serve to invalidate any remaining provisions
hereof. The Parties shall negotiate in good faith to replace any invalid or
unenforceable provision with a valid and enforceable one such that the
objectives contemplated by the Parties when entering this Agreement may be
realized.

 

16.17. Third Party Beneficiaries. Except as expressly provided with respect to
Amgen Indemnitees or Licensee Indemnities in Article 13 (Indemnification), there
are no third party beneficiaries intended hereunder and no Third Party shall
have any right or obligation hereunder.

 

16.18. Waivers and Modifications. The failure of any Party to insist on the
performance of any obligation hereunder shall not be deemed to be a waiver of
such obligation. Waiver of any breach of any provision hereof shall not be
deemed to be a waiver of any other breach of such provision or any other
provision on such occasion or any other occasion. No waiver, modification,
release or amendment of any right or obligation under or provision of this
Agreement shall be valid or effective unless in writing and signed by all
Parties hereto.

*********

(Signature page follows)

 

CONFIDENTIAL    Page 47   

--------------------------------------------------------------------------------

IN WITNESS WHEREOF, the Parties have executed this License Agreement as of the
Effective Date.

 

TAKEDA PHARMACEUTICAL COMPANY LIMITED     AMGEN INC. By:  

/s/ Yasuhiko Yamanaka

    By:  

/s/ Kevin W. Sharer

Name:   Yasuhiko Yamanaka     Name:   Kevin W. Sharer Title:   Director
General Manager, Pharmaceutical Marketing Division     Title:   Chairman of the
Board,
CEO and President

CONFIDENTIAL