Exhibit 10.83

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

   10

3       GRANT OF LICENSE

   14

4       DEVELOPMENT AND REGULATORY ACTIVITIES

   18

5       COMMERCIALIZATION

   25

6       DILIGENT EFFORTS; DISTRACTING PROGRAMS AND TRANSACTIONS

   27

7       MANUFACTURE AND SUPPLY

   30

8       PAYMENT

   31

9       INTELLECTUAL PROPERTY

   36

10     CONFIDENTIALITY AND PUBLICATIONS

   38

11     REPRESENTATIONS, WARRANTIES AND COVENANTS

   41

12     LIMITATIONS OF LIABILITY; INSURANCE

   43

13     INDEMNIFICATION

   43

14     TERM AND TERMINATION

   45

15     MISCELLANEOUS

   47 SCHEDULES   

 

CONFIDENTIAL    i   

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

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, CA 91320-1799 (“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, Licensee is a global pharmaceutical company that conducts
pharmaceutical research, development, manufacturing and commercialization; and

WHEREAS, Amgen wishes to partner with Licensee, and Licensee wishes to partner
with Amgen, in each case with respect to the worldwide development and
commercialization of a product Amgen is developing that is referred to as AMG706
in the Indications (each as defined below), all 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. “Additional Indications” shall mean, with respect to Licensed Product, any
specific indications other than the NSCLC Indication that are mutually agreed
upon by the Parties through the Development Committee pursuant to Section 6.6
(Additional Indications).

 

1.2. “Affiliate” shall mean any corporation, person 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 1.2 (“Affiliate”), “control” of a corporation or other entity 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.

 

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

 

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

 

CONFIDENTIAL    Page 1   

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

1.5. “Amgen Development Data” shall mean the preclinical and clinical data
generated by or on the behalf of Amgen or its Affiliates on a worldwide basis in
the course of its preclinical and clinical development of Licensed Product in an
Indication, both before and after [*] of this Agreement.

 

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

 

1.7. “Amgen Territory” shall mean the United States, Canada and Mexico and their
respective territories and possessions.

 

1.8. “AMG706” shall mean that certain small molecule known as motesanib
diphosphate in clinical development as of [*].

 

1.9. “Asia” shall mean the following countries and their respective territories
and possessions: [*] and [*].

 

1.10. “Bundle” shall mean the Licensed Product sold to an end-user together with
another pharmaceutical compound for a single price.

 

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

 

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

 

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

 

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

 

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

 

1.16. “Commercialization Committee” shall mean the committee established by the
Parties to oversee and coordinate the commercialization of the Licensed Product
pursuant to the Collaboration and shall have the responsibilities set forth in
Section 2.10 (Commercialization Committee).

 

1.17. “Commercialization Costs” shall mean [*]. Commercialization Costs shall
not include any of the foregoing costs in this Section 1.17 with respect to
Japan.

 

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

 

1.19. “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 [*] (or, if unavailable on such date, [*] on which such rate is available),
or, if lower, the maximum rate permitted by Law.

 

CONFIDENTIAL    Page 2   

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

1.20. “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 right 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, with respect to
Japan only, 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.

 

1.21. “Cost of Goods Sold” shall mean the [*]. Cost of Goods Sold shall include
[*] such activities. Cost of Goods Sold shall not include any of the foregoing
costs in this Section 1.21 with respect to Japan.

 

1.22. “Cost of Sales” shall mean the sum of Cost of Goods Sold and [*].

 

1.23. “Development Committee” shall mean the committee established by the
Parties to oversee and coordinate the development of the Licensed Product
pursuant to the Collaboration and shall have the responsibilities set forth in
Section 2.9 (Development Committee).

 

1.24. “Development Costs” shall mean [*]. Development Costs shall not include
any of the foregoing costs in this Section 1.24 with respect to Japan.

 

1.25. “Development Plan” shall have the meaning set forth in Section 2.9.3
(Development Plans).

 

1.26. “Distracting Product” shall mean any [*].

 

1.27. “Distracting Product Commercial Conditions” shall have the meaning set
forth in Section 6.3 (Addition of Distracting Products).

 

1.28. “Distracting Product Expiration Date” shall have the meaning set forth in
Section 6.3 (Addition of Distracting Products).

 

1.29. “Distracting Program” shall mean the [*] by either Party of any
Distracting Product.

 

1.30. “Distracting Transaction” shall mean any transaction entered into by a
Party or its Affiliate after [*] whereby a Third Party that is engaged in a
Distracting Program becomes an Affiliate of such Party prior to the Distracting
Product Expiration Date.

 

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

 

1.32. “Distracting Transaction Party” shall have the meaning set forth in
Section 6.4 (Distracting Transactions).

 

CONFIDENTIAL    Page 3   

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

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

 

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

 

1.35. “EMEA” shall mean the European Medicines Evaluation Agency or any
successor agency thereof.

 

1.36. “Europe” shall mean the following countries and territories: [*].

 

1.37. “FDA” shall mean the United States Food and Drug Administration, and any
successor agency thereto.

 

1.38. “Federal Court” shall have the meaning set forth in Section 15.12
(Jurisdiction and Venue).

 

1.39. “First Commercial Sale” shall mean with respect to a Party, the first sale
of a Licensed Product following Regulatory Approval by or on the behalf of such
Party or any of its Affiliates or licensees.

 

1.40. “Force Majeure” shall have the meaning set forth in Section 15.9 (Force
Majeure).

 

1.41. “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.

 

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

 

1.43. “GAAP” shall mean either Japanese (with respect to Licensee) or U.S. (with
respect to Amgen) generally accepted accounting principles, consistently
applied, as used by a Party to record the relevant transaction.

 

1.44. “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.

 

1.45. “Gross Profit” shall mean Net Sales of Licensed Product (excluding Net
Sales in Japan) less the Cost of Sales for such Licensed Product, plus any
Recoveries.

 

CONFIDENTIAL    Page 4   

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

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

 

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

 

1.48. “Indications” shall mean with respect to each Licensed Product, the
treatment, palliation, prevention or prophylaxis of disease in humans with
respect only to (i) the NSCLC Indication, and (ii) any Additional Indication.

 

1.49. “Information” shall mean all tangible and intangible techniques,
information, technology, practices, trade secrets, inventions (whether
patentable or not and whether or not reduced to practice), processes, 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.

 

1.50. “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.

 

1.51. “Joint Loss(es)” shall have the meaning set forth in Section 13.3 (Joint
Losses).

 

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

 

1.53. “Joint Project Team” shall mean the committee established by the Parties
to coordinate the activities of the Parties hereunder and to establish and
designate subcommittees as necessary to manage the activities of the Parties
hereunder.

 

1.54. “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.

 

1.55. “Licensed Amgen Know-How” shall mean Information Controlled by Amgen (or
its Affiliates), as of [*] or thereafter during the Term, that is reasonably
necessary for Licensee to develop or commercialize a Licensed Product in the
Indications in the Licensee 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 Indications in the Licensee Territory.
Except to the extent otherwise mutually agreed by the Parties in connection with
any supply arrangement entered into pursuant to Section 7.3 (Commercial Supply),
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., Amgen’s wholly-owned subsidiary that is being acquired by Licensee,
as of the consummation of the transactions contemplated in that certain Sale and
Purchase Agreement executed concurrently herewith that is reasonably necessary
for Licensee to develop or commercialize a Licensed Product in the Indications
in the Licensee Territory.

 

CONFIDENTIAL    Page 5   

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

1.56. “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 applications 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.

 

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

 

1.58. “Licensed Licensee Know-How” shall mean Information Controlled by Licensee
(or its Affiliates), as of [*] or thereafter during the Term, that is reasonably
necessary for Amgen to develop, manufacture or commercialize a Licensed Product
in 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 in the Territory in any
Indication.

 

1.59. “Licensed Licensee Patents” shall mean those patents and patent
applications Controlled by Licensee or its Affiliates (including an interest in
a patent or Joint Patent pursuant to Section 9.1 (Ownership)) that [*]. 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.

 

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

 

1.61. “Licensed Product” shall mean any pharmaceutical composition comprising
[*].

 

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

 

1.63. “Licensee Assumed Item” shall have the meaning set forth in
Section 9.2.1(ii) (Licensee Secondary Prosecution).

 

1.64. “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
[*].

 

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

 

1.66. “Licensee Territory” shall mean the entire world excluding the Amgen
Territory.

 

CONFIDENTIAL    Page 6   

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

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

 

1.68. “Licensee Territory Patents and Trademarks” shall have the meaning set
forth in Section 9.2.1 (i) (Amgen Primary Prosecution).

 

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

 

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

 

1.71. “Net Operating Profit” shall mean, with respect to each Party, such
Party’s share of Gross Profit less such Party’s share of Operating Expenses.

 

1.72. “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 a Party, its
Affiliates or licensees hereunder to Third Parties (not including such Party’s
Affiliates, unless and to the extent such Affiliate is the end-user of such a
Licensed Product) during such period, less the total of the following charges or
expenses, as determined in accordance with GAAP:

 

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

 

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

 

  1.72.3. Retroactive price reductions;

 

  1.72.4. 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;

 

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

 

  1.72.6. 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 an
Indication and actually given.

 

1.73. “NSCLC Indication” shall mean the treatment, palliation, prevention or
prophylaxis of disease in humans with respect only to non-small cell lung cancer
(NSCLC).

 

1.74. “Ongoing Studies” shall mean those clinical studies that are being
undertaken by Amgen as of [*] with respect to the Licensed Product, including
those set forth on the Ongoing Studies Schedule.

 

1.75. “Operating Expenses” shall mean [*]. Operating Expenses shall include
Commercialization Costs and Other Collaboration Costs. Operating Expenses shall
not include any of the foregoing costs in this Section 1.75 with respect to
Japan.

 

CONFIDENTIAL    Page 7   

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

1.76. “Other Collaboration Costs” shall mean [*]. Other Collaboration Costs
shall not include any of the foregoing costs in this Section 1.76 with respect
to Japan.

 

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

 

1.78. “Patent Matters” shall have the meaning set forth in Section 9.2.1(i)
(Amgen Primary Prosecution).

 

1.79. “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.

 

1.80. “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.

 

1.81. “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 FDA 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.

 

1.82. “Prior Agreement” shall have the meaning set forth in Section 10.4 (Prior
Agreement).

 

1.83. “Publishing Party” shall have the meaning set forth in Section 10.5.2
(Oversight and Review).

 

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

 

1.85. “Recall” means a “recall” or “market withdrawal” (each as defined per
Section 7.3 of Title 21 (Food and Drugs) of the Code of Federal Regulations, or,
with respect to a jurisdiction other than the United States, the equivalent
regulations of the applicable Governmental Authority in such jurisdiction) of
Licensed Product or any lots thereof.

 

CONFIDENTIAL    Page 8   

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

1.86. “Recoveries” shall mean [*]. Recoveries shall not include any of the
foregoing amounts in this Section 1.86 with respect to Japan.

 

1.87. “Regulatory Approval” shall mean, with respect to a country or territory,
the product-specific approvals from a Governmental Authority necessary for the
marketing, distribution and sale of a Licensed Product in such country or
territory.

 

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

 

1.89. “Reviewing Party” shall have the meaning set forth in Section 10.5.2
(Oversight and Review).

 

1.90. “SOPs” shall have the meaning set forth in Section 4.14 (Recalls).

 

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

 

1.92. “State Court” shall have the meaning set forth in Section 15.12
(Jurisdiction and Venue).

 

1.93. “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, as set forth in Section 2.7
(Steering Committee).

 

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

 

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

 

1.96. “Termination Date” shall have the meaning set forth in Section 14.3
(Effect of Termination).

 

1.97. “Territory” shall mean the entire world.

 

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

 

1.99. “Third Party Royalties” shall mean [*]. Third Party Royalties shall not
include any of the foregoing amounts in this Section 1.99 with respect to Japan.

 

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

 

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

 

CONFIDENTIAL    Page 9   

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

2 COLLABORATION SCOPE AND GOVERNANCE

 

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

 

2.2 Governance. The Collaboration shall be governed by (i) a Steering Committee,
which shall oversee the activities of the Parties hereunder generally, (ii) a
Joint Project Team, which shall coordinate the activities of the Parties
hereunder, and (iii) subcommittees of the Joint Project Team which shall be
established by the Joint Project Team as necessary to manage the activities of
the Parties hereunder. Two such subcommittees shall be those of the Development
Committee and the Commercialization Committee, which shall oversee the
development and commercialization of the Licensed Product hereunder,
respectively. The Steering Committee, the Joint Project Team, the Development
Committee and the Commercialization Committee shall be formed promptly following
[*].

 

2.3 Membership. Unless otherwise mutually agreed by the Parties, the Joint
Project Team, the Development Committee and the Commercialization Committee
shall each be comprised of [*] members appointed by Amgen and [*] members
appointed by Licensee. Each 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 [*] members appointed by
Amgen and [*] member appointed by Licensee. The Joint Project Team shall have
the right to delegate any of its responsibilities to one or more subcommittees
as it determines appropriate.

 

2.4 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.

 

2.5 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.

 

2.6 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.

 

2.7 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.

 

  2.7.1.

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. As appropriate, other employee representatives

 

CONFIDENTIAL    Page 10   

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

 

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 co-chair appointed by the other Party. All Steering Committee meetings
must have at least [*] member appointed by each Party in attendance.

 

  2.7.2. Reporting. The Joint Project Team shall keep the Steering Committee
fully and promptly informed of progress and results of activities conducted by
the Parties hereunder and shall fully inform the Steering Committee with respect
to all relevant facts and activities reasonably requested by any member thereof
regarding Licensed Product.

 

  2.7.3. Decision Making. The Steering Committee shall make decisions by
consensus. In the event the Steering Committee fails to reach consensus with
respect to any matter that may [*], such matter shall be [*].

 

2.8 Joint Project Team. The Joint Project Team shall be responsible for
overseeing and coordinating the overall plans of the Parties and resolving
matters that are otherwise not resolved within the various subcommittees as may
exist hereunder and for ensuring an appropriate level of communication between
the Parties.

 

  2.8.1. Meetings. The Joint Project Team shall meet [*] in person, via
teleconference or videoconference or otherwise (with at least [*] meetings 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. As appropriate, other
employee representatives of the Parties may attend Joint Project Team meetings
as nonvoting participants, but no Third Party personnel may attend unless
otherwise agreed by the Parties. All Joint Project Team meetings must have at
least [*] member appointed by each Party in attendance.

 

  2.8.2. Reporting. Each Party, through the members appointed by it on each
subcommittee, shall keep the Joint Project Team fully and promptly informed of
progress and results of activities for which each subcommittee is responsible.
Each Party, through the members appointed by it on each subcommittee, shall
fully inform the Joint Project Team with respect to all relevant facts and
activities reasonably requested by any member thereof regarding any Licensed
Product.

 

  2.8.3.

Decision Making. With respect to unresolved development matters, the Joint
Project Team shall make decisions by consensus. In the event the Joint Project
Team fails to reach consensus with respect to any such matter, and the Joint
Project Team determines that it is appropriate to do so, such matter shall be
escalated to the Steering Committee for resolution. With respect to unresolved
commercialization matters, [*] shall make the final determination with respect
to commercialization of Licensed Product in the Licensee Territory, and [*]
shall

 

CONFIDENTIAL    Page 11   

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

 

make the final determination with respect to commercialization of Licensed
Product in the Amgen Territory.

 

2.9 Development Committee. With respect to each Licensed Product, the
Development Committee shall be responsible for: (i) subject to Section 2.9.3
(Development Plans), reviewing and approving new development plans prior to
adoption of such plans by a Party; (ii) reviewing and approving changes to
development plans (including the AMG706 Development Plan) prior to adoption of
such changes by a Party; (iii) providing for communication and discussion
between the Parties to, as appropriate, coordinate the development activities of
the Parties and to optimize the efficacy and safety of the development of the
applicable Licensed Product; (iv) reviewing and monitoring the activities and
progress of the Parties against the development plans, including site
enrollment, patient enrollment, progress of trials and data received;
(v) communicating with the Commercialization Committee regarding the
interrelationship between development activities and potential
commercialization; and (vi) communicating with the Joint Project Team 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. 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 Product as reasonably requested by the other Party through the
Development Committee. Each Party shall fully inform the applicable Development
Committee with respect to all relevant facts and activities reasonably requested
by any member thereof regarding any Licensed Product development matter. At
least five (5) business days prior to the first meeting of each Development
Committee of each Calendar 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. The development plan and budget for development of AMG706 for
the NSCLC Indication in the Territory and completion of the

 

CONFIDENTIAL    Page 12   

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

 

Ongoing Studies has been mutually agreed upon by the Parties as of [*] and is
attached hereto as the Development Plan Schedule (as amended by Agreement of the
Development Committee from time to time, “Development Plan”). Should either
Party seek to make changes to an approved Development Plan, then at least [*]
days prior to the next meeting of the Development Committee, it shall provide
the Development Committee any proposed changes to the previously approved
Development Plan for the Development Committee’s review and approval (including
approval for any Additional Indication).

 

  2.9.4. Decision Making. The Development Committee shall make decisions by
consensus. In the event the Development Committee fails to reach consensus with
respect to any matter, such matter shall be [*].

 

2.10 Commercialization Committee. The Commercialization Committee shall be
responsible for: (i) reviewing and approving global commercialization plans (and
changes thereto) prior to adoption of such plans (or changes) by the Parties;
(ii) communicating with the Development Committee regarding the
interrelationship between development activities and potential
commercialization; (iii) reviewing the commercialization activities of the
Parties; (iv) overseeing the trademark and publication strategies; and
(v) communicating with the Joint Project Team regarding all of the foregoing.

 

  2.10.1. Meetings. The Commercialization Committee shall meet [*] in person,
via teleconference or videoconference or otherwise (with at least [*] meetings
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. 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 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 reasonably requested
by any member thereof regarding any Licensed Product commercialization matter.
At least [*] days prior to the 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.

 

CONFIDENTIAL    Page 13   

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

  2.10.3. Commercialization Plans. At least [*] days prior to the last meeting
of the Commercialization Committee of each [*] Year (or such other time as
mutually agreed), each Party shall provide the Commercialization Committee a
copy of its proposed commercialization plan for the Licensed Product in such
Party’s respective territory under the Collaboration for the next [*] Year for
the Commercialization Committee’s review, comment and approval (either by
Indication or for all Indications for which it is responsible in such Party’s
respective territory)). In addition, should a Party seek to make material
changes to an approved commercialization plan, then at least [*] days prior to
the next meeting of the 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. The Commercialization Committee shall strive to reach
consensus on decisions, taking into account the views of each committee member.
Decisions with respect to day-to-day commercial operations for which a Party has
responsibility (other than any matter that could reasonably be expected to
adversely affect the other Party’s commercialization in its territory), shall be
made by such Party and notice thereof shall be submitted to the
Commercialization Committee solely for informational purposes. With respect to
any commercial matter that could reasonably be expected to adversely affect the
other Party’s commercialization of Licensed Product in such Party’s respective
territory, if the Commercialization Committee fails to reach consensus, such
matter shall be [*]. Notwithstanding the above, with respect to unresolved
matters that could reasonably be expected to adversely affect the other Party’s
commercialization of Licensed Product and that have been [*], in the event that
exigent circumstances require a Party to take action in the best interests of
the Licensed Product with respect to its territory, such Party shall be allowed
to do so by providing written notice of such decision or action to the
Commercialization Committee.

3 GRANT OF LICENSE

 

3.1 Licensed Amgen Patents. Amgen hereby grants Licensee [*] right and license
under the Licensed Amgen Patents during the Term, subject to the terms and
conditions hereof, solely to research, develop, commercialize, use, import and
sell Licensed Product only in the Indications in the Licensee Territory, except
that Amgen retains non-exclusive rights in the Licensee Territory to develop,
use, commercialize and sell (in accordance with Section 5.3 (Commercialization
in Europe) or as otherwise agreed by the Commercialization Committee), and
manufacture Licensed Product. Such license to Licensee shall include the right
to sublicense only as set forth in Section 3.4 (Licensee Sublicensing). Amgen
also hereby grants Licensee [*] right and license under the Licensed Amgen
Patents during the Term, subject to the terms and conditions hereof, solely to
develop Licensed Product only in the Indications in the Amgen Territory.

 

3.2

Licensed Amgen Know-How. Amgen hereby grants Licensee [*] right and license
during the Term, subject to the terms and conditions hereof, to utilize the
Licensed Amgen

 

CONFIDENTIAL    Page 14   

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

 

Know-How solely for the purpose of supporting its research, development,
commercialization, use, importation and sale of Licensed Product only in the
Indications in the Licensee Territory, except that Amgen retains non-exclusive
rights in the Licensee Territory to research, develop, use, import,
commercialize and sell (in accordance with Section 5.3 (Commercialization in
Europe) or as otherwise agreed by the Commercialization Committee), and
manufacture Licensed Product. Such license shall include the right to sublicense
only as set forth in Section 3.4 (Licensee Sublicensing). Amgen also hereby
grants Licensee [*] 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 of Licensed Product only in the Indications in the
Amgen Territory.

 

3.3 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 (i) solely for the
purpose of the development, commercialization, manufacture, use, importation and
sale of Licensed Product in the Amgen Territory for all uses, (ii) solely for
the purpose of the development, manufacture, use and importation of Licensed
Product in the Licensee Territory (excluding Japan during the Term) and for the
purpose of commercialization and sale of Licensed Product in the Licensee
Territory (x) during the Term in accordance with Section 5.3 (Commercialization
in Europe) or as otherwise agreed by the Commercialization Committee and
(y) after the Term for all uses, and (iii) for performing its obligations
hereunder, including any supply obligations with respect to Licensed Product.
Such license shall include the right to grant sublicenses to those persons and
entities to which Amgen (or its Affiliate or licensee) is also granting licenses
to any Amgen patent or know-how relating to Licensed Product or the use thereof;
provided, however, that: (a) any sublicensee shall be required to enter into a
written agreement obligating it to maintain the confidentiality of the
Confidential Information of Licensee; (b) 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);
(c) no such sublicense shall operate to excuse Amgen’s compliance with its
obligations hereunder; and (d) Amgen shall be responsible for a breach by such
sublicensee of any such obligations or prohibitions.

 

3.4

Licensee Sublicensing. Licensee shall have the right to sublicense the rights
granted it hereunder only with Amgen’s prior written consent, which consent may
not be unreasonably withheld or delayed, except with respect to any of the
parties [*] for which Amgen may withhold or condition its consent 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

 

CONFIDENTIAL    Page 15   

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

 

obligations hereunder. Licensee shall have the right to distribute a Licensed
Product in the Licensee Territory through reputable distributors with prior
written notice to Amgen.

 

3.5 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-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 (except as may be expressly agreed to by the Parties pursuant to
Section 7.3 (Commercial Supply)) unless provision of such information is
necessary to develop and commercialize Licensed Products in accordance with this
Agreement and neither Party shall have an obligation to provide information
relating to any product other than the Licensed Product.

 

3.6 Trademarks.

 

  3.6.1.

Grant to Licensee. Amgen hereby grants to Licensee [*] right and license during
the Term, subject to the terms and conditions hereof, solely to develop,
commercialize, use, import and sell Licensed Product in the Licensee Territory
in the Indications under the same Licensed Amgen Trademarks as used by Amgen for
Licensed Product in such Indications in the Amgen Territory. Such license shall
include the right to sublicense only as set forth in Section 3.4 (Licensee
Sublicensing). The Parties acknowledge that the use of the Licensed Amgen
Trademarks in the Licensee Territory may have commercial value to Licensee, and
that Licensee shall have the right to commercialize Licensed Product in the
Indications in the Licensee Territory under the same Licensed Amgen Trademarks
as utilized for Licensed Product in such Indications by Amgen in the Amgen
Territory. Should the Parties desire that a different trademark be used for
Indications in the Licensee Territory, or if additional trademarks to those used
in the Amgen Territory are otherwise required, the Parties shall consult and
agree upon an additional or replacement trademark (or trademarks) (which
additional or replacement trademark(s) shall, as between the Parties, be owned
by Amgen). In addition, if the manufacture of Licensed Product for Licensee for
use in the Licensee Territory materially varies from the manufacture of Licensed
Product for Amgen or its Affiliates for use in the Amgen Territory, then upon
the request of Amgen, the Parties shall consult and agree upon a replacement
trademark (or trademarks) (which replacement trademark(s) shall, as between the
Parties, be owned by Amgen). 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 in a form and manner
approved by Amgen. Amgen hereby grants Licensee a non-exclusive right and
license, with the right to sublicense only as set forth in Section 3.4 (Licensee
Sublicensing), during the Term, subject to the terms and conditions hereof, to
use

 

CONFIDENTIAL    Page 16   

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

 

such Amgen marks solely for such purpose. Such Amgen marks shall be subject to
the quality control provisions set forth in Section 3.7 (Trademark Quality
Standards). All uses by Licensee of the Licensed Amgen Trademarks and other
Amgen marks permitted hereunder, and all goodwill associated therewith, shall
inure solely to the benefit of Amgen.

 

  3.6.2. Grant to Amgen. Licensee hereby grants to Amgen [*] right and license
during the Term to use Licensed Licensee Trademarks in connection with Amgen’s
activities pursuant to Section 5.3 (Commercialization in Europe) and Section 5.5
(Co-Promotion Rights). All uses by Amgen of the Licensed Licensee Trademarks,
and all goodwill associated therewith, shall inure solely to the benefit of
Licensee. Upon any termination or expiration of this Agreement, such license
shall become paid-up and perpetual, and shall include the right to use the
relevant Licensed Licensee Trademarks in connection with Licensed Product in all
indications and throughout the Territory unless, at Licensee’s option, Licensee
decides to assign the relevant Licensed Licensee Trademarks (and the associated
goodwill) to Amgen at no charge.

 

3.7 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) at least as high as
the standards 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 representative specimens 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 shall not seek to register or obtain ownership
rights in any Licensed Licensee Trademark (or confusingly similar trademark) and
Licensee shall not seek to register or obtain ownership rights in any Licensed
Amgen Trademark or any trademark used by Amgen in connection with Licensed
Product in the Amgen Territory in any indication (or confusingly similar
trademark to any of the foregoing).

 

3.8

Retained Rights and Limitations. Except as expressly granted in this Article 3,
no rights are granted to Licensee hereunder to Licensed Amgen Patents, Licensed
Amgen Know-How or Licensed Amgen Trademarks outside the Indications, or outside
the Licensee Territory. Except to the extent expressly set forth in Sections 7.2
(Clinical Supply) or 7.3 (Commercial Supply), no rights are granted to Licensee
hereunder to make or have made

 

CONFIDENTIAL    Page 17   

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

 

a Licensed Product or any other product. No rights are granted to Licensee
hereunder to import or export a Licensed Product manufactured by Amgen or its
licensee, except as specifically contemplated herein. No rights are granted
herein to Licensee to control the research, development or commercialization of
a Licensed Product in the Amgen Territory except, with respect to development,
as otherwise agreed by the Parties through the Development Committee and, with
respect to commercialization, as allowed under Section 5.5 (Co-Promotion
Rights). No rights to either Party’s patents, trademarks or other intellectual
property or proprietary rights are granted pursuant to this Agreement except as
expressly set forth herein, and all other rights are reserved.

4 DEVELOPMENT AND REGULATORY ACTIVITIES

 

4.1 Collaboration for Development. The Parties shall use Reasonably Diligent
Efforts to develop the Licensed Product in the NSCLC Indication, and in such
Additional Indications as may be mutually agreed upon by the Parties for the
Licensed Product through the Development Committee, and such development shall
be conducted in accordance with the Development Plan. The Parties shall also use
Reasonably Diligent Efforts to develop Licensed Product in such other
Indications, as may be mutually agreed upon by the Parties through the
Development Committee, and development, if any, of Licensed Product in any such
mutually agreed Indication(s) shall be conducted in accordance with the
then-current Development Plan approved by the Development Committee for Licensed
Product in such Indication(s).

 

4.2 Preclinical Development in Indications. Licensee shall not conduct any
preclinical research with respect to Licensed Product without the prior written
approval of the Development Committee. Any such research shall be conducted in
accordance with a research plan to be agreed in writing by the Parties through
the Development Committee. If such research is approved by the Development
Committee, Licensee shall promptly and diligently conduct such research (itself
or through a subcontractor) and shall keep Amgen updated with respect to such
pre-clinical research activities through the Development Committee, and as may
be requested by Amgen from time to time.

 

4.3 Clinical Trials.

 

  4.3.1.

Conduct of Clinical Trials Outside Japan. Amgen shall have the sole right and
obligation to manage and conduct all aspects of all clinical trials for the
Licensed Product in the NSCLC Indication that have been Initiated as of [*] in
the Territory (excluding Japan) and all Ongoing Studies. To the extent any of
the Ongoing Studies currently contemplate use of Japanese sites, Licensee shall
be obligated to conduct the Japanese aspects of the Ongoing Studies pursuant to
Amgen’s overall management of such studies. Amgen shall have the first right,
but not the obligation, to manage and conduct all aspects of all clinical trials
for the Licensed Product in the NSCLC Indication that are Initiated from and
after [*] in the Territory (excluding Japan). Licensee shall have the first
right, but not the obligation, to manage and conduct all aspects of all clinical
trials for the Licensed Product in the first Additional Indication in the
Territory (and shall have the

 

CONFIDENTIAL    Page 18   

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

 

obligation to do so in Japan). For all other Indications, responsibilities
between the Parties shall be decided by the Development Committee.

 

  4.3.2. Licensee’s Conduct of Clinical Trials in Japan. Except with respect to
Ongoing Studies, Licensee shall have the sole right and obligation to manage and
conduct all aspects of all clinical trials for the Licensed Product in all
Indications in Japan, including (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; (v) analyzing and summarizing clinical trial
results; (vi) forecasting clinical manufacturing production requirements; and
(vii) reporting on study design, study outcome, other communications and
regulatory filings to the MHLW. Licensee shall keep the Development Committee
updated with respect to all of its clinical trials in Japan for the Licensed
Product in all Indications.

 

4.4 Regulatory Activities.

 

  4.4.1. Licensee Responsibility. Licensee shall own and be solely responsible
for filing, obtaining and maintaining all Regulatory Approvals for the Licensed
Product in the Indications in the Licensee Territory and any approval for any
product labeling or promotional materials in the Licensee Territory with respect
thereto; and unless otherwise agreed or required by applicable Law, all such
approvals shall be held in the name of Licensee. Licensee shall also be
responsible for any post-approval activities required to be conducted by any
Governmental Authority in the Licensee Territory for Licensed Product; provided
that any post-marketing studies not required by the MHLW or any other
Governmental Authority in the Licensee Territory, shall be submitted to and
approved by the Development Committee prior to commencing any such
post-marketing studies (as set forth in Section 4.5 (Voluntary Post-Marketing
Studies)), and in any event, Licensee shall submit a proposal detailing such
post-marketing studies required by any Governmental Authority in the Licensee
Territory to the Development Committee for review (not approval) and shall keep
the Development Committee apprised of the progress and results thereof.

 

  4.4.2.

Amgen Responsibility. Amgen shall own and be solely responsible for filing,
obtaining and maintaining all Regulatory Approvals for the Licensed Product in
the Indications in the Amgen Territory and any approval for any product labeling
or promotional materials in the Amgen Territory with respect thereto; and unless
otherwise agreed or required by applicable Law, all such approvals shall be held
in the name of Amgen (or its designee). Amgen shall also be responsible for any
post-approval activities required to be conducted by any Governmental Authority
in the Amgen Territory for any Licensed Product; provided that any
post-marketing studies not required by the FDA or any other Governmental
Authority in the Amgen Territory, shall be submitted to and approved by the
Development Committee prior to commencing any such post-marketing studies (as
set forth in Section 4.5 (Voluntary Post-Marketing Studies)), and in any event,
Amgen shall

 

CONFIDENTIAL    Page 19   

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

 

submit a proposal detailing such post-marketing studies required by any
Governmental Authority in the Amgen Territory to the Development Committee for
review (not approval) and shall keep the Development Committee apprised of the
progress and results thereof.

 

4.5 Voluntary Post-Marketing Studies. Should either Party desire to conduct any
post-marketing studies (other than post-marketing studies required by any
Governmental Authority in such Party’s respective territory under the
Collaboration), such Party shall submit a proposal detailing such post-marketing
studies to the Development Committee for review and approval. The Development
Committee shall give due consideration to any concern expressed by a Party that
the conduct of any such post-marketing study could reasonably be expected to
adversely affect such Party’s development or commercialization of a Licensed
Product in any Indication. Should the Development Committee approve any such
post-marketing study, the then-current applicable development plan shall be
amended accordingly and the Party proposing to conduct such post-approval study
shall conduct such study in accordance with the amended development plan and
shall keep the Development Committee apprised of the progress and results
thereof.

 

4.6 Development in Combination. Licensee shall not, without Amgen’s prior
express written consent, conduct any development of Licensed Product in
combination with any other pharmaceutical product. Amgen reserves the right to
develop Licensed Product in combination with other Amgen products or product
candidates but does not intend to develop a single pharmaceutical agent
containing both Licensed Product and another pharmaceutical product. If Amgen
proposes to conduct development of Licensed Product in combination with another
Amgen product or product candidate, the Parties shall discuss conducting such
development within the Collaboration. If and only if the Parties do not agree on
conducting such development within the Collaboration, then Amgen shall have the
right to conduct such development outside the Collaboration at its sole expense.
For the avoidance of doubt, nothing in this Section 4.6 (Development in
Combination) is intended to limit or take away from the exclusive right of
Licensee to sell Licensed Product in the Licensee Territory in accordance with
Sections 3.1 (Licensed Amgen Patents) and 3.2 (Licensed Amgen Know-How).

 

4.7

Sharing of Regulatory Filings. Each Party shall disclose to the other Party a
draft copy of any Regulatory Filing for a Licensed Product in an Indication no
less than [*] days prior to filing it with a Governmental Authority. Each Party
shall consider in good faith any comments made by the other Party with respect
to such filings. Where documents are not in English, each Party shall also
provide an English translation. Amgen shall maintain a centralized 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 each Party
under the Collaboration (in a computer readable format as reasonably specified
by Amgen), and each Party shall have full access to the database. Upon the
request of either Party, the other Party shall provide a right of reference to
any requested Regulatory Filings or Regulatory Approvals for a Licensed Product
in such Party’s respective territory under the Collaboration, in each case as
reasonably necessary for the requesting Party’s development or commercialization
of such Licensed Product as permitted

 

CONFIDENTIAL    Page 20   

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

 

hereunder (and/or, with respect to Amgen, as reasonably necessary for the
manufacture of such Licensed Product). Notwithstanding the foregoing, (i) 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 4.13 (Amgen
Cooperation – Manufacturing Information) to the extent necessary) to Amgen’s
manufacturing information with respect to a Licensed Product or any sections of
any Regulatory Filing related thereto, and (ii) 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 shall develop and agree upon a quality agreement governing
the quality and specifications of clinical Licensed Product to be supplied
hereunder (with commercial product handled separately through the supply
agreement to be entered into pursuant to Section 7.3 (Commercial 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 the
Licensed Product. 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 Japan with respect to the 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 Licensed Product in Japan
without the express 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.

 

4.10 Safety Agreement. Promptly following [*] the safety departments of Amgen
and Licensee shall 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 Product
sufficient to permit each Party, its Affiliates, permitted licensees (including
permitted sublicensees) to comply with Law, including, to the extent applicable,
those obligations contained in applicable Governmental Authority regulations
(including those of the FDA, EMEA and MHLW). The safety data exchange procedures
shall 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 in its respective territory all adverse events
with respect to the Licensed Product anywhere in the Territory, to the extent
required by and in accordance with Law. Each Party shall ensure that its
Affiliates, and permitted licensees (including permitted sublicensees), as
applicable, comply with all such reporting obligations. Each

 

CONFIDENTIAL    Page 21   

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

 

Party will designate a safety liaison to be responsible for communicating with
the other Party regarding the reporting of adverse events with respect to
Licensed Product.

 

4.12 Regulatory Communications.

 

  4.12.1. Licensee Responsibility. Licensee shall have primary 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 Product in Indications with applicable Governmental Authorities in the
Licensee Territory (other than (i) as set forth in Section 4.12.2 (Amgen
Responsibility), with respect to the NSCLC Indication for the Licensed Product;
and (ii) with respect to manufacturing in the Territory (except 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)), and Licensee shall do so in a timely manner and in
accordance with Law. Without prejudice to the time periods relevant to
Regulatory Filings pursuant to Section 4.7 (Sharing of Regulatory Filings),
Licensee shall supply to Amgen a copy of: (a) all material 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 (b) all material 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 Section 4.12.1
(Licensee Responsibility) unless changed. Where correspondence or communications
are not in English, Licensee shall also provide an English summary and
translation. Licensee shall consider in good faith any comments or suggestions
made by Amgen with respect to any such communication. Amgen shall, upon
Licensee’s request, reasonably cooperate with Licensee in responding to any
inquiry made by a Governmental Authority in the Licensee Territory regarding
Licensed Product in any Indications, and, with respect to Japan, 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
Licensed Product, and Licensee shall give Amgen at least [*] days prior written
notice 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 (i) the Licensed
Product in Indications with applicable Governmental Authorities in the Amgen

 

CONFIDENTIAL    Page 22   

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

 

Territory, (ii) the Licensed Product in the NSCLC Indication with applicable
Governmental Authorities in the Territory (other than Japan), provided that, in
the Licensee Territory, such responsibility shall transition to Licensee as of
the time that a Regulatory Filing seeking Regulatory Approval has been submitted
by Licensee, and further provided that Amgen shall reasonably cooperate with
Licensee in such transition in accordance with Section 4.12.1 (Licensee
Responsibility) and (iii) regarding the manufacture of the Licensed Product in
the Territory. Without prejudice to the time periods relevant to Regulatory
Filings pursuant to Section 4.7 (Sharing of Regulatory Filings), Amgen shall
supply to Licensee a copy of: (a) all material 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
(b) all material correspondence and communications from any such Governmental
Authority within [*] days after receipt of any such correspondence. Amgen shall
consider in good faith any comments or suggestions made by Licensee with respect
to any such communication. Licensee shall reasonably cooperate with Amgen in
responding to any inquiry made by a Governmental Authority in the Amgen
Territory regarding Licensed Product in any Indications. Licensee shall be
entitled to observe and participate in any discussions between Amgen and any
Governmental Authority relating to Licensed Product, and Amgen shall give
Licensee at least [*] days prior written notice thereof (or prompt written
notice, if [*] days notice is impractical). Should Amgen be unable to solicit
Licensee’s participation in any such discussion (as, for example, with respect
to a call or visit to Amgen by such Governmental Authority without notice), then
Amgen shall provide Licensee prompt written notice of such communication with a
summary of the discussion. Notwithstanding the above, Amgen shall not be
required to disclose manufacturing information (except as set forth in
Section 4.13 (Amgen Cooperation – Manufacturing Information)).

 

4.13 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 Licensee 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 Licensee 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).

 

CONFIDENTIAL    Page 23   

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

4.14 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 a
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 4.14.1 (Licensee Right) or
4.14.2 (Amgen Right) shall have the right to take immediate action with notice
to the other Party when the regulatory timeframes or public safety
considerations 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 4.14.1 (Licensee Right) or 4.14.2 (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 4.14.1 (Licensee Right) or 4.14.2 (Amgen Right) shall promptly comply
with such order with written notice to the other Party.

 

  4.14.1. Licensee Right. Licensee shall have the sole right to control a Recall
of a Licensed Product in the Licensee Territory in all Indications. Licensee
shall maintain complete and accurate records of any Recall it has the right to
control pursuant to this Section 4.14 (Recalls) for such periods as may be
required by Law, but in any event for no less than [*] years.

 

  4.14.2. Amgen Right. Amgen shall have the sole right to control a Recall of a
Licensed Product in the Amgen Territory in all Indications. Amgen shall maintain
complete and accurate records of any Recall it has the right to control pursuant
to this Section 4.14 (Recalls) for such periods as may be required by Law, but
in any event for no less than [*] years.

 

CONFIDENTIAL    Page 24   

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

4.15 Cooperation.

 

  4.15.1. Cooperation Generally. Subject to the oversight of the Development
Committee as set forth in Article 2 (Collaboration Scope and Governance), and
without limiting any of the Parties’ obligations hereunder, the Parties shall
provide each other with any cooperation reasonably requested by the other with
respect to Licensee’s development of Licensed Product in the Licensee Territory,
and Amgen’s development of Licensed Product in the Amgen Territory.

 

  4.15.2. Licensee Development in Japan. Licensee shall keep the Development
Committee fully and promptly informed of the progress and results of Licensee’s
development activities with respect to Licensed Product in Japan and shall take
into consideration, and act on as appropriate, any reasonable requests by the
Development Committee with respect thereto.

5 COMMERCIALIZATION

 

5.1 Operational Control in Licensee Territory. Licensee shall have control and
responsibility for commercialization of the Licensed Product in the Licensee
Territory in all Indications, subject to Section 5.3 (Commercialization in
Europe), Amgen’s right to co-promote in accordance with Section 5.5
(Co-Promotion Rights) or as otherwise agreed by the Commercialization Committee.
Licensee shall promote and commercialize the Licensed Product using only
professional and well-trained employees of Licensee, and may utilize a contract
sales organization hired only on a fee-for-service basis in connection with a
Licensed Product upon prior written notice to Amgen except with respect to
Europe for which region the Parties shall engage in good faith discussions as
how best to utilize the capabilities of Amgen with respect to commercialization
activities in Europe. In no event shall Licensee use the sales personnel of a
Third Party pharmaceutical or biotech company or affiliate thereof without
Amgen’s prior written approval. Licensee shall reasonably consider any interest
that Amgen may have in providing its sales personnel to supplement the sales
personnel of Licensee.

 

5.2 Operational Control in the Amgen Territory. Amgen shall have control and
responsibility for commercialization of the Licensed Product in the Amgen
Territory in all Indications, subject to Licensee’s right to co-promote in
accordance with Section 5.5 (Co-Promotion Rights).

 

5.3 [*] With respect to [*].

 

5.4

Responsibilities. Each Party shall conduct such commercialization in accordance
with the then-current commercialization plan approved by the Commercialization
Committee. Subject to the foregoing, with respect to Licensee and Licensed
Product in Indications in the Licensee Territory, and Amgen and Licensed Product
in Indications in the Amgen Territory, each Party’s responsibilities shall
include: (i) execution of the global commercial plan approved by the
Commercialization Committee within each Party’s respective territory (e.g.,
strategies for branding, product positioning, pre-launch activities (e.g.,
market research), launch and post-launch marketing and promotion, and field
sales

 

CONFIDENTIAL    Page 25   

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

 

force optimization); (ii) pricing and reimbursement; (iii) determination of
packaging and labeling (provided, however, that each Party shall have the right
to participate in any discussions with Governmental Authorities in the other
Party’s territory with respect to labeling in accordance with Section 4.12
(Regulatory Communications)); (iv) creation of promotional materials regarding
the Licensed Product which are intended for distribution to Third Parties
(including medical professionals) and to such Party’s sales force (subject to
Section 3.7 (Trademark Quality Standards)); (v) conducting post-marketing
studies required by a Governmental Agency; (vi) determining and conducting
promotion activities; and (vii) 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 and collecting prescription tracking, call reporting,
handling data regarding sales to hospitals and other end users and handling all
other customer service-related functions.

 

5.5 Co-Promotion Rights. Amgen shall have the right, on an
Indication-by-Indication basis, upon [*] months prior written notice to
Licensee, to co-promote each Licensed Product in one or more Indications in one
or more countries of the Licensee Territory, and Licensee shall have the right,
on an Indication-by-Indication basis, upon [*] months prior written notice to
Amgen, to co-promote Licensed Product in one or more Indications in one or more
countries in the Amgen Territory, from and after the First Commercial Sale of
such Licensed Product in the applicable country. Each Party shall provide the
other Party with any information reasonably requested by the other Party to
allow the other Party to consider whether to exercise such right. Neither party
shall have the right to elect to co-promote in any country of the other Party’s
territory after the First Commercial Sale of such Licensed Product has taken
place in that country. Should a Party elect to co-promote a Licensed Product in
one or more Indications in the other Party’s territory, such Party may elect to
provide up to [*] of the details for such Indication, and such Party’s notice of
exercise of its option shall specify the percentage of total details (up to such
[*] maximum) that such Party desires to perform for such Indication. The Parties
shall discuss the means by which each sales force has the appropriate incentives
to promote the Licensed Product. 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 each Party’s
sales force composition and strategic focus in the applicable country or
territory, as applicable, so as not to unreasonably interfere with the other
Party’s commercialization activities hereunder but each Party shall have the
right to make the final decision with respect to commercialization of Licensed
Product in its territory. Each Party shall have the right to terminate its
co-promotion activities with respect to any or all Indications for a Licensed
Product and/or in one or more countries of the other Party’s territory upon [*]
days notice to the other Party, and the Parties shall cooperate to transition
such activities to the other Party 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, consistent with the terms and
conditions set forth in this Agreement.

 

5.6

Compliance with Laws, Regulations and Guidelines. Each Party shall comply with
Law with respect to the development and commercialization of the Licensed
Product in the

 

CONFIDENTIAL    Page 26   

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

 

Indications in connection with the Collaboration. Neither Party shall be
required to undertake any activity relating to the commercialization of a
Licensed Product in, with respect to Licensee, the Licensee Territory, or with
respect to Amgen, the Amgen Territory, that it believes, in good faith, may
violate any Law.

 

5.7 Cooperation.

 

  5.7.1. Cooperation Generally. Subject to the oversight of the
Commercialization Committee as set forth in Article 2 (Collaboration Scope and
Governance), and without limiting any of the Parties’ obligations hereunder, the
Parties shall provide each other with any cooperation reasonably requested by
the other with respect to Licensee’s commercialization of Licensed Product in
the Licensee Territory, and Amgen’s commercialization of Licensed Product in the
Amgen Territory.

 

  5.7.2. Licensee Commercialization in Japan. Without limiting any of its
obligations hereunder, Licensee shall keep the Commercialization Committee fully
and promptly informed of the progress and results of Licensee’s
commercialization activities with respect to Licensed Product in Japan and shall
take into consideration, and act on as appropriate, any reasonable requests by
the Commercialization Committee with respect thereto.

 

6 DILIGENT EFFORTS; DISTRACTING PROGRAMS AND TRANSACTIONS

 

6.1 Reasonably Diligent Efforts. Each Party shall use Reasonably Diligent
Efforts to develop, and obtain Regulatory Approval for and commercialize in its
respective territory, in all cases in accordance with the then-current
Development Plan or commercialization plan, as applicable, the Licensed Product
in the NSCLC Indication, and in such Additional Indications as may be mutually
agreed upon by the Parties through the Development Committee.

 

6.2 Activities Outside the Collaboration. Except as set forth in Sections 6.3
(Addition of Distracting Products) and 6.4 (Distracting Transactions), prior to
the Distracting Product Expiration Date, neither Party shall, itself or through
its Affiliates, directly or indirectly, [*]. For the avoidance of doubt, either
Party may, itself or through its Affiliates, directly or indirectly, [*] and [*]
any Distracting Product prior to [*] for such Distracting Product.

 

6.3

Addition of Distracting Products. Each of the Parties may pursue [*] the
clinical development of a Distracting Product (and manufacture Distracting
Product for such purpose) at its sole expense until such time as the Party is
ready to [*] of such Distracting Product with the first Governmental Authority.
The Party developing the Distracting Product (the “Developing Party”) shall
provide prompt written notice to the other Party (the “Non-Developing Party”)
upon the [*] for such Distracting Product, and thereafter update the Development
Committee at least annually, regarding the progress and results of the [*] of
such Distracting Product. As of the time the Developing Party has [*] for such
Distracting Product, the Non-Developing Party shall have the right to [*] of
Licensed Product throughout the Territory, including having a [*] by any of the
committees provided for under this Agreement, and shall [*] in the best
interests of

 

CONFIDENTIAL    Page 27   

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

 

Licensed Product. The Developing Party shall provide prompt written notice of
the [*] for a Distracting Product to the Non-Developing Party, but in no event
later than [*] after the occurrence of such [*]. At least [*] prior to the
expected date of [*] of such Distracting Product, the Developing Party shall
provide the Commercialization Committee a commercialization plan for such
Distracting Product (and any other Information related to such Distracting
Product reasonably requested by any member of the other Party of the
Commercialization Committee, including the [*] for such Distracting Product) for
the Non-Developing Party’s review and determination of whether to include such
Distracting Product in the Collaboration. The Non-Developing Party will have the
right to approve inclusion of the Distracting Product into the Collaboration
within [*] days following the date the Developing Party provides the
commercialization plan for the Distracting Product to the Commercialization
Committee (and the Developing Party shall seek to promptly provide to the
Non-Developing Party any other Information reasonably requested during such
period). If the Non-Developing Party approves the inclusion of such Distracting
Product into the Collaboration, such Distracting Product shall be deemed a
Licensed Product and the Parties shall [*] with respect to such Licensed Product
[*] of this Agreement, in each case except as set forth in Section 6.5
(Collaboration Terms with respect to a Distracting Product). If the
Non-Developing Party does not approve the inclusion of such Distracting Product
into the Collaboration, the Developing Party shall [*]; provided however,
(i) the Developing Party shall [*] of such Distracting Product in the Territory
during the Term; and (ii) as of the time the Developing Party has s[*] of such
Distracting Product, the Non-Developing Party shall (x) have the right to [*] of
Licensed Product throughout the Territory, including having a [*] any of the
committees provided for under this Agreement, and shall [*] in the best
interests of Licensed Product, and (y) have the right to [*], with respect to
Licensed Product throughout the Territory (collectively the items in clauses
(i) and (ii), the “Distracting Product Commercial Conditions”). The Developing
Party shall provide prompt written notice of the [*] of such Distracting Product
to the Non-Developing Party, but in no event later than [*] days after the
occurrence of such [*]. Unless and until a Distracting Product has been approved
for inclusion in the Collaboration pursuant to this Section 6.3 (Addition of
Distracting Products), the Developing Party shall ensure that information and
materials relating to the Collaboration are not shared with or used for the
benefit of, and are sequestered from, personnel working on the Distracting
Program (and vice versa) and that no personnel working on the Distracting
Program works on the Collaboration (and vice versa). The obligations of the
Developing Party and the rights of the Non-Developing Party under this
Section 6.3 (Addition of Distracting Products) shall expire [*] (the applicable
date, the “Distracting Product Expiration Date”); provided, however, that any
right (other than a right to receive annual progress reports) of the
Non-Developing Party under this Section 6.3 (Addition of Distracting Products)
that is triggered (e.g., the applicable event occurs to permit exercise of such
right) prior to the Distracting Product Expiration Date shall survive, and with
respect to any Distracting Product for which the first [*] of such Distracting
Product had been filed prior to the Distracting Product Expiration Date, (1) if
such Distracting Product is included into the Collaboration, such inclusion (and
the corresponding rights and obligations under this Agreement) shall survive
such expiration, and (2) if such Distracting Product is not included into the
Collaboration, the Distracting

 

CONFIDENTIAL    Page 28   

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

  Product Commercial Conditions, and the obligation to maintain the Distracting
Program separate from the Licensed Product program, shall survive such
expiration with respect to such Distracting Product.

 

6.4 Distracting Transactions. In the event that either Party or any of its
Affiliates (a “Distracting Transaction Party”), directly or indirectly, enter
into, or agree with a Third Party to enter into, a Distracting Transaction, then
it shall provide prompt written notice to the other Party, but in no event later
than [*] days after the closing of the Distracting Transaction, specifying the
identity of the actual or potential Distracting Transaction Affiliate(s) and
describing in reasonable detail, to the extent permitted by Law and without
disclosing any proprietary information of or about the Distracting Program, the
Distracting Program and its focus. Unless and until the Distracting Products
have been approved for inclusion in the Collaboration pursuant to Section 6.3
(Addition of Distracting Products), the Distracting Transaction Party shall
ensure that information and materials relating to the Collaboration are not
shared with or used for the benefit of, and are sequestered from, such
Distracting Transaction Affiliate(s) and personnel working on the Distracting
Program (and vice versa) and that no personnel working on the Distracting
Program works on the Collaboration (and vice versa). The notice provided by the
Distracting Transaction Party shall include a notification as to whether the
Distracting Transaction Party intends to: (i) Divest the Distracting Program, in
which case it shall hold separate such Distracting Program and use its
commercially reasonable, good-faith efforts to Divest such Distracting Program;
(ii) terminate such Distracting Program, in which case the Distracting
Transaction Party shall terminate all activities of such program within [*] days
after the closing of the Distracting Transaction, during which period the
Distracting Transaction Party shall hold separate such Distracting Program; or
(iii) continue the development of such Distracting Program at its sole expense
subject to Section 6.3 (Addition of Distracting Products). In the event the
Distracting Transaction Party selects option (i) and fails to complete such
divestiture within [*] of the closing of the Distracting Transaction, then the
Distracting Transaction Party shall be deemed to have selected option
(iii) (effective as of the date of the notice provided pursuant to this
Section 6.4 (Distracting Transactions). In the event a Distracting Product is
already being commercialized at the time of the closing of the Distracting
Transaction, such Distracting Product shall trigger the Distracting Product
Commercial Conditions, including the obligation to [*] the other Party, unless
and until (a) the Distracting Transaction Party has completed the divestiture of
such Distracting Program under option (i) or fully terminated such Distracting
Program under option (ii); or (b) the Parties negotiate and consummate terms and
conditions under which such Distracting Product shall be included in the
Collaboration.

 

6.5

Collaboration Terms with respect to a Distracting Product. Upon inclusion of a
Distracting Product into the Collaboration as a Licensed Product pursuant to
Section 6.3 (Addition of Distracting Products), the following exceptions with
respect to Article 8 shall apply: (i) [*] will be applicable with respect to
such Licensed Product; (ii) from and after inclusion of the Licensed Product in
the Collaboration, the Parties will [*], such that the Non-Developing Party will
[*] and the Developing Party will [*]; (iii) the non-Developing Party will [*]
for such Licensed Product; and (iv) if Licensee is the Developing Party or the
Distracting Transaction Party with respect to such new Licensed

 

CONFIDENTIAL    Page 29   

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

 

Product, the [*] with respect to such new Licensed Product shall be [*] of such
new Licensed Product in Japan. Further, each Party shall have primary
responsibility for Patent Matters of the patents and patent applications
Controlled by it relating to such Licensed Product not already being handled
hereunder with respect to another Licensed Product in the Collaboration, and
each Party shall have the first right to enforce such patents (and the
corresponding know-how) in its respective commercial territory. The Parties will
discuss in good faith how best to provide clinical and commercial supply of such
Licensed Product and the handling of regulatory responsibilities with respect to
the manufacture of such Licensed Product.

 

6.6 Additional Indications. The Parties shall develop and commercialize the
Licensed Product in the NSCLC Indication and will discuss the merits of pursuing
additional indications. Should either Party wish to develop or commercialize the
Licensed Product in an indication other than the NSCLC Indication, such Party
shall submit to the Development Committee for review and approval a written
proposal for the expansion of the definition of Indications to include such
indication. The Party wanting to develop any such additional Indication shall
provide the Development Committee any and all information reasonably requested
by the Development Committee in order to allow the Development Committee to
understand the circumstances and relevant factors with respect to such request.
The Development Committee shall have the right to approve or reject the
expansion of the definition of Indications in accordance with Section 2.9.4
(Decision Making). Should the Development Committee approve expansion of the
definition of Indication to include the newly proposed indication, then such
indication shall, from such point forward, be an Indication for all purposes
under this Agreement. Should the Development Committee not approve the addition
of the newly proposed indication, then the Parties shall not develop or
commercialize such Licensed Product in the indication so proposed under the
Collaboration nor outside the Collaboration.

 

7 MANUFACTURE AND SUPPLY

 

7.1 Manufacturing Rights. No rights are granted to Licensee hereunder to
manufacture Licensed Product or to obtain Licensed Product from any entity other
than Amgen or its designee. Licensee shall not manufacture Licensed Product or
obtain Licensed Product from any entity other than Amgen or its designee, except
as expressly provided in this Agreement, 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 Product
for use in clinical development solely from Amgen or its designee, and Amgen
shall supply or shall cause its designee to supply Licensee with Licensee’s
requirements of Licensed Product for use in clinical development, 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 a commercial supply agreement
to be entered into in accordance with Section 7.3 (Commercial Supply) with
respect to Licensed Product provisions for clinical supply of such Licensed
Product.

 

CONFIDENTIAL    Page 30   

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

7.3 Commercial Supply. Licensee shall obtain its requirements of Licensed
Product for commercial use in the Licensee Territory solely from Amgen or, at
Amgen’s option, Amgen’s designee, and Amgen shall supply or, at Amgen’s option,
shall cause its designee to supply Licensee with Licensee’s requirements of
Licensed Product for commercial use. Upon the request of either Party, the
Parties shall negotiate in good faith a commercial supply agreement for the
commercial supply of Licensed Product to Licensee for use in the Licensee
Territory. The terms of such commercial supply agreement shall be materially
consistent with the Supply Agreement Term Sheet Schedule attached hereto. At
Amgen’s election, in lieu of entering into a commercial supply agreement with
respect to Licensed Product, Licensee will contract directly with the Third
Party manufacturer(s) used by Amgen for supply of Licensed Product in order to
obtain Licensee’s requirements of Licensed Product.

 

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 Licensed Product supplied 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 commercial supply agreement between the Parties or other agreement
between the Parties; or (ii) Amgen has maintained manufacturing responsibility
but notifies Licensee that it wishes to transition Manufacturing Filing
Responsibilities with respect to Licensed Product to Licensee. In any of the
foregoing cases, the Parties shall cooperate to transition such responsibility.
In any such case, Licensee thereafter shall be solely responsible for the
Manufacturing Filing Responsibilities and shall provide Amgen the same rights
with respect to correspondence, communication and regulatory filings related to
such manufacturing as provided for other correspondence, communication and
Regulatory Filings in Sections 4.7 (Sharing of Regulatory Filings) and 4.12.1
(Licensee Responsibility) (including as if regulatory filings for manufacturing
of Licensed Product were Regulatory Filings). Each Party shall provide the Party
responsible for such regulatory filings any cooperation reasonably requested by
such responsible Party in connection with any such filings.

 

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 One Hundred Million U.S. Dollars (US$100,000,000)
within [*] days after [*].

 

  8.1.2.

Development Milestone Payments. Licensee shall pay Amgen the following
non-refundable, non-creditable development and commercial milestone payments as
set forth below, in each case within [*] days after the occurrence of the

 

CONFIDENTIAL    Page 31   

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

 

corresponding event with respect to the first Licensed Product to achieve such
event. If a milestone payment becomes due for occurrence of a milestone event
with respect to Licensed Product in a particular country or region of the
Territory (i.e., the United States, Europe or Japan) for a particular Indication
and Licensee has not paid a milestone payment listed prior in order in the below
table to the milestone payment then due for such Licensed Product with respect
to such country or region for such Indication, then Licensee shall pay all such
previously listed and unpaid milestone payment concurrently with payment of the
milestone payment then due (regardless of whether or not the milestone event
corresponding to the previously unpaid milestone payment has occurred with
respect to such Licensed Product in such country or region for such Indication).
For the avoidance of doubt, in the event the first sale of a Licensed Product
takes place for a use recognized by insurance payers, established drug compendia
or other process enabling payment or reimbursement prior to Regulatory Approval,
Licensee shall pay Amgen both the Regulatory Approval and First Commercial Sale
milestone payments with respect to such first sale event.

 

Milestone Event

   Payment Amount (in US Dollars)      [*]   [*]

[*]

    

[*]

   [*]   [*]

[*]

   [*]   [*]

[*]

   [*]   [*]

[*]

   [*]   [*]

[*]

   [*]   [*]

[*]

   [*]   [*]

[*]

   [*]   [*]

 

8.2 Cost Sharing and Profit Sharing Arrangement.

 

  8.2.1. Cost Sharing and Profit Sharing.

(i) The Parties shall share Development Costs for the Licensed Product on a
worldwide basis (excluding Japan), such that Licensee shall bear a sixty percent
(60%) share and Amgen shall bear a forty percent (40%) share.

(ii) The Parties shall share Operating Expenses for the Licensed Product on a
worldwide basis (excluding Japan), such that Licensee shall bear a fifty percent
(50%) share and Amgen shall bear a fifty percent (50%) share.

(iii) The Parties shall share all Gross Profit generated under the Collaboration
for the Licensed Product in all Indications in the Territory (excluding Japan)
(when recognized, in accordance with GAAP) equally, with each Party having a
fifty percent (50%) share.

 

CONFIDENTIAL    Page 32   

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

(iv) Neither the license fee nor any of the development milestone payments paid
by Licensee pursuant to Section 8.1 (License Payments by Licensee), nor any
amounts paid by License with respect to Japan or supply therefor, to Amgen shall
be included in the cost sharing and profit sharing arrangement between the
Parties.

 

  8.2.2. Reports. Within [*] days after the end of each [*] Quarter, each Party
shall provide to the other Party a written report specifying in reasonable
detail (and any other supporting information reasonably requested by the
Parties) the Gross Profit, Operating Expenses and Development Costs for such
Party incurred during such [*] Quarter (excluding Japan), and, if reasonably
requested by the other Party, supporting documentation. Such written report of
each Party shall state for such [*] Quarter and for each country covered by such
Party’s territory under the Collaboration (excluding Japan): (i) such Party’s
Development Costs; (ii) such Party’s Operating Expenses and the calculation
thereof; and (iii) such Party’s Gross Profit and the calculation thereof
(including specifying gross sales, the Net Sales by or on behalf of such Party,
its Affiliates or licensees during the applicable [*] Quarter (detailed with
gross invoiced amounts and deductions, including Cost of Goods Sold), Cost of
Sales and Recoveries, if any). Any reports that contain currency conversions
shall provide the details and background information used to calculate such
conversions. In no event will any individual cost be counted more than once
(e.g., the same individual cost will not be included within Development Costs
and Other Collaboration Costs). The Parties will report all amounts required
under this Section 8.2.2 (Reports) in U.S. Dollars.

 

  8.2.3. Reconciliation and Payment. Within [*] days after each Party’s receipt
of such report (and any requested supporting documentation), Amgen shall
calculate each Party’s share of the total Development Costs, Operating Expenses
and the Gross Profit for the applicable [*] Quarter, in each case in accordance
with Section 8.2.1 (Cost Sharing and Profit Sharing) and perform one
reconciliation of the Development Costs, and a second reconciliation of
Operating Expenses and Gross Profit to derive each Party’s Net Operating Profit,
and provide to Licensee a written report of each such reconciliation
calculation. With respect to each reconciliation calculation, if one Party owes
a payment to the other Party, then such owing Party shall make such payment to
the other Party within [*] days after delivery of such report to Licensee.

 

8.3 Royalty Payments with respect to Sales in Japan. In consideration of the
rights granted by Amgen to Licensee hereunder, Licensee shall pay Amgen a
royalty of [*] on Net Sales of Licensed Product (across all Indications) in
Japan during the Term.

 

8.4 Calculation of Net Sales. In calculating Net Sales:

 

  8.4.1. 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.

 

CONFIDENTIAL    Page 33   

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

  8.4.2. 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 Product) in the
applicable country or territory; Y is the sum of the average sales price during
the applicable reporting period generally achieved in the applicable country or
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.

 

  8.4.3. Non-Monetary Consideration. Upon any sale or other disposal of Licensed
Product that should be included within Net Sales for any consideration other
than an exclusively monetary consideration on bona fide arm’s length terms, then
for purposes of calculating the Net Sales under this Agreement, such Licensed
Product shall be deemed to be sold exclusively for money at the average sales
price during the applicable reporting period generally achieved for such
Licensed Product in the country in which such sale or other disposal occurred
when such Licensed Product is sold alone and not with other products.

 

8.5 Reports for Net Sales in Japan. Beginning with the [*] Quarter after the
First Commercial Sale of a Licensed Product in Japan and thereafter for each [*]
Quarter until the expiration of Licensee’s obligation to pay royalties hereunder
with respect to Japan pursuant to Section 8.3 (Royalty Payments with respect to
Sales in Japan), royalty payments and reports of the sale of each Licensed
Product in Japan 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 in Japan stating: (i) Net Sales of each
Licensed Product in Japan (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
(ii) a calculation of the royalty payment due from Licensee hereunder for such
[*] Quarter. Any reports that contain currency conversions shall provide the
details and background information used to calculate such conversions. Licensee
shall include in such reports such additional information as reasonably
requested by Amgen, whether to enable Amgen to comply with its obligations to
its licensors or otherwise.

 

8.6 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.

 

CONFIDENTIAL    Page 34   

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

8.7 Payment Method. All payments made hereunder between the Parties shall be
made in U.S. Dollars except as set forth in Section 8.9 (Blocked Currency).
Licensee shall pay all sums due hereunder by check, wire transfer, or electronic
funds transfer (EFT) in 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 8.11 (Withholding) and Section 8.12 (VAT)).

 

8.8 Audits. Each Party shall keep complete and accurate records relating to
expenses and costs pertaining to the development and sale of the Licensed
Product in its respective territory in sufficient detail to permit the other
Party 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 8.8 (Audits)) to
inspection for [*] following the end of the period to which they pertain. Each
Party shall have the right, at its own expense, to have an independent,
certified public accountant, selected by it review the records of the other
Party 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. Each Party’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 [*]. Should the inspection lead to
the discovery of a discrepancy to the detriment of the auditing Party, then the
other Party shall pay to the auditing Party the amount of the discrepancy plus
interest accrued at the Contract Interest Rate, compounded daily from the day
the relevant payment(s) were due. Should the inspection lead to the discovery of
a discrepancy to the detriment of the Party being audited, then the auditing
party shall pay to the other Party the amount of the discrepancy without
interest. The auditing Party shall pay the full cost of the inspection unless
the discrepancy is to the detriment of the auditing Party and is greater than
[*] of the amount actually paid for the audited period, in which case the Party
being audited shall pay the cost of such inspection.

 

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

 

8.10 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 8.11 (Withholding).

 

8.11

Withholding. In the event that Law requires a Party to pay or withhold Taxes
with respect to any payment to be made by such Party pursuant to this Agreement,
such Party shall notify the other Party in writing of such payment or
withholding requirements prior to making the first payment to the other Party in
which any such payment or withholding of Taxes will be deducted and provide such
assistance to the other Party, including the

 

CONFIDENTIAL    Page 35   

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

 

provision of such documentation as may be required by a tax authority, as may be
reasonably necessary in the other Party’s efforts to claim an exemption from or
reduction of such Taxes. If the Party required to make the payment pursuant to
this Agreement, in accordance with Law, withholds Taxes from the amount due, it
shall remit such Taxes to the appropriate tax authority, and furnish the other
Party with proof of payment of such Taxes within [*] days following payment
thereof. If Taxes are paid to a tax authority, the Party that made the
withholding shall provide such assistance to the other Party as is reasonably
required to obtain a refund of Taxes withheld, or obtain a credit with respect
to Taxes paid.

 

8.12 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).

 

8.13 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 8.13 (Late Payment) shall in no way limit any other remedies available
to either Party.

 

8.14 Third Party Royalties. Except as expressly set forth in Sections 8.11
(Withholding) and 8.12 (VAT), Licensee shall not have the right to make any
deduction from amounts payable to Amgen pursuant to Sections 8.1 (License
Payments by Licensee) and 8.3 (Royalty Payments with respect to Sales in Japan)
of 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,
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 Licensee Territory.

 

  (i)

[*] shall have the right, but not the obligation, to control, itself or through
outside counsel reasonably acceptable to [*] and directed by [*], the

 

CONFIDENTIAL    Page 36   

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

 

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 [*] shall reasonably [*].

 

  (ii) [*] it shall give [*] reasonable notice thereof [*] and continue the
prosecution or maintenance of such patent, trademark or application and [*] with
respect to [*] control Patent Matters with respect to such patent, trademark or
application [*] in accordance with this Section 9.2.1(ii) ([*] shall control,
itself or through outside counsel reasonably acceptable to [*] and directed by
[*] with respect to [*] as well as preparation and filing for any patent term
extensions or similar protections [*].

 

  9.2.2. [*] Territory. [*] shall control and be [*] responsible for all Patent
Matters with respect to its patent rights, trademark rights and other
intellectual property [*]. [*] shall control and be [*] responsible for Patent
Matters with respect to Joint Patents [*]. [*]

 

9.3 Defense and Settlement of Third Party Claims. [*] that a [*] by the [*], [*]
shall have the [*] right [*] that a [*] by the [*] shall have the [*] right to
[*] with respect to [*] Subject to such [*] may [*] this Section 9.3 (Defense
and Settlement of Third Party Claims), [*] with respect to [*]. The [*] shall
seek and reasonably [*] for such matter. [*] shall keep [*], and shall [*]

 

     [*].

 

9.4 Enforcement.

 

  9.4.1. In Licensee Territory. Each Party shall promptly notify the other Party
in writing if it reasonably believes that any Licensee Territory Patents and
Trademarks or Licensed Amgen Know-How in the Licensee Territory (collectively,
“Licensee Territory IP”) are infringed or misappropriated by a Third Party in
the Licensee Territory.

 

  (i) [*]. Without limiting the foregoing, [*].

 

  (ii) [*] Without limiting the foregoing, [*].

 

  9.4.2. Amgen Territory. Licensee shall promptly notify Amgen in writing if it
reasonably believes that any patent, trademark, know-how or other intellectual
property Controlled by Amgen that relates to the Licensed Product are infringed
or misappropriated by a Third Party in the Amgen Territory. [*].

 

CONFIDENTIAL    Page 37   

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

9.5 Allocation of Recoveries. All Recoveries [*] shall be [*]. With respect to
[*], all Recoveries shall [*]. Any Recoveries that are [*] shall be [*]. For the
avoidance of doubt, 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.

 

9.7 Employee Agreements. Prior to [*] relating to [*], [*] shall have [*]
pursuant to which [*] and appropriate, and substantially including: [*] It is
understood and agreed by the Parties that [*] and that the [*] shall be
sufficient to [*] Each Party shall [*].

 

9.8 Patent Marking. Licensed Product 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 Licensee
Territory.

 

9.9 Cooperation. Each Party shall provide the other Party, at the other Party’s
reasonable request, such assistance and cooperation as may be requested with
respect to any Patent Matters, litigation or other activities related to patent
rights and other intellectual property.

 

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, or otherwise obtained from, the other Party
pursuant to this Agreement, in whatever form or medium (collectively,
“Confidential Information”) (including information known by the employees of
Amgen KK, a wholly-owned subsidiary of Amgen, and/or materials in the possession
of Amgen KK prior to the consummation of the transactions contemplated in that
certain Sale and Purchase Agreement executed concurrently herewith, which shall
be considered the Confidential Information of Amgen). Licensee acknowledges the
value of Confidential Information (including data provided by Amgen hereunder)
and shall have no right to and shall not utilize any Confidential Information of
Amgen for activities in the Territory (including, with respect to the research,
development or commercialization of any Distracting Product or other programs or
products of Licensee in the Territory or for any other purpose) except as
expressly provided for in this Agreement. For the avoidance of doubt,
Confidential Information of a Party shall include 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

 

CONFIDENTIAL    Page 38   

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

 

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:

 

  (i) 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;

 

  (ii) was generally available to the public or otherwise part of the public
domain at the time of its disclosure to the receiving Party;

 

  (iii) 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;

 

  (iv) 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

 

  (v) 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

 

CONFIDENTIAL    Page 39   

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

 

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 Terms and Conditions Confidential. Neither Party shall disclose the terms
and conditions of this Agreement except as may be required by 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). 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 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 Product 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).

 

10.4 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 thereunder relating to the Licensed Product 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.

 

10.5 Publications.

 

  10.5.1. Publication Plan. The Parties shall regularly consult (no less than
[*]) and confer with respect to a global publication plan for Licensed Product
with the understanding that neither Party can publish without the consent of the
other Party. Should the Parties agree in writing that the publication with
respect to Licensed Product by Amgen or Licensee is appropriate, then Amgen or
Licensee, respectively, shall have the right to make such publication subject to
Section 10.5.2 (Oversight and Review).

 

  10.5.2.

Oversight and Review. Except as required by Law or court order, with respect to
any publication or presentation concerning the activities conducted in the

 

CONFIDENTIAL    Page 40   

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

 

Territory hereunder with respect to Licensed Product, including studies or
clinical trials carried out by a Party under this Agreement, 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.

 

10.6 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;

 

CONFIDENTIAL    Page 41   

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

  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 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; and

 

  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.

 

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

 

  11.2.1. Amgen has provided Licensee with [*] with respect to Licensed Product,
and has [*] information relating to [*] that are [*] 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. To the best of Amgen’s knowledge, there are [*] with respect to [*]
outside the [*], and there is no [*] of the [*] outside the [*]; and

 

  11.2.4. Except as referenced on the [*] Schedule, to the best of Amgen’s
knowledge Amgen has [*] which [*] that the [*] of an [*].

 

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:

 

CONFIDENTIAL    Page 42   

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

  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;

 

  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 relating to any
patent, trademark or other proprietary right 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 12
(Indemnification), (ii) breach of Section 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) paid to a Third Party

 

CONFIDENTIAL    Page 43   

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

 

(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 gross negligence or willful
misconduct of Licensee, or its Affiliates or agents in exercising its rights or
performing its obligations under this Agreement, or (ii) a material breach by
Licensee of this Agreement, including any failure of Licensee’s representations
or warranties in Section 11.1 (Mutual Representations and Warranties) to be true
in any material respect when made, but excluding such Losses to the extent they
arise from (y) or (z) below. Subject to the remainder of this Article 13
(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 gross
negligence or willful misconduct of Amgen, or its Affiliates or agents in
exercising its rights or performing its obligations under this Agreement, or
(z) a material 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 in any material respect when made, but excluding such
Losses to the extent they arise from (i) or (ii) above. The indemnification
obligations of this Article 13 (Indemnification) shall not apply to commercial
supply obligations; any indemnification obligations related to commercial supply
shall be handled under the supply agreement to be entered into pursuant to
Section 7.3 (Commercial 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 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

 

CONFIDENTIAL    Page 44   

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

 

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).

 

13.3 Joint Losses. Any and all liabilities, losses, costs, damages, fees or
expenses (including reasonable legal expenses and attorneys’ fees (“Joint
Loss(es)”) arising from Third Party claims, suits, actions or demands (other
than those subject to indemnification pursuant to Section 13.1 (Indemnity) or
addressed under Section 9.3 (Defense and Settlement of Third Party Claims))
resulting directly or indirectly out of [*] shall be treated as [*]. In the
event a Party becomes aware of a claim which, if resulting in a Joint Loss, it
intends to treat as [*], such Party shall inform the other Party of such claim
as soon as reasonably practicable after it receives notice thereof. With respect
to any such Third Party claims, the Party conducting or operationally
controlling the activity giving rise to the claim shall have the right to assume
direction and control of the defense of such claim. The Party not in control of
such defense shall co-operate as reasonably requested in the defense of the
claim. The Party in control of any such claim shall keep the other Party
regularly and fully informed about the claim and defense, and shall cooperate
with the other Party in facilitating its involvement as reasonably requested.
The Party not in control of such defense may participate, subject to such
control, in such defense or settlement with its own counsel. The Party in
control shall not settle any such claim without the other Party’s prior written
consent, such consent not to be unreasonably withheld or delayed.

 

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 to the other Party. 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 sublicensee bring or join any challenge to the validity or
enforceability of any Licensed Amgen Patent or Licensed Amgen Trademark.

 

  14.2.3. Change of Control Termination. Amgen shall have the right to terminate
this Agreement in accordance with Section 15.3 (Change of Control).

 

  14.2.4.

Failure of Licensee to Use Reasonably Diligent Efforts. In the event Licensee
fails to use Reasonably Diligent Efforts with respect to the development and

 

CONFIDENTIAL    Page 45   

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

 

commercialization of Licensed Product in a Major Market Country, and fails to
cure such breach within [*] days after the receipt of such notice, without
limiting other available remedies, Amgen shall have the right to terminate this
Agreement for the entire region of Europe, if such Major Market Country is
within Europe, or for the entire region of Asia, if such Major Market Country is
within Asia. In the event Licensee fails to use Reasonably Diligent Efforts with
respect to the development and commercialization of Licensed Product in a
country other than a Major Market Country, and fails to cure such breach within
[*] days after receipt of such notice, without limiting other available
remedies, Amgen shall have the right to terminate this Agreement in such
particular country. For the purpose of this provision, “Major Market Country”
means [*].

 

14.3 Effect of Termination. Expiration or termination of this Agreement shall
have the following effects: 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, [*]

 

14.4 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 10.5 (Publications)); 12 (Limitations of Liability; Insurance); 13
(Indemnification); 14 (Term and Termination) and 15 (Miscellaneous); and
Sections 3.3 (Licensed Licensee Know-How and Patents); 3.6.2 (Grant to Amgen);
6.3 (Addition of Distracting Products) and 6.4 (Distracting Transactions) (with
respect only to sequestration of personnel and information and any accrued
payment obligations and the ancillary provisions with respect thereto); 8.1.1
(License Fee); 8.1.2 (Development Milestone Payments) (with respect to
milestones reached prior to such expiration or termination); 8.2 (Cost Sharing
and Profit Sharing Arrangement) (with respect to Development Costs and Operating
Expenses incurred, and Gross Profit generated, prior to such expiration or
termination); 8.3 (Royalty Payments with respect to Sales in Japan) through 8.6
(No Wrongful Reductions) (inclusive) (with respect to sales made prior to such
expiration or termination); 8.7 (Payment Method) through 8.14 (Third Party
Royalties) (inclusive); 9.1 (Ownership); 9.5 (Allocation of Recoveries) (with
respect to periods prior to such expiration or termination); and 11.3
(Disclaimer of Warranties).

 

14.5

Transition Period. During the [*] period following [*] (the “Transition
Period”), the Parties shall cooperate to transition the development (including
any ongoing trials, to the extent permitted by Law) and commercialization of,
regulatory responsibility for, and, if applicable, manufacture of the Licensed
Product in the Territory in Indications from Licensee to Amgen. Licensee shall
take all actions reasonably requested by Amgen to facilitate such transition,
and the Parties shall conduct such transition expeditiously and as reasonably
necessary to minimize disruption in the development and commercialization of a
Licensed Product in the Territory. The Parties shall each be responsible for [*]
in accordance with this Section 14.5 (Transition Period), provided that, in the
event of

 

CONFIDENTIAL    Page 46   

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

 

termination by Licensee under Section 14.2.1 (Termination for Breach), [*] in
accordance with this Section 14.5 (Transition Period).

 

14.6 Bankruptcy. All licenses (and to the extent applicable rights) granted
under or pursuant to this Agreement are, and shall otherwise be deemed to be,
for purposes of Section 365(n) of Title 11, U.S. Code Sections 101 et seq.
(“Bankruptcy Code”), licenses of rights to “intellectual property” as defined
under the Bankruptcy Code. The Parties agree that the non-bankrupt Party shall
retain and may fully exercise all of its rights and elections under Law. The
Parties further agree that, in the event of the commencement of a bankruptcy
proceeding by or against a bankrupt Party the other Party shall be entitled to a
complete duplicate of (or complete access to, as appropriate) any intellectual
property which at that date is known to be necessary or useful to Licensed
Product (then the subject of research, development or commercialization) for the
non-bankrupt Party’s territory and all embodiments of such intellectual
property; and same, if not already in the other Party’s possession, shall be
promptly delivered to the other Party (a) upon any such commencement of a
bankruptcy proceeding, upon the other Party’s written request therefor (which
request must identify the specific intellectual property), unless the bankrupt
Party (or a trustee on behalf of the bankrupt Party) elects within [*] days to
continue to perform all of its obligations under this Agreement or (b) if not
delivered under (a) above, upon the rejection of this Agreement by or on behalf
of the bankrupt Party, upon written request therefor by the other Party.

 

15 MISCELLANEOUS

 

15.1 Affiliates. Each Party 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 that each Party shall be responsible for its Affiliates’ performance
hereunder.

 

15.2 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 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
Licensed Product to a Party or Parties to which Amgen licenses or transfers
rights with respect to such product in the Amgen 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.

 

15.3

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,
then upon written

 

CONFIDENTIAL    Page 47   

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

 

notice by Amgen to Licensee: [*]. In addition, should such Change of Control
involve [*], Amgen shall have the right to [*].

 

15.4 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.

 

CONFIDENTIAL    Page 48   

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

15.5 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.

 

15.6 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.

 

15.7 Currency. With respect to amounts received or expenses incurred in a
currency other than U.S. Dollars, such amounts received 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 receipt or expenditure, for the
respective reporting period, related to recording such amounts received or
expenses incurred 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 the [*] 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.

 

15.8

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

 

CONFIDENTIAL    Page 49   

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

 

Agreement relating to Japan rights to multiple products, and the Vectibix Supply
Agreement, each between the Parties and executed concurrently herewith.

 

15.9 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.

 

15.10 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.

 

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

 

15.12 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 15.14 (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 15.12 (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.

 

15.13 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).

 

CONFIDENTIAL    Page 50   

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

15.14 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, CA 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 and 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 15.14 (Notices).

 

15.15 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 Licensee Territory from being distributed or sold in the Amgen
Territory, except where Amgen and Licensee agree that the exporting person or
entity is in possession of all regulatory 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 Licensee Territory and discuss with Amgen the same.

 

15.16 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.

 

15.17 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.

 

CONFIDENTIAL    Page 51   

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

15.18 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.

 

15.19 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 52   

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

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

 

TAKEDA PHARMACEUTICAL   AMGEN INC. COMPANY LIMITED     By:  

/s/ Yasuchika Hasegawa

  By:  

/s/ Kevin W. Sharer

Name:   Yasuchika Hasegawa   Name:   Kevin W. Sharer Title:   President   Title:
  Chairman of the Board,
CEO and President

 

CONFIDENTIAL