Exhibit 10.84

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.

Supply Agreement

by and between

Amgen Inc.

and

Takeda Pharmaceutical Company Limited

dated

February 1, 2008

CONFIDENTIAL

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Supply Agreement

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

Recitals

WHEREAS, Amgen and Purchaser have entered into the License Agreement of even
date herewith (the “License Agreement”) regarding, among other things, Amgen’s
proprietary product Vectibix (as defined below).

WHEREAS, pursuant to the License Agreement, Purchaser has the right to develop
and commercialize Vectibix in Licensee Indications in the Territory (each as
defined below).

WHEREAS, Purchaser has requested and Amgen has agreed to supply Purchaser, on
the terms set forth herein, with Drug Product (as defined below) for clinical
and commercial use in Licensee Indications in the Territory.

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

1. DEFINITIONS

 

1.1 “Affiliate” shall mean any corporation or other entity which directly or
indirectly controls, is controlled by or is under common control with a Party,
for so long as such control exists. For the purposes of this Section 1.1
(“Affiliate”), “control” and its cognates 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%).

 

1.2 “Allocable Overhead” shall mean [*]. Allocable Overhead may be allocated
based upon [*].

 

1.3 “Available SKU” shall mean an SKU (stock keeping unit) of Drug Product set
forth on the Vectibix Available SKU Schedule or added to such schedule pursuant
to Section 2.2.6 (Available SKUs).

 

1.4 “Bulk Drug Substance” shall mean Vectibix in purified bulk form.

 

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

 

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

 

1.7 “Change Notice” shall have the meaning set forth in Section 2.9 (Changes to
Manufacturing).

 

1.8

“Confidential Information” shall have the meaning set forth in Section 4.1

 

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(Confidentiality; Exceptions).

 

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

 

1.10 “Direct Costs” shall mean [*].

 

1.11 “Drug Product” shall mean Bulk Drug Substance in finished, labeled form in
accordance with the Specifications.

 

1.12 “Employment Costs” shall mean [*].

 

1.13 “Federal Court” shall have the meaning set forth in Section 8.11
(Jurisdiction and Venue).

 

1.14 “Force Majeure” shall have the meaning set forth in Section 8.8 (Force
Majeure).

 

1.15 “FTE” shall mean the equivalent of the work of one employee full time for
one year (consisting of at least a total of 45.5 weeks or 1,820 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.

 

1.16 “FTE Rate” shall mean [*] (as of the [*]), increasing by [*] of the
then-current FTE Rate on [*].

 

1.17 “GAAP” shall mean U.S. generally accepted accounting principals,
consistently applied.

 

1.18 “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.

 

1.19 “Indirect Costs” shall mean Employment Costs and Allocable Overhead [*].

 

1.20 “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.

 

1.21 “License Agreement” shall have the meaning set forth in the recitals of
this Agreement.

 

1.22 “Licensee Indication” shall mean an indication designated as a “Licensee
Indication” pursuant to the License Agreement.

 

1.23 “Long-Range Projections” or “LRP” shall have the meaning set forth in
Section 2.2.1.2 (Long-Range Forecast).

 

1.24 “Necessary Approval” shall mean all approvals, permits, licenses,
registrations, authorizations, or similar permissions required by Law for the
purchase, transit, export or import of Drug Product hereunder.

 

1.25 “Net Sales” shall have the meaning set forth in the License Agreement for
such term.

 

1.26 “Rolling Forecast” shall have the meaning set forth in Section 2.2.1.1
(Provision of Forecasts).

 

1.27

“Specifications” shall mean the specifications for Drug Product as set forth in
the

 

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Specifications Schedule.

 

1.28 “Standard Costs” shall mean, with respect to an Available SKU, [*].

 

1.29 “State Court” shall have the meaning set forth in Section 8.11
(Jurisdiction and Venue).

 

1.30 “Support Costs” shall mean [*]. For the avoidance of doubt, any costs and
expenses included in Standard Costs shall not also be included in Support Costs.

 

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

 

1.32 “Territory” shall mean Japan.

 

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

 

1.34 “VAT” shall mean any value added tax.

 

1.35

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

2. SUPPLY OF DRUG PRODUCT

 

2.1 Supply of Drug Product; Requirements. Subject to the terms and conditions of
this Agreement: (i) except as expressly provided in Section 2.14 (Alternate
Supply), Purchaser agrees to purchase from Amgen hereunder all of Purchaser’s
(and its permitted licensees’) requirements of Vectibix and Drug Product for any
use from Amgen; and (ii) Amgen agrees to sell to Purchaser all of Purchaser’s
(and its permitted licensees’) requirements of Vectibix and Drug Product for
uses permitted under the License Agreement. Certain rights and licenses with
respect to the use and sale of Vectibix are granted to Purchaser pursuant to the
License Agreement, and no rights with respect to Vectibix (including with
respect to any intellectual property related to Vectibix) are granted or shall
be implied hereunder.

 

2.2 Forecasts and Orders.

 

  2.2.1 Provision of Forecasts. Purchaser shall provide to Amgen forecasts of
its requirements of Drug Product as follows:

 

  2.2.1.1 ROLLING FORECAST. On a [*] basis during the term of this Agreement,
Purchaser shall provide to Amgen a rolling [*] forecast setting forth, [*],
Purchaser’s requirements for Drug Product by Available SKU for the Territory (a
“Rolling Forecast”). Purchaser shall provide to Amgen by the [*] (i.e., [*]) a
Rolling Forecast for the period beginning as of the [*] in which the Rolling
Forecast is due (e.g., by [*] Purchaser shall submit a Rolling Forecast for the
[*] period from [*] through [*]). The initial [*] of the Rolling Forecast shall
be denoted therein as [*], and the remainder of the [*] shall be denoted as [*]
(in chronological order). Promptly following the [*], the Parties shall mutually
agree upon the initial Rolling Forecast which shall include, at a minimum, the
supply requirements necessary.

 

  2.2.1.2

LONG-RANGE FORECAST. [*] per [*] Year, at a particular [*] to be agreed to by
the Parties, Purchaser shall provide to Amgen along with a Rolling Forecast its
projected requirements for Drug Product by Available SKU for the Territory for
the [*] in which the projection is due plus the [*] period that follows (a
“Long-Range Projection” or “LRP”). The first [*] and subsequent

 

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[*] of the LRP shall be the same as the Rolling Forecast which the LRP
accompanies. The LRP shall specify, by [*] for the period covered by the Rolling
Forecast and by [*] for [*] of the LRP, Purchaser’s requirements for Drug
Product by Available SKU for the Territory. The initial [*] of the LRP shall be
denoted therein as [*], and the remainder of the [*] through [*] shall be
denoted as [*] (in chronological order). The forecast for [*] of the LRP shall
be non-binding, but Purchaser shall use its reasonable good-faith efforts to
provide the best estimate of its requirements for such [*].

 

  2.2.2 Purchase Orders. The forecast for [*] of a Rolling Forecast (the
“Purchase Order Period”) shall be binding purchase orders with respect to the
forecasted quantities of each Available SKU for such [*] and may not be varied.
Amgen may deliver each [*] ordered quantity of Available SKUs at anytime during
the applicable delivery [*].

 

  2.2.3 Forecast Variance. With respect to each Rolling Forecast, the forecasted
quantities for each Available SKU set forth in such Rolling Forecast for [*]
thereof shall be binding. The forecasted quantities of each Available SKU for
the Purchase Order Period shall be binding (as set forth in Section 2.2.2
(Purchase Orders)) and Purchaser may not vary such ordered quantities. The
forecasted quantities of each Available SKU for [*] of a Rolling Forecast (the
“Binding Forecast Period”) shall be binding, but Purchaser shall be permitted to
vary such forecasted quantities only as set forth in this Section 2.2.3
(Forecast Variance). For each [*] within the Binding Forecast Period of a
Rolling Forecast, Purchaser shall be permitted to vary the forecasted quantity
of an Available SKU for such [*] (e.g., [*]) by a specified percentage of such
forecasted quantity in Purchaser’s forecasted quantity of such Available SKU for
such same [*] (e.g., [*]) in the next subsequent Rolling Forecast. The specified
percentages for permitted variance by [*] during the Binding Forecast Period are
set forth below.

 

[*]   [*]   [*]   [*]   [*]   [*]   [*] Percentage   [*]   [*]   [*]   [*]   [*]
  [*]

For purposes of example, if in a Rolling Forecast covering [[*]] through [*]]
the quantity of a particular Available SKU forecasted for [*] is [*] units, then
in the next subsequent Rolling Forecast (covering [*] through [*]) the aggregate
quantity of such Available SKU forecasted for [*] shall be no less than [*]
units and no more than [*] units.

 

  2.2.4

Non-Compliant Forecasts. In the event Purchaser provides a Rolling Forecast that
contains a forecast for any [*] therein that is not in compliance with
Section 2.2.3 (Forecast Variance), Purchaser shall provide notice of such
non-compliance to Amgen in writing. Amgen shall have the right to adjust such
non-compliant forecasted quantity for such [*] to increase or reduce the amount
forecasted for such [*] by up to the minimum amount necessary to bring such
forecasted quantity into compliance with such provision. By way of example, if
the Rolling Forecast covering the period from [*] through [*] forecasted a
quantity of [*] units of a particular Available SKU for [*], and the next
subsequent Rolling Forecast

 

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(covering the period from [*] through [*] forecasted a quantity of [*] units for
such Available SKU for [*], which exceeds the permitted [*] percent variance for
such period (as set forth in Section 2.2.3 (Forecast Variance)), then Amgen
shall have the right (but not the obligation) to reduce the quantity of such
Available SKU forecasted for [*] in such Rolling Forecast to any number between
[*] and [*] units (inclusive). In such event, Amgen shall provide to Purchaser
the Rolling Forecast revised to be in compliance with the terms of this Clinical
Supply Schedule, and such Rolling Forecast shall be deemed the Rolling Forecast
for the applicable period.

 

  2.2.5 Orders not in Compliance with Forecasts. Amgen shall have no obligation
to fill any purchase order placed by Purchaser that exceeds the maximum amount
permitted hereunder as set forth in Section 2.2 (Forecasts and Orders), and
shall have the right to reduce any excessive purchase order by up to the minimum
amount necessary to bring such purchase order into conformance with this
Agreement. If Purchaser does not want to receive the full amount of any purchase
order, Amgen shall have the right to invoice Purchaser for the full amount
ordered hereunder and Purchaser shall be obligated to pay such full invoice
amount; and Amgen shall have the right, in its sole discretion, to either
deliver to Purchaser the full amount of Drug Product ordered hereunder for such
[*] (in which case Purchaser shall receive and accept such Drug Product), use
the unwanted portion of the ordered Drug Product for other purposes or otherwise
dispose of the unwanted portion of the ordered Drug Product.

 

  2.2.6 Available SKUs. The Vectibix Available SKU Schedule attached hereto sets
forth the Available SKUs as of [*]. Amgen shall add any new SKUs used by Amgen
outside the Territory to the Vectibix Available SKU Schedule by written notice
to Purchaser, and such SKUs shall be Available SKUs and Purchaser shall have the
right to order such added Available SKUs. The Parties shall mutually agree upon
the first period for which such new Available SKU can be ordered by Purchaser,
and upon any permitted adjustments to Purchaser’s then applicable Rolling
Forecast and LRP to enable Purchaser to add units of the newly Available SKU in
substitution for units of previously forecasted Available SKUs; provided that,
the Parties shall seek to minimize any disruption to Amgen’s introduction of the
new Available SKU outside the Territory and Amgen’s manufacturing plans based on
the previously established Rolling Forecast. All purchase orders of Purchaser
hereunder shall be for Available SKUs set forth on (or added to) the Vectibix
Available SKU Schedule, and Purchaser shall not have the right to order Bulk
Drug Substance hereunder (except as incorporated in such Drug Product) unless
formulation, fill and finish manufacturing activities are assumed by Purchaser
pursuant to Section 2.14 (Alternate Supply).

 

  2.2.7

Quantities Forecast and Ordered. Purchaser shall forecast and order quantities
of an Available SKU according to full standard lot sizes of manufactured Drug
Product. Amgen shall communicate to Purchaser full standard lot sizes. The
Parties shall coordinate and cooperate, through the Manufacturing Committee or
otherwise, to modify Rolling Forecasts, LRPs and purchase orders as needed to
reflect for each [*] a quantity of an Available SKU that is divisible by full
standard

 

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lot sizes for such Available SKU. Amgen shall have no obligation to manufacture
or use partial lots of Drug Product to meet Purchaser’s purchase orders or
forecasts.

 

  2.2.8 Commercial and Non-Commercial. For forecast and order purposes under
this Agreement, Purchaser shall separately specify the quantity of each
Available SKU to be used for commercial purposes (which shall include Drug
Product used for post-marketing commitments and samples distributed for free or
less than full sale price) and the quantity of each Available SKU to be used for
non-commercial purposes (including clinical development), as if they were
distinct and separate Available SKUs.

 

2.3 Provision of Drug Product. Amgen shall use its reasonably diligent efforts
to fill purchase orders for Available SKUs placed by Purchaser in accordance
with Section 2.2 (Forecasts and Orders), so long as Purchaser is in compliance
with its obligations hereunder and under the License Agreement. Drug Product
shall be provided [*] or, if Amgen supplies Bulk Drug Substance following
assumption of formulation, fill and finish manufacturing activities by Purchaser
pursuant to Section 2.14 (Alternate Supply), [*]. Purchaser shall: (i) receive
each shipment, (ii) promptly notify Amgen when the shipment has been received;
and (iii) forward to Amgen any applicable chain of custody forms, in-transport
temperature recorder(s) and receipt verification documentation and such other
documentation reasonably requested by Amgen.

 

2.4 Labeling and Packaging. Amgen shall perform primary labeling (i.e., labeling
of vials) of Drug Product supplied hereunder. Purchaser shall be responsible for
and bear all costs associated with the design, development, quality release and
any required approvals of any Governmental Authority of all primary labels of
Drug Product supplied hereunder. Purchaser shall perform its design,
development, quality release and approval obligations hereunder in a timely
manner sufficient for Amgen to satisfy its supply obligations hereunder for Drug
Product. Purchaser shall select and contract with a party in the Territory
mutually acceptable to the Parties for producing primary labels for Drug Product
for Purchaser. Purchaser shall consult with Amgen with respect to any proposed
primary labels (or changes thereto), including design, size, material and other
properties. Prior to final approval of any primary label for use with Drug
Product, Purchaser shall provide to Amgen samples thereof for its review and
approval. Amgen shall have no obligation to use, or provide Drug Product labeled
with, primary labels that have not been approved by Amgen. Amgen shall be
responsible for procuring all primary labels directly from Purchaser’s label
provider and Purchaser shall cooperate to enable such direct procurement by
Amgen. Purchaser shall perform, be solely responsible for and bear all costs
associated with final packaging and secondary labeling of Drug Product supplied
hereunder. If at any time Amgen elects to transition the performance of primary
labeling to a Third Party mutually agreeable to the Parties (or to Purchaser if
mutually agreed), then the Parties shall promptly meet to discuss and implement
such a transition of such responsibilities.

 

2.5

Necessary Approvals. Purchaser shall be responsible, at its own cost, for
obtaining, maintaining and submitting all Necessary Approvals, except that Amgen
will be responsible for obtaining and maintaining all Necessary Approvals
related to the export of Drug Product ordered by Purchaser hereunder, any drug
master file submitted by or on behalf of Amgen and the accreditation of any
foreign manufacturers used by Amgen in the

 

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Territory with respect to Drug Product ordered by Purchaser. Each Party shall
reasonably cooperate with the other with respect to obtaining, maintaining and
submitting all Necessary Approvals. Each Party shall also promptly provide to
the other Party copies of Necessary Approvals as reasonably requested. At least
[*] days prior to the first scheduled export of Drug Product or Bulk Drug
Substance hereunder, Purchaser shall provide to Amgen copies of all
documentation of the Necessary Approvals obtained by Purchaser. Purchaser
thereafter shall promptly provide Amgen with supplemental documentation promptly
in the event of any changes to Necessary Approvals or other regulatory
compliance documents, as well as upon request by Amgen. Amgen shall not have any
obligation to export Drug Product, or to provide Drug Product to Purchaser,
unless and until Purchaser demonstrates to Amgen that Purchaser has received all
Necessary Approvals for which it has responsibility.

 

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2.6 Product Specifications. A Amgen certificate of analysis shall accompany each
shipment of Drug Product to Purchaser. Purchaser shall be responsible for any
failure of Drug Product to meet the Specifications to the extent caused by
shipping or handling conditions after delivery to Purchaser hereunder.

 

2.7 Product Testing; Noncompliance. Purchaser shall have [*] days from the date
of delivery of Drug Product to Purchaser’s premises in which to test, at
Purchaser’s cost, a shipment for compliance with the Specifications and notify
Amgen of any non-compliance. Purchaser shall use its reasonably diligent efforts
to obtain and test the Drug Product as soon as reasonably practicable. Amgen and
Purchaser shall agree on the testing procedures to be employed and the Third
Parties to be contracted to conduct testing hereunder. Purchaser shall be
responsible for storage and maintenance of the Drug Product until it is tested
and released. In the event Purchaser determines that a shipment of Drug Product
(or portion thereof) did not, upon delivery, meet the Specifications, Purchaser
shall notify Amgen in writing (within the [*] day period set forth above) and
provide Amgen with complete copies of all testing data and a reasonably detailed
explanation of the reasons for such suspected non-compliance. If Amgen disagrees
with such initial determination of non-compliance and the Parties can not come
to agreement, Amgen and Purchaser shall elect an independent Third Party to
review the data and/or repeat the testing and make a final determination, which
shall be binding upon both Purchaser and Amgen. If the shipment is determined by
the independent Third Party to have been, upon delivery, in compliance with the
Specifications, Purchaser shall pay the costs of such testing; if the shipment
is found not to have been in compliance with the Specifications upon delivery,
Amgen shall pay the costs of such testing. In the event any shipment (or portion
thereof) shall be agreed or determined pursuant to this Section 2.7 (Product
Testing; Noncompliance) to have failed to comply with the Specifications upon
delivery, Purchaser shall, at Amgen’s election and expense, either destroy the
shipment or return the shipment to Amgen. Amgen shall replace the Available SKUs
found to have been not in compliance with the Specifications upon delivery, as
Purchaser’s sole remedy (other than indemnity under Section 6.2.2 (Amgen
Obligation)) with respect to such non-complying Drug Product. Purchaser shall be
responsible for, and Amgen shall have no obligation to provide replacement Drug
Product for, any Available SKUs supplied hereunder other than the Available SKUs
agreed or determined to be not in compliance with the Specifications upon
delivery. Purchaser shall be solely responsible for taking all steps necessary
to determine that Drug Product is suitable for commercial release before making
such Drug Product available for human use.

 

2.8 Notice of Reports. Purchaser shall provide Amgen within [*] written notice
of any and all material problems (including adverse events) with any Drug
Product hereunder that have been reported to Purchaser by any of its customers
or Third Parties (including any events reportable to Governmental Authorities in
the United States under 21 CFR §314.80) or of which Purchaser becomes aware and
shall cooperate with Amgen in any efforts to investigate and cure such problems.

 

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2.9 Changes to Manufacturing.

 

  2.9.1 Changes by Amgen. If Amgen determines to make a material change to the
manufacturing of Drug Product to be supplied to Purchaser hereunder (e.g.,
material change to Specifications or manufacturing process), it shall provide
Purchaser prompt written notice of such determination (a “Change Notice”). Such
notice shall provide the relevant details of such change (“Manufacturing
Change”) (but Amgen shall have no obligation to include any confidential Amgen
manufacturing information) and the proposed date for such change. The Parties
shall meet and determine if such change would require notice to or approval by a
Governmental Authority in the Territory.

 

  2.9.1.1 CHANGES NOT REQUIRING APPROVAL. If a proposed change does not require
notice to or approval of any such Governmental Authority, then Amgen shall have
the right to provide Drug Product to Purchaser hereunder in accordance with the
Manufacturing Change [*] days from the date of the Change Notice. If such change
requires notice to (but not the approval of) a Governmental Authority in the
Territory, then the Parties shall cooperate to promptly submit such notice and
Amgen shall continue to provide Purchaser Drug Product as prior to the
Manufacturing Change to allow for such notice to such Governmental Authority and
after [*] days from the date of the Change Notice (or such earlier time as such
notice to the relevant Governmental Authority has been made (and any required
waiting periods have expired)) Amgen shall have the right to provide Drug
Product to Purchaser hereunder in accordance with the Manufacturing Change.

 

  2.9.1.2 CHANGES REQUIRING APPROVAL. If a proposed Manufacturing Change
requires the approval of a Governmental Authority in the Territory, then
Purchaser shall use its reasonably diligent efforts to obtain such approval, and
Amgen shall continue to provide Drug Product as prior to the Manufacturing
Change as necessary to allow Purchaser to obtain the required approval;
provided, however, that Amgen shall have the right to transition Purchaser to an
alternate source of supply in accordance with Section 2.14 (Alternate Supply) at
any time upon written notice given by Amgen to Purchaser. If Purchaser does not
obtain approval of a proposed Manufacturing Change from the Governmental
Authority in the Territory within the relevant time period, or becomes aware of
a potential failure to timely receive such approval, Purchaser shall promptly
notify Amgen thereof. In such event, Amgen shall have the right to transition
Purchaser to an alternate source of supply in accordance with Section 2.14
(Alternate Supply) at any time upon written notice given by Amgen to Purchaser.

 

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Notwithstanding anything to the contrary in this Section 2.9 (Changes to
Manufacturing), Amgen shall have the right to immediately make any change
required to protect patient safety or as required by Law, and shall give
Purchaser prompt written notice thereof.

 

  2.9.2 Changes for Regulatory Necessity. If the applicable Governmental
Authorities in the Territory require a Manufacturing Change in order to permit
Purchaser to use or sell Drug Product in Licensee Indications in the Territory,
Purchaser shall immediately inform Amgen of the same in writing and provide
Amgen any related information as reasonably requested by Amgen. Amgen shall use
reasonably diligence efforts to implement the Manufacturing Change for Drug
Product to be supplied hereunder, and the Parties shall discuss and cooperate in
good faith to minimize the time for and disruption of such transition to Drug
Product conforming to such Manufacturing Change; provided, however, that Amgen
shall have the right to transition Purchaser to an alternate source of supply in
accordance with Section 2.14 (Alternate Supply) at any time upon written notice
given by Amgen to Purchaser. If Amgen elects to transition Purchaser to an
alternate source of supply, the Parties shall cooperate to facilitate such
transition so as to minimize disruption to the Parties and shall discuss in good
faith the feasibility of Amgen providing transitional supply conforming to the
Manufacturing Change until the transition obligations under Section 2.14 have
been completed. In any case, Purchaser shall be responsible for all incremental
costs incurred by Amgen (including Amgen FTEs at the FTE Rate) in developing and
providing Drug Product in accordance with the Manufacturing Change.

 

  2.9.3 Regulatory Communication. In the event of any Manufacturing Change
pursuant to this Section 2.9 (Changes to Manufacturing), Amgen shall cooperate
with Purchaser to provide to the applicable Governmental Authority in the
Territory documentation required by Law to be provided with respect to such
change (through Purchaser or directly to the relevant Governmental Agency). In
no event will Amgen be obligated under this Agreement to (i) conduct any studies
(pre-clinical, clinical or other) to support Purchaser’s regulatory filings or
(ii) transfer to Purchaser any technology, know-how, cell lines or other
materials in connection with any Manufacturing Change implemented by Amgen.
Should Purchaser request that Amgen agree to conduct additional work for the
purpose of supplementing Purchaser’s regulatory filing in the Territory, the
Parties shall discuss in good faith the terms and conditions (including economic
terms) upon which Amgen in its discretion may agree to conduct such work and any
agreement of the Parties with respect thereto shall be reflected in writing and
signed by each of the Parties. Purchaser shall provide to Amgen copies of all
regulatory filings and correspondence submitted or received by Purchaser or its
agents in connection with any Manufacturing Changes, and any other documentation
reasonably requested by Amgen related thereto.

 

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2.10 Shortage; Allocation. In the event of a shortage of Drug Product such that
Amgen reasonably believes that it will not be able to supply Purchaser’s
requirements (as set forth in a Rolling Forecast) and its own requirements
(including those of any other Amgen licensees’ and distributors), Amgen shall
provide written notice to Purchaser thereof. If Amgen actually cannot supply
Purchaser’s purchase orders in accordance with this Agreement and Amgen’s
requirements (including those of any other Amgen licensees’ and distributors),
then Amgen shall reasonably allocate Drug Product (on an Available SKU by
Available SKU basis) such that [*]. Allocation of Drug Product in accordance
with this Section 2.10 (Shortage; Allocation) will be Purchaser’s exclusive
remedy with respect to any shortage of Drug Product.

 

2.11 Manufacturing Regulatory Responsibility. The responsibilities of the
Parties with respect to communication and regulatory filings with Governmental
Authorities related to Vectibix and Drug Product shall be as set forth in the
License Agreement, including Sections 4.12.2 (Amgen Responsibility) and 7.4
(Responsibility for Regulatory Filings with Respect to Manufacturing) of the
License Agreement.

 

2.12 Inspections and Review of Records. If Purchaser is notified in writing by a
Governmental Authority within the Territory that an inspection of Amgen’s
manufacturing facilities or a review of Amgen’s batch records for Bulk Drug
Substance or Drug Product by that authority is required by Law, Amgen agrees to
reasonably cooperate and allow such Governmental Authority to inspect such
manufacturing facilities or review such records to the extent reasonably
required. Purchaser shall give Amgen reasonable advance written notice of any
such notification by a Governmental Authority. Purchaser shall reimburse Amgen
for any costs incurred by Amgen in connection with any such inspections, as well
as the cost of any Amgen personnel time at the FTE Rate.

 

2.13

Purchaser Inspections. Subject to the terms and conditions of this Agreement,
Purchaser may visit and inspect, at its own expense, (i) Amgen’s manufacturing
facilities for Bulk Drug Substance or Drug Product (but not Amgen’s Third Party
manufacturer’s facilities without Amgen’s prior written approval), (ii) Amgen’s
quality control and analytical laboratories for the testing of Bulk Drug
Substance or Drug Product, and (iii) Amgen’s documents and records relating to
(i) and (ii) above, in each case to the extent such facilities or records relate
solely to the Drug Product or constituent Bulk Drug Substance supplied to
Purchaser pursuant to this Agreement. Purchaser’s inspections will be limited in
scope to what is reasonably necessary to confirm that Amgen has complied with
current Good Manufacturing Practices (as defined in the United States Code of
Federal Regulations) in manufacturing the Bulk Drug Substance and/or Drug
Product. Purchaser may conduct inspections no more frequently than once in any
[*] period. It is anticipated that any inspections conducted in accordance with
this Section 2.13 (Purchaser Inspections) shall be for a duration of no more
than [*]. Purchaser will coordinate all inspections with Amgen and provide Amgen
with no less than [*] prior written notice of any inspection. Inspections shall
be conducted in accordance with Amgen procedures during normal hours of
operation, in the presence of Amgen representatives. Any information obtained by
Purchaser in the course of such inspections shall be treated as Amgen
Confidential Information, and the Purchaser personnel conducting such
inspections shall not share any such information with other employees of
Purchaser, other than (on a need-to-know basis) whether or not such inspection
showed any Amgen failure to comply

 

CONFIDENTIAL    11   

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with current Good Manufacturing Practices and the details of any such
non-compliance. Amgen shall have no obligation under this Agreement to provide
Purchaser with any information regarding Amgen’s manufacturing facility, any
information pertaining to the manufacture of products other than Bulk Drug
Substance or Drug Product, or proprietary manufacturing information (including
cell lines, host cells and vectors). Purchaser shall reimburse Amgen for any
costs incurred by Amgen in connection with any such inspections, as well as the
cost of any Amgen personnel time at the FTE Rate.

 

2.14 Alternate Supply.

 

  2.14.1 Process of Transition. In the event Amgen provides a notice to
Purchaser of the intent to transition the manufacturing (either in the entirety,
only the formulation, fill and finish manufacturing activities, or only the
manufacture of Bulk Drug Substance (if Amgen has previously transitioned the
formulation, fill and finish manufacturing activities)) of Drug Product (such
manufacturing activities to be transitioned, the “Transitioned Manufacturing”),
to an alternate source pursuant to Sections 2.9 (Changes to Manufacturing),
2.14.3 (Bulk Drug Substance), 7.4 (Termination by Amgen for Discontinuation) or
7.4 (Change of Control), then Amgen and Purchaser shall cooperate to transition
the Transitioned Manufacturing to a mutually acceptable Third-Party
manufacturer. Purchaser shall contract directly with the Third-Party
manufacturer and shall be responsible for the Transitioned Manufacturing of Drug
Product for Purchaser, its Affiliates and sublicensees for Licensee Indications
in the Territory. Amgen shall cooperate to provide to such Third-Party
manufacturer, under obligations of confidentiality, [*] such Transitioned
Manufacturing of Drug Product for Purchaser in the Licensee Indications in the
Territory. Amgen shall also, in connection therewith, grant to such Third-Party
manufacturer a non-exclusive license to use such manufacturing technology solely
for the purposes of performing the Transitioned Manufacturing of Drug Product
for Purchaser for the Licensee Indications in the Territory. Purchaser shall be
solely responsible for all costs associated with the transition to such
Third-Party manufacturer (including payment at the FTE Rate for hours of [*]
provided by Amgen) and all costs associated with the purchase of Drug Product
from such Third-Party manufacturer. Amgen shall have no responsibility to
Purchaser for Purchaser’s supply of Drug Product to be provided by a Third-Party
manufacturer pursuant to this Section 2.14 (Alternate Supply).

 

  2.14.2

Completion of Transition. The Parties shall use their commercially reasonable
efforts to complete the transition of the Transitioned Manufacturing as soon as
practicable. Upon request of Purchaser, Amgen shall provide [*] for the
transition of the manufacturing of Bulk Drug Substance, as the case may be, in
each case as reasonably necessary to facilitate the transition of the
Transitioned Manufacturing, but in no event shall Amgen have any obligation to
provide [*] with respect to the transition of the Transitioned Manufacturing.
Amgen shall continue to provide to Purchaser supply of Drug Product in
accordance with Purchaser’s purchase orders for Drug Product in the Licensee
Indications in the Territory in accordance with Section 2.2 (Forecasts and
Orders) until the Third-Party manufacturer is approved by the applicable
Regulatory Authorities to perform the Transitioned Manufacturing of the Drug
Product in the Licensee Indications in the Territory (the

 

CONFIDENTIAL    12   

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“Transition Period”) or, if sooner, [*] following delivery of Amgen’s notice to
transition the Transitioned Manufacturing. Amgen shall have the right to meet
such obligation by manufacturing and providing to Purchaser a quantity of Drug
Product that the Parties agree would be reasonably sufficient to prevent the
disruption of the sales of Drug Product in the Licensee Indications in the
Territory during the Transition Period. Notwithstanding the foregoing, in no
event shall Amgen have any obligation to perform Transitioned Manufacturing or
provide [*] beyond such [*] period.

 

  2.14.3 Transition Plan. The transfer of Transitioned Manufacturing and
continued supply of Drug Product pursuant to this Section 2.14 (Alternate
Supply) shall be conducted in accordance with a transition plan which shall be
mutually approved by the Parties and which sets forth responsibilities and
schedules for transferring the Transitioned Manufacturing as expeditiously as
practicable. Amgen will have no obligation to perform any additional process
development with respect to the Transitioned Manufacturing of Drug Product
following a determination to transition the Transitioned Manufacturing of Drug
Product. If during the transition Purchaser seeks to change the process for the
Transitioned Manufacturing or fails to timely pay any amount due hereunder,
Amgen shall have no further obligation to provide [*] for such transition. If
mutually agreed by the Parties, any Transitioned Manufacturing of Drug Product
may be transitioned to Purchaser instead of a contract manufacturer.

 

  2.14.4 Bulk Drug Substance. Amgen shall have the right at anytime, upon
written notice to Purchaser, to transition the formulation, fill and finish
manufacturing activities of Drug Product to an alternate source pursuant to this
Section 2.14 (Alternate Supply). In the event Amgen transitions only the
formulation, fill and finish manufacturing activities of Drug Product to an
alternate source pursuant to this Section 2.14 (Alternate Supply), then
thereafter Amgen’s obligations under this Agreement with respect to Drug Product
shall instead apply only with respect to Bulk Drug Substance, as applicable and
appropriate, and the provisions hereunder applicable to Drug Product shall
instead apply to Bulk Drug Substance, as applicable and appropriate. In such
event, the Parties shall promptly meet to establish a forecasting and order
procedure applicable to Bulk Drug Substance, and the forecasting and order
procedure set forth in Section 2.2 (Forecasts and Orders) shall no longer apply.

 

  2.14.5 Manufacturing Improvements. Subject to Section 2.14.1 (Process of
Transition), the Parties shall consider whether to share manufacturing
improvements with respect to Drug Product in circumstances where Amgen
transitions manufacturing activities to Purchaser or a Third-Party manufacturer
on behalf of Purchaser. Unless the Parties otherwise mutually agree in writing,
neither Party shall have any obligation to share manufacturing improvements with
respect to Transitioned Manufacturing with the other Party or its Third-Party
manufacturer following the transition of such Transitioned Manufacturing.

 

2.15

Use of Contract Manufacturer. The Parties acknowledge that Amgen shall have the
right at any time to utilize Third-Party manufacturers in the manufacture of
Bulk Drug Substance and/or formulation, fill and finish manufacturing activities
of Drug Product. If

 

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Amgen utilizes a Third-Party manufacturer in the manufacture of Drug Product,
the Parties shall discuss and cooperate to implement any adjustments to the
forecasting or other terms under this Agreement as reasonably necessary to be
consistent and permit compliance with the terms of the Third-Party manufacturer
agreements. If Amgen utilizes a Third-Party manufacturer in the manufacture of
Drug Product, Amgen shall have the right at any time by written notice to
Purchaser to cause Purchaser to [*]. In such event, Purchaser shall [*]. Upon
Purchaser [*], Amgen shall have no further obligation to perform such
manufacturing for Purchaser and Purchaser shall assume responsibility therefor.

 

2.16 Cessation of Manufacturing. In the event Amgen determines that it will no
longer manufacture (either in the entirety or only the formulation, fill and
finish manufacturing activities) commercial Drug Product for its own use outside
the Territory, then Amgen shall have the right to notify Purchaser thereof and
to transition Purchaser to an alternate source for such manufacturing in
accordance with Section 2.14 (Alternate Supply).

 

2.17 Change of Control. In the event Purchaser undergoes a Change of Control (as
defined in the License Agreement), Purchaser shall notify Amgen thereof within
five days and Amgen shall have the right, by notice given to Purchaser at any
time, to transition Purchaser to an alternate source for some or all
manufacturing activities in accordance with Section 2.14 (Alternate Supply).

 

2.18 Manufacturing Committee. At the request of Amgen, the Parties shall
establish a Manufacturing Committee to regularly coordinate and discuss matters
related to manufacturing and supply of Drug Product hereunder. The Manufacturing
Committee shall be a forum for the Parties to discuss supply matters, but shall
not have binding authority or authority to amend, modify or waive compliance
with this Agreement. The Manufacturing Committee shall be formed promptly
following request by Amgen. Unless otherwise agreed by the Parties, the
Manufacturing Committee shall be comprised of three members appointed by Amgen
and three members appointed by Purchaser. The Manufacturing Committee shall be
led by two co-chairs, one appointed by each of the Parties. The Manufacturing
Committee shall have the right to delegate any of its responsibilities to one or
more subcommittees as it determines appropriate. Each Party shall have the right
to replace its committee members or co-chairs by written notice to the other
Party. The Manufacturing Committee shall meet quarterly in person, via
teleconference or videoconference or otherwise, or as otherwise agreed by the
Parties. Each Party shall be responsible for its own expenses relating to such
meetings. As appropriate, other employee representatives of the Parties may
attend Manufacturing 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 five business days written notice to
the co-chair appointed by the other Party. All committee meetings must have at
least one member appointed by each Party in attendance. Amgen shall have the
right to terminate its participation in the Manufacturing Committee by [*] days
prior written notice to Purchaser. Unless and until a Manufacturing Committee is
established hereunder, or in the event the Manufacturing Committee is terminated
hereunder, matters subject to the Manufacturing Committee shall be dealt with
directly between Amgen and Purchaser.

 

2.19

Quality Agreement. Promptly following the [*], the quality assurance departments
of

 

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Amgen and Purchaser will develop and agree upon a quality agreement governing
the quality and Specifications of Drug Product to be supplied hereunder,
including with respect to product quality and product complaints (to the extent
not covered in a separate safety agreement with respect to Vectibix entered into
accordance with the License Agreement. The quality agreement will be documented
in writing, and routinely updated by mutual written agreement of the Parties.

3. PAYMENT

 

3.1 Pricing. Purchaser shall pay for the supply of Drug Product in accordance
with the pricing terms set forth on the Pricing Schedule attached hereto.

 

3.2 Third Party Payments. In addition to payments under Section 3.1 (Pricing),
Purchaser shall pay all royalties and other amounts payable by Amgen to Third
Parties due to the manufacture, use and/or supply Drug Product, or any component
thereof, and/or sale of Drug Product to, by or on behalf of Purchaser, its
Affiliates and licensees; provided that, if Purchaser pays any such payment
under Section 8.10 (Sublicense Payments) of the License Agreement, it shall not
be obligated to make a duplicative payment under this Section 3.2 (Third Party
Payments). In the event Amgen determines there will be any such applicable Third
Party royalties or other payments under this Section 3.2 (Third Party Payments),
Amgen shall notify Purchaser of such obligations and the relevant terms
associated therewith and Purchaser shall comply with such obligations and, upon
request of Amgen, shall perform such obligations directly to the Third Party.
Prior to [*] for [*] which would result in [*] under [*], Amgen shall use
reasonable efforts to consult with Purchaser and will duly consider any comments
provided by Purchaser.

 

3.3 Support Costs. On a quarterly basis, Purchaser shall pay to Amgen all
Support Costs incurred with respect to such quarter. Amgen shall invoice
Purchaser for any amounts payable by Purchaser under this Section 3.3 (Support
Costs).

 

3.4 Taxes. All Taxes levied on account of a payment made by Purchaser to Amgen
pursuant to this Agreement will be subject to the withholding and remittance
provisions of Section 3.5 (Withholding).

 

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

 

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

 

3.7

Terms of Payment. Amounts payable by Purchaser hereunder shall be payable within
[*]

 

CONFIDENTIAL    15   

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days of the date of the relevant invoice or statement. All amounts payable
hereunder shall be paid in U.S. Dollars.

4. CONFIDENTIALITY

 

4.1 Confidentiality; Exceptions. Except to the extent expressly authorized by
this Agreement or otherwise agreed in writing, the Parties agree that, during
the term of this Agreement and for [*] years thereafter, the receiving Party
shall keep confidential and shall not publish or otherwise disclose or use for
any purpose other than as provided for in this Agreement any confidential and
proprietary information and materials furnished to it by the other Party
pursuant to this Agreement (collectively, “Confidential Information”).
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:

 

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

 

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

 

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

 

  4.1.4 was independently developed by the receiving Party as demonstrated by
documented evidence prepared contemporaneously with such independent
development; or

 

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

 

4.2 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) to the extent such disclosure is to a Governmental
Authority as reasonably necessary in filing regulatory filings, obtaining
regulatory approval or fulfilling post-approval regulatory obligations for
Vectibix, or otherwise required by Law, provided, however, that if a Party is
required by Law or the rules of any securities exchange or automated quotation
system to make any such disclosure of the other Party’s Confidential Information
it shall, except where impracticable for necessary disclosures (for example, in
the event of medical emergency), give reasonable advance notice to the other
Party of such disclosure requirement and, in the case of each of the foregoing,
shall use its reasonable efforts to secure confidential treatment of such
Confidential Information required to be disclosed; (ii) 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 (iii) to the extent
mutually agreed to by the Parties.

 

CONFIDENTIAL    16   

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4.3 Terms and Conditions Confidential. Neither Party shall disclose the terms
and conditions of this Agreement except to permitted assignees or as may be
required by Law. Notwithstanding the foregoing, with respect to complying with
the disclosure requirements of any Governmental Authority in connection with any
required filing of this Agreement, the Parties shall consult with one another
concerning which terms of this Agreement shall be requested to be redacted in
any public disclosure of the Agreement (with price terms requested to be
redacted in any event), and in any event each Party shall seek reasonable
confidential treatment for any public disclosure by any such Governmental
Authority. Each Party shall additionally have the right to issue press releases
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 three business days after such notice).

 

4.4 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: (a) share a common legal and commercial interest in
such disclosure that is subject to such privileges and protections; (b) are or
may become joint defendants in proceedings to which the information covered by
such protections and privileges relates; (c) 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 (d) intend that after
the Effective Date both the receiving Party and the disclosing Party shall have
the right to assert such protections and privileges.

5. REPRESENTATIONS, WARRANTIES AND COVENANTS

 

5.1 Mutual Representations and Warranties. Each of the Parties hereby represents
and warrants to the other Party as of [*] as follows:

 

  5.1.1 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;

 

  5.1.2 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; the person or persons executing
this Agreement on such Party’s behalf has been duly authorized to do so by all
requisite corporate action;

 

  5.1.3

To its knowledge, as of [*] no government authorization, consent, approval,
license, exemption of or filing or registration with any court or Governmental
Authority, under any applicable Laws currently in effect, is or shall be
necessary for, or in connection with, the transaction contemplated by this
Agreement (except

 

CONFIDENTIAL    17   

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for any Japanese Ministry of Health, Labour and Welfare or other regulatory
approvals, licenses, clearances and the like necessary for the manufacture,
import, export or transport 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; and

 

  5.1.4 Each Party represents and warrants that it has not been debarred or the
subject of debarment proceedings by any Governmental Authority.

 

5.2 Party Representations and Warranties; Disclaimer.

 

  5.2.1 Specification. [*].

 

  5.2.2 Use. Purchaser represents and warrants that it is acquiring Drug Product
only for clinical development and for commercial sale in the Licensee
Indications in the Territory, in each case in accordance with the License
Agreement,

 

  5.2.3 Disclaimer. EXCEPT AS SPECIFICALLY PROVIDED FOR IN SECTION 5.2.1
(Specification), THE BULK DRUG SUBSTANCE AND DRUG PRODUCT IS PROVIDED WITH NO
WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING
ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR THAT THE
BULK DRUG SUBSTANCE OR DRUG PRODUCT IS FREE FROM THE RIGHTFUL CLAIM OF ANY THIRD
PARTY BY WAY OF INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OR THE LIKE.
FURTHER, EXCEPT TO THE EXTENT SPECIFICALLY PROVIDED FOR IN SECTION 5.2.1
(Specification) AMGEN DOES NOT WARRANT OR MAKE ANY REPRESENTATION REGARDING THE
USE, RESULTS OF THE USE OR APPROPRIATENESS OF THE USE OF BULK DRUG SUBSTANCE OR
DRUG PRODUCT OR ANY PRODUCT MADE USING BULK DRUG SUBSTANCE OR DRUG PRODUCT.
PURCHASER SHALL CONDUCT ITS OWN ANALYSIS OF THE BULK DRUG SUBSTANCE OR DRUG
PRODUCT AND ASSUME ALL RESPONSIBILITY FOR THE QUALITY AND USE OF THE BULK DRUG
SUBSTANCE OR DRUG PRODUCT AND PRODUCTS MADE USING BULK DRUG SUBSTANCE OR DRUG
PRODUCT (INCLUDING BUT NOT LIMITED TO ALL PRODUCT LIABILITY) EXCEPT TO THE
EXTENT SPECIFICALLY PROVIDED IN SECTION 6.2.2 (Amgen Obligation) AND, EXCEPT TO
THE EXTENT SPECIFICALLY PROVIDED IN SECTION 4.3.2 (Amgen Obligation),
PURCHASER’S SOLE REMEDY FOR FAILURE OF THE BULK DRUG SUBSTANCE OR DRUG PRODUCT
TO CONFORM TO THE SPECIFICATIONS WILL BE REPLACEMENT OF THE BULK DRUG SUBSTANCE
OR DRUG PRODUCT IN ACCORDANCE WITH SECTION 2.7 (Product Testing; Noncompliance)
ABOVE.

 

5.3 Covenants.

 

  5.3.1 For Use within Territory. Purchaser covenants that it shall order Drug
Product hereunder only as it reasonably anticipates it will need for such
purposes.

 

  5.3.2

Forecasts. Purchaser covenants to use its reasonably diligent efforts and all
available information in its forecasting for Drug Product pursuant to
Section 2.2

 

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(Forecasts and Orders) above, and agrees to use its reasonably diligent efforts
to comply with all such forecasts given to Amgen.

 

  5.3.3 Debarment. Neither Party shall knowingly use in connection with the
activities to take place pursuant to this Agreement any employee or consultant
that has been debarred or the subject of debarment proceedings by any regulatory
agency.

 

  5.3.4 Product Integrity. Purchaser covenants to use all commercially
reasonable efforts to ensure that Drug Product is not damaged, altered, or
spoiled in any way, including during storage and transportation, after delivery
of Drug Product to Purchaser hereunder.

 

  5.3.5 Compliance with United States Regulations. Purchaser covenants that it
shall comply with all U.S. Laws prohibiting the re-export, directly or
indirectly, of certain controlled U.S.-origin items without a license to parties
located in certain countries or appearing on certain U.S. Government lists of
restricted parties; U.S. Laws prohibiting participation in non-U.S. boycotts
that the United States does not support; and U.S. Laws prohibiting the sale of
products to parties from any country subject to U.S. economic sanctions or who
are identified on related U.S. Government lists of restricted parties.

 

5.4 Disclaimer of Warranties. EXCEPT AS SET FORTH IN THIS ARTICLE 5
(Representations, Warranties and Covenants), PURCHASER AND AMGEN EXPRESSLY
DISCLAIM ANY AND ALL REPRESENTATIONS AND WARRANTIES, EXPRESS, IMPLIED, STATUTORY
OR OTHERWISE, WITH RESPECT TO THE SUBJECT MATTER OF THIS AGREEMENT, INCLUDING
ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OR
NONINFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS.

6. LIMITATION OF LIABILITY, INSURANCE AND INDEMNIFICATION

 

6.1 Insurance. During the term of this Agreement 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 (or reasonable self-insurance sufficient
to provide materially the same level and type of protection).

 

6.2 Indemnity.

 

  6.2.1

Licensee Obligation. Subject to Section 6.3 (Limitations of Liability) and
Section 6.1 (Insurance), Purchaser shall indemnify and hold harmless Amgen, its
Affiliates, and their respective directors, officers, employees, and agents
(including subcontractors) (collectively, “Amgen Indemnitees”), at Purchaser’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 Purchaser has assumed
the defense of such claim) paid to a Third Party (collectively, “Losses”)
arising out of any claim, action, lawsuit, or other proceeding (collectively,
“Claims”) brought against any Amgen Indemnitee by a Third Party to the extent
such Losses result from (i) a

 

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material breach of any representation or warranty of Purchaser under Section 5.1
(Mutual Representations and Warranties) or Section 5.2.2 (Use), (ii) a material
breach of any material obligation in this Agreement or (iii) Purchaser’s, its
Affiliate’s, agent’s or licensee’s development or commercialization of Vectibix
but excluding such Losses to the extent they arise from (i), (ii) or (iii) in
Section 6.2.2 (Amgen Obligation) below.

 

  6.2.2 Amgen Obligation. Subject to Section 6.3 (Limitations of Liability) and
Section 6.1 (Insurance), Amgen shall indemnify and hold harmless Purchaser, its
Affiliates, and their respective directors, officers, employees and agents
(collectively, “Purchaser Indemnitees”), at Amgen’s cost and expense, from and
against any and all Losses (including reasonable legal expenses and attorneys’
fees incurred by any Purchaser Indemnitees until such time as Amgen has assumed
the defense of such claim) arising out of any Claim brought against any
Purchaser Indemnitee by a Third Party to the extent such Losses result from
(i) a material breach of any representation or warranty of Purchaser under
Section 5.1 (Mutual Representations and Warranties) or Section 5.2.1
(Specification), (ii) a material breach of any material obligation in this
Agreement, or (iii) a [*]. Any obligation of Amgen under this Section 6.2.2
(Amgen Obligation) with respect to any [*]. Notwithstanding anything herein to
the contrary, Amgen, its Affiliates and agents shall not have any liability for
any Losses arising out of or resulting from [*]. Without prejudice to the
foregoing, if Amgen notifies Purchaser of the [*] hereunder, Purchaser shall
comply with Amgen’s instructions with respect to such [*]; provided that, if
Purchaser elects not to comply with Amgen’s instructions with respect to such
[*]. The indemnification obligations under this Section 6.2.2 (Amgen Obligation)
exclude Losses to the extent they arise from (i), (ii) or (iii) of Section 6.2.1
(Purchaser Obligation) above.

 

  6.2.3

Claim for Indemnification. Whenever any Claim or Loss shall arise for which a
Purchaser Indemnitee or an Amgen Indemnitee (the “Indemnified Party”) may seek
indemnification under this Section 6.2 (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 Section 6.2.1 (Purchaser Obligation) or
6.2.2 (Amgen Obligation), as the case may be, shall not relieve the Indemnifying
Party of its indemnification obligation under this Agreement except and only to
the extent that the Indemnifying Party is actually prejudiced as a result of
such failure. The Indemnifying Party shall have the right to assume the defense
of the Claim on behalf of the Indemnified Party. Upon assumption of the defense
of the Claim by the Indemnifying Party, the Indemnifying Party shall have
exclusive control of the defense and settlement of the Claim. 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, which will not be unreasonably withheld. The Indemnifying
Party shall not be liable for any settlement or compromising of a Claim by the
Indemnified Party without the Indemnifying Party’s prior written consent, which
will not be unreasonably withheld. In no event shall the Indemnifying Party
settle any Claim without the

 

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prior written consent of the other Party if such settlement does not include a
complete release from liability on such Claim or if such settlement would
involve undertaking an obligation other than the payment of money, would bind or
impair the other Party, or includes any admission of wrongdoing or that any
intellectual property or proprietary right of the other Party is invalid or
unenforceable. The Indemnified Party shall reasonably cooperate with the
Indemnifying Party at the Indemnifying Party’s expense and shall make available
to the Indemnifying Party reasonably requested information under the control of
the Indemnified Party, which information shall be subject to Section 4.1
(Confidentiality; Exceptions) of this Agreement. The provisions of this
Section 6.2 (Indemnification) shall govern indemnification with respect to the
manufacture and supply of Drug Product and the indemnification provisions of the
License Agreement shall not apply with respect to such activities.

 

6.3 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 6.3 (Limitations of Liability) shall not apply with respect to
(i) either Party’s indemnification obligations under Article 6 (Limitation of
Liability; Insurance and Indemnification), (ii) breach of Article 4
(Confidentiality) or (iii) gross negligence or willful misconduct of a Party.

7. TERM AND TERMINATION

 

7.1 Term. This Agreement shall commence on the Effective Date and shall
terminate upon the earliest to occur of any of the following: (i) the Parties
mutually agree in writing to terminate this Agreement; (ii) either Party
terminates this Agreement, pursuant to Section 7.2 (Termination by Either
Party); and (iii) this Agreement terminates automatically pursuant to
Section 7.3 (Termination of License Agreement) or Section 7.4 (Termination by
Amgen for Discontinuation).

 

7.2 Termination by Either Party.

 

  7.2.1 Breach. If a Party is in material breach of this Agreement, then the
other Party may deliver notice of such material breach (specifying the nature of
the breach in reasonable detail) to the breaching Party. In such written notice,
the noticing Party shall identify the actions or conduct that such Party would
consider to be an acceptable cure of such material breach (if curable). If the
breaching Party 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.

 

  7.2.2

Bankruptcy. Either Party may terminate this Agreement, effective immediately
upon the giving of written notice to the other Party, if the other Party
(i) becomes

 

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bankrupt or insolvent, or files a petition in bankruptcy or makes a general
assignment for the benefit of creditors or otherwise acknowledges in writing
insolvency, or is adjudged bankrupt, and such Party (A) fails to assume this
Agreement in any such bankruptcy proceeding within [*] days after filing or
(B) assumes and assigns this Agreement to a Third Party; (ii) goes into or is
placed in a process of complete liquidation; (iii) a trustee or receiver is
appointed for any substantial portion of such Party’s business and such trustee
or receiver is not discharged within [*] days after appointment; (iv) any case
or proceeding shall have been commenced or other action taken against such Party
in bankruptcy or seeking liquidation, reorganization, dissolution, a winding-up
arrangement, composition or readjustment of its debts or any other relief under
any applicable bankruptcy, insolvency, reorganization or similar Law now or
hereafter in effect and is not dismissed or converted into a voluntary
proceeding governed by clause (i) above within [*] days after filing; or
(v) there shall have been issued a warrant of attachment, execution, distraint
or similar process against any substantial part of the property of such Party
and such event shall have continued for a period of [*] days and none of the
following has occurred: (A) it is dismissed, (B) it is bonded in a manner
reasonably satisfactory to the other Party, or (C) it is discharged.

 

7.3 Termination of License Agreement. This Agreement shall terminate
automatically in the event that the License Agreement, or the license with
respect to Vectibix under the License Agreement, expires or is terminated for
any reason.

 

7.4 Termination by Amgen for Discontinuation. This Agreement shall terminate
automatically in the event Amgen transitions the entirety of manufacturing of
Drug Product pursuant to Section 2.14 of this Agreement.

 

7.5 Effect of Termination. In the event of expiration or termination of this
Agreement:

 

  7.5.1 The Parties shall cooperate to perform hereunder as necessary to
effectuate the purposes of the Transition Period provided for in Section 14.5
(Transition Period) of the License Agreement (if applicable);

 

  7.5.2 Purchaser shall promptly pay Amgen for all purchase orders for which
Amgen has not been paid and Amgen will be obligated to deliver to Purchaser the
supply represented by such purchase orders paid (if not previously provided),
and Amgen shall invoice Purchaser, and Purchaser shall pay Amgen within [*] days
of the date of such invoice, for any goods in-process or other costs incurred on
behalf of Purchaser which goods or costs (or portion thereof) cannot be
practically used for other purposes.

 

  7.5.3 Purchaser shall promptly pay Amgen all other accrued but unpaid payments
due Amgen under the Agreement; and

 

  7.5.4 The following terms and conditions of this Agreement shall survive:

 

  7.5.4.1

Sections 2.5 (Provision of Drug Product); 2.5 (Necessary Approvals); 2.7
(Product Testing; Noncompliance); 5.2.3 (Disclaimer); 5.3.1 (For Use within
Territory); 5.3.4 (Product Integrity); 5.3.5 (Compliance with United States
Regulations) and Article 3 (Payment) (all of the foregoing solely with respect
to Drug Product provided prior to such termination). In

 

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addition, Sections 5.3.1 (For Use within Territory); and 5.3.4 (Product
Integrity) shall survive with respect to Drug Product provided by an alternate
supplier pursuant to Section 2.14 (Alternate Supply)); and

 

  7.5.4.2 Sections 2.8 (Notice of Reports); 3.5 (Withholding); 3.7 (Annual
Determination) (solely with respect to a final reconciliation following
termination); 2.5.2 (Disclaimer); 5.4 (Disclaimer of Warranties) and this
Section 7.5 (Effect of Termination); and Articles 4 (Confidentiality); 6
(Limitation of Liability, Insurance and Indemnification) and 8 (Miscellaneous).

8. MISCELLANEOUS

 

8.1 Affiliates. Amgen shall have the right to exercise its rights and perform
its obligations hereunder through its Affiliates, provided Amgen shall be
responsible for such Affiliates’ performance hereunder. Where this Agreement
makes reference to costs incurred by Amgen, such reference shall be deemed to
include costs incurred by Amgen’s Affiliates or its Third-Party agents
(provided, however, that such costs shall not be double-counted as costs of
Amgen and such Affiliates or such Third-Party agents).

 

8.2 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 Purchaser 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
any or all of its rights and delegate any or all of its obligations under this
Agreement to a Party or Parties to whom Amgen licenses or transfers rights with
respect to Vectibix outside the Territory; and upon request of Amgen, Purchaser
will execute a novation with respect to any such assignment. 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.

 

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

 

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8.4 Construction. The definitions of the terms herein shall apply equally to the
singular and plural forms of the terms defined. 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.

 

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

 

8.6 Currency. All amounts due hereunder are expressed in U.S. Dollars. With
respect to Net Sales invoiced or expenses incurred in a currency other than U.S.
Dollars, such Net Sales invoiced or expenses incurred shall be converted into
the U.S. Dollar equivalent using a rate of exchange which corresponds to the
rate used by whichever of Purchaser or Amgen (or an Affiliate of one of them)
recorded such receipt or expenditure, for the respective reporting period,
related to recording such Net Sales or expenses in its books and records that
are maintained in accordance with GAAP. Any royalty amount shall be calculated
based upon the U.S. Dollar equivalent calculated in accordance with the
foregoing.

 

8.7 Entire Agreement. This Agreement, including any 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. This
Agreement does not supersede the License Agreement. In the event of any conflict
between the terms of the License Agreement and those contained herein, the
relevant provisions of the License Agreement shall control.

 

CONFIDENTIAL    24   

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8.8 Force Majeure. Neither Party shall be liable for delay or failure in the
performance of any of its obligations hereunder if such delay or failure is due
to causes beyond its reasonable control, including acts of God, fires, floods,
earthquakes, labor strikes, acts of war, terrorism or civil unrest (“Force
Majeure”); provided, however, that the affected Party promptly notifies the
other Party in writing (and continues to provide status updates to the other
Party for the duration of the effect) and further provided that the affected
Party shall use its reasonably diligent 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.
For the purposes of this Section 8.8 (Force Majeure), a Force Majeure affecting
Amgen’s Affiliate or a Third-Party contract manufacturer of Amgen shall operate
to excuse any delay or failure in performance as and to the same extent of a
Force Majeure affecting a Party as specified above.

 

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

 

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

 

8.11 Jurisdiction and Venue. Each Party hereby irrevocably submits to the
exclusive jurisdiction of the courts of the State of California (“State Court”)
and the courts of the United States of America located in the State of
California (“Federal Court”), for the purposes of any suit, action or other
proceeding arising out of or relating to this Agreement or out of any
transaction contemplated hereby. Each Party agrees that service of any process,
summons, notice or document by personal delivery, by registered mail, or by a
recognized international express delivery service to such Party’s respective
address set forth in Section 8.13 (Notices) (as such address may be changed by
notice delivered pursuant to such section) shall be effective service of process
for any action, suit or proceeding in the applicable Federal Court or State
Court with respect to any matters to which it has submitted to jurisdiction in
this Section 8.11 (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.

 

CONFIDENTIAL    25   

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

 

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

 

If to Amgen:    Amgen Inc.    One Amgen Center Drive    Thousand Oaks,
California 91320-1799    Attention: Corporate Secretary    Telephone:
805-447-1000    Facsimile: [*] If to Purchaser:    Takeda Pharmaceutical Company
Limited    1-1, Doshomachi 4-chome, Chuo-ku    Osaka 540-8645, Japan   
Attention: General Manager, Global Licensing & Business Development   
Telephone: [*]    Facsimile: [*]

Any such notice shall be deemed given on the date delivered. A Party may add,
delete (so long as at least one person is remaining), or change the person or
address to which notices should be sent at any time upon written notice
delivered to the other Party in accordance with this Section 8.13 (Notices).

 

8.14 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 Purchaser 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.

 

8.15 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.

 

8.16 Third Party Beneficiaries. Except as expressly provided with respect to
Indemnitees in Article 6 (Indemnification), there are no Third Party
beneficiaries intended hereunder and no Third Party shall have any right or
obligation hereunder.

 

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8.17 United Nations Convention. Notwithstanding anything to the contrary
contained in this Agreement, the United Nations Convention on Contracts for the
International Sale of Goods shall have no application to, and shall be of no
force and effect with respect to, this Agreement or the matters herein set forth
or contemplated.

 

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

*********

(Signature page immediately follows)

 

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

 

TAKEDA PHARMACEUTICAL COMPANY LIMITED     AMGEN INC. By:  

/s/ Yasuhiko Yamanaka

    By:  

/s/ Kevin W. Sharer

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

 

CONFIDENTIAL    28   

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Schedule

Pricing

A. Price for Commercial Product. The price (“Supply Price”) for commercial Drug
Product shall be [*].

B. Price for Non-Commercial Product. The price for non-commercial Drug Product
shall be [*].