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Sourcing and Supply Agreement – Amgen Inc.

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.

SOURCING AND SUPPLY AGREEMENT

This Sourcing and Supply Agreement (this “Agreement”) is made by and between
Amgen USA Inc. (“Amgen”), a wholly-owned subsidiary of Amgen Inc., and DaVita
Inc. (“Dialysis Center”) to set forth the terms and conditions upon which
Dialysis Center Purchasers shall purchase EPOGEN ® (Epoetin alfa) and
Amgen shall provide discounts and pay rebates to Dialysis Center on EPOGEN. Each
of Amgen and Dialysis Center are referred to herein as a “Party” and
together as the “Parties“. Amgen Inc. is a party to this Agreement for
the purposes set forth in Sections 3.1, 8.2, 9.4, 9.5.1, and 11.14 of
this Agreement. Capitalized terms used herein and not otherwise defined herein
shall have the meaning set forth in Section 1.

RECITALS

WHEREAS, Amgen is a leading innovator in the field of ESAs
with expertise in the field of anemia management and the ability to manufacture
and supply safe and efficacious ESAs for the treatment of dialysis patients;

WHEREAS, Dialysis Center is a leading provider of dialysis
services in the Territory with expertise in establishing and delivering
state-of-the-art, quality-of-care standards, practices and procedures for the
care of patients undergoing dialysis;

WHEREAS, Dialysis Center desires to select one ESA supplier
to meet its primary ESA needs on a long term basis for patients undergoing
dialysis;

WHEREAS, Dialysis Center has evaluated the ESAs available
for commercial use and those in clinical development, including potential [*]
ESAs, and has determined that EPOGEN ® (Epoetin alfa) will be its
preferred ESA for managing anemia for patients undergoing dialysis;

WHEREAS, the Parties wish to enter into this Agreement to,
among other things, provide for Dialysis Center’s selection of Amgen as the
Dialysis Center Purchasers’ supplier of EPOGEN to meet the Dialysis Center
Purchasers’ requirements for EPOGEN for the treatment of dialysis patients
during the Term, on all of the terms provided herein;

WHEREAS, Dialysis Center seeks stable, predictable and
competitive pricing over a seven year period, which it can achieve through the
discounts, rebates and other price concessions set forth herein;

WHEREAS, in order to provide Dialysis Center with such
pricing over a seven year period, Amgen will make substantial long-term
investments and forego other potential opportunities to scale and schedule its
manufacturing capacity and supply of EPOGEN for Dialysis Center Purchasers in
accordance with Dialysis Center Purchasers’ anticipated demand for EPOGEN for
use in the Territory as provided under this Agreement;

NOW THEREFORE, in consideration of the foregoing recitals
and of the mutual promises and covenants set forth herein, and for other good
and valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, and intending to be legally bound, each Party hereby agrees as
follows:

1.

DEFINITIONS

When used with initial capitals herein, the following terms shall have the
meaning ascribed to them below:

Page 1 of 136


1.1.

Actual Supply Shortfall” has the meaning set forth in Section
2.5
.

1.2.

Added Dialysis Center Purchaser” has the meaning set forth in
Section 2.8.2.

1.3.

Added Dialysis Center Purchaser Effective Date” has the meaning set
forth in Section 2.8.2.

1.4.

Added Dialysis Center Purchaser Transaction Date” means with respect
to each Added Dialysis Center Purchaser: (a) in the case of a new Dialysis
Center Affiliate, the effective date of the acquisition or establishment of the
new Dialysis Center Affiliate; or (b) in the case of a new Managed Center, the
earlier of (i) the effective date of the contract pursuant to which a dialysis
facility becomes a Managed Center or (ii) the date Dialysis Center first
provides services to a dialysis facility that results in such facility becoming
a Managed Center, in each case after the Term Start Date.

1.5.

Administrator” has the meaning set forth in Section 9.2.1.

1.6.

Affiliate” of a given entity shall mean an entity that controls, is
controlled by, or under common control with such given entity. Control shall
mean ownership of more than fifty percent (50%) of the voting stock of an entity
or, for non-stock entities, the right to more than fifty percent (50%) of the
profits of such entity.

1.7.

[*]” has the meaning set forth in Section 2.5.1.

1.8.

Alternative ESA” means an ESA that is available for use in the
Territory that is not EPOGEN or Aranesp.

1.9.

Alternative ESA Purchase Amount” has the meaning set forth in
Section 2.1.1.

1.10.

Alternative ESA Purchase Event” has the meaning set forth in
Section 2.1.1.

1.11.

Alternative ESA Purchase Event Share of Sales” shall be calculated as
follows

[*]

A = Committed Unit Purchases of Amgen ESAs during the [*] which an
Alternative ESA Purchase Event has occurred

B = Committed Unit Purchases of Amgen ESAs during the [*] which such
Alternative ESA Purchase Event has occurred

C = Committed Unit Purchases of Alternative ESAs during the [*] which an
Alternative ESA Purchase Event has occurred

D = Committed Unit Purchases of Alternative ESAs during the [*] which such
Alternative ESA Purchase Event has occurred

1.12.

Amgen Business Representative” has the meaning set forth in
Section 4.1.

1.13.

[*]” means [*] for use with patients receiving Dialysis Services,
which [*] is the subject of a written agreement between the Parties or their
Affiliates.

1.14.

Amgen ESA Risk Evaluation Program” has the meaning set forth in
Section 11.18.

1.15.

Amgen ESAs Share of Sales” shall mean Committed [*] Purchases of
Amgen ESAs during the Quarter divided by the sum of Committed [*]
Purchases of Amgen ESAs and Committed [*] Purchases of Alternative ESAs during
the Quarter.

Page 2 of 136


Amgen ESAs Share of Sales Illustration:

Committed [*] Purchases of Amgen ESAs

Committed [*] Purchases of Amgen ESAs + Committed [*]
Purchases of Alternative ESAs

1.16.

Amgen Indemnitees” has the meaning set forth in Section
9.5.2
.

1.17.

Appeal Procedures” has the meaning set forth in Section
9.2.3
.

1.18.

Aranesp” means Amgen’s proprietary darbepoetin alfa product that is
marketed by Amgen in the Territory under the trademark Aranesp ®.

1.19.

Arbitrator” has the meaning set forth in Section 9.2.1.

1.20.

Authorized Removal Occurrence” has the meaning set forth in
Section 2.8.3.

1.21.

Authorized Wholesalers” shall mean those wholesalers listed on
Exhibit B, as such list may be modified pursuant to Section 2.7.

1.22.

Authorized Wholesaler List” has the meaning set forth in Section
2.7
.

1.23.

Available EPOGEN SKUs” have the meaning set forth in Section
2.4.5
.

1.24.

Award” has the meaning set forth in Section 9.2.3.

1.25.

Base Invoice Discount” means the base invoice discount described in
Section 2.1 of Exhibit A.

1.26.

Base Rate Rebate” means the base rebate described in Section
3.1
of Exhibit A.

1.27.

Baseline [*]” has the meaning set forth in Section 2.1.2.

1.28.

[*] Rebate” means the [*] rebate described in Section 3.2 of
Exhibit A.

1.29.

Best Price” has the meaning set forth in Section 3.6.

1.30.

[*] Rebate” means the [*] rebate described in Section 3.3 of
Exhibit A.

1.31.

Business Representatives” has the meaning set forth in Section
4.1
.

1.32.

Certification” has the meaning set forth in Section 5.2.

1.33.

Committed [*] Purchases of Amgen ESAs” means, for any period, the
aggregate amounts in [*] of EPOGEN and Aranesp purchased by all Dialysis Center
Committed Purchasers during such period for use in providing Dialysis Services,
net of product returns and adjustments, which aggregate [*] data have been
independently confirmed by Amgen through the Relevant Information.

1.34.

Committed [*] Purchases of Alternative ESAs” means, for any period,
the aggregate amounts in [*] of all Alternative ESAs purchased by all Dialysis
Center Committed Purchasers from any source during such period for use in
providing Dialysis Services, (provided that any Alternative ESA provided
to a Dialysis Center Committed Purchaser at no or nominal cost from any source
shall be considered a purchase), adjusted to be an equivalent [*] of EPOGEN (in
[*]) based on the [*] (if the [*] is clearly set forth therein) or otherwise as
reasonably determined pursuant to Section 2.1.2, and which aggregate [*]
data have been independently confirmed by Amgen through the Relevant
Information.

1.35.

Compensation Data” has the meaning set forth in Section 6.1.

1.36.

Confidential Information” has the meaning set forth in Section
11.14
.

Page 3 of 136


1.37.

Data” means the data set forth on Schedule 1 provided by
Dialysis Center to Amgen pursuant to the terms and conditions of Section
5
and Exhibit A.

1.38.

Debarred Party” has the meaning set forth in Section 10.2.3.

1.39.

Designated Affiliates” shall mean any Affiliate of Dialysis Center
listed on Exhibit C, as such list may be modified pursuant to Section
2.8.1
.

1.40.

Designated Affiliates List” has the meaning set forth in Section
2.8.1
.

1.41.

Dialysis Center Business Representative” has the meaning set forth in
Section 4.1.

1.42.

Dialysis Center Committed Purchasers” has the meaning set forth in
Section 2.8.5.

1.43.

Dialysis Center Committed Purchasers List” has the meaning set forth
in Section 2.8.5.

1.44.

Dialysis Center Indemnitees” has the meaning set forth in Section
9.5.1
.

1.45.

Dialysis Center Purchasers” shall mean Dialysis Center, the
Designated Affiliates, and the Managed Centers. Dialysis Center Purchasers
include Added Dialysis Center Purchasers from and after the Added Dialysis
Center Purchaser Effective Date.

1.46.

Dialysis Services” means services related to the treatment of
patients receiving renal dialysis, including hemodialysis, peritoneal dialysis,
nocturnal dialysis, and home hemodialysis in the Territory during the Term.

1.47.

Disclosing Party” has the meaning set forth in Section 11.14.

1.48.

Discounts” means all rebates and discounts set forth on Exhibit
A
that may be earned by the Dialysis Center Purchasers pursuant to the terms
and conditions set forth in this Agreement, which shall be earned, calculated
and vested as provided in Exhibit A.

1.49.

Disputes” has the meaning set forth in Section 9.1.

1.50.

[*]” has the meaning set forth in Section 2.1.2.

1.51.

EPOGEN” means Amgen’s proprietary epoetin alfa product that is
marketed by Amgen in the Territory under the trademark EPOGEN ®.

1.52.

EPOGEN Equivalent Quantity” has the meaning set forth in Section
2.1.1
.

1.53.

ESAs” shall mean agents that stimulate erythropoiesis.

1.54.

FDA” has the meaning set forth in Section 8.3.

1.55.

FDA Website” has the meaning set forth in Section 11.18.

1.56.

Firm” has the meaning set forth in Section 3.2.

1.57.

Forecast Shortfall” has the meaning set forth in Section
2.4.2
.

1.58.

Forecast Shortfall Amount” has the meaning set forth in Section
2.4.2
.

1.59.

Force Majeure Event” has the meaning set forth in Section
11.8
.

1.60.

Governmental Authority” shall mean in respect of any individual or
entity, any government administrative agency, commission or other governmental
authority, body or instrumentality, or any federal, state, or local governmental
regulatory body having legal jurisdiction over that individual or entity.

1.61.

Gross Purchases of Amgen ESAs” means, for any period, the aggregate
gross amounts paid for purchases of EPOGEN and Aranesp by all Dialysis Center
Purchasers during such period for use in providing Dialysis Services, calculated
by using [*] in effect on

Page 4 of 136


each date of purchase, net of product returns and adjustments, which
aggregate sales data have been independently confirmed by Amgen through the
Relevant Information.

1.62.

Hearing” has the meaning set forth in Section 9.2.3.

1.63.

HIPAA” shall mean the Health Insurance Portability and Accountability
Act of 1996 and its implementing regulations, each as may be amended.

1.64.

IMS” means IMS Health Incorporated, a Delaware corporation and its
Affiliates.

1.65.

Indemnified Party” has the meaning set forth in Section
9.6.1
.

1.66.

Indemnifying Party” has the meaning set forth in Section
9.6.1
.

1.67.

Individually Identifiable Health Information” shall have the meaning
specified in HIPAA.

1.68.

Initial [*]” has the meaning set forth in Section 2.1.2.

1.69.

[*]” means an [*] for EPOGEN, Aranesp or an Alternative ESA, as
applicable, based on its measured biological activity or effect.

1.70.

Joint Project” has the meaning set forth in Section 7.1.

1.71.

Joint Project Committee” has the meaning set forth in Section
7.1
.

1.72.

Law” means, individually and collectively, any and all applicable
laws, ordinances, rules, regulations, directives, administrative circulars,
guidances and other pronouncements having the effect of law of any Governmental
Authority.

1.73.

Liquidated Damages” has the meaning set forth in Section
10.3
.

1.74.

Managed Center” shall mean a dialysis facility that is not an
Affiliate of Dialysis Center but for which Dialysis Center or an Affiliate of
Dialysis Center provides management services or administrative services in which
it controls the selection or procurement of ESAs.

1.75.

Managed Centers List” has the meaning set forth in Section
2.8.1
.

1.76.

Material Label Change” means a material amendment, change, revision,
and/or modification to the Chronic Kidney Disease section of the Boxed Warning
of the US prescribing information for EPOGEN as it relates to dialysis use.

1.77.

Minimum Forecast Commitment” has the meaning set forth in Section
2.4.2
.

1.78.

[*] Rebate” means the [*] rebate described in Section 3.4 of
Exhibit A.

1.79.

Non-Disclosing Party” has the meaning set forth in Section
11.14
.

1.80.

Notice of Added Dialysis Center Purchaser” has the meaning set forth
in Section 2.8.2.

1.81.

Objection Notice” has the meaning set forth in Section 3.2.

1.82.

Other Agreement(s)” has the meaning set forth in Section 2.2.

1.83.

Other Agreement Early Termination Date” has the meaning set forth in
Section 2.2.

1.84.

Party” and “Parties” have the meaning set forth in the
preamble hereto.

1.85.

[*]” has the meaning set forth in Section 5.5.

1.86.

Permitted Percentage Variances” has the meaning set forth in
Section 2.4.3.

1.87.

Permitted Variance Period” has the meaning set forth in Section
2.4.3
.

1.88.

Policies and Procedures” has the meaning set forth in Section
2.8.6
.

1.89.

Project Plan” has the meaning set forth in Section 7.1.

Page 5 of 136


1.90.

Project Proposal” has the meaning set forth in Section 7.1.

1.91.

Purchase Commitment” has the meaning set forth in Section
2.1
.

1.92.

Qualified Gross Purchases of EPOGEN” shall mean the amount of EPOGEN
purchased by Dialysis Center Purchasers during the Term from an Authorized
Wholesaler (or from Amgen pursuant to Section 2.7) for use in providing
Dialysis Services, and confirmed by Amgen through sales tracking data. Qualified
Gross Purchases of EPOGEN shall be calculated using the [*] in effect at the
time of the relevant purchase, net of product returns and adjustments.

1.93.

Quarter” shall mean each calendar quarter during the Term
(i.e., January 1 through March 31, April 1 through June 30, July 1
through September 30, and/or October 1 through December 31, as applicable).

1.94.

Recall” has the meaning set forth in Section 11.19.

1.95.

Relevant Information” means the Data, all sales tracking data,
Self-Reported Purchase Data, Compensation Data and other relevant information,
including relevant Third Party reporting agency data.

1.96.

Research Study” has the meaning set forth in Section 5.5.

1.97.

Rolling Forecast” has the meaning set forth in Section 2.4.1.

1.98.

Rolling Forecasts” has the meaning set forth in Section
2.4.1
.

1.99.

Rules” has the meaning set forth in Section 9.2.1.

1.100.

Self-Reported Purchase Data” means all [*] purchased of each ESA and
the number of patients who received each such ESA from Dialysis Center
Purchasers and such other related data as may be specified on Exhibit
SR-1
.

1.101.

[*]” has the meaning set forth in Section 5.5.

1.102.

Supply Commitment” has the meaning set forth in Section 2.1.

1.103.

Supply Shortfall” has the meaning set forth in Section 2.5.

1.104.

Supply Shortfall Notice” has the meaning set forth in Section
2.5
.

1.105.

Supply Shortfall Quarter” has the meaning set forth in Section
2.5
.

1.106.

Term” means the period commencing on the Term Start Date and ending
on the Term End Date.

1.107.

Term End Date” shall mean December 31, 2018.

1.108.

Term Start Date” shall mean January 1, 2012.

1.109.

Termination Date” means the date upon which this Agreement shall have
been terminated in accordance with the terms and conditions of this Agreement
pursuant to Section 10.2.

1.110.

Territory” means the United States, and its territories and
possessions, including Puerto Rico.

1.111.

Third Party” means any individual or entity other than a Party or an
Affiliate of a Party (or, in the case of Dialysis Center, a Managed Center).

1.112.

Third Party Claim(s)” has the meaning set forth in Section
9.5.1
.

1.113.

[*]” shall mean the [*] for EPOGEN to [*] as established by [*] in
its [*] from time to time, not including prompt pay or other discounts, rebates,
or reductions in [*].

Page 6 of 136


2.

PURCHASE AND SUPPLY COMMITMENTS

2.1.

Purchase and Supply Commitments. Subject to the terms and conditions
of this Agreement, (i) the Dialysis Center Committed Purchasers shall purchase
from Amgen through one or more Authorized Wholesalers those quantities of EPOGEN
that are needed to meet an Amgen ESAs Share of Sales of at least ninety percent
(90%) during each Quarter of the Term (the “Purchase Commitment“), and
(ii) Amgen shall ensure that during each Quarter of the Term [*] percent ([*]%)
of the [*] for each such Quarter is available for purchase by the Dialysis
Center Purchasers from one or more Authorized Wholesalers (the “Supply
Commitment
“). Subject to Section 2.3.2 and Section 2.3.3,
Amgen acknowledges and agrees that nothing in this Agreement shall prohibit any
Dialysis Center Committed Purchaser from purchasing an amount of EPOGEN
necessary to satisfy the Purchase Commitment in a particular Quarter regardless
of whether such EPOGEN was actually administered by the Dialysis Center
Committed Purchasers to their patients for the provision of Dialysis Services
during such Quarter.

2.1.1.

Alternative ESA Purchases. If in any Quarter the Dialysis Center
Committed Purchasers do not meet the Purchase Commitment (an “Alternative ESA
Purchase Event
“), then Dialysis Center shall (i) within thirty (30) days of
the end of any such applicable Quarter provide notice to Amgen of such
Alternative ESA Purchase Event, including the Committed [*] Purchases of
Alternative ESAs in such Quarter and (ii) within thirty (30) days of the end of
the Quarter immediately following the Quarter in which the Alternative ESA
Purchase Event occurred, the Committed [*] Purchases of Alternative ESAs in such
subsequent Quarter. If Dialysis Center provides such notice pursuant to this
Section 2.1.1, or if Amgen, in its sole discretion, through the use of
Relevant Information determines that there has been an Alternative ESA Purchase
Event, then Amgen shall have the right to deliver to Dialysis Center a notice
that sets forth the “EPOGEN Equivalent Quantity,” which shall be that
quantity of EPOGEN (in [*]) [*] but for the Alternative ESA Purchase Event
(based on the [*] (if the [*] is clearly set forth therein), or otherwise as
reasonably determined by Amgen through the Relevant Information as set forth in
Section 2.1.2). In the event the Alternative ESA Purchase Event Share of
Sales is equal to or greater than ninety percent (90%), then Dialysis Center
shall be deemed to have met the Purchase Commitment for the Quarter in which the
Alternative ESA Purchase Event occurred. If the Alternative ESA Purchase Event
Share of Sales is less than ninety percent (90%) for any reason, including a
Force Majeure Event related to Dialysis Center and/or the Dialysis Center
Purchasers, and not the result of a Supply Shortfall, then Amgen shall deliver
to Dialysis Center a notice, and Dialysis Center shall pay to Amgen within
thirty (30) days of its receipt of such notice, an amount (the “Alternative
ESA Purchase Amount
“) indicated by Amgen (as determined by Amgen based on
the Relevant Information) in such notice equal to (a) the EPOGEN Equivalent
Quantity multiplied by (b) [*] of EPOGEN earned by the Dialysis Center Committed
Purchasers during such Quarter. At Amgen’s option, any Alternative ESA Purchase
Amount may be offset in whole or in part against any Discounts earned by the
Dialysis Center Purchasers on Qualified Gross Purchases of EPOGEN in the
applicable Quarter or any subsequent Quarter.

2.1.2.

If a Party, in its reasonable discretion, feels that the Dialysis Center
Committed Purchasers potentially may not meet the Purchase Commitment due to
purchases of Alternative ESAs by the Dialysis Center Committed Purchasers in a
Quarter, then Amgen shall in consultation with Dialysis Center determine the
appropriate methodology to be used to determine the [*] (in [*]) of an
Alternative ESA that was

Page 7 of 136


used by the Dialysis Center Committed Purchasers patients’ during the
applicable measurement period that is equivalent to a [*] (in [*]) of EPOGEN
that was used by the Dialysis Center Committed Purchasers patients’ during the
applicable measurement period (the “[*]“) and Dialysis Center shall
reasonably cooperate with Amgen and provide any other reasonable data, including
[*] of ESAs utilized during the applicable measurement period, necessary to
complete the determination. If Dialysis Center has a reasonable objection to the
methodology proposed by Amgen, the Parties shall appoint a mutually agreeable
Third Party to determine the methodology to be used with the costs of such Third
Party to be borne equally by the Parties. The initial [*] for any particular
Alternative ESA as determined by either the Parties or the Third Party appointed
by the Parties, as applicable, pursuant to this Section 2.1.2 (the
Initial [*]“) shall only apply to the Quarter immediately preceding the
Initial [*]. The determination of the [*] for each particular Alternative ESA
shall be recalculated for each of the first [*] after the Initial [*] for such
Alternative ESA and the calculation of the [*] for such Alternative ESA after
each Quarter during such [*] period shall only apply to the immediately
preceding Quarter after each such recalculation. The [*] for a particular
Alternative ESA for all periods after such [*] period shall be the [*]
determined as of the end of the [*] Quarter after the Initial [*] for such
Alternative ESA (the “Baseline [*]“); provided, either Party may, no more
frequently than once per calendar year, request a recalculation of the Baseline
[*], which recalculation shall be applied prospectively, if such Party
reasonably believes that the Baseline [*] has materially changed over time, in
which event the requesting Party shall bear the costs of any Third Party
appointed by the Parties in connection therewith.

2.2.

Purchase Commitment Transition Period for Added Dialysis Center
Purchasers
. If, after the Term Start Date, there is a new Added Dialysis
Center Purchaser pursuant to Section 2.8.2, that is a Dialysis Center
Committed Purchaser, Dialysis Center shall use its commercially reasonable
efforts to cause such Added Dialysis Center Purchaser to meet the Purchase
Commitment as soon as practicable, but such Added Dialysis Center Purchaser
shall not be obligated to meet the Purchase Commitment until [*] days after the
Added Dialysis Center Purchaser Effective Date. If, as of the Added Dialysis
Center Purchaser Effective Date regarding an Added Dialysis Center Purchaser,
such Added Dialysis Center Purchaser was a party to a written agreement with a
Third Party which includes an obligation on the part of such Added Dialysis
Center Purchaser to exclusively purchase an Alternative ESA to meet a majority
of its ESA requirements for the provision of Dialysis Services in the Territory
(an “Other Agreement(s)“) and Dialysis Center can demonstrate via
reasonable evidence to Amgen that such Other Agreement was entered into by such
Added Dialysis Center Purchaser at least [*] days prior to the Added Dialysis
Center Purchaser Transaction Date, then such Added Dialysis Center Purchaser
shall not be subject to the Purchase Commitment until [*] days after such time
that such Other Agreement(s) can be terminated and/or amended to terminate such
obligation with respect to the Alternative ESAs without such Added Dialysis
Center Purchaser and/or Dialysis Center and/or any of its Affiliates paying any
damages and/or other amounts to such Third Party (the “Other Agreement Early
Termination Date
“); provided that Dialysis Center shall use its best efforts
to terminate such Other Agreement as soon Dialysis Center can do so without such
Added Dialysis Center Purchaser and/or Dialysis Center and/or any of its
Affiliates paying any damages and/or other amounts to such Third Party. Amgen
shall not be obligated to meet the Supply Commitment for any Added Dialysis
Center Purchaser until the expiration of the [*] day period after the Added
Dialysis Center Purchaser Effective Date or, in the case of an

Page 8 of 136


Added Dialysis Center Purchaser that is a party to an Other Agreement, [*]
days after the Other Agreement Early Termination Date.

2.3.

Eligible Purchases.

2.3.1.

Purchases from Authorized Wholesaler. Only purchases
of EPOGEN made by a Dialysis Center Purchaser from an Authorized Wholesaler
shall be eligible to receive the Discounts provided under this Agreement.

2.3.2.

Own Use. The Dialysis Center Purchasers shall purchase EPOGEN
under this Agreement solely for their own use in providing Dialysis Services,
and only purchases made by Dialysis Center Purchasers for such use shall be
eligible for the Discounts provided under this Agreement and shall be considered
Committed [*] Purchases of Amgen ESAs. Dialysis Center on behalf of itself and
each other Dialysis Center Purchaser covenants that none of them shall seek to
procure any of the Discounts available under this Agreement for any purchases of
EPOGEN not for its or their use in providing Dialysis Services, and Dialysis
Center shall promptly notify Amgen in the event Amgen shall have provided any
Dialysis Center Purchaser with any Discounts hereunder for any EPOGEN that was
not used by them for the provision of Dialysis Services.

2.3.3.

Maximum Quarterly Purchase Increases. Notwithstanding any
other provision of this Agreement, no Discounts earned by Dialysis Center shall
apply to Qualified Gross Purchases of EPOGEN for any Quarter that exceed [*]
percent ([*]%) of the Qualified Gross Purchases of EPOGEN in the immediately
preceding Quarter unless Amgen, in its sole discretion, determines that such
increase is necessary for Dialysis Center to meet its Purchase Commitment for
any such Quarter. Such calculation shall be adjusted to remove from the
calculation the effect of any change in [*], or increases/decreases in the
number of Dialysis Center Purchasers during the relevant comparison periods.

2.4.

Quantity Forecasts and Minimum Forecast Commitment.

2.4.1.

Rolling Forecast. Each Quarter during the Term,
Dialysis Center shall submit in writing to Amgen a rolling [*] month forecast
setting forth on a month-by-month basis the aggregate quantities in [*] of
EPOGEN by Available EPOGEN SKU that Dialysis Center has determined in good faith
are required for all Dialysis Center Purchasers for each month in the forecast
period, starting with an initial [*] month forecast beginning as of [*] which
shall be delivered to Amgen by [*] (each, a “Rolling Forecast” and
collectively the “Rolling Forecasts“). With the exception of the initial
Rolling Forecast, Dialysis Center shall submit each Rolling Forecast by no later
than the [*] of the [*] of each Quarter during the Term (e.g., by [*] Dialysis
Center shall submit a Rolling Forecast for the [*] month period from [*] through
[*]). The Rolling Forecasts shall not reflect any EPOGEN requirements for
periods after the Term End Date. If Dialysis Center has not timely delivered a
Rolling Forecast as provided above, the Rolling Forecast previously in effect
shall remain in effect for the periods covered thereby. The purpose of this
Section 2.4.1 is to allow Amgen adequate time to adjust its manufacturing
planning and operations to properly reflect the anticipated mix of Available
EPOGEN SKUs.

2.4.2.

Minimum Forecast Commitment. Without reducing or
limiting the Purchase Commitment set forth in Section 2.1, the forecasted
quantities of each Available EPOGEN SKU for months [*] of each Rolling Forecast
shall constitute the Dialysis Center Purchasers’ aggregate minimum purchase
commitment of [*] of EPOGEN by Available EPOGEN SKU (the “Minimum Forecast
Commitment
“). If

Page 9 of 136


the Dialysis Center Purchasers purchase an aggregate quantity in [*] of
EPOGEN by Available EPOGEN SKU during any Quarter that is less than the Minimum
Forecast Commitment for any such Quarter (the quantity of any such difference,
the “Forecast Shortfall“), then Amgen shall notify Dialysis Center of the
Forecast Shortfall in writing. If the Dialysis Center Purchasers purchase a
quantity in [*] of EPOGEN by Available EPOGEN SKU during the Quarter in which
the Forecast Shortfall occurred and the immediately following Quarter in the
aggregate that is less than the aggregate Minimum Forecast Commitments for such
two Quarters, Amgen shall notify Dialysis Centers of such failure in writing,
and within thirty (30) days of Dialysis Center’s receipt of such notice, it
shall pay to Amgen an amount equal to [*] percent ([*]%) of (i) the Forecast
Shortfall for the applicable Quarter multiplied by (ii) [*] less
the Discounts per [*] of EPOGEN for each Available EPOGEN SKU earned by the
Dialysis Center Purchasers during such Quarter (the “Forecast Shortfall
Amount
“). At Amgen’s option, any Forecast Shortfall Amount may be offset in
whole or in part against any Discounts earned by the Dialysis Center Purchasers
on purchases of EPOGEN in the applicable Quarter or any subsequent Quarter.

2.4.3.

Forecast Variance. Each Rolling Forecast provided by Dialysis
Center may [*] quantities of each Available EPOGEN SKU only for new months [*]
and may [*] quantities of each Available EPOGEN SKU in the new months [*] from
the corresponding months in the immediately prior Rolling Forecast by the
Permitted Percentage Variances” in the table below. The Permitted
Percentage Variances for the months of each Rolling Forecast (the “Permitted
Variance Period
“) are as follows:

Months

[

*]

[

*]

[

*]

[

*]

[

*]

Permitted Percentage Variance

[

*]%

[

*]%

[

*]%

[

*]%

[

*]%

If Dialysis Center submits a Rolling Forecast that contains a forecast for
any month therein that is not in compliance with this Section 2.4.3,
Amgen shall have the right, in its sole discretion, to either (a) accept such
forecast for any month therein that is not in compliance with this Section; or
(b) adjust such non-compliant forecasted quantity for any such month to increase
or decrease the amount forecasted for such month by up to the minimum amount
necessary to bring such forecasted quantity into compliance with this
Section 2.4.3. Dialysis Center may, at any time for any good faith
reason, request additional variances to the Permitted Percentage Variances and,
in such event, the Parties shall work in good faith to accommodate such request;
provided, however, that (i) in no event shall Amgen be liable for any resulting
Supply Shortfall or Actual Supply Shortfall and (ii) Dialysis Center shall
remain liable for any Forecast Shortfall that may occur. If in any Quarter
during the Term, the Dialysis Center Purchasers have a Forecast Shortfall and
the Parties have determined, after good faith discussions, that such Forecast
Shortfall is the necessary result of a Material Label Change, then the Dialysis
Center Purchasers shall not be liable for such Forecast Shortfall.

2.4.4.

Good Faith Estimates. Each Rolling Forecast submitted by
Dialysis Center shall represent good faith estimates of the Dialysis Center
Purchasers’ actual anticipated purchases of EPOGEN for the treatment of dialysis
patients in the

Page 10 of 136


Territory and reasonable inventory requirements for EPOGEN in the Territory
during the relevant timeframes.

2.4.5.

Available EPOGEN SKUs. The Available EPOGEN SKU
Schedule attached as Schedule 3 hereto sets forth the “Available
EPOGEN SKUs
” as of the Term Start Date. Amgen may add Available EPOGEN SKUs
to, or remove Available EPOGEN SKUs (with respect to all purchasers of EPOGEN
for free-standing dialysis clinics) from, the Available EPOGEN SKUs Schedule
upon at least [*] advance written notice to Dialysis Center; provided that Amgen
may not remove any Available EPOGEN SKUs from the Available EPOGEN SKUs Schedule
that accounted for [*] percent ([*]%) or more of the Qualified Gross Purchases
of EPOGEN during the immediately preceding [*] without the prior written consent
of Dialysis Center, which consent may be withheld by Dialysis Center in its sole
discretion, unless there is an Available EPOGEN SKU that corresponds to the same
dosage, size and potency of the deleted Available EPOGEN SKU; and provided
further that, notwithstanding the foregoing, Amgen may immediately remove any
Available EPOGEN SKU should Amgen determine, in its sole discretion, that the
removal of any such Available EPOGEN SKU is for safety or quality or similar
reasons. The Parties shall mutually agree upon (a) the first period for which
any such new Available EPOGEN SKU may be ordered by the Dialysis Center
Purchasers and (b) any permitted adjustments to the EPOGEN SKU mix contained in
Dialysis Center’s then applicable Rolling Forecast to reflect any changes in the
Available EPOGEN SKUs or as otherwise may be required due to any production
shortfall applicable to all EPOGEN customers.

2.5.

Supply Commitment Shortfalls. Dialysis Center shall promptly notify
Amgen in writing (the “Supply Shortfall Notice“) if a Dialysis Center
Purchaser has not been able to purchase from the Authorized Wholesalers a
quantity of EPOGEN in [*] for any Available EPOGEN SKU that meets the Minimum
Forecast Commitment for any Quarter for any reason, including as a result of a
Force Majeure Event related to Amgen (a “Supply Shortfall Quarter“),
setting forth in such notice the quantity of EPOGEN in [*] by Available EPOGEN
SKU representing such shortfall, including as a result of a Force Majeure Event
related to Amgen (the “Supply Shortfall“). In the event of a Supply
Shortfall, Amgen shall not intentionally discriminate against any of the
Dialysis Center Purchasers in its allocation of the available quantities of an
Available EPOGEN SKU subject to such Supply Shortfall by making its allocation
decisions, in whole or in part, on the basis of the prices, Discounts, and/or
other financial terms offered to the Dialysis Center Purchasers pursuant to the
terms and conditions of this Agreement. In no event shall the inability to
obtain a particular Available EPOGEN SKU in a Minimum Forecast Commitment be
deemed a Supply Shortfall, if a Dialysis Center Purchaser can purchase (i) the
same quantity of EPOGEN in [*] through other Available EPOGEN SKUs or (ii)
Aranesp, other than with respect to use by physicians with privileges at a
Dialysis Center Purchaser who have obtained approval through Dialysis Center’s
formulary exception process to use a “short-acting” Alternative ESA instead of
Aranesp. If the Authorized Wholesalers are actually unable to supply the
Dialysis Center Purchasers with a quantity of (i) EPOGEN or (ii) Aranesp equal
to the Supply Shortfall within the time period reasonably required by the
Dialysis Center Purchasers as set forth in the Supply Shortfall Notice, which in
no event will be less than five (5) business days after Amgen’s receipt of the
applicable Supply Shortfall Notice, the Purchase Commitment shall be reduced by
the quantity of any Supply Shortfall that actually occurs (the “Actual Supply
Shortfall
“).

2.5.1.

In the event of an Actual Supply Shortfall, Dialysis Center shall use good
faith efforts to procure any Alternative ESAs from a Third Party at the [*].
Dialysis

Page 11 of 136


Center shall deliver to Amgen a statement setting forth the aggregate [*]
(i.e., the aggregate [*] less all applicable discounts, rebates,
chargebacks and other price adjustments) actually paid by the Dialysis Center
Purchasers to any such Third Party for that quantity of Alternative ESAs
purchased by such Dialysis Center Purchasers during the Supply Shortfall Quarter
solely as a substitute for the Actual Supply Shortfall (the “[*]“);
provided that should Dialysis Center be subject to any confidentiality
restrictions that Dialysis Center may have with any Third Party from which it
procured Alternative ESAs, then the Parties agree to send such [*] to the Firm
to be verified. Amgen shall pay to Dialysis Center an amount of cash equal to
the difference, if any, between (a) the [*] and (b) the product of (i) (1) [*]
in effect for the Supply Shortfall Quarter less (2) the Discounts per [*]
of Available EPOGEN SKU earned by the Dialysis Center Purchasers in such Supply
Shortfall Quarter multiplied by (ii) the Actual Supply Shortfall.
Amgen shall also pay to Dialysis Center any incremental difference in the
aggregate [*] of Aranesp purchased by Dialysis Center Purchasers as a result of
the Supply Shortfall compared to the aggregate [*] of EPOGEN unless Amgen shall
have notified Dialysis Center in advance that Dialysis Center Purchasers may
purchase an Alternative ESA as opposed to Aranesp during the Actual Supply
Shortfall.

2.5.2.

Upon the completion of an Actual Supply Shortfall, the Purchase Commitment,
with respect to the quantities of EPOGEN in [*] of the Available EPOGEN SKUs
that constitute the Actual Supply Shortfall shall be suspended for a period of
[*] days to allow the Dialysis Center Purchasers to transition back from any
Alternative ESA’s used by the Dialysis Center Purchasers during such Actual
Supply Shortfall back to such applicable Available EPOGEN SKU.

2.5.3.

Provided that Amgen complies with its obligations under Section
2.5.1
, then Amgen will not be in breach of Section 2.1 and the Supply
Commitment as a result of the Actual Supply Shortfall.

2.6.

[*]. The Dialysis Center Purchasers shall purchase EPOGEN from an
Authorized Wholesaler at the then-prevailing [*] (subject to any wholesaler
markup, discount, services fees or other charges), and any Discounts shall be
applied in accordance with the schedules and terms set forth in Exhibit A
and this Agreement. Amgen reserves the right to change [*] at any time, by any
amount, without notice. Amgen shall promptly notify Dialysis Center of any
change to [*].

2.7.

Authorized Wholesalers. Prior to the Term Start Date, Dialysis Center
shall select one or more Authorized Wholesalers from the Authorized Wholesaler
list prepared by Amgen and set forth on Exhibit B (as such list may be
amended from time to time as provided in this Agreement, the “Authorized
Wholesaler List
“), and only such selected Authorized Wholesalers shall be
Authorized Wholesalers for purposes of this Agreement. From and after the Term
Start Date, Dialysis Center shall have the right to change its selection of
Authorized Wholesalers from the Authorized Wholesaler List with thirty (30) days
prior written notice to Amgen. Dialysis Center may request Amgen to add
wholesalers to the Authorized Wholesaler List, and Amgen, at its sole
discretion, shall have the right to determine whether to approve of such
addition to the Authorized Wholesaler List. Amgen shall have the right to add or
remove wholesalers from the Authorized Wholesaler List set forth on Exhibit
B
in the exercise of its commercially reasonable discretion by thirty (30)
days prior written notice to Dialysis Center, provided that for any removal (a)
Amgen removes such Authorized Wholesaler with respect to providing EPOGEN to all
purchasers of EPOGEN for free standing dialysis clinics, or (b) such Authorized
Wholesaler requests Amgen to remove it as an Authorized Wholesaler for

Page 12 of 136


Dialysis Center Purchasers. In the event of any removal of an Authorized
Wholesaler from the Authorized Wholesaler List by Amgen, Amgen shall work with
Dialysis Center to transition the Dialysis Center Purchasers’ purchases of
EPOGEN to an alternative Authorized Wholesaler, and if no alternative Authorized
Wholesaler exists at such time, the Parties shall use reasonable efforts to
establish a direct purchasing relationship in any interim period between the
removal of the removed Authorized Wholesaler and the initiation of purchases
from a new Authorized Wholesaler, if no Authorized Wholesaler exists at such
time. Any such direct purchasing relationship shall be subject to credit
qualification and the approval by Amgen of an application for direct ship
account. If the Dialysis Center Purchasers purchase EPOGEN directly from Amgen
as contemplated in this Section 2.7, all purchases of EPOGEN made from
Amgen by such Dialysis Center Purchasers shall be deemed Qualified Gross
Purchases of EPOGEN and eligible for the Discounts.

2.8.

Dialysis Center Purchasers

2.8.1.

Designated Affiliates and Managed Centers. Only the
Designated Affiliates listed on Exhibit C (as such list may be amended
from time to time as provided in this Agreement, the “Designated Affiliates
List
“) and the Managed Centers set forth on Exhibit D (as such list
may be amended from time to time as provided in this Agreement, the “Managed
Centers List
“) shall be Dialysis Center Purchasers for purposes of this
Agreement. Dialysis Center shall promptly update and maintain the accuracy of
the Designated Affiliates List and the Managed Centers List throughout the Term,
but in no event later than thirty (30) days after the addition or removal of a
Dialysis Center Purchaser pursuant to Section 2.8.2 or 2.8.3
below. Dialysis Center shall not acquire, divest, restructure, reorganize or
reclassify its Affiliates or Managed Centers, or request any addition or removal
of any Dialysis Center Purchaser, with the purpose or intent in whole or in part
to avoid or eliminate its obligations or commitments, or the obligations and
commitments of each of the Dialysis Center Purchasers set forth in this
Agreement.

2.8.2.

Addition of Dialysis Center Purchasers. After the Term Start
Date, subject to Amgen’s reasonable consent under this Section 2.8.2, all
new Affiliates and Managed Centers in the Territory shall be added to this
Agreement and become Dialysis Center Purchasers. Dialysis Center shall provide
prior written notice to Amgen of each new Affiliate and Managed Center in the
Territory (each a “Notice of Added Dialysis Center Purchaser“), which
notice shall include the proposed Added Dialysis Center Purchaser Transaction
Date, plus any additional information regarding the proposed Dialysis Center
Purchaser that Amgen shall reasonably request. Upon Amgen’s reasonable consent
and subject to the terms and conditions of Section 2.2 with respect to
the Purchase Commitment, the Designated Affiliates List and the Managed Centers
List shall be amended to include such Affiliates or Managed Centers effective as
of the later of (i) thirty (30) days from the date of Amgen’s receipt of a
Notice of Added Dialysis Center Purchaser or (ii) the applicable Added Dialysis
Center Purchaser Transaction Date (each such effective date, the “Added
Dialysis Center Purchaser Effective Date
“, and each of the Affiliates and
Managed Centers added by such amendments, an “Added Dialysis Center
Purchaser
“). The Designated Affiliates List and the Managed Centers List
shall be amended without further action required of the Parties to reflect
additions made in accordance with this Section 2.8.2.

Page 13 of 136


2.8.3.

Removal of Dialysis Center Purchasers. (A) Dialysis Center
may remove Designated Affiliates from the Designated Affiliates List and Managed
Centers from the Managed Center List only (i) upon the written consent of Amgen,
which consent shall not be unreasonably withheld, conditioned, and/or delayed or
(ii) upon thirty (30) days prior written notice to Amgen in the event such
removal is a result of a (a) sale of all or substantially all of the assets or
equity interests of a Designated Affiliate to a Third Party, whether by
reorganization, merger, sales of assets, or sale of equity interests, (b)
permanent closure of a Designated Affiliate facility or (c) termination of the
relevant management agreement for a Managed Center that has ceased its
management relationship with Dialysis Center and/or any Affiliate of Dialysis
Center (each of the events described in this clause (ii), an “Authorized
Removal Occurrence
“). Dialysis Center shall provide Amgen written notice
describing the nature of any requested removal, including the anticipated
effective date of any Authorized Removal Occurrence, and such removal shall be
effective thirty (30) days after Amgen has provided Dialysis Center with written
consent to such removal or such earlier period as may be agreed to by Amgen or,
in the event of an Authorized Removal Occurrence, the effective date of the
Authorized Removal Occurrence.

(B) Amgen shall also have the right to remove any Designated Affiliates from
the Designated Affiliates List and any Managed Centers from the Managed Centers
List upon thirty (30) days (or such shorter /period as may be required by Law or
any Governmental Authority) written notice to Dialysis Center (a) that such
removal is required by order of a court or Governmental Authority or (b) in
instances in which Amgen determines, in its reasonable discretion, that such
removal is required (i) to comply with Law or (ii) as a result of any such
Designated Affiliate’s or Managed Center’s negligence or willful misconduct in
the use or administration of EPOGEN.

(C) The Designated Affiliates List and the Managed Centers List shall be
amended without further action required of the Parties to reflect removals made
in accordance with this Section 2.8.3.

2.8.4.

Adjustments to Rolling Forecast. Following the addition or
removal of an Affiliate to or from the Designated Affiliates List or a Managed
Center to or from the Managed Centers List, the Parties shall mutually agree in
good faith to implement any reasonable and necessary adjustments to the Rolling
Forecast to account for such addition or removal of an Affiliate to or from the
Designated Affiliates List or a Managed Center to or from the Managed Centers
List; provided, that Amgen shall have no obligation under Section 2.5
for an Actual Supply Shortfall in the event that any increase to the quantities
of each Available EPOGEN SKU set forth in such adjusted Rolling Forecast is in
excess of the applicable Permitted Percentage Variances.

2.8.5.

Dialysis Center Committed Purchasers List. The Dialysis
Center Purchasers as of the Term Start Date shall constitute the initial list of
Dialysis Center Committed Purchasers” as listed on Exhibit E (as
such list may be amended from time to time as provided in this Agreement, the
Dialysis Center Committed Purchasers List“). Each Added Dialysis Center
Purchaser shall automatically be added to the Dialysis Center Committed
Purchasers List as of the Added Dialysis Center Purchaser Effective Date unless
Amgen shall have provided notice to the contrary prior to the Added Dialysis
Center Purchaser Effective Date. Any Dialysis Center Purchaser removed from the
Designated Affiliates List or the Managed Center List in accordance with
Section 2.8.3 shall automatically be removed from the Dialysis

Page 14 of 136


Center Committed Purchaser List as of the effective date of such removal from
the Designated Affiliates List or the Managed Center List. Amgen shall have the
right in its sole discretion to add or remove any Dialysis Center Purchasers
from the Dialysis Center Committed Purchasers List upon at least fifteen (15)
days’ written notice to Dialysis Center, effective as of the first day of the
Quarter after the expiration of the fifteen (15) day notice period; provided,
that Amgen shall work together with Dialysis Center to agree as to which
specific Dialysis Center Purchasers will be added or removed and, in the event,
the Parties are unable to agree in a reasonable time, Amgen may in its
discretion add or remove specific Dialysis Center Purchasers that are not
disproportionate in their use of Alternative ESAs compared to all Dialysis
Center Purchasers. For avoidance of doubt, any Dialysis Center Committed
Purchaser that is removed from the Dialysis Center Committed Purchasers List but
remains on the Designated Affiliates List or the Managed Center List shall still
be considered a Dialysis Center Purchaser.

2.8.6.

Access to Dialysis Center Facilities. Amgen covenants and
agrees that neither it nor any of its employees and/or agents shall have the
right to access to any Individually Identifiable Health Information while
accessing any of the Dialysis Center Purchasers’. The Parties acknowledge and
agree that (a) all of Dialysis Center’s applicable policies and procedures
regarding visitors and any updates thereto (the “Policies and
Procedures
“) that will be in effect during the Term are and will be
available for viewing by Amgen and its employees and/or agents during the Term
at http://www.davita.com/about/vendor-policies and (b) Amgen and its
employees and/or agents shall have [*] during [*] to the Dialysis Center
Purchasers’ facilities for the purpose of promoting and providing [*] regarding
[*] and shall abide by all the Policies and Procedures during the Term to the
extent that such Policies and Procedures have not changed since the Term Start
Date, other than as required by any applicable Law and/or generally accepted
industry guidance covering vendor access to facilities, in a manner that would
limit Amgen’s rights under this Section 2.8.6; provided, however, that,
notwithstanding anything contained in the Policies and Procedures, Amgen’s
employees and/or agents shall be permitted to utilize, without any pre-approval
or review by Dialysis Center, any Amgen internally approved (i) [*] materials
that have been submitted to the FDA, (ii) [*] materials, and (iii) [*]
materials, provided, such [*] materials have been previously submitted to
Dialysis Center’s Vice President of Clinical Management and Vendor Relations for
approval and not objected to by Dialysis Center’s Vice President of Clinical
Management and Vendor Relations within [*] business days of such submission; and
provided, further, that Amgen shall provide Dialysis Center’s Vice President of
Clinical Management and Vendor Relations with copies of all materials to be
utilized at the Dialysis Center Purchaser’s facilities prior to their first use
at any facility of the Dialysis Center Purchasers.

3.

DISCOUNTS

3.1.

Earning, Calculating, Payment and Vesting of Discounts. All Discounts
will be earned, calculated and vested as set forth in Exhibit A. For the
purposes of calculating the Discounts hereunder, Qualified Gross Purchases of
EPOGEN by any Dialysis Center Purchaser shall be deemed to be made on the date
of invoice by an Authorized Wholesaler or Amgen pursuant to Section 2.7
to any such Dialysis Center Purchaser. The Discounts (other than invoice
discounts) shall be paid in arrears by electronic funds transfer using
information provided to Amgen by Dialysis Center as necessary to enable payment.
All Discounts, excluding the Base Rate Rebate and the Base Invoice Discount,
shall be conditioned upon material compliance with Section 2.8.6. Amgen
Inc.

Page 15 of 136


hereby guarantees Amgen’s obligations to pay all Discounts earned by Dialysis
Center hereunder.

3.2.

Verification and Audit. Discounts (including any qualification
criteria for any Discounts) specified herein and/or any other amounts paid by
one Party to the other Party pursuant to this Agreement are subject to
verification and audit of the relevant purchase and other data (including the
Data, the Self-Reported Data and the Compensation Data), as reasonably necessary
to calculate any amounts payable hereunder. Dialysis Center Purchasers shall
maintain their books and records in accordance with U.S. generally accepted
accounting principles, consistently applied. To the extent either Amgen or
Dialysis Center, in its reasonable discretion, determines that it is necessary
to verify and confirm the calculation of: (a) any Discount described in this
Agreement in order to audit and assure compliance with the terms of this
Agreement and/or (b) any other amount that one Party must pay to the other Party
under this Agreement, the requesting Party shall provide written notice of same
to the other Party (an “Objection Notice”) setting forth in detail any and all
items of disagreement related to such computation, statement, and/or amount that
must be paid by one Party to the other Party. Amgen and Dialysis Center shall
jointly engage (at the requesting Party’s sole cost and expense, subject to any
reimbursement by the other Party as set forth below) and refer the items in
dispute to a nationally recognized firm of independent, certified public
accountants as to which Amgen and Dialysis Center mutually agree (the
Firm“), to resolve any disagreements. Amgen and Dialysis Center will
direct the Firm to render a written determination within twenty (20) days of its
retention, and Amgen and Dialysis Center and their respective employees and/or
agents will cooperate with the Firm during its engagement. The Firm shall keep
strictly confidential all data reviewed and information learned or obtained in
connection with resolving any Objection Notice and shall report to the
requesting Party only the conclusion of its review without the disclosure of any
Confidential Information. All reports of the Firm shall be made available to
both Parties simultaneously, promptly upon completion, and shall be deemed to
conclusively and definitively resolve the related Objection Notice, which shall
be reimbursed (if applicable) in accordance with this Section 3.2. Any
such audit shall be conducted during normal business hours, and so as not to
unreasonably interfere with the business of Amgen and/or any of the Dialysis
Center Purchasers. In the event any such audit is requested by Amgen and shows
that Dialysis Center Purchasers have submitted incorrect information resulting
in Dialysis Center receiving in excess of [*] percent ([*]%) of the amount to
which it was entitled in any Quarter, Dialysis Center shall reimburse Amgen for
the reasonable costs of such audit; otherwise, Amgen shall be responsible for
the costs of such audit. In the event any such audit is requested by Dialysis
Center and shows that Dialysis Center Purchasers have submitted correct
information but have been underpaid by more than [*] percent ([*]%) of the
amount to which they were entitled in any Quarter, Amgen shall reimburse
Dialysis Center for the reasonable costs of such audit; otherwise, Dialysis
Center shall be responsible for the costs of such audit. The determination of
the Firm will be conclusive and binding upon Amgen and Dialysis Center.
Following any audit that shows any over or underpayment hereunder, the relevant
Party shall, within sixty (60) days, make payment to the other Party for the
difference between the amount paid hereunder and the amount actually payable
hereunder based upon the results of such audit.

3.3.

Adjustments for Changes. In accordance with Section 2.8.2
and/or 2.8.3 above, in the event of an Affiliate’s addition to or
deletion from the Designated Affiliates List or a Managed Center’s addition to
or deletion from the Managed Centers List during any Quarter of the Term, Amgen
shall adjust Qualified Gross Purchases of EPOGEN to account for such Affiliate’s
addition to or deletion from the Designated Affiliates List or a

Page 16 of 136


Managed Center’s addition to or deletion from the Managed Centers List by
adding or deleting such Designated Affiliates’ or Managed Centers’, as
applicable, purchases to or from the relevant Quarter or comparison Quarter (or
portion thereof).

3.4.

Treatment of Discounts and Rebates.

3.4.1.

Dialysis Center agrees that Dialysis Center Purchasers shall properly
disclose and account for all Discounts earned hereunder, in whatever form, in
compliance with all applicable federal, state, and local Laws, including
§1128B(b) of the Social Security Act, as amended and its implementing
regulations. Dialysis Center agrees that, if required by such statutes or
regulations, it (together with its Designated Affiliates) shall and it shall
cause its Managed Centers to (i) claim the benefit of such Discount received in
the fiscal year in which such Discount was earned or the year after, (ii) fully
and accurately report the value of such Discount in any cost reports filed under
Title XVIII or Title XIX of the Social Security Act, as amended or a state or
local health care program, and (iii) provide, upon request by the U.S.
Department of Health and Human Services or a state or local agency or any other
federally funded state health care program, the information furnished to
Dialysis Center Purchasers by Amgen concerning the amount or value of such
Discount.

3.4.2.

In order to assist Dialysis Center’s compliance with its obligations as set
forth in Section 3.4.1 above, Amgen agrees that it will fully and
accurately report all Discounts on the invoices or statements submitted to
Dialysis Center and use reasonable efforts to inform Dialysis Center of its
obligations to report all such Discounts to the extent specified by 42 C.F.R §
1001.952(h)(2)(ii)(A) or where the value of a Discount is not known at the time
of sale, Amgen shall fully and accurately report the existence of the Discount
program on the invoices or statements submitted to Dialysis Center and use
reasonable efforts to inform Dialysis Center of its obligations to report all
such Discounts to the extent specified by 42 C.F.R § 1001.952(h)(2)(ii)(B), and
when the value of the Discounts become known, provide Dialysis Center with
documentation of the calculation of the Discount identifying the specific goods
or services purchased to which the Discount will be applied, in accordance with
Section 3.5 below.

3.5.

Reports. Within ninety (90) days of the end of each Quarter, Amgen
shall provide to Dialysis Center a statement of the Discounts earned hereunder
with the itemization of EPOGEN purchases made in a particular Quarter, broken
down for each Dialysis Center Purchaser and any other information that Dialysis
Center may reasonably request that is reasonably available to Amgen and
necessary for Dialysis Center to obtain in order to comply with its obligations
hereunder. Dialysis Center agrees that it will provide such information to its
Dialysis Center Purchasers in a timely manner in order to allow such Dialysis
Center Purchasers to meet their reporting and other obligations hereunder and
under applicable Law.

3.6.

Best Price Limitation. At any time following the repeal, enactment or
modification of any Law, policy, program memorandum, or the interpretation
thereof, including a decision by the Centers for Medicare & Medicaid
Services, that affects the definition of “Best Price” (which, for
purposes of this Agreement, shall mean the price reported in Amgen’s Best Price
Submission under Title XIX of the Social Security Act) or the methodology by
which Best Price must be calculated, Amgen shall have the right, in its sole
discretion, to determine the extent to which any [*] to any Third Party due to
such repeal, enactment, modification or decision may impact Amgen’s Best Price
calculation under this Agreement alone or in combination with any other [*] in
other agreements with Dialysis Center or any Third Party. In the event that
Amgen determines reasonably and in good

Page 17 of 136


faith that the then-existing [*] under this Agreement establishes or would
establish a new “Best Price,” Amgen shall have the right, in its sole
discretion, upon the later of (a) the effective date of such repeal, enactment,
modification or decision, or (b) notice to Dialysis Center, to [*] the Discounts
offered under this Agreement [*], and shall promptly notify Dialysis Center of
the [*]; provided that the [*] as adjusted by Amgen shall result in [*]
available to Dialysis Center which would [*] the Best Price prior to the
effective date of such repeal, enactment, modification or decision, calculated
using the modified definition or methodology by which Best Price is to be
calculated.

4.

GOVERNANCE

4.1.

Business Representatives. The “Business Representatives” shall
be comprised of: (i) in the case of Amgen, Amgen’s General Manager of the
Nephrology Business Unit (the “Amgen Business Representative“); and (ii)
in the case of Dialysis Center, the Chief Operating Officer of DaVita Inc. (the
Dialysis Center Business Representative“). Each Business Representative
shall be entitled to appoint designees who have been identified to the other
Business Representative in writing and have equivalent authority to the Party’s
Business Representative or have been expressly given all requisite authority by
the Party’s Business Representative.

4.2.

Responsibilities of Business Representatives. The Business
Representatives shall be responsible for overseeing the Parties’ activities and
conduct under this Agreement generally, and for ensuring an appropriate level of
oversight. The Business Representatives shall meet in person, via teleconference
or videoconference at such times as may be deemed necessary by the Parties).

5.

PATIENT AND PRODUCT DATA

5.1.

Data Submission. Dialysis Center shall deliver all Data to Amgen (or
to a data collection vendor specified by Amgen) in the format and manner
provided in Exhibit A and subject to the provisions of this Section
5
. To the extent Amgen requests that Dialysis Center deliver Data to a data
collection vendor, Amgen agrees to cause any such data collection vendor to
adhere to and be bound by a substantially similar confidentiality obligation as
is applicable to Amgen under this Agreement, and Amgen shall be liable for any
failure by any such data collection vendor to act in accordance with such
requirements.

5.2.

HIPAA Compliance. Neither Party has the intent that Dialysis Center
will provide Amgen (or any specified data collection vendor) any Data in
violation of HIPAA. Accordingly, the Parties shall engage an appropriately
qualified statistician, reasonably acceptable to each Party, who meets the
requirements set forth in 45 C.F.R. § 164.514(b)(1) to review the Data and
deliver a written certification that shall conclude that, subject to any
conditions, requirements or assumptions set forth therein, each delivery of Data
pursuant to this Agreement will meet the standards for “de-identification” under
HIPAA (the “Certification“). In connection with the Certification, the
Parties agree to use their commercially reasonable best efforts to facilitate
the completion and delivery of such Certification to each Party in an expedited
manner, and Amgen shall bear the pre-approved costs of such Certification.
Notwithstanding anything in this Agreement to the contrary, in order to assure
compliance, as determined by either Party in its reasonable discretion, with any
existing Law relating to patient privacy of medical records, or at any time
following the enactment of any Law relating to patient privacy of medical
records that in any manner reforms, modifies, alters, restricts, or otherwise
affects any of the Data received or to be received in connection with any of the
Discounts contemplated under this Agreement, either Party may, upon thirty (30)
days’ prior written notice, seek to amend this Agreement with respect to the
affected Discount. Dialysis Center and

Page 18 of 136


Amgen shall meet and in good faith mutually agree to modify this Agreement to
accommodate any such change in the Law, with the intent to, if possible, retain
the essential terms of this Section 5 and the affected Discount and
pricing structure of this Agreement.

5.3.

Case Identifier. Dialysis Center shall consistently use a unique
alpha-numeric code (which shall not be derived from Individually Identifiable
Health Information) as a “case identifier” to track the care rendered to each
individual patient over time, and such case identifier shall be included in the
Data provided to Amgen. The key or list matching patient identities to their
unique case identifiers shall not be provided to Amgen.

5.4.

Data Use. Amgen and its Affiliates shall have the right to use Data
(a) to support verification of the services under this Agreement, (b) for its
[*] and [*], development of [*], running [*] analyses, overall analyses of how
to improve treatment of patients on dialysis and creating tools by its marketing
personnel, (c) in the aggregate for publications as part of a larger data set
incorporating comparable clinical data received from other dialysis providers in
the Territory and provided that no portion of such data shall be attributed to
Dialysis Center or its Affiliates, and (d) for purposes of verifying the
Dialysis Center Purchasers’ performance under this Agreement and the calculation
of amounts payable hereunder, including verifying the Dialysis Center
Purchasers’ Purchase Commitment performance under this Agreement and calculating
or determining the Dialysis Center Purchasers’ eligibility to receive any
Discount. Notwithstanding the foregoing, without Dialysis Center’s prior written
consent (such consent not to be unreasonably conditioned, withheld or delayed):
Amgen and its Affiliates shall not (i) disclose to Third Parties the Data
provided by Dialysis Center hereunder except (1) in any publication referenced
in clause (c) above, (2) pursuant to public health activities, (3) to agents of
Amgen bound by obligations of confidentiality no less restrictive than those
contained in Section 11.14 or (4) to other Third Parties as required by
Law or regulation as determined in Amgen’s discretion; and (ii) sell or resell
any such data or derivative works thereof to any Third Party.

5.5.

Clinical Research Studies. Dialysis Center and Amgen acknowledge that
Dialysis Center, either directly or through DaVita Clinical Research, Inc., an
Affiliate of Dialysis Center, may from time to time be engaged in research
studies in which patients of the Dialysis Center Purchasers, may serve as
clinical trial subjects (a “Research Study“). Notwithstanding any
obligation of Dialysis Center in this Agreement to the contrary, including any
requirement in Section 3.5 of Exhibit A, Dialysis Center shall not
be required to submit Data for any patients of the Dialysis Center Purchasers
that are participating in a Research Study (a “[*]“), but shall continue
without limitation to be eligible for, and if earned receive, all Discounts
granted pursuant to this Agreement, so long as (i) Dialysis Center notifies
Amgen of the [*] whose Data will not be delivered by Dialysis Center to Amgen as
otherwise required by this Agreement as a result of such patient being a [*],
and (ii) the aggregate number of [*] whose Data is excluded by Dialysis Center
does not exceed the [*]. For purposes of the foregoing, “[*]” means [*]
percent ([*]%) of the aggregate number of persons receiving treatment from the
Dialysis Center Purchasers in any calendar month.

6.

OTHER DATA

6.1.

Compensation Data. Dialysis Center agrees that it shall provide the
data, with respect to EPOGEN, set forth on Schedule 2 attached hereto
(the “Compensation Data“) to Amgen in the electronic format set forth on
Schedule 2 on a calendar [*] basis no later than the fourteenth
(14th) day of the following calendar [*] following the [*] for which
such Compensation Data is being provided. Amgen acknowledges, agrees and
covenants

Page 19 of 136


that it shall only use the Compensation Data for sales force targeting and
compensation. Dialysis Center and Amgen acknowledge and agree that the
Compensation Data does not include and shall never include any Individually
Identifiable Health Information of any patient of Dialysis Center Purchasers.
Notwithstanding the foregoing, Amgen acknowledges and agrees that Dialysis
Center shall only be required to deliver the Compensation Data to Amgen for as
long as [*]. Amgen shall indemnify, defend and hold harmless Dialysis Center
from and against any and all loss, damage and/or expense (including reasonable
attorney’s fees) that it may suffer as a result of claims, demands, actions,
proceedings, liabilities, costs or judgments, or threats thereof arising out
Dialysis Center’s supply of the Compensation Data to Amgen.

6.2.

Self-Reported Purchase Data. Dialysis Center, on behalf of the
Dialysis Center Purchasers, acknowledges, covenants and agrees that it shall
submit full and complete Self-Reported Purchase Data for each Quarter to Amgen
within forty-five (45) days of the end of each such Quarter through a Purchase
Data Submission Form attached here to as Exhibit SR-1. Exhibit
SR-1
is subject to modification by mutual written agreement of the Parties.
Dialysis Center on behalf of the Dialysis Center Purchasers shall submit
Exhibit SR-1 in an Excel file format electronically by e-mail to [*] or
in such other manner as may be specified by Amgen through written notification
to Dialysis Center.

7.

JOINT PROJECTS

7.1.

Joint Projects. The Parties shall form a “Joint Project
Committee
” comprised of three (3) executives from each Party, one (1) of
whom shall be a clinical executive, and shall be led by two (2) co-chairs, one
(1) appointed by each of the Parties. During the Term, either Party may present
to the Joint Project Committee one or more written proposals (a “Project
Proposal
“) for a project or projects to be undertaken jointly by the Parties
related to the provision of Dialysis Services (a “Joint Project“),
together with a draft project plan for the Joint Project (a “Project
Plan
“) which the Parties shall discuss in good faith. If the Parties agree
in writing to undertake a Joint Project, the Parties shall jointly pursue such
Joint Project in accordance with the Project Plan without any further approval
action required by the Parties.

7.2.

Joint Project Committee.

7.2.1.

Joint Project Committee Responsibilities. The Joint
Project Committee shall be responsible for the following:

a)

Reviewing and approving each new Project Proposal prior to adoption of any
Joint Projects set forth in such new Project Proposal;

b)

Reviewing and approving changes to the Project Plans for existing Joint
Projects prior to adoption of such changes;

c)

Providing for communication and discussion between the Parties to, as
appropriate, coordinate and optimize the development activities of the Parties
under each Joint Project;

d)

Reviewing and monitoring the activities and progress of the Parties against
the Joint Projects;

e)

Communicating with the Business Representatives regarding all of the
foregoing; and

f)

Such other matters as are appropriate to make operational the terms of this
Agreement in respect of Joint Projects and as the Parties shall agree in
writing.

Page 20 of 136


7.2.2.

Meetings. The Joint Project Committee shall meet in person,
via teleconference or videoconference or otherwise, as frequently as deemed
necessary by the Joint Project Committee. All Joint Project Committee meetings
shall have at least one (1) member appointed by each Party in attendance.

7.2.3.

Decision Making. The Joint Project Committee shall make
decisions by a unanimous vote. The Parties shall use good faith, reasonable
efforts to come to a complete agreement. In the event the Joint Project
Committee fails to reach unanimity with respect to any matter, such matter shall
be escalated to the Business Representatives.

8.

WARRANTIES, REPRESENTATIONS AND COVENANTS

8.1.

Power and Authority. Each Party represents and warrants to the other
that this Agreement: (a) has been duly authorized, executed, and delivered by
it, (b) constitutes a valid, legal, and binding agreement enforceable against it
in accordance with the terms contained herein, and (c) does not and shall not
conflict with or violate any of its other contractual obligations, expressed or
implied, to which it is a party or by which it may be bound.

8.2.

Compliance with Law and Regulation. Amgen and Amgen Inc. shall, and
Dialysis Center shall, comply with all applicable Laws related to the
performance of their respective obligations under this Agreement. Each Party
represents and warrants that (which representations and warranties shall be
ongoing representations and warranties during the Term): (i) it is not currently
named on any of the following lists: (A) HHS/OIG List of Excluded
Individuals/Entities, (B) GSA List of Parties Excluded from Federal Programs, or
(C) OFAC “SDN and Blocked Individuals” and (ii) it shall promptly notify the
other Party in the event it becomes named on any of the following lists: (x)
HHS/OIG List of Excluded Individuals/Entities, (y) GSA List of Parties Excluded
from Federal Programs, or (z) OFAC “SDN and Blocked Individuals”.

8.3.

Product. Amgen covenants and agrees that EPOGEN is not and will not be
adulterated or misbranded within the meaning of the Federal Food, Drug and
Cosmetic Act, as amended, or within the meaning of any applicable Law, or is or
will be a product which may not be introduced in to interstate commerce. Amgen
warrants that EPOGEN purchased pursuant to this Agreement (a) is manufactured,
and up to the time of its receipt by Authorized Wholesalers is handled, stored,
and transported in accordance with all applicable Laws, and meet all
specifications for effectiveness and reliability as required by the United
States Food and Drug Administration (the “FDA“), and (b) when used in
accordance with the directions in its labeling is fit for the purposes and
indications described in its labeling. Amgen warrants that the use of EPOGEN by
Dialysis Center Purchasers shall not infringe upon any ownership rights of any
other individual or entity or upon any patent, copyright, trademark or other
intellectual property or proprietary right or trade secret of any individual or
entity. Amgen agrees that as soon as practicable it will notify Dialysis Center
of any material defect in EPOGEN delivered to any Dialysis Center Purchasers in
accordance with applicable Law.

8.4.

Data. Dialysis Center represents and warrants to Amgen that: (a) the
Data, the Compensation Data, and the Self-Reported Purchase Data that the
Dialysis Center Purchasers deliver to Amgen pursuant to Section 5 and
Section 6 shall be: (i) prepared and delivered in accordance with the
provisions of Section 5, Section 6 and Exhibit A and (ii)
as complete and accurate as is reasonably obtainable in view of the Dialysis
Center Purchasers’ customary method of compilation and the nature and accuracy
of the Dialysis Center Purchasers’ resources; (b) the Dialysis Center Purchasers
shall not knowingly and intentionally misrepresent any of the Data, the
Compensation Data,

Page 21 of 136


and/or the Self-Reported Purchase Data provided by the Dialysis Center
Purchasers to Amgen; and (c) Dialysis Center shall promptly notify Amgen in the
event it has actual knowledge that any of the Data, the Compensation Data,
and/or the Self-Reported Purchase Data is not complete and/or accurate.

8.5.

Designated Affiliates List and Managed Centers List. Dialysis Center
represents and warrants that the Designated Affiliates List and the Managed
Centers List, as each of them is attached to this Agreement as of the Term Start
Date (and as of any subsequent date that such lists are updated in accordance
with the terms hereof) are complete and accurate lists of all Affiliates of
Dialysis Center and Managed Centers of Dialysis Center providing Dialysis
Services in the Territory as of the Term Start Date (and as of each such
subsequent date).

8.6.

Adverse Claims. Each Party represents and warrants to the other Party
that, as of the execution of this Agreement, such Party has no actual knowledge
of any legal claim or right to be asserted against the other Party or its
Affiliates related to the negotiation or execution of this Agreement.

8.7.

NO OTHER WARRANTIES. OTHER THAN THE WARRANTIES EXPRESSLY SET FORTH IN
THIS AGREEMENT, NEITHER PARTY MAKES, AND EACH PARTY EXPRESSLY DISCLAIMS, ALL
OTHER WARRANTIES, STATUTORY, EXPRESS, AND/OR IMPLIED, INCLUDING THOSE OF
MERCHANTABILITY AND/OR FITNESS FOR A PARTICULAR PURPOSE. EACH PARTY HEREBY
EXPRESSLY WAIVES ANY AND ALL OTHER WARRANTIES, STATUTORY, EXPRESS, AND/OR
IMPLIED, INCLUDING THOSE OF MERCHANTABILITY AND/OR FITNESS FOR A PARTICULAR
PURPOSE.

9.

DISPUTE RESOLUTION, INSURANCE and INDEMNITY

9.1.

Escalation of Disputes to Business Representatives. The Parties
recognize that claims, disputes or controversies arising out of or relating to
this Agreement (“Disputes“) may occur from time to time. It is the
objective of the Parties to establish procedures to facilitate the resolution of
Disputes arising under this Agreement in an expedient manner by mutual
cooperation and, if possible, without resort to litigation.

In the event of any Dispute, and prior to either Party (a) commencing any
action in a court of law or under any Governmental Authority, or (b) taking any
action to terminate this Agreement as provided in Section 10, the Parties
shall first undertake that the employees of each Party with relevant expertise
and authority with respect to a Dispute shall meet to discuss such Dispute
within five (5) business days of a Party receiving notice of a Dispute (except
in the case where delay in resolving any such Dispute would be materially
prejudicial to a Party, in which case the Dispute will be referred directly to
the Business Representatives). In the event the Parties are unable to resolve
any such Dispute within thirty (30) business days of the initial meeting between
the Parties, it shall be referred to the Business Representatives, who shall
negotiate with one another in good faith to reach a good faith resolution of the
Dispute; provided, that the Parties shall use commercially reasonable
best efforts to expedite the resolution of any Disputes which by their nature
need to be made quickly by the Business Representatives. In the event the
Dispute cannot be resolved by the Business Representatives within fifteen (15)
business days of the initial meeting between the Business Representatives or
such other period of time as is mutually agreed to by the Parties, then, upon
the written demand of either Party, the Dispute shall be subject to arbitration,
as provided in Section 9.2. Pending resolution of any Dispute, both
Parties will continue their performance under this Agreement of all obligations
that are not the subject of any such Dispute. If there is a Dispute relating to
any amount owed by either Party to the other Party, the undisputed

Page 22 of 136


portion of such amount shall be paid to the other Party in accordance with
the terms hereof, and the Parties shall first attempt to resolve the disputed
balance in accordance with this Section 9.1.

9.2.

Arbitration.

9.2.1.

Claims. Subject to Section 9.3 below, any Dispute that
is not resolved under Section 9.1 within thirty (30) days after a Party’s
initial written request for resolution, shall be resolved by final and binding
arbitration administered by JAMS (the “Administrator“) in accordance with
its Comprehensive Arbitration Rules and Procedures (the “Rules“), except
to the extent any such Rule conflicts with the express provisions of this
Section 9.2. (capitalized terms in this Section 9.2 used but not
otherwise defined in this Agreement shall have the meanings provided in the
Rules.) For Disputes valued at less than Five Million Dollars ($5,000,000), the
Arbitration shall be conducted by one (1) neutral arbitrator
(“Arbitrator“) selected in accordance with the Rules, provided that such
Arbitrator shall not be a current or former employee or director, or a current
stockholder, of either Party or any of their respective Affiliates. For Disputes
valued at or more than Five Million Dollars ($5,000,000), the Arbitration shall
be conducted by a panel of three (3) neutral Arbitrators selected in accordance
with the Rules, provided that any such Arbitrator shall not be a current or
former employee or director, or a current stockholder, of either Party or any of
their respective Affiliates. The Arbitration shall be held in Los Angeles,
California.

9.2.2.

Discovery. Within forty-five (45) days after selection of the
Arbitrator(s), the Arbitrator(s) shall conduct the Preliminary Conference. In
addressing any of the subjects within the scope of the Preliminary Conference,
the Arbitrator(s) shall take into account both the needs of the Parties for an
understanding of any legitimate issue raised in the Arbitration and the
desirability of making discovery efficient and cost-effective. In that regard,
the Parties agree to the application of the E-Discovery procedures set forth in
Rule 16.2(c) of JAMS’ Expedited Procedures; provided that the Parties agree that
the time limitations identified in Rule 16.2 of JAMS’ Expedited Procedures shall
not be binding and the Arbitrator(s) shall set time limitations for discovery
and depositions that are reasonable and necessary in light of the issues and
matters raised in the Preliminary Conference. In no event shall the time
limitations set by the Arbitrator(s) for discovery and depositions be shorter
than the time periods for discovery and depositions that are set forth in Rule
16.2 of JAMS’ Expedited Procedures.

9.2.3.

Hearing; Decision. The hearing (“Hearing“) shall
commence within a reasonable time after the discovery cutoff. The Arbitrator(s)
shall require that each Party submit concise written statements of position and
shall permit the submission of rebuttal statements, subject to reasonable
limitations on the length of such statements to be established by the
Arbitrator(s). The Arbitrator(s) shall also permit the submission of expert
reports. The Arbitrator(s) shall render the award (“Award“) within thirty
(30) days after the Arbitrator(s) declares the Hearing closed, and the Award
shall include a written statement describing the essential findings and
conclusions on which the Award is based, including the calculation of any
damages awarded. The Arbitrator(s) will, in rendering his, her or their
decision, apply the substantive law of the State of California, without giving
effect to its principles of conflicts of law, and without giving effect to any
rules or laws relating to arbitration. The Award rendered by the Arbitrator(s)
shall be final, binding and non-appealable, and judgment may be entered upon it
in any court of competent jurisdiction. However, the Parties agree that the JAMS
Optional Arbitration Appeal Procedures

Page 23 of 136


(“Appeal Procedures“) shall apply to the Arbitration, at the request
by either Party in accordance with such Appeal Procedures. If a Party appeals
the Award rendered by the Arbitrator(s), the Award issued by the Appeal Panel
(as defined in such Appeal Procedures) shall be final, binding and
non-appealable, and judgment may be entered upon it in any court of competent
jurisdiction.

9.2.4.

Costs. Each Party shall bear its own attorney’s fees, costs,
and disbursements arising out of the Arbitration, and shall pay an equal share
of the fees and costs of the Arbitrator(s); provided, however, the Arbitrator(s)
shall be authorized to determine whether a Party is the prevailing party, and if
so, to award to that prevailing party reimbursement for any or all of its
reasonable attorneys’ fees, costs and disbursements (including, for example,
expert witness fees and expenses, photocopy charges, travel expenses, etc.),
and/or the fees and costs of the Administrator and the Arbitrator(s).

9.2.5.

Confidentiality. Each Party acknowledges and agrees that: (a)
any discovery pursuant to this Section 9.2, (b) the Hearing, (c) any and
all documents exchanged or delivered in connection with the Hearing, settlement
negotiations, and/or settlement terms, including the statements of position,
rebuttal statements, and expert reports, (d) settlement negotiations and/or
settlement terms, and (e) the Award shall be treated as Confidential Information
and subject to the terms and conditions of Section 11.14.

9.3.

Court Actions. Nothing contained in this Agreement shall deny either
Party the right to seek injunctive or other equitable relief from a court of
competent jurisdiction in the context of a bona fide emergency or prospective
irreparable harm, and such an action may be filed and maintained notwithstanding
any ongoing discussions between the Parties or any ongoing arbitration
proceeding.

9.4.

Insurance. Each Party shall secure and maintain in full force and
effect throughout the Term (and following termination, to the extent necessary
to cover any claims arising from this Agreement) commercial general liability
insurance and product liability (in the case of Amgen only) which include
contractual liability with limits of no less than [*] dollars ($[*] USD);
professional liability insurance (in the case of Dialysis Center only) with
limits of no less than [*] dollars ($[*] USD), and workers’ compensation with
statutory limits. Any limits on each of a Party’s insurance coverage shall not
be construed to create any limit on such Party’s liability with respect to its
obligations under this Agreement or otherwise. Each of the Parties shall have
the right to satisfy its obligations under this Section 9.4 through
self-insurance. Amgen Inc. hereby guarantees the performance of Amgen’s
obligations as set forth in this Section 9.4.

9.5.

Indemnity.

9.5.1.

By Amgen. Amgen agrees to indemnify, defend, and hold Dialysis
Center, its officers, directors, agents and employees (collectively, the
Dialysis Center Indemnitees“) harmless from and against any and all
loss, damage and/or expense (including reasonable attorney’s fees) that they may
suffer as a result of Third Party claims, demands, actions, proceedings,
liabilities, costs or judgments, or threats thereof (“Third Party
Claim(s)
“) arising out of (i) any defect in the design and/or manufacture of
EPOGEN or the storage and/or transportation of EPOGEN in Amgen’s possession,
including claims for property damage, loss of life, and/or bodily injury; and/or
(ii) the breach by Amgen or Amgen Inc. of any of their respective warranties,
representations, and/or covenants contained in this Agreement. Notwithstanding
anything to the contrary contained herein, Amgen and Amgen Inc. shall not have
any obligation to defend, indemnify, and/or hold the

Page 24 of 136


Dialysis Center Indemnitees harmless from any Third Party Claims arising out
of the negligent acts and/or omissions and/or willful misconduct of the Dialysis
Center Indemnitees. This indemnification shall survive the termination or
expiration of this Agreement. Amgen Inc. hereby guarantees the performance of
Amgen’s obligations as set forth in this Section 9.5.1.

9.5.2.

By Dialysis Center. Dialysis Center agrees to indemnify, defend, and
hold Amgen, its officers, directors, agents and employees (collectively, the
Amgen Indemnitees“) harmless from and against any and all Third Party
Claims arising out of (i) any Dialysis Center Purchasers’ administration,
promotion or use of EPOGEN purchased under this Agreement to its patients; (ii)
any Dialysis Center Purchasers’ failure to store and/or transport any EPOGEN in
its possession in accordance with any applicable Law and/or labeling
information; and/or (iii) the breach by Dialysis Center of any of its
warranties, representations, and/or covenants contained in this Agreement. For
purposes of the foregoing, the “administration” of EPOGEN by Dialysis Center
shall mean the dispensing and handling by Dialysis Center and its employees of
EPOGEN and the actual administration of EPOGEN to patients by Dialysis Center
and its employees, but shall exclude physician prescriptions of EPOGEN to
patients. Notwithstanding anything to the contrary contained herein, Dialysis
Center shall not have any obligation to defend, indemnify, and/or hold the Amgen
Indemnitees harmless from any Third Party Claims arising out of the negligent
acts and/or omissions and/or willful misconduct of the Amgen Indemnitees. This
indemnification shall survive the termination or expiration of this Agreement.

9.6.

Procedure for Third Party Claims.

9.6.1.

Notice. The Party receiving indemnification
hereunder (the “Indemnified Party“) shall give the Party providing
indemnification hereunder (the “Indemnifying Party“) written notice
within fifteen (15) business days after the Indemnified Party receives notice of
any Third Party Claim, subject to indemnification hereunder upon which such
Indemnified Party intends to base a request for indemnification under
Section 9.5.1 or Section 9.5.2. Failure to give any such notice
shall not constitute a waiver of any right to indemnification or reduce in any
way the indemnification available hereunder, except and only to the extent that
as a result of such failure the Indemnifying Party demonstrates that it was
directly and materially damaged as a result of such failure to give timely
notice.

9.6.2.

Control of Defense. The Indemnifying Party, at its expense,
shall assume control of the defense and resolution of each Third Party Claim
using legal counsel reasonably approved by the Indemnified Party and shall keep
the Indemnified Party fully and timely informed of the progress of such defense
and resolution. With respect to each Third Party Claim, the Indemnified Party
shall have the right to retain independent legal counsel at its cost and monitor
such Third Party Claim’s defense and resolution. In such a case, the
Indemnifying Party and its legal counsel shall fully cooperate with the
Indemnified Party and its legal counsel in providing such information as the
Indemnified Party may reasonably request. Notwithstanding this Section
9.6.2
, the Indemnifying Party shall not be entitled to control, but may
participate in, and the Indemnified Party shall be entitled to have sole control
over and select counsel to conduct, the defense or settlement of each Third
Party Claim that: (i) seeks a temporary restraining order, a preliminary or
permanent injunction, and/or specific performance against the Indemnified Party,
(ii) involves criminal allegations against the Indemnified Party, (iii) if
unsuccessful, would set a precedent that would materially interfere with

Page 25 of 136


and/or have a material adverse effect on the business and/or financial
condition of the Indemnified Party, and/or (iv) imposes liability on the part of
the Indemnified Party for which the Indemnified Party is not entitled to
indemnification hereunder. In such an event, the Indemnifying Party will still
have all of its obligations hereunder with respect to any such affected Third
Party Claims; provided that the Indemnified Party will not settle
any such affected Third Party Claims without the prior written consent of the
Indemnifying Party, which consent will not be unreasonably withheld,
conditioned, and/or delayed by the Indemnifying Party.

9.6.3.

Representation. If both the Indemnifying Party and the
Indemnified Party are named parties in any Third Party Claim and representation
of both Parties by the same legal counsel would be inappropriate due to the
actual or potential differing interests between them, then the Indemnified
Party, at the Indemnifying Party’s expense, shall have the right to be
represented by separate counsel of the Indemnified Party’s choosing.

9.6.4.

Resolution. The Indemnifying Party shall not settle,
compromise or resolve any Third Party Claim without the written consent of the
Indemnified Party; provided that, the Indemnifying Party may, without
such consent, enter into any such judgment, settlement, compromise or resolution
that relates solely to the payment of money damages, involves a full release of
the Indemnified Party and does not result in any admission of any fault of the
Indemnified Party with respect to such Third Party Claim.

9.6.5.

Payment. Any final judgment entered or settlement agreed upon
in the manner provided in this Section 9.6, as applicable, shall be
binding upon the Indemnifying Party and shall conclusively be deemed to be an
obligation with respect to which the Indemnified Party is entitled to prompt
indemnification hereunder, if applicable. Payment of all amounts owing by the
Indemnifying Party under this Section 9.6, as applicable, shall be made
promptly upon a final settlement between the Indemnifying Party and the
Indemnified Party or upon a final adjudication determined by the Arbitrator(s)
that an indemnification obligation is owed by the Indemnifying Party to the
Indemnified Party.

10.

TERM AND TERMINATION

10.1.

Term. This Agreement shall come into effect as of the Term Start Date
and shall expire on the earlier of the Term End Date, or the Termination Date.

10.2.

Termination for Cause. Amgen or Dialysis Center may terminate this
Agreement only in the event of the following:

10.2.1.

Breach of Purchase Commitment. The Parties
acknowledge and agree that the Purchase Commitment is the principal value
expected to be received by Amgen under this Agreement and it is the essential
inducement for Amgen to enter into this Agreement, pursuant to which it has
agreed, among other things, (a) to provide the Dialysis Center Purchasers for
the duration of the Term the economic benefits of the Discounts provided for
herein, (b) to make the Supply Commitment, which requires that Amgen commit
facilities to the manufacture of EPOGEN at the expense of other Amgen uses and
allocate significant resources to maintain its manufacturing capabilities and
capacity at a commensurate level, (c) to assume the business risks and financial
liability in respect of the representations, warranties and covenants made by it
hereunder and (d) to forego potential other commercial opportunities in respect
of its nephrology business. In the event that the Dialysis

Page 26 of 136


Center Committed Purchasers do not meet an Amgen ESAs Share of Sales of (i)
at least [*] percent ([*]%) for [*] or more [*] during the Term with respect to
which the Dialysis Center is required to pay the Alternative ESA Purchase Amount
with respect to each of such [*] in any [*] period during the Term, or (ii) at
least [*] percent ([*]%) in any [*], then Amgen shall be entitled to terminate
this Agreement immediately upon written notice to Dialysis Center and,
notwithstanding any other provision of this Agreement, thereupon either receive
the “Liquidated Damages” defined below or exercise such other rights and
remedies as may be allowed at law or in equity under applicable Law.

10.2.2.

Termination for Failure to Supply. Dialysis Center may
terminate this Agreement immediately upon written notice to Amgen in the event
that Amgen has not been able to supply to Dialysis Center through one or more
Authorized Wholesalers EPOGEN in [*] (or Aranesp subject to the terms of
Section 2.5) equal to at least [*] percent ([*]%) of the Minimum Forecast
Commitment (other than as a result of one or more Force Majeure Events) for [*].

10.2.3.

Termination for Exclusion from Federal Health Care Program.
Either Amgen or Dialysis Center may immediately terminate this Agreement upon
written notice to the other Party in the event there is change in the other
Party’s status which excludes it from participation in any “Federal health care
program” (as defined under 42 U.S.C. § 1320a-7b(f)) (a “Debarred
Party
“), provided that no Party shall have the right to terminate this
Agreement pursuant to this Section 10.2.3 if the Debarred Party can
complete its obligations through, or otherwise transfer its obligations to, an
Affiliate as permitted by applicable Law.

10.3.

Liquidated Damages. The Parties acknowledge that Amgen’s actual
damages in the event of a termination by Amgen, pursuant to Section
10.2.1
or Section 10.2.3, would be difficult to ascertain, and that
the payment of the Liquidated Damages represents the best estimate of the amount
of such damages by the Parties at this time. The Parties further expressly
acknowledge and agree that the Liquidated Damages are intended not as a penalty,
but as full liquidated damages, in the event of Amgen’s termination of this
Agreement pursuant to Section 10.2.1 or Section 10.2.3 and as
compensation for Amgen’s losses and other expenses associated with this
Agreement.

For purposes of this Agreement, “Liquidated Damages” means, in
addition to any amounts owed to Amgen under this Agreement, including for breach
of the Purchase Commitment under Section 2.1, an amount in cash equal to
[*] percent ([*]%) of the [*] of Amgen’s projected [*] for each remaining
Quarter (including any fractional Quarters) in the Term, with such [*] equal to
A : B, grown Quarterly at a [*] percent ([*]%) annual rate and discounted on a
Quarterly basis, at a rate equal to the average annual increase in [*] for
EPOGEN on an [*] basis for all calendar years during the Term prior to the
related [*] calculation, where:

A =

The average [*] for the [*] most recent Quarters prior to the Termination
Date in which Dialysis Center satisfied the Purchase Commitment in full (or, if
less than [*] such Quarters exist, then “A” shall equal the average of the sum
of (i) [*] plus (ii) the [*], for the [*] most recent Quarters prior to the
Termination Date); and

B =

The average aggregate [*] (other than the [*] Rebate, the [*] Rebate and the
[*] Rebate) earned by Dialysis Center Purchasers during the [*] most recent
Quarters prior to the Termination Date, regardless of whether Dialysis Center
satisfied the Purchase Commitment in such Quarters.

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10.4.

Effect of Termination. Upon any termination or expiration of this
Agreement, (a) any earned and vested Discounts shall be paid in accordance with
the terms set forth in Exhibit A, (b) any Alternative ESA Purchase
Amounts shall be paid pursuant to Section 2.1.1, (c) any payments by
Amgen owing to Dialysis Center under Section 2.5.1 shall be paid, (d) any
payment by Dialysis Center owing to Amgen under Section 2.4.2 shall be
paid and (e) the Liquidated Damages pursuant to Section 10.3 shall be
paid. All Discounts available to Dialysis Center in the particular Quarter in
which such termination occurs shall be paid to Dialysis Center based on an
achievement of the eligibility and vesting requirements set forth in Exhibit
A
.

10.5.

Survival. Any provision that, either expressly or by its nature is
intended to survive this Agreement, shall survive any expiration or termination
of this Agreement, including Sections 1, 3, 8, 9, 10, and 11.

11.

MISCELLANEOUS

11.1.

Amendment. Except as expressly set forth herein, no amendment of this
Agreement shall be effective unless expressed in a writing signed by a duly
authorized representative of each Party.

11.2.

Assignment. Neither Party shall have the right to assign or otherwise
transfer this Agreement, or any of its rights and obligations hereunder, in
whole or in part, without the other Party’s prior written consent, and any
attempted assignment or transfer without such consent shall be void; provided,
however, that Amgen may assign or otherwise transfer this Agreement and its
rights and obligations hereunder to any of its Affiliates that is not in the
business of providing Dialysis Services in the Territory. Notwithstanding the
foregoing, each Party shall be obligated to assign and transfer this Agreement,
without any required consent, to any Person to whom either such Party has
transferred all or substantially all of its business relating to this Agreement,
and the Parties agree that they shall take all reasonable and necessary actions
in respect thereof including the execution and delivery of all appropriate
instruments to effectuate such assignment and transfer of this Agreement;
provided that any assignment and transfer of this Agreement by Amgen to any
Person, a substantial portion of whose business consists of providing Dialysis
Services in the Territory, shall require the prior written consent of Dialysis
Center, which consent may be withheld by Dialysis Center in its sole and
absolute discretion. This Agreement and the provisions hereof shall be binding
upon, and inure to the benefit of, the Parties’ permitted successors and
assigns.

11.3.

Modification of Law. If at any time following the Term Start Date, the
enactment or modification of any Law occurs and, as a result, either Party’s
performance of its obligations under this Agreement would not comply with such
Law, either Party may, upon notice to the other Party, recommend an amendment to
modify this Agreement to address those provisions of the Agreement that may not
comply with such Law. The Parties agree to use their commercially reasonable
best efforts to modify this Agreement as necessary to bring it into compliance
with the Law if that can be done while retaining, in all material respects, the
essential rights and benefits of each Party under this Agreement, including the
Purchase Commitment, the Supply Commitment, the collection, exchange and use of
the Data and the ability for Dialysis Center Purchasers to earn the Discounts
that the Dialysis Center Purchasers are eligible to receive hereunder. Promptly
following the delivery of such notice describing the Law at issue and the
proposed modifications to bring this Agreement into compliance with such Law,
Dialysis Center and Amgen shall meet and in good faith seek to mutually agree to
amend this Agreement to accommodate any such Law in accordance with this
Section 11.3.

Page 28 of 136


11.4.

Conflicting Provisions. To the extent that any provisions of Amgen’s
general or customary policies and procedures or any terms of any purchase order
conflict with or are in addition to the terms of this Agreement or any Exhibit
or Schedule attached hereto, the terms of this Agreement and its Exhibits and
Schedules shall govern.

11.5.

Construction. This Agreement shall be deemed to have been jointly
drafted by the Parties, and no rule of strict construction shall apply against
either Party. As used herein, the word “including” shall mean “including,
without limitation.”

11.6.

Counterparts; Facsimile/PDF Signatures. This Agreement may be executed
in one or more counterparts, each of which shall be considered an original. The
Parties agree that facsimile or PDF transmission of original signatures shall
constitute and be accepted as original signatures.

11.7.

Currency. All amounts herein are set forth in United States Dollars.

11.8.

Force Majeure. Except as provided in Section 2.1.1 or
Section 2.5, neither Party will be liable for delays in performance or
nonperformance of this Agreement or any covenant contained herein if such delay
or nonperformance is a result of acts of God, acts of civil or military
authority, acts of any Governmental Authority, civil disobedience or commotion,
epidemics, war, terrorist acts, failure or default of public utilities or common
carriers, destruction of production facilities or materials by fire, earthquake,
storm or like catastrophe, inability to procure necessary raw materials in a
commercially reasonable manner or default of suppliers or subcontractors or any
events beyond the reasonable control and without the fault or negligence of a
Party (all of the foregoing, a “Force Majeure Event“). Force Majeure
Events shall not adversely affect Dialysis Center’s eligibility for any
Discounts.

11.9.

Further Assurances. Each Party shall perform all further acts
reasonably requested by the other to effectuate the purposes of this Agreement,
including obtaining the Certifications under Section 5 or obtaining
purchase data necessary from third parties to calculate any amounts payable
pursuant to Exhibit A.

11.10.

Governing Law. This Agreement shall be governed by the laws of the
State of California (without regard to its conflict of law rules) and, except as
otherwise set forth in this Agreement, the Parties submit to the jurisdiction of
the California courts, both state and federal.

11.11.

Merger/No Reliance. This Agreement, together with the Schedules, and
the Exhibits constitutes the entire agreement, written or oral, of the Parties
as of the Term Start Date concerning the subject matter hereof. The Parties
acknowledge that, in making the determination to enter into this Agreement or
otherwise, they have not relied, in whole or in part, on any promise,
information, understanding, guarantees, discussions, representation, or
warranty, expressed or implied, not contained specifically in this Agreement.
Without limiting the generality of the foregoing, the Parties agree that neither
Party makes or has made any representation or warranty with respect to any
potential changes in the dialysis segment or the use or pricing of ESAs in
dialysis, including as a result of the introduction of Alternative ESAs
(including [*]) including the timing of such introduction(s), the pricing of
such Alternative ESAs and their potential physician acceptance and impact on
prescribing practices.

11.12.

No Partnership. The relationship between Amgen and Dialysis Center is
that of independent contractors, and not a partnership or an agency, franchise
or other relationship. Neither Party shall have the authority to bind the other.

11.13.

Notices. Any notice or other communication required or permitted
hereunder (excluding purchase orders) shall be in writing and shall be deemed
given or made five (5) days

Page 29 of 136


after deposit in the United States mail with proper postage for first-class
registered or certified mail prepaid, return receipt requested, or when
delivered personally or by facsimile (as shown by concurrent written
transmission confirmation and confirmed by overnight mail), or one (1) day
following traceable delivery to a nationally recognized overnight delivery
service with instructions for overnight delivery, in each case addressed to the
address set forth below, or at such designated address that either Party shall
have furnished to the other in accordance with this Section 11.13:

If to Amgen:

Amgen USA Inc.

One Amgen Center Drive, [*]

Thousand Oaks, CA 91320-1789

Attn: Specialist, Contracts & Pricing : Nephrology Business Unit

Fax: [*]

with a copy to :

Amgen USA Inc.

One Amgen Center Drive, [*]

Thousand Oaks, CA 91320-1789

Attn: General Counsel

Fax: [*]

If to Amgen Inc.:

Amgen Inc.

One Amgen Center Drive, [*]

Thousand Oaks, CA 91320-1789

Attn: General Counsel

Fax No.: [*]

If to Dialysis Center:

DaVita Inc.

1350 Old Bayshore Highway, Suite 777

Burlingame, California 94010

Attn: Vice-President of Purchasing

Fax No.: [*]

with a copy to:

DaVita Inc.

1551 Wewatta Street

Denver, CO 80202

Attn: Chief Legal Officer

Fax No.: [*]

11.14.

Confidentiality. “Confidential Information” means any and all
information provided by one Party and/or any of its Affiliates (including
Managed Centers in the case of Dialysis Center) (the “Disclosing Party“)
to the other Party and/or any of its Affiliates (including Managed Centers in
the case of Dialysis Center) (the “Non-Disclosing Party“) which is
identified in writing or orally as confidential by the Disclosing Party to the
Non-Disclosing Party or given the nature of the information or circumstances
surrounding its disclosure reasonably should be considered as confidential,
whether in written, computerized, oral, tangible or intangible, and/or other
form. Nothing in this Section 11.14 shall prohibit,

Page 30 of 136


Amgen from using the Data, the Compensation Data, and/or the Self-Reported
Purchase Data as provided in Section 5 and Section 6.

11.14.1.

Confidentiality Covenants. Except to the extent expressly
authorized by this Agreement or otherwise agreed in writing by the Parties, the
Non-Disclosing Party agrees that for the Term, and for a period of five (5)
years following the Term, the Non-Disclosing Party will keep confidential and
not publish or otherwise disclose to any Third Party or use for any purpose,
other than in accordance with this Agreement, any Confidential Information,
provided, however, that the Non-Disclosing Party may disclose any
such Confidential Information to its directors, officers, employees, agents,
consultants and advisors as necessary for the Non-Disclosing Party to carry out
its rights and obligations under this Agreement on the condition that such
directors, officers, employees, agents, consultants and advisors are bound by
confidentiality provisions at least as restrictive as those contained in this
Agreement. The confidentiality provisions contained in this Section 11.14
shall not apply to the extent that it can be established by the Non-Disclosing
Party by competent proof that such Confidential Information:

(a)

was generally available to the public or otherwise part of the public domain
at the time of its disclosure to the Non-Disclosing Party by the Disclosing
Party; or

(b)

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

(c)

was independently discovered or developed by the Non-Disclosing Party without
the use of or reference to the Confidential Information belonging to the
Disclosing Party.

11.14.2.

Retention and Destruction of Confidential Information. At any
time upon the written request of the Disclosing Party the Non-Disclosing Party
shall promptly return to the Disclosing Party or destroy all Confidential
Information. Notwithstanding the return or destruction of the Confidential
Information to the Disclosing Party or such other party as designated by the
Disclosing Party to the Non-Disclosing Party, the Non-Disclosing Party covenants
and agrees that it will continue to abide by its obligations hereunder with
respect to any and all Confidential Information.

11.14.3.

Disclosures Required By Law. In the event that the
Non-Disclosing Party and/or any of its directors, officers, employees, agents,
consultants and advisors that have received any Confidential Information is
required by Law (e.g., by oral questions, interrogatories, request for
information or documents, subpoena, civil investigative demand, or similar
process) to disclose any Confidential Information, the Non-Disclosing Party
agrees to (and shall cause each of its directors, officers, employees, agents,
consultants and advisors that have received any Confidential Information to)
provide the Disclosing Party with immediate written notice of any such
disclosure of Confidential Information that is required by Law in order to
provide the Disclosing Party with an opportunity to seek a protective order or
other similar order with respect to such Confidential Information. If disclosure
of any Confidential Information is required by Law, the Non-Disclosing Party
will (and will cause each of its directors, officers, employees, agents,
consultants and advisors that have received any Confidential

Page 31 of 136


Information to) furnish only that portion of the Confidential Information
which it is legally obligated to disclose by Law and consistent with the terms
of any protective order or other similar order obtained by the Disclosing Party
with respect to such Confidential Information required to be disclosed by Law.

11.14.4.

Public Announcements; Authorized Disclosure.
Neither Party shall make a public announcement or other public disclosure
concerning this Agreement without the consent of the other Party, except that
either Party may make such announcement or disclosure if it is required by
applicable Law, reasonably necessary for any filings with any Governmental
Authority or pursuant to the rules of any securities exchange or interdealer
quotation system; provided, that the disclosing Party shall give
reasonable prior advance notice of the proposed text of such announcement or
disclosure to the other Party for its prior review and approval, which review
and approval shall not be unreasonably conditioned, withheld or delayed. The
proviso in the immediately preceding sentence shall not apply to Relevant
Information included in any cost report filed under Title XVIII or Title XIX of
the Social Security Act, or health care program of any Governmental Authority.

11.14.5.

Confidential Terms. Notwithstanding the foregoing, each Party
may disclose the terms of this Agreement in confidence under terms and
conditions at least as restrictive as set forth herein on a need-to-know basis
to its legal and financial advisors to the extent such disclosure shall be
reasonably necessary in connection with such Party’s activities as expressly
permitted by this Agreement.

11.14.6.

Enforcement. Each Party agrees that money damages alone would
not be an adequate remedy for any breach of the terms and conditions of this
Section 11.14. Therefore, in the event of a breach or threatened breach
of this Section 11.14, the non-breaching Party may, in addition to other
rights and remedies existing in its favor, apply to any court of competent
jurisdiction for specific performance and/or injunctive and/or other relief in
order to enforce and/or prevent any violation of the provisions of this
Section 11.14 by the breaching Party (without proving monetary damages
and/or posting a bond and/or other security).

11.15.

Severability. Subject to the provisions of Section 11.3, if any
one or more of the provisions of this Agreement is held to be invalid or
unenforceable, the provisions shall be considered severed from this Agreement
and shall not serve to invalidate any remaining provisions hereof.

11.16.

Waiver. No Party shall be deemed to have waived any right hereunder,
unless such waiver is expressed in a writing signed by such Party.

11.17.

Open Records. To the extent required by §1861(v)(1)(I) of the Social
Security Act, as amended, the Parties will allow the U.S. Department of Health
and Human Services, the U.S. Comptroller General and their duly authorized
representatives, access to this Agreement and all books, documents and records
necessary to certify the nature and extent of costs incurred pursuant to it
during the Term and for four (4) years following the last date any EPOGEN or
services are furnished under it. If Amgen carries out the duties of this
Agreement through a subcontract worth $10,000 or more over a 12-month period
with a related organization, the subcontract shall also contain an access clause
to permit access by the U.S. Department of Health and Human Services, the U.S.
Comptroller General, and their duly authorized representatives to the related
organization’s books and records.

Page 32 of 136


11.18.

Amgen’s ESA Risk Evaluation and Mitigation Strategy Program. Dialysis Center
and its Designated Affiliates and Managed Centers shall reasonably cooperate and
comply with Amgen in Amgen’s implementation of its ESA Risk Evaluation and
Mitigation Strategy program as found at the FDA website:
http://www.fda.gov/downloads/Drugs
/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM200105.pdf

(“the FDA Website”) and which may be modified from time to time by the FDA (the
Amgen ESA Risk Evaluation Program“). Dialysis Center shall refer to the
FDA Website for updates to the Amgen ESA Risk Evaluation Program.

11.19.

Recall. In the event the FDA initiates a mandatory recall or Amgen
initiates a recall, field market withdrawal, stock recovery, or other similar
action with respect to EPOGEN (a “Recall“), the Dialysis Center
Purchasers shall cooperate with Amgen in implementing the Recall consistent with
applicable Law, any industry guidance issued by the FDA, and the terms or
procedures of the Recall, including reasonable cooperation with any Amgen
designated Third Party vendors.

11.20.

Assumption of Risk. Each Party expressly accepts and assumes all risks
that may arise out of or result from uncertainties or changes to the dialysis
market including those resulting from the introduction of Alternative ESAs
(including [*]), including the timing of such introduction(s), the pricing of
such Alternative ESAs and their potential physician acceptance and impact on
prescribing practices.

Page 33 of 136


The Parties have executed this Agreement by their designated representatives
set forth below.

AMGEN USA INC.

By:

/s/ Anthony C. Hooper

Name (print):

Anthony C. Hooper

Title:

EVP

Date:

11/15/2011

DIALYSIS CENTER

By:

/s/ Dennis Kogod

Name (print):

Dennis Kogod

Title:

Chief Operating Officer

Date:

11/15/2011

Amgen Inc. with respect to certain provisions of this Agreement as
set forth herein.

Amgen Inc.

By:

/s/ Anthony C. Hooper

Name (print):

Anthony C. Hooper

Title:

EVP

Date:

11/15/2011

Page 34 of 136


[Exhibits omitted by Findlaw]

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