Document:

exv4w12

 

Exhibit 4.12

AMENDMENT

FOR

LEASE AGREEMENT FOR OFFICE BUILDINGS

This Amendment made and entered into by and between

Fresenius AG

		
	
    – Landlord –	 

and

		
	
    Fresenius Medical Care Deutschland GmbH, Bad Homburg
    v.d.H.	 
	
    – Tenant –	 

     
Whereas, as part of the formation of Fresenius Medical
Care in 1996, the Landlord and the Tenant (hereinafter together
referred to as “the Parties”) entered into a Lease
Agreement for Office Buildings for the leased space in Bad
Homburg, Daimler Strasse 15, on September 30, 1996
(hereinafter referred to as “the Lease Agreement”);

     
Whereas, the Lease Agreement, as amended from time, to
time had a 10-year term
and shall terminate December 31, 2006;

     
Whereas, by executing a Memorandum of Understanding,
dated September 26, 2006, the Parties have already
expressed their mutual desire to renew the Lease Agreement on
comparable terms for a new term of 10 years;

     
Now, Therefore, the Parties hereto agree as follows:

     
Section 1.          Term
and Termination.

     
By this Amendment Article 2, Section 1 of the Lease
Agreement shall read as follows:

			
	 	1.	
    The lease relationship shall be renewed for a term of
    10 years. Therefore, the Lease Agreement shall terminate
    December 31, 2016.

Section 2.          Escalator
Clause.

     
By this Amendment Article 6 of the Lease Agreement shall
read as follows:

     
In the event that the Consumer-Price-Index for Germany
determined by the Federal Statistical Office (Basis 2000 = 100)
increases or decreases (in percent) in relation to its state as
of December 2006, the rent shall be changed in the same
proportion.

     
An adjustment shall, in each case, be made as if
January 1st, of the year in accordance with the state of
the index in December of the preceding year.

     
The Landlord shall be responsible for obtaining the
authorization of the respective “Bundesamt für
Wirtschaft und Ausfuhrkontrolle”, as far as legally
required.

Section 3.          Others.

     
As by this Amendment the Lease Agreement is prolonged, the
Parties agree that the Landlord shall not be entitled to a lump
sum compensation as set forth in Article 2, Section 3
of the Lease Agreement. Notwithstanding

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the modifications stipulated by this Amendment all other
provisions of the Lease Agreement remain unchanged; this relates
especially to the rent as set forth in Article 3,
Section 1 of the Lease Agreement, as amended from time to
time in the past due to the previous Escalator Provision as set
forth in Article 6 of the Lease Agreement.

Section 4.          Governing
Law.

     
This agreement shall be governed by the laws of the Federal
Republic of Germany.

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IN WITNESS WHEREOF, this Agreement has been duly executed and
delivered by the duly authorized officers of the parties hereto
on December 19, 2006

	 	 	 
	
    Fresenius AG

    

    Landlord	 	
    Fresenius Medical Care

     Deutschland GmbH

    Tenant
	 
	
     
ppa.
    Dr. Karl-Dieter Schwab	 	
     
Dr.
    Emanuele Gatti
	 
	
     
ppa.
    Dr. Dietmar Blumenhagen	 	
     
ppa.
    Dr. Rainer Runte

3exv4w18

 

Exhibit 4.18

Sourcing & Supply Agreement

     
This Sourcing and Supply Agreement is entered into on the date
the last party has signed this Agreement and shall be effective
as of October 1, 2006, (the “Agreement”) by and
among Amgen USA Inc. (“Amgen”), a wholly-owned
subsidiary of Amgen Inc.; Amgen Inc.; and Fresenius Medical Care
Holdings, Inc. (“FMCH”) (Amgen and FMCH each a
“Party” and together, the “Parties”). Amgen
Inc. is a party to this Agreement for the purposes set forth in
Sections 3.2, 5.1, 6.1, 6.2,
and 7.1 of this Agreement.

Recitals

     
WHEREAS, FMCH is the leading provider of outpatient
dialysis services in the United States with expertise in
establishing and delivering state of the art quality of care
standards, practices and procedures for the care of patients
with end stage renal disease undergoing dialysis; and

     
WHEREAS, FMCH desires to select one erythropoiesis
stimulating protein (“ESP”) supplier to meet its ESP
needs for its ESRD dialysis patients; and

     
WHEREAS, FMCH has evaluated the ESPs available for
commercial use and those in the late stages of clinical
development, and

     
WHEREAS, FMCH has determined that
EPOGEN®
(Epoetin alfa) is currently its preferred ESP for managing
anemia in in-center hemodialysis patients, and

     
WHEREAS, FMCH desires to collaborate with an ESP supplier
who is willing to work with FMCH to develop new and improved ESP
SKUs, other product forms and standards of care; and

     
WHEREAS, Amgen is the leading innovator in the field of
ESPs with the demonstrated expertise in the ability to
manufacture and supply safe and efficacious ESPs for the
treatment of dialysis patients (including EPOGEN and
Aranesp®
(darbepoetin alfa)); and

     
WHEREAS, FMCH also desires to benefit from Amgen’s
demonstrated experience in the field of anemia
management; and

     
WHEREAS, Amgen desires to scale and schedule its
manufacturing capacity and supply Products to FMCH in accordance
with FMCH’s anticipated demand for ESPs for use in the
United States and Puerto Rico (collectively, the
“Territory”); and

     
WHEREAS, Amgen is willing to collaborate with FMCH to
explore development of new ESP product forms and standards of
care;

     
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, the Parties hereto agree as follows:

		
	1.	
    DEFINITIONS

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

		
	1.1.	
    “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 fifty percent
    (50%) or more of the voting stock of an entity or, for non-stock
    entities, the right to fifty percent (50%) or more of the
    profits of such entity.

		
	1.2.	
    “Authorized Wholesalers” shall mean those wholesalers
    listed on Schedule 1.2, as such list may be modified
    pursuant to Section 2.9.
	 
	1.3.	
    “Data” shall mean the data provided by FMCH to Amgen
    hereunder in accordance with Article 4.

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	1.4.	
    “Designated Affiliates” shall mean any Affiliate of
    FMCH listed on Schedule 1.4, as such list may be
    modified pursuant to Section 2.8.
	 
	1.5.	
    “HIPAA” shall mean the Health Insurance Portability
    and Accountability Act of 1996 and its implementing regulations,
    each as amended.
	 
	1.6.	
    “Individually Identifiable Health Information” shall
    have the meaning specified in HIPAA.
	 
	1.7.	
    “Managed Centers” shall mean a dialysis facility or
    home dialysis program that FMCH has an ownership interest of
    less than fifty percent (50%) or no ownership in, but for which
    FMCH provides management and administrative services including
    the purchase and billing of Products, and that is listed on
    Schedule 1.7, as such list may be modified pursuant
    to Section 2.8.
	 
	1.8.	
    “Products” shall mean the following Amgen products:
    EPOGEN®
    (Epoetin alfa) and
    Aranesp®
    (darbepoetin alfa).
	 
	1.9.	
    [*]
	 
	1.10.	
    [*]
	 
	1.11.	
    “Term End Date” shall mean December 31, 2011.
	 
	1.12.	
    “Term Start Date” shall mean October 1, 2006.
	 
	1.13.	
    “WAC” shall mean the wholesaler acquisition cost
    established by Amgen in its sole discretion from time to time.
    WAC is subject to change by Amgen in its sole discretion at any
    time, by any amount, without notice, provided, however, that
    Amgen shall use commercially reasonable efforts to notify FMCH
    of any change to WAC, and nothing herein limits or alters
    FMCH’s rights under Section 8.4.

		
	2.	
    DEMAND FORECASTS; PURCHASE AND SALE OF PRODUCTS

		
	2.1.	
    Purchase and Supply Commitment.

			
	 	2.1.1.	
    [*]
	 
	 	2.1.2.	
    [*]
	 
	 	2.1.3.	
    Own Use. FMCH, its Designated Affiliates and its Managed
    Centers shall purchase the Products for their own use for the
    treatment of dialysis patients in the Territory and only such
    purchases shall be eligible for the pricing, discounts and
    rebates offered pursuant to this Agreement. FMCH, its Designated
    Affiliates and its Managed Centers covenant that they shall not
    seek any such pricing, discounts or rebates for any Products not
    for its or their “own use” for the treatment of
    dialysis patients in the Territory, and shall promptly notify
    Amgen in the event Amgen does provide FMCH, its Designated
    Affiliate or a Managed Center any such pricing, discount or
    rebates on any Products not for their own use.

		
	2.2.	
    [*]

			
	 	2.2.1.	
    [*]

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	 	2.2.2.	
    [*]
	 
	 	2.2.3.	
    [*]
	 
	 	2.2.4.	
    [*]
	 
	 	2.2.5.	
    [*]

		
	2.3.	
    [*]
	 
	2.4.	
    [*]

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	2.5.	
    [*]
	 
	2.6.	
    [*]
	 
	2.7.	
    [*]
	 
	2.8.	
    Affiliates. Only purchases of Products made pursuant to
    this Agreement by FMCH, its Designated Affiliates and Managed
    Centers shall be eligible for the pricing, discounts and rebates
    offered pursuant to this Agreement. FMCH represents and warrants
    that the lists of Designated Affiliates and Managed Centers set
    forth on Schedule 1.4 and on
    Schedule 1.7 are true, complete and accurate lists
    of all Affiliates and Managed Centers of FMCH engaged in the
    business of providing dialysis services in the Territory on the
    date hereof. FMCH agrees that it shall use its commercially
    reasonable best efforts to work with Amgen to update and
    maintain the accuracy of such Schedule 1.4 and
    Schedule 1.7 throughout the term of this Agreement
    and agrees and warrants that it shall not divest, restructure,
    reorganize or reclassify its Affiliates or Managed Centers with
    any intent in whole or in part to avoid, reduce or eliminate its
    obligations or commitments set forth in this Agreement.

			
	 	2.8.1.	
    After the Term Start Date, FMCH shall request the addition of
    all Affiliates FMCH acquires to the list of Designated
    Affiliates and all Managed Centers it contracts with to the list
    of Managed Centers by thirty (30) days prior written notice
    to Amgen. The schedules of Designated Affiliates and Managed
    Centers shall be amended to reflect such additions. Except as
    provided below, FMCH may remove Affiliates and Managed Centers
    from the respective lists only upon providing Amgen written
    notice and such removal shall be effective thirty (30) days
    after Amgen has provided FMCH with written approval of the
    removal of the Affiliates and Managed Centers. In the event FMCH
    requires removal of Affiliates and Managed Centers from the
    respective lists due to a (i) divestiture of the Affiliate
    to a third party with no affiliation to FMCH or any of its
    Affiliates; (ii) closure of a designated Affiliate facility
    or (iii) termination of the relevant management agreement
    for a Managed Center that has ceased its management relationship
    with FMCH or any of its Affiliates, FMCH shall provide Amgen
    notice of such removal within five (5) business days after
    the date of the divestiture, closure or termination of the
    management agreement, as the case may be, and such removal shall
    be effective as of the date of the divestiture, closure or
    management agreement termination. In such instances no Amgen
    approval shall be required. The schedules of Designated
    Affiliates and Managed Centers shall be amended to reflect
    removals as described above. In the event of a change to
    information regarding a Designated Affiliate or Managed Center
    (such as address), FMCH shall promptly notify Amgen and Amgen
    shall update the relevant schedule.
	 
	 	2.8.2.	
    Amgen shall have the right to remove Affiliates and Managed
    Centers of FMCH from the schedule of Designated Affiliates and
    Managed Centers from the schedule thereof (a) in instances
    in which Amgen determines, in its sole discretion, that such
    removal is required by law or order of any court or regulatory
    agency or as a result of negligence or willful misconduct in the
    use or administration of Products by such Designated Affiliate
    or Managed Center by thirty (30) days

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    prior written notice to FMCH; or (b) in all other instances
    upon thirty (30) days prior written notice to FMCH
    provided, however, that FMCH shall have the right to object to
    the removal of a Designated Affiliate or Managed Center other
    than if required by law or order of any court or regulatory
    agency.

			
	 		
    In the event FMCH objects to such removal, FMCH must notify
    Amgen within five (5) business days of such objection,
    explaining the basis for such objection. If FMCH and Amgen
    cannot, after good faith discussions, agree on the removal of
    the Designated Affiliate or Managed Center, the Parties shall
    submit the matter to the Commercial Arbitration Panel of the
    American Arbitration Association. The arbitration shall be
    conducted with the assistance of a special master knowledgeable
    about the pharmaceutical and healthcare industries jointly
    selected by the Parties in accordance with the procedures
    established by the American Arbitration Association. If the
    arbitrator determines that Amgen may remove such Designated
    Affiliate or Managed Center, then such termination of the
    Designated Affiliate or Managed Center shall be effective within
    thirty (30 days) of such determination.
	 
	 		
    FMCH may amend its Quarterly Updated Quantity Forecasts to
    account for any such removal. Any Affiliate or Managed Center
    removed by action of Amgen shall be excluded from FMCH’s
    purchase obligations hereunder. FMCH shall ensure compliance
    with the terms and conditions of this Agreement applicable to
    FMCH by its Designated Affiliates and Managed Centers. FMCH
    shall be jointly and severally liable for the acts and omissions
    of its Affiliates and Managed Centers, and Amgen shall have the
    right (but not the obligation) to proceed directly against FMCH
    in the event of a breach of this Agreement by any such Affiliate
    or Managed Center, without first proceeding against such
    Affiliate or Managed Center.

			
	 	2.8.3.	
    Within one hundred twenty (120) days following the
    execution of this Agreement by the last Party, FMCH shall
    provide to Amgen an updated Schedule 1.4 and
    1.7 indicating a current list of Designated Affiliates
    and Managed Centers who will be bound by the terms hereof.
    Concurrent with the delivery of such updated list, FMCH shall
    have the right to make an adjustment to its Quarterly Updated
    Quantity Forecast pursuant to Section 2.2 to reflect
    those Designated Affiliates or Managed Centers that are owned in
    whole or in part by third parties that have exercised their
    rights and have opted to not be bound by this Agreement. In
    addition, if after the Term Start Date FMCH enters into
    agreements with individuals or other entities to serve as a
    manager and/or a partner in an entity that is expected to
    operate an outpatient dialysis facility within the Territory,
    and such entity does not elect to participate in this Agreement
    prior to entering into the partnership or management arrangement
    with FMCH, FMCH shall not be obligated to add such entities to
    the schedule of Designated Affiliates or Managed Centers
    pursuant to Section 2.8.1 hereof, and such entities
    shall not be bound by the purchase commitments set forth in
    Section 2.1 above; provided, however, the number of
    such outpatient dialysis facilities associated with such
    entities may not exceed ten (10) per calendar year. To the
    extent such outpatient dialysis facility has not been added to
    the schedule of Designated Affiliates or Managed Centers
    concurrent with entering into the partnership or management
    arrangement with FMCH, such outpatient dialysis facility may not
    be added to the schedule of Designated Affiliates or Managed
    Centers without the prior written approval of Amgen.

		
	2.9.	
    Authorized Wholesalers. Only Products purchased from
    Authorized Wholesalers or directly from Amgen shall be eligible
    for the pricing, discounts and rebates offered pursuant to this
    Agreement. FMCH shall have the right to remove wholesalers from
    the list of Authorized Wholesalers by thirty (30) days
    prior written notice to Amgen, and shall have the right to add
    wholesalers to the list of Authorized Wholesalers by thirty (30)
    days notice to Amgen upon Amgen’s approval, which shall not
    be unreasonably conditioned, withheld or delayed. Amgen shall
    have the right to add or remove wholesalers in the exercise of
    its commercially reasonable discretion from the list of
    Authorized Wholesalers by thirty (30) days prior written
    notice to FMCH, provided (a) Amgen removes such wholesaler
    with respect to providing Products to all purchasers of
    Products, or (b) such wholesaler requests Amgen to remove
    it as an Authorized Wholesaler for FMCH. In the event of any
    such removal by Amgen, Amgen shall work

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    with FMCH to transition FMCH’s purchasing to an alternative
    Authorized Wholesaler and 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
    alternative Authorized Wholesaler exists at such time. Any such
    relationship shall be subject to credit qualification and the
    approval by Amgen of an application for direct ship account.
	 
	2.10.	
    [*]
	 
	3.	
    REBATES
	 
	3.1.	
    [*]
	 
	3.2.	
    [*]

			
	 	3.2.1.	
    [*]

		
	3.3.	
    [*]
	 
	3.4.	
    [*]
	 
	3.5.	
    Treatment of Discounts and Rebates. FMCH agrees that it,
    its Affiliates and Managed Centers shall properly disclose and
    account for all discounts and rebates earned hereunder, in
    whatever form, in compliance with all applicable federal, state,
    and local laws and regulations, including §1128B(b) of the
    Social Security Act and its implementing regulations. FMCH also
    agrees that it, its Affiliates and Managed Centers shall
    (i) claim the benefit of such discount or rebate received
    in the fiscal year in which such discount or rebate was earned
    or the year after, (ii) fully and accurately report the
    value of such discount or rebate in any cost reports filed under
    Title XVIII or Title XIX of the Social Security Act,
    or a state health care program, and (iii) provide, upon
    request by the U.S. Department of Health and Human Services
    or a state agency or any other federally funded state health
    care program, the information furnished to FMCH, its Affiliates
    or Managed Centers by Amgen concerning the amount or value of
    such discount or rebate. Amgen shall properly disclose to FMCH
    and account for all discounts and rebates given hereunder in
    accordance with its obligations under all applicable federal,
    state, and local laws and regulations, including §1128B(b)
    of the Social Security Act and its implementing regulations.
	 
	3.6.	
    Reports. Amgen shall provide to FMCH a quarterly
    statement of the rebates earned hereunder with the itemization
    of Product purchases made in a particular calendar quarter,
    broken down by individual Designated Affiliates and Managed
    Centers; and any other information that FMCH may reasonably
    request that is reasonably available to Amgen and necessary for
    FMCH to obtain in order to comply with its obligations hereunder
    or to calculate or confirm purchases, discounts, or rebates due
    or paid. FMCH agrees that it will provide such information to
    its Affiliates and Managed Centers in a timely manner in order
    to allow such Affiliates and Managed Centers to meet their
    reporting and other obligations hereunder and under applicable
    law and regulation.

		
	4.	
    PRODUCT DATA

		
	4.1.	
    Data Submission. FMCH shall provide the data specified in
    Exhibit 3.1 to Amgen (or to a data collection vendor
    specified by Amgen) within thirty (30) days of the end of
    each calendar month. Such Data shall be provided in the format
    set forth in such Exhibit. To the extent Amgen requests that
    FMCH 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 requirement as stated
    hereunder as applicable to Amgen, and Amgen shall be liable for
    any failure by any such data collection vendor to act in
    accordance with such requirements.
	 
	4.2.	
    HIPAA Compliance. FMCH has no intent to provide Amgen (or
    any specified data collection vendor) any Data in violation of
    HIPAA. Accordingly, the Parties agree to use their commercially
    reasonable best efforts to cause any Individually Identifiable
    Health Information to be de-identified in accordance with HIPAA
    prior to provision to Amgen or its designee. The Parties shall
    engage an appropriately qualified statistician, reasonably
    acceptable to each Party, who meets the requirements set forth
    in 45 C.F.R.

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    Section 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
    (“Certification”). In connection with the
    Certification, the Parties agree to use their reasonable best
    efforts to facilitate the delivery of such Certification in an
    expedited manner and Amgen shall bear the cost of such
    Certification. Notwithstanding anything contained herein to the
    contrary, in order to assure compliance, as determined by either
    Party in its reasonable discretion, with any existing federal,
    state or local statute, regulation or ordinance relating to
    patient privacy of medical records, or at any time following the
    enactment of any federal, state, or local law or regulation
    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 incentives contemplated under this Agreement,
    either Party may upon thirty (30) days’ notice, seek
    to modify this Agreement with respect to the affected incentive.
    FMCH and Amgen shall meet and in good faith seek to mutually
    agree to modify this Agreement to accommodate any such change in
    law or regulation, with the intent to, if possible, retain the
    essential terms of the affected incentive and pricing structure.
    If the Parties, after a reasonable time, are unable to agree
    upon such a modification, Amgen shall be entitled to terminate
    the affected incentive upon thirty (30) days’ notice
    or upon the date such change in law or regulation goes into
    effect, whichever is earlier. Notwithstanding the foregoing, in
    the event Amgen terminates such affected incentive as
    contemplated in the preceding sentence, any amount earned by
    FMCH under such incentive through the effective date of such
    change in law or regulation or the date of termination, as
    applicable, shall be due and owing to FMCH. In such a case, FMCH
    agrees that it shall provide Amgen with such Data as may be
    necessary for Amgen to calculate such incentive. In the event
    FMCH fails to provide Amgen with such Data, Amgen shall have no
    obligation to pay such incentive. Nothing in this Agreement
    shall require Amgen to enter into a business associate agreement
    with FMCH or any of its Affiliates or Managed Centers.
	 
	4.3.	
    Case Identifier. FMCH 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.
	 
	4.4.	
    Data Use. Amgen shall have the right to use Data to
    support verification of the services referenced in this
    Agreement, for Amgen-sponsored research and analysis,
    development of marketing materials, running internal trending
    analyses, overall analyses of how to improve treatment of
    patients on dialysis, creating tools by Amgen marketing
    personnel, and other internal Amgen business purposes.
    Notwithstanding the foregoing, without FMCH’s prior written
    consent (such consent not to be unreasonably conditioned,
    withheld or delayed): (i) Amgen shall not disclose to third
    parties the health information data provided by FMCH hereunder
    except pursuant to public health activities and to agents of
    Amgen bound by commercially reasonable obligations of
    confidentiality (or as required by law or regulation); and
    (ii) Amgen shall not sell or resell any such data or
    derivative works thereof to any third party.

		
	5.	
    [*]

5.1.   [*]

5.2.   [*]

		
	6.	
    WARRANTIES, REPRESENTATIONS AND COVENANTS

		
	6.1.	
    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. The party executing this
    Agreement on behalf of FMCH specifically

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    warrants and represents to Amgen that he or she is authorized to
    execute this Agreement on behalf of and has the power to bind
    FMCH and its wholly owned Designated Affiliates to the terms set
    forth in this Agreement. The parties executing this Agreement on
    behalf of Amgen and Amgen Inc. specifically warrant and
    represent to FMCH that they are authorized to execute this
    Agreement on behalf of and has the power to bind Amgen and Amgen
    Inc.
	 
	6.2.	
    Compliance with Law and Regulation. Amgen and Amgen Inc.
    shall, and FMCH, its Affiliates and Managed Centers shall,
    comply with all applicable law and regulation.
	 
	6.3.	
    Products. Amgen warrants that, as of the time of delivery
    by Amgen to a common carrier or other third party that:

			
	 	6.3.1.	
    the Products are manufactured, labeled, handled, stored and
    transported to Authorized Wholesalers or Authorized Distribution
    Centers, as applicable, in accordance with all applicable
    federal, state and local laws and regulations pertaining to the
    manufacturing, labeling, handling, storing and transporting of
    the Products including without limitation, the Federal Food,
    Drug and Cosmetic Act and implementing regulations and meet all
    the specifications for effectiveness and reliability as required
    by the United States Food and Drug Administration; and;
	 
	 	6.3.2.	
    when used in accordance with the directions on their labeling,
    the Products are fit for the purposes and indications described
    in such labeling.
	 
	 	6.3.3.	
    Amgen warrants that the use of the Products by FMCH, its
    Designated Affiliates and/or Managed Centers shall not infringe
    upon the ownership rights of any other person or any patent,
    copyrights, trademarks or other intellectual property rights of
    any third party.

		
	 	
     Amgen agrees that it will promptly notify FMCH if it determines
    that there has been any material defect in any of the Products
    delivered to FMCH.

			
	 	6.4.	
    NO OTHER WARRANTIES. OTHER THAN THE WARRANTIES EXPRESSLY
    SET FORTH HEREIN, NEITHER PARTY MAKES, AND EACH PARTY EXPRESSLY
    DISCLAIMS, ALL OTHER WARRANTIES, INCLUDING THOSE OF
    MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

		
	7.	
    INDEMNITY AND INSURANCE

		
	7.1.	
    Insurance. Each of the Parties agrees that it shall
    secure and maintain in full force and effect throughout the term
    of this Agreement (and following termination, to the extent
    necessary to cover any claims arising from the Agreement)
    comprehensive general liability insurance. Such insurance shall
    provide, among other things, product liability, professional
    liability, workmen’s compensation, and broad form
    contractual liability coverage for its indemnification
    obligations hereunder, and shall have limits reasonably
    acceptable to the other Party. Any limits on each of a
    Party’s insurance coverage shall not be construed to create
    a limit on such Party’s liability with respect to its
    obligations under this Agreement or otherwise. Each Parties
    shall have the right to satisfy its obligations under this
    Section 7.1 through self-insurance. Amgen Inc.
    hereby guarantees the performance of Amgen’s obligations as
    set forth in this Section 7.1.

7.2.   Indemnity.

			
	 	7.2.1.	
    By Amgen. Amgen agrees to indemnify, defend and hold
    harmless FMCH, its Affiliates and Managed Centers, and its and
    their respective employees, officers and directors from and
    against any and all amounts payable to third parties pursuant to
    a written settlement agreement or court order (including but not
    limited to reasonable attorney fees and other costs related to
    the defense or prosecution of the case incurred by FMCH in the
    defense of a third party claim prior to Amgen’s assumption
    of the defense thereof) (“Third Party Awards”) that
    result directly from: (a) breach of any Amgen
    representation or warranty hereunder, (b) Products that as
    of the date of shipment by Amgen: (i) contain defects in
    material and workmanship, (ii) are adulterated or
    misbranded within the meaning of applicable provisions of the
    FDC Act, or (iii) are prohibited from being introduced into
    interstate commerce by Section 301 of the FDC Act or
    Section 351 of

8

 

			
	 		
    the Public Health Service Act, or (c) Amgen’s or its
    Affiliates gross negligence or willful misconduct; provided that
    such indemnity shall not apply to Third Party Awards arising out
    of the negligent or willful actions or omissions of FMCH, its
    Affiliates or Managed Centers, or its or their respective
    agents, employees, representatives, successors or assigns, or to
    the extent arising out of a matter for which FMCH is required to
    indemnify Amgen pursuant to Section 7.2.2 of this
    Agreement, or due to defects in the Products caused by persons
    other than Amgen or that result from neglect, misuse,
    unauthorized adulteration or modification, improper testing,
    handling or storage or any cause beyond the range of normal
    usage; and further provided that (a) Amgen is promptly
    notified in writing of any such third party claim for which this
    indemnity obligation may apply, (b) Amgen shall have sole
    control of the defense and settlement thereof, and (c) FMCH
    cooperates fully and gives Amgen all reasonably requested
    information and assistance for such defense. The preceding
    paragraph and FMCH’s rights under Section 8.2,
    if any, set forth FMCH’s and its Affiliates’ sole
    remedies for third party claims relating to Amgen of Product
    defect, adulteration, misbranding, or infringement.
	 
	 	7.2.2.	
    By FMCH. FMCH, its Affiliates and Managed Centers agree
    to indemnify, defend and hold harmless Amgen and its respective
    employees, officers and directors from and against any and all
    Third Party Awards that result directly from (a) a breach
    of any FMCH representation and warranty hereunder or
    (b) FMCH’s, its Affiliates’ or its Managed
    Centers’ transportation, handling, storage, administration,
    promotion or sale of the Products and not arising solely or
    principally out of Amgen’s negligence, or a matter for
    which Amgen is required to indemnify FMCH pursuant to the above
    paragraph, provided that (a) FMCH is promptly notified in
    writing of any such third party claim for which this indemnity
    obligation may apply, (b) FMCH shall have sole control of
    the defense and settlement thereof, and (c) Amgen
    cooperates fully and gives FMCH all reasonably requested
    information and assistance for such defense. The preceding
    paragraph and Amgen’s rights under Section 8.2,
    if any, set forth Amgen’s sole remedies for third party
    claims relating to FMCH, any transportation, handling, storage,
    administration, promotion or sale of the Products.

		
	8.	
    TERM AND TERMINATION

		
	8.1.	
    Term. This Agreement shall come into effect as of the
    Term Start Date and shall expire as of the Term End Date, unless
    sooner terminated in accordance with this Article 8.
	 
	8.2.	
    Termination for Cause. Subject to the obligations set
    forth in Section 2.1.2, either party may terminate
    this Agreement in the event of an uncured material breach
    following thirty (30) days written notice of same (which
    termination shall be automatically effective at the end of such
    thirty (30) day period should such breach remain uncured).
	 
	8.3.	
    Termination to Assure Compliance with Law.
    Notwithstanding anything contained herein to the contrary, in
    order to assure compliance, as determined by either Party in its
    reasonable discretion, with any existing federal, state or local
    statute, regulation or ordinance (each a “Law”), or at
    any time following the enactment of any Law pertaining to the
    supply, purchase and sale of the Products and the payment of the
    rebates and discounts contemplated hereby, either Party may upon
    notice to the other Party, seek to modify this Agreement to
    address the aspect of the Agreement that may not comply with
    such Law. Promptly following the delivery of such notice
    describing the Law at issue, FMCH and Amgen shall meet and in
    good faith seek to mutually agree to modify this Agreement to
    accommodate any such Law with the intent to, if possible, retain
    the essential terms of the Agreement. If the Parties, after a
    reasonable time, not to exceed ninety (90) days, are unable
    to agree upon such a modification, either shall be entitled to
    terminate the Agreement effective upon ninety days
    (90) days’ notice or upon the date such Law goes into
    effect, whichever is earlier.

8.4.   [*]

8.5.   [*]

9

 

		
	8.6.	
    Effect of Termination. Upon any termination or expiration
    of this Agreement, any earned and vested rebates shall be paid
    in accordance with the terms set forth in Article 3.
    If termination occurs at FMCH’s election under
    Section 8.2 or 8.4 all rebates and incentives
    available to FMCH in the particular calendar quarter or year in
    which such termination occurs shall be prorated and paid to FMCH
    based on an achievement of the prorated requirements (such
    proration shall be based on the effective date of termination
    relative to the measurement period for the particular calendar
    quarter or year in which such termination occurs). In the event
    of any termination during a calendar quarter or year, Amgen
    shall pro-rate any data used in calculating payments hereunder,
    and make prorated payments, as appropriate.

		
	8.7.	
    Survival. The following provisions shall survive any
    expiration or termination of this Agreement: Sections
    3.2 — 3.5 (with respect to periods prior to such
    expiration or termination), Article 4 (with respect to
    periods prior to such expiration or termination), Section
    6.3 (with respect to Products purchased during the term of
    the Agreement or any prior Dialysis Organization Agreement),
    Section 8.6, and Articles 7 and 9.

		
	9.	
    MISCELLANEOUS

		
	9.1.	
    Amendment. Except as expressly set forth herein, no
    amendment of this Agreement shall be effective unless expressed
    in a writing signed by each of the Parties.

		
	9.2.	
    Assignment. Neither Party shall have the right to assign
    this Agreement without the other’s prior written consent
    which shall not be unreasonably, withheld, conditioned or
    delayed. Any attempted assignment without prior consent shall be
    void. Notwithstanding the foregoing, either Party shall have the
    right to assign this Agreement, in its entirety, to an
    Affiliate. This Agreement shall be binding on the Parties’
    permitted successors and assigns.
	 
	9.3.	
    Conflicting Provisions. In the event of any conflict
    between this Agreement and any purchase order or invoice
    relating to the subject matter of this Agreement, including
    service fees, purchase orders or payment terms, this Agreement
    shall control.
	 
	9.4.	
    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.”
	 
	9.5.	
    Counterparts. This Agreement may be executed in one or
    more counterparts, each of which shall be considered an original.
	 
	9.6.	
    Currency. All amounts herein are set forth in United
    States Dollars.
	 
	9.7.	
    Force Majeure. 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, civil
    disobedience, epidemics, war, terrorist acts, or any other cause
    of like nature beyond the control of such Party. Force Majeure
    shall not adversely affect FMCH’s eligibility for rebates
    and incentives hereunder. Force Majeure shall not affect either
    Party’s right to terminate this Agreement under
    Section 8.2.
	 
	9.8.	
    Further Assurances. The Parties shall perform all further
    acts reasonably requested by the other Party to effectuate the
    purposes of this Agreement.
	 
	9.9.	
    Governing Law. This Agreement shall be governed by the
    laws of the State of Delaware, excluding its choice of law
    rules. Each Party hereby irrevocably submits to the jurisdiction
    of the state and Federal courts located in the State of
    Delaware, and agrees that any dispute arising out of or relating
    to this Agreement shall be heard in a state or Federal court
    located in Wilmington, Delaware, and agrees that it shall not
    assert any objection or defense of lack of jurisdiction,
    improper venue or forum non conveniens in any dispute brought in
    such courts. The Parties agree that any such dispute shall be
    adjudicated as between the Parties, and neither Party shall seek
    certification as a class. Notwithstanding the foregoing, either
    Party shall have the right to join any party ruled indispensable
    by the relevant court.

10

 

		
	9.10.	
    Merger. This Agreement constitutes the entire Agreement,
    written or oral, of the Parties concerning the subject matter
    hereof. The Exhibits and Schedules to this Agreement are hereby
    incorporated into and made a part of this Agreement. This
    Agreement supersedes any prior or contemporaneous agreements on
    the subject matter hereof, including the Data Use Agreement
    between the Parties dated January 1, 2004. In addition, the
    Parties hereby agree that upon the Term Start Date of this
    Agreement, the Dialysis Organization Agreement
    No. 200600023 by and between Amgen USA Inc. and National
    Medical Care, Incorporated shall be terminated and of no further
    force or effect, except as otherwise provided therein.
	 
	9.11.	
    No Partnership. The relationship between Amgen and FMCH,
    its Affiliates and Managed Centers 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.
	 
	9.12.	
    Notices. Any notice or other communication required or
    permitted hereunder shall be in writing and shall be deemed
    given or made five (5) days after deposit in the United
    States mail with proper postage for first-class mail, or when
    delivered personally or by facsimile (as shown by concurrent
    written transmission confirmation), 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 9.12:

	 	 	 	 	 
	 	 	
    If to Amgen:	 	 
	 	 	 	 	
    Amgen USA Inc.
	 	 	 	 	
    One Amgen Center Drive, M/ S 27-4-A
	 	 	 	 	
    Thousand Oaks, CA 91320-1789
	 	 	 	 	
    Attn: Contract and Pricing Advisor — Nephrology
    Business Unit
	 	 	 	 	
    Fax: (805) 376-8558
	 	 	
    with a copy to:	 	 
	 	 	 	 	
    Amgen Inc.
	 	 	 	 	
    One Amgen Center Drive, M/ S 38-5-A
	 	 	 	 	
    Thousand Oaks, CA 91320-1789
	 	 	 	 	
    Attn: General Counsel
	 	 	
    If to FMCH on or before November 30, 2006:
	 	 	 	 	
    Fresenius Medical Care Holdings, Inc.
	 	 	 	 	
    95 Hayden Avenue
	 	 	 	 	
    Lexington, MA 02420
	 	 	 	 	
    Attn: General Counsel
	 	 	 	 	
    Fax: (781) 402-9713
	 	 	
    If to FMCH after November 30, 2006:
	 	 	 	 	
    Fresenius Medical Care Holdings, Inc.
	 	 	 	 	
    920 Winter Street
	 	 	 	 	
    Waltham, MA 02451
	 	 	 	 	
    Attn: General Counsel
	 	 	 	 	
    Fax:

		
	9.13.	
    Confidentiality. “Confidential Information”
    shall mean all proprietary or confidential information disclosed
    to a Party by or on the behalf of the other Party in connection
    with the performance of this Agreement and indicated in writing
    as “Confidential” (or, if disclosed orally, indicated
    as confidential in a written summary that is delivered to the
    other Party within thirty (30) days of such disclosure).

			
	 	9.13.1.	
    Except to the extent expressly authorized by this Agreement or
    otherwise agreed in writing by the Parties, the Parties agree
    for the Term, and for a period of five (5) years following
    the Term, to 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
    of the other Party, provided, however, that the Party
    receiving the other Party’s Confidential Information may
    disclose such Confidential Information to its directors,
    officers, employees, agents, consultants and advisors as
    necessary for the receiving Party to carry out its rights and
    obligations under this

11

 

			
	 		
    Agreement on the condition that such directors, officers,
    employees, agents, consultants and advisors agree to be bound by
    the confidentiality provisions of this Agreement. The
    confidentiality provisions contained in this
    Section 9.13 shall not apply to the extent that it
    can be established by the receiving 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 receiving
    Party;
	 
	 	(b)	
    became generally available to the public or otherwise part of
    the public domain after its disclosure and other than through
    any act or omission of the receiving Party in breach of this
    Agreement;
	 
	 	(c)	
    was independently discovered or developed by the receiving Party
    without the use of or reference to the Confidential Information
    belonging to the disclosing Party; or
	 
	 	(d)	
    is required to be disclosed by Section 3.5 above,
    applicable law or regulation, or court order, provided,
    however, that notice is promptly delivered to the other
    Party in order to provide the other Party an opportunity to seek
    a protective order or other similar order with respect to such
    Confidential Information and, if disclosure is made, the
    receiving Party discloses only the minimum information required
    to be disclosed in order to comply with such law or court order.

			
	 	9.13.2.	
    Public Announcements. The Parties agree that the
    existence of and the material terms of this Agreement shall be
    considered Confidential Information of both Parties. Without
    limiting the generality of Section 9.13, neither
    Party shall make a public announcement concerning this Agreement
    or the subject matter hereof without the consent of the other
    Party, except that either Party may make such public
    announcement if required by law or court order; provided,
    however, that, the announcing Party shall give reasonable
    prior advance notice of the proposed text of such announcement
    to the other Party for its prior review and approval, which
    review and approval shall not be unreasonably conditioned,
    withheld or delayed.
	 
	 	9.13.3.	
    Authorized Disclosure. Notwithstanding the foregoing,
    either Party may disclose Confidential Information of the other
    Party to the extent such disclosure is reasonably necessary for
    any filings with Regulatory Agencies; provided, however,
    that the Party required or intending to disclose the other
    Party’s Confidential Information under this
    Section 9.13.3 shall first consult with the other Party and
    shall have given prompt notice to such other Party to enable it
    to seek any available exemptions from or limitations on the
    disclosure of its Confidential Information and the receiving
    Party shall reasonably cooperate in such efforts by the other
    Party.
	 
	 	9.13.4.	
    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.

		
	9.14.	
    Severability. Should any one or more of the provisions of
    this Agreement be determined to be illegal or unenforceable, the
    Parties shall attempt, in good faith, to negotiate a
    modification of this Agreement so as to comply with the relevant
    law or regulation. Should they be unable to do so within thirty
    (30) days, either Party shall have the right to terminate
    this Agreement upon ten (10) days prior written notice to
    the other.
	 
	9.15.	
    Waiver. No party shall be deemed to have waived any right
    hereunder, unless such waiver is expressed in a writing signed
    by such Party.
	 
	9.16.	
    [*]
	 
	9.17.	
    [*]

*******

12

 

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

	 	 	 	 	 	 	 
	
    AMGEN USA INC	 	
    FRESENIUS MEDICAL CARE HOLDINGS, INC.
	 
	
    
    By:

    	 	
    /s/ George Morrow
    	 	
    By:	 	
    /s/ Mats Wahlstrom
    
	 	 	 	 	 	 	 
	 
	
    
    Name (print):

    	 	
    George Morrow	 	
    Name (print):	 	
    Mats Wahlstrom
	 	 	 	 	 	 	 
	 
	
    Title:	 	
    Chairman of the Board and President	 	
    Title:	 	
    Co-CEO
	 	 	 	 	 	 	 
	 
	
    Date:	 	
    October 13, 2006	 	
    Date:	 	
    October 13, 2006
	 	 	 	 	 	 	 

AMGEN INC.

with respect to certain provisions of this

Agreement as set forth herein

	 	 	 	 	 	 	 
	
    
    By:

    	 	
    /s/ George Morrow
    	 	 	 	 
	 	 	 	 	 	 	 
	 
	
    
    Name (print):

    	 	
    George Morrow	 	 	 	 
	 	 	 	 	 	 	 
	
    
    Title:

    	 	
    EVP Global Commercial Ops	 	 	 	 
	 	 	 	 	 	 	 
	
    
    Date:

    	 	
    October 13, 2006	 	 	 	 
	 	 	 	 	 	 	 

13

 

Schedule 1.2

Authorized Wholesalers

American Medical Distributors, Inc, a subsidiary of Bellco Drug
Corporation

Amityville, NY

CMA 600644

AmerisourceBergen Drug Corporation

Thorofare, NJ

CMA 600124

Bellco Drug Corporation

North Amityville, NY

CMA 600051

J.M. Blanco Wholesaler, A Division of Amerisource Bergen

Guaynabo, PR

CMA 600093

Fresenius USA Manufacturing, Inc.

d/b/a Nephromed and affiliates

CMA 600683

14

 

Schedule 1.4

Designated Affiliates

     
[*]

15

 

Schedule 1.7

Managed Centers

     
[*]

16

 

Schedule 2.10

Approved Distribution Centers

Fresenius USA Manufacturing, Inc.

d/b/a Nephromed and affiliates

95 Hayden Avenue

Lexington, MA 92420-9192

17

 

Exhibit 2.10

Terms for Purchase of Direct Product

     
[*]

		
	1.	
    [*]
	 
	2.	
    [*]
	 
	3.	
    [*]
	 
	4.	
    [*]
	 
	5.	
    Credit. FMCH Distribution Center shall send annually,
    within one hundred twenty (120) days of Fresenius Medical
    Care Holdings, Inc.’s (“FMCH”) fiscal year end,
    or more frequently as requested by Amgen, copies of FMCH’s
    audited financial statements for such fiscal year to:

	 	 	 	 	 
	 	 	
    Amgen USA Inc.	 	 
	 	 	
    Customer Finance Department	 	 
	 	 	
    One Amgen Center Drive	 	 
	 	 	
    Thousand Oaks, CA 91320-1799	 	 

		
	 	
     If no audited financial statements are available, FMCH
    Distribution Center shall send unaudited financial statements
    which are certified by FMCH Distribution Center’s principal
    financial officer as being accurate in all material respects.
    Amgen shall not be obligated to ship Direct Product to FMCH
    Distribution Center if there are any amounts past due on FMCH
    Distribution Center’s account or if FMCH Distribution
    Center’s outstanding balance due exceeds FMCH Distribution
    Center’s predetermined credit limit. FMCH Distribution
    Center shall supply Amgen written notice of the sale or transfer
    of all or substantially all of its assets of, or a controlling
    interest in, FMCH Distribution Center at least thirty
    (30) days prior to such action if not otherwise prohibited
    by law or contractual obligations. Amgen reserves the right in
    its sole discretion to modify its credit policies and to require
    prepayment or satisfactory security at any time.

		
	6.	
    Sales Data. FMCH Distribution Center shall submit all
    Direct Product sales data, including Customer returns,
    rebillings and associated credits to IMS America, Ltd.
    (“IMS”) and to any other third-party sales reporting
    organization as reasonably requested by Amgen, on a monthly
    basis, and within two (2) weeks after the close of each
    month. FMCH Distribution Center shall provide all information
    and assistance reasonably required by Amgen to determine and
    verify Medicaid, other government, or third-party rebate claims
    or obligations. If FMCH Distribution Center is unable to report
    such sales data to the agreed upon independent third-party sales
    reporting organization(s) due to unwillingness of the third
    party to deal with FMCH Distribution Center, Amgen’s sole
    recourse shall be to terminate the Direct Product purchase
    components of this Agreement.
	 
	7.	
    Contracts and Chargebacks. FMCH Distribution Center
    agrees to service contracts that Amgen has entered into with
    Customers in accordance with the terms specified in bid award
    notifications sent by Amgen to FMCH Distribution Center. Amgen
    shall credit FMCH Distribution Center for the difference between
    the Customer’s contracted price and the WAC, for Direct
    Product sold and shipped to Customer designated by Amgen to
    receive special contract pricing. Adjustments or credits will be
    made in accordance with Amgen’s Chargeback Policy (See
    Article One) attached hereto and incorporated herein.
    FMCH Distribution Center further agrees to submit chargebacks to
    Amgen via EDI in a format acceptable to Amgen at least once per
    week, and in accordance with Amgen’s Chargeback Policy.
    FMCH Distribution Center shall retain all documentation
    supporting such chargebacks for a period of eighteen
    (18) months from the date of sale and permit Amgen
    employees or contractors (who shall not be compensated by Amgen
    on a contingency basis) to review this documentation upon
    request.
	 
	8.	
    [*]
	 
	9.	
    Rebillings and Associated Credits. FMCH Distribution
    Center agrees to submit to Amgen all Customer rebillings and
    associated credits in conformance with Amgen’s Chargeback
    Policy.

18

 

		
	10.	
    Product Recall. In the event of a recall, Amgen will
    promptly notify FMCH Distribution Center and relevant Customer
    of such recall and arrange for Direct Product to be shipped
    directly to Amgen. Amgen will provide a third-party billing
    number (common carrier) to Customer and FMCH Distribution Center
    for shipping of recalled Direct Product directly to Amgen. FMCH
    Distribution Center shall provide a list of Customer names and
    addresses to Amgen who may have received recalled Direct
    Product. In consideration for FMCH Distribution Center’s
    administrative expenses, Amgen will pay FMCH Distribution Center
    for a list of each Customer that may have received recalled
    Direct Product in the amount equal to $1.00 per Customer
    name up to a maximum $100.00 per distribution center. FMCH
    Distribution Center shall render its services and assist Amgen
    in returning all recalled Direct Product to Amgen. Amgen shall
    provide reasonable compensation to FMCH Distribution Center per
    HDMA standards for additional services that may be requested by
    Amgen. A credit memo will be issued to FMCH Distribution Center
    for all recalled Direct Product returned to Amgen. FMCH
    Distribution Center shall promptly issue credit to Customer for
    recalled Direct Product returned directly to Amgen for which
    Amgen has issued a credit memoranda to FMCH Distribution Center.
    FMCH Distribution Center may call Amgen Customer Service at
    1-800-282-6436 for
    further instructions in the event of a recall.
	 
	11.	
    Applicable Laws and Regulations. Amgen and FMCH
    Distribution Center agree to comply with all laws (local, state
    and federal) applicable to the purchase, handling, sale, and
    distribution of Direct Product. FMCH has previously provided
    Amgen with the statutory citation of all local and state laws
    and regulations contemplated by this Article 11. In
    the event there shall be a change in federal or state statutes
    (including, but not limited to Medicare or Medicaid statutes,
    Federal Food, Drug and Cosmetic Act (the “FDC Act”),
    and any other statutes governing distribution, handling,
    purchasing, or sale of drugs, medical supplies and durable
    medical equipment), case laws, regulations or general
    instructions, the interpretation of any of the foregoing, the
    adoption of new federal or state legislation, or a change in any
    third party reimbursement system, any of which are reasonably
    likely to materially and adversely affect the manner in which
    either party may perform or be compensated for its services
    under this Agreement or which shall make this Agreement
    unlawful, the Parties shall immediately enter into good faith
    negotiations regarding a new service arrangement or basis for
    compensation for the services furnished pursuant to this
    Agreement that complies with the law, regulation, or policy. If
    good faith negotiations cannot resolve the matter within thirty
    (30) days, the Parties shall terminate the Agreement.
	 
	12.	
    Diversion. FMCH Distribution Center shall distribute
    Direct Product only to those approved Designated Affiliates and
    Managed Centers listed on Schedule 1.4 and
    Schedule 1.7. FMCH Distribution Center shall
    promptly notify Amgen upon learning of any activity that appears
    to be diversion of Direct Product, including the sale,
    distribution or purchase of Direct Product for uses beyond the
    provision of care for dialysis patients, or the sale or
    distribution of Direct Product outside of the United States and
    Puerto Rico. Amgen may terminate this Agreement upon written
    notice if it is determined by Amgen, in its sole discretion,
    that FMCH Distribution Center has purchased Direct Product from
    sources other than Amgen or distributed Direct Product to
    entities not listed on Schedule 1.4 and/or
    Schedule 1.7.

19

 

Article 1

Chargeback Policy

		
	1.	
    INITIAL SUBMISSIONS:

		
	 	
     Chargeback claims must be submitted via EDI in a format
    acceptable to Amgen. Claims must be received by Amgen no later
    than sixty (60) calendar days after FMCH Distribution
    Center has invoiced the Customer. Each item must contain the
    information necessary to uniquely identify the Customer,
    including the Health Industry Number (HIN) and complete
    ship-to name and address, or other identifier as required by
    Amgen.

		
	2.	
    PROCESSING TIME:

		
	 	
     Amgen will process all initial chargeback claims received in an
    acceptable format within ten (10) business days. Once the
    chargeback claim has been processed, FMCH Distribution Center
    will receive, by mail, the credit memoranda and/or discrepancy
    report.

		
	3.	
    DISCREPANCIES:

		
	 	
     Partial Rejections: If any item cannot be validated from the
    claim, it will be rejected and credit will not be issued for
    that item. FMCH Distribution Center will receive the credit
    memoranda for the validated items in conjunction with the
    discrepancy report for rejected items. A reason will be given
    for each rejected item.
	 
	 	
     Full Rejections: Submissions not in an acceptable format or
    with a rejection rate greater than ten percent (10%) may be
    rejected in full. Upon such notification, FMCH Distribution
    Center must correct the error(s) and electronically retransmit
    the entire claim.

		
	4.	
    RESUBMISSIONS:

		
	 	
     Amgen will accept resubmissions for rejected chargebacks within
    sixty (60) calendar days after FMCH Distribution Center has been
    notified of the rejection. Claims must be submitted on
    Amgen’s discrepancy report with any corrections or
    additional information necessary to validate such claim.

		
	5.	
    CUSTOMER RETURNS:

		
	 	
     FMCH Distribution Center must report its Customer returns as
    “negative” or “reverse” chargebacks.

		
	6.	
    CREDITS AND REBILLS:

		
	 	
     FMCH Distribution Center shall submit simultaneously to Amgen
    the credits and their associated rebills within sixty
    (60) calendar days after FMCH Distribution Center rebills a
    Customer.

		
	7.	
    CONTRACT ELIGIBILITY:

		
	 	
     Claims will only be honored for sales made in accordance with
    the Bid Award Notifications sent by Amgen to FMCH Distribution
    Center. A facility may only participate on one (1) contract
    for each product at any given time. An individual contract will
    take precedence over any group purchasing organization contract
    of which the facility may be a part.

		
	8.	
    AUDIT:

		
	 	
     Amgen shall have access to all information necessary to verify
    chargeback claims.

		
	9.	
    DEDUCTIONS:

		
	 	
     Deductions of chargeback claims are not permitted unless
    supported with a valid credit memoranda from Amgen. Amgen’s
    Chargeback Policy conforms with the guidelines set by the
    Healthcare Distribution Management Association. Amgen reserves
    the right to modify its Chargeback Policy upon notice to FMCH
    pursuant to Section 9.12 in the Agreement.

20

 

Article Two

Product Return Policy

AUTHORIZATION:

     
Contact Amgen Customer Service Department at 800-282-6436 for
proper instructions for Amgen Products.

RETURNABLE ITEMS:

			
	 	• 	
    Unused partials or full pack quantities with less than one year
    post expiration date.
	 
	 	• 	
    Product received in error or damaged in transit.

NON-REFUNDABLE ITEMS:

     
Although all products may be returned, no credit will be issued
for:

			
	 	• 	
    Product twelve (12) months or more post expiration date.
	 
	 	• 	
    Product destroyed or damaged due to improper storage, heat,
    cold, water, or smoke, left unrefrigerated or other conditions
    beyond the control of Amgen.
	 
	 	• 	
    Product destroyed or losses suffered in a natural disaster
    (flood, hurricane, tornado, etc.).
	 
	 	• 	
    Product obtained other than through normal channels of
    distribution.
	 
	 	• 	
    Product that is in unsaleable condition through no fault of
    Amgen.
	 
	 	• 	
    Product shipped as a no charge item.
	 
	 	• 	
    Unauthorized excess stock.

TRANSPORTATION CHARGES:

			
	 	• 	
    Prepaid by customer

TERMS OF RETURN POLICY:

			
	 	• 	
    Credit if applicable for outdated Product, will be based on
    then-current WAC less ten percent (10%).
	 
	 	• 	
    Credit for indirect customers for outdated product, will be
    issued in the form of a check by Capital Returns Inc. on behalf
    of Amgen.
	 
	 	• 	
    Credit for direct customers for outdated product, will be issued
    by Amgen in the form of a credit invoice.
	 
	 	• 	
    Amgen will not be responsible for any charges associated with
    third party return processors.
	 
	 	• 	
    No credit for shipping, handling and return processing fees.
	 
	 	• 	
    Product ordered or received in error must be reported within
    fifteen (15) business days of Product receipt.
	 
	 	• 	
    Pre-deductions from invoices are not allowed.
	 
	 	• 	
    All items are subject to credit approval by Amgen Customer
    Service.

Third Party Returns Processors:

			
	 	• 	
    For all outdated Product, please forward return with detail
    manifest directly to:

Capital Returns, Inc.

Attn: Amgen Return Goods

6101 North 64th Street

Milwaukee, WI 53218

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COMPANY DISCLAIMER:

			
	 	• 	
    Products returned are subject to Amgen’s and or Capital
    Returns’ evaluation at the time of receipt for final count
    and inspection.
	 
	 	• 	
    Amgen may, with notice to Wholesaler in its sole discretion,
    make exceptions, changes and/or modifications to the Returned
    Goods Policy.

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Exhibit 3.1

Discount Terms and Conditions

			
	 	[*]	

	 
	 	1.1.1	
    [*]
	 
	 	1.1.2	

		
	1.2	
    [*]

			
	 	1.2.1	

	 
	 	[*]	

	 
	 	[*]	

	 
	 	[*]	

		
	1.3	
    [*]
	 
	1.4	
    [*]
	 
	1.5	
    [*]
	 
	1.6	

	 
	1.7	
    [*]
	 
	2	
    [*]

			
	 	2.1.1	
    [*]

		
	2.2	
    [*]
	 
	2.3	
    [*]
	 
	2.4	
    [*]
	 
	3	
    [*]

			
	 	3.1.1	

		
	3.2	
    [*]
	 
	3.3	
    [*]
	 
	3.4	
    [*]
	 
	4	
    [*]

			
	 	4.1.1.1	
    [*]
	 
	 	4.1.1.2	

		
	4.2	
    [*]
	 
	4.3	
    [*]
	 
	4.4	
    [*]
	 
	5	
    [*]

			
	 	[*]	

		
	5.1	
    [*]
	 
	5.2	
    [*]

23

 

		
	5.3	
    [*]

*****

24

 

Addendum A: [*]

[*]

25

 

Addendum B: [*]

[*]

26

 

Addendum C: [*]

[*]

27

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00117-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00117-of-00352.parquet"}]]