EXHIBIT 4.19
AMGEN
FREESTANDING DIALYSIS CENTER AGREEMENT
This Agreement ("Agreement"), between Amgen USA Inc. ("Amgen"), a
wholly-owned subsidiary of Amgen Inc., and National Medical Care, Inc.,
including all subsidiaries and affiliates that are at least fifty and one-tenth
percent (50.10%) owned by National Medical Care, Inc. and listed on Appendix B,
(collectively, "NMC"), sets forth the terms and conditions for the purchase of
EPOGEN(R) (Epoetin alfa) and Aranesp(R) (darbepoetin alfa) (collectively,
"Products") by NMC, exclusively for the treatment of dialysis patients.
1. TERM OF AGREEMENT. The "Term" of this Agreement shall be defined as
January 1, 2004 ("Commencement Date") through January 31, 2006
("Termination Date").
2. QUALIFIED PURCHASES. All terms contained herein apply only to purchases
made hereunder, as confirmed by Amgen ("Qualified Purchases"), by NMC and,
subject to the terms of Section 11, all Affiliates (as such term is defined
in Section 11 below) opened, acquired, or managed by NMC during the Term,
for so long as such Affiliates remain at least fifty and one-tenth percent
(50.10%) owned or managed by National Medical Care, Inc., through
wholesalers chosen by NMC and authorized by Amgen to participate in the
program ("Authorized Wholesalers") or directly from Amgen. In addition, and
also subject to the terms of Section 11, Renaissance Health Care, Inc.,
Optimal Renal Care, L.L.C., Integrated Renal Care of the Pacific, LLC
and/or any joint venture of NMC in which NMC holds at least a fifty and
one-tenth percent (50.10%) ownership interest, will also be eligible to
participate, although not required to purchase under this Agreement. Amgen
agrees to reasonably approve Authorized Wholesalers requested by NMC. The
option to purchase on a direct basis from Amgen is subject to receipt and
approval, not to be unreasonably withheld, of an "Application for Direct
Ship Account".
3. PRICING. See Appendix A.
4. PAYMENT TERMS. The terms and conditions of this Agreement shall apply
whether NMC and/or Affiliates purchase Products through an Authorized
Wholesaler or from Amgen directly.
5. DISCOUNT. NMC shall qualify for discounts and incentives subject to
material compliance with the terms and conditions of this Agreement as well
as the schedules and terms set forth in Appendix A. Discounts in arrears
will be paid by Amgen in the form of a [*] to NMC's corporate headquarters,
and Amgen Inc. hereby guarantees Amgen's obligation to pay all discounts
earned by NMC hereunder. Discounts in arrears will be calculated in
accordance with the terms set forth in Appendix A. For purposes of all of
the discounts paid in arrears contained herein, including, without
limitation, those discounts and incentives provided in Appendix A, if any
Affiliates are added to or deleted from this Agreement during any quarter,
Amgen shall appropriately adjust NMC's purchases for the relevant periods
(i) for deleted Affiliates, by excluding purchases by such Affiliates
effective from the effective date of their deletion and during the relevant
quarter used for comparison, or (ii) for added Affiliates, by including any
purchases made by acquired Affiliates effective from the date they are
added to the list of Affiliates on Appendix B and during the relevant
quarter used for comparison, and by including any purchases made by any de
novo Affiliates commencing in the quarter in which they commence
operations. Amgen and NMC agree that, for purposes of determining
eligibility for and calculation of all discounts and all incentives
provided in this Agreement (including, without limitation, all discounts
and incentives as are set forth in Appendix A), a Qualified Purchase of
EPOGEN(R) or Aranesp(R) shall be deemed made on the date of invoice to NMC
from an Authorized Wholesaler. Upon any termination of this Agreement,
Amgen shall pay to NMC all discounts and incentives earned by NMC through
the date of termination. Failure of NMC to qualify for or receive any
particular discount or incentive hereunder shall not automatically affect
its qualification for or receipt of any other discount or incentive
provided under this Agreement.
6. PAYMENT OF DISCOUNTS. Any discount (hereinafter defined as including a
discount at time of purchase, rebate, incentive or other concession
impacting the total pricing of a Product) earned hereunder which is
1
applicable to purchases of EPOGEN(R) shall be calculated in accordance with
this Agreement, based on Qualified Purchases, using the [*] as the basis
for the calculation price, and shall be paid in the form of a [*] to NMC's
corporate headquarters, except as otherwise provided hereunder. Any
discount earned hereunder which is applicable to purchases of Aranesp(R)
used to treat dialysis patients shall be calculated in accordance with this
Agreement, based on Qualified Purchases, using [*] as the basis for the
calculation price. NMC and Affiliates shall make available to Amgen any
records concerning NMC's and Affiliates' purchase amounts that Amgen or its
auditors may reasonably request for purposes of verifying discounts. [*] In
the event of a discrepancy between data provided by NMC and that provided
by an Authorized Wholesaler, verifiable data submitted by NMC shall be
used. Amgen will use its best efforts to make any discount (excluding
discounts at time of purchase) pursuant to this Agreement available in
accordance with the terms referenced in Appendix A. Availability of
discounts is contingent upon Amgen receiving all relevant purchase data
from all Authorized Wholesalers designated by NMC, in a form reasonably
acceptable to Amgen, detailing NMC's and Affiliates' Qualified Purchases of
Products for the relevant period, along with any other data required by the
terms of Appendix A. In the event of any purchases directly from Amgen, all
such purchase data shall be included in the calculation of all discounts.
In no event shall Amgen pay any discount on Products distributed by NMC or
Affiliates to non-Affiliates of NMC. In the event that Amgen is notified in
writing that National Medical Care, Inc. and/or any of its subsidiaries or
Affiliates (the "Acquiree") is acquired by another entity or a change of
control otherwise occurs with respect to the Acquiree, any discount or
rebate which may have been earned and vested hereunder prior to the
effective date of the acquisition shall be paid in the form of a [*] to
Fresenius Medical Care North America's corporate headquarters subject to
the conditions described herein.
7. TREATMENT OF DISCOUNTS. (a) The parties agree that they will account for
any discount or rebate earned hereunder in a way that complies with all
applicable federal, state, and local laws and regulations, including
without limitation, Section 1128B(b) of the Social Security Act and its
implementing regulations, and if required by such statutes or regulations
(1) claim the benefit of such discount received, in whatever form, in the
fiscal year in which such discount was earned or the year after, (2) 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, or a state
health care program, and (3) 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 by Amgen
concerning the amount or value of such discount. NMC agrees that it will
advise all Affiliates, in writing, of any discount received by NMC's
corporate headquarters hereunder with respect to purchases made by such
Affiliates and that NMC will advise said Affiliates as to their requirement
under the Agreement to account for any such discount in accordance with the
above stated requirements.
(b) In order to assist NMC in its compliance with its obligations as set
forth in Section 7(a) immediately above, Amgen agrees that, along with the
quarterly delivery of its payment of the discounts earned hereunder, it
will provide to NMC on a quarterly basis a statement stating the incentives
and discounts earned by NMC for such quarter.
8. [*]
9. OWN USE. NMC hereby certifies that Products purchased hereunder will be
for the "own use" by NMC and the Affiliates of NMC. NMC hereby further
certifies that all of the Products purchased hereunder shall be for the
exclusive use of treating dialysis patients.
10. AUTHORIZED WHOLESALERS. A complete list of NMC's and Affiliates' current
Authorized Wholesalers, through which NMC and Affiliates may purchase
Products hereunder is attached as Appendix C. NMC and Affiliates agree to
promptly provide Amgen with any additions, deletions, or changes to the
initial list of Authorized Wholesalers. Amgen requires no less than thirty
(30) days notice before the effective date of change for any addition or
deletion by NMC of Authorized Wholesalers hereunder. Any proposed changes by
NMC to the initial list of Authorized Wholesalers must be in writing by NMC
and are subject to reasonable approval by Amgen.
11. SUBSIDIARIES AND AFFILIATES. Attached as Appendix B is a current listing of
all Affiliates, and other entities, that will be participating in this
Agreement, designating which affiliates are owned and/or managed by
2
NMC. Affiliates listed in Appendix B, as so designated by NMC and approved
by Amgen, will be deemed "Affiliates" for the purposes of this Agreement.
Subsequent to approval and acceptance by Amgen, a list of Affiliates shall
be attached to this Agreement as Appendix B and incorporated herein. Only
those Affiliates approved by Amgen and referenced in Appendix B will be
eligible to participate under this Agreement. Any NMC managed Affiliate, or
other entity with an existing contract, may participate in either their
existing agreement with Amgen, or this Agreement, but not both. Each managed
Affiliate or entity must declare under which single Amgen contract it will
participate. Only Qualified Purchases under this Agreement will be used in
the calculation of pricing, discounts or other incentives under this
Agreement. NMC will notify Amgen monthly of changes to Appendix B., and the
effective date of change. Such effective date of change may not be earlier
than the date the notice is received by Amgen. Any proposed change to
Appendix B will be subject to the reasonable approval of Amgen based upon
Amgen's then current legal and contractual requirements, and such proposed
Affiliate's classification as a freestanding dialysis center or a home
dialysis support facility.
12. TERMINATION. If either party materially breaches this Agreement the other
party may terminate this Agreement upon thirty (30) days advance written
notice specifying the breach, provided that such breach remains uncured at
the end of the thirty (30) day period unless such breach is in violation of
state, federal, or other applicable laws. In the event that NMC materially
breaches any provision of this Agreement and the breach remains uncured for
thirty (30) days following Amgen's notice of such breach, Amgen shall have
no obligation to continue to offer the terms described herein or pay any
further unvested discounts to NMC. However, any rebates or discounts that
have been earned and vested at the time of termination shall still be paid
pursuant to the applicable terms of Appendix A.
13. CONFIDENTIALITY. Both Amgen and NMC agree that this Agreement represents
and contains confidential information which will not be disclosed to any
third party, or otherwise made public, without prior written authorization
of the other party, except where such disclosure is contemplated hereunder
or required by law or court order. In the event NMC believes it is
obligated to disclose any such information as required by law or court
order, NMC will provide Amgen with prior written notice and an opportunity
to seek a protective order and NMC shall furnish only that portion of the
information that its counsel advises is required to be disclosed by law.
Amgen acknowledges and agrees that NMC may file this Agreement as an exhibit
to its parents' periodic reports to the Securities and Exchange Commission.
14. WARRANTIES. 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 conflict with
or violate any of its of the 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 NMC specifically warrants and represents to Amgen
that it is authorized to execute this Agreement on behalf of and has the
power to bind NMC and the Affiliates to the terms set forth in this
Agreement. The parties executing this on behalf of Amgen and Amgen Inc.
specifically warrant and represent to NMC that they are authorized to
execute this Agreement on behalf of and have the power to bind Amgen and
Amgen Inc. to the terms set forth in this Agreement. Amgen warrants that the
Products purchased pursuant to this Agreement (a) are manufactured and
labeled in accordance with all applicable federal, state and local laws and
regulations pertaining to the manufacturing of the Products including
without limitation, the Federal Food, Drug, and Cosmetic Act and
implementing regulations, and meet all specifications for effectiveness and
reliability as required by the United States Food and Drug Administration,
and (b) when used in accordance with the directions on the labeling, are fit
for the purposes and indications described in the labeling. Amgen agrees
that it will promptly notify NMC once it determines that there has been any
material defect in any of the Products delivered to NMC.
15. GOVERNING LAW. This Agreement will be governed by the laws of the State of
Delaware and the parties submit to the jurisdiction of Delaware courts, both
state and federal.
3
16. 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 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 (Receipt verified
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 parties
as follows (or at such other addresses as the parties may notify each other
in writing):
If to NMC:
Fresenius Medical Care Holdings, Inc.
00 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attn: Xxxxxx XxXxxxx, Senior Vice President
Fax: 000-000-0000
with a copy to:
Fresenius Medical Care Holdings, Inc.
00 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attn: General Counsel
Fax: (000) 000-0000
If to Amgen:
Amgen USA Inc.
One Amgen Center Drive, M/S 37-2-B
Xxxxxxxx Xxxx, XX 00000-0000
Attn: Xxxx Xxxxxxxxxxx, Manager, Contract Administration
Fax: (000) 000-0000
with a copy to:
Amgen USA Inc.
One Amgen Center Drive, M/S 27-4-A
Xxxxxxxx Xxxx, XX 00000-0000
Attn: General Counsel
Fax: (000) 000-0000
If to Amgen, Inc.:
Amgen Inc.
One Amgen Center Drive, M/S 37-2-B
Xxxxxxxx Xxxx, XX 00000-0000
Attn: Xxxx Xxxxxxxxxxx, Manager, Contract Administration
Fax: (000) 000-0000
with a copy to:
Amgen Inc.
One Amgen Center Drive, M/S 27-4-A
Xxxxxxxx Xxxx, XX 00000-0000
Attn: General Counsel
Fax: (000) 000-0000
17. COMPLIANCE WITH HEALTH CARE PRICING AND PATIENT PRIVACY LEGISLATION AND
STATUTES; DATA USE AGREEMENT. (a) Notwithstanding anything contained herein
to the contrary, at any time following the enactment of any federal, state,
or local law, regulation, rule or interpretation that materially reforms,
4
modifies, alters, restricts, or otherwise affects the pricing of or
reimbursement available for any of the Products and/or results in material
increase in Aranesp usage in dialysis clinics in the United States,
including a reimbursement or use decision by Centers for Medicare and
Medicaid Services ("CMS"), either party may initiate good faith negotiations
to modify this Agreement as necessary. If the parties, after thirty (30)
days, are unable to agree upon such a modification, (i) either party may
terminate this Agreement immediately or (ii) Amgen may exclude any owned or
managed Affiliate(s) from participating in this Agreement unless such owned
or managed Affiliate(s) certifies in writing that they are, or will be,
exempt from the provisions of such enacted law, regulation, rule or
interpretation. Additionally, in order to assure compliance with any
existing federal, state or local statute, regulation or ordinance, Amgen
reserves the right, in its reasonable discretion, to exclude any owned or
managed Affiliates from the pricing, discount, and incentive provisions of
this Agreement. In the event there is a future change in Medicare, Medicaid,
or other federal or state statutes or regulations or in the interpretation
thereof, which renders any of the material terms of this Agreement unlawful
or unenforceable, this Agreement shall continue only if amended by the
parties as a result of good faith negotiations as necessary to bring the
Agreement into compliance with such statute and regulation.
(b) 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. NMC 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, [*]. If the parties in good faith determine that such
modification is not possible, the parties shall seek to modify the
Agreement in another manner acceptable to both parties. 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 anything contained herein to the contrary, this Agreement
is effective only as of the date the parties hereto execute a mutually
agreeable Data Use Agreement pursuant to which NMC may disclose a Limited
Data Set of patient information to Amgen (as specified in the Data Use
Agreement and which shall include, at a minimum, the data fields to be
received by Amgen in connection with this Agreement) for purposes of
Amgen's Research and Public Health analyses and NMC Health Care Operations.
Unless otherwise specifically defined in this Agreement, each capitalized
term used in this Section 17(c) shall have the meaning assigned to such
term by the Health Insurance Portability and Accountability Act codified
under 45 C.F.R. parts 160 and 164 ("HIPAA"). If NMC terminates the Data Use
Agreement for any reason, Amgen shall be entitled to terminate the
incentives described in Appendix A.
18. INSURANCE AND INDEMNITY. During the Term of this Agreement, Amgen shall
insure coverage of its obligations hereunder consistent with Amgen corporate
policy through such programs of self-insurance and/or policies of general
liability insurance through third-party carriers as Amgen shall determine in
its sole discretion. Amgen agrees to indemnify, defend and hold harmless NMC
and its Affiliates and their respective employees, officers and directors
from and against any and all liabilities, losses, claims, or costs,
including reasonable attorneys' fees, which result directly from Product
which 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 Federal Food, Drug and Cosmetic Act (the "FDC
Act"), or (iii) are prohibited from being introduced into interstate
commerce by Section 301 of the FDC Act or Section 351 of the Public Health
Service Act; provided that such indemnity shall not apply to claims arising
out of the negligent or willful actions or omissions of NMC or its agents,
employees, representatives, successors or assigns or due to defects in the
Product caused by persons other than Amgen which 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
claim, (b) Amgen shall have sole control of the defense and settlement
thereof, and (c) NMC
5
reasonably cooperates and gives Amgen all requested information and
reasonable assistance for such defense. Notwithstanding the foregoing, Amgen
shall not be liable for loss of profit or loss of use, incidental or
consequential damages arising out of any claim asserted by NMC under this
Agreement or otherwise. This paragraph sets forth NMC's sole indemnity
remedy for claims of Product defect, adulteration or misbranding.
19. [*]
20. DIRECT PURCHASE OF PRODUCTS. NMC may purchase XXXXXX(X) X00, 20,000U, 1mL
vials, NDC 00000-000-00 packaged as ten (10) vials per pack and four (4)
packs per case; S4, 4,000U, 1mL vials, NDC 00000-000-00 packaged as ten (10)
vials per pack and ten (10) packs per case; and Aranesp? 25 mcg, 1.0 mL
vials, NDC 00000-000-00 packaged as four (4) vials per pack and ten (10)
packs per case; 40 mcg, 1.0 mL vials, NDC 00000-000-00 packaged as four (4)
vials per pack and ten (10) packs per case; 60 mcg, 1.0 mL vials, NDC
00000-000-00 packaged as four (4) vials per pack and ten (10) packs per
case; 100 mcg, 1.0 mL vials, NDC 00000-000-00 packaged as four (4) vials per
pack and ten (10) packs per case; 200 mcg, 1.0 mL vials, NDC 00000-000-00
packaged as one (1) vial per pack and four (4) packs per case; 150mcg,
0.75mL single-use vials, NDC 00000-000-00 packaged as four (4) vials per
pack and ten (10) packs per case; 300mcg, 1.0mL single-use vials, NDC
00000-000-00 packaged as one (1) vial per pack and four (4) packs per case;
Aranesp(R) SingleJect(R) Prefilled Syringe 60 mcg, 0.3 mL (200 mcg/mL),
single-use syringe, NDC 00000-000-00 packaged as 4 syringes per pack; 10
packs per case; Aranesp(R) SingleJect(R) Prefilled Syringe 100 mcg, 0.5 mL
(200 mcg/mL), single-use syringe, NDC 00000-000-00 packaged as 4 syringes
per pack; 10 packs per case; Aranesp(R) SingleJect(R) Prefilled Syringe 200
mcg, 0.4 mL (500 mcg/mL), single-use syringe, NDC 00000-000-00, packaged as
1 syringe per pack; 4 packs per case; and Aranesp(R) SingleJect(R) Prefilled
Syringe 300 mcg, 0.6 mL (500 mcg/mL), single-use syringe, NDC 00000-000-00,
packaged as 1 syringe per pack; 4 packs per case (the "Direct Product") on a
direct basis from Amgen in accordance with the terms set forth in Appendix D
which is incorporated herein by reference.
21. DATA COLLECTION. NMC agrees all data to be provided to Amgen pursuant to
this Agreement shall be in a form that does not disclose the identity of any
patient or any other patient-identifying information such as name, address,
telephone number, birth date, all or part of a social security number,
medical record number or prescription number. NMC and Amgen agree to use and
accept only those patient identifiers compliant with HIPAA. Amgen and NMC
acknowledge and agree that the data to be supplied to Amgen pursuant to this
Agreement shall be used by Amgen solely to support verification of the
discounts and incentives referenced herein, as well as for Amgen-sponsored
research concerning the role of EPOGEN(R) in improving treatment outcomes
and quality of life of dialysis patients. Notwithstanding the foregoing or
any other provision of this Agreement, Amgen shall not obtain hereby any
legal title to any NMC data and shall not sell or sublicense any data
obtained hereunder. Any use by Amgen of such data shall be in a format that
will not identify NMC or any Affiliates as the source of such data. NMC
shall consistently use a unique alpha-numeric code (which shall not be the
same as part or all of the patient's social security number) 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 personnel. In furtherance of Amgen research,
NMC may agree from time to time to use its key to update the patient care
data by linking it with information concerning health outcomes, quality of
life, and other pertinent data that may become available to Amgen from other
sources. Any such linking of data sources shall not provide the identity of
any patient to Amgen. Amgen agrees it will maintain data supplied under this
Agreement in confidence and it will not use such data to identify or contact
any patient. No reports by Amgen concerning analyses of the data or the
results of such research shall disclose the identity of any patient. Nothing
in this Agreement shall limit NMC's use of its patient data, including
without limitation, any data to be supplied to Amgen hereunder. For purposes
of this Agreement, including Appendix A, NMC shall only be obligated to
provide Amgen data with respect to its "Permanent" patients, as such term is
defined in NMC's database. Generally, Permanent patients are those patients
for whom NMC is the primary provider of dialysis services.
22. ACCESS. Amgen and NMC agree that it and its agents and employees shall, at
all times, comply with all applicable laws and regulations.
6
23. MISCELLANEOUS. No modification of this Agreement shall be effective unless
mutually agreed upon, made in writing and signed by a duly authorized
representative of each party. This Agreement constitutes the entire
agreement of the parties pertaining to the subject matter hereof and
supersedes all prior written and oral agreements and understandings
pertaining hereto including without limitation, any previous or existing
contract, amendment, or agreement for the purchase of Products for use in
the treatment of dialysis patients. Neither party shall have the right to
assign this Agreement to a third party without the prior written consent of
the other party provided, however, that Amgen may assign this Agreement to
any of its subsidiaries or affiliates without the written consent of NMC.
Neither party shall be liable for delays in performance and nonperformance
of this Agreement or any covenant contained herein caused by fire, flood,
storm, earthquake or other act of God, war, terrorist acts, rebellion, riot,
failure of carriers to furnish transportation, strike, lockout or other
labor disturbances, act of government authority, inability to obtain
material or equipment, or any other cause of like or different nature beyond
the control of such party. The parties shall execute and deliver all
documents, provide all information, and take or refrain from taking action
as may be necessary or appropriate to achieve the purposes of this
Agreement. This Agreement may be executed in one or more counterparts, each
of which is deemed to be an original but all of which taken together
constitutes one and the same agreement. Upon expiration or early termination
of this Agreement, the rights and obligations set forth in Sections 5, 6, 7,
13,14, 18 and 22 shall survive such expiration or termination. In the event
that the outcomes data proves to not serve and yield the beneficial results
intended by both parties, Amgen and NMC will agree to meet, and negotiate in
good faith.
24. PRODUCT INTEGRITY. Amgen and NMC shall reasonably cooperate with each other
in connection with each party's efforts to ensure the genuineness and
integrity of Products purchased hereunder.
Please retain one fully executed original for your records and return the
other fully executed original to Amgen.
THE PARTIES EXECUTED THIS AGREEMENT AS OF THE DATES SET FORTH BELOW.
AMGEN USA INC.
Signature: /s/ XXXXXXX X. XXXXX
Print Name: Xxxxxxx X. Xxxxx
Print Associate Director
Title:
Date: 12/23/03
AMGEN INC.
Signature: /s/ XXXXX XXXXXX
Print Name: Xxxxx Xxxxxx
Print Vice President -- General Mgr.
Title:
Date: 1/6/04
NATIONAL MEDICAL CARE, INC.
Signature: /s/ XXXXXX X. XXXXXXX
Print Name: Xxxxxx X. XxXxxxx
Print Vice President Finance and
Title: Administration
Date: 12/23/03
7
APPENDIX A [*]
8
APPENDIX B: LIST OF NMC SUBSIDIARIES AND AFFILIATES
SUBSIDIARIES:
Bio-Medical Applications Management Co., Inc. and its subsidiaries
Dialysis America, Georgia, LLC.
Xxxxx, Inc.
Integrated Renal Care of the Pacific, LLC.
Renal Research Institute, LLC.
SRC Holding Company, Inc. and its subsidiaries
Everest Healthcare Holdings, Inc. and its subsidiaries
The Extracorporeal AllianceLLC
Fresenius Medical Care Cardiovascular Resources, Inc.
Fresenius Medical Care Pharmacy Services, Inc.
Fresenius USA Manufacturing, Inc.
d/b/a Nephromed and affiliates
AFFILIATES:
See Contract List Attached
9
APPENDIX C [*]
10
APPENDIX D: TERMS FOR PURCHASE OF DIRECT PRODUCT
Pursuant to Section 20 of the Agreement, the terms under which NMC may
purchase Direct Product on a direct basis from Amgen are as follows:
1. ORDERS/INVOICES. NMC shall place Direct Product orders with NMC
Distribution Center. NMC Distribution Center shall transmit orders and
receive corresponding invoices via electronic data interchange ("EDI") in a
format specified by Amgen.
Orders may be submitted via facsimile, mail, or telephone to the address
and telephone/fax numbers listed below. [*]
Amgen Customer Service may be reached at the following address and phone
numbers:
Amgen USA Inc.
Customer Service Department Fax: 0-000-000-0000
One Amgen Center Drive Tel: 0-000-000-0000
Xxxxxxxx Xxxx, XX 00000-0000
2. SHIPPING, TRANSPORTATION AND CHARGES. [*]
3. TITLE AND RISK OF LOSS. [*]
4. PRICING FOR DIRECT PRODUCT. [*]
5. TERMS OF PAYMENT. NMC Distribution Center agrees to pay [*] for Direct
Product ordered, at terms of [*].
6. CREDIT. NMC 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
Xxx Xxxxx Xxxxxx Xxxxx
Xxxxxxxx Xxxx, XX 00000-0000
If no audited financial statements are available, NMC Distribution Center
shall send unaudited financial statements which are certified by NMC
Distribution Center's principal financial officer as being accurate in all
material respects. Amgen shall not be obligated to ship Direct Product to
NMC Distribution Center if there are any amounts past due on NMC
Distribution Center's account or if NMC Distribution Center's outstanding
balance due exceeds NMC Distribution Center's predetermined credit limit.
NMC 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, NMC 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.
7. SALES DATA. NMC 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. NMC 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 NMC 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 NMC
Distribution Center, Amgen's sole recourse shall be to terminate the Direct
Product purchase components of this Agreement.
8. CONTRACTS AND CHARGEBACKS. NMC 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 NMC
Distribution Center. [*]. Adjustments or credits will be made in accordance
with Amgen's
11
Chargeback Policy (See Article One) attached hereto and incorporated
herein. NMC 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. NMC 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.
9. PRODUCT RETURNS. NMC Distribution Center shall comply with Amgen's Product
Return Policy (See Article Two) and all requirements of the Prescription
Drug Marketing Act of 1987 (as amended from time to time).
a. Returns by Customer to NMC Distribution Center
NMC Distribution Center shall notify Amgen of all Direct Product returned
to NMC Distribution Center in the form of a negative chargeback. This will
ensure that the proper adjustment is made to NMC Distribution Center's
account.
b. Returns by NMC Distribution Center to Amgen
Amgen shall only accept Direct Product returns from NMC Distribution Center
that have been pre-authorized by Amgen Customer Service. Direct Product
must be in original, unopened and undamaged cartons and returned within
twelve (12) months post expiration and must be in full compliance with
Amgen's Product Return Policy (See Article Two) attached hereto and
incorporated herein. Amgen will promptly issue credit to NMC Distribution
Center in accordance with Amgen's Product Return Policy.
c. Returns by Customer to Amgen
Amgen shall accept from Customer Direct Product returns that have been
pre-authorized by Amgen Customer Service. NMC Distribution Center agrees to
promptly issue credit to Customer returning Direct Product directly to
Amgen and for which Amgen has issued a credit memo to NMC Distribution
Center.
10. REBILLINGS AND ASSOCIATED CREDITS. NMC Distribution Center agrees to submit
to Amgen all Customer rebillings and associated credits in conformance with
Amgen's Chargeback Policy.
11. PRODUCT RECALL. In the event of a recall, Amgen will promptly notify NMC
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 NMC Distribution
Center for shipping of recalled Direct Product directly to Amgen. NMC
Distribution Center shall provide a list of Customer names and addresses to
Amgen who may have received recalled Direct Product. In consideration for
NMC Distribution Center's administrative expenses, Amgen will pay NMC
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. NMC Distribution Center shall
render its services and assist Amgen in returning all recalled Direct
Product to Amgen. Amgen shall provide reasonable compensation to NMC
Distribution Center per HDMA standards for additional services that may be
requested by Amgen. A credit memo will be issued to NMC Distribution Center
for all recalled Direct Product returned to Amgen. NMC 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 NMC
Distribution Center. NMC Distribution Center may call Amgen Customer Service
at 0-000-000-0000 for further instructions in the event of a recall.
12. APPLICABLE LAWS AND REGULATIONS. Amgen and NMC Distribution Center agree to
comply with all laws (local, state and federal) applicable to the purchase,
handling, sale, and distribution of Direct Product. NMC agrees to provide
Amgen with the statutory citation of all local and state laws and
regulations contemplated by this Section 12. 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
12
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.
13. DIVERSION. NMC Distribution Center shall distribute Direct Product only to
those approved Subsidiaries and Affiliates listed on Exhibit B. NMC
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 NMC Distribution Center has purchased Direct Product from
sources other than Amgen or distributed Direct Product to entities not
listed on Exhibit B.
13
APPENDIX E: LIST OF APPROVED DISTRIBUTION CENTERS
Fresenius USA Manufacturing, Inc.
d/b/a Nephromed and affiliates
00 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000-0000
14
ARTICLE ONE
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 NMC 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, NMC 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. NMC
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, NMC 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 NMC 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:
NMC Distribution Center must report its Customer returns as "negative" or
"reverse" chargebacks.
6. CREDITS AND REBILLS:
NMC Distribution Center shall submit simultaneously to Amgen the credits
and their associated rebills within sixty (60) calendar days after NMC
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 NMC 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.
15
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 NMC pursuant to Section 16 in the
Agreement.
ARTICLE TWO
PRODUCT RETURN POLICY
AUTHORIZATION:
Contact Amgen Customer Service Department at 000-000-0000 for proper
instructions and procedures for returning Direct Product.
RETURNABLE ITEMS:
- Expired Direct Product in full pack quantity with less than one-year
post expiration date.
- Direct Product received in error or damaged in transit.
NON-REFUNDABLE ITEMS: Although all Direct Product may be returned, no credit
will be issued for:
- Direct Product twelve (12) months or more post expiration date.
- Direct Product destroyed or damaged due to improper storage, heat, cold,
water, and smoke, left out of refrigeration or other conditions beyond
the control of Amgen.
- Direct Product destroyed or losses suffered in a natural disaster
(flood, hurricane, tornado, etc.).
- Direct Product obtained other than through normal channels of
distribution.
- Direct Product that is in unsaleable condition through no fault of
Amgen.
- Direct Product shipped as a "no charge" item.
- Unauthorized excess stock.
TRANSPORTATION CHARGES:
- Prepaid by Customer
TERMS OF RETURN POLICY:
- Credit, if applicable, for outdated Direct Product, will be based on
current price less fifteen percent (15%).
- No credit for shipping, handling and return processing fees.
- Amgen will not be responsible for any charges associated with third
party return processors.
- Pre-authorized excess stock returns will be credited at eighty percent
(80%) of the original purchase price.
- Direct Product ordered or received in error must be reported within ten
(10) business days of Direct Product receipt.
- Credit for indirect Customer, for outdated Direct Product, will be
issued in the form of a check by Capital Returns Inc. on behalf of
Amgen.
- Credit for direct Customer, for outdated Direct Product, will be issued
by Amgen in the form of a credit invoice.
- Unauthorized deductions from invoices are not allowed.
16
- All items are subject to credit approval by Amgen Customer Service.
THIRD PARTY RETURN PROCESSORS:
- For all outdated Direct Product, please forward return with detail
manifest directly to:
Capital Returns, Inc.
Attn: Amgen Return Goods
000 Xxxxx Xxxx Xxxxxxxxxx Xxxx
Xxxxxxxxx, XX 00000
COMPANY DISCLAIMER:
- Direct Product returned is subject to Amgen's and or Capital Returns'
evaluation at the time of receipt for final count and inspection.
- Amgen may, in its sole discretion, make exceptions, changes and/or
modifications to Returned Goods Policy.
17
EXHIBIT #1
SAMPLE CERTIFICATION LETTER
Month X, 2004
FSDC Legal Name
Xxxxxx Xxxxxxx
Xxxx, XX Xxx
RE: Agreement No. ____________
Dear ____________ :
Thank you for your participation in the [*] program. In order for us to
enroll you, we require that a duly authorized representative of your
organization sign the certification below.
Upon receipt of this executed document, we will calculate the value of your
incentive. If we do not receive the executed certification, we cannot provide
you with this incentive.
If you have any questions regarding this letter please contact me at [*].
Thank you for your assistance in returning this certification.
Sincerely,
---------------------------------------------------------
[*]
CERTIFICATION:
On behalf of FSDC Legal Name and all eligible Affiliates participating in
the [*] program under Agreement No. , the undersigned hereby certifies
that the data submitted for each eligible Affiliate includes the required
results from all dialysis patients of such Affiliate, and does not include
results from non-patients. The party executing this document also represents and
warrants that it (i) has no reason to believe that the submitted data is
incorrect, and (ii) is authorized to make this certification on behalf of all
eligible Affiliates submitting data.
FSDC LEGAL NAME
Signature: ---------------------------------------------
Print Name: ---------------------------------------------
Print ---------------------------------------------
Title:
Date: ---------------------------------------------
18
