Attached files
| file | filename |
|---|---|
| EX-32 - EXHIBIT 32 - AMGEN INC | amgn-ex32_2017331xq1.htm |
| EX-31 - EXHIBIT 31 - AMGEN INC | amgn-ex31_2017331xq1.htm |
| EX-10.16 - SECOND AMENDMENT TO THE EXECUTIVE INCENTIVE PLAN - AMGEN INC | amgn-ex1016_2017033110q.htm |
| 10-Q - 10-Q - AMGEN INC | amgn-2017331x10q.htm |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
SOURCING AND SUPPLY AGREEMENT
This Sourcing and Supply Agreement (this “Agreement”) is made by and between Amgen USA Inc. (“Amgen”), a wholly-owned subsidiary of Amgen Inc., and DaVita Inc. (“Dialysis Center”) to set forth the terms and conditions upon which Dialysis Center Purchasers shall purchase EPOGEN® (Epoetin alfa) and Aranesp® (darbepoetin alfa) and Amgen shall provide discounts and pay rebates to Dialysis Center on purchases of EPOGEN and Aranesp. Each of Amgen and Dialysis Center are referred to herein as a “Party” and together as the “Parties”. Amgen Inc. is a party to this Agreement for the purposes set forth in Sections 4.1, 8.2, 9.4, 9.5.1, and 11.14 of this Agreement.
RECITALS
WHEREAS, Amgen is a leading innovator in the field of ESAs with expertise in the field of anemia management and the ability to manufacture and supply ESAs for the treatment of dialysis patients;
WHEREAS, Dialysis Center is a leading provider of dialysis services in the Territory with expertise in delivering state-of-the-art care to patients undergoing dialysis;
WHEREAS, Amgen and Dialysis Center are parties to that certain Sourcing and Supply Agreement No. 00053958 (formerly known as Agreement No. 920110286) effective January 1, 2012, as amended by Amendment No. 1, effective January 1, 2013, pursuant to which Amgen agreed to supply, and Dialysis Center agreed to purchase, Amgen ESAs to meet Dialysis Center Purchasers’ requirements for Amgen ESAs for the treatment of dialysis patients for a seven-year term on the terms set forth therein (the “Original Agreement”);
WHEREAS, Amgen and Dialysis Center wish to extend the term of the Original Agreement by four years, by terminating the Original Agreement and entering into this Agreement to set forth the terms and conditions upon which Dialysis Center Purchasers will purchase, and Amgen will supply Amgen ESAs to meet Dialysis Center Purchasers’ requirements for Amgen ESAs for the treatment of dialysis patients for the six-year period commencing January 6, 2017; and
WHEREAS, the Parties wish to enter into this Agreement to set forth the terms and conditions upon which Dialysis Center Purchasers will purchase, and Amgen will supply Amgen ESAs to meet Dialysis Center Purchasers’ requirements for Amgen ESAs for the treatment of dialysis patients during the Term.
NOW THEREFORE, in consideration of the foregoing recitals and of the mutual promises and covenants set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, and intending to be legally bound, each Party hereby agrees as follows:
1. | TERMINATION OF EXISTING AGREEMENTS |
1.1. | Termination of Original Agreement. The Parties hereby agree that the Original Agreement is hereby terminated in its entirety and shall be of no further force or effect as of the Term Start Date, except for provisions that by their terms survive termination under the Sourcing and Supply Agreement No. 00053958. |
1.2. | Termination of Aranesp Agreement. The Parties hereby agree that the Dialysis Organization Agreement No. 00104122 entered into by the Parties, effective January 1, 2015, as amended by Amendment No. 1, effective March 30, 2016, is hereby terminated in its entirety and shall be of no further force or effect as of the Term Start Date, except for provisions |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
that by their terms survive termination under the Dialysis Organization Agreement No. 00104122.
2. | DEFINITIONS |
When used with initial capitals herein, the following terms shall have the meaning ascribed to them below:
2.1. | “Actual Supply Shortfall” has the meaning set forth in Section 3.4.2. |
2.2. | “Added Aranesp Dialysis Center Purchaser” means an Added Dialysis Center Purchaser that during the two Quarter period prior to the Added Dialysis Center Purchaser Effective Date had Aranesp utilization in its provision of Dialysis Services constituting more than [*] percent ([*]%) of its total utilization of ESAs based on the Aranesp-EPOGEN Dose Equivalency Ratio. |
2.3. | “Added Dialysis Center Purchaser” has the meaning set forth in Section 3.7.2. |
2.4. | “Added Dialysis Center Purchaser Effective Date” has the meaning set forth in Section 3.7.2. |
2.5. | “Added Dialysis Center Purchaser Transaction Date” means with respect to each Added Dialysis Center Purchaser: (a) in the case of a new Dialysis Center Affiliate that provides Dialysis Services, the effective date of the acquisition or establishment of the new Dialysis Center Affiliate that provides Dialysis Services; or (b) in the case of a new Managed Center, the earlier of (i) the effective date of the contract pursuant to which a dialysis facility becomes a Managed Center or (ii) the date Dialysis Center first provides services to a dialysis facility that results in such facility becoming a Managed Center, in each case after the Term Start Date. |
2.6. | “Administrator” has the meaning set forth in Section 9.2.1. |
2.7. | “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 direct or indirect ownership of more than [*] percent ([*]%) of the voting stock of an entity or, for non-stock entities, the direct or indirect right to more than [*] percent ([*]%) of the profits of such entity. |
2.8. | “Aggregate Alternative ESA Net Price” has the meaning set forth in Section 3.4.3.3. |
2.9. | “Alternative ESA” means an ESA that is available for use in the Territory that is not an Amgen ESA. |
2.10. | “Alternative Amgen ESA” has the meaning set forth in Section 3.4.3.2. |
2.11. | “Alternative Amgen ESA Cover” has the meaning set forth in Section 3.4.3.2.1. |
2.12. | “Alternative ESA Purchase Amount” has the meaning set forth in Section 3.1.4. |
2.13. | “Alternative ESA Purchase Event” has the meaning set forth in Section 3.1.3. |
2.14. | “Amgen Business Representative” has the meaning set forth in Section 5.1. |
2.15. | “Amgen ESA” means EPOGEN® (Epoetin alfa) and/or Aranesp® (darbepoetin alfa), as applicable. |
2.16. | “Amgen ESA Equivalent Quantity Shortfall” has the meaning set forth in Section 3.1.3. |
2.17. | “Amgen ESA Risk Evaluation Program” has the meaning set forth in Section 11.18. |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
2.18. | “Amgen ESAs Share of Sales” shall mean Committed Unit Purchases of Amgen ESAs during the Quarter divided by the sum of Committed Unit Purchases of Amgen ESAs and Committed Unit Purchases of Alternative ESAs during such Quarter. |
Amgen ESAs Share of Sales Illustration: |
Committed Unit Purchases of Amgen ESAs ÷ Committed Unit Purchases of Amgen ESAs + Committed Unit Purchases of Alternative ESAs |
2.19. | “Amgen Indemnitees” has the meaning set forth in Section 9.5.2. |
2.20. | “Amgen Shortfall Activities” has the meaning set forth in Section 3.4.1. |
2.21. | “Appeal Procedures” has the meaning set forth in Section 9.2.3. |
2.22. | “Aranesp” means Amgen’s proprietary darbepoetin alfa product that is marketed by Amgen in the Territory under the trademark Aranesp®. |
2.23. | “Aranesp-EPOGEN Dose Equivalency Ratio” shall be 1:270 where one mcg of Aranesp shall be deemed to be equivalent to 270 IUs of EPOGEN and 0.0037037 mcg of Aranesp shall be deemed to be equivalent to 1 IU of EPOGEN. |
2.24. | “Aranesp Fixed Price Rebate” means the rebate described in Section 2.2 of Exhibit A. |
2.25. | “Arbitration” has the meaning set forth in Section 9.2.1. |
2.26. | “Arbitrator” has the meaning set forth in Section 9.2.1. |
2.27. | “Authorized Removal Occurrence” has the meaning set forth in Section 3.7.3. |
2.28. | “Authorized Wholesalers” shall mean those wholesalers listed on Exhibit B, as such list may be modified pursuant to Section 3.6. |
2.29. | “Authorized Wholesaler List” has the meaning set forth in Section 3.6. |
2.30. | “Available Amgen ESA SKUs” have the meaning set forth in Section 3.3.8. |
2.31. | “Award” has the meaning set forth in Section 9.2.3. |
2.32. | “Base Invoice Discount” means the base invoice discount described in Section 1.1 of Exhibit A. |
2.33. | “Baseline Dose Equivalency Ratio” has the meaning set forth in Section 3.1.5. |
2.34. | “Best Net Aranesp Price Rebate” means the rebate described in Section 3.2 of Exhibit A. |
2.35. | “Best Net EPOGEN Price Rebate” means the rebate described in Section 3.3 of Exhibit A. |
2.36. | “Best Price” has the meaning set forth in Section 4.8. |
2.37. | “Business Representatives” has the meaning set forth in Section 5.1. |
2.38. | “Certification” has the meaning set forth in Section 6.3. |
2.39. | “Committed Unit Purchases of Amgen ESAs” means, for any period, the aggregate amounts in IUs of (i) EPOGEN purchased by all Dialysis Center Committed Purchasers, (ii) Aranesp (in equivalent IUs of EPOGEN using the Aranesp-EPOGEN Dose Equivalency Ratio) purchased by Added Aranesp Dialysis Center Purchasers that are Dialysis Center Committed Purchasers, and (iii) Aranesp (in equivalent IUs of EPOGEN using the Aranesp-EPOGEN Dose Equivalency Ratio) purchased by Dialysis Center Committed Purchasers [*] percent ([*]%) [*] (the "[*]"), during such period for use in providing Dialysis Services, net |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
of product returns and adjustments, which aggregate IUs data have been independently confirmed by Amgen through the Relevant Information. Any purchases of Amgen ESAs as a result of either notice of the Amgen ESA Equivalent Quantity Shortfall under Section 3.1.4 or notice of Forecast Shortfall under Section 3.3.4 shall not be considered to be Committed Unit Purchase of Amgen ESAs.
2.40. | “Committed Unit Purchases of Alternative ESAs” means, for any period, the aggregate amounts in IUs of (i) all Alternative ESAs [*] by any Dialysis Center Committed Purchaser for treatment of anemia in patients receiving Dialysis Services at any Dialysis Center Committed Purchaser from any source during such period, (provided, that any Alternative ESA provided to a Dialysis Center Committed Purchaser at no or nominal cost from any source shall be considered a purchase), adjusted to be an equivalent dose of EPOGEN (in IUs) based on the Alternative ESA’s FDA approved package insert (if the dose conversion ratio is clearly set forth therein) or otherwise as reasonably determined pursuant to Section 3.1.5, (ii) Aranesp (in equivalent IUs of EPOGEN using the Aranesp-EPOGEN Dose Equivalency Ratio) purchased by Dialysis Center Committed Purchasers [*] net of product returns and adjustments, which aggregate IUs data have been independently confirmed by Amgen through the Relevant Information. |
2.41. | “Compensation Data” has the meaning set forth in Section 7.1. |
2.42. | “Confidential Information” has the meaning set forth in Section 11.14. |
2.43. | “Data” means the data set forth on Schedule 1 provided by Dialysis Center to Amgen pursuant to the terms and conditions of Section 6. |
2.44. | “Debarred Party” has the meaning set forth in Section 10.2.2. |
2.45. | “Designated Affiliates” shall mean any Affiliate of Dialysis Center listed on Exhibit C, as such list may be modified pursuant to Section 3.7.1. |
2.46. | “Designated Affiliates List” has the meaning set forth in Section 3.7.1. |
2.47. | “Dialysis Center Business Representative” has the meaning set forth in Section 5.1. |
2.48. | “Dialysis Center Committed Purchasers” has the meaning set forth in Section 3.7.5. |
2.49. | “Dialysis Center Committed Purchasers List” has the meaning set forth in Section 3.7.5. |
2.50. | “Dialysis Center Indemnitees” has the meaning set forth in Section 9.5.1. |
2.51. | “Dialysis Center Purchasers” shall mean Dialysis Center, the Designated Affiliates, and the Managed Centers. Dialysis Center Purchasers include Added Dialysis Center Purchasers from and after the Added Dialysis Center Purchaser Effective Date. |
2.52. | “Dialysis Services” means services related to the provision of renal dialysis, including hemodialysis, peritoneal dialysis, nocturnal dialysis, and home hemodialysis in the Territory during the Term. For avoidance of doubt, “Dialysis Services” does not include the treatment of pre-dialysis chronic kidney disease. |
2.53. | “Disclosing Party” has the meaning set forth in Section 11.14. |
2.54. | “Discounts” means all rebates and discounts set forth on Exhibit A that may be earned by the Dialysis Center Purchasers pursuant to the terms and conditions set forth in this Agreement, which shall be earned, calculated and vested as provided in Exhibit A. |
2.55. | “Disputes” has the meaning set forth in Section 9.1. |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
2.56. | “Dose Equivalency Ratio” shall mean the ratio setting forth the IUs of an Alternative ESA that is equivalent to one (1) IU of EPOGEN based on its measured biological activity or effect as set forth in Section 3.1.5. |
2.57. | “Economic Interest” shall mean any [*] any entity that has [*] including, without limitation, any such [*] derived from a binding agreement related to (i) [*], or (ii) [*]; provided, however, it shall not be considered to be an Economic Interest [*] (A) Dialysis Center’s Affiliate, DaVita Rx, LLC [*] in the ordinary course of its pharmacy operations, (B) Dialysis Center’s Affiliate, DaVita Clinical Research, Inc. [*] in the ordinary course of its clinical operations [*], (C) Dialysis Center develops internal clinical protocols [*] by Dialysis Center Purchasers [*], or (D) Dialysis Center’s Affiliate, DaVita Medical Group [*] in the ordinary course of its medical operations, if, [*] (A), (B), (C) or (D) is [*] has an [*] interest [*]. |
2.58. | “EPOGEN” means Amgen’s proprietary Epoetin alfa product that is marketed by Amgen in the Territory under the trademark EPOGEN®. |
2.59. | “EPOGEN Fixed Price Rebate” means the rebate described in Section 2.3 of Exhibit A. |
2.60. | “ESAs” shall mean agents that stimulate erythropoiesis including, but not limited to, [*]. |
2.61. | “FDA” has the meaning set forth in Section 8.3. |
2.62. | “FDA Website” has the meaning set forth in Section 11.18. |
2.63. | “Firm” has the meaning set forth in Section 4.3.2. |
2.64. | “Forecast Shortfall” has the meaning set forth in Section 3.3.4. |
2.65. | “Forecast Shortfall Amount” has the meaning set forth in Section 3.3.4. |
2.66. | “Force Majeure Event” has the meaning set forth in Section 11.8. |
2.67. | “Governmental Authority” shall mean in respect of any individual or entity, any government administrative agency, commission or other governmental authority, body or instrumentality, or any federal, state, or local governmental regulatory body having legal jurisdiction over that individual or entity. |
2.68. | “Hearing” has the meaning set forth in Section 9.2.3. |
2.69. | “[*]” shall mean [*]. |
2.70. | “HIPAA” shall mean the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, each as may be amended. |
2.71. | “IMS” means IMS Health Incorporated, a Delaware corporation and its Affiliates. |
2.72. | “[*]” shall mean any [*] (i) [*] (ii) Dialysis Center, any Dialysis Center Purchaser or any Affiliate of Dialysis Center [*] (whether directly or through one or more intermediaries) [*] in the provision of Dialysis Services. |
2.73. | “Indemnified Party” has the meaning set forth in Section 9.6.1. |
2.74. | “Indemnifying Party” has the meaning set forth in Section 9.6.1. |
2.75. | “Individually Identifiable Health Information” shall have the meaning specified in HIPAA. |
2.76. | “Initial Dose Equivalency Ratio” has the meaning set forth in Section 3.1.5. |
2.77. | “IU” means an international unit of measurement for EPOGEN, Aranesp (in equivalent IUs of EPOGEN using the Aranesp-EPOGEN Dose Equivalency Ratio) or an Alternative ESA (in equivalent IUs of EPOGEN using the applicable Dose Equivalency Ratio). |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
2.78. | “Law” means, individually and collectively, any and all applicable laws, ordinances, rules, regulations, directives, administrative circulars, guidances and other pronouncements having the effect of law of any Governmental Authority. |
2.79. | “Liquidated Damages” has the meaning set forth in Section 10.3. |
2.80. | “Managed Center” shall mean a dialysis facility that is not an Affiliate of Dialysis Center but for which Dialysis Center or an Affiliate of Dialysis Center provides management services or administrative services in which it controls the selection or procurement of ESAs. |
2.81. | “Managed Centers List” has the meaning set forth in Section 3.7.1. |
2.82. | “Material Label Change” means a material amendment, change, revision, and/or modification to the Chronic Kidney Disease section of the Boxed Warning of the US prescribing information for an Amgen ESA as it relates to dialysis use. |
2.83. | “[*]” has the meaning set forth in [*]. |
2.84. | “Minimum Forecast Commitment” has the meaning set forth in Section 3.3.3. |
2.85. | “Mircera” means the methoxy polyethylene glycol-epoetin beta product that is marketed under the trademark Mircera®. |
2.86. | “Non-Disclosing Party” has the meaning set forth in Section 11.14. |
2.87. | “Notice of Added Dialysis Center Purchaser” has the meaning set forth in Section 3.7.2. |
2.88. | “Objection Notice” has the meaning set forth in Section 4.3.1. |
2.89. | “Party” and “Parties” have the meaning set forth in the preamble hereto. |
2.90. | “Permitted Excluded Group” has the meaning set forth in Section 6.6. |
2.91. | “Permitted Percentage Variances” has the meaning set forth in Section 3.3.5. |
2.92. | “Permitted Variance Period” has the meaning set forth in Section 3.3.5. |
2.93. | “Purchase Commitment” has the meaning set forth in Section 3.1.1. |
2.94. | “Purchase Commitment Percentage” shall be [*] percent ([*]%) [*] percent ([*]%) [*] percent ([*]%) [*]. |
2.95. | “Qualified Gross Purchases of Amgen ESAs” shall mean the amount of Amgen ESAs purchased by Dialysis Center Purchasers during the Term from an Authorized Wholesaler (or from Amgen pursuant to Section 3.6) for use in providing Dialysis Services, and confirmed by Amgen through sales tracking data including, without limitation, chargeback data from wholesalers. Qualified Gross Purchases of Amgen ESAs shall be calculated using the WAC in effect at the time of the relevant purchase, net of product returns and adjustments. |
2.96. | “Quarter” shall mean each calendar quarter during the Term (i.e., January 1 through March 31, April 1 through June 30, July 1 through September 30, and/or October 1 through December 31, as applicable). |
2.97. | “Recall” has the meaning set forth in Section 11.19. |
2.98. | “Relevant Information” means the Data, all sales tracking data, including, without limitation, chargeback data from wholesalers, Self-Reported Data, Compensation Data, and applicable Third Party reporting agency data. |
2.99. | “Research Study” has the meaning set forth in Section 6.6. |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
2.100. | “Rolling Forecast” has the meaning set forth in Section 3.3.1. |
2.101. | “Rolling Forecasts” has the meaning set forth in Section 3.3.1. |
2.102. | “Rules” has the meaning set forth in Section 9.2.1. |
2.103. | “Self-Reported Data” means all units of each ESA (including, but not limited to [*]), [*] by any Dialysis Center Purchaser for treatment of anemia in patients receiving Dialysis Services in any Dialysis Center Purchaser and the number of such patients who received each such ESA and such other related data as may be specified on Exhibit SR-1. |
2.104. | “Shortfall Amgen ESA” has the meaning set forth in Section 3.4.3.2. |
2.105. | “Significant Supply Shortfall” has the meaning set forth in Section 3.4.4. |
2.106. | “Study Patient” has the meaning set forth in Section 6.6. |
2.107. | “Supply Commitment” has the meaning set forth in Section 3.1.2. |
2.108. | “Term” means the period commencing on the Term Start Date and ending on the Term End Date. |
2.109. | “Term End Date” shall mean December 31, 2022. |
2.110. | “Term Start Date” shall mean January 6, 2017. |
2.111. | “Termination Date” means the date upon which this Agreement shall have been terminated in accordance with the terms and conditions of this Agreement pursuant to Section 10.2. |
2.112. | “Territory” means the United States, and its territories and possessions, including Puerto Rico. |
2.113. | “Third Party” means any individual or entity other than a Party or an Affiliate of a Party (or, in the case of Dialysis Center, a Managed Center). |
2.114. | “Third Party Claim(s)” has the meaning set forth in Section 9.5.1. |
2.115. | “[*]” has the meaning set forth in [*]. |
2.116. | “WAC” shall mean the list price for EPOGEN or Aranesp, as applicable, to wholesalers as established by Amgen in its sole discretion from time to time, not including prompt pay or other discounts, rebates, or reductions in price. |
2.117. | “Wind-Down Period” has the meaning set forth in Section 3.3.2. |
2.118. | “Wind-Down Price” has the meaning set forth in Section 3.3.2. |
3. | PURCHASE AND SUPPLY COMMITMENTS |
3.1. | Purchase and Supply Commitments. |
3.1.1. | Dialysis Center Purchase Commitment. Subject to the terms and conditions of this Agreement, the Dialysis Center Committed Purchasers in aggregate shall purchase from Amgen through one or more Authorized Wholesalers (or from Amgen pursuant to Section 3.6) those quantities of Amgen ESAs that are needed to meet an Amgen ESAs Share of Sales at least equal to the applicable Purchase Commitment Percentage during each Quarter of the Term (the “Purchase Commitment”). For purposes of clarity, the Purchase Commitment shall be measured in aggregate across all Dialysis Center Committed Purchasers. |
3.1.1.1. | The Parties acknowledge that it is their intent that the purchase and/or use of a [*] is not an arm’s length purchaser of a pharmaceutical product |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
in the ordinary course of providing Dialysis Services. If either Party believes that the application of the terms of this Agreement results [*] that is not consistent with this intent, then such Party may refer the matter to Arbitration for a determination of whether [*] based on the Parties’ intent.
3.1.2. | Amgen Supply Commitment. Subject to the terms and conditions of this Agreement, Amgen shall ensure that during each Quarter of the Term [*] percent ([*]%) of the Minimum Forecast Commitment for each such Quarter is available for purchase by the Dialysis Center Purchasers from one or more Authorized Wholesalers or from Amgen pursuant to Section 3.6 (the “Supply Commitment”). Subject to Section 3.2.2 and Section 3.3.6, Amgen acknowledges and agrees that nothing in this Agreement shall prohibit any Dialysis Center Committed Purchaser from purchasing an amount of Amgen ESAs necessary to satisfy the Purchase Commitment in a particular Quarter regardless of whether such Amgen ESAs are actually administered by the Dialysis Center Committed Purchasers to their patients for the provision of Dialysis Services during such Quarter. |
3.1.2.1. | [*] dialysis centers [*] and as a result, Amgen develops [*] percent ([*]%) [*] Committed Unit Purchases of Amgen ESAs during the prior Quarter which is reasonably likely to remain through the remaining Term of the Agreement (the “[*]”), the Parties shall meet in good faith to determine the [*] for purchase by Dialysis Center Purchasers in accordance with the Discounts set forth in Exhibit A. |
3.1.3. | Alternative ESA Purchase Event. If in any Quarter the Dialysis Center Committed Purchasers do not meet the Purchase Commitment (an “Alternative ESA Purchase Event”), then within thirty (30) days of the end of any such applicable Quarter, Dialysis Center shall provide notice to Amgen of such Alternative ESA Purchase Event and the Committed Unit Purchases of Alternative ESAs in such Quarter. If Dialysis Center provides such notice pursuant to this Section 3.1.3, or if Amgen, through the use of Relevant Information reasonably determines that there has been an Alternative ESA Purchase Event, then Amgen shall, within forty-five (45) days of Amgen’s receipt of the Self-Reported Data pursuant to Section 7.2, deliver to Dialysis Center a notice that sets forth the “Amgen ESA Equivalent Quantity Shortfall,” which shall be equal to the (1) difference between the applicable Purchase Commitment Percentage less Amgen ESA Share of Sales (if positive), multiplied by (2) the sum of Committed Unit Purchases of Amgen ESAs and Committed Unit Purchases of Alternative ESAs (in equivalent IUs of EPOGEN using the applicable Dose Equivalency Ratios). |
3.1.3.1. | In the event Dialysis Center has a reasonable basis to believe that any Amgen ESA Equivalent Quantity Shortfall calculation or determination made by Amgen is inaccurate or incomplete in any material respect, Dialysis Center shall provide an Objection Notice to Amgen within thirty (30) days of the notice of the Amgen ESA Equivalent Quantity Shortfall and the Parties shall follow the Audit Process set forth in Section 4.3 to resolve any dispute regarding the Amgen ESA Equivalent Quantity Shortfall. |
3.1.4. | Alternative ESA Purchase Amount. Within ninety (90) days of receipt by Dialysis Center of notice from Amgen of the Amgen ESA Equivalent Quantity Shortfall pursuant to Section 3.1.3 above, Dialysis Center shall make a binding purchase order from one or more Authorized Wholesalers (or from Amgen pursuant to Section 3.6), of Amgen ESAs in applicable Available Amgen ESA SKUs equal to the Amgen ESA Equivalent Quantity Shortfall and reasonably commensurate with those Amgen ESA SKUs included in the Minimum Forecast Commitment for the Quarter in which the Amgen ESA Equivalent Quantity Shortfall occurred, subject to the [*] in the Quarter in which |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
such purchase order is completed. Such purchase shall be eligible for the Discounts applicable during the Quarter in which the Alternative ESA Purchase Event occurred and shall be excluded from consideration as part of the Committed Unit Purchases of Amgen ESAs during the Quarter in which such purchase occurred. Dialysis Center shall promptly provide Amgen notice of the completion of such purchase order along with a copy of the invoice for such purchase order. In the event that Dialysis Center fails timely to complete such purchase order, Dialysis Center shall pay to Amgen within one hundred and five (105) days of receipt of the notice of the Amgen ESA Equivalent Quantity Shortfall pursuant to Section 3.1.3 above an amount equal to (a) the Amgen ESA Equivalent Quantity Shortfall multiplied by (b) WAC less the Discounts per IU of EPOGEN earned by Dialysis Center Committed Purchasers during the Quarter in which the Alternative ESA Purchase Event occurred (the “Alternative ESA Purchase Amount”). At Amgen’s option, any Alternative ESA Purchase Amount not so paid by Dialysis Center that is not the subject of an Objection Notice pursuant to Section 3.1.3.1 above may be offset in whole or in part against any Discounts earned by the Dialysis Center Purchasers in the applicable Quarter or any subsequent Quarter.
3.1.5. | Dose Equivalency Ratio. The Parties agree that for purposes of this Agreement the “Dose Equivalency Ratio” between (i) EPOGEN and Mircera is 223:1 such that 223 IUS of EPOGEN shall be considered equivalent to 1 mcg of Mircera, and (ii) the Dose Equivalency Ratio between EPOGEN and any biosimilar of EPOGEN is 1:1.10 such that 1.10 IUs of such biosimilar of EPOGEN shall be considered equivalent to 1 IU of EPOGEN. If a Party, in its reasonable discretion, feels that the Dialysis Center Committed Purchasers potentially may not meet the Purchase Commitment due to purchases of Alternative ESAs by the Dialysis Center Committed Purchasers in a Quarter for which the Dose Equivalency Ratio is not specified above, then Amgen and Dialysis Center shall mutually agree upon the appropriate methodology to be used to determine the dose (in IUs) of such Alternative ESA that was used by the Dialysis Center Committed Purchasers’ patients during the applicable measurement period that is equivalent to a dose (in IUs and/or mcg) of the applicable Amgen ESA that was used by the Dialysis Center Committed Purchasers patients’ during the applicable measurement period and Dialysis Center shall reasonably cooperate with Amgen and provide any other reasonable data, including units of ESAs utilized during the applicable measurement period, necessary to complete the determination. If Dialysis Center and Amgen are unable to agree upon the methodology to be used to determine the dose (in IUs) of such Alternative ESA, the Parties shall appoint a mutually agreeable Third Party to determine the methodology to be used, with the costs of such Third Party to be borne equally by the Parties. The initial Dose Equivalency Ratio for any such Alternative ESA as determined by either the Parties or the Third Party appointed by the Parties, as applicable, pursuant to this Section 3.1.5 (the “Initial Dose Equivalency Ratio”) shall only apply to the Quarter immediately preceding the Initial Dose Equivalency Ratio. The determination of the Dose Equivalency Ratio for each such particular Alternative ESA shall be recalculated for each of the first three (3) Quarters after the Initial Dose Equivalency Ratio for such Alternative ESA and the calculation of the Dose Equivalency Ratio for such Alternative ESA after each Quarter during such three (3) Quarters period shall only apply to the immediately preceding Quarter after each such recalculation. The Dose Equivalency Ratio for such Alternative ESA for all periods after such three (3) Quarter period shall be the Dose Equivalency Ratio determined as of the end of the third Quarter after the Initial Dose Equivalency Ratio for such Alternative ESA (the “Baseline Dose Equivalency Ratio”); provided, either Party may, no more frequently than once per calendar year, request a recalculation of the Baseline Dose Equivalency Ratio, which recalculation shall be applied prospectively, if such Party reasonably believes that the Baseline Dose |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
Equivalency Ratio has materially changed over time, in which event the requesting Party shall bear the costs of any Third Party appointed by the Parties in connection therewith.
3.2. | Eligible Purchases. |
3.2.1. | Purchases from Authorized Wholesaler. Only purchases of Amgen ESAs made by a Dialysis Center Purchaser from an Authorized Wholesaler or Amgen pursuant to Section 3.6 shall be eligible to receive the Discounts provided under this Agreement. |
3.2.2. | Own Use. The Dialysis Center Purchasers shall purchase Amgen ESAs under this Agreement solely for their own use in providing Dialysis Services, and only purchases made by Dialysis Center Purchasers for such use shall be eligible for the Discounts provided under this Agreement and shall be considered Committed Unit Purchases of Amgen ESAs. Dialysis Center on behalf of itself and each other Dialysis Center Purchaser covenants that none of them shall seek to procure any of the Discounts available under this Agreement for any purchases of Amgen ESAs not for its or their use in providing Dialysis Services, and Dialysis Center shall promptly notify Amgen in the event Amgen shall have provided any Dialysis Center Purchaser with any Discounts hereunder for any Amgen ESAs that were not used by them for the provision of Dialysis Services. |
3.3. | Quantity Forecasts and Minimum Forecast Commitment. |
3.3.1. | Rolling Forecast. Each Quarter during the Term, Dialysis Center shall submit in writing to Amgen a rolling twelve (12) month good faith forecast setting forth on a month-by-month basis the aggregate quantities in IUs of EPOGEN and a rolling eighteen (18) month good faith forecast setting forth on a month-by-month basis the aggregate quantities in mcg of Aranesp, each such forecast by Available Amgen ESA SKU required for all Dialysis Center Purchasers for each month in the forecast period, starting with an initial twelve (12) month forecast for EPOGEN beginning as of January 1, 2017 to December 31, 2017 which shall be the existing forecast for such period pursuant to the Original Agreement and an initial eighteen (18) month forecast for Aranesp beginning as of January 1, 2017 to June 31, 2018 which shall be delivered to Amgen within thirty (30) days of the Term Start Date (each, a "Rolling Forecast" and collectively the “Rolling Forecasts”). With the exception of the initial Rolling Forecast, Dialysis Center shall submit each Rolling Forecast by no later than the first day of the last month of each Quarter during the Term (e.g., by March 1, 2017 Dialysis Center shall submit a Rolling Forecast for the twelve (12) month period from April 2017 through March 2018 for EPOGEN and the eighteen (18) month period from April 2017 through September 2018 for Aranesp). If Dialysis Center has not timely delivered a Rolling Forecast as provided above, the Rolling Forecast previously in effect shall remain in effect for the periods covered thereby. The purpose of this Section 3.3.1 is to allow Amgen adequate time to adjust its manufacturing planning and operations to properly reflect the anticipated mix of Available Amgen ESA SKUs. |
3.3.2. | Wind-Down Period. The final Rolling Forecast shall reflect Dialysis Center Purchasers’ Amgen ESA requirements for the twelve (12) month period after the Term End Date (the “Wind-Down Period”). During the Wind-Down Period, Dialysis Center shall continue to submit Rolling Forecasts to Amgen and such Rolling Forecasts shall be subject to the Permitted Percentage Variance set forth below. During the Wind-Down Period, (i) Dialysis Center shall be obligated to purchase the Minimum Forecast Commitment of Amgen ESAs in accordance with the Discount terms set forth in Exhibit A, [*] (the “Wind-Down Price”) and (ii) Amgen |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
shall be obligated to supply the Minimum Forecast Commitment of Amgen ESAs at the Wind-Down Price. In no event shall the Purchase Commitment or the Supply Commitment apply during the Wind-Down Period.
3.3.3. | Minimum Forecast Commitment. Without reducing or limiting the Purchase Commitment set forth in Section 3.1.1, the forecasted quantities of each Available Amgen ESA SKU for months 1-3 of each Rolling Forecast shall constitute the Dialysis Center Purchasers’ aggregate minimum purchase commitment of IUs of EPOGEN and/or mcg of Aranesp by Available Amgen ESA SKU for such Quarter (the “Minimum Forecast Commitment”). Any forecasted quantity of (i) Available Amgen ESA SKUs that constitutes less than one and five-tenths of a percent (1.5%) of the forecasted quantities of total Amgen ESAs for that Quarter and (ii) any Available Amgen ESA SKUs of Aranesp if the aggregate quantity of mcg of Aranesp constitutes less than five percent (5%) of the forecasted quantities of total Amgen ESAs for that Quarter shall be excluded from the Minimum Forecast Commitment and shall not be subject to the Supply Commitment. |
3.3.4. | Forecast Shortfall. If the Dialysis Center Purchasers purchase an aggregate quantity in IUs or mcg of Amgen ESAs by Available Amgen ESA SKU during any Quarter that is less than the Minimum Forecast Commitment for any such Quarter (the quantity of any such difference, the “Forecast Shortfall”), then within forty-five (45) days of the end of such Quarter, Amgen shall notify Dialysis Center of the Forecast Shortfall in writing. In the event Dialysis Center has a reasonable basis to believe that any Forecast Shortfall calculation or determination made by Amgen is inaccurate or incomplete in any material respect, Dialysis Center shall provide Amgen an Objection Notice within thirty (30) days of the notice of Forecast Shortfall and follow the Audit Process set forth in Section 4.3 to resolve any dispute regarding the Forecast Shortfall. Within ninety (90) days of receipt by Dialysis Center of the notice of the Forecast Shortfall from Amgen, Dialysis Center shall make a binding purchase order from one or more Authorized Wholesalers (or from Amgen pursuant to Section 3.6), of Amgen ESAs in applicable Available Amgen ESA SKUs equal to the Forecast Shortfall and reasonably commensurate with those Amgen ESA SKUs included in the Minimum Forecast Commitment for the Quarter in which the Forecast Shortfall occurred, subject to the [*] in the Quarter in which such purchase order is completed. Such purchase shall be eligible for the Discounts applicable during the Quarter in which the Forecast Shortfall occurred and shall be excluded from consideration as part of the Committed Unit Purchases of Amgen ESAs during the Quarter in which such purchase occurred. Dialysis Center shall promptly provide Amgen notice of the completion of such purchase order along with a copy of the invoice for such purchase order. In the event that Dialysis Center fails timely to complete such purchase order, Dialysis Center shall pay to Amgen within one hundred and five (105) days of receipt of the notice from Amgen of the Forecast Shortfall an amount equal to (a) the Forecast Shortfall multiplied by (b) WAC less the Discounts per IU of EPOGEN or per mcg of Aranesp, as applicable, earned by Dialysis Center Committed Purchasers during the Quarter in which the Forecast Shortfall occurred (the “Forecast Shortfall Amount”). At Amgen’s option, any Forecast Shortfall Amount not so paid by Dialysis Center that is not the subject of an Objection Notice above may be offset in whole or in part against any Discounts earned by the Dialysis Center Purchasers in the applicable Quarter or any subsequent Quarter. |
3.3.5. | Forecast Variance. Each new Rolling Forecast submitted by Dialysis Center on a Quarterly basis pursuant to Section 3.3.1 may decrease (but not increase) quantities of each Available Amgen ESA SKU for new months 1-6, and may increase or |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
decrease quantities of each Available Amgen ESA SKU in the new months 7-12 for EPOGEN and in the new months 7-18 for Aranesp, each from the corresponding months in the immediately prior Rolling Forecast by the “Permitted Percentage Variance” in the table below. The Permitted Percentage Variance for the months of each Rolling Forecast (the “Permitted Variance Period”) are as follows:
Old Months | 4-6 | 7-9 | 10-12 | |||
New Months | 1-3 | 4-6 | 7-9 | 10-12 | ||
EPOGEN: Percentage Variance Permitted in New Forecast for New Months from Old Months (Same Calendar Months) in Prior Forecast | [*]% (decrease only) | [*]% (decrease only) | [*]% (decrease or increase) | Initial Rolling Forecast | ||
Old Months | 4-6 | 7-9 | 10-12 | 13-15 | 16-18 | |
New Months | 1-3 | 4-6 | 7-9 | 10-12 | 13-15 | 16-18 |
Aranesp: Percentage Variance Permitted in New Forecast for New Months from Old Months (Same Calendar Months) in Prior Rolling Forecast | [*]% (decrease only) | [*]% (decrease only) | [*]% (decrease or increase) | [*]% (decrease or increase) | [*]% (decrease or increase) | Initial Rolling Forecast |
If Dialysis Center submits a Rolling Forecast that contains a forecast that is not in compliance with the applicable Permitted Percentage Variance, Amgen shall have the right within thirty (30) days of receipt of such Rolling Forecast by written notice to Dialysis Center to either (a) accept such forecast for any month therein that is not in compliance with this Section 3.3.5; or (b) adjust such non-compliant forecasted quantity for any such month to increase or decrease the amount forecasted for such month by up to the minimum amount necessary to bring such forecasted quantity into compliance with this Section 3.3.5. Dialysis Center may, at any time for any good faith reason, request additional variances to the Permitted Percentage Variance and, in such event, the Parties shall work in good faith to accommodate such request; provided, however, that (i) in no event shall Amgen be liable for any resulting Actual Supply Shortfall and (ii) Dialysis Center shall remain liable for any Forecast Shortfall that may occur. If in any Quarter during the Term, the Dialysis Center Purchasers have a Forecast Shortfall and the Parties have determined, after good faith discussions, that such Forecast Shortfall is the necessary result of a Material Label Change, then the Dialysis Center Purchasers shall not be liable for such Forecast Shortfall.
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
3.3.6. | Maximum Forecast Commitment Increase. Notwithstanding any other provision of this Agreement, Dialysis Center may make a written request to Amgen to purchase additional quantities of Amgen ESAs for any Quarter in excess of [*] percent ([*]%) of the Minimum Forecast Commitment (the “Maximum Forecast Commitment Increase”) in accordance with the Discounts and pricing terms set forth in Exhibit A [*] percent ([*]%) [*]. Amgen shall not be obligated to supply any such request by Dialysis Center for the Maximum Forecast Commitment Increase and Amgen’s inability to meet Dialysis Center’s request for the Maximum Forecast Commitment Increase shall not be considered an Actual Supply Shortfall. |
3.3.6.1. | If the reason for the request for a Maximum Forecast Commitment Increase is that within the previous three (3) months of the request, [*] from the dialysis market and the Maximum Forecast Commitment Increase is for a quantity of Amgen ESAs [*] (such quantity less the amount of Amgen ESAs available in excess of the Maximum Forecast Commitment, [*] "[*]"), then for each of the four (4) Quarters commencing with the Quarter in [*], (i) any Alternative ESA Purchase Amount owed from Dialysis Center to Amgen pursuant to Section 3.1.4 with respect to such [*] shall not exceed [*] per Quarter and (ii) [*] shall not give rise to Amgen’s right to terminate this Agreement pursuant to Section 10.2.1. |
3.3.7. | Good Faith Estimates. Each Rolling Forecast submitted by Dialysis Center shall represent good faith estimates of the Dialysis Center Purchasers’ actual anticipated purchases of Amgen ESAs for the treatment of dialysis patients in the Territory and reasonable inventory requirements for Amgen ESAs in the Territory during the relevant timeframes. |
3.3.8. | Available Amgen ESA SKUs. The Available Amgen ESA SKU Schedule attached as Schedule 3 hereto sets forth the “Available Amgen ESA SKUs” as of the Term Start Date. Amgen may add Available Amgen ESA SKUs to, or remove Available Amgen ESA SKUs (with respect to all purchasers of Amgen ESAs for free-standing dialysis clinics) from, the Available Amgen ESA SKUs Schedule upon at least six (6) months advance written notice to Dialysis Center; provided, that Amgen may not remove any Available Amgen ESA SKUs from the Available Amgen ESA SKUs Schedule that accounted for five percent (5%) or more of the Qualified Gross Purchases of Amgen ESAs during the immediately preceding three (3) Quarters without the prior written consent of Dialysis Center, which consent may be withheld by Dialysis Center in its sole discretion, unless there is an Available Amgen ESA SKU that corresponds to the same dosage, size and potency of the deleted Available Amgen ESA SKU; and provided further, that, notwithstanding the foregoing, Amgen may immediately remove any Available Amgen ESA SKU should Amgen determine, in its sole discretion, that the removal of any such Available Amgen ESA SKU is for safety or quality or similar reasons. The Parties shall mutually agree upon (a) the first period for which any such new Available Amgen ESA SKU may be ordered by the Dialysis Center Purchasers and (b) any permitted adjustments to the Amgen ESA SKU mix contained in Dialysis Center's then applicable Rolling Forecast to reflect any changes in the Available Amgen ESA SKUs or as otherwise may be required due to any production shortfall applicable to all Amgen ESA customers. |
3.4. | Supply Commitment Shortfalls. |
3.4.1. | Amgen Shortfall Activities. Dialysis Center shall promptly notify Amgen and the Amgen Business Representative if the Authorized Wholesalers do not have sufficient quantities of (i) EPOGEN in the aggregate to meet firm purchase orders |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
from the Dialysis Center Purchasers that are within the quantity of EPOGEN that constitutes the Minimum Forecast Commitment for that month or (ii) Aranesp in the aggregate to meet firm purchase orders from the Dialysis Center Purchasers that are within the quantity of Aranesp that constitutes the Minimum Forecast Commitment for that month, setting forth in such notice the aggregate amount of each such Amgen ESA that the Authorized Wholesalers are unable to supply. Within seven (7) business days after receipt of such notice from Dialysis Center, Amgen shall use commercially reasonable efforts to (i) deliver to the Authorized Wholesalers additional amounts of Amgen ESAs, (ii) direct Dialysis Center to one or more Authorized Wholesalers or other wholesalers that have stock of Amgen ESAs and/or (iii) make other arrangements with Dialysis Center to provide shipment of Amgen ESAs to Dialysis Center (the “Amgen Shortfall Activities”).
3.4.2. | An “Actual Supply Shortfall” shall mean, after taking into account Amgen ESAs identified or made available through Amgen Shortfall Activities, there is not available a quantity of (i) EPOGEN that is part of the Minimum Forecast Commitment for a particular month and constitutes [*] percent ([*]%) or more of the aggregate quantities in IUs (calculated using the Aranesp-EPOGEN Dose Equivalency Ratio) of Amgen ESAs that form the Minimum Forecast Commitment for such month or (ii) Aranesp that is part of the Minimum Forecast Commitment for a particular month and constitutes [*] percent ([*]%) or more of the aggregate quantities in IUs (calculated using the Aranesp-EPOGEN Dose Equivalency Ratio) of Amgen ESAs that form the Minimum Forecast Commitment for such month. |
3.4.3. | Supply Disruption Notice. To the extent permitted by Law and Amgen’s internal quality and compliance policies and procedures, Amgen shall provide Dialysis Center with written notice of anticipated supply disruptions for Amgen ESAs that would impact the Minimum Forecast Commitment. |
3.4.3.1. | Non-Discrimination and Priority. Subject to any existing obligations that Amgen or any Affiliate of Amgen may have, Amgen shall give Dialysis Center Purchasers’ orders first priority among dialysis center purchasers when allocating available Amgen ESAs during an Actual Supply Shortfall. |
3.4.3.2. | Amgen ESA Cover Purchases. If there is limited availability of an Amgen ESA during an Actual Supply Shortfall (the “Shortfall Amgen ESA”) and another Amgen ESA (the “Alternative Amgen ESA”) is available, then Dialysis Center Purchaser shall purchase the Alternative Amgen ESA, pursuant to the following process: |
3.4.3.2.1. | Within fifteen (15) days of notice from Dialysis Center of an Actual Supply Shortfall, Amgen will send Dialysis Center Purchasers written notice of the quantities (in mcg or IUs as the case may be) of the Alternative Amgen ESA available (“Alternative Amgen ESA Cover”). The Parties will meet and negotiate in good faith to set the date by which Dialysis Center Purchasers (as determined by Dialysis Center in its sole discretion) will convert to ordering the Alternative Amgen ESA Cover, which shall be as soon as reasonably practicable. |
3.4.3.2.2. | When the Actual Supply Shortfall ends, Dialysis Center may, in its sole discretion, either (i) continue to purchase Alternative Amgen ESA Cover for the converted Dialysis Center Purchasers or (ii) resume purchasing the Shortfall Amgen ESA for such Dialysis Center Purchasers. |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
3.4.3.2.3. | For all purchases of Aranesp that constitute Alternative Amgen ESA Cover Purchases by Dialysis Center Purchasers and for the remainder of the Term, (i) the [*] shall not apply to such volumes of Aranesp purchased by Dialysis Center Purchasers, and (ii) the price for Aranesp as the Alternative Amgen ESA Cover shall be equal to the EPOGEN price available under Exhibit A converted using the Aranesp-EPOGEN Dose Equivalency Ratio. |
3.4.3.3. | Alternative ESA Cover Purchases. If Amgen is unable to supply an Alternative Amgen ESA in accordance with Section 3.4.3.2 above, Dialysis Center shall use good faith efforts to procure any Alternative ESAs from a Third Party at the lowest commercially reasonable price. Dialysis Center shall deliver to Amgen a statement setting forth the aggregate net purchase price (i.e., the aggregate list price less all applicable discounts, rebates, chargebacks and other price adjustments) actually paid by the Dialysis Center Purchasers to any such Third Party for that quantity of Alternative ESAs purchased by such Dialysis Center Purchasers during the Quarter in which the Actual Supply Shortfall occurs solely as a substitute for the Actual Supply Shortfall (the “Aggregate Alternative ESA Net Price”); provided, that, should Dialysis Center be subject to any confidentiality restrictions that Dialysis Center may have with any Third Party from which it procured Alternative ESAs, then the Parties agree to send such Aggregate Alternative ESA Net Price to the Firm to be verified. Amgen shall pay to Dialysis Center an amount of cash equal to the difference, if any, between (a) the Aggregate Alternative ESA Net Price and (b) the product of (i) (1) WAC in effect for the applicable Quarter of the Actual Supply Shortfall less (2) the Discounts per IU or mcg, as applicable, of Available Amgen ESA SKU earned by the Dialysis Center Purchasers in such Quarter, multiplied by (ii) the amount of the Actual Supply Shortfall. |
3.4.4. | A “Significant Supply Shortfall” shall mean there has been an Actual Supply Shortfall of Amgen ESAs in a Quarter equal to or greater than [*] percent ([*]%) of the aggregate quantities in IUs (calculated using the Aranesp-EPOGEN Dose Equivalency Ratio) of Amgen ESAs that constitute the Minimum Forecast Commitment for such Quarter. |
3.4.5. | Purchase Commitment Reduction/Suspension and Remedies. For any Quarter that is part of an Actual Supply Shortfall, the Purchase Commitment for the applicable Quarter shall be reduced by the amount of the Actual Supply Shortfall less the Alternative Amgen ESA Cover and shall remain so reduced for a period of sixty (60) days after completion of the Actual Supply Shortfall. Each time there is a Significant Supply Shortfall for [*] then, [*] percent ([*]%) commencing with the Quarter immediately following such second Quarter in which there is a Significant Supply Shortfall. The foregoing shall be the sole remedy for any Actual Supply Shortfall or any Significant Supply Shortfalls except as set forth below. |
3.4.5.1. | If there is a Significant Supply Shortfall for [*] during which Alternative Amgen ESAs and/or Alternative ESAs are available, Dialysis Center shall not be required to comply with the dispute resolution requirements set forth in Section 9.1 and may proceed directly to Arbitration pursuant to Section 9.2, and in addition, may exercise any and all rights and remedies provided for in this Agreement or that may be allowed at law or in equity, including, |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
without limitation, requests for specific performance; provided, that Dialysis Center may not terminate the Agreement, unless such termination is permitted pursuant to an Award of the Arbitrator.
3.4.5.2. | If there is (i) a Significant Supply Shortfall for [*] or (ii) an Actual Supply Shortfall of Amgen ESAs [*] percent ([*]%) of the aggregate quantities in IUs (calculated using the Aranesp-EPOGEN Dose Equivalency Ratio) of Amgen ESAs that constitute the Minimum Forecast Commitment for [*] during which (i) or (ii), [*] Dialysis Center shall not be required to comply with the dispute resolution requirements set forth in Section 9.1 and may proceed directly to Arbitration pursuant to Section 9.2, and in addition, may exercise any and all rights and remedies provided for in this Agreement or that may be allowed at law or in equity, including, without limitation, requests for specific performance; provided, that Dialysis Center may not terminate the Agreement, unless such termination is permitted pursuant to an Award of the Arbitrator. |
3.4.6. | Response to Actual Supply Shortfall. Amgen shall work in good faith to address and end any Actual Supply Shortfall as soon as possible and will use commercially reasonable efforts to make available additional manufacturing capacity. |
3.5. | WAC. The Dialysis Center Purchasers shall purchase Amgen ESAs from an Authorized Wholesaler (or from Amgen pursuant to Section 3.6) at the then-prevailing WAC (subject to any wholesaler markup, discount, services fees or other charges), and any Discounts shall be applied in accordance with the schedules and terms set forth in Exhibit A and this Agreement. Amgen reserves the right to change WAC at any time, by any amount, without notice. Subsequent to any WAC changes, Amgen shall promptly notify Dialysis Center. |
3.6. | Authorized Wholesalers. Prior to the Term Start Date, Dialysis Center shall select one or more Authorized Wholesalers from the Authorized Wholesaler list prepared by Amgen and set forth on Exhibit B (as such list may be amended from time to time as provided in this Agreement, the “Authorized Wholesaler List”), and only such selected Authorized Wholesalers shall be Authorized Wholesalers for purposes of this Agreement. From and after the Term Start Date, Dialysis Center shall have the right to change its selection of Authorized Wholesalers from the Authorized Wholesaler List with ninety (90) days prior written notice to Amgen. Dialysis Center may request Amgen to add wholesalers to the Authorized Wholesaler List, and Amgen, at its sole discretion, shall have the right to determine whether to approve of such addition to the Authorized Wholesaler List. Amgen shall have the right to add or remove wholesalers from the Authorized Wholesaler List set forth on Exhibit B in the exercise of its commercially reasonable discretion by ninety (90) days prior written notice to Dialysis Center, provided, that, for any removal, (a) Amgen removes such Authorized Wholesaler with respect to providing Amgen ESAs to all purchasers of Amgen ESAs for free standing dialysis clinics, or (b) such Authorized Wholesaler requests Amgen to remove it as an Authorized Wholesaler for Dialysis Center Purchasers. In the event of any removal of an Authorized Wholesaler from the Authorized Wholesaler List by Amgen, Amgen shall work with Dialysis Center to transition the Dialysis Center Purchasers’ purchases of Amgen ESAs to an alternative Authorized Wholesaler, and if no alternative Authorized Wholesaler exists at such time, the Parties shall use reasonable efforts to establish a direct purchasing relationship in any interim period between the removal of the removed Authorized Wholesaler and the initiation of purchases from a new Authorized Wholesaler, if no Authorized Wholesaler exists at such time. Any such direct purchasing relationship shall be subject to credit qualification and the approval by Amgen of an application for direct ship account. If the Dialysis Center Purchasers purchase Amgen ESAs directly from Amgen as contemplated in this Section 3.6, all purchases of |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
Amgen ESAs made from Amgen by such Dialysis Center Purchasers shall be deemed Qualified Gross Purchases of Amgen ESAs and eligible for the Discounts.
3.7. | Dialysis Center Purchasers |
3.7.1. | Designated Affiliates and Managed Centers. Only the Designated Affiliates listed on Exhibit C (as such list may be amended from time to time as provided in this Agreement, the “Designated Affiliates List”) and the Managed Centers set forth on Exhibit D (as such list may be amended from time to time as provided in this Agreement, the “Managed Centers List”) shall be Dialysis Center Purchasers for purposes of this Agreement. Dialysis Center shall promptly update and maintain the accuracy of the Designated Affiliates List and the Managed Centers List throughout the Term, but in no event later than thirty (30) days after the addition or removal of a Dialysis Center Purchaser pursuant to Section 3.7.2 or 3.7.3 below. Dialysis Center shall not acquire, divest, restructure, reorganize or reclassify its Affiliates or Managed Centers, or request any addition or removal of any Dialysis Center Purchaser, with the purpose or intent in whole or in part to avoid or eliminate its obligations or commitments, or the obligations and commitments of each of the Dialysis Center Purchasers set forth in this Agreement. |
3.7.2. | Addition of Dialysis Center Purchasers. After the Term Start Date, subject to the terms and conditions of this Agreement, all new Affiliates that provide Dialysis Services and Managed Centers in the Territory shall be added to this Agreement and become Dialysis Center Purchasers. Dialysis Center shall provide written notice to Amgen of each new Affiliate that provides Dialysis Services and Managed Center in the Territory (each a “Notice of Added Dialysis Center Purchaser”), which notice shall include the proposed Added Dialysis Center Purchaser Transaction Date, plus any additional information regarding the proposed Dialysis Center Purchaser that Amgen shall reasonably request. Subject to the terms and conditions of Section 3.1.1 with respect to the Purchase Commitment, the Designated Affiliates List and the Managed Centers List shall be amended to include such Affiliates that provide Dialysis Services or Managed Centers effective as of (i) thirty (30) days from the date of Amgen’s receipt of a Notice of Added Dialysis Center Purchaser or (ii) the applicable Added Dialysis Center Purchaser Transaction Date if such Added Dialysis Center Purchaser Transaction Date is later than thirty (30) days after the Notice of Added Dialysis Center Purchaser (each such effective date, the “Added Dialysis Center Purchaser Effective Date”, and each of the Affiliates that provide Dialysis Services and Managed Centers added by such amendments, an “Added Dialysis Center Purchaser”). The Designated Affiliates List and the Managed Centers List shall be amended without further action required of the Parties to reflect additions made in accordance with this Section 3.7.2. |
3.7.3. | Removal of Dialysis Center Purchasers. (A) Dialysis Center may remove Designated Affiliates from the Designated Affiliates List and Managed Centers from the Managed Center List only (i) upon the written consent of Amgen, which consent shall not be unreasonably withheld, conditioned, and/or delayed or (ii) upon thirty (30) days prior written notice to Amgen in the event such removal is a result of a (a) sale of all or substantially all of the assets or equity interests of a Designated Affiliate to a Third Party, whether by reorganization, merger, sales of assets, or sale of equity interests, (b) permanent closure of a Designated Affiliate facility or (c) termination of the relevant management agreement for a Managed Center that has ceased its management relationship with Dialysis Center and/or any Affiliate of Dialysis Center (each of the events described in this clause (ii), an “Authorized Removal Occurrence”). Dialysis Center shall provide Amgen written notice |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
describing the nature of any requested removal, including the anticipated effective date of any Authorized Removal Occurrence, and such removal shall be effective thirty (30) days after Amgen has provided Dialysis Center with written consent to such removal or such earlier period as may be agreed to by Amgen or, in the event of an Authorized Removal Occurrence, the effective date of the Authorized Removal Occurrence.
(B) Amgen shall also have the right to remove any Designated Affiliates from the Designated Affiliates List and any Managed Centers from the Managed Centers List upon ninety (90) days (or such shorter /period as may be required by Law or any Governmental Authority) written notice to Dialysis Center (a) that such removal is required by order of a court or Governmental Authority or (b) in instances in which Amgen determines, in its reasonable discretion, that such removal is required (i) to comply with Law, based on the advice of counsel and subject to Section 3.7.5.1, or (ii) as a result of any such Designated Affiliate’s or Managed Center’s negligence or willful misconduct in the use or administration of Amgen ESAs.
(C) The Designated Affiliates List and the Managed Centers List shall be amended without further action required of the Parties to reflect removals made in accordance with this Section 3.7.3.
3.7.4. | Adjustments to Rolling Forecast. Following the addition or removal of an Affiliate that provides Dialysis Services to or from the Designated Affiliates List or a Managed Center to or from the Managed Centers List, the Parties shall mutually agree in good faith to implement any reasonable and necessary adjustments to the Rolling Forecast to account for such addition or removal of an Affiliate that provides Dialysis Services to or from the Designated Affiliates List or a Managed Center to or from the Managed Centers List; provided, that unless otherwise agreed to by the Parties pursuant to Section 3.3.5, Amgen shall have no obligation under Section 3.4 for an Actual Supply Shortfall in the event that any increase to the quantities of each Available Amgen ESA SKU set forth in such adjusted Rolling Forecast is in excess of the applicable Permitted Percentage Variances. |
3.7.5. | Dialysis Center Committed Purchasers List. The Dialysis Center Purchasers as of the Term Start Date shall constitute the initial list of “Dialysis Center Committed Purchasers” as listed on Exhibit E (as such list may be amended from time to time as provided in this Agreement, the “Dialysis Center Committed Purchasers List”). Each new Affiliate that provides Dialysis Services and Managed Center shall automatically be added to the Dialysis Center Committed Purchasers List as of the ninetieth (90th) day after the Added Dialysis Center Purchaser Transaction Date. Notwithstanding the foregoing sentence, if, during the two Quarter period prior to the Added Dialysis Center Purchaser Effective Date, such Added Dialysis Center Purchaser had utilization of Alternative ESAs in its provision of Dialysis Services constituting more than [*] percent ([*]%) of its total utilization of ESAs based on the Dose Equivalency Ratios, then such Added Dialysis Center Purchaser shall not be a Dialysis Center Committed Purchaser until the date that is twelve months following the Added Dialysis Center Committed Purchaser Transaction Date. Any Dialysis Center Purchaser removed from the Designated Affiliates List or the Managed Center List in accordance with Section 3.7.3 shall automatically be removed from the Dialysis Center Committed Purchaser List and shall not be subject to the Purchase Commitment as of the effective date of such removal from the Designated Affiliates List or the Managed Center List. |
3.7.5.1. | In accordance with Section 3.7.3(B)(b)(i), based on the advice of counsel, Amgen shall have the right in its reasonable discretion to add or remove any Dialysis Center Purchasers from the Dialysis Center Committed Purchasers List |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
upon at least ninety (90) days’ written notice to Dialysis Center, effective as of the first day of the Quarter after the expiration of the ninety (90) day notice period; provided, that Amgen shall work together with Dialysis Center to mutually agree as to the specific Dialysis Center Purchasers that will be added or removed and, in the event the Parties are unable to agree in a reasonable time, Amgen shall add or remove specific Dialysis Center Purchasers designated by Dialysis Center that typically purchase an aggregate volume of ESAs as specified by Amgen and that are not disproportionate in their use of Alternative ESAs compared to all Dialysis Center Purchasers. For avoidance of doubt, any Dialysis Center Committed Purchaser that is removed from the Dialysis Center Committed Purchasers List but remains on the Designated Affiliates List or the Managed Center List shall still be considered a Dialysis Center Purchaser such that such Dialysis Center Committed Purchaser removed from the Dialysis Center Committed Purchasers List in accordance with this Section 3.7.5.1 shall not be subject to the Purchase Commitment but shall continue to receive Discounts under this Agreement. Once a Dialysis Center Purchaser is removed from the Dialysis Center Committed Purchasers List, Amgen shall provide Dialysis Center with ninety (90) days’ notice if it intends to add such Dialysis Center Purchaser back on to the Dialysis Center Committed Purchaser List.
3.7.6. | Access to Dialysis Center Facilities. Amgen and its employees and/or agents shall have access during normal business hours to the Dialysis Center Purchasers’ facilities subject to Amgen and its employees’ and/or agents’ full compliance with all of Dialysis Center’s applicable policies and procedures regarding visitors and any updates thereto that will be in effect during the Term are and will be available for viewing by Amgen and its employees and/or agents during the Term at http://www.davita.com/about/vendor-policies. Amgen covenants and agrees that neither it nor any of its employees and/or agents shall have the right to access to any Individually Identifiable Health Information while accessing any of the Dialysis Center Purchasers’ facilities. |
3.7.7 | Marketing of Amgen ESAs |
3.7.7.1. | Amgen represents and warrants to Dialysis Center that during the Term of this Agreement, neither Amgen, nor any of its agents or representatives, including, without limitation, Amgen’s commercial representatives, [*] in the Territory for Amgen ESAs for Dialysis Services [*]. In the event that Dialysis Center has a reasonable basis to believe that Amgen has not complied with its obligations under this Section 3.7.7.1, Dialysis Center shall [*]. |
4. | DISCOUNTS |
4.1. | Earning, Calculating, Payment and Vesting of Discounts. All Discounts will be earned, calculated and vested as set forth in Exhibit A. For purposes of calculating the Discounts hereunder, Qualified Gross Purchases of Amgen ESAs by any Dialysis Center Purchaser shall be deemed to be made on the date of invoice by an Authorized Wholesaler or Amgen pursuant to Section 3.6 to any such Dialysis Center Purchaser. The Discounts (other than the Base Invoice Discounts) shall be paid in arrears by electronic funds transfer using information provided to Amgen by Dialysis Center as necessary to enable payment. Amgen Inc. hereby guarantees Amgen’s obligations to pay all Discounts earned by Dialysis Center hereunder. |
4.2. | Verification and Audit. Discounts (including any qualification criteria for any Discounts) specified herein and/or any other amounts paid by one Party to the other Party pursuant to this Agreement are subject to verification and audit of the relevant purchase and other |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
data (including the Data, the Self-Reported Data and the Compensation Data), as reasonably necessary to calculate any amounts payable hereunder. Dialysis Center Purchasers shall maintain their books and records in accordance with U.S. generally accepted accounting principles, consistently applied.
4.3. | Audit Process. |
4.3.1. | Objection Notice. To the extent either Amgen or Dialysis Center, in its reasonable discretion, determines that it is necessary to verify and confirm the calculation of: (a) any Discount described in this Agreement in order to audit and assure compliance with the terms of this Agreement and/or (b) any other calculation or amount that one Party must pay to the other Party under this Agreement, the requesting Party shall provide written notice of same to the other Party (an “Objection Notice”) setting forth in detail any and all items of disagreement related to such computation, statement, and/or amount that must be paid by one Party to the other Party. |
4.3.2. | Determination by the Firm. Amgen and Dialysis Center shall jointly engage (at the requesting Party’s sole cost and expense, subject to any reimbursement by the other Party as set forth below) and refer the items in dispute to a nationally recognized firm of independent, certified public accountants as to which Amgen and Dialysis Center mutually agree (the “Firm”), to resolve any disagreements. Amgen and Dialysis Center will direct the Firm to render a written determination within twenty (20) days of its retention, and Amgen and Dialysis Center and their respective employees and/or agents will cooperate with the Firm during its engagement. The Firm shall keep strictly confidential all data reviewed and information learned or obtained in connection with resolving any Objection Notice and shall report to the requesting Party only the conclusion of its review without the disclosure of any Confidential Information. All reports of the Firm shall be made available to both Parties simultaneously, promptly upon completion, and shall be deemed to conclusively and definitively resolve the related Objection Notice, which shall be reimbursed (if applicable) in accordance with this Section 4.3.2. Any such audit shall be conducted during normal business hours, upon reasonable advance notice, and so as not to unreasonably interfere with the business of Amgen and/or any of the Dialysis Center Purchasers. |
4.4. | Audit Results and Payment. In the event any such audit is requested by Amgen and shows that Dialysis Center Purchasers have submitted incorrect information resulting in Dialysis Center receiving in excess of one hundred five percent (105%) of the amount to which it was entitled in any Quarter, Dialysis Center shall reimburse Amgen for the reasonable costs of such audit; otherwise, Amgen shall be responsible for the costs of such audit. In the event any such audit is requested by Dialysis Center and shows that Dialysis Center Purchasers have submitted correct information but have been underpaid by more than five percent (5%) of the amount to which they were entitled in any Quarter, Amgen shall reimburse Dialysis Center for the reasonable costs of such audit; otherwise, Dialysis Center shall be responsible for the costs of such audit. The determination of the Firm will be conclusive and binding upon Amgen and Dialysis Center. Following any audit that shows any over or underpayment hereunder, the relevant Party shall, within sixty (60) days, make payment to the other Party for the difference between the amount paid hereunder and the amount actually payable hereunder based upon the results of such audit. |
4.5. | Adjustments for Changes. In accordance with Section 3.7.2 and/or 3.7.3 above, in the event of an addition to or deletion from the Designated Affiliates List of an Affiliate that provides Dialysis Services or a Managed Center’s addition to or deletion from the Managed Centers List during any Quarter of the Term, Amgen shall adjust Qualified Gross Purchases |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
of Amgen ESAs to account for such addition to or deletion from the Designated Affiliates List of an Affiliate that provides Dialysis Services or a Managed Center’s addition to or deletion from the Managed Centers List by, as applicable, adding or deleting such Designated Affiliates’ or Managed Centers’, as applicable, purchases to or from the relevant Quarter or comparison Quarter (or portion thereof).
4.6. | Treatment of Discounts and Rebates. |
4.6.1. | Dialysis Center Reporting and Disclosure of Discounts. Dialysis Center agrees that Dialysis Center Purchasers shall properly disclose and account for all Discounts earned hereunder, in whatever form, in compliance with all applicable federal, state, and local Laws, including §1128B(b) of the Social Security Act, as amended and its implementing regulations. Dialysis Center agrees that, if required by such statutes or regulations, it (together with its Designated Affiliates) shall and it shall cause its Managed Centers to (i) claim the benefit of such Discount received in the fiscal year in which such Discount was earned or the year after, (ii) fully and accurately report the value of such Discount in any cost reports filed under Title XVIII or Title XIX of the Social Security Act, as amended or a state or local health care program, and (iii) provide, upon request by the U.S. Department of Health and Human Services or a state or local agency or any other federally funded state health care program, the information furnished to Dialysis Center Purchasers by Amgen concerning the amount or value of such Discount. |
4.6.2. | Amgen Reporting of Discounts. In order to assist Dialysis Center's compliance with its obligations as set forth in Section 4.6.1 above, Amgen agrees that it will fully and accurately report all Discounts on the invoices or statements submitted to Dialysis Center and use reasonable efforts to inform Dialysis Center of its obligations to report all such Discounts to the extent specified by 42 C.F.R § 1001.952(h)(2)(ii)(A) or where the value of a Discount is not known at the time of sale, Amgen shall fully and accurately report the existence of the Discount program on the invoices or statements submitted to Dialysis Center and use reasonable efforts to inform Dialysis Center of its obligations to report all such Discounts to the extent specified by 42 C.F.R § 1001.952(h)(2)(ii)(B), and when the value of the Discounts become known, provide Dialysis Center with documentation of the calculation of the Discount identifying the specific goods or services purchased to which the Discount will be applied, in accordance with Section 4.7 below. |
4.7. | Discount Reports. Within ninety (90) days of the end of each Quarter, Amgen shall provide to Dialysis Center a statement of the Discounts earned hereunder with the itemization of Amgen ESA purchases made in a particular Quarter, broken down for each Dialysis Center Purchaser and any other information that Dialysis Center may reasonably request that is reasonably available to Amgen and necessary for Dialysis Center to obtain in order to comply with its obligations hereunder. Dialysis Center agrees that it will provide such information to its Dialysis Center Purchasers in a timely manner in order to allow such Dialysis Center Purchasers to meet their reporting and other obligations hereunder and under applicable Law. |
4.8. | Best Price Limitation. At any time following the repeal, enactment or modification of any Law, policy, program memorandum, or the interpretation thereof, including a decision by the Centers for Medicare & Medicaid Services, that affects the definition of “Best Price” (which, for purposes of this Agreement, shall mean the price reported in Amgen’s Best Price Submission under Title XIX of the Social Security Act) or the methodology by which Best Price must be calculated, Amgen shall have the right, in its sole discretion, to determine the extent to which any potential price concession to any Third Party due to such repeal, enactment, modification or decision may impact Amgen’s Best Price calculation |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
under this Agreement alone or in combination with any other price concessions in other agreements with Dialysis Center or any Third Party. In the event that Amgen determines reasonably and in good faith that the then-existing price concessions under this Agreement establishes or would establish a new “Best Price,” Amgen shall have the right, in its sole discretion, upon the later of (a) the effective date of such repeal, enactment, modification or decision, or (b) notice to Dialysis Center, to modify the Discounts offered under this Agreement prospectively, and shall promptly notify Dialysis Center of the new amount; provided, that the new amount as adjusted by Amgen shall result in price concessions available to Dialysis Center which would equal the Best Price prior to the effective date of such repeal, enactment, modification or decision, calculated using the modified definition or methodology by which Best Price is to be calculated.
5. | GOVERNANCE |
5.1. | Business Representatives. The “Business Representatives” shall be comprised of: (i) in the case of Amgen, Amgen’s General Manager of the Inflammation / Nephrology Business Unit (the “Amgen Business Representative”); and (ii) in the case of Dialysis Center, the Chief Operating Officer of DaVita Inc. (the “Dialysis Center Business Representative”). Each Business Representative shall be entitled to appoint designees who have been identified to the other Business Representative in writing and have equivalent authority to the Party’s Business Representative or have been expressly given all requisite authority by the Party’s Business Representative. |
5.2. | Responsibilities of Business Representatives. The Business Representatives shall be responsible for overseeing the Parties’ activities and conduct under this Agreement generally, and for ensuring an appropriate level of oversight. The Business Representatives shall meet in person, via teleconference or videoconference at such times as may be deemed necessary by the Parties. |
6. | PATIENT AND PRODUCT DATA |
6.1. | Data Submission. Subject to the provisions of this Section 6 and the validity of a Certification as described in Section 6.3, in order to qualify to receive Discounts under this Agreement as set forth in Exhibit A, Dialysis Center shall deliver to Amgen (or to a data collection vendor specified by Amgen) the Data set forth in Schedule I from a minimum of eighty-seven percent (87%) of all Dialysis Center Purchasers in the aggregate, provided, however, that if such eighty-seven percent (87%) threshold is not met in any month due to the inclusion of de novo facilities that have not yet treated patients and/or inactive facilities, Amgen shall exclude any such facilities identified by Amgen and Dialysis Center from such month when determining whether or not Dialysis Center has met the data submission requirement set forth in this Section 6.1. Dialysis Center shall submit Data to Amgen, on a monthly basis by the last day of the following calendar month (or the next business day if such last day is not a business day) and such submission of Data via Schedule I shall be substantially complete and accurate as set forth in Section 8.5. If Amgen determines that any Dialysis Center Purchaser is consistently not submitting the required Data, Amgen and Dialysis Center will work collaboratively in resolving such inconsistencies. Amgen will use commercially reasonable efforts to notify Dialysis Center in writing, no later than fifteen (15) business days after the receipt and acceptance by Amgen of the Data of the identity of all Dialysis Center Purchasers, if any, which have failed to meet the Data submission requirements for that month. If Dialysis Center reasonably determines, based on the advice of counsel, that it is prohibited by law or Governmental Authority from providing certain Data to Amgen, Dialysis Center shall have no obligation under this Agreement to provide such Data to Amgen. |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
6.2. | Data Submission Format. Subject to the validity of a Certification as described below, Dialysis Center Purchasers must provide to Amgen on a calendar monthly basis by the last day of the following calendar month (or the next business day if such last day is not a business day) the Data in a machine readable format acceptable to Amgen (Excel; or text file that is tab delimited, comma delimited, colon delimited or space delimited including a line of column headers identifying the column contents and units, if applicable). The Data files shall contain record counts for each file contained in the data submission; provided, however, that Dialysis Center shall be required to submit such test results only for those dialysis patients whose test results are actually determined by laboratories owned and operated by Dialysis Center. To the extent Amgen requests that Dialysis Center deliver Data to a data collection vendor, Amgen agrees to cause any such data collection vendor to adhere to and be bound by a substantially similar confidentiality obligation as is applicable to Amgen under this Agreement, and Amgen shall be liable for any failure by any such data collection vendor to act in accordance with such requirements. |
6.3. | HIPAA Compliance. Neither Party has the intent that Dialysis Center will provide Amgen (or any specified data collection vendor) any Data in violation of HIPAA. Accordingly, the Parties shall engage an appropriately qualified statistician, reasonably acceptable to each Party, who meets the requirements set forth in 45 C.F.R. § 164.514(b)(1) to review the Data and deliver a written certification that shall conclude that, subject to any conditions, requirements or assumptions set forth therein, each delivery of Data pursuant to this Agreement will meet the standards for “de-identification” under HIPAA (the “Certification”). In connection with the Certification, the Parties agree to use their commercially reasonable efforts to facilitate the completion and delivery of such Certification to each Party in an expedited manner. Notwithstanding anything in this Agreement to the contrary, in order to assure compliance, as determined by either Party in its reasonable discretion, with any existing Law relating to patient privacy of medical records, or at any time following the enactment of any Law relating to patient privacy of medical records that in any manner reforms, modifies, alters, restricts, or otherwise affects any of the Data received or to be received in connection with any of the Discounts contemplated under this Agreement, either Party may, upon thirty (30) days’ prior written notice, seek to amend this Agreement with respect to the affected Discount. Dialysis Center and Amgen shall meet and in good faith mutually agree to modify this Agreement to accommodate any such change in the Law, with the intent to, if possible, retain the essential terms of this Section 6 and the affected Discount and pricing structure of this Agreement. |
6.4. | Case Identifier. Dialysis Center shall consistently use a unique alpha-numeric code (which shall not be derived from Individually Identifiable Health Information) as a "case identifier" to track the care rendered to each individual patient over time, and such case identifier shall be included in the Data provided to Amgen. The key or list matching patient identities to their unique case identifiers shall not be provided to Amgen. |
6.5. | Data Use. Amgen and its Affiliates shall have the right to use Data (a) to support verification of the services under this Agreement, (b) for its sponsored research and analysis, development of marketing materials, running internal trending analyses, overall analyses of how to improve treatment of patients on dialysis and creating tools by its marketing personnel, (c) in the aggregate for publications as part of a larger data set incorporating comparable clinical data received from other dialysis providers in the Territory and provided that no portion of such data shall be attributed to Dialysis Center or its Affiliates, and (d) for purposes of verifying the Dialysis Center Purchasers’ performance under this Agreement and the calculation of amounts payable hereunder, including verifying the Dialysis Center Purchasers’ Purchase Commitment performance under this Agreement and calculating or determining the Dialysis Center Purchasers’ eligibility to receive any Discount. Notwithstanding the foregoing, without Dialysis Center’s prior written consent (such consent |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
not to be unreasonably conditioned, withheld or delayed): Amgen and its Affiliates shall not (i) disclose to Third Parties the Data provided by Dialysis Center hereunder except (1) in any publication referenced in clause (c) above, (2) pursuant to public health activities, (3) to agents of Amgen bound by obligations of confidentiality no less restrictive than those contained in Section 11.14 or (4) to other Third Parties as required by Law or regulation as determined by Amgen based on the advice of counsel; or (ii) sell or resell any such data or derivative works thereof to any Third Party.
6.6. | Clinical Research Studies. Dialysis Center and Amgen acknowledge that Dialysis Center, either directly or through DaVita Clinical Research, Inc., an Affiliate of Dialysis Center, may from time to time be engaged in research studies in which patients of the Dialysis Center Purchasers, may serve as clinical trial subjects (a “Research Study”). Notwithstanding any obligation of Dialysis Center in this Agreement to the contrary, including any requirement in Section 6.1, Dialysis Center shall not be required to submit Data for any patients of the Dialysis Center Purchasers that are participating in a Research Study (a “Study Patient”), but shall continue without limitation to be eligible for, and if earned receive, all Discounts granted pursuant to this Agreement, so long as (i) Dialysis Center notifies Amgen of the aggregate number of Study Patients whose Data will not be delivered by Dialysis Center to Amgen as otherwise required by this Agreement as a result of such patient being a Study Patient, and (ii) the aggregate number of Study Patients whose Data is excluded by Dialysis Center does not exceed the Permitted Excluded Group. For purposes of the foregoing, “Permitted Excluded Group” means four percent (4%) of the aggregate number of persons receiving treatment from the Dialysis Center Purchasers in any calendar month. |
7. | OTHER DATA |
7.1. | Compensation Data. Dialysis Center agrees that it shall provide the data, with respect to Amgen ESAs, set forth on Schedule 2 attached hereto (the “Compensation Data”) to Amgen in the electronic format set forth on Schedule 2 on a calendar monthly basis no later than the fourteenth (14th) day of the following calendar month following the month for which such Compensation Data is being provided. Amgen acknowledges, agrees and covenants that it shall only use the Compensation Data for sales force targeting and compensation. Dialysis Center and Amgen acknowledge and agree that the Compensation Data does not include and shall never include any Individually Identifiable Health Information of any patient of Dialysis Center Purchasers. Notwithstanding the foregoing, Amgen acknowledges and agrees that Dialysis Center shall only be required to deliver the Compensation Data to Amgen for as long as EPOGEN or Aranesp is dispensed through DaVita Rx, LLC. Amgen shall indemnify, defend and hold harmless Dialysis Center from and against any and all loss, damage and/or expense (including reasonable attorney’s fees) that it may suffer as a result of claims, demands, actions, proceedings, liabilities, costs or judgments, or threats thereof arising out Dialysis Center’s supply of the Compensation Data to Amgen. |
7.2. | Self-Reported Data. Dialysis Center, on behalf of the Dialysis Center Purchasers, acknowledges, covenants and agrees that it shall submit full and complete Self-Reported Data for each Quarter to Amgen within forty-five (45) days of the end of each such Quarter through a Data Submission Form attached here to as Exhibit SR-1. Exhibit SR-1 is subject to modification by mutual written agreement of the Parties. Dialysis Center on behalf of the Dialysis Center Purchasers shall submit Exhibit SR-1 in an Excel file format electronically by e-mail to Dialysissdata@amgen.com or in such other manner as may be specified by Amgen through written notification to Dialysis Center. |
8. | WARRANTIES, REPRESENTATIONS AND COVENANTS |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
8.1. | Power and Authority. Each Party represents and warrants to the other that this Agreement: (a) has been duly authorized, executed, and delivered by it, (b) constitutes a valid, legal, and binding agreement enforceable against it in accordance with the terms contained herein, and (c) does not and shall not conflict with or violate any of its other contractual obligations, expressed or implied, to which it is a party or by which it may be bound. |
8.2. | Compliance with Law and Regulation. Amgen and Amgen Inc. shall, and Dialysis Center shall, comply with all applicable Laws related to the performance of their respective obligations under this Agreement. Each Party represents and warrants that (which representations and warranties shall be ongoing representations and warranties during the Term): (i) it is not currently named on any of the following lists: (A) HHS/OIG List of Excluded Individuals/Entities, (B) GSA List of Parties Excluded from Federal Programs, or (C) OFAC “SDN and Blocked Individuals” and (ii) it shall promptly notify the other Party in the event it becomes named on any of the following lists: (x) HHS/OIG List of Excluded Individuals/Entities, (y) GSA List of Parties Excluded from Federal Programs, or (z) OFAC “SDN and Blocked Individuals”. |
8.3. | Product. Amgen covenants and agrees that Amgen ESAs are not and will not be adulterated or misbranded within the meaning of the Federal Food, Drug and Cosmetic Act, as amended, or within the meaning of any applicable Law, or is or will be a product which may not be introduced in to interstate commerce. Amgen warrants that an Amgen ESA purchased pursuant to this Agreement (a) is manufactured, and up to the time of its receipt by Authorized Wholesalers is handled, stored, and transported in accordance with all applicable Laws, and meet all specifications for effectiveness and reliability as required by the United States Food and Drug Administration (the “FDA”), and (b) when used in accordance with the directions in its labeling, is fit for the purposes and indications described in its labeling. Amgen warrants that the use of Amgen ESAs by Dialysis Center Purchasers shall not infringe upon any ownership rights of any other individual or entity or upon any patent, copyright, trademark or other intellectual property or proprietary right or trade secret of any individual or entity. Amgen agrees that as soon as practicable, it will notify Dialysis Center of any material defect in any Amgen ESA delivered to any Dialysis Center Purchasers in accordance with applicable Law. |
8.4. | [*]. Dialysis Center represents and warrants to Amgen that: (a) as of the Term State Date, neither Dialysis Center, nor Designated Affiliates, nor any Affiliate of Dialysis Center [*] (b) prior to [*], neither Dialysis Center, nor Designated Affiliates, nor any Affiliate of Dialysis Center [*] , and (c) [*] in whole or in part in order to [*] with the intent to circumvent its Purchase Commitment obligations under this Agreement. In the event that Amgen has a reasonable basis to believe that Dialysis Center has not complied with its obligations under this Section 8.4, Amgen shall follow the Arbitration process set forth in Section 9.2. |
8.5. | Data. Dialysis Center represents and warrants to Amgen that: (a) the Data, the Compensation Data, and the Self-Reported Data that the Dialysis Center Purchasers deliver to Amgen pursuant to Section 6 and Section 7 shall be: (i) prepared and delivered in accordance with the provisions of Section 6 and Section 7 and (ii) as complete and accurate as is reasonably obtainable in view of the Dialysis Center Purchasers’ customary method of compilation and the nature and accuracy of the Dialysis Center Purchasers’ resources; (b) the Dialysis Center Purchasers shall not knowingly and intentionally misrepresent or omit any of the Data, the Compensation Data, and/or the Self-Reported Data provided by the Dialysis Center Purchasers to Amgen; and (c) Dialysis Center shall promptly notify Amgen in the event it has actual knowledge that any of the Data, the Compensation Data, and/or the Self-Reported Data is not complete and/or accurate. |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
8.6. | Designated Affiliates List and Managed Centers List. Dialysis Center represents and warrants that the Designated Affiliates List and the Managed Centers List, as each of them is attached to this Agreement as of the Term Start Date (and as of any subsequent date that such lists are updated in accordance with the terms hereof) are complete and accurate lists of all Affiliates of Dialysis Center and Managed Centers of Dialysis Center providing Dialysis Services in the Territory as of the Term Start Date (and as of each such subsequent date). |
8.7. | Adverse Claims. Each Party represents and warrants to the other Party that, as of the execution of this Agreement, such Party has no actual knowledge of any legal claim or right to be asserted against the other Party or its Affiliates related to the negotiation or execution of this Agreement. |
8.8. | NO OTHER WARRANTIES. OTHER THAN THE WARRANTIES EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES, AND EACH PARTY EXPRESSLY DISCLAIMS, ALL OTHER WARRANTIES, STATUTORY, EXPRESS, AND/OR IMPLIED, INCLUDING THOSE OF MERCHANTABILITY AND/OR FITNESS FOR A PARTICULAR PURPOSE. EACH PARTY HEREBY EXPRESSLY WAIVES ANY AND ALL OTHER WARRANTIES, STATUTORY, EXPRESS, AND/OR IMPLIED, INCLUDING THOSE OF MERCHANTABILITY AND/OR FITNESS FOR A PARTICULAR PURPOSE. |
9. | DISPUTE RESOLUTION, INSURANCE and INDEMNITY |
9.1. | Escalation of Disputes to Business Representatives. The Parties recognize that claims, disputes or controversies arising out of or relating to this Agreement (“Disputes”) may occur from time to time. It is the objective of the Parties to establish procedures to facilitate the resolution of Disputes arising under this Agreement in an expedient manner by mutual cooperation and, if possible, without resort to litigation. |
In the event of any Dispute, and prior to either Party (a) commencing any action in a court of law or under any Governmental Authority, or (b) taking any action to terminate this Agreement as provided in Section 10, the Parties shall first undertake that the employees of each Party with relevant expertise and authority with respect to a Dispute shall meet to discuss such Dispute within five (5) business days of a Party receiving notice of a Dispute (except in the case where delay in resolving any such Dispute would be materially prejudicial to a Party, in which case the Dispute will be referred directly to the Business Representatives). In the event the Parties are unable to resolve any such Dispute within thirty (30) business days of the initial meeting between the Parties, it shall be referred to the Business Representatives, who shall negotiate with one another in good faith to reach a good faith resolution of the Dispute; provided, that the Parties shall use commercially reasonable efforts to expedite the resolution of any Disputes which by their nature need to be made quickly by the Business Representatives. In the event the Dispute cannot be resolved by the Business Representatives within fifteen (15) business days of the initial meeting between the Business Representatives or such other period of time as is mutually agreed to by the Parties, then, upon the written demand of either Party, the Dispute shall be subject to arbitration, as provided in Section 9.2. Pending resolution of any Dispute, both Parties will continue their performance under this Agreement. If there is a Dispute relating to any amount owed by either Party to the other Party, the undisputed portion of such amount shall be paid to the other Party in accordance with the terms hereof, and the Parties shall first attempt to resolve the disputed balance in accordance with this Section 9.1.
9.2. | Arbitration. |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
9.2.1. | Claims. Subject to Section 9.3 below, any Dispute that is not resolved under Section 9.1 within thirty (30) days after a Party’s initial written request for resolution, shall be resolved by final and binding arbitration administered by JAMS (the “Administrator”) in accordance with its Comprehensive Arbitration Rules and Procedures (the “Rules”), except to the extent any such Rule conflicts with the express provisions of this Section 9.2 (“Arbitration”). (Capitalized terms in this Section 9.2 used but not otherwise defined in this Agreement shall have the meanings provided in the Rules.) For Disputes valued at less than Five Million Dollars ($5,000,000 USD), the Arbitration shall be conducted by one (1) neutral arbitrator (“Arbitrator”) selected in accordance with the Rules, provided, that such Arbitrator shall not be a current or former employee or director, or a current stockholder, of either Party or any of their respective Affiliates. For Disputes valued at or more than Five Million Dollars ($5,000,000 USD), the Arbitration shall be conducted by a panel of three (3) neutral Arbitrators selected in accordance with the Rules, provided, that any such Arbitrator shall not be a current or former employee or director, or a current stockholder, of either Party or any of their respective Affiliates. The Arbitration shall be held in Los Angeles, California. |
9.2.2. | Discovery. Within forty-five (45) days after selection of the Arbitrator(s), the Arbitrator(s) shall conduct the Preliminary Conference. In addressing any of the subjects within the scope of the Preliminary Conference, the Arbitrator(s) shall take into account both the needs of the Parties for an understanding of any legitimate issue raised in the Arbitration and the desirability of making discovery efficient and cost-effective. In that regard, the Parties agree to the application of the E-Discovery procedures set forth in Rule 16.2(c) of JAMS’ Expedited Procedures; provided, that the Parties agree that the time limitations identified in Rule 16.2 of JAMS’ Expedited Procedures shall not be binding and the Arbitrator(s) shall set time limitations for discovery and depositions that are reasonable and necessary in light of the issues and matters raised in the Preliminary Conference. In no event shall the time limitations set by the Arbitrator(s) for discovery and depositions be shorter than the time periods for discovery and depositions that are set forth in Rule 16.2 of JAMS’ Expedited Procedures. |
9.2.3. | Hearing; Decision. The hearing (“Hearing”) shall commence within a reasonable time after the discovery cutoff. The Arbitrator(s) shall require that each Party submit concise written statements of position and shall permit the submission of rebuttal statements, subject to reasonable limitations on the length of such statements to be established by the Arbitrator(s). The Arbitrator(s) shall also permit the submission of expert reports. The Arbitrator(s) shall render the award (“Award”) within thirty (30) days after the Arbitrator(s) declares the Hearing closed, and the Award shall include a written statement describing the essential findings and conclusions on which the Award is based, including the calculation of any damages awarded. The Arbitrator(s) will, in rendering his, her or their decision, apply the substantive law of the State of California, without giving effect to its principles of conflicts of law, and without giving effect to any rules or laws relating to arbitration. The Award rendered by the Arbitrator(s) shall be final, binding and non-appealable, and judgment may be entered upon it in any court of competent jurisdiction. However, the Parties agree that the JAMS Optional Arbitration Appeal Procedures (“Appeal Procedures”) shall apply to the Arbitration, at the request by either Party in accordance with such Appeal Procedures. If a Party appeals the Award rendered by the Arbitrator(s), the Award issued by the Appeal Panel (as defined in such Appeal Procedures) shall be final, binding and non-appealable, and judgment may be entered upon it in any court of competent jurisdiction. |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
9.2.4. | Costs. Each Party shall bear its own attorney’s fees, costs, and disbursements arising out of the Arbitration, and shall pay an equal share of the fees and costs of the Arbitrator(s); provided, however, the Arbitrator(s) shall be authorized to determine whether a Party is the prevailing party, and if so, to award to that prevailing party reimbursement for any or all of its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel expenses, etc.), and/or the fees and costs of the Administrator and the Arbitrator(s). |
9.2.5. | Confidentiality. Each Party acknowledges and agrees that: (a) any discovery pursuant to this Section 9.2, (b) the Hearing, (c) any and all documents exchanged or delivered in connection with the Hearing, settlement negotiations, and/or settlement terms, including the statements of position, rebuttal statements, and expert reports, (d) settlement negotiations and/or settlement terms, and (e) the Award shall be treated as Confidential Information and subject to the terms and conditions of Section 11.14. |
9.3. | Court Actions. Nothing contained in this Agreement shall deny either Party the right to seek injunctive or other equitable relief from a court of competent jurisdiction in the context of a bona fide emergency or prospective irreparable harm, and such an action may be filed and maintained notwithstanding any ongoing discussions between the Parties or any ongoing arbitration proceeding. |
9.4. | Insurance. Each Party shall secure and maintain in full force and effect throughout the Term (and following termination, to the extent necessary to cover any claims arising from this Agreement) commercial general liability insurance and product liability (in the case of Amgen only) which include contractual liability with limits of no less than five million dollars ($5,000,000.00 USD); professional liability insurance (in the case of Dialysis Center only) with limits of no less than five million dollars ($5,000,000.00 USD), and workers’ compensation with statutory limits. Any limits on each of a Party’s insurance coverage shall not be construed to create any limit on such Party’s liability with respect to its obligations under this Agreement or otherwise. Each of the Parties shall have the right to satisfy its obligations under this Section 9.4 through self-insurance. Amgen Inc. hereby guarantees the performance of Amgen’s obligations as set forth in this Section 9.4. |
9.5. | Indemnity. |
9.5.1. | By Amgen. Amgen agrees to indemnify, defend, and hold Dialysis Center, its officers, directors, agents and employees (collectively, the “Dialysis Center Indemnitees”) harmless from and against any and all loss, damage and/or expense (including reasonable attorney’s fees) that they may suffer as a result of Third Party claims, demands, actions, proceedings, liabilities, costs or judgments, or threats thereof (“Third Party Claim(s)”) arising out of (i) any defect in the design and/or manufacture of any Amgen ESA or the storage and/or transportation of any Amgen ESA in Amgen’s possession, including claims for property damage, loss of life, and/or bodily injury; and/or (ii) the breach by Amgen or Amgen Inc. of any of their respective warranties, representations, and/or covenants contained in this Agreement. Notwithstanding anything to the contrary contained herein, Amgen and Amgen Inc. shall not have any obligation to defend, indemnify, and/or hold the Dialysis Center Indemnitees harmless from any Third Party Claims arising out of the negligent acts and/or omissions and/or willful misconduct of the Dialysis Center Indemnitees. This indemnification shall survive the termination or expiration of this Agreement. Amgen Inc. hereby guarantees the performance of Amgen’s obligations as set forth in this Section 9.5.1. |
9.5.2. | By Dialysis Center. Dialysis Center agrees to indemnify, defend, and hold Amgen, its officers, directors, agents and employees (collectively, the “Amgen Indemnitees”) harmless from and against any and all Third Party Claims arising out of (i) any Dialysis |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
Center Purchasers’ administration of any Amgen ESA purchased under this Agreement to its patients; (ii) any Dialysis Center Purchasers’ failure to store and/or transport any Amgen ESA in its possession in accordance with any applicable Law and/or labeling information; and/or (iii) the breach by Dialysis Center of any of its warranties, representations, and/or covenants contained in this Agreement. For purposes of the foregoing, the "administration" of an Amgen ESA by Dialysis Center shall mean the dispensing and handling by Dialysis Center and its employees of an Amgen ESA and the actual administration of an Amgen ESA to patients by Dialysis Center and its employees, but shall exclude physician prescriptions of Amgen ESAs to patients. Notwithstanding anything to the contrary contained herein, Dialysis Center shall not have any obligation to defend, indemnify, and/or hold the Amgen Indemnitees harmless from any Third Party Claims arising out of the negligent acts and/or omissions and/or willful misconduct of the Amgen Indemnitees. This indemnification shall survive the termination or expiration of this Agreement.
9.6. | Procedure for Third Party Claims. |
9.6.1. | Notice. The Party receiving indemnification hereunder (the “Indemnified Party”) shall give the Party providing indemnification hereunder (the “Indemnifying Party”) written notice within fifteen (15) business days after the Indemnified Party receives notice of any Third Party Claim, subject to indemnification hereunder upon which such Indemnified Party intends to base a request for indemnification under Section 9.5.1 or Section 9.5.2. Failure to give any such notice shall not constitute a waiver of any right to indemnification or reduce in any way the indemnification available hereunder, except and only to the extent that as a result of such failure the Indemnifying Party demonstrates that it was directly and materially damaged as a result of such failure to give timely notice. |
9.6.2. | Control of Defense. The Indemnifying Party, at its expense, shall assume control of the defense and resolution of each Third Party Claim using legal counsel reasonably approved by the Indemnified Party and shall keep the Indemnified Party fully and timely informed of the progress of such defense and resolution. With respect to each Third Party Claim, the Indemnified Party shall have the right to retain independent legal counsel at its cost and monitor such Third Party Claim’s defense and resolution. In such a case, the Indemnifying Party and its legal counsel shall fully cooperate with the Indemnified Party and its legal counsel in providing such information as the Indemnified Party may reasonably request. Notwithstanding this Section 9.6.2, the Indemnifying Party shall not be entitled to control, but may participate in, and the Indemnified Party shall be entitled to have sole control over and select counsel to conduct, the defense or settlement of each Third Party Claim that: (i) seeks a temporary restraining order, a preliminary or permanent injunction, and/or specific performance against the Indemnified Party, (ii) involves criminal allegations against the Indemnified Party, (iii) if unsuccessful, would set a precedent that would materially interfere with and/or have a material adverse effect on the business and/or financial condition of the Indemnified Party, and/or (iv) imposes liability on the part of the Indemnified Party for which the Indemnified Party is not entitled to indemnification hereunder. In such an event, the Indemnifying Party will still have all of its obligations hereunder with respect to any such affected Third Party Claims; provided, that the Indemnified Party will not settle any such affected Third Party Claims without the prior written consent of the Indemnifying Party, which consent will not be unreasonably withheld, conditioned, and/or delayed by the Indemnifying Party. |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
9.6.3. | Representation. If both the Indemnifying Party and the Indemnified Party are named parties in any Third Party Claim and representation of both Parties by the same legal counsel would be inappropriate due to the actual or potential differing interests between them, then the Indemnified Party, at the Indemnifying Party’s expense, shall have the right to be represented by separate counsel of the Indemnified Party’s choosing. |
9.6.4. | Resolution. The Indemnifying Party shall not settle, compromise or resolve any Third Party Claim without the written consent of the Indemnified Party; provided that, the Indemnifying Party may, without such consent, enter into any such judgment, settlement, compromise or resolution that relates solely to the payment of money damages, involves a full release of the Indemnified Party and does not result in any admission of any fault of the Indemnified Party with respect to such Third Party Claim. |
9.6.5. | Payment. Any final judgment entered or settlement agreed upon in the manner provided in this Section 9.6, as applicable, shall be binding upon the Indemnifying Party and shall conclusively be deemed to be an obligation with respect to which the Indemnified Party is entitled to prompt indemnification hereunder, if applicable. Payment of all amounts owing by the Indemnifying Party under this Section 9.6, as applicable, shall be made promptly upon a final settlement between the Indemnifying Party and the Indemnified Party or upon a final adjudication determined by the Arbitrator(s) that an indemnification obligation is owed by the Indemnifying Party to the Indemnified Party. |
10. | TERM AND TERMINATION |
10.1. | Term. This Agreement shall come into effect as of the Term Start Date and shall expire on the earlier of the Term End Date, or the Termination Date. |
10.2. | Termination for Cause. This Agreement will continue for its full six-year term ending on the Term End Date unless sooner terminated in accordance with the exclusive provisions set forth below in Section 10.2.1, Section 10.2.2 and Section 10.2.3 or as contemplated by Sections 3.4.5.1 or 3.4.5.2. For the avoidance of doubt, other than termination for fraud or bad faith in the course of performance of this Agreement, this Section 10.2 precludes termination on any other basis whatsoever, including but not limited to, any common law right to termination or rescission for a material breach not identified in this Section 10.2. Amgen or Dialysis Center may terminate this Agreement only in the event of the following: |
10.2.1. | Breach of Purchase Commitment. The Parties acknowledge and agree that the Purchase Commitment is the principal value expected to be received by Amgen under this Agreement and it is the essential inducement for Amgen to enter into this Agreement, pursuant to which it has agreed, among other things, (a) to provide the Dialysis Center Purchasers for the duration of the Term the economic benefits of the Discounts provided for herein, (b) to make the Supply Commitment, which requires that Amgen commit facilities to the manufacture of EPOGEN at the expense of other Amgen uses and allocate significant resources to maintain its manufacturing capabilities and capacity at a commensurate level, (c) to assume the business risks and financial liability in respect of the representations, warranties and covenants made by it hereunder and (d) to forego potential other commercial opportunities in respect of its nephrology business. Except as set forth in Section 3.3.6.1, in the event that the Dialysis Center Committed Purchasers do not meet an Amgen ESAs Share of Sales of (i) at least [*] percent ([*]%) [*] during the Term with respect to which the Dialysis Center is required to pay the Alternative ESA Purchase Amount with respect |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
to each of [*] during the Term, or (ii) at least [*] percent ([*]%) [*], then Amgen shall be entitled to terminate this Agreement immediately upon written notice to Dialysis Center and, notwithstanding any other provision of this Agreement, thereupon either receive the “Liquidated Damages” defined below or exercise such other rights and remedies as may be allowed at law or in equity under applicable Law.
10.2.2. | Termination for Exclusion from Federal Health Care Program. Either Amgen or Dialysis Center may immediately terminate this Agreement upon written notice to the other Party in the event there is change in the other Party’s status which excludes it from participation in any “Federal health care program” (as defined under 42 U.S.C. § 1320a-7b(f)) (a “Debarred Party”), provided, that no Party shall have the right to terminate this Agreement pursuant to this Section 10.2.2 if the Debarred Party can complete its obligations through, or otherwise transfer its obligations to, an Affiliate as permitted by applicable Law. |
10.2.3. | Termination for Payment Failure. Either Party may terminate this Agreement in the event the other Party fails to make payment of any undisputed amount due hereunder in excess of [*] following thirty (30) days’ written notice from the Party (which termination shall be automatically effective at the end of such thirty (30) day period should such undisputed amount remain unpaid). |
10.3. | Liquidated Damages. The Parties acknowledge that Amgen’s actual damages in the event of a termination by Amgen, pursuant to Section 10.2.1 or Section 10.2.2, would be difficult to ascertain, and that the payment of the Liquidated Damages represents the best estimate of the amount of such damages by the Parties at this time. The Parties further expressly acknowledge and agree that the Liquidated Damages are intended not as a penalty, but as full liquidated damages, in the event of Amgen’s termination of this Agreement pursuant to Section 10.2.1 or Section 10.2.2 and as compensation for Amgen’s losses and other expenses associated with this Agreement. |
For purposes of this Agreement, “Liquidated Damages” means, in addition to any amounts owed to Amgen under this Agreement, including for breach of the Purchase Commitment under Section 3.1.1, an amount in cash equal to [*] percent ([*]%) of the net present value of Amgen’s projected cash flows for each remaining Quarter (including any fractional Quarters) in the Term, with such cash flows equal to A – B, grown Quarterly at a six percent (6%) annual rate and discounted on a Quarterly basis, at a rate equal to the average annual increase in WAC for EPOGEN on an IU basis or Aranesp on a mcg basis for all calendar years during the Term prior to the related NPV calculation, where:
A = The average Gross Purchases of Amgen ESAs for the three (3) most recent Quarters prior to the Termination Date in which Dialysis Center satisfied the Purchase Commitment in full (or, if less than three (3) such Quarters exist, then “A” shall equal the average of the sum of (i) Qualified Gross Purchases of Amgen ESAs plus (ii) the Alternative ESA Purchase Amount, for the three (3) most recent Quarters prior to the Termination Date); and
B = | The average aggregate Discounts (other than the Aranesp Fixed Price Rebate, EPOGEN Fixed Price Rebate, the Best Net Aranesp Price Rebate, and the Best Net EPOGEN Price Rebate) earned by Dialysis Center Purchasers during the three (3) most recent Quarters prior to the Termination Date, regardless of whether Dialysis Center satisfied the Purchase Commitment in such Quarters. |
10.4. | Effect of Termination. Upon any termination or expiration of this Agreement, (a) any earned and vested Discounts shall be paid in accordance with the terms set forth in Exhibit A, (b) any Alternative ESA Purchase Amounts shall be paid pursuant to Section 3.1.4, (c) any |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
payments by Amgen owing to Dialysis Center under Section 3.4.3.3 shall be paid, (d) any payment by Dialysis Center owing to Amgen under Section 3.3.4 shall be paid and (e) as applicable, the Liquidated Damages pursuant to Section 10.3 shall be paid. All Discounts available to Dialysis Center in the particular Quarter in which such termination occurs shall be paid to Dialysis Center based on an achievement of the eligibility and vesting requirements set forth in Exhibit A.
10.5. | Survival. Any provision that, either expressly or by its nature is intended to survive this Agreement, shall survive any expiration or termination of this Agreement, including Sections 2, 3.3.2, 4, 8, 9, 10, and 11. |
11. | MISCELLANEOUS |
11.1. | Amendment. Except as expressly set forth herein, no amendment of this Agreement shall be effective unless expressed in a writing signed by a duly authorized representative of each Party. |
11.2. | Assignment. Neither Party shall have the right to assign or otherwise transfer this Agreement, or any of its rights and obligations hereunder, in whole or in part, without the other Party’s prior written consent, and any attempted assignment or transfer without such consent shall be void; provided, however, that Amgen may assign or otherwise transfer this Agreement and its rights and obligations hereunder along with all or substantially all of its business relating to this Agreement to any of its Affiliates that is not in the business of providing Dialysis Services in the Territory and Dialysis Center may assign or transfer this Agreement and its rights and obligations hereunder along with all or substantially all of its business relating to this Agreement to any of its Affiliates that is not in the business of manufacturing or supplying ESAs or any product that could be used as a substitute for ESAs in the Territory. Notwithstanding the foregoing, each Party shall be obligated to assign and transfer this Agreement, without any required consent, to any Person to whom either such Party has transferred all or substantially all of its business relating to this Agreement, and the Parties agree that they shall take all reasonable and necessary actions in respect thereof including the execution and delivery of all appropriate instruments to effectuate such assignment and transfer of this Agreement; provided, that any assignment and transfer of this Agreement by Amgen to any Person, a substantial portion of whose business consists of providing Dialysis Services in the Territory, shall require the prior written consent of Dialysis Center, which consent may be withheld by Dialysis Center in its sole and absolute discretion. This Agreement and the provisions hereof shall be binding upon, and inure to the benefit of, the Parties’ permitted successors and assigns. Upon an assignment or transfer of this Agreement to an Affiliate pursuant to this Section 11.2, each Party shall remain liable under this Agreement for the duration of the Term. |
11.3. | Modification of Law. If at any time following the Term Start Date, the enactment or modification of any Law occurs and, as a result, either Party’s performance of its obligations under this Agreement would not comply with such Law, either Party may, upon notice to the other Party, recommend an amendment to modify this Agreement to address those provisions of the Agreement that may not comply with such Law. The Parties agree to use their commercially reasonable efforts to modify this Agreement as necessary to bring it into compliance with the Law if that can be done while retaining, in all material respects, the essential rights and benefits of each Party under this Agreement, including the Purchase Commitment, the Supply Commitment, the collection, exchange and use of the Data and the ability for Dialysis Center Purchasers to earn the Discounts that the Dialysis Center Purchasers are eligible to receive hereunder. Promptly following the delivery of such notice describing the Law at issue and the proposed modifications to bring this Agreement into compliance with such Law, Dialysis Center and Amgen shall meet and in good faith seek |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
to mutually agree to amend this Agreement to accommodate any such Law in accordance with this Section 11.3.
11.4. | Conflicting Provisions. To the extent that any provisions of Amgen’s general or customary policies and procedures or any terms of any purchase order conflict with or are in addition to the terms of this Agreement or any Exhibit or Schedule attached hereto, the terms of this Agreement and its Exhibits and Schedules shall govern. |
11.5. | Construction. This Agreement shall be deemed to have been jointly drafted by the Parties, and no rule of strict construction shall apply against either Party. As used herein, the word “including” shall mean “including, without limitation.” |
11.6. | Counterparts; Facsimile/PDF Signatures. This Agreement may be executed in one or more counterparts, each of which shall be considered an original. The Parties agree that facsimile or PDF transmission of original signatures shall constitute and be accepted as original signatures. |
11.7. | Currency. All amounts herein are set forth in United States Dollars. |
11.8. | Force Majeure. Neither Party will be liable for delays in performance or nonperformance of this Agreement or any covenant contained herein if such delay or nonperformance is a result of acts of God, acts of civil or military authority, acts of any Governmental Authority, civil disobedience or commotion, epidemics, war, terrorist acts, failure or default of public utilities, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe, or any other similar catastrophic events beyond the reasonable control and without the fault or negligence of a Party (all of the foregoing, a “Force Majeure Event”). Force Majeure Events shall not adversely affect Dialysis Center’s eligibility for any Discounts. |
11.9. | Further Assurances. Each Party shall perform all further acts reasonably requested by the other to effectuate the purposes of this Agreement, including obtaining the Certifications under Section 6 or obtaining purchase data necessary from third parties to calculate any amounts payable pursuant to Exhibit A. |
11.10. | Governing Law. This Agreement shall be governed by the laws of the State of California (without regard to its conflict of law rules) and, except as otherwise set forth in this Agreement, the Parties submit to the jurisdiction of the California courts, both state and federal. |
11.11. | Merger/No Reliance. This Agreement, together with the Schedules, and the Exhibits constitutes the entire agreement, written or oral, of the Parties as of the Term Start Date concerning the subject matter hereof. The Parties acknowledge that, in making the determination to enter into this Agreement or otherwise, they have not relied, in whole or in part, on any promise, information, understanding, guarantees, discussions, representation, or warranty, expressed or implied, not contained specifically in this Agreement. |
11.12. | No Partnership. The relationship between Amgen and Dialysis Center is that of independent contractors, and not a partnership or an agency, franchise or other relationship. Neither Party shall have the authority to bind the other. |
11.13. | Notices. Any notice or other communication required or permitted hereunder (excluding purchase orders) shall be in writing and shall be deemed given or made five (5) days after deposit in the United States mail with proper postage for first-class registered or certified mail prepaid, return receipt requested, or when delivered personally or by facsimile (as shown by concurrent written transmission confirmation and confirmed by overnight mail), or one (1) day following traceable delivery to a nationally recognized overnight delivery |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
service with instructions for overnight delivery, in each case addressed to the address set forth below, or at such designated address that either Party shall have furnished to the other in accordance with this Section 11.13:
If to Amgen:
Amgen USA Inc.
One Amgen Center Drive, [*]
Thousand Oaks, CA 91320-1789
Attn: [*]
Fax: [*]
with a copy to:
Amgen USA Inc.
One Amgen Center Drive, [*]
Thousand Oaks, CA 91320-1789
Attn: [*]
Fax: [*]
If to Amgen Inc.: Amgen Inc.
One Amgen Center Drive, [*]
Thousand Oaks, CA 91320-1789
Attn: [*]
Fax: [*]
If to Dialysis Center:
DaVita Inc.
500 N. Capitol Street, NW
Suite 300
Washington DC, 20001
Attn: [*]
Fax: [*]
with a copy to:
DaVita Inc.
2000 16th Street
Denver, CO 80202
Attn: [*]
Fax: [*]
11.14. | Confidentiality. “Confidential Information” means any and all information provided by one Party and/or any of its Affiliates (including Managed Centers in the case of Dialysis Center) (the “Disclosing Party”) to the other Party and/or any of its Affiliates (including Managed Centers in the case of Dialysis Center) (the “Non-Disclosing Party”) which is identified in writing or orally as confidential by the Disclosing Party to the Non-Disclosing Party or given the nature of the information or circumstances surrounding its disclosure reasonably should be considered as confidential, whether in written, computerized, oral, tangible or intangible, and/or other form. Nothing in this Section 11.14 shall prohibit, Amgen from using the Data, the Compensation Data, and/or the Self-Reported Data as provided in Section 6 and Section 7. |
11.14.1. | Confidentiality Covenants. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties, the Non-Disclosing Party agrees that for the Term, and for a period of five (5) years following the Term, the Non-Disclosing Party will keep confidential and not publish or otherwise disclose to |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
any Third Party or use for any purpose, other than in accordance with this Agreement, any Confidential Information, provided, however, that the Non-Disclosing Party may disclose any such Confidential Information to its directors, officers, employees, agents, consultants and advisors as necessary for the Non-Disclosing Party to carry out its rights and obligations under this Agreement on the condition that such directors, officers, employees, agents, consultants and advisors are bound by confidentiality provisions at least as restrictive as those contained in this Agreement. The confidentiality provisions contained in this Section 11.14 shall not apply to the extent that it can be established by the Non-Disclosing Party by competent proof that such Confidential Information:
(a) | was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Non-Disclosing Party by the Disclosing Party; or |
(b) | became generally available to the public or otherwise part of the public domain after its disclosure to the Non-Disclosing Party by the Disclosing Party and other than through any act or omission of the Non-Disclosing Party in breach of this Agreement; or |
(c) | was independently discovered or developed by the Non-Disclosing Party without the use of or reference to the Confidential Information belonging to the Disclosing Party. |
11.14.2. | Retention and Destruction of Confidential Information. At any time upon the written request of the Disclosing Party the Non-Disclosing Party shall promptly return to the Disclosing Party or destroy all Confidential Information. Notwithstanding the return or destruction of the Confidential Information to the Disclosing Party or such other party as designated by the Disclosing Party to the Non-Disclosing Party, the Non-Disclosing Party covenants and agrees that it will continue to abide by its obligations hereunder with respect to any and all Confidential Information. |
11.14.3. | Disclosures Required By Law. In the event that the Non-Disclosing Party and/or any of its directors, officers, employees, agents, consultants and advisors that have received any Confidential Information is required by Law (e.g., by oral questions, interrogatories, request for information or documents, subpoena, civil investigative demand, or similar process) to disclose any Confidential Information, the Non-Disclosing Party agrees to (and shall cause each of its directors, officers, employees, agents, consultants and advisors that have received any Confidential Information to) provide the Disclosing Party with immediate written notice of any such disclosure of Confidential Information that is required by Law in order to provide the Disclosing Party with an opportunity to seek a protective order or other similar order with respect to such Confidential Information. If disclosure of any Confidential Information is required by Law, the Non-Disclosing Party will (and will cause each of its directors, officers, employees, agents, consultants and advisors that have received any Confidential Information to) furnish only that portion of the Confidential Information which it is legally obligated to disclose by Law and consistent with the terms of any protective order or other similar order obtained by the Disclosing Party with respect to such Confidential Information required to be disclosed by Law. |
11.14.4. | Public Announcements; Authorized Disclosure. Neither Party shall make a public announcement or other public disclosure concerning this Agreement without the consent of the other Party, except that either Party may make such announcement or disclosure if it is required by applicable Law, reasonably necessary for any filings with any Governmental Authority or pursuant to the rules of any |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
securities exchange or interdealer quotation system; provided, that the disclosing Party shall give reasonable prior advance notice of the proposed text of such announcement or disclosure to the other Party for its prior review and approval, which review and approval shall not be unreasonably conditioned, withheld or delayed. The proviso in the immediately preceding sentence shall not apply to Relevant Information included in any cost report filed under Title XVIII or Title XIX of the Social Security Act, or health care program of any Governmental Authority.
11.14.5. | Confidential Terms. Notwithstanding the foregoing, each Party may disclose the terms of this Agreement in confidence under terms and conditions at least as restrictive as set forth herein on a need-to-know basis to its legal and financial advisors to the extent such disclosure shall be reasonably necessary in connection with such Party’s activities as expressly permitted by this Agreement. |
11.14.6. | Enforcement. Each Party agrees that money damages alone would not be an adequate remedy for any breach of the terms and conditions of this Section 11.14. Therefore, in the event of a breach or threatened breach of this Section 11.14, the non-breaching Party may, in addition to other rights and remedies existing in its favor, apply to any court of competent jurisdiction for specific performance and/or injunctive and/or other relief in order to enforce and/or prevent any violation of the provisions of this Section 11.14 by the breaching Party (without proving monetary damages and/or posting a bond and/or other security). |
11.15. | Severability. Subject to the provisions of Section 11.3, if any one or more of the provisions of this Agreement is held to be invalid or unenforceable, the provisions shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. |
11.16. | Waiver. No Party shall be deemed to have waived any right hereunder, unless such waiver is expressed in a writing signed by such Party. |
11.17. | Open Records. To the extent required by §1861(v)(1)(I) of the Social Security Act, as amended, the Parties will allow the U.S. Department of Health and Human Services, the U.S. Comptroller General and their duly authorized representatives, access to this Agreement and all books, documents and records necessary to certify the nature and extent of costs incurred pursuant to it during the Term and for four (4) years following the last date any Amgen ESA or services are furnished under it. If Amgen carries out the duties of this Agreement through a subcontract worth $10,000 or more over a 12-month period with a related organization, the subcontract shall also contain an access clause to permit access by the U.S. Department of Health and Human Services, the U.S. Comptroller General, and their duly authorized representatives to the related organization’s books and records. |
11.18. | Amgen’s ESA Risk Evaluation and Mitigation Strategy Program. Dialysis Center and its Designated Affiliates and Managed Centers shall reasonably cooperate and comply with Amgen in Amgen’s implementation of its ESA Risk Evaluation and Mitigation Strategy program as found at the FDA website: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM200105.pdf (the “FDA Website”) and which may be modified from time to time by the FDA (the “Amgen ESA Risk Evaluation Program”). Dialysis Center shall refer to the FDA Website for updates to the Amgen ESA Risk Evaluation Program. |
11.19. | Recall. In the event the FDA initiates a mandatory recall or Amgen initiates a recall, field market withdrawal, stock recovery, or other similar action with respect to any Amgen ESA (a “Recall”), the Dialysis Center Purchasers shall cooperate with Amgen in implementing the Recall consistent with applicable Law, any industry guidance issued by the FDA, and |
Exhibit 10.40
Note: Redacted portions have been marked with [*]. The redacted portions are subject to a request for confidential treatment that has been filed with the Securities and Exchange Commission.
the terms or procedures of the Recall, including reasonable cooperation with any Amgen designated Third Party vendors.
11.20. | Non-Exclusive Remedies. Except as otherwise set forth herein and as set forth in the exclusive termination provision set forth in Section 10.2 and subject to the provisions of Section 9.1 and 9.2, the various rights and remedies provided in this Agreement are cumulative and in addition to any other rights and remedies the Parties may be entitled to pursue under law and equity, and the exercise of any of the rights in this Agreement will not impair the right of either Party to exercise any other right or remedy at law or equity. |
[Signature Page Follows]
The Parties have executed this Agreement by their designated representatives set forth below.
AMGEN USA INC. | DAVITA INC. |
By: /s/ Anthony C. Hooper Name (print):Anthony C. Hooper Title: Executive Vice President Date: January 6, 2017 | By: /s/ Javier Rodriguez Name (print):Javier Rodriguez Title: President and CEO of Kidney Care Date: January 5, 2017 |
Amgen Inc. with respect to certain provisions of this Agreement as set forth herein.
Amgen Inc. |
By: /s/ Anthony C. Hooper Name (print):Anthony C. Hooper Title: Executive Vice President Date: January 6, 2017 |
Signature Page to the Sourcing and Supply Agreement
Signature Page to the Sourcing and Supply Agreement
EXHIBIT A
DISCOUNT TERMS AND CONDITIONS
1. | AMGEN ESA INVOICE DISCOUNTS |
1.1 | Base Invoice Discounts. Subject to the terms and conditions contained in the Agreement, Dialysis Center Purchasers shall be entitled to the Base Invoice Discount set forth in the following Base Invoice Discount Table, applied to WAC in effect at the time of purchase of EPOGEN or Aranesp, as applicable, by Dialysis Center Purchasers under the Agreement, exclusive of any wholesaler markup, discount, service fees or other charges: |
Base Invoice Discount Table | ||
PRODUCT | NDC | BASE INVOICE DISCOUNT PERCENTAGE |
EPOGEN | All NDCs | [*]% |
Aranesp | All NDCs | [*]% |
2. | FIXED PRICE REBATE |
2.1 | Definitions. In addition to the defined terms set forth in Section 2 of the Agreement, the following terms, as used in this Exhibit A, shall have the meaning ascribed below. |
2.1.1 | “Aranesp Fixed Price” shall mean the applicable Aranesp Fixed Price per microgram of Aranesp as set forth in the Aranesp Fixed Price Table below. |
Aranesp Fixed Price Table | |
Calendar Year | Aranesp Fixed Price per mcg |
2017 | [*] |
2018 | [*] |
2019 | [*] |
2020 | [*] |
2021 | [*] |
2022 | [*] |
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2.1.2 | “EPOGEN Fixed Price” shall mean the applicable EPOGEN Fixed Price per 1,000 IUs of EPOGEN as set forth below: |
EPOGEN Fixed Price Table | |
Calendar Year | EPOGEN Fixed Price per 1,000 IUs |
2017 | [*] |
2018 | [*] |
2019 | [*] |
2020 | [*] |
2021 | [*] |
2022 | [*] |
Notwithstanding the foregoing, if, for any Quarter [*], (a) [*] or (b) there is no [*], as indicated by a third-party reporting agency, such as DDD™ data provided by IMS or if third-party data is unavailable, by some alternative means mutually agreed to by the Parties (an "[*]") and for so long as such [*] continues, then the EPOGEN [*] as follows: (i) in the second consecutive Quarter [*], EPOGEN [*] percent ([*]%) [*] and the applicable EPOGEN [*] in which there was the [*]; (ii) [*] EPOGEN [*] percent ([*]%) [*] and the applicable EPOGEN [*] in the Quarter in which there was [*]; (iii) [*] EPOGEN [*] percent ([*]%) and the applicable EPOGEN [*] in which there was [*]; (iv) [*] EPOGEN [*] as long as there is [*]. If, for any Quarter [*], there is no longer [*], the EPOGEN [*] as set forth in the EPOGEN Fixed Price Table above.
2.1.3 | “Aranesp Fixed Price Rebate Percentage” shall mean, at any date of determination, an amount equal to: [(A minus B), divided by A] minus C, where (i) “A” equals Aranesp WAC in effect at time of purchase; (ii) “B” equals Aranesp Fixed Price, and (iii) “C” equals Aranesp Base Invoice Discount Percentage. For example, a determination of the Aranesp Fixed Price Rebate Percentage would be as follows: |
Aranesp Fixed Price Rebate Percentage Illustration: |
[(Aranesp WAC – Aranesp Fixed Price) / Aranesp WAC] – Aranesp Base Invoice Discount Percentage |
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2.1.4 | “EPOGEN Fixed Price Rebate Percentage” shall mean, at any date of determination, an amount equal to: [(A minus B), divided by A] minus C, where (i) “A” equals EPOGEN WAC in effect at time of purchase; (ii) “B” equals EPOGEN Fixed Price, and (iii) “C” equals EPOGEN Base Invoice Discount Percentage. For example, a determination of the EPOGEN Fixed Price Rebate Percentage would be as follows: |
EPOGEN Fixed Price Rebate Percentage Illustration: |
[(EPOGEN WAC – EPOGEN Fixed Price) / EPOGEN WAC] – EPOGEN Base Invoice Discount Percentage |
2.1.5 “Qualified Gross Purchases of Aranesp” shall mean the amount of Aranesp purchased by Dialysis Center Purchasers during the Term from an Authorized Wholesaler (or from Amgen pursuant to Section 3.6) for use in providing Dialysis Services, and confirmed by Amgen through sales tracking data, including, without limitation, chargeback data from wholesalers. Qualified Gross Purchases of Aranesp shall be calculated using the WAC in effect at the time of the relevant purchase, net of product returns and adjustments.
2.1.6 | “Qualified Gross Purchases of EPOGEN” shall mean the amount of EPOGEN purchased by Dialysis Center Purchasers during the Term from an Authorized Wholesaler (or from Amgen pursuant to Section 3.6) for use in providing Dialysis Services, and confirmed by Amgen through sales tracking data, including, without limitation, chargeback data from wholesalers. Qualified Gross Purchases of EPOGEN shall be calculated using the WAC in effect at the time of the relevant purchase, net of product returns and adjustments. |
2.2 | Aranesp Fixed Price Rebate. Dialysis Center shall earn the Aranesp Fixed Price Rebate for each Quarter during the Term in the manner described below in this Section 2.2; provided, that, any Aranesp purchases by Dialysis Center Purchasers in a Quarter in excess of the [*] shall not be eligible for the Aranesp Fixed Price Rebate, except that any such Aranesp purchases made pursuant to Section 3.1.2.1 of the Agreement shall be eligible for the Aranesp Fixed Price Rebate. |
2.2.1 | Calculation of Aranesp Fixed Price Rebate. Amgen shall calculate the amount of Dialysis Center’s Aranesp Fixed Price Rebate by multiplying the Qualified Gross Purchases of Aranesp during the applicable Quarter by the Aranesp Fixed Price Rebate Percentage for such Quarter. |
2.2.2 | Payment of Aranesp Fixed Price Rebate. Amgen will pay such Aranesp Fixed Price Rebate to Dialysis Center within ninety (90) days after the end of the corresponding Quarter. |
2.2.3 | Vesting of Aranesp Fixed Price Rebate. The Aranesp Fixed Price Rebate for a given Quarter shall vest on the last day of such Quarter. |
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2.3 | EPOGEN Fixed Price Rebate. Dialysis Center shall earn the EPOGEN Fixed Price Rebate for each Quarter during the Term in the manner described below in this Section 2.3. |
2.3.1 | Calculation of EPOGEN Fixed Price Rebate. Amgen shall calculate the amount of Dialysis Center’s EPOGEN Fixed Price Rebate by multiplying the Qualified Gross Purchases of EPOGEN during the applicable Quarter by the EPOGEN Fixed Price Rebate Percentage for such Quarter. |
2.3.2 | Payment of EPOGEN Fixed Price Rebate. Amgen will pay such EPOGEN Fixed Price Rebate to Dialysis Center within ninety (90) days after the end of the corresponding Quarter. |
2.3.3 | Vesting of EPOGEN Fixed Price Rebate. The EPOGEN Fixed Price Rebate for a given Quarter shall vest on the last day of such Quarter. |
3. BEST NET PRICE REBATE
3.1 | Definitions. In addition to the defined terms set forth in Section 2 of the Agreement, the following terms, as used in this Exhibit A, shall have the meaning ascribed below. |
3.1.1 | “Amgen Dialysis Contract” shall mean, as of any determination date, a contract between Amgen or one of its Affiliates and a Qualified Customer in effect as of such date that provides for such Qualified Customer to purchase EPOGEN or Aranesp for its own commercial use in providing Dialysis Services in the Territory. |
3.1.2 | “Lowest Aranesp Net Price” shall mean for each microgram of Aranesp purchased by a Dialysis Center Purchaser under this Agreement in any Quarter, the WAC in effect on the date of purchase less for such Quarter (i) the Discounts that Dialysis Center is eligible to earn under this Agreement during the applicable Quarter, including the Base Invoice Discount, and the Aranesp Fixed Price Rebate, as applicable, and (ii) any other discount, rebate or other price adjustment received by a Dialysis Center Purchaser per microgram of Aranesp which is not exempt from consideration in the calculation of Best Price as defined by the Social Security Act at section 1927(c)(1)(C), as amended, and as implemented by regulation. The Lowest Aranesp Net Price shall not take into account any reallocation of discount for purposes of any reports filed under Title XVIII or Title XIX of the Social Security Act, under any health care program of a Governmental Authority or pursuant to any other Law. |
3.1.3 | “Lowest EPOGEN Net Price” shall mean for each 1,000 IUs of EPOGEN purchased by a Dialysis Center Purchaser under this Agreement in any Quarter, the WAC in effect on the date of purchase less for such Quarter (i) the Discounts that Dialysis Center is eligible to earn under this Agreement during the applicable Quarter, including the Base Invoice Discount, the EPOGEN Fixed Price Rebate, as applicable, and (ii) any other discount, rebate or other price adjustment received by a Dialysis Center Purchaser per 1,000 IUs of EPOGEN which is not exempt from consideration in the calculation of Best Price as defined by the Social Security Act at section 1927(c)(1)(C), as amended, and as implemented by regulation. The Lowest EPOGEN Net Price shall not take into account any reallocation of discount for purposes of any reports filed under Title XVIII or Title XIX of the Social Security Act, under any health care program of a Governmental Authority or pursuant to any other Law. |
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3.1.4 | “Lowest Qualified Customer Aranesp Net Price” shall mean for purposes of determining the Best Net Aranesp Price Rebate, the lowest Qualified Customer Aranesp Net Price in any Best Net Aranesp Price Event recorded from the Term Start Date through the date of such determination. |
3.1.5 | “Lowest Qualified Customer EPOGEN Net Price” shall mean for purposes of determining the Best Net EPOGEN Price Rebate, the lowest Qualified Customer EPOGEN Net Price in any Best Net EPOGEN Price Event recorded from the Term Start Date through the date of such determination. |
3.1.6 | “Qualified Customer” shall mean a (i) Third Party commercial enterprise collectively with all of its Affiliates or (ii) any dialysis facility in which a Third Party commercial enterprise and/or any of its Affiliates has an ownership interest of less than fifty percent (50%) but for which the Third Party commercial enterprise and/or any of its Affiliates provides management services or administrative services in which it controls the selection or procurement of ESAs that, in the case of either (i) or (ii) above, (a) has entered into an Amgen Dialysis Contract and (b) is not exempt from consideration in the calculation of Best Price as defined by the Social Security Act at section 1927(c)(1)(C), as amended, and as implemented by regulation (e.g., any hospital participating in 340B Drug Pricing Program, any qualified state pharmaceutical assistance program, or any purchaser under the Federal Supply Schedule would not be a “Qualified Customer” for purposes of this Agreement). |
3.1.7 | “Qualified Customer Aranesp Net Price” shall mean for each microgram of Aranesp purchased by a Qualified Customer in any Quarter, whether directly as a party to an Amgen Dialysis Contract or as a member of a group purchasing organization that is a party to an Amgen Dialysis Contract, [*] percent ([*]%) [*]; provided, that if any such discounts and rebates once paid are subsequently returned, revised or withdrawn, including pursuant to any retroactive amendment of the Amgen Dialysis Contract or payment settlement (whether in such Quarter or any subsequent Quarter), the applicable “Qualified Customer Aranesp Net Price” shall be based on the discounts, rebates and chargebacks taking into full account such returns, revisions or withdrawals. The Qualified Customer Aranesp Net Price shall not take into account any reallocation of discount for purposes of any reports filed under Title XVIII or Title XIX of the Social Security Act, under any health care program of a Governmental Authority or pursuant to any other Law. |
3.1.8 | “Qualified Customer EPOGEN Net Price” shall mean for each 1,000 IUs of EPOGEN purchased by a Qualified Customer in any Quarter, whether directly as a party to an Amgen Dialysis Contract or as a member of a group purchasing organization that is a party to an Amgen Dialysis Contract, the lower of either (a) [*] percent ([*]%) [*], provided, that if any such discounts and rebates once paid are subsequently returned, revised or withdrawn, including pursuant to any retroactive amendment of the Amgen Dialysis Contract or payment settlement (whether in such Quarter or any subsequent Quarter), the applicable “Qualified Customer EPOGEN Net Price” shall be based on the discounts, rebates and chargebacks taking into full account such returns, revisions or withdrawals; or (b) [*]. The Qualified Customer EPOGEN Net Price shall not take into account any reallocation of discount for purposes of any reports filed under Title XVIII or Title |
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XIX of the Social Security Act, under any health care program of a Governmental Authority or pursuant to any other Law.
3.2 | Best Net Aranesp Price Rebate. Dialysis Center shall earn the Best Net Aranesp Price Rebate, if any, for each Quarter during the Term in accordance with the terms and conditions set forth in this Section 3.2, provided, that, it meets the requirements described below in Section 3.2.1 and provided further, that, any Aranesp purchases by Dialysis Center Purchasers in a Quarter in [*] shall not be eligible for the Best Net Aranesp Price Rebate, except that any such Aranesp purchase made pursuant to Section 3.1.2.1 of the Agreement shall be eligible for the Best Net Aranesp Price Rebate. |
3.2.1 | Eligibility for Best Net Aranesp Price Rebate. Dialysis Center shall be eligible to receive the Best Net Aranesp Price Rebate as of the date on which any Qualified Customer receives a Qualified Customer Aranesp Net Price that is lower than the Lowest Aranesp Net Price (“Best Net Aranesp Price Event”) and [*], so long as the Lowest Qualified Customer Aranesp Net Price is lower than the Lowest Aranesp Net Price, if either (a) the aggregate net sales for all Aranesp purchased by any such Qualified Customer who received a Qualified Customer Aranesp Net Price that is lower than the Lowest Aranesp Net Price during a Quarter in which the Best Net Aranesp Price Event occurred were greater than [*] percent ([*]%) of the aggregate net sales of Aranesp to all purchasers in the Territory in such Quarter or (b) the aggregate net sales for all Aranesp purchased during a Quarter by all Qualified Customers in the aggregate who received a Qualified Customer Aranesp Net Price that is lower than the Lowest Aranesp Net Price were greater than [*] percent ([*]%) of the aggregate net sales of Aranesp to all purchasers in the Territory in such Quarter. Amgen’s calculation of the Best Net Aranesp Price Rebate shall not take into account any reallocation of discounts for purposes of any reports filed under Title XVIII or Title XIX of the Social Security Act, under any health care program of a Governmental Authority or pursuant to any other Law. |
3.2.2 | Calculation of Best Net Aranesp Price Rebate. Subject to the conditions set forth in Section 3.2.1 above, Amgen shall calculate the amount of Dialysis Center’s Best Net Aranesp Price Rebate for any Quarter by subtracting the Lowest Qualified Customer Aranesp Net Price from the Lowest Aranesp Net Price for such Quarter, and if the difference is positive, multiplying such difference by the number of micrograms of Aranesp purchased by Dialysis Center Purchasers in such Quarter. |
Best Net Aranesp Price Rebate Illustration: |
[(Lowest Aranesp Net Price – Lowest Qualified Customer Aranesp Net Price) x (Number of micrograms of Aranesp purchased by Dialysis Center Purchasers in the Quarter)]* *If the foregoing product results in a negative number, such amount shall be deemed to equal zero |
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3.2.3 | Payment of Best Net Aranesp Price Rebate Amount. Amgen will pay the Best Net Aranesp Price Rebate to Dialysis Center within ninety (90) days after the end of the corresponding Quarter. |
3.2.4 | Vesting of Best Net Aranesp Price Rebate. The Best Net Aranesp Price Rebate for a given Quarter shall vest on the last day of such Quarter. |
3.3 | Best Net EPOGEN Price Rebate. Dialysis Center shall earn the Best Net EPOGEN Price Rebate, if any, for each Quarter during the Term in accordance with the terms and conditions set forth in this Section 3.3, provided, that it meets the requirements described below in Section 3.3.1. |
3.3.1 | Eligibility for Best Net EPOGEN Price Rebate. Dialysis Center shall be eligible to receive the Best Net EPOGEN Price Rebate as of the date on which any Qualified Customer receives a Qualified Customer EPOGEN Net Price that is lower than the Lowest EPOGEN Net Price (“Best Net EPOGEN Price Event”) and, [*], so long as the Lowest Qualified Customer EPOGEN Net Price is lower than the Lowest EPOGEN Net Price, if either (a) the aggregate net sales for all EPOGEN purchased by any such Qualified Customer who received a Qualified Customer EPOGEN Net Price that is lower than the Lowest EPOGEN Net Price during a Quarter in which the Best Net EPOGEN Price Event occurs were greater than [*] percent ([*]%) of the aggregate net sales of EPOGEN to all purchasers in the Territory in such Quarter or (b) the aggregate net sales for all EPOGEN purchased during such Quarter by all Qualified Customers in the aggregate who received a Qualified Customer EPOGEN Net Price that is lower than the Lowest EPOGEN Net Price were greater than [*] percent ([*]%) of the aggregate net sales of EPOGEN to all purchasers in the Territory in such Quarter. Amgen’s calculation of the Best Net EPOGEN Price Rebate shall not take into account any reallocation of discounts for purposes of any reports filed under Title XVIII or Title XIX of the Social Security Act, under any health care program of a Governmental Authority or pursuant to any other Law. |
3.3.2 | Calculation of Best Net EPOGEN Price Rebate. Subject to the conditions set forth in Section 3.3.1 above, Amgen, shall calculate the amount of Dialysis Center’s Best Net EPOGEN Price Rebate for any Quarter by subtracting the Lowest Qualified Customer EPOGEN Net Price from the Lowest EPOGEN Net Price for such Quarter, and if the difference is positive, multiplying such difference by the number of IUs of EPOGEN purchased by Dialysis Center Purchasers in such Quarter. |
Best Net EPOGEN Price Rebate Illustration: |
[(Lowest EPOGEN Net Price – Lowest Qualified Customer EPOGEN Net Price) x (Number of IUs of EPOGEN purchased by Dialysis Center Purchasers in the Quarter)]* *If the foregoing product results in a negative number, such amount shall be deemed to equal zero. |
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3.3.3 | Payment of Best Net EPOGEN Price Rebate Amount. Amgen will pay the Best Net EPOGEN Price Rebate to Dialysis Center within ninety (90) days after the end of the corresponding Quarter. |
3.3.4 | Vesting of Best Net EPOGEN Price Rebate. The Best Net EPOGEN Price Rebate for a given Quarter shall vest on the last day of such Quarter. |
3.4 | Quarterly Report. Within ninety (90) days of the end of each Quarter, Amgen shall provide Dialysis Center as part of the Discount Reports required under Section 4.7 of the Agreement, a written statement of the Best Net Aranesp Price Rebate and the Best Net EPOGEN Price Rebate Dialysis Center has earned in such Quarter, if any, consistent with the requirements set forth in Section 4.7 of the Agreement. |
3.5 | Audit Rights. In the event Dialysis Center has a reasonable basis to believe that any Best Net Aranesp Price Rebate or Best Net EPOGEN Price Rebate data, calculations or determinations made by Amgen are inaccurate or incomplete in any material respect, Dialysis Center, shall provide Amgen an Objection Notice within thirty (30) days of the quarterly report and follow the Audit Process set forth in Section 4.3 of the Agreement to resolve any dispute regarding the Best Net Aranesp Price Rebate or Best Net EPOGEN Price Rebate. |
Exhibit B
Authorized Wholesalers
The below represents a list of wholesalers authorized for participation under the attached Agreement. Any changes must be made in accordance with Section 3.6 of the Agreement. Only purchases from wholesalers set forth on this List (as may be modified pursuant to such Section 3.6) shall be eligible for the discounts and fees set forth in the Agreement. Notice(s) regarding pricing and membership alignment for the Agreement shall be sent to the wholesalers that Dialysis Center has designated for such notification below. In the absence of any such designation, Amgen shall send pricing and membership alignment notices for the Agreement to those Authorized Wholesalers as designated by Dialysis Center in its previously executed Agreement.
AmerisourceBergen Corporation through its operating subsidiaries, AmerisourceBergen Drug Corporation and Bellco Drug Corp.
ASD Healthcare, a division of ASD Specialty Healthcare, Inc.
Cesar Castillo, Inc. dba Drougeria Castillo
McKesson Specialty Care Distribution Corporation, Div. of McKesson Corporation
Metro Medical Supply Inc.
Henry Schein, Inc.
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Exhibit C
Designated Affiliates List
[See Tab C – Designated Affiliates List in accompanying document
titled ‘Agreement No. 00135085 - Exhibits C, D & E’]
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Exhibit D
Managed Centers List
[See Tab D – Managed Centers List in accompanying document
titled ‘Agreement No. 00135085 - Exhibits C, D & E’]
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Exhibit E
Dialysis Center Committed Purchasers List
[See Tab E – Dialysis Center Committed Purchasers List in accompanying document
titled ‘Agreement No. 00135085 - Exhibits C, D & E’]
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Exhibit SR-1
Purchase Data Submission Form
Contract #: «Contract» Dialysis Center: [ ]
1. | [*]: [Enter Measurement Period (for example, Q4 2013)] |
ESA 1: [Product NameX]
ESA 2: [Product NameY]
ESA 3: [Product NameZ]
[Example 1 for illustration purposes only]
Dialysis Center Committed Purchasers | |
ESA | Total Number of Units [*] |
ESA 1 | 1,000 IU |
ESA 2 | XX mcg |
ESA 3 | 2,000 IU |
[Example 2 for illustration purposes only]
Dialysis Center Purchasers | |
ESA | Total Number of Units [*] |
ESA 1 | 1,000 IU |
ESA 2 | XX mcg |
ESA 3 | 2,000 IU |
2. | Number of Dialysis Center Purchasers’ patients who received any and each ESA or combination during the entire Measurement Period. |
[Example 1 for illustration purposes only]
ESA | Total Number of Patients |
ESA 1 | 50 |
ESA 2 | 10 |
ESA 3 | 5 |
[Example 2 for illustration purposes only]
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ESA | Total Number of Patients |
ESA 1 | 60 |
ESA 2 | |
[Example 3 for illustration purposes only]
ESA | Total Number of Patients |
ESA 1 | 100 |
ESA 3 | |
[Example 4 for illustration purposes only]
ESA | Total Number of Patients |
ESA 2 | 100 |
tESA 3 | |
Completed Data Submission Forms should be submitted electronically as an Excel file to Amgen by e-mail at Dialysissdata@amgen.com, or as otherwise specified in writing by Amgen.
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Schedule 1
Data
Category | Data Element | Facility | Patient |
Facility Reference | Facility Name | [ ] | |
Address | [ ] | ||
City, State, Zip | [ ] | ||
Phone | [ ] | ||
Facility ID (unique within account) | [ ] | ||
Regional ID (unique within account) | [ ] | ||
State in which facility is located | [ ] | ||
Patient Demographics | De-identified Patient ID | [ ] | |
Date of Service (Treatment Date) | [ ] | ||
Treatment Date/Date of Encounter (evaluated as treatment date) | [ ] | ||
Patient Birth Year Ranges (in ten year increments ) | [ ] | ||
First Dialysis Date | [ ] | ||
Date of Patient Death (month, day & year) | [ ] | ||
Date of Missed Treatments | [ ] | ||
Hospitalization Admission Date | [ ] | ||
Hospitalization Discharge Date | [ ] | ||
Hospitalization ICD9 Dx Code | [ ] | ||
Vascular Access Type (fistula, graft, catheter)* | [ ] | ||
Vascular Access Date* | [ ] | ||
Primary Payor (Govnt - Medicare, Medicaid, VA or Commercial - Medicare Advantage, MCO, HMO, PPO) | [ ] | ||
Secondary Payor (Govnt - Medicare, Medicaid, VA or Commercial - Medicare Advantage, MCO, HMO, PPO) | [ ] | ||
Medications | ESA Name | [ ] | |
ESA Dose ([*]) | [ ] | ||
EPOGEN Administration Frequency (On DVA offered Protocol) | [ ] | ||
Aranesp Administration Frequency* | [ ] | ||
Other ESA Administration Frequency* | [ ] | ||
ESA Route of Administration | [ ] | ||
ESA Start Date | [ ] | ||
ESA Stop Date (Missed dose due to held)* | [ ] | ||
IV Iron Name | [ ] | ||
IV Iron Dose | [ ] | ||
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IV Iron Administration Frequency (Maintenance / Loading)* | [ ] | ||
IV Iron Order (Not administered, stop)* | [ ] | ||
Vitamin D Name | [ ] | ||
Vitamin D Dose | [ ] | ||
Vitamin D Order (Stop date)* | [ ] | ||
Lab Measurements | Hemoglobin | [ ] | |
Hematocrit | [ ] | ||
Ferritin | [ ] | ||
Transferrin Saturation / Iron Saturation | [ ] | ||
Total Iron Binding Capacity (TIBC) | [ ] | ||
Parathyroid Hormone (iPTH or BiPTH) | [ ] | ||
Phosphorus | [ ] | ||
Corrected Calcium | [ ] | ||
Corrected Calcium Phosphorus Product | [ ] | ||
Albumin | [ ] | ||
Other Measurements | Body Mass Index (BMI) | [ ] | |
Body Surface Area | [ ] | ||
Interdialytic Weight Gain | [ ] | ||
Kt/v | [ ] | ||
URR (until CMS no longer requires) | [ ] | ||
Modality | [ ] | ||
PD treatments (# pts per month) | [ ] | ||
Home HD treatments (# pts per month)* | [ ] | ||
Home HD treatments (# txs per month) | [ ] | ||
* For designated fields, Dialysis Center will provide Amgen business rules to calculate value of the field based on the submitted Data.
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Schedule 2
Compensation Data
Product Data Submission Requirements. Compensation Data shall be sent in either Excel or a tab-delimited text file to the following email address: salesadj@amgen.com. The file naming convention shall include the Dialysis Center name, EPOGEN/Aranesp, and data month and year (i.e. DaVita_Epogen_January_2017). Dialysis Center must supply all of the information set forth in the table below.
ID | Data Field Name | Data Field Description |
1 | Unique Account Identifier | DaVita’s numeric identifier for each account (PFac & OFac) |
2 | Account Name | Account requesting EPOGEN/Aranesp |
3 | Account Street Address | Account requesting EPOGEN/Aranesp |
4 | Account City | Account requesting EPOGEN/Aranesp |
5 | Account State | Account requesting EPOGEN/Aranesp |
6 | Account zip | Account requesting EPOGEN/Aranesp |
7 | Dispensing Pharmacy for EPOGEN/Aranesp | DaVita’s numeric identifier for location that has dispensed EPOGEN/Aranesp |
8 | EPOGEN/Aranesp NDC Number | |
9 | EPOGEN/Aranesp Description | Name of EPOGEN/Aranesp including strength (Label Name) |
10 | Quantity Shipped | |
11 | Unit Of Measure | Tabs, bottles, vials, etc. |
12 | EPOGEN/Aranesp shipped/dispensed date | |
Page 54 of 54
Schedule 3
Available EPOGEN SKU Schedule
EPOGEN® (Epoetin alfa):
NDC | Description |
55513-126-10 | 2,000 Unit, 1 mL (2,000 Units/mL) single-use vial 10 vials/pack, 10 packs/case |
55513-267-10 | 3,000 Unit, 1 mL (3,000 Units/mL) single-use vial 10 vials/pack, 10 packs/case |
55513-148-10 | 4,000 Unit, 1 mL (4,000 Units/mL) single-use vial 10 vials/pack, 10 packs/case |
55513-144-10 | 10,000 Unit, 1 mL (10,000 Units/mL) single-use vial 10 vials/pack, 10 packs/case |
55513-283-10 | 20,000 Unit, 2 mL (10,000 Units/mL) multi-use vial 10 vials/pack, 4 packs/case |
55513-478-10 | 20,000 Unit, 1 mL (20,000 Units/mL) multi-use vial 10 vials/pack, 4 packs/case |
Available Aranesp SKU Schedule
Aranesp® (darbepoetin alfa)
Page 55 of 55
NDC | Description | |
Aranesp® SingleJect Prefilled Syringes | ||
55513-098-04 | 10 mcg, 0.4 mL (25 mcg/mL) single-use syringe 4 syringes/pack; 10 packs/case | |
55513-057-04 | 25 mcg, 0.42 mL (60 mcg/mL) single-use syringe 4 syringes/pack; 10 packs/case | |
55513-021-04 | 40 mcg, 0.4 mL (100 mcg/mL) single-use syringe 4 syringes/pack; 10 packs/case | |
55513-023-04 | 60 mcg, 0.3 mL (200 mcg/mL) single-use syringe 4 syringes/pack; 10 packs/case | |
55513-025-04 | 100 mcg, 0.5 mL (200 mcg/mL) single-use syringe 4 syringes/pack; 10 packs/case | |
55513-027-04 | 150 mcg, 0.3 mL (500 mcg/mL) single-use syringe 4 syringes/pack; 10 packs/case | |
55513-028-01 | 200 mcg, 0.4 mL (500 mcg/mL) single-use syringe 1 syringe/pack; 4 packs/case | |
55513-111-01 | 300 mcg, 0.6 mL (500 mcg/mL) single-use syringe 1 syringe/pack; 4 packs/case | |
55513-032-01 | 500 mcg, 1.0 mL (500 mcg/mL) single-use syringe 1 syringe/pack; 4 packs/case | |
Aranesp® Vials | ||
55513-002-04 | 25 mcg, 1.0 mL (25 mcg/mL) single-use vial 4 vials/pack; 10 packs/case | |
55513-003-04 | 40 mcg, 1.0 mL (40 mcg/mL) single-use vial 4 vials/pack; 10 packs/case | |
55513-004-04 | 60 mcg, 1.0 mL (60 mcg/mL) single-use vial 4 vials/pack; 10 packs/case | |
55513-005-04 | 100 mcg, 1.0 mL (100 mcg/mL) single-use vial 4 vials/pack; 10 packs/case | |
55513-006-01 | 200 mcg, 1.0 mL (200 mcg/mL) single-use vial 1 vial/pack; 4 packs/case | |
55513-110-01 | 300 mcg, 1.0 mL (300 mcg/mL) single-use vial 1 vial/pack; 4 packs/case | |
Page 56 of 56
Agreement No. 00135085 - Exhibit C - Designated Affiliates List
Customer SAP ID | Customer Name | Address Street | City | State | Zip | Customer HIN |
10082398 | DAVITA PDI EBENSBURG | 429 MANOR DR STE 650 | EBENSBURG | PA | 15931 | 004FEYV00 |
10180537 | DAVITA 5148 | 3812 E BELKNAP ST | FORT WORTH | TX | 76111 | 004HNJR00 |
10232394 | DAVITA 5075 | 7797 HOWELL BLVD | BATON ROUGE | LA | 70807 | 00AC5YP00 |
10136027 | DAVITA #1836 TREASURE VALLEY DIALYSIS PD UNIT | 3045 E ST LUKES ST STE 105 | MERIDIAN | ID | 83642 | 00BV77K00 |
10266786 | DAVITA #11022 ALSIP HOME TRAINING PD | 11500 S PULASKI RD STE 100 | ALSIP | IL | 60803 | 00EN56C00 |
10135029 | DAVITA GREENWOOD DIALYSIS CENTER | 1345 N LANSING AVE | TULSA | OK | 74106 | 00L4W2N00 |
10025642 | DAVITA MOUNT BAKER KIDNEY CENTER | 410 BIRCHWOOD AVE STE 100 | BELLINGHAM | WA | 98225 | 00VJVGP00 |
10279728 | DAVITA WALTON AT HOME 12613 | 13250 SERVICE RD | WALTON | KY | 41094 | 00Y0CGQ00 |
10025698 | DAVITA CAMELOT DIALYSIS CENTER | 1800 CAMELOT DR STE 100 | VIRGINIA BEACH | VA | 23454 | 00YQ6E800 |
10185075 | DAVITA FORT WAYNE AT HOME | 1940 BLUFFTON RD | FORT WAYNE | IN | 46809 | 00YVG6F00 |
10136768 | DAVITA RAVEN DIALYSIS CENTER | 3540 E BASELINE RD STE 110 | PHOENIX | AZ | 85042 | 011RJBN00 |
10167735 | DAVITA DIALYSIS JACKSONVILLE ARLINGTON | 929 UNIVERSITY BLVD N | JACKSONVILLE | FL | 32211 | 017GDQR00 |
10140096 | DAVITA MEMPHIS DOWNTOWN PD/AT HOME DIALYSIS # 1988 | 2076 UNION AVE FL 2 | MEMPHIS | TN | 38104 | 017P58A00 |
10138326 | DAVITA MONTCLARE DIALYSIS CENTER | 7009 W BELMONT AVE | CHICAGO | IL | 60634 | 018AM3800 |
10120602 | DAVITA STEUBENVILLE DIALYSIS | 1799 SINCLAIR AVE STE 1 | STEUBENVILLE | OH | 43953 | 018RYXV00 |
10135676 | DAVITA PASCUA YAQUI | 7490 S CAMINO DE OESTE | TUCSON | AZ | 85746 | 01BMTMD00 |
10027063 | DAVITA VANCE COUNTY DIALYSIS | 854 S BECKFORD DR | HENDERSON | NC | 27536 | 01JBM0H00 |
10067567 | DAVITA DUNMORE DIALYSIS | 1212 ONEILL HWY | DUNMORE | PA | 18512 | 01MRYQ200 |
10135291 | DAVITA SPRING BRANCH DIALYSIS | 1425 BLALOCK RD STE 100 | HOUSTON | TX | 77055 | 02093KY00 |
10138966 | DAVITA CARSON CITY DIALYSIS | 3246 N CARSON ST | CARSON CITY | NV | 89706 | 020CAMA00 |
10107843 | DAVITA OAKLAND PERITONEAL AT HOME | 5352 CLAREMONT AVE | OAKLAND | CA | 94618 | 023GHVX00 |
10176963 | DAVITA DRIFTWOOD DIALYSIS | 1808 S WEST AVE | FREEPORT | IL | 61032 | 023XR0T00 |
10064772 | DAVITA PARMA DIALYSIS CENTER | 6735 AMES RD | CLEVELAND | OH | 44129 | 026232F00 |
10082835 | DAVITA WOODFOREST DIALYSIS | 12626 WOODFOREST BLVD | HOUSTON | TX | 77015 | 02DA6GB00 |
10108496 | DAVITA FOSTER CITY DIALYSIS | 1261 E HILLSDALE BLVD STE 2 | FOSTER CITY | CA | 94404 | 02JYVDR00 |
10247931 | DAVITA 11068 GRAND BLANC | 8195 S SAGINAW ST | GRAND BLANC | MI | 48439 | 02R32NL00 |
10185608 | DAVITA BUFORD AT HOME 6194 | 1550 BUFORD HWY STE 1E | BUFORD | GA | 30518 | 02XHJBA00 |
10160952 | DAVITA NORTHEAST COLORADO DIALYSIS | 603 HOLLY DR | STERLING | CO | 80751 | 03CBY5T00 |
10055864 | DAVITA NORTH FULTON DIALYSIS | 1250 NORTHMEADOW PKWY STE 120 | ROSWELL | GA | 30076 | 03EQ5LX00 |
10135724 | DAVITA MERRILLVILLE DIALYSIS | 9223 TAFT ST | MERRILLVILLE | IN | 46410 | 03H9VK800 |
10138747 | DAVITA MARRERO DIALYSIS CENTER | 1908 JUTLAND DR | HARVEY | LA | 70058 | 03TC8AQ00 |
10054820 | DAVITA LONGVIEW DIALYSIS CENTER | 425 N FREDONIA ST | LONGVIEW | TX | 75601 | 040FBA400 |
10246067 | DAVITA 11803 WEST HAMILTON DIALYSIS | 1532 MAIN ST | HAMILTON | OH | 45013 | 042FECB00 |
10277414 | DAVITA OSLO DIALYSIS 11383 | 100 S US HIGHWAY 1 | VERO BEACH | FL | 32962 | 044GQXB00 |
Page 57 of 57
Customer SAP ID | Customer Name | Address Street | City | State | Zip | Customer HIN |
10135489 | DAVITA DUNDALK DIALYSIS | 14 COMMERCE ST | DUNDALK | MD | 21222 | 04AJLP700 |
10137158 | DAVITA 5988 PENNSAUKEN AT HOME DIALYSIS | 7024 KAIGHNS AVE | PENNSAUKEN | NJ | 8109 | 04AWTQT00 |
10133305 | DAVITA EAST FORT LAUDERDALE DIALYSIS CENTER | 1301 S ANDREWS AVE STE 101 | FORT LAUDERDALE | FL | 33316 | 04BB70X00 |
10135892 | DAVITA HOLLYWOOD DIALYSIS CENTER | 5108 W SUNSET BLVD | LOS ANGELES | CA | 90027 | 04DNX3400 |
10038910 | DAVITA MEMPHIS CENTRAL DIALYSIS | 889 DR MARTIN LUTHER KING JR DR | MEMPHIS | TN | 38126 | 04FYV4G00 |
10278148 | DAVITA TOWN PARK DIALYSIS 11307 | 401 TOWN PARK BLVD | EVANS | GA | 30809 | 04PB1GL00 |
10026854 | DAVITA VICTOR VALLEY DIALYSIS | 16049 KAMANA RD | APPLE VALLEY | CA | 92307 | 04VFH5000 |
10180191 | DAVITA 5231 SILVERBRIDGE AT HOME | 2410 ALFT LN STE 101 | ELGIN | IL | 60124 | 050AV5F00 |
10136807 | DAVITA SAINT LOUIS PARK DIALYSIS | 3505 LOUISIANA AVE S STE 200 | SAINT LOUIS PARK | MN | 55426 | 0560PAA00 |
10052584 | DAVITA NORTH LOOP EAST DIALYSIS | 7139 NORTH LOOP E | HOUSTON | TX | 77028 | 057PG0H00 |
10137521 | DAVITA HOOSIER HILLS DIALYSIS | 143 S KINGSTON DR | BLOOMINGTON | IN | 47408 | 05AM7PX00 |
10185614 | DAVITA FEDERAL WAY AT HOME 6022 | 1015 S 348TH ST | FEDERAL WAY | WA | 98003 | 05P47GL00 |
10256597 | DAVITA KIDNEY DIALYSIS CENTER, LLC AT HOME | 640 MARTIN LUTHER KING JR BLVD STE 200 | MACON | GA | 31201 | 05QQP1B00 |
10138693 | DAVITA YPSILANTI AT HOME | 2766 WASHTENAW RD | YPSILANTI | MI | 48197 | 05QR5MD00 |
10083996 | DAVITA OREGON KIDNEY CENTER | 5318 NE IRVING ST | PORTLAND | OR | 97213 | 061W21600 |
10133072 | DAVITA PDI ELMORE COUNTY | 125 HOSPITAL DR | WETUMPKA | AL | 36092 | 063MAAF00 |
10273094 | DAVITA LABURNUM DIALYSIS 11347 | 4352 S LABURNUM AVE | HENRICO | VA | 23231 | 066YVTY00 |
10260476 | DAVITA PARTRIDGE CREEK DIALYSIS 11207 | 46360 GRATIOT AVE | CHESTERFIELD | MI | 48051 | 068JD5F00 |
10253166 | DAVITA 11170 HULEN | 5832 S HULEN ST | FORT WORTH | TX | 76132 | 06MG6FT00 |
10054436 | DAVITA SOUTHWESTERN DALLAS | 204 E AIRPORT FWY | IRVING | TX | 75062 | 06RQBNL00 |
10025888 | DAVITA COLLEGE STATION DIALYSIS | 1640 BRIARCREST DR STE 100 | BRYAN | TX | 77802 | 06X535G00 |
10266788 | DAVITA 9759 QUENTIN CIRCLE | 966 ISABEL DR | LEBANON | PA | 17042 | 06X6PXV00 |
10082437 | DAVITA MISSION VALLEY | 1203 ST CLAIRE BLVD | MISSION | TX | 78572 | 0726LJJ00 |
10178780 | DAVITA BOYD DIALYSIS | 925 UNION ST | BANGOR | ME | 4401 | 07595ND00 |
10277848 | DAVITA BRIDGEVIEW DIALYSIS 11448 | 2480 US HIGHWAY 41 N STE J | HENDERSON | KY | 42420 | 07BC6QQ00 |
10135760 | DAVITA LAKEWOOD COMMUNITY DIALYSIS | 5919 LAKEWOOD TOWNE CENTER BLVD SW | TACOMA | WA | 98499 | 07H0QJX00 |
10254372 | DAVITA FRESNO NORTH HT AT HOME 09708 | 6655 N MILBURN AVE | FRESNO | CA | 93722 | 07HG78J00 |
10133822 | DAVITA RIVER CITY DIALYSIS | 1970 NORTHWESTERN AVE S | STILLWATER | MN | 55082 | 07JDA2F00 |
10133977 | DAVITA MAGNOLIA WEST AT HOME | 3660 PARK SIERRA DR STE 103 | RIVERSIDE | CA | 92505 | 07NHBXJ00 |
10019247 | MILLER COUNTY DIALYSIS UNIT | 816 EAST ST | TEXARKANA | AR | 71854 | 07VRH6G00 |
10070433 | DAVITA MERCED EAST DIALYSIS | 464 E YOSEMITE AVE STE B | MERCED | CA | 95340 | 07X11AG00 |
10179761 | DAVITA, INC | 419 VILLAGE DR | CARLISLE | PA | 17015 | 088Y0XB00 |
10139117 | DAVITA FAYETTEVILLE DIALYSIS | 509 E MILLSAP RD STE 111 | FAYETTEVILLE | AR | 72703 | 08BJM8W00 |
10274485 | DAVITA JERSEY CITY SUMMIT AT HOME 09787 | 418 SUMMIT AVE | JERSEY CITY | NJ | 7306 | 08CBDEM00 |
10264829 | DAVITA #9741 ROCHESTER AT HOME | 2660 S BROADWAY STE A | ROCHESTER | MN | 55904 | 08GGFWF00 |
10219677 | DAVITA HOME OPTIONS OF DOTHAN AT HOME | 1763 E MAIN ST | DOTHAN | AL | 36301 | 08JF8XB00 |
Page 58 of 58
Customer SAP ID | Customer Name | Address Street | City | State | Zip | Customer HIN |
10050542 | DAVITA SOUTHERN LANE DIALYSIS | 1840 SOUTHERN LN | DECATUR | GA | 30033 | 08KPJTT00 |
10187135 | DAVITA 4229 | 3190 N COUNTY ROAD 25A | TROY | OH | 45373 | 08L1E6E00 |
10052105 | DAVITA LAKE SAINT LOUIS | 200 BREVCO PLZ STE 202 | LAKE SAINT LOUIS | MO | 63367 | 08MCNKD00 |
10181165 | DAVITA HILLIARD AT HOME 05813 | 19133 HILLIARD BLVD | ROCKY RIVER | OH | 44116 | 08QA45H00 |
10138493 | DAVITA CORNHUSKER DIALYSIS | 505 CORNHUSKER RD STE 107 | BELLEVUE | NE | 68005 | 08T7FRE00 |
10181854 | DAVITA ROME AT HOME | 15 JOHN MADDOX DR NW | ROME | GA | 30165 | 090C1CY00 |
10132794 | DAVITA PLANO | 481 SHILOH RD | PLANO | TX | 75074 | 09ACMXE00 |
10111751 | DAVITA BALLENGER POINTE AT HOME DIALYSIS | 2262 S BALLENGER HWY | FLINT | MI | 48503 | 09FK13C00 |
10037477 | DAVITA SANTA FE SPRINGS DIALYSIS | 10012 NORWALK BLVD STE 190 | SANTA FE SPRINGS | CA | 90670 | 09GDWZX00 |
10254667 | DAVITA RAINBOW DIALYSIS LAHAINA 04477 | 305 KEAWE ST STE 503 | LAHAINA | HI | 96761 | 09QLNJQ00 |
10082406 | DAVITA SHORE DIALYSIS | 300 W SYLVANIA AVE STE 1 | NEPTUNE | NJ | 7753 | 09XT9HP00 |
10179459 | DAVITA LOS ALAMITOS | 4141 KATELLA AVE | LOS ALAMITOS | CA | 90720 | 0B0A2BY00 |
10037491 | DAVITA EDENTON DIALYSIS | 312 MEDICAL ARTS DR | EDENTON | NC | 27932 | 0B0FR8P00 |
10252863 | DAVITA 5024 DENTON | 3305 UNICORN LAKE BLVD | DENTON | TX | 76210 | 0B2KE3E00 |
10083666 | DAVITA RENAL CARE OF MEMPHIS NORTH | 4913 RALEIGH COMMON DR STE 100 | MEMPHIS | TN | 38128 | 0B3MKJ300 |
10134430 | DAVITA MIRAMAR KIDNEY CENTER | 2501 DYKES RD | HOLLYWOOD | FL | 33027 | 0B3P0AD00 |
10140737 | DAVITA, INC | 330 S LOLA LN STE 100 | PAHRUMP | NV | 89048 | 0B97ACD00 |
10095856 | DAVITA, INC | 297 PETE HOLLIS BLVD | GREENVILLE | SC | 29601 | 0BDG0DH00 |
10172846 | DAVITA #5862 MILL ST | N54W6135 MILL ST | CEDARBURG | WI | 53012 | 0BE4K3G00 |
10190554 | DAVITA, INC | 8219 ROCHESTER AVE | RANCHO CUCAMONGA | CA | 91730 | 0BGRV1E00 |
10139492 | DAVITA, INC | 1164 E ROUTE 130 | BURLINGTON | NJ | 8016 | 0BT81DQ00 |
10223252 | DAVITA 6372 | 3812 CENTER RD STE 101 | BRUNSWICK | OH | 44212 | 0BVEQ4E00 |
10133070 | DAVITA HAYWARD MISSION HILLS DIALYSIS | 1661 INDUSTRIAL PKWY W | HAYWARD | CA | 94544 | 0BW6CPE00 |
10095813 | DAVITA HARBOUR VIEW DIALYSIS | 1039 CHAMPIONS WAY STE 500 | SUFFOLK | VA | 23435 | 0C758NJ00 |
10083838 | DAVITA, INC | 4215 167TH ST | COUNTRY CLUB HILLS | IL | 60478 | 0CF0MGT00 |
10136361 | DAVITA OCALA AT HOME | 2860 SE 1ST AVE | OCALA | FL | 34471 | 0CGVEMN00 |
10051719 | DAVITA KATY DIALYSIS CENTER | 403 W GRAND PKWY S STE T | KATY | TX | 77494 | 0D159LD00 |
10133621 | DAVITA SOUTH LAS VEGAS DIALYSIS CENTER | 2250 S RANCHO DR STE 115 | LAS VEGAS | NV | 89102 | 0D2YHB500 |
10138098 | DAVITA SAINT PETERSBURG SOUTH | 2850 34TH ST S | SAINT PETERSBURG | FL | 33711 | 0D48XG200 |
10181207 | DAVITA DIALYSIS AT MANKATO CLINIC | 1400 MADISON AVE STE 400 | MANKATO | MN | 56001 | 0D881KE00 |
10139262 | DAVITA SOUTHEASTERN DIALYSIS CENTER KENANSVILLE | 305 BEASLEY ST | KENANSVILLE | NC | 28349 | 0DDZF1500 |
10135094 | DAVITA ROSEBUD DIALYSIS FACILITY | 1 SOLDIER CREEK RD | ROSEBUD | SD | 57570 | 0DK4T5Z00 |
10038120 | SOUTHWEST KIDNEY -DAVITA DIALYSIS #5660 PD DBA: ARROWHEAD LAKES - DIALYSIS CENTER | 20325 N 51ST AVE BLDG 11 STE 184 | GLENDALE | AZ | 85308 | 0DN2FVC00 |
10202381 | DAVITA FIVE RIVERS DIALYSIS | 4750 N MAIN ST | DAYTON | OH | 45405 | 0DNGHQN00 |
Page 59 of 59
Customer SAP ID | Customer Name | Address Street | City | State | Zip | Customer HIN |
10271977 | DAVITA 11074 GLENSIDE | 7001 W BROAD ST | RICHMOND | VA | 23294 | 0DQMMNY00 |
10105204 | DAVITA GRANITE CITY DIALYSIS CENTER | 9 AMERICAN VLG | GRANITE CITY | IL | 62040 | 0E0LGGV00 |
10083646 | DAVITA CARTERSVILLE RENAL CENTER | 203 S TENNESSEE ST | CARTERSVILLE | GA | 30120 | 0EGELQJ00 |
10027049 | DAVITA, INC | 2609 HOSPITAL RD | GOLDSBORO | NC | 27534 | 0ET7FE700 |
10083912 | DAVITA PLATTE WOODS DIALYSIS | 7667 NW PRAIRIE VIEW RD | KANSAS CITY | MO | 64151 | 0F2BGX500 |
10083662 | DAVITA MUNROE FALLS DIALYSIS | 265 N MAIN ST STE 1 | MUNROE FALLS | OH | 44262 | 0F4APM400 |
10135464 | DAVITA, INC | 16892 BOLSA CHICA ST | HUNTINGTON BEACH | CA | 92649 | 0F88CKR00 |
10106379 | DAVITA CORNELL ROAD DIALYSIS | 1700 NW 167TH PL STE 230 | BEAVERTON | OR | 97006 | 0FL75DP00 |
10136738 | DAVITA WILLIAMS STREET DIALYSIS | 2812 WILLIAMS ST | SAVANNAH | GA | 31404 | 0FVCGVX00 |
10111175 | DAVITA NORTHSIDE AT HOME #5923 | 930 MADISON AVE | PITTSBURGH | PA | 15212 | 0FYAKCJ00 |
10274186 | DAVITA SCHAUMBURG HOME TRAINING 11310 | 1156 S ROSELLE RD | SCHAUMBURG | IL | 60193 | 0G1LB8L00 |
10256823 | DAVITA BRANDYWINE DIALYSIS 11230 | 7651 MATAPEAKE BUSINESS DR STE 206 | BRANDYWINE | MD | 20613 | 0G31BFA00 |
10225818 | DAVITA MODEL CITY HOME TRAINING DIALYSIS | 1724 LEIGHTON AVE | ANNISTON | AL | 36207 | 0G49YWN00 |
10254702 | DAVITA SAVANNAH RIVERSIDE AT HOME 09703 | 540 E OGLETHORPE AVE | SAVANNAH | GA | 31401 | 0G71EHJ00 |
10102299 | DAVITA MORGAN AVENUE DIALYSIS | 2222 MORGAN AVE | CORPUS CHRISTI | TX | 78405 | 0GB54PP00 |
10052961 | DAVITA, INC | 1 OAKWOOD BLVD STE 100 | HOLLYWOOD | FL | 33020 | 0GC16ED00 |
10137845 | DAVITA LAKEWOOD CROSSING DIALYSIS CENTER | 1057 S WADSWORTH BLVD | LAKEWOOD | CO | 80226 | 0GC3P5P00 |
10264837 | DAVITA CAPE CORAL HOME TRAINING AT HOME 9764 | 3637 DEL PRADO BLVD S STE 202 | CAPE CORAL | FL | 33904 | 0GC57LP00 |
10228627 | LOWVILLE DIALYSIS CENTER | 7785 N STATE ST | LOWVILLE | NY | 13367 | 0GECTED00 |
10136935 | DAVITA MAPLE GROVE DIALYSIS UNIT | 15655 GROVE CIR N | MAPLE GROVE | MN | 55369 | 0GGQ73W00 |
10139396 | DAVITA CHERRY VALLEY DIALYSIS | 1627 W MAIN ST | NEWARK | OH | 43055 | 0GM0P0R00 |
10251511 | DAVITA EL PASO PERITONEAL DIALYSIS 05123 | 1310 MURCHISON DR STE C | EL PASO | TX | 79902 | 0GN0RWQ00 |
10081285 | DAVITA FORT STOCKTON DIALYSIS | 387 INTERSTATE 10 W | FORT STOCKTON | TX | 79735 | 0GNDX9M00 |
10136850 | DAVITA NORTH METRO DIALYSIS CENTER | 12365 HURON ST STE 500 | WESTMINSTER | CO | 80234 | 0GNWPPD00 |
10139584 | DAVITA CRESTVIEW HILLS | 400 CENTRE VIEW BLVD | CRESTVIEW HILLS | KY | 41017 | 0GV23P500 |
10136648 | DAVITA BOSTON POST ROAD DIALYSIS CENTER | 4026 BOSTON RD | BRONX | NY | 10475 | 0GVMMRA00 |
10135997 | DAVITA SOUTH SHORE DIALYSIS CENTER | 212 GULF FWY S | LEAGUE CITY | TX | 77573 | 0H4MX3700 |
10139343 | DAVITA OMNI DIALYSIS CENTER | 9350 KIRBY DR STE 110 | HOUSTON | TX | 77054 | 0H4YHAA00 |
10177780 | DAVITA #6196- SOUTH VALLEY AT HOME | 17815 VENTURA BLVD STE 100 | ENCINO | CA | 91316 | 0JDAWAC00 |
10251701 | DAVITA 1164 EMPORIA | 1616 INDUSTRIAL RD | EMPORIA | KS | 66801 | 0JFPV7P00 |
10230319 | DAVITA MODESTO ARCHWAY HOMETRAINING 05375 | 3001 HEALTH CARE WAY STE 101 | MODESTO | CA | 95356 | 0JPEJEJ00 |
10140180 | DAVITA, INC | 16101 N CLEVELAND AVE | FORT MYERS | FL | 33903 | 0JPFEFG00 |
10068923 | DAVITA, INC | 255 E NORTH ST | MADISONVILLE | KY | 42431 | 0JPXHCY00 |
10063225 | DAVITA DENVER DIALYSIS | 2900 N DOWNING ST STE C | DENVER | CO | 80205 | 0KDMTMY00 |
10112694 | DAVITA, INC | 1600 CENTRE PARK DR | ASHEVILLE | NC | 28805 | 0KKH9HB00 |
Page 60 of 60
Customer SAP ID | Customer Name | Address Street | City | State | Zip | Customer HIN |
10270099 | DAVITA AIR CAPITAL DIALYSIS 11244 | 1812 S SENECA ST STE 110 | WICHITA | KS | 67213 | 0KT2D3V00 |
10020622 | DAVITA LOUISA DIALYSIS | 2145 HIGHWAY 2565 | LOUISA | KY | 41230 | 0L5QHYV00 |
10136638 | DAVITA BURLEY DIALYSIS PD | 741 N OVERLAND AVE | BURLEY | ID | 83318 | 0L9428800 |
10083665 | DAVITA RENAL CARE OF MIDTOWN MEMPHIS | 1166 MONROE AVE | MEMPHIS | TN | 38104 | 0LA31RQ00 |
10182218 | DAVITA-ROXBURY AT HOME | 622 ROXBURY RD | ROCKFORD | IL | 61107 | 0LHFBC400 |
10138086 | DAVITA EASTGATE HOME TRAINING #2340 | 4435 AICHOLTZ RD | CINCINNATI | OH | 45245 | 0LTR32A00 |
10063233 | DAVITA LANCASTER DIALYSIS | 2424 W PLEASANT RUN RD | LANCASTER | TX | 75146 | 0LXRV0400 |
10110901 | DAVITA SOUTH BRONX DIALYSIS CENTER | 1940 WEBSTER AVE | BRONX | NY | 10457 | 0PLOHU900 |
10140244 | DAVITA PREMIERE DIALYSIS CENTER | 7612 ATLANTIC AVE | CUDAHY | CA | 90201 | 0XM3R9M00 |
10136051 | DAVITA WESTLAKE DALY CITY DIALYSIS CENTER | 2201 JUNIPERO SERRA BLVD | DALY CITY | CA | 94014 | 105CWFT00 |
10105260 | DAVITA SILVERADO DIALYSIS | 1100 TRANCAS ST STE 267 | NAPA | CA | 94558 | 10AF76300 |
10135728 | DAVITA, INC | 7335 YANKEE RD STE 101 | LIBERTY TWP | OH | 45044 | 10LQJLG00 |
10254700 | DAVITA 11056 EL DORADO | 2977 REDONDO AVE | LONG BEACH | CA | 90806 | 10M2TDV00 |
10081151 | DAVITA, INC | 1366 VICTORY BLVD | STATEN ISLAND | NY | 10301 | 10MHL8X00 |
10138790 | DAVITA INC | 2690 MONROEVILLE BLVD | MONROEVILLE | PA | 15146 | 10PBVXT00 |
10145674 | DAVITA NORTH BURLINGTON DIALYSIS | 2019 N CHURCH ST | BURLINGTON | NC | 27217 | 10RQ4CY00 |
10083919 | DAVITA CORPUS CHRISTI DIALYSIS | 2733 SWANTNER ST | CORPUS CHRISTI | TX | 78404 | 10UIU9G00 |
10151815 | DAVITA GENERAL BUTLER DIALYSIS | 329 FLOYD DR | CARROLLTON | KY | 41008 | 112XDHV00 |
10132975 | DAVITA DIALYSIS OF LITHONIA | 2485 PARK CENTRAL BLVD STE A | DECATUR | GA | 30035 | 11DHG5H00 |
10251190 | MANITO DIALYSIS, LLC | 750 W ROUTE 66 STE Q | GLENDORA | CA | 91740 | 11E2N5A00 |
10254698 | DAVITA CHILTON DIALYSIS 05457 | 425 M-B LN | CHILTON | WI | 53014 | 11EE7KL00 |
10137082 | DAVITA JASPER DIALYSIS CENTER | 671 3RD AVE | JASPER | IN | 47546 | 11EK89H00 |
10083663 | DAVITA WHITE PONDS DIALYSIS | 534 WHITE POND DR STE A | AKRON | OH | 44320 | 11K2DGH00 |
10175477 | DAVITA #5146 LUCAS COUNTY HOME TRAINING | 2702 NAVARRE AVE STE 203 | OREGON | OH | 43616 | 11K4WBX00 |
10271458 | DAVITA KIDNEY HM DOWNTOWN AT HM 09783 | 200 SAINT PAUL ST STE 5 | BALTIMORE | MD | 21202 | 11KBFEQ00 |
10136023 | DAVITA GRANT PARK DIALYSIS | 5000 NANNIE HELEN BURROUGHS AVE NE | WASHINGTON | DC | 20019 | 11KUCTL00 |
10133865 | DAVITA NEVADA DIALYSIS CENTER | 1510 W WARM SPRINGS RD | HENDERSON | NV | 89014 | 11QGT9A00 |
10225826 | DAVITA LANSDOWNE AT HOME 06374 | 44084 RIVERSIDE PKWY STE 240 | LEESBURG | VA | 20176 | 11VY6XY00 |
10221663 | DAVITA 2407 | 2550 S TELSHOR BLVD | LAS CRUCES | NM | 88011 | 120RP6P00 |
10138737 | DAVITA WHITE LANE DIALYSIS | 7701 WHITE LN STE D | BAKERSFIELD | CA | 93309 | 12182Q400 |
10178536 | DAVITA MOORHEAD AT HOME | 1710 CENTER AVE W STE 100 | DILWORTH | MN | 56529 | 126WWLM00 |
10061988 | DAVITA WESTPARK DIALYSIS | 6400 SOUTHWEST FWY STE G | HOUSTON | TX | 77074 | 12EEL5L00 |
10137621 | DAVITA CARMEL DIALYSIS | 180 E CARMEL DR | CARMEL | IN | 46032 | 12P9VFB00 |
10138451 | DAVITA INC | 1112 WASHINGTON SQUARE SHOPPING CTR | WASHINGTON | MO | 63090 | 12PWWL500 |
10161764 | DAVITA CEDAR RAPIDS | 5945 COUNCIL ST NE | CEDAR RAPIDS | IA | 52402 | 1361LFB00 |
10135870 | DAVITA AMELIA DIALYSIS | 15151 PATRICK HENRY HWY | AMELIA COURT HOUSE | VA | 23002 | 136X1LT00 |
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Customer SAP ID | Customer Name | Address Street | City | State | Zip | Customer HIN |
10140855 | DAVITA STERLING DIALYSIS | 46396 BENEDICT DR STE 100 | STERLING | VA | 20164 | 1379DWT00 |
10023606 | DAVITA SOUTH MEADOWS DIALYSIS | 10085 DOUBLE R BLVD STE 160 | RENO | NV | 89521 | 139NQD300 |
10063377 | DAVITA RIVER PARK DIALYSIS | 2010 S LOOP 336 W STE 200 | CONROE | TX | 77304 | 13B5D6300 |
10145857 | DAVITA NATIONAL TRAIL DIALYSIS | 171 S TUTTLE RD | SPRINGFIELD | OH | 45505 | 13C460Q00 |
10010620 | DAVITA LAKE JACKSON DIALYSIS | 450 THIS WAY ST | LAKE JACKSON | TX | 77566 | 145VQYT00 |
10136395 | DAVITA SAINT CHARLES | 2125 BLUESTONE DR | SAINT CHARLES | MO | 63303 | 147M7TY00 |
10136893 | DAVITA ATHENS EAST DIALYSIS | 2026 S MILLEDGE AVE STE A2 | ATHENS | GA | 30605 | 14CKQ5W00 |
10135976 | DAVITA RIVERTOWNE DIALYSIS CENTER | 6192 OXON HILL RD | OXON HILL | MD | 20745 | 14KF5MV00 |
10135702 | DAVITA FLORISSANT DIALYSIS | 100887 W FLORISSANT AVE | SAINT LOUIS | MO | 63136 | 14KH2QY00 |
10138817 | DAVITA WASHINGTON NURSING DIALYSIS | 2425 25TH ST SE | WASHINGTON | DC | 20020 | 14NWGTX00 |
10105333 | DAVITA GRANDVIEW DIALYSIS | 13812 S US HIGHWAY 71 | GRANDVIEW | MO | 64030 | 14QA1GM00 |
10064370 | DAVITA, INC | 72 CYPRESS CREEK PKWY | HOUSTON | TX | 77090 | 14TDPGG00 |
10182258 | DAVITA OLYMPIA AT HOME DIALYSIS #5954 | 335 COOPER POINT RD NW STE 1 | OLYMPIA | WA | 98502 | 14VNJ7D00 |
10270806 | DAVITA ALBERMARLE AT HOME 09780 | 101 DAVITA LN | ELIZABETH CITY | NC | 27909 | 1545Y3G00 |
10133341 | DAVITA TORRINGTON | 780 LITCHFIELD ST STE 100 | TORRINGTON | CT | 6790 | 157TM3V00 |
10136677 | DAVITA BAYTOWN | 4665 GARTH RD STE 900 | BAYTOWN | TX | 77521 | 158VMMH00 |
10134162 | DAVITA THREE CHOPT DIALYSIS | 8813 THREE CHOPT RD | RICHMOND | VA | 23229 | 15BH1DC00 |
10083650 | DAVITA SOUTH HOLLAND RENAL CENTER | 16136 S PARK AVE | SOUTH HOLLAND | IL | 60473 | 15JQ9C000 |
10139941 | DAVITA SHAKER SQUARE DIALYSIS | 12800 SHAKER BLVD STE 1 | CLEVELAND | OH | 44120 | 15NQAMF00 |
10275107 | DAVITA OCEANA DIALYSIS 11423 | 1375 OCEANA BLVD STE 114 | VIRGINIA BEACH | VA | 23454 | 15RQWFY00 |
10137382 | DAVITA #6090 E EVANSVILLE | 1312 PROFESSIONAL BLVD | EVANSVILLE | IN | 47714 | 15XDM0200 |
10136662 | DAVITA GRAPEVINE DIALYSIS | 1651 W NORTHWEST HWY | GRAPEVINE | TX | 76051 | 16765PE00 |
10138383 | DAVITA EASTON DIALYSIS | 500 CADMUS LN STE 201 | EASTON | MD | 21601 | 167MK0K00 |
10140092 | DAVITA SANFORD DIALYSIS | 1701 W 1ST ST | SANFORD | FL | 32771 | 169EQM600 |
10176935 | DAVITA, INC | 3147 OAK VALLEY DR | ANN ARBOR | MI | 48103 | 16D7WTG00 |
10216506 | DAVITA SOUTHLAND AT HOME 06376 | 3401 GLENDALE AVE STE 110 | TOLEDO | OH | 43614 | 16F4EBF00 |
10136927 | DAVITA MARSHALL DIALYSIS CENTER 00217 | 1420 E COLLEGE DR STE 600 | MARSHALL | MN | 56258 | 16GKVFH00 |