Submission of Data. In order to satisfy the requirements of this Section 1.1 and subject to the validity of a Certification as described in Article 4 of this Agreement, Dialysis Center, its Designated Affiliates and Eligible Managed Centers shall submit the following information to Amgen (or its designated data collection vendor) on a [DELETED] basis by the [DELETED] of the following [DELETED] (or the next business day if such last day is not a business day) : (i) all [DELETED] for each dialysis patient and the date of each such test (including test results for patients from at least [DELETED] of its Designated Affiliates and Eligible Managed Centers); (ii) a consistent, unique, alpha-numeric case identifier for each patient (which shall be sufficient to consistently track an individual patient without constituting Individually Identifiable Health Information or enabling identification of any previously de-identified data); and (iii) the name, address and phone number of the physical location at which such patient received treatment; 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 that a Certification (as such term is defined in Article 4 of the Agreement) is not valid for any period in which Dialysis Center is otherwise obligated, pursuant to this Section 1.1.3 of this Exhibit 3.1, to submit Data, Dialysis Center shall independently calculate the appropriate clinical outcomes in accordance with the terms of this Section 1.1.3 of this Exhibit 3.1 and deliver the results of such outcome calculations in writing to Amgen, which submission to Amgen shall: (i) be deemed to satisfy Dialysis Center’s obligations under this Section 1.1.3 of this Exhibit 3.1 related to delivery of Data; and (ii) to the extent the [DELETED] is met following any such calculation by Dialysis Center, entitle Dialysis Center to continue to earn and receive incentives and rebates available under this Exhibit 3.1, in each case until such time as a Certification is then valid and Dialysis Center may resume submission of Data to Amgen. Upon such Certification, Dialysis Center shall submit to Amgen all Data dating back to the date Dialysis Center stopped submitting Data to Amgen within thirty (30) days. As described in Article 4 of the Agreement, to the extent Dialysis Center conducts such calculations, the calculation of Dialysis Center shall be definitive for purposes of determining whether the required incentive has been satisfied; provided, however Amgen shall reserve the right in its discretion to verify and audit all such calculations, either directly or through a third party, subject to the execution and delivery of appropriate agreements regarding confidentiality and compliance with laws, including HIPAA.
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Submission of Data. In order to satisfy the requirements of this Section 1.1 and subject Subject to the validity of a Certification as described in Article 4 of this Agreement, Dialysis Center, its Designated Affiliates and Eligible Managed Centers shall submit the following information Data items to Amgen (or its designated data collection vendor) on a [DELETED] basis by the [DELETED] of the following [DELETED] (or the next business day if such last day [DELETED] is not a business day) 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. Such data files shall contain record counts for each file contained in the data submission.) in accordance with the data submission requirements contained in Article 3 of this Exhibit 3.1: (i) all [DELETED] for each dialysis patient and the date of each such test (including test results for patients from at least [DELETED] of by Dialysis Center, its Designated Affiliates and Eligible Managed Centers); (ii) a consistent. In the event [DELETED] data is submitted, uniqueinstead of [DELETED] data, alpha-numeric case identifier Amgen will convert such [DELETED] data values to [DELETED] values by [DELETED]. Amgen will take all such converted lab values taken of [DELETED] for each patient by Dialysis Center, its Designated Affiliates and Eligible Managed Centers into the [DELETED] for each patient by Dialysis Center, its Designated Affiliates and Eligible Managed Centers for each [DELETED] Measurement Period (which as defined below). Each [DELETED] only the most recent test results will be submitted for each patient, and all or some of those test results may be from that [DELETED] or from a prior [DELETED]. Dialysis Center hereby covenants that the Data submitted for each Designated Affiliate and Eligible Managed Center shall be sufficient to consistently track an individual patient without constituting Individually Identifiable Health Information or enabling identification include the required results from all dialysis patients of any previously desuch Designated Affiliate and Eligible Managed Center, and shall not include results from non-identified data); and (iii) the name, address and phone number of the physical location at which such patient received treatmentpatients; 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. Dialysis Center also (i) covenants that it shall not submit any Data that it has any reason to believe is or is likely to be incorrect, and (ii) represents and warrants that is authorized to make this certification on behalf of all Designated Affiliate and Eligible Managed Center submitting data. To the extent that a Certification (as such term is defined in Article 4 of the Agreement) is not valid for any period in which Dialysis Center is otherwise obligated, pursuant to this Section 1.1.3 Article 6 of this Exhibit 3.1, to submit Data, Dialysis Center shall independently calculate the appropriate clinical outcomes in accordance with the terms of this Section 1.1.3 Article 6 of this Exhibit 3.1 and deliver the results of such clinical outcome calculations in writing to Amgen, which submission to Amgen shall: (i) be deemed to satisfy Dialysis Center’s obligations under this Section 1.1.3 Article 6 of this Exhibit 3.1 related to delivery of Data; and (ii) to the extent the clinical requirements necessary to receive the [DELETED] is Incentive are met following any such calculation by Dialysis Center, entitle Dialysis Center to continue to earn earn, and if earned, receive incentives and rebates available under this Exhibit 3.1the [DELETED] Incentive described herein, in each case until such time as a Certification is then valid and Dialysis Center may resume resumes submission of Data to Amgen. Upon such Certification, Dialysis Center shall submit to Amgen all Data dating back to the date Dialysis Center stopped submitting Data to Amgen within thirty (30) days[DELETED]. As described in Article 4 of the Agreement, to the extent Dialysis Center conducts such calculations, the calculation of Dialysis Center shall be definitive for purposes of determining whether the required incentive has been satisfied; provided, however Amgen shall reserve the right in its discretion to verify and audit all such calculations, either directly or through a third party, subject to the execution and delivery of appropriate agreements regarding confidentiality and compliance with laws, including HIPAA.
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