Common use of MANUFACTURER’S RESPONSIBILITIES Clause in Contracts

MANUFACTURER’S RESPONSIBILITIES. 4.1 Nothing in this agreement shall be construed to relieve the Manufacturer from its obligation to provide the Department a CMS Rebate for the Covered Product(s), including but not limited to the CMS Basic Rebate and as appropriate, the CMS CPI Rebate (hereinafter referred to collectively as "CMS Rebates"). 4.2 In addition to the CMS Rebates described in Section 4.1 of this Agreement, the Manufacturer will remit to the Department a State Supplemental Rebate for Covered Product(s) included on the Preferred Drug List. The Manufacturer shall pay to the Department the State Supplemental Rebate amount in accordance with the formula set forth in Attachment B. This State Supplemental Rebate is in addition to the CMS Rebates. 4.3 The quarters to be used for calculating the Rebates in Sections 4.1 and 4.2 of this Agreement will be those ending on March 31, June 30, September 30 and December 31 of each calendar year during the term of this Agreement. 4.4 Each participating Manufacturer will be required to submit the supplemental rebate payment within thirty (30) days of the Manufacturer's receipt of the Rebate Summary from the Department. The Department shall submit the State Supplemental Rebate invoice to the Manufacturer within ninety (90) days after the fiscal quarter in which the Product was paid by the Department. The Manufacturer shall have no obligation for claims that are not submitted as part of the Rebate Summary from the Department. 4.5 The Manufacturer will pay the State Supplemental Rebate, including any applicable interest in accordance with Section 1903(d)(5) of the Act, pursuant to Section 1927 of the Social Security Act ('the ACT') (42 USC 1396r-8) Interest on the Rebates payable under Section 4.1 and 4.2 of this Agreement begins accruing 38 calendar days from receipt of the Department's invoice and supporting Rebate Summary sent to the Manufacturer and interest will continue to accrue until the postmark date of the Manufacturer's payment. For Rebates invoiced for first Contract Quarter [DATE] or thereafter, if the date of mailing of the Rebate payable under Section 4.2 of this Agreement is 69 days or more from the date of mailing of the invoice, the interest rate will be calculated as required under federal guidelines. For Rebates invoiced for first Contract Quarter [DATE] and thereafter, if the Department has not received the Rebates payable under Section 4.1 or 4.2 of this Agreement, including interest, within 180 days of the postmark date of the Department's invoice and supporting Rebate Summary sent to the Manufacturer, this Agreement will be deemed to be in default and will be terminated in accordance with Section 8.2 of this Agreement. Interest will not accrue on any amount withheld pursuant to Section 6.2. 4.6 The Manufacturer may deduct any overpayment from subsequent State Supplemental Rebates payable under this Agreement. In the event that no subsequent State Supplemental Rebates are payable, the Department will refund any such overpayment to the Manufacturer within thirty (30) days after an acknowledgement or final determination that the overpayment has been made. The Manufacturer will remit any underpayment to the Department within thirty (30) days after an acknowledgement or final determination that an underpayment has been made. 4.7 Nothing in this Agreement shall be construed to prohibit the Manufacturer from discontinuing production, marketing or distribution of any Covered Product or from transferring or licensing any Covered Product to a third party. If the Manufacturer elects to discontinue production, marketing or distribution of any Covered Product or to transfer or license any Covered Product to a third party, the Manufacturer shall make every reasonable effort to notify the Department prior to such action so that the Department can negotiate with such third party for State Supplemental Rebates on such Covered Product or remove such Covered Product from the Preferred Drug List and/or Recommended Drug List. Upon notification of the Manufacturer's election to discontinue production, marketing or distribution of any Covered Product or to transfer or license any Covered Product to a third party, the Covered Product shall be removed from the definition of "Covered Products." 4.8 Unless notified otherwise, the Manufacturer will send Rebate payments by certified mail, return receipt requested, to the following address. Check Payable to: State of Wyoming

Appears in 2 contracts

Samples: Medicaid Supplemental Drug Rebate Agreement, Medicaid Supplemental Drug Rebate Agreement

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MANUFACTURER’S RESPONSIBILITIES. 4.1 Nothing in this agreement shall be construed to relieve the Manufacturer from its obligation to provide the Department a CMS Rebate for the Covered Product(s), including but not limited to the CMS Basic Rebate and as appropriate, the CMS CPI Rebate (hereinafter referred to collectively as "CMS Rebates"). 4.2 In addition to the CMS Rebates described in Section 4.1 of this Agreement, the Manufacturer will remit to the Department a State Supplemental Rebate for Covered Product(s) included on the Preferred Drug List and/or Recommended Drug List. The Manufacturer shall pay to the Department the State Supplemental Rebate amount in accordance with the formula set forth in Attachment B. This State Supplemental Rebate is in addition to the CMS Rebates. 4.3 The quarters to be used for calculating the Rebates in Sections 4.1 and 4.2 of this Agreement will be those ending on March 31, June 30, September 30 and December 31 of each calendar year during the term of this Agreement. 4.4 Each participating Except as provided under Section 6.2, to make such rebate payments for each calendar quarter within 30 days after receiving from the State the Medicaid Utilization Information defined in this agreement. Although a specific amount of information has been defined in Section 3.9 of this agreement, the Manufacturer will be required to submit is responsible for timely payment of the supplemental rebate payment within thirty (30) 30 days of receiving, at a minimum, information on the Manufacturer's receipt number of the Rebate Summary from the Department. The Department shall submit the State Supplemental Rebate invoice to the Manufacturer within ninety (90) days after the fiscal quarter in which the Product was paid units paid, by the Department. The Manufacturer shall have no obligation for claims that are not submitted as part of the Rebate Summary from the DepartmentNDC number. 4.5 The Manufacturer will pay the State Supplemental Rebate, including any applicable interest in accordance with Section 1903(d)(5) of the Act, pursuant to Section 1927 of the Social Security Act ('the ACT') (42 USC 1396r-8) . Interest on the Rebates payable under Section 4.1 and 4.2 of this Agreement begins accruing 38 calendar days from receipt of the Department's invoice and supporting Rebate Summary Iowa’s Medicaid Utilization Information sent to the Manufacturer and interest will continue to accrue until the postmark date of the Manufacturer's ’s payment. For Rebates invoiced for first Contract Quarter [DATE] (YEAR) or thereafter, if the date of mailing of the Rebate payable under Section 4.2 of this Agreement is 69 days or more from the date of mailing of the invoice, Manufacturer shall include interest with payment of the interest rate Rebate. Interest will be calculated as required under federal guidelines. For Rebates invoiced for first Contract Quarter [DATE] and thereafter, if the Department has not received the Rebates payable under Section 4.1 or 4.2 of this Agreement, including interest, within 180 days of the postmark date of the Department's invoice and supporting Rebate Summary sent to the Manufacturer, this Agreement will be deemed to be in default and will be terminated in accordance with Section 8.2 of this Agreement. Interest will not accrue on any amount withheld pursuant to Section 6.2. 4.6 The Manufacturer may deduct any overpayment from subsequent State Supplemental Rebates payable under this Agreement. In the event that no subsequent State Supplemental Rebates are payable, the Department will refund any such overpayment to the Manufacturer within thirty (30) days after an acknowledgement or final determination that the overpayment has been made. The Manufacturer will remit any underpayment to the Department within thirty (30) days after an acknowledgement or final determination that an underpayment has been made. 4.7 Nothing in this Agreement shall be construed to prohibit the Manufacturer from discontinuing production, marketing or distribution of any Covered Product or from transferring or licensing any Covered Product to a third party. If the Manufacturer elects to discontinue production, marketing or distribution of any Covered Product or to transfer or license any Covered Product to a third party, the Manufacturer shall make every reasonable effort to notify the Department prior to such action so that the Department can negotiate with such third party for State Supplemental Rebates on such Covered Product or remove such Covered Product from the Preferred Drug List and/or Recommended Drug List. Upon notification of the Manufacturer's ’s election to discontinue production, marketing or distribution of any Covered Product or to transfer or license any Covered Product to a third party, the Covered Product shall be removed from the definition of "Covered Products." 4.8 4.7 Unless notified otherwise, the Manufacturer will send Rebate payments by certified mail, return receipt requested, to the following address. Check Payable to: State of Wyoming.

Appears in 1 contract

Samples: Medicaid Supplemental Drug Rebate Agreement

MANUFACTURER’S RESPONSIBILITIES. 4.1 Nothing in this agreement shall be construed to relieve the Manufacturer from its obligation to provide the Department a CMS Rebate for the Covered Product(s), including but not limited to the CMS Basic Rebate and as appropriate, the CMS CPI Rebate (hereinafter referred to collectively as "CMS Rebates"). 4.2 In addition to the CMS Rebates described in Section 4.1 of this Agreement, the Manufacturer will remit to the Department a State Supplemental Rebate for Covered Product(s) included on the Preferred Drug List and/or Recommended Drug List. The Manufacturer shall pay to the Department the State Supplemental Rebate amount in accordance with the formula set forth in Attachment B. This State Supplemental Rebate is in addition to the CMS Rebates. 4.3 The quarters to be used for calculating the Rebates in Sections 4.1 and 4.2 of this Agreement will be those ending on March 31, June 30, September 30 and December 31 of each calendar year during the term of this Agreement. 4.4 Each participating Manufacturer will be required to submit the supplemental rebate payment within thirty (30) days of the Manufacturer's ’s receipt of the Rebate Summary from the Department. The Department shall submit the State Supplemental Rebate invoice to the Manufacturer within ninety (90) days after the fiscal quarter in which the Product was paid by the Department. The Manufacturer shall have no obligation for claims that are not submitted as part of the Rebate Summary from the Department. 4.5 The Manufacturer will pay the State Supplemental Rebate, including any applicable interest in accordance with Section 1903(d)(5) of the Act, pursuant to Section 1927 of the Social Security Act ('the ACT') (42 USC 1396r-8) . Interest on the Rebates payable under Section 4.1 and 4.2 of this Agreement begins accruing 38 calendar days from receipt of the Department's ’s invoice and supporting Rebate Summary sent to the Manufacturer and interest will continue to accrue until the postmark date of the Manufacturer's ’s payment. For Rebates invoiced for first Contract Quarter [DATE] (YEAR) or thereafter, if the date of mailing of the Rebate payable under Section 4.2 of this Agreement is 69 days or more from the date of mailing of the invoice, the interest rate will be calculated as required under federal guidelines. For Rebates invoiced for first Contract Quarter [DATE] (YEAR) and thereafter, if the Department has not received the Rebates payable under Section 4.1 or 4.2 of this Agreement, including interest, within 180 days of the postmark date of the Department's ’s invoice and supporting Rebate Summary sent to the Manufacturer, this Agreement will be deemed to be in default and will be terminated in accordance with Section 8.2 of this Agreement. Interest will not accrue on any amount withheld pursuant to Section 6.2. 4.6 The Manufacturer may deduct any overpayment from subsequent State Supplemental Rebates payable under this Agreement. In the event that no subsequent State Supplemental Rebates are payable, the Department will refund any such overpayment to the Manufacturer within thirty (30) days after an acknowledgement or final determination that the overpayment has been made. The Manufacturer will remit any underpayment to the Department within thirty (30) days after an acknowledgement or final determination that an underpayment has been made. 4.7 Nothing in this Agreement shall be construed to prohibit the Manufacturer from discontinuing production, marketing or distribution of any Covered Product or from transferring or licensing any Covered Product to a third party. If the Manufacturer elects to discontinue production, marketing or distribution of any Covered Product or to transfer or license any Covered Product to a third party, the Manufacturer shall make every reasonable effort to notify the Department prior to such action so that the Department can negotiate with such third party for State Supplemental Rebates on such Covered Product or remove such Covered Product from the Preferred Drug List and/or Recommended Drug List. Upon notification of the Manufacturer's ’s election to discontinue production, marketing or distribution of any Covered Product or to transfer or license any Covered Product to a third party, the Covered Product shall be removed from the definition of "Covered Products." 4.8 Unless notified otherwise, the Manufacturer will send Rebate payments by certified mail, return receipt requested, to the following address. Check Payable to: State of Wyoming.

Appears in 1 contract

Samples: Medicaid Supplemental Drug Rebate Agreement

MANUFACTURER’S RESPONSIBILITIES. 4.1 Nothing in this agreement shall be construed to relieve the Manufacturer from its obligation to provide the Department a CMS Rebate for the Covered Product(s), including but not limited to the CMS Basic Rebate and as appropriate, the CMS CPI Rebate (hereinafter referred to collectively as "CMS Rebates"). 4.2 In addition to the CMS Rebates described in Section 4.1 of this Agreement, the Manufacturer will remit to the Department a State Supplemental Rebate for Covered Product(s) included on the Preferred Drug List. The Manufacturer shall pay to the Department the State Supplemental Rebate amount in accordance with the formula set forth in Attachment B. This State Supplemental Rebate is in addition to the CMS Rebates. 4.3 The quarters to be used for calculating the Rebates in Sections 4.1 and 4.2 of this Agreement will be those ending on March 3131st, June 3030th, September 30 30th and December 31 31st of each calendar year during the term of this Agreement. 4.4 Each participating Manufacturer will be required to submit the supplemental rebate payment within thirty (30) days of the Manufacturer's ’s receipt of the Rebate Summary from the Department. The Department shall submit the State Supplemental Rebate invoice to the Manufacturer within ninety (90) days after the fiscal quarter in which the Product was paid by the Department. The Manufacturer shall have no obligation for claims that are not submitted as part of the Rebate Summary from the Department. 4.5 The Manufacturer will pay the State Supplemental Rebate, including any applicable interest in accordance with Section 1903(d)(5) of the ActAct , pursuant to Section 1927 of the Social Security Act ('the ACT') (42 USC 1396r-8) Interest on the Rebates payable under Section 4.1 and 4.2 of this Agreement begins accruing 38 calendar days from receipt of the Department's ’s invoice and supporting Rebate Summary sent to the Manufacturer and interest will continue to accrue until the postmark date of the Manufacturer's ’s payment. For Rebates invoiced for first Contract Quarter [DATE] <YEAR>) or thereafter, if the date of mailing of the Rebate payable under Section 4.2 of this Agreement is 69 days or more from the date of mailing of the invoice, the interest rate will be calculated as required under federal guidelines. For Rebates invoiced for first Contract Quarter [DATE] <YEAR> and thereafter, if the Department has not received the Rebates payable under Section 4.1 or 4.2 of this Agreement, including interest, within 180 days of the postmark date of the Department's ’s invoice and supporting Rebate Summary sent to the Manufacturer, this Agreement will be deemed to be in default and will be terminated in accordance with Section 8.2 of this Agreement. Interest will not accrue on any amount withheld pursuant to Section 6.2. 4.6 The Manufacturer may deduct any overpayment from subsequent State Supplemental Rebates payable under this Agreement. In the event that no subsequent State Supplemental Rebates are payable, the Department will refund any such overpayment to the Manufacturer within thirty (30) days after an acknowledgement or final determination that the overpayment has been made. The Manufacturer will remit any underpayment to the Department within thirty (30) days after an acknowledgement or final determination that an underpayment has been made. 4.7 Nothing in this Agreement shall be construed to prohibit the Manufacturer from discontinuing production, marketing or distribution of any Covered Product or from transferring or licensing any Covered Product to a third party. If the Manufacturer elects to discontinue production, marketing or distribution of any Covered Product or to transfer or license any Covered Product to a third party, the Manufacturer shall make every reasonable effort to notify the Department prior to such action so that the Department can negotiate with such third party for State Supplemental Rebates on such Covered Product or remove such Covered Product from the Preferred Drug List and/or Recommended Drug List. Upon notification of the Manufacturer's ’s election to discontinue production, marketing or distribution of any Covered Product or to transfer or license any Covered Product to a third party, the Covered Product shall be removed from the definition of "Covered Products." 4.8 Unless notified otherwise, the Manufacturer will send Rebate payments by certified mail, return receipt requested, to the following address. Check Payable to: State of Wyoming.

Appears in 1 contract

Samples: Medicaid Supplemental Drug Rebate Agreement

MANUFACTURER’S RESPONSIBILITIES. 4.1 Nothing in this agreement shall be construed to relieve the Manufacturer from its obligation to provide the Department a CMS Rebate for the Covered Product(s), including including, but not limited to to, the CMS Basic Rebate and and, as appropriate, the CMS CPI Rebate (hereinafter referred to collectively as "CMS Rebates"). 4.2 In addition to the CMS Rebates described in Section 4.1 of this Agreement, the Manufacturer will remit to the Department a State Supplemental Rebate for Covered Product(s) included on the Preferred Drug List. The supplemental rebates shall be paid based on the utilization data for Medicaid members. The Manufacturer shall pay to the Department the State Supplemental Rebate amount in accordance with the formula set forth in Attachment B. A. This State Supplemental Rebate is in addition to the CMS Rebates. 4.3 The quarters to be used for calculating the Rebates in Sections 4.1 and 4.2 of this Agreement will be those ending on March 3131st, June 3030th, September 30 30th, and December 31 31st of each calendar year during the term of this Agreement. 4.4 Each participating Manufacturer will be required to submit the supplemental rebate payment within thirty (30) 30 days of the Manufacturer's ’s receipt of the Rebate Summary from the Department. The Department shall submit the State Supplemental Rebate invoice to the Manufacturer within ninety (90) 90 days after the fiscal quarter in which the Product was paid by the Department. The Manufacturer shall have no obligation for claims that are not submitted as part of the Rebate Summary from the Department. 4.5 The Manufacturer will pay the State Supplemental Rebate, including any applicable interest in accordance with Section 1903(d)(5) of the Act, pursuant to Section 1927 of the Social Security Act ('the ACT') (42 USC 1396r-8) . Interest on the Rebates payable under Section 4.1 and 4.2 of this Agreement begins accruing 38 calendar days from receipt of the Department's ’s invoice and supporting Rebate Summary sent to the Manufacturer and interest will continue to accrue until the postmark date of the Manufacturer's ’s payment. For Rebates invoiced for first Contract Quarter [DATE] (2023) or thereafter, if the date of mailing of the Rebate payable under Section 4.2 of this Agreement is 69 days or more from the date of mailing of the invoice, the interest rate will be calculated as required under federal guidelines. For Rebates invoiced for first Contract Quarter [DATE] (2023) and thereafter, if the Department has not received the Rebates payable under Section 4.1 or 4.2 of this Agreement, including interest, within 180 days of the postmark date of the Department's ’s invoice and supporting Rebate Summary sent to the Manufacturer, this Agreement will be deemed to be in default and will be terminated in accordance with Section 8.2 of this Agreement. Interest will not accrue on any amount withheld pursuant to Section 6.2. 4.6 The Manufacturer may deduct any overpayment from subsequent State Supplemental Rebates payable under this Agreement. In the event that no subsequent State Supplemental Rebates are payable, the Department will refund any such overpayment to the Manufacturer within thirty (30) 30 days after an acknowledgement or final determination that the overpayment has been made. The Manufacturer will remit any underpayment to the Department within thirty (30) 30 days after an acknowledgement or final determination that an underpayment has been made. 4.7 Nothing in this Agreement shall be construed to prohibit the Manufacturer from discontinuing production, marketing marketing, or distribution of any Covered Product or from transferring or licensing any Covered Product to a third party. If the Manufacturer elects to discontinue production, marketing marketing, or distribution of any Covered Product or to transfer or license any Covered Product to a third party, the Manufacturer shall make every reasonable effort to notify the Department prior to such action so that the Department can negotiate with such third party for State Supplemental Rebates on such Covered Product or remove such Covered Product from the Preferred Drug List and/or Recommended Drug List. Upon notification of the Manufacturer's ’s election to discontinue production, marketing marketing, or distribution of any Covered Product or to transfer or license any Covered Product to a third party, the Covered Product shall be removed from the definition of "Covered Products." 4.8 Unless notified otherwise, the Manufacturer will send Rebate payments by certified mail, return receipt requested, to the following address. Check Payable payable to: State South Dakota Department of WyomingSocial Services Division of Finance Attn: Drug Rebates 000 Xxxxxxxxx Xxxxx Pierre, SD 57501

Appears in 1 contract

Samples: Medicaid Supplemental Drug Rebate Agreement

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MANUFACTURER’S RESPONSIBILITIES. 4.1 Nothing in this agreement shall be construed to relieve the Manufacturer from its obligation to provide the Department a CMS Rebate for the Covered Product(s), including including, but not limited to to, the CMS Basic Rebate and and, as appropriate, the CMS CPI Rebate (hereinafter referred to collectively as "CMS Rebates"). 4.2 In addition to the CMS Rebates described in Section 4.1 of this Agreement, the Manufacturer will remit to the Department a State Supplemental Rebate for Covered Product(s) included on the Preferred Drug List. The supplemental rebates shall be paid based on the utilization data for both fee-for-service and managed care Medicaid members if managed care Medicaid members are subject to follow the Preferred Drug List adopted by the Department during the contract quarter. The Manufacturer shall pay to the Department the State Supplemental Rebate amount in accordance with the formula set forth in Attachment B. A. This State Supplemental Rebate is in addition to the CMS Rebates. 4.3 The quarters to be used for calculating the Rebates in Sections 4.1 and 4.2 of this Agreement will be those ending on March 3131st, June 3030th, September 30 30th and December 31 31st of each calendar year during the term of this Agreement. 4.4 Each participating Manufacturer will be required to submit the supplemental rebate payment within thirty (30) 30 days of the Manufacturer's ’s receipt of the Rebate Summary from the Department. The Department shall submit the State Supplemental Rebate invoice to the Manufacturer within ninety (90) 90 days after the fiscal quarter in which the Product was paid by the Department. The Manufacturer shall have no obligation for claims that are not submitted as part of the Rebate Summary from the Department. 4.5 The Manufacturer will pay the State Supplemental Rebate, including any applicable interest in accordance with Section 1903(d)(5) of the Act, pursuant to Section 1927 of the Social Security Act ('the ACT') (42 USC 1396r-8) . Interest on the Rebates payable under Section 4.1 and 4.2 of this Agreement begins accruing 38 calendar days from receipt of the Department's ’s invoice and supporting Rebate Summary sent to the Manufacturer and interest will continue to accrue until the postmark date of the Manufacturer's ’s payment. For Rebates invoiced for first Contract Quarter [DATE] (2017) or thereafter, if the date of mailing of the Rebate payable under Section 4.2 of this Agreement is 69 days or more from the date of mailing of the invoice, the interest rate will be calculated as required under federal guidelines. For Rebates invoiced for first Contract Quarter [DATE] (2017) and thereafter, if the Department has not received the Rebates payable under Section 4.1 or 4.2 of this Agreement, including interest, within 180 days of the postmark date of the Department's ’s invoice and supporting Rebate Summary sent to the Manufacturer, this Agreement will be deemed to be in default and will be terminated in accordance with Section 8.2 of this Agreement. Interest will not accrue on any amount withheld pursuant to Section 6.2. 4.6 The Manufacturer may deduct any overpayment from subsequent State Supplemental Rebates payable under this Agreement. In the event that no subsequent State Supplemental Rebates are payable, the Department will refund any such overpayment to the Manufacturer within thirty (30) 30 days after an acknowledgement or final determination that the overpayment has been made. The Manufacturer will remit any underpayment to the Department within thirty (30) 30 days after an acknowledgement or final determination that an underpayment has been made. 4.7 Nothing in this Agreement shall be construed to prohibit the Manufacturer from discontinuing production, marketing or distribution of any Covered Product or from transferring or licensing any Covered Product to a third party. If the Manufacturer elects to discontinue production, marketing or distribution of any Covered Product or to transfer or license any Covered Product to a third party, the Manufacturer shall make every reasonable effort to notify the Department prior to such action so that the Department can negotiate with such third party for State Supplemental Rebates on such Covered Product or remove such Covered Product from the Preferred Drug List and/or Recommended Drug List. Upon notification of the Manufacturer's ’s election to discontinue production, marketing or distribution of any Covered Product or to transfer or license any Covered Product to a third party, the Covered Product shall be removed from the definition of "Covered Products." 4.8 Unless notified otherwise, the Manufacturer will send Rebate payments by certified mail, return receipt requested, to the following address. Check Payable payable to: North Dakota Department of Human Services Fiscal Administration 000 Xxxx Xxxxxxxxx Xxxxxx, Xxxxxxxxxx 000 Xxxxxxxx, XX 00000-0000 5.1 Preferred Drug List: Preferred Products shall not be discouraged or disadvantaged in any way relative to any other drug product in its therapeutic class unless specifically stated otherwise in Attachment A of this Agreement. The Department may apply clinical edits, prior authorization, step therapy or similar utilization management controls to a Preferred Product that are consistent with, but not more restrictive than, the FDA-approved Prescribing Information as of the effective date of this Agreement. The Department may also apply other clinical edits, prior authorization, step therapy or similar utilization management controls equally to all products in a therapeutic class. The Department shall place Covered Products in an advantaged position relative to non-preferred Products regarding Preferred Drug List status, and depending on the designated preferred tier, the Department may place Covered products in an advantaged position relative to other preferred products (Step Utilization). Certain- Preferred drugs, including Step Utilization drugs may be subject to prior authorization, i.e., preferred but with prior authorization. The Department will comply with all provisions of Section 1927(d). 5.2 The Department will provide State Utilization Data for claims paid for fee-for- service and managed care Medicaid members if managed care Medicaid members are subject to follow the Preferred Drug List adopted by the Department during the contract quarter to the Manufacturer on a quarterly basis. Fee-for-service utilization data will be based on claims paid during a quarter. Managed Care utilization data will be based on claims paid with a date of Wyomingservice during a quarter. 5.3 The Department will maintain the data systems and audits as are necessary to ensure the accuracy of the data used to calculate the State Supplemental Rebates. In the event material discrepancies are discovered, the Department will promptly justify its data or make an appropriate adjustment, which may include a credit as to the amount of the Rebates, or a refund to the Manufacturer as the parties may agree. 5.4 The Department shall maintain electronic claims records for the most recent four Contract Quarters that will permit the Manufacturers to verify through an audit process the Rebate Summaries provided by the Department. The Department will also cooperate with the Manufacturer to develop mutually beneficial audit procedures, should such audit(s) be required to resolve disputes regarding Utilization Information. 5.5 Upon implementation of this Agreement, and from time to time thereafter, the Department and the Manufacturer will meet to discuss any data or data system improvements which are necessary or desirable to ensure that the data and any information provided by the Department to the Manufacturer are adequate for the purposes of this Agreement. 5.6 The Department warrants that it received CMS approval to receive State Supplemental Rebates for fee-for-service and managed care Medicaid members as provided under this Agreement and that the Manufacturer’s participation in the North Dakota Supplemental Drug Rebate Program will not affect the Manufacturer’s Best Price and the AMP.

Appears in 1 contract

Samples: Medicaid Supplemental Drug Rebate Agreement

MANUFACTURER’S RESPONSIBILITIES. 4.1 Nothing in this agreement shall be construed to relieve the Manufacturer from its obligation to provide the Department a CMS Rebate for the Covered Product(s), including but not limited to the CMS Basic Rebate and as appropriate, the CMS CPI Rebate (hereinafter referred to collectively as "CMS Rebates"). 4.2 In addition to the CMS Rebates described in Section 4.1 of this Agreement, the Manufacturer will remit to the Department a State Supplemental Rebate for Covered Product(s) included on the Preferred Drug List. The Manufacturer shall pay to the Department the State Supplemental Rebate amount in accordance with the formula set forth in Attachment B. This State Supplemental Rebate is in addition to the CMS Rebates. 4.3 The quarters to be used for calculating the Rebates in Sections 4.1 and 4.2 of this Agreement will be those ending on March 31, June 30, September 30 and December 31 of each calendar year during the term of this Agreement. 4.4 Each participating Manufacturer will be required to submit the supplemental rebate payment within thirty (30) days of the Manufacturer's ’s receipt of the Rebate Summary from the Department. The Department shall submit the State Supplemental Rebate invoice to the Manufacturer within ninety (90) days after the fiscal quarter in which the Product was paid by the Department. The Manufacturer shall have no obligation for claims that are not submitted as part of the Rebate Summary from the Department. 4.5 The Manufacturer will pay the State Supplemental Rebate, including any applicable interest in accordance with Section 1903(d)(5) of the Act, pursuant to Section 1927 of the Social Security Act ('the ACT') (42 USC 1396r-8) . Interest on the Rebates payable under Section 4.1 and 4.2 of this Agreement begins accruing 38 calendar days from receipt of the Department's ’s invoice and supporting Rebate Summary sent to the Manufacturer and interest will continue to accrue until the postmark date of the Manufacturer's ’s payment. For Rebates invoiced for first Contract Quarter [DATE] 2010 (YEAR) or thereafter, if the date of mailing of the Rebate payable under Section 4.2 of this Agreement is 69 days or more from the date of mailing of the invoice, the interest rate will be calculated as required under federal guidelines. For Rebates invoiced for first Contract Quarter [DATE] 2010 (YEAR) and thereafter, if the Department has not received the Rebates payable under Section 4.1 or 4.2 of this Agreement, including interest, within 180 days of the postmark date of the Department's ’s invoice and supporting Rebate Summary sent to the Manufacturer, this Agreement will be deemed to be in default and will be terminated in accordance with Section 8.2 of this Agreement. Interest will not accrue on any amount withheld pursuant to Section 6.2. 4.6 The Manufacturer may deduct any overpayment from subsequent State Supplemental Rebates payable under this Agreement. In the event that no subsequent State Supplemental Rebates are payable, the Department will refund any such overpayment to the Manufacturer within thirty (30) days after an acknowledgement or final determination that the overpayment has been made. The Manufacturer will remit any underpayment to the Department within thirty (30) days after an acknowledgement or final determination that an underpayment has been made. 4.7 Nothing in this Agreement shall be construed to prohibit the Manufacturer from discontinuing production, marketing or distribution of any Covered Product or from transferring or licensing any Covered Product to a third party. If the Manufacturer elects to discontinue production, marketing or distribution of any Covered Product or to transfer or license any Covered Product to a third party, the Manufacturer shall make every reasonable effort to notify the Department prior to such action so that the Department can negotiate with such third party for State Supplemental Rebates on such Covered Product or remove such Covered Product from the Preferred Drug List and/or Recommended Drug List. Upon notification of the Manufacturer's ’s election to discontinue production, marketing or distribution of any Covered Product or to transfer or license any Covered Product to a third party, the Covered Product shall be removed from the definition of "Covered Products." 4.8 Unless notified otherwise, the Manufacturer will send Rebate payments by certified mail, return receipt requested, to the following address. Check Payable to: State of Wyoming.

Appears in 1 contract

Samples: Medicaid Supplemental Drug Rebate Agreement

MANUFACTURER’S RESPONSIBILITIES. 4.1 Nothing in this agreement Agreement shall be construed to relieve the Manufacturer from its obligation to provide the Department a CMS Rebate for the Covered Product(s), including but not limited to the CMS Basic Rebate and as appropriate, the CMS CPI Rebate (hereinafter referred to collectively as "CMS Rebates"). 4.2 In addition to the CMS Rebates described in Section 4.1 of this AgreementRebate, the Manufacturer will remit to the Department a State Supplemental Rebate for Covered Product(s) included on the Preferred Drug ListPDL. The State Supplemental Rebate shall be paid based on the State Utilization Data for both fee-for-service and managed care Medicaid Members if managed care. Medicaid Members are required to follow the PDL adopted by the Department during the Contract Quarter, including prior quarter adjustments (“PQAs”). The Manufacturer shall pay to the Department the State Supplemental Rebate amount in accordance with the formula set forth in Attachment B. A. This State Supplemental Rebate is in addition to the CMS RebatesRebate. 4.3 The quarters Contract Quarters to be used for calculating the State Supplemental Rebates in Sections 4.1 and 4.2 of this Agreement will be those ending on March 31, June 30, September 30 30, and December 31 31, of each calendar year during the term of this Agreement. 4.4 Each participating Manufacturer will be required to submit the supplemental rebate State Supplemental Rebate payment within thirty (30) 30 days of the Manufacturer's ’s receipt of the Rebate Summary from the Department. The Department shall submit the State Supplemental Rebate invoice to the Manufacturer within ninety (90) days after the fiscal quarter in which the Product was paid by the Department. The Manufacturer shall have no obligation for claims that are not submitted as part of the Rebate Summary from the Department. 4.5 The Manufacturer will pay the State Supplemental Rebate, including any applicable interest in accordance with Section 1903(d)(5) of the Act, pursuant to Section 1927 of the Social Security Act ('the ACT') (42 USC 1396r-8) . Interest on the State Supplemental Rebates payable under Section Sections 4.1 and 4.2 of this Agreement begins accruing 38 calendar days from receipt of the Department's ’s invoice and supporting Rebate Summary sent to the Manufacturer and interest will continue to accrue until the postmark date of the Manufacturer's ’s payment. For State Supplemental Rebates invoiced for first Contract Quarter [DATE] (1Q2015) or thereafter, if the date of mailing of the State Supplemental Rebate payable under Section 4.2 of this Agreement is 69 days or more from the date of mailing of the invoice, the interest rate will be calculated as required under federal guidelines. For State Supplemental Rebates invoiced for first Contract Quarter [DATE] (1Q2015) and thereafter, if the Department has not received the State Supplemental Rebates payable under Section Sections 4.1 or 4.2 of this Agreement, including interest, within 180 days of the postmark date of the Department's ’s invoice and supporting Rebate Summary sent to the Manufacturer, this Agreement will be deemed to be in default and will be terminated in accordance with Section 8.2 of this Agreement. Interest will not accrue on any amount withheld pursuant to Section 6.2. 4.6 The Manufacturer may deduct any overpayment from subsequent State Supplemental Rebates payable under this Agreement. In the event that no subsequent State Supplemental Rebates are payable, the Department will refund any such overpayment to the Manufacturer within thirty (30) 30 days after an acknowledgement or final determination that the overpayment has been made. The Manufacturer will remit any underpayment to the Department within thirty (30) 30 days after an acknowledgement or final determination that an underpayment has been made. 4.7 Nothing in this Agreement shall be construed to prohibit the Manufacturer from discontinuing production, marketing marketing, or distribution of any Covered Product or from transferring or licensing any Covered Product to a third party. If the Manufacturer elects to discontinue production, marketing marketing, or distribution of any Covered Product or to transfer or license any Covered Product to a third party, the Manufacturer shall make every reasonable effort to notify the Department prior to such action so that the Department can negotiate with such third party for State Supplemental Rebates on such Covered Product or remove such Covered Product from the Preferred Drug List PDL and/or Recommended Drug List. Upon notification of the Manufacturer's ’s election to discontinue production, marketing marketing, or distribution of any Covered Product or to transfer or license any Covered Product to a third party, the Covered Product shall be removed from the definition of "Covered Products." 4.8 Unless notified otherwise, the Manufacturer will send State Supplemental Rebate payments by certified mail, return receipt requested, to the following address. Check Payable payable to: North Dakota Department of Health and Human Services Attn: Finance Division 000 Xxxx Xxxxxxxxx Xxxxxx, Department 325 Bismarck, ND 58505-0250 5.1 PDL: Preferred Products shall not be discouraged or disadvantaged in any way relative to any other drug product in its therapeutic class unless specifically stated otherwise in Attachment A of this Agreement. The Department may apply clinical edits, prior authorization, step therapy, or similar utilization management controls to a Preferred Product that are consistent with, but not more restrictive than, the FDA-approved Prescribing Information as of the effective date of this Agreement. The Department may also apply other clinical edits, prior authorization, step therapy, or similar utilization management controls equally to all products in a therapeutic class. The Department shall place Covered Products in an advantaged position relative to non-preferred products regarding PDL status, and depending on the designated preferred tier, the Department may place Covered Products in an advantaged position relative to other preferred products (Step Utilization). Certain preferred drugs, including Step Utilization drugs, may be subject to prior authorization, i.e., preferred but with prior authorization. The Department will comply with all provisions of Section 1927(d). 5.2 The Department will provide State Utilization Data for claims paid, including Prior Quarter Adjustments (PQAs), for fee-for- service and managed care Medicaid Members if managed care Medicaid Members are required to follow the PDL adopted by the Department during the Contract Quarter to the Manufacturer on a quarterly basis. Fee-for-service utilization data will be based on claims paid during a Contract Quarter. Managed Care utilization data will be based on claims paid with a date of Wyomingservice during a Contract Quarter. 5.3 The Department will maintain the data systems and audits as are necessary to ensure the accuracy of the data used to calculate the State Supplemental Rebates. 5.4 The Department shall maintain electronic claims records for the most recent four Contract Quarters that will permit the Manufacturers to verify through an audit process the Rebate Summaries provided by the Department. The Department will also cooperate with the Manufacturer to develop mutually beneficial audit procedures, should such audit(s) be required to resolve disputes regarding State Utilization Data. 5.5 Upon implementation of this Agreement, and from time to time thereafter, the Department and the Manufacturer will meet to discuss any data or data system improvements which are necessary or desirable to ensure that the data and any information provided by the Department to the Manufacturer are adequate for the purposes of this Agreement. 5.6 The Department warrants that it received CMS approval to receive State Supplemental Rebates for fee-for-service and managed care Medicaid Members as provided under this Agreement and that the Manufacturer’s participation in the North Dakota Supplemental Drug Rebate Program will not affect the Manufacturer’s Best Price and the AMP. 5.7 Department shall submit the State Supplemental Rebate invoice to Manufacturer within 90 days after the Contract Quarter in which the Covered Product(s) was paid by Department. State Supplemental Rebate invoices may be amended after submission to reflect newly adjudicated claims that reflect Covered Product(s) provided in the Contract Quarter covered by the quarterly State Supplemental Rebate invoice.

Appears in 1 contract

Samples: Medicaid Supplemental Drug Rebate Agreement

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