Common use of MANUFACTURER’S RESPONSIBILITIES Clause in Contracts

MANUFACTURER’S RESPONSIBILITIES. 3.1 Nothing in this agreement shall be construed as relieving the Manufacturer from its obligation to provide the Department National Rebates for the Covered Product(s). 3.2 In addition to the National Rebates, the Manufacturer will remit to the Department a State Supplemental Rebate for Covered Product(s) included on the PDL and/or RDL. 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 National Rebates. 3.3 Quarters shall be used in calculating both the National Rebates and the State Supplemental Rebate. 3.4 Absent a dispute raised pursuant to the Dispute Resolution section of this Agreement, Manufacturer shall make State Supplemental Rebate payments to the Department for each Quarter no later than the Rebate Payment Due Date. The Manufacturer is responsible for timely payment of the rebate by the Rebate Payment Due Date following receipt of, at a minimum, information on the number of Units paid, by NDC number. 3.5 The Manufacturer will pay the State Supplemental Rebate, including any applicable interest calculated in accordance with 42 U.S.C. § 1396b(d)(5). Interest on the Rebates payable this Agreement begins accruing 38 calendar days from receipt of Iowa’s Medicaid Utilization Information sent to the Manufacturer, and interest will continue to accrue until the postmark date of the Manufacturer’s payment. Rebate payments mailed more than 68 days from the date of invoice shall include interest, calculated in accordance with federal guidelines. 3.6 Nothing in this Agreement shall be construed as prohibiting 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 PDL and/or RDL. 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.” 3.7 Unless notified otherwise, the Manufacturer will send Rebate payments by certified mail, return receipt requested, to the Department Primary Billing Address identified on the first page of this Agreement.

MANUFACTURER’S RESPONSIBILITIES. 3.1 Nothing in this agreement shall be construed as relieving the Manufacturer from its obligation to provide the Department National Rebates for the Covered Product(s). 3.2 In addition to the National Rebates, the Manufacturer will remit to the Department a State Supplemental Rebate for Covered Product(s) included on the PDL and/or RDL. 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 National Rebates. 3.3 Quarters shall be used in calculating both the National Rebates and the State Supplemental Rebate. 3.4 Absent a dispute raised pursuant to the Dispute Resolution section of this Agreement, Manufacturer shall make State Supplemental Rebate payments to the Department for each Quarter no later than the Rebate Payment Due Date. The Manufacturer is responsible for timely payment of the rebate by the Rebate Payment Due Date following receipt of, at a minimum, information on the number of Units paid, by NDC number. 3.5 The Manufacturer will pay the State Supplemental Rebate, including any applicable interest calculated in accordance with 42 U.S.C. § 1396b(d)(5). Interest on the Rebates payable this Agreement begins accruing 38 calendar days from receipt of Iowa’s Medicaid Utilization Information sent to the Manufacturer, and interest will continue to accrue until the postmark date of the Manufacturer’s payment. Rebate payments mailed more than 68 days from the date of invoice shall include interest, calculated in accordance with federal guidelines. 3.6 Nothing in this Agreement shall be construed as prohibiting 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 PDL and/or RDL. 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.” 3.7 Unless notified otherwise, the Manufacturer will send Rebate payments by certified mail, return receipt requested, to the Department Primary Billing Address identified on the first page of this Agreement. 3.8 The Manufacturer must notify the Department if any Covered Product will be a Line Extension Drug. To the extent that applicable law requires redesignation of a Covered Product as a Line Extension Drug based on new indications, the Manufacturer shall notify the Department of any application to the Food and Drug Administration (FDA) for new indications for a Covered Product. This notification must occur no later than the date of the new indication application to the FDA.

MANUFACTURER’S RESPONSIBILITIES. 3.1 Nothing in this agreement shall be construed as relieving the Manufacturer from its obligation to provide the Department National Rebates for the Covered Product(s). 3.2 In addition to the National Rebates, the Manufacturer will remit to the Department a State Supplemental Rebate for Covered Product(s) included on the PDL and/or RDL. The supplemental rebate shall be paid based on utilization data for the Medicaid Population. 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 National Rebates. 3.3 Quarters shall be used in calculating both the National Rebates and the State Supplemental Rebate. 3.4 Absent a dispute raised pursuant to the Dispute Resolution section of this Agreement, Manufacturer shall make State Supplemental Rebate payments to the Department for each Quarter no later than the Rebate Payment Due Date. The Manufacturer is responsible for timely payment of the rebate by the Rebate Payment Due Date following receipt of, at a minimum, information on the number of Units paid, by NDC number. 3.5 The Manufacturer will pay the State Supplemental Rebate, including any applicable interest calculated in accordance with 42 U.S.C. § 1396b(d)(5). Interest on the Rebates payable this Agreement begins accruing 38 calendar days from receipt of Iowa’s Medicaid Utilization Information sent to the Manufacturer, and interest will continue to accrue until the postmark date of the Manufacturer’s payment. Rebate payments mailed more than 68 days from the date of invoice shall include interest, calculated in accordance with federal guidelines. 3.6 Nothing in this Agreement shall be construed as prohibiting 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 PDL and/or RDL. 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.” 3.7 Unless notified otherwise, the Manufacturer will send Rebate payments by certified mail, return receipt requested, to the Department Primary Billing Address identified on the first page of this Agreement. 3.8 The Manufacturer must notify the Department if any Covered Product will be a Line Extension Drug. To the extent that applicable law requires redesignation of a Covered Product as a Line Extension Drug based on new indications, the Manufacturer shall notify the Department of any application to the Food and Drug Administration (FDA) for new indications for a Covered Product. This notification must occur no later than the date of the new indication application to the FDA.

MANUFACTURER’S RESPONSIBILITIES. 3.1 Nothing in this agreement shall be construed as relieving the Manufacturer from its obligation to provide the Department DOM National Rebates for the Covered Product(s). 3.2 In addition to the National Rebates, the Manufacturer will remit to the Department DOM a State Supplemental Rebate for Covered Product(s) included on the PDL and/or RDLPDL. The Manufacturer shall pay to the Department DOM the State Supplemental Rebate amount in accordance with the formula set forth in Attachment B. This State Supplemental Rebate is in addition to the National Rebates. 3.3 Quarters shall be used in calculating both the National Rebates and the State Supplemental Rebate. 3.4 Absent a dispute raised pursuant to the Dispute Resolution section of this Agreement, Manufacturer shall make State Supplemental Rebate payments to the Department DOM for each Quarter no later than the Rebate Payment Due Date. The Manufacturer is responsible for timely payment of the rebate by the Rebate Payment Due Date following receipt of, at a minimum, information on the number of Units paid, by NDC number. 3.5 The Manufacturer will pay the State Supplemental Rebate, including any applicable interest calculated in accordance with 42 U.S.C. § 1396b(d)(5). Interest on the Rebates payable this Agreement begins accruing 38 calendar days from receipt of IowaMississippi’s Medicaid Utilization Information sent to the Manufacturer, and interest will continue to accrue until the postmark date of the Manufacturer’s payment. Rebate payments mailed more than 68 days from the date of invoice shall include interest, calculated in accordance with federal guidelines. 3.6 Nothing in this Agreement shall be construed as prohibiting 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 DOM prior to such action so that the Department DOM can negotiate with such third party for State Supplemental Rebates on such Covered Product or remove such Covered Product from the PDL and/or RDLPDL. 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.” 3.7 Unless notified otherwise, the Manufacturer will send Rebate payments by certified mail, return receipt requested, to the Department DOM Primary Billing Address identified on the first page of this Agreement.