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 th...
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 r...
MANUFACTURER’S RESPONSIBILITIES. In order for Part D coverage to be available for covered Part D drugs of a Manufacturer, the Manufacturer agrees to the following:
(a) To reimburse all applicable discounts provided by Part D sponsors on behalf of the Manufacturer for all applicable drugs having NDCs with the Manufacturer’s FDA-assigned labeler code(s) invoiced to the Manufacturer within a maximum of three (3) years of the date of dispensing based upon PDE information reported to CMS by Part D sponsors and utilized by CMS (or the TPA) to calculate the invoice.
(b) To pay each Part D sponsor within 38 calendar days of receipt from the TPA of the electronic invoice and Medicare Part D Discount Information for the quarterly applicable discounts included on the invoice provided by such Part D sponsor on behalf of the Manufacturer for all of the applicable drugs having NDCs with the Manufacturer’s FDA-assigned labeler code(s). The invoice will be calculated by CMS (or the TPA) based upon PDE information reported to CMS by such Part D sponsor during the specified quarter, which may include PDEs with dates of service from prior quarters. Receipt of the invoice shall be considered to be one (1) calendar day after the TPA electronically transmits the invoice to the Manufacturer or otherwise notifies the Manufacturer that it is available (e.g., it is posted on a secure web site for download).
(c) To provide the Secretary with all labeler codes covered under this Agreement and to promptly update such list with any additional labeler codes for applicable drugs.
(d) To collect and have available appropriate data, including data related to Manufacturer’s labeler codes, expiration date of NDCs, utilization and pricing information relied on by the Manufacturer to dispute quarterly invoices and any other data the Secretary determines are necessary to carry out the Discount Program, for a period of not less than 10 years from the date of payment of the invoice to ensure that it can demonstrate to the Secretary compliance with the requirements of the Discount Program.
(e) To comply with conditions in sections 1860D-14A and 1860D-43 of the Act as interpreted and applied by this Agreement and any changes to the Medicare statute that affect the Discount Program.
(f) To comply with the requirements imposed by the Secretary for purposes of administering the Discount Program.
(g) To pay all applicable discounts provided by Part D sponsors on behalf of the Manufacturer for all applicable drugs having NDCs with the ...
MANUFACTURER’S RESPONSIBILITIES. A. OBLIGATIONS FOR MODEL DRUGS
1. The Manufacturer agrees that Appendix I of this Addendum lists all currently marketed NDCs of the Manufacturer’s Model Drugs and agrees to promptly update such list with any additional NDCs.
2. The Manufacturer shall comply with all obligations in the Underlying Contract with respect to Model Drugs, including without limitation the obligation to reimburse all Applicable Discounts provided by Part D Sponsors for all Model Drugs without regard to the Special Rule for Supplemental Benefits.
B. DATA REPORTING & COOPERATION WITH MONITORING AND EVALUATION
1. The Manufacturer shall cooperate with CMS’s efforts to evaluate the effectiveness of the Model and shall participate in all Model-related monitoring, auditing, and evaluation. The obligation to cooperate in Model-related monitoring, auditing, and evaluation shall survive termination of the Manufacturer’s participation in the Model.
2. The Manufacturer shall submit to CMS, in a form, manner, frequency, and by a deadline specified by CMS data to monitor the real-time impact of the Model and to perform the requisite Model evaluation. The Manufacturer shall comply with any instructions regarding the collection and submission of data regarding the Manufacturer’s participation in Model. CMS will make a reasonable effort to limit data submission from the Manufacturer to data that are not readily available to CMS. CMS will not require information from the Manufacturer regarding any rebates or price concessions negotiated with Part D Sponsors as part of Model-related monitoring, auditing, and evaluation.
3. For the purposes of monitoring, the Manufacturer shall provide CMS, within 30 (thirty) calendar days of execution of this Addendum, the wholesale acquisition cost (WAC) of each NDC of each Model Drug and, for the term of the Addendum, provide CMS written notice within 30 (thirty) calendar days of any change in the WAC of the NDC of a Model Drug. Such notice shall include the date of the change, the previous WAC, and the new WAC. The Manufacturer acknowledges that WAC data is required by CMS to implement and evaluate the Model.
C. OTHER MODEL IMPLEMENTATION REQUIREMENTS Manufacturer shall:
1. Comply with all applicable laws governing its operation and participation in the Discount Program, except as specifically waived in writing for this Model in accordance with section 1115A(d) of the Act.
2. Not provide or offer funding, in kind resources, or any remuneration directly or indirec...
MANUFACTURER’S RESPONSIBILITIES. 4.1 The Manufacturer will calculate and provide the Department a CMS Rebate for the Covered Product(s), which includes the CMS Basic Rebate and CMS CPI Rebate, as appropriate. The CMS Rebate represents the discount obtained by multiplying the Units of the Covered Product(s) reimbursed by the Department in the preceding quarter by the per unit rebate amount provided to the Department by CMS. CMS will calculate the CMS Rebate amount in accordance with the Manufacturer’s CMS Agreement. The Manufacturer’s obligation for CMS Rebates will continue for the duration of the Manufacturer’s CMS Agreement.
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. shall pay to the Department the State Supplemental Rebate amount in accordance with the formula set forth in Attachment B. At no time shall the National Rebate amount plus the State Supplemental Rebate amount for any given product fall under 25.1% of the AMP of that Covered Product.
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 for 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. 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 (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 ra...
MANUFACTURER’S RESPONSIBILITIES. In order for the Secretary to authorize that a Statestate receive payment for the Manufacturer'smanufacturer's drugs under Title XIX of the Act, 42 U.S.C. Section 1396 et seq., the Manufacturermanufacturer agrees to the following: (a) To calculate and requirements as implemented by 42 CFR 447.510 and the following:
(a) The manufacturer shall identify an individual point of contact for the Legal, Invoice, and Technical contacts at a United States address to facilitate the necessary communications with states with respect to rebate invoice issues.
(b) Beginning with the quarter in which the National Drug Rebate Agreement (rebate agreement) is signed for all covered outpatient drugs of all labeler codes of a manufacturer, calculate, and report all required pricing data on every covered outpatient drug by NDC in accordance with section 1927 of the Act and as implemented by 42 CFR 447.510. Furthermore, except as provided under section V.(b). of this agreement, to make a Rebate Payment manufacturers are required to calculate a URA and make a rebate payment in accordance with each calculated URA to each State Medicaid Agency for the Manufacturer's Covered Outpatient Drugs paid for by the State Medicaid Agency during a quarter. A separate listing of all Covered Outpatient Drugs and other information, inmanufacturer's covered outpatient drug(s) by NDC paid for by the state during a rebate period. CMS may calculate a URA based on manufacturer-submitted product and pricing data and provide the URA to states in order to facilitate rebate billing. However, CMS’s URA calculation does not relieve the manufacturer of its responsibility to calculate the URA.
(c) In accordance with CMS's the specifications pursuant to Appendix A, must be submitted within 30 calendar days of entering into this agreement and be updated quarterly. The Manufacturer's quarterly report is to include all new NDC numbers and continue to list those NDC numbers for drugs no longer marketed. 5 (b Office of Management and Budget (OMB)-approved CMS-367c form, report all covered outpatient drugs and corresponding drug product, pricing, and related data to the Secretary, upon entering into this agreement. This information is to be updated as necessary to include new NDCs and updates to existing NDCs. CMS uses drug information listed with FDA, such as Marketing Category and Drug Type, to be able to verify that an NDC meets the definition of a covered outpatient drug, therefore, manufacturers should ensure ...
MANUFACTURER’S RESPONSIBILITIES. 3.1. Manufacturer will provide the Department with the National Unit Rebate Amount for the Contracted Product(s) in accordance with Manufacturer’s National Rebate Agreement.
MANUFACTURER’S RESPONSIBILITIES. 7.1 In support of Distributor's sales efforts to promote Product in the Territory, Manufacturer will furnish, at no cost to Distributor, (i) to the extent known and available to Manufacturer, medical literature regarding or relating to the Product, including abstracts of clinical studies and medical journal articles, (ii) sales and promotional materials as may be developed by Manufacturer, limited to technical data and technical journal reprints, and (iii) samples of Product in reasonable quantities, as requested by Distributor and agreed to by Manufacturer, each acting in good faith. Manufacturer will furnish information to aid in the orientation and training of Distributor's service and sales personnel.
7.2 Manufacturer will package the Product in conformance with the packaging specifications provided by Distributor. Distributor will provide camera-ready artwork for labels and packaging.
7.3 Manufacturer shall take such actions as are necessary (such as cutting off supply of Product) to prevent any domestic or foreign entity from distributing or selling, directly or indirectly, the Product in the Exclusive Market in the Territory.
7.4 Manufacturer shall, with the exception of an IND, underwrite the cost of any clinical studies necessary to support the Citizens Petition or other similar FDA filings. Distributor and Manufacturer shall jointly underwrite the cost of any mutually agreed upon clinical studies intended to broaden Product claims beyond the monograph. Neither party shall be obligated to file an IND or perform any clinical studies with respect to the Product.
7.5 Manufacturer shall give Distributor 180 days' written notice prior to discontinuing the manufacture of the Product and shall not discontinue manufacturing the Product prior to December 31, 1997 without Distributor's written approval, unless the Food and Drug Administration forbids production or distribution of the Product.
7.6 Manufacturer shall maintain a 30-day inventory of Product to meet Distributor's forecasted volume requirements provided to Manufacturer pursuant to Section 8.2.
MANUFACTURER’S RESPONSIBILITIES. 3.1 Manufacturer will provide DOM with the National Rebate for the Contracted Product(s) in accordance with the Manufacturer’s National Drug Rebate Agreement.
3.2 In addition to the National Rebates, the Manufacturer will remit to the DOM a State Supplemental Rebate for Covered Product(s) included on the PDL. The Manufacturer shall pay to the DOM the State Supplemental Rebate amount in accordance with the formula set forth in Attachment A. This State Supplemental Rebate is in addition to the National Rebates.
3.3 Absent a dispute raised pursuant to the Dispute Resolution section of this Agreement, Manufacturer shall pay the State Supplemental Rebate amount to DOM for each Quarter no later than the Rebate Payment Due Date. 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.
3.4 Manufacturer will pay the State Supplemental Rebate, including any applicable interest. Interest on the State Supplemental Rebates payable under Section 4.2 of this Agreement begins accruing 38 calendar days from the postmark date of the State Supplemental Rebate invoice sent to Manufacturer and will continue to accrue until the postmark date of Manufacturer’s payment. Interest on State Supplemental Rebates is calculated in the same manner as interest on the National Rebate:
(a) Obtain yield rates of weekly auction of 13-Week Treasury bills under Investment Rate% or in the DDR.
(b) Determine the date range for which interest is owed beginning with the 38th day from the invoice postmark date.
(c) Total the yield rates of each weekly auction for the period during which interest applies.
MANUFACTURER’S RESPONSIBILITIES. Pursuant to the Negotiation Program Agreement(s) including any applicable guidance, regulations and technical instructions describing the obligations thereunder and the MTF Program Agreement:
