Government Price Reporting. CAMBER will be responsible for all government price reporting obligations related to the Product, including all related expenses.
Government Price Reporting. With respect to the Product in the Territory, Auxilium shall be responsible for any and all price reporting, payment and rebate obligations ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. including average manufacturer price, best price, average sales price, non-federal average manufacturer price, and federal ceiling prices, and best price, under government healthcare programs including Medicare, Medicaid, 340B, Tricare, or VA, and any successor government program, including the accuracy and completeness of all reports relating thereto (“Government Price Reporting”).
Government Price Reporting. (a) “Governmental Price Reports” means (1) any and all data that may be reported relating to the Products under the Medicaid drug rebate program, including without limitation the Average Manufacturer Price (as defined at 42 U.S.C. § 1396r-8(k)(1)) (“AMP”) and the Best Price (as defined at 42 U.S.C. § 1396r-8(c)(1)(C)) and (2) Non-FAMP and Average Sales Price (as defined by 42 U.S.C. § 1395w-3a), and any and all data that may be reported relating to the Products under state drug price reporting requirements. “PHS Price Reports” means any and all data that may be used to calculate, submit, or otherwise offer a PHS price relating to the Products under a Pharmaceutical Pricing Agreement under section 340B of the Public Health Service Act, 42 U.S.C. 256b.
Government Price Reporting. From and after the Closing Date, MEDA will (a) calculate and/or collect government pricing data relating to the Business Products as required by the reporting requirements of applicable U.S. Governmental Entities, including under applicable rules and regulations relating * [***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8 and implementing regulations) and the Medicare program (42 U.S.C. § 1395w-3a and implementing regulations), and (b) timely certify and report such data to the applicable U.S. Governmental Entities, including the Center for Medicare and Medicaid Services of the U.S. Department of Health and Human Services. Should such U.S. Governmental Entities require the inclusion of pricing data from sales of Business Products by VIVUS with respect to a period ending on or prior to Closing, VIVUS will promptly provide MEDA with such data, together with all reasonable support and a certification of accuracy in form and substance reasonably satisfactory to MEDA, and MEDA will continue to provide such reports for as long as required by applicable Law. For the avoidance of doubt, nothing contained herein shall require MEDA to calculate, collect, certify or report any information related to any products bearing VIVUS’ National Drug Code or labeler code other than the Business Products. LABORATORY & STABILITY SERVICES: MEDA shall cause certain of the MEDA Personnel who are Transferred Employees to provide the following laboratory and stability testing services, including, without limitation, [***]*, [***]* and [***]*(to the extent still employed by MEDA):
Government Price Reporting. 8.5.1 Seller shall be responsible for submitting all Governmental Price Reports for all Product(s) bearing an NDC of Seller for all reporting periods ending on or before the Closing Date as required. Unless otherwise agreed, beginning with the reporting period in which the Closing Date occurs, Purchaser shall be responsible for submitting all Governmental Price Reports, with the exception of ASP, for Product(s) bearing an NDC of Seller. Effective with the reporting period in which the Closing Date occurs, Seller shall name Purchaser as a designee, with certification access, in the Drug Data Reporting for Medicaid system for purposes of reporting the Average Manufacturer Price (“AMP”) (as defined at 42 U.S.C. § 1396r-8(k)(1)) and the Best Price (as defined at 42 U.S.C. § 1396r-8(c)(1)(C)) and other required pricing data for the Product(s) bearing an NDC of Seller. If other Product(s) are reported to the CMS by Seller under the labeler of any Product(s), Seller shall remain as the Technical, Invoice and Legal contacts for such Product(s) with CMS. Beginning with the reporting period in which the Closing Date occurs, for ASP, Purchaser shall be responsible for calculating the ASP bearing an NDC of Seller and sending the mandated ASP data, including a signed, original certification document to a designated contact of Seller within five (5) days of the submission due date to CMS.
Government Price Reporting. 3.10.1 BMS agrees that, for each NDC-11 of any Product, it shall provide to Purchaser, within ten (10) days after the Purchase Closing Date, the following: (a) if the Purchase Closing Date occurs in calendar quarters 1, 2, or 3, BMS shall provide the Federal Ceiling Prices in effect during the calendar year in which the Purchase Closing Date occurs; (b) if the Purchase Closing Date occurs in calendar quarter 4, BMS shall provide both the Federal Ceiling Price in effect during the calendar year in which the Purchase Closing Date occurs and the calculated Federal Ceiling Price for the next calendar year; (c) commercial sales data required for Non-FAMP calculation for the current calendar quarter through the Purchase Closing Date, as well as such data for preceding calendar quarters within the federal fiscal year (October 1 - September 30) in which the Purchase Closing Date occurs; (d) relevant Non-FAMP data necessary to complete annual updates as required by Public Law 102-585 (the Veterans Health Care Act of 1992); and (e) all commercial sales data for the current calendar quarter through the Purchase Closing Date, as well as all such data for the preceding calendar quarters within the federal fiscal year (October 1 - September 30) in which the Purchase Closing Date occurs. All pricing data furnished by BMS pursuant to this subsection shall be provided in the same format that such data are provided by BMS to the Department of Veterans Affairs or in a format otherwise prescribed by Purchaser. For pricing and sales data that are required in order to submit Governmental Price Reports, but that are not themselves provided to the VA, BMS will furnish that data in a format agreed to between BMS and Purchaser.
Government Price Reporting. From and after the Closing, (a) Buyer shall be solely and exclusively responsible for submitting all PHS Price Reports required to be submitted at or after the Closing, as well as all Governmental Price Reports and other required pricing data required to be submitted at or after the Closing in the Drug Data Reporting for Medicaid system for purposes of reporting the Average Manufacturer Price (as defined at 42 U.S.C. § 1396r-8(k)(1)) and the Best Price (as defined at 42 U.S.C. § 1396r-8(c)(1)(C)), for all sales of Products and (b) Buyer shall be the Centers for Medicare and Medicaid Services Technical, Invoice and Legal contacts for the Product, in each case of the foregoing clauses (a) and (b) regardless of whether for a Product bearing an NDC of Seller or of Buyer. Seller shall provide to Buyer any pricing data readily available to Seller for Products sold prior to the Closing bearing an NDC of Seller to the extent reasonably necessary for Buyer to comply with its reporting obligations under the preceding sentence.
Government Price Reporting. From and after the Closing Date, MEDA will (a) calculate and/or collect government pricing data relating to the Business Products as required by the reporting requirements of applicable U.S. Governmental Entities, including under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8 and implementing regulations) and the Medicare program (42 U.S.C. § 1395w-3a and implementing regulations), and (b) timely certify and report such data to the applicable U.S. Governmental Entities, including the Center for Medicare and Medicaid Services of the U.S. Department of Health and Human Services. Should such U.S. Governmental Entities require the inclusion of pricing data from sales of Business Products by VIVUS with respect to a period ending on or prior to Closing, VIVUS will promptly provide MEDA with such data, together with all reasonable support and a certification of accuracy in form and substance reasonably satisfactory to MEDA, and MEDA will continue to provide such reports for as long as required by applicable Law. For the avoidance of doubt, nothing contained herein shall require MEDA to calculate, collect, certify or report any [***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. information related to any products bearing VIVUS’ National Drug Code or labeler code other than the Business Products. LABORATORY & STABILITY SERVICES: MEDA shall cause certain of the MEDA Personnel who are Transferred Employees to provide the following laboratory and stability testing services, including, without limitation, [***], [***] and [***] (to the extent still employed by MEDA):
Government Price Reporting. (a) KKUS will deliver to Cumberland the following government price reporting information for Product following the Closing, transactional detail that is necessary to perform post-Closing government price calculations such as “Average Manufacturer Price” or “AMP” (as defined in 42 U.S.C. § 1396r-8(k)(1) and 42 C.F.R. § 447.500 et seq., as may be amended from time to time), “Best Price” (as defined in 42 U.S.C. § 1396r-8(c)(1)(C) (relating to the definition of Best Price) and 42 C.F.R. § 447.500 et seq., as may be amended from time to time), and the “Non-Federal Average Manufacturer Price” or “Non-FAMP” and “
Government Price Reporting. 8.6.1 Sellers shall be responsible for submitting all Governmental Price Reports for all Product(s) bearing an NDC of Sellers for all reporting periods ending on or before the Transition Date. Unless otherwise agreed, beginning with the reporting period in which the Transition Date occurs, Purchasers shall be responsible for submitting all Governmental Price Reports for Product(s) bearing an NDC of Sellers. Effective with the reporting period in which the Transition Date occurs, Sellers shall name Purchasers as a designee, with certification access, in the Drug Data Reporting for Medicaid system for purposes of reporting the Average Manufacturer Price (“AMP”) (as defined at 42 U.S.C. § 1396r-8(k)(1)) and the Best Price (as defined at 42 U.S.C. § 1396r-8(c)(1)(C)) and other required pricing data for the Product(s) bearing an NDC of Sellers. If other product(s) are reported to the CMS by Sellers under the labeler of any Product(s), Sellers shall remain as the Technical, Invoice and Legal contacts for such Product(s) with CMS.
