Sunshine Act Reporting Clause Samples
The Sunshine Act Reporting clause requires parties, typically healthcare providers or manufacturers, to disclose certain financial relationships or payments to government authorities as mandated by the federal Sunshine Act. In practice, this means that any transfers of value, such as consulting fees, gifts, or travel expenses provided to physicians or teaching hospitals, must be accurately documented and reported. The core function of this clause is to promote transparency in financial interactions within the healthcare industry, thereby helping to prevent conflicts of interest and ensuring compliance with federal regulations.
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Sunshine Act Reporting. Auxilium shall be responsible for the reporting of matters required under the Sunshine Act and related state laws, if any, relating to the commercialization and promotion of the Product by Auxilium and GSK. GSK shall promptly provide to Auxilium all information that Auxilium notifies GSK in writing is required to be reported by Auxilium pursuant to the Sunshine Act or related state laws in connection with GSK’s commercialization and promotion of the Product, in a commercially reasonable electronic format designated by Auxilium. Notwithstanding the foregoing, GSK reserves the right to report matters as required under the Sunshine Act, related state laws or in accordance with GSK’s voluntary reporting policies. Auxilium shall promptly provide to GSK all reasonable information reasonably requested by GSK to enable GSK to fulfill its reporting obligations under the Sunshine Act, related state laws or GSK’s voluntary reporting policies; provided that GSK will provide Auxilium with excerpted copies of any such reports as they relate to the Product prior to filing thereof.
Sunshine Act Reporting. Each Party shall report any reportable payments or transfers of value that it makes to covered recipients pursuant to §6002 of the Affordable Care Act of 2010, and other similar laws in connection with Activities under this Agreement.
Sunshine Act Reporting. MGH understands and agrees that for purposes of complying with Company's reporting obligations under the Patient Protection and Affordable Care Act of 2010 (together with any regulations and official guidelines promulgated thereunder) and any applicable state reporting requirements, Company may collect, aggregate and report any and all payments made pursuant to this Agreement as research payments made to MGH.
Sunshine Act Reporting. 8.13.1 Bayer shall cooperate with Loxo in order for Loxo to meet its obligations to file with applicable U.S. federal, state and local government authorities pursuant to Law (including the Sunshine Act and Laws promulgated by U.S. states and local governments) information related to payments made and other transfers of value provided or activities conducted by Loxo. Reasonable Out-of-Pocket Costs incurred by Loxo to engage a Third Party to meet such reporting obligations shall be considered Co-Promotion Costs and included in the applicable Co-Promotion Budget.
8.13.2 To the extent that Bayer determines in its reasonable discretion, in consultation with Loxo, that Loxo’s activities pursuant to Section 8 with respect to the Co-Promotion of a Licensed Product in the Co-Promotion Territory and/or Development activities pursuant to Section 4 require Bayer to file with applicable U.S. federal, state or local government authorities pursuant to Law (including the Sunshine Act and Laws promulgated by U.S. states and local governments) information related to payments made and other transfers of value provided to healthcare professionals and healthcare organizations and other activities conducted by Loxo in each case solely with respect to a Licensed Product (“Reportable Data”), Loxo shall collect, maintain, prepare and provide to Bayer any Reportable Data and back-up documentation reasonably requested by Bayer in accordance with methodologies and intervals specified by Bayer, and shall advise Bayer if there is any respect in which it has been unable to do so. In providing such Reportable Data and back-up documentation to Bayer, Loxo shall certify in a written statement signed by an officer of Loxo that such Reportable Data and back-up documentation is true, complete and correct. For the avoidance of doubt, Bayer accepts no liability for the accuracy of such Reportable Data (except to the extent caused by Loxo’s adherence to methodologies provided by Bayer or to manipulation of the Reportable Data once delivered by Loxo to Bayer). By accepting such Reportable Data for reporting purposes pursuant to this [***] Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Confidential treatment has been requested with respect to this information.