Compliance History Clause Samples

Compliance History. M▇▇▇▇ shall provide Medtronic with a review of M▇▇▇▇’▇ regulatory compliance history, which, in the U.S. shall include, but not be limited to: (i) any Form FDA 483 List of Inspectional Observations from FDA inspections conducted within the last five (5) years and any related correspondence between the M▇▇▇▇ and FDA; (ii) any FDA warning letters and related correspondence between the M▇▇▇▇ and FDA within the last five (5) years; and (iii) all reports and/or findings from any third party audits, including, but not limited to audits conducted by a Notified Body, and related correspondence between the M▇▇▇▇ and the third party auditor, within the last five (5) years.

Compliance History. This section contains a summary of the compliance history for this facility and was obtained from documentation contained in the District’s administrative file.

Compliance History. Supplier shall provide 4C with a review of Supplier’s regulatory compliance history, which shall include, but not be limited to: (i) any reports and/or records from Regulatory Authority inspections conducted within the last five (5) years and any related correspondence between Supplier and any Regulatory Authority; (ii) any warning letters and related correspondence between Supplier and any Regulatory Authority within the last five (5) years; (iii) all reports and/or findings from any third party audits, and related correspondence between Supplier and the third party auditor, within the last five (5) years, and (iv) notice of any regulatory matters relating to Supplier’s other buyers directly or indirectly due to Supplier’s Manufacturing responsibilities.

Compliance History. Has the facility been subject to an official enforcement action regarding its operation, including but not limited to, a notice of violation or noncompliance with a statute, regulation, or permit condition within the last five years? ☐ Yes If yes, please describe below and provide copies of each enforcement action with this application. ☐ No Description of official enforcement actions in the last five years:

Compliance History. Vention shall provide Nevro with a review of Vention’s regulatory compliance history related to the Products or related to the manufacturing processes used to manufacture the Products. ¨ x ¨

Compliance History. To the extent permissible at law, upon CUSTOMER’s reasonable written request, H▇▇▇▇▇ shall provide CUSTOMER with a review of H▇▇▇▇▇’▇ regulatory compliance history to the extent relating to the Products supplied to CUSTOMER consisting of: (i) any reports and/or records from Government Authority inspections conducted within the last five (5) years and any related correspondence between H▇▇▇▇▇ and any Government Authority; (ii) any warning letters and related correspondence between H▇▇▇▇▇ and any Government Authority within the last five (5) years; (iii) all reports and/or findings from any third party audits, and related correspondence between H▇▇▇▇▇ and the third party auditor, within the last five (5) years; and (iv) any other relevant reports regarding the Products supplied to CUSTOMER reasonably requested by CUSTOMER.

Compliance History. ​ Upon request, Business Partner will provide COMPANY with a review of Business Partner's regulatory compliance history, which will include: (i) any observations or findings from inspections conducted by any regulatory body with authority over the Business Partners Product(s) within the last five years, and (ii) any related correspondence between the Business Partner and the associated regulatory body within the last five years. ​ ​ ​ ​ PROPRIETARY AND CONFIDENTIAL Page 42 of 56 ​ ​ SECTION 1: JOINT MARKETING

Compliance History. At SRS, waste materials regulated under the Resource Conservation and Recovery Act (RCRA) are managed in accordance with the requirements of RCRA. Certain SRS activities have required treatment, storage, disposal or post-closure permits under RCRA. Non-regulatory units, called solid waste management units (SWMU), include any activity where hazardous constituents may remain uncontrolled and may potentially release to the environment. Investigation and potential corrective action for these SWMU(s) are mandated under RCRA 3004(u). In 1995, SRS received a hazardous waste permit from the South Carolina Department of Health and Environmental Control (SCDHEC) which includes corrective action requirements. Specifically, part V of the permit mandates that SRS establish and implement a RCRA Facility Investigation (RFI) Program to fulfill the requirements specified in Section 3004(u) of RCRA. <IMG SRC 97026E> <IMG SRC 97026F> Hazardous substances, as defined by CERCLA, are also present in the environment at SRS. On December 21, 1989, SRS was placed on the National Priorities List (NPL). A site placed on the NPL comes under the requirements of CERCLA. In accordance with Section 120 of CERCLA, DOE has entered into an FFA with the EPA and SCDHEC to coordinate cleanup activities at SRS into one comprehensive strategy that fulfills RCRA Section 3004(u) and CERCLA assessment, investigation, and response action requirements. The remedial investigation for Grace Road Site was completed in 1994. The results of the investigation indicate that there is no impact (or potential impact) to human health or the environment from the Grace Road Site. Therefore, no action is warranted. No other alternatives were considered. According to EPA guidance, if there is no current or potential threat to human health and the environment and no action is warranted, the CERCLA 121 requirements are not triggered. This means that there is no need to evaluate other alternatives or the no action alternative against the nine criteria specified under CERCLA. The remedy selected satisfies both the CERCLA and RCRA 3004(u) requirements. The SCDHEC has modified the SRS RCRA permit to incorporate the selected remedy. Public participation requirements are listed in Sections 113 and 117 of CERCLA. These requirements include the establishment of an Administrative Record File that documents the selection of remedial alternatives and allows for review and comment by the public regarding those alternatives. The A...

Compliance History. Aran shall provide Anteris with a review of Aran’s regulatory compliance history as reasonably requested by A▇▇▇▇▇▇ and relevant to the Aran Components, which shall include, but not be limited to: (i) any reports and/or records from Government Authority inspections conducted within the last five (5) years and any related correspondence between Aran and any Government Authority; (ii) any warning letters and related correspondence between Aran and any Government Authority within the last five (5) years; (iii) all reports and/or findings from any third party audits, and related correspondence between A▇▇▇ and the third party auditor, within the last five (5) years, and (iv) notice of any regulatory matters relating to Aran’s other buyers directly or indirectly due to A▇▇▇’s Manufacturing responsibilities.