Compliance History Sample Clauses

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.
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Compliance History. Xxxxx shall provide Medtronic with a review of Xxxxx’x 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 Xxxxx and FDA; (ii) any FDA warning letters and related correspondence between the Xxxxx 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 Xxxxx and the third party auditor, within the last five (5) years.
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Compliance History. Supplier shall provide Nevro with a review of Supplier’s regulatory compliance history related to the Products or related to the manufacturing processes used to manufacture the Products. o x o
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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 ​ ​ ​ EXHIBIT F JOINT MARKETING, TRAINING, AND CHANNEL MANAGEMENT
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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 ¨
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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:
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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...
Sample 1
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Compliance History 
Sample 1

Related to Compliance History

  • Compliance Reporting a. Provide reports to the Securities and Exchange Commission, the National Association of Securities Dealers and the States in which the Fund is registered.

  • Compliance Reports The Subadvisor at its expense will provide the Advisor with such compliance reports relating to its duties under this Agreement as may be agreed upon by such parties from time to time.

  • Compliance Audits D.4.1 Compliance Audit(s). Without limiting the generality of section A.7.4 (Records Review), if requested by the Province from time to time, which request shall be at the Province’s sole discretion, the Recipient, at its own expense, will forthwith retain an independent third party auditor to conduct one or more compliance audits of the Recipient or any Project. The audit will be conducted in accordance with Canadian Generally Accepted Auditing Standards, as adopted by the Canadian Institute of Chartered Accountants, applicable as of the date on which a record is kept or required to be kept under such standards. In addition, the audit will assess the Recipient’s compliance with the terms of the Agreement and will address, with respect to each Project, without limitation, the following:

  • Reporting Compliance The Company is subject to, and is in compliance in all material respects with, the reporting requirements of Section 13 and Section 15(d), as applicable, of the Exchange Act.

  • FDA Compliance The Company: (A) is and at all times has been in material compliance with all statutes, rules or regulations of the FDA and other comparable governmental entities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”); (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any governmental entity alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; (D) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) has not received notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action; and (F) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).

  • Y2K Compliance PFPC further represents and warrants that any and all electronic data processing systems and programs that it uses or retains in connection with the provision of services hereunder on or before January 1, 1999 will be year 2000 compliant.

  • FCPA Compliance The Company has not and, to the Company’s actual knowledge, none of its employees or agents at any time during the last five years have (i) made any unlawful contribution to any candidate for foreign office, or failed to disclose fully any contribution in violation of law, or (ii) made any payment to any federal or state governmental officer or official, or other person charged with similar public or quasi-public duties, other than payments required or permitted by the laws of the United States or any jurisdiction thereof.

  • Regulatory Compliance Cooperation (a) CIT/VC agrees to use commercially reasonable best efforts to avoid the occurrence of a Regulatory Problem. In the event that CIT/VC determines that it has a Regulatory Problem, the Company agrees to use commercially reasonable efforts to take all such actions as are reasonably requested by CIT/VC in order (A) to effectuate and facilitate any transfer by CIT/VC of any Securities of the Company then held by CIT/VC to any Person designated by CIT/VC (subject, however, to compliance with Section 3 of this Agreement), (B) to permit CIT/VC (or any Affiliate of CIT/VC) to exchange all or any portion of the voting Securities of the Company then held by such Person on a share-for-share basis for shares of a class of non-voting Securities of the Company, which non-voting Securities shall be identical in all respects to such voting Securities, except that such new Securities shall be non-voting and shall be convertible into voting Securities on such terms as are requested by CIT/VC in light of regulatory considerations then prevailing, and (C) to continue and preserve the respective allocation of the voting interests with respect to the Company arising out of CIT/VC's ownership of voting Securities of the Company and/or provided for in this Agreement before the transfers and amendments referred to above (including entering into such additional agreements as are requested by CIT/VC to permit any Person(s) designated by CIT/VC to exercise any voting power which is relinquished by CIT/VC upon any exchange of voting Securities for nonvoting Securities of the Company); and the Company shall enter into such additional agreements, adopt such amendments to this Agreement, the Company's Charter and the Company's By-laws and other relevant agreements and taking such additional actions, in each case as are reasonably requested by CIT/VC in order to effectuate the intent of the foregoing. If CIT/VC elects to transfer Securities of the Company to a Regulated Holder in order to avoid a Regulatory Problem, the Company shall enter into such agreements with such Regulated Holder as it may reasonably request in order to assist such Regulated Holder in complying with applicable laws, and regulations to which it is subject. Such agreements may include restrictions on the 39. redemption, repurchase or retirement of Securities of the Company that would result or be reasonably expected to result in such Regulated Holder holding more voting securities or total securities (equity and debt) than it is permitted to hold under such laws and regulations.

  • ADA Compliance A. The Americans with Disabilities Act (42 U.S.C. § 12101, et seq.) and the regulations thereunder (28 C.F.R. § 35.130) (“ADA”) prohibit discrimination against persons with disabilities by the State, whether directly or through contractual arrangements, in the provision of any aid, benefit, or service. As a condition of receiving this Agreement, the Company certifies that services, programs, and activities provided under this Agreement are and will continue to be in compliance with the ADA.

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