Definition of Manufacturing Reportable Event Sample Clauses

Definition of Manufacturing Reportable Event. For purposes of this Appendix, a “Manufacturing Reportable Event” means conduct related to a Covered Manufacturing Facility or Covered Product that involves: a. a matter that a reasonable person would consider a probable violation of criminal, civil, or administrative laws applicable to cGMP Activities; or b. the employment of or contracting with a Covered Person who is an Ineligible Person as defined by Section III.G.1.a of the CIA; A Manufacturing Reportable Event may be the result of an isolated event or a series of occurrences. A Manufacturing Reportable Event does not include the following: a. Field Alert Reports submitted to FDA and related correspondence; b. Observations contained in FDA 483 Reports, GSK’s responses to those observations and any related correspondence; c. Drug Quality Reporting System (DQRS) reports submitted to FDA and any related correspondence; d. Reports submitted to FDA relating to suspected or known counterfeit products and any related correspondence; and e. GSK Annual Product Reports for marketed products submitted to FDA and any related correspondence.
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Related to Definition of Manufacturing Reportable Event

  • Definition of Reportable Event For purposes of this CIA, a “Reportable Event” means anything that involves: a. a substantial Overpayment; b. a matter that a reasonable person would consider a probable violation of criminal, civil, or administrative laws applicable to any Federal health care program for which penalties or exclusion may be authorized; c. the employment of or contracting with a Covered Person who is an Ineligible Person as defined by Section III.G.1.a; or d. the filing of a bankruptcy petition by Good Shepherd. A Reportable Event may be the result of an isolated event or a series of occurrences.

  • Reportable Events Involving the Xxxxx Law Notwithstanding the reporting requirements outlined above, any Reportable Event that involves solely a probable violation of section 1877 of the Social Security Act, 42 U.S.C. §1395nn (the Xxxxx Law) should be submitted by Practitioner to CMS through the self-referral disclosure protocol (SRDP), with a copy to the OIG. If Practitioner identifies a probable violation of the Xxxxx Law and repays the applicable Overpayment directly to the CMS contractor, then Practitioner is not required by this Section III.G to submit the Reportable Event to CMS through the SRDP.

  • Reportable Events No such Employee Benefit Plan which is an Employee Pension Benefit Plan has been completely or partially terminated or been the subject of a Reportable Event as to which notices would be required to be filed with the PBGC. No proceeding by the PBGC to terminate any such Employee Pension Benefit Plan has been instituted or threatened; and

  • Reporting of Reportable Events If Xxxxx determines (after a reasonable opportunity to conduct an appropriate review or investigation of the allegations) through any means that there is a Reportable Event, Xxxxx shall notify OIG, in writing, within 30 days after making the determination that the Reportable Event exists.

  • Reportable Event Reportable Event" means a "reportable event" as defined in Section 4043(b) of ERISA.

  • Reportable Events under Section III J.1.d. For Reportable Events under Section III.J.1.d, the report to OIG shall include documentation of the bankruptcy filing and a description of any Federal health care program requirements implicated.‌

  • ERISA Reportable Event A reportable event with respect to a Guaranteed Pension Plan within the meaning of §4043 of ERISA and the regulations promulgated thereunder as to which the requirement of notice has not been waived.

  • CERTIFICATION REGARDING DEBARMENT AND SUSPENSION The undersigned (authorized official signing for the contracting organization) certifies to the best of his or her knowledge and belief, that the contractor, defined as the primary participant in accordance with 45 CFR Part 76, and its principals: are not presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from covered transactions by any Federal Department or agency have not within a 3-year period preceding this contract been convicted of or had a civil judgment rendered against them for commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a public (Federal, State, or local) transaction or contract under a public transaction; violation of Federal or State antitrust statutes or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, or receiving stolen property; are not presently indicted or otherwise criminally or civilly charged by a governmental entity (Federal, State, or local) with commission of any of the offenses enumerated in Section 2 of this certification; and have not within a 3-year period preceding this contract had one or more public transactions (Federal, State, or local) terminated for cause or default. Should the Contractor or Subrecipient not be able to provide this certification, an explanation as to why should be placed after the assurances page in the contract. The contractor agrees by signing this contract that it will include, without modification, the clause above certification in all lower tier covered transactions (i.e., transactions with sub-grantees and/or contractors) and in all solicitations for lower tier covered transactions in accordance with 45 CFR Part 76.

  • CERTIFICATION REGARDING DEBARMENT, SUSPENSION, INELIGIBILITY AND VOLUNTARY EXCLUSION

  • Single Audit Act Compliance If the Contractor is a subrecipient and expends $750,000 or more in federal awards from any and/or all sources in any fiscal year, the Contractor shall procure and pay for a single audit or a program-specific audit for that fiscal year. Upon completion of each audit, the Contractor shall: (1) Submit to the DSHS contact person the data collection form and reporting package specified in 2 CFR Part 200, Subpart F, reports required by the program-specific audit guide (if applicable), and a copy of any management letters issued by the auditor; (2) Follow-up and develop corrective action for all audit findings; in accordance with 2 CFR Part 200, Subpart F; prepare a “Summary Schedule of Prior Audit Findings” reporting the status of all audit findings included in the prior audit's schedule of findings and questioned costs.

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