Notification of Regulatory Events Sample Clauses

Notification of Regulatory Events. To the extent permitted under applicable law, Grantee shall notify PHC in writing as soon as reasonably practicable (but no later than within seven (7) business days after it becomes aware of any of the following events during the Term of this Agreement): (a) Residency Program or any of its employees or contractors are or have become the subject of, or is materially involved in, any investigation, proceeding or disciplinary action by any Federal HealthCare Program, any state’s medical board, any specialty board, or any agency responsible for professional licensing, standards or behavior; or (b) sponsoring institution or Program’s ACGME accreditation is under disciplinary investigation. If an event described in this Section occurs, Grantee shall be responsive to any questions, inquiries, requests for updates, proof of outcome or resolution, or other communications from PHC to the extent required by law, limited to findings related to the Residency Program being funded by the Grant. PHC may, in its sole discretion, suspend payments and any other contractual obligations for the duration of any such event, without regard for the date PHC was notified thereof.
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Notification of Regulatory Events. After the Effective Date, Licensee shall notify the Joint Committee, as soon as reasonably practicable, of any action by, or notice or other information that Licensee or its Affiliates receives (directly or indirectly) from, any Third Party (including any Governmental Authority), which: (1) considered in light of all other information related to the Compound or any Product, raises any material concerns regarding the safety of the Product; (2) is reasonably likely to lead to a recall or clinical hold with respect to such Product; or (3) constitutes notice of an investigation, inspection or formal inquiry by any Regulatory Authority regarding such Product. At Takeda’s written request, Licensee shall provide Takeda with copies of any documents issued by a Regulatory Authority to Licensee following any such investigation or formal inquiry.
Sample 1

Related to Notification of Regulatory Events

  • NOTIFICATIONS AND SUBMISSION OF REPORTS Unless otherwise stated in writing after the Effective Date, all notifications and reports required under this IA shall be submitted to the following entities: Administrative and Civil Remedies Branch Office of Counsel to the Inspector General Office of Inspector General U.S. Department of Health and Human Services Xxxxx Building, Room 5527 000 Xxxxxxxxxxxx Xxxxxx, XX Xxxxxxxxxx, XX 00000 Telephone: (000) 000-0000 Facsimile: (000) 000-0000 LFAC: Xxxxxxx X. Xxxxx, DPM 0000 Xxxxxxxxxxx Xx. X-000 Xxxxxxxxx, XX 00000 Telephone: (000) 000-0000 Email: xx.xxxxx@xxxxx.xxx Unless otherwise specified, all notifications and reports required by this IA may be made by electronic mail, overnight mail, hand delivery, or other means, provided that there is proof that such notification was received. Upon request by OIG, LFAC may be required to provide OIG with an additional copy of each notification or report required by this IA in OIG’s requested format (electronic or paper).

  • 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.

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