Notification of Adverse Events. The Borrower shall notify the Bank of all Events of Default within five days of the occurrence thereof.
Notification of Adverse Events. The School Board agrees with the Province that it shall immediately notify the Province of any liens registered against the School Sites or lawsuits affecting the Schools or the School Sites or the work of the Contractor at the Schools, of which it is aware.
Notification of Adverse Events. Investigator shall promptly notify Sponsor and the Institution’s IRB in writing of any serious adverse drug experience within twenty-four (24) hours of learning of the event. For serious adverse drug experiences, Institution and Investigator shall assist in the investigation of the medical circumstances and shall provide Sponsor with all requested information so that Sponsor can submit any required IND Safety Report to FDA within fifteen (15) days of its initial receipt of the information. For fatal or life-threatening experiences, Institution and Investigator shall provide Sponsor with all requested information so that Sponsor can submit any required Telephone and Facsimile Transmittal Safety Report to FDA within seven (7) days of its initial receipt of the information. Investigator shall follow-up with any Study participant who experienced an adverse drug experience and continue to provide Sponsor with updates.
Notification of Adverse Events. Each party shall be obligated to immediately notify the other if it is the subject of any investigatory action by any federal, state or local agency or affiliation/accreditation organization, or if it is sanctioned or disciplined by any such agency or organization.
Notification of Adverse Events. ARC shall participate in the management of a Corrective and Preventive Action System (“CAPA System”) and a customer compliance system. The ARC and MacroCure shall handle the notification of adverse events pursuant to MacroCure’s Specifications. ARC agrees to notify MacroCure promptly upon receipt from any entity of any complaint or Adverse Reaction Report relating to the Products and supply all information that is required to perform this action. MacroCure shall be solely responsible for paying or reimbursing all ARC costs incurred as a result of any recall of any Product, except to the extent such recall is due to the negligence or willful misconduct of the ARC or any non-compliance of ARC with the terms and conditions of this Agreement, including without limitation, any non compliance of the Batches and/or Products with the Procedures and/or Specifications. ARC shall be solely responsible for paying or reimbursing MacroCure all costs incurred as a result of any recall of any Product to the extent such recall is due to the negligence or willful misconduct of the ARC or non-compliance of ARC with the terms and conditions of this Agreement, including without limitation, any non compliance of the Batches and/or Products with the Procedures and/or Specifications. This notification process shall be more specifically delineated in the Quality Agreement. If there is a suspected problem with a Product which may result from a blood unit, ARC will immediately supply to MacroCure the necessary information to investigate same.
Notification of Adverse Events. During the Designated Period, Supplier shall, immediately upon becoming aware thereof, inform BNP of (a) any pending or threatened litigation, governmental investigation, proceeding or action involving the Substance or Supplier's manufacturing facilities for the Substance, (b) any defective, adulterated or misbranded Substance, (c) any information suggesting that the Substance is defective or fails to meet the Specifications.
Notification of Adverse Events. Ethicon and Omrix shall each give the other prompt written notice of any information either of them receives regarding the safety of the Ethicon Components and/or the Products, including any confirmed or unconfirmed information on adverse, serious or unexpected events associated with the use of the Ethicon Components and/or the Products. For serious, unexpected events, notice must be given by telephone within 72 hours after receipt of the information, followed by written notice promptly thereafter (which written notice shall be delivered in no event more than 5 calendar days after receipt of such information. Each Party shall cooperate with the other in connection with the investigation of any such adverse, serious or unexpected events. Omrix shall be responsible for filing any reports and performing any analysis required by the applicable Regulatory Agency in or outside of the Territory. Each Party shall have the right to conduct audits during normal business hours and make other reasonable inquiries concerning the other Party's reporting system to ensure that such system functions properly and is in compliance with the Applicable Legal Requirements.
Notification of Adverse Events. The sponsor is responsible for reporting AEs, SAEs and Device Deficiencies to regulatory authorities in line with applicable regulatory requirements and for reviewing the risk analysis, determining the need for corrective or preventative action and informing Investigators and regulatory authorities accordingly.
Notification of Adverse Events. The Borrower will give the Bank prompt and full written notice of:
(a) the occurrence of any Default or Event of Default; and
(b) any other event or occurrence which could reasonably be expected to cause a Material Adverse Change.
Notification of Adverse Events. The Customer shall notify Medartis as soon as practicably possible of any circumstances that may adversely affect the Products or Ancillary Items.
