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 promtly 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. 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. 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. During the Designated Period, Supplier shall, immediately upon becoming aware thereof, inform [ ] 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. (a) 3RP shall notify SAMARITAN promptly of any pending or threatened litigation or governmental investigation, proceeding or action involving the Product or the facility where the Product is being manufactured of which 3RP becomes aware and of any defective, adulterated or misbranded Product or any other information which may suggest that the Product is or may be defective, adulterated or misbranded or fail to meet the Specifications or to maintain the stability as indicated. 3RP shall notify SAMARITAN promptly of any material product quality complaints which it receives from customers of SAMARITAN or others concerning the Product.
(b) SAMARITAN shall notify 3RP:
(i) of any customer complaints or alleged adverse drug reaction relating to a Product within the meaning of the FDA Safety Information and Adverse Event Reporting Program (21 CFR, Part 20) (an "ADR" which, on the Effective Date, means a noxious and unintended response to the Product, which occurs at dosages normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function) promptly following their receipt by SAMARITAN (but in any event within ten (10) days of receipt thereof, except in the case of a Serious ADR [as defined below] in which event SAMARITAN shall notify 3RP of same within seventy-two (72) hours, which latter notification shall be by telephone with a facsimile confirmation immediately following; or
(ii) of any Regulatory Authority complaints or complaints of any other governmental or regulatory body, agency or official in the Territory within five (5) days, except on weekends and holidays.
Notification of Adverse Events. Reporting to Governmental or Regulatory Authorities. Serious Adverse Events for the Product learned by Xxxxx shall be submitted to BMS in sufficient time to reasonably allow BMS to comply with applicable regulations. Non-Serious Adverse Events for the Product that are spontaneously reported to Xxxxx shall be submitted to BMS no more than one (1) month from the date received by Xxxxx; provided, however, that medical and scientific judgment should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent a Serious Adverse Event outcome. BMS shall have the reporting responsibility for all adverse events to applicable Governmental or Regulatory Authorities anywhere in the world. BMS shall inform Xxxxx of all adverse events reported by it to the FDA at the same time as BMS reports same to the FDA. Xxxxx shall report all such adverse events involving the Product learned by it to:
X. Facsimile No.: (000) 000-0000 Telephone No.: (000) 000-0000 A CIOMS-I form or a form that contains the data elements of a CIOMS-I form shall be used. Adverse events concerning the Product learned by BMS shall be reported by BMS to Xxxxx at the time that BMS reports such events to the FDA, and shall be sent to: Xxxxxx Xxxxxxxx, Inc. 000 Xxxxxxxxxx Xxxxx Xxxxxxxx, XX 00000 Attention: Medical Director Telephone No.: (000) 000-0000 Facsimile No.: (000) 000-0000 A Party may change its contact at any time for future notices upon written notice given to the other. BMS shall create and maintain at its expense a master safety database which shall cross-reference any adverse drug experience relating to the Product occurring anywhere in the world.
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 form of notice, summons, citation or other written or oral communication received by the Borrower or any of its Subsidiaries from the EPA, or any other Governmental Authority, concerning (i) material violations or alleged material violations of Environmental Laws, which seeks to impose material liability therefor, (ii) any action or omission on the part of the Borrower or such Subsidiary in connection with Hazardous Substances which could reasonably be expected to result in the imposition of liability therefor, which liability, if imposed, could reasonably be expected to cause a Material Adverse Change, including without limitation any notice of potential responsibility under CERCLA, or (iii) a Lien upon any Collateral, or a Lien arising under any Environmental Law against or in connection with the Borrower or such Subsidiary, or any of its leased or owned Property, wherever located, if the effect of such Lien could reasonably be expected to cause a Material Adverse Change;
(c) any confirmed plan to open a new sales or production facility which would involve moving inventory of the Borrower into any state in which the Bank has not filed a financing statement;
(d) any other event or occurrence which could reasonably be expected to cause a Material Adverse Change.
Notification of Adverse Events. The Company, Bidco and TLC shall promptly notify PAG of the occurrence of any transaction or event (i) as a consequence of which (whether alone or together with any one or more transactions or events occurring before, on or after the First Completion Date) any material liability of any Group Member has arisen or will or may arise, including any material legal proceedings or, to their knowledge, threatened legal proceedings, (ii) which may otherwise cause a Material Adverse Effect on any Group Member or (iii) which constitutes or is likely to constitute a material breach of any Basic Documents.
