Adverse Events of Special Interest (AESI) Sample Clauses

Adverse Events of Special Interest (AESI). Reports concerning an AESI communicated to Strakan by Aptalis (serious or non-serious regardless of source) or to Aptalis by Strakan will be exchanged by the Parties by Calendar Day 7 from Receipt Date on an FDA 3500 A MedWatch form or Council for International Organizations of Medical Sciences’ (CIOMS) I form via designated e-mail.
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Adverse Events of Special Interest (AESI). Specific adverse events, or groups of adverse events, will be followed as part of standard safety monitoring activities. These events, regardless of seriousness, will be reported. 7.1.4.1 Study specific AESIs

Related to Adverse Events of Special Interest (AESI)

  • Master Servicer Events of Default 116- SECTION 7.02. Trustee to Act; Appointment of Successor....................................................-118- SECTION 7.03. Notification to Certificateholders..........................................................-119- SECTION 7.04. Waiver of Master Servicer Events of Default.................................................-119- ARTICLE VIII

  • Servicer Events of Default (a) Notwithstanding Section 8.03 of the Basic Servicing Agreement, only the occurrence and continuation of any of the following events will be an “Exchange Note Servicer Event of Default” with respect to the 2021-A Exchange Note, and the “Exchange Note Servicer Events of Default” set forth in Section 8.03(a) of the Basic Servicing Agreement shall not apply to the 2021-A Exchange Note or to this 2021-A Servicing Supplement: (i) any failure by the Servicer to deliver to the Indenture Trustee any proceeds or payment required to be so delivered with respect to the 2021-A Exchange Note under the Basic Servicing Agreement or this 2021-A Servicing Supplement that continues unremedied for ten Business Days after the earlier of the date on which (A) notice of such failure is given to the Servicer by the Indenture Trustee or (B) an Authorized Officer of the Servicer has actual knowledge of such failure; (ii) any failure by the Servicer to duly observe or perform in any material respect any other of its covenants or agreements in the 2021-A Servicing Agreement, which failure materially and adversely affects the rights of holders of interests in the 2021-A Exchange Note, the Noteholders or, in the event that Certificates are sold to unaffiliated third parties, the Certificateholders, and which continues unremedied for 90 days after written notice thereof is given to the Servicer by the Indenture Trustee; (iii) any representation, warranty or statement of the Servicer made in the 2021-A Servicing Agreement or any certificate, report or other writing delivered pursuant to the 2021-A Servicing Agreement shall prove to be incorrect in any material respect when made, which failure materially and adversely affects the rights of holders of interests in the 2021-A Exchange Note, the Noteholders or, in the event that Certificates are sold to unaffiliated third parties, the Certificateholders, and which failure continues unremedied for 90 days after written notice thereof is given to the Servicer by the Indenture Trustee; or (iv) the occurrence of an Insolvency Event with respect to the Servicer; provided, however, that the occurrence of any event set forth in clauses (i) through (iii) with respect to the 2021-A Reference Pool will be an Exchange Note Servicer Event of Default only with respect to the 2021-A Reference Pool and will not be a Servicer Event Default with respect to any other Reference Pool or the Revolving Facility Pool. Notwithstanding the foregoing, a delay in or failure of performance referred to under clause (i), (ii) or (iii) for a period of 120 days will not constitute an Exchange Note Servicer Event of Default if that failure or delay was caused by Force Majeure. Upon the occurrence of any such event, the Servicer will not be relieved from using all commercially reasonable efforts to perform its obligations in a timely manner in accordance with the terms of the Basic Servicing Agreement and this 2021-A Servicing Supplement. (b) With respect to actions taken under Section 8.03(c) of the Basic Servicing Agreement after the occurrence of an Exchange Note Servicer Event of Default, any actions to be taken by the 2021-A Exchange Noteholder thereunder shall be exercised by the Indenture Trustee, acting at the written direction of 66 2/3% of the Holders of the Outstanding Amount of the Controlling Class. (c) In accordance with Section 8.05 of the Basic Servicing Agreement, after the occurrence of an Exchange Note Servicer Event of Default, the 2021-A Exchange Noteholder (which for purposes of this Section shall be the Indenture Trustee, acting at the written direction of 66 2/3% of the Holders of the Outstanding Amount of the Controlling Class) may waive any such Servicer Event of Default and its consequences. Upon any such waiver, the applicable Exchange Note Servicer Event of Default will cease to exist, and will be deemed to have been remedied for every purpose of this Agreement. No such waiver will extend to any subsequent or other event or impair any right consequent thereon. (d) On or after the receipt by the Servicer of notice of an Exchange Note Servicer Event of Default, all authority and power of the Servicer under this 2021-A Servicing Supplement, whether with respect to the Notes, the Certificates, the Trust Estate or otherwise, shall, without further action, pass to and be vested in the Indenture Trustee or such Successor Servicer as may be appointed pursuant to the terms of the Basic Servicing Agreement. If the Indenture Trustee shall become Successor Servicer pursuant to this Section, the Indenture Trustee shall be entitled to appoint as sub-Servicer any one of its Affiliates or agents; provided that the Indenture Trustee in its capacity as Servicer shall be fully liable for the actions or omissions of such Affiliate or agent in such capacity as sub-Servicer. The outgoing Servicer shall cooperate with the Indenture Trustee, the Owner Trustee and such Successor Servicer in effecting the termination of the responsibilities and rights of the outgoing Servicer under this 2021-A Servicing Supplement, including the transfer to the Indenture Trustee or such Successor Servicer for administration by it of all cash amounts that shall at the time be held by the outgoing Servicer for deposit, or have been deposited by the outgoing Servicer, in the 2021-A Bank Accounts or thereafter received with respect to the 2021-A Leases and 2021-A Vehicles and all information or documents that the Indenture Trustee or such Successor Servicer may require, and the Successor Servicer shall not be liable if it cannot perform due to the failure of the predecessor Servicer to so deliver. In addition, the Servicer shall transfer its electronic records relating to the 2021-A Leases and 2021-A Vehicles to the Successor Servicer in such electronic form as the Successor Servicer may reasonably request. All Transition Costs shall be paid by the outgoing Servicer (or by the initial Servicer if the outgoing Servicer is the Indenture Trustee acting on an interim basis) upon presentation of reasonable documentation of such costs and expenses.

  • Waiver of Master Servicer Events of Default Subject to Section 11.09(d), the Holders representing at least 66% of the Voting Rights evidenced by all Classes of Certificates affected by any default or Master Servicer Event of Default hereunder may waive such default or Master Servicer Event of Default; provided, however, that a default or Master Servicer Event of Default under clause (i) or (vi) of Section 7.01 may be waived only by all of the Holders of the Regular Certificates. Upon any such waiver of a default or Master Servicer Event of Default, such default or Master Servicer Event of Default shall cease to exist and shall be deemed to have been remedied for every purpose hereunder. No such waiver shall extend to any subsequent or other default or Master Servicer Event of Default or impair any right consequent thereon except to the extent expressly so waived.

  • Adverse Events Subsequent to the date hereof, there shall not have occurred any of the following: (i) a suspension or material limitation in trading in securities generally on the New York Stock Exchange, the NASDAQ National Market or the NASDAQ Global Market, (ii) a general moratorium on commercial banking activities in the People’s Republic of China or New York, (iii) the outbreak or escalation of hostilities involving the United States or the People’s Republic of China or the declaration by the United States or the People’s Republic of China of a national emergency or war if the effect of any such event specified in this clause (iii) in your reasonable judgment makes it impracticable or inadvisable to proceed with the public offering or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus, or (iv) such a material adverse change in general economic, political, financial or international conditions affecting financial markets in the United States or the People’s Republic of China having a material adverse impact on trading prices of securities in general, as, in your reasonable judgment, makes it impracticable or inadvisable to proceed with the public offering of the Shares or the delivery of the Shares on the terms and in the manner contemplated in the Prospectus.

  • Additional Events of Default Section 4.1 For purposes of this Supplemental Indenture and the Notes, in addition to the Events of Default set forth in Section 501 of the Indenture, each of the following also shall constitute an “Event of Default:” (a) default in the payment of the principal of or any premium on the Notes at Maturity; (b) there shall occur a default under any bond, debenture, note or other evidence of indebtedness of the Company, or under any mortgage, indenture or other instrument of the Company (including a default with respect to Securities of any series other than that series) under which there may be issued or by which there may be secured any indebtedness of the Company (or by any Subsidiary, the repayment of which the Company has guaranteed or for which the Company is directly responsible or liable as obligor or guarantor), whether such indebtedness now exists or shall hereafter be created, which default shall constitute a failure to pay an aggregate principal amount exceeding $10,000,000 of such indebtedness when due and payable after the expiration of any applicable grace period with respect thereto and shall have resulted in such indebtedness in an aggregate principal amount exceeding $10,000,000 becoming or being declared due and payable prior to the date on which it would otherwise have become due and payable, without such indebtedness having been discharged, or such acceleration having been rescinded or annulled, within a period of 10 days after there shall have been given, by first class mail, to the Company by the Trustee or to the Company and the Trustee by the Holders of at least a majority in principal amount of the Outstanding Notes a written notice specifying such default and requiring the Company to cause such indebtedness to be discharged or cause such acceleration to be rescinded or annulled and stating that such notice is a “Notice of Default” under the Indenture; and (c) the entry by a court of competent jurisdiction of one or more judgments, orders or decrees against the Company or any of its Subsidiaries in an aggregate amount (excluding amounts covered by insurance) in excess of $10,000,000 and such judgments, orders or decrees remain undischarged, unstayed and unsatisfied in an aggregate amount (excluding amounts covered by insurance) in excess of $10,000,000 for a period of 30 consecutive days. Section 4.2 Notwithstanding any provisions to the contrary in the Indenture, upon the acceleration of the Notes in accordance with Section 502 of the Indenture, the amount immediately due and payable in respect of the Notes shall equal the Outstanding principal amount thereof, plus accrued and unpaid interest, plus the Make-Whole Amount.

  • Listing of Events of Default Each of the following events or occurrences described in this Section 8.1 shall constitute an "Event of Default".

  • Meteorological Data Reporting Requirement (Applicable to wind generation facilities only)

  • Covenants for Reporting of Repurchase Demands due to Breaches of Representations and Warranties (a) The Owner Trustee will (i) in accordance with its obligations pursuant to Section 3.2 of the Sale and Servicing Agreement, provide prompt written notice upon the discovery of any breach of the Seller’s representations and warranties, (ii) no later than five (5) Business Days after the end of each calendar quarter, provide to the Servicer, GM Financial and the Seller, a notice in substantially the form of Exhibit C, or any other form agreed upon between the Owner Trustee and the Seller, which shall be deemed acceptable to the Seller unless the Seller notifies the Owner Trustee within five (5) Business Days of its receipt thereof, with respect to any requests (in writing or orally) for the repurchase of any Receivable pursuant to Section 5.1 of the Purchase Agreement or Section 3.2 of the Sale and Servicing Agreement received by a Responsible Officer of the Owner Trustee during the immediately preceding calendar quarter (or, in the case of the initial notice, since the Closing Date) and (iii) promptly upon reasonable written request by the Servicer, GM Financial or the Seller, provide to them any other information reasonably requested in good faith that is in actual possession of the Owner Trustee and necessary to facilitate compliance by them with Rule 15Ga-1 under the Exchange Act, and Items 1104(e) and 1121(c) of Regulation AB. (b) In no event will the Owner Trustee or the Trust have any responsibility or liability in connection with (i) the compliance by the Servicer, GM Financial, the Seller or any other Person with the Exchange Act or Regulation AB or (ii) any filing required to be made by a securitizer under the Exchange Act or Regulation AB. The Owner Trustee will not have a duty to conduct any affirmative investigation as to the occurrence of any conditions requiring the repurchase of any Receivable pursuant to Section 5.1 of the Purchase Agreement or Section 3.2 of the Sale and Servicing Agreement.

  • Reports of unusual occurrence The Contractor shall, during the Maintenance Period, prior to the close of each day, send to the Authority and the Authority’s Engineer, by facsimile or e- mail, a report stating accidents and unusual occurrences on the Project Highway relating to the safety and security of the Users and Project Highway. A monthly summary of such reports shall also be sent within 3 (three) business days of the closing of month. For the purposes of this Clause 15.4, accidents and unusual occurrences on the Project Highway shall include: (a) accident, death or severe injury to any person; (b) damaged or dislodged fixed equipment; (c) flooding of Project Highway; and (d) any other unusual occurrence.

  • Adverse Event Reporting Both Parties acknowledge the obligation to comply with the Protocol and / or applicable regulations governing the collection and reporting of adverse events of which they may become aware during the course of the Clinical Trial. Both Parties agree to fulfil and ensure that their Agents fulfil regulatory requirements with respect to the reporting of adverse events.

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