Adverse Events and Special Situations Sample Clauses

Adverse Events and Special Situations. Guidance on AEs and special situations is provided in the master protocol. With regard to AESIs, no AESIs have been reported to date for TSR-042, therefore all serious AEs assessed by the Investigator or Sponsor to be reasonably associated with the use of TSR-042 are considered to be unexpected and should be reported as described in the master protocol. For bevacizumab, the local approved product label should be consulted. The AESIs for niraparib are described in the master protocol.
AutoNDA by SimpleDocs

Related to Adverse Events and Special Situations

  • Special Situations XXXXXXX BENEFICIARY agrees to inform AGENCY within one (1) business day of any circumstances or events which may reasonably be considered to jeopardize its capability to continue to meet its obligations under the terms of this Agreement. Incidents may include, but are not limited to, those resulting in injury, media coverage or public reaction that may have an impact on the AGENCY’S or GRANTEE BENEFICIARY’S ability to protect and serve its participants, or other significant effect on the AGENCY or GRANTEE BENEFICIARY. Incidents shall be reported to the designated AGENCY contact below by phone or email only. Incident report information shall not include any identifying information of the participant.

  • Environmental Site Assessment Perform in accordance with the City Design Manual and other City requirements as designated in writing by the Director.

  • DEVELOPMENTAL REQUIREMENTS The Personal Development Plan (PDP) for addressing developmental gaps is attached as Annexure B.

  • 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.

  • Project Overview Project Title [Drafting note: ARENA to complete. Insert full long name in accordance with ARENA’s naming convention] i.e. [GMS Number] [Powerworks, voltage control on the Pacific Islands Study] [GMS Number] [study/ project/ fellowship/ scholarship/ R&D Project] Contract Number [Drafting note: ARENA to complete – to be obtained from ARENA’s GMS] Recipient [Drafting note: Recipient to insert full legal name and ABN] Guidelines and policies Advancing Renewables Program – Program Guidelines, 2020 (xxxxx://xxxxx.xxx.xx/xxxxxx/0000/00/XXXXX_XXX_Xxxxxxxxxx_XX_Xxxxxx_Xxxxx_XXXXX.xxx) ARENA Variation Policy (xxxxx://xxxxx.xxx.xx/xxxxxx/0000/00/xxxxx-xxxxxxx-xxxxxxxxx-xxxxxxxxx-xxxxxx.xxx) ARENA Report Writing Guidelines (xxxxx://xxxxx.xxx.xx/xxxxxx/0000/00/xxxxx-xxxxxx-xxxxxxx-xxxxxxxxxx.xxx)

  • Emergency Situations If the condition is an emergency, this will be communicated to the Contractor with the request that corrections are to be accomplished immediately. The Contractor shall respond to the notice in emergency situations within twenty-four hours. If the Contractor fails to respond within this time limit, the Owner may correct the defect and charge the Contractor for the Work. If it is determined the complaint is not the responsibility of the Contractor, the Contractor shall be promptly paid for the cost of the corrective work. The Contractor shall give notice in writing to the Owner when corrections have been completed.

  • Environmental Management (a) The Operator must, prior to the commencement of any Train Services (including any new or varied Train Services): (i) cause a suitably qualified person reasonably acceptable to both Parties to prepare a report (“Environmental Investigation and Risk Management Report”) containing an environmental investigation component and an environmental risk management component which respectively identify: (A) possible risks of Environmental Harm arising out of the proposed use of the Nominated Network by the Operator, including risks associated with those matters identified in Part 3 of Schedule 6; and (B) the manner in which the Operator proposes to address the possible risks of Environmental Harm identified in the Environmental Investigation and Risk Management Report as well as the roles and responsibilities, including financial responsibility, for the control measures proposed and an audit regime, provided that if the Operator has an existing Environmental Management System it proposes to use in connection with the proposed Train Services on the Nominated Network, the Environmental Investigation and Risk Management Report should also detail the extent to which the Operator believes its existing Environmental Management System addresses the risks identified in the Environmental Investigation and Risk Management Report; and (ii) provide a copy of the Environmental Investigation and Risk Management Report to Aurizon Network for its consideration and, if requested by Aurizon Network, a copy of the relevant parts of the Operator’s existing Environmental Management System referred to in the Environmental Investigation and Risk Management Report. (b) If the Environmental Investigation and Risk Management Report discloses areas of risk which, in the reasonable opinion of Aurizon Network, cannot be adequately managed by the proposals set out in the Environmental Investigation and Risk Management Report or, in the reasonable opinion of Aurizon Network, fails to identify and adequately deal with additional relevant environmental risks, then Aurizon Network may give notice to that effect to the Operator within thirty (30) days after the date on which the Environmental Investigation and Risk Management Report was received by Aurizon Network (or such other period as the Parties, acting reasonably, may agree), detailing the risks not so adequately managed or not so identified or adequately dealt with. If Aurizon Network does not give such notice, the Environmental Investigation and Risk Management Report, subject to Clause 9.1(k), shall be included in Part 1 of Schedule 9 and amendments made to this Agreement [(including variations to the Base Access Charges)] if applicable. [Bracketed text is only included where Operator pays non-TOP Access Charges] (c) If Aurizon Network gives notice pursuant to Clause 9.1 (b) the Operator may respond, by a date agreed by the Parties, with a written proposal which demonstrates how the Operator proposes to manage those risks (“Operator’s Proposal”). The Operator’s Proposal must: (i) contain an investigation of the areas of risk and/or additional relevant environmental risks referred to in Clause 9.1(b); (A) specify risk abatement or attenuation measures which the Operator proposes to undertake in relation to them; and/or (B) specify how the Access Charges might contain a component reflecting the cost to Aurizon Network of assuming all or some portion of the risk; (ii) in relation to paragraph (ii)(A) specify a timeframe for implementation of those measures; and (iii) specify details of any public consultation the Operator proposes to undertake in connection with the implementation of any such measures. (d) Aurizon Network may, acting reasonably, accept or reject all or part of the Operator’s Proposal. (e) If Aurizon Network accepts the Operator’s Proposal, then it will be incorporated into and form part of the Environmental Investigation and Risk Management Report which, subject to Clause 9.1(k), shall be included in Part 1 of Schedule 9 and amendments made to the Agreement [(including variations to the Base Access Charges)] if applicable. [Bracketed text is only included where Operator pays non-TOP Access Charges] (f) If the Operator fails to submit to Aurizon Network an Operator’s Proposal by the date agreed by the Parties or if Aurizon Network rejects all or part of the Operator’s Proposal, Aurizon Network may advise the Operator of the risks not adequately managed or not identified or adequately dealt with and then either Party may refer the issue of whether the Environmental Investigation and Risk Management Report and/or the Operator’s Proposal does or does not adequately manage or does or does not identify or adequately deal with the relevant environmental risks to an expert for determination in accordance with Clause 18.3. (g) If the expert determines that the Environmental Investigation and Risk Management Report and/or Operator’s Proposal does adequately manage the risks or identifies and adequately deals with the risks, then the Environmental Investigation and Risk Management Report as modified by the Operator’s Proposal (if applicable) will, subject to Clause 9.1(k), be accepted and included in Part 1 of Schedule 9 and amendments made to this Agreement [(including variations to the Base Access Charges)] if applicable. [Bracketed text is only included where Operator pays non-TOP Access Charges] (h) If the expert determines that the Environmental Investigation and Risk Management Report and/or Operator’s Proposal does not adequately manage the risks or does not identify and adequately deal with the risks, then provided the Operator amends the Environmental Investigation and Risk Management Report in accordance with the expert’s determination and/or recommendations within the time frame specified by the expert, the Environmental Investigation and Risk Management Report as amended will, subject to Clause 9.1(k), be accepted and included in Part 1 of Schedule 9 and amendments made to the Agreement [(including variations to the Base Access Charges)] if applicable. [Bracketed text is only included where Operator pays non-TOP Access Charges] (i) If the expert determines that the Environmental Investigation and Risk Management Report and/or Operator’s Proposal does not adequately manage the risks or does not identify and adequately deal with the risks and the Operator fails to amend the Environmental Investigation and Risk Management Report in accordance with the expert’s determination and/or recommendations within the time frame specified by the expert, Aurizon Network may terminate this Agreement by written notice to the Operator and the End User. (j) The Parties agree to implement the determination of the expert. (k) If: (i) an Environmental Investigation and Risk Management Report is included in Part 1 of Schedule 9; and (ii) amendments (if any) are made to this Agreement as a result of or in connection with that inclusion of the Environmental Investigation and Risk Management Report, then the commencement of the amendment of this Agreement to include the Environmental Investigation and Risk Management Report and those amendments is subject to and conditional upon the Operator being notified by Aurizon Network that all necessary amendments (if any) to the End User Access Agreement (including variations to the amounts payable by the End User) have been made in respect of such matters and any relevant nomination of the Operator by the End User in accordance with the End User Access Agreement has, if necessary, been varied.

  • Environmental Services 1. Preparation of Environmental Documentation (CEQA/NEPA) including but not limited to the following: a. Initial Study b. Categorical Exemption (CE) c. Notice of Exemption (XXX) d. Negative Declaration (ND) e. Mitigated Negative Declaration (MND) f. Notice of Preparation (NOP) g. Environmental Impact Report (EIR) i. Initial Document (Screen Check/Administrative Draft) ii. Addendum iii. Supplemental

  • Environmental Compliance and Reports Borrower shall comply in all respects with any and all Environmental Laws; not cause or permit to exist, as a result of an intentional or unintentional action or omission on Borrower’s part or on the part of any third party, on property owned and/or occupied by Borrower, any environmental activity where damage may result to the environment, unless such environmental activity is pursuant to and in compliance with the conditions of a permit issued by the appropriate federal, state or local governmental authorities; shall furnish to Lender promptly and in any event within thirty (30) days after receipt thereof a copy of any notice, summons, lien, citation, directive, letter or other communication from any governmental agency or instrumentality concerning any intentional or unintentional action or omission on Borrower’s part in connection with any environmental activity whether or not there is damage to the environment and/or other natural resources. Additional Assurances. Make, execute and deliver to Lender such promissory notes, mortgages, deeds of trust, security agreements, assignments, financing statements, instruments, documents and other agreements as Lender or its attorneys may reasonably request to evidence and secure the Loans and to perfect all Security Interests.

  • Environmental Compliance (a) No Loan Party or Restricted Subsidiary (i) has failed to comply in all material respects with applicable Environmental Law or to obtain, maintain or comply with any Environmental Permit, (ii) has become subject to any Environmental Liability, (iii) has received notice of any claim with respect to any material Environmental Liability or (iv) has a Responsible Officer with knowledge of any basis for any material Environmental Liability, except, in each case, as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. (i) None of the properties currently or formerly owned or operated by any Loan Party or Restricted Subsidiary is or was listed or, to the knowledge of any Responsible Officer was proposed for listing on the NPL or on the CERCLIS or any analogous state or local list at any time while such property was owned by such Loan Party or, to the knowledge of any Responsible Officer, at any time prior to or after such property was owned by such Loan Party, and, to the knowledge of any Responsible Officer, no property currently owned or operated by any Loan Party or Restricted Subsidiary is adjacent to any such property, in each case in connection with any matter for which any Loan Party or Restricted Subsidiary would have any material Environmental Liability; (ii) there are no, or, to the knowledge of any Responsible Officer, never have been any underground or above-ground storage tanks or any surface impoundments, septic tanks, pits, sumps or lagoons in which Hazardous Materials are being or have been treated, stored or disposed on any property currently owned or operated by any Loan Party or Restricted Subsidiary in violation of any Environmental Laws or, to the knowledge of any Responsible Officer, on any property formerly owned or operated by any Loan Party or Restricted Subsidiary; (iii) there is no friable asbestos or friable asbestos-containing material on any property currently owned or operated by any Loan Party or Restricted Subsidiary; (iv) Hazardous Materials have not been Released, discharged or disposed of on any property currently or formerly owned or operated by any Loan Party or Restricted Subsidiary in violation of any Environmental Laws; and (v) to the knowledge of any Responsible Officer, there are no pending or threatened Liens under or pursuant to any applicable Environmental Laws on any real property or other assets owned or leased by any Loan Party or Restricted Subsidiary, and to the knowledge of any Responsible Officer, no actions by any Governmental Authority have been taken or are in process which would subject any of such properties or assets to such Liens, except, in the case of clauses (i) through (v) above, as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. (c) No Loan Party or Restricted Subsidiary is undertaking, and no Loan Party or Restricted Subsidiary has completed, either individually or together with other potentially responsible parties, any investigation or assessment or remedial or response action relating to any actual or threatened Release, discharge or disposal of Hazardous Materials at any site, location or operation, either voluntarily or pursuant to the order of any Governmental Authority or the requirements of any Environmental Law that has or would reasonably be expected to have a Material Adverse Effect; and all Hazardous Materials generated, used, treated, handled or stored at, or transported to or from, any property currently or formerly owned or operated by any Loan Party or Restricted Subsidiary have been disposed of in a manner not reasonably expected, individually or in the aggregate, to have a Material Adverse Effect.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!