Early Termination of Subjects from the Study Sample Clauses

Early Termination of Subjects from the Study. Subjects who discontinue the study should complete all scheduled safety assessments at the Early Termination Visit. If an Early Termination Visit and a scheduled visit coincide, procedures for both visits should be completed, without duplication. Subjects must discontinue the study for the following reasons: • Subject withdraws consent; • Subject unwilling or unable to follow study procedures, per judgment of the investigator; • Investigator, sponsor, or Regulatory Authority judge that further dosing with study drug would be harmful to the subject; • Subject experiences an SAE that is judged, by the investigator and the sponsor, to be related to study drug; • Subject experiences a Grade 3 CTCAE AE judged, by the investigator and the sponsor, to be related to study drug; • Subject experiences a Grade 4 CTCAE AE judged, by the investigator and the sponsor, regardless of the relation to study drug; • Subject experiences a Grade 3 or Grade 4 CTCAE laboratory abnormality judged by the investigator and the sponsor, to be related to study drug except for asymptomatic elevations in cholesterol or triglycerides which are accepted; • Subject with normal ALT and bilirubin at baseline who experiences confirmed, non- cholestatic ALT >3 x ULN and bilirubin >2 x ULN OR subjects with elevated ALT at baseline who experiences confirmed, non-cholestatic ALT >10 x baseline value and bilirubin >2 x ULN; • Subject experiences a confirmed, − QTcF interval 500 msec; OR − QTcF interval change from baseline ≥60 msec that has an absolute value ≥480 msec. The value of an individual ECG time point is the average of the triplicate values − “confirmed” is defined as the abnormality duplicated, at least 1 hour after the abnormality is first noted, by the results of a set of 3 ECGs performed in triplicate, at least 5, but not more than 10 minutes between each assessment; • Subject experiences any hepatic AE or SAE judged by the investigator or sponsor as DILI and to be related to study drug and not to the subject’s underlying XXXX. Subjects who discontinue the study due to the safety stopping criteria will be replaced if the investigator and sponsor agree and the criteria outlined in Section 7.5 are not violated. Subjects who discontinue the study for non-safety reasons may be replaced. If a subject is withdrawn from the study the reason(s) for withdrawal must be documented in the subject’s medical record and CRF. An Early Termination Visit should be performed. All subjects must be follow...
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Related to Early Termination of Subjects from the Study

  • Early Termination of Agreement (a) The City and the Contractor, by mutual written agreement, may terminate this Agreement at any time.

  • Rescission and Early Termination of Contract The Illinois Commerce Commission is considering rescission and early termination of contract regulations that may afford you opportunities within certain parameters to rescind or terminate your contract without incurring an early termination fee. In addition, your DSP’s tariff (which is on file with the Illinois Commerce Commission) may contain provisions regarding penalty-free rescission periods. DES will comply with all applicable provisions and regulations concerning rescission and early termination of contract. Shortly after your election to take service from DES, your DSP should provide you an enrollment notice informing you of any rescission rights you may have and the last day for making a request to rescind. If you rescind this Agreement within the timeframe specified by your DSP, your enrollment with DES will be cancelled without penalty to you. Upon rescission in accordance with applicable law, this Agreement will be considered cancelled and neither party shall have any further obligation hereunder to each other. If you do not rescind this Agreement, you still may terminate the Agreement without any termination fee or penalty within 10 business days after the date of the first xxxx issued to you under this Agreement by calling DES toll-free at 000-000-0000 to let DES know to terminate this Agreement. You may terminate a residential electric supply agreement in this manner only one time in any 12 month period. Upon termination, you will remain responsible for all obligations, including payment for Retail Power and related costs and charges, incurred under this Agreement prior to the effective date of termination, including any applicable termination fee.

  • Early Termination In the absence of any material breach of this Agreement, should the Trust elect to terminate this Agreement prior to the end of the term, the Trust agrees to pay the following fees:

  • Termination of Use These terms and Your access to Our Website may be terminated by Us (at Our sole discretion) at any time without notice or any requirement to give You a reason why. In the event of termination under this clause We shall have no liability to You whatsoever (including for any consequential or direct loss You may suffer).

  • EARLY TERMINATIONS The Student may be released from this agreement for:

  • Certification of Funds; Budget and Fiscal Provisions; Termination in the Event of Non-Appropriation This Agreement is subject to the budget and fiscal provisions of the City’s Charter. Charges will accrue only after prior written authorization certified by the Controller, and the amount of City’s obligation hereunder shall not at any time exceed the amount certified for the purpose and period stated in such advance authorization. This Agreement will terminate without penalty, liability or expense of any kind to City at the end of any fiscal year if funds are not appropriated for the next succeeding fiscal year. If funds are appropriated for a portion of the fiscal year, this Agreement will terminate, without penalty, liability or expense of any kind at the end of the term for which funds are appropriated. City has no obligation to make appropriations for this Agreement in lieu of appropriations for new or other agreements. City budget decisions are subject to the discretion of the Mayor and the Board of Supervisors. Contractor’s assumption of risk of possible non-appropriation is part of the consideration for this Agreement. THIS SECTION CONTROLS AGAINST ANY AND ALL OTHER PROVISIONS OF THIS AGREEMENT.

  • Payment on Early Termination Upon termination pursuant to Section 14 (Early Termination), District shall pay Contractor as follows:

  • H3 Termination on Notice H3.1 The Authority shall have the right to terminate the Contract at any time by giving thirty (30) days written notice to the Contractor.

  • Orderly Termination Upon termination or other expiration of this Contract, each Party shall promptly return to the other Party all papers, materials, and other properties of the other held by each for purposes of execution of the Contract. In addition, each Party will assist the other Party in orderly termination of this Contract and the transfer of all assets, tangible and intangible, as may be necessary for the orderly, non-disruptive business continuation of each Party.

  • Termination on Notice The Province may terminate the Agreement at any time without liability, penalty, or costs upon giving at least 30 days’ Notice to the Recipient.

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