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 If a subject is withdrawn from the study the reason(s) for withdrawal must be documented in the subject’s medical record and CRF.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 This agreement may be terminated at any time upon a thirty (30) day written notice from either party, and without fault or claim for damages by either party.

  • Early Termination of Services Termination at any time upon 90 days’ prior written notice. Following the written notice period and coinciding with the early termination by the Recipient of any Service(s) in this Schedule, Early Termination Fees equal to 75% of the monthly cost of such terminated Services shall be charged to Recipient monthly until the earlier of (i) three (3) months after termination or (ii) the expiration of the Term of this Schedule. Recipient: Mead Johnson Nutrition (Spain) S.L. Provider: Bristol-Myers Squibb S.A. Point of Contact, Recipient: Leanne Metz Point of Contact, Provider: Loic Senechal Payment Terms: All payments due within thirty (30) days of receipt of invoice by Recipient.

  • 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. Homefield Energy will comply with all applicable provisions and regulations concerning rescission and early termination of contract. Shortly after your election to take service from Homefield Energy, 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 Homefield Energy 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 bill issued to you under this Agreement by calling Homefield Energy toll-free at 000-000-0000 to let Homefield Energy 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: a. all monthly fees through the life of the contract, including the rebate of any negotiated discounts; b. all fees associated with converting services to successor service provider; c. all fees associated with any record retention and/or tax reporting obligations that may not be eliminated due to the conversion to a successor service provider; d. all out-of-pocket costs associated with a-c above.

  • Complete Disposal Upon Termination of Service Agreement Upon Termination of the Service Agreement Provider shall dispose or delete all Student Data obtained under the Service Agreement. Prior to disposition of the data, Provider shall notify LEA in writing of its option to transfer data to a separate account, pursuant to Article II, section 3, above. In no event shall Provider dispose of data pursuant to this provision unless and until Provider has received affirmative written confirmation from LEA that data will not be transferred to a separate account.

  • Early Termination of Option The Option, to the extent not previously exercised, and all other rights in respect thereof, whether vested and exercisable or not, shall terminate and become null and void prior to the Expiration Date in the event of: • the termination of the Participant’s employment or services as provided in Section 5.6 of the Plan, or • the termination of the Option pursuant to Section 7.3 of the Plan.

  • Payment upon Early Termination (a) Within three (3) calendar days after an Early Termination Effective Date, the Corporate Taxpayer shall pay to each TRA Party an amount equal to the Early Termination Payment in respect of such TRA Party. Such payment shall be made by wire transfer of immediately available funds to a bank account or accounts designated by such TRA Party or as otherwise agreed by the Corporate Taxpayer and such TRA Party or, in the absence of such designation or agreement, by check mailed to the last mailing address provided by such TRA Party to the Corporate Taxpayer.

  • Procedure Upon Termination of Trust Fund (a) Notice of any termination pursuant to the provisions of Section 7.01, specifying the Distribution Date upon which the final distribution shall be made, shall be given promptly by the Trustee by first class mail to Certificateholders mailed upon (x) the sale of all of the property of the Trust Fund by the Trustee pursuant to Section 7.01(b) or (y) upon the final payment or other liquidation of the last Mortgage Loan or REO Property in the Trust Fund. Such notice shall specify (A) the Distribution Date upon which final distribution on the Certificates of all amounts required to be distributed to Certificateholders pursuant to Section 5.02 will be made upon presentation and surrender of the Certificates at the Corporate Trust Office, and (B) that the Record Date otherwise applicable to such Distribution Date is not applicable, distribution being made only upon presentation and surrender of the Certificates at the office or agency of the Trustee therein specified. The Trustee shall give such notice to the Master Servicer and the Certificate Registrar at the time such notice is given to Holders of the Certificates. Upon any such termination, the duties of the Certificate Registrar with respect to the Certificates shall terminate and the Trustee shall terminate or request the Master Servicer to terminate, the Collection Account it maintains, the Certificate Account and any other account or fund maintained with respect to the Certificates, subject to the Trustee’s obligation hereunder to hold all amounts payable to Certificateholders in trust without interest pending such payment. (b) In the event that all of the Holders do not surrender their Certificates for cancellation within three months after the time specified in the above mentioned written notice, the Trustee shall give a second written notice to the remaining Certificateholders to surrender their Certificates for cancellation and receive the final distribution with respect thereto. If within one year after the second notice any Certificates shall not have been surrendered for cancellation, the Trustee may take appropriate steps to contact the remaining Certificateholders concerning surrender of such Certificates, and the cost thereof shall be paid out of the amounts distributable to such Holders. If within two years after the second notice any Certificates shall not have been surrendered for cancellation, the Trustee shall, subject to applicable state law relating to escheatment, hold all amounts distributable to such Holders for the benefit of such Holders. No interest shall accrue on any amount held by the Trustee and not distributed to a Certificateholder due to such Certificateholder’s failure to surrender its Certificate(s) for payment of the final distribution thereon in accordance with this Section. (c) Any reasonable expenses incurred by the Trustee in connection with any termination or liquidation of the Trust Fund shall be reimbursed from proceeds received from the liquidation of the Trust Fund.

  • Alternative Calculations and Payment on Early Termination and on Certain Extraordinary Events If (a) an Early Termination Date (whether as a result of an Event of Default or a Termination Event) occurs or is designated with respect to the Transaction or (b) the Transaction is cancelled or terminated upon the occurrence of an Extraordinary Event (except as a result of (i) a Nationalization, Insolvency or Merger Event in which the consideration to be paid to holders of Shares consists solely of cash, (ii) a Merger Event or Tender Offer that is within Counterparty’s control, or (iii) an Event of Default in which Counterparty is the Defaulting Party or a Termination Event in which Counterparty is the Affected Party other than an Event of Default of the type described in Section 5(a)(iii), (v), (vi), (vii) or (viii) of the Agreement or a Termination Event of the type described in Section 5(b) of the Agreement, in each case that resulted from an event or events outside Counterparty’s control), and if Dealer would owe any amount to Counterparty pursuant to Section 6(d)(ii) of the Agreement or any Cancellation Amount pursuant to Article 12 of the Equity Definitions (any such amount, a “Payment Obligation”), then Dealer shall satisfy the Payment Obligation by the Share Termination Alternative (as defined below), unless (a) Counterparty gives irrevocable telephonic notice to Dealer, confirmed in writing within one Scheduled Trading Day, no later than 12:00 p.m. (New York City time) on the Merger Date, Tender Offer Date, Announcement Date (in the case of a Nationalization, Insolvency or Delisting), Early Termination Date or date of cancellation, as applicable, of its election that the Share Termination Alternative shall not apply, (b) Counterparty remakes the representation set forth in Section 8(f) as of the date of such election and (c) Dealer agrees, in its sole discretion, to such election, in which case the provisions of Section 12.7 or Section 12.9 of the Equity Definitions, or the provisions of Section 6(d)(ii) of the Agreement, as the case may be, shall apply.

  • 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.

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