Discontinuation of Study Drug Sample Clauses

Discontinuation of Study Drug. Subjects who discontinue study drug post-randomization will complete the Week 12/Early Withdrawal assessments specified in the Schedule of Assessments (Section 1.3). Reasons for discontinuation from double-blind study drug treatment and the study include the following: • Adverse event (AE) • Lack of efficacy • Noncompliance • Withdrawal of consent • Lost to follow-up • Physician decision • Protocol deviation • Pregnancy • Death • Other Discontinuation of study drug for abnormal liver function should be considered by the Investigator when a subject meets all of the conditions outlined in Section 8.4.7.2 for Hy’s law or if the Investigator believes that it is in the best interest of the subject (reason for discontinuation will be AE). Reporting and follow-up requirements for pregnancy are provided in Section 8.4.5 and Section 10.6.2. For subjects who are not randomized into the 12-week double-blind treatment period and, therefore, are either screen failures or run-in failures, the End of Study eCRF should be completed (refer to eCRF completion guidelines for additional information).
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Discontinuation of Study Drug. ‌ Indications for study drug discontinuation include symptoms of hypocalcemia confirmed on blood assay and development of an acute fall in urine output confirmed by a rise in creatinine. Additional indications for discontinuation include the development of a study drug related SAE during infusion or any other study drug related adverse event that the investigator believes warrants discontinuation.
Discontinuation of Study Drug. ‌ If a subject discontinues study drug early for any reason they should be encouraged to return for an Early Discontinuation of Study Drug Visit (Refer to section 10.6). Subjects will not be withdrawn from the study and will be encouraged to complete all remaining visits and procedures. If a subject discontinues study drug due to a related AE, the subject will be followed and treated by the Investigator until the abnormal parameter or symptom has resolved or stabilized.

Related to Discontinuation of Study Drug

  • Discontinuation Either party may discontinue the job/time sharing arrangement with ninety

  • Continuation of Health Benefits An employee on an approved Military Caregiver Leave shall be entitled to continue participation in health plan coverage (medical, dental, and optical) as if on pay status during the leave.

  • Continuation of Work Pending the resolution of any dispute or claim pursuant to this Article 11, the Parties agree that performance of all obligations will be pursued diligently.

  • Continuation of or Change in Business Each of the Loan Parties shall not, and shall not permit any of its Unregulated Subsidiaries to, engage in any business other than a Permitted Business.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Continuation of Benefits (i) For a period of three years following the Termination of Employment (the “Benefit Continuation Period”), the Employee shall be treated as if Employee had continued to be an executive for all purposes under the Company’s health insurance plan and dental insurance plan; or if the Employee is prohibited from participating in such plans, the Company shall otherwise provide such benefits. Employee shall be responsible for any employee contributions for such insurance coverage. Following the Benefit Continuation Period, Employee shall be entitled to receive continuation coverage under Part 6 of Title I of ERISA (“COBRA Benefits”) by treating the end of this period as the applicable qualifying event (i.e., as a termination of employment) for purposes of ERISA Section 603(2)) and with the concurrent loss of coverage occurring on the same date, to the extent allowed by applicable law. (ii) For the Benefit Continuation Period, the Company shall maintain in force, at its expense, the Employee’s life insurance in effect under the Company’s voluntary life insurance benefit plan as of the Change-in-Control Date or as of the date of Termination of Employment, whichever coverage limits are greater. For purposes of clarification, the portion of the premiums in respect of such voluntary life insurance for which Employee and the Company are responsible, respectively, shall be the same as the portion for which the Company and Employee are responsible, respectively, immediately prior to the date of Termination of Employment or the Change-in-Control Date, as applicable. (iii) For the Benefit Continuation Period, the Company shall provide short-term and long-term disability insurance benefits to Employee equivalent to the coverage that the Employee would have had Employee remained employed under the disability insurance plans applicable to Employee on the date of Termination of Employment, or, at the Employee’s election, the plans applicable to Employee as of the Change-in-Control Date. Should Employee become disabled during such period, Employee shall be entitled to receive such benefits, and for such duration, as the applicable plan provides. For purposes of clarification, the portion of the premiums in respect of such short-term and long-term disability benefits for which Employee and the Company are responsible, respectively, shall be the same as the portion for which Employee and the Company are responsible, respectively, immediately prior to the date of Termination of Employment or the Change-in-Control Date, as applicable. (iv) Notwithstanding anything in this Agreement to the contrary, in no event shall the provision of in-kind benefits pursuant to this Section 3 during any taxable year of Employee affect the provision of in-kind benefits pursuant to this Section 3 in any other taxable year of Employee.

  • Implementation of Corrective Action Plan After the Corrective Action Plan is finalized, the Purchasers shall use reasonable best efforts to implement the finalized Corrective Action Plan on the timeline set forth therein and provide periodic reports (as provided for therein) to the Sellers on the status of their implementation of the Corrective Action Plan.

  • Continuation of Agreement This Agreement shall become effective for each Fund as of the date first set forth above and shall continue in effect for each Fund until August 1, 2010, unless sooner terminated as hereinafter provided, and shall continue in effect from year to year thereafter for each Fund only as long as such continuance is specifically approved at least annually (i) by either the Board of Directors or by the vote of a majority of the outstanding voting securities of such Fund, and (ii) by the vote of a majority of the Directors, who are not parties to the Agreement or interested persons of any such party, cast in person at a meeting called for the purpose of voting on such approval. The annual approvals provided for herein shall be effective to continue this Agreement from year to year if given within a period beginning not more than 90 days prior to August 1st of each applicable year, notwithstanding the fact that more than 365 days may have elapsed since the date on which such approval was last given.

  • Separation of Components The SOFTWARE PRODUCT is licensed as a single product. Its component parts may not be separated for use on more than one computer.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

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