Study Drug Withdrawal Sample Clauses

Study Drug Withdrawal. Participation in the study is strictly voluntary. Subjects are free to discontinue the study at any time without giving their reason(s). A subject must be withdrawn from the study treatment in the event of any of the following: • Withdrawal of the subject’s consent; • New onset of a condition that would have met exclusion criterion, is clinically relevant and affects the subject’s safety, and discontinuation is considered necessary by the Investigators or Sage; • Occurrence of intolerable adverse events; • Intake of nonpermitted concomitant medication; • Subject noncompliance; • Significant protocol deviation determined in consultation with the Medical Monitor. If a subject failed to attend scheduled assessments during the course of the study, the Investigators must determine the reasons and the circumstances as completely and accurately as possible and document this in the subject’s source documents. Subjects may be withdrawn from the study if there is concern for the subject’s safety or it is determined that the subject is no longer a qualified participant. Subjects who withdraw or are withdrawn from the study will be replaced only if they withdraw prior to dosing. Subjects who are withdrawn from the study, fail to return or are no longer qualified will not be replaced.
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Related to Study Drug Withdrawal

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.

  • 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.

  • Withdrawal Any holder of Registrable Securities may elect to withdraw such holder’s request for inclusion of Registrable Securities in any Piggy-Back Registration by giving written notice to the Company of such request to withdraw prior to the effectiveness of the Registration Statement. The Company (whether on its own determination or as the result of a withdrawal by persons making a demand pursuant to written contractual obligations) may withdraw a Registration Statement at any time prior to the effectiveness of such Registration Statement. Notwithstanding any such withdrawal, the Company shall pay all expenses incurred by the holders of Registrable Securities in connection with such Piggy-Back Registration as provided in Section 3.3.

  • Prescription Drug Plan Retail and mail order prescription drug copays for bargaining unit employees shall be as follows:

  • 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.

  • Withdrawal Events In the event of the death, retirement, withdrawal, expulsion, or dissolution of a Member, or an event of bankruptcy or insolvency, as hereinafter defined, with respect to a Member, or the occurrence of any other event which terminates the continued membership of a Member in the Company pursuant to the Statutes (each of the foregoing being hereinafter referred to as a “Withdrawal Event”), the Company shall terminate sixty days after notice to the Members of such withdrawal Event unless the business of the Company is continued as hereinafter provided. Notwithstanding a Withdrawal Event with respect to a Member, the Company shall not terminate, irrespective of applicable law, if within aforesaid sixty day period the remaining Members, by the unanimous vote or consent of the Members (other than the Member who caused the Withdrawal Event), shall elect to continue the business of the Company. In the event of a Withdrawal Event with respect to an Member, any successor in interest to such Member (including without limitation any executor, administrator, heir, committee, guardian, or other representative or successor) shall not become entitled to any rights or interests of such Member in the Company, other than the allocations and distributions to which such Member is entitled, unless such successor in interest is admitted as a Member in accordance with this Agreement. An “event of bankruptcy or insolvency” with respect to a Member shall occur if such Member:

  • No Withdrawal No Person shall be entitled to withdraw any part of such Person’s Capital Contribution or Capital Account or to receive any Distribution from the Company, except as expressly provided in this Agreement.

  • Recall Employees who have been laid off shall be re-employed in seniority order from most senior to least senior. Employees whose positions have been eliminated through layoff or otherwise, shall be called first to fill a vacancy within their job family. 1. Prior to other employees being recalled from the recall list, an employee who displaced another employee pursuant to provisions contained in this article shall have the right to be recalled to a vacant position for which they are qualified. However, the employee who displaces another employee shall not be eligible for a position at a higher pay grade than the one he/she originally held at the time of layoff. If the employee who displaced another employee fills a vacancy in his/her original department, then the employee whom he/she displaced will automatically be recalled into the position from which he/she previously held. After this process, other employees will be recalled to fill a vacancy for which they are qualified in the same department they were assigned at the time of their layoff. 2. Employees may be offered a position outside their department/program for which they are qualified. Employees may refuse a position outside their department/program. Employees who refuse such a position a second time shall have no further rights to recall. 3. Each employee on layoff shall be required to provide the District Personnel Office, in writing, with a current address to which a letter of recall may be sent. Employees being recalled shall be notified by “Certified Mail Delivery Confirmation” and shall have five (5) working days from the date of the receipt of notice to respond to the School Board’s offer and return to work. The School Board reserves the right to temporarily assign an employee to the vacancy until the recalled employee reports to work. If the letter is mailed to the address provided by the employee and is returned to the School Board because the address is incorrect, the School Board has fulfilled the obligation of this sub-section. If the School Board does not receive an affirmative response, the employee will be moved to the bottom of the recall list. If the recall notice is returned in the allotted time, yet not marked appropriately by the Human Resources & Equity Department, the employee shall retain his/her place on the recall list for the next job opening for which he/she is qualified. However, after the third returned notice, the employee’s name will be dropped from the recall list and the School Board shall have no further obligation to the employee. 4. An employee whose contract is non-renewed due to reorganization shall be entitled to recall rights for a layoff period of eighteen (18) months. All other employees shall be entitled to recall rights for a layoff period of twelve (12) months. 5. The employee laid off pursuant to this Article shall be given the opportunity to continue insurance coverages in existing programs during the layoff provided that the premium for such insurance programs shall be paid by the employee on a monthly basis in advance of the month due. 6. No new or substitute appointments may be made while there are laid off employees available who are qualified to fill the vacancies, except that employees may be hired into positions that have been offered and refused by employees on the layoff/recall list.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

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