SUSPENSION OF THE STUDY Sample Clauses

SUSPENSION OF THE STUDY. Notwithstanding Article 5.1, in the event the conditions for a favorable opinion of the ethics committee or authorization from the Minister in relation to the conduct of the Study are no longer met, or when doubts arise about the safety or scientific validity of the Study, the SPONSOR may immediately and at any time suspend this Agreement and the conduct of the Study for a maximum period of twelve (12) months. The SPONSOR shall notify the INSTITUTION and the INVESTIGATOR in writing of any such suspension; upon notification date the said maximum period shall start. Before the end of the twelve (12) months period, the SPONSOR may notify in writing the INSTITUTION and the INVESTIGATOR of the restart of the Study. In such case, the INSTITUTION and the INVESTIGATOR undertake to restart forthwith the services stated in this Agreement in accordance with the SPONSOR’s instructions. Should the SPONSOR not have notified the INSTITUTION and the INVESTIGATOR of the restart of the Study within the twelve (12) month period, the Agreement may be terminated by either of the Parties upon thirty (30) Days prior written notice to the other Party. Any further decision taken by the SPONSOR with regard to the restart of further actions regarding the Study will be communicated by the SPONSOR in due time and in accordance with all applicable laws and regulations.
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SUSPENSION OF THE STUDY. Notwithstanding Article 5.1, in the event the conditions for a favorable opinion of the ethics committee or authorization from the Minister in relation to the conduct of the Study are no longer met, or when doubts arise about the safety or scientific validity of the Study, the SPONSOR may immediately and at any time suspend this Agreement and the conduct of the Study for a maximum period of [twelve (12)] months. The SPONSOR shall notify the INSTITUTION and the INVESTIGATOR in writing of any such suspension. Before the end of the [twelve (12)] months period, the SPONSOR may notify in writing the INSTITUTION and the INVESTIGATOR of the restart of the Study. In such case, the INSTITUTION and the INVESTIGATOR undertake to restart forthwith the services stated in this Agreement in accordance with the SPONSOR’s instructions. Should the SPONSOR not have notified the INSTITUTION and the INVESTIGATOR of the restart of the Study within the [twelve (12)] month period, the Agreement may be terminated by either of the Parties in accordance with Article 5.2.1 of this Agreement. Any further decision taken by the SPONSOR with regard to the restart of further actions regarding the Study will be communicated by the SPONSOR in due time and in accordance with all applicable laws and regulations. TERMINATION OR SUSPENSION – PRACTICAL CONSEQUENCES AND OBLIGATIONS FOR THE PARTIES AND THE INVESTIGATOR Upon any termination or suspension of this Agreement or the Study, the INSTITUTION and the INVESTIGATOR will comply with the provisions of the Protocol pertaining notably to the practical consequences of such termination or suspension. Immediately upon receipt of a notice of termination or suspension, the INVESTIGATOR and the INSTITUTION shall stop enrolling Study Participants into the Study, shall cease conducting procedures on Study Participants already enrolled in the Study as directed by the SPONSOR, to the extent medically and ethically permissible, and shall refrain from incurring additional costs and expenses to the extent possible. In the event the Study is terminated or suspended for other reasons than Study Participant safety or public health motivations, but also in case of completion of the Study, the SPONSOR and the INVESTIGATOR shall discuss the on-going treatment needs of Study Participants and will, if appropriate given the circumstances of the Study termination, agree on a plan for discontinuing treatment of Study Drug to ensure enrolled Study Participants have adeq...
Sample 1Sample 2See All (6)
SUSPENSION OF THE STUDY. Ukončení nebo vypršení této Smlouvy nezbavuje žádnou ze smluvních stran jejích povinností k ostatním stranám, a to s ohledem na následující ustanovení: Oddíl 1.4 b) a c) [Studijní lék a Studijní materiál], Oddíl 1.8 [Majetkové přiznání], Oddíl 3 [Důvěrnost], Oddíl 4 [Duševní vlastnictví], Oddíl 5 [Publikace a propagace], Oddíl 6 [Zproštění odpovědnosti, oznámení nároků a pojištění], Oddíl 7 [Kontroly, audity, monitorování a záznamy], Oddíl 8.4 [Platnost po ukončení], Oddíl 10 [Protiúplatková a protikorupční ustanovení], Oddíl 11 [Ochrana osobních údajů], Oddíl 12 [Různé] a Oddíl 13 [Platné zákony a soudní příslušnost].
Sample 1Sample 2Sample 3See All (5)
SUSPENSION OF THE STUDY. [Duševní vlastnictví], Oddíl 5 [Publikace a propagace], Oddíl 6 [Zproštění odpovědnosti, oznámení nároků a pojištění], Oddíl 7 [Kontroly, audity, monitorování a záznamy], Oddíl 8.4 [Platnost po ukončení], Oddíl 10 [Protiúplatková a protikorupční ustanovení], Oddíl 11 [Ochrana údajů], Oddíl 12 [Různé] a Oddíl 13 [Platné zákony a soudní příslušnost].
Sample 1
SUSPENSION OF THE STUDY. The study may be suspended either for any of the reasons set forth in Royal Legislative Decree 1/2015, of July 24, which approves the revised text of the Law on guarantees and rational use of medicines and health products, or mutual agreement of the parties or at the request of one of the parties if the following conditions are met: Impossibility of including a minimum number of patients within a reasonable time that allows the final evaluation of the Study Causes of force majeure. In case an intermediate analysis of the data advises it. At the request of the SPONSOR or main researcher for duly justified reasons. The suspension will be processed by the SPONSOR. In the event of suspension of the study, the Principal Investigator will stop the inclusion of patients in the study, as well as any activity related to it. The final settlement of the study will be adjusted based on the actual number of patients included and visits and examinations performed. If as a result of this liquidation, amounts are in favor of IDIBGI, the SPONSOR must pay them. Likewise, if the amounts are in favor of the SPONSOR, IDIBGI must reimburse them.
Sample 1
SUSPENSION OF THE STUDY. [Platnost po ukončení], Oddíl 10 [Protiúplatková a protikorupční ustanovení], Oddíl 11 [Zpracování údajů a mezinárodní předávání osobních údajů], Oddíl 12 [Různé] a Oddíl 13 [Platné zákony a soudní příslušnost].
Sample 1
SUSPENSION OF THE STUDY. V případě ukončení 1) mají strany povinnost spolupracovat za účelem bezpečného ukončení účasti Subjektů hodnocení ve Studii, a to co nejdříve bude přiměřeně možné; 2) má Poskytovatel zdravotních služeb povinnost dle pokynů neprodleně navrátit PSI nebo Zadavateli veškerý nepoužitý Studijní materiál;
Sample 1
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SUSPENSION OF THE STUDY. Ukončení nebo vypršení této Smlouvy nezbavuje žádnou ze smluvních stran jejích povinností k ostatním stranám, a to s ohledem na následující ustanovení: Oddíl 1.4 b) a c) [Studijní lék a Studijní materiál], Oddíl 1.8 [Majetkové piiznání], Oddíl 3 [Důvěrnost], Oddíl 4 [Duševní vlastnictví], Oddíl 5 [Publikace a propagace], Oddíl 6 [Zproštění odpovědnosti, oznámení nároků a pojištění], Oddíl 7 [Kontroly, audity, monitorování a záznamy], Oddíl
Sample 1
SUSPENSION OF THE STUDY jejích povinností k ostatním stranám, a to s ohledem na následující ustanovení: Oddíl 1.4
Sample 1

Related to SUSPENSION OF THE STUDY

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