Common use of SUSPENSION OF THE STUDY Clause in Contracts

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.

Appears in 7 contracts

Samples: Clinical Trial Agreement, Clinical Trials Agreement, Clinical Trial Agreement

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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 competent authority 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 the applicable Work Order 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 the applicable Work Order 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 regulationsApplicable Laws.

Appears in 1 contract

Samples: Master Agreement for Commercial Clinical Research

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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; 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 Partyin 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.

Appears in 1 contract

Samples: Clinical Trial Agreement

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