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. 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 adequate continuum of care during the reasonable period necessary to organise and provide an alternative treatment to ensure the Study Participant’s safety. In the event this Agreement or the Study is terminated, the INSTITUTION and the INVESTIGATOR shall stop the Study as expeditiously as possible and in accordance with Article 5.4.3 and all applicable national and local laws, regulations and guidelines. The INSTITUTION and the INVESTIGATOR undertake not to start any work not already engaged.

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 adequate continuum of care during the reasonable period necessary to organise and provide an alternative treatment to ensure the Study Participant’s safety. In the event this Agreement or the Study is terminated, the INSTITUTION and the INVESTIGATOR shall stop the Study as expeditiously as possible and in accordance with Article 5.4.3 5.4.3. and all applicable national and local laws, regulations and guidelines. The INSTITUTION and the INVESTIGATOR undertake not to start any work not already engaged.

SUSPENSION OF THE STUDY. Notwithstanding Article 5.15, 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 5.2.2 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 premature termination or suspension of this Agreement or the Study, the INSTITUTION and the INVESTIGATOR will comply with the provisions of the Protocol Investigational Plan 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 patients into the Study, shall cease conducting procedures on Study Participants patients 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 patient 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 patients and will, if appropriate given the circumstances of the Study termination, agree on a plan for discontinuing treatment of Study Drug Device / Software to ensure enrolled Study Participants patients have adequate continuum of care during the reasonable period necessary to organise and provide an alternative treatment to ensure for the Study Participant’s safetypatient. In the event this Agreement or the Study is prematurely terminated, the INSTITUTION and the INVESTIGATOR shall stop the Study as expeditiously as possible and in accordance with Article 5.4.3 and all applicable national and local laws, regulations and guidelines. The INSTITUTION and the INVESTIGATOR undertake not to start any work not already engaged.

SUSPENSION OF THE STUDY. Notwithstanding Article 5.15., 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 5.2.2 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 premature termination or suspension of this Agreement or the Study, the INSTITUTION and the INVESTIGATOR will comply with the provisions of the Protocol Investigational Plan 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 patients into the Study, shall cease conducting procedures on Study Participants patients 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 patient 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 patients and will, if appropriate given the circumstances of the Study termination, agree on a plan for discontinuing treatment of Study Drug Device / Software to ensure enrolled Study Participants patients have adequate continuum of care during the reasonable period necessary to organise and provide an alternative treatment to ensure for the Study Participant’s safetypatient. In the event this Agreement or the Study is prematurely terminated, the INSTITUTION and the INVESTIGATOR shall stop the Study as expeditiously as possible and in accordance with Article 5.4.3 and all applicable national and local laws, regulations and guidelines. The INSTITUTION and the INVESTIGATOR undertake not to start any work not already engaged.