Study Completion. The Sponsor shall, within 90 days of the study completion, inform the State Institute for Drug Control and relevant Ethics Committees on completion of the study. Provided the completion of the study has been aborted, above mentioned period shall be reduced to 15 days. The Contract may be terminated as follows: a) If at least one (1) Study subject has not been enrolled by the Key Enrollment Date then Sponsor may terminate this Contract in accordance with section 3 of this Article. Key Enrollment Date is defined as a 100th (hundredth) calendar day after Site Initiation Visit. b) The Sponsor or the Health Service Provider is entitled to withdraw from the Contract that is effective on the day notice has been delivered to the last of parties in cases as follows: (i) Any of the Contract parties does not meet some provision of this Contract and does not eliminate the discrepancies within 60 days after obtaining a written request to do so; (ii) Any of the Contract parties performs settlement with its creditors or files a petition for bankruptcy; (iii) Any of the Contract parties ceases to be authorised to pursue its activities within the field in concern; (iv) The risk incurred by the subjects increases significantly; or (v) The necessary authorisation, approval, consent or exception are revoked or suspended, or expires without prolongation. c) The Contract may be terminated by written mutual agreement or notice, with the period of notice being 30 days from the day following the day of delivery of the notice to the last of Contract parties. d) Sponsor may suspend enrolment or terminate this Contract effective immediately upon written notice.
Appears in 1 contract
Sources: Clinical Trial Agreement
Study Completion. The Sponsor shall, within 90 days of the study completion, inform the State Institute for Drug Control and relevant Ethics Committees on completion of the study. Provided the completion of the study has been aborted, above mentioned period shall be reduced to 15 days. The Contract may be terminated as follows:
: a) If at least one (1) Study subject has not been enrolled by the Key Enrollment Date then Sponsor may terminate this Contract in accordance with section 3 of this Article. Key Enrollment Date is defined as a 100th (hundredth) calendar day after Site Initiation Visit.
. b) The Sponsor or the Health Service Provider Medical Facility is entitled to withdraw from the Contract that is effective on the day notice has been delivered to the last of parties in cases as follows:
: (i) Any of the Contract parties does not meet some provision of this Contract and does not eliminate the discrepancies within 60 days after obtaining a written request to do so;
; (ii) Any of the Contract parties performs settlement with its creditors or files a petition for bankruptcy;
; (iii) Any of the Contract parties ceases to be authorised to pursue its activities within the field in concern;
; (iv) The risk incurred by the subjects increases significantly; or
or (v) The necessary authorisation, approval, consent or exception are revoked or suspended, or expires without prolongation.
c) The Contract may be terminated by written mutual agreement or notice, with the period of notice being 30 days from the day following the day of delivery of the notice to the last of Contract parties.
d) Sponsor may suspend enrolment or terminate this Contract effective immediately upon written notice.
Appears in 1 contract
Sources: Clinical Trial Agreement