Insurance cover. 8.1 The Sponsor/CRO confirms that it has taken out a third party liability insurance policy (no. _____, with the insurer _____) to cover the risk of injury to patients from taking part in the Trial, in accordance with M.D. of 14 July 2009). The Ethics Committee considers that the insurance policy complies with the provisions of the law and adequately protects the patients taking part in the Trial. 8.2 Subject to the provisions of law no. 24 of 8 March 2017, the insurance cover provided by the Sponsor is guaranteed with regard to the civil liability of the Sponsor, as well as the healthcare facility at which the Trial will take place, the Principal Investigator, and the other investigators involved at the Entity’s Centre. 8.3 The Sponsor is liable for any consequences resulting from any present or future deficiencies in the insurance cover mentioned above. 8.4 In particular, in the event that the Sponsor intends to withdraw from the Agreement, the Sponsor warrants that the insurer shall in all cases guarantee the cover of the patients already included in the clinical trial also during the continuation of the Trial, in accordance with Article 2 para. III of M.D. of 17/07/09. 8.5 It is acknowledged that the Entity has insurance policies for Medical Malpractice (“MEDMAL”) stipulated to cover both the Entity and the medical staff administering the drug, in accordance with article 1910 of the Italian Civil Code. (c) In the case of observational studies on drugs
Appears in 3 contracts
Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement
Insurance cover. 8.1 The Sponsor/CRO confirms that it has taken out a third party liability insurance policy (no. _____, with the insurer _____) to cover the risk of injury to patients from taking part in the Trial, in accordance with M.D. of 14 July 2009). The Ethics Committee considers that the insurance policy complies with the provisions of the law and adequately protects the patients taking part in the Trial.
8.2 Subject to the provisions of law no. 24 of 8 March 2017, the insurance cover provided by the Sponsor is guaranteed with regard to the civil liability of the Sponsor, as well as the healthcare facility at which the Trial will take place, the Principal Investigator, and the other investigators involved at the Entity’s Centre.
8.3 The Sponsor is liable for any consequences resulting from any present or future deficiencies in the insurance cover mentioned above.
8.4 In particular, in the event that the Sponsor intends to withdraw from the Agreement, the Sponsor warrants that the insurer shall in all cases guarantee the cover of the patients already included in the clinical trial also during the continuation of the Trial, in accordance with Article 2 para. III of M.D. of 17/07/0914/07/09.
8.5 It is acknowledged that the Entity has insurance policies for Medical Malpractice (“MEDMAL”) stipulated to cover both the Entity and the medical staff administering the drug, in accordance with article 1910 of the Italian Civil Code.
(c) In the case of observational studies on drugs
Appears in 2 contracts
Insurance cover. 8.1 The Sponsor/CRO Sponsor confirms that it has taken out a third party liability insurance policy (no. _____ITLSCQ37557, with the insurer _____Chubb European Group SE) to cover the risk of injury to patients from taking part in the Trial, in accordance with M.D. of 14 July 2009). The Ethics Committee considers that the insurance policy complies with the provisions of the law and adequately protects the patients taking part in the Trial.
8.2 Subject to the provisions of law no. 24 of 8 March 2017, the insurance cover provided by the Sponsor is guaranteed with regard to the civil liability of the Sponsor, as well as the healthcare facility at which the Trial will take place, the Principal Investigator, and the other investigators involved at the Entity’s Centre.
8.3 The Sponsor is liable for any consequences resulting from any present or future deficiencies in the insurance cover mentioned above.
8.4 In particular, in the event that the Sponsor intends to withdraw from the Agreement, the Sponsor warrants that the insurer shall in all cases guarantee the cover of the patients already included in the clinical trial also during the continuation of the Trial, in accordance with Article 2 para. paragraph III of M.D. of 17/07/0914/07/09.
8.5 It The Entity is acknowledged that required to disclose the Entity has insurance existence of MEDMAL policies for Medical Malpractice (“MEDMAL”) stipulated to cover both the Entity and the medical staff administering the drug, ) in accordance with article Article 1910 of the Italian Civil Code.
(c) In the case of observational studies on drugs
Appears in 1 contract
Samples: Authorization Agreement