Common use of Safety Notification Clause in Contracts

Safety Notification. In case a Product is potentially deviating from the Product Specification, or under any other circumstance where such Product might cause, or already has caused, harm to a patient, user or other person, each Party shall notify the other Party in writing (“Safety Notification”), irrespective of the time or location of detection of the potentially faulty Product, as soon as the respective Party gains knowledge of such. It is CONOR’s sole responsibility to file Medical Device Reports or Vigilance Reports to any legal authority for the Products in order to comply with the applicable laws and regulations in the Territory. Should BIOTRONIK by any applicable law or regulation be obliged to report medical device incidents, this Agreement shall not prevent BIOTRONIK to do so. Safety Notifications and any other complaints on the Products are to be effected to the following address: BIOTRONIK AG CONOR MEDSYSTEMS IRELAND, LTD. Medical Device Safety Officer Medical Safety Officer Ackerstr. 6 ▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Dublin 2, Ireland ▇▇-▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇ Tel: [*] Tel.: [*] Fax: [*] Fax: [*] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.