definiens: means : Any injury or illness that i ) is life threatening, or ii ) result in permanent impairment of a body function or permanent damage to a body structure, or iii ) necessities medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure . To be reported a d irect link with the Product and its possible short -comings should be clearly established . 13.5 The Parties shall be responsible for reporting under United States reporting requirements such as 21 CFR Part 803, the Japanese Ministry of Health and Welfare a nd the European Union reporting requirements and under the reporting requirements of any other country as may be applicable . Before submitting a report involving a Product either Party shall use its best efforts to notify the other Party and to obtain any information it may have relating to any incident involving a Product . Copies of such reports shall be sent to the other Party without delay . If JMHW or any governmental authorities require to take any product corrective action ( including notification, reca ll, removal and correction ) involving a Product in Japan, NK shall use its best efforts to notify CSC by email within 24 hours from the receipt of such information and CSC shall be responsible to determine the conduction or non -conduction of the corrective action within a commercially reasonable time and manner after the receipt of the information from NK . In case that CSC decides to take any corrective action for any product in overseas which is substantially the same as the Product specified herein, the P roduct sold or distributed by NK in Japan shall also to be taken corrective action . If FDA or other regulatory authorities contact either Party to inquire about or investigate the Products sold under this Agreement, the contacted Party, unless required to maintain confidentiality by such authorities, shall inform the other Party immediately thereof . The Parties shall co -operate closely to clear any regulatory issues or potential regulatory issues promptly . [ * ] Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission