definiens: shall mean any infornlation regarding threatened or pending action by any regulatory authorities of the country where each party markets the Preparation, including, but not limited to, cancellation of the approval or order to terminate sales of its Preparation, to recall and destroy the Preparation on the market or to revise the approved indication, dosage and administration or impOltant caution for use of the Preparation, or the government issue of Dear Doctor Letter regarding the Preparation which may give serious impact to the sales of Preparation . As used in this Article, the term of ( as described in the most current U. S. Code of Federal Regulation s ) shall mean any noxious, pathological or unintended change in anatomical, physiological or metabolic function as indicated by physical signs, symptoms occurring in clinical trials, post - marketing surveillance, or clinical practice during the use of Preparation, or published in the medical literature, whether or not considered casually related to Preparation . This includes an exacerbation of a pre - existing condition, inter - current illness, drug interaction, significant failure of expected pharmacological or biological action . With respect to Adverse Event, the following shall apply : ( a ) As long as each Patty maintains governmental approval of the Preparation in any country of the world, ACSENTIENT and SENJU shall repOlt any Adverse Event known to it in respect of the Preparation or Compound to the appropriate regulatOlY authorities in the countries in which it is developing or commercializing the Preparation or Compound, in accordance with the laws and regulations of the relevant counllies and authorities, provided that in the Territory, ACSENTfENT shall control all communications by the Parties to the FDA, and any successor agency thereof ; ( b ) ACSENTIENT will submit safety data on the Preparation in the Territory to FDA in accordance with the regulations of FDA ; ( c ) Promptly after the Effective Date, each Party shall appraise the other Party of the standard operating procedur es for the investigation and reporting of Adverse Event and Regulatory Information regarding its products . The Parties shall then promptly develop and agree 9 DOCSOCI96JJ97v21 14202.0001 upon procedures to exchange infonnation concerning Adverse Event and Regulatory Infonnation of Preparation . The Parties shall immediately implement such agreed procedures and shall provide each other on a regular basis with any appropriate infonnation which enables the other Party to meet its regulatory obligations including but not limited to submission of periodic safety update report ( PSUR ) in countries in which it is developing or commercializing and/or distributing the Preparation or which is relevant to the safe use of the Preparation . The agreed procedures will be reviewed jointly on a regular basis or when there is a change in regulations governing Adverse Event and Regulatory Infonnation reporting ; ( d ) All Adverse Event reports and queries for SENJU should be addressed to Director, Post Marketing Surveillance Department, SENJU Phannaceutical Co., Ltd., 4 - 9, Hiranomachi 2 - chome, Chuo - ku, Osaka 541 - 0046, Japan ( facsimile number : 81 - 6 - 6229 - 3293, telephone number : 81 - 6 - 6201 - 9621 ) and for ACSENTIENT should be addressed to Manager of Drug Safety, ACSENTIENT Inc., 110 Doric Court, Morrisville, North Carolina 27560, U.S.A. ( facsimile number : 919 - 460 - 8729, telephone number : 813 - 631 - 9551 ) or such other safety representative as may be designated by SENJU for SENJU or by ACSENTIENT for ACSENTIENT