definiens: for the Products is defined as anyuntoward medical occurrence that at any dose for any of the Products ( a)results in death, ( b ) is life - threatening, ( c ) requires inpatienthospitalization or prolongation of existing hospitalization, ( d ) results inpersistent or significant disability / incapacity, ( e ) is a congenitalanomalylbirth defect, ( f ) results in drug dependency or drug abuse, ( g)causes cancer, or ( h ) results in an overdose . A for the Products is defined as an untoward medical occurrence atany dose for any of the Products that is not a Serious Adverse Event5.6 . Recall . In the event that either Party believes it may be necessary to conduct arecall, field correction, market withdrawal, stock recovery, or other similar action with respect toany Product which was sold under this Agreement ( a ), [COMPANY] and [COMPANY] shall promptlyconsult with each other as to how best to proceed ; it being understood and agreed that the finaldecision as to any Recall of any Product shall be made by [COMPANY] ; provided, that neither Party beprohibited hereunder from taking any action that it is required to take by Applicable Law andrespective national laws . The cost of any Recall of any Product occasioned or reqnired as part ofa general Recall of the products of either Party shall be borne by that Party . Any Recall requiredbecause of the breach of this Agreement by [COMPANY], shall be at [COMPANY] 's sole expense . AnyRecall required because of a negligent act or omission in the manufacture, handling, storage, marketing, promotion, sale or distribution of Product or other breach of this Agreement by Parshall be at [COMPANY] 's sole expense