definiens: means a withdrawal of a Product from the market in a country or countrieswhich has or is reasonably expected to have an adverse effect ( which is material ) on sales of such Productrespectively, in Territory A, or all the Territory A Opt - out Country(ies ), as a whole, and is ( a ) mandated bya Governmental Authority ; ( b ) implemented by [COMPANY] or its Affiliates in anticipation of a withdrawal thatSanofi believes in good faith to be reasonably likely to be mandated in the future by a GovernmentalAuthority ( either by reason of statements from such Governmental Authority, mandated withdrawals inother jurisdictions or other objective facts ) ; or ( c ) implemented by [COMPANY] or its Affiliates in lieu ofcomplying with new requirements or conditions imposed by a Governmental Authority, which requirementsor conditions are reasonably expected by [COMPANY] to have an adverse effect ( which is material ) on sales ofsuch Product in such country or result in material costs and other burdens to [COMPANY] or its Affiliates in respectof such Product in such country, which expectation is reasonably supported by available facts ; in each case, to the extent such Governmental Authority mandated withdrawal or the imposition of such requirements orconditions by a Governmental Authority is not attributable to acts or omissions of [COMPANY] or its Affiliatesthat constitute negligence or willful misconduct . For purposes of this Agreement, [COMPANY] ’s or its Affiliate’swithdrawal or decision to withdraw a Product by [COMPANY] ( instead of complying with a new requirement orcondition of a Governmental Authority contemplated under clause ( c ) above ) shall not in and of itself bedeemed to be negligent or willful misconduct