definiens: means any ( a ) withdrawal of the Product in the Field from the market in the Territory,(b ) material medical or scientific concerns as to toxicity, safety and/or efficacy of Product in the Field, ( c ) written request ofany Governmental Authority or the applicable institutional review board or data safety monitoring board to stop clinical trialsof the Product in the Field, ( d ) failure of the Product to meet all primary endpoints in clinical trials conducted prior toRegulatory Approval of Product in the Field, ( e ) a Patent Right controlled by a Third Party is identified that is not included inthe [COMPANY] Patents and that is not otherwise licensed to Solvay, which Patent Right ( i ) claims inventions reasonablynecessary for the manufacture, use, sale, offer for sale or import of the Product in the Field in the Territory and ( ii ) is notavailable for licensing or otherwise transferable to Solvay on terms reasonably acceptable to Solvay, or ( f ) any of thefollowing events : ( i ) a determination that the Product is not approvable by FDA, as evidenced by a written communicationfrom FDA to Solvay, its Affiliate 8 Confidential Information, indicated by [ * * * ] has been omitted from this filing and filed separately with the SecuritiesExchange Commission or sublicensee ; ( ii ) a Governmental Authority imposing significant restrictions on Solvay ’s ability to promote the Product in amanner consistent with standard practices in the pharmaceutical industry for products of similar market potential ; or(iii ) managed care providers, comprising at least a majority of the managed care environment in the United States, blocking, materially restricting ( including, without limitation, imposition of step edits or prior authorizations ) or declining coverageand / or reimbursement for the Product