definiens: means the materials listed on Schedule C hereto ; means the value to be attributed to the Active Materials for certain purposes of this Agreement, and [COMPANY] 's maximum liability for the replacement cost of the Active Materials, as set out in Schedule D hereto ; means : ( a ) a business entity which owns, directly or indirectly, a controlling interest in a party to this Agreement, by stock ownership or otherwise ; or Doc # : 924418.5 ( b ) a business entity which is owned by a party to this Agreement, either directly or indirectly, by stock ownership or otherwise ; or ( c ) . a business entity, the majority ow"nership of which is directly or indirectly common to the majority ownership of a party to this Agreement ; means any unfavourable and unintended change in the structure, function, or chemistry of the body temporally associated with any use of the Products or of a derivative thereof, whether or not the adverse experience is considered to be related to the use of the Products, including but not limited to any of the following : an unexpected side effect, injury, toxicity or sensitivity reaction, which may include an experience of unexpected frequency or severity ; an adverse experience occurring in the course of the use of a drug product in professional practice ; an adverse experience occurring in clinical studies ; an advers~ experience occurring from drug overdose, whether accid ~ tal or intentional ; an adverse experience occurring from drug abuse ; an adverse experience occurring from drug withdrawal ; or any significant failure of expected pharmacological action .