definiens: shall mean any ofthe following events : ( i ) a change in worker shift patterns related to the manufacture of the Product, including withoutlimitation a change from a two - shift to a three - shift pattern ; ( ii ) a change in the number of manufacturing lines involved in themanufacture of the Product ; and/or ( iii ) adding an additional manufacturing site as a Production Site to manufacture theProduct . The Parties agree that Organizational Changes should be avoided as much as possible, and thatsanofi - aventis shall not be required to implement an Organizational Change more frequently than [ … * * * … ] . In the event of alabour action or dispute, [ … * * * … ] will use commercially reasonable efforts to [ … * * * … ], so long as [ … * * * … ] . All costsassociated [ … * * * … ] will be borne by [ … * * * … ] . The Coordinators shall regularly discuss Horizon ’s forecasts of demand forthe Product and the resulting implications for Organizational Changes, if any . It is understood and acknowledged by Horizonthat sanofi - aventis shall not be required to fill purchase orders for commercial supply quantities greater than the then - currentactual capacity of the then - qualified sanofi - aventis Production Sites ( at the time of receiving written notice from Horizonoutlined immediately above ) until such time as the an Organizational Change is implemented in accordance with thisAgreement and applicable law