definiens: means any change t o the Development Plan or the Manufacturing Plan other than a Non - Substantive Amendment, such as : ( i ) the addition to the Development Plan of any new Clinica l Study, ( ii ) the deletion of any Clinical Study from the Development Plan, ( iii ) any amendment which is likely to result in a delay to any time - specific action formi ng part of the Development Plan or the Manufacturing Plan of more than six ( 6 ) months, and ( iv ) any other amendment which has any substantial effect on the timing, qua lity or costs of the activities thereby affected ; and ( ii ) the term means any chan ge to the Development Plan ( such as protocol design changes, including for exa mple, change of endpoints due to new information / learnings that could not have been foreseen at the time of preparing the Development Plan ) or the Manufacturing Plan, wh ich has no adverse consequences in terms of the timing or quality of t he planned Development or Manufacturing and does not result in a change in an y specific part ( set forth as a line item ) of 26 the applicable budget of more than [ * * * ] percent [ * * * ] % )