definiens: means a document to support a meanin gful deviation from a Scope mutually approved in writing by both Parties that ( i ) describes in re asonable detail an amendment and/or modification to the Program and/or the Scope, and ( ii ) that is requ ired : ( a ) to meet new or unforeseen applicable regulatory or quality assurance requirements ; ( b ) t o address unforeseen issues which arise from the empirical results related to the biology of the mol ecule ; and/or ( c ) as a result of a change in the wr itten assumptions for the Scope agreed upon by the Partie s in relation to the Program design and objectives, manpower requirements, timing, and capital expendit ure requirements, if any ; ( d ) to perform activities that meaningfully deviate from the Scope but reques ted by Sponsor . After duly executed by both Parties, a Change Order is hereby deemed to be inco rporated into the applicable Scope