definiens: means any of the following material Development events, a summary of which shall be included in any Development Report : ( a ) any material interaction and/or written correspondence between TGTX or its Sublicensees and any Regulatory Authority with respect to a Compound or a Licensed Product ; ( b ) any material event with respect to any Clinical Trial involving the Compound and/or a Licensed Product, including any such event that is ongoing as of the date of the applicable Development Report, or is reasonably expected to occur or be initiated within twelve ( 12 ) months of the date of the applicable Development Report ; and ( c ) any material result obtained in the conduct of any Clinical Trial involving a Compound and/or a Licensed Product during the period covered by the Development Report . For purposes of this definition, shall be defined as any event and/or result which have had or may have a significant impact on the activities and time lines defined in the Development Plan of a Licensed Product