definiens: means the direct expenses incurred by a Party through its internal efforts or the efforts of a Third Party on account of such Party, provided such costs are incurred after the Effective Date and consistent with the Development Plan and Development Budget ( or the equivalent for a [COMPANY] Tenninated Product or [COMPANY] Tenninated Product ) and are specifically attributable to the Compound Screening or Preclinical Development of Target Inhibitors, the Clinical Development of Collaboration Products under Development Plans and Development Budgets, or the Clinical Development of [COMPANY] Terminated Products or [COMPANY] Tenninated Products under the equivalent of a Development Plan and Development Budget, including, without limitation : ( a ) costs of conducting Compound Screening efforts ; ( b ) costs of conducting Preclinical Development to accept or reject a Lead Candidate as an IND Ready Candidate ; ( c ) costs ofGMP manufacturing of Drug Substance ; ( d ) costs of designing and manufacturing of C1 M for Phase I Trials, Phase II Trials and Phase IlIa Trials ( and where approved by the Parties pursuant to Section 3.2(e ), certain Phase lUb Trials ) ; ( e ) costs of conducting Clinical Development of an IND Ready Candidate ; ( f ) costs of preparing, submitting, reviewing or developing data or infonnation for IND or NDA submission, or equivalent regulatory filings outside of the United States ; ( g ) fees, including FDA user fees, associated with U.S. and foreign regulatory filings or other U.S. and foreign governmental requirements related to Collaboration Products ; ( h ) manufacturing process development and scale - up of eTM for Phase IDa Trials ( and Phase lIIb Trials to the extent such is treated as being included under Development as opposed to Commercialization ) in bulk and finished form ; and ( i ) such other costs directly related to Development that are later identified and mutually agreed upon by the JOe