definiens: shall mean, .. vith respeGt to a Lieensed Pro duet, dosing of the tirst patieHt in a Phase III Clinioal Trial eonducted pursuant to the DeveloprneHt Plan, or oondueted by or under authority of [COMPANY], as an Indepel'ldel'lt Project, for sueh Lieel'lsed Produot . } < [ * * * J. > ( d ) { " C8mpleti61 t ofPalient EnFo/!ment in a Phase II ! CliniC8:1 Trial ' shall mean, ' .'lith respect to a Lieel'lsed Produet, el'lrollmeHt and dosing of the last patient to be dosed ( in aceordanee with the protoGol for such trial ) in a Phase III Clinieal Trial GOl'lducted in accordanGe vlith the Development Plan for sueh Licel'lsed Product, or in a Phase III Clil'lieal Trial eonducted by or under authority of [COMPANY] as an Independent Projeet . } < [ * * * J. > ( e ) { shall mean, with respeet to a Licensed ProduGt in a Primary Market in Europe, that an MAA has been acGepted for substantive re"/iew by ( i ) the Regulatory Authority of ¥ ranee, Germany, Italy, Spail'l, or the United Kingdom 01 ' ( b ) the EMEA uader a centralized procedure . For purposes of the foregoing, ' Validation of an MAA by sueh Regulatory Authority of a country or the EMEA shall be deemed of sueh l\4AA by sueh Regulatory Authority or E1\4E/\ :, as applicable, and if an .l\4AA is submitted under the EO mutual recognition procedure and validated by the reierenee rnember state ( the ), sush MAA shall be deemed aeeepted by the Regulatory Authority of a Gountry upon eonfimlatiol'l that the reSUlting approval in the RMS will serve as the basis for a mutual recognition proeedure in such country . } < [ * * * J. > ( f ) For purposes of this Article 7, a { Phase II Clinieal Trial}<[***J > shall be deemed to constitute a { Phase III Clinical Trial } < [ * * * J > if the JDC determines to proceed with filing an { NDA or MAA}<[***l > based upon the use of Data from such { Phase II Clil'lieal Trial}<[***J > as a pivotal trial