definiens: means a method for ide ntifying clinical trial subjects, which method meet s the following criteria : ( a ) such method is intended to be used in both a clinical trial and clinical u se setting ; ( b ) such method does not require the performance of significant additional activities besides completi on of a brief questionnaire and clinical status observation s ; ( c ) such method is actually used in a Phase II C linical Trial of the Product except as otherwise provided in this Section 1.59 ; and ( d ) if such method is used in a Phase II Clinical Trial, the use of such method in such Phas e II Clinical Trial is intended to ( i ) demonstrate the utility of such method and ( ii ) provide evidence of the validi ty of such method and its appropriateness for use i n a Phase III Clinical Trial . Notwithstanding anything to the contrary in this Agreement, the foregoing requirem ents shall not apply if ( x ) compliance with applicable Law ren ders compliance with such requirement impracticable or impossible ; ( y ) compliance with such requirement is not authorized by any Governmental Authority or Regulatory Authority or is not consistent with a Re gulatory Approval ; or ( z ) compliance with such requ irement is prohibited by, or would impede, delay or adverse ly impact the approval of the Product by, any Gover nmental Authority or Regulatory Authority