definiens: means a human clinical study of a Product performedafter evidence suggesting effectiveness of such Product has been obtained pursuant to * * * Certain confidential information contained in this document, marked with 3 asterisks, has been omitted and filedseparately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.one ( 1 ) or more Phase II Clinical Study(ies ), conducted for inclusion in : ( a ) that portion of an FDAsubmission and approval process which provides for the continued clinical studies of a such Product onsufficient numbers of human patients to confirm with statistical significance the safety and efficacy of suchProduct sufficient to support a Regulatory Approval for the proposed Indication, as more fully described in21 C.F.R. 312.21(c ), or ( b ) equivalent Regulatory Filings with similar requirements in a country other thanthe United States