definiens: ( a ) and have the meanings given such terms under Section 13(d ) and 14(d ) of the United States Securities Exchange Act of 1934 and the te rm includes any group acting for the purpose of acquiring, holding or disposing of securities within the meaning of Rule 13d -5(b)(1 ) under the said Act ; ( b ) a will be determined in accordance with Rule 13d -3 under the aforesaid A ct ; and ( c ) the terms and will have meanings correlative to that of 1.31 means, collectively, First In -Human Clinical Trials, Non -Pivotal Clinical Trials and Pivotal Clinical Tria ls, and such other tests and studies in human subjects or patients that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Product for one or -5- more Indications, i ncluding tests or studies that are intended to expand the Product Labeling for such Product with respect to one or more such Indications or are otherwise deemed useful with respect to the continued Development of a Compound and/or Product . For clarity, Pha se IV Studies are not part of Clinical Trials