definiens: shall mean ( a ) any clinical study undertaken ( i ) for approval of newindications for the Product, ( ii ) to obtain a compendial listing, ( iii ) for the purpose of providing datathat will result in a labeling change for the Product, or ( iv ) for any other purpose under an IND forthe Product ( e.g., Phase I through Phase III studies ), ( b ) any Phase IIIb Clinical Trial or Phase IVClinical Trial for the Product, and ( c ) any non - clinical study that is ( 1 ) required, requested oradvised by a Regulatory Authority or ( 2 ) undertaken with the intention to obtain or maintain aregulatory approval or compendial listing, or to develop and provide additional information forinclusion in the label for the Product . A clinical study shall be deemed to have commenced whenthe first patient in such study is enrolled . For clarity, for purposes of this Agreement, ClinicalStudies do not include clinical trials or other studies where a Product is used in such study asprovided in Section 4.3(a)(iii )