definiens: means a product support human clinical trial, or other test orstudy, of a Compound or Product for an indication that is either ( a ) commenced after receipt ofthe initial Regulatory Approval for such indication in the country for which such trial is beingconducted and that is conducted within the parameters of the Regulatory Approval for theCompound or Product for such indication ( and which may include investigator - sponsored clinicaltrials ( ) ), but shall not include any Phase IIIb Clinical Trial or ( b ) is an IST that does not fallwithin the approved label for a Product . Phase IV Clinical Trials may include trials or studiesconducted in support of pricing / reimbursement, epidemiological studies, life cycle management, modeling and pharmacoeconomic studies, post - marketing surveillance studies, outcomeresearch studies and health economics studies . For clarity, for purposes of this Agreement, Phase IV Clinical Trials do not include clinical trials or other studies where a Product is used insuch study as provided in Section 4.3(a)(iii )