definiens: means a human clinical trial of a pharmaceutical product for a particular Indication andpatient population, after receipt of Regulatory Approval for such Indication and patient population, whether or not suchclinical trial is required to be conducted as a condition to obtaining or maintaining such Regulatory Approval . For clarity, forpurposes of this Agreement, a human clinical trial designed to support an expansion of the patient population for which aparticular Licensed Product is labeled for use in the U.S. Territory or the EU is not a Phase 4 Clinical Trial ; provided that ahuman clinical trial designed to support the modification of a label to include expressly a subset of the patient population forwhich a particular Licensed Product is already labeled for use is a Phase 4 Clinical Trial . For clarity and notwithstanding theforegoing, any human clinical trial of a pharmaceutical product for a particular Indication, after receipt of RegulatoryApproval for such Indication, that is not required by the applicable Regulatory Authority to maintain such RegulatoryApproval ( or to obtain Regulatory Approval in another country in the Territory ) and that [COMPANY] reasonably determinesto be a Phase 4 Clinical Trial shall, for purposes of this Agreement, be a Phase 4 Clinical Trial