definiens: shall mean any human clinical trial, the principal purpose of which is to establish safety and efficacy in patientswith the disease being studied as required under 21 CFR 312.21(c ), as such regulation may be subsequently modified, or similar clinical studyin a country other than the United States . Phase III Trial shall also include a human clinical trial that has been designated by [COMPANY] as apivotal trial whether or not such trial is a traditional ‘ Phase III ’ clinical trial, as shown in communications with the FDA ( or other RegulatoryAuthority ) or meeting minutes of discussions with the FDA ( or other Regulatory Authority ) ( such as a trial which [COMPANY] has designated to theFDA as a Phase II / III trial, a trial for which the protocol has been designated as a Phase II / III protocol, or a trial that [COMPANY] has otherwiseindicated to the FDA ( or other Regulatory Authority ) it intends to use for purposes of Phase III )