definiens: means, with respect to the United States, the then - current requirements for non - clinical ( animal orlaboratory ) trials that will be submitted to a Regulatory Authority to support a Drug Approval Application, specified in21 C.F.R. § 58, as may be amended, and, with respect to any other country or jurisdiction in the Territory, theequivalent regulations in such other country or jurisdiction, including any such standards or guidelines set forth by ICHand any analogous set of regulations, guidelines or standards as defined, from time to time, by any relevantRegulatory Authority having jurisdiction over the development, manufacture or Commercialization of a Compound or aLicensed Product in a particular jurisdiction of the Territory ( including the EMA or any successor agency thereto or thecorresponding national health authorities ), as applicable, in each case as in effect as of the date such non - clinicalstudies for the applicable Compound or Licensed Product are or were conducted