definiens: shall mean the secure archive containing all Raw Data ( defined below ) that exist asof the Amendment Date from any study conducted by or on behalf of [COMPANY] ( other than by Synosia ) regarding aProgram Compound within the Tier 1 Program ( until such time, if ever, as [COMPANY] exercises its Opt - In Right underSection 3.1(d ) ), Tier 2 Program or Tier 3 Program ( excluding the Tier 3 Program for mGluR1 agonists ) ; or a Tier 1Product ( during the period specified above ), Tier 2 Product or Tier 3 Product ( excluding a Tier 3 Product incorporatinga Program Compound from the Tier 3 Program for mGluR1 agonists ) ; which data, in each case, is either included in afinal report submitted or intended for submission to the FDA, EMEA or other regulatory body, or may be suitable forfuture submission to such regulatory bodies . For the purposes of this section, shall be defined as all data, laboratory worksheets, laboratory notebooks, laboratory standard operating procedures, records, instrument recordingsand readouts, memoranda, notes and similar materials from any study, that are the results of original observationsand activities and are necessary for the reconstruction and evaluation of the report of such study