definiens: shall mean :] ( A ) any of the following, [ as determined by aSK, ] in the context of [ a clinical study described in sub - sections 6.2(c)(iii ), ( iv ) or ( vi ) below, ] as applicable : [ ( 1 ) pregabalin ; ( 2 ) gabapentin ; or ( 3 ) duloxetine ; or ( B ) an alternative comparator ] mutually agreed by the Parties ; provided that, [ in the event aSK selects one ] of the [ comparators in paragraph ( A ) above, aSK makes such selection prior to the initiation of the relevant clinical study described in sub - sections 6.2(c)(iii ), ( iv ) or ( vi ) below, ] as applicable, and [ provides [COMPANY] written notice ] of such [ selection ; ] and in the event [ aSK elects to use a comparator ] other than [ as described in paragraph ( A ) in a trial that could trigger a milestone under ] this Section 6.2, [ such trial shall not be initiated ] until the Parties mutually agree [ in writing upon such comparator . ] ( ii ) [, ] as provided in [ Milestone 5 above, ] shall be [ deemed to occur upon receipt by aSK ] of the [ audited and statistically validated data tables and graphs from all Existing Phase III Studies, ] together with [ written summaries of the key study outcomes of such Existing Phase III Studies . ] ( iii ) [ shall mean ] as to [ Milestone 11 ] above, the achievement of [ positive results demonstrating statistical superiority on all primary endpoints versus a Comparator ] against which [ Comparator a Product is tested ] in the [ clinical studies in appropriate populations designed to support a promotional claim of superior efficacy versus such Comparator in PDN ] and/or [ PHN with a safety / tolerability profile ] that is [ not meaningfully worse ] than such Comparator . ] ( iv ) [ shall mean ] as to [ Milestone 13 ] above, receipt [ by aSK of Marketing Approval for ] the Product [ with labeling for a Neuropathic Pain Indication ] that would [ support a promotional claim of superior efficacy versus a Comparator in PDN ] and/or [ PHN with a safety / tolerability profile ] that is [ not meaningfully worse ] than such [ Comparator ]