definiens: or means, with respect to a given Development Candidate or class ofcompounds, and a given Indication, the desired and required attributes for an aspirational drug product based thereon to treat, delay or prevent such Indication . These attributes will be determined through an understanding of current and future unmetmedical and market needs, and of the product performance necessary for regulatory approval and competitive differentiationat the time of anticipated launch . A TPP should contain information on at least the following parameters : Indication(s);Summary product proposition ( e.g. improved symptom reliever, disease modifier ) ; Target label summary - outline basis forregulatory approval ; Target patients for drug - segment(s ) of patient population for whom drug would be most relevant;Clinical efficacy - key endpoints, acceptable clinical effects versus baseline and placebo, main comparators ; Safety andtolerability – acceptable / unacceptable level and types of adverse events, contra - indications, drug interactions;Presentation / administration - route and frequency of administration ; Cost of Goods – target threshold level for cost of goods -19 - for finished commercial product ; Competitive set - current gold standard and treatment options, those expected at time ofpotential TPP launch ; Timing information – time period of future product launch for which TPP is relevant ( e.g. for 2015 - 2020 launch )