definiens: means data, knowledg e and information, including materials, samples . chemical manufacturing data, toxicological data, pharmacological data, preclinical and clinical data, assavs . platform s. formulations, specificati ons . gualitv control testing data . that are necessary or useful for the discovery . Regulatorv Approval, manufacture . development or commercialization of the Compound and the Product in the Territorv.1 1.25 means all ( a ) constitutions, treaties, laws, statutes, codes, ordinances, orders, decrees, rules, regulations and municipal by·laws, whether domestic, foreign or international, ( b ) judgments, orders, writs, injunctions, decisions, rulings, decrees and words of any governmenta l or regulatory body or authority, and ( c ) all policies, voluntary restraints, practices and guidelines of any governmental or regulatory body or authority, in each case binding on or affecting the Party referred to in the context in which such word is used