definiens: shall mean, with respect to a particular Party, an entity that, directly or indirectly, through one or moreintermediaries, controls, is controlled by or is under common control with such Party . As used in this section, the term ( with correlative meanings for the terms or ) means ( a ) that an entityor company owns, directly or indirectly, more than fifty percent ( 50 % ) of the voting stock of another entity, or ( b ) that anentity, person or group otherwise has the actual ability to control and direct the management of the entity, whether by contractor otherwise . For clarity, Novartis Pharma AG shall not be considered an Affiliate of Idenix.1.13 shall mean, with respect to a Party ’s Single Agent Compound, the ( a ) safetyinformation for such Single Agent Compound that is Joint Study Data in combination with ( b ) safety information from allother clinical trials of such Single Agent Compound, whether alone or in combination with another pharmaceutical agent, ineach case including information related to serious adverse events, adverse drug reactions, adverse events, discontinuations dueto adverse events, and Grade 3 and Grade 4 laboratory abnormalities . Aggregate Safety Information, that is not Joint SafetyData, shall be presented in a tabular format only, without attribution to the specific clinical trial in which the data wasgenerated, and disclosed in accordance with Section 9.3