definiens: means a party ’s directors, officers, employees, a dvisers, agents, consultants, subcontractors, service partners, professional advi sors, or representatives ; shall mean all information relating to known or p otential risk to humans obtained or otherwise received from any source, including infor mation derived from clinical investigations, commercial marketing experience, post - authorization, post - authorization epidemiological / surveillance studies, reports in the scientific literature, unpu blished scientific papers, animal or in vitro studies, electronic communications and reports . Safety Infor mation may include Adverse Events, lack of efficacy, suspected transmission of infectious agents, overdo se, abuse, misuse, medication errors, pregnancy / breastfeeding exposure and off - label use ; means the file, for each Product, which is given by Client to [COMPANY] in accordance with the procedures listed in Schedule A and which conta ins documents relating to each Product, including, without limitation : ( a ) specifications for Active Materials and Components ; ( b ) manufacturing specifications, directions, and proce sses ; ( c ) storage requirements ; ( d ) all environmental, health and safety informatio n for each Product including material safety data s heets ; and ( e ) the finished Product specifications, packaging specifications and shipping requirements for each Prod uct ; all as updated, amended and revised from time to ti me by Client in accordance with the terms of this Agreement ; has the meaning specified in Section 2.2 ; has the meaning specified in Section 5.1(h ) ; has the meaning specified in Section 4.5 ; or have the meaning specified in Section 13.6(a ) ; has the meaning specified in Section 8.1 ; means the entire world where Products manufacture d by [COMPANY] will be distributed by Client ; means the Intellectual Property of any third part y other than an Affiliate of a party hereto ; has the meaning specified in Section 5.1(c ) ; - 7 - [ * * ] = Portions of this exhibit have been omitted p ursuant to a confidential treatment request