safety information, which contains at a minimum a suspect medicinal product and a suspect event i.e. an incomplete case. Unless otherwise indicated in the Applicable Law the Regulatory Clock Start Date or Day Zero for regulatory reporting, is the date the minimum criteria for reporting as defined by the Applicable Law becomes available (i.e., an identifiable subject/ patient, identifiable reporter, suspect product, and event). 1.6 "Incomplete Case" means a case that does not contain minimum criteria for reporting (as defined by the Applicable Law) to a Regulatory Authority (i.e., an identifiable subject/ patient, identifiable reporter, suspect medicinal product, and event), but at a minimum contains a suspect medicinal product and a suspect event. Such reports are entered on the safety database maintained by Janssen as potential cases of value for signal detection purposes. 1.7 "Personal Data" means any information relating to an identified or identifiable natural person. 1.8 "Product" has the meaning set forth in Section 1.77 of the Agreement. 1.9 "Product Quality Complaint" (PQC) Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a product after it is released for distribution. 1.10 "Regulatory Authority" means any applicable federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Product in the relevant Territory. 1.11 "Special Situation" Occurrences or reports that may not contain an adverse event, which must still be collected and reported in order to meet regulatory safety reporting requirements and Janssen policies: • Overdose of Product, • Pregnancy exposure (maternal and paternal), • Exposure to the Product from breastfeeding, • Suspected abuse/misuse of the Product, • Inadvertent or accidental exposure to the Product (including occupational exposure), • Any failure of