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 expected pharmacological action (i.e. lack of effect) of the Product, • Unexpected therapeutic or clinical benefit from use of the Product, • Medication error (includes potential, intercepted or actual) involving the Product with or without patient/consumer exposure to the Product, (e.g. name confusion) OR that caused an unintended effect or could cause an intended effect (e.g. adult medicine given to a young child), • Suspected transmission of an infectious agent via Product, • Expired drug use and falsified medicine, • Off-label use - situations where the Product is intentionally used for a medical purpose not in accordance with the authorized product information. Off-label use without an associated AE, Special Situation, UE or AEPQC should be collected only when it is specifically and voluntarily brought to the attention of a Company Employee in an unsolicited manner by a reporter e.g., Health Care Professional or data obtained from databases where off-label use may be systematically collected (e.g., reimbursement database in US), and in accordance with local procedure in compliance with local laws and regulations. Follow-up of off-label use is not required. 1.12 "Territory" means the United States of America, including its territories and possessions. 1.13 "Undesirable Effect" (UE) shall mean an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product. Note: All capitalized terms used but not defined in this Schedule shall have the meanings ascribed to them (if any) in the Agreement. 2 Reporting Requirements 2.1 If any Company Employee receives or otherwise