This clause applies to all Service Providers that may become aware of adverse events and product quality complaints in the regular course of providing services to the Johnson & Johnson Family of Consumer Companies (each, a Company for purposes of these provisions): 1. Definitions: (i) Adverse Event: Any untoward medical occurrence in a patient/consumer or investigation/program subject administered a Company product, which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, disease or injury temporally associated with the use of a Company product, whether or not related to the Company product. (ii) Date of First Receipt (Day 0): means the date of receipt or coming into possession or control of an AE, UE, SS or PQC report by Service Provider (e.g., date informed of AE, UE, SS or PQC during interview, generated fax receipt date, date e-mail received in an electronic inbox, date telephone call received, date voicemail message recorded, date postal mail received, date of posting on website, date completed questionnaire is available on server). (iii) Product Quality Complaint: 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. (iv) Special Situation (SS): Occurrences or reports that may not contain an AE, which must still be collected and reported in order to meet regulatory safety reporting requirements and Company policies: a. Overdose of a Company product, b. Pregnancy exposure (maternal and paternal), c. Exposure to a Company product from breastfeeding, d. Suspected abuse/misuse of a Company product, e. Inadvertent or accidental exposure to a Company product (including occupational exposure), f. Any failure of expected pharmacological or medical device action (i.e. lack of effect) of a Company product, g. Unexpected therapeutic or clinical benefit from use of a Company product, h. Medication error involving a Company product with or without patient/consumer exposure to the Company 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), i. Suspected transmission of an infectious agent via a Company product, j. Expired drug use and falsified medicine k. Off-label use - situations where a Company product is intentionally used for a medical purpose not in accordance with the authorized product information Off-label use without an associated AE or UE should be collected only when it is specifically and voluntarily brought to the attention of the company in an unsolicited manner by a reporter e.g., Health Care Professional (HCP) 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. (v) Undesirable Effect (UE): An adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product (Article 2, 1223/2009/EEC). Responsibilities of Service Provider 2. Data Collection and Reporting Obligations Service Provider shall collect any information coming into its possession or control relating to an Adverse Event (AE), Undesirable Effect (UE), Special Situation (SS) and/or Product Quality Complaint (PQC) in a format as agreed upon by Service Provider and Company). If Service Provider intends to collect the data electronically, Service Provider shall ensure the system for data collection is validated. Service Provider shall report to Company immediately, but in no case later than twenty four (24) hours from the Date of First Receipt by Service Provider, or as otherwise defined within the project protocol/scope of work, the occurrence of any AE, UE, SS, and/or PQC relating to Company product as defined above. Reporting criteria to Service Provider are met when an AE, UE, SS, PQC is linked to a Company product, i.e. the minimal information required for notification is a suspect Company product and a suspected AE, UE, SS and/or PQC. If reporter and patient/consumer details are not available, Service Provider should forward the case regardless to Company, as the minimum requirements of a Company product and event are met. 3. Reconciliation. Service Provider shall establish and maintain a tracking system for the collection, recording and collation of safety information for the product. At a frequency to be agreed between Service Provider and Company but at a minimum at the conclusion of the project, Service Provider must provide a summary of all identified AE, UE, SS and PQC reports as outlined in the vendor training and/or project protocol/scope of work. The frequency of reconciliation must be agreed prior to project initiation and will depend on the duration and extent of the project. Service Provider and Company will collaborate to identify any missing safety information in case of discrepancies, to ensure receipt of all collected safety information by Company. 4. Training. Service Provider shall ensure that its personnel involved in the execution of services pertaining to this project (including applicable subcontractors) are trained in the collection and reporting of AEs, UEs, SSs and PQCs, prior to the start of the project and at least annually thereafter if such services remain in effect. This includes defining training responsibilities, monitoring applicable AE, UE, SS and PQC training, and maintaining documentation. Company may require Service Provider to provide additional training when there is a change in the governing contracts, if applicable, and/or processes or change in Service Provider management staffing that relates to oversight of AEs, UEs, SSs or PQCs. 5. Information Storage. Service Provider shall maintain and archive records of all source documentation generated by the activity (including emails, questionnaires, and reports) and personnel training records relating to Company obligations under this project. Before Service Provider destroys any of the above safety records, it will notify Company of its intention to do so, affording Company the opportunity to retain such records if it so wishes. Responsibilities of Company 6. Audit: Company reserves the right to periodically audit Service Provider to verify that Service Provider processes are in accordance with Company policies and procedures. Service Provider will allow such access to its facilities, systems, personnel and records, in whatever form and in any location (including locations owned or operated by a third party) to facilitate audit by Company. Service Provider and Company agree to cooperate with each other to diligently investigate and resolve any audit findings. Responsibilities of Service Provider and Company 7. Data Privacy: in the performance of the above pharmacovigilance activities, Service Provider and Company will comply with all applicable laws in respect of data privacy in order to protect personal data. Service Provider and Company will collect, use and disclose any personal data obtained in the course of performing the pharmacovigilance activities above solely for the purposes of complying with regulatory obligations, or as otherwise required by applicable law or by a court order. Service Provider and Company will use electronic, physical and other safeguards appropriate to the nature of the information to prevent any use or disclosure of personal data other than as provided for above. Service Provider and Company will also take reasonable precautions to protect the personal data from accidental, unauthorized or unlawful alteration or destruction. Service Provider and Company will notify the other promptly of any accidental, unauthorized or unlawful destruction, loss, alteration, or disclosure of, or access to, the personal data and take immediate steps to rectify any such security breach. Acceptance Service Provider accepts and agrees to all terms in this Purchase Order relating to AE/PQC/SS/UE reporting as specified above, including, but not limited to, completion of training and the reporting and reconciliation of all AE/PQC/SS/UEs. Service Provider shall provide Company with the name of a key contact and shall assist the Company in implementation of the applicable AE/PQC/SS Management Plan required by the Company. If you have any questions regarding any of these requirements, send an email to [email protected]