basis that such Party drafted this Agreement or any portion hereof. [The remainder of this page is intentionally left blank.] IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date. JANSSEN BIOTECH, INC. By: /s/Reshema Keups-Polanco Name: Reshema Keups-Polanco Title: VP, Sales and Marketing, Solid Tumor IMMUNOMEDICS, INC. By: /s/Jared Freedberg Name: Jared Freedberg Title: General Counsel Schedule 1.16 Janssen Universal Calendar Schedule 6.2 Pharmacovigilance Provisions 1 Definitions 1.1 "Adverse Event" (AE) means any untoward medical occurrence in a patient or a clinical-trial subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (for example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. 1.2 "Agreement" means the Promotion Agreement to which this Schedule is attached. 1.3 "Applicable Law" means the applicable laws, rules, regulations, including any guidelines or other requirements of any Regulatory Authority in the relevant country of the Territory, and industry guidelines or codes of conduct that may apply to the review and analysis of safety information, the reporting of safety information to Regulatory Authorities and the maintenance of records thereof. 1.4 "Company Employee" means any employee of Immunomedics, Inc. or any of its Affiliates conducting activities under the Agreement. 1.5 "Date of First Receipt" means the date of receipt or coming into possession or control of 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