Spectrum Responsibilities Sample Clauses
Spectrum Responsibilities. Spectrum’s responsibilities for the Products include, as set forth in the Pharmacovigilance Agreement: (i) notifying Eagle in writing by secure e-mail or facsimile of information concerning Adverse Events (except as set forth in the next sentence of this Section 9.1(c)) within two (2) business days of the date first learned; (ii) carrying out risk management plan obligations in the Territory; and (iii) communicating information about Adverse Events to Healthcare Professionals in the Territory. In addition, throughout the Term, Spectrum agrees to notify Eagle within one (1) day of relevant information, if any, that Spectrum obtains during its performance of the obligations hereunder concerning a side effect, injury, toxicity or sensitivity reaction, or an unexpected incident, and the severity thereof, whether or not determined to be attributable to the Product (“Adverse Event”), where such Adverse Event is: (i) serious or unexpected and associated with the clinical uses, studies, investigations, tests and marketing of any Product; or (ii) non-serious and spontaneously reported in connection with the marketing of any Product in the Territory. “Serious” as used in this Section refers to an experience which is fatal or life threatening, results in a persistent or significant disability or incapacity, in-patient hospitalization or prolongation of hospitalization; or is a congenital anomaly, a birth defect, a cancer, or the result of an overdose (whether
Spectrum Responsibilities
