Adverse Events and Serious Adverse Events. The definitions of an AE and SAE can be found in Section 10.3. AEs will be reported by the subject (or, when appropriate, by a caregiver, surrogate, or the subject’s legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE and remain responsible for following up AEs that are serious, considered related to the study drug or study procedures, or that caused the subject to discontinue the study drug or the study (see Section 7).
Adverse Events and Serious Adverse Events. (A) To ensure that all relevant safety information for Toremifene is shared between the Parties, the following information will be exchanged: (i) GTX will provide to Orion all regulatory safety updates (e.g. 120-day safety updates, annual reports, and post-authorization safety updates) concerning Product and information regarding all serious adverse events from clinical studies and all spontaneous adverse reactions, including reports from literature concerning the Product coming to the knowledge of GTX; and (ii) Orion will provide to GTX Periodic Safety Update Reports prepared in accordance with ICH E2C or equivalent guidelines as adopted by the European Medicines Evaluation Agency (EMEA) relevant to Product for use in the Orion Field in the Orion Territory, and information regarding all serious adverse events from clinical studies and all spontaneous adverse reactions, including reports from literature concerning Product, coming to the knowledge of Orion. All of the above mentioned safety information shall be exchanged reasonably in advance of any applicable regulatory deadlines or upon release of such information. In addition, any safety information which may negatively affect the benefit-risk ratio of Products or that may have consequences regarding the product information (e.g. labeling, data sheets, instruction leaflets) or may require immediate safety measures to be taken by either Party shall be forwarded to the other Party without any delay. Each Party is responsible for any regulatory safety reporting requirements [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Adverse Events and Serious Adverse Events. Detailed information related to the collection and reporting of AEs and SAEs is in Section 9. All AEs will be reported by the patient (or, when appropriate, by a caregiver, surrogate, or the patient's legally authorized representative). The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE and remain responsible for following up AEs that are serious, considered related to study treatment or study procedures, or that caused the patient to discontinue study drug (Section 9.1).
Adverse Events and Serious Adverse Events. The definitions of AEs and SAEs can be found in Section 10.3. All AEs will be reported to the Investigator or qualified designee by the participant (or, when appropriate, by a caregiver, surrogate, or the participant’s legally authorized representative. The Investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE and remain responsible for following up AEs that are serious, considered related to the study intervention or study procedures, or that caused the participant to discontinue the study intervention (see Section 7). Procedures for recording, evaluating, follow-up, and reporting AEs and SAEs are outlined in Section 10.3.
Adverse Events and Serious Adverse Events. Detailed information related to the collection and reporting of AEs and SAEs in Section 8.
