Common use of Site Termination Clause in Contracts

Site Termination. If ImmunoGen, an Investigator, or regulatory authorities discover conditions during the study that indicate that the study or related activities at a particular center should be terminated, this action may be taken after appropriate consultation between ImmunoGen and the Investigator. Conditions that may warrant study or center termination include but are not limited to: • Discovery of an unexpected, serious, and/or unacceptable risk to patients enrolled in the study • Decision on the part of ImmunoGen to suspend or discontinue testing, evaluation, or development of the clinical program • Unacceptable benefit-risk relationship of the investigational product • Recommendations of the IDMC or regulatory body • Investigator failure to comply with applicable regulatory authority requirements or protocol requirements • Submission of knowingly false information from the center to ImmunoGen or regulatory authorities Study or center termination and follow-up will be performed in compliance with the conditions set forth in 21 CFR Section 312 and in compliance with the principles set forth in International Conference on Harmonisation (ICH) Good Clinical Practices (GCPs).

Site Termination. If ImmunoGen, an Investigator, or regulatory authorities discover conditions during the study that indicate that the study or related activities at a particular center should be terminated, this action may be taken after appropriate consultation between ImmunoGen and the Investigator. Conditions that may warrant study or center termination include but are not limited to: • Discovery of an unexpected, serious, and/or unacceptable risk to patients enrolled in the study • Decision on the part of ImmunoGen to suspend or discontinue testing, evaluation, or development of the clinical program • Unacceptable benefit-risk relationship of the investigational product • Recommendations of the IDMC or a regulatory body • Investigator failure to comply with applicable regulatory authority requirements or protocol requirements • Submission of knowingly false information from the center to ImmunoGen or regulatory authorities Study or center termination and follow-up will be performed in compliance with the conditions set forth in 21 CFR Section § 312 and in compliance with the principles set forth in International Conference on Harmonisation (ICH) Good Clinical Practices (GCPsGCP).