Material Safety Issue definition
Material Safety Issue means a Party’s good faith belief that there is an unacceptable risk for harm in humans based upon: (a) pre-clinical safety data, including data from animal toxicology studies, or (b) the observation of Serious Adverse Events in humans after the Recipient Study Drug or the BMS Study Drug, either as a Single Agent Compound or in combination with another pharmaceutical agent (including as the Combined Therapy), has been administered to or taken by humans, such as during the Combined Therapy Clinical Trial.
Material Safety Issue means a Party’s good faith belief that there is an unacceptable risk for harm in humans based upon: (i) pre-clinical safety data, including data from animal toxicology studies; or (ii) the observation of serious adverse effects in humans after the Nektar Compound or the BMS Compound, either as a single agent or in combination with another pharmaceutical agent (including as the Combined Therapy), has been administered to or taken by humans, such as during the Combined Therapy Trial.
Material Safety Issue means the occurrence of any significant safety-related event, incident or circumstance with respect to a Licensed Compound or Licensed Product that leads a Party to reasonably determine that the continued use of such Licensed Compound or Licensed Product by patients may result in patients being exposed to a product for which the risks outweigh the benefits. Examples of Material Safety Issues include the issuance of a clinical hold order (or similar requirement or recommendation) by a Regulatory Authority, where the clinical hold is not resolvable in the ordinary course, or an IRB requirement or recommendation to terminate or suspend a Clinical Trial.
Examples of Material Safety Issue in a sentence
The Parties will then promptly meet and each Party may propose good faith modifications to the Clinical Study to address such Material Safety Issue and, if both Parties agree, Immatics shall act to implement immediately such modifications.
If, notwithstanding the Parties’ implementation of any such modifications or other good-faith efforts to address such Material Safety Issue, such Material Safety Issue has not been resolved within [***] following the temporary pause of the Clinical Study, then either Party may terminate this Project Agreement immediately effective upon written notice to the other Party.
More Definitions of Material Safety Issue
Material Safety Issue means a Party’s good faith belief that [*] based upon (i) pre-clinical safety data [*] or (ii) [*].
Material Safety Issue means any safety, tolerability or other data, indicating or signaling, as measured by customary safety and efficacy evaluation criteria and methodology, that the Co-Exploited Product is unsafe for medical applications in humans.
Material Safety Issue means that there is an unacceptable potential risk of harm to humans based upon (i) technical data; (ii) pre-clinical safety data, including data from animal toxicology studies; or (iii) the observation of adverse effects in humans following a Product (or product developed outside this Agreement using Collaboration IP) having been administered to or taken by humans.
Material Safety Issue means *** good-faith determination that there is an unacceptable risk for harm in humans based upon the ***.
Material Safety Issue means the occurrence of any significant safety-related event, incident or circumstance with respect to a Compound or Product that leads a Party to reasonably determine that the continued use of such Compound or Product by patients may result in patients being exposed to a product for which the risks outweigh the benefits. Examples of Material Safety Issues include the issuance of a clinical hold order (or similar requirement or recommendation) by a Regulatory Authority, where the clinical hold is not resolvable in the ordinary course, or an IRB/EC requirement or recommendation to terminate or suspend a Clinical Trial.
Material Safety Issue means the occurrence of any significant safety-related event, incident or circumstance with respect to a Compound or Product that leads a Party to reasonably determine that [***]. Examples of Material Safety Issues include [***].
Material Safety Issue means a Party’s good faith belief that there is an unacceptable risk for harm in humans based upon the observation of serious adverse effects in humans after the Dermata Compound or the Revance Compound, either as a single agent or in combination with another pharmaceutical agent, has been administered to or taken by humans, such as during the Initial Trial.