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 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.

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.

Examples of Material Safety Issue in a sentence

• If the Executive Officers approve a course of action to address such Material Safety Issue, then the Parties shall thereafter take all actions necessary to implement such course of action.

• If the registration of which the Company gives notice under Section 3(a) is for a registered public offering involving an underwriting, the Company shall so advise the Holders as a part of the written notice given pursuant to Section 3(a)(i).

• If, during the Development Term, either Party determines that there is a Material Safety Issue, such Party shall promptly notify the other Party and the JSC shall promptly meet to discuss such Material Safety Issue and to seek to approve an appropriate course of action to address such Material Safety Issue (which may include delaying, modifying, suspending or terminating one or more of the Collaboration Activities).

• If the JSC approves a course of action to address such Material Safety Issue, then the Parties shall thereafter take all actions necessary to implement such course of action.

• Notwithstanding the foregoing, neither Party shall be required to continue a Combined Therapy Trial if a Party reasonably deems there to be a Material Safety Issue for such Combined Therapy Trial.

More Definitions of Material Safety Issue

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 CPI Compound, BioXcel Compound or the Nektar 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 Compound or Product that leads a Party to reasonably determine that [***]. Examples of Material Safety Issues include [***].

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 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 *** good-faith determination that there is an unacceptable risk for harm in humans based upon the ***.

Material Safety Issue means a Party’s good faith belief that [*] based upon (i) pre-clinical safety data [*] or (ii) [*].

Material Safety Issue means a significant safety concern that is bona fide, serious and unexpected or, if expected, is observed at a higher rate and grade, and is generally not monitorable or reversible and that, in any case, would significantly impact or delay anticipated Regulatory Approval for, or Commercialization of the Licensed Product.