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: (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 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.

Examples of Material Safety Issue in a sentence

• In the event that either Party believes in good faith that there is a Material Safety Issue with respect to the Product in the United States, and the other Party disagrees with such belief, either Party may request that the issue be discussed at the JSC for resolution.

• Termination due to Material Safety Issue; Clinical Hold; Study Termination.

• Prior to the discontinuation of such Collaboration Study, representatives of the JDC shall meet and discuss in good faith such Material Safety Issue or such Regulatory Authority communication.

• All licenses granted by Partner to Company under Sections 2.4(a) and (c), and sublicenses granted by Company, to any Partner IP shall automatically terminate upon termination of the Agreement (i) by Partner in accordance with Section 14.2 or (ii) by Company on the basis of Sections 14.2(c) (Material Safety Issue) or 14.2(d) (Clinical Hold); provided that such Clinical Hold is not imposed as a result of the acts or omissions of Partner.

• 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.

More Definitions of Material Safety Issue

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 [***]. Examples of Material Safety Issues include [***].

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, with respect to a given Licensed Product, a Party’s good faith belief that, after reviewing applicable safety data and other relevant safety factors, such Licensed Product should not [*].”

Material Safety Issue means, with respect to one or more Licensed Products, any safety, tolerability or other data, indicating or signaling, as measured by customary safety and efficacy evaluation criteria and methodology, that such Licensed Product(s) are 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 a Party’s good faith belief that [*] based upon (i) pre-clinical safety data [*] or (ii) [*].