Safety Concern definition
Safety Concern means, with respect to any Agreement Product, (a) any safety concern required to be reported under 21 C.F.R. § 312.32(c)(1)(iii) (“Findings from animal or in vitro testing”) if an IND with respect to such Agreement Product was open at the time of the observation or (b) a material toxicity or material drug safety issue or a Serious Adverse Event reasonably related to an Agreement Product.
Safety Concern means any toxicity, serious adverse event, or other safety finding in any preclinical or clinical studies required by or performed for the purpose of submission to Regulatory Authorities that leads to a good faith determination by any data monitoring committee or by Regulatory Authorities that the Licensed Product exposes or could expose humans to an unacceptable safety risk in relation to therapeutic benefit.
Safety Concern means [***].
Examples of Safety Concern in a sentence
Promptly following Isis’ determination that a High Response Outcome, Medium Response Outcome or Low Response Outcome has occurred, Isis will provide AstraZeneca with written notice (an “Outcome Notice”) of whether (i) there is a High Response Outcome (and whether at least [***]), Medium Response Outcome or Low Response Outcome, (ii) there is a Safety Concern, and (iii) Target Knock-Down was achieved, and will include with such Outcome Notice the available components of the Phase 1/2 Trial Data Package.
Within 30 days of receiving the Phase 1/2 Trial Data Package, to the extent disputed by the Parties, such Third Party expert will determine whether there is a High Response Outcome, Medium Response Outcome, or Low Response Outcome and whether there is a Safety Concern, and/or if there is Target Knock-Down.
More Definitions of Safety Concern
Safety Concern means, with respect to any Licensed Product, (a) any safety concern required to be reported under 21 C.F.R. § 312.32 (or any successor or analogous Law outside of the United States) (“IND Safety Reporting”) if an IND with respect to such Licensed Product was open at the time of the observation (or that would be so reportable if an IND was open at such time), or (b) a toxicity or drug safety issue or a Serious Adverse Event reasonably related to or observed in connection with Development or Commercialization activities with respect to a Licensed Product.
Safety Concern is an important identified risk, important potential risk or missing information (as further defined in EMA/876333/2011 Guideline on good pharmacovigilance practices (GVP) Annex I – Definitions).
Safety Concern means (a) any safety concern required to be reported under 21 C.F.R. § 312.32(c)(1)(iii) (“Findings from animal or in vitro testing”) if an IND with respect to such Antibody Candidate or Licensed Product was open at the time of the observation or (b) a toxicity or drug safety issue or a Serious Adverse Event reasonably related to or observed in connection with Research, Development or Commercialization activities with respect to an Antibody Candidate or Licensed Product. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
Safety Concern means, with respect to any compound or product, (a) any safety concern required to be reported under 21 C.F.R. § 312.32 if an IND with respect to such product was open at the time of the observation (or that would be so reportable to a Regulatory Authority if an IND was not open at such time), or (b) a toxicity or drug safety issue or a Serious Adverse Event reasonably related to or observed in connection with development or commercialization activities with respect to a product, as determined by (i) prior to a Sanofi Participation Election Effective Date (if any), either Party, in accordance with its standard operating procedures and (ii) on or after a Sanofi Participation Election Effective Date (if any), Sanofi, in accordance with its standard operating procedures.
Safety Concern means a Serious Adverse Event reasonably related to or observed in connection with Development or Commercialization activities with respect to a Licensed Product.
Safety Concern means a good faith determination by Celldex, after using Commercially Reasonable Efforts, that it is not able to develop or commercialize a Product for safety reasons.
Safety Concern has the meaning set forth in Section 16.4 (Termination for Safety Reason).