Valid Safety Issue definition

Valid Safety Issue means the ceasing of Development activities or withdrawal from any market as a result of reasonable concerns that the Product is unsafe for administration to humans. During the period of notice until the effective date of termination, [*****].
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Valid Safety Issue has the meaning set forth in section 12.2.2.
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Valid Safety Issue is defined in Section 11.2.
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Examples of Valid Safety Issue in a sentence

  • The notice will provide sufficient information for ACI to confirm the existence of the Valid Safety Issue.

  • To be effective, such notice must be given no later than thirty (30) days following the notification by Amgen that such Valid Safety Issue has occurred.

  • For the avoidance of doubt, in the case of termination in accordance with Section 14.6 (Valid Safety Issue) GSK will have no obligation to Detail or commercialize Ivory, or take any other action that it reasonably believes presents a safety risk to patients (and GSK’s decision to not take such action will not be subject to Amgen’s final decision-making authority under Article 2 (Scope and Governance), but will carry out its other obligations pursuant to Section 14.8 (Effects of Expiration or Termination).

  • For the purposes of this Agreement, a "Valid Safety Issue" shall mean [***].

  • The notice will provide sufficient information for J▇▇▇▇▇▇ to confirm the existence of the Valid Safety Issue.

  • For the purposes of this Agreement, a "Valid Safety Issue" [***].

  • Notwithstanding anything contained herein to the contrary, after the end of the Back-up Program Term GSK shall have the right to terminate this Agreement at any time in its sole discretion by giving [***] advance written notice to Vertex; provided, however, if a Product has received a Marketing Authorization in the [***] advance written notice shall be required, unless such termination is for a reason other than a Valid Safety Issue, in which case termination may be with immediate effect.

  • Notwithstanding anything contained herein to the contrary, ▇▇▇▇▇▇▇ shall have the right to terminate this Agreement at any time in its sole discretion by giving six months’ advance written notice to Vertex; provided, however, if a Product has received a Marketing Authorization in any Major Market Country, the notice required shall be [***] unless such termination is for a reason other than a Valid Safety Issue, in which case termination may be with immediate effect.

  • For the avoidance of doubt, the [***] notice period applicable to termination under Sections 11.2.1(a)(i) and (ii) shall not apply in the case of termination for a Valid Safety Issue.