Safety Reason definition

Safety Reason means it is BMS’ or any of its Affiliates’ or Sublicensees’ reasonable belief that based upon additional information that becomes available or an analysis of the existing information at any time, that the medical risk/benefit of such Compound or Product is sufficiently unfavorable as to be incompatible with the welfare of patients to Develop or Commercialize or to continue to Develop or Commercialize it.

Safety Reason has the meaning set forth in Section 13.2(a).

Safety Reason means [***].

Examples of Safety Reason in a sentence

• If Jazz disputes the existence of a Safety Reason, the Parties shall submit the dispute to an independent Third Party or committee (such as an investigator review board) to be appointed by both Parties jointly for determination of the existence or not of such Safety Reason.

• Except in the event of (i) termination by Licensee for an uncured material breach by Ovid, or (ii) termination by Licensee in the circumstances set forth in Section 14.2(b)(i) with respect to Ovid, or (iii) Ovid’s termination for Safety Reason (where Licensee elects to continue the Development and Commercialization of the Product), Ovid shall have the right, at its discretion, to obtain from Licensee any or all of the inventory of the Products held by Licensee as of the date of termination, free of charge.

• Except in the event of (i) termination by Licensee for an uncured material breach by Ovid, or (ii) termination by Licensee in the circumstances set forth in Section 14.2(b)(i) with respect to Ovid, or (iii) Ovid’s termination for Safety Reason, if there is any ongoing Clinical Trial of the Product under the Development Plan for which the Parties are sharing costs, then Licensee shall continue to share the cost of such Clinical Trial until the effective date of termination.

• Except in the event of (i) termination by Licensee for an uncured material breach by Ovid, or (ii) termination by Licensee in the circumstances set forth in Section 14.2(b)(i) with respect to Ovid, or (iii) Ovid’s termination for Safety Reason, the licenses granted by Licensee to Ovid shall survive such termination and shall automatically become worldwide.

• Takeda shall have the right to terminate this Agreement for Safety Reasons, upon [***] days’ prior written notice to TBIL, which notice shall set forth, in reasonable detail, the applicable Safety Reason(s) and shall include reasonably detailed documentation supporting the existence of such Safety Reason; provided that [***], and shall provide [***].

More Definitions of Safety Reason

Safety Reason means Servier’s reasonable belief, that, based upon scientific data, there are safety and public health issues relating to the Licensed Product such that the medical benefit/risk ratio of such Licensed Product is sufficiently unfavorable as to materially compromise the welfare of patients to Develop or Commercialize or to continue to Develop or Commercialize it.

Safety Reason means that it is AbbVie’s or its Affiliate’s or Sublicensee’s good faith belief that the medical risk/benefit of such Licensed Compound or Licensed Product is sufficiently unfavorable to Exploit or to continue to Exploit such Licensed Compound or Licensed Product.

Safety Reason means that the Data Safety Monitoring Board for a Clinical Trial, or the Parties by mutual written agreement, based upon additional information that becomes available or an analysis of then-existing information at any time, determines that Development or Commercialization, as applicable, of the Co-Co Candidate and/or Co-Co Products should be discontinued because the medical risk/benefit of the Co-Co Candidate or Co-Co Products is sufficiently unfavorable as to be incompatible with the welfare of patients to Develop or Commercialize or to continue to Develop or Commercialize it. If this Celgene Lead Co-Co Agreement is terminated pursuant to this Section 8.2.2, then subject to applicable data privacy laws, and on Jounce’s request, Celgene shall provide Jounce with full access to all relevant data relating to the terminated Co-Co Product.

Safety Reason means it is BMS’s reasonable belief that, based upon an analysis of the existing information at any time in a manner that is consistent with BMS’s then-current decision-making policies and procedures, that the medical risk/benefit of a Licensed Antibody or Licensed Product (or combination therapy relating thereto) in a given therapeutic field (e.g., Oncology or immunology) is sufficiently unfavorable as to be incompatible with the welfare of patients to Develop or Commercialize or to continue to Develop or Commercialize it in such therapeutic field, which Safety Reason (including the material data supporting such reason) shall be disclosed to Five Prime (subject to confidentiality obligations to any Third Party).

Safety Reason means any medical risk in relation to a Qualifying Molecule or Qualifying Product that is sufficiently unfavourable as to be incompatible with the welfare of patients to Develop or Commercialise or to continue to Develop or Commercialise that Qualifying Molecule or Qualifying Product.

Safety Reason has the meaning set forth in Section 4.15.

Safety Reason means that the Data Safety Monitoring Board for a Clinical Trial, or the Parties by mutual written agreement, based upon additional information that becomes available or an analysis of then-existing information at any time, determines that Development or Commercialization, as applicable, of the Licensed Candidate and/or Licensed Products should be discontinued because the medical risk/benefit of the Licensed Candidate or Licensed Products is sufficiently unfavorable as to be incompatible with the welfare of patients to Develop or Commercialize or to continue to Develop or Commercialize 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.