Termination for Safety Concerns. Either Party may terminate this Agreement upon written notice to the other Party if (a) the independent data monitoring committee for the Phase 3 Trial recommends termination of the Phase 3 Trial for reasons pertaining to the health or safety of the Subjects or for futility, or (b) the Parties mutually agree a material health or safety concern with respect to the Subjects exists. In the event that this Agreement terminates pursuant to this Section 14.2.7, then PB will not be obligated to pay to SFJ any Development Costs or Approval Payments. Notwithstanding the foregoing, (A) if this Agreement terminates pursuant to this Section 14.2.7 and such termination: (i) arises as a result of gross negligence on the part of PB; or (ii) is due to (x) the applicable independent data monitoring committee recommending termination of the Phase 3 Trial or (y) PB and SFJ mutually agreeing to terminate the Phase 3 Trial, in either case ((x) or (y)), due to a Serious Safety Issue that was previously known, demonstrated or identified by PB as being material as of the Effective Date and the material data showing, demonstrating, or identifying such Serious Safety Issue were not included in the Data Room, disclosed in writing to SFJ or otherwise publicly known prior to the Effective Date; then, in either case ((i) or (ii)), PB will pay SFJ within [***] of the date of termination an amount equal to three hundred percent (300%) of Development Costs paid or incurred by SFJ, and (B) if PB elects to continue development of the Product and obtains Regulatory Approval following such termination, in exchange for purchasing the Trial Data Package including the Research Results included therein as set forth in Section 11.1.1.4, PB will remain obligated to pay any Approval Payments that become due and payable pursuant to ARTICLE 6 at such time as such Approval Payments become due and payable (if ever) pursuant to ARTICLE 6 (except to the extent of the amount of any Buy-Out Payment paid by PB pursuant to Section 6.7), provided that such Approval Payments (or Buy-Out Payment, as applicable) shall be adjusted as set forth in Section 6.2 and shall be reduced by the amount previously paid by PB to SFJ pursuant to this Section 14.2.7.
Termination for Safety Concerns. LICENSEE may terminate this Agreement in its entirety on not less than sixty (60) days prior written notice to PFIZER if LICENSEE has evidence of safety issues on the basis of which a reasonable investigator would conclude that such issues will prevent the successful Development and Commercialization of Products hereunder. LICENSEE shall provide such evidence to PFIZER together with such notice and shall discuss such evidence as reasonably requested by PFIZER. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Termination for Safety Concerns. If either Party has a serious concern about the safety of Drug Product, Drug Substance or Product, taking into consideration the balance of harm and benefit to patients, the Parties will seek to resolve such concern in good faith. If the Parties are not able to resolve the concern, either Party may raise the matter for discussion between senior executives of the Parties (or their designees), and the Parties will use reasonable efforts to cause their senior executives (or designees) to meet promptly to discuss such concern. If after such senior executives (or designees) meet, [*]
Termination for Safety Concerns. This Agreement shall automatically terminate if (a) the independent data monitoring committee for the Trial recommends termination of either of the PEGASUS Trial and the PRINCE Trial for reasons pertaining to the health or safety of the Subjects or for futility, (b) a Program Failure as set forth in clause (a) of the definition of Program Failure occurs or (c) the Parties mutually agree a material health or safety concern with respect to the Subjects exists.
Termination for Safety Concerns. In the event that this Agreement terminates pursuant to Section 14.2.6 above, then Apellis will not be obligated to pay SFJ any SFJ Development Costs or Approval Payments. Notwithstanding the foregoing, if this Agreement terminates pursuant to Section 14.2.6 above and such termination (i) arises as a result of gross negligence on the part of Apellis or (ii) is due to the applicable independent data monitoring committee recommending termination of the Trial or Apellis and SFJ mutually agreeing to terminate the Trial due to a Serious Safety Issue that was previously known, demonstrated or identified by Apellis as being material as of the Effective Date and the material data showing, demonstrating, or identifying such Serious Safety Issue were not included in the Data Room or otherwise publicly known prior to the Effective Date, then (A) Apellis will pay SFJ an amount equal to one hundred fifty percent (150%) of SFJ Development Costs paid to Apellis by SFJ within [**] of the date of termination, and (B) if Apellis elects to continue development and obtains Regulatory Approval following such termination, Apellis will remain obligated to pay any Approval Payments that become due and payable pursuant to Article 6 at such time as such Approval Payments become due and payable (if ever) pursuant to Article 6, provided that the payments set forth in Article 6 shall be adjusted as set forth in Section 6.2 and shall be reduced by the amount previously paid by Apellis to SFJ pursuant to this Section 14.3.6.
Termination for Safety Concerns. If Jazz has any significant safety concerns regarding the Development and Commercialization of the Licensed Product and is considering terminating this Agreement pursuant to this Section 10.3, then at least [***] days prior to sending any notice of termination pursuant to this Section 10.3, Jazz shall send ImmunoGen written notice describing such safety concern and informing ImmunoGen that Jazz is considering its options to address such concerns, which may include terminating this Agreement pursuant to this Section 10.3. At ImmunoGen’s request, the Parties will engage in good faith discussions regarding any such potential termination. After the expiration of such [***] day period, Jazz may terminate this Agreement if Jazz determines in good faith, based on a review of clinical data or other information, that ceasing the Development and Commercialization of the Licensed Product is warranted due to significant safety concerns; such termination shall be effective immediately upon Jazz’s written notice to ImmunoGen.
Termination for Safety Concerns. Either Party may terminate this Agreement upon written notice to the other Party if (a) the IDMC for a Product Clinical Trial recommends termination of such Product Clinical Trial for reasons pertaining to the health or safety of the Subjects or for futility or (b) the Parties mutually agree that a material health or safety concern with respect to the Subjects exists. In the event that this Agreement terminates pursuant to this Section 13.3.6, then CymaBay will not be obligated to pay to Abingworth any Success Payments following the effective date of such termination. Notwithstanding the foregoing, if this Agreement terminates pursuant to this Section 13.3.6 and such termination (i) arises as a result of gross negligence on the part of CymaBay; or (ii) is due to (x) the applicable IDMC recommending termination of the applicable Product Clinical Trial or (y) CymaBay and Abingworth mutually agreeing to terminate the applicable Product Clinical Trial, in either case ((x) or (y)), due to a Serious Safety Issue that was material as of the Effective Date and the material data showing, demonstrating, or identifying such Serious Safety Issue were not included in the Data Room, disclosed in writing to Abingworth or otherwise publicly known prior to the Effective Date; then, in either case (i) or (ii), CymaBay will pay Abingworth within [***] of the date of termination an amount equal to the full MoIC of Development Costs paid by Abingworth as of the effective date of such termination. [***].
Termination for Safety Concerns. If: (i) after the filing of a Registration Application for the Product, Kos determines, in its reasonable judgment after discussions with Jagotec, that the Product should be withdrawn due to a significant concern for the safety of the study subjects, which concern is based on a reasonable review of clinical data developed during the Development Program; or (ii) during the Product’s Commercialization Program, such Product becomes subject to a pattern of Serious Adverse Drug Experiences or either Party receives notice from a Regulatory Authority relating to a significant concern for safety, in each case which Kos, in good faith, reasonably believes would significantly impact the long-term viability of the Product; Kos shall have the right, upon **** prior written notice to Jagotec setting forth the reasons therefor in reasonable detail, to have the Steering Committee determine whether or not there exists such significant safety concerns or such significantly impact on the long-term viability of a Product and what, if anything, the Parties should do to address the matter; provided, however, that Kos shall have the right to immediately temporarily cease the marketing, sale and distribution of the Product until a final resolution is reached as provided in this Section 13.5. In the event the Steering Committee is unable to reach a unanimous resolution of the matter within **** of the matter being referred to the Steering Committee, Kos may terminate this Agreement upon **** prior written notice to Jagotec only if Kos, in good faith, reasonably believes that the patient safety issue would significantly eliminate the long-term viability of such Product and certifies the same to Jagotec in such written notice.
Termination for Safety Concerns. Either Party shall have the right to terminate this Agreement upon written notice to the other Party upon the occurrence of Serious Adverse Events related to the use of the Licensed Product that causes such Party to conclude based upon specific and verifiable information that the Licensed Product is unsafe for human use.
Termination for Safety Concerns. Pint may terminate this Agreement in its entirety on not less than sixty (60) days prior written notice to Puma if Pint has evidence of safety issues on the basis of which a reasonable investigator would conclude that such [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Confidential Treatment Requested by Puma Biotechnology, Inc. issues will prevent the successful Development and Commercialization of Products hereunder. Pint shall provide such evidence to Puma together with such notice and shall discuss such evidence as reasonably requested by Puma.
