Termination for Safety Concerns. Either Party may terminate this Agreement upon written notice to the other Party if (a)(i) the IDMC recommends termination of the HNC Clinical Trial for reasons pertaining to the health or safety of the Subjects or as a result of HNC Clinical Trial Futility and (ii) Nektar in good faith reasonably believes there to be a basis for termination of the HNC Clinical Trial based upon such IDMC recommendation for reasons pertaining to the health or safety of the Subjects or for HNC Clinical Trial Futility, or (b) the Parties mutually agree a material health or safety concern with respect to the Subjects of the HNC Clinical Trial exists (either (a) or (b) being a “Safety Concern”). In the event that this Agreement terminates pursuant to this Section 13.2.5 due to a Safety Concern, then Nektar will not be obligated to pay SFJ any Success Payments arising from an HNC Regulatory Approval or reimburse SFJ for any Development Costs incurred by SFJ in connection with the HNC Clinical Trials (provided, that for the avoidance of doubt, Nektar will remain obligated to pay SFJ for any Success Payments arising from a Melanoma Regulatory Approval or an Other Regulatory Approval, regardless of whether such Melanoma Regulatory Approval or Other Regulatory Approval occurs before or after such termination of this Agreement). Notwithstanding the foregoing, if this Agreement terminates pursuant to this Section 13.2.5: (A) if (i) such termination was due to a Safety Concern that was Known by Nektar as being material as of the Effective Date, (ii) the material data Known to Nektar as of the Effective Date that show, 67 ACTIVE/105681617.22 demonstrate, or identify such material Safety Concern were not included in the Data Room, disclosed in writing to SFJ or otherwise publicly known prior to the Effective Date and (iii) SFJ was not otherwise aware of such Safety Concern as of the Effective Date, then Nektar will pay SFJ within sixty (60) days of the date of termination an amount equal to three hundred percent (300%) of Development Costs paid or incurred by SFJ through the date of termination, with all Success Payments previously made to SFJ to be credited against such termination payment, and (B) if following such termination Nektar elects to continue development of the Product pursuant to the HNC Clinical Trials and obtains HNC Regulatory Approval, Nektar will remain obligated to pay any Success Payments that become due and payable pursuant to Article 6 at such time as such Success P...
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. 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. 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. 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. 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. 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. In the event that this Agreement terminates pursuant to Section 14.2.4 above prior to receipt of the Approval and such termination (i) arises as a result of gross negligence on the part of Reata, or (ii) is due to the applicable independent data monitoring committee recommending termination of the Product Trials or Reata and BXLS mutually agreeing to terminate the Product Trials, in either case due to a Serious Safety Issue that was previously known by Reata as being material as of the Effective Date and such Specific terms in this Exhibit have been redacted because such terms are both not material and would likely cause competitive harm to the Company if publicly disclosed. These redacted terms have been marked in this Exhibit with three asterisks [***]. Serious Safety Issue was not included in the Data Room or otherwise disclosed in writing to BXLS by Reata prior to the Effective Date, then (A) Reata will pay BXLS a fully creditable amount equal to [***]% of BXLS Development Payment, less Cumulative Payments as of such time, within [***] of the date of termination, and (B) if Reata elects to continue Development and obtains Approval following such termination, Reata will remain obligated to pay any Product Payments that become due and payable pursuant to Article 6 at such time as such Product Payments become due and payable (if ever) pursuant to Article 6, provided any amounts paid by Reata to BXLS pursuant to this Section 14.3.4 shall be fully credited toward the future Product Payments.
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. Notwithstanding any other provision of this Section, when immediate action is necessary to protect life and safety or to reduce significant exposure or liability, the City may immediately order Contractor to cease Work until such safety or liability issues are addressed to the satisfaction of the City or the Contract is terminated.
