Termination for Safety Concerns Clause Samples
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Termination for Safety Concerns. Either Opthea or the Required Investors 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) all of the Parties mutually agree that a material health or safety concern with respect to the Subjects exists. In the event that Opthea or its successor terminates this Agreement pursuant to this Section 13.4.8, then Opthea will not be obligated to make any Success Payments to the Investors following the effective date of such termination, provided that if Opthea elects to continue Development of the Product and achieves the Success Payment Trigger following such termination, then Opthea will remain obligated to pay to each Investor any Success Payments that become due and payable pursuant to Article 6 at such time that such payments become due and payable (if ever) pursuant to Article 6, provided that the Fixed Success Payments and the Fixed Return Cap will be adjusted as set forth in Section 6.3 and be reduced by the amount of any Change of Control Payment previously paid by Opthea to such Investor. Notwithstanding the foregoing, if this Agreement terminates pursuant to this Section 13.4.8 and the reason for such termination (as set forth in the foregoing (a) or (b), as applicable): (i) arose as a result of gross negligence on the part of Opthea; or (ii) is due to (x) the applicable IDMC recommending termination of the applicable Product Clinical Trial or (y) Opthea and Investors mutually agreeing to terminate the applicable Product Clinical Trial, in either case ((x) or (y)), due to a Serious Safety Issue that was previously known, demonstrated or identified by Opthea as being material prior to or as of the Restatement 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 Investors or otherwise publicly known prior to the Restatement Effective Date; then, in either case (i) or (ii), Opthea will pay each Investor within [***] following the date of termination, an amount equal to the Development Costs paid by such Investor as of the effective date of such termination multiplied by the MoIC reduced by the amount of any Success Payments or Change of Control Payment previously paid by Opthea.
Termination for Safety Concerns. This Agreement shall automatically terminate if (a) the independent data safety monitoring committee for the Product Trials recommends termination of any of the Product Trials for reasons pertaining to the health or safety of the Subjects or for futility, or (b) a Program Failure as set forth in clause (a), (d) or (e) of the definition of Program Failure occurs.
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 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. 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. 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. Novartis may elect, in its sole discretion, to terminate this Agreement, in its entirety or on a Collaboration Target-by-Collaboration Target basis, upon five (5) Business Days’ prior written notice to Schrödinger if Novartis determines in good faith that a Safety Concern exists with respect to a Collaboration Product Directed Against such Collaboration Target and that it is not advisable for Novartis to continue to Develop or Commercialize such Collaboration Product due to such Safety Concern. Prior to the effective date of any termination pursuant to this Section 13.2(b), Novartis shall use reasonable efforts to discuss the applicable Safety Concern(s) with Schrӧdinger. Following such written notice to Schrödinger under this Section 13.2(b), no milestone payments will be due on milestones achieved during the period between the notice of termination and the effective date of the termination.
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.
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.
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 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.