Common use of Termination for Safety Concerns Clause in Contracts

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 Payments become due and payable (if ever) pursuant to Article 6 as a result of such Regulatory Approval or Other Indication Regulatory Approval (except to the extent of the amount of any Buy-Out Payment paid by Nektar pursuant to Section 6.7), provided that such Success 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 Nektar to SFJ pursuant to this Section 13.2.5.

Termination for Safety Concerns. Either Party Opthea or the Required Investors may terminate this Agreement upon written notice to the other Party if (a)(ia) the IDMC for a Product Clinical Trial recommends termination of the HNC such Product 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, futility or (b) all of the Parties mutually agree that 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”)exists. In the event that Opthea or its successor terminates this Agreement terminates pursuant to this Section 13.2.5 due to a Safety Concern‎13.4.8, then Nektar Opthea will not be obligated to pay SFJ make any Success Payments arising from an HNC Regulatory Approval or reimburse SFJ for any to the Investors following the effective date of such termination, provided that if Opthea elects to continue Development Costs incurred by SFJ in connection with of the HNC Clinical Trials (providedProduct and achieves the Success Payment Trigger following such termination, that for the avoidance of doubt, Nektar then Opthea will remain obligated to pay SFJ for to each Investor any Success Payments arising from a Melanoma Regulatory Approval or an Other Regulatory Approvalthat become due and payable pursuant to ‎Article 6 at such time that such payments become due and payable (if ever) pursuant to ‎Article 6, regardless 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 whether any Change of Control Payment previously paid by Opthea to such Melanoma Regulatory Approval or Other Regulatory Approval occurs before or after such termination of this Agreement)Investor. Notwithstanding the foregoing, if this Agreement terminates pursuant to this Section 13.2.5: ‎13.4.8 and the reason for such termination (Aas set forth in the foregoing (a) if or (b), as applicable): (i) such arose as a result of gross negligence on the part of Opthea; or (ii) is due to (x) the applicable IDMC recommending termination was 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 Concern Issue that was Known previously known, demonstrated or identified by Nektar Opthea as being material prior to or as of the Restatement Effective Date, (ii) Date and the material data Known to Nektar as of the Effective Date that showshowing, 67 ACTIVE/105681617.22 demonstratedemonstrating, or identify identifying such material Serious Safety Concern Issue were not included in the Data Room, disclosed in writing to SFJ Investors or otherwise publicly known prior to the Effective Date and (iii) SFJ was not otherwise aware of such Safety Concern as of the Restatement Effective Date; then, then Nektar in either case (i) or (ii), Opthea will pay SFJ each Investor 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 [***] following the date of termination, with all Success Payments previously made an amount equal to SFJ to be credited against the Development Costs paid by such Investor as of the effective date of such termination payment, and (B) if following such termination Nektar elects to continue development of multiplied by 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 Payments become due and payable (if ever) pursuant to Article 6 as a result of such Regulatory Approval or Other Indication Regulatory Approval (except to the extent of MoIC reduced by the amount of any Buy-Out Payment paid by Nektar pursuant to Section 6.7), provided that such Success Payments (or Buy-Out Payment, as applicable) shall be adjusted as set forth in Section 6.2 and shall be reduced by the amount Change of Control Payment previously paid by Nektar to SFJ pursuant to this Section 13.2.5Opthea.

Termination for Safety Concerns. Either Party may terminate this Agreement with respect to a Product upon written notice to the other Party if (a)(ia) the IDMC for a Product Clinical Trial recommends termination of the HNC such Product 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 Futilityfutility, or (b) the Parties mutually agree that 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”)exists. In the event that this Agreement terminates pursuant to this Section 13.2.5 due to a Safety Concern13.3.6, then Nektar will not be obligated if Alnylam elects to pay SFJ any Success Payments arising from an HNC continue Development of the terminated Product(s) and obtains Regulatory Approval or reimburse SFJ for any Development Costs incurred by SFJ in connection with the HNC Clinical Trials (provideda Major Market Country following such termination, that for the avoidance of doubt, Nektar Alnylam will remain obligated to pay SFJ for to Blackstone the Royalty (as applicable) and make any Success Payments arising from a Melanoma Regulatory Approval or an Other Regulatory Approvalfor such terminated Product(s) 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, regardless of whether provided that such Melanoma Regulatory Approval or Other Regulatory Approval occurs before or after such termination of this Agreement)Success Payments will be adjusted as set forth in Section 6.2. Notwithstanding the foregoing, if this Agreement terminates pursuant to this Section 13.2.513.3.6 and such termination: (A) if (i) such arises as a result of gross negligence on the part of Alnylam; or (ii) is due to (x) the applicable IDMC recommending termination was of the applicable Product Clinical Trial or (y) Alnylam and Blackstone mutually agreeing to terminate the applicable Product Clinical Trial, in either case ((x) or (y)), due to a Serious Safety Concern Issue that was Known previously known, demonstrated or identified by Nektar Alnylam as being material as of the Effective Date, (ii) Date and the material data Known to Nektar as of the Effective Date that showshowing, 67 ACTIVE/105681617.22 demonstratedemonstrating, or identify identifying such material Serious Safety Concern Issue were not included in the Data Room, disclosed in writing to SFJ Blackstone or otherwise publicly known prior to the Effective Date and Date; then, in either case (iii(i) SFJ was not otherwise aware of such Safety Concern as of the Effective Dateor (ii)), then Nektar Alnylam will pay SFJ Blackstone 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 Alnylam elects to continue development the Development of the Product pursuant to the HNC Clinical Trials terminated Product(s) and obtains HNC Regulatory ApprovalApproval for such terminated Product(s) following such termination, Nektar then Alnylam will remain obligated to pay any Success Payments to Blackstone the Royalty (as applicable) for the terminated Product(s) that become becomes due and payable pursuant to Article 6 at such time as such Success Payments Royalty payments become due and payable (if ever) pursuant to Article 6 as a result of such Regulatory Approval or Other Indication Regulatory Approval (except to the extent of the amount of any Buy-Out Payment paid by Nektar pursuant to Section 6.7), provided that such Success 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 Nektar to SFJ pursuant to this Section 13.2.56.

Termination for Safety Concerns. Either Party may terminate this Agreement upon written notice to the other Party if (a)(ia) the IDMC for a Product Clinical Trial recommends termination of the HNC such Product 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, futility or (b) the Parties mutually agree that 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”)exists. In the event that Opthea or its successor terminates this Agreement terminates pursuant to this Section 13.2.5 due to a Safety Concern13.4.8, then Nektar Opthea will not be obligated to pay SFJ make any Success Payments arising from an HNC Regulatory Approval or reimburse SFJ for any to the Investor following the effective date of such termination, provided that if Opthea elects to continue Development Costs incurred by SFJ in connection with of the HNC Clinical Trials (providedProduct and achieves the Success Payment Trigger following such termination, that for the avoidance of doubt, Nektar then Opthea 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 Investor any Success Payments that become due and payable pursuant to Article 6 at such time as that such Success Payments payments become due and payable (if ever) pursuant to Article 6 as a result of such Regulatory Approval or Other Indication Regulatory Approval (except to the extent of the amount of any Buy-Out Payment paid by Nektar pursuant to Section 6.7)6, provided that such the Fixed Success Payments (or Buy-Out Payment, as applicable) shall and the Fixed Return Cap will be adjusted as set forth in Section 6.2 6.3 and shall be reduced by the amount of any Change of Control Payment previously paid by Nektar to SFJ Opthea. Notwithstanding the foregoing, if this Agreement terminates pursuant to this Section 13.2.513.4.8 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 Investor 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 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 Investor or otherwise publicly known prior to the Effective Date; then, in either case (i) or (ii), Opthea will pay Investor within [***] following the date of termination, an amount equal to the Development Costs paid by 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. Either Party may terminate this Agreement upon written notice to the other Party if (a)(ia) the IDMC independent data monitoring committee for the Phase 3 Trial recommends termination of the HNC Clinical Phase 3 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 Futilityfutility, 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”)exists. In the event that this Agreement terminates pursuant to this Section 13.2.5 due to a Safety Concern14.2.7, then Nektar PB will not be obligated to pay to 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 or 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)Payments. Notwithstanding the foregoing, (A) if this Agreement terminates pursuant to this Section 13.2.514.2.7 and such termination: (A) if (i) such 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 was 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 Concern Issue that was Known previously known, demonstrated or identified by Nektar PB as being material as of the Effective Date, (ii) Date and the material data Known to Nektar as of the Effective Date that showshowing, 67 ACTIVE/105681617.22 demonstratedemonstrating, or identify identifying such material Serious Safety Concern Issue were not included in the Data Room, disclosed in writing to SFJ or otherwise publicly known prior to the Effective Date and Date; then, in either case (iii(i) SFJ was not otherwise aware of such Safety Concern as of the Effective Dateor (ii)), then Nektar PB 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 paymentSFJ, and (B) if following such termination Nektar PB elects to continue development of the Product pursuant to the HNC Clinical Trials and obtains HNC Regulatory ApprovalApproval following such termination, Nektar 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 Success Approval Payments that become due and payable pursuant to Article ARTICLE 6 at such time as such Success Approval Payments become due and payable (if ever) pursuant to Article ARTICLE 6 as a result of such Regulatory Approval or Other Indication Regulatory Approval (except to the extent of the amount of any Buy-Out Payment paid by Nektar PB pursuant to Section 6.7), provided that such Success 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 Nektar PB to SFJ pursuant to this Section 13.2.514.2.7.