Here is the DFA if anyone is interested is combing through the entrails.
https://www.sec.gov/Archives/edgar/data/1815620/000156459022032651/opt-ex414_1272.htm
---------------------------13.4Termination.
13.4.1Mutual Termination. This Agreement may be terminated at any time by mutual written agreement of Investor and Opthea.
13.4.2Fundamental Material Breach. This Agreement may be terminated by, the other Party immediately, in its entirety, in the event of (i) a failure to fund by Investor as set forth
-68-
in Section 4.1 and Section 4.2, (ii) the failure by Opthea to pay any Success Payment when due, (iii) a breach by Opthea of Section 2.1, Section 3.3, Section 3.7, or Section 10.3.1, (iv) a failure by Opthea to complete a Clinical Trial Activity within thirty (30) days (or such longer period as may be agreed to between Opthea and Investor) following the date specified for completion on the applicable Timeline Remediation Plan, pursuant to Section 2.4.3, or (v) a failure by Opthea to use Commercially Reasonable Efforts to Develop, Commercialize and maximize Net Sales of the Product as set forth herein, provided, in each case (i) through (v), that (A) the failing or breaching Party has received written notice from the non-breaching Party of such breach, specifying in reasonable detail the particulars of the alleged breach and (B) solely if the consequences of such failure or breach can be cured, such breach or failure has not been cured within [***] after the date of the relevant notice, in the case of clauses (i) and (ii), or [***] after the date of the relevant notice, in the case of clauses (iii) (except with respect to Section 3.7.2) and (v). The non-breaching Party will have the right to pursue remedies it may have at law or equity for such breach, including the right to seek damages from the breaching Party.
13.4.2.1 By Investor. In the event that Investor terminates this Agreement pursuant to clause (iii) or (iv) of Section 13.4.2, Opthea will pay Investor within [***] of the date of termination, an amount equal to the Development Costs paid by Investor prior to 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.
13.4.2.2 By Opthea. In the event that Opthea terminates this Agreement pursuant to clause (i) or (ii) of Section 13.4.2, Opthea will not be required to pay any further Success Payments.
13.4.3Termination for Material Breach. In the event of a material breach of this Agreement by a Party not otherwise covered in Section 13.4.2, the other Party will have the right to terminate this Agreement on [***] written notice to the breaching Party (which notice shall specify in reasonable detail the particulars of the alleged breach), unless (solely if the consequences of such breach can be cured) the breaching Party cures such breach within such [***] period. The non-breaching Party will have the right to pursue remedies it may have at law or equity for such breach, including the right to seek damages from the breaching Party.
13.4.3.1 If Investor terminates this Agreement pursuant to this Section 13.4.3, Opthea will pay Investor, within [***] following the date of termination, an amount equal to [***]of the Development Costs paid by Investor prior to the effective date of such termination, reduced by the amount of any Success Payments or Change of Control Payment previously paid by Opthea. In the event that Investor terminates this Agreement pursuant to this Section 13.4.3.1, and Opthea has achieved the Success Payment Trigger prior to such termination or elects to continue Development of the Product and achieves the Success Payment Trigger following such termination, then Opthea will remain obligated to pay to Investor any Success Payments that become due and payable pursuant to Article 6 at the time that such payments become due and payable pursuant to Article 6, provided that the Fixed Success Payments and the Fixed Return Cap will be adjusted as set forth in
-69-
Section 6.3 and the Fixed Return Cap will be reduced by the amount previously paid to Investor as set forth in this Section 13.4.3.1.
13.4.3.2 If Opthea terminates this Agreement pursuant to this Section 13.4.3.2, and Opthea has achieved the Success Payment Trigger prior to such termination or elects to continue Development of the Product and achieves the Success Payment Trigger following such termination, then Opthea will remain obligated to pay to Investor any Success Payments that become due and payable pursuant to Article 6 at the time that such payments become due and payable 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.
13.4.4Termination by Investor for Material Adverse Event. If a Material Adverse Event occurs, Investor will have the right to terminate this Agreement on [***] written notice to Opthea, unless (solely if the consequences of such Material Adverse Event can be cured) the Material Adverse Event is cured by Opthea within such [***] period. If Investor terminates this Agreement pursuant to this Section 13.4.4 and Opthea has achieved the Success Payment Trigger prior to such termination or elects to continue Development of the Product and achieves the Success Payment Trigger following such termination, then Opthea will remain obligated to pay to Investor any Success Payments that become due and payable pursuant to Article 6 at the time that such payments become due and payable pursuant to Article 6, provided that the Fixed Success Payment and the Fixed Return Cap will be adjusted as set forth in Section 6.3.
13.4.5Termination for Failure to Receive Regulatory Approval.
13.4.5.1 Failure to Obtain Regulatory Approval. This Agreement will, upon written notice from either Party to the other Party, terminate in its entirety with no further action from either Party, if the Product has not received Regulatory Approval following conduct and completion of the Product Clinical Trials, Opthea’s submission of applications for Regulatory Approval in the U.S., EU or UK in accordance with this Agreement, and Opthea’s use of Commercially Reasonable Efforts to obtain such Regulatory Approvals in accordance with this Agreement. For the avoidance of doubt, if Regulatory Approval is received in any jurisdiction, then this Agreement may not thereafter be terminated pursuant to this Section 13.4.5.1.
13.4.5.2 Development Program Failure. Investor will have the right to terminate this Agreement upon written notice to Opthea if the ShORe Trial or the COAST Trial is completed or terminated and either (i) the primary endpoint in such trial is not achieved, or (ii) Investor reasonably determines that the Research Results of such trial do not support Regulatory Approval. For the avoidance of doubt, if an application for Regulatory Approval is accepted for filing by a Regulatory Authority in the U.S, EU or UK then this Agreement may not thereafter be terminated pursuant to this Section 13.4.5.2.
13.4.5.3 If Investor terminates this Agreement pursuant to this Section 13.4.5 and Opthea elects to continue Development of the Product and
-70-
achieves the Success Payment Trigger following such termination, then Opthea will remain obligated to pay to Investor any Success Payments that become due and payable pursuant to Article 6 at the time that such payments become due and payable pursuant to Article 6, reduced by the amount of any Change of Control Payment previously paid by Opthea, provided that the Fixed Success Payments and the Fixed Return Cap will be adjusted as set forth in Section 6.3.
13.4.6Termination for Bankruptcy. Either Party may terminate this Agreement if the other Party (a) (i) commences a voluntary case under the U.S. federal or Australian bankruptcy or insolvency laws (as now or hereafter in effect), (ii) files a petition seeking to take advantage of any other Applicable Laws relating to bankruptcy, insolvency, reorganization, winding up or composition for adjustment of debts, (iii) consents to or fails to contest within [***] and in appropriate manner any petition filed against it in an involuntary case under such bankruptcy laws or other laws, (iv) applies for or consents to, or fails to contest within [***] and in appropriate manner, the appointment of, or the taking of possession by, a receiver, custodian, trustee, administrator, or liquidator of itself or of a substantial part of its property, (v) admits in writing its inability to pay its debts as they become due (or, in respect of Opthea, is presumed or deemed at law to be unable to pay its debts as they fall due), (vi) makes a general assignment for the benefit of creditors, or (vii) takes any corporate action for the purpose of authorizing any of the foregoing; or (b) a case or other proceeding is commenced against such other Party in any court of competent jurisdiction seeking (i) relief under the U.S. federal or Australian bankruptcy or insolvency laws (as now or hereafter in effect) or under any other Applicable Laws relating to bankruptcy, insolvency, reorganization, winding up or adjustment of debts, or (ii) the appointment of a trustee, receiver, custodian, liquidator, administrator, or the like for such other Party for all or any substantial part of its assets, and under either clause (i) or (ii), such case or proceeding has continued without dismissal or stay for a period of [***] or an order granting the relief requested in such case or proceeding is entered.
13.4.6.1 In the event that Investor terminates this Agreement pursuant to this Section 13.4.6, then Opthea will pay Investor 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.
13.4.6.2 In the event that Opthea terminates this Agreement pursuant to this Section 13.4.6, if Opthea has achieved the Success Payment Trigger prior to such termination or elects to continue Development of the Product and achieves the Success Payment Trigger following such termination, then Opthea will remain obligated to pay to 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, reduced by the amount of any Change of Control Payment previously paid by Opthea, provided that such Fixed Success Payments and Fixed Return Cap will be adjusted as set forth in Section 6.3.
13.4.7Termination for Change of Control.
-71-
13.4.7.1 Within [***] following a Change of Control, either Investor or Opthea (or its successor in such Change of Control) may, in its sole discretion, terminate this Agreement (for the avoidance of doubt, whether or not this Agreement is terminated pursuant to this Section 13.4.7, Opthea (or its successor, if applicable) will pay to Investor the Change of Control Payment pursuant to Section 6.7.3). In the event that Opthea or its successor terminates this Agreement pursuant to this Section 13.4.7, then Opthea will pay to Investor, within [***] after the date of termination, a one-time payment, in lieu of the Success Payments (other than Success Payments already paid), calculated based on the remaining Success Payments in the same manner as the Approval Buy-Out Payment in Section 6.7.1, if Regulatory Approval has previously been obtained, or in the same manner as the General Buy-Out Payment in Section 6.7.2, if Regulatory Approval has not previously been obtained, and in each case as adjusted pursuant to Section 6.3 and reduced by the Change of Control Payment previously paid.
13.4.7.2 If this Agreement is not terminated pursuant to Section 13.4.7.1, this Agreement shall continue in full force and effect, provided that any Fixed Success Payments and the Fixed Return Cap that become due and payable will be adjusted as set forth in Section 6.3 and the Fixed Return Cap will be reduced by the Change of Control Payment previously paid.
13.4.8Termination 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 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 Investor 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 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. 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 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.
Add to My Watchlist
What is My Watchlist?