Common use of Dispute regarding Clinical Activities Clause in Contracts

Dispute regarding Clinical Activities. (A) If the Board cannot reach a decision as to whether or not to continue or commence a clinical activity (as opposed to decisions regarding the manner in which a Clinical Trial is to be continued or commenced) for a Product for an indication in a Field in a country or countries (such activity, the “Disputed Activity”), the Shareholder wishing to undertake a Disputed Activity has the right to require the Company and its subsidiaries to do so if and for so long as such Shareholder (the “Funding Shareholder”): [**] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. (1) provides written notice to the Company and the other Shareholder confirming that they require the Company to undertake the Disputed Activity; and (2) pays all reasonable incremental costs (including without limitation out-of-pocket costs and additional staff cost required to undertake the Disputed Activity) within [**] days of an invoice provided by the Company and its subsidiaries for such payment (such costs, the “Disputed Activity Costs”), subject to the Company and the relevant Shareholder agreeing (such agreement not to be unreasonably withheld) a detailed budget for such Disputed Activity Costs. Each Shareholder agrees to act in good faith with respect to such discussions. The Company will update the Shareholders on a monthly basis of the actual costs incurred versus the agreed budget and in any event will notify the Shareholders in the event the actual costs for the clinical activity relating to a Disputed Activity are likely to vary materially from the agreed Budget. (B) In the event that Regulatory Approval is received for a Product for an indication in a field which is and continues to be the subject of a Disputed Activity when Regulatory Approval is received, the Company will, and the Shareholders will cause the Company to, reimburse the Funding Shareholder of all Disputed Activity Costs for such Disputed Activity and the non-Funding Shareholder will pay a further amount equal to [**] of the Disputed Activity Costs for such Disputed Activity to the Funding Shareholder as compensation for the risk incurred by the Funding Shareholder (both payments from the Company and from the non-Funding Shareholder to be made within [**] days of such Regulatory Approval). Upon receipt of such payment in full by the Funding Shareholder the clinical activity will cease to be a Disputed Activity. In the event Regulatory Approval is not received for the Product for an indication in the Field which is the subject of a Disputed Activity, the Company will not have any obligation to pay any Disputed Activity Costs for such Disputed Activity. (C) At any time after a Disputed Activity commences for a Product in an indication in a Field until [**] months prior to the estimated date of Regulatory Approval for such Product in such indication (as reasonably estimated and notified in writing to the Shareholders by the Company), the Company may decide to Develop such Product in such indication under the Development Plan by reimbursing all Disputed Activity Costs for such Disputed Activity to the Funding Shareholder; provided that the non-Funding Shareholder may, during such [**] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. period, in its own sole discretion and on behalf of the Company, elect for the Company to take over the Disputed Activity and to continue to Develop such Product in such indication pursuant to this Section 3.2.5(iv)(C). Upon receipt of the payment of such Disputed Activity Costs in full by the Funding Shareholder, the clinical activity will cease to be a Disputed Activity. (D) For clarity, with respect to any Disputed Activity, the Funding Shareholder will have all decision-making authority regarding the conduct of the Disputed Activity, and the Company and its subsidiaries will conduct such Disputed Activity along with the Development activities of the Company under the Development Plan. The Company will ensure that it has sufficient resources to conduct both the Disputed Activity and the Development activities under the Development Plan in accordance with the timelines set out in the Development Plan. If necessary, and subject to the provisioning of costs set out in this Section 3.2.5(iv)(D), the Company will obtain additional resources to conduct the Disputed Activity at the Funding Shareholder’s expense as part of the Disputed Activity Costs. The Funding Shareholder will indemnify, defend and hold harmless the other Shareholder and the Company (and, to the extent not affiliated with the Funding Shareholder, each of its and their respective employees, officers, directors, agents and sublicensees) for any losses, claims, liabilities, settlements, penalties, fines damages and expenses (including reasonable attorneys’ fees and expenses) that the other Shareholder or the Company may be required to pay to one or more Third Parties arising from or relating to a Disputed Activity initiated by such Funding Shareholder; provided that such Funding Shareholder will not incur any indemnification obligation to the extent that such claims, damages or expenses relate to or arise from (1) negligence or willful misconduct on the part of the Company, its subsidiaries or the other Shareholder (or their respective employees, officers, directors, agents and subsidiaries) or (2) conduct of an activity which is no longer a Disputed Activity. The provision of Section 7.6 will not apply to any matters referred to in Section 3.2.5(iv) above on which the Board cannot reach agreement.

Dispute regarding Clinical Activities. (A) If the Board cannot reach a decision as to whether or not to continue or commence a clinical activity (as opposed to decisions regarding the manner in which a Clinical Trial is to be continued or commenced) for a Product for an indication in a Field in a country or countries (such activity, the “Disputed Activity”), the Shareholder wishing to undertake a Disputed Activity has the right to require the Company and its subsidiaries to do so if and for so long as such Shareholder (the “Funding Shareholder”): [**] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.): (1) provides written notice to the Company and the other Shareholder confirming that they require the Company to undertake the Disputed Activity; and (2) pays all reasonable incremental costs (including without limitation out-of-pocket costs and additional staff cost required to undertake the Disputed Activity) within [**] days of an invoice provided by the Company and its subsidiaries for such payment (such costs, the “Disputed Activity Costs”), subject to the Company and the relevant Shareholder agreeing (such agreement not to be unreasonably withheld) a detailed budget for such Disputed Activity Costs. Each Shareholder agrees to act in good faith with respect to such discussions. The Company will update the Shareholders on a monthly basis of the actual costs incurred versus the agreed budget and in any event will notify the Shareholders in the event the actual costs for the clinical activity relating to a Disputed Activity are likely to vary materially from the agreed Budget. (B) In the event that Regulatory Approval is received for a Product for an indication in a field which is and continues to be the subject of a Disputed Activity when Regulatory Approval is received, the Company will, and the Shareholders will cause the Company to, reimburse the Funding Shareholder of all Disputed Activity Costs for such Disputed Activity and the non-Funding Shareholder will pay a further amount equal to [**] of the Disputed Activity Costs for such Disputed Activity to the Funding Shareholder as compensation for the risk incurred by the Funding Shareholder (both payments from the Company and from the non-Funding Shareholder to be made within [**] days of such Regulatory Approval). Upon receipt of such payment in full by the Funding Shareholder the clinical activity will cease to be a Disputed Activity. In the event Regulatory Approval is not received for the Product for an indication in the Field which is the subject of a Disputed Activity, the Company will not have any obligation to pay any Disputed Activity Costs for such Disputed Activity. (C) At any time after a Disputed Activity commences for a Product in an indication in a Field until [**] months prior to the estimated date of Regulatory Approval for such Product in such indication (as reasonably estimated and notified in writing to the Shareholders by the Company), the Company may decide to Develop such Product in such indication under the Development Plan by reimbursing all Disputed Activity Costs for such Disputed Activity to the Funding Shareholder; provided that the non-Funding Shareholder may, during such [**] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. period, in its own sole discretion and on behalf of the Company, elect for the Company to take over the Disputed Activity and to continue to Develop such Product in such indication pursuant to this Section 3.2.5(iv)(C). Upon receipt of the payment of such Disputed Activity Costs in full by the Funding Shareholder, the clinical activity will cease to be a Disputed Activity. (D) For clarity, with respect to any Disputed Activity, the Funding Shareholder will have all decision-making authority regarding the conduct of the Disputed Activity, and the Company and its subsidiaries will conduct such Disputed Activity along with the Development activities of the Company under the Development Plan. The Company will ensure that it has sufficient resources to conduct both the Disputed Activity and the Development activities under the Development Plan in accordance with the timelines set out in the Development Plan. If necessary, and subject to the provisioning of costs set out in this Section 3.2.5(iv)(D), the Company will obtain additional resources to conduct the Disputed Activity at the Funding Shareholder’s expense as part of the Disputed Activity Costs. The Funding Shareholder will indemnify, defend and hold harmless the other Shareholder and the Company (and, to the extent not affiliated with the Funding Shareholder, each of its and their respective employees, officers, directors, agents and sublicensees) for any losses, claims, liabilities, settlements, penalties, fines damages and expenses (including reasonable attorneys’ fees and expenses) that the other Shareholder or the Company may be required to pay to one or more Third Parties arising from or relating to a Disputed Activity initiated by such Funding Shareholder; provided that such Funding Shareholder will not incur any indemnification obligation to the extent that such claims, damages or expenses relate to or arise from (1) negligence or willful misconduct on the part of the Company, its subsidiaries or the other Shareholder (or their respective employees, officers, directors, agents and subsidiaries) or (2) conduct of an activity which is no longer a Disputed Activity. The provision of Section 7.6 will not apply to any matters referred to in Section 3.2.5(iv) above on which the Board cannot reach agreement.