Reimbursement for Additional Development. With respect to any reimbursement of Out-Of-Pocket Costs, Development FTE Costs, and Manufacturing Costs, and the corresponding premium, required by Section 3.4.3(b) (Proof of Concept Data) or Section 3.4.3(c) (Receipt of Regulatory Approval), following the end of the Calendar Quarter during which either the JDC determines to add further Additional Development Activities to the Global Development Plan following completion of a Proof of Concept Trial or receipt of Regulatory Approval with respect to such Additional Development Activities, as applicable, ITEOS or GSK (as applicable), in accordance with its Accounting Standards, shall submit to the Financial Working Group a written report setting forth in reasonable detail all Out-Of-Pocket Costs, Development FTE Costs, and Manufacturing Costs required to be reimbursed in accordance with 3.4.3(b) (Proof of Concept Data) or Section 3.4.3(c) (Receipt of Regulatory Approval), as applicable. Within [***] Business Days following the receipt by the Financial Working Group of such written reports setting forth the actual amounts of such reimbursable Out-Of-Pocket Costs, Development FTE Costs, and Manufacturing Costs incurred by a Party, the Financial Working Group shall prepare and submit to each Party a written report setting forth in reasonable detail (i) the calculation of all such reimbursable Out-Of-Pocket Costs, Development FTE Costs, and Manufacturing Costs and any deviations from the budget set forth in the applicable Additional Development Proposal, and (ii) the calculation of the net amount owed by GSK to ITEOS or by ITEOS to GSK in order to ensure the appropriate reimbursement of Out-Of-Pocket Costs, Development FTE Costs, and Manufacturing Costs and the corresponding premium in accordance with Section 3.4.3(b) (Proof of Concept Data) or Section 3.4.3(c) (Receipt of Regulatory Approval), as applicable. The Party that is due for reimbursement shall invoice the other Party within [***] Business Days of receipt of such report from the Financial Working Group. Such payments by one Party to reimburse the other Party’s expenditures for such Additional Development Activities shall be payable on the [***] following receipt of the invoice. Any Out-Of-Pocket Costs, Development FTE Costs, and Manufacturing Costs incurred in excess of [***] the budget set forth in the applicable Additional Development Proposal will be the responsibility of the proposing Party.
Reimbursement for Additional Development. If the JSC [***] such Additional Development or the proposing Party elects to proceed with Additional Development as permitted under Section 4.2.1(b) (Licensee Proposal) or Section 4.2.1(c) (Akebia Proposal) and the non-proposing Party does not agree to participate in the Additional Development at such time, then if the proposing Party [***] of the Licensed Products in a [***], in each case, resulting from the applicable Additional Development, then (1) if Licensee is the proposing Party, then Akebia will reimburse to Licensee the applicable Akebia Collaboration Share Percentage plus a [***]% xxxx-up, and (2) if Akebia is the proposing Party, then Licensee will reimburse to Akebia the applicable Licensee Collaboration Share Percentage plus a [***]% xxxx-up, in each case, ((1) and (2)), of the Development costs borne by the proposing Party attributable to such Additional Development and allocable to the Territory, as provided below in clauses (a) through (c) of this Section 4.2.3 (Reimbursement for Additional Development). As an example, if Akebia is the proposing Party, and if the Licensee Collaboration Share Percentage is [***]% and the Additional Development is for a New Formulation in an Initial Indication, then Licensee will reimburse to Akebia [***]% ([***]% plus a [***]% xxxx-up) of [***]% of the total Development costs borne by Akebia in conducting such Additional Development.
Reimbursement for Additional Development. If (a) the JSC [***] any Additional Development as Other Global Development and the Proposing Party elects to proceed with such Additional Development as permitted under Section 4.3.1(b) (JSC [***]; Failure to Agree) without the non-Proposing Party’s agreement to participate in such Additional Development at such time, or (b) Akebia elects to proceed with any Additional Development, notwithstanding the failure of Licensee’s representatives on the JSC to [***] such Additional Development, as permitted under Section 4.3.1(c)(ii) (No JSC [***]; Akebia Proposal), then, in each case ((a) and (b)), at any time, the non-Proposing Party may request, in its discretion and upon written notice to the Proposing [***] Portions of this exhibit have been redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Party, to [***] with respect to such Additional Development and [***] to compensate the Proposing Party for conducting such Additional Development at risk and for the time value of money at such time. Such [***] will become effective upon the Parties’ agreement to such [***] amount.
