Reimbursement of Development Costs. (A) Each Calendar Quarter, the Party (with its Affiliates) that incurs more than its share of the total actual Development Costs during such Calendar Quarter shall be paid by the other Party an amount of cash sufficient to reconcile to the agreed percentage of actual Development Costs as set forth in Section 3.10(f)(i). Notwithstanding the foregoing, on a Calendar Year-to-date basis, the Parties shall not share any Development Costs in excess of the amounts allocated for such Calendar Year-to-date period in the Development Budget; provided, however, that Development Costs in excess of the Development Budget shall be included in the calculation of Development Costs to be shared by the Parties to the extent such excess Development Costs do not exceed by more than [*] the total Development Costs allocated to be incurred by such Party and its Affiliates in the applicable Calendar Year-to-date period in accordance with the applicable Development Budget for such Calendar Year (a “Permitted Cost Overrun”).
(B) The Development Reconciliation Procedures shall provide for the JSC to develop a written report setting forth in reasonable detail the calculation of any net amount owed by Xxxxxxx to Xxxxxxx or by Xxxxxxx to Xxxxxxx, as the case may be, as necessary to accomplish the sharing of Development Costs set forth in Section 3.10(f)(i) and this Section 3.10(f)(iii), and to prepare such report promptly following delivery of the report described in Section 3.10(f)(ii) and in a reasonable time (to be defined in the Development Reconciliation Procedures) in advance of payment. The net amount payable to accomplish the sharing of Development Costs as provided under this Agreement shall be paid by Xxxxxxx or Xxxxxxx or by Xxxxxxx to Xxxxxxx, as the case may be, within [*] days after the end of the applicable Calendar Quarter.
Reimbursement of Development Costs. In the case of all terminations covered by this Section 10.6, but excluding termination under Section 10.3 (Insolvency), Xencor shall reimburse MorphoSys for its fully burdened, documented costs incurred between the Effective Date of this Agreement and the termination date for the development of Licensed Antibody(ies) and Licensed Products including, but not limited to clinical trial costs and FTE-based compensation accounted for at the FTE rate (“MorphoSys Development Costs”), at the following rates and according to the following payment schedule:
(i) Termination prior to dosing the first patient in the first Phase 2 Trial for the Licensed Product: […***…] reimbursement
(ii) Termination after dosing the first patient in the first Phase 2 Trial but prior to dosing the first patient in the first Phase 3 Trial for the Licensed Product: twenty […***…] reimbursement
(iii) Termination after dosing the first patient in the first Phase 3 Trial for the Licensed Product: […***…] reimbursement. Xencor shall only be required to make such reimbursement at the time when Xencor receives or generates revenue related to the development and/or commercialization of Licensed Antibody(ies) and/or Licensed Products. Xencor shall only be required to pay to MorphoSys a maximum of […***…] of each installment of such received or generated revenue at any time and/or in any period until the time at which the applicable percentage of MorphoSys Development Costs has been fully reimbursed. As an example, if MorphoSys Development Costs are […***…] dollars ($[…***…]) and the applicable percentage of reimbursement is […***…] ([…***…]%), and Xencor receives a payment of […***…] dollars ($[…***…]) from a future licensee of Licensed Antibody(ies) and/or Licensed Products, then Xencor shall pay […***…] ($[…***…]) to MorphoSys and such payment shall count against the required reimbursement of […***…] dollars ($[…***…]).
Reimbursement of Development Costs. The party electing to continue development under the terms of Section 8.5 shall be deemed to be the party who "wishes to develop the Future Blood Screening Assay" described in Section 3.2.1(c) of the Agreement. The provisions of Section 3.2.1(c) and the provisions of Section 3.2.3(b)(i) of the Agreement shall govern the rights and obligations of the parties from and after the effective date of termination under Section 8.2 or the effective date of withdrawal under Section 8.4 of the Ultrio Development Program as a joint development program under this Ultrio Addendum, except Section 3.2.1(b) of the Agreement shall be deleted in its entirety, and replaced with the following.
Reimbursement of Development Costs. Corium shall use commercially reasonable efforts to control Development Costs and remain within the Development Budget or Amended Development Budget as the case may be. At the end of each month, Corium shall issue an invoice to Xxxx for the Development Costs actually incurred during such month with respect to the Products. Xxxx shall reimburse Corium within [*] of receiving the invoice from Corium, provided that the Development Cost for such month did not exceed the approved Development Budget or Amended Development Budget for that month as the case may be, and subject to the Audit Rights set forth in Section 10.4. Corium shall promptly notify Xxxx when a Target Achievement Date is not likely to be achieved during a quarter, or in the event that the Development Cost for such quarter exceeds or is likely to exceed the approved Development Budget or Amended Development Budget as the case may be. Corium, in the Development Progress Report, shall propose an additional time frame and/or budget required to achieve such Target Achievement Date. Xxxx shall review the reasons for such budget increase or time delay, and if Xxxx does not approve such additional budget, Xxxx shall not be responsible for, in part or in whole, any costs in excess of the Development Budget or Amended Development Budget.
Reimbursement of Development Costs. CUMBERLAND shall reimburse FAULDING for development costs incurred and approved as agreed by the parties. Reimbursement of Regulatory Costs - CUMBERLAND shall reimburse FAULDING for regulatory costs incurred and approved as agreed by the parties. Reimbursement of Inspection and Audit Costs - CUMBERLAND shall reimburse FAULDING for inspection and audit costs incurred and approved as agreed by the parties. Documentation/Activity FHF CPI Comments GMP certificate and other permits / Supply of API / CPI to identify source Provide specifications / Approval of API specifications / / Provide sampling and testing methods / Approval of sampling and testing methods / / Sampling and testing / Release / Storage of samples / Storage of documents / / Supply of starting materials / CPI to identify arginine source Provide specifications of starting materials / Approval of starting materials specifications / / Providing sampling and testing methods / Approval of sampling and testing materials / / Sampling and testing / Release / Storage of samples / Storage of documentation / / Development of manufacturing formula / / Approval of manufacturing formula / / Development of processing instructions / Approval of processing instructions / / Supply of Bulk Product / Provide specifications of Bulk Product / / Approval of Bulk Product specifications / / Providing sampling and testing methods / Approval of sampling and testing methods / / Sampling and testing / Release / Storage of samples / Prepare stability data for Bulk Product / Storage of documentation / Supply of packaging materials / Provide packaging materials specifications / Approval of specifications / Providing sampling and testing methods / Approval of sampling and testing methods / / Sampling and testing / Release / Storage of samples / Storage of documentation / / Preparation of batch processing records / Review of batch processing records / Release of batch processing records / / Storage of batch processing records / / Providing sampling and testing methods / Approval of sampling and testing methods / / Sampling and testing / Release / Storage of samples / Storage of documentation / / Prepare stability data for Product / Documentation/Activity FHF CPI Comments Active Pharmaceutical Ingredient / CPI will identify source (Auxiliaries, fluids, gases, etc.): Excipients / WFI / N2 / Vials / Stoppers / Seals / Boxes / Shippers / Labeling / Distribution of responsibilities:
Reimbursement of Development Costs. If Vitae exercises its Co-Development Option, it shall reimburse BI for Vitae’s specified share of any reasonable Development costs actually incurred by BI in performing such Phase III Studies from the Initiation of such Phase III Studies until the submission of an NDA with the FDA or the EMEA. Vitae shall make its reimbursement payments in arrears on a quarterly basis within thirty (30) days after receipt of an invoice from BI. For avoidance of doubt, reimbursable Development costs shall also include BI’s internal expenses (such as employees’ salaries or overhead expenses), as determined and calculated in accordance with BI’s normal operating protocols for internal development projects. If actual Development costs for the Phase III Studies exceed BI’s initial budget forecast (provided to Vitae pursuant to Section 5.4.1) by more than ten percent (10%), then Vitae shall have the right to continue to share Development costs in accordance with the original budget (with a corresponding pro rata reduction in the royalty increase Vitae would be entitled to, as set forth in more detail in Section 9.6.5(b)), but shall not prevent or require Vitae to reduce its reimbursement percentage.
Reimbursement of Development Costs. In the event that GenVec exercises the Co-Promotion Option for a particular Collaboration Product for a particular indication, then at the time of execution by the Parties of a co- promotion agreement for such Collaboration Product, GenVec will reimburse Warner for a percentage of the Development Costs with respect to the relevant Development Candidate (and corresponding Collaboration Product) incurred from the commencement of Phase III or Pivotal clinical trials for Regulatory Approval in the Co-Promotion Countries until the date of such co-promotion agreement, which percentage shall be equivalent to the percentage of total required sales effort which GenVec is obligated to provide in the first 12 months following commercial launch of the applicable Collaboration Product. Thereafter, GenVec shall be obligated to pay for all future Development Costs incurred with respect to the relevant Collaboration Product to the extent of such percentage of initial required sales effort. In the event that GenVec is unable to pay any of its obligations with respect to the Development Costs in cash and continue to reasonably operate its business in a prudent manner, Warner agrees to consider alternative forms of payment (e.g., GenVec capital stock, loans or cash advances). In no event will Warner be required to accept any alternative form of payment and in no event will Warner agree to accept GenVec capital stock if, in its sole judgment, the value of such stock is likely to decrease over time.
Reimbursement of Development Costs. The Party that incurs more than its share of the total actual Development Costs for Licensed Product, as allocated under Section 4.4(a), shall be paid by the other Party an amount of cash sufficient to reconcile to its agreed percentage of actual Development Costs in each Calendar Quarter; provided that, except as set forth in Section 4.5(b) total actual Development Costs for a Party for a Calendar Year shall not exceed []* percent ([]*%) of the budgeted Development Costs for such Party for such Calendar Year, as shown in the then current version of the Development Plan, except to the extent the JSC approves the increase over []* percent ([]*%) of the budgeted Development Costs for such Party before the additional costs are incurred. Subject to Section 4.5(b), if actual Development Costs for a Calendar Year to date incurred by either Party exceed budgeted Development Costs for such Party for such Calendar Year by more than []* percent ([]*%) and the JSC did not approve some or all of such increase before the costs were incurred, the Development Costs deemed to have been incurred by such Party for purposes of determining the balancing payment under the first sentence of this Section 4.5(a) shall be limited to []* percent ([]*%) of such Party’s budgeted Development Costs plus any portion of the increase over such amount that was approved in advance by the JSC or approved under Section 4.5(b). Decisions of the JSC with respect to Development Cost overruns shall be made in accordance with Section 2.5. Reconciling payments under this Section 4.5 for any Calendar Quarter shall be made within []* after the end of such Calendar Quarter.
Reimbursement of Development Costs. The Parties shall reimburse each other for Development Costs incurred after the Effective Date with respect to all Collaboration Products as set forth in Section 12.2 below.
Reimbursement of Development Costs. Each party shall be responsible for its share of Development Costs as provided under Section 4.6(a). Reconciliation and reimbursement for Development Costs shall be carried out pursuant to Section 4.6(b).
