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:
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. SCHEDULE II MANUFACTURING PROJECT MANUAL (To be expanded by mutual written consent of F.X. Xxxxxxxx & Co., Limited (“FHF”) and Cumberland Pharmaceuticals, Inc. (“CPI”)) Responsibility Documentation/Activity FHF CPI Comments GMP certificate and other permits / Active Pharmaceutical Ingredient (“API”) 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 / / Starting Materials (except API) 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 / / Manufacturing Formula Development of manufacturing formula / / Approval of manufacturing formula / / Processing Instructions Development of processing instructions / Approval of processing instructions / / FHF CPI Comments Bulk Product 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 / Packaging 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 / / Batch Processing Records Preparation of batch processing records / Review of batch processing records / Release of batch processing records / / Storage of batch processing records / / Product Providing sampling and testing methods / Approval of sampling and testing methods / / Sampling and testing / Release / Storage of sa...
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 EXECUTION COPY 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. (i) The Party (with its Affiliates) that incurs more than its share of the total actual Development Costs for the Co-Development Products 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. 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 budget approved by the JSC; provided, however, that Development Costs in excess of the such budget shall be included in the calculation of Development Costs to be shared by the Parties if (i) the JSC approves such excess Development Costs (either before or /after they are incurred), which approval shall not be unreasonably withheld to the extent the Development Costs in excess of the budget were not within the reasonable control of the Party (or Affiliate) incurring such expense or (ii) to the extent such excess Development Costs do not exceed by more than 10% 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 budget for such Calendar Year. If any excess Development Costs are excluded from sharing by the Parties for a particular Calendar Year-to-date period pursuant to the foregoing sentence, such excess Development Costs shall be carried forward to the subsequent Calendar Quarters (provided that such Calendar Quarters fall within the same Calendar Year) and, to the extent the total Development Costs incurred by such Party and its Affiliates for the Calendar Year-to-date as of the end of such subsequent Calendar Quarter are less than 110% of the aggregate Development Costs allocated to such Party under the budget for such Calendar Year-to-date period, such carried forward amounts shall be included in Development Costs to be shared by the Parties for such Calendar Year-to-date-period (i.e., so that the total Development Costs incurred by such Party and its Affiliates that are shared pursuant to this Section 9.12 (Costs of Joint Development) during any Calendar Year do not exceed 110% of the Development Costs allocated to such Party under the budget for such Calendar Year, unless otherwise approved by the JSC).
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 A request for confidential treatment has been made with respect to portions of the following document that are marked with [*]. The redacted portions have been filed separately with the SEC. accordance with the applicable Development Budget for such Calendar Year (a “Permitted Cost Overrun”).
Reimbursement of Development Costs. Subject to Sections 4.1(c), Incyte shall reimburse Agenus for all Development Costs incurred by Agenus and its Affiliates (a) with respect to each Royalty-Bearing Product in accordance with the relevant Development Plan and (b) constituting Patent and Trademark Costs pertaining to Bullpen Targets as provided in Section 1.103, in each case within [**] following receipt by Incyte of an invoice therefor, but only to the extent that such invoiced amount, together with all other Development Costs reimbursed by Incyte for Development activities conducted by Agenus and its Affiliates during such Calendar Year, does not exceed [**] of the total Development Costs budgeted in the Development Plan for the relevant Royalty-Bearing Product (except to the extent such excess is approved pursuant to Section 4.1(c) hereof).
Reimbursement of Development Costs. The parties acknowledge that Takagi has incurred 19,572,000 YEN in costs prior to the date of this Agreement in developing a multi-unit TEP on Histogenics behalf. On the Effective Date Histogenics shall pay that amount to Takagi. Takagi acknowledges that Histogenics intends to continue the development of a multi-unit TEP with an alternative supplier and that Histogenics shall not be liable for any future costs incurred by Takagi in developing a multi-unit TEP absent a separate written agreement between the parties for that purpose. ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
