Shared Development Costs. Except as otherwise provided herein, each Party shall bear fifty percent (50%) of all Shared Development Costs.
Shared Development Costs. The Xencor Sharing Percentage specified in the Cost Sharing Election Notice shall apply from the Option Exercise Date until the end of the first full calendar year after the Option Exercise Date. Xencor agrees and acknowledges that Xencor’s failure to provide any such notice within such period shall be deemed to constitute Xencor’s election to share […***…]% of Shared Development Costs.
Shared Development Costs. Rib-X will pay [***] percent ([***]%) and Sanofi will pay [***] percent ([***]%) of all Shared Development Costs to the extent incurred after the US Profit Share Option Exercise Date. Commencing upon the US Profit Share Option Exercise Date, each Party will report its actual Shared Development Costs to the other Party within thirty (30) Business Days after the end of each Calendar Quarter in each case tracked by activity to the amounts for such activities shown on the then current Development Plan. Notwithstanding the foregoing, within fifteen (15) Business Days after the end of the third month of each Calendar Quarter, Rib-X and Sanofi will each provide to the other an estimate of Shared Development Costs for such Calendar Quarter. The Parties will seek to resolve any questions related to any such reports within ten (10) Business Days after receipt. If a balancing payment is due to ensure that the Shared Development Costs have been allocated in accordance with the first sentence of this Section, the Party due the payment will invoice the other Party at the end of each Calendar Quarter for such other Party’s share of Shared Development Costs for such Calendar Quarter calculated in accordance with this Section, and such paying Party will pay amounts due with respect to Shared Development Costs under this Section within forty-five (45) days after receipt of the corresponding invoice.
Shared Development Costs. Within sixty (60) days after exercising its Option Right with respect to each of Program 2 and Program 4, Roche shall provide BPM with an initial Development Plan and a budget for such Program outlining the planned activities and related Development Costs (“Shared Development Cost Budget”) for such Development Plan. The Shared Development Cost Budget shall include the anticipated Development Costs pursuant to the Development Plan for the remainder of the then current Calendar Year and each of the next two (2) Calendar Years expected to be incurred by each Party and in total. Thereafter, annually, the Development Plan and the Shared Development Cost Budget shall be updated by the JDC such that the Shared Development Cost Budget shall always reflect the planned activities under the Development Plan for three (3) Calendar Years. If a Party’s actually incurred Development Costs for the current Calendar Year exceeds […***…] of its portion of the Shared Development Cost Budget, such excess portion of Development Costs shall be entirely borne by the Party that exceeded its portion of the Shared Development Cost Budget provided that (A) BPM approved the amount included in the Shared Development Cost Budget specifically attributable to the activities conducted by BPM under such Shared Development Cost Budget, and (B) the JDC shall have the right during a Calendar Year to update the Shared Development Cost Budget in the event of (i) faster than planned Clinical Study enrollment, (ii) written guidance or requirements from a Regulatory Authority that would result in amendments to the Development Plan or (iii) mutual agreement by the Parties to amend the Development Plan, each of (i), (ii) and (iii) an “Allowable Exception”. Additional Development Costs incurred in a Calendar Year resulting from an Allowable Exception shall be subject to sharing of Development Costs pursuant to Section 12.6.
Shared Development Costs. This Section 12.6 applies to Development Costs for Dose Range Finding Studies and GLP Tox Studies for Original Products, to Development Costs for Phase I Completed Original Products and to Development Costs for C4T Co-Dev Products.
Shared Development Costs. (a) During the Term, a Financial Working Group (as defined in Exhibit D) shall be established as of the Effective Date and responsible for management of the Development Costs. All reasonable Direct Costs incurred by either Party or its Affiliates in conducting Development activities for the Product solely for the US pursuant to the Development Plan (including any Clinical Trials but excluding any Phase IV Studies conducted following Regulatory Approval which shall be included in the determination of Operating Profits or Losses) in accordance with terms and conditions of this Agreement, but excluding (i) HEC’s Financial Responsibility; (ii) Xxxxxxx’s Financial Responsibility ([***]), and (iii) subject to Appendix 2 of the Development Plan, the costs and expenses of conducting Clinical Trials for the Product prior to Regulatory Approval (such costs, after exclusion of the costs in clauses (i) through (iii), the “Shared Development Costs”) shall be borne fifty percent (50%) by HEC and fifty percent (50%) by Xxxxxxx (the “Development Cost Share”) as provided in this Agreement; it being understood and agreed that (x) [***], (y) [***] and (z) neither Party shall be required to share any Shared Development Costs in excess of Thirteen Million U.S. Dollars ($13,000,000) in the aggregate (unless otherwise agreed by the Parties in writing). The Parties shall seek to mutually and reasonably agree whether any Development activities were intended solely for the US or ROW or intended to be included in regulatory filings for Regulatory Approval on a global basis; provided, however, that, Development activities that are not designed solely for the US, shall be excluded from Shared Development Costs. Shared Development Costs shall initially be borne by the Party incurring the applicable costs or expenses, subject to reimbursement in accordance with Section 9.1(b).
Shared Development Costs. With respect to Joint Development Activities conducted pursuant to Section 4.2(b) or Section 4.3 directed to obtaining Regulatory Approval for any Indication, excluding the Ovid Ongoing Trials, Ovid shall bear [***] and Licensee shall bear [***] of all Development Costs for such Joint Development Activities. No later than [***] after the beginning of each Calendar Quarter during which a Party will perform any Joint Development Activities pursuant to Section 4.2(b) or Section 4.3 in such Calendar Quarter, such Party shall submit to the other Party a statement setting forth the Development Costs incurred, including the other Party’s share (calculated in accordance with the foregoing sentence) of (i) estimated Development Costs for the then current quarter; (ii) variances from prior invoiced estimates and [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. actual Development Costs; and (iii) Development Costs incurred by or on account of such Party in the past quarter not previously invoiced. Such invoice shall include a reasonably detailed report for such Development Costs, including reasonable supporting documents. The other Party shall pay the amount invoiced within [***] after the receipt of the invoice, subject to the other Party’s right to audit the invoicing Party’s records and books related to such costs as provided in Section 9.4. If both Parties will perform Joint Development Activities pursuant to Section 4.2(b) or Section 4.3 under the Development Plan in such Calendar Quarter, the Parties shall consolidate the payments for such Calendar Quarter into a single payment from one Party to the other Party, as applicable.
Shared Development Costs. For clarity, Section 4.5 shall govern the payment terms with respect to shared Development Costs.
Shared Development Costs. Except for Initial Development Costs or PNH Development Costs, and except as otherwise unanimously agreed by the JEC in accordance with Section 3.2.3(k) (Responsibilities), each Party shall bear fifty percent (50%) of all Development FTE Costs, Manufacturing Costs, and Out-of-Pocket Costs incurred by a Party or any of its Affiliates in accordance with the Global Development Plan and associated Global Development Budget, as well as all costs set forth in Section 5.5.2(a) (Cost Allocation) (collectively, the “Shared Development Costs”). Following each [**] in which either Party incurs any Shared Development Costs, such Party will provide to the other Party a written report of the Shared Development Costs incurred by or on behalf of such Party and, no later than [**] after receipt of each such written report, the applicable Party will make a balancing payment to the other Party such that each Party pays its share of all undisputed Shared Development Costs. For the avoidance of doubt, neither Party shall be responsible for any costs or expenses (including Development FTE Costs and Out-of-Pocket Costs) incurred by the other Party or any of its Affiliates that are not in accordance with the then-current Global Development Budget.
Shared Development Costs. With respect to (i) all Post-Approval Cross-Territory Mandatory Studies for the treatment of HAE that are included in the Cross-Territory Clinical Development Plan as of the Effective Date] and (ii) [any other Post-Approval Cross-Territory Mandatory Studies for the treatment of HAE or any Future Cross-Territory Studies, in each case, that are added to the Cross-Territory Clinical Development Plan in accordance with Section 4.2.1 (Cross-Territory Clinical Development Plan), the Parties will share, [***], in each case, in accordance with the Cross-Territory Clinical Development Plan and Shared Development Budget (such costs, “Shared Cross-Territory Development Costs”) in accordance with the terms of Section 4.4.3 (Shared Cross-Territory Development Costs).
