Common use of Commercialisation Budget Clause in Contracts

Commercialisation Budget. (a) Prior to the First Commercial Sale and before the end of each Contract Year following the First Commercial Sale, at a time to be agreed by the Joint Commercialisation Committee, but consistent with the annual budget cycles of each Party, each Party shall provide the Joint Commercialisation Committee with a budget of expected Commercialisation Expenses and forecasted revenue (calculated as set forth in Schedule B) for the ensuing Contract Year for that Party’s Lead Territory. Such budget shall be in a form to be agreed by the Joint Commercialisation Committee and shall, unless agreed otherwise by the Joint Commercialisation Committee, be prepared by each Party as a consolidation of the individual budgets for each country in such Party’s Lead Territory. For the avoidance of doubt, each budget prepared by a Territorial Commercial Lead will be provided to the Joint Commercialisation Committee for its information but not for its approval. The Joint Commercialisation Committee shall also agree a budget for and agree on an allocation of responsibilities between the Parties for any Joint Activities on which the Parties agree for the ensuing year. (b) The Joint Commercialisation Committee shall review on a quarterly basis the Commercialisation Expenses actually incurred against the budget for such expenses in the applicable calendar year and will consider for approval any appropriate changes to such budget. If in the course of the quarterly review, the Joint Commercialisation Committee should determine for any Antibody Product that the actual amounts incurred are, in the aggregate, likely to be greater than [*] ([*]%) of the amount budgeted, the Joint Commercialisation Committee shall review the reasons for such potential overrun and determine whether such overrun is appropriate. If the Joint Commercialisation Committee determines that such overrun is appropriate, the Joint Commercialisation Committee shall approve a revised Commercialisation budget. If the Joint Commercialisation Committee determines that such overrun is not appropriate, the Joint Commercialisation Committee shall initiate (within [*]) such actions as required to remedy the situation. If the Joint Commercialisation Committee is unable to agree on any matter relating to said overrun, [*].

Commercialisation Budget. (a) Prior In conjunction with the approval of the first Commercialisation Plan or, in any event, no later than [***] [Confidential Treatment Required] after the first Commercialisation Plan is agreed, and thereafter, no later than [***] [Confidential Treatment Required] prior to the First Commercial Sale and before the end start of each subsequent Contract Year following Year, each Party shall prepare and submit to the First Commercial Saleother Party (via the JCT) a proposed budget for its activities for the ensuing Contract Year, at as set forth in the Commercialisation Plan, in support of the Commercialisation of Antibody Products (other than for Independent Indications for which it is the Continuing Party) in a time format to be agreed by the Joint Commercialisation CommitteeParties, but consistent with the annual which budget cycles of each Party, each Party shall provide the Joint Commercialisation Committee with a budget must include (i) line item estimates of expected Commercialisation Expenses Reimbursable Commercial Costs and forecasted revenue Net Receipts (calculated as set forth out in Schedule B2) for the ensuing Contract Year for the countries for which that Party’s Party is Territorial Lead; and (ii) in respect of any Commercialisation activities which will not be completed in that Contract Year, line item estimates of the total Reimbursable Commercial Costs required to complete such Commercialisation activities in countries for which that Party is Territorial Lead Territoryon an activity-by-activity basis (regardless of whether such Reimbursable Commercial Costs will be incurred in that Contract Year or subsequent Contract Years). Such The Collaboration Committee shall review, revise and approve these budgets in relation to the first such budget within [***] [Confidential Treatment Required] after receipt thereof and thereafter no later than [***] [Confidential Treatment Required] prior to the commencement of each Contract Year (each such approved budget, a Commercialisation Budget). Once approved, the Collaboration Committee, upon recommendation of the JCT, shall be modify the Commercialisation Budget from time to time based upon changes in a form to be agreed patent status, new product launches by competitors, adverse drug reactions, the results of clinical studies, changes in pricing and reimbursement regimes and other unanticipated events. If the Commercialisation Plan is updated or amended by the Joint Collaboration Committee pursuant to Article 6.5(b) with respect to the then-current Contract Year, the Parties shall prepare and submit proposals for any necessary amendments to the Commercialisation Budget for such Contract Year within [***] [Confidential Treatment Required] after such update or amendment to the Commercialisation Plan and the Collaboration Committee and shall, unless agreed otherwise by the Joint shall approve any necessary amendments to Commercialisation Committee, be prepared by each Party as a consolidation Budget for such Contract Year within [***] [Confidential Treatment Required] after such update or amendment of the individual budgets for each country in such Party’s Lead Territory. For the avoidance of doubt, each budget prepared by a Territorial Commercial Lead will be provided to the Joint Commercialisation Committee for its information but not for its approval. The Joint Commercialisation Committee shall also agree a budget for and agree on an allocation of responsibilities between the Parties for any Joint Activities on which the Parties agree for the ensuing yearPlan. (b) The Joint Commercialisation Committee JCT shall review on a quarterly basis the Commercialisation Expenses actually incurred against Budget at least Quarterly, and shall make recommendations with respect to any updates or amendments thereto to the budget Collaboration Committee. Either Party may at any time propose an amendment to the Commercialisation Budget. No update or amendment to the Commercialisation Budget shall become effective unless it is approved by the Collaboration Committee or, if the Collaboration Committee cannot reach agreement on an update or amendment, the dispute resolution process set forth in Article 15. (c) In any Contract Year, each Party shall promptly inform the other Party upon such Party determining that it is likely to overspend or underspend by more than [***] [Confidential Treatment Required] its respective total Reimbursable Commercial Costs for such expenses an activity set forth in the applicable calendar year and will consider Commercialisation Budget for approval any appropriate changes to such budgetthat Contract Year. If in the course of the quarterly review, the Joint Commercialisation Committee should determine for any Antibody Product that the actual amounts incurred are, in the aggregate, likely to be greater such Contract Year a Party exceeds its budgeted costs and expenses by more than [***] [Confidential Treatment Required] for an activity, the Party that has so exceeded its budget shall provide to the JCT and to the Collaboration Committee (if the matter is escalated to the Collaboration Committee because it cannot be resolved by the JCT) a full explanation for exceeding the Commercialisation Budget for such activity. If and to the extent that any such overspend was [*]%) **] [Confidential Treatment Required] of the amount budgetedapplicable Party, then, provided the applicable Party has promptly notified the other Party of such overspend and used [***] [Confidential Treatment Required] to mitigate the size of such overspend, such overspend shall be included in Reimbursable Commercial Costs and used to calculate Operating Profits and Losses, which shall be shared by the Parties as provided in Article 2.3(b). In addition, the Joint JCT or Collaboration Committee (as applicable) may, by unanimous agreement and [***] [Confidential Treatment Required], allow some or all of any other overspend to be included in the Reimbursable Commercial Costs as it considers equitable under the circumstances. Where any Commercialisation Committee Budget sets out a line item estimate for the total Reimbursable Commercial Costs required to complete any activity which will not be completed in that Contract Year: (i) the budgeted costs and expenses for that activity shall review [***] [Confidential Treatment Required] and (ii) any [***] [Confidential Treatment Required] against such line item estimate shall be [***] [Confidential Treatment Required] to the reasons Commercialisation Budgets for [***] [Confidential Treatment Required] in each case as necessary to reflect any reasonable acceleration or delay in such potential overrun and determine whether such overrun activity. To the extent that the overspend is appropriate. If the Joint Commercialisation Committee determines that such overrun is appropriatenot included in Reimbursable Commercial Costs as provided in this Article 6.8, the Joint Commercialisation Committee shall approve a revised Commercialisation budget. If the Joint Commercialisation Committee determines that such overrun is not appropriate, the Joint Commercialisation Committee shall initiate (within Party who has exceeded its budget by more than [*]) such actions as required to remedy **] [Confidential Treatment Required] will be solely responsible for the situation. If the Joint Commercialisation Committee is unable to agree on any matter relating to said overrun, [*]overspend.

Commercialisation Budget. (a) Prior to the First Commercial Sale and before the end of each Contract Year following the First Commercial Sale, at a time to be agreed by the Joint Commercialisation Committee, but consistent with the annual budget cycles of each Party, each Party shall provide the Joint Commercialisation Committee with a budget of expected Commercialisation Expenses and forecasted revenue (calculated as set forth in Schedule B) for the ensuing Contract Year for that Party’s 's Lead Territory. Such budget shall be in a form to be agreed by the Joint Commercialisation Committee and shall, unless agreed otherwise by the Joint Commercialisation Committee, be prepared by each Party as a consolidation of the individual budgets for each country in such Party’s 's Lead Territory. For the avoidance of doubt, each budget prepared by a Territorial Commercial Lead will be provided to the Joint Commercialisation Committee for its information but not for its approval. The Joint Commercialisation Committee shall also agree a budget for and agree on an allocation of responsibilities between the Parties for any Joint Activities on which the Parties agree for the ensuing year. (b) The Joint Commercialisation Committee shall review on a quarterly basis the Commercialisation Expenses actually incurred against the budget for such expenses in the applicable calendar year and will consider for approval any appropriate changes to such budget. If in the course of the quarterly review, the Joint Commercialisation Committee should determine for any Antibody Product that the actual amounts incurred are, in the aggregate, likely to be greater than [*] ([*]%) of the amount budgeted, the Joint Commercialisation Committee shall review the reasons for such potential overrun and determine whether such overrun is appropriate. If the Joint Commercialisation Committee determines that such overrun is appropriate, the Joint Commercialisation Committee shall approve a revised Commercialisation budget. If the Joint Commercialisation Committee determines that such overrun is not appropriate, the Joint Commercialisation Committee shall initiate (within [*]) such actions as required to remedy the situation. If the Joint Commercialisation Committee is unable to agree on any matter relating to said overrun, [*].