Common use of RLP Development Budgets Clause in Contracts

RLP Development Budgets. Each RLP Development Plan will contain a [***] rolling budget covering the anticipated RLP Development Activities to be performed during the then-current Calendar Year (broken down by Calendar Quarter) and the next Calendar Year (broken down by Calendar Quarter), and a forecast of the budgets for each subsequent Calendar Year thereafter through completion of all RLP Development Activities set forth in any such RLP Development Plan, provided that each initial RLP Development Plan will also include such a budget for the partial Calendar Year commencing as of the date of such RLP Development Plan and ending December 31 of such Calendar Year (each such two-year budget plus any such partial Calendar Year is a “RLP Development Budget”). Each RLP Development Budget will be updated [***] by the JDC in accordance with Section 5.2.2.3. The initial RLP Development Budget for a Regional Target, and each update thereto, will be prepared by the JDC, based on (a) the Parties’ good faith estimation of the anticipated RLP Development Activities to be conducted during the relevant [***] year period and (b) information prepared by the Parties in good faith for their own internal planning processes relating to anticipated RLP Development Activities for such Regional Target, a summary of which will be provided to the JDC for review and incorporation into the RLP Development Budget. Each RLP Development Budget will include an itemized list of the applicable RLP Development Activities to be performed during the [***] year period covered by such RLP Development Budget, with detailed line item entries for each RLP Development Activity setting forth the costs directly related to such RLP Development Activity (broken out to show Out-of-Pocket Costs and FTE Costs for FTEs directly engaged to perform such RLP Development Activity) and specifying what Party or Third Party is responsible for performing the applicable RLP Development Activity, which itemized list may include: (i) Any material preclinical, non-clinical studies or GLP Toxicology Studies, itemized by study; (ii) Clinical Studies, including (A) the following costs itemized by Clinical Study: [***] and (B) the following information itemized by Clinical Study: [***] and (iii) allocation of responsibility for Manufacturing the applicable Regional Antibody Candidates and Regional Licensed Products. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

RLP Development Budgets. Each RLP Development Plan will contain (i) a [...***...] rolling budget covering costs associated with, and not subject to the following subclause (ii), the anticipated RLP Development Activities to be performed during the then-current Calendar Year (broken down by Calendar Quarter) and the next Calendar Year (broken down by Calendar Quarter), and a forecast of the budgets for each subsequent Calendar Year thereafter through completion of all RLP Development Activities set forth in any such RLP Development PlanPlan and (ii) a specific budget for the entirety of each Clinical Trial that the Parties include in the RLP Development Plan (“Clinical Trial Budget”), provided that each initial RLP Development Plan will also include such a budget for the partial Calendar Year commencing as of the date of such RLP Development Plan and ending December 31 of such Calendar Year (each such two-year budget plus any such partial Calendar Year is a “RLP Development Budget”). Each RLP Development Budget will be updated [...***...] by the JDC in accordance with Section 5.2.2.35.1.2.3; provided that, a Clinical Trial Budget shall -48- not be further revised thereafter until the next [...***...] update without the Parties’ mutual agreement. The initial RLP Development Budget for a Regional TargetTarget Pair, and each update thereto, will be prepared by the JDC, based on (a) the Parties’ good faith estimation of the anticipated RLP Development Activities to be conducted during the relevant [...***...] year period and (b) information prepared by the Parties in good faith for their own internal planning processes relating to anticipated RLP Development Activities for such Regional TargetTarget Pair, a summary of which will be provided to the JDC for review and incorporation into the RLP Development Budget. Each RLP Development Budget will include an itemized list of the applicable RLP Development Activities to be performed during the [...***...] year period covered by such RLP Development Budget, with detailed line item entries for each RLP Development Activity setting forth the costs directly related to such RLP Development Activity (broken out to show Out-of-Pocket Costs and FTE Costs for FTEs directly engaged to perform such RLP Development Activity) and specifying what Party or Third Party is responsible for performing the applicable RLP Development Activity, which itemized list may include: (i) Any material preclinical, non-clinical studies or GLP Toxicology Studiestoxicology studies, itemized by study;, (ii) Clinical Studies, including (A) the following costs itemized by Clinical Study, if applicable: [***] itemized cost of study drug (if available), per-patient costs (if available), study initiation costs, per-protocol costs, investigator payments, monthly study fixed costs, statistical analysis costs, study report development costs and study close-out expenses and (B) the following information itemized by Clinical Study: [***] number of study sites and number of patients, and (iii) allocation of responsibility for Manufacturing the applicable Regional Antibody Candidates Licensed Antibodies and Regional Licensed Products. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “Each RLP Development Budget will also include a high level summary of the Parties’ plans with respect to the Development of such Regional Target Pair as they relate to such budget for the years following the [...***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED...] of such RLP Development Budget.