Reconciliation Statements. Within [****] following the end of a Calendar Quarter, each Party shall submit to the other Party its report of actual results as outlined above (including a summary of charges and credits allocated to its Development Expense Project Account). Expenses charged by either Party as Ongoing Development Expenses, Other Out-of-Pocket Costs and Development Expenses shall not exceed [****] of the amount included for the total expenditure in the then current Development Plan or Annual Workplan/Budget, as the case may be, unless the JFC recommends, and the JSC approves such excess expense. If actual costs of any expense line item in implementing an Annual Work Plan/Budget or the Development Plan is expected to vary by more than [****], then the Party incurring the variance(s) has the obligation to inform the other Party of such variance(s) in a timely manner and to discuss with such Party the causes of the variance(s). Any such discussion as to the cause of the variances shall occur at the JFC. If the actual costs of implementing an Annual Work Plan/Budget or the Development Plan are expected to vary by more than [****] from the amounts budgeted for expenditure during the calendar year, the Responsible Development Party will promptly revise, as applicable, the Annual Workplan/Budget or Development Plan and submit it in writing, with an explanation of the variance and the reasons therefore, for approval to the JSC. If the JSC does not approve the variance, the amount by which the actual costs exceed [****] of the budgeted costs shall be borne by the Party that incurred the costs. The financial representatives from each Party on the JFC shall be responsible for, within [****] days following the end of a Calendar Quarter, preparing a statement (“Reconciliation Statement”) in a format agreed to by the Parties showing each Party’s results, the calculations of Ongoing Development Expenses, Other Out-of-Pocket Costs, Cost of Clinical Supplies, COGM and Development Expenses sharing under Section 3.6 of the Agreement and any cash settlement required. The Reconciliation Statement and reports of actual results compared to budget will be sent to the JFC, within [****] following the end of a Calendar Quarter for approval. After approval by the JFC, the JFC will forward the Reconciliation Statement to the JSC for its information or approval in the case of a dispute. The Reconciliation Statement shall be provided to the JSC [****] prior to the date upon which the JSC shall meet to approve the Reconciliation Statement, if approval is being sought. Reconciliation Statements shall be made by PDL or Biogen Idec in the manner set forth in Section A.5 of this Exhibit C.
Appears in 3 contracts
Samples: Collaboration Agreement (Protein Design Labs Inc/De), Collaboration Agreement (Facet Biotech Corp), Collaboration Agreement (Biotech Spinco, Inc.)
Reconciliation Statements. Within [*] following the end of a Calendar Quarter, each Party shall submit to the other Party a Pre-Reconciliation Report encompassing[**]. Within [*] following the end of a Calendar Quarter, each Party shall submit to the other Party its report of actual results as outlined above (including a summary of charges and credits allocated to its Development Expense Project Account)above. Expenses charged by either Party as Ongoing Development Expenses, Other Out-of-Pocket Costs and Development Expenses shall not exceed [****] of the amount included for the total expenditure in the then current Development Plan or Annual Workplan/Budget, as the case may be, unless the JFC recommends, and the JSC approves such excess expense. If actual costs of any expense line item in implementing an Annual Work Plan/Budget or the Development Plan is expected to vary by more than [****], then the Party incurring the variance(s) has the obligation to inform the other Party of such variance(s) in a timely manner and to discuss with such Party the causes of the variance(s). Any such discussion as to the cause of the variances shall occur at the JFC. If the actual costs of implementing an Annual Work Plan/Budget a Collaboration or the Development Plan are expected to vary by more than more[*]than [****] from the amounts budgeted for expenditure during the calendar year, the Responsible Development Party will promptly revise, as applicable, the Annual Workplan/Collaboration Budget or Development Plan and submit it in writing, with an explanation of the variance and the reasons therefore, for approval to the JSC. If the JSC does not approve the variance, the amount by which the actual costs exceed [****] of the budgeted costs shall be borne by the Party that incurred the costs. The financial representatives from each Party on the JFC shall be responsible for, within [****] days following the end of a Calendar Quarter, preparing a statement (“Reconciliation Statement”) in a format agreed to by the Parties showing each Party’s results, the calculations of Ongoing Development Expenses, Other Out-of-Pocket Costs, Cost of Clinical Supplies, COGM and Development Expenses sharing under Section 3.6 of the Agreement and any cash settlement required[*]. The Reconciliation Statement and reports of actual results compared to budget will be sent to the JFC, within each party within[****] following the end of a Calendar Quarter for approval. After Each party shall provide notice of approval by the JFC, the JFC will forward or disapproval of the Reconciliation Statement within [*] of receipt. If both parties approve, the Reconciliation Statement will be sent to the JSC for its information or approval in information. If either party disapproves, within [*] after receipt of the case of a dispute. The Reconciliation Statement shall be provided to the JSC [****] prior to the date upon which the JSC shall meet to approve or otherwise resolve the Reconciliation Statement, if approval is being sought. Reconciliation Statements shall be made by PDL Portola or Biogen Idec in the manner set forth in Section A.5 Y (section titled “Payments Between Parties” of this Exhibit C.Financial Exhibit.] [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Development Expense Reporting after Opt-Out Option is exercised. After Portola exercises its Opt-Out option, pursuant to 4.5 (b), Portola shall provide Biogen IDEC reports of [*] on a quarterly basis within [*] after the end of the Calendar Quarter. Within [*] after receiving such report from Portola, [*].
Appears in 3 contracts
Samples: License and Collaboration Agreement (Portola Pharmaceuticals Inc), License and Collaboration Agreement (Portola Pharmaceuticals Inc), License and Collaboration Agreement (Portola Pharmaceuticals Inc)
Reconciliation Statements. Within [***] following the end of a Calendar Quarter, each Party shall submit to the other Party a Pre-Reconciliation Report encompassing actual results of the first two months of such quarter and preliminary actual results for the third month. Within [***] following the end of a Calendar Quarter, each Party shall submit to the other Party its report of actual results as outlined above (including a summary of charges and credits allocated to its Development Expense Project Account)above. Expenses charged by either Party as Ongoing Development Expenses, Other Out-of-Pocket Costs and Development Expenses shall not exceed [****] of the amount included for the total expenditure in the then current Development Plan or Annual Workplan/Budget, as the case may be, Collaboration Budget unless the JFC recommends, and the JSC other Party approves such excess expense. If actual costs of any expense line item in implementing an Annual Work Plan/Budget or the Development Plan is expected to vary by more than [****], then the Party incurring the variance(s) has the obligation to inform the other Party of such variance(s) in a timely manner and to discuss with such Party the causes of the variance(s). Any such discussion as to the cause of the variances shall occur at the JFC. If the actual costs of a Party implementing an Annual Work Plan/the activities of such Party under the Collaboration Budget or the Development Plan are expected to vary by more than [****] from the amounts budgeted for expenditure during the calendar year, the Responsible Development such Party will promptly revise, as applicable, revise the Annual Workplan/Collaboration Budget or Development Plan and submit it in writing, with an explanation of the variance and the reasons thereforetherefor, for approval to the JSCJDC or JCC, as applicable. If the JSC JDC or JCC, as applicable, does not approve the variance, the amount by which the actual costs exceed [****] of the budgeted costs in the Collaboration Budget shall be borne by the Party that incurred the costs. The financial representatives from each Party on the JFC shall be responsible for, within [****] days following the end of a Calendar Quarter, preparing a statement (“Reconciliation Statement”) in a format agreed to by the Parties showing each Party’s full quarter actual results, the calculations of Ongoing Net Sales, Co-Developed Product Revenues, COGM, Cost of Sales, Development Expenses, Marketing Costs, Medical Education Costs, Sales Costs, Distribution Costs, and Other Out-of-Pocket Costs, Cost of Clinical Supplies, COGM and Development Expenses sharing under Section 3.6 of the Agreement and any cash settlement required. The Reconciliation Statement and reports of actual results compared to budget the Collaboration Budget will be sent to the JFC, each party within [****] following the end of a Calendar Quarter for approval. After Each party shall provide notice of approval by the JFC, the JFC will forward or rejection of the Reconciliation Statement to the JSC for its information or approval in the case of a dispute. The Reconciliation Statement shall be provided to the JSC within [***] of receipt. If both parties approve, the Reconciliation Statement will be sent to the JDC or JCC, as applicable, for its information. If either Party rejects the Reconciliation Statement, within [***] prior to days after receipt, the date upon which the JSC JDC or JCC, as applicable shall meet to approve or otherwise resolve the Reconciliation Statement. 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. Execution Version If the approved Reconciliation Statement shows that one Party has incurred more than its share of costs and expenses in the applicable Calendar Quarter as provided in the Collaboration Budget, such Party will, promptly upon approval of the Reconciliation Statement, if approval submit to the other Party an invoice for the difference between its actual costs and expenses in such Calendar Quarter and its share of the Collaboration Budget, which will be paid by the receiving Party within [***] after receipt of such invoice. Development Expense Reporting after Phase II PTI Co-Development Termination Option is being soughtexercised. Reconciliation Statements If Proteostasis exercises its Phase II PTI Co-Development Termination Option pursuant to Section 5.3 of this Agreement, Proteostasis shall be made by PDL or provide to Biogen Idec a final report of its Development Expenses for the Collaboration Compounds within [***] after the end of the Calendar Quarter in the manner set forth in Section A.5 of this Exhibit C.which such Phase II PTI Co-Development Termination Option takes effect.
Appears in 1 contract
Samples: Collaborative Research, Development, Commercialization and License Agreement
Reconciliation Statements. Within [***] following the end of a Calendar Quarter, each Party shall submit to the other Party a Pre-Reconciliation Report encompassing actual results of the first two months of such quarter and preliminary actual results for the third month. Within [***] following the end of a Calendar Quarter, each Party shall submit to the other Party its report of actual results as outlined above (including a summary of charges and credits allocated to its Development Expense Project Account)above. Expenses charged by either Party as Ongoing Development Expenses, Other Out-of-Pocket Costs and Development Expenses shall not exceed [****] of the amount included for the total expenditure in the then current Development Plan or Annual Workplan/Budget, as the case may be, Collaboration Budget unless the JFC recommends, and the JSC other Party approves such excess expense. If actual costs of any expense line item in implementing an Annual Work Plan/Budget or the Development Plan is expected to vary by more than [****], then the Party incurring the variance(s) has the obligation to inform the other Party of such variance(s) in a timely manner and to discuss with such Party the causes of the variance(s). Any such discussion as to the cause of the variances shall occur at the JFC. If the actual costs of a Party implementing an Annual Work Plan/the activities of such Party under the Collaboration Budget or the Development Plan are expected to vary by more than [****] from the amounts budgeted for expenditure during the calendar year, the Responsible Development such Party will promptly revise, as applicable, revise the Annual Workplan/Collaboration Budget or Development Plan and submit it in writing, with an explanation of the variance and the reasons thereforetherefor, for approval to the JSCJDC or JCC, as applicable. If the JSC JDC or JCC, as applicable, does not approve the variance, the amount by which the actual costs exceed [****] of the budgeted costs in the Collaboration Budget shall be borne by the Party that incurred the costs. The financial representatives from each Party on the JFC shall be responsible for, within [****] days following the end of a Calendar Quarter, preparing a statement (“Reconciliation Statement”) in a format agreed to by the Parties showing each Party’s full quarter actual results, the calculations of Ongoing Net Sales, Co-Developed Product Revenues, COGM, Cost of Sales, Development Expenses, Marketing Costs, Medical Education Costs, Sales Costs, Distribution Costs, and Other Out-of-Pocket Costs, Cost of Clinical Supplies, COGM and Development Expenses sharing under Section 3.6 of the Agreement and any cash settlement required. The Reconciliation Statement and reports of actual results compared to budget the Collaboration Budget will be sent to the JFC, each party within [****] following the end of a Calendar Quarter for approval. After Each party shall provide notice of approval by the JFC, the JFC will forward or rejection of the Reconciliation Statement to the JSC for its information or approval in the case of a dispute. The Reconciliation Statement shall be provided to the JSC within [***] of receipt. If both parties approve, the Reconciliation Statement will be sent to the JDC or JCC, as applicable, for its information. If either Party rejects the Reconciliation Statement, within [***] prior to days after receipt, the date upon which the JSC JDC or JCC, as applicable shall meet to approve or otherwise resolve the Reconciliation Statement. 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. If the approved Reconciliation Statement shows that one Party has incurred more than its share of costs and expenses in the applicable Calendar Quarter as provided in the Collaboration Budget, such Party will, promptly upon approval of the Reconciliation Statement, if approval submit to the other Party an invoice for the difference between its actual costs and expenses in such Calendar Quarter and its share of the Collaboration Budget, which will be paid by the receiving Party within [***] after receipt of such invoice. Development Expense Reporting after Phase II PTI Co-Development Termination Option is being soughtexercised. Reconciliation Statements If Proteostasis exercises its Phase II PTI Co-Development Termination Option pursuant to Section 5.3 of this Agreement, Proteostasis shall be made by PDL or provide to Biogen Idec a final report of its Development Expenses for the Collaboration Compounds within [***] after the end of the Calendar Quarter in the manner set forth in Section A.5 of this Exhibit C.which such Phase II PTI Co-Development Termination Option takes effect.
Appears in 1 contract