Common use of Frequency of Reporting Clause in Contracts

Frequency of Reporting. (a) The fiscal year for the purposes of reporting and other activities undertaken by the Parties pursuant to this Exhibit D will be a Calendar Year. Unless the schedule of such reporting is altered by the JSC, reporting by each Party for revenues and expenses will be as set forth in this Paragraph 2 of this Exhibit D. (b) Unless otherwise directed by the JCC or JDC, as applicable, the Finance Working Group will prepare, for sales or Development of Shared Products and Companion Diagnostics, a consolidated reporting of the activities undertaken by the Parties hereunder (including Operating Profits or Losses), the calculation of the Profit & Loss Share, and determination of the cash settlement as between the Parties. Unless otherwise directed by the JCC or JDC, as applicable, the Finance Working Group will provide the Parties within [***] days after the end of each Calendar Quarter, a detailed statement showing the consolidated results and calculations of the Profit & Loss Share and cash settlement required in a format agreed to by the Parties (each, a “Report”). Each Party will cooperate as appropriate and provide the other Party with financial statements, within [***] days after the end of each Calendar Quarter, with respect to Shared Products and Companion Diagnostics (if any), prepared in accordance with the terms contained in the financial planning, accounting and reporting procedures set forth in this Exhibit D in order for each Party to prepare the consolidated reports, including in reasonable detail the following costs and expenses incurred by each Party (if any) in such Calendar Quarter: (i) Cost of Goods Sold, (ii) Marketing Costs, (iii) Sales Costs, (iv) Distribution Costs, (v) Development Costs, (vi) Manufacturing Costs and (vii) Other Operating Income/Expense. (c) On a quarterly basis, each applicable Lead Party will supply the JCC or JDC, as applicable, and the other Party with an estimate of Annual Net Sales (for the applicable portion of the Territory for which such Party is the Lead Party) for such Calendar Quarter of Shared Products and, as applicable, Companion Diagnostics, in units, local currency and U.S. dollars (using the conversion method set forth in this Agreement) according to such Lead Party’s sales reporting system, which will be consistent with the financial planning, accounting and reporting procedures set forth in this Exhibit D. Each Party shall also provide to the other Party (and the JCC or JDC, as applicable, if then in existence) information regarding the gross sales and gross-to-net sales for all Shared Products and Companion Diagnostics for such Calendar Quarter. Each such report will be provided as early as possible, but no later than [***] days after the last day of the Calendar Quarter in question, and will separately provide quarterly and year-to-date cumulative figures. Each applicable Lead Party will provide to the other Party (and the JCC or JDC, as applicable, if then in existence), together with the next Calendar Quarter estimate under this Section 2(c), an updated report for the immediately preceding Calendar Quarter providing a reconciliation of the estimated amounts for such preceding Calendar Quarter against the actual Annual Net Sales during such Calendar Quarter of all such Shared Products and Companion Diagnostics within [***] days after the last day of such Calendar Quarter.

Appears in 2 contracts

Sources: Master Research and Collaboration Agreement (Vividion Therapeutics, Inc.), Master Research and Collaboration Agreement (Vividion Therapeutics, Inc.)

Frequency of Reporting. (a) The fiscal year for the purposes of reporting and other activities undertaken by the Parties pursuant to this Exhibit D will be a Calendar Year. Unless the schedule of such reporting is altered by the JSC, reporting by each Party for revenues and expenses will be as set forth in this Paragraph 2 of this Exhibit D. (b) Unless otherwise directed by the JCC or JDC, as applicableJCC, the Finance Working Group will prepare, for sales or Development of Shared Products and Companion Diagnostics, a consolidated reporting of the activities undertaken by the Parties hereunder (including Operating Profits or Losses), the calculation of the Profit & Loss Share, and determination of the cash settlement as between the Parties. Unless otherwise directed by the JCC or JDC, as applicableJCC, the Finance Working Group will provide the Parties within [***] days after the end of each Calendar Quarter, a detailed statement showing the consolidated results and calculations of the Profit & Loss Share and cash settlement required in a format agreed to by the Parties (each, a “Report”). Each Party will cooperate as appropriate and provide the other Party with financial statements, within [***] days after the end of each Calendar Quarter, with respect to Shared Products and Companion Diagnostics (if any), prepared in accordance with the terms contained in the financial planning, accounting and reporting procedures set forth in this Exhibit D in order for each Party to prepare the consolidated reports, including in reasonable detail the following costs and expenses incurred by each Party (if any) in such Calendar Quarter: (i) Cost of Goods Sold, (ii) Marketing Costs, (iii) Sales Costs, (iv) Distribution Costs, (v) Development Costs, Other Operating Income/Expense and (vi) Manufacturing Costs and (vii) Other Operating Income/ExpenseCosts. (c) On a quarterly basis, each applicable Lead Party Celgene will supply the JCC or JDC, as applicable, and the other Party Vividion with an estimate of Annual Net Sales (for the applicable portion of the Territory for which such Party is the Lead Party) for such Calendar Quarter of Shared Products and, as applicable, Companion DiagnosticsDiagnostics in the US Territory, in units, local currency and U.S. dollars (using the conversion method set forth in this Agreement) according to such Lead PartyCelgene’s sales reporting system, which will be consistent with the financial planning, accounting and reporting procedures set forth in this Exhibit D. Each Party shall also provide to the other Party (and the JCC or JDC, as applicable, if then in existence) information regarding the gross sales and gross-to-net sales for all Shared Products and Companion Diagnostics for such Calendar Quarter. Each such report will be provided as early as possible, but no later than [***] days after the last day of the Calendar Quarter in question, and will separately provide quarterly and year-to-date cumulative figures. Each applicable Lead Party Celgene will provide to the other Party Vividion (and the JCC or JDC, as applicable, if then in existence), together with the next Calendar Quarter estimate under this Section 2(c), an updated report for the immediately preceding Calendar Quarter providing a reconciliation of the estimated amounts for such preceding Calendar Quarter against the actual Annual Net Sales during such Calendar Quarter of all such Shared Products and Companion Diagnostics in the US Territory within [***] days after the last day of such Calendar Quarter.

Appears in 2 contracts

Sources: Master Research and Collaboration Agreement (Vividion Therapeutics, Inc.), Master Research and Collaboration Agreement (Vividion Therapeutics, Inc.)

Frequency of Reporting. (a) The fiscal year for the purposes of reporting and other activities undertaken by the Parties pursuant to this Exhibit D will be a Calendar Year. Unless the schedule of such reporting is altered by the JSC, reporting by each Party for revenues and expenses will be as set forth in this Paragraph 2 of this Exhibit D. (b) Unless otherwise directed by the JCC or JDC, as applicable, the Finance Working Group Jounce will prepare, for sales or Development of Shared Products Co-Co Product and Companion DiagnosticsCo-Co Diagnostic Product, a consolidated reporting of the activities undertaken by the Parties hereunder (including Operating Profits Profit or LossesLoss), the calculation of the Operating Profit & or Loss Sharesharing, and determination of the cash settlement as between the Parties. Unless otherwise directed by the JCC or JDC, as applicable, the Finance Working Group Jounce will provide the Parties Celgene within [***] days after the end of each Calendar Quarter, a detailed statement showing the consolidated results and calculations of the Operating Profit & or Loss Share sharing and cash settlement required in a format agreed to by the Parties (each, a the “Report”). Each Party Celgene will cooperate as appropriate and provide the other Party Jounce with financial statements, within [***] days after of the end of each Calendar Quarter, for Celgene’s activities with respect to Shared Products Co-Co Product and Companion Diagnostics Co-Co Diagnostic Product (if any), prepared in accordance with the terms contained in the financial planning, accounting and reporting procedures set forth in this Exhibit D in order for each Party Jounce to prepare the consolidated reports, including in reasonable detail the following costs and expenses incurred by each Party Celgene (if any) , in such Calendar Quarter: (i) Cost of Goods Sold, (ii) Marketing Costs, (iii) Sales Costs, (iv) Distribution Costs, and (v) Development Costs, (vi) Manufacturing Costs and (vii) Other Operating Income/Expense. (c) On a quarterly monthly basis, each applicable Lead Party Jounce will supply the JCC or JDC, as applicable, and the other Party Celgene with an estimate of Co-Co Annual Net Sales (for during the applicable portion prior month of such Co-Co Product and Co-Co Diagnostic Product in the Territory for which such Party is the Lead Party) for such Calendar Quarter of Shared Products and, as applicable, Companion DiagnosticsUnited States, in units, local currency and U.S. dollars (using the conversion method set forth in this Jounce Lead Co-Co Agreement) according to such Lead PartyJounce’s sales reporting system, which will be consistent with the financial planning, accounting and reporting procedures set forth in this Exhibit D. Each Party Jounce shall also provide to the other Party (and the JCC or JDC, as applicable, if then in existence) Celgene information regarding the Allowable Expenses for such month, gross sales and gross-to-net sales for all Shared Products Co-Co Product and Companion Diagnostics for such Calendar QuarterCo-Co Diagnostic Product. Each such report will be provided as early as possible, but no later than [***] days after the last day of the Calendar Quarter month in question, and will separately provide quarterly monthly and year-to-date cumulative figures. Each applicable Lead Party Jounce will provide to the other Party (and the JCC or JDC, as applicable, if then in existence)Celgene, together with the next Calendar Quarter monthly estimate under this Section 2(c), an updated report for the immediately preceding Calendar Quarter month providing a reconciliation of the estimated amounts for such preceding Calendar Quarter month against the actual Co-Co Annual Net Sales during such Calendar Quarter of all such Shared Products and Companion Diagnostics within [***] days after the last day month of such Calendar QuarterCo-Co Product and Co-Co Diagnostic Product in the United States.

Appears in 2 contracts

Sources: Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.), Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.)

Frequency of Reporting. (a) The fiscal year for In order to prepare the purposes of reporting and consolidated P&L, each Party shall submit to the other activities undertaken by the Parties pursuant to this Exhibit D will be Party a Calendar Year. Unless the schedule financial statement of such reporting is altered by Party’s Commercialization and Medical Affairs activities, Net Sales, Licensing Income, Cost of Sales, Eligible Medical Affairs Costs, Commercialization Costs, and Other Operating Expenses in the JSC, reporting by each Party for revenues and expenses will be as set forth in this Paragraph 2 of this Exhibit D. (b) Unless otherwise directed by the JCC or JDC, as applicable, the Finance Working Group will prepare, for sales or Development of Shared Products and Companion Diagnostics, a consolidated reporting format of the activities undertaken by the Parties hereunder (including Operating Profits or Losses), the calculation of the Profit & Loss Share, and determination of the cash settlement as between the Parties. Unless otherwise directed by the JCC or JDC, as applicable, the Finance Working Group will provide the Parties P&L within [***] days after the end of [***]. Each such individual P&L shall specify in reasonable detail all categories of actual costs related to Eligible Medical Affairs Costs, Commercialization Costs and Other Operating Expenses, and, upon a Party’s request the other Party shall promptly provide any invoices or other supporting documentation for any External Costs or with respect to which documentation is otherwise reasonably requested. Within [***] after the last day of each Calendar Quarter, Moderna shall prepare a reconciliation report and send it to Metagenomi. Within [***] after the end of each Calendar Quarter, the Parties shall agree on a detailed statement showing consolidated P&L for the applicable Calendar Quarter and for such Calendar Quarter, a consolidated results and calculations reporting of the Profit & Loss Share Operating Profits or Losses, the calculation of the Operating Profits or Losses, and the applicable sharing and determination of the corresponding cash settlement required in a an agreed format agreed to by (such report, the Parties (each, a Consolidated Report”). Each Party will cooperate as appropriate and provide the other Party with financial statements, within Within [***] days after the end of each Calendar Quarter, with respect to Shared Products and Companion Diagnostics (if any), prepared in accordance with the terms contained in the financial planning, accounting and reporting procedures set forth in this Exhibit D in order for each Party to prepare the consolidated reports, including in reasonable detail the following costs and expenses incurred by each Party (if any) in such Calendar Quarter: (i) Cost of Goods Sold, (ii) Marketing Costs, (iii) Sales Costs, (iv) Distribution Costs, (v) Development Costs, (vi) Manufacturing Costs and (vii) Other Operating Income/Expense. (c) On a quarterly basis, each applicable Lead Party will supply the JCC or JDC, as applicable, and the other Party with an estimate of Annual Net Sales (for the applicable portion of the Territory for which such whichever Party is the Lead Party) owed a payment shall prepare an invoice for such Calendar Quarter of Shared Products and, as applicable, Companion Diagnostics, in units, local currency payment and U.S. dollars (using the conversion method set forth in this Agreement) according to deliver such Lead Party’s sales reporting system, which will be consistent with the financial planning, accounting and reporting procedures set forth in this Exhibit D. Each Party shall also provide invoice to the other Party. The paying Party (and the JCC or JDC, as applicable, if then in existence) information regarding the gross sales and gross-to-net sales for all Shared Products and Companion Diagnostics for shall pay such Calendar Quarter. Each such report will be provided as early as possible, but no later than invoice within [***] days after receipt of the invoice. For clarity, the first P&L prepared with respect to each DT Co-Co Product shall be prepared for the first Calendar Quarter in which either Party incurs Eligible Medical Affairs Costs, Commercialization Costs, or Other Operating Expenses (regardless of whether such Eligible Medical Affairs Costs, Commercialization Costs, or Other Operating Expenses are incurred before or after Regulatory Approval for any DT Co-Co Product). In addition to the above, within [***] after the last day of the Calendar Quarter in question, and will separately provide quarterly and year-to-date cumulative figures. Each applicable Lead Party will provide to the other Party (and the JCC or JDC, as applicable, if then in existence), together with the next Calendar Quarter estimate under this Section 2(c), an updated report for the immediately preceding Calendar Quarter providing a reconciliation of the estimated amounts for such preceding Calendar Quarter against the actual Annual Net Sales during such Calendar Quarter of all such Shared Products and Companion Diagnostics within [***] days after the last day of such every Calendar Quarter, each Party shall submit to the other Party a report, with respect to each DT Co-Co Product, setting forth the P&L representing for each DT Co-Co Product (if any) the actual Net Sales, Cost of Sales, Licensing Income, Eligible Medical Affairs Costs, Commercialization Costs, and Other Operating Expenses recognized by such Party in such just-completed two month period as well as an estimate of expected Net Sales, Cost of Sales, Licensing Income, Eligible Medical Affairs Costs, Commercialization Costs, and Other Operating Expenses to be recognized in the third month of the current Calendar Quarter for each such DT Co-Co Product (if any).

Appears in 1 contract

Sources: Strategic Collaboration and License Agreement (Metagenomi Technologies, LLC)

Frequency of Reporting. (a) The fiscal year for the purposes of reporting and other activities undertaken by the Parties pursuant to this Exhibit D GenGain will be a Calendar Yearcalendar year. Unless the schedule of such reporting is altered by the JSC, reporting Reporting by each Party for GenGain revenues and expenses will be performed as set forth in this Paragraph 2 follows, with submissions due on the date indicated or the next business day if such date is a weekend or U.S. holiday: ------------------------------------------------------------------------------------- Reporting Event Frequency Timing of this Exhibit D. Submission ------------------------------------------------------------------------------------- Actuals Quarterly Q1-Q4: End of quarter + 30 working days ------------------------------------------------------------------------------------- Forecasts Approximately As soon as practicable after each Quarterly quarterly meeting of Genentech's board of directors ------------------------------------------------------------------------------------- Preliminary Budgets Annually September 1 (bone year; by year) Unless otherwise directed ------------------------------------------------------------------------------------- Final Budgets Annually October 17 (one year; by quarter) ------------------------------------------------------------------------------------- Long-Range Plan Annually April 30 (current year plus 5 years) ------------------------------------------------------------------------------------- Reports of actual results compared to budget shall be made to the relevant Joint Project Team on a quarterly basis. After approval by the JCC Joint Project Team as to amounts, such Joint Project Team shall forward the report to the JSC for its approval. Variances from the total overall budgets, and significant variances in budget line items, shall only be included in calculation of Operating Profit or JDC, as applicable, Loss when approved by the Finance Working Group JSC after referral by the Joint Project Team. Genentech will prepare, be responsible for sales or Development the preparation of Shared Products and Companion Diagnostics, a consolidated reporting of the activities undertaken by the Parties hereunder GenGain (including Operating Profits Profit or LossesLoss), the calculation of the Profit & Loss Share, profit/loss sharing and determination of the cash settlement as between the Partiessettlement. Unless otherwise directed by the JCC or JDC, as applicable, the Finance Working Group Genentech will provide the Parties within [***] days after the end of financial representatives from each Calendar Quarter, Party a detailed statement showing the consolidated results and calculations of the Operating Profit & or Loss Share sharing and cash settlement required in a format agreed to by the Parties (each, a “Report”)Parties. Each Party will cooperate as appropriate and provide the other Party with financial statements, within [***] days after the end of each Calendar Quarter, with respect to Shared Products and Companion Diagnostics (if any), prepared in accordance with the terms contained in the financial planning, accounting and reporting procedures set forth in this Exhibit D in order for each Party to prepare the consolidated reports, including in reasonable detail the following costs and expenses incurred by each Party (if any) in such Calendar Quarter: (i) Cost of Goods Sold, (ii) Marketing Costs, (iii) Sales Costs, (iv) Distribution Costs, (v) Development Costs, (vi) Manufacturing Costs and (vii) Other Operating Income/Expense. (c) On a quarterly monthly basis, each applicable Lead Party Genentech will supply the JCC or JDC, as applicable, Magainin with each month's Gross Sales and the other Party with an estimate of Annual Net Sales (for the applicable portion of the Territory for which such Party is the Lead Party) for such Calendar Quarter of Shared Products and, as applicable, Companion Diagnostics, in units, local currency and U.S. dollars (using the month-end rate for conversion method set forth for such month as shown in this AgreementReuters) by country in the Territories according to such Lead Party’s Genentech's sales reporting system, which will shall be consistent with the financial planning, accounting and reporting procedures set forth in this Exhibit D. Each Party shall also provide to the other Party (and the JCC or JDC, as applicable, if then in existence) information regarding the gross sales and gross-to-net sales for all Shared Products and Companion Diagnostics for such Calendar Quarterdefinitions herein. Each such report will shall be provided as early as possible, but no later than [***] fifteen (15) days after the last day of the Calendar Quarter month in question, and will separately shall provide quarterly monthly and year-to-date cumulative figures. Each applicable Lead Party The financial representatives from the Parties will provide meet as appropriate but at least quarterly to review and approve the following: . actual results . forecasts . budgets . long range plans . inventory levels ________________________________________________________________________________ ** Certain portions of this exhibit have been omitted based upon a request for confidential treatment that has been filed with the Commission. The omitted potions have been filed separately with the Commission. . Sales Returns and Allowances . other Party (financial matters, including Genentech's methodologies for charging costs and allocating sales representatives to GenGain for determination of actuals, forecasts, budgets and long-range plans and the JCC or JDC, as applicable, if then in existence), together with the next Calendar Quarter estimate under this Section 2(c), an updated report for the immediately preceding Calendar Quarter providing a reconciliation results of the estimated amounts for applying such preceding Calendar Quarter against the actual Annual Net Sales during such Calendar Quarter of all such Shared Products and Companion Diagnostics within [***] days after the last day of such Calendar Quartermethodologies.

Appears in 1 contract

Sources: License and Collaboration Agreement (Magainin Pharmaceuticals Inc)

Frequency of Reporting. (a) The fiscal year for the purposes of reporting and other activities undertaken by the Parties pursuant to this Exhibit D GenSpire will be a Calendar Yearcalendar year. Unless the schedule of such reporting is altered by the JSC, reporting Reporting by each Party for GenSpire revenues and expenses will be performed as set forth in this Paragraph 2 follows, with submissions due on the date indicated or the next business day if such date is a weekend or U.S. holiday: B-2 --------------------------------------------------------------------------------------- Reporting Event Frequency Timing of this Exhibit D. (b) Unless otherwise directed Submission --------------------------------------------------------------------------------------- Actuals Quarterly ----------------------------------------------- Forecasts Approximately Quarterly ----------------------------------------------- [CONFIDENTIAL TREATMENT REQUESTED] Preliminary Budgets Annually ----------------------------------------------- Final Budgets Annually ----------------------------------------------- Long-Range Plan Annually ----------------------------------------------- Reports of actual results compared to budget shall be made to the relevant Joint Project Team on a * basis. After approval by the JCC Joint Project Team as to amounts, such Joint Project Team shall forward the report to the JSC for its approval. Variances from the total overall budgets, and significant variances in budget line items, shall only be included in calculation of Operating Profit or JDC, as applicable, Loss when approved by the Finance Working Group JSC after referral by the Joint Project Team. Genentech will prepare, be responsible for sales or Development the preparation of Shared Products and Companion Diagnostics, a consolidated reporting of the activities undertaken by the Parties hereunder GenSpire (including Operating Profits Profit or LossesLoss), the calculation of the Profit & Loss Share, profit/loss sharing and determination of the cash settlement as between the Partiessettlement. Unless otherwise directed by the JCC or JDC, as applicable, the Finance Working Group Genentech will provide the Parties financial representatives from each Party within [***] fifteen (15) working days after of the end of each Calendar Quartersubmission date shown above, a detailed statement showing the consolidated results and calculations of the Operating Profit & or Loss Share sharing and cash settlement required in a format agreed to by the Parties (eachParties. Inspire shall promptly provide all orders received by its sales people, a “Report”). Each Party will cooperate as appropriate and provide the other Party with financial statements, within [***] days after the end of each Calendar Quarter, with respect to Shared Products and Companion Diagnostics (if any), prepared in accordance with the terms contained in the financial planning, accounting to Genentech for processing and reporting procedures set forth in this Exhibit D in order for each Party to prepare the consolidated reports, including in reasonable detail the following costs and expenses incurred by each Party (if any) in such Calendar Quarter: (i) Cost of Goods Sold, (ii) Marketing Costs, (iii) Sales Costs, (iv) Distribution Costs, (v) Development Costs, (vi) Manufacturing Costs and (vii) Other Operating Income/Expense. (c) distribution. On a quarterly * basis, each applicable Lead Party Genentech will supply the JCC or JDC, as applicable, Inspire with each * Gross Sales and the other Party with an estimate of Annual Net Sales (for the applicable portion of the Territory for which such Party is the Lead Party) for such Calendar Quarter of Shared Products and, as applicable, Companion Diagnostics, in units, local currency and U.S. dollars (using the * rate for conversion method set forth for such * as shown in this AgreementThe Wall Street Journal) by country in the Territories according to such Lead Party’s Genentech's sales reporting system, which will shall be consistent with the financial planning, accounting and reporting procedures set forth in this Exhibit D. Each Party shall also provide to the other Party (and the JCC or JDC, as applicable, if then in existence) information regarding the gross sales and gross-to-net sales for all Shared Products and Companion Diagnostics for such Calendar Quarterdefinitions herein. Each such report will shall be provided as early as possible, but no later than [***] fifteen (15) days after the last day of the Calendar Quarter * in question, and will separately shall provide quarterly * and year-to-date * cumulative figures. Each applicable Lead Party * [CONFIDENTIAL TREATMENT REQUESTED] The financial representatives from the Parties will provide meet as appropriate but at least quarterly to review and approve the following: . actual results . forecasts . budgets . inventory levels . Sales Returns and Allowances . other Party financial matters, including Genentech's (and the JCC or JDC, as applicableInspire's, if then in existence)applicable) methodologies for charging costs and allocating sales representatives to GenSpire for determination of actuals, together with forecasts, budgets and long-range plans and the next Calendar Quarter estimate under this Section 2(c), an updated report for the immediately preceding Calendar Quarter providing a reconciliation results of the estimated amounts for applying such preceding Calendar Quarter against the actual Annual Net Sales during such Calendar Quarter of all such Shared Products and Companion Diagnostics within [***] days after the last day of such Calendar Quartermethodologies.

Appears in 1 contract

Sources: Development, License and Supply Agreement (Inspire Pharmaceuticals Inc)

Frequency of Reporting. (a) The fiscal year for the purposes of reporting and other activities undertaken by the Parties pursuant to this Exhibit D will be a Calendar Yearcalendar year. Unless the schedule of such reporting is altered by the JSC, reporting Reporting by each Party for revenues and expenses will be performed as set forth in this Paragraph 2 follows: Reporting Event Frequency Timing of this Exhibit D. Submission Actuals (bincluding draft settlement statements) Unless otherwise directed Quarterly Q1-Q3: +45 days Q4: +45 days Forecasts (rest of year - by month) Quarterly Q1-Q3 +60 days Settlement payments between the Parties Quarterly Quarter end +60 days Preliminary budgets (one year) Annually September 15 Final combined commercial and development budget (one year - by quarter) Annually October 15 Long Range Plan (current year plus 5 years) Annually April 15 TABLE OF CONTENTS (CONTINUED) PAGE Reports of actual results compared to budget will be made by the JCC Parties to the CSC on a quarterly basis. Variances from the total overall budgets, and significant variances in budget line items for costs or JDCrevenue line items, as applicable, will be included in the Finance Working Group calculation of Operating Profits and Losses only when approved by the CSC. Genentech will prepare, be responsible for sales or Development the preparation of Shared Products and Companion Diagnostics, a consolidated reporting of the activities undertaken by the Parties hereunder Collaboration (including Development Costs and any Operating Profits Profit or LossesLoss), the calculation of the Profit & Loss Share, sharing and initial determination of the cash settlement as between the Parties. Unless otherwise directed (subject to approval by the JCC or JDCCSC). Within forty-five (45) days of each quarter end, as applicable, the Finance Working Group Genentech will provide the Parties within [***] days after the end of financial representatives from each Calendar Quarter, Party with a detailed statement showing the consolidated results and calculations of the Operating Profit & or Loss Share sharing (or calculation of expenses to be shared) and cash settlement required in a format agreed to by the Parties (each, a “Report”)substantially as depicted above. Each Party will cooperate as appropriate and provide the other Party with financial statements, within [***] days after the end of each Calendar Quarter, with respect to Shared Products and Companion Diagnostics (if any), prepared in accordance with the terms contained Genentech shall record sales in the financial planning, accounting and reporting procedures set forth in this Exhibit D in order for each Party to prepare the consolidated reports, including in reasonable detail the following costs and expenses incurred by each Party (if any) in such Calendar Quarter: (i) Cost of Goods Sold, (ii) Marketing Costs, (iii) Sales Costs, (iv) Distribution Costs, (v) Development Costs, (vi) Manufacturing Costs and (vii) Other Operating Income/Expense. (c) United States. On a quarterly monthly basis, each applicable Lead Party Genentech will supply the JCC or JDC, as applicable, Curis with each month’s gross sales and the other Party with an estimate of Annual Net Sales (for the applicable portion of the Territory for which such Party is the Lead Party) for such Calendar Quarter of Shared Collaboration Products and, as applicable, Companion Diagnostics, in units, local currency units and U.S. dollars (using in the conversion method set forth in this Agreement) according to such Lead Party’s sales reporting system, which will be consistent with the financial planning, accounting and reporting procedures set forth in this Exhibit D. Each Party shall also provide to the other Party (and the JCC or JDC, as applicable, if then in existence) information regarding the gross sales and gross-to-net sales for all Shared Products and Companion Diagnostics for such Calendar QuarterUnited States. Each such report will shall be provided as early as possible, but no later than [***] ten (10) days after the last day of the Calendar Quarter month in question, and will separately shall provide quarterly monthly and year-to-date cumulative figures. Each applicable Lead The financial representatives from the Parties will meet as appropriate but at least quarterly to review and approve the following: • Development Costs • Costs of Products Sold • Selling and Marketing expenses • actual results • forecasts • budgets • inventory levels • sales returns and allowances • other financial matters, including each Party’s methodologies for charging costs to the collaboration, for determination of actuals, forecasts, budgets and long range plans and the results of applying such methodologies. Co-Development Budgets. Co-Development Budgets will be prepared annually by the Parties. Co-Development Budgets under this Schedule 4.2 will be supplemented with detailed plans for U.S. clinical trials and drug approval applications as determined by the Parties in accordance with the Agreement. Co-Development Budgets, once approved by the CSC, can only be changed with the approval of the CSC. -iii- TABLE OF CONTENTS (CONTINUED) PAGE The financial representatives of each Party will provide be responsible for identifying, analyzing and reporting all significant line item budget variances and all overall, total budget variances. Except as provided otherwise in the Agreement, only the CSC may approve materially unfavorable line item budget variations, and all total budget variations, chargeable to the collaboration during the course of the year. Payments between the Parties. Payments to each Party of the agreed upon percentages of Operating Profit or Loss as provided under the applicable Cost Sharing Ratio will be made quarterly, based on actual results within sixty (60) days after the end of each quarter. A report, as approved by the CSC, specifying how each payment was calculated shall also be submitted with each payment to both Parties. Balancing payments by one Party to reimburse the other Party (and the JCC or JDC, as applicable, if then in existence), together with the next Calendar Quarter estimate under this Section 2(c), an updated report for the immediately preceding Calendar Quarter providing a reconciliation purposes of the estimated amounts for such preceding Calendar Quarter against sharing of Operating Loss, including Development Costs, under the actual Annual Net Sales during such Calendar Quarter Agreement will be approved by the CSC and shall be made within sixty (60) days of all such Shared Products and Companion Diagnostics within [***] days receipt of the approved CSC report. In the event any payment is made after the last day of such Calendar Quartertime period specified herein, the paying Party shall increase the amount otherwise due and payable by adding interest thereon, computed at the Prime Rate plus two percent (2%). Genentech will perform the consolidation and settlement calculations for submission to the CSC.

Appears in 1 contract

Sources: Collaborative Research, Development and License Agreement

Frequency of Reporting. (a) The fiscal year for the purposes of reporting and other activities undertaken by the Parties pursuant to this Exhibit D GenRoche Development will be a Calendar Yearcalendar year. Unless An Annual Budget for each year will be defined and agreed between the schedule Parties on or before December 1 of such reporting is altered by the JSC, reporting previous year. Reporting by each Party for revenues GenRoche Development revenues, expenses and expenses royalties will be performed as set forth in this Paragraph 2 follows (with copies provided to the JFC and to the other Party): Actuals Quarterly Q1-Q3: Q4: +30 days +45 days Development Costs (Actuals) Monthly Jan-Nov: Dec: +30 days +45 days Settlement Payments Quarterly +90 days Annual Budget Annually October-December Forecasts (current and following 5 quarters) Quarterly Within first 10 (ten) business days of this Exhibit D. (b) Unless otherwise directed the third month of quarter excluding Q4, where the Forecasting event is replaced by the JCC Annual Budget Long Range Plan (next 5 calendar years) Annually May-July * * - ROCHE acknowledges that GENENTECH's current internal Long Range Plan timing is completed annually in December and that until such time as the two Parties are further coordinated on the timing of their efforts, GENENTECH submissions may be out-dated. The committee appointed by the Management Committee with oversight responsibility for the particular Molecules, Drug Candidates, and Products (i.e. the JRC, JDC or JDCJCC, as applicable, ) ("Committee(s)") will be responsible for the Finance Working Group will prepare, for sales or Development of Shared Products and Companion Diagnostics, a consolidated reporting applicable portions of the activities undertaken Budget and Long Range Plan with regard to Products. The applicable Committee(s) will develop budgets for research, development and commercialization in coordination with the JFC for review and approval by the Parties hereunder Management Committee. Unless otherwise mutually agreed by the Parties, ROCHE will be responsible for the preparation of consolidated global and ROW reporting (including Operating Profits or Lossesactuals, budgets, forecasts, and long range plans), the calculation of the Profit & Loss Shareprofit/loss sharing and determination of the consolidated Settlement Payments. In the US, the Lead Party will be responsible for the preparation of consolidated US reporting (actuals, budgets, forecasts, and long range plans and reporting such to ROCHE), calculation of the profit/loss sharing, development costs, and determination of the cash settlement as between the PartiesUS-related Settlement Payments. Unless otherwise directed by the JCC or JDC, as applicable, the Finance Working Group ROCHE will provide the Parties JFC (and GENENTECH) within [***] five (5) working days after of the end of each Calendar Quartersubmission date shown above, the Commercial Income Statement, a detailed statement showing the global consolidated results (and forecasts) and calculations of the Profit & Loss Share profit/loss sharing, development costs and cash settlement royalties and resulting Settlement Payments required in a format agreed to by the Parties Parties. Reports of actual results compared to budget (eachas to all Molecules, a “Report”). Each Party will cooperate as appropriate Drug Candidates, and provide the other Party with financial statements, within [***] days after the end of each Calendar Quarter, with respect to Shared Products and Companion Diagnostics (also on a product-by-product basis) will be made, if any)requested, prepared in accordance with to the terms contained in the financial planning, accounting and reporting procedures set forth in this Exhibit D in order for each Party to prepare the consolidated reports, including in reasonable detail the following costs and expenses incurred by each Party (if any) in such Calendar Quarter: (i) Cost of Goods Sold, (ii) Marketing Costs, (iii) Sales Costs, (iv) Distribution Costs, (v) Development Costs, (vi) Manufacturing Costs and (vii) Other Operating Income/Expense. (c) On applicable Committee on a quarterly basis. After acceptance by the JFC as to amounts, the JFC will forward the report to the applicable Committee for its acceptance. The Parties will work together to keep actual spend within the Annual Budget. Any deviations greater than five percent (5%) above the Annual Budget will have to be accepted by the JFC. In this event, each applicable Lead Party will be given the time to receive internal approval from their respective decision making bodies before making any firm commitment on additional spending. On a monthly basis, within seven (7) working days following that particular month end, each party will supply the JCC or JDC, as applicable, and the other Party party with an estimate of Annual Net Sales (for the applicable portion of the Territory for which such Party is the Lead Partyas to all Products and also on a product-by-product basis) for such Calendar Quarter of Shared Products and, as applicable, Companion Diagnostics, in units, local currency and U.S. US dollars (using the conversion method set forth in this Agreementby GENENTECH) or Swiss Francs (by ROCHE) by country of each month's sales according to such Lead the selling Party’s 's sales reporting system, which will shall be consistent with the financial planningdefinitions in Section A.3. The JFC will meet as appropriate, accounting at least twice a year and alternating between the locations of GENENTECH and ROCHE, to review and approve the reporting procedures set forth events (Actuals, Annual Budget, Forecasts and Long Range Plan) as to all Molecules, Drug Candidates, and Products and also on a product-by-product basis. The minimum scope that the JFC will cover in this Exhibit D. Each Party shall also provide work is: - FTE rate to be charged between the parties - inventory levels and write offs - sales returns and allowances - other Party (and the JCC or JDCfinancial matters, as applicable, if then in existence) information regarding the gross sales and gross-to-net sales including each Party's methodologies for all Shared Products and Companion Diagnostics for such Calendar Quarter. Each such report will be provided as early as possible, but no later than [***] days after the last day of the Calendar Quarter in question, and will separately provide quarterly and year-to-date cumulative figures. Each applicable Lead Party will provide charging costs to the other Party (and the JCC or JDC, as applicable, if then in existence), together with the next Calendar Quarter estimate under this Section 2(c), an updated report for the immediately preceding Calendar Quarter providing a reconciliation of the estimated amounts for such preceding Calendar Quarter against the actual Annual Net Sales during such Calendar Quarter of all such Shared Products and Companion Diagnostics within [***] days after the last day of such Calendar QuarterGenRoche Development.

Appears in 1 contract

Sources: Collaborative Agreement (Genentech Inc)

Frequency of Reporting. (a) The fiscal year for the purposes of reporting and other activities undertaken by the Parties pursuant to this Exhibit D GenGain will be a Calendar Yearcalendar year. Unless the schedule of such reporting is altered by the JSC, reporting Reporting by each Party for GenGain revenues and expenses will be performed as set forth in this Paragraph 2 follows, with submissions due on the date indicated or the next business day if such date is a weekend or U.S. holiday: --------------------------------------------------------------------------------------- Reporting Event Frequency Timing of this Exhibit D. Submission --------------------------------------------------------------------------------------- Actuals Quarterly Q1-Q4: End of quarter + 30 working days --------------------------------------------------------------------------------------- Forecasts Approximately As soon as practicable after each quarterly Quarterly meeting of Genentech's board of directors --------------------------------------------------------------------------------------- Preliminary Annually September 1 (bone year; by year) Unless otherwise directed Budgets --------------------------------------------------------------------------------------- Final Budgets Annually October 17 (one year; by quarter) --------------------------------------------------------------------------------------- Long-Range Plan Annually April 30 (current year plus 5 years) --------------------------------------------------------------------------------------- Reports of actual results compared to budget shall be made to the relevant Joint Project Team on a quarterly basis. After approval by the JCC Joint Project Team as to amounts, such Joint Project Team shall forward the report to the JSC for its approval. Variances from the total overall budgets, and significant variances in budget line items, shall only be included in calculation of Operating Profit or JDC, as applicable, Loss when approved by the Finance Working Group JSC after referral by the Joint Project Team. Genentech will prepare, be responsible for sales or Development the preparation of Shared Products and Companion Diagnostics, a consolidated reporting of the activities undertaken by the Parties hereunder GenGain (including Operating Profits Profit or LossesLoss), the calculation of the Profit & Loss Share, profit/loss sharing and determination of the cash settlement as between the Partiessettlement. Unless otherwise directed by the JCC or JDC, as applicable, the Finance Working Group Genentech will provide the Parties within [***] days after the end of financial representatives from each Calendar Quarter, Party a detailed statement showing the consolidated results and calculations of the Operating Profit & or Loss Share sharing and cash settlement required in a format agreed to by the Parties (each, a “Report”)Parties. Each Party will cooperate as appropriate and provide the other Party with financial statements, within [***] days after the end of each Calendar Quarter, with respect to Shared Products and Companion Diagnostics (if any), prepared in accordance with the terms contained in the financial planning, accounting and reporting procedures set forth in this Exhibit D in order for each Party to prepare the consolidated reports, including in reasonable detail the following costs and expenses incurred by each Party (if any) in such Calendar Quarter: (i) Cost of Goods Sold, (ii) Marketing Costs, (iii) Sales Costs, (iv) Distribution Costs, (v) Development Costs, (vi) Manufacturing Costs and (vii) Other Operating Income/Expense. (c) On a quarterly monthly basis, each applicable Lead Party Genentech will supply the JCC or JDC, as applicable, Magainin with each month's Gross Sales and the other Party with an estimate of Annual Net Sales (for the applicable portion of the Territory for which such Party is the Lead Party) for such Calendar Quarter of Shared Products and, as applicable, Companion Diagnostics, in units, local currency and U.S. dollars (using the month-end rate for conversion method set forth for such month as shown in this AgreementReuters) by country in the Territories according to such Lead Party’s Genentech's sales reporting system, which will shall be consistent with the financial planning, accounting and reporting procedures set forth in this Exhibit D. Each Party shall also provide to the other Party (and the JCC or JDC, as applicable, if then in existence) information regarding the gross sales and gross-to-net sales for all Shared Products and Companion Diagnostics for such Calendar Quarterdefinitions herein. Each such report will shall be provided as early as possible, but no later than [***] fifteen (15) days after the last day of the Calendar Quarter month in question, and will separately shall provide quarterly monthly and year-to-date cumulative figures. Each applicable Lead Party The financial representatives from the Parties will provide meet as appropriate but at least quarterly to review and approve the following: . actual results . forecasts . budgets . long range plans . inventory levels ________________________________________________________________________________ ** Certain portions of this exhibit have been omitted based upon a request for confidential treatment that has been filed with the Commission. The omitted portions have been filed separately with the Commission. . Sales Returns and Allowances . other Party (financial matters, including Genentech's methodologies for charging costs and allocating sales representatives to GenGain for determination of actuals, forecasts, budgets and long-range plans and the JCC or JDC, as applicable, if then in existence), together with the next Calendar Quarter estimate under this Section 2(c), an updated report for the immediately preceding Calendar Quarter providing a reconciliation results of the estimated amounts for applying such preceding Calendar Quarter against the actual Annual Net Sales during such Calendar Quarter of all such Shared Products and Companion Diagnostics within [***] days after the last day of such Calendar Quartermethodologies.

Appears in 1 contract

Sources: License and Collaboration Agreement (Magainin Pharmaceuticals Inc)

Frequency of Reporting. (a) The fiscal year for of the purposes of reporting and other activities undertaken by the Parties pursuant to this Exhibit D Collaboration will be a Calendar Yearcalendar year but OSI shall be furnished with the information it requires to enable it to report in a timely manner to its stockholders on a September 30 fiscal year basis. Unless the schedule of such reporting is altered by the JSC, reporting Reporting by each Party for Collaboration revenues and expenses will be performed as set forth in this Paragraph 2 follows: ** ------------------- ** This portion has been redacted pursuant to a confidential treatment request. Reports of this Exhibit D. (b) Unless otherwise directed actual results compared to budget will be made to the Joint Project Team on a quarterly basis. After approval by the JCC or JDC, Joint Project Team as applicableto amounts, the Finance Working Group Joint Project Team will prepareforward the report to the JSC for its approval. Variances from the total overall budgets, and significant variances in budget line items, will only be included in the calculation of OSI/GNE Development Costs or Operating Profits and Losses when approved by the JSC. Genentech will be responsible for sales or Development the preparation of Shared Products and Companion Diagnostics, a consolidated reporting of the activities undertaken by the Parties hereunder Collaboration (including GNE/OSI Development Costs and any Operating Profits Profit or LossesLoss), the calculation of the Profit & Loss Share, sharing and determination of the cash settlement as between the Parties. Unless otherwise directed (subject to dispute resolution by the JCC JSC or JDC, arbitration as applicable, the Finance Working Group case may be). Genentech will provide the Parties financial representatives from each Party within [***] * days after the of quarter end of each Calendar Quarter, a detailed statement showing the consolidated results and calculations of the Operating Profit & or Loss Share sharing (or calculation of expenses to be shared) and cash settlement required in a format agreed to by substantially listed above. Genentech shall record sales in the U.S. ** The financial representatives from the Parties (each, a “Report”). Each Party i.e. the Joint Finance Subcommittee members) will cooperate meet as appropriate but at least quarterly to review and provide approve the following: - OSI/GNE Development Costs - actual results - forecasts - budgets - inventory levels - Sales Returns and Allowances - other Party with financial statements, within [***] days after the end of each Calendar Quarter, with respect to Shared Products and Companion Diagnostics (if any), prepared in accordance with the terms contained in the financial planning, accounting and reporting procedures set forth in this Exhibit D in order for each Party to prepare the consolidated reportsmatters, including in reasonable detail each Party's methodologies for charging costs to the following costs Collaboration, for determination of actuals, forecasts, budgets and expenses incurred by each Party (if any) in such Calendar Quarter: (i) Cost of Goods Sold, (ii) Marketing Costs, (iii) Sales Costs, (iv) Distribution Costs, (v) Development Costs, (vi) Manufacturing Costs and (vii) Other Operating Income/Expense. (c) On a quarterly basis, each applicable Lead Party will supply the JCC or JDC, as applicable, long range plans and the other Party with an estimate results of Annual Net Sales (for the applicable applying such methodologies. ------------------- ** This portion of the Territory for which such Party is the Lead Party) for such Calendar Quarter of Shared Products and, as applicable, Companion Diagnostics, in units, local currency and U.S. dollars (using the conversion method set forth in this Agreement) according has been redacted pursuant to such Lead Party’s sales reporting system, which will be consistent with the financial planning, accounting and reporting procedures set forth in this Exhibit D. Each Party shall also provide to the other Party (and the JCC or JDC, as applicable, if then in existence) information regarding the gross sales and gross-to-net sales for all Shared Products and Companion Diagnostics for such Calendar Quarter. Each such report will be provided as early as possible, but no later than [***] days after the last day of the Calendar Quarter in question, and will separately provide quarterly and year-to-date cumulative figures. Each applicable Lead Party will provide to the other Party (and the JCC or JDC, as applicable, if then in existence), together with the next Calendar Quarter estimate under this Section 2(c), an updated report for the immediately preceding Calendar Quarter providing a reconciliation of the estimated amounts for such preceding Calendar Quarter against the actual Annual Net Sales during such Calendar Quarter of all such Shared Products and Companion Diagnostics within [***] days after the last day of such Calendar Quarterconfidential treatment request.

Appears in 1 contract

Sources: Development and Marketing Collaboration Agreement (Osi Pharmaceuticals Inc)

Frequency of Reporting. (a) The fiscal year for the purposes of reporting and other activities undertaken by the Parties pursuant to this Exhibit D GenIDEC will be a Calendar Yearcalendar year. Unless the schedule of such reporting is altered by the JSC, reporting Reporting by each Party for GenIDEC revenues and expenses will be performed as set forth in this Paragraph 2 follows (with copies provided to the JFC and to the other Party): Actuals Quarterly Q1-Q3: +30 days Q4: +45 days Forecasts (rest of this Exhibit D. year—by month) Quarterly Mid Quarter Budgets (bone year—by month) Unless otherwise directed by Annually October 31st Long Range Plan (current year plus 5 years) Annually July 31st Genentech will be responsible for the JCC or JDC, as applicable, the Finance Working Group will prepare, for sales or Development preparation of Shared Products and Companion Diagnostics, a consolidated reporting of the activities undertaken by the Parties hereunder (including Operating Profits or Lossesactuals, budgets, forecasts, and long range plans), the calculation of the Profit & Loss Share, profit/loss sharing and determination of the cash settlement as between the Partiessettlement. Unless otherwise directed by the JCC or JDC, as applicable, the Finance Working Group Genentech will provide the Parties JFC (and IDEC) within [***] five working days after of the end of each Calendar Quartersubmission date shown above, a detailed statement showing the consolidated results (and forecasts) and calculations of the Profit & Loss Share profit/loss sharing and cash settlement required in a format agreed to by the Parties Parties. Reports of actual results compared to budget (each, a “Report”). Each Party will cooperate as appropriate and provide the other Party with financial statements, within [***] days after the end of each Calendar Quarter, with respect to Shared all Franchise Products and Companion Diagnostics (if any), prepared in accordance with also on a product-by-product basis) will be made to the terms contained in the financial planning, accounting and reporting procedures set forth in this Exhibit D in order for each Party to prepare the consolidated reports, including in reasonable detail the following costs and expenses incurred by each Party (if any) in such Calendar Quarter: (i) Cost of Goods Sold, (ii) Marketing Costs, (iii) Sales Costs, (iv) Distribution Costs, (v) Development Costs, (vi) Manufacturing Costs and (vii) Other Operating Income/Expense. (c) On Committees on a quarterly basis. After approval by the JFC as to amounts, each applicable Lead Party the JFC will forward the report to the Management Committee for its approval. Line item variances from budgets judged to be significant by the JFC will only be included in calculation of Operating Profit and Loss when approved by the JCC and the Management Committee. On a monthly basis Genentech will supply the JCC or JDC, as applicable, and the other Party IDEC with an estimate of Annual Net Gross Sales (for the applicable portion of the Territory for which such Party is the Lead Partyas to all Franchise Products and also on a product-by-product basis) for such Calendar Quarter of Shared Products and, as applicable, Companion Diagnostics, in units, local currency and U.S. dollars (using the conversion method set forth in this Agreement) by country of each month's sales according to such Lead Party’s Genentech's sales reporting system, which will shall be consistent with the definitions in Section A.4. The Joint Finance Committee will meet as appropriate to review and approve the following (as to all Franchise Products and also on a product-by-product basis): - Actual Results - Forecasts - Budget - Inventory Levels - Sales Returns and Allowances - Other financial planningmatters, accounting including each Party's methodologies for charging costs and reporting procedures set forth in this Exhibit D. Each Party shall also provide allocating Sales Representatives to the other Party (GenIDEC for actuals, forecasts, budgets and long range plans and the JCC or JDC, as applicable, if then in existence) information regarding the gross sales and gross-to-net sales for all Shared Products and Companion Diagnostics for results of applying such Calendar Quarter. Each such report will be provided as early as possible, but no later than [***] days after the last day of the Calendar Quarter in question, and will separately provide quarterly and year-to-date cumulative figures. Each applicable Lead Party will provide to the other Party (and the JCC or JDC, as applicable, if then in existence), together with the next Calendar Quarter estimate under this Section 2(c), an updated report for the immediately preceding Calendar Quarter providing a reconciliation of the estimated amounts for such preceding Calendar Quarter against the actual Annual Net Sales during such Calendar Quarter of all such Shared Products and Companion Diagnostics within [***] days after the last day of such Calendar Quartermethodologies.

Appears in 1 contract

Sources: Collaboration Agreement (Idec Pharmaceuticals Corp / De)

Frequency of Reporting. (a) The fiscal year for of the purposes of reporting and other activities undertaken by the Parties pursuant to this Exhibit D Collaboration will be a Calendar Yearcalendar year. Unless the schedule of such reporting is altered by the JSC, reporting ***Confidential Treatment Requested Reporting by each Party for Collaboration revenues and expenses will be performed as set forth in this Paragraph 2 follows: Reporting Event Frequency Timing of this Exhibit D. Submission --------------- --------- -------------------- Actuals (bincluding draft Quarterly Q1-Q3: +45 days settlement statements) Unless otherwise directed Q4: +45 days Forecasts Quarterly Q1-Q3 +60 days (rest of year - by month) Settlement payments between the Parties Quarterly Quarter end +60 days Preliminary Budgets Annually September 15 (one year) Final Combined Commercial Annually October 15 And Development Budget (one year - by quarter) Long Range Plan Annually April 15 (current year plus 5 years) Reports of actual results compared to budget will be made by the JCC or JDC, Parties to the Joint Project Team on a quarterly basis. After approval by the Joint Project Team as applicableto amounts, the Finance Working Group Joint Project Team will prepareforward the report to the JSC for its approval. Variances from the total overall budgets, and significant variances in budget line items for sales DENDREON/GNE Development Costs and other costs or Development revenue line items, will be included in the calculation of Shared Products Operating Profits and Companion Diagnostics, a Losses only when approved by the JSC. Genentech will be responsible for the preparation of consolidated reporting of the activities undertaken by the Parties hereunder Collaboration (including DENDREON/GNE Development Costs and any Operating Profits Profit or LossesLoss), the calculation of the Profit & Loss Share, sharing and initial determination of the cash settlement as between the Parties. Unless otherwise directed (subject to approval by the JCC or JDCJSC). Within forty-five (45) days of each quarter end, as applicable, the Finance Working Group Genentech will provide the Parties within [***] days after the end of financial representatives from each Calendar Quarter, Party with a detailed statement showing the consolidated results and calculations of the Operating Profit & or Loss Share sharing (or calculation of expenses to be shared) and cash settlement required in a format agreed to by the Parties (each, a “Report”)substantially as depicted above. Each Party will cooperate as appropriate and provide the other Party with financial statements, within [***] days after the end of each Calendar Quarter, with respect to Shared Products and Companion Diagnostics (if any), prepared in accordance with the terms contained Genentech shall record sales in the financial planning, accounting and reporting procedures set forth in this Exhibit D in order for each Party to prepare the consolidated reports, including in reasonable detail the following costs and expenses incurred by each Party (if any) in such Calendar Quarter: (i) Cost of Goods Sold, (ii) Marketing Costs, (iii) Sales Costs, (iv) Distribution Costs, (v) Development Costs, (vi) Manufacturing Costs and (vii) Other Operating Income/Expense. (c) United States. On a quarterly monthly basis, each applicable Lead Party Genentech will supply the JCC or JDC, as applicable, Dendreon with each month's Gross Sales and the other Party with an estimate of Annual Net Sales (for the applicable portion of the Territory for which such Party is the Lead Party) for such Calendar Quarter of Shared Licensed Products and, as applicable, Companion Diagnostics, in units, local currency units and U.S. dollars (using in the conversion method set forth in this Agreement) according to such Lead Party’s sales reporting system, which will be consistent with the financial planning, accounting and reporting procedures set forth in this Exhibit D. Each Party shall also provide to the other Party (and the JCC or JDC, as applicable, if then in existence) information regarding the gross sales and gross-to-net sales for all Shared Products and Companion Diagnostics for such Calendar QuarterUnited States. Each such report will shall be provided as early as possible, but no later than [***] ten (10) days after the last day of the Calendar Quarter month in question, and will separately shall provide quarterly monthly and year-to-date cumulative figures. Each applicable Lead Party The financial representatives from the Parties will provide meet as appropriate but at least quarterly to review and approve the following: - DENDREON/GNE Development Costs - Costs of Sales and other costs - actual results - forecasts - budgets - inventory levels - Sales Returns and Allowances - other financial matters, including each Party's methodologies for charging costs to the other Party (Collaboration, for determination of actuals, forecasts, budgets and long range plans and the JCC or JDC, as applicable, if then in existence), together with the next Calendar Quarter estimate under this Section 2(c), an updated report for the immediately preceding Calendar Quarter providing a reconciliation results of the estimated amounts for applying such preceding Calendar Quarter against the actual Annual Net Sales during such Calendar Quarter of all such Shared Products and Companion Diagnostics within [***] days after the last day of such Calendar Quartermethodologies.

Appears in 1 contract

Sources: Collaborative Development and Marketing Agreement (Dendreon Corp)