Common use of Development Costs Clause in Contracts

Development Costs. With respect to the Licensed Product, during the Initial Development Period, NVS will be responsible for one hundred percent (100%) of all Development Costs set forth in the JSC approved Development Plan. During the Initial Development Period commencing upon the first Calendar Quarter immediately following JSC approval of the Development Plan for the Licensed Product and continuing thereafter so long as Pliant incurs Development Costs under this Agreement, Pliant will, within [***] Business Days of such Calendar Quarter submit to NVS a report setting forth the Development Costs it incurred in such Calendar Quarter with respect to Licensed Products as approved by the JSC. Each such report will specify in reasonable detail all such costs, and, if requested by NVS, any such invoices or other supporting documentation for any Out-of-Pocket Costs paid or payable to a Third Party or with respect to which documentation is otherwise reasonably requested will be promptly provided, and in the case of the report provided for the fourth Calendar Quarter of a given Calendar Year, shall additionally include an assessment of actual aggregate costs incurred for the preceding four (4) Calendar Quarters compared with the JSC approved Development Budget for the same Calendar Year. NVS will reimburse the Development Costs incurred by Pliant as detailed in such report within [***] days of receipt of Pliant's invoice for such amount, which invoice will be delivered by Pliant to NVS no sooner than [***] days following NVS' receipt of the report from Pliant; provided, however, that in the event of any disagreement with respect to the calculation of such reimbursable Development Costs, any undisputed portion of such reimbursement payment will be paid in accordance with the foregoing timetable and the remaining, disputed portion will be paid within [***] Business Days after the date on which the Parties, using good faith efforts, resolve the dispute. Notwithstanding the foregoing, during the Initial Development Period, NVS will not be obligated to reimburse Pliant for any Development Costs for Licensed Products in excess of [***] dollars ($[***]) (the "Development Reimbursement Cap"). Following the Initial Development Period, NVS will be solely responsible for, at its sole cost and expense, Developing the Licensed Product.

Development Costs. With respect (a) Within one hundred eighty (180) days following the Closing Date, Seller shall prepare and furnish to Purchaser a calculation of the aggregate Development Costs for the Future Restaurant with supporting documentation in reasonable detail. If, within fifteen (15) days after receipt of Seller’s calculation, Purchaser does not notify Seller as set forth in the following sentence, such calculation shall be final and binding on the Parties. During such period, Seller shall provide Purchaser with all information reasonably necessary and available to Seller relating to the Licensed Productcomputation of the Development Costs and Seller will make reasonably available the employees of Seller responsible for and knowledgeable about the information used in, during and the Initial preparation of, such computation of the Development PeriodCosts. If, NVS within fifteen (15) days after receipt of Seller’s calculation, Purchaser notifies Seller in writing that Purchaser objects to one or more items reflected in Seller’s calculation, Purchaser and Seller shall seek in good faith to resolve such objections and to reach agreement in writing on the calculation. If any such objections are not so resolved (the “Unresolved Objections”) within thirty (30) days after Seller’s receipt of Purchaser’s notice of objection, either Seller or Purchaser may submit the Unresolved Objections to an independent accounting firm mutually agreed upon by Seller and Purchaser (the “Accounting Firm”) for resolution, which resolution will be responsible for final and binding on the Parties. The scope of the review by the Accounting Firm shall be limited to a determination of the Unresolved Objections and a determination as to what, if any, adjustments are required to be made to the calculation based upon the determination of such Unresolved Objections. The Accounting Firm is not to make or be asked to make any determination other than as set forth in the previous sentence. Purchaser and Seller shall use commercially reasonable efforts to cause the Accounting Firm to render its written decision resolving the matters submitted to it as promptly as practicable and, if at all possible, within thirty (30) days after such submission of the Unresolved Objections. The fees and expenses of the Accounting Firm incurred pursuant to this Section 3.04(a) shall be borne by Purchaser, on the one hundred percent hand, and Seller, on the other hand, in proportion to those matters submitted to the Accounting Firm that are resolved against that Party, as such fees and expenses are allocated by the Accounting Firm pursuant to the foregoing. (100%b) Within five (5) days following the determination of all the final calculation of the Development Costs pursuant to Section 3.04(a) (whether by failure of Purchaser to object within the applicable 15-day period, by mutual agreement of the Parties or by determination of the Accounting Firm, as applicable), if (i) the aggregated Development Costs reflected in such final calculation exceed the aggregate amount of the estimated Development Costs set forth in Section 2.05(a)(ii), then Purchaser shall pay an amount equal to such excess to Seller or (ii) the JSC approved aggregated Development Plan. During Costs reflected in such final calculation are less than the Initial Development Period commencing upon the first Calendar Quarter immediately following JSC approval aggregate amount of the Development Plan for the Licensed Product and continuing thereafter so long as Pliant incurs estimated Development Costs under this Agreementset forth in Section 2.05(a)(ii), Pliant will, within [***] Business Days of then Seller shall pay an amount equal to such Calendar Quarter submit shortfall to NVS a report setting forth the Development Costs it incurred in such Calendar Quarter with respect to Licensed Products as approved by the JSC. Each such report will specify in reasonable detail all such costs, and, if requested by NVS, any such invoices or other supporting documentation for any Out-of-Pocket Costs paid or payable to a Third Party or with respect to which documentation is otherwise reasonably requested will be promptly provided, and in the case of the report provided for the fourth Calendar Quarter of a given Calendar Year, shall additionally include an assessment of actual aggregate costs incurred for the preceding four (4) Calendar Quarters compared with the JSC approved Development Budget for the same Calendar Year. NVS will reimburse the Development Costs incurred by Pliant as detailed in such report within [***] days of receipt of Pliant's invoice for such amount, which invoice will be delivered by Pliant to NVS no sooner than [***] days following NVS' receipt of the report from Pliant; provided, however, that in the event of any disagreement with respect to the calculation of such reimbursable Development Costs, any undisputed portion of such reimbursement payment will be paid in accordance with the foregoing timetable and the remaining, disputed portion will be paid within [***] Business Days after the date on which the Parties, using good faith efforts, resolve the dispute. Notwithstanding the foregoing, during the Initial Development Period, NVS will not be obligated to reimburse Pliant for any Development Costs for Licensed Products in excess of [***] dollars ($[***]) (the "Development Reimbursement Cap"). Following the Initial Development Period, NVS will be solely responsible for, at its sole cost and expense, Developing the Licensed ProductPurchaser.

Development Costs. With respect (a) Within nine (9) months following the date on which a New Site opens, Seller shall prepare and furnish to Purchaser a calculation of the aggregate Development Costs for such New Site with supporting documentation in reasonable detail (“Final New Site Development Costs”). Within nine (9) months following the date on which the Future Restaurant opens, Seller shall prepare and furnish to Purchaser a calculation of the aggregate Development Costs for the Future Restaurant with supporting documentation in reasonable detail (“Final Future Restaurant Development Costs”). If, DB02/0502991.0000/9783465.8 WP01 within fifteen (15) days after receipt of Seller’s calculation, Purchaser does not notify Seller as set forth in the following sentence, such calculation shall be final and binding on the Parties. During such period, Seller shall provide Purchaser with all information reasonably necessary and available to Seller relating to the Licensed Productcomputation of the Final New Site Development Costs and Final Future Restaurant Development Costs, during as applicable, and Seller will make reasonably available the Initial employees of Seller responsible for and knowledgeable about the information used in, and the preparation of, such computation of the Final New Site Development PeriodCosts and Final Future Restaurant Development Costs, NVS as applicable. If, within fifteen (15) days after receipt of Seller’s calculation, Purchaser notifies Seller in writing that Purchaser objects to one or more items reflected in Seller’s calculation, Purchaser and Seller shall seek in good faith to resolve such objections and to reach agreement in writing on the calculation. If any such objections are not so resolved (the “Unresolved Objections”) within thirty (30) days after Seller’s receipt of Purchaser’s notice of objection, either Seller or Purchaser may submit the Unresolved Objections to an independent accounting firm mutually agreed upon by Seller and Purchaser (the “Accounting Firm”) for resolution, which resolution will be responsible for final and binding on the Parties. The scope of the review by the Accounting Firm shall be limited to a determination of the Unresolved Objections and a determination as to what, if any, adjustments are required to be made to the calculation based upon the determination of such Unresolved Objections. The Accounting Firm is not to make or be asked to make any determination other than as set forth in the previous sentence. Purchaser and Seller shall use commercially reasonable efforts to cause the Accounting Firm to render its written decision resolving the matters submitted to it as promptly as practicable and, if at all possible, within thirty (30) days after such submission of the Unresolved Objections. The fees and expenses of the Accounting Firm incurred pursuant to this Section 3.04(a) shall be borne by Purchaser, on the one hundred percent hand, and Seller, on the other hand, in proportion to those matters submitted to the Accounting Firm that are resolved against that Party, as such fees and expenses are allocated by the Accounting Firm pursuant to the foregoing. (100%b) Within five (5) days following the determination of all the final calculation of the Final New Site Development Costs pursuant to Section 3.04(a) (whether by failure of Purchaser to object within the applicable 15-day period, by mutual agreement of the Parties or by determination of the Accounting Firm, as applicable), if (i) the aggregated Final New Site Development Costs reflected in such final calculation exceed the aggregate amount of the Estimated New Site Development Costs set forth in Section 2.05(a)(iii), then Purchaser shall pay an amount equal to such excess to Seller or (ii) the JSC approved aggregated Final New Site Development Plan. During Costs reflected in such final calculation are less than the Initial Development Period commencing upon the first Calendar Quarter immediately following JSC approval aggregate amount of the Development Plan for the Licensed Product and continuing thereafter so long as Pliant incurs Estimated New Site Development Costs under this Agreementset forth in Section 2.05(a)(iii), Pliant willthen Seller shall pay an amount equal to such shortfall to Purchaser, within [***] Business Days subject in each case to adjustment as provided in Section 2.05(e). (c) Within five (5) days following the determination of such Calendar Quarter submit to NVS a report setting forth the final calculation of the Final Future Restaurant Development Costs it incurred pursuant to Section 3.04(a) (whether by failure of Purchaser to object within the applicable 15-day period, by mutual agreement of the Parties or by determination of the Accounting Firm, as applicable), if (i) the aggregated Final Future Restaurant Development Costs reflected in such Calendar Quarter with respect to Licensed Products as approved by final calculation exceed the JSC. Each such report will specify in reasonable detail all such costs, and, if requested by NVS, any such invoices or other supporting documentation for any Out-of-Pocket Costs paid or payable to a Third Party or with respect to which documentation is otherwise reasonably requested will be promptly provided, and in the case aggregate amount of the report provided for the fourth Calendar Quarter of a given Calendar Year, shall additionally include an assessment of actual aggregate costs incurred for the preceding four (4) Calendar Quarters compared with the JSC approved Development Budget for the same Calendar Year. NVS will reimburse the Estimated Future Restaurant Development Costs incurred by Pliant as detailed set forth in Section 2.05(a)(iv), then Purchaser shall pay an amount equal to such excess to Seller or (ii) the aggregated Final Future Restaurant DB02/0502991.0000/9783465.8 WP01 Development Costs reflected in such report within [***] days of receipt of Pliant's invoice for such amount, which invoice will be delivered by Pliant to NVS no sooner final calculation are less than [***] days following NVS' receipt the aggregate amount of the report from Pliant; provided, however, that in the event of any disagreement with respect to the calculation of such reimbursable Development Costs, any undisputed portion of such reimbursement payment will be paid in accordance with the foregoing timetable and the remaining, disputed portion will be paid within [***] Business Days after the date on which the Parties, using good faith efforts, resolve the dispute. Notwithstanding the foregoing, during the Initial Development Period, NVS will not be obligated to reimburse Pliant for any Estimated Final Future Restaurant Development Costs for Licensed Products set forth in excess of [***] dollars ($[***]) (the "Development Reimbursement Cap"Section 2.05(a)(iv). Following the Initial Development Period, NVS will be solely responsible forthen Seller shall pay an amount equal to such shortfall to Purchaser, at its sole cost and expense, Developing the Licensed Productsubject in each case to adjustment as provided in Section 2.05(e).

Development Costs. With GNE shall be responsible for, and shall reimburse SGEN on a [***] basis for, all costs and expenses actually incurred by or on behalf of SGEN in connection with SGEN’s performance of its Development responsibilities specified in the Development Plan and agreed to by SGEN pursuant to Section 4.1(b). In particular, GNE shall reimburse SGEN for such costs and expenses as follows: (a) [***]; and (b) [***]. For clarity, Development activities are exclusive of any Other SGEN Research activities and [***], at which time GNE shall reimburse SGEN for all costs and expenses actually incurred by or on behalf of SGEN since the Execution Date in connection with SGEN’s performance of such [***]. In determining [***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the Licensed Product, during the Initial Development Period, NVS will be responsible for one hundred percent (100%) of all omitted portions. Development Costs set forth in the JSC approved Development Plan. During the Initial Development Period commencing upon the first Calendar Quarter immediately following JSC approval of the Development Plan for the Licensed Product and continuing thereafter so long as Pliant incurs Development Costs chargeable under this Agreement, Pliant willSGEN will use its project accounting systems, as consistently applied across all its projects. Within [***] after the beginning of [***], SGEN shall provide to GNE a report detailing all Development Costs incurred during such prior [***], including the number of FTEs dedicated to Development activities during that calendar quarter accompanied by the associated cost of such FTEs at the SGEN FTE Rate. Such report shall be accompanied by a [***]. Such report will provide information on out-of-pocket expenses incurred during the [***] at a sufficient level of detail to enable GNE to evaluate the reasonableness of such expenses. Such report will be accompanied by an itemized invoice for the Development Costs incurred during the [***]. GNE shall pay SGEN for such Development Costs incurred within [***] Business Days of such Calendar Quarter submit to NVS a report setting forth the Development Costs it incurred in such Calendar Quarter with respect to Licensed Products as approved by the JSC. Each such report will specify in reasonable detail all such costs, and, if requested by NVS, any such invoices or other supporting documentation for any Out-of-Pocket Costs paid or payable to a Third Party or with respect to which documentation is otherwise reasonably requested will be promptly provided, and in the case of the report provided for the fourth Calendar Quarter of a given Calendar Year, shall additionally include an assessment of actual aggregate costs incurred for the preceding four (4) Calendar Quarters compared with the JSC approved Development Budget for the same Calendar Year. NVS will reimburse the Development Costs incurred by Pliant as detailed in such report within [***] days of receipt of Pliant's invoice a true and correct invoice. As between the Parties, GNE shall be responsible for such amountall costs and expenses incurred by or on behalf of GNE, which invoice will its Affiliates, or its Sublicensees in connection with Development of Licensed Products. All Development Costs shall be delivered by Pliant to NVS no sooner than [***] days following NVS' receipt of the report from Pliant; provided, however, that in the event of any disagreement with respect to the calculation of such reimbursable Development Costs, any undisputed portion of such reimbursement payment will be paid recorded in accordance with the foregoing timetable and the remaining, disputed portion will be paid within [***] Business Days after the date on which the Parties, using good faith efforts, resolve the dispute. Notwithstanding the foregoing, during the Initial Development Period, NVS will not be obligated to reimburse Pliant for any Development Costs for Licensed Products in excess of [***] dollars ($[***]) (the "Development Reimbursement Cap"). Following the Initial Development Period, NVS will be solely responsible for, at its sole cost and expense, Developing the Licensed ProductGAAP.

Development Costs. With respect (a) Subject to Sections 2.1 (c) and (d), Clinical Plan Development Costs incurred by the Parties in relation to the Licensed ProductClinical Development Plan attached as at the Effective Date to this Agreement as Exhibit C, during [***]. For the Initial avoidance of doubt, if the Clinical Development PeriodPlan is amended to include any further studies or activities, NVS will the costs for such further studies and activities shall, subject to Section 2.1(c) and (d), be responsible borne by the Parties as may be agreed at the time of amendment to the Clinical Development Plan. (b) All costs, including Other Development Costs incurred by ASTELLAS following the Effective Date in relation to the Development of the Product solely for one hundred percent the Territory shall be borne by ASTELLAS. (100%c) All costs including Other Development Costs incurred by BASILEA following the Effective Date in relation to the Development of the Product solely for the Retained Territory shall be borne by BASILEA. (d) [***] of the costs including Other Development Costs for activities and studies agreed by the Parties under Section 2.1(d) shall be borne by [***], and [***] of such costs shall be borne by [***]. (e) The Party requesting reimbursement of Development Costs shall keep records of all of its Development Costs set forth and make them available for inspection by the other Party in accordance with Article 9. (f) Within [***] after the JSC approved Development Plan. During the Initial Development Period commencing upon the first end of each Calendar Quarter immediately following JSC approval the Party requesting reimbursement of its Development Costs shall provide the other with records of all of its Development Costs and the Party requesting reimbursement shall calculate any amount due to it from the other in respect of the Development Plan for Costs incurred in the Licensed Product and continuing thereafter so long as Pliant incurs preceding Calendar Quarter. The Party requesting reimbursement of its Development Costs under this Agreement, Pliant will, shall submit an invoice to the other Party within [***] Business Days of such Calendar Quarter submit after the date it provides its records to NVS a report setting forth the other Party relating to the Development Costs it incurred in is seeking to have reimbursed and the other Party shall pay such Calendar Quarter with respect to Licensed Products as approved by the JSC. Each such report will specify in reasonable detail all such costs, and, if requested by NVS, any such invoices or other supporting documentation for any Out-of-Pocket Costs paid or payable to a Third Party or with respect to which documentation is otherwise reasonably requested will be promptly provided, and in the case of the report provided for the fourth Calendar Quarter of a given Calendar Year, shall additionally include an assessment of actual aggregate costs incurred for the preceding four (4) Calendar Quarters compared with the JSC approved Development Budget for the same Calendar Year. NVS will reimburse the Development Costs incurred by Pliant as detailed in such report invoice within [***] days of receipt of Pliant's invoice for such amount, which invoice will be delivered by Pliant to NVS no sooner than [***] days following NVS' receipt of the report from Pliant; provided, however, that after its date in the event of any disagreement with respect CHF to the calculation bank account specified by the receiving Party. Any disagreement as to the amount of such reimbursable Development Costs, any undisputed portion of such reimbursement payment will Costs shall be paid resolved in accordance with the foregoing timetable and the remaining, disputed portion will be paid within [***] Business Days after the date on which the Parties, using good faith efforts, resolve the dispute. Notwithstanding the foregoing, during the Initial Development Period, NVS will not be obligated to reimburse Pliant for any Development Costs for Licensed Products in excess of [***] dollars ($[***]) (the "Development Reimbursement Cap"). Following the Initial Development Period, NVS will be solely responsible for, at its sole cost and expense, Developing the Licensed ProductArticle 9.

Development Costs. During the Term, Schering shall be responsible for all costs and expenses related to the Development of Licensed Product under this Agreement in the Field in the Territory that are incurred following the Effective Date (“Development Costs”). With respect to the Licensed Product, during the Initial Development Period, NVS will be responsible for one hundred percent (100%) of all Development Costs set forth in the JSC approved Development Plan. During the Initial Development Period commencing upon the first Calendar Quarter immediately following JSC approval of the Development Plan for the Licensed Product and continuing thereafter so long as Pliant incurs Development Costs under this Agreement, Pliant will, within [***] Business Days of such Calendar Quarter submit to NVS a report setting forth the Development Costs it incurred in such Calendar Quarter with respect to Licensed Products as approved by the JSC. Each such report will specify in reasonable detail all such costs, and, if requested by NVS, any such invoices or other supporting documentation for any Out-of-Pocket Costs paid or payable to a Third Party or with respect to which documentation is otherwise reasonably requested will be promptly provided, and in the case of the report provided for the fourth Calendar Quarter of a given Calendar Year, shall additionally include an assessment of actual aggregate costs incurred for the preceding four (4) Calendar Quarters compared with the JSC approved Development Budget for the same Calendar Year. NVS will reimburse the those Development Costs incurred by Pliant as detailed Novacea after the Effective Date, Schering’s obligations under this Section 5.3 shall be limited to those reasonable documented direct costs and expenses incurred by Novacea following the Effective Date in such report within connection with the conduct [***] days = 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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. Page 20 of receipt Development activities provided for in the Development Plans, including (i) the forward funding of Pliant's invoice Novacea’s ongoing clinical studies pursuant to the Core Development Plan and (ii) compensating Novacea at the FTE Rate for such amountthose FTEs that are engaged in the execution of Development Plans, which invoice will be delivered by Pliant to NVS no sooner than [***] days following NVS' receipt of the report from Pliant; provided, however, that such Novacea costs and expenses must not exceed the amounts attributed to such activities in the event budget set forth in the Development Plan by more than [*] percent without Schering’s prior written consent. Novacea shall be responsible for providing, once every calendar quarter, an estimate of the Development Costs it expects to incur for the next [*]. To the extent that Novacea anticipates any disagreement with respect variance [*] percent or more from the amount attributed to a budgeted line item activity exceeding [*] (as identified in a Development Plan) or to the calculation activities as a whole, Novacea shall promptly inform Schering and may not incur such additional costs without Schering’s prior written consent. For the avoidance of such reimbursable Development Costsdoubt, any undisputed portion of such reimbursement payment will be paid in accordance with the foregoing timetable and the remaining, disputed portion will be paid within [***] Business Days after the date on which the Parties, using good faith efforts, resolve the dispute. Notwithstanding the foregoing, during the Initial Development Period, NVS will not be obligated to reimburse Pliant for any Development Costs for Licensed Products in excess of [***] dollars ($[***]) (the "Development Reimbursement Cap"). Following the Initial Development Period, NVS will be Novacea shall remain solely responsible for, at its sole cost for all costs and expense, Developing expenses accrued or incurred in the Development of Licensed ProductProduct in the Territory prior to the Effective Date.

Development Costs. With respect (a) CTI shall be solely responsible for all costs associated with the Development of the Product prior to the Licensed Novartis Development Commencement Date. After the Novartis Development Commencement Date, (i) Novartis shall be solely responsible for all costs associated with its Development of the Product, during the Initial Development Periodexcept as set forth in Section 5.3(b), NVS will and (ii) Novartis shall be responsible for one hundred the reimbursement of CTI and it Affiliates pursuant to Section 5.3(c). (b) Notwithstanding anything contained in this Agreement to the contrary, following the Novartis Development Commencement Date, Licensor shall reimburse Novartis for twenty percent (10020%) of all Development Costs incurred by Novartis or its Affiliates anywhere in the Territory relating to any clinical study sponsored by Novartis or its Affiliates or investigator sponsored study funded by Novartis or its Affiliates, which study, in either case, is intended (or is subsequently used) to support expanded labeling for such Product, or to satisfy requirements imposed by Regulatory Authorities in connection with Regulatory Approvals for such Product (including, by way of example, to support conditional approvals). Such reimbursement shall be made quarterly in arrears, payable in accordance with Section 9.1(c); provided, that if Licensor fails to reimburse Novartis for any such Development Costs, Novartis shall have the right to offset the amount thereof, in whole or in part, against any Milestone Payments or royalties due to Licensor hereunder and such failure to so reimburse shall not be considered a breach hereof. After the Novartis Development Commencement Date, CTI shall not fund or otherwise support any investigator sponsored study with respect to the Product without the prior written consent of Novartis. (c) Following the Novartis Development Commencement Date, Novartis shall reimburse Licensor solely for (i) fifty percent (50%) of all Development Costs incurred by Licensor or its Affiliates after the Novartis Development Commencement Date in connection with clinical trials for the Product in the Territory that were commenced by Licensor prior to the Novartis Development Commencement Date and which Novartis elects to continue pursuant to Section 5.2(d), provided that such reimbursement obligation shall in no event exceed fifty percent (50%) of the budget for any such trial for the applicable period as set forth in the JSC approved Development Plan. During Budget in effect immediately prior to Novartis’ exercise of its Development Rights; (ii) fifty percent (50%) of all Development Costs incurred by Licensor or its Affiliates after the Initial Novartis Development Period commencing upon Commencement Date directly in connection with the first Calendar Quarter immediately following JSC approval winding down and termination of the Development Plan clinical trials for the Licensed Product in the Territory that were commenced by Licensor prior to the Novartis Development Commencement Date and continuing thereafter so long as Pliant incurs Development Costs under this Agreement, Pliant will, within [***] Business Days of such Calendar Quarter submit which Novartis elects not to NVS a report setting forth the Development Costs it incurred in such Calendar Quarter with respect continue pursuant to Licensed Products as approved by the JSC. Each such report will specify in reasonable detail all such costs, and, if requested by NVS, any such invoices or other supporting documentation for any Section 5.2(d); and (iii) Out-of-Pocket Costs incurred after the Novartis Development Commencement Date and paid to Third Parties by Licensor or payable its Affiliates in connection with manufacturing scale-up for the Product, such Out-of-Pocket Costs not to a Third Party or with respect to which documentation is otherwise reasonably requested will be promptly provided, and exceed the amount budgeted therefor in the case of the report provided for the fourth Calendar Quarter of a given Calendar Year, shall additionally include an assessment of actual Development Budget. The aggregate costs incurred for the preceding four (4) Calendar Quarters compared with the JSC approved Development Budget for the same Calendar Year. NVS will reimburse the Development Costs incurred by Pliant as detailed in such report within [***] days of receipt of Pliant's invoice for such amount, which invoice will be delivered by Pliant to NVS no sooner than [***] days following NVS' receipt of the report from Pliant; provided, however, that in the event of any disagreement with respect to the calculation amount of such reimbursable Development Costsreimbursements shall be made quarterly in arrears, any undisputed portion of such reimbursement payment will be paid payable in accordance with the foregoing timetable and the remaining, disputed portion will be paid within [***] Business Days after the date on which the Parties, using good faith efforts, resolve the dispute. Notwithstanding the foregoing, during the Initial Development Period, NVS will not be obligated to reimburse Pliant for any Development Costs for Licensed Products in excess of [***] dollars ($[***]) (the "Development Reimbursement Cap"Section 9.1(c). Following the Initial Development Period, NVS will be solely responsible for, at its sole cost and expense, Developing the Licensed Product.

Development Costs. During the Term, Schering shall be responsible for all costs and expenses related to the Development of Licensed Product under this Agreement in the Field in the Territory that are incurred following the Effective Date (“Development Costs”). With respect to the Licensed Product, during the Initial Development Period, NVS will be responsible for one hundred percent (100%) of all Development Costs set forth in the JSC approved Development Plan. During the Initial Development Period commencing upon the first Calendar Quarter immediately following JSC approval of the Development Plan for the Licensed Product and continuing thereafter so long as Pliant incurs Development Costs under this Agreement, Pliant will, within [***] Business Days of such Calendar Quarter submit to NVS a report setting forth the Development Costs it incurred in such Calendar Quarter with respect to Licensed Products as approved by the JSC. Each such report will specify in reasonable detail all such costs, and, if requested by NVS, any such invoices or other supporting documentation for any Out-of-Pocket Costs paid or payable to a Third Party or with respect to which documentation is otherwise reasonably requested will be promptly provided, and in the case of the report provided for the fourth Calendar Quarter of a given Calendar Year, shall additionally include an assessment of actual aggregate costs incurred for the preceding four (4) Calendar Quarters compared with the JSC approved Development Budget for the same Calendar Year. NVS will reimburse the those Development Costs incurred by Pliant as detailed Novacea after the Effective Date, Schering’s obligations under this Section 5.3 shall be limited to those reasonable documented direct costs and expenses incurred by Novacea following the Effective Date in such report within connection with the conduct [***] days = 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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. of receipt Development activities provided for in the Development Plans, including (i) the forward funding of Pliant's invoice Novacea’s ongoing clinical studies pursuant to the Core Development Plan and (ii) compensating Novacea at the FTE Rate for such amountthose FTEs that are engaged in the execution of Development Plans, which invoice will be delivered by Pliant to NVS no sooner than [***] days following NVS' receipt of the report from Pliant; provided, however, that such Novacea costs and expenses must not exceed the amounts attributed to such activities in the event budget set forth in the Development Plan by more than [*] percent without Schering’s prior written consent. Novacea shall be responsible for providing, once every calendar quarter, an estimate of the Development Costs it expects to incur for the next [*]. To the extent that Novacea anticipates any disagreement with respect variance [*] percent or more from the amount attributed to a budgeted line item activity exceeding [*] (as identified in a Development Plan) or to the calculation activities as a whole, Novacea shall promptly inform Schering and may not incur such additional costs without Schering’s prior written consent. For the avoidance of such reimbursable Development Costsdoubt, any undisputed portion of such reimbursement payment will be paid in accordance with the foregoing timetable and the remaining, disputed portion will be paid within [***] Business Days after the date on which the Parties, using good faith efforts, resolve the dispute. Notwithstanding the foregoing, during the Initial Development Period, NVS will not be obligated to reimburse Pliant for any Development Costs for Licensed Products in excess of [***] dollars ($[***]) (the "Development Reimbursement Cap"). Following the Initial Development Period, NVS will be Novacea shall remain solely responsible for, at its sole cost for all costs and expense, Developing expenses accrued or incurred in the Development of Licensed ProductProduct in the Territory prior to the Effective Date.

Development Costs. With respect (a) Within one hundred eighty (180) days following the Closing Date or, if later, the last Subsequent Closing, Seller shall prepare and furnish to Purchaser a calculation of the aggregate Development Costs for each of the Future Restaurants with supporting documentation in reasonable detail. If, within fifteen (15) days after receipt of Seller’s calculation, Purchaser does not notify Seller as set forth in the following sentence, such calculation shall be final and binding on the Parties. During such period, Seller shall provide Purchaser with all information reasonably necessary and available to Seller relating to the Licensed Productcomputation of the Development Costs and Seller will make reasonably available the employees of Seller responsible for and knowledgeable about the information used in, during and the Initial preparation of, such computation of the Development PeriodCosts. If, NVS within fifteen (15) days after receipt of Seller’s calculation, Purchaser notifies Seller in writing that Purchaser objects to one or more items reflected in Seller’s calculation, Purchaser and Seller shall seek in good faith to resolve such objections and to reach agreement in writing on the calculation. If any such objections are not so resolved (the “Unresolved Objections”) within thirty (30) days after Seller’s receipt of Purchaser’s notice of objection, either Seller or Purchaser may submit the Unresolved Objections to an independent accounting firm mutually agreed upon by Seller and Purchaser (the “Accounting Firm”) for resolution, which resolution will be responsible for final and binding on the Parties. The scope of the review by the Accounting Firm shall be limited to a determination of the Unresolved Objections and a determination as to what, if any, adjustments are required to be made to the calculation based upon the determination of such Unresolved Objections. The Accounting Firm is not to make or be asked to make any determination other than as set forth in the previous sentence. Purchaser and Seller shall use commercially reasonable efforts to cause the Accounting Firm to render its written decision resolving the matters submitted to it as promptly as practicable and, if at all possible, within thirty (30) days after such submission of the Unresolved Objections. The fees and expenses of the Accounting Firm incurred pursuant to this Section 3.04(a) shall be borne by Purchaser, on the one hundred percent hand, and Seller, on the other hand, in proportion to those matters submitted to the Accounting Firm that are resolved against that Party, as such fees and expenses are allocated by the Accounting Firm pursuant to the foregoing. (100%b) Within five (5) days following the determination of all the final calculation of the Development Costs pursuant to Section 3.04(a) (whether by failure of Purchaser to object within the applicable 15-day period, by mutual agreement of the Parties or by determination of the Accounting Firm, as applicable), if (i) the aggregated Development Costs reflected in such final calculation exceed the aggregate amount of the estimated Development Costs set forth in Section 2.05(a)(v)(A) and Section 2.05(a)(v)(B), then Purchaser shall pay an amount equal to such excess to Seller or (ii) the JSC approved aggregated Development Plan. During Costs reflected in such final calculation are less than the Initial Development Period commencing upon the first Calendar Quarter immediately following JSC approval aggregate amount of the Development Plan for the Licensed Product and continuing thereafter so long as Pliant incurs estimated Development Costs under this Agreementset forth in Section 2.05(a)(v)(A) and Section 2.05(a)(v)(B), Pliant will, within [***] Business Days of then Seller shall pay an amount equal to such Calendar Quarter submit shortfall to NVS a report setting forth the Development Costs it incurred in such Calendar Quarter with respect to Licensed Products as approved by the JSC. Each such report will specify in reasonable detail all such costs, and, if requested by NVS, any such invoices or other supporting documentation for any Out-of-Pocket Costs paid or payable to a Third Party or with respect to which documentation is otherwise reasonably requested will be promptly provided, and in the case of the report provided for the fourth Calendar Quarter of a given Calendar Year, shall additionally include an assessment of actual aggregate costs incurred for the preceding four (4) Calendar Quarters compared with the JSC approved Development Budget for the same Calendar Year. NVS will reimburse the Development Costs incurred by Pliant as detailed in such report within [***] days of receipt of Pliant's invoice for such amount, which invoice will be delivered by Pliant to NVS no sooner than [***] days following NVS' receipt of the report from Pliant; provided, however, that in the event of any disagreement with respect to the calculation of such reimbursable Development Costs, any undisputed portion of such reimbursement payment will be paid in accordance with the foregoing timetable and the remaining, disputed portion will be paid within [***] Business Days after the date on which the Parties, using good faith efforts, resolve the dispute. Notwithstanding the foregoing, during the Initial Development Period, NVS will not be obligated to reimburse Pliant for any Development Costs for Licensed Products in excess of [***] dollars ($[***]) (the "Development Reimbursement Cap"). Following the Initial Development Period, NVS will be solely responsible for, at its sole cost and expense, Developing the Licensed ProductPurchaser.

Development Costs. With respect a) Intuitive shall be solely responsible for all costs and expenses incurred in conducting the development work related to the Licensed Product8mm Stapler (including for any such work performed by Cardica, at Intuitive’s request). b) With regard to costs and expenses incurred in conducting the development work related to the 8mm Reload (“Reload Development Costs”), Intuitive shall contribute [*] of the Reload Development Costs during the Initial first two and one half years after the Effective Date (the “Joint Development Period”), up to a maximum amount not to exceed [*] per year and [*] in total (collectively, the “Cap”). Within thirty (30) days after the end of each quarter in the Joint Development Period, NVS will be responsible for one hundred percent (100%) of all Development Costs set forth in each party shall provide the JSC approved Development Plan. During the Initial Development Period commencing upon the first Calendar Quarter immediately following JSC approval of the Development Plan for the Licensed Product and continuing thereafter so long as Pliant incurs Development Costs under this Agreement, Pliant will, within [***] Business Days of such Calendar Quarter submit to NVS a report other with documentation setting forth the Development Costs it incurred in such Calendar Quarter with respect to Licensed Products as approved by the JSC. Each such report will specify in reasonable detail all such costs, and, if requested by NVS, any such invoices or other supporting documentation for any Out-of-Pocket Costs paid or payable to a Third Party or with respect to which documentation is otherwise reasonably requested will be promptly provided, and in the case of the report provided for the fourth Calendar Quarter of a given Calendar Year, shall additionally include an assessment of actual aggregate costs incurred for the preceding four (4) Calendar Quarters compared with the JSC approved Development Budget for the same Calendar Year. NVS will reimburse the Reload Development Costs incurred by Pliant as detailed in such report within [***] days of receipt of Pliant's invoice for such amount, which invoice them during the preceding quarter. Intuitive will be delivered by Pliant to NVS no sooner than [***] days following NVS' receipt then calculate each Party’s respective share of the report from Pliant; providedReload Development Costs and, however, that in the event Cardica incurred more costs than its [*] share, Intuitive shall pay to Cardica the balance due, subject to the Cap, for that quarter within thirty (30) days after the receipt of documentation from Cardica setting forth its Reload Development Costs. In the event that Intuitive incurred more Reload Development Costs than its [*] share in a given quarter, then any disagreement amount incurred by Intuitive over and above its share shall be applied as credit to subsequent quarters. For avoidance of doubt, Intuitive shall not be credited for any Reload Development Costs for Reload Development Work that Cardica has not authorized. In the event of a dispute between the parties with regard to Development Costs incurred by either party, the parties shall proceed as set forth above with respect to the calculation undisputed amount, and any disputed amounts shall be resolved pursuant to the Article 10 of such reimbursable Development Coststhe License Agreement (Dispute Resolution). [*] = Certain confidential information contained in this document, any undisputed portion of such reimbursement payment will be paid in accordance marked by brackets, has been omitted and filed separately with the foregoing timetable Securities and Exchange Commission pursuant to Rule 24b-2 of the remainingSecurities Exchange Act of 1934, disputed portion will as amended. c) Development Costs shall include parties’ internal (calculated at the FTE rate set forth below) and out of pocket costs and expenses incurred to conduct the development work under the Development Plan. For the purpose of this Development Agreement, (i) “FTE Rate” means the cost of an FTE performing development work under the Development Plan, which rate shall be paid within calculated as (a) for an employee, [***] Business Days after the date on which the Partiesof that employee’s annual salary, using good faith efforts, resolve the dispute. Notwithstanding the foregoing, during the Initial Development Period, NVS will not be obligated up to reimburse Pliant for any Development Costs for Licensed Products in excess a maximum of [**] per FTE per year, or (b) for a contractor, that contractor’s hourly rate of pay, up to a maximum of [*] dollars per hour; and ($ii) “FTE” means the equivalent of a full-time individual’s work, at [***]) ] hours per year, for a twelve (12)-month period, performing development work under the "Development Reimbursement Cap")Plan. Following For clarity, the Initial Parties intend the FTE to be a unit of measurement used to calculate the amount of time dedicated to the performance of this Development PeriodAgreement. One FTE may constitute work performed by an individual whose time is dedicated solely to this Development Agreement or may be comprised of the efforts of several individuals, NVS will be solely responsible for, at its sole cost and expense, Developing the Licensed Producteach of whom dedicates only part of his or her time to work under this Development Agreement.