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 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) All Development Costs of Palatin which have been incurred by Palatin prior to July 1, 1999 shall be the Licensed Productliability and responsibility of Palatin. (b) Subject to Section 5.7(d) below, during the Initial Development Period, NVS will be responsible for one hundred percent (100%) of all Development Costs of Palatin that are incurred by Palatin after date hereof shall be shared equally by the parties and Mallinckrodt shall, therefore, pay one-half of all such Development Costs (i.e., the "Development Payments") to Palatin, such Development Payments to be made (subject to offset in accordance with Section 5.8(a) below and subject to audit in accordance with the provisions of subsection (c) set forth immediately below) on a monthly basis within thirty (30) days after the submission by Palatin to Mallinckrodt of an invoice and written report (accompanied by a statement of the principles and assumptions utilized by Palatin in the JSC approved calculating such Development Plan. During the Initial Development Period commencing upon the first Calendar Quarter immediately following JSC approval Costs, a breakdown of the Development Plan for Costs between and among wages, supplies and contract research expenses which constitute "qualified research expenses" within the Licensed Product meaning of Section 41(b)(1) of the Internal Revenue Code of 1986, as amended, and continuing thereafter so long as Pliant incurs Development Costs under this Agreement, Pliant will, within [***] Business Days of by 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 information as Mallinckrodt may request) demonstrating the case 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 qualifying Development Costs incurred by Pliant as detailed Palatin in such report the previous calendar month. All Development Payments shall be payable in United States dollars. Any amounts payable under this subsection (b) and not paid by Mallinckrodt within [***] days the applicable thirty (30) day period shall accrue interest at an annual rate of receipt eight percent (8%) on the unpaid balance due until paid. (c) Upon the written request of Pliant's invoice for such amountMallinckrodt, Palatin shall permit an independent public accountant selected by Mallinckrodt and acceptable to Palatin, which invoice will acceptance shall not be delivered unreasonably withheld or delayed, to have access during normal business hours to such records of Palatin as may be necessary to verify the amount of any Development Costs incurred by Pliant Palatin in accordance herewith in respect of any calendar year (or portion thereof) ending not more than twelve (12) months prior to NVS no sooner the date of such request. Subject to other relevant provisions of this subsection (c), all such verifications shall be conducted at Mallinckrodt's expense and not more than [***] days following NVS' receipt of the report from Pliant; provided, however, that twice in each calendar year. In the event of any disagreement that Mallinckrodt's representative concludes that adjustments should be made in Mallinckrodt's favor with respect to any audited period, then any appropriate refund of Development Payments, plus accrued interest at the calculation annual rate of eight percent (8%) on any amounts due Mallinckrodt measured from the date on which any amount to be refunded was originally paid by Mallinckrodt, shall be made by Palatin within thirty (30) days of the date Mallinckrodt delivers to Palatin such reimbursable representative's written report so concluding (or, at Mallinckrodt's option, shall be offset by Mallinckrodt against any future Development CostsPayments due by Mallinckrodt to Palatin hereunder), any undisputed unless Palatin shall have a good faith dispute as to the conclusions set forth in such written report, in which case Palatin need not make the disputed portion of such reimbursement payment repayment and shall provide written notice to Mallinckrodt within such thirty (30) day period of the nature of its disagreement with such written report. If Palatin shall have in writing so disputed such written report by Mallinckrodt's representative, the parties shall thereafter, for a period of sixty (60) days after Palatin has provided written notice of such dispute, attempt in good faith to resolve such dispute and if they are unable to do so then the matter will be submitted to arbitration in accordance with Section 10.6 hereof. The fees charged by Mallinckrodt's representative shall be paid by Mallinckrodt unless the audit discloses that adjustments in Mallinckrodt's favor for the period under review are greater than five percent (5%) of the amount of Development Costs invoiced by Palatin to Mallinckrodt for such period, in which case Palatin shall pay the reasonable fees and expenses charged by such representative. Mallinckrodt agrees that all information subject to review under this subsection (c) is confidential and that it shall cause its representatives to retain all such information in confidence in accordance with the foregoing timetable requirements of Article 7 below. (d) Notwithstanding the provisions of Section 5.7(b) above, (i) no Development Payments will be made for any costs incurred after the termination of the Development Phase in any portion of the Territory with respect to a LeuTech Indication which is being developed in accordance with the Development Program and (ii) [INFORMATION OMITTED AND FILED SEPARATELY WITH THE COMMISSION UNDER RULE 24b-2]. Mallinckrodt hereby represents and warrants to Palatin that the Development Payments have been approved by all necessary action on the part of the Board of Directors of Mallinckrodt Inc., a New York corporation publicly traded on the New York Stock Exchange and the remainingultimate parent of Mallinckrodt, disputed portion and that Mallinckrodt will take all steps necessary to ensure that Development Payments 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 made to reimburse Pliant for any Development Costs for Licensed Products Palatin as and when due 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 Productaccordance herewith.

Development Costs. With respect (a) Subject to the Licensed ProductSection 3.4(d), during the Initial Development Period, NVS will Enzon shall be responsible for one hundred percent all costs associated with the Development and Commercialization of Products incurred after the Effective Date. For the avoidance of doubt, NatImmune shall be responsible for costs related to services provided by Diosynth B.V. under the Diosynth Agreement through the date of this Agreement. (100%b) NatImmune agrees to use commercially reasonable efforts in performing the tasks set forth on Schedule 3.4(b) related to the Development of all Development Costs the Products; provided, that NatImmune may cease any such task at any time, if, after exerting such commercially reasonable efforts, NatImmune determines in good faith that it is not capable of performing the applicable task. Enzon shall pay NatImmune the payments in the amounts and at the times 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 such Schedule, plus Enzon shall reimburse NatImmune 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 [Redacted***] days of receipt of Pliant's invoice for such amount, which invoice will be delivered by Pliant to NVS ]. Enzon shall pay NatImmune the particular amounts specified on Schedule 3.4(b) no sooner later 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 [***] ten (10) Business Days after the date occurrence of the event associated with each such amount. (c) If the Parties agree that NatImmune shall perform other activities in connection with the Development, the Parties will agree on which reasonable compensation to NatImmune for performing such services. If applicable, within thirty (30) days after the Partiesend of each Enzon Quarter, using good faith effortsNatImmune shall submit to Enzon an accounting of all costs NatImmune incurs under the Development Plan during that Enzon Quarter, resolve including reasonable detail demonstrating the disputespecific basis for the costs and expenses included in the summary. Notwithstanding Enzon shall on an Enzon Quarterly basis, within forty-five (45) days after the foregoingend of each Enzon Quarter (provided that NatImmune submitted its accounting report on time), during prepare and submit to NatImmune a reimbursement of the Initial Development Period, NVS will not be obligated to reimburse Pliant for any Development Costs for Licensed Products in excess of costs [***] dollars ($[*Redacted**]. (d) (NatImmune shall be responsible for costs related to additional activities specifically required for obtaining Regulatory Approvals in the "Development Reimbursement Cap"). Following NatImmune Territory, and NatImmune shall be responsible for all costs related to Commercialization of Products in the Initial Development Period, NVS will be solely responsible for, at its sole cost and expense, Developing the Licensed ProductNatImmune Territory.

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.