Common use of Cost Sharing Clause in Contracts

Cost Sharing. Except as provided in Section 2.7.4(a) with respect to Declined Activities, fifty percent (50%) of all Research Costs and Development Costs (other than Post-Approval U.S. Development Costs and Medical Affairs Costs for Co-Promoted Products, which shall be included in the calculation of the Annual U.S. Profit/Loss) shall be borne by Astellas, and fifty percent (50%) of such costs shall be borne by Ambit. (a) In order to facilitate booking accruals and for financial reporting purposes, on a monthly basis each Party shall provide the other Party with an estimated amount of its Development Costs incurred during the immediately preceding month. Each Party shall use good faith efforts to provide such estimate on or before the […***…] Business Day of each month and in any event shall provide such estimate no later than the […***…] Business Day of such month. (b) Within […***…] of each Calendar Quarter, each Party shall provide the other a report listing in detail all Development Costs incurred by such Party. Within […***…], the Parties respective designated finance officers shall confer and agree in writing on whether a reconciliation payment is due from Ambit to Astellas or Astellas to Ambit, and if so, the amount of such reconciliation payment, so that Ambit and Astellas share Research Costs and Development Costs in accordance with this Agreement (the “Conferral Period”). Ambit or Astellas, as applicable, if required to pay such reconciliation payment, shall submit such payment to Astellas or Ambit, respectively, as applicable, […***…] of such Conferral Period; provided, however, that in the event of any disagreement with respect to the calculation of such reconciliation payment, any undisputed portion of such reconciliation payment shall be paid in accordance with the foregoing timetable. […***…]. In the case of any such dispute, the Parties shall promptly meet (by CONFIDENTIAL telephone or otherwise as appropriate) and discuss the issue in the invoice and seek to agree on whether the disputed amount (or what proportion thereof) is properly included in Development Costs or Research Costs, as applicable, incurred by the Parties during such Calendar Quarter. If the Parties cannot agree on any such dispute as to Development Costs or Research Costs reported by one or the other Party […***…], then the dispute shall be elevated to the Executive Officers of Astellas and Ambit. Prior to escalating the dispute to the Executive Officer, the Parties shall exchange a written description of the issue in dispute. If the Executives cannot resolve the issue after good-faith efforts […***…], then such dispute (as to such aspects of costs) shall be resolved by expedited arbitration pursuant to Exhibit E, with each Party providing access to all invoices, receipts and other documents required to establish the Development Costs or Research Cost, as applicable, actually incurred by the Party during such quarter that are in dispute, as needed to determine the actual total amounts of payments to be made by each Party hereunder.

Appears in 4 contracts

Samples: Exclusive License and Collaborative Research, Co Development and Commercialization Agreement (Ambit Biosciences Corp), Exclusive License and Collaborative Research, Co Development and Commercialization Agreement (Ambit Biosciences Corp), Exclusive License and Collaborative Research, Co Development and Commercialization Agreement (Ambit Biosciences Corp)

AutoNDA by SimpleDocs

Cost Sharing. Except as provided in Section 2.7.4(a) with respect to Declined Activities, Lightlake shall bear fifty percent (50%) of all Research Costs and Development Costs (other than Post-Approval U.S. Development Costs and Medical Affairs Costs for Co-Promoted Products, which Adapt shall be included in the calculation of the Annual U.S. Profit/Loss) shall be borne by Astellas, and bear fifty percent (50%) of such costs shall be borne by Ambit. (a) In order to facilitate booking accruals and for financial reporting purposes, on a monthly basis each Party shall provide the other Party with an estimated amount of its all Development Costs (whether incurred during by Lightlake or Adapt or their respective Affiliates, Sublicensees or subcontractors) incurred after the immediately preceding month. Each Party shall use good faith efforts to provide such estimate on or before Effective Date in accordance with the […Development Plan in connection with the Development of Products using the ***…] Business Day * Unit Dose Device and Lightlake shall bear fifty percent (50%) of each month all Regulatory Costs and Commercialization Costs incurred by Adapt and Adapt shall bear fifty percent (50%) of all Regulatory Costs and Commercialization Costs incurred by Adapt (whether incurred by Adapt or its Affiliates, Sublicensees or subcontractors), in any event shall provide such estimate no later than connection with the […Development and Commercialization of the Product using the ***…] Business Day * Unit Dose Device until such time as Lightlake has incurred Development Costs, Regulatory Costs and Commercialization Costs of such month. Two Million Five Hundred Thousand Dollars (b$2,500,000) Within […(the “Lightlake Cost Cap”). After the Lightlake Cost Cap has been reached, Adapt shall be responsible for one hundred percent (100%) of all Development Costs, Regulatory Costs and Commercialization Costs. For clarity, Lightlake shall not have any obligation to bear any Development Costs, Regulatory Costs or Commercialization Costs in connection with the Development or Commercialization of a Product using a drug delivery device other than the ***…] * Unit Dose Device; provided, however, in the event that Adapt determines, in good faith, that the Product cannot be further Developed using the **** Unit Dose Device, whether due to a technical failure or failure of each Calendar Quarterany clinical study using such device, each Party then Adapt may proceed with Development using another device and the foregoing cost sharing provisions shall provide apply to the other a report listing in detail all Development Costs, Regulatory Costs and Commercialization Costs associated with such alternate Product as well. Notwithstanding the foregoing, Development Costs incurred by such Party. Within […***…]Lightlake (or its Affiliates, Sublicensees or subcontractors) shall only be shared and credited towards the Parties respective designated finance officers shall confer and agree in writing on whether a reconciliation payment is due from Ambit to Astellas or Astellas to Ambit, and if so, the amount of such reconciliation payment, so that Ambit and Astellas share Research Costs and Development Costs Lightlake Cost Cap in accordance with this Agreement Section 3.8.1 to the extent the same are either (a) contemplated in the “Conferral Period”). Ambit Initial Development Plan or Astellasa subsequent Development Plan and are expressly approved in advance by Adapt, as applicableor are set forth on Schedule 3.8.2 or (b) paid by Lightlake after the Effective Date to suppliers and/or vendors, if required to pay such reconciliation paymentincluding their affiliates, shall submit such payment to Astellas or Ambitwhose names are listed on Schedule 3.8.2, respectively, as applicable, […other than ***…] of *, for activities related exclusively to the Product where such Conferral Periodactivities commenced before the Effective Date; provided, however, that in the event aggregate amount contemplated by this clause (b) shall not exceed $150,000. Confidential Treatment has been granted for portions of any disagreement with respect this exhibit. The copy filed herewith omits certain information subject to the calculation of such reconciliation payment, any undisputed portion of such reconciliation payment shall be paid in accordance with the foregoing timetableconfidentiality request. […Omissions are designated as “***…]*”. In A complete version of this exhibit has been filed separately with the case of any such dispute, the Parties shall promptly meet (by CONFIDENTIAL telephone or otherwise as appropriate) Securities and discuss the issue in the invoice and seek to agree on whether the disputed amount (or what proportion thereof) is properly included in Development Costs or Research Costs, as applicable, incurred by the Parties during such Calendar Quarter. If the Parties cannot agree on any such dispute as to Development Costs or Research Costs reported by one or the other Party […***…], then the dispute shall be elevated to the Executive Officers of Astellas and Ambit. Prior to escalating the dispute to the Executive Officer, the Parties shall exchange a written description of the issue in dispute. If the Executives cannot resolve the issue after good-faith efforts […***…], then such dispute (as to such aspects of costs) shall be resolved by expedited arbitration pursuant to Exhibit E, with each Party providing access to all invoices, receipts and other documents required to establish the Development Costs or Research Cost, as applicable, actually incurred by the Party during such quarter that are in dispute, as needed to determine the actual total amounts of payments to be made by each Party hereunderExchange Commission.

Appears in 1 contract

Samples: License Agreement (Opiant Pharmaceuticals, Inc.)

Cost Sharing. Except as provided in Section 2.7.4(a) with respect to Declined Activities, Lightlake shall bear fifty percent (50%) of all Research Costs and Development Costs (other than Post-Approval U.S. Development Costs and Medical Affairs Costs for Co-Promoted Products, which Adapt shall be included in the calculation of the Annual U.S. Profit/Loss) shall be borne by Astellas, and bear fifty percent (50%) of such costs shall be borne by Ambit. (a) In order to facilitate booking accruals and for financial reporting purposes, on a monthly basis each Party shall provide the other Party with an estimated amount of its all Development Costs (whether incurred during by Lightlake or Adapt or their respective Affiliates, Sublicensees or subcontractors) incurred after the immediately preceding month. Each Party Effective Date in accordance with the Development Plan in connection with the Development of Products using the *** REDACTED *** and Lightlake shall use good faith efforts to provide bear fifty percent (50%) of all Regulatory Costs and Commercialization Costs incurred by Adapt and Adapt shall bear fifty percent (50%) of all Regulatory Costs and Commercialization Costs incurred by Adapt (whether incurred by Adapt or its Affiliates, Sublicensees or subcontractors), in connection with the Development and Commercialization of the Product using the *** REDACTED *** until such estimate on or before the […time as Lightlake has incurred Development Costs, Regulatory Costs and Commercialization Costs of *** REDACTED ***…] Business Day Dollars (the “Lightlake Cost Cap”). After the Lightlake Cost Cap has been reached, Adapt shall be responsible for one hundred percent (100%) of each month all Development Costs, Regulatory Costs and Commercialization Costs. For clarity, Lightlake shall not have any obligation to bear any Development Costs, Regulatory Costs or Commercialization Costs in any event shall provide such estimate no later connection with the Development or Commercialization of a Product using a drug delivery device other than the […*** REDACTED ***…] Business Day of such month. (b) Within […; provided, however, in the event that Adapt determines, in good faith, that the Product cannot be further Developed using the *** REDACTED ***…] , whether due to a technical failure or failure of each Calendar Quarterany clinical study using such device, each Party then Adapt may proceed with Development using another device and the foregoing cost sharing provisions shall provide apply to the other a report listing in detail all Development Costs, Regulatory Costs and Commercialization Costs associated with such alternate Product as well. Notwithstanding the foregoing, Development Costs incurred by such Party. Within […***…]Lightlake (or its Affiliates, Sublicensees or subcontractors) shall only be shared and credited towards the Parties respective designated finance officers shall confer and agree in writing on whether a reconciliation payment is due from Ambit to Astellas or Astellas to Ambit, and if so, the amount of such reconciliation payment, so that Ambit and Astellas share Research Costs and Development Costs Lightlake Cost Cap in accordance with this Agreement Section 3.8.1 to the extent the same are either (a) contemplated in the “Conferral Period”). Ambit Initial Development Plan or Astellasa subsequent Development Plan and are expressly approved in advance by Adapt, as applicableor are set forth on Schedule 3.8.2 or (b) paid by Lightlake after the Effective Date to suppliers and/or vendors, if required to pay such reconciliation paymentincluding their affiliates, shall submit such payment to Astellas or Ambitwhose names are listed on Schedule 3.8.2, respectively, as applicable, […*** REDACTED ***…] of , for activities related exclusively to the Product where such Conferral Periodactivities commenced before the Effective Date; provided, however, that in the event of any disagreement aggregate amount contemplated by this clause (b) shall not exceed *** REDACTED ***. IRS Employer Identification No. 40-0000000 Confidential treatment requested with respect to the calculation of such reconciliation payment, any undisputed portion of such reconciliation payment shall be paid in accordance certain portions hereof denoted with the foregoing timetable. […“*** REDACTED ***…]. In the case of any such dispute, the Parties shall promptly meet (by CONFIDENTIAL telephone or otherwise as appropriate) and discuss the issue in the invoice and seek to agree on whether the disputed amount (or what proportion thereof) is properly included in Development Costs or Research Costs, as applicable, incurred by the Parties during such Calendar Quarter. If the Parties cannot agree on any such dispute as to Development Costs or Research Costs reported by one or the other Party […***…], then the dispute shall be elevated to the Executive Officers of Astellas and Ambit. Prior to escalating the dispute to the Executive Officer, the Parties shall exchange a written description of the issue in dispute. If the Executives cannot resolve the issue after good-faith efforts […***…], then such dispute (as to such aspects of costs) shall be resolved by expedited arbitration pursuant to Exhibit E, with each Party providing access to all invoices, receipts and other documents required to establish the Development Costs or Research Cost, as applicable, actually incurred by the Party during such quarter that are in dispute, as needed to determine the actual total amounts of payments to be made by each Party hereunder.

Appears in 1 contract

Samples: License Agreement (Lightlake Therapeutics Inc.)

Cost Sharing. Except (a) Mall I Owner shall pay to H/C I Owner, as its required share of Hotel/Casino/Mall/SECC Common Area Charges ("MALL I OWNER'S SHARE"), the amounts set forth on SCHEDULE II attached hereto and made a part hereof, and absolutely no other amounts except as expressly provided in Section 2.7.4(a) with respect for herein. SECC Owner's payments to Declined Activities, fifty percent H/C I Owner on account of Hotel/Casino/Mall/SECC Common Area Charges (50%) of all Research Costs and Development Costs (other than Post-Approval U.S. Development Costs and Medical Affairs Costs for Co-Promoted Products, which shall be included in the calculation of the Annual U.S. Profit/Loss"SECC OWNER'S SHARE") shall be borne by Astellas, consistent with past practice and fifty percent (50%) of such costs shall be borne by Ambit. (a) In order to facilitate booking accruals and for financial reporting purposes, on a monthly basis each Party shall provide the other Party with an estimated amount of its Development Costs incurred during the immediately preceding month. Each Party shall use good faith efforts to provide such estimate on or before the […***…] Business Day of each month and in any event shall provide such estimate no later than the […***…] Business Day of such monthmethodology. (b) Within […***…] Each of Mall I Owner's Share and SECC Owner's Share shall be subject to further adjustment from time to time during the Term to the extent equitable by agreement of H/C I Owner, Mall I Owner and SECC Owner after consultation with the Mortgagees of H/C I Owner, Mall I Owner and SECC Owner; provided, that if any such Mortgagee shall believe that such adjustment would (i) not be agreed to by a Commercially Reasonable Owner or (ii) will cause a Material Adverse Effect, then such Owners and Mortgagees will negotiate in good-faith until they agree on adjustments acceptable to all such parties; if the parties shall not agree within thirty (30) days, such Owners and Mortgagees shall agree to an Independent Expert reasonably acceptable to all such Owners and Mortgagees who shall deliver to SECC Owner, Mall I Owner and each of their respective Mortgagees (as well as H/C I Owner's Mortgagee) a written statement describing and certifying to an adjustment to SCHEDULE II that (i) would be agreed to by a Commercially Reasonable Owner, (ii) will not cause a Material Adverse Effect and (iii) has appropriately allocated costs to reflect relative benefits. Such written statement shall be binding on the Owners and their Mortgagees. (c) Hotel/Casino/Mall/SECC Common Area Charges shall be payable in monthly installments on the first day of each Calendar Quarter, each Party shall provide month during the other a report listing in detail all Development Costs incurred by such Party. Within […***…]balance of the Term, the Parties respective designated finance officers first and last installment of which shall confer be reduced on a pro rata basis to reflect the actual number of days in said month included within the Term. (d) Not less than thirty (30) days prior to the commencement of each calendar year, H/C I Owner shall submit to each of SECC Owner and agree in writing on whether Mall I Owner a reconciliation payment is due from Ambit to Astellas or Astellas to Ambitstatement setting forth (i) H/C I Owner's good-faith estimate of the amount of Hotel/Casino/Mall/SECC Common Area Charges for such calendar year, and if so, (ii) Mall I Owner's Share thereof (the amount of such reconciliation paymentMall I Owner's Share being hereinafter referred to as "MALL I OWNER'S COMMON AREA CHARGE OBLIGATIONS") and (iii) SECC Owner's Share thereof (the amount of such SECC Owner's Share being hereinafter referred to as "SECC OWNER'S COMMON AREA CHARGE OBLIGATIONS"). (e) Within ninety (90) days following the end of each calendar year, so that Ambit H/C I Owner shall furnish to each of SECC Owner and Astellas share Research Costs Mall I Owner, and Development Costs each of their Mortgagees, a written statement (the "OPERATING EXPENSE Statement"), showing in reasonable detail by categories (i) the total Hotel/Casino/Mall/SECC Common Area Charges for such calendar year, (ii) Mall I Owner's Common Area Charge Obligations for such calendar year and payments, if any, made by Mall I Owner with respect thereto and (iii) SECC Owner's Common Area Charge Obligations for such calendar year and payments, if any, made by SECC Owner with respect thereto together, in each case (but subject to the last parenthetical clause of the first "Note" in Schedule II), with copies of supporting invoices, receipts and such other data reasonably necessary for SECC Owner and Mall I Owner to verify such charges (collectively, "SUPPORTING DOCUMENTATION"). If SECC Owner's or Mall I Owner's aggregate actual payments on account of Hotel/Casino/Mall/SECC Common Area Charges for any calendar year shall be less than SECC Owner's or Mall I Owner's, as the case may be, actual Common Area Charge Obligations for such calendar year, SECC Owner or Mall I Owner, as the case may be, shall pay such deficiency within ten (10) days of receipt by such Party of the Operating Expense Statement and Supporting Documentation from H/C I Owner. If SECC Owner's or Mall I Owner's aggregate actual payments on account of Hotel/Casino/Mall/SECC Common Area Charges for any calendar year exceed SECC Owner's actual Common Area Charge Obligations or Mall I Owner's actual Common Area Charge Obligations, as the case may be, as indicated by the Operating Expense Statement for such calendar year, then H/C I Owner shall, within ten (10) days of its preparation of the Operating Expense Statement, refund the amount of such excess payment to SECC Owner or Mall I Owner, as the case may be, in cash. H/C I Owner shall keep complete and accurate books and records, in accordance with this Agreement generally accepted accounting principles consistently applied, of the Hotel/Casino/Mall/ XXXX Xxxxxx Xxxx Charges and shall retain those books and records at its corporate offices. For a period of three (3) years after the “Conferral Period”end of each calendar year, and for so long thereafter as any dispute exists with respect thereto, H/C I Owner shall preserve all such books and records, including any payroll and time records, vouchers, receipts, correspondence and memos pertaining to the Hotel/Casino/Mall/SECC Common Area Charges for such calendar year. Each of SECC Owner or Mall I Owner may, within three (3) years after the delivery of any Operating Expense Statement and Supporting Documentation, examine, at such Owner's expense (unless otherwise provided herein), H/C I Owner's books and records relating to the charges set forth on such Operating Expense Statement. Ambit Such examination shall be conducted during ordinary business hours upon not less than five (5) Business Days' Notice, in a manner so as to reasonably minimize any interference with H/C I Owner's business. If such examination discloses that H/C I Owner has overstated Mall I Owner's actual Common Area Charge Obligations or AstellasSECC Owner's actual Common Area Charge Obligations, as applicablethe case may be, if required then H/C I Owner shall promptly refund the overpayment to pay such reconciliation payment, shall submit such payment to Astellas Mall I Owner or Ambit, respectivelySECC Owner, as applicablethe case may be, […***…] and if the overpayment is more than three percent (3%) of the amount such Owner should have paid, H/C I Owner shall also pay the reasonable, out-of-pocket costs of such Conferral Period; provided, however, that in Owner's examination and interest on the event of any disagreement with overpayment at the Interest Rate from the date such Owner overpaid H/C I Owner until such Owner receives such refund. (f) With respect to the calculation of such reconciliation paymentHotel/Casino/Mall/SECC Common Area Charges, any undisputed portion of such reconciliation payment dispute between H/C I Owner and SECC Owner or Mall I Owner shall be paid resolved by determination of the Independent Expert in accordance with Section 16 of Article XIV, which shall be the foregoing timetable. […***…]. In exclusive and binding method for the case resolution of any such dispute. H/C I Owner, the Parties shall promptly meet (by CONFIDENTIAL telephone SECC Owner and Mall I Owner each agree to execute and deliver, or otherwise as appropriate) cause to be executed and discuss the issue in the invoice and seek delivered, to agree on whether the disputed amount (or what proportion thereof) is properly included in Development Costs or Research Costs, as applicable, incurred by the Parties during such Calendar Quarter. If the Parties cannot agree on any such dispute as to Development Costs or Research Costs reported by one or the other Party […***…], then any instruments that may be required to effectuate or facilitate the dispute shall be elevated provisions of this Agreement relating to the Executive Officers matters set forth in this Section 3 of Astellas and Ambit. Prior to escalating the dispute to the Executive Officer, the Parties shall exchange a written description of the issue in dispute. If the Executives cannot resolve the issue after good-faith efforts […***…], then such dispute (as to such aspects of costs) shall be resolved by expedited arbitration pursuant to Exhibit E, with each Party providing access to all invoices, receipts and other documents required to establish the Development Costs or Research Cost, as applicable, actually incurred by the Party during such quarter that are in dispute, as needed to determine the actual total amounts of payments to be made by each Party hereunder.Article V.

Appears in 1 contract

Samples: Reciprocal Easement, Use and Operating Agreement (Las Vegas Sands Corp)

Cost Sharing. Except as provided 1. Negotiation of the Infrastructure Funding Agreement (‘IFA’) The Colorado Workforce Development Council (‘CWDC”), with the authority of the Governor, provides that (a) each Partner that operates in Section 2.7.4(athe Local Area is required to begin contributing its Proportionate Share of the Total Costs of operating each comprehensive and affiliate one-stop center in the Local Area (‘One-Stop Delivery System Budget’); (b) with respect the cost sharing methodology must be decided by consensus agreement among the LWDB, the CEO, and all the Parties; (c) if any Party fails to Declined Activitiesagree to a IFA that meets the requirements set forth by the CWDC, fifty percent the State will implement the State Funding Mechanism to determine each Partner’s Contribution. The Parties agree to participate in good faith in the negotiation of an IFA that meets all requirements set forth by the CWDC. At a minimum, the IFA should (50%a) specify the effective time period, which may be different from that of all Research the duration of the MOU; (b) identify the Infrastructure Costs, Shared Costs and Development Costs Total Costs; (other than Post-Approval U.S. Development c) identify the formula used to calculate Proportionate Share; (d) identify the CEO, the LWDB, and the Parties participating in the IFA; and (e) establish a process by which the Parties will reconcile the Total Costs, the Proportionate Share and the Partner Contribution at least once per quarter throughout the term of the IFA. Upon agreement, any IFAs for the local area shall be incorporated as legally binding components of this MOU as if fully set forth herein, and shall be attached hereto and incorporated herein as Exhibit B. The Parties agree that (a) the Infrastructure Costs, Shared Costs and Medical Affairs Total Costs for Co-Promoted Productswill be calculated using actual cost data, which shall be included in where possible, or reasonable cost estimates, where actual data is not available; (b) the cost data or estimates underlying the calculation of the Annual U.S. Profit/LossInfrastructure Costs, Shared Costs and Total Costs will be disclosed to the Partners; (c) shall the methodology for calculating each Partner’s Proportionate Share of the Total Costs will be borne determined through a reasonable cost allocation methodology that assigns costs to Partners in proportion to relative benefits received; (d) the Parties will negotiate in good faith to identify the methodology as well as the formula by Astellaswhich each Partner will make the Partner Contribution and to establish a process by which the Parties will reconcile the Total Costs, the Proportionate Share and the Partner Contribution at least once per quarter throughout the term of the IFA; and (e) in negotiating the IFA, the Parties will comply with both the letter and the spirit of the WIOA law, regulations, Office of Management and Budget Circulars, and fifty percent (50%) of such costs shall be borne by AmbitCWDC-issued policy guidance. 2. Abide by State Funding Mechanism, if Implemented, Subject to the Appeals Process If the Parties fail to agree to an IFA that meets the requirements of the CWDC, the State will implement the State Funding Mechanism to determine each Partner’s Contribution. As applicable, (a) In order the Parties agree to facilitate booking accruals abide by the terms of the State Funding Mechanism, if implemented, subject to the appeals process set forth by the CWDC; and for financial reporting purposes, on a monthly basis each Party shall provide the other Party with an estimated amount of its Development Costs incurred during the immediately preceding month. Each Party shall use good faith efforts to provide such estimate on or before the […***…] Business Day of each month and in any event shall provide such estimate no later than the […***…] Business Day of such month. (b) Within […***…] of each Calendar Quarter, each Party shall provide the other a report listing in detail all Development Costs incurred by such Party. Within […***…], Partners who are not subject to the Parties respective designated finance officers shall confer and State Funding Mechanism agree in writing on whether a reconciliation payment is due from Ambit to Astellas or Astellas to Ambit, and if so, the amount of such reconciliation payment, so that Ambit and Astellas share Research Costs and Development Costs in accordance with this Agreement (the “Conferral Period”). Ambit or Astellas, as applicablethat, if required the State Funding Mechanism is implemented, such Partner will continue in good faith to pay such reconciliation payment, shall submit such payment to Astellas or Ambit, respectively, as applicable, […***…] of such Conferral Period; provided, however, negotiate an IFA that in meets the event of any disagreement with respect to the calculation of such reconciliation payment, any undisputed portion of such reconciliation payment shall be paid in accordance with the foregoing timetable. […***…]. In the case of any such dispute, the Parties shall promptly meet (by CONFIDENTIAL telephone or otherwise as appropriate) and discuss the issue in the invoice and seek to agree on whether the disputed amount (or what proportion thereof) is properly included in Development Costs or Research Costs, as applicable, incurred by the Parties during such Calendar Quarter. If the Parties cannot agree on any such dispute as to Development Costs or Research Costs reported by one or the other Party […***…], then the dispute shall be elevated to the Executive Officers of Astellas and Ambit. Prior to escalating the dispute to the Executive Officer, the Parties shall exchange a written description requirements of the issue in dispute. If the Executives cannot resolve the issue after good-faith efforts […***…], then such dispute (as to such aspects of costs) shall be resolved by expedited arbitration pursuant to Exhibit E, with each Party providing access to all invoices, receipts and other documents required to establish the Development Costs or Research Cost, as applicable, actually incurred by the Party during such quarter that are in dispute, as needed to determine the actual total amounts of payments to be made by each Party hereunderCWDC.

Appears in 1 contract

Samples: Memorandum of Understanding

Cost Sharing. Except as provided in Section 2.7.4(a) with respect to Declined Activities, Lightlake shall bear fifty percent (50%) of all Research Costs and Development Costs (other than Post-Approval U.S. Development Costs and Medical Affairs Costs for Co-Promoted Products, which Adapt shall be included in the calculation of the Annual U.S. Profit/Loss) shall be borne by Astellas, and bear fifty percent (50%) of all Development Costs (whether incurred by Lightlake or Adapt or their respective Affiliates, Sublicensees or subcontractors) incurred after the Effective Date in accordance with the Development Plan in connection with the Development of Products using the [**] Unit Dose Device and Lightlake shall bear fifty percent (50%) of all Regulatory Costs and Commercialization Costs incurred by Adapt and Adapt shall bear fifty percent (50%) of all Regulatory Costs and Commercialization Costs incurred by Adapt (whether incurred by Adapt or its Affiliates, Sublicensees or subcontractors), in connection with the Development and Commercialization of the Product using the [**] Unit Dose Device until such costs time as Lightlake has incurred Development Costs, Regulatory Costs and Commercialization Costs of Two Million Five Hundred Thousand Dollars ($2,500,000) (the “Lightlake Cost Cap”). After the Lightlake Cost Cap has been reached, Adapt shall be borne by Ambit. responsible for one hundred percent (a100%) In order of all Development Costs, Regulatory Costs and Commercialization Costs. For clarity, Lightlake shall not have any obligation to facilitate booking accruals and for financial reporting purposesbear any Development Costs, on Regulatory Costs or Commercialization Costs in connection with the Development or Commercialization of a monthly basis each Party shall provide the Product using a drug delivery device other Party with an estimated amount of its Development Costs incurred during the immediately preceding month. Each Party shall use good faith efforts to provide such estimate on or before the […***…] Business Day of each month and in any event shall provide such estimate no later than the [***…] Business Day of such month. (b) Within Unit Dose Device; provided, however, in the event that Adapt determines, in good faith, that the Product cannot be further Developed using the [***…] Unit Dose Device, whether due to a technical failure or failure of each Calendar Quarterany clinical study using such device, each Party then Adapt may proceed with Development using another device and the foregoing cost sharing provisions shall provide apply to the other a report listing in detail all Development Costs, Regulatory Costs and Commercialization Costs associated with such alternate Product as well. Notwithstanding the foregoing, Development Costs incurred by such Party. Within […***…]Lightlake (or its Affiliates, Sublicensees or subcontractors) shall only be shared and credited towards the Parties respective designated finance officers shall confer and agree in writing on whether a reconciliation payment is due from Ambit to Astellas or Astellas to Ambit, and if so, the amount of such reconciliation payment, so that Ambit and Astellas share Research Costs and Development Costs Lightlake Cost Cap in accordance with this Agreement Section 3.8.1 to the extent the same are either (a) contemplated in the “Conferral Period”). Ambit Initial Development Plan or Astellasa subsequent Development Plan and are expressly approved in advance by Adapt, as applicableor are set forth on Schedule 3.8.2 or (b) paid by Lightlake after the Effective Date to suppliers and/or vendors, if required to pay such reconciliation paymentincluding their affiliates, shall submit such payment to Astellas or Ambitwhose names are listed on Schedule 3.8.2, respectively, as applicable, other than [***…] of ], for activities related exclusively to the Product where such Conferral Periodactivities commenced before the Effective Date; provided, however, that in the event of any disagreement with respect to the calculation of such reconciliation payment, any undisputed portion of such reconciliation payment shall be paid in accordance with the foregoing timetable. […***…]. In the case of any such dispute, the Parties shall promptly meet aggregate amount contemplated by this clause (by CONFIDENTIAL telephone or otherwise as appropriate) and discuss the issue in the invoice and seek to agree on whether the disputed amount (or what proportion thereof) is properly included in Development Costs or Research Costs, as applicable, incurred by the Parties during such Calendar Quarter. If the Parties cannot agree on any such dispute as to Development Costs or Research Costs reported by one or the other Party […***…], then the dispute shall be elevated to the Executive Officers of Astellas and Ambit. Prior to escalating the dispute to the Executive Officer, the Parties shall exchange a written description of the issue in dispute. If the Executives cannot resolve the issue after good-faith efforts […***…], then such dispute (as to such aspects of costsb) shall be resolved by expedited arbitration pursuant to Exhibit E, with each Party providing access to all invoices, receipts and other documents required to establish the Development Costs or Research Cost, as applicable, actually incurred by the Party during such quarter that are in dispute, as needed to determine the actual total amounts of payments to be made by each Party hereundernot exceed $150,000.

Appears in 1 contract

Samples: License Agreement (Emergent BioSolutions Inc.)

Cost Sharing. Except as provided in Section 2.7.4(a) with respect to Declined Activities, Lightlake shall bear fifty percent (50%) of all Research Costs and Development Costs (other than Post-Approval U.S. Development Costs and Medical Affairs Costs for Co-Promoted Products, which Adapt shall be included in the calculation of the Annual U.S. Profit/Loss) shall be borne by Astellas, and bear fifty percent (50%) of such costs shall be borne by Ambit. (a) In order to facilitate booking accruals and for financial reporting purposes, on a monthly basis each Party shall provide the other Party with an estimated amount of its all Development Costs (whether incurred during by Lightlake or Adapt or their respective Affiliates, Sublicensees or subcontractors) incurred after the immediately preceding month. Each Party shall use good faith efforts to provide such estimate on or before Effective Date in accordance with the […Development Plan in connection with the Development of Products using the ***…] Business Day * Unit Dose Device and Lightlake shall bear fifty percent (50%) of each month all Regulatory Costs and Commercialization Costs incurred by Adapt and Adapt shall bear fifty percent (50%) of all Regulatory Costs and Commercialization Costs incurred by Adapt (whether incurred by Adapt or its Affiliates, Sublicensees or subcontractors), in any event shall provide such estimate no later than connection with the […Development and Commercialization of the Product using the ***…] Business Day * Unit Dose Device until such time as Lightlake has incurred Development Costs, Regulatory Costs and Commercialization Costs of such month. Two Million Five Hundred Thousand Dollars (b$2,500,000) Within […(the “Lightlake Cost Cap”). After the Lightlake Cost Cap has been reached, Adapt shall be responsible for one hundred percent (100%) of all Development Costs, Regulatory Costs and Commercialization Costs. For clarity, Lightlake shall not have any obligation to bear any Development Costs, Regulatory Costs or Commercialization Costs in connection with the Development or Commercialization of a Product using a drug delivery device other than the ***…] * Unit Dose Device; provided, however, in the event that Adapt determines, in good faith, that the Product cannot be further Developed using the **** Unit Dose Device, whether due to a technical failure or failure of each Calendar Quarterany clinical study using such device, each Party then Adapt may proceed with Development using another device and the foregoing cost sharing provisions shall provide apply to the other a report listing in detail all Development Costs, Regulatory Costs and Commercialization Costs associated with such alternate Product as well. Notwithstanding the foregoing, Development Costs incurred by such Party. Within […***…]Lightlake (or its Affiliates, Sublicensees or subcontractors) shall only be shared and credited towards the Parties respective designated finance officers shall confer and agree in writing on whether a reconciliation payment is due from Ambit to Astellas or Astellas to Ambit, and if so, the amount of such reconciliation payment, so that Ambit and Astellas share Research Costs and Development Costs Lightlake Cost Cap in accordance with this Agreement Section 3.8.1 to the extent the same are either (a) contemplated in the Initial Development Plan or a subsequent Development Plan and EAST\151813552.1 Confidential Treatment has been granted for portions of this exhibit. The copy filed herewith omits certain information subject to the confidentiality request. Omissions are designated as Conferral Period”). Ambit or Astellas, as applicable, if required to pay such reconciliation payment, shall submit such payment to Astellas or Ambit, respectively, as applicable, […***…] *”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. are expressly approved in advance by Adapt, or are set forth on Schedule 3.8.2 or (b) paid by Lightlake after the Effective Date to suppliers and/or vendors, including their affiliates, whose names are listed on Schedule 3.8.2, other than ****, for activities related exclusively to the Product where such Conferral Periodactivities commenced before the Effective Date; provided, however, that in the event of any disagreement with respect to the calculation of such reconciliation payment, any undisputed portion of such reconciliation payment shall be paid in accordance with the foregoing timetable. […***…]. In the case of any such dispute, the Parties shall promptly meet aggregate amount contemplated by this clause (by CONFIDENTIAL telephone or otherwise as appropriate) and discuss the issue in the invoice and seek to agree on whether the disputed amount (or what proportion thereof) is properly included in Development Costs or Research Costs, as applicable, incurred by the Parties during such Calendar Quarter. If the Parties cannot agree on any such dispute as to Development Costs or Research Costs reported by one or the other Party […***…], then the dispute shall be elevated to the Executive Officers of Astellas and Ambit. Prior to escalating the dispute to the Executive Officer, the Parties shall exchange a written description of the issue in dispute. If the Executives cannot resolve the issue after good-faith efforts […***…], then such dispute (as to such aspects of costsb) shall be resolved by expedited arbitration pursuant to Exhibit E, with each Party providing access to all invoices, receipts and other documents required to establish the Development Costs or Research Cost, as applicable, actually incurred by the Party during such quarter that are in dispute, as needed to determine the actual total amounts of payments to be made by each Party hereundernot exceed $150,000.

Appears in 1 contract

Samples: License Agreement (Opiant Pharmaceuticals, Inc.)

Cost Sharing. Except as provided (1) Negotiation of the Infrastructure Funding Agreement (‘IFA’) The Colorado Workforce Development Council (‘CWDC”), with the authority of the Governor, provides that (a) each Partner that operates in Section 2.7.4(athe Local Area is required to begin contributing its Proportionate Share of the Total Costs of operating each comprehensive and affiliate one- stop center in the Local Area (‘One-Stop Delivery System Budget’); (b) with respect the cost sharing methodology must be decided by consensus agreement among the LWDB, the CEO, and all the Parties; (c) if any Party fails to Declined Activitiesagree to a IFA that meets the requirements set forth by the CWDC the State will implement the State Funding Mechanism to determine each Partner’s Contribution. The Parties agree to participate in good faith in the negotiation of an IFA that meets all requirements set forth by the CWDC. At a minimum, fifty percent the IFA should (50%a) specify the effective time period, which may be different from that of all Research the duration of the MOU; (b) identify the Infrastructure Costs, Shared Costs and Development Costs Total Costs; (other than Post-Approval U.S. Development c) identify the formula used to calculate Proportionate Share; (d) identify the CEO, the LWDB, and the Parties participating in the IFA; and (e) establish a process by which the Parties will reconcile the Total Costs, the Proportionate Share and the Partner Contribution at least once per quarter throughout the term of the IFA. Upon agreement, any IFAs for the local area shall be incorporated as legally binding components of this MOU as if fully set forth herein, and shall be attached hereto and incorporated herein as Exhibit B. The Parties agree that (a) the Infrastructure Costs, Shared Costs and Medical Affairs Total Costs for Co-Promoted Productswill be calculated using actual cost data, which shall be included in where possible, or reasonable cost estimates, where actual data is not available; (b) the cost data or estimates underlying the calculation of the Annual U.S. Profit/LossInfrastructure Costs, Shared Costs and Total Costs will be disclosed to the Partners; (c) shall the methodology for calculating each Partner’s Proportionate Share of the Total Costs will be borne by Astellas, and fifty percent determined through a reasonable cost allocation methodology that assigns costs to Partners in proportion to relative benefits received; (50%d) of such costs shall be borne by Ambit. (a) In order to facilitate booking accruals and for financial reporting purposes, on a monthly basis each Party shall provide the other Party with an estimated amount of its Development Costs incurred during the immediately preceding month. Each Party shall use Parties will negotiate in good faith efforts to provide such estimate on or before identify the […***…] Business Day methodology as well as the formula by which each Partner will make the Partner Contribution and to establish a process by which the Parties will reconcile the Total Costs, the Proportionate Share and the Partner Contribution at least once per quarter throughout the term of each month the IFA; and (e) in any event shall provide such estimate no later than negotiating the […***…] Business Day of such month. (b) Within […***…] of each Calendar Quarter, each Party shall provide the other a report listing in detail all Development Costs incurred by such Party. Within […***…]IFA, the Parties respective designated finance officers shall confer will comply with both the letter and agree in writing on whether a reconciliation payment is due from Ambit to Astellas or Astellas to Ambitthe spirit of the WIOA law, regulations, Office of Management and Budget Circulars, and if so, the amount of such reconciliation payment, so that Ambit and Astellas share Research Costs and Development Costs in accordance with this Agreement (the “Conferral Period”). Ambit or Astellas, as applicable, if required to pay such reconciliation payment, shall submit such payment to Astellas or Ambit, respectively, as applicable, […***…] of such Conferral Period; provided, however, that in the event of any disagreement with respect to the calculation of such reconciliation payment, any undisputed portion of such reconciliation payment shall be paid in accordance with the foregoing timetable. […***…]. In the case of any such dispute, the Parties shall promptly meet (by CONFIDENTIAL telephone or otherwise as appropriate) and discuss the issue in the invoice and seek to agree on whether the disputed amount (or what proportion thereof) is properly included in Development Costs or Research Costs, as applicable, incurred by the Parties during such Calendar Quarter. If the Parties cannot agree on any such dispute as to Development Costs or Research Costs reported by one or the other Party […***…], then the dispute shall be elevated to the Executive Officers of Astellas and Ambit. Prior to escalating the dispute to the Executive Officer, the Parties shall exchange a written description of the issue in dispute. If the Executives cannot resolve the issue after good-faith efforts […***…], then such dispute (as to such aspects of costs) shall be resolved by expedited arbitration pursuant to Exhibit E, with each Party providing access to all invoices, receipts and other documents required to establish the Development Costs or Research Cost, as applicable, actually incurred by the Party during such quarter that are in dispute, as needed to determine the actual total amounts of payments to be made by each Party hereunderCWDC- issued policy guidance.

Appears in 1 contract

Samples: Memorandum of Understanding

Cost Sharing. Except as provided in Section 2.7.4(a) with respect to Declined Activities, Lightlake shall bear fifty percent (50%) of all Research Costs and Development Costs (other than Post-Approval U.S. Development Costs and Medical Affairs Costs for Co-Promoted Products, which Adapt shall be included in the calculation of the Annual U.S. Profit/Loss) shall be borne by Astellas, and bear fifty percent (50%) of such costs shall be borne by Ambit. (a) In order to facilitate booking accruals and for financial reporting purposes, on a monthly basis each Party shall provide the other Party with an estimated amount of its all Development Costs (whether incurred during by Lightlake or Adapt or their respective Affiliates, Sublicensees or subcontractors) incurred after the immediately preceding month. Each Party shall use good faith efforts to provide such estimate on or before Effective Date in accordance with the […Development Plan in connection with the Development of Products using the ***…] Business Day * Unit Dose Device and Lightlake shall bear fifty percent (50%) of each month all Regulatory Costs and Commercialization Costs incurred by Adapt and Adapt shall bear fifty percent (50%) of all Regulatory Costs and Commercialization Costs incurred by Adapt (whether incurred by Adapt or its Affiliates, Sublicensees or subcontractors), in any event shall provide such estimate no later than connection with the […Development and Commercialization of the Product using the ***…] Business Day * Unit Dose Device until such time as Lightlake has incurred Development Costs, Regulatory Costs and Commercialization Costs of such month. Two Million Five Hundred Thousand Dollars (b$2,500,000) Within […(the “Lightlake Cost Cap”). After the Lightlake Cost Cap has been reached, Adapt shall be responsible for one hundred percent (100%) of all Development Costs, Regulatory Costs and Commercialization Costs. For clarity, Lightlake shall not have any obligation to bear any Development Costs, Regulatory Costs or Commercialization Costs in connection with the Development or Commercialization of a Product using a drug delivery device other than the ***…] * Unit Dose Device; provided, however, in the event that Adapt determines, in good faith, that the Product cannot be further Developed using the **** Unit Dose Device, whether due to a technical failure or failure of each Calendar Quarterany clinical study using such device, each Party then Adapt may proceed with Development using another device and the foregoing cost sharing provisions shall provide apply to the other a report listing in detail all Development Costs, Regulatory Costs and Commercialization Costs associated with such alternate Product as well. Notwithstanding the foregoing, Development Costs incurred by such Party. Within […***…]Lightlake (or its Affiliates, Sublicensees or subcontractors) shall only be shared and credited towards the Parties respective designated finance officers shall confer and agree in writing on whether a reconciliation payment is due from Ambit to Astellas or Astellas to Ambit, and if so, the amount of such reconciliation payment, so that Ambit and Astellas share Research Costs and Development Costs Lightlake Cost Cap in accordance with this Agreement Section 3.8.1 to the extent the same are either (a) contemplated in the Initial Development Plan or a subsequent Development Plan and 19 EAST\151813552.1 Exhibit 10.1 Confidential Treatment has been granted for portions of this exhibit. The copy filed herewith omits certain information subject to the confidentiality request. Omissions are designated as Conferral Period”). Ambit or Astellas, as applicable, if required to pay such reconciliation payment, shall submit such payment to Astellas or Ambit, respectively, as applicable, […***…] *”. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. are expressly approved in advance by Adapt, or are set forth on Schedule 3.8.2 or (b) paid by Lightlake after the Effective Date to suppliers and/or vendors, including their affiliates, whose names are listed on Schedule 3.8.2, other than ****, for activities related exclusively to the Product where such Conferral Periodactivities commenced before the Effective Date; provided, however, that in the event of any disagreement with respect to the calculation of such reconciliation payment, any undisputed portion of such reconciliation payment shall be paid in accordance with the foregoing timetable. […***…]. In the case of any such dispute, the Parties shall promptly meet aggregate amount contemplated by this clause (by CONFIDENTIAL telephone or otherwise as appropriate) and discuss the issue in the invoice and seek to agree on whether the disputed amount (or what proportion thereof) is properly included in Development Costs or Research Costs, as applicable, incurred by the Parties during such Calendar Quarter. If the Parties cannot agree on any such dispute as to Development Costs or Research Costs reported by one or the other Party […***…], then the dispute shall be elevated to the Executive Officers of Astellas and Ambit. Prior to escalating the dispute to the Executive Officer, the Parties shall exchange a written description of the issue in dispute. If the Executives cannot resolve the issue after good-faith efforts […***…], then such dispute (as to such aspects of costsb) shall be resolved by expedited arbitration pursuant to Exhibit E, with each Party providing access to all invoices, receipts and other documents required to establish the Development Costs or Research Cost, as applicable, actually incurred by the Party during such quarter that are in dispute, as needed to determine the actual total amounts of payments to be made by each Party hereundernot exceed $150,000.

Appears in 1 contract

Samples: License Agreement

Cost Sharing. Except as provided Subject to the provisions below in this Section 2.7.4(a4.5, (i) with respect to Declined Activities, fifty percent (50%) of all Research Costs and Development Costs (other than Post-Approval U.S. Development Costs and Medical Affairs Costs incurred by either Party or its Affiliate for Co-Promoted ProductsPromote Products for activities conducted in the U.S., which including the U.S. component of a global Clinical Study, shall be included borne equally by Arcellx and Kite, (ii) Development Costs incurred by either Party or its Affiliates for Co-Promote Products for activities conducted outside the U.S. as part of a global Clinical Study shall be borne sixty percent (60%) by Kite and forty percent (40%) by Arcellx, (iii) any costs incurred by Kite or its Affiliates for Co-Promote Products specific for a country within the ExUS Territory (e.g., a Clinical Study that is specific to a country in the calculation ExUS Territory), shall be borne solely by Kite, (iv) [***] shall be borne [***], (v) [***] shall be borne [***], (vi) CMC Development Costs incurred by Arcellx for the iMMagine-1 Program or iMMagine-2 Program, [***] shall be borne [***] (vii) CMC Development Costs incurred by a Party [***] shall be borne by [***], (viii) (a) CMC Development Costs incurred by Arcellx or Kite in connection with commercial readiness of the Annual U.S. Profit/LossExisting Product and (b) CMC Development Costs incurred by Kite for Co-Promote Products (collectively (a) and (b), “Kite CMC Development Costs”) shall be borne by Astellas, and fifty percent (50%) Kite. For the avoidance of such costs shall be borne by Ambit. (a) In order to facilitate booking accruals and for financial reporting purposes, on a monthly basis each Party shall provide the other Party with an estimated amount of its Development Costs incurred during the immediately preceding month. Each Party shall use good faith efforts to provide such estimate on or before the […***…] Business Day of each month and in any event shall provide such estimate no later than the […***…] Business Day of such month. (b) Within […***…] of each Calendar Quarter, each Party shall provide the other a report listing in detail all Development Costs incurred by such Party. Within […***…]double-counting, the Parties respective designated finance officers shall confer acknowledge and agree in writing on whether a reconciliation payment is due from Ambit to Astellas or Astellas to Ambit, and if so, the amount of such reconciliation payment, so that Ambit and Astellas share Research Costs and Development Costs or CMC Development Costs shall not be included in accordance with this Agreement (the “Conferral Period”). Ambit Allowable Expenses for purposes of calculating Pre-Tax Profit or Astellas, as applicable, if required to pay such reconciliation payment, shall submit such payment to Astellas or Ambit, respectively, as applicable, […***…] of such Conferral Period; provided, however, that in the event of any disagreement with respect to the calculation of such reconciliation payment, any undisputed portion of such reconciliation payment shall be paid Loss in accordance with the foregoing timetable. […***…]. In the case of Financial Exhibit (and, likewise, that any such dispute, the Parties amounts included in Allowable Expenses shall promptly meet (by CONFIDENTIAL telephone or otherwise as appropriate) and discuss the issue in the invoice and seek to agree on whether the disputed amount (or what proportion thereof) is properly not be included in Development Costs or Research CMC Development Costs). Payments under Existing Manufacturing Contracts incurred after the Effective Date that are attributable and allocable to the Development activities for which the Parties share (or reimburse) Development Costs, Shared CMC Development Costs, Pre-Effective Date Kite Costs, or Kite CMC Development Costs under this Agreement shall be included as Development Costs, Shared CMC Development Costs or Pre-Effective Date Kite Costs, or Kite CMC Development Costs, as applicablethe case may be, incurred by the Parties during such Calendar Quarter. If the Parties cannot agree on any such dispute as to Development Costs and shared (or Research Costs reported by one or the other Party […***…], then the dispute shall be elevated to the Executive Officers of Astellas and Ambit. Prior to escalating the dispute to the Executive Officer, the Parties shall exchange a written description of the issue in dispute. If the Executives cannot resolve the issue after good-faith efforts […***…], then such dispute (as to such aspects of costs) shall be resolved by expedited arbitration pursuant to Exhibit E, with each Party providing access to all invoices, receipts and other documents required to establish the Development Costs or Research Costreimbursed, as applicable, actually incurred ) by the Party during such quarter that are in dispute, as needed to determine the actual total amounts of payments to be made by each Party hereunderParties.

Appears in 1 contract

Samples: Collaboration and License Agreement (Arcellx, Inc.)

AutoNDA by SimpleDocs

Cost Sharing. Except as provided in Section 2.7.4(a) with respect to Declined Activities, Lightlake shall bear fifty percent (50%) of all Research Costs and Development Costs (other than Post-Approval U.S. Development Costs and Medical Affairs Costs for Co-Promoted Products, which Adapt shall be included in the calculation of the Annual U.S. Profit/Loss) shall be borne by Astellas, and bear fifty percent (50%) of all Development Costs (whether incurred by Lightlake or Adapt or their respective Affiliates, Sublicensees or subcontractors) incurred after the Effective Date in accordance with the Development Plan in connection with the Development of Products using the *** REDACTED *** Unit Dose Device and Lightlake shall bear fifty percent (50%) of all Regulatory Costs and Commercialization Costs incurred by Adapt and Adapt shall bear fifty percent (50%) of all Regulatory Costs and Commercialization Costs incurred by Adapt (whether incurred by Adapt or its Affiliates, Sublicensees or subcontractors), in connection with the Development and Commercialization of the Product using the *** REDACTED *** Unit Dose Device until such costs time as Lightlake has incurred Development Costs, Regulatory Costs and Commercialization Costs of Two Million Five Hundred Thousand Dollars ($2,500,000) (the “Lightlake Cost Cap”). After the Lightlake Cost Cap has been reached, Adapt shall be borne by Ambit. responsible for one hundred percent (a100%) In order of all Development Costs, Regulatory Costs and Commercialization Costs. For clarity, Lightlake shall not have any obligation to facilitate booking accruals and for financial reporting purposesbear any Development Costs, on Regulatory Costs or Commercialization Costs in connection with the Development or Commercialization of a monthly basis each Party shall provide Product using a drug delivery device other than the other Party with an estimated amount of its Development Costs incurred during the immediately preceding month. Each Party shall use good faith efforts to provide such estimate on or before the […*** REDACTED ***…] Business Day of each month and Unit Dose Device; provided, however, in any the event shall provide such estimate no later than that Adapt determines, in good faith, that the […Product cannot be further Developed using the *** REDACTED ***…] Business Day Unit Dose Device, whether due to a technical failure or failure of any clinical study using such month. (b) Within […***…] of each Calendar Quarterdevice, each Party then Adapt may proceed with Development using another device and the foregoing cost sharing provisions shall provide apply to the other a report listing in detail all Development Costs, Regulatory Costs and Commercialization Costs associated with such alternate Product as well. Notwithstanding the foregoing, Development Costs incurred by such Party. Within […***…]Lightlake (or its Affiliates, Sublicensees or subcontractors) shall only be shared and credited towards the Parties respective designated finance officers shall confer and agree in writing on whether a reconciliation payment is due from Ambit to Astellas or Astellas to Ambit, and if so, the amount of such reconciliation payment, so that Ambit and Astellas share Research Costs and Development Costs Lightlake Cost Cap in accordance with this Agreement Section 3.8.1 to the extent the same are either (a) contemplated in the “Conferral Period”). Ambit Initial Development Plan or Astellasa subsequent Development Plan and are expressly approved in advance by Adapt, as applicableor are set forth on Schedule 3.8.2 or (b) paid by Lightlake after the Effective Date to suppliers and/or vendors, if required to pay such reconciliation paymentincluding their affiliates, shall submit such payment to Astellas or Ambitwhose names are listed on Schedule 3.8.2, respectively, as applicable, […other than *** REDACTED two words ***…] of , for activities related exclusively to the Product where such Conferral Periodactivities commenced before the Effective Date; provided, however, that in the event of any disagreement with respect to the calculation of such reconciliation payment, any undisputed portion of such reconciliation payment shall be paid in accordance with the foregoing timetable. […***…]. In the case of any such dispute, the Parties shall promptly meet aggregate amount contemplated by this clause (by CONFIDENTIAL telephone or otherwise as appropriate) and discuss the issue in the invoice and seek to agree on whether the disputed amount (or what proportion thereof) is properly included in Development Costs or Research Costs, as applicable, incurred by the Parties during such Calendar Quarter. If the Parties cannot agree on any such dispute as to Development Costs or Research Costs reported by one or the other Party […***…], then the dispute shall be elevated to the Executive Officers of Astellas and Ambit. Prior to escalating the dispute to the Executive Officer, the Parties shall exchange a written description of the issue in dispute. If the Executives cannot resolve the issue after good-faith efforts […***…], then such dispute (as to such aspects of costsb) shall be resolved by expedited arbitration pursuant to Exhibit E, with each Party providing access to all invoices, receipts and other documents required to establish the Development Costs or Research Cost, as applicable, actually incurred by the Party during such quarter that are in dispute, as needed to determine the actual total amounts of payments to be made by each Party hereundernot exceed $150,000.

Appears in 1 contract

Samples: License Agreement (Lightlake Therapeutics Inc.)

Cost Sharing. Except (a) Mall I Owner shall pay as its required share of applicable Hotel/Casino/Mall/SECC Common Area Charges ("Mall I Owner's Share"), and Mall II Owner shall pay as its required share of applicable Hotel/Casino/Mall/SECC Common Area Charges ("Mall II Owner's Share"), to H/C I Owner or H/C II Owner, as appropriate, the respective amounts set forth on Schedule II attached hereto and made a part hereof, and absolutely no other amounts except as expressly provided in Section 2.7.4(a) with respect for herein. SECC Owner's payments to Declined ActivitiesH/C I Owner or H/C II Owner, fifty percent as appropriate, on account of Hotel/Casino/Mall/SECC Common Area Charges (50%) of all Research Costs and Development Costs (other than Post-Approval U.S. Development Costs and Medical Affairs Costs for Co-Promoted Products, which shall be included in the calculation of the Annual U.S. Profit/Loss"SECC Owner's Share") shall be borne by Astellas, consistent with past practice and fifty percent (50%) of such costs shall be borne by Ambit. (a) In order to facilitate booking accruals and for financial reporting purposes, on a monthly basis each Party shall provide the other Party with an estimated amount of its Development Costs incurred during the immediately preceding month. Each Party shall use good faith efforts to provide such estimate on or before the […***…] Business Day of each month and in any event shall provide such estimate no later than the […***…] Business Day of such monthmethodology. (b) Within […***…] Each of Mall I Owner's Share, Mall II Owner's Share and SECC Owner's Share shall be subject to further adjustment from time to time during the Term to the extent equitable by agreement of the Owners after consultation with the Mortgagees of the Owners; provided, that if any such Mortgagee shall believe that such adjustment would (i) not be agreed to by a Commercially Reasonable Owner or (ii) will cause a Material Adverse Effect, then the Owners and their Mortgagees will negotiate in good faith until they agree on adjustments acceptable to all such parties; if the parties shall not agree within thirty (30) days, the Owners and their Mortgagees shall agree to an Independent Expert reasonably acceptable to all the Owners and their Mortgagees who shall deliver to SECC Owner, Mall I Owner, Mall II Owner and each of their respective Mortgagees (as well as the Mortgagees of H/C I Owner and H/C II Owner) a written statement describing and certifying to an adjustment to Schedule II that (i) would be agreed to by a Commercially Reasonable Owner, (ii) will not cause a Material Adverse Effect and (iii) has appropriately allocated costs to reflect relative benefits. Such written statement shall be binding on the Owners and their Mortgagees. (c) Hotel/Casino/Mall/SECC Common Area Charges shall be payable in monthly installments on the first day of each Calendar Quarter, each Party shall provide month during the other a report listing in detail all Development Costs incurred by such Party. Within […***…]balance of the Term, the Parties respective designated finance officers first and last installment of which shall confer be reduced on a pro rata basis to reflect the actual number of days in said month included within the Term. (d) Not less than thirty (30) days prior to the commencement of each calendar year, H/C I Owner and agree in writing on whether H/C II Owner shall submit to each of SECC Owner, Mall I Owner and Mall II Owner a reconciliation payment is due from Ambit to Astellas or Astellas to Ambitstatement setting forth (i) H/C I Owner and H/C II Owner's good-faith estimate of the amount of Hotel/Casino/Mall/SECC Common Area Charges for such calendar year, and if so, (ii) Mall I Owner's Share thereof (the amount of such reconciliation paymentMall I Owner's Share being hereinafter referred to as "Mall I Owner's Common Area Charge Obligations"), so that Ambit and Astellas share Research Costs and Development Costs in accordance with this Agreement (iii) Mall II Owner's Share thereof (the “Conferral Period”amount of such Mall II Owner's Share being hereinafter referred to as "Mall II Owner's Common Area Charge Obligations") and (iv) SECC Owner's Share thereof (the amount of such SECC Owner's Share being hereinafter referred to as "SECC Owner's Common Area Charge Obligations"). Ambit or Astellas. (e) Within ninety (90) days following the end of each calendar year, as applicableH/C I Owner and/or H/C II Owner shall furnish to each of SECC Owner, Mall I Owner and Mall II Owner, and each of their Mortgagees, a written statement (the "Operating Expense Statement"), showing in reasonable detail by categories (i) the total Hotel/Casino/Mall/SECC Common Area Charges for such calendar year, (ii) Mall I Owner's Common Area Charge Obligations for such calendar year and payments, if required to pay such reconciliation paymentany, shall submit such payment to Astellas or Ambit, respectively, as applicable, […***…] of such Conferral Period; provided, however, that in the event of any disagreement made by Mall I Owner with respect thereto, (iii) Mall II Owner's Common Area Charge Obligations for such calendar year and payments, if any, made by Mall II Owner with respect thereto and (iv) SECC Owner's Common Area Charge Obligations for such calendar year and payments, if any, made by SECC Owner with respect thereto together, in each case (but subject to the calculation of such reconciliation payment, any undisputed portion of such reconciliation payment shall be paid in accordance with the foregoing timetable. […***…]. In the case of any such dispute, the Parties shall promptly meet (by CONFIDENTIAL telephone or otherwise as appropriate) and discuss the issue in the invoice and seek to agree on whether the disputed amount (or what proportion thereof) is properly included in Development Costs or Research Costs, as applicable, incurred by the Parties during such Calendar Quarter. If the Parties cannot agree on any such dispute as to Development Costs or Research Costs reported by one or the other Party […***…], then the dispute shall be elevated to the Executive Officers of Astellas and Ambit. Prior to escalating the dispute to the Executive Officer, the Parties shall exchange a written description last parenthetical clause of the issue first "Note" in dispute. If the Executives cannot resolve the issue after good-faith efforts […***…], then such dispute (as to such aspects of costs) shall be resolved by expedited arbitration pursuant to Exhibit ESchedule II), with each Party providing access to all copies of supporting invoices, receipts and such other documents required data reasonably necessary for SECC Owner, Mall I Owner and Mall II Owner to establish the Development Costs verify such charges (collectively, "Supporting Documentation"). If SECC Owner's, Mall I Owner's or Research CostMall II Owner's aggregate actual payments on account of Hotel/Casino/Mall/SECC Common Area Charges for any calendar year shall be less than SECC Owner's, Mall I Owner's or Mall II Owner's, as applicablethe case may be, actually incurred actual Common Area Charge Obligations for such calendar year, SECC Owner, Mall I Owner or Mall II Owner, as the case may be, shall pay such deficiency within ten (10) days of receipt by such Party of the Operating Expense Statement and Supporting Documentation from H/C I Owner and/or H/C II Owner, as the case may be. If SECC Owner's, Mall I Owner's or Mall II Owner's aggregate actual payments on account of Hotel/Casino/Mall/SECC Common Area Charges for any calendar year exceed SECC Owner's actual Common Area Charge Obligations, Mall I Owner's actual Common Area Charge Obligations or Mall II Owner's actual Common Area Charge Obligations, as the case may be, as indicated by the Party during Operating Expense Statement for such quarter that are in disputecalendar year, then H/C I Owner and/or H/C II Owner, as needed to determine the actual total amounts of payments to be made by each Party hereunder.appropriate, shall, within ten

Appears in 1 contract

Samples: Reciprocal Easement, Use and Operating Agreement (Las Vegas Sands Corp)

Cost Sharing. Except as provided in Section 2.7.4(a(A) with respect to Declined ActivitiesAfter the Amendment Effective Date, fifty percent (50%) of Xxxxxxx shall be solely responsible for all Research Costs and Development Costs (other than Post-Approval U.S. including any Development Costs payable by Xxxxxxx but not yet paid as of the Amendment Effective Date (which Xxxxxxx hereby expressly waives)) for the Phase II Trials MDD2001, MDD2002, and Medical Affairs ISM2005, the Ongoing Preclinical/Safety/Phase I Studies, the preclinical studies, safety studies and Phase I Trials set forth on Annex 2 (collectively, the “DP4 Activities”). Xxxxxxx shall have no further obligation to share in any Development Costs for Co-Promoted ProductsDP4 Activities. Xxxxxxx may not exercise its final decision making authority under Section 3.3(c)(i) to amend the Development Plan or the Development Budget in a manner that would increase Development Costs for the DP4 Activities above (or would accelerate such Development Costs, which shall so that they would be included incurred sooner) than the total amounts budgeted for the DP4 Activities in (x) the calculation preliminary budget attached hereto as Annex 3 or (y) if the JSC has approved a Development Budget, the latest Development Budget approved by the JSC (without the exercise of final decision making authority by either Party). Notwithstanding the Annual U.S. Profit/Lossforegoing, if Xxxxxxx does not consent to any such increase or acceleration, then (1) shall be borne by Astellas, and fifty Xxxxxxx may elect to fund one hundred percent (50100%) of such costs shall be borne by Ambitadditional or accelerated Development Costs and (2) if Xxxxxxx makes such an election, the JSC will update the applicable activity in the Development Plan to reflect such increase or acceleration. (aB) In order After the Amendment Effective Date, Xxxxxxx shall be solely responsible for all Development Costs described in clause (e) of the definition of “Development Costs” set forth in Section 1.27 that are incurred on or prior to facilitate booking accruals and for financial reporting purposes, on a monthly basis each Party shall provide Decision Point 4 (including any such Development Costs payable by Xxxxxxx but not yet paid as of the other Party with an estimated amount of its Amendment Effective Date (which Xxxxxxx hereby expressly waives)) (any such Development Costs incurred during such period, the immediately preceding month“DP4 PDMS Costs”). Each Party Xxxxxxx shall use good faith efforts have no further obligation to provide such estimate on or before the […***…] Business Day of each month and share in any event shall provide DP4 PDMS Costs. Xxxxxxx may not exercise its final decision making authority under Section 3.3(c)(i) to amend the Development Plan or the Development Budget in a manner that would increase DP4 PDMS Costs above (or would accelerate such estimate no later Development Costs, so that they would be incurred sooner) than the […***…] Business Day total amounts budgeted for the DP4 PDMS Costs in (x) the preliminary budget attached hereto as Annex 3 or (y) if the JSC has approved a Development Budget, the latest Development Budget approved by the JSC (without the exercise of final decision making authority by either Party). Notwithstanding the foregoing, if Xxxxxxx does not consent to any such increase or acceleration, (1) Xxxxxxx may elect to fund one hundred percent (100%) of such monthadditional or accelerated Development Costs and (2) if Xxxxxxx makes such an election, the JSC will update the applicable activity in the Development Plan to reflect such increase or acceleration. Xxxxxxx may not exercise its final decision making authority under Section 3.3(c)(i) to amend the Development Plan or the Development Budget in a manner that would decrease DP4 PDMS Costs below (or would delay such Development Costs, so that they would be incurred later) than the total amounts budgeted for the DP4 PDMS Costs in (x) the preliminary budget attached hereto as Annex 3 or (y) if the JSC has approved a Development Budget, the latest Development Budget approved by the JSC (without the exercise of final decision making authority by either Party). (bC) Within […***…] of each Calendar Quarter, each Party Xxxxxxx shall provide the other a report listing in detail be solely responsible for all Development Costs incurred by for Phase III Trials of a Licensed Product in the insomnia indication and related Development activities, including activities related to initiation of such PartyPhase III Trials (collectively, “PIII Insomnia Activities”). Within […***…]For purposes of this Section 3.10(f)(i)(C), any clinical trial that satisfies both the definition of Phase II Trial set forth in Section 1.71 and the definition of Phase III Trial set forth in Section 1.74 shall be deemed to be a Phase III Trial. If the Parties disagree as to whether a proposed Phase II Trial in the insomnia indication also satisfies the definition of Phase III Trial, such matter shall be an Expert Dispute that will be referred upon the request of either Party to an Expert in accordance with Section 13.6. (D) The Parties shall share, on a sixty percent (60%) to forty percent (40%) basis (Xxxxxxx:Xxxxxxx), all Development Costs that are not related to DP4 Activities or PIII Insomnia Activities or that are not DP4 PDMS Costs. Notwithstanding the foregoing sentence, the Parties respective designated finance officers provisions of Section 3.10(c)(ii) shall confer and agree still apply in writing on whether the event a reconciliation payment is due from Ambit Party elects not to Astellas or Astellas to Ambit, and if so, the amount of such reconciliation payment, so that Ambit and Astellas share Research Costs and Development Costs in accordance with this Agreement the provisions of such Section 3.10(c)(ii). (E) Notwithstanding the “Conferral Period”). Ambit or Astellas, as applicableprovisions of Section 3.10(f)(i)(D) to the contrary, if required either Party exercises its final decision-making authority under Section 3.3(c)(i) to pay start any activity that is not set forth on Annex 1 or Annex 2 (whether or not such reconciliation payment, shall submit such payment to Astellas or Ambit, respectively, as applicable, […***…] of such Conferral Period; provided, however, that activity is in the event Development Plan as of any disagreement with respect the Amendment Effective Date) prior to Decision Point 4, such Party shall bear one hundred percent (100%) of the calculation of Development Costs for such reconciliation paymentactivity that are incurred on or prior to Decision Point 4. For clarity, any undisputed portion of Development Costs incurred for such reconciliation payment activity after Decision Point 4 shall be paid shared in accordance with the foregoing timetable. […***…]. In the case of any such dispute, the Parties shall promptly meet (by CONFIDENTIAL telephone or otherwise as appropriate) and discuss the issue in the invoice and seek to agree on whether the disputed amount (or what proportion thereof) is properly included in Development Costs or Research Costs, as applicable, incurred by the Parties during such Calendar Quarter. If the Parties cannot agree on any such dispute as to Development Costs or Research Costs reported by one or the other Party […***…], then the dispute shall be elevated to the Executive Officers of Astellas and Ambit. Prior to escalating the dispute to the Executive Officer, the Parties shall exchange a written description of the issue in dispute. If the Executives cannot resolve the issue after good-faith efforts […***…], then such dispute (as to such aspects of costs) shall be resolved by expedited arbitration pursuant to Exhibit E, with each Party providing access to all invoices, receipts and other documents required to establish the Development Costs or Research Cost, as applicable, actually incurred by the Party during such quarter that are in dispute, as needed to determine the actual total amounts of payments to be made by each Party hereunderSection 3.10(f)(i)(D).

Appears in 1 contract

Samples: Co Development and License Agreement (Minerva Neurosciences, Inc.)

Cost Sharing. Except as provided in Section 2.7.4(a) with respect to Declined Activities, Lightlake shall bear fifty percent (50%) of all Research Costs and Development Costs (other than Post-Approval U.S. Development Costs and Medical Affairs Costs for Co-Promoted Products, which Adapt shall be included in the calculation of the Annual U.S. Profit/Loss) shall be borne by Astellas, and bear fifty percent (50%) of such costs shall be borne by Ambit. (a) In order to facilitate booking accruals and for financial reporting purposes, on a monthly basis each Party shall provide the other Party with an estimated amount of its all Development Costs (whether incurred during by Lightlake or Adapt or their respective Affiliates, Sublicensees or subcontractors) incurred after the immediately preceding month. Each Party Effective Date in accordance with the Development Plan in connection with the Development of Products using the *** REDACTED *** and Lightlake shall use good faith efforts to provide bear fifty percent (50%) of all Regulatory Costs and Commercialization Costs incurred by Adapt and Adapt shall bear fifty percent (50%) of all Regulatory Costs and Commercialization Costs incurred by Adapt (whether incurred by Adapt or its Affiliates, Sublicensees or subcontractors), in connection with the Development and Commercialization of the Product using the *** REDACTED *** until such estimate on or before the […time as Lightlake has incurred Development Costs, Regulatory Costs and Commercialization Costs of *** REDACTED ***…] Business Day Dollars (the “Lightlake Cost Cap”). After the Lightlake Cost Cap has been reached, Adapt shall be responsible for one hundred percent (100%) of each month all Development Costs, Regulatory Costs and Commercialization Costs. For clarity, Lightlake shall not have any obligation to bear any Development Costs, Regulatory Costs or Commercialization Costs in any event shall provide such estimate no later connection with the Development or Commercialization of a Product using a drug delivery device other than the […*** REDACTED ***…] Business Day of such month. (b) Within […; provided, however, in the event that Adapt determines, in good faith, that the Product cannot be further Developed using the *** REDACTED ***…] , whether due to a technical failure or failure of each Calendar Quarterany clinical study using such device, each Party then Adapt may proceed with Development using another device and the foregoing cost sharing provisions shall provide apply to the other a report listing in detail all Development Costs, Regulatory Costs and Commercialization Costs associated with such alternate Product as well. Notwithstanding the foregoing, Development Costs incurred by such Party. Within […***…]Lightlake (or its Affiliates, Sublicensees or subcontractors) shall only be shared and credited towards the Parties respective designated finance officers shall confer and agree in writing on whether a reconciliation payment is due from Ambit to Astellas or Astellas to Ambit, and if so, the amount of such reconciliation payment, so that Ambit and Astellas share Research Costs and Development Costs Lightlake Cost Cap in accordance with this Agreement Section 3.8.1 to the extent the same are either (a) contemplated in the “Conferral Period”). Ambit Initial Development Plan or Astellasa subsequent Development Plan and are expressly approved in advance by Adapt, as applicableor are set forth on Schedule 3.8.2 or (b) paid by Lightlake after the Effective Date to suppliers and/or vendors, if required to pay such reconciliation paymentincluding their affiliates, shall submit such payment to Astellas or Ambitwhose names are listed on Schedule 3.8.2, respectively, as applicable, […*** REDACTED ***…] of , for activities related exclusively to the Product where such Conferral Periodactivities commenced before the Effective Date; provided, however, that in the event of any disagreement aggregate amount contemplated by this clause (b) shall not exceed $*** REDACTED ***. IRS Employer Identification No. 40-0000000 Confidential treatment requested with respect to the calculation of such reconciliation payment, any undisputed portion of such reconciliation payment shall be paid in accordance certain portions hereof denoted with the foregoing timetable. […“*** REDACTED ***…]. In the case of any such dispute, the Parties shall promptly meet (by CONFIDENTIAL telephone or otherwise as appropriate) and discuss the issue in the invoice and seek to agree on whether the disputed amount (or what proportion thereof) is properly included in Development Costs or Research Costs, as applicable, incurred by the Parties during such Calendar Quarter. If the Parties cannot agree on any such dispute as to Development Costs or Research Costs reported by one or the other Party […***…], then the dispute shall be elevated to the Executive Officers of Astellas and Ambit. Prior to escalating the dispute to the Executive Officer, the Parties shall exchange a written description of the issue in dispute. If the Executives cannot resolve the issue after good-faith efforts […***…], then such dispute (as to such aspects of costs) shall be resolved by expedited arbitration pursuant to Exhibit E, with each Party providing access to all invoices, receipts and other documents required to establish the Development Costs or Research Cost, as applicable, actually incurred by the Party during such quarter that are in dispute, as needed to determine the actual total amounts of payments to be made by each Party hereunder.

Appears in 1 contract

Samples: License Agreement (Lightlake Therapeutics Inc.)

Cost Sharing. Except as provided in Section 2.7.4(a(a) If Voyager exercises its Cost-Sharing Option with respect to Declined Activitiesone (1) or more Cost-Share Indications with respect to a Cost-Share Product, fifty within [**] after the end of each Calendar Quarter thereafter, AbbVie shall provide to Voyager a summary report of the AbbVie Development Costs incurred by AbbVie during such Calendar Quarter (or, with respect to the first such report, since the License Option Effective Date) (each, an “AbbVie Development Cost Report”), broken out by Cost-Share Product and Cost-Share Indication. Subject to Section 7.4.3(b) and Section 7.4.3(c), within [**] after receipt of each such AbbVie Development Cost Report, Voyager shall reimburse AbbVie for [**] percent (50[**]%) of all Research Costs and the AbbVie Development Costs (other than Post-Approval U.S. set forth therein; provided that if Voyager disputes any portion of such AbbVie Development Cost Report, it shall pay the undisputed portion of AbbVie Development Costs for which it is responsible and Medical Affairs Costs for Co-Promoted Products, which shall be included in the calculation provide AbbVie with written notice of the Annual U.S. Profit/Loss) shall be borne by Astellasdisputed portion and its reasons therefor, and fifty percent (50%) Voyager shall not be obligated to pay such disputed portion unless and until such dispute is resolved in favor of such costs shall be borne by Ambit. (a) In order to facilitate booking accruals and for financial reporting purposes, on a monthly basis each Party shall provide the other Party with an estimated amount of its Development Costs incurred during the immediately preceding monthAbbVie. Each Party The Parties shall use good faith efforts to provide resolve any such estimate on or before the […***…] Business Day of each month and in any event shall provide such estimate no later than the […***…] Business Day of such monthdisputes promptly. (b) Within If the aggregate AbbVie Development Costs for a Cost-Share Product for a Cost-Share Indication exceed the initial AbbVie Budget for such Cost-Share Product for such Cost-Share Indication (the “Cost Overrun” for such Cost-Share Product and Cost-Share Indication), then (i) to the extent the aggregate AbbVie Development Costs for such Cost-Share Product for such Cost-Share Indication exceed the initial AbbVie Budget for such Cost-Share Product for such Cost-Share Indication by no more than [**] percent ([**]%), (A) Voyager shall reimburse AbbVie for [**] percent ([**]%), not [**] percent ([**]%), of each Calendar Quartersuch Cost Overrun (such [**] percent ([**]%) of such Cost Overrun, each Party the “Voyager Cost Overrun Share”), and (B) AbbVie shall provide bear [**] percent ([**]%), not [**] percent ([**]%), of such Cost Overrun, (ii) to the other a report listing in detail all extent the aggregate AbbVie Development Costs incurred for a Cost-Share Product for a Cost-Share Indication exceed the initial AbbVie Budget for such Cost-Share Product for such Cost-Share Indication by such Party. Within more than [**] percent ([**]%), AbbVie shall bear [**] percent ([**]%) of any such additional Cost Overrun that exceeds the Parties respective designated finance officers shall confer initial AbbVie Budget for such Cost-Share Product for such Cost-Share Indication by more than [**] percent ([**]%) and agree (iii) Voyager may, in writing on whether a reconciliation its sole discretion, elect to defer payment is due from Ambit to Astellas or Astellas to Ambit, and if so, of the amount of Voyager Cost Overrun Share for such reconciliation payment, so that Ambit and Astellas share Research Costs and Development Costs Cost-Share Product for such Cost-Share Indication in accordance with this Agreement Section 7.4.3(c) by providing written notice of such election (the a Conferral PeriodDeferral Notice). Ambit or Astellas, as applicable, if required ) to pay such reconciliation payment, shall submit such payment to Astellas or Ambit, respectively, as applicable, AbbVie within [***…] of such Conferral Period; provided, however, that in the event after receipt of any disagreement AbbVie Development Cost Report in which the aggregate AbbVie Development Costs for such Cost-Share Product for such Cost-Share Indication exceed the initial AbbVie Budget for such Cost-Share Product for such Cost-Share Indication (which does not have to be the first AbbVie Development Cost Report in which the aggregate AbbVie Development Costs for such Cost-Share Product for such Cost-Share Indication exceed the initial AbbVie Budget for such Cost-Share Product for such Cost-Share Indication). (c) If Voyager provides AbbVie a Deferral Notice pursuant to Section 7.4.3(b) with respect to the calculation Voyager Cost Overrun Share of the AbbVie Development Costs for a Cost-Share Product for a Cost-Share Indication, then (i) Voyager shall no longer be obligated to reimburse AbbVie for the Voyager Cost Overrun Share of the AbbVie Development Costs for such Cost-Share Product for such Cost-Share Indication (including any Voyager Cost Overrun Share for the Calendar Quarter immediately prior to the Calendar Quarter in which Voyager provides such Deferral Notice to AbbVie) on a quarterly basis as such AbbVie Development Costs are incurred by AbbVie (such Voyager Cost Overrun Share of the Cost Overrun for such Cost-Share Product for such Cost-Share Indication that Voyager elects to defer, “Deferred AbbVie Development Costs”) and (ii) if such Cost-Share Product receives Regulatory Approval for such Cost-Share Indication, then AbbVie shall notify Voyager of such reconciliation paymentRegulatory Approval, and AbbVie shall be entitled to deduct from any undisputed payments to Voyager under Section 10.2 or Section 10.3 with respect to such Cost-Share Product for such Cost-Share Indication, such Deferred AbbVie Development Costs; provided that in no event shall the deductions made pursuant to this Section 7.4.3(c) reduce by more than [**] percent ([**]%) the amounts that would otherwise be owed under Section 10.2 or Section 10.3.1 (as adjusted by Section 10.3.2 or Section 10.5) in any Calendar Quarter with respect to such Cost-Share Product for such Cost-Share Indication; provided further that if Voyager disputes any portion of an AbbVie Development Cost Report that contains any Deferred AbbVie Development Costs, it shall provide AbbVie with written notice of the disputed portion and its reasons therefor, and if such reconciliation payment dispute is resolved in favor of Voyager and AbbVie has deducted such disputed portion from amounts otherwise owed to Voyager pursuant to Section 10.2 or Section 10.3, AbbVie shall be paid promptly pay such disputed portion to Voyager with interest in accordance with the foregoing timetableSection 10.12. […***…]. In the case of The Parties shall use good faith efforts to resolve any such dispute, the Parties shall promptly meet (by CONFIDENTIAL telephone or otherwise as appropriate) and discuss the issue in the invoice and seek to agree on whether the disputed amount (or what proportion thereof) is properly included in disputes promptly. Credits for any Deferred AbbVie Development Costs or Research Costs, as applicable, incurred by the Parties during such not fully deducted in any Calendar Quarter. If the Parties cannot agree on any such dispute as to Development Costs or Research Costs reported by one or the other Party […***…], then the dispute shall be elevated to the Executive Officers of Astellas and Ambit. Prior to escalating the dispute to the Executive Officer, the Parties shall exchange a written description of the issue in dispute. If the Executives cannot resolve the issue after good-faith efforts […***…], then such dispute (as to such aspects of costs) shall be resolved by expedited arbitration Quarter pursuant to Exhibit E, with each Party providing access to all invoices, receipts and other documents required to establish the Development Costs or Research Cost, as applicable, actually incurred by the Party during such quarter that are in dispute, as needed to determine the actual total amounts of payments to this Section 7.4.3(c) may be made by each Party hereundercarried into future Calendar Quarters.

Appears in 1 contract

Samples: Collaboration and Option Agreement (Voyager Therapeutics, Inc.)

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!