Combined Therapy Trial Expenses Sample Clauses

Combined Therapy Trial Expenses. Expenses incurred as described in Article 4 (regarding Manufacturing and supply up to the point where the applicable BioXcel Compound or Nektar Compound arrives at the BioXcel labeling and distribution facility for the applicable Combined Therapy Trial), and Article 6 (regarding intellectual property) shall be borne or shared by the Parties as provided in such Articles. In addition, each Party shall bear its own Third Party License Payments as set forth in Section 2.6(b). For all other expenses that are directly attributable or reasonably allocable to the conduct of the Combined Therapy Trials, (a) Nektar will be responsible for [***] percent ([***]%) of all out-of-pocket costs paid to Third Parties (including taxes, to the extent non-creditable to BioXcel) reasonably incurred in connection with Third Party Contractors, CROs, laboratories and clinical sites/IRBs or otherwise by either Party in connection with the performance of the Combined Therapy Trials including, but not limited to, BioXcel’s out-of-pocket costs of labeling and packaging the unlabeled vials of the Nektar Compound provided by Nektar, labeling and packaging the commercially labeled vials of the CPI Compound provided by the CPI Compound supplier, and labeling and packaging the BioXcel Compound, in each case for distribution to clinical sites, and those costs described under Section 8.5, and that are incurred consistent with the JDC-approved budget for each Combined Therapy Trial (“Third Party Study Costs”); and (b) each Party shall be solely responsible for all of its own internal costs (including all internal full-time equivalents and all costs of individuals engaged as independent contractors) incurred by such Party or any of its Affiliates in the performance of each Combined Therapy Trial, to the extent not included in the definition of Third Party Study Costs. For the avoidance of doubt, Third Party Study Costs does not include Third Party License Payments by Nektar, Third Party License Payments by BioXcel or any Third Party Claims.
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Combined Therapy Trial Expenses. BMS and Exelixis will share the Shared Costs (in accordance with Section 7.2), with BMS responsible for fifty percent (50%) and Exelixis responsible for fifty percent (50%) of the Shared Costs for each control arm and each double therapy arm (i.e., Cabozantinib + Nivolumab or Cabozantinib + Ipilimumab) of each Combined Therapy Trial and with BMS responsible for sixty-seven percent (67%) and Exelixis responsible for thirty-three percent (33%) of the Shared Costs for each triple therapy arm (i.e., Cabozantinib + Nivolumab + Ipilimumab) of a Combined Therapy Trial. The cost allocation (on a percent basis) for the Shared Costs of each Combined Therapy Trial will be calculated prior to the initiation or an amendment of such Combined Therapy Trial and will be the weighted percentages for BMS’ share and for Exelixis’s share of such Combined Therapy Trial, with such weighted percentages calculated on the basis of [ * ] and the applicable allocation percentages above in this Section 7.1 for each arm of such Combined Therapy Trial. The weighted percentages calculated before the initiation of a Combined Therapy Trial will not change and will be applied to all of the Shared Costs of such Combined Therapy Trial unless the number of arms in such Combined Therapy Trial increases or decreases, in which case the weighted percentages will be recalculated and applied to all subsequent Shared Costs for such Combined Therapy Trial (with the weighted percentages being recalculated and applied thereafter whenever there is a change in the number of arms in such Combined Therapy Trial). By way of illustration, if there are [ * ], then the weighted percentage for BMS at the initiation of such Combined Therapy Trial would be calculated as follows: [ * ]. The weighted percentage for Exelixis would be [ * ]. Page 40 [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 7.2 Each Party shall calculate Shared Costs in accordance with GAAP. “Shared Costs” means the costs directly attributable or reasonably allocable by each Party (both out-of-pocket and internal) for the conduct of the Combined Therapy Trial (including but not limited to [ * ]) based on [ * ]. The Shared Costs shall be incurred consistent with the JDC‑approved budget for such Shared Costs. The final budget for each Combined Therapy T...
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Combined Therapy Trial Expenses. Roche shall be responsible for fifty percent (50%), and Exelixis shall be responsible for fifty percent (50%), of the Shared Costs for each Combined Therapy Trial. Shared Costs shall be incurred consistent with the JSC-approved budget for such Combined Therapy Trial. The Parties must approve, under the JSC, a final budget prior to [ * ] for a given Combined Therapy Trial. A JPT will review the budget on a [ * ] basis, and re-calibration of study forecast will be conducted by the Conducting Party if the applicable JPT determines it is necessary. Each Party shall calculate Shared Costs in accordance with US GAAP (Generally Accepted Accounting Principles) or International Financial Reporting Standards. For clarity, expenses incurred as described in Article 5 (regarding manufacturing and supply) and Article 7 (regarding intellectual property) shall not be considered “Shared Costs”, and shall be borne or shared by the Parties as provided in such Articles. In addition, each Party shall bear its own Third Party License Payments as set forth in Section 5.1(b). For the avoidance of doubt, nothing in this Agreement shall establish an employment relationship between one Party and the employees of the other Party regardless of the reimbursement to such other Party for work performed by its employees under this Agreement.
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Combined Therapy Trial Expenses. Expenses incurred as described in Article 4 (regarding manufacturing and supply), and Article 6 (regarding intellectual property) shall be borne or shared by the Parties as provided in such Articles. In addition, each Party shall bear its own Third Party License Payments as set forth in Section 2.6(b). For all other expenses that are directly attributable to the conduct of activities under the Development Plan, including any pharmacokinetic, pharmacodynamics and biomarker research, any Combined Therapy Trials and any additional studies required under Section 2.1(d), (a) BMS will be responsible for all payments made to Third Parties for such expenses (“Third Party Study Costs”) , and (b) each Party shall be solely responsible for all of its own internal costs (including costs of individual independent contractors) incurred by such Party or any of its Affiliates, to the extent not included in the definition of Third Party Study Costs. For avoidance of doubt, Third Party Study Costs do not include Third Party License Payments by Five Prime or any Third Party Claims. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. EXECUTION VERSION
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Related to Combined Therapy Trial Expenses

  • Development Expenses Novartis shall be solely responsible for the costs and expenses of Developing and commercializing Licensed Products pursuant to the terms of this Agreement, except with respect to Infinity’s research, development and commercialization activities with respect to an Abandoned Profile pursuant to Section 3.3.1 (subject to Section 2.3).

  • Development Costs With respect to activities prior to the Amendment Effective Date, each Party was to pay [*] of the total Direct Development Costs of a Product incurred in accordance with the Development Budget (as defined in the Original Agreement). Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement to the contrary, with respect to activities on and after the Amendment Effective Date, subject to Sections 3.1.2, Alimera will be solely responsible for, and shall pay one hundred percent (100%) of, all development costs of a Product, including Direct Development Costs. Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement to the contrary, (i) all payments owing by CDS hereunder with respect to development activities prior to the Amendment Effective Date are hereby deemed fully paid by CDS (or waived, to the extent such waiver may be required), including any Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Costs (as all defined in the Original Agreement), further including any penalties and interest which might have accrued with respect thereto, and further including all CDS payments deferred pursuant to that February 11, 2008 letter agreement sent by CDS and executed by CDS and Alimera regarding deferral of payments under the Original Agreement as of such date; (ii) all payments owing by Alimera hereunder with respect to development activities prior to the Amendment Effective Date are hereby deemed fully paid by Alimera (or waived, to the extent such waiver may be required), including any Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Costs (as all defined in the Original Agreement), and further including any penalties and interest which might have accrued with respect thereto; and (iii) subject to Sections 3.1.1 and 3.1.2, from and after the Amendment Effective Date, CDS will have no liability whatsoever hereunder for any past, present or future development costs, including Direct Development Costs (which includes those incurred before, on and after the Amendment Effective Date), and instead Alimera shall have sole liability therefor.

  • Patent Expenses Unless agreed otherwise, the Party filing a Patent Application will pay all preparation and filing expenses, prosecution fees, issuance fees, post issuance fees, patent maintenance fees, annuities, interference expenses, and attorneys’ fees for that Patent Application and any resulting Patent(s). If a license to any CRADA Subject Invention is granted to Collaborator, then Collaborator will be responsible for all expenses and fees, past and future, in connection with the preparation, filing, prosecution, and maintenance of any Patent Applications and Patents claiming exclusively licensed CRADA Subject Inventions and will be responsible for a pro-rated share, divided equally among all licensees, of those expenses and fees for non-exclusively licensed CRADA Subject Inventions. Collaborator may waive its exclusive option rights at any time, and incur no subsequent financial obligation for those Patent Application(s) or Patent(s).

  • Limit on Operating Expenses The Advisor hereby agrees to limit the Fund’s current Operating Expenses to an annual rate, expressed as a percentage of the Fund’s average daily net assets for the month, to the amounts listed in Appendix A (the “Annual Limit”). In the event that the current Operating Expenses of the Fund, as accrued each month, exceed its Annual Limit, the Advisor will pay to the Fund, on a monthly basis, the excess expense within the first ten days of the month following the month in which such Operating Expenses were incurred (each payment, a “Fund Reimbursement Payment”).

  • Organizational Expenses The Partnership shall elect to deduct expenses, if any, incurred by it in organizing the Partnership ratably over a sixty (60) month period as provided in Section 709 of the Code.

  • Development Budget Attached hereto as Exhibit "B" and incorporated herein by this reference is the Development Budget in an amount equal to $_____________. Owner acknowledges and represents that the attached Development Budget includes the total costs and expenses to acquire, develop, renovate and construct the Real Property and the Apartment Housing.

  • Legal Expenses The Borrower hereby agrees to pay all reasonable fees and expenses of special counsel to the Administrative Agent incurred by the Administrative Agent in connection with the preparation, negotiation and execution of this Amendment and all related documents.

  • Marketing Expenses Certain marketing expenses, such as Selected Dealer conferences, may be advanced to Selected Dealer and later deducted from the portion of the Dealer Manager Fee re-allowed to that Selected Dealer. If the offering of Shares in a Feeder Fund is not consummated, Selected Dealer will repay any such advance to the extent not previously expended on marketing expenses. Any such advance shall be deducted from the maximum amount of the Dealer Manager Fee that may otherwise be re-allowable to Selected Dealer. Notwithstanding anything herein to the contrary, as to any Feeder Fund, Selected Dealer will not be entitled to receive any Dealer Manager Fee and/or Distribution and Shareholder Servicing Fee which would cause the aggregate amount of selling commissions, dealer manager fees, Distribution and Shareholder Servicing Fees and other forms of underwriting compensation (as defined in accordance with applicable FINRA rules) received by the Dealer Manager and all Selected Dealers to exceed 10.0% of the gross proceeds raised from the sale of Shares in the Feeder Fund’s primary offering.

  • Definition of Operating Expenses (a) Subject to the exclusions and provisions hereinafter contained, the term "

  • Additional Expenses The Underwriter will pay all expenses (e.g., shipping, postage and courier costs) associated with the delivery of the Prospectus to prospective investors and investors, other than the costs of delivery to the Underwriter's facilities, provided, that if courier services (other than overnight delivery services utilized in the ordinary course of business) are required to ensure that the Prospectus is delivered to investors on the day immediately preceding the Closing Date, the Company will pay such courier expenses. If the foregoing is in accordance with your understanding of our agreement, please sign and return to the undersigned a counterpart hereof, whereupon this letter and your acceptance shall represent a binding agreement between the Underwriter and the Company. Very truly yours, PAINEWEBBER INCORPORATED By:____________________________ Name: Title: The foregoing Agreement is hereby confirmed and accepted as of the date hereof. GE CAPITAL MORTGAGE SERVICES, INC. By:____________________________ Name: Title:

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