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.
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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.
Sample 1
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.
Sample 1
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 or reasonably allocable to the conduct of the Combined Therapy Trials, (a) BMS will be responsible for fifty percent (50%) of all out-of-pocket costs (including taxes) reasonably incurred in connection with Third Party CROs and laboratories and clinical sites/IRBs or otherwise by either Party in connection with the performance of each Combined Therapy Trial and that are incurred consistent with the JDC-approved budget for the 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, 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 BMS, Nektar or any Third Party Claims.
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Related to Combined Therapy Trial Expenses

  • Development Costs Licensee shall be responsible for all of its costs and expenses in connection with the Development of, and obtaining and maintaining Regulatory Approvals for, the Licensed Products in the Field in the Territory.

  • Medical Expenses 1. Employees exposed to hazardous physical, biological, or chemical agents shall be provided, at no cost to the employee, with medical examinations or evaluations required by VOSHA regulations. If there are no specific VOSHA regulations or standards for the agent in question, recommendations of the National Institute of Occupational Safety and Health or other generally recognized expert organization shall be used, as determined by the Commissioner of Health. 2. Employees determined by the Health Department to be at substantial risk for exposure to contagious diseases shall be provided appropriate vaccines. Groups at risk will be defined by the Vermont Department of Health. If no guidelines have been published by the Department of Health, the guidelines published by the Center for Disease Control in Atlanta, Georgia will apply. Vaccines and/or appropriate medical examinations will be provided at no cost to the employee according to applicable guidelines. 3. Any Department wishing to implement a Medical Monitoring Program on or after July 1, 1990, shall do so by conferring with the Health Department, and the Department of Human Resources. Prior to implementation, the Department of Human Resources shall notify VSEA. The parties shall meet within ten (10) days (unless mutually extended) after a request for negotiations by either party and thereafter on a regular basis for a period not exceeding forty-five (45) calendar days, after which the State may implement the program, whether or not the parties have bargained to genuine impasse. The VSEA shall retain all statutory impasse procedure rights as may be lawfully available to VSEA during the life of this Agreement, provided, however, the State at any time may withdraw its proposed medical monitoring program or terminate without further bargaining a medical monitoring program previously implemented, in which case, such retained statutory impasse procedure rights are extinguished.

  • 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”).

  • Covered Expenses Supervisors must have received prior authorization from their Appointing Authority before incurring any expenses authorized by this Article.

  • 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 Each Credit Party 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.

  • Definition of Operating Expenses Operating Expenses" shall mean and include all expenses incurred and payable in connection with the ownership, operation, maintenance, repair and management of the Premises and the improvements thereon and, without restricting the generality of the foregoing, shall include:

  • Additional Expenses to be inserted if applicable.

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