Unsponsored Work Sample Clauses

Unsponsored Work. Each Party shall be solely responsible for costs it incurs in the performance of any Unsponsored Work.
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Unsponsored Work. If a Party desires to use the data resulting from any Unsponsored Work conducted by the other Party and related Regulatory Materials for purposes other than to comply with any regulatory reporting requirements in its territory, such Party shall notify the other Party in writing, and within [*] days after the receipt of such notice, the other Party shall submit to such Party a reasonable detailed invoice setting forth [*] of the Unsponsored Work Development Costs incurred by such other Party in the course of conducting the Development work that generated such data. If the Party seeking to use such data desires to use such data for such other purposes after reimbursing such costs, such Party shall notify the other Party in writing and shall pay to the other Party the amount invoiced within [*] days after the receipt of the invoice.
Unsponsored Work. Either Party shall have the right, through the JRDC, to propose that one or more additional Clinical Trial(s) (beyond what is then included in the applicable Clinical Development Plan) be conducted for development of the Product, and shall provide the JRDC with any supporting data or publications supporting any such proposal. In such event, the JRDC shall consider such proposal and evaluate the supporting data in good faith. If both Parties’ JRDC representatives agree to conduct such proposed development, the JRDC shall prepare an amendment to the applicable Clinical Development Plan to include the proposed Clinical Trials, for approval by the JSC. If the non-proposing Party (i) does not believe that such additional Clinical Trials are necessary for Regulatory Approval of the Product, (ii) does not wish to fund such proposed activities, and (iii) does not reasonably believe that such proposed activities are substantially likely to create a Material Impact, then the proposing Party shall have the right to perform the proposed activities (the “Unsponsored Work”) at its own expense. The proposing Party shall deliver to the JRDC all proposed plans for such Unsponsored Work in advance of commencing such activities and deliver an update on such Unsponsored Work at each meeting of the JRDC. Promptly following completion of the Unsponsored Work, the proposing Party shall deliver to the JRDC the top-line data summary and shall disclose all other Information resulting from such Unsponsored Work to the other Party. The non-proposing Party shall have access to and the right to use all Information resulting from the Unsponsored Work solely as necessary to comply with the regulatory requirements in its territory in particular with respect to safety reporting and a Party’s license rights to such Information shall be limited solely to such purpose.

Related to Unsponsored Work

  • Scope of Work The Contractor has overall responsibility for and shall provide and furnish all materials, equipment, tools and labor as necessary or reasonably inferable to complete the Work, or any phase of the Work, in accordance with the Owner’s requirements and the terms of the Contract Documents.

  • Continuous Improvement 3.1 The Supplier shall adopt a policy of continuous improvement in relation to the Services pursuant to which it will regularly review with the Authority the Services and the manner in which it is providing the Services with a view to reducing the Authority's costs (including the Framework Prices), the costs of Contracting Bodies and/or improving the quality and efficiency of the Services. The Supplier and the Authority will provide to each other any information which may be relevant to assisting the objectives of continuous improvement and in particular reducing costs.

  • Design At no cost to SCE, Seller shall be responsible for:

  • Tenant Improvements a. Tenant shall cause to be constructed certain tenant improvements (including those listed in Sections 7(e), 7(f) and 7(g) below) in the Additional Premises (“Tenant’s Work”) pursuant to the Work Letter attached as Exhibit E hereto (the “Work Letter”). Landlord shall provide Tenant with an improvement allowance in an amount not to exceed Nine Hundred Five Thousand Five Hundred Thirty-Five Dollars ($905,535) (based upon Forty-Five Dollars ($45) per rentable square foot) (the “TI Allowance”). The TI Allowance may be used to pay for the following costs related to Tenant’s Work: (i) construction, (ii) project oversight by Landlord (which fee shall equal three percent (3%) of the TI Allowance), (iii) space planning, architect, engineering and other related services performed by third parties unaffiliated with Tenant and (iv) building permits and other taxes, fees, charges and levies by Governmental Authorities for permits or for inspections of Tenant’s Work. In no event shall the TI Allowance be used for: (v) payments to Tenant or any affiliates of Tenant, (w) the purchase of any furniture, personal property or other non-building system equipment, (x) the cost of work that is not authorized by the Approved Plans or otherwise approved in writing by Landlord, (y) costs resulting from any default by Tenant of its obligations under the Amended Lease or (z) costs that are recoverable or reasonably recoverable by Tenant from a third party (e.g., insurers, warrantors, or tortfeasors). If the total cost of Tenant’s Work exceeds Forty-Five Dollars ($45) per rentable square foot of the Additional Premises, then Tenant shall pay the overage as and when due. Tenant shall have until December 31, 2008, to expend any unused portion of the TI Allowance, after which date Landlord’s obligation to fund such costs shall expire. Tenant shall deliver to Landlord (Y) a certificate of occupancy for the Additional Premises suitable for the permitted use and (Z) a Certificate of Substantial Completion in the form of the American Institute of Architects document G704, executed by the project architect with respect to Tenant’s Work in the Additional Premises.

  • Performance of Work The Work shall be constructed in a good and workmanlike manner substantially in accordance with the Construction Plans. The Work shall be subject, at the option of Landlord, to the inspection of Landlord, Landlord's Architect and Landlord's General Contractor from time to time, during the period in which the Work is being performed, provided that such inspection does not unreasonably interfere with the completion of the Work. If such inspections reveal that any of the Work is not being constructed substantially in conformance with the provisions of this Agreement or the Final Plans, Tenant at its expense shall correct same forthwith. Only new, first class materials shall be used in the performance of the Work. At all times during the construction of the Work, it shall be Tenant's responsibility to cause each of Tenant's contractors and subcontractors to maintain protection of the Premises in such a manner as to prevent any damage to the Work, or to adjacent property and improvements by reason of the performance of the Work. Tenant's contractor and subcontractors shall properly secure the Premises, including, to the extent required, the furnishing of temporary guard rails and barricades. Landlord for good cause shall have the right to require Tenant to terminate any construction work at any time being performed by or on behalf of Tenant in the Premises, and to require that any contractor or subcontractor, or any employee of same, leave the Building. Upon written notification, setting forth in reasonable detail such good cause, from Landlord to Tenant to cease any work, Tenant shall forthwith remove from the Premises all agents, employees and contractors of Tenant performing such work until such time as Landlord shall have given its written consent for the resumption of such construction work (such consent not to be unreasonably withheld or delayed), and Tenant shall have no claim for damages of any nature whatsoever against Tenant in connection therewith.

  • THE WORK The Work comprises the completed construction required by the Contract Documents and includes all labor necessary to produce such construction, and all materials and equipment incorporated or to be incorporated in such construction.

  • System Maintenance The Trust understands that USBFS will perform periodic maintenance to the System(s), which may cause temporary service interruptions. To the extent possible, USBFS shall notify the Trust of all planned outages and will perform any necessary maintenance during non-business hours.

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