Cost-Covering Study Sample Clauses

Cost-Covering Study. (a) Avenue agrees to collaborate with and accordingly requests the service support from Licensor for the performance of the: (i) Phase 1b/2a Clinical Trial (i.e., JM17-201-201 with clinical trial identifier NCT 05517603); and (ii) long-term chronic toxicity studies (six (6)-month GLP in rats (i.e., JM-17-03-23-001) and nine (9)-month GLP in dogs (i.e., JM-17-03-23-002) respectively conducted for the development of Licensed Product in the Territory (“Cost-Covering Study”). (b) Avenue has approved and agreed to protocols and all operation plans of Cost- Covering Study, including standard operating procedure, provided by Licensor. Cost-Covering Study is projected be completed no later than March 31, 2025. Any extension request should be provided to Avenue with the reason of such request in writing before March 1, 2025. (c) Unless otherwise provided in Agreement, Licensor shall conduct the Cost Covering Study until it is completed (i.e., issuance of the final clinical study report), and shall, unless otherwise approved by Avenue in writing, complete the Cost-Covering Study on or before March 1, 2025. Licensor shall not terminate conduct of the Cost Covering Study without Avenue’s prior written consent. Without limiting the generality of the foregoing, in connection with conducting the Cost Covering Study, License shall perform the following activities: (i) For Phase 1b/2a Clinical Trial: (A) Clinical project management, including: (1) Vendor management (monitoring, supervising, and communicating with the vendors, which include CRO for Clinical operation, PD assays, PK bioanalysis, to ensure all activities are executed as planned; (2) Negotiate & finalize contract and budget terms with each site and monitor spending; (3) Sites management: maintaining open communication with PIs and site staff; conducting on-site visits to ensure site compliance and CRO performance; (4) Patient engagement, recruitment, and retention; (5) Overall logistics, such as management and transportation of investigational product, biological samples, and ancillary supplies, and; (6) Risks detection, mitigation, and management; (B) Conduct and/or supervise all trainings required; (C) Develop and review study related documents/materials; (D) Revise/amend study protocol when necessary and ensure compliance; (E) Perform query resolution related to regulatory and site startup activities; (F) Oversee the stability, shipment, and inventory of the investigational product, and; (G) Review, confirm...
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Related to Cost-Covering Study

  • Project Cost Overruns In the event that the Recipient determines that the moneys granted pursuant to Section II hereof, together with the Local Subdivision Contribution, are insufficient to pay in full the costs of the Project, the Recipient may make a request for supplemental assistance to its District Committee. The Recipient must demonstrate that such funding is necessary for the completion of the Project and the cost overrun was the result of circumstances beyond the Recipient's control, that it could not have been avoided with the exercise of due care, and that such circumstances could not have been anticipated at the time of the Recipient's initial application. Should the District Committee approve such request the action shall be recorded in the District Committee's official meeting minutes and provided to the OPWC Director for the execution of an amendment to this Agreement.

  • Project Cost An updated cost spreadsheet reflecting the current forecasted cost vs. the latest approved budget vs. the baseline budget should be included in this section. One way to track project cost is to show: (1) Baseline Budget, (2) Latest Approved Budget, (3) Current Forecasted Cost Estimate, (4) Expenditures or Commitments to Date, and (5) Variance between Current Forecasted Cost and Latest Approved Budget. Line items should include all significant cost centers, such as prior costs, right-of-way, preliminary engineering, environmental mitigation, general engineering consultant, section design contracts, construction administration, utilities, construction packages, force accounts/task orders, wrap-up insurance, construction contingencies, management contingencies, and other contingencies. The line items can be broken-up in enough detail such that specific areas of cost change can be sufficiently tracked and future improvements made to the overall cost estimating methodology. A Program Total line should be included at the bottom of the spreadsheet. Narratives, tables, and/or graphs should accompany the updated cost spreadsheet, basically detailing the current cost status, reasons for cost deviations, impacts of cost overruns, and efforts to mitigate cost overruns. The following information should be provided:

  • Project Schedule Construction must begin within 30 days of the date set forth in Appendix A, Page 2, for the start of construction, or this Agreement may become null and void, at the sole discretion of the Director. However, the Recipient may apply to the Director in writing for an extension of the date to initiate construction. The Recipient shall specify the reasons for the delay in the start of construction and provide the Director with a new start of construction date. The Director will review such requests for extensions and may extend the start date, providing that the Project can be completed within a reasonable time frame.

  • Cost Overruns The Borrower shall ensure that all cost-overruns over the estimated construction costs of the Project as certified by a quantity surveyor or the Architect or as ascertained by the Lender as and when they occur shall be funded by the Borrower’s own equity;

  • Project Work Plan The Statement of Work is the formal document incorporated into the Grant. The Project Work Plan documents how the Grantee will achieve the performance measures outlined in the Grant. Changes to the Statement of Work require an amendment. Project Work Plans may be changed with written approval from PEI and the Grantee.

  • Project Costs Simultaneously with the execution of this Agreement, the Company shall disclose to the Department all of the Project Costs which the Company seeks to include for purposes of determining the limitation of the amount of the Credit pursuant to Section 5-30 of the Act and provide to the Department a Schedule of Project Costs in the form as attached hereto as Exhibit C.

  • Construction Contract; Cost Budget Prior to execution of a construction contract, Tenant shall submit a copy of the proposed contract with the Contractor for the construction of the Tenant Improvements, including the general conditions with Contractor (the “Contract”) to Landlord for its approval, which approval shall not be unreasonably withheld, conditioned or delayed. Following execution of the Contract and prior to commencement of construction, Tenant shall provide Landlord with a fully executed copy of the Contract for Landlord’s records. Prior to the commencement of the construction of the Tenant Improvements, and after Tenant has accepted all bids and proposals for the Tenant Improvements, Tenant shall provide Landlord with a detailed breakdown, by trade, for all of Tenant’s Agents, of the final estimated costs to be incurred or which have been incurred in connection with the design and construction of the Tenant Improvements to be performed by or at the direction of Tenant or the Contractor (the “Construction Budget”), which costs shall include, but not be limited to, the costs of the Architect’s and Engineers’ fees and the Landlord Coordination Fee. The amount, if any, by which the total costs set forth in the Construction Budget exceed the amount of the Tenant Improvement Allowance is referred to herein as the “Over Allowance Amount”. In the event that an Over-Allowance Amount exists, then prior to the commencement of construction of the Tenant Improvements, Tenant shall supply Landlord with cash in an amount equal to the Over-Allowance Amount. The Over-Allowance Amount shall be disbursed by Landlord prior to the disbursement of any of the then remaining portion of the Tenant Improvement Allowance, and such disbursement shall be pursuant to the same procedure as the Tenant Improvement Allowance. In the event that, after the total costs set forth in the Construction Budget have been delivered by Tenant to Landlord, the costs relating to the design and construction of the Tenant Improvements shall change, any additional costs for such design and construction in excess of the total costs set forth in the Construction Budget shall be added to the Over-Allowance Amount and the total costs set forth in the Construction Budget, and such additional costs shall be paid by Tenant to Landlord immediately as an addition to the Over-Allowance Amount or at Landlord’s option, Tenant shall make payments for such additional costs out of its own funds, but Tenant shall continue to provide Landlord with the documents described in items (i), (ii), (iii) and (iv) of Section 2.2.2.1 of this Tenant Work Letter, above, for Landlord’s approval, prior to Tenant paying such costs. All Tenant Improvements paid for by the Over-Allowance Amount shall be deemed Landlord’s property under the terms of the Lease.

  • 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.

  • Tenant Improvement Plans Any work proposed by Tenant (the “Tenant Improvements”) shall be subject to Landlord’s reasonable prior approval and shall be subject to the other terms and conditions of this Exhibit C; provided that it will be reasonable for Landlord to withhold its approval or consent (as and when applicable under this Exhibit C) if Landlord’s Mortgagee has not consented to the matter that is the subject of such approval or consent. All architectural, engineering and other design fees shall be paid by Tenant. Tenant shall use its architect, engineers and other design professionals, all of whom shall comply with any applicable licensing or governmental requirements of the City of Seattle and the State of Washington; Tenant’s architect shall be approved by Landlord (“Tenant’s Architect”), which approval shall not be unreasonably withheld, conditioned or delayed. Landlord shall also be entitled to receive a copy of the agreement between Tenant and Tenant’s Architect (the “Architect Agreement”). Tenant shall cause Tenant’s Architect to prepare a draft space plan (the “Space Plan”) for the Tenant Improvements and shall submit the proposed Space Plan to Landlord for the latter’s approval (not to be unreasonably withheld) in a time period to allow Tenant to timely complete its Tenant Improvements under this Lease. Landlord shall deliver to Tenant any written objections, questions or comments of Landlord with regard to the Space Plan within ten (10) business days of receipt; Landlord’s consent thereto shall be deemed given if not denied in writing within said ten (10) business day period. If Landlord denies its approval, it shall specify the reasons for doing so in detail. Tenant shall cause the Space Plan to be revised to address such written comments and shall resubmit said Space Plan to Landlord for approval. Such process shall continue until Landlord has approved the Space Plan. Tenant’s Architect shall then prepare working drawings and specifications for the Tenant Improvements, including architectural, structural, plumbing, mechanical, electrical, and fire protection drawings as required, suitable for permit application (the “Working Drawings”) and shall submit the proposed Working Drawings to Landlord for the latter’s approval in a time period to allow Tenant to timely complete its Tenant Improvements under this Lease. The Space Plan and Working Drawings shall be subject to Landlord’s approval, which Landlord agrees shall not be unreasonably withheld, conditioned, or delayed. Landlord shall not be deemed to have acted unreasonably if it withholds its approval thereof because, in Landlord’s reasonable opinion, the work, as described in any such item: (i) is likely to adversely affect Building Systems, the structure of the Building or the safety of the Building and/or their occupants; (ii) might impair Landlord’s ability to furnish services to Tenant or other tenants in the Building; (iii) would materially increase the cost of operating the Building; (iv) would violate any governmental laws, rules or ordinances (or interpretations thereof); (v) contains or uses hazardous or toxic materials or substances; (vi) would negatively affect the appearance of the Building; (vii) is reasonably likely to adversely affect another tenant’s premises; or (viii) is prohibited by any ground lease affecting the Building or any mortgage, trust deed or other instrument encumbering the Building. Landlord shall deliver to Tenant any written objections, questions or comments of Landlord with regard to the Working Drawings, within ten (10) business days of Landlord’s receipt of the Working Drawings; Landlord’s consent thereto shall be deemed given if not denied in writing within said ten (10) business day period. If Landlord denies its approval, it shall specify the reasons for doing so in detail. Tenant shall cause the Working Drawings to be revised to address such written comments and shall resubmit said Working Drawings to Landlord for approval. Landlord may, when approving the Tenant Improvement Plans, elect to require Tenant to remove any Non-Standard Improvements which are made to the Premises. If Landlord so elects, Tenant shall, at its own cost, restore the Premises to the condition designated by Landlord in its election, before the last day of the Term. Such process shall continue until both parties have approved the Working Drawings. Landlord’s approval of the Space Plan and/or the Working Drawings shall not be deemed any representation or warranty that the same comply with applicable codes.

  • Total Project Cost With regard to any Real Property acquired prior to or during the development, construction or improvement stages, all hard and soft costs and expenses paid or incurred by or on behalf of the Corporation that are in any way related to the development, construction, improvement or stabilization (including tenant improvements) of such Real Property, including, but not limited to, any debt, whether borrowed or assumed, land and construction costs.

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