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. Portions of this Exhibit, indicated by the mxxx “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

Related to Unsponsored Work

  • 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.

  • Development Work The Support Standards do not include development work either (i) on software not licensed from CentralSquare or (ii) development work for enhancements or features that are outside the documented functionality of the Solutions, except such work as may be specifically purchased and outlined in Exhibit 1. CentralSquare retains all Intellectual Property Rights in development work performed and Customer may request consulting and development work from CentralSquare as a separate billable service.

  • Improvement Plans A professional improvement plan is a clearly articulated assistance program for a teacher whose student growth measure dimension of the evaluation is below the expected level of student growth. For the purposes of this agreement, improvement plans shall be based on the individual student growth measure level, and not for overall subjects or classes taught.

  • General Scope of Work The Scope of Work and projected level of effort required for these SERVICES is described in Exhibit “A” attached hereto and by this reference made a part of this AGREEMENT. The General Scope of Work was developed utilizing performance based contracting methodologies.

  • Performance Improvement Plan timely and accurate completion of key actions due within the reporting period 100 percent The Supplier will design and develop an improvement plan and agree milestones and deliverables with the Authority 3.2 The Authority may from time to time make changes to the KPIs measured as set out in paragraph 3.1 above and shall issue a replacement version to the Supplier. The Authority shall give notice In Writing of any such change to the KPIs measured and shall specify the date from which the replacement KPIs must be used for future reports. Such date shall be at least thirty (30) calendar days following the date of the notice to the Supplier.

  • STOP WORK (a) SELLER shall stop Work for up to ninety (90) days in accordance with any written notice received from LOCKHEED XXXXXX, or for such longer period of time as the parties may agree and shall take all reasonable steps to minimize the incurrence of costs allocable to the Work during the period of Work stoppage. (b) Within such period, LOCKHEED XXXXXX shall either terminate in accordance with the provisions of this Contract or continue the Work by written notice to SELLER. In the event of a continuation, an equitable adjustment in accordance with the principles of the "Changes" clause shall be made to the price, delivery schedule, or other provision(s) affected by the Work stoppage, if applicable, provided that the claim for equitable adjustment is made within thirty (30) days after date of notice to continue.

  • Quality Improvement VRC shall develop programs designed to improve the quality of care provided by the Radiologists and encourage identification and adoption of best demonstrated processes. Practice and VRC acknowledge that, in connection with such quality improvement activities, it may be necessary to provide VRC with Protected Health Information and Practice and VRC agree to treat such information in accordance with Article 9;

  • Scope of Work For the 2022/2023 Grant Period, the Provider will maintain a victim services program that will be available to provide direct services to victims of crime who are identified by the Provider or are presented to the Provider, as specified in the Provider’s 2022/2023 Grant Application as approved by the OAG and incorporated herein by reference.

  • 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.

  • Extra Work At any time during the Term of this Agreement, City may request that Consultant perform Extra Work. As used herein, “Extra Work” means any work which is determined by City to be necessary for the proper completion of the Project, but which the Parties did not reasonably anticipate would be necessary at the execution of this Agreement. Consultant shall not perform, nor be compensated for, Extra Work without written authorization from City’s Representative.

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