Required Regulatory Approvals (a) The obligations of each Party under this Agreement are expressly contingent upon (i) each Party receiving all licenses, permits, permissions, certificates, approvals, authorizations, consents, franchises and releases from any local, state, or federal regulatory agency or other governmental agency or authority (which may include, without limitation and as applicable, the NYISO and the PSC) or any other third party that may be required for such Party in connection with the performance of such Party’s obligations under or in connection with this Agreement (the “Required Approvals”), (ii) each Required Approval being granted without the imposition of any modification or condition of the terms of this Agreement or the subject transactions, unless such modification(s) or condition(s) are agreed to by both Parties in their respective sole discretion, and (iii) all applicable appeal periods with respect to the Required Approvals having expired without any appeal having been made or, if such an appeal has been made, a full, final and non-appealable determination having been made regarding same by a court or other administrative body of competent jurisdiction, which determination disposes of or otherwise resolves such appeal (or appeals) to the satisfaction of both Parties in their respective sole discretion.
(b) If any application or request is made in connection with seeking any Required Approval and is denied, or is granted in a form, or subject to conditions, that either Party rejects, in its sole discretion, as unacceptable, this Agreement shall terminate as of the date that a Party notifies the other Party of such denial or rejection, in which event the obligations of the Parties under this Agreement shall cease as of such date and this Agreement shall terminate, subject to NYSEG’s obligation to pay National Grid in accordance with the terms of this Agreement (including, without limitation, Section 10.3 above) for all Reimbursable Costs. All of National Grid’s actual costs in connection with seeking Required Approvals shall be included within the meaning of the term Reimbursable Costs and shall be paid for by NYSEG.
Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.
Requisite Regulatory Approvals All Consents required to be obtained from or made with any Governmental Authority in order to consummate the transactions contemplated by this Agreement shall have been obtained or made.
Project Approval The County may issue a Job Order Authorization for the Work, to include the firm-fixed-price of the Job Order and the project duration. Contractor agrees that all clauses of this Contract are applicable to any Job Order issued hereunder. The County reserves the right to reject a Contractor’s Quote based on unjustifiable quantities and/or methods, performance periods, inadequate documentation, or other inconsistencies or deficiencies on the Contractor’s part in the sole opinion of the County. The County reserves the right to issue a unilateral Job Order authorization for the Work if a Quote price cannot be mutually agreed upon. This is based upon unjustifiable quantities in the sole opinion of the County. The County also reserves the right to not issue a Job Order Authorization if the County’s requirement is no longer valid or the project is not funded. In these instances, the Contractor has no right of claim to recover Quote expenses. The County may pursue continuing valid requirements by other means where Contract was not reached with the Contractor.
No Regulatory Approval By Buyer or Company, if either of their respective boards of directors so determines by a vote of a majority of the members of its entire board, in the event any Regulatory Approval required for consummation of the transactions contemplated by this Agreement shall have been denied by final, non-appealable action by such Governmental Authority or an application therefor shall have been permanently withdrawn at the request of a Governmental Authority.
Course Approval Approval for dual credit shall be by the LEA and POSTSECONDARY INSTITUTION representatives on a course-by-course basis each semester based on the student’s prior coursework, career pathway, and/or academic readiness. There is no state limit to the number of credits a student may earn through dual credit in an academic term; however, the student must meet eligibility requirements.
FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.
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.
New Project Approval Consultant and District recognize that Consultant’s Services may include working on various projects for District. Consultant shall obtain the approval of District prior to the commencement of a new project.
Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.
