Approval of Core Sample Clauses

Approval of Core. Data Sheet and CMC Information. (a) Subject to the terms and conditions of this Section 8.1.6(a), SGI shall be responsible for preparing a draft Core Data Sheet for the Product and may propose amendments thereto from time to time during the Term. The JRT, together with the CDS Working Group, will (i) review a draft Core Data Sheet prepared by SGI and any amendments thereto proposed by SGI, and (ii) agree on a proposed version of the Core Data Sheet to submit to the JDC. The JDC will then review such version and approve a draft of the Core Data Sheet for submission to the JSC for the JSC’s approval. The Core Data Sheet and any amendments thereto must be approved by the JSC. Notwithstanding the foregoing, each Party shall (A) be responsible for creating and updating the local product information for the Product in its Party Major Market(s) (and SGI shall have such responsibility for the Royalty Territory) and (B) solely with respect to such Party’s Major Market(s) shall submit such information to the JRT and CDS Working Group. All such local product information (including with respect to the Royalty Territory) shall be subject to approval by the JSC if any substantive deviations are made from the then-current Core Data Sheet as last approved by the JSC. The JRT and CDS Working Group shall decide if any such local product information requires approval of the JSC. Notwithstanding anything herein to the contrary, (1) the Lead Regulatory Party shall be responsible for maintaining the Core Data Sheet, including local product information, for each country in the Territory for which it is Lead Regulatory Party, and (2) any changes to the local product information required by Applicable Law or a Governmental Authority in any Major Market may be made by the applicable Lead Regulatory Party irrespective of any Committee review or approval contemplated by this Section 8.1.6(a); provided, that any such changes shall be communicated by the applicable Party to the JRT and the CDS Working Group in a timely manner. For the avoidance of doubt, SGI shall be responsible for (x) maintaining the Core Data Sheet for each country in the Royalty Territory, (y) making any amendments thereto subject to JSC approval, and (z) creating, updating and maintaining any local product information for the Product for each country in the Royalty Territory without an obligation to obtain JSC approval unless such local product information would constitute a substantive deviation from the then-cur...
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Related to Approval of Core

  • Approval of Plan Approval of the Plan by the Commissioner of Internal Revenue as referred to in 17.1 means a continuing approval sufficient to establish that the Plan and related trust(s) are at all times qualified and exempt from income tax under Section 401(a) and other applicable provisions of the Internal Revenue Code of 1986, and that contributions made by the Company under the Plan are deductible for income tax purposes in accordance with law. The cognizant governmental authorities referred to in 17.1 include, without limitation, the Department of Labor, the Pension Benefit Guaranty Corporation and the Securities and Exchange Commission, and their approval means their confirmation with respect to any matter within their regulatory authority that the Plan does not conflict with applicable law.

  • Approval of Listing At the Closing Time, the Securities shall have been approved for listing on the New York Stock Exchange, subject only to official notice of issuance.

  • Approval of Agreement The Board of Directors of the Company has authorized the execution and delivery of this Agreement by the Company and has approved this Agreement and the transactions contemplated hereby.

  • Approval of Counsel The exercise of the Option and the issuance and delivery of shares of Class A Stock pursuant thereto shall be subject to approval by the Corporation's counsel of all legal matters in connection therewith, including, but not limited to, compliance with the requirements of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder, and the requirements of any stock exchange upon which the Class A Stock may then be listed.

  • Waiver of Notice; Approval of Meeting; Approval of Minutes The transactions of any meeting of Limited Partners, however called and noticed, and whenever held, shall be as valid as if it had occurred at a meeting duly held after regular call and notice, if a quorum is present either in person or by proxy. Attendance of a Limited Partner at a meeting shall constitute a waiver of notice of the meeting, except when the Limited Partner attends the meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened; and except that attendance at a meeting is not a waiver of any right to disapprove the consideration of matters required to be included in the notice of the meeting, but not so included, if the disapproval is expressly made at the meeting.

  • Approval of Plans Landlord will not check Tenant drawings for building code compliance. Approval of the Final Plans by Landlord is not a representation that the drawings are in compliance with the requirements of governing authorities, and it shall be Tenant’s responsibility to meet and comply with all federal, state, and local code requirements. Approval of the Final Plans does not constitute assumption of responsibility by Landlord or its architect for their accuracy, sufficiency or efficiency, and Tenant shall be solely responsible for such matters.

  • Approval of Merger The Merger shall be governed by Section 251(h) of the DGCL and shall be effected by Parent, Merger Sub and the Company as soon as practicable following the consummation of the Offer, without a vote of the stockholders of the Company, pursuant to Section 251(h) of the DGCL.

  • Effect of non-approval of proposals (6) Notwithstanding that under subclause (1) any proposals of the Company are approved by the Minister or determined by arbitration award, unless each and every such proposal and matter is so approved or determined by 31 October 1992 or by such extended date or period if any as the Company shall be granted pursuant to the provisions of this Agreement then the Minister may give to the Company 12 months notice of intention to determine this Agreement and unless before the expiration of the said 12 months period all the detailed proposals and matters are so approved or determined this Agreement shall cease and determine subject however to the provisions of Clause 35. Implementation of proposals

  • State Approval of Replacement Personnel The Engineer may not replace the project manager or key personnel without prior consent of the State. The State must be satisfied that the new project manager or other key personnel is qualified to provide the authorized services. If the State determines that the new project manager or key personnel is not acceptable, the Engineer may not use that person in that capacity and shall replace him or her with one satisfactory to the State within forty-five (45) days.

  • Application Approval Our representative will notify you (or one of you, if there are co-applicants) of the Application approval, execute the Lease agreements for signature prior to occupancy, and, once complete, credit the application deposit of all applicants toward the required security deposit.

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