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.
APPROVAL OF PLANS AND SPECIFICATIONS The Plans and Specifications will conform to the requirements and conditions set out by applicable law or any effective restrictive covenant, and to all governmental authorities which exercise jurisdiction over the Leased Premises or the construction thereon.
Product Recall (a) If any governmental agency with jurisdiction over the recall of any goods supplied hereunder provides written notice to Buyer or Seller, or Buyer or Seller has a reasonable basis to conclude, that any goods supplied hereunder could possibly create a potential safety hazard or unsafe condition, pose an unreasonable risk of serious injury or death, contain a defect or a quality or performance deficiency, or are not in compliance with any applicable code, standard or legal requirement so as to make it advisable, or required, that such goods be recalled and/or repaired, Seller or Buyer will promptly communicate such relevant facts to each other. Buyer shall determine whether a recall of the affected goods is warranted or advisable, unless Buyer or Seller has received notice to that effect from any governmental agency with jurisdiction over the recalled goods.
Required Regulatory Approvals Certain transactions required, permitted or otherwise contemplated by this Agreement may under certain circumstances require prior filings with and approvals, or non-disapprovals, from the Indiana Department of Insurance or the Indiana Insurance Commissioner. Such transactions include: (a) issuance or purchase of any additional capital stock of the Company or other securities convertible into or exchangeable or exercisable for capital stock of the Company pursuant to Sections 1.2 or 3.4; (b) transfer of Shares to a wholly owned subsidiary of a Shareholder, to another Shareholder or to a wholly owned subsidiary of another Shareholder pursuant to Sections 3.1(a) or 3.4; (c) exercise of preemptive rights by a Shareholder pursuant to Section 3.2; and (d) exercise of call rights by the Company or a Shareholder pursuant to Section 3.3 (including pursuant to the two provisos in Section 3.1(b)). Notwithstanding anything to the contrary contained in this Agreement, any such transactions requiring filings with and approvals, or non-disapprovals, from the Indiana Department of Insurance or the Indiana Insurance Commissioner shall not, to the extent within the control of a party hereto, be entered into or consummated unless and until the required filings have been made and the required approvals (or non-disapprovals) have been obtained, and to the extent not within the control of an applicable party hereto, such party shall use best efforts to cause such transactions not to be entered into or consummated unless and until the required filings have been made and the required approvals (or non-disapprovals) have been obtained.
Reporting Obligations and Regulatory Approvals Applicable laws and regulations may require holders and beneficial owners of Shares, including the Holders and Beneficial Owners of ADSs, to satisfy reporting requirements and obtain regulatory approvals in certain circumstances. Holders and Beneficial Owners of ADSs are solely responsible for determining and complying with such reporting requirements and obtaining such approvals. Each Holder and each Beneficial Owner hereby agrees to make such determination, file such reports, and obtain such approvals to the extent and in the form required by applicable laws and regulations as in effect from time to time. Neither the Depositary, the Custodian, the Company or any of their respective agents or affiliates shall be required to take any actions whatsoever on behalf of Holders or Beneficial Owners to determine or satisfy such reporting requirements or obtain such regulatory approvals under applicable laws and regulations.
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.
Product Orders All Product orders shall be submitted by the Operators to DISTRIBUTOR and shall specify the location of the Operator’s Stores, the type of Product, and the quantity desired. Operators may place orders electronically (“Electronic Orders”) or by telephoning or faxing DISTRIBUTOR’s customer service center in accordance with the guidelines detailed below. All shipment expenses from DISTRIBUTOR’s distribution center to the Operator’s location shall be at DISTRIBUTOR’s expense unless otherwise noted elsewhere in this Agreement. Product order guides will be provided by DISTRIBUTOR to the Operators monthly via DISTRIBUTOR’s website and with a hard copy delivered to each Store, with availability of such order guides to be made prior to the beginning of the month, but only after review and approval of the order guide by COMPANY. The order guides will be organized by Product categories and will include, among other things, the Product Sell Price (as defined herein), Product units and new Products. DISTRIBUTOR will assign one product code number to each stock-keeping unit (“SKU”) of each Product, which will be common throughout its entire distribution system and will be used on all documents such as order guides, invoices, monthly reports, etc. SKU’s, and, accordingly, the assigned product code number, must differ for equivalent Products supplied by different suppliers. DISTRIBUTOR will use its best efforts to utilize the existing TCBY product item numbers. Only Products approved for sale to its Operators by the COMPANY will be listed on this order guide. Electronic Orders will be placed via telephone modem or internet using DISTRIBUTOR’s automated order entry system. All orders are subject to the standard order cut-off time of 4:00 p.m. local time, one (1) day prior to their scheduled delivery day for Stores located in the states of Florida and Georgia and 4:00 p.m. local time. In no event will Electronic Orders be required more than two (2) days prior to the scheduled delivery day. Operators will be notified prior to the time of final order cut-off if a product is expected to be out of stock so that an alternative may be ordered, subject to the provisions of Section 3.02. Operators will have until 5:00 p.m. local time, one (1) day before their order shipping day to modify or add-on to their order. Notwithstanding the foregoing, Stores that do not place Electronic Orders and have scheduled delivery days of Monday in Florida and Georgia, must have their orders placed by 4 p.m. local time, on the preceding Friday. DISTRIBUTOR may schedule deliveries any day of the week. Where reasonably possible, DISTRIBUTOR will schedule ordering days and delivery days that are mutually agreed upon by and between DISTRIBUTOR and each Operator and will provide notice to the affected Operator at least fourteen (14) days before routing changes. On an exception basis, DISTRIBUTOR will consider shortening the permissible time frames for scheduled deliveries for those Operators that, given unique and compelling business needs, require the same. Operator will be notified of any Product shortages at the time of order placement or, in the case of an Electronic Order, one (1) day prior to the loading of the delivery truck.
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.
Approval Order The Bankruptcy Court shall have entered the Approval Order and such Order shall be a Final Order.
Regulatory Approval Any waiting period applicable to the Transactions under the HSR Act shall have been terminated or shall have expired.
