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.
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 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 internet using DISTRIBUTOR’s web-site. All Electronic Orders are subject to the standard order cut-off time of 4:00 p.m. local time, two (2) days prior to their scheduled delivery day. Operators will have until 5:00 p.m. local time, two (2) days before their order shipping day to modify or add-on to their order. Orders not placed electronically may be subject to earlier cut-off times than those established above as mutually agreed upon between COMPANY and DISTRIBUTOR. Operators will be notified prior to 10:00 a.m. the day after their 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. Notwithstanding the foregoing, Stores that have a scheduled delivery day of Monday, must have their orders placed by 12:00 p.m. local time, on the preceding Saturday and Stores that have a scheduled delivery day of Tuesday must have their orders placed by 12:00 p.m. local time, on the preceding Sunday. DISTRIBUTOR may schedule deliveries at any time and day of the week. However, 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.
