FDA Matters 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 or reasonably be expected to result in 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 or reasonably be expected to result in 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.
FCC Matters (a) The license attached hereto as Exhibit A is a true and correct copy of the License. There is no other condition, to the knowledge of Seller, imposed by the FCC as part of the License that is neither set forth on the face of the License as issued by the FCC, or contained in the FCC rules applicable generally to the licenses of the type, nature and class or location of the License. No other licenses or authorizations are required from the FCC for the operations of facilities in compliance with the License on the Seller Channels in the market area as of the Effective Date. Except as set forth in Section 3.5 below, no Person other than Seller has any right, title, interest or claim in or to the License. The License has been granted to Seller by Final Order and is in full force and effect.
(b) Excluding the proceedings in WT Docket No. 03-66, there is not pending or, to the knowledge of Seller, threatened against Seller or the License before the FCC or any other Governmental Authority any application, action, petition, objection or other pleading, or any proceeding with the FCC or any other Governmental Authority, which (i) questions or contests the validity of, or seeks the revocation, forfeiture, non-renewal or suspension of, the License, (ii) seeks the imposition of any modification or amendment with respect thereof, (iii) which would adversely affect the ability of Seller to consummate the Transactions, or (iv) seeks the payment of a fine, sanction, penalty, damages or contribution in connection with the use of the License. To Seller's knowledge there are no facts or circumstances existing that would give rise to any such application, action, petition, objection or other pleading, or proceeding with the FCC or any other Governmental Authority.
(c) Other than under the Interference Agreements listed in Exhibit E hereto, Seller has not located, in a search of its readily available records as of the Effective Date, any other written agreements to accept or allow any electromagnetic interference from any other FCC licensees, permittees or applicants with respect to the License and/or Seller Channels, and, to Seller's knowledge, no other such licensees, permittees or applicants have agreed to accept electromagnetic interference from Seller with respect to their respective facilities.
(d) To Seller's knowledge, Seller is in compliance with all applicable Laws except for any non-compliance that, individually or in the aggregate, will not have a material adverse effect on the License or on Seller's ability to consummate the Transactions. To Seller's knowledge, since the grant of the Seller's most recent renewal application for the License, Seller has complied in all material respects with FCC Laws applicable to the License, including without limitation the Communication Act of 1934, as amended. Since the issuance of the License, Seller has not received a notice of non-compliance from the FCC. To Seller's knowledge all material documents required to be filed at any time by Seller with the FCC with respect to the License have been timely filed or the time period for such filing has not lapsed. To Seller's knowledge, all such documents filed since the date that the License was issued to Seller are correct in all material respects. All amounts owed to the FCC in connection with the License have been timely paid.
(e) As of the Effective Date, the facilities subject to the License for which certification or notification of completion of construction has been filed with the FCC are not operating.