Common use of Compliance with Law; Permits and Licenses Clause in Contracts

Compliance with Law; Permits and Licenses. (a) Except as set forth in Section 3.13(a) of the Seller Disclosure Schedule, the JRH Business has been at all times since January 1, 2000 and is being conducted in compliance with all Laws (provided that the foregoing representation and warranty is not made as to compliance with specific Laws where such compliance with the specifically identified Law is explicitly addressed by compliance representations in Sections 3.10(c), 3.13(b), 3.16, 3.19, 3.20, 3.23, 3.27, 3.31 (first sentence) and 3.35, as to which compliance Sellers are making the representations and warranties set forth in such other Sections). Each Company has obtained and is in compliance with all Governmental Entity approvals, permits and licenses required to conduct the JRH Business as currently conducted. Neither the Sellers nor any Company has received any written notice nor, to the Knowledge of Sellers, any unwritten notice, alleging a default, breach or violation of any Law, approval, permit or license. Neither the execution of this Agreement nor the consummation of the transactions contemplated hereunder does or will constitute or result in any such default, breach or violation. (i) Except as set forth in Section 3.13(b)(i) of the Seller Disclosure Schedule, all necessary notifications, applications, licenses, approvals, and amendments and/or supplements thereto, as required by any Laws administered by the FDA, USDA, DEA and the various U.S. states, the TGA Act and Regulations or any Laws of any other jurisdiction relating to human or veterinary medical products and devices have been filed with the FDA, USDA, DEA and any other relevant Governmental Entity for all current products (“Current Products”) and products discontinued since January 1, 2000 (“Past Products” and, together with Current Products, “Products”) manufactured or supplied by or on behalf of any Company in connection with the JRH Business, and all necessary clearances, approvals, licenses and permits have been obtained from the FDA, USDA, U.S. states, TGA and any other relevant Governmental Entity, as applicable. (ii) Except as set forth in Section 3.13(b)(ii) of the Seller Disclosure Schedule, each Company has at all times since January 1, 2000 complied with, and is in compliance with, all relevant Laws governing the Products manufactured or supplied by or on behalf of such Company in connection with the JRH Business and relating to the pre-market development, manufacturing and production, sale and distribution, post-marketing surveillance, adverse event reporting and marketing thereof, including any conditions for approval and/or post-market requirements that are specific to such Products. (iii) Except as set forth in Section 3.13(b)(iii) of the Seller Disclosure Schedule, since January 1, 2002, (A) no Product collected, stored, manufactured, marketed, or distributed by or on behalf of the JRH Business has been recalled, suspended or discontinued, as a result of any action by the FDA, USDA, DEA, U.S. state, TGA, or any other Governmental Entity, by any Company or by any licensee, distributor, or marketer of any such Product, in the U.S. or outside of the U.S., and (B) no Company has received a written notification of a claim seeking the recall, withdrawal, suspension or seizure of any Product manufactured, marketed or distributed by or on behalf of the JRH Business which is pending or, to the Knowledge of Seller, threatened against any Company in relation to the JRH Business. (iv) Except as set forth in Section 3.13(b)(iv) of the Seller Disclosure Schedule, since January 1, 2002, there have been no (A) inspections by the FDA, USDA, DEA, U.S. states, TGA, or other Governmental Entity relating to the JRH Business, or (B) adverse regulatory letters or warning letters, notices of adverse findings, or any other correspondence received by any Company or Sellers in which the FDA, USDA, DEA, a U.S. state, TGA, or other Governmental Entity has stated or explicitly suggested that any Company has violated any Laws administered by such Governmental Entity in connection with such Company’s operation of the JRH Business. Since January 1, 2002 there have been no adverse experience reports or complaints relating to product quality except as set forth in the incidents list, a true and complete copy of which has been made available to Buyer.

Compliance with Law; Permits and Licenses. (a) Except as set forth is disclosed in Schedule 4.5 or Schedule 4.9 attached hereto and for the United States securities laws matters covered in Section 3.13(a) 4.14, and except for any violation or alleged violation of any Law by GTI or any of the Seller Disclosure Schedule, the JRH Business Key GTI Companies that has been fully and finally resolved before a court of competent jurisdiction or otherwise settled in a manner not likely to result in any further loss or liability to GTI or any Key GTI Company, (i) GTI and each of the Key GTI Companies are, and have at all times since January 1been, 2000 and is being conducted in compliance with all Laws of the Russian Federation and any other jurisdiction applicable to GTI or any of the Key GTI Companies, except for such non-compliance which could not be expected to have a material adverse effect on GTI and the Key GTI Companies taken as a whole, (provided that ii) those Key GTI Companies which are organized as joint stock companies under the foregoing representation and warranty is not Laws of the Russian Federation have made as to compliance with specific Laws where such compliance all required filings (if any) with the specifically identified Law is explicitly addressed by compliance representations Federal Commission for the Securities Market in Sections 3.10(c)the Russian Federation in respect of their issued and outstanding capital stock, 3.13(b), 3.16, 3.19, 3.20, 3.23, 3.27, 3.31 and (first sentenceiii) and 3.35, as to which compliance Sellers are making neither GTI nor any of the representations and warranties set forth in such other Sections). Each Company Key GTI Companies has obtained and is in compliance with all received notice from any Governmental Entity approvalsof any pending Action to take all or any part of the properties or assets of GTI or any of the Key GTI Companies by condemnation, permits and licenses required to conduct the JRH Business as currently conducted. Neither the Sellers nor any Company has received any written notice nornationalization or right of eminent domain and, to the Knowledge of SellersGTI, any unwritten noticeno such Actions are threatened. (b) Schedule 4.5 sets forth all telecommunications licenses relating to the provision of telecommunications services by GTI and each of the Key GTI Companies. All material Authorizations necessary for the lawful operation of the business of GTI and each of the Key GTI Companies as previously conducted are validly held by GTI or the relevant Key GTI Company and are, alleging and shall continue to be, in full force and effect for their respective terms. Except as described in Schedule 4.5, GTI and each of the Key GTI Companies are, and have been since the date of issuance of each such Authorization, in compliance in all material respects with all terms and conditions thereof, and the same will not be subject to suspension, modification, revocation, termination or nonrenewal as a default, breach or violation result of any Law, approval, permit or license. Neither the execution and delivery of this Agreement nor and the Related Agreements or the consummation of the transactions contemplated hereunder does or will constitute or result in hereby and thereby. Any applications for the renewal of any such default, breach Authorization which are due prior to the Closing Date will be timely made or violation. (i) Except as set forth in Section 3.13(b)(i) of filed by GTI or the Seller Disclosure Schedule, all necessary notifications, applications, licenses, approvals, and amendments and/or supplements thereto, as required by any Laws administered by the FDA, USDA, DEA and the various U.S. states, the TGA Act and Regulations or any Laws of any other jurisdiction relating to human or veterinary medical products and devices have been filed with the FDA, USDA, DEA and any other relevant Governmental Entity for all current products (“Current Products”) and products discontinued since January 1, 2000 (“Past Products” and, together with Current Products, “Products”) manufactured or supplied by or on behalf of any Company in connection with the JRH Business, and all necessary clearances, approvals, licenses and permits have been obtained from the FDA, USDA, U.S. states, TGA and any other relevant Governmental EntityKey GTI Company, as applicable. (ii) Except as set forth in Section 3.13(b)(ii) of the Seller Disclosure Schedule, each Company has at all times since January 1, 2000 complied with, and is in compliance with, all relevant Laws governing the Products manufactured or supplied by or on behalf of such Company in connection with the JRH Business and relating to the pre-market development, manufacturing and production, sale and distribution, post-marketing surveillance, adverse event reporting and marketing thereof, including any conditions for approval and/or post-market requirements that are specific to such Products. (iii) Except as set forth in Section 3.13(b)(iii) of the Seller Disclosure Schedule, since January 1, 2002, (A) no Product collected, stored, manufactured, marketed, or distributed by or on behalf of the JRH Business has been recalled, suspended or discontinued, as a result of any action by the FDA, USDA, DEA, U.S. state, TGA, or any other Governmental Entity, by any Company or by any licensee, distributor, or marketer of any such Product, in the U.S. or outside of the U.S., and (B) no Company has received a written notification of a claim seeking the recall, withdrawal, suspension or seizure of any Product manufactured, marketed or distributed by or on behalf of the JRH Business which . No Action is pending or, to the Knowledge of SellerGTI, threatened against any Company that may result in relation to the JRH Business. (iv) Except as set forth in Section 3.13(b)(iv) of the Seller Disclosure Schedulemodification, since January 1suspension, 2002revocation, there have been no (A) inspections by the FDA, USDA, DEA, U.S. states, TGA, withdrawal or other Governmental Entity relating to the JRH Business, or (B) adverse regulatory letters or warning letters, notices of adverse findingstermination of, or any other correspondence received by limitation on, any Company or Sellers in which the FDAsuch Authorization, USDA, DEA, a U.S. state, TGA, or other Governmental Entity has stated or explicitly suggested that and GTI is not aware of any Company has violated any Laws administered by valid basis for such Governmental Entity in connection with such Company’s operation of the JRH Business. Since January 1, 2002 there have been no adverse experience reports or complaints relating to product quality except as set forth in the incidents list, a true and complete copy of which has been made available to Buyeran Action.