Common use of Filings with Governmental Authorities Clause in Contracts

Filings with Governmental Authorities. 9.2.1 Adolor Products in the United States. Adolor will be solely ------------------------------------ responsible for and will use Commercially Reasonable Efforts in applying for, obtaining and maintaining Investigational Authorizations and Marketing Authorizations for the Adolor Products in the United States, including without limitation the responsibility for applying for price approvals for the Adolor Products if required. Upon request by Adolor, GSK shall use Commercially Reasonable Efforts to assist Adolor in applying for, obtaining and maintaining such Investigational Authorizations and Marketing Authorizations (including, with respect to price approvals, as requested by Adolor) for the Adolor Products in the United States. Adolor will be the sole owner of any Investigational Authorizations and Marketing Authorizations for the Adolor Products in the United States. Upon receipt of the initial Investigational Authorizations and Marketing Authorization for the Adolor Products in the United States, Adolor shall have exclusive authority and responsibility to and will use Commercially Reasonable Efforts to maintain and seek appropriate revisions of the conditions of each such Investigational Authorization and Marketing Authorization for the Adolor Products, provided any such revisions are not inconsistent with the provisions of this Agreement or the U.S. Marketing Plan. Adolor shall promptly and in accordance with applicable Law provide to GSK copies of any material documents or correspondence received from any Governmental Authority in the United States, but in no event more than two (2) Business Days after such receipt, that pertains to the Adolor Products (including without limitation any minutes from a meeting with respect thereto). In addition, Adolor shall provide GSK with drafts of any material documents or correspondence to be submitted to any Governmental Authority in the United States that pertains to the Adolor Products. Adolor will consult in advance with, and consider in good faith any comments of, GSK with respect to any filings made or other actions taken by Adolor in accordance with the terms of this Section 9.2, including without limitation any such filings or actions with respect to any changes or modification to labeling for or the indications of the Adolor Products.

Filings with Governmental Authorities. 9.2.1 Adolor Products in the United States. Adolor will be solely ------------------------------------ responsible for and will use Commercially Reasonable Efforts in applying for, obtaining and maintaining Investigational Authorizations and Marketing Authorizations for the Adolor Products in the United States, including without limitation the responsibility for applying for price approvals for the Adolor Products if required. Upon request by Adolor, GSK (a) Each party hereto shall use Commercially Reasonable Efforts to assist Adolor in applying for, obtaining and maintaining such Investigational Authorizations and Marketing Authorizations (including, cooperate with respect to price the notices and filings to be made in connection with the consents, approvals, waivers and authorizations under Law required prior to Closing in connection with the transactions contemplated hereby. Each party hereto shall use reasonable efforts to effect all necessary notifications, registrations and filings with any Governmental Authority in connection with transactions contemplated by this Agreement, including any filings in respect of the Required Consents, the consents, waivers, approvals, licenses, authorizations, Permits, filings and notifications set forth on Schedule 4.4 and the submissions of information requested or required by any Governmental Authority (including any such notifications, registrations or filings required post-Closing). (b) In furtherance and not in limitation of the foregoing, each of the Company and Buyer Parent shall use its commercially reasonable efforts to take, or cause to be taken, all action and to do, or cause to be done, all things necessary under applicable antitrust laws and regulations to consummate and make effective the transactions contemplated by this Agreement, including, without limitation, (i) to comply promptly with all legal requirements which may be imposed on it with respect to this Agreement and the transactions contemplated hereby by any Governmental Authority with regulatory jurisdiction over enforcement of any applicable antitrust Laws ("Governmental Antitrust Authority") (which actions shall include, without limitation, furnishing all information required by applicable Law in connection with approvals of or filings with any Governmental Antitrust Authority), including filing, or causing to be filed, as requested by Adolorpromptly as practicable, any required notification and report forms (x) for under the Adolor Products in HSR Act with the FTC and the Antitrust Division of the United StatesStates Department of Justice (the "Antitrust Division") or (y) under other applicable non-U.S. laws with the applicable non-U.S. Governmental Antitrust Authority, including, without limitation, filings required pursuant to Council Regulation No. Adolor will be the sole owner of any Investigational Authorizations and Marketing Authorizations for the Adolor Products in the United States. Upon receipt 4064/89 of the initial Investigational Authorizations European Community, as amended (the "EC Merger Regulation"), (ii) to obtain any consent, authorization, order, writ, judgment, decree, injunction, or approval of, or any exemption by, any Governmental Antitrust Authority required to be obtained or made by the Company and Marketing Authorization for the Adolor Products Buyer Parent, or any of their respective subsidiaries or Affiliates in the United States, Adolor shall have exclusive authority and responsibility to and will use Commercially Reasonable Efforts to maintain and seek appropriate revisions of the conditions of each such Investigational Authorization and Marketing Authorization for the Adolor Products, provided any such revisions are not inconsistent connection with the provisions of transaction contemplated by this Agreement or the U.S. Marketing Plantaking of any action contemplated by this Agreement and (iii) to take any action necessary to defend vigorously, lift, mitigate or rescind the effect of any Action involving any Governmental Antitrust Authority adversely affecting the transactions contemplated by this Agreement or this Agreement, including promptly appealing any adverse court or administrative decision. Adolor Without limitation of the foregoing, the Company, Buyer Parent and their respective Affiliates shall promptly not extend any waiting period under the HSR Act, the EC Merger Regulation or any other foreign antitrust merger control Laws or enter into any agreement with the FTC or the Antitrust Division not to consummate the transactions contemplated by this Agreement, except with the prior written consent of the other parties hereto. (c) Without limiting the generality of the undertakings and subsections (b) and (d) of this Section 6.5 and subject to appropriate confidentiality protections, the Company and Buyer Parent shall each furnish to the other such necessary information and reasonable assistance as the other party may request in accordance connection with applicable Law the foregoing and shall each provide to GSK counsel for the other party with copies of any material documents or all filings made by such party, and all correspondence received from between such party (and its advisors) with any Governmental Antitrust Authority and any other information supplied by such party and such party's Affiliates to a Governmental Antitrust Authority in connection with this Agreement and the United Statestransactions contemplated hereby. Each party shall, but subject to applicable Law, permit counsel for the other party to review in no event more than two advance (2) Business Days after such receipt, that pertains to the Adolor Products (including without limitation extent practical) any minutes from a meeting with respect thereto). In addition, Adolor shall provide GSK with drafts of any material documents or correspondence to be submitted proposed written communication to any Governmental Authority in Antitrust Authority. Upon the United States that pertains terms and subject to the Adolor Products. Adolor will consult conditions herein provided, in advance withcase at any time after the Closing Date any further action is necessary or desirable to secure the approvals from any and all Governmental Antitrust Authorities necessary to carry out the purposes of this Agreement, the proper officers and/or directors of the parties shall use their best efforts to take or cause to be taken all such necessary action. (d) Without limiting the generality of the undertakings and consider subsections (b) and (c) of this Section 6.5, the Company and Buyer Parent agree to take or cause to be taken the following actions: (i) provide as promptly as practicable information and documents requested by any Governmental Antitrust Authority necessary, proper or advisable to permit consummation of the transactions contemplated by this Agreement, (ii) without in good faith any comments way limiting the provisions of (c)(i) above, use its best efforts to certify as soon as practicable its substantial compliance with any requests for additional information or documentary material that may be made under the HSR Act, (iii) proffer no later than the date that is two months from the date of this Agreement by Buyer Parent of its willingness to (X) sell or otherwise dispose of, GSK or hold separate and agree to sell or otherwise dispose of, any entities, assets or facilities of the Company or the Company Subsidiaries or any entity, facility or asset of Buyer Parent or its subsidiaries or affiliates, (Y) terminate such existing relationships and contractual rights and obligations (other than termination that would result in a breach of a contractual obligation to a third party) and (Z) amend or terminate such existing licenses or other agreements (other than a termination that would result in a breach of a license or such other agreement with a third party) and to enter into such new licenses or other agreements (and, in each case, to enter into agreements with the relevant Governmental Antitrust Authority giving effect thereto) in each case with respect to the foregoing clauses (X), (Y) or (Z) if such action is necessary or reasonably advisable or as may be required by any filings made Governmental Antitrust Authority, provided that any such action contemplated by this clause (iii) shall not be required to be effective prior to the Closing and (iv) take promptly, in the event that any permanent or preliminary injunction or other actions taken writ, judgment, decree or similar order is entered or becomes reasonably foreseeable to be entered in any proceeding that would make consummation of the transactions contemplated by Adolor this Agreement in accordance with the terms of this Section 9.2, including without limitation Agreement unlawful or that would prevent or delay consummation of any such filings or actions with respect to transactions, any changes or modification to labeling for and all commercially reasonable steps (including the appeal thereof, the posting of a bond or the indications taking of the Adolor Productssteps contemplated by clause (iii) of this subsection (d)) necessary to vacate, modify or suspend such injunction or writ, judgment, decree or order so as to permit such consummation on a schedule as close as possible to that contemplated by this Agreement. The Company and Buyer Parent agree to offer the other party, if possible, a reasonable opportunity to participate in all telephonic calls and all meetings with a Governmental Antitrust Authority in which these matters are discussed. (e) The filing fees under the HSR Act, the EC Merger Regulation or any other foreign antitrust merger control laws shall be borne by Buyer Parent.