In the ROW Sample Clauses

In the ROW. GSK shall promptly notify Adolor of any material ---------- actions to be taken by GSK with respect to any recall or market withdrawal or other corrective action related the Collaboration Products in the ROW prior to such action to permit Adolor a reasonable opportunity to consult with GSK with respect thereto. To the extent Adolor reasonably believes any such action is likely to adversely affect the POI Product in the United States, Adolor shall notify GSK and GSK shall not take any action without the prior written consent of Adolor unless otherwise required by Law. All costs and expenses with respect to a recall, market withdrawal or other corrective action in the ROW shall be borne by GSK unless such recall, market withdrawal or other corrective action was due solely to the negligence, willful misconduct or breach of this Agreement by Adolor. In accordance with the foregoing, GSK shall have sole responsibility for and shall make all decisions with respect to any recall, market withdrawals or any other corrective action related to the Collaboration Products in the ROW.
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In the ROW. Subject to Sections 4.2 and 5.4, GSK will be solely ---------- responsible for and will use Commercially Reasonable Efforts in applying for, obtaining and maintaining Investigational Authorizations and Marketing Authorizations for the Collaboration Products in the ROW, including without limitation the responsibility for applying for price approvals for the Collaboration Products if required. GSK will be the sole owner of any Investigational Authorizations and Marketing Authorizations for the Collaboration Products in the ROW. Upon receipt of the initial Investigational Authorization and Marketing Authorization for the Collaboration Products in the ROW, GSK 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 Collaboration Products, provided any such revisions are not inconsistent with the provisions of this Agreement or the Commercialization of Products in the United States. GSK shall promptly and in accordance with applicable Laws, but in no event more than five (5) Business Days after such receipt, provide to Adolor copies of any material documents or correspondence received from any Governmental Authority in a Major Market Country relating to the Adolor Products (including without limitation any minutes from a meeting with respect thereto). In addition, GSK shall provide Adolor with drafts of any material documents or correspondence to be submitted to any Governmental Authority in a Major Market Country that pertains to the Adolor Products. GSK will consult in advance with and, subject to the terms of Section 9.1 and the Pharmacovigilance Agreement, and consistent with this Section 9.2, GSK will not file any such material document with any Governmental Authority in a Major Market Country relating to the Collaboration Products that could have an effect on the Adolor Products in the United States without the prior written consent of Adolor, such consent not to be unreasonably withheld, refused, conditioned or delayed; provided that if Adolor does not respond to GSK within two (2) Business Days after receipt of a copy of such material document, GSK shall be permitted to file such material document without the prior written consent of Adolor.
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In the ROW. Serono (or one of its Affiliates) shall be responsible for and act as the sole point of contact for communications with Governmental Authorities in the ROW. Any correspondence directed to CancerVax from Governmental Authorities in the ROW shall promptly, but in no event more than two (2) Business Days after such receipt or contact, be forwarded to Serono for coordination of response. Subject to the provisions of Section 5.5 and the Pharmacovigilance Agreement, CancerVax shall not, without the consent of Serono (which consent shall not be unreasonably withheld or delayed), correspond or communicate with any Governmental Authority in the ROW concerning the Product, or otherwise take any action with any Governmental Authority in the ROW concerning any Approval under which the Product is sold or any application for the same, except as may be required by Law (and then only pursuant to the terms of this Section 5.4.2, Section 5.5 and the Pharmacovigilance Agreement to the extent reasonably possible). Furthermore, CancerVax shall, promptly upon receipt of any contact with or communication from any Governmental Authority relating to the Product, but in no event more than two (2) Business Days after such receipt or contact, forward a copy or description of the same to Serono and respond to all reasonable inquiries by Serono relating thereto. If CancerVax is advised by its counsel that it must communicate with any Governmental Authority in the ROW concerning the Product notwithstanding the first sentence of this Section 5.4.2, then CancerVax shall promptly, but in no event more than two (2) Business Days later, advise Serono of the same and provide Serono in advance with a copy of any proposed written communication with such Governmental Authority and comply with any and all reasonable requests of Serono concerning any meeting or written or oral communication with such Governmental Authority.
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In the ROW 
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