Common use of In the ROW Clause in Contracts

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.

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 ** = Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 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.