By Adolor. Subject to the provisions of the Pharmacovigilance --------- Agreement, Adolor shall not, without the consent of GSK, correspond or communicate with any Governmental Authority in the United States concerning the GI Products, or otherwise take any action with any Governmental Authority in the United States concerning any Marketing Authorization or permission under which the GI Products are sold or any application for the same, except as may be required by Law. Furthermore, Adolor shall, promptly upon receipt of any material contact with or communication from any Governmental Authority relating to a Collaboration 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 GSK and respond to all reasonable inquiries by GSK relating thereto. Adolor shall notify GSK of any meeting with a Governmental Authority relating to a Collaboration Product and GSK may elect one person reasonably acceptable to Adolor (such approval not to be unreasonably withheld, refused, conditioned or delayed) to participate as an observer (at GSK's cost and expense) in such meeting. If Adolor is advised by its counsel that it must communicate with any Governmental Authority, then Adolor shall promptly, but in no event more than two (2) Business Days, advise GSK of the same and provide GSK in advance with a copy of any proposed written communication with such Governmental Authority and comply with any and all reasonable requests of GSK concerning any meeting or written or oral communication with such Governmental Authority.
Appears in 5 contracts
Samples: Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp), Collaboration Agreement (Adolor Corp)