By Adolor Clause Samples
By Adolor. Subject to the provisions of this Article 9, Adolor, --------- in the United States, shall have sole authority and responsibility to seek and/or obtain any necessary Governmental Authority approvals of any label, labeling, package inserts or outserts, monographs and packaging, and Promotional Materials that are approved by the Joint Marketing Committee for use in connection with the Adolor Products, and for determining whether the same requires Governmental Authority approval. Upon request by Adolor, GSK shall use Commercially Reasonable Efforts to assist Adolor in its efforts to seek and obtain such Governmental Authority approvals.
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.
By Adolor. Every six (6) months following the Effective Date, Adolor shall provide EpiCept a written report summarizing the efforts and accomplishments of Adolor, its Affiliates and its sublicensees during the preceding six (6) month period in developing and commercializing Licensed Products and their development and commercialization plans for the subsequent six (6) month period. Such reports shall include, without limitation, summaries of scientific and clinical data obtained in furtherance of Adolor’s attempts to develop and commercialize Licensed Products and a showing of compliance with Adolor’s obligations under Section 3.3 above. EpiCept shall have the right to provide Adolor with comments regarding Adolor’s development and commercialization plans for the subsequent six (6) month period contained in such reports and Adolor shall take such comments into consideration, provided that Adolor shall retain final decision-making authority with respect to any and all such development and/or commercialization plans.