Examples of Adolor Products in a sentence
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.
In the event the Parties agree pursuant to Article 10 that GSK will manufacture Adolor Products for sale in the United States, the license grant in Section 2.1.1(a) shall also include rights to make and have made (subject to Section 2.3) Adolor Products in the United States.
All licenses granted by Adolor to GSK with -------------- respect to the Adolor Products under this Agreement for the United States shall be terminated, except for any trademark or trade dress licenses if GSK is utilizing such Adolor Product Trademark with a GI Product being Commercialized in the United States or with a Collaboration Product being utilized in the ROW.
Adolor -------------------------------------------------- shall promptly, but in no event more than two (2) Business Days after receipt of any inspections, proposed regulatory actions, investigations or requests by any Governmental Authority with respect to the Adolor Products in the United States, as well as any corrective actions initiated by Adolor with respect thereto, notify GSK in detail with respect thereto and will provide GSK with copies of all material related documentation.
Subject to the provisions of the Pharmacovigilance ------ Agreement, GSK shall not, without the consent of Adolor, correspond or communicate with any Governmental Authority in the United States concerning the Adolor Products, or otherwise take any action with any Governmental Authority in the United States concerning any Investigational Authorization or Marketing Authorization or permission under which the Adolor Products are sold or any application for the same, except as may be required by Law.
Notwithstanding the foregoing, the Parties may determine that some or all of any aspect of secondary manufacturing activity, including but not limited to formulation manufacturing, labeling and packaging, of the Adolor Products may be performed by GSK on terms to be determined by the Parties.
When an ---------------------------------------------- Additional Product is added as a Collaboration Product pursuant to Section 4.3, within sixty (60) days following the date of such inclusion, for those Additional Products designated Adolor Products, Adolor shall prepare, and for those Additional Products designated GI Products, GSK shall prepare, for review by the Joint Development Committee and approval by the Joint Steering Committee, a U.S. Development Plan for each such Additional Product.
GSK shall have the right to participate in all material preparation, internal caucus, and debriefing sessions related to meetings or discussions to the extent practicable, whether in person, by teleconference or otherwise, between Adolor or its agents and any Governmental Authority with respect to the Adolor Products in the United States, and Adolor shall provide GSK with reasonable prior written notice of any such sessions and copies of meeting minutes with respect thereto.
Adolor shall have the overall responsibility --------------- for the performance of all Development activities, including regulatory filings, for each Adolor Product that is required to obtain Marketing Authorization for the Adolor Products in the United States and, in furtherance thereof, the Parties shall perform the Development activities, all in accordance with the applicable U.S. Development Plan, for an Adolor Product.
Subject to the ---------------------------------------------- terms and conditions of this Agreement, Adolor shall be responsible to supply, or to obtain supply, of commercial requirements of formulated, packaged and labeled Adolor Products for the United States during the Adolor Product Promotion Term.