Examples of POI Product in a sentence
In the event that a Collaboration Product other than the POI Product receives the first Marketing Authorization Approval in the United States, then such percentage limitation on dose of Compound shall be redefined by the Parties.
The --------------------------------------------- initial U.S. Development Plan for all Development activities for the POI Product, which the Parties hereby approve, is attached to this Agreement as Schedule 1.146.
Unless otherwise agreed to by the Joint Development Committee, all Development Expenses for the POI Product for Commercialization in the United States shall be incurred by Adolor, subject to reimbursement as provided for herein.
It ------------------------- is understood that Adolor has submitted to the FDA for consideration the trademarks "Entereg" and "Alvanop" for possible use with the POI Product.
Each --------------------------------------------------- Party shall offer incentive compensation to its Sales Representatives with respect to the sale of the POI Product in the United States for each Calendar Year during the Adolor Product Promotion Term.
Unless otherwise agreed to by the Joint Marketing Committee, all ------ Marketing Expenses for the POI Product shall be incurred by Adolor, subject to reimbursement as provided for herein.
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.
The Parties acknowledge that Adolor is in the process of conducting clinical studies on the POI Product necessary to file the NDA.
If the Parties agree to ------------------------------------------ Develop the OBD Acute Product, or any Additional Product that becomes an Adolor Product, the Adolor Product Promotion Term shall be extended until the sooner to occur of (a) ** (**) years following the First Commercial Sale in the United States of the OBD Acute Product or such Additional Product that is designated an Adolor Product, or (b) ** (**) years after the First Commercial Sale of the POI Product in the United States.
In the United States, the total daily dose of Compound (in milligrams) in either the IBS Product or the Constipation Product shall be less than ** percent (**%) of the average total daily dose of Compound (in milligrams) recommended in the FDA approved label in the POI Product.