POI Product definition
Examples of POI Product in a sentence
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.
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 Parties acknowledge that Adolor is in the process of conducting clinical studies on the POI Product necessary to file the NDA.
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.
For the avoidance of doubt, GSK’s deployment of its personnel in the ROW shall have no effect on the calculation of its Sales Representative FTE Requirements for the POI Product in the United States under the Agreement.
For the POI Product in the ROW, the first ROW Net Sales Forecast shall be furnished to Adolor within one hundred twenty (120) days after the Effective Date.
GSK shall, in accordance with the requirements of the E.A.S.E.™ Program, introduce, educate and cause all parties that seek to order the POI Product in the ROW to first apply for registration in the E.A.S.E.™ Program.
The Parties acknowledge and agree that the Agreement, as amended, shall supplement the terms and conditions of the Supply Agreement between Adolor and GSK, dated of even date herewith, (including, without limitation, with respect to the supply of POI Product in the ROW, information required to be shared by the Parties, and indemnification by the Parties).
For the purposes of this Amendment No. 5, the “E.A.S.E.™ Program” means the then-current ENTEREG Access Support and Education (E.A.S.E.™) Program implemented by the Parties as part of the Risk Evaluation and Mitigation Strategy approved by the FDA for the POI Product.
It ------------------------- is understood that Adolor has submitted to the FDA for consideration the trademarks "Entereg" and "Alvanop" for possible use with the POI Product.