Tibotec Countries definition
Examples of Tibotec Countries in a sentence
Tibotec’s regulatory filings with the Regulatory Authorities, including Drug Approval Applications, with respect to the Combination Product in the Tibotec Countries shall be consistent with the CTD.
The following TCP Annual True-Up calculations shall be calculated collectively for the Tibotec Countries of Region B and Region C (which are collectively the “Region” for purposes of this Section C.2) such that there shall be a single TCP Annual True-Up for Region B and Region C.
If at any time Tibotec or any of its Affiliates or Third Party Distributors determines that it desires to sell Generic Region C Combination Product in a Tibotec Country in Region C, Tibotec shall promptly provide advance notice to Gilead of such election and specify in which Tibotec Countries in Region C it intends to sell Generic Region C Combination Product.
Tibotec shall not participate in or sponsor any formal presentation or panel with respect to the Combination Product at any conference or symposia without the prior written consent of Gilead; provided, however, that Tibotec may participate in or sponsor such presentations or panels at conferences or symposia (other than international meetings) in the Tibotec Countries.
The Parties acknowledge and agree that the supply of Combination Product to Tibotec for Distribution in the Tibotec Countries (if any) shall be governed by the applicable Tibotec Distributor Agreement with respect to such country.
Gilead shall provide electronic versions of the CTD (including any such updates) to Tibotec in a mutually agreed-upon format for the purpose of expediting Tibotec’s activities in preparing and filing Regulatory Documentation for the Tibotec Countries.
During a Calendar Year, Gilead shall supply each Unit of Branded Region B/C Combination Product to Tibotec or its designated Affiliate at the TCP Interim Supply Price calculated for the Region B and Region C Tibotec Countries (collectively, the Tibotec Countries of Region B and Region C shall constitute a “Region” for purposes of this Section B.2) during such Calendar Year.
The CTD shall be used by Tibotec solely to obtain Approvals for the Combination Product in the Field in the Tibotec Countries.
Tibotec shall include the CTD in each Drug Approval Application (to the extent required to comply with the requirements for such Drug Approval Application) filed to obtain and maintain Approvals in the Field for the Combination Product in the Tibotec Countries.
For purposes of this Annex DD, “Region” shall be deemed to mean each of (a) Region A (excluding [*]), (b) Region B and Region C collectively (such that there shall be one calculation for all Tibotec Countries in Region B and Region C), (c) [*] An example of the calculation of the Revaluation TCP Invoice with respect to the Tibotec Countries is included below.