EU Territory definition
Examples of EU Territory in a sentence
EUDRAVIGILANCE MEDICINAL PRODUCTS DICTIONARY RESPONSIBILITIES (“XEVMPD”) The Party holding the MA for the Product in any given EU Territory is responsible for the entry and maintenance of article 57(2) data into the XEVMPD for the Product in the Territory concerned and is responsible for the payment of any related regulatory fees.
The Responsible Trademark Party for a Product to be Commercialized under this Agreement shall select, subject to approval by the Joint Commercialization Committee, a minimum of [****] trademarks in each of the North American Territory and EU Territory and appropriate corresponding trade dress for such Product (whether as a Collaboration Product or Royalty Product).
Solely in the EU Territory (“ET”), which shall be defined, collectively, * * * * *, PROSENSA shall have the right to participate, in some activities as set forth in Exhibit E related to the commercialization of all Products resulting from the GSK Development Programs.
ARS undertakes to proceed promptly with all the activities needed to transfer such responsibility, it being understood that the Product will not be commercialized in the EU Territory without the finalization of the transfer of such responsibilities.
If the Parties elect to form a Committee for the oversight of Commercialization activities in the EU Territory, then the JCC shall be reconstituted with such roles and responsibilities as the Parties may agree.
The Company and each of its Subsidiaries have all permits, licenses and franchises from Governmental Entities required to conduct their businesses as now being conducted and to manufacture for commercial sale, market, sell and otherwise commercialize the Company’s MEPACT product candidate in the EU Territory, and in each case that are material to the Company and its Subsidiaries, taken as a whole (the “Company Permits”).
CMS UK Marketing Authorisation – Qualified Person for Pharmacovigilance (“EU QPPV”) NORGINE will assume this role for the Product for the Marketing Authorisations held by NORGINE and CMS in the EU Territory.
Royalties SIBV shall pay earned royalties to Aridis according to the following terms: · SIBV shall pay the Royalty Rate for: (i) Net Sales of Aridis Products in the Limited Territory (and the EU Territory, if applicable pursuant to section 6); and (ii) Net Sales of Development Products and AR-201 Product in the Worldwide Territory.
Any such EU Territory Grant shall be applicable solely to those Aridis Products specifically noted in the amendment, and for which the conditions below are met.
ARS shall be responsible for all associated expenses to transfer such responsibilities and shall not commercialize the Product in the EU Territory prior to the completion of such transfer.