Examples of EU Regulatory Approval in a sentence
Millennium shall use commercially reasonable efforts to follow such advice and shall take all actions reasonably necessary to accomplish the EU Regulatory Approval Transfer on or as soon as possible after the Effective Date.
Prior to the Effective Date, Spark has independently initiated ongoing clinical studies in the United States of Luxturna to support Spark’s efforts to obtain EU Regulatory Approval and Regulatory Approval in the Spark Territory (collectively, the “Existing Luxturna Clinical Program”).
The following three items (x), (y) and (z) may be discussed at meetings of the JSC, but, in the event that the JSC is unable to resolve any such issue to the satisfaction of the Parties within [**], such issue shall be treated as a dispute and either Party may evoke the dispute resolution procedures set forth in ARTICLE 11.(x) Issues arising with respect to obtaining the EU Regulatory Approval and the Parties’ obligations pursuant to Section 4.4.1(a).
Any responsibility of ASTELLAS for the preparation of the Common Technical Document or any MAA does not, pursuant to this Agreement or otherwise, guarantee that EU Regulatory Approval will be obtained.
From the Effective Date up until two years following the first EU Regulatory Approval of a Product, either Party may, upon written notice to the other Party, unilaterally terminate this Agreement if the Parties are prevented in any manner that materially adversely affects the progression of the Development or Commercialization of Product(s) as contemplated in this Agreement for a period of six (6) months or more as a result of any Government Order based on antitrust or competition Law grounds.