Examples of Core Dossier in a sentence
Notwithstanding the foregoing, Amgen shall have no obligation to share with the non-Regulatory Lead the contents of the CMC Core Dossier.
The Manufacturing Lead shall have sole responsibility for preparing the draft of the [*] Marketing Application Core Dossier for the United States (the “CMC Core Dossier”).
As between the Parties and notwithstanding anything to the contrary provided in this Agreement, Nanobiotix shall retain the full unfettered ownership of the Core Dossier.
In addition, Lian shall provide to Nanobiotix an English translation of those selected Promotional Materials reasonably requested by Nanobiotix for its review and, as applicable, discussion with Lian; (c) all Promotional Materials shall be consistent with the Core Dossier for the Licensed Product; and (d) [***].