Examples of Drug Approval Application in a sentence
Novartis may dissolve the JDC upon achievement of the first approval of a Drug Approval Application by the applicable Regulatory Authority for any Licensed Product or upon [***].
The Party that has filed the Drug Approval Application in such country within the Territory or, if no Drug Approval Application has been filed, the Party which has filed the IND (or foreign equivalent) in such country within the Territory shall provide an appropriate response to such contact after such consultation with the other Party.
Prior to submitting any Drug Approval Application, the Parties, through the JDC, shall consult, cooperate in preparing and mutually agree on such Applications and their content and scope.
Catalyst shall have a right to review the content and subject matter of each Drug Approval Application to be filed in the ROW, all correspondence submitted to Regulatory Authorities in the ROW related to Clinical Trial design, all proposed labeling of Licensed Products and post-Regulatory Approval labeling changes, in each case relating to Licensed Product.
As between the Parties, Ruthigen shall be the legal and beneficial owner of the Drug Approval Application and related Regulatory Approval in the Territory.