Examples of Marketing Approval Application in a sentence
Phase III Clinical Study shall also include any other human clinical trial serving as a pivotal study from which the data are actually submitted to the applicable Regulatory Authority in connection with a Regulatory Marketing Approval Application, whether or not such trial is called a “Phase III” study.
Subject to Section 13.3(a)(ii), at any time after […***…] (the “Earliest Termination Date”), Gilead shall have the right to terminate this Agreement upon (Y) if prior to the date of submission of the first Marketing Approval Application for a Licensed Product, […***…] days prior written notice, and (Z) if on or after the date of submission of the first Marketing Approval Application for a Licensed Product, […***…] days prior written notice, (such termination in each case, a “Termination at Will”).
ArthroCare reserves the right to modify Marks or substitute alternative marks for any or all of the Marks at any time upon ninety (90) days prior written notice, provided that ArthroCare shall not modify the Marks unreasonably after the filing of the Marketing Approval Application.
In the event (i) Pioneer does not elect to co-fund the Additional Development within [***] days from receiving NBY’s notice thereof, or (ii) Pioneer elects to co-fund the Additional Development, but after the performance of such Additional Development and filing of the applicable Marketing Approval Application based thereon, NBY is still unable to obtain MAA Approval for the Product, then this Agreement will terminate automatically and NBY will refund Pioneer US$312,500.
On March 4, 2008, the Company submitted a Marketing Approval Application (a “MAA”) for OPAXIO to the EMA based on discussions with the EMA Scientific Advice Working Party.