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.
Commencing in the year in which Teva-Tuteur submits a Marketing Approval Application to a Regulatory Authority within the Territory for a particular Indication, Teva-Tuteur shall prepare, develop and submit to Valera an annual marketing plan in relation to use of the Product for such Indication in the Territory (each, a "MARKETING PLAN") for Valera's review and approval by no later than the 15th of February of each year during the Term for the then-current Calendar Year.
Hanmi shall consult with RAPT via the JSC with respect to any Marketing Approval Applications and applications for Pricing Approval in the Territory, and shall require each of its Affiliates and Sublicensees to, provide RAPT with drafts of each proposed Marketing Approval Application and application for Pricing Approval at least [***] and [***], respectively, before submitting such proposed Regulatory Filing to any Regulatory Authority.