Marketing Approval Application definition

Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

Marketing Approval Application or “MAA” means an application submitted to a Regulatory Authority for Marketing Approval (together with supporting documentation), including in the United States a biologic license application (as described in 21 CFR 601.2).

Marketing Approval Application or “MAA” means an NDA or any corresponding application in the applicable country or jurisdiction outside of the United States.

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.

More Definitions of Marketing Approval Application

Marketing Approval Application means a marketing authorization application (including or comparable to an NDA), including all supporting documentation and data submitted for such application to be accepted for review or approval, filed with the requisite REGULATORY AUTHORITY of any country of the TERRITORY, and requesting approval for commercialization of PRODUCT for a particular indication in such country.

Marketing Approval Application means a BLA, NDA, MAA or similar application for Regulatory Approval that is filed with the applicable Regulatory Authority(ies) in any country or jurisdiction.

Marketing Approval Application or “MAA” means BLA, sBLA, NDA, sNDA and any equivalent thereof in the United States or any other country or jurisdiction in the Territory. As used herein: “BLA” means a Biologics License Application and amendments thereto filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. § 600 et seq., for FDA approval of a Licensed Product and “sBLA” means a supplemental BLA; and “NDA” means a New Drug Application and amendments thereto filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. § 314 et seq., for FDA approval of a Licensed Product and “sNDA” means a supplemental NDA.

Marketing Approval Application or "MAA" shall mean a New Drug Application (as defined in 21 C.F.R.Section 314.50 et. seq.), or a comparable filing for Marketing Approval (not including pricing or reimbursement approval) in a country, in each case with respect to a Licensed Product in the Territory.

Marketing Approval Application means the appropriate application or registration submitted to the appropriate Regulatory Authority in the Territory to seek Regulatory Approval.

Marketing Approval Application. (or “MAA”) shall mean a BLA submitted to (and the submission of which has been accepted for review by) the FDA in the United States or a corresponding application which has been submitted to (and the submission of which has been accepted for review by) a Regulatory Authority in any other jurisdiction.

Marketing Approval Application means generally a marketing authorization application filed with the FDA, EMA or other applicable health/regulatory authority, for approval to market and distribute Licensed Products in the applicable jurisdiction, including, without limitation, an NDA or PMA filed with the FDA.