Marketing Authorization Approval definition

Marketing Authorization Approval means approval by a Governmental Authority for sale of a Collaboration Product, including any applicable pricing, final labeling or reimbursement approvals.

Marketing Authorization Approval means, with respect to a country or extra-national territory, any and all approvals (including a New Drug Application or Biologics License Application approved by the FDA), licenses, registrations or authorizations of any Regulatory Authority necessary in order to commercially distribute, sell or market a product in such country or some or all of such extranational territory, including any pricing or reimbursement approvals.

Marketing Authorization Approval means approval by a Governmental Authority for sale of a Product, including any applicable pricing, final labeling or reimbursement approvals.

Examples of Marketing Authorization Approval in a sentence

• If such termination occurs prior to receipt of Marketing Authorization Approval in the United States, then Daré shall provide notice of termination upon ninety (90) days’ notice to SST, and thereafter Daré shall provide notice of termination upon one hundred eighty(180) days’ prior written notice to SST.

• After the completion of Phase II Development, Daré shall use Commercially Reasonable Efforts to implement the strategies set by the JDC with respect to all objectives concerning Marketing Authorization Approval of Licensed Products in the Territory, and Daré shall take the lead with respect to the submission of information to the applicable Regulatory Authorities in connection therewith, all in accordance with the Development Plan.

• Commercial Sale in [***] within [***] ([***]) years after receipt of Marketing Authorization Approval in the United States.

• The obligation to provide such reports shall cease on the earliest to occur of (i) the receipt of Marketing Authorization Approval in each Major Market; (ii) the end of the Royalty Term or (iii) the cessation of on-going Development activities.

• Product that contains TD-3327 are approved in the same Marketing Authorization Approval, then in addition to the relevant milestone for the single-agent TD-3327 Collaboration Product, the relevant milestone for the LABA/ICS Combination Product shall be paid simultaneously.

More Definitions of Marketing Authorization Approval

Marketing Authorization Approval means the decision(s) of a Governmental Authority to issue, renew, amend and/or register Marketing Authorization.

Marketing Authorization Approval means approval by a Regulatory Authority necessary for commercialization of a Licensed Product in the corresponding jurisdiction, including NDA Approval.

Marketing Authorization Approval or “MAA” means marketing authorization approval (including approval of a BLA) that has been granted for any Product.

Marketing Authorization Approval means all of the respective government registrations, including drug regulatory approval and other licenses and permits necessary for the production, storage, importation into, and the marketing, sale and distribution of the Fumaric Acid Products or use of the Fumaric Acid Processes;

Marketing Authorization Approval means approval by a Regulatory Authority, including but not limited to, any applicable pricing, final labeling or reimbursement approvals, necessary to Manufacture and Commercialize a Licensed Product within an applicable country of the Territory.

Marketing Authorization Approval means, with respect to any country or region, any registration, license, approval or authorization from any Regulatory Authority required for the Development, Manufacture or Commercialization of a Product in a regulatory jurisdiction in such country or region, including any pricing or reimbursement approval required by Applicable Laws to obtain such registration, license, approval or authorization.

Marketing Authorization Approval means a legally valid approval by the European Commission of a “marketing authorisation application” in the European Union, through the centralized procedure, which grants the right to sell, market and promote the E-Product in the European Union for human use in accordance with applicable Legal Requirements. For the avoidance of doubt, Marketing Authorization Approval does not refer to approval in one or more individual member states in the European Union or to a positive opinion by EMA’s Committee for Medicinal Products for Human Use.