Marketing Authorization Approval definition

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

Examples of Marketing Authorization Approval in a sentence

• BI shall also be solely responsible for submission of drug approval applications for Products and will use Diligent Efforts in seeking Marketing Authorization Approval for Products in accordance with this Agreement in the Major Markets and such other countries as BI reasonably determines, following consultation with the applicable Committee.

• In the event that a Collaboration Product other than the POI Product receives the first Marketing Authorization Approval in the United States, then such percentage limitation on dose of Compound shall be redefined by the Parties.

• Licensee shall only use the Licensed Cell Line in the way as permitted by this Agreement and shall not use or have used the Licensed Cell Line for any purpose other than as provided hereunder, including operating the Process, the manufacture of Client Product, Drug Substance and Drug Product, and for other purposes reasonably related to securing Marketing Authorization Approval for the Client Product and/or Drug Product.

• Upon Clinigen’s request, and at Theravance’s sole discretion and cost, Theravance will endeavor to provide Clinigen such other reasonable assistance as may be reasonably required by Clinigen to achieve its Marketing Authorization Approval objectives and Diligent Efforts obligations related to the Licensed Product, which such assistance may be provided directly or through Theravance’s vendors or contractors.

• If agreed by the Joint Steering Committee, and if consistent with Clinigen’s Diligent Efforts obligations, Clinigen may choose not to seek Marketing Authorization and Marketing Authorization Approval for the Licensed Product in a particular Country.

More Definitions of Marketing Authorization Approval

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 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 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 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.

Marketing Authorization Approval means, with respect to a particular country, the approval by the Regulatory Authority of the BLA or MAA filed in such country for the Product, Product Component, or Antibody.