MAA Approval definition

MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.

MAA Approval means, with respect to each country or region, approval of the applicable MAA by the applicable Regulatory Authority.

MAA Approval shall be achieved upon receiving Regulatory Approval of an MAA and, where applicable, receipt of pricing and reimbursement approvals, for the applicable Product in a Major European Country.

Examples of MAA Approval in a sentence

• The Contractor shall deliver the evidence required in the MAA MFOC Contractor Order (CO) 2101 to obtain MAA Approval of: c.

• Should all development of a particular Licensed Product discontinue prior to MAA Approval in the first country, for any reason, and be replaced by an alternative Licensed Product, then, when the next Licensed Product achieves a milestone for which a corresponding milestone payment was made for the discontinued Licensed Product, no payment shall be due with respect to such alternative Licensed Product with respect to milestones 3 through 7.

• For the purpose of this Section 15.3(a), if EMA conditions such MAA Approval on the performance of additional Phase 3b or other studies, then EMA shall not be deemed to have refused the approval of such MAA.

• The GDP shall set forth the timeline and details (including line of therapy, tumor type, primary endpoints, approximate patient size, combination agents and comparator agents) of all preclinical and clinical Development activities to be conducted by the Parties as necessary to generate Data sufficient to meet the common requirements of both the EMA and FDA for MAA Approval of the Compound and Products for RCC, HCC, and other indications agreed upon by the Parties.

• The Parties acknowledge that the transfer of responsibility for the release of Astellas API from NGX or its nominee to Astellas or its nominee in accordance with Section 2.1.2(d) requires a variation to the MAA Approval.

More Definitions of MAA Approval

MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the applicable country or jurisdiction, but excluding any Pricing and Reimbursement Approval.

MAA Approval means the Approval of an MAA by the EMA for the Product in any country in the EU.

MAA Approval means, with respect to a particular country in the TERRITORY, approval by the applicable REGULATORY AUTHORITIES in such country of an MAA filed in such country, permitting PRODUCT to be marketed in that country for the indication(s) for which approval is sought, including, if applicable, approval of pricing or reimbursement.

MAA Approval means the final marketing authorization approval, including full marketing, pricing and reimbursement approval, for the applicable Product, in [**].

MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

MAA Approval means the Approval of an MAA by the EMA for a Product in any country in the EU.

MAA Approval means Approval by the EMA of a MAA filed with the EMA for the applicable Licensed Product under the centralized European procedure. If the centralized EMA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in three of the following countries: France, Germany, Italy, Spain and the United Kingdom. For clarity, MAA Approval shall include any pricing and reimbursement approvals required prior to sale of such Licensed Product in the European Union, or in connection with Approvals achieved in three of the foregoing five European Union member states; provided, that MAA Approval shall in any event be deemed achieved upon First Commercial Sale in any country in the European Union.