MAA Approval definition

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.

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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 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 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.

• Grünenthal shall be responsible for the costs and conduct of Regulatory Filings in the Territory, including MAA Approval, and/or other regulatory approvals at a country-specific level.

• 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.

• For the purpose of this Section 14.3(a), if the PMDA grants such MAA Approval conditioned on the performance of additional Phase 3b or other studies, then the PMDA shall be deemed to have granted approval of such MAA.

• Licensee shall also be responsible, at its sole expense, for any specific manufacturing requirements, such as stability studies or development of finished Product presentations, necessary to obtain MAA Approval of the Product in the Licensee Territory.

More Definitions of MAA 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 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/or reimbursement approval.

MAA Approval means, with respect to a Product in Europe, approval of the MAA from the applicable Regulatory Authority in at least three Core European Countries sufficient for the manufacture, distribution, use, marketing and sale of such Product and either (x) pricing and reimbursement approval in such three Core European Countries in accordance with Applicable Laws has been obtained, or (y) the sale of a Product in such three Core European Countries has occurred.

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.

MAA Approval means, with respect to the European Union, approval by the EMA of a MAA filed with the EMA for the applicable Licensed Product under the centralized European procedure or, with respect to Japan, approval by the PMDA of a MAA filed with the PMDA for the applicable Licensed Product in Japan.

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 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 [***].