Centralized Procedure definition

Centralized Procedure means the European Community Centralized Procedure for marketing authorization in accordance with Council Regulation EEC (2309-93) or any successor regulations.

Centralized Procedure means the procedures of the EU for obtaining marketing authorisation for a medicinal product as set forth in Regulation (EC) No 726/2004 of 31 March 2004, as amended from time to time during the Term.

Centralized Procedure means the procedure through which a Drug Approval Application filed with the EMA results in a single marketing authorization valid throughout the European Union.

Examples of Centralized Procedure in a sentence

• Before the Effective Date of this Agreement, AcelRx has obtained clearance from the EMA that the Licensed Product can (but need not) be submitted through a Centralized Procedure and has submitted a respective letter of intent to the EMA and has requested a corresponding pre-submission meeting with the EMA and Grünenthal has received a copy of such documentation.

• Furthermore, AcelRx has initiated the clearance procedure(s) regarding the AcelRx Trademarks to be used for the commercialization of the Licensed Product under the EMA in accordance with the Centralized Procedure.

• In further consideration of the rights granted hereunder and subject to the other terms and conditions of this Agreement, MIOL shall: (i) if a Marketing Authorization for the Finished Product is granted via the Centralized Procedure [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.

• On June 25, 2015, the MAA was validated by the European Medicines Agency (EMA) and review began under the Centralized Procedure.

• For Products sold in countries subject to Centralized Procedure if Valid Claim exists in such country, for each Royalty Year: Annual Net Sales Royalty Rate Annual Net Sales for the first USD [**] [**] For annual Net Sales more than USD [**] but less than USD [**] [**] For annual Net Sales more than USD [**] [**] ** CERTAIN INFORMATION (INDICATED BY ASTERISKS) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

More Definitions of Centralized Procedure

Centralized Procedure means the procedure for the authorization and supervision of medicinal products for human use set forth in Council Regulation (EEC) No. 2309/93 (the “Regulation”);

Centralized Procedure means, to the extent compulsory or permitted for the Regulatory Approval of a pharmaceutical product in [ * ] any country in the EU, the procedure administrated by the EMA which results in a single Regulatory Approval granted by the European Commission (excluding any pricing or reimbursement approval) that is valid in all countries in the EU and following recognition, [ * ].

Centralized Procedure means submission of an MAA to the EMA using the centralised procedure.

Centralized Procedure means, to the extent compulsory or permitted for the Regulatory Approval of a pharmaceutical product in Iceland, Liechtenstein, Norway, or any country in the EU, the procedure administrated by the EMA which results in a single Regulatory Approval granted by the European Commission (excluding any pricing or reimbursement approval) that is valid in all countries in the EU and, following recognition, in Iceland, Liechtenstein and Norway. 1.11 [*]. 1.12 “China” means, for purposes of this Agreement, the People’s Republic of China, including the Hong Kong Special Administrative Region, the Macau Special Administrative Region, and the Taiwan Region. 1.13 “Clinical Supply” means, with respect to the Product, Product intended or used for the purpose of Development or obtaining Regulatory Approval of the Product in accordance with the Global Development Plan. 1.14 “Clinical Supply Agreement” means the Tisotumab Vedotin Clinical Supply Agreement, by and between Genmab and SGI, dated as of March 15, 2018, as amended. 1.15 “Clinical Trial” means a Phase I Clinical Trial, a Phase II Clinical Trial, a Phase III Clinical Trial, a Phase III-B Study, or a Phase IV Study, as the case may be, as such terms are defined in the Collaboration Agreement. For clarity, “Clinical Trials” do not include any investigator-initiated trials or investigator-sponsored research, which shall be considered Medical Affairs Activities. 1.16 “CMC Development” means the Development activities related to the composition, manufacture, and specification of the drug substance and the drug product (including Combination Products in a single formulation) intended to assure the proper identification, quality, purity and strength of the drug, including site transfer (as conducted pursuant to and in accordance with this Agreement), test method development and stability testing, process development, process improvements (i.e., improving product robustness or manufacturing efficiencies), drug substance development, process validation, process scale-up, formulation development, delivery system development, QA and QC development. 1.17 “CMC Development Costs” means, with respect to the Product, the [*] and [*] that are incurred by a Party or any of its Affiliates on or after the Effective Date that are directly attributable or reasonably allocable to CMC Development activities undertaken directly or

Centralized Procedure the European Union-wide procedure for receipt of the MA for the Product from the EMA, where there is a single application, a single evaluation and a single authorisation for the Product throughout the European Union.

Centralized Procedure means the procedures of the EU for obtaining marketing authorisation for a medicinal product as set forth in

Centralized Procedure means, to the extent compulsory or permitted for the Regulatory Approval of a pharmaceutical product in [ * ] any country in the EU, the procedure administrated by the EMA which results in a single Regulatory Approval granted by the European Commission (excluding any pricing or reimbursement approval) that is valid in all countries in the EU and following recognition, [ * ] .