EMA Territory definition

EMA Territory means, with respect to an MAA filed under the centralized EMA filing procedure, the European Union.
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EMA Territory means those countries in the Territory subject to the jurisdiction of the EMA. “Enforcing Party” has the meaning set forth in S ection 14.3.
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EMA Territory means those countries in the Territory subject to the jurisdiction of the EMA.
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Examples of EMA Territory in a sentence

  • Nektar shall keep Daiichi Sankyo reasonably informed of the submissions for Conditional Marketing Authorization in the EMA Territory and Final Marketing Authorization, including any major supplements or amendments thereto and the progress of such submissions.

  • Nektar will use Commercially Reasonable Efforts to prepare and submit in a timely manner, (i) the Conditional MA seeking Conditional Marketing Authorization for the Licensed Product in the EMA Territory, including all annual renewals thereto, until [***]; and (ii) if applicable, [***].

  • Without limiting the foregoing, in no event will Daiichi Sankyo allow any Health Registration Approval related to the Licensed Product in the 24/66Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016 EMA Territory or Switzerland to lapse, expire or otherwise terminate without Nektar’s prior written consent.

  • The Service provided advice to the Council in connection with an unauthorised agricultural shed adjacent to the scheduled Dunadd fort, the former capital of Dalriata.

  • Without limiting the foregoing, in no event will Daiichi Sankyo allow any Health Registration Approval related to the Licensed Product in the24/66Collaboration & License Agreement_Nektar_Daiichi Sankyo Europe_May 2016 EMA Territory or Switzerland to lapse, expire or otherwise terminate without Nektar’s prior written consent.

  • Until the receipt of Final Marketing Authorization in the EMA Territory, subject to Nektar’s right to terminate this Agreement pursuant to Section 16.2(g), Nektar shall be solely responsible for undertaking, at its cost and expense, all post-approval commitments and obligations imposed by the Health Authority in the EMA Territory with respect to the Licensed Product under the Conditional Marketing Authorization.

  • Subject to the other provisions of this Article 6, including Section 6.2, Nektar shall have the sole right and responsibility, at its sole expense, to prepare and submit the applications for Conditional Marketing Authorization and Final Marketing Authorization, and make all other related submissions with the applicable Health Authority for the Licensed Product in the EMA Territory, as well as to conduct all correspondence and communications with such Health Authority regarding such matters.


More Definitions of EMA Territory

EMA Territory. EMA Territory shall mean, with respect to an MAA filed under the centralized EMA filing procedure, the European Union.
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Related to EMA Territory

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Licensed Territory means worldwide.

  • Territory means worldwide.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Relevant Territory means Hong Kong or such other territory as the Directors may from time to time decide if the issued ordinary share capital of the Company is listed on a stock exchange in such territory;

  • Licensed Field means all fields of use.

  • Exclusive Territory means (1) the states of Illinois, Wisconsin, and Indiana; and

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Union territory means the territory of—

  • Licensed Fields of Use means the fields of use identified in Appendix B.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound or the active pharmaceutical contained in a Unity Bcl-2 [***] Product, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Licensed Field of Use means all fields.

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

  • Service Territory means the geographic area within which PG&E as a Utility Distribution Company is authorized and required to provide electric transmission and distribution service.

  • Traditional Territory means, subject to a Yukon First Nation Final Agreement, with respect to each Yukon First Nation and each Yukon Indian Person enrolled in that Yukon First Nation's Final Agreement, the geographic area within the Yukon identified as that Yukon First Nation's Traditional Territory on the map referred to in 2.9.0.

  • Competing Product means [***].

  • Sales territory means an area of exclusive sales responsibility for the brand or brands of beer sold by a supplier as designated by an agreement.

  • Commercialized shall have corresponding meanings.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • customs territory means the territory of the country of each Contracting Party in which the Customs laws of that country are in force;

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).