Data Exclusivity Right definition

Data Exclusivity Right means the right or protection, granted by a Regulatory Authority in a jurisdiction, providing with respect to a drug product: (i) marketing exclusivity that prevents the Regulatory Authority from accepting or approving an application for Regulatory Approval such as a New Drug Application (whether new or abbreviated), a BLA or an application relating to a biosimilar product submitted by a party, for a pharmaceutical product (including a generic, biosimilar, similar medicinal product or generic or competing version of a pharmaceutical product) that is the same or a bioequivalent of the drug product, such as through new molecular entity or biological product or orphan drug or pediatric exclusivity designation by the applicable Regulatory Authority, or an exclusive right to sell pursuant to the data exclusivity provisions such as those under EC Directives 2004/27/EC and 2001/83/EC and Regulation 726/2004/EC; or (ii) data protection for regulatory data relating to the drug product against unfair commercial use or public release consistent with, or no less stringent than, Article 39.3 of the TRIPS Agreement.
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Data Exclusivity Right means any data exclusivity rights or exclusive marketing rights conferred by any Regulatory Authority with respect to a Product (other than Patents), including orphan drug exclusivity, market exclusivity, data exclusivity, or pediatric exclusivity.
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Data Exclusivity Right means the right or protection, granted by a Regulatory Authority in a jurisdiction, providing with respect to a drug product in such jurisdiction: (i) marketing exclusivity that prevents the Regulatory Authority from accepting or approving an application for Marketing Authorisation such as a an NDA(whether new or abbreviated), a Biologics License Application or an application relating to a biosimilar product submitted by a party other than the Parties (or their Affiliates, or licensees or sublicensees as applicable), for a pharmaceutical product (including a generic, biosimilar, similar medicinal product or generic or competing version of a pharmaceutical product) that is the same or a bioequivalent of the drug product, such as through new molecular entity or biological product or orphan drug or paediatric exclusivity designation by the applicable Regulatory Authority, or an exclusive right to sell pursuant to the data exclusivity provisions such as those under EC Directives 2004/27/EC and 2001/83/EC and Regulation 726/2004/EC; or (ii) data protection for regulatory data relating to the drug product against unfair commercial use or public release consistent with, or no less stringent than, Article 39.3 of the TRIPS Agreement.
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More Definitions of Data Exclusivity Right

Data Exclusivity Right means any data exclusivity rights or exclusive marketing rights conferred by any Regulatory Authority with respect to a Product (other than Patents), including orphan drug exclusivity, market exclusivity, data exclusivity, or pediatric exclusivity. Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by MeiraGTx Holdings plc
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Related to Data Exclusivity Right

  • Regulatory Exclusivity means any exclusive marketing rights or data exclusivity rights granted by a Regulatory Authority (other than Patents) with respect to a Licensed Product sold in a given country, including orphan drug exclusivity, new chemical entity exclusivity, data exclusivity or pediatric exclusivity.

  • Technology Rights means BOARD's rights in any technical information, know-how, processes, procedures, compositions, devices, methods, formulae, protocols, techniques, software, designs, drawings or data created by the inventor(s) listed in Exhibit I at UTMDACC before the EFFECTIVE DATE, which are not claimed in PATENT RIGHTS but that are necessary for practicing PATENT RIGHTS.

  • Licensed IP Rights means, collectively, the Licensed Patent Rights and the Licensed Know-How Rights.

  • Regulatory Exclusivity Period means, with respect to each Licensed Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country that prevents the approval or marketing of any Biosimilar Product of such Licensed Product in such country.

  • Licensed Technology means the Licensed Know-How and Licensed Patents.

  • Exclusivity means the specificity of the test method for validating microbial testing methods. It evaluates the ability of the method to distinguish the target organisms from similar but genetically distinct non-target organisms.

  • Licensor Technology means the Licensor Patents, the Licensor Know-How, Licensor Materials, Product IP, and Licensor’s rights in the Program IP and Joint Patents.

  • Product Technology means the Product Know-How and Product Patents.

  • Licensed Know-How means all Know-How that (a) is Controlled by Pfizer or any of its Affiliates as of the effective date of the Pfizer-MPP Agreement, (b) directly relates to the use of the Compound, Product or Licensed Product in the Field, and (c) is not in the public domain or otherwise generally known. For the avoidance of doubt, (i) Licensed Know-How shall not include any Know-How to the extent solely and directly related to any other Pfizer compound or to the extent related to the use of the Compound, Product or Licensed Product outside the Field and (ii) Licensed Know-How includes only that Know-How, designated by Pfizer in its sole discretion, necessary for the manufacture, registration and commercialization of the Compound and/or Licensed Product for use in the Field. For the avoidance of doubt, Licensed Know-How excludes any Know-How related to ritonavir that has been (either as of the Effective Date or at any time during the term of this Agreement) in-licensed by Pfizer from any Third Party.

  • Background Technology means all Software, data, know-how, ideas, methodologies, specifications, and other technology in which Contractor owns such Intellectual Property Rights as are necessary for Contractor to grant the rights and licenses set forth in Section 14.1, and for the State (including its licensees, successors and assigns) to exercise such rights and licenses, without violating any right of any Third Party or any Law or incurring any payment obligation to any Third Party. Background Technology must: (a) be identified as Background Technology in the Statement of Work; and (b) have been developed or otherwise acquired by Contractor prior to the date of the Statement of Work, or have been developed by Contractor outside of its performance under the Statement of Work. Background Technology will also include any general consulting tool or methodology created by Contractor, which will not be required to be identified in the Statement of Work.

  • Licensee Technology means the Licensee Know-How and Licensee Patents.

  • Product Know-How means Know-How

  • Third Party Technology means all Intellectual Property and products owned by third parties and licensed pursuant to Third Party Licenses.

  • Patent Rights means the rights and interests in and to issued patents and pending patent applications (which, for purposes of this Agreement, include certificates of invention, applications for certificates of invention and priority rights) in any country or region, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, all letters patent granted thereon, and all reissues, re-examinations and extensions thereof, and all foreign counterparts of any of the foregoing.

  • Patent Right means: (a) an issued or granted patent, including any extension, supplemental protection certificate, registration, confirmation, reissue, reexamination, extension or renewal thereof; (b) a pending patent application, including any continuation, divisional, continuation-in-part, substitute or provisional application thereof; and (c) all counterparts or foreign equivalents of any of the foregoing issued by or filed in any country or other jurisdiction.

  • Licensed Patent Rights means:

  • License Key means a unique key-code that enables Licensee to run Software subject to the obtained User Pack.

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

  • Licensed Patents means (a) all United States patents and patent applications listed in Exhibit A, as modified pursuant to Section 2.6.1, including patents arising from such patent applications; and (b) any re-examination certificates thereof, and their foreign counterparts and extensions, continuations, divisionals, and re-issue applications; provided that “Licensed Patents” will not include any claim of a patent or patent application covering any Manufacturing Technology.

  • Background IPR means any Intellectual Property Rights (other than Project IPR) belonging to either party before the Commencement Date or not created in the course of or in connection with the Project;

  • Licensed IP means the Intellectual Property owned by any person other than the Corporation and to which the Corporation has a license which has not expired or been terminated;

  • Licensed Intellectual Property Rights means all Intellectual Property Rights owned by a third party and licensed or sublicensed to either the Company or any of its Subsidiaries.

  • Collaboration Technology means all Collaboration Patents and Collaboration Know-How.

  • Intellectual Property Right means any patent, patent right, trademark, trademark right, trade name, trade name right, service xxxx, service xxxx right, copyright and other proprietary intellectual property right and computer program.

  • Program Patent Rights means all Patent Rights that claim or cover patentable Program Know-How, including any Program-Specific Patent Rights.

  • 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.