Regulatory Rights definition

Regulatory Rights shall have the meaning set forth in Section 19.1.2.
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Regulatory Rights means the following regulatory filings, filed by Xxxxxxx with the United States Food and Drug Administration ("FDA"): the Pre-IDE Meeting Briefing Document, dated May 15, 1996; the Investigational Device Exemption Application for use of T8 Mab-DP, dated December 19, 1996; and the Type II Drug Master File for T8 Mab-DP product, dated December 23, 1996.
Sample 1
Regulatory Rights means all third party (including legal and regulatory) rights, licenses, waivers, priorities, permits, consents, or other authorizations necessary to test or provide the Deliverables and Services, including filings with the ITU, FCC, or any other country’s regulatory body or international organization, landing rights, user allocations, experimental licenses, certifications, or applications for non-conforming operations.
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Examples of Regulatory Rights in a sentence

  • The closing of the sale of the Excess Shares shall take place within five Business Days of the original notice (assuming no regulatory consents are required) if the party not seeking to exercise the Regulatory Rights has not timely objected to the notice; if the party not seeking to exercise the Regulatory Rights had timely objected to the notice, then the closing shall take place within five Business Days of the arbitral resolution of the dispute.

  • In the event that the other party disagrees that the Company has become a Regulatory Affiliate, that party shall provide notice of such disagreement within three Business Days of the notice from the party, and both parties' regulatory counsel shall thereupon consult with each other to come to an agreement on whether or not the Company has become a Regulatory Affiliate seeking to exercise the Regulatory Rights.

  • During this quarter, TGCC formally finalized and received approval for the Task 2 Tool for Clarifying Legal and Regulatory Rights to Benefit from REDD+ that was developed during Year 1 of the TGCC contract.

  • As of the Effective Date and until the execution of any such confirmatory instruments, so far as may be legally possible, RedHill and Salix shall have the same rights in respect of the Transferred RedHill Regulatory Rights and Information and be under the same obligations to each other in all respects as if the said confirmatory instruments had been executed.

  • With the exception of the AG013 Regulatory Rights, Oragenics shall own and control all clinical data and regulatory filings relating to Commercialization of Oragenics Products (except to the extent such become Reverted Products).

  • The Indemnitors shall not assert, and shall cause the Indemnitor Parties (including the Grantee Administrative Agent) not to assert, that any Indemnified Party owes any duty to the Indemnitors, any of the Indemnitor Parties or any other Person, or otherwise is restricted or prohibited in any way from exercising the Grantor Regulatory Rights or otherwise acting in the best interests of any such Indemnified Party in connection with the exercise of any of the Grantor Regulatory Rights.

  • The execution, delivery and performance of this Agreement by ZymoGenetics, and ZymoGenetics’ compliance with the terms and conditions hereof, do not and will not conflict with or result in a breach of any of the terms and conditions of or constitute a default, with or without the passage of time and the giving of notice, under any material contract or other instrument or obligation binding or affecting ZymoGenetics, Recothrom Products, Recothrom Intellectual Property or Recothrom Regulatory Rights.

  • The Indemnitors shall not assert, and shall cause the Indemnitor Parties (including the Administrative Agent) not to assert, that any Indemnified Party owes any duty to the Indemnitors, any of the Indemnitor Parties or any other Person, or otherwise is restricted or prohibited in any way from exercising the Grantor Regulatory Rights or otherwise acting in the best interests o f any such Indemnified Party in connection with the exercise of any of the Grantor Regulatory Rights.

  • Others need better access to outpatient substance abuse treatment and support.

  • The aim of this paper was to identify relevant factors for enhancing competitiveness of BiH manufacturing industry in order to make appropriate recommendations for the formu- lation of adequate industrial policies on the basis of obtained results.


More Definitions of Regulatory Rights

Regulatory Rights means all rights in any jurisdiction to develop or commercialize any product, including rights to conduct any in vitro or in vivo testing, rights to import or export, manufacture, market, advertise, distribute, use or sell a product in any jurisdiction, including, without limitation, rights under any authorization, license, approval or the like to market or test any product, including any supplements or amendments thereto, any marketing or data or other exclusivity rights, any supplementary protection rights, as well as any other regulatory right, in any jurisdiction in which any of the above rights have been or could be granted by an entity authorized to confer same, including, without limitation, any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, in all cases to the extent such rights are owned by Intracel and relate to a product that is part of the OncoVax Program.
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Related to Regulatory Rights

  • Joint Intellectual Property Rights means any work under the Subcontract, which:

  • Licensed Intellectual Property Rights means any Intellectual Property Rights owned by a third party that a Person has a right to use, exploit or practice by virtue of a license grant, immunity from Legal Action or otherwise.

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

  • Intellectual Property Rights (IPR) (11/18) means any patent rights, copyrights, trade secrets, trade names, service marks, trademarks, trade dress, moral rights, know-how and any other similar rights or intangible assets to which rights of ownership accrue, and all registrations, applications, disclosures, renewals, extensions, continuations, or reissues of the foregoing now or hereafter in force. “Key Personnel” (11/18) means the specific individuals identified in Section 3.11 to fill Key Positions.

  • IP Rights has the meaning specified in Section 5.17.

  • Intellectual Property Rights shall have the meaning ascribed to such term in Section 3.1(p).

  • Intellectual Property Right means any patent, trade mark, service mark, copyright, moral right, right in a design, know-how and any other intellectual or industrial property rights, anywhere in the world whether or not registered.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • Ancillary Rights means, in each case with respect to the relevant Seller Receivable:

  • Regulatory Filings means all applications, filings, dossiers and the like submitted to a Regulatory Authority in a particular jurisdiction for the purpose of obtaining Regulatory Approval of a Licensed Product from that regulatory authority with respect to such jurisdiction. Regulatory Filings shall include, but not be limited to, all INDs and Drug Approval Applications for Licensed Product.

  • Third Party Intellectual Property Rights means any Intellectual Property owned by a third party.

  • Company IP Rights means all Intellectual Property owned, licensed, or controlled by the Company or its Subsidiaries that is necessary for or used in the operation of the business of the Company and its Subsidiaries as presently conducted.

  • IP Ancillary Rights means, with respect to any other Intellectual Property, as applicable, all foreign counterparts to, and all divisionals, reversions, continuations, continuations-in-part, reissues, reexaminations, renewals and extensions of, such Intellectual Property and all income, royalties, proceeds and Liabilities at any time due or payable or asserted under or with respect to any of the foregoing or otherwise with respect to such Intellectual Property, including all rights to xxx or recover at law or in equity for any past, present or future infringement, misappropriation, dilution, violation or other impairment thereof, and, in each case, all rights to obtain any other IP Ancillary Right.

  • Transferred Intellectual Property Rights means (a) the Transferred Patents, (b) the Transferred Copyrights, (c) the Transferred Internet Properties, (d) the Transferred Industrial Designs, (e) The Transferred Database Rights,(f) the Transferred Mask Work Rights, (g) the Transferred Trade Secrets, and (h) the Transferred Trademarks.

  • Business Intellectual Property Rights means (a) the Intellectual Property Rights owned or licensed by the Group Companies and (b) any other Intellectual Property Rights owned or licensed by Seller or any of its other Subsidiaries and used solely in the conduct of the Business.

  • 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.

  • Intellectual Property Rights or IPR means copyright, rights related to or affording protection similar to copyright, rights in databases, patents and rights in inventions, semi-conductor topography rights, trade marks, rights in internet domain names and website addresses and other rights in trade or business names, designs, Know-How, trade secrets and other rights in Confidential Information; applications for registration, and the right to apply for registration, for any of the rights listed at (a) that are capable of being registered in any country or jurisdiction; and all other rights having equivalent or similar effect in any country or jurisdiction;

  • Company Licensed Intellectual Property means Intellectual Property Rights owned by any Person (other than a Group Company) that is licensed to any Group Company.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

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

  • Joint Intellectual Property means, collectively, Joint Know-How and Joint Patents.

  • Background Intellectual Property Rights means all Intellectual Property Rights owned, controlled, obtained, or licensed by a Party at any time prior to or after the term of this Agreement, or arising from development of Technology created independently of this Agreement.

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing, and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).

  • Regulatory Bodies means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate, investigate, or influence the matters dealt with in the Contract or any other affairs of the Authority and “Regulatory Body” shall be construed accordingly.

  • Patents means all patents, patent applications and like protections including without limitation improvements, divisions, continuations, renewals, reissues, extensions and continuations-in-part of the same.

  • Regulatory entity means any board, commission, agency,