Regulatory Rights definition

Regulatory Rights shall have the meaning set forth in Section 19.1.2.
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.
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.

Examples of Regulatory Rights in a sentence

  • 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).

  • Regulatory Rights When requested, Rubic will inform and copy Dyadic and its designated consultants, if any, on all communications between Rubic and any regulatory authority relating to this Agreement, including any Candidate Product, Commercial Product or the C1 Platform.

  • Notwithstanding the foregoing, no Lien or security interest is hereby granted on any Excluded Property and the Collateral securing the Secured Obligations to Milestone Creditors shall be limited to the Product Intellectual Property, Product Regulatory Rights and all Proceeds thereof.

  • ZymoGenetics owns or holds a valid license to use the Recothrom Intellectual Property (including, without limitation, U.S. Patents 5,476,777, 5,502,034, and 5,527,692), the Recothrom License and the Recothrom Regulatory Rights.

  • In case of any delays, if necessary, Sepracor expressly permits Nycomed or its designee to Sepracor's Regulatory Rights for the registration and/or Commercialization of the Product in the Territory and in the Field.

  • Indemnitor shall not assert, and shall cause the Indemnitor Parties not to assert, that any Indemnified Party owes any duty to Indemnitor, any of the Indemnitor Parties or any other Person, or otherwise is restricted or prohibited in any way from exercising the Indemnitee Regulatory Rights or otherwise acting in the best interests of any such Indemnified Party in connection with the exercise of any of the Indemnitee Regulatory Rights.

  • Any one or more of the Indemnified Parties shall have the right, but not the obligation, to access the Operating Records in order to verify that Mining Operations at the Mine comply with the Mining Industry Best Practices and the Operating Parameters, and to exercise their respective Indemnitee Regulatory Rights (the “ Inspection Right”).

  • The Indemnified Parties may use any non-public information obtained pursuant to the Inspection Rights to confirm compliance by the Indemnitor Parties under this Deed and in furtherance of the exercise of the Indemnitee Regulatory Rights, and shall not use such non-public information for any other purpose.

  • 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.

  • ZymoGenetics shall take all commercially reasonable actions, at no cost or expense to Deerfield, to obtain and maintain all Recothrom Intellectual Property and Recothrom Regulatory Rights necessary to manufacture or have manufactured, package, label, promote, distribute, offer for sale and sell Recothrom Products throughout the Royalty Term throughout the United States (but not necessarily its territories or possessions).


More Definitions of Regulatory Rights

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.

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, including but not limited to, any patent, registered design, copyright, trademark, trade secrets and any other intellectual or industrial property right as well as the right to apply to register any of the mentioned rights.

  • Regulatory Materials means materials developed or compiled in preparation for Regulatory Authority meetings, regulatory applications, submissions, dossiers, notifications, registrations, Regulatory Approvals and/or other filings made to or with, or other approvals granted by, a Regulatory Authority that are necessary or reasonably desirable for the Development, manufacture, market, sale, or Commercialization of a Licensed Product in a particular regulatory jurisdiction.

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

  • Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

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

  • Company IP Rights means (a) any and all Intellectual Property used in the conduct of the business of the Company or any of its Subsidiaries as currently conducted, and (b) any and all other Intellectual Property owned by the Company or any of its Subsidiaries.

  • 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.

  • 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 all Intellectual Property that is licensed to the Company by any third party.

  • 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 Intellectual Property Rights owned, controlled or furnished by either Party other than Foreground Intellectual Property Rights.

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product (including any applicable 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,

  • Owned Intellectual Property Rights means any and all Intellectual Property Rights owned or purported to be owned by the Company or any of its Subsidiaries.