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 ▇▇▇▇▇▇▇ 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.

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

• 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.

• 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.

• 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.

• 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).

• 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.

• 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.

• 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.

• 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.

• It is further agreed that the Employer is entitled to make any changes which may be necessary to comply with the requirements of the British Columbia Lottery Corporation, or any other legislation, policies, directives or regulations of any government which apply to the operations of the Employer, pursuant to Article 23 - 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.

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.