Regulatory Application definition

Regulatory Application means any regulatory application or any other application for marketing approval for a Product, which Newco will file in any country of the Territory, including any supplements or amendments thereto.

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Regulatory Application means a regulatory application or other application (including any supplements or amendments thereto) required to be filed or filed with a Regulatory Authority in a country in connection with the Commercialization of a pharmaceutical product in such country.

Regulatory Application means the applications submitted by Noven to the FDA seeking approval for the development, manufacture, testing, storage, transport, marketing, advertisement, promotion, sale, use, distribution or other disposal of the Product in all or any portion of the Territory, including the Product ANDA.

Examples of Regulatory Application in a sentence

Upon mutual agreement, Regeneron will grant to the Government a right of reference to any Regulatory Application submitted in support of this Project Agreement, solely for the purpose of the Government conducting a clinical trial with the drug product supplied under this Project Agreement under a protocol approved by Regeneron for performance by the Government.
The U.S. Government is hereby granted a right of reference as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous applicable law recognized outside of the U.S.) to any Regulatory Application submitted in support of the statement of work for the Project Agreement.
The Company shall be responsible for filing all Regulatory Applications (whether prepared by the Company or ERS) and, thereafter, to conduct all communications with the Regulatory Authorities during the registration process (provided that, if ERS is the responsible Party for the preparation of such Regulatory Application, it will work with the Company with respect to all such regulatory activities).
The Sponsor of the Regulatory Application to FDA (as the terms “sponsor” and “applicant” are defined or used in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C, or 814.20) has certain standing before the FDA that entitles it to exclusive communications related to the Regulatory Application.
Without limiting the generality of the foregoing, no later than six (6) months after the later of (i) Cardiome’s receipt of access to a complete electronic copy of SteadyMed’s New Drug Application for Product as filed with the FDA and (ii) Cardiome’s receipt from SteadyMed of 12 months of stability data for Product, Cardiome shall file a Regulatory Application with each of the EMA and the applicable national Regulatory Authority in Canada.

More Definitions of Regulatory Application

Regulatory Application means a regulatory application or other application (including any supplements or amendments thereto) required to be filed or filed with a Governmental Authority in a country in connection with the marketing and sale of the Product in such country;

Regulatory Application means any application necessary and appropriate to obtain a Regulatory Approval, including, without limitation, all required documents, data and information concerning, filed or required to be filed, or otherwise submitted by either Party to a Governmental Authority in connection with obtaining such Regulatory Approval.

Regulatory Application has the meaning provided in Section 5.1(c).

Regulatory Application as used in this Article is an investigational new drug application (IND), investigational device exemption (IDE), new drug application (NDA), biologics license application (BLA), premarket approval application (PMA), or 510(k) pre-market notification filing (510(k)) or another regulatory filing submitted or planned for submission to the U.S. Food and Drug Administration (FDA) related to the research under a Research Project Award.” “Restricted rights” as used in this Article is as defined in DFARS 252.227-7014(a)(15) (Jun 1995). “Small Business Innovated Research (SBIR) data rights” as used in this Article is as defined in DFARS 252.227-7018(a)(19). “Specially Negotiated License Rights” are those rights to Data that have been specifically negotiated between the Government and the CM on behalf of the Research Project Awardee whose proposal is selected by the Government under a call for proposals issued under the Agreement.

Regulatory Application means the new drug application or other submission made by Customer to the FDA, or any equivalent regulatory agency in the Territory, seeking allowance to market, distribute, and sell the Product in the United States and/or elsewhere in the Territory, as such application may be amended or supplemented.

Regulatory Application means an application filed to obtain Regulatory Approval, including, without limitation, a Biologics License Application (“BLA”) or New Drug Application (“NDA”) and their foreign equivalents.

Regulatory Application means an application submitted to a Governmental Authority that issues Regulatory Authorizations.