Regulatory Authorization definition

Regulatory Authorization means any Governmental Authorization of the FCC or any PUC.

Regulatory Authorization means any registration, authorization, approval, clearance, license, permit, certificate or exemption issued by any Regulatory Authority or Governmental Authority (including new drug applications, new drug submissions, investigational new drug applications, clinical trial applications, manufacturing approvals and authorizations, pricing and reimbursement approvals, labeling approvals, registration notifications or their foreign equivalent) that are required for the research, development, manufacture, distribution, marketing, storage, transportation, use and sale of the products of QLT or Auxilium and their respective Subsidiaries.

Regulatory Authorization means any approval, product license, registration or other authorization necessary for the development, manufacture or commercialization of a Regulated Product in a regulatory jurisdiction.

Examples of Regulatory Authorization in a sentence

• To the Knowledge of the Company, there is no condition that would preclude the renewal of a Health Care Regulatory Authorization upon its expiration.

• To the Knowledge of the Company, there is no threatened suspension, revocation or withdrawal of any Health Care Regulatory Authorization.

• Neither SpinCo nor any of its Subsidiaries holds any Regulatory Authorization, or has any such application for a Regulatory Authorization pending with the FDA or any other applicable Regulatory Authority or, to the Knowledge of the Company, has at any time in the past three (3) years has been required to hold a Regulatory Authorization in connection with the SpinCo Products or operations.

• Since December 31, 2017, there has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Regulatory Authorization, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on Grace.

• Grace is in material compliance with the terms of all Regulatory Authorizations, and no event has occurred that, to the knowledge of Grace, would reasonably be expected to result in the suspension, revocation, cancellation, non-renewal or adverse modification of any Regulatory Authorization.

More Definitions of Regulatory Authorization

Regulatory Authorization means any approvals, clearances, authorizations, registrations, certifications and licenses granted by any Health Authority, including of any INDs and NDAs.

Regulatory Authorization means, with respect to a Licensed Product and country or regulatory jurisdiction, any and all approvals, registrations, certificates, licenses or authorizations of any Regulatory Authority necessary to commercially distribute, sell or market or otherwise Commercialize such Licensed Product in such country or regulatory jurisdiction, including, where applicable: (a) pricing or reimbursement approval in such country or regulatory jurisdiction; (b) pre- and post-approval manufacturing and marketing authorizations (including any prerequisite marketing approval or authorization related thereto); (c) labeling approval; and (d) technical, medical and scientific licenses.

Regulatory Authorization means any permit and other legal or regulatory consent, approval or permission, under any and all Applicable Laws that may be required as a condition for a Party to perform any of its obligations hereunder.

Regulatory Authorization means any registration, authorization, approval, clearance, license, permit, certificate or exemption issued by any Regulatory Authority or Governmental Authority (including new drug applications, new drug submissions, investigational new drug applications, clinical trial applications, manufacturing approvals and authorizations, pricing and reimbursement approvals, labeling approvals, registration notifications or their foreign equivalent) that are required for the research, development, manufacture, distribution, marketing, storage, transportation, use and sale of the products of Acasti or Grace and their respective Subsidiaries.

Regulatory Authorization means any approval or authorization of any REGULATORY AUTHORITY in a particular jurisdiction that is necessary for the development (including human clinical trials), manufacture, use, storage, import, transport and/or sale of LICENSEE PRODUCTS in such jurisdiction in accordance with LAWS.

Regulatory Authorization means the authorization of the Arkansas Public Service Commission granted to the Borrower in docket number 15-035-U dated as of June 17, 2015.

Regulatory Authorization means any registration, authorization, approval, clearance, license, permit, certificate or exemption issued by any Regulatory Authority or Governmental Authority (including new drug applications, new drug submissions, investigational new drug applications, clinical trial applications, manufacturing approvals and authorizations, pricing and reimbursement approvals, labeling approvals, registration notifications or their foreign equivalent, including but not limited to Canadian notices of compliance, drug identification numbers, new drug submissions, abbreviated new drug submissions, supplemental new drug submissions, drug establishment license applications and licenses, medical device establishment, site license and investigational testing applications and resulting licenses) that are required for the research, development, manufacture, distribution, marketing, storage, transportation, use and sale of the products of Pozen, Tribute and their respective Subsidiaries.