Regulatory Authorization definition

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 Governmental Authorization of the FCC or any PUC.

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

• The Borrower and each of the Subsidiaries shall (i) maintain each Permit, including each Regulatory Authorization, from, or file any notice or registration in, each jurisdiction in which the Borrower or any of the Subsidiaries are required to obtain any Permit or Regulatory Authorization or to file any notice or registration, in order to sell or distribute the Products and (ii) promptly provide evidence of same to the Lender.

• Since December 31, 2011, 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 Auxilium.

• Since December 31, 2011, 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 QLT.

• The Borrower and each of the Subsidiaries shall maintain each Key Permit, including each Regulatory Authorization, from, or file any notice or registration in, each jurisdiction in which the Borrower or any of the Subsidiaries are required to obtain any Key Permit or Regulatory Authorization or to file any notice or registration, in order to design, manufacture, store, label, sell, promote, import or distribute any Product.

• Each Loan Party shall (i) maintain each Permit, including each Regulatory Authorization, from, or file any notice or registration in, each jurisdiction in which such Loan Party is required to obtain any Permit or Regulatory Authorization or to file any notice or registration, in order to sell or distribute the Products and (ii) promptly provide evidence of same to the Lender.

More Definitions of Regulatory Authorization

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

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 DPRX or PLx 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 (i) the authorization of the Arkansas Public Service Commission in docket number 12-059-U granted to the Borrower dated as of September 13, 2012, and (ii) the authorization of the Tennessee Regulatory Authority in docket number 12-00109 granted to the Borrower dated as of October 24, 2012.

Regulatory Authorization means, with respect to a particular jurisdiction, any and all approvals, licenses, registrations, certificates, permits, consents, notifications, clearances or authorizations of any Governmental Authority as are necessary to manufacture, commercially distribute, import, export, sell and market a Company Product in such jurisdiction, which shall include where applicable: 510(k) or premarket notification clearances, de novo classifications, pre-market approvals, investigational device exemptions, product recertifications, manufacturing approvals and authorizations, CE Xxxx certifications, pricing and reimbursement approvals, labeling approvals, registration notifications or their foreign equivalents.

Regulatory Authorization means (i) all affirmative approvals, licenses (including product or establishment licenses), registrations, clearances or authorizations, and controlled substance scheduling determinations by or of any Regulatory Agency necessary for the development, Manufacture, production, use, import, export, transport or sale of any Product; (ii) the ongoing absence of any adverse governmental inspection observations alleging material violations of applicable laws or regulations; and (iii) the ongoing absence of any judicial decision against Holdings, any of its subsidiaries, or any other company marketing CBD products directly to consumers in which the court rules pursuant to the FDCA that CBD-containing products are illegal or ineligible for sale and marketing as “dietary supplements,” conventional food, or as a component of either.