U.S. Marketing Authorization definition

U.S. Marketing Authorization means the New Drug application (NDA) for the Product that is a combination product of EGP-437 and the EyeGate® II Delivery System, together with any other Marketing Authorizations required to market and sell the Product in the Development Field in the United States.

Examples of U.S. Marketing Authorization in a sentence

  • Notwithstanding the foregoing, following the approval of the U.S. Marketing Authorization, if Valeant conducts its own Development of the Product in the Field in the United States, Valeant will make the final determination with respect to such Development.

  • Observations areThe J-test of non-nested models always prefers reported income to clean surplus income over various testing windows because the statistics suggest that clean surplus income doesn’t encompass reported income in explaining returns (Panel D, the last column).

  • Following such transfer, during the Term of this Agreement, Valeant shall maintain such U.S. Marketing Authorization, at Valeant’s cost.

  • Valeant and Eyegate shall mutually agree on a strategy and plan to obtain the U.S. Marketing Authorization.

  • Following the receipt of the U.S. Marketing Authorization, Valeant and its Affiliates shall also have the right to Develop the Product in the Field for the United States and Valeant shall be responsible for its own costs of any such Development.

  • Upon obtaining such U.S. Marketing Authorization for the Product, Eyegate shall, as promptly as practicable, transfer such U.S. Marketing Authorization, together with the regulatory dossier associated with such U.S. Marketing Authorization, to Valeant (or its designee), at Valeant’s cost and with Valeant’s assistance, support and cooperation.

  • Florida Asset Financial 7The defendants do not identify whether their claim is brought under the United States Constitution or the Iowa Constitution.

  • Eyegate shall use Commercially Reasonable Efforts to seek and obtain the U.S. Marketing Authorization for the Product in the Development Field, with Valeant’s assistance, support and cooperation; provided, however, that, except as set forth in Section 4.7, Eyegate shall be responsible for one hundred percent (100%) of all costs with respect to seeking and obtaining such U.S. Marketing Authorization.

  • Further, after [*] from the year the first US Marketing Authorization is obtained, the Parties do not intend for ASTELLAS to further pay the medical marketing services fee described in this Section 3.03(d).

  • Plan and Basic Commercial Plan represent the Parties’ agreement as of the Signing Date as to Development and Commercialization, respectively (until [*] after the first US Marketing Authorization) of Licensed Product for the Initial Indications for the US market.

Related to U.S. Marketing Authorization

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • Regulatory Authorizations means all approvals, clearances, notifications, authorizations, orders, exemptions, registrations, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies, including all Product Authorizations.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Marketing Authorisation means any approval (including all applicable pricing and governmental reimbursement approvals) required from the FDA or relevant Competent Authority to market and sell a Product in a particular country.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Product Authorizations means any and all approvals, including applicable supplements, amendments, pre- and post-approvals, clearances, licenses, notifications, registrations, certifications or authorizations of any Governmental Authority, any Standard Body necessary for the manufacture, development, distribution, use storage, import, export, transport, promotion, marketing, sale or other commercialization of a Product in any country or jurisdiction.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Regulatory Authorities means the Commissions and the Exchange;

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Securities Regulatory Authorities means the securities commission or similar regulatory authority in each province and territory of Canada that is responsible for administering the Canadian securities legislation in force in such jurisdictions;

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • Necessary Authorizations means all approvals and licenses from, and all filings and registrations with, any governmental or other regulatory authority, including, without limiting the foregoing, the Licenses and all approvals, licenses, filings and registrations under the Communications Act, necessary in order to enable the Borrower and its Subsidiaries to own, construct, maintain, and operate communications tower facilities and to invest in other Persons who own, construct, maintain, manage and operate communications tower facilities.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Product Approval(s) means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that Product.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of a Licensed Compound or a Licensed Product in the Territory.

  • Development Approvals means all permits, licenses, and/or other entitlements for the Development of the Property, including any and all conditions of approval, subject to approval or issuance by the City in connection with Development of the Property including:

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.