Marketing Authorization definition

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 means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

Marketing Authorization means, with respect to a Country, the regulatory authorization required to market and sell a Collaboration Product in such Country as granted by the relevant Governmental Authority.

Examples of Marketing Authorization in a sentence

• Sxxxxxxxx will support Customer efforts to obtain and maintain Marketing Authorization approvals for a reasonable fee after Customer review and approval.

• With respect to Licensed Adjuvanted Products, Sanofi shall have the exclusive right to conduct Regulatory Activities, be the Regulatory Responsible Party for, and file for and obtain Marketing Authorization in its sole discretion at its own cost and expense, within the scope of the Adjuvant License and subject to other restrictions applicable to Sanofi as set forth in Article 2 (License Grants; Exclusivity) and in this Article 4 (Regulatory).

• For the avoidance of doubt, Novavax shall not have the right to extend the term of any Novavax Patent in connection with a Licensed Product of which the Marketing Authorization is in the name of Sanofi or its Affiliate or Sublicensees.

• No Obligor shall withdraw or abandon, or fail to take any action necessary to prevent the withdrawal or abandonment of, Marketing Authorization in any applicable jurisdiction for the Product once obtained, other than to the extent that such withdrawal is required for safety reasons or otherwise required under applicable Law, or where maintenance of such Marketing Authorization would not constitute Commercially Reasonable Efforts.

• Following the receipt of a Marketing Authorization in any jurisdiction, each applicable Loan Party shall use Commercially Reasonable Efforts to Commercialize the Product in each jurisdiction in respect of which Marketing Authorization has been received.

More Definitions of Marketing Authorization

Marketing Authorization means the authorization to market Finished Product in a jurisdiction issued by the appropriate Regulatory Agency in such jurisdiction.

Marketing Authorization means a Regulatory Authority approval necessary to commercially promote and distribute the Product for a Licensed Indication in the Territory including where applicable, price and reimbursement approval which must be granted for the Product to be sold in such country. Marketing Authorization as applied to any country within the Territory does not include the approval of a treatment IND, pre-approval human use trials under a protocol or distribution of a product under an emergency use program, e.g., distribution on a Named Patient Basis.

Marketing Authorization or "MA" means the authorization granted by the relevant Governmental Authority for the marketing, sale and/or distribution of the Product.

Marketing Authorization means an approved New Drug Application as defined in the FFDCA and the regulations promulgated thereunder, or any corresponding foreign application, registration or certification, necessary or reasonably useful to market any Product in a country or regulatory jurisdiction in the Territory other than the United States, including applicable pricing and reimbursement approvals.

Marketing Authorization means any governmental approval by the FDA or other applicable governmental agency which is legally required under applicable laws, regulations or administrative decisions to put a pharmaceutical product on the market in such country for use in the treatment of any Indication (including pricing and reimbursement approvals, if applicable).

Marketing Authorization means such governmental approval for the marketing of the PRODUCT in a country or countries in the TERRITORY as is necessary to enable EYETECH, its AFFILIATES, or its SUBLICENSEES to sell and distribute lawfully the PRODUCT to such countries in the TERRITORY.

Marketing Authorization means approval of an MAA by the applicable Regulatory Authority.