Marketing Approvals definition

Marketing Approvals means, with respect to a Product, all approvals, licenses, registrations, or authorizations, including emergency use authorizations, of the Regulatory Authorities in a country that are necessary for the commercial marketing and sale of such Product in such country.

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Marketing Approvals means, with respect to a Licensed Product, all approvals, licenses, registrations, or authorizations of the Regulatory Authorities in a country that are necessary for the commercial marketing and sale of such Licensed Product in such country within the Territory.

Marketing Approvals means, with respect to a Licensed Product, the approvals, registrations, licenses and permits of any Regulatory Authority in a country, including pricing and/or reimbursement approvals, that are necessary to be obtained in order to market and sell commercially such Licensed Product in that country.

Examples of Marketing Approvals in a sentence

• Each Party will consult with the other Party regarding (and provide copies of materials prior to any submission to a Regulatory Authority and materials after receipt from a Regulatory Authority), and keep such other Party reasonably and regularly informed of, the status of the preparation of all Regulatory Materials in the Territory, review of such materials by the relevant Regulatory Authority in the Territory, and Marketing Approvals received for the Initial POZEN Product in the Territory.

• Genentech shall own all regulatory submissions, including all Marketing Approvals and applications therefor, for Licensed Products in the United States.

• Licensee will own and maintain all regulatory filings and Marketing Approvals in the Territory for POZEN Products, including all INDs and NDAs for the Initial POZEN Product.

• For clarity, Licensee shall own all Marketing Approvals and Regulatory Materials pertaining to Products in the Territory.

• If NeurogesX reasonably requests LTS to undertake such activities LTS shall use its [***] to support NeurogesX’s efforts to obtain and maintain Marketing Approvals for the Patch, provided, however, that NeurogesX shall pay for all labor costs of such activities at the then current man-hour rates of LTS and reimburse LTS for third party costs incurred with respect thereto, in each case as requested by NeurogesX.

• Arcus shall have the right to grant access and reference to such Regulatory Filings and Marketing Approvals to its Affiliates and to its sublicensees and their Affiliates solely for the purposes described in the foregoing clauses (i) and (ii).

• Except as set forth in this Section 3.2 or otherwise required by law, LTS shall not correspond directly with the FDA or other health regulatory agencies relating to the process of obtaining Marketing Approvals or any obtained Marketing Approvals for the Patch, without NeurogesX’s permission.

• Unless otherwise mutually agreed to by the Parties, Elpiscience shall not license or authorize, under any rights owned, controlled or licensed to Elpiscience, including any rights in or to any regulatory filings, Marketing Approvals or granted by a Regulatory Authority, a Third Party to develop, market or sell a Generic Product.

• Licensee shall have the sole authority and responsibility to obtain in its own name and maintain any Regulatory Approvals and Marketing Approvals with respect to the Licensed Product in the Territory.

• In the event that such a transfer is not possible, Indivior shall use reasonable endeavors to provide Addex with the benefit of the existing Marketing Approvals and applications therefor for Products, including, without limitation, granting Addex and/or its designees rights to cross-refer to the data and information on file with Regulatory Authorities as may be necessary to facilitate the granting of separate Marketing Approvals to Addex.

More Definitions of Marketing Approvals

Marketing Approvals means any and all active or inactive (i) approvals, licenses, registrations and authorizations, of all governmental agencies in a jurisdiction for the development, manufacture, use or sale of the Product in the applicable jurisdiction, including any pricing or reimbursement approval with respect to the sale of the Product in the applicable jurisdiction; and (ii) applications for any of the foregoing; in each case in countries or jurisdictions outside the Prior Territory. Schedule 1.13 attached hereto sets forth a complete list of all Marketing Approvals and the status thereof as of the Closing Date, including the date of any required renewals after the Closing Date.

Marketing Approvals mean all approvals and permissions (excluding reimbursement approvals) from the Regulatory Authorities in the Territory (as defined in the Sub-License Agreement) (or parts of the Territory) that are necessary for the importation or manufacturing (if applicable) of the Products and their distribution, use, marketing, and sale in the Territory (or parts of the Territory).

Marketing Approvals means any and all Approvals required for the marketing, distribution and sale of the Product in the Territory, and includes the NOC and DIN.