Approval

Approval. Means FDA approval of the Product (as defined below) by the FDA for use as a pharmaceutical product for the treatment of pain pursuant to the FDA's abbreviated new drug application ("ANDA") process to be filed by Mikart for the Product.

Approval. Means the approval by the relevant Governmental Authority required for the initial launch, marketing and sale of the Royalty Product for human therapeutic use.

Approval. Securities Act 7.06

Approval. Shall mean, with respect to a country, all authorizations by the appropriate governmental entity or entities necessary for the marketing and commercial sale of a Licensed Product in that country. * * * Confidential Information, indicated by ***, has been omitted from this filing and filed separately with the Securities and Exchange Commission.

Approval. Means the first approval during the Term of this Agreement by the FDA authorizing CVT to market the Product in the United States.

Approval. Shall mean receipt from the FDA or other applicable Governmental Authority of final approval, including any applicable pricing, final labeling or reimbursement approvals, necessary to manufacture, market and sell a Commercial Product in a country of the Territory.

Approval. Formal approval or qualification by and/or due registration with the appropriate taxation, social security, supervisory, fiscal or other applicable regulatory authorities in the relevant state or jurisdiction, in order to obtain tax approved, favoured or qualified status in the relevant jurisdiction, and Approved shall be construed accordingly

Approval. Means any consent, approval, authorization, waiver, grant, agreement or exemption of any Person that is required in connection with (i) the execution and delivery by any Party of this Agreement or (ii) the consummation by the Purchaser or the Seller of the Transactions;

Approval. Means any license, permit, consent, approval, authorization, order, registration, filing, waiver, qualification or certification.

Approval. All authorizations by the appropriate governmental entity or entities necessary for commercial sale of a Product in that country, including, without limitation and where applicable, approval of labeling, price, reimbursement and manufacturing