NDA

NDA. Means a New Drug Application, as defined in the United States Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or similar application filed with an equivalent regulatory body in another country.

NDA. Means a New Drug Application filed with the FDA in the Territory for authorization to market the Product, as defined in the applicable Laws and regulations.

NDA. That certain Mutual Non-Disclosure Agreement between the parties dated as of May 8, 2006

NDA. A New Drug Application for a Licensed Product submitted to the FDA or a comparable application submitted to another Regulatory Agency.

NDA. A New Drug Application filed pursuant to the requirements of the FDA.

NDA. A new drug application (Form FDA 356h), or any successor form or foreign equivalent.

NDA. A New Drug Application or a Product License Application, as the case may be, to be filed with the FDA, or the equivalent thereof in other countries or regulatory jurisdictions.

NDA. Means New Drug Application, as described in FDA regulations, 21 C.F.R. 50, including all amendments and supplements to the application.

NDA. An application (whether original, supplementary or abbreviated) to the applicable Regulatory Authority in a country of the Territory, for approval by such Regulatory Authority, necessary for the commercial sale of Product in such country. An NDA, together with all supplemental filings referencing the initial NDA filing, shall be deemed one and the same NDA for all purposes of this Agreement

NDA. A New Drug Application filed with the FDA or any equivalent filed with the regulatory authorities in any country or territory other than the United States to obtain approval for the marketing and sale of a Product in such country or territory, but excluding any pricing or reimbursement approvals.