An Act of Putting Something To Use Application of New

Product Applications means each new drug application, abbreviated new drug application or investigation al new drug application or other application or other filings seeking to allow for the manufacturing, distribution, sale, marketing or investigation of a pharmaceutical product (or similar applications or filings in jurisdictions outside the United States) that has been filed with, or submitted to, the FDA (or similar Governmental Entity outside the United States), in each case as amended, and has not been approved or authorized by the FDA or similar Governmental Entity outside the United States.

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