First to File Exclusivity definition

First to File Exclusivity means, to the extent applicable, up to 180 days of marketing exclusivity in the United States from the FDA under and pursuant to 21 U.S.C. Section 355(j)(5)(B)(iv) of the Federal Food, Drug and Cosmetic Act, as amended.
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First to File Exclusivity means the period of up to one hundred and eighty (180) days of Marketing exclusivity in the United States granted for each of the Products (under approved ANDAs) by the FDA under and pursuant to 21 U.S.C. Section 355(j)(5)(B)(iv) of the Federal Food, Drug and Cosmetic Act, as amended.
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First to File Exclusivity means the period of one hundred eighty (180) days of marketing exclusivity in the Territory granted by FDA under and pursuant to 21 U.S.C. section 355(j)(5)(B)(iv).
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Examples of First to File Exclusivity in a sentence

  • In the event that there are any claims, actions, demands or suits by a third party, attempting to invalidate ALO's entitlement to First to File Exclusivity, Teva shall, upon the reasonable request and at the expense of ALO, assist ALO in defending such action, and provided ALO is not in breach of any of its material obligations hereunder, Teva shall not take any action that would invalidate ALO's entitlement to First to File Exclusivity.

  • Neither ALO nor any of its Affiliates shall directly or indirectly, assign, transfer or otherwise encumber in any respect its First to File Exclusivity rights relating to any Product to any Person other than Teva (or a Teva Affiliate); provided, however, that the foregoing shall not apply to ALO Tablet Products if Teva exercises its option under Section 2.1(b)(iii) hereof.