Examples of Taro ANDA in a sentence
Each Party acknowledges and agrees that the 30 month stay imposed by FDA in relation to the approval of the Taro ANDA under 21 U.S.C. § 355(j)(5)(B)(iii) should be terminated.
From and after the Effective Date, Plaintiffs shall not (a) file any citizen petition or other regulatory submissions with the FDA or any other governmental agency, or otherwise interfere with Taro’s efforts to: (i) obtain FDA approval of the Taro ANDA; or (ii) Market the Taro Generic Product as of the date and under the terms provided in this Settlement Agreement; or (b) Officially Discontinue the NDA Product prior to expiration of the Licensed Patents for reasons other than safety or efficacy.
No provision of this Settlement Agreement shall be affected by any delay in the approval of the Taro ANDA by the FDA, or the failure of Taro to obtain FDA approval of the Taro ANDA.
For the avoidance of doubt, the foregoing shall not preclude Taro from filing and/or maintaining in the Taro ANDA any certifications under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) to any patents listed in the Orange Book in connection with the PENNSAID® 2% NDA.
If a Governmental Entity directs or recommends to Taro that Taro transfer the Taro ANDA to a Third Party, Taro may disclose a copy of this Settlement Agreement to a Third Party in connection with such a possible transfer so long as the Third Party agrees to confidential treatment of this Settlement Agreement.