Teva ANDA definition
Examples of Teva ANDA in a sentence
Notwithstanding anything to the contrary in this Section 6 or otherwise in this Agreement, nothing shall preclude a Teva API Affiliate or Teva Wholesaler Affiliate from contesting the infringement, validity and/or enforceability of the Licensed Patents – or assisting or cooperating with a Third Party to do the same -- in connection with a litigation or administrative proceeding concerning any product other than the Teva ANDA Products.
Notwithstanding the foregoing, nothing herein shall prevent Teva from maintaining a “Paragraph IV Certification” under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) within the Teva ANDA with respect to the Licensed Patents that may be listed in the Orange Book for the NDA Products.
For the avoidance of doubt, the right and license granted under this Section 2.1 shall not apply to the Manufacture or distribution of Teva ANDA Products for sale to Third Parties for use or consumption outside the Territory.
Each Defendant represents and warrants to Plaintiff that the Teva ANDA Product used, sold, offered for sale or imported by Defendants will be manufactured, stored, shipped, handled and marketed by it and its designees in accordance with GMP and all Applicable Laws.
Plaintiff has prosecuted, and Defendants have defended, an action for patent infringement in the United States District Court for the District of Delaware (the “District Court”) regarding the Teva ANDA and the proposed generic product that is the subject thereof, which action is captioned Cubist Pharmaceuticals, Inc.
In addition, such Party shall give notice to the other Parties of its intent to disclose as soon as practical, and in addition provide the text of such disclosure to the other Parties at least 24 hours in advance prior to its release to the public.
For the further avoidance of doubt, the right and license granted under this Section 2.1 shall not apply to the Manufacture or distribution of any finished product aside from the Teva ANDA Products, or to the supply of API or any other ingredients for any finished product aside from the Teva ANDA Products.
Nothing in this License Agreement, the Settlement Agreement, or any of the Settlement Documents shall be interpreted as Neos or its Affiliates consenting to the accuracy or sufficiency of any scientific, medical, bioequivalence, regulatory, or other information contained in the Teva ANDA and/or consenting to the FDA approving the Teva ANDA on the basis of any such information.
AND SUBSIDIARIESNOTES TO CONSOLIDATED FINANCIAL STATEMENTS(in millions, except share data) HealthCare patents were also the subject of another Teva ANDA seeking approval to sell a generic version of Bayer HealthCare's systemic moxifloxacin product, Avelox®.
Teva Pharmaceutical Industries, Ltd., now Teva Pharmaceuticals USA, (Teva), ANDA 77-445, did not submit a request for a hearing.