Examples of Product ANDA in a sentence
As of the date hereof, Buyer has not begun developing a generic version of any Product, has not filed a Product ANDA for a generic version of any Product, and does not own or have a right to distribute any product under a Product ANDA for a generic version of any Product or the corresponding NDA.
Buyer acknowledges and agrees that Seller does not guarantee that FDA approval will be obtained for a Product ANDA that has not already been approved by FDA as of the date hereof and makes no representation or warranty hereunder with respect to any Product that has not already been approved by FDA as of the date hereof.
Subject to the terms and conditions of this Agreement, Noven hereby grants to Endo an exclusive license under the Product ANDA and its Intellectual Property Rights solely to use and sell or otherwise dispose of the Licensed Product solely in the Territory.
Endo shall use commercially reasonable efforts to Launch the Licensed Product promptly after Regulatory Approval of the Product ANDA and, at its own expense, to actively and diligently promote, market and sell the Licensed Product in the Territory during the term of this Agreement.
Noven agrees to keep Endo fully informed of its progress in seeking Regulatory Approval, including providing Endo with copies of any and all correspondence between Noven and the FDA relating to the Product ANDA.