Common use of Generics Clause in Contracts

Generics. (i) To the Knowledge of BPA, no AB Rated generic equivalent to the Product (a “Generic”) has been Launched, (ii) to the Knowledge of BPA, no ANDA seeking approval of a Generic has been filed with the FDA and (iii) BPA has not received written notice expressly indicating that any Person intends to submit an ANDA in respect of a Generic with the FDA.