In the event that either Party (a) receives a copy of an application submitted to the FDA under Section 351(k) of the PHSA (a “ Biosimilar Application ”) for which the Licensed Product is a “reference product,” whether or not such notice or copy is provided under any Applicable Laws (including under the BPCIA, the United States Patient Protection and Affordable Care Act, or implementing FDA regulations and guidance applicable to the approval or manufacture of any “biosimilar or interchangeable biological product”) (a “ Proposed Biosimilar Product ”), or (b) otherwise becomes aware that such a Biosimilar Application has been filed (such as in an instance described in Section 351(l)(9)(C) of the PHSA), then such Party shall promptly provide the other Party with written notice. The terms “reference product” and “biosimilar or interchangeable biological product” shall have the meanings given to such terms in the BPCIA.