BPCIA Clause Samples

The BPCIA clause refers to provisions governed by the Biologics Price Competition and Innovation Act, which establishes a regulatory pathway for the approval of biosimilar and interchangeable biological products. In practice, this clause typically outlines the procedures for information exchange, patent litigation, and exclusivity periods between reference biologic manufacturers and biosimilar applicants. Its core function is to balance the interests of innovator companies and biosimilar manufacturers, facilitating market entry of biosimilars while protecting intellectual property rights and ensuring regulatory clarity.
BPCIA. Notwithstanding sections 10.5 (b)(1)-(3), if a Third Party (a) files a biosimilar application under the Biologics Price Competition and Innovation Act of 2009 or similar provision which requires a listing of all Patents Rights and/or Know-How in an enforcement action or (b) is infringing a Patent Right licensed hereunder, and Applicable Law requires all Patent Rights and/or Know-How to be enforced in the same action; then Parties shall cooperate in good faith in such enforcement actions.
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