Is an Applicant required by 42 U.S.C. section 262(l)(2)(A) to provide the Sponsor with a
copy of its biologics license application and related manufacturing information, which the
statute says the Applicant "shall provide," and, where an Applicant fails to provide that
required information, is the Sponsor's sole recourse to commence a declaratory-judgment
action under 42 U.S.C. section 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. section 271
(e)(2)(C)(ii)?
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