; or if an action was brought within such time period, such an action was withdrawn or dismissed by a court (including a district court) without a decision that the patent was valid and infringed; or if an action was brought within such time period and was not withdrawn or so dismissed, such applicant has obtained the decision of a court (including a district court) that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity, and including a settlement order or consent decree signed and entered by the court stating that the patent is invalid or not infringed). (III) If an applicant described in clause (v)(I) has begun commercial marketing of such drug, the applicant described in clause (v)(II) does not begin commercial marketing of such drug until the date that is 30 days after the date on which the applicant described in clause (v)(I) began such commercial marketing. . (2) Conforming amendment Section 505(j)(5)(D)(i)(IV) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5)(D)(i)(IV) ) is amended by striking The first applicant and inserting The first applicant, as defined in subparagraph (B)(v)(I), . (b) Applicability The amendments made by subsection (a) shall apply only with respect to an application filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j) ) to which the amendments made by section 1102(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ( Public Law 108–173 ) apply. 403. 180-day exclusivity period amendments regarding agreements to defer commercial marketing (a) Amendments to Federal Food, Drug, and Cosmetic Act (1) Limitations on agreements to defer commercial marketing date Section 505(j)(5)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5)(B) ), as amended by section 402, is further amended by adding at the end the following: (vii) Agreement by first applicant to defer commercial marketing