Examples of Notice Letter in a sentence
In Apotex’s ’369 Notice Letter, Apotex also notified Merck that, as part of its ANDA, Apotex had filed certifications of the type described in Section 505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C. § 355 (j)(2)(A)(vii)(IV), with respect to the ’708 patent.
Omitted from the Notice Letter were the date that Defendant detected the Data Breach, the dates of Defendant’s investigation, the details of the root cause of the Data Breach, the vulnerabilities exploited, and the remedial measures 8 Notice Letter.
Upon information and belief, the factual and legal bases in the July 29 Notice Letter regarding the ’580 patent do not establish good-faith bases to comply with the statutory provisions and regulations set out in 21 U.S.C. §355(j)(2)(B)(iv)(II) and 21 C.F.R. § 314.95(c)(7).
In Apotex’s ’369 Notice Letter, Apotex stated that Apotex’s ’369 ANDA Product contains sitagliptin phosphate as an active ingredient.
I am familiar with the Notice Letter attached as Exhibit C-1 and caused the Notice Letter to be sent to the parties set out in the chart attached as Exhibit C-2.