Section viii Statement definition

Section viii Statement means any statement filed at any time by Core, its Affiliate or any Third Party under 21 USC § 355(j)(2)(A)(viii) in conjunction with its ANDA seeking marketing approval from the FDA with respect to a label for a generic metaxalone product, in any dosage strength, from which information described or claimed in the Asserted Patents or the King Patent Rights, including without limitation information relating to the bioavailability of metaxalone, has been carved out.
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Examples of Section viii Statement in a sentence

  • Core agrees that it shall not, during the Term of this Agreement, file any Section viii Statement in connection with the Core ANDA or the Core 800 mg Product.

  • Core agrees that it shall not, during the Term of this Agreement, file any Section viii Statement in connection with the Core ANDA or the Core 400 mg Product.

  • Within seven (7) business days of the execution hereof by all Parties hereto, Core shall withdraw the Section viii Statement filed with the Core ANDA in connection with the Core 400 mg Product and shall, as soon as reasonably practicable, file a certification pursuant to 21 USC § 355(j)(2)(A)(vii)(III) in connection with the Core 400 mg Product.

Related to Section viii Statement

  • E-Statement means an electronic version of daily confirms, monthly, quarterly or annual statements, and shareholder tax statements created with investor transaction data housed on DST’s TA2000® mutual fund record keeping system, with images available online via a secure web site.

  • Section 404 Report means management’s report on “internal control over financial reporting” as defined by the SEC and the related attestation report of the independent certified public accountant as described in Section 3(A)(1).

  • Statutory Statement means a statement of the condition and affairs of an Insurance Subsidiary, prepared in accordance with accounting procedures and practices prescribed or permitted by an applicable insurance regulatory authority or the NAIC, as modified in accordance with permitted practices approved by an applicable insurance regulatory authority, and filed with an applicable insurance regulatory authority or the NAIC.

  • Statement of Grievance shall name the employee involved, shall state the facts giving rise to the grievance, shall identify by appropriate reference all the provisions of this Master Contract alleged to be violated, shall state the contention of the employee and of the Association with respect to these provisions, and shall indicate the specific relief requested.

  • Closing Date Statement has the meaning set forth in Section 2.06(b).