Abbreviated Application definition

Abbreviated Application means (a) an application submitted to the FDA under subsection (k) of Section 351 of the PHSA, or (b) any analogous application to an application set forth in clause (a) submitted to a Regulatory Authority.
View Source
Abbreviated Application means the Abbreviated Application for a Certificate of Convenience and Necessity in FERC Docket No. CP12-351 allowing for Bi-directional flow of Natural Gas through the Facilities.
View Source
Abbreviated Application means (a) any application submitted to the FDA under (i) subsection (k) of Section 351 of the PHSA (42 U.S.C. 262(k)) or (ii) Section 505(j) of the FD&C Act (21 U.S.C. 355(j)), or (iii) Section 505(b)(2) of the FD&C Act (21 U.S.C. 355), (b) any application submitted to the EMA under a provision of Articles 10, 10a, or 10b of Parliament and Council Directive 2001/83/EC as amended (including any application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision), or (c) any analogous application to those applications set forth in clauses (a) or (b) submitted to any Regulatory Authority in the US, European Union, or in another country or jurisdiction in the world.
View Source

Examples of Abbreviated Application in a sentence

  • If either Party receives a copy of any equivalent or similar Abbreviated Application or notice in any other jurisdiction in the Territory, then either Party will, within 10 Business Days, notify and provide the other Party with copies of such communication.

  • Notwithstanding Section 10.9.2 (Enforcement in Roche Territory) or Section 10.9.3 (Enforcement in Sarepta Territory), if either Party or their Affiliate or Sublicensee receives a copy of an Abbreviated Application naming a Licensed Product as a reference product or otherwise becomes aware that such an Abbreviated Application has been filed (such as in an instance described in Section 351(1)(9)(C) of the PHSA), then such Party will promptly notify the other Party.

  • Other than any actions and procedures that would not comply with such Applicable Law, the Parties will pursue any legal actions they may have against the applicant of an Abbreviated Application in accordance with the provisions of Section 10.9.2 (Enforcement in Roche Territory), Section 10.9.3 (Enforcement in Sarepta Territory) and Section 10.9.5 (Cooperation; Procedures).


More Definitions of Abbreviated Application

Abbreviated Application means (a) a Biologics License Application submitted to the FDA under subsection (k) of Section 351 of the Public Health Service Act (PHSA) (42 USC 262(k)), (b) an abbreviated New Drug Application submitted to the FDA under Section 505(j) of the FDC Act (21 USC 355(j)), or (c) any analogous application to those applications set forth in clauses (a) or (b) submitted to a Regulatory Authority outside the United States.
View Source