Biosimilar Application has the meaning set forth in Section 7.3.3.
Biosimilar Application means an application or submission filed with a Regulatory Authority for marketing authorization of a Biosimilar Product.
Biosimilar Application means an application submitted to the FDA under subsection (k) of the PHSA or a similar application submitted under a similar regulatory scheme to another Regulatory Authority.
Examples of Biosimilar Application in a sentence
If either Party receives any equivalent Biosimilar Application or otherwise becomes aware that such an equivalent Biosimilar Application has been filed in any other jurisdiction in the Territory, then such Party shall, within [***], notify and provide the other Party with copies of such communication.
Either Party shall, within [***], notify and provide the other Party with copies of any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to Section 351(l)(8)(A) of the PHSA, or any equivalent or similar certification or notice in any other jurisdiction.
More Definitions of Biosimilar Application
Biosimilar Application means an application submitted to the FDA under subsection (k) of Section 351 of the PHSA, or any analogous application submitted to a Regulatory Authority in the United States or in another country in the world.
Biosimilar Application means an application or submission filed with a Regulatory Authority for Marketing Approval of a Biosimilar Product.
Biosimilar Application means a Regulatory Approval Application for a product claimed to be biosimilar or interchangeable to any Licensed Product, or otherwise relying on the approval of such Licensed Product, in each case in accordance with Applicable Law in the jurisdiction in which the product is sought to be marketed and sold.
Biosimilar Application has the meaning set forth in Section 10.1.2.
Biosimilar Application means an application submitted to the FDA under 42 U.S.C. §262(k) or Section 351(k) of the PHS Act, or any analogous application submitted to a Regulatory Authority in the United States or in another country in the world.
Biosimilar Application has the meaning set forth in Section 8.2(f)(iii).
Biosimilar Application has the definition set forth in Section 12.6.5(a) (Receipt of Application; Responsibilities).