Paragraph IV Certification definition

Paragraph IV Certification means any certification filed pursuant to 21 U.S.C. § 355(b)(2)(A)(iv), 21 U.S.C. § 355(j)(2)(A)(vii)(IV), or any comparable Applicable Law (or any amendment or successor statute thereto) in any country or regulatory jurisdiction in the Territory.

Split View

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Get StartedSchedule a Demo

Paragraph IV Certification has the meaning set forth in Section 4.1(f)(iii).

Paragraph IV Certification will have the meaning set forth in Section 9.3(a)(i)(A).

Examples of Paragraph IV Certification in a sentence

• Notwithstanding the foregoing, each Party shall notify the other Party within two (2) Business Days of its receipt of, or receipt of notice of, any Paragraph IV Certification.

• The “Applicable Period” shall, in the context of a Paragraph IV Certification by a Third Party, mean (a) a period of twenty-one (21) days after USL receives notice of the Third Party Paragraph IV certification, and (b) shall otherwise mean a period of thirty (30) days after giving or receiving notice under Section 14.1 of this Agreement of the alleged Third Party infringement.

• In the event either Party receives notice that a Third Party has filed a patent certification under the ▇▇▇▇▇-▇▇▇▇▇▇ Act or any successor statute (e.g., a Paragraph IV Certification under 21 C.F.R. §314.50(i) or 314.94(a)(12)) referencing a Patent licensed under Section 3.1, then such Party shall immediately notify the other Party in writing of such notice.

• Checkpoint and Licensor shall have (i) the right, but not the obligation to undertake control of, and manage and prosecute, compromise or settle, including selection of counsel (collectively, “Prosecute”), any Offensive Enforcement Action relating to a Paragraph IV Certification and (ii) the right but not the obligation to Prosecute any other Offensive Infringement Action.

• The Parties will consult with each other through each Party’s patent attorneys to determine the response to any such infringement or challenge by a Third Party of any Intellikine Patent, including any Paragraph IV Certification which references the foregoing (collectively “Third Party Infringement”).

More Definitions of Paragraph IV Certification

Paragraph IV Certification means a certification pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417), as amended, which shall include but not be limited to any such certification pursuant to 21 U.S.C. §355(b)(2)(A)(iv) or 21 U.S.C. §355(j)(2)(A)(vii)(IV), or any reasonably similar or equivalent certification or notice in the United States or any jurisdiction outside the United States, included in (or made with respect to or in connection with) a Regulatory Filing concerning a Licensed Product and challenging the validity, infringement, or enforceability of any Licensor Patent.

Paragraph IV Certification means a certification pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417), as amended, which shall include but not be limited to any such certification pursuant to 21 U.S.C. §355(b)(2)(A)(iv) or 21 U.S.C. §355(j)(2)(A)(vii)(IV), or any reasonably similar or equivalent certification or notice in the United States or any jurisdiction outside the United States, included in (or made with respect to or in connection with) a regulatory filing concerning a Product and challenging the validity, infringement, or enforceability of any Patent.

Paragraph IV Certification means a certification described in section 505(j)(2)(A)(vii)(IV) and 505(b)(2)(A)(iv) of the U.S Food, Drugs and Cosmetics Act.

Paragraph IV Certification means a certification by an applicant filing an ANDA or 505(b)(2) NDA referencing a drug listed in Approved Drug Products with Therapeutic Equivalence Evaluations to the FDA that the patent relating to such listed drug is invalid or will not be infringed upon by the manufacture, use or sale of the drug product for which the ANDA or 505(b)(2) NDA is submitted.

Paragraph IV Certification has the meaning set forth in Section 11.4 (Enforcement of Listed Patents).

Paragraph IV Certification means a certification that a patent listed in the Orange Book is invalid or will not be infringed by the generic drug for which the ANDA applicant seeks approval.

Paragraph IV Certification means a certification as defined in 21 U.S.C. 355(j)(2)(A)(vii)(IV) relating to any patent listed in the Orange Book for the NDA.