§ 1112. NOTIFICATION OF AGREEMENTS.

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Agreement With Brand Name Drug Company.— Requirement .— A generic drug applicant that has submitted an ANDA containing a certification under section 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(j)(2)(A)(vii)(IV) ] or a biosimilar biological product applicant who has submitted a biosimilar biological product application and a brand name drug company that enter into an agreement described in paragraph

(2)shall each file the agreement in accordance with subsection (c). The agreement shall be filed prior to the date of the first commercial marketing of the generic drug that is the subject of the ANDA or the biosimilar biological product that is the subject of the biosimilar biological product application, as applicable. Subject matter of agreement .— An agreement described in this paragraph between a generic drug applicant or a biosimilar biological product applicant and a brand name drug company is an agreement regarding— the manufacture, marketing, or sale of the brand name drug that is the listed drug in the ANDA or the reference product in the biosimilar biological product application involved; the manufacture, marketing, or sale of the generic drug for which the ANDA was submitted or of the biosimilar biological product for which the biosimilar biological product application was submitted; or as applicable— the 180-day period referred to in section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(j)(5)(B)(iv) ] as it applies to such ANDA or to any other ANDA based on the same listed drug; or any of the time periods referred to in section 351(k)(6) of the Public Health Service Act [ 42 U.S.C. 262(k)(6) ] as such period applies to such biosimilar biological product application or to any other biosimilar biological product application based on the same reference product. Agreement With Another Generic Drug Applicant or Biosimilar Biological Product Applicant.— Requirement.— Generic drugs .— A generic drug applicant that has submitted an ANDA containing a certification under section 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(j)(2)(A)(vii)(IV) ] with respect to a listed drug and another generic drug applicant that has submitted an ANDA containing such a certification for the same listed drug shall each file the agreement in accordance with subsection (c). The agreement shall be filed prior to the date of the first commercial marketing of either of the generic drugs for which such ANDAs were submitted. Biosimilar biological products .— A biosimilar biological product applicant that has submitted a biosimilar biological product application that references a reference product and another biosimilar biological product applicant that has submitted a biosimilar biological product application that references the same reference product shall each file the agreement in accordance with subsection (c). The agreement shall be filed prior to the date of the first commercial marketing of either of the biosimilar biological products for which such biosimilar biological product applications were submitted. Subject matter of agreement .— An agreement described in this paragraph is, as applicable, an agreement between 2 or more generic drug applicants regarding the 180-day period referred to in section 505(j)(5)(B)(iv) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 355(j)(5)(B)(iv) ] as it applies to the ANDAs with which the agreement is concerned,, [sic] an agreement between 2 or more biosimilar biological product applicants regarding a time period referred to in section 351(k)(6) of the Public Health Service Act [ 42 U.S.C. 262(k)(6) ] as it applies to the biosimilar biological product, or an agreement between 2 or more biosimilar biological product applicants regarding the manufacture, marketing, or sale of a biosimilar biological product. Filing.— Agreement .— The parties that are required in subsection

(a)or

(b)to file an agreement in accordance with this subsection shall file with the Assistant Attorney General and the Commission the text of any such agreement, except that such parties are not required to file an agreement that solely concerns— purchase orders for raw material supplies; equipment and facility contracts; employment or consulting contracts; or packaging and labeling contracts. Other agreements .— The parties that are required in subsection

(a)or

(b)to file an agreement in accordance with this subsection shall file with the Assistant Attorney General and the Commission the text of any agreements between the parties that are not described in such subsections and are contingent upon, provide a contingent condition for, were entered into within 30 days of, or are otherwise related to an agreement that is required in subsection

(a)or

(b)to be filed in accordance with this subsection. Description .— In the event that any agreement required in subsection

(a)or

(b)to be filed in accordance with this subsection has not been reduced to text, each of the parties involved shall file written descriptions of such agreement that are sufficient to disclose all the terms and conditions of the agreement.

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§ 1112

NOTIFICATION OF AGREEMENTS.

Stat.×4

U.S.C.§ 355

U.S.C.§ 262

Cites 2Cited by 4 across 1 source