Title 40

SECTION 152.98

152.98 Procedures for transfer of exclusive use or compensation rights to another person.

§ 152.98 Procedures for transfer of exclusive use or compensation rights to another person.

A person who possesses rights to exclusive use or compensation under FIFRA section 3(c)(1)(F) may transfer such rights to another person in accordance with this section.

(a) The original data submitter must submit to the Agency a transfer document that contains the following information:

(1) The name, address and state of incorporation (if any) of the original data submitter (the transferor);

(2) The name, address and state of incorporation (if any) of the person to whom the data rights are being transferred (the transferee);

(3) Identification of each item of data transferred including:

(i) The name of the study or item of data;

(ii) Whether the study is an exclusive use study, and, if so, when the period of exclusive use protection expires;

(iii) The name of the person or laboratory that conducted the study;

(iv) The date the study was submitted to the Agency;

(v) The EPA document number assigned to the item of data (the Master Record Identification Number or Accession Number), if known. If not known, the EPA administrative number (such as the EPA Registration Number, petition number, file symbol, or permit number) with which the item of data was submitted, such that the Agency can identify the item of data.

(vi) A statement that the transferor transfers irrevocably to the transferee all rights, titles, and interest in the items of data named;

(vii) A statement that the transferor and transferee understand that any false statement may be punishable under 18 U.S.C. 1001; and

(viii) The names, signatures and titles of the transferor and transferee, and the date signed.

(b) In addition, the original data submitter must submit to the Agency a notarized statement affirming that:

(1) The person signing the transfer agreement is authorized by the original data submitter to bind the data submitter;

(2) No court order prohibits the transfer, and any required court approvals have been obtained; and

(3) The transfer is authorized under Federal, State, and local law and relevant corporate charters, bylaws or partnership agreements.

(c) The Agency will acknowledge the transfer of the data by notifying both transferor and transferee, and will state the effective date of the transfer. Thereafter the transferee will be considered to be the original data submitter of the items of data transferred for all purposes under FIFRA section 3(c)(1)(F), unless a new transfer agreement is submitted to the Agency.

[49 FR 30903, Aug. 1, 1984, as amended at 73 FR 75595, Dec. 12, 2008]

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