CHAPTER 13 - TRANSFER OF PRODUCT REGISTRATIONS AND/OR DATA RIGHTS FROM ONE PERSON OR COMPANY TO ANOTHER A. GENERAL INFORMATION 40 CFR 152.135 provides information necessary for the transfer of the registration of a product from one person or company to another. Applications for the registration of products which are still pending registration (not registered) may also be transferred. 40 CFR 152.98 provides information for the transfer of data rights from one person or company to another. You should refer to these references for specific details on the transfer of registrations and/or data rights. A discussion of transfer requirements is provided below. B. TRANSFER OF PRODUCT REGISTRATIONS A registrant may transfer the registration of a product to another person, and the registered product may be distributed and sold without the requirement of a new application for registration by that other person, if the parties submit to the Agency the documents as described in 40 CFR 152.135 and receive approval by the Agency. 1. Persons seeking approval of a transfer of a product registration must provide a document (a Transfer Document) signed by the authorized representative of the registrant of the product to be transferred (the transferor) and of the person to whom the product registration is to be transferred (the transferee) that contains the following information: a. The name, address, phone number, EPA-assigned company number, and State of incorporation (if any) of the transferor, b. The name, address, phone number, EPA-assigned company number, and State of incorporation of the transferee (If the transferee does not have an EPA- assigned company number, he or she should request that one be assigned), c. The product name(s) and EPA registration number(s), or the EPA File Symbol for pending products, of the products to be transferred, d. A statement that the transferor transfers irrevocably to the transferee all right, title, and interest in the EPA registration(s) listed by product name and EPA Registration Number in the document, e. A statement that the transferred registration(s) shall not serve as collateral or otherwise secure any loan or other payment arrangement or executory promise, and that the registration(s) shall not revert to the transferor unless a new transfer agreement is submitted to and approved by the Agency, f. A description of the general nature of the underlying transaction, e.g., merger, spinoff, bankruptcy transfer (no financial information need be disclosed), g. A statement that the transferor and transferee understand that any false statement may be punishable under 18 U.S.C. 1001, and h. An acknowledgement by the transferee that his rights and duties concerning the registration under FIFRA and this chapter will be deemed by EPA to be the same as those of the transferor at the time the transfer is approved. 2. In addition, the transferor must submit to the Agency as required by 40 CFR 152.135(c) a notarized statement affirming that: a. The person signing the transfer agreement is authorized by the registrant to bind the transferor, b. No court order prohibits the transfer, and that any required court approvals have been obtained, and c. The transfer is authorized under all relevant Federal, State and local laws and all relevant corporate charters, bylaws, partnerships, or other agreements. IMPORTANT NOTE: Notary rules do not generally allow a person to notarize their own signature. Therefore, it is recommended that the same person not sign both the transfer document and the notarized statement. IMPORTANT NOTE: In the event that the original documents cannot be submitted for the attachments to the transfer document, each of the copied documents must be notarized and certified as a true copy of the originals. 3. If the required documents are submitted, and no information available to the Agency indicates that the information is incorrect, the Agency will approve the transfer without requiring that the transferee obtain a new registration(s). The Agency will notify the transferor and the transferee of its approval. 4. The transfer will be effective on the date of Agency approval. Thereafter, the transferee will be regarded as the registrant for all purposes under FIFRA. 5. The rights to exclusive use of data or data compensation under FIFRA section 3(c)(1)(D) are separate from the product registration itself and may be retained by the transferor, or may be transferred independently in accordance with 40 CFR 152.98. If the registrant as the original data submitter wishes to transfer data rights at the same time as he transfers the registration, he may submit a single transfer document containing the information required by this section for both the registration and the data. IMPORTANT NOTE: When product registrations are transferred from one registrant to another, all restrictions, data requirements, conditions of registration, including timeframes for the submittal of data or other information, suspensions or any other requirements existing on the registration are transferred with the registration. The new registrant (transferee) is responsible for adhering to or complying with all such restrictions, data requirements, conditions of registration, timeframes, suspensions or any other requirements that have been imposed on the acquired product registration. With respect to timeframes for the submittal of data or other information, the new registrant is responsible for the submittal of all required data according to the schedules already established by the Agency as a result of a data call-in under FIFRA section 3(c)(2)(B), or a condition of the registration under FIFRA section 6(e), for the acquired product registrations. Failure to comply with these timeframes, may result in the issuance of a Notice of Intent to Suspend the registration of the affected product under FIFRA section 3(c)(2)(B), or a Notice of Intent to Cancel the registration of the affected product under FIFRA section 6(e). Requests for the extension of time to submit required data or other information from the new registrant, merely because they acquired the registration after the 3(c)(2)(B) data call-in was issued, or after the conditions of registration under section 6(e) were imposed will not be granted. If the new registrant has other valid reasons for delays in the testing which were clearly outside their control, then such a request for time extensions will be considered in accordance with established procedures. If such delays are expected to be encountered, and a time extension is believed to be necessary, the Agency should be informed as soon as possible, and in any event prior to the due date. Transfers that occur while a 3(c)(2)(B) data call-in is being issued or during the 90 day response time to the data call- in are subject to the same conditions expressed above. C. TRANSFER OF DATA RIGHTS A person who possesses rights to exclusive use data or data compensation under FIFRA section 3(c)(1)(F) may transfer such rights to another person in accordance with 40 CFR 152.98. In order for the Agency to process a request for the transfer of data rights, certain documentation is required. 1. The original data submitter must submit to the Agency a transfer document that contains the following information: a. The name, address, phone number and State of incorporation (if any) of the original data submitter (the transferor), b. The name, address, phone number and State of incorporation of the person to whom the data rights are being transferred (the transferee), c. Identification of each item of data transferred including: 1) The name of the study or item of data, 2) Whether the study is an exclusive use study, and, if so, when the period of exclusive use protection expires, 3) The name of the person or laboratory that conducted the study, 4) The date the study was submitted to the Agency, 5) The EPA document number assigned to the item of data [the Master Record Identification Number (MRID) 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. 6) A statement that the transferor transfers irrevocably to the transferee all rights, and interest in the items of data named, 7) A statement that the transferor and transferee understand that any false statement may be punishable under 18 U.S.C. 1001, and 8) The names, signatures and titles of the transferor and transferee, and the date signed. 2. In addition, the transferor must submit to the Agency as required by 40 CFR 152.98, a notarized statement from a company official or from the company legal counsel affirming that: a. The person signing the transfer agreement is authorized by the original data submitter to bind the data submitter, b. No court order prohibits the transfer, and any required court approvals have been obtained, and c. The transfer is authorized under Federal, State and local laws and relevant corporate charters, bylaws or partnership agreements. IMPORTANT NOTE: Notary rules do not generally allow a person to notarize their own signature. Therefore, it is recommended that the same person not sign both the transfer document and the notarized statement. 3. 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. D. WHO TO CONTACT FOR FURTHER INFORMATION If you have any questions or require additional information concerning the transfer of product registrations or data rights please contact the Administrative Processing Section, Registration Support Branch. Refer to Chapter 18 of this manual. E. REFERENCES CITED IN CHAPTER 13 - Refer to Chapter 16 for information on the source of these documents. 1. Code of Federal Regulations, Title 40 Part 152 - Pesticide registration and classification procedures 2. Federal Insecticide, Fungicide and Rodenticide Act, as amended October, 1988 Section 3 - Registration of pesticides Section 6 - Administrative review; suspension