Transferred Registrations definition

Transferred Registrations means all Product Registrations and INDs, pending or issued, for the Product (which shall include all FDA Product Marketing Authorizations and other U.S. and non-U.S. regulatory approvals and licenses for, and all related applications and other information submitted for the purposes of or prepared in connection with obtaining the approval for, the Product), including the registrations and/or applications set forth on Schedule 1.1(i) to this Agreement.

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Transferred Registrations means all regulatory filings, applications, marketing authorizations, permits, licenses, registrations, regulatory clearances, approvals and similar items issued by any Governmental Authority, and any material correspondence and reports submitted to or received from any Governmental Authority and all supporting documents with respect thereto, including adverse event files and complaint files, in each case, that relate solely to the RHOFADE Product, including any INDs, NDAs and foreign equivalents thereof.

Transferred Registrations means all product and marketing registrations and applications, pending or issued, for the Transferred Products (which shall include all FDA and other U.S. and non-U.S. regulatory approvals and licenses related to, and all related applications and other information submitted for the purposes of or prepared in connection with obtaining the approval for, a product candidate), including the registrations and/or applications listed or described on Section 1.1(a)(ii) of the Seller Disclosure Letter.

Examples of Transferred Registrations in a sentence

Books and records relating to the NDA included in the Transferred Registrations, as set out in Schedule 7.1(c) (which, for the avoidance of doubt, may be delivered in electronic format).
The term “Non-Assignable Assets” as used in this Section 5.5 shall not, for the avoidance of doubt, include (A) any Transferred Registrations that have not transferred to Purchaser at the Closing (B) any French Transferred Assets, or (C) any Dutch Transferred Assets, except, in each case as provided in the immediately preceding sentence.
Promptly after the Settlement Effective Date the Parties will cooperate to transfer the IND included in the Transferred Registrations to TRIS.
The list of Transferred Registrations set forth on Schedule 1.1(i) to this Agreement is true, correct and complete.
Purchaser shall be responsible for all fees and expenses associated with transferring the Transferred Registrations and all fees and expenses associated with the Transferred Registrations that become due and payable following the Closing, including any out-of-pocket expenses of TDCC or any of its Affiliates.
The term “Non-Assignable Assets” as used in this Section 5.5 shall not, for the avoidance of doubt, include any Transferred Registrations that have not transferred to Purchaser at the Closing.
All Transferred Registrations are true, correct and complete (except for such Transferred Registrations in the process of being supplemented by a subsequent filing in compliance with applicable Law described on Section 4.7.1 of the Disclosure Schedules) in all material respects.
Seller has not received any written notice that any loss, revocation, termination, suspension or expiration of any Transferred Registrations is pending or threatened, and to the Knowledge of Seller, no such loss, revocation, termination, suspension or expiration is threatened, other than expiration in accordance with the terms thereof.
Further, the Seller shall reasonably consult with the Purchaser in connection with the Purchaser’s efforts to obtain replacement Registrations, permits, licenses, certifications and approvals relating to the Business not included in the Transferred Registrations and Transferred Permits, provided that the Seller shall not be required to prepare any applications or other documentation, provide any legal advice or pay any fees or other amounts in connection with such activities.
Promptly following the Settlement Effective Date, ▇▇▇▇ and TRIS will cooperate in good faith and use commercially reasonable efforts to give all notices to and make all filings with any governmental authority necessary to transfer any Transferred Registrations from Aytu to TRIS effective as of the Settlement Effective Date.

More Definitions of Transferred Registrations

Transferred Registrations means (a) all Product Registrations, pending or issued, for the Products (which shall include all FDA Permits required for the conduct of the Business as currently conducted , and other U.S. and non-U.S. regulatory approvals and licenses for, and all related applications and other information submitted for the purposes of or prepared in connection with obtaining the approval for, and sale of, the Products), all of which registrations and/or applications are set forth on Schedule 1.1(i)(i) to this Agreement, and (b) all Manufacturing Registrations, all of which are set forth on Schedule 1.1(i)(ii).

Transferred Registrations has the meaning given that term in Exhibit K.

Transferred Registrations any and all Regulatory Approvals granted or issued by, or applied for to a national, regional, state, or regulatory authority, department, bureau, commission, council or other Governmental Entity for any activities in relation to or with a medicinal product in a given country, jurisdiction, or region (including for the Development, Manufacture, supply, and Commercialization of such medicinal product).

Transferred Registrations is defined in Section 2.1(a)(i) hereof.