Ownership After Transfer. After the transfer of the IND in accordance with Article 3 and approval of the first NDA related to a Product, Coronado shall maintain the IND and subsequent NDA with the applicable Regulatory Authority. The IND, NDA and all other Regulatory Documentation shall reflect Coronado (or its designated Affiliate) as the owner of the Product and all Regulatory Approvals issued pursuant thereto shall thereafter be in the name of and owned by Coronado (or its designated Affiliate). The amendment of the IND, NDA and any Regulatory Documentation in accordance herewith to reflect Coronado (or its designated Affiliate) as the owner of the Product or any transfer to such an Affiliate shall be conditioned upon the written undertaking by that Affiliate to accept all of the terms and conditions of this Agreement applicable to the IND or NDA. After the transfer of the IND in accordance with Article 3, Coronado shall be the sole and exclusive owner of all right, title and interest in and to the IND and NDA for the Product and shall retain the exclusive control of such IND and NDA, including all amendments, supplements and all other communications with the FDA. After the transfer of the IND in accordance with Article 3, Coronado shall comply with all requests of the Regulatory Authorities and shall be responsible for all regulatory costs and related legal expenses. After the transfer of the IND in accordance with Article 3, Revogenex, shall have no liability for any regulatory costs or related legal expenses. Coronado shall maintain a complete copy of the IND and NDA filed with the FDA and all Regulatory Documentation or any proposed amendment to the IND and NDA, and Coronado shall make such IND, NDA, proposed amendments and Regulatory Documentation available to Revogenex at reasonable times upon prior written notice from Revogenex.
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Samples: Assignment and Assumption Agreement, Assignment and Assumption Agreement (Avenue Therapeutics, Inc.), Assignment and Assumption Agreement (Avenue Therapeutics, Inc.)