Common use of Registrations; Regulatory Matters Clause in Contracts

Registrations; Regulatory Matters. All Registrations held by Seller with respect to the CV Products are listed on Attachment 2.1(e). The Registrations are owned exclusively by Seller. To Seller’s Knowledge, all of the Registrations are valid and in full force and effect as of the Effective Date. The Registrations (i) are in the name of Seller; and (ii) except as set forth in Schedule 6.6(l) of the Disclosure Schedule, constitute all licenses, permits, approvals, qualifications, authorizations or requirements of any Governmental Entity in the applicable Territory necessary to manufacture and sell the Marketed Products in the applicable Territory. Seller has furnished Buyer with access to a complete copy of the NDA, including all amendments and supplements thereto. Each of the Registrations has been approved by the FDA or other relevant Governmental Entity, as the case may be, and each of the Registrations is in good standing with the FDA or other relevant Governmental Entity, as the case may be. There is no action or proceeding by any Governmental Entity pending or, to the Knowledge of Seller as of the Closing Date, threatened seeking the revocation or suspension of any Registration relating to the manufacture or sale of the Marketed Products in the applicable Territory.

Registrations; Regulatory Matters. All Registrations held by Seller with respect to the CV Products are listed on Attachment 2.1(e). The Registrations are owned exclusively by Seller. To Seller’s Knowledge, all of the Registrations are valid and in full force and effect as of the Effective Date. The Registrations (i) are in the name of Seller; and (ii) except as set forth in Schedule 6.6(l) of the Disclosure Schedule, constitute all licenses, permits, approvals, qualifications, authorizations or requirements of any Governmental Entity in the applicable Territory necessary to manufacture and sell the Marketed Products in the applicable Territory. Seller has furnished Buyer with access to a complete copy of the NDA, including all amendments and supplements thereto. Each of the Registrations has been approved by the FDA or other relevant Governmental Entity, as the case may be, and each of the Registrations is in good standing with the FDA or other relevant Governmental Entity, as the case may be. There is no action or proceeding by any Governmental Entity pending or, to the Knowledge of Seller as of the Closing Date, threatened seeking the revocation or suspension of any Registration relating to the manufacture or sale of the Marketed Products in the applicable Territory. * Certain information on this page has been omitted and filed separately with the SEC. Confidential treatment has been requested with respect to the omitted portions.