Purchased Regulatory Approvals definition

Purchased Regulatory Approvals has the meaning set forth in Section 2.1.1(b).

Purchased Regulatory Approvals means NDA #8975 and NDA #9854 and all supplements to either such NDA.

Purchased Regulatory Approvals means the Regulatory Approvals listed in Schedule 1.1.8.

Examples of Purchased Regulatory Approvals in a sentence

• Without limitation of the foregoing, except as expressly set forth herein or in the Ancillary Agreements, neither Seller nor Buyer shall have any obligation to assist or otherwise participate in the amendment or supplementation of the Purchased Regulatory Approvals or otherwise to participate in any filings or other activities relating to the Purchased Regulatory Approvals other than as necessary to effect the assignment thereof to Buyer in connection with the Closing pursuant to this Agreement.

• Except to the extent provided otherwise in the Transitional Services Agreement, transfer of title to the Purchased Regulatory Approvals shall be effective as of the Closing.

• Without limitation of the foregoing, except as expressly set forth in the Ancillary Agreements, neither Seller nor Purchaser shall have any obligation to assist or otherwise participate in the amendment or supplementation of the Purchased Regulatory Approvals or otherwise to participate in any filings or other activities relating to the Purchased Regulatory Approvals other than as necessary to effect the assignment thereof to Purchaser in connection with the Closing pursuant to this Agreement.

• Without limitation of the foregoing, neither Seller nor Buyer shall have any obligation to assist or otherwise participate in the amendment or supplementation of the Purchased Regulatory Approvals or otherwise to participate in any filings or other activities relating to the Purchased Regulatory Approvals other than as necessary to effect the assignment thereof to Buyer in connection with the Closing pursuant to this Agreement.

• The Purchased Regulatory Approvals are approved but in a “discontinued” state, per the definition of that term in the Drugs@FDA Glossary of Terms.

More Definitions of Purchased Regulatory Approvals

Purchased Regulatory Approvals means the Regulatory Approvals listed in Schedule 1.1.93, in each case, in the form currently maintained by Seller (e.g., electronic).

Purchased Regulatory Approvals means the Regulatory Approvals set forth on Section 1.1.5 of the Seller Disclosure Schedules; provided, however, “Purchased Regulatory Approvals” shall not include Permits other than Purchased Permits.

Purchased Regulatory Approvals means the Regulatory Approvals listed on Schedule 1.1.119, in each case, in the form currently maintained by Seller (e.g., electronic).

Purchased Regulatory Approvals means the Regulatory Approvals listed in Schedule 1.1.3, including all materials, information or data related to the Manufacture of the Products included therein (including any such information included in the Chemistry, Manufacturing and Controls section of any such Regulatory Approvals), but excluding, in all cases, the Excluded Items. For the avoidance of doubt, Purchased Regulatory Approvals shall not include inactive INDs. Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential Portions are marked: [***]

Purchased Regulatory Approvals means the Regulatory Approvals set forth on Section 1.01(b) of the Seller Disclosure Schedules. “Purchased Regulatory Documentation” means, with respect to the Product Business, all (a) documentation comprising the PurchasedRegulatory Approvals, (b) correspondence and reports exclusively related to the Product Business and necessary to, or otherwise limiting the ability to,commercially distribute, sell or market the Products as of the Closing Date in the Territory submitted to or received from Governmental Authorities (including minutes and official contact reports relating to any communications with any Governmental Authority), including all regulatory drug lists, final versions of advertising and promotion materials, and adverse drug experience reports (periodic and expedited), the safety data base, and adverse event files and (c) data (including clinical and pre-clinical data) referenced in any of the foregoing, in each case ((a), (b) and (c)), to the extent in the possession and custody of Seller or any of its Subsidiaries.

Purchased Regulatory Approvals means all Regulatory Approvals held by the Seller or any of the Selling Affiliates exclusively related to the Product or the Business, as listed on Section 1.1(j) of the Seller Schedule, in each case in the form currently maintained by Seller or any of the Selling Affiliates (e.g., electronic).

Purchased Regulatory Approvals means the Regulatory Approvals listed in Schedule 1.1.3, including all materials, information or data related to the Manufacture of the Products included therein (including any such information included in the Chemistry, Manufacturing and Controls section of any such Regulatory Approvals), but excluding, in all cases, the Excluded Items. For the avoidance of doubt, Purchased Regulatory Approvals shall not include inactive INDs.