Product NDA definition

Product NDA means the New Drug Application filed with the FDA for the Product pursuant to the Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder, and any amendments or Supplemental New Drug Applications thereto, or documents incorporated by reference.

Product NDA means any NDA filed in the Territory seeking Marketing Approval for a Product in the Field or any indication in the Field, filed with a Regulatory Authority during the Term, including any supplements or amendments thereto.

Product NDA means the NDA owned by Titan as of the Effective Date relating to Probuphine® (No. 204442), together with all amendments, supplements and updates thereto, as well as the corresponding IND (IND 70852).

Examples of Product NDA in a sentence

• ENDO acknowledges and agrees that, notwithstanding the license grant in Section 2.1, neither NOVARTIS nor any Affiliate thereof shall be under any obligation to disclose to ENDO any NOVARTIS Know-How, including the Licensed Product NDA or any data therein, all of which shall constitute NOVARTIS Confidential Information.

• From and after the Closing Date through the Mallinckrodt Exit Date, Seller, at its sole cost and expense, shall cause Mallinckrodt to maintain an open and active Product NDA in compliance with applicable Laws.

• The Ancillary Agreements executed and delivered by Seller to Buyer at the Closing, together with the Mallinckrodt FDA Transfer Letters, effectively vest in Buyer (or, in the case of the Product NDA and the Product IND, upon the Transfer Date, will vest in Buyer Designee) good, valid and marketable title to, and ownership of, the Purchased Assets free and clear of all Encumbrances.

• Seller (or, solely with respect to the Product NDA and the Product IND, Mallinckrodt or its Affiliates) owns, leases or has the legal right to use all of the Purchased Assets.

• Unless and until agreed otherwise, Arena (or one of its Affiliates) shall remain responsible for safety reporting for any clinical trials of the Initial Product for the Territory until the transfer of the Initial Product NDA to Eisai under Section 3.10(a), at which time Eisai shall become responsible therefor.

More Definitions of Product NDA

Product NDA means any NDA filed in the Territory which seeks Regulatory Approval for a Product in the Field, including any supplements or amendments thereto.

Product NDA means the New Drug Application (“NDA”) to be filed with the FDA seeking approval of the Product (or any subsequent NDA filed with the FDA for any other strength, dosage or indication for the Product not included in the first NDA for the Product) for marketing, sale and use in the Field in the United States. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

Product NDA means the NDA No. 208552, as filed with the FDA and approved on January 18, 2017, including all amendments, supplements, variations, extensions and renewals thereof through the Closing Date.

Product NDA means NDA No. 21-748 filed with FDA on April 27, 2004, including, without limitation, any and all amendments and supplements thereto and all written FDA communications related thereto, whether existing on the NDA Transfer Date or filed thereafter.

Product NDA means [***], including all amendments, supplements, variations, extensions and renewals thereof.

Product NDA means NDA # 20-2088.

Product NDA means the New Drug Application filed by Seller seeking marketing approval for the Products.