AG Product definition

AG Product means a product that is not Labeled with the Trokendi XR® trademark containing the Compound as its sole active ingredient that is Marketed or supplied under the Supernus NDA, described therein now or hereafter.

Split View

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Get StartedSchedule a Demo

AG Product means a generically labeled version of the Brand Product that is approved for sale under the Regulatory Approval for such Brand Product.

AG Product means a hydroxyprogesterone caproate injection supplied in (i) 250 mg/mL preservative free in 1 mL single dose glass vial in a single unit carton bundled with four in each tray or pack, and (ii) 250 mg/mL in 5 mL multidose glass vial in a single unit carton, each in Manufactured form and sold under AMAG’s NDA.

Examples of AG Product in a sentence

• Sandoz and Eagle agree to promptly notify the other party in the event they receive any communication or notice from FDA with respect to the AG Product and each party will promptly provide a copy of such communications to the other.

• Notwithstanding the foregoing, Eagle will have final authority for regulatory decisions and responsibility for all communications with FDA concerning the AG Product.

• In the event that either party is required to change the Specifications for the AG Product pursuant to Applicable Law, or in response to a regulatory request, the parties will agree to reasonable and equitable modifications in the Product Cost for the AG Product to reflect any increase in the manufacturing cost caused by this change.

• For purposes of clarification, the parties acknowledge that the foregoing complaint handling procedures will only apply to complaints which implicate the manufacturing, packaging, testing or storage of the AG Product.

• All AG Product shipped to Sandoz will have expiration dating as set forth on Schedule A.

More Definitions of AG Product

AG Product means an unbranded (generic) form of the Eagle Branded Product as described on Schedule A distributed exclusively by Sandoz under a label not referencing the Eagle Trademark.

AG Product means Shire authorized and supplied generically Labeled Adderall XR.

AG Product means any product, other than the Innovator Product, promoted, distributed, marketed, offered for sale and/or sold as a branded or non-branded generic product under or pursuant to the Innovator Pharmaceutical Company’s approved New Drug Application filed with the FDA pursuant to and under 21 U.S.C. Section 355(b) of the Act, for the Innovator Product.

AG Product means a generic version of the Brand Product that is manufactured and sold under the Brand Product NDA without a trademark or using a trademark other than Lidoderm® or a successor trademark thereto.

AG Product means any product, promoted, distributed, marketed, offered for sale and/or sold as a branded or non-branded generic product, or any Private Label product, under or pursuant to an approved Product NDA.

AG Product means generically Labeled Adderall XR, commonly called an authorized generic product, approved for sale by the FDA pursuant to a labeling supplement to Shire’s NDA.

AG Product means a generically-labeled version of the Product (i.e., such Product does not bear the Trade Name) supplied by Alfacell and sold by Par and/or its Sub-distributors or permitted sublicensees.