AG Product definition

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.

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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.

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.

Examples of AG Product in a sentence

Deliveries of AG Product will be made in accordance with the delivery schedule set forth in the purchase orders provided, subject to Sections 4.3, 4.4 and 4.5.
As such, Sandoz will provide Eagle with aggregate sales figures for the AG Product sales made by Sandoz and the related Net Profit split by product NDC number.
Any deviations and investigations related to the AG Product will be documented by Eagle in accordance with the Eagle NDA and the Quality Agreement referred to in Section 6.1.
Notwithstanding the foregoing, Eagle will have final authority for regulatory decisions and responsibility for all communications with FDA concerning the AG Product.
To the extent there is an increase in Eagle’s cost to acquire the AG Product as a result of an increase in API costs and filling costs at the Contract Manufacturer’s facility (as evidenced by written records reasonably acceptable to Sandoz), in any case outside of the control of Eagle, 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 such change.

More Definitions of AG Product

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

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 Shire authorized and supplied generically Labeled Adderall XR.

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

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.