NDA Product definition

NDA Product means the products supplied by HMRI to Rugby pursuant to the Supply and License Agreement.

NDA Product or “RAVICTI®” means the glycerol phenylbutyrate oral liquid product approved under the RAVICTI® NDA, including any amendments and supplements thereto.

NDA Product or “PENNSAID® 2%” means the diclofenac sodium topical solution product approved under the PENNSAID® 2% NDA, including any amendments and supplements thereto.

Examples of NDA Product in a sentence

• Infringement Belcher seeks judgment that Hospira’s NDA Product infringes claims 6 and 7 of the ’197 Patent under the doctrine of equivalents (“DOE”).

• PLANTEX shall not supply API to any other entity during the Term of this Agreement for use in the field of the treatment, diagnosis, and/or prevention of any cancer, except for a pharmaceutical product that in the reasonable judgment of NOVACEA shall not be in direct competition with NOVACEA’s approved NDA Product, such determination to be made by NOVACEA promptly following the written request therefore by PLANTEX.

• Belcher sued Hospira for infringing the ’197 Patent pursuant to 35 U.S.C. § 271(a), (b), (c) and (e)(2), based on the filing of Hospira’s NDA and the accompanying Paragraph IV certification as to Hospira’s NDA Product.

• A “Licensor Design Defect” shall be a defect in the design or formulation of the NDA Product as such NDA Product is designed and formulated as set forth in the NDA on the Effective Date.

• In the event of such shortage, Seller shall allocate its available production capacity or available raw material available for the production of the NDA Product to be sold in the Territory to the production of Products in accordance with Exhibit D.

More Definitions of NDA Product

NDA Product means the Product that is the subject of the NDA.

NDA Product means a herbal Licensed Product which (i) it or its method of manufacture or use is claimed in one or more claims of a patent or patent application within the Patent Rights in the country of its manufacture, use or sale, (ii) is the subject of an NDA program proposed by PharmaPrint or an approved NDA based on an application filed by PharmaPrint in the Territory.

NDA Product means a pharmaceutical product that (a)(i) is a bendamustine hydrochloride solution, (ii) is therapeutically equivalent to the Bendeka® NDA Product, as manufactured or sold for use in the Territory in a 100 mg/4 mL (25 mg/mL) dosage strength in a multiple-dose vial, and (iii) has an FDA approved label [***] and (b) is sold, offered for sale or distributed under an NDA that references the Bendeka® NDA Product as the reference-listed drug and is filed or otherwise controlled by a person or entity other than Plaintiffs or their Affiliates. For the avoidance of doubt, an NDA Product does not include (1) [***], or (2) [***].

NDA Product means the products approved and marketed in the United States under NDA No. 021121, as amended or supplemented.

NDA Product means the product Marketed under the Trademark that contains the Compounds as the only active ingredients and that is approved for Marketing in the Territory pursuant to NDA No. 022580 as of the Execution Date.

NDA Product means a Licensed Product under the Agreement approved for marketing in the United States pursuant to a New Drug Application.

NDA Product or “Relistor® Injection” means the 8 mg/0.4 mL methylnaltrexone bromide in single-dose pre-filled syringe and 12 mg/0.6 mL methylnaltrexone bromide in a single-dose pre-filled syringe or single-dose vial products approved under the Salix NDA.