NDA Product definition

NDA Product means the products supplied by HMRI to Rugby pursuant to the Supply and License Agreement.
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NDA Product means the products approved and marketed in the United States under NDA No. 021121, as amended or supplemented.
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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) [***].
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Examples of NDA Product in a sentence

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

  • 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.

  • BBI hereby covenants and agrees that all work product created by BBI arising from the performance of Services under this Agreement, including the NDA for the NDA Product, Intellectual Property and Regulatory Materials, in each case that BBI shall actually conceive and first actually reduce to practice on behalf of Botanix as a result of performing Services hereunder (hereafter, the “Works”), shall be the sole and exclusive property of Botanix.

  • Notwithstanding the provision of the Services, at all times after the effective date of such transfer, Botanix agrees that it shall be, and will act as, the sponsor (or legal holder) of the Transferred IND and the NDA for the NDA Product.

  • Corium shall manufacture, test, label, package, and ship all Product, or cause the Product to be manufactured, tested, labeled, packaged, and shipped in accordance with the respective NDA, Product Specifications, cGMP, the Quality Agreement, and the Act, as amended.


More Definitions of NDA Product

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.
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NDA Product or “RAVICTI®” means the glycerol phenylbutyrate oral liquid product approved under the RAVICTI® NDA, including any amendments and supplements thereto.
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NDA Product means the Product that is the subject of the NDA.
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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.
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NDA Product or “PENNSAID® 2%” means the diclofenac sodium topical solution product approved under the PENNSAID® 2% NDA, including any amendments and supplements thereto. ***Confidential Treatment Requested ***Text Omitted and Filed Separately with the Securities and Exchange Commission. Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) and 240.24b-2 EXECUTION VERSION
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NDA Product means
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NDA Product means the 10 milligrams, 20 milligrams, 25 milligrams, 30 milligrams, 35 milligrams, or 40 milligrams capsule products Marketed under the Trademark that contain the Compound as the sole active ingredient and that are approved for Marketing in the Territory pursuant to NDA 021951 as of the Execution Date.
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