Par ANDA definition

Par ANDA means ANDA No. 202842 filed by Par, as amended from time to time.

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Par ANDA means: (i) ANDA No. 208757 for 12 mg/0.6 mL methylnaltrexone bromide in a single-dose vial product; and (ii) any ANDA filed by Par for 8 mg/0.4 mL and/or 12 mg/0.6 mL methylnaltrexone bromide in a single-dose pre-filled syringe for which Relistor® Injection is the Reference Listed Drug, and, with respect to (i) and (ii), including any amendments, replacements, or supplements that have been made or may in the future be made thereto. For clarity, “supplements” or “replacements” means with respect to an ANDA for 12 mg/0.6 mL methylnaltrexone bromide in a single-dose vial product for which Relistor® Injection is the Reference Listed Drug.

Par ANDA means ANDA No. 205976 (together with any amendments, supplements, or other changes thereto) seeking approval to engage in the ** This portion has been redacted pursuant to a confidential treatment request. Manufacture, use and sale of an extended release oral capsule product containing the Compound as its sole active ingredient.

Examples of Par ANDA in a sentence

• No provision of this Settlement Agreement shall be affected by any delay in the approval of the Par ANDA by the FDA, or the failure of Par to obtain FDA approval of the Par ANDA.

• Notwithstanding anything in the foregoing to the contrary, the covenant in this Section 6.4 will not apply to (i) any Claims that arise from or relate to any breach of any representation, warranty, obligation, or other term or condition of this Agreement, or (ii) any proceeding with respect to any Par product other than the Par ANDA Products or any patent other than any of the Licensed Patents.

• If and when so developed, the Parties agree that any filings made with the FDA in respect of applications for approval to commercialize such strengths, or any other strengths as may be introduced into the Territory by the owner of the Brand Product, shall be made as amendments to the IPC ANDA or to the Par ANDA, as the case may be, and not as new ANDAs.

• Par has, prior to the date hereof, undertaken a parallel development of a Generic of the Brand Product in the 5, 10, 15, 20, 30 and 40 mg strengths, using Intellectual Property other than IPC Intellectual Property, with IPC’s knowledge and consent, and has filed the Par ANDA in respect thereof, and IPC does not now and will not in the future object to or take issue with such prior or further development by Par.

• Plaintiffs therefore make no warranty and no representation with respect to the actual date that the Par ANDA Products will be available for sale.

• The Parties herein acknowledge that Par’s ability to launch the Par ANDA Products may be limited by (a) the FDA’s failure to finally approve the Par ANDA Products; (b) a period of exclusivity associated with a Third Party’s “first-filer” status; (c) Par’s inability to manufacture, package, and otherwise prepare a sufficient amount of the Par ANDA Products by the Generic Entry Date; or (d) other situations not currently within the Parties’ contemplation.

• Notwithstanding anything in the foregoing to the contrary, the covenant in this Section 6.5 will not apply to (i) any Claims that arise from or relate to any breach of any representation, warranty, obligation, or other term or condition of this Agreement, or (ii) any proceeding with respect to any Par product other than the Par ANDA Products or any patents other than the Licensed Patents.

• The Parties hereby agree that Par may elect to develop a 40 mg strength of the Product under the Par ANDA and at its own expense.

• No provision of this Agreement shall be affected by any delay in the approval of the Par ANDA by the FDA, […***…], except to the extent that such provision is affected by the delay of Par’s Commercial Marketing.

• If a Governmental Entity directs or recommends to Par that Par transfer the Par ANDA to a Third Party, Par may disclose a copy of this Settlement Agreement to a Third Party in connection with such a possible transfer so long as the Third Party agrees in writing to confidential treatment of this Settlement Agreement no less restrictive than the confidentiality obligations set forth in Paragraph 12 of this Agreement.

More Definitions of Par ANDA

Par ANDA means ANDA No. 205742 for glycerol phenylbutyrate oral liquid, 1.1 gm/mL as it exists as of the Effective Date, including any future supplements, amendments and/or modifications to the ANDA that were made to gain approval from the FDA, provided such supplements, amendments and/or modifications do not change the active ingredient, dosage form, reference listed drug, or AB rating of any generic product described in the ANDA as it exists as of the Effective Date.