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 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.
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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.
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Examples of Par ANDA in a sentence

  • While we believe that licensing agreements are possible, there can be no assurance that any can be secured.3. Includes a Company ANDA final approval for our 15 and 30 mg strengths, and a Par ANDA final approval for their 5, 10, 15, 20, 25, 30, 35 and 40 mg strengths.

  • Except as noted in the RAM PPA at Appendix B to this RFO, the Project must be commercially operational no later than 24 months following final and non-appealable CPUC approval of the RAM PPA associated with the Project.

  • 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.

  • For the avoidance of doubt, in no event shall Par and its Affiliates and Related Parties offer for sale, sell, launch, Commercially Market, distribute, or ship the Par ANDA Products prior to the License Effective Date.

  • 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.

  • 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.

  • 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.

  • 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.

  • Par and its Affiliates and Related Parties may, but not earlier than […***…] ([…***…]) calendar days prior to the License Effective Date, […***…] and otherwise take such steps necessary to develop inventory of the Par ANDA Products solely for the purpose of preparing for commercial launch as of the License Effective Date.


More Definitions of Par ANDA

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.
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Related to Par ANDA

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  • SWDocID [[6027980]]" "" [[6027980]] on the date that such L/C Disbursement is made, if the Borrower shall have received notice of such L/C Disbursement prior to 10:00 a.m., New York City time, on such date, or, if such notice has not been received by the Borrower prior to such time on such date, then not later than 12:00 p.m., New York City time, on the Business Day immediately following the day that the Borrower receives such notice, if such notice is not received prior to such time on the day of receipt; provided that the Borrower may, subject to the conditions to borrowing set forth herein, request in accordance with Section 2.03 or 2.04 that such payment be financed with an ABR Revolving Facility Borrowing, a Swingline Borrowing, a Term SOFR Revolving Facility Borrowing or, if applicable pursuant to Section 2.14, a Daily Simple SOFR Revolving Facility Borrowing in the amount of such L/C Disbursement and, to the extent so financed, the Borrower’s obligation to make such payment shall be discharged and replaced by the resulting ABR Revolving Facility Borrowing, Swingline Borrowing, Term SOFR Revolving Facility Borrowing or Daily Simple SOFR Revolving Facility Borrowing, as applicable. If the Borrower fails to reimburse any L/C Disbursement when due, then the Administrative Agent shall promptly notify the Issuing Bank and each other Revolving Facility Lender of the applicable L/C Disbursement, the payment then due from the Borrower and, in the case of a Revolving Facility Lender, such Xxxxxx’s Revolving Facility Percentage thereof. Promptly following receipt of such notice, each Revolving Facility Lender shall pay to the Administrative Agent in Dollars, its Revolving Facility Percentage of the payment then due from the Borrower, in the same manner as provided in Section 2.06 with respect to Loans made by such Lender (and Section 2.06 shall apply, mutatis mutandis, to the payment obligations of the Revolving Facility Lenders), and the Administrative Agent shall promptly pay to the Issuing Bank in Dollars, the amounts so received by it from the Revolving Facility Lenders. Promptly following receipt by the Administrative Agent of any payment from the Borrower pursuant to this paragraph, the Administrative Agent shall distribute such payment to the Issuing Bank or, to the extent that Revolving Facility Lenders have made payments pursuant to this paragraph to reimburse the Issuing Bank, then to such Lenders and the Issuing Bank as their interests may appear. Any payment made by a Revolving Facility Lender pursuant to this paragraph to reimburse the Issuing Bank for any L/C Disbursement (other than the funding of an ABR Revolving Facility Borrowing, a Swingline Borrowing, a Term SOFR Revolving Facility Borrowing or a Daily Simple SOFR Revolving Facility Borrowing as contemplated above) shall not constitute a Loan and shall not relieve the Borrower of its obligation to reimburse such L/C Disbursement.

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