Extended Release definition

Extended Release means a pharmaceutical product containing [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the active ingredient [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] in an extended release dosage form consisting of a fast-dissolving tablet using the CIMA Technology.
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Examples of Extended Release in a sentence

  • In addition to EURAND’s rights described in Section 5.1, and subject to Section 4.3(b) hereof, EURAND and its Affiliates shall have the right to use all Know-How developed by EURAND during the course of the performance of this Agreement which is directed solely to the Extended Release Composition or the Product, provided such use, disclosure or license does not conflict with the rights granted to RELIANT under this Agreement.

  • Each party warrants to the other that to the best of its knowledge, the Extended Release Composition and Product in the case of EURAND and the Active Ingredient, Product, and Finished Dosage Form in the case of RELIANT do not infringe any third party patent or other intellectual property rights.

  • Comply with System Agency Guidelines for the Use of Extended Release Injectable Naltrexone.

  • Each party will timely report to the other any information concerning any side effect, injury, toxicity or sensitivity reaction associated with clinical uses, studies, investigations or tests of the Extended Release Composition, Product or Finished Dosage Form.

  • For the avoidance of doubt, the Trademark License shall not extend to the sale or marketing of Finished Dosage Form which is manufactured from an Extended Release Composition which is not manufactured by EURAND.

  • If ANDA #205327 (Methylphenidate Extended Release Tablets) is not approved by September 30th, of a Contract Year, the minimum Annual Purchase Commitment ([***]) for the following Contract Year will be waived.

  • We also market branded Ampyra (dalfampridine) Extended Release Tablets, 10 mg.

  • Comply with System Agency Guidelines for the Use of Extended Release Injectable Naltrexone (included as Attachment K to the Contract).

  • Andrx shall maintain complete and ---------------------------------- accurate books and records in connection with the sale of Metformin Extended Release by Andrx and its Affiliates to their non-Affiliated customers in the normal course of business by Andrx or its Affiliates ("Commercial Sales").

  • Aventis seeks an injunction preventing us from marketing its Fexofenadine and Pseudoephedrine Hydrochloride 60 mg/120 mg Extended Release Tablet product until the patents-in-suit have expired, and an award of damages for any commercial manufacture, use, or sale of our Fexofenadine and Pseudoephedrine Hydrochloride 60 mg/120 mg Extended Release Tablet product, together with costs and attorneys' fees.

Related to Extended Release

  • Earned release means earned release from confinement as

  • Release of Claims means the Release of Claims in substantially the same form attached hereto as Exhibit B (as the same may be revised from time to time by the Company upon the advice of counsel).

  • Pre-Release shall have the meaning set forth in Section 2.09.

  • Waiver and Release means the Waiver and Release attached hereto as Exhibit A.

  • Threatened Release means a substantial likelihood of a Release which requires action to prevent or mitigate damage to the soil, surface waters, groundwaters, land, stream sediments, surface or subsurface strata, ambient air or any other environmental medium comprising or surrounding any Property which may result from such Release.