Available Product definition

Available Product means a Drug Candidate that either: (a) is composed of a combination of two or more Pharmaceutical Products, each said Pharmaceutical Product being suitable for administration to patients as part of a co-therapy regimen in which neither Pharmaceutical Product is in any way altered with respect to its registration in the FDA Orange Book registry; or (b) is a single Pharmaceutical Product suitable for administration to patients without being in any way altered with respect to its registration in the FDA Orange Book registry.
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Available Product means a human therapeutic product that (a) has previously received final approval from the FDA for marketing in the United States and (b) is suitable for administration to patients in its currently marketed formulation for the treatment of spinal muscular atrophy.
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Examples of Available Product in a sentence

  • Medium - Minor Operational Impact, Workaround Available, Product Feature not working to Specifications.

  • Supplier acknowledges that Company’s estimates and determination of Available Product Volumes will be based on production data provided Section 3 Right to Take Plant Products and Residue Gas In-Kind by Supplier and to the extent such data is inaccurate or does not coincide with actual production flows, Company shall be allowed to adjust the Available Product Volumes accordingly, provided a Supplier representative is advised of such adjustments.

  • The provisions of this Section 3.A(7) shall not be applicable to any volumes of Plant Products which Supplier is entitled to take-in-kind which Company has not advised are available for Supplier’s receipt; i.e., which are not within the Available Product Volumes.

  • Notwithstanding anything in the definition of “Proceeds” in Section A.1, DEFINITIONS, of the General Terms and Conditions (or any other terms in the Agreement) to the contrary, Company shall retain (**) percent (**)% of the total proceeds received by Company from the sale of any portions of Supplier’s Available Product Volumes, provided same was sold in compliance with the terms of this Section 3.A(7), as Company’s fee for marketing such volumes of Plant Products.

  • When CBV becomes aware of an Available Product Opportunity, CBV shall promptly notify Echo of such Available Product Opportunity and proceed within a reasonable time frame to discuss the Available Product Opportunity exclusively with Echo for a period of at least ninety (90) days (the “Echo Exclusivity Period”); provided, however, that CBV may discuss the Available Product Opportunity with an Affiliate of CBV and the Owner during the Echo Exclusivity Period.

  • The Status of a Roche Product Class or a 4DMT Product Class may also be changed to an Available Product Class in accordance with Article 5 and/or Section 22.3.1.

  • Upon payment of such Option fee, the same rights granted in Sections 2.1 through 2.3 of this Agreement shall be extended automatically to cover the use of the Available Product Opportunity.

  • In any case in which the E▇▇▇▇▇▇ Money is provided herein to be returned to Purchaser, then nevertheless One Hundred Dollars ($100.00) thereof shall be paid to or retained by Seller and deducted from the amount due Purchaser; such amount shall belong to Seller in any and all events and shall in effect constitute option money, making this Agreement binding even if any conditions or provisions herein are entirely with the discretion or control of Purchaser.

  • If Echo has not given notice to CBV of its interest in pursuing the Available Product Opportunity within ninety (90) days of the date CBV gives notice to Echo of the Available Product Opportunity, then Echo shall be deemed to have declined the Available Product Opportunity and CBV shall be free to offer the Available Product Opportunity to any third-party free of Echo’s right of first offer under this Agreement.

  • If Roche does not exercise such right, then the Status remains as a 4DMT Product Class, but is sub-categorized as a Non-Optionable 4DMT Product Class, unless and until the Status once again becomes an Available Product Class.