Minimum Remaining Shelf Life definition
Minimum Remaining Shelf Life has the meaning given to it in clause 3.4(B).
Minimum Remaining Shelf Life means, on a Product-by-Product basis, a minimum remaining shelf life upon delivery as set forth on Schedule G.
Minimum Remaining Shelf Life shall have the meaning set forth in Section 6.7 of the Agreement.
Examples of Minimum Remaining Shelf Life in a sentence
On the date of shipment, the Products shall have at least the Minimum Remaining Shelf Life.
CyDex shall warrant that such Captisol shall, at a minimum, meet the Specifications as set forth in Exhibit B and the Minimum Remaining Shelf Life and have been manufactured in accordance with all applicable laws and regulations, including under conditions of GMP and under the same DMF and manufacturing processes referenced in Company’s IND or NDA.
In the event that Celgene is only able to propose Product with less than the Minimum Remaining Shelf Life to BeiGene, BeiGene has the right to refuse shipment.
Minimum Remaining Shelf Life at the time of Delivery: not less than the current approved Product shelf life less four (4) months.
CyDex shall and hereby does warrant that such Captisol shall, at a minimum, meet and satisfy the Specifications as set forth in Exhibit B, not have any Defects, comply with all Quality Agreement obligations and the Minimum Remaining Shelf Life and have in all material respects been manufactured in accordance with all applicable laws and regulations, including under conditions of GMP.
More Definitions of Minimum Remaining Shelf Life
Minimum Remaining Shelf Life means the minimum remaining of the maximum shelf-life (i.e., for purposes of this Agreement, the maximum shelf-life for Product shall be the stated shelf-life for the Product) for Product that is required to be remaining at the time of Delivery of such Product pursuant to this Agreement. Subject to Section 3.13, the Minimum Remaining Shelf-Life for the Product will be [***].
Minimum Remaining Shelf Life means, with respect to Product, the minimum percentage of the maximum shelf-life for such Product that is required to be remaining at the time of - Delivery by Corden of such Product hereunder, which shall in all cases be eighty percent (80%) of the maximum shelf-life for the Product (based upon the shelf-life of the Product configuration with the shortest shelf-life) set forth in the Health Registration for the Product. 1.63 “Minimum Time” has the meaning set forth in Section 3.2(c). 1.64 “MSA” has the meaning set forth in the Recitals. 1.65 “Non-Binding Forecast” has the meaning set forth in Section 3.1(b). 1.66 “Non-Conforming Product” has the meaning set forth in Section 4.33(a). 1.67 “Note” has the meaning set forth in Section 2.6. 1.68 “Partner(s)” means licensees, sublicensees or distributors that Customer engages for the purpose of marketing, promoting, distributing, offering for sale and selling the Product. 1.69 “Party(ies)” has the meaning set forth in the Preamble. 1.70 “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision, department or agency of a government. 1.71 “Product” means bulk drug product as more specifically described in the Product Addendum attached as Appendix 2. 1.72 “Product Addendum” means a written individual agreement between the Parties for Corden to provide Services with respect to the Product and Manufacture such Product for Customer’s commercial use according to the terms and conditions set forth in this Agreement. For the avoidance of doubt, a Project Addendum shall not be used to address activities undertaken pursuant to the MSA, 1.73 “Product Invention” means any Invention that relates exclusively to (a) the Product or any derivative thereof, (b) the use of the Product and/or (c) any process, method or procedure specifically related to the Processing of the Products including analytical methods directed solely to the Product (such as, but not limited to, assays that may only be used for testing the Products, and not to test any other product) and that can not be used without incorporating: (A) Customer Background Intellectual Property, (B) Customer Confidential Information, or (C) Customer Material. 1.74
Minimum Remaining Shelf Life means with respect to Captisol, a remaining shelf life of not less than the longer of (i) four years or (ii) the period that is 80% of the duration of stability reasonably confirmed by CyDex in the ordinary course of its stability testing program.
Minimum Remaining Shelf Life means with respect to Captisol, a remaining shelf life of not less [***].
Minimum Remaining Shelf Life means, with respect to Drug Product, the minimum percentage of the maximum shelf-life for such Drug Product that is required to be remaining at the time of Delivery of such Drug Product hereunder, which shall in all cases be eighty percent (80%) of the maximum shelf-life for the Drug Product (based upon the shelf-life of the finished product configuration with the shortest shelf-life) set forth in the Regulatory Approval for the Product, subject to Section 8.2(e).
Minimum Remaining Shelf Life means with respect to Captisol, a remaining shelf life of at least two years.
Minimum Remaining Shelf Life means the minimum remaining of the maximum shelf-life (i.e., for purposes of this Agreement, the maximum shelf-life for Drug Substance shall be the stated shelf-life for the Drug Substance) for Drug Substance that is required to be remaining at the time of Delivery pursuant to this Agreement. The Minimum Remaining Shelf-Life for the Drug Substance shall be [**]. Once stability data confirms that an extension of shelf life is possible, Apellis agrees to extend the Minimum Remaining Shelf Life, accordingly.