Table P Sample Clauses

Table P. 2-8 provides information on the materials used to manufacture the setting mechanism. Table P.2-8: Components of the Setting Mechanism [***].3
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Table P. 2-9 provides information on the actuator and setting mechanism materials, and rationale for their selection. 3 *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. [***].4
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Table P. 5.1-1 Release Specifications for Drug Product Method Purpose ICH Q6B Test Category Specification Appearance Evaluate color and clarity General [**] Sub-visible particles Measure sub-visible particles General [**] Total protein Measure protein concentration Quantity [**] pH Measure pH General [**] Reducing gel electrophoresis Detect fragments Identity, Purity [**] Non-reducing gel electrophoresis Detect fragments and aggregates Identity, Purity [**] High performance size exclusion chromatography (HPSEC) Detect fragments and aggregates Purity [**] Capillary isoelectric focusing (cIEF) Detect charge isoforms Identity, Purity [**] MEDI3379 Bioassay Measure bioactivity Identity, Potency [**] Endotoxin (LAL) Detect endotoxins Contaminants [**] Sterility Test for sterility Contaminants [**] Osmolality Measure tonicity General [**] Extractable volume Measure volume General [**] [**]. CONFIDENTIAL AND PRXXXXXXXXX XxxXxxxxx XXXX0000
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Table P. 2-9 provides information on the actuator and setting mechanism materials, and rationale for their selection. [***]
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Related to Table P

  • Provisions Define Relative Rights This Agreement is intended solely for the purpose of defining the relative rights of the Issuer on the one hand and the Subordinated Lenders and the Subordinated Borrowers on the other, and no other Person shall have any right, benefit or other interest under this Agreement.

  • First Lien Leverage Ratio On the last day of any Test Period on which the Revolving Facility Test Condition is then satisfied (it being understood and agreed that this Section 6.15 shall not apply until the last day of the first full Fiscal Quarter ending after the Closing Date), the Borrowers shall not permit the First Lien Leverage Ratio to be greater than 7.75:1.00.

  • Cash Flow Leverage Ratio The Borrower will not permit the Cash Flow Leverage Ratio on the last day of any fiscal quarter to exceed 3.50 to 1.00.

  • Minimum Consolidated Fixed Charge Coverage Ratio Borrower shall not permit the Consolidated Fixed Charge Coverage Ratio, determined as at the end of each fiscal quarter, commencing with the fiscal quarter ending June 30, 2019, to be less than 1.00 to 1.00.

  • Provisions Solely to Define Relative Rights The provisions of this Article XII are and are intended solely for the purpose of defining the relative rights of the Holders of the Securities on the one hand and the holders of Senior Debt on the other hand. Nothing contained in this Article XII or elsewhere in this Indenture or in the Securities is intended to or shall (a) impair, as between the Company and the Holders of the Securities, the obligations of the Company, which are absolute and unconditional, to pay to the Holders of the Securities the principal of and any premium and interest (including any Additional Interest) on the Securities as and when the same shall become due and payable in accordance with their terms, (b) affect the relative rights against the Company of the Holders of the Securities and creditors of the Company other than their rights in relation to the holders of Senior Debt or (c) prevent the Trustee or the Holder of any Security (or to the extent expressly provided herein, the holder of any Preferred Security) from exercising all remedies otherwise permitted by applicable law upon default under this Indenture, including filing and voting claims in any Proceeding, subject to the rights, if any, under this Article XII of the holders of Senior Debt to receive cash, property and securities otherwise payable or deliverable to the Trustee or such Holder.

  • Total Net Leverage Ratio The Borrower will not permit the Total Net Leverage Ratio as of the end of any Fiscal Quarter to exceed 3.50 to 1.00.

  • Net Leverage Ratio Subject to the proviso set forth in Section 10.3, the Company will not permit the Consolidated Net Leverage Ratio at any time during any period of four consecutive fiscal quarters of the Company to be greater than (a) 3.50 to 1.00 or (b) during an Acquisition Holiday Period, 4.00 to 1.00.

  • Minimum Fixed Charge Coverage Ratio The Borrowers shall not permit the Fixed Charge Coverage Ratio to be less than 1.05 to 1.00, measured as of the last day of each Fiscal Quarter for the prior four fiscal quarters subject to adjustments to such measurement period as set forth in the definition of Fixed Charge Coverage Ratio.

  • Maximum Consolidated Leverage Ratio As of the last day of each Fiscal Quarter of the Borrower (commencing with the Fiscal Quarter ending March 31, 2018), the Borrower shall not permit the Consolidated Leverage Ratio to be greater than 0.60 to 1.00.

  • Limitation on Aggregate Principal Amount The aggregate principal amount of the Notes shall not be limited. The Company shall not execute and the Trustee shall not authenticate or deliver Notes except as permitted by the terms of the Indenture.

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