Definition of Usable Product Sample Clauses

Definition of Usable Product. Usable product is defined as the final formulation of drug product derived from a fully validated manufacturing process, i.e., consistency lot FDP. There must be a high degree of confidence, as determined by the FDA, that all manufactured units of FDP from successive lots will meet acceptable product specifications as demonstrated by comprehensive and satisfactory in-process and release testing. A minimum of three (3) consistency lots must be manufactured at commercial scale to demonstrate reproducibility and provide an accurate measure of variability among successive runs. The product must meet stability specifications to the satisfaction of FDA prior to entry into the SNS. The efficacy data to support usable product and license requirements must be derived from studies using FDP produced from a fully validated manufacturing process. An ongoing stability program must be in place using a stability indicating assay(s) that has been agreed upon by FDA.
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Related to Definition of Usable Product

  • Definition of Customer Information Any Customer Information will remain the sole and exclusive property of the Trust. “Customer Information” shall mean all non-public, personally identifiable information as defined by Xxxxx-Xxxxx-Xxxxxx Act of 1999, as amended, and its implementing regulations (e.g., SEC Regulation S-P and Federal Reserve Board Regulation P) (collectively, the “GLB Act”).

  • Definition of Market Price The market price for any security shall be (i) the market price for that security quoted at the close of the trading day effective on the Bank Closing Date as published electronically by Bloomberg, L.P., or alternatively, at the discretion of the Receiver, by IDC/Financial Times (FT) Interactive Data; (ii) provided that if such market price is not available for such security, the Assuming Institution will submit a written purchase price bid for such security within three days of notification/bid request by the Receiver (unless a different time period is agreed to by the Assuming Institution and the Receiver) and the Receiver, in its sole and absolute discretion, will accept or reject each such purchase price bid; (iii) further provided that in the absence of an acceptable bid from the Assuming Institution, or in the event that a security is deemed essential to the Receiver as determined by the Receiver in its discretion (see Section 3.6 Retention or Repurchase of Assets Essential to the Receiver) such security shall not pass to the Assuming Institution and shall be deemed to be an excluded asset hereunder and listed on Schedule 3.5(l).

  • Definition of Company Solely for purposes of this Article 6, the term "Company" also shall include any existing or future subsidiaries of the Company that are operating during the time periods described herein and any other entities that directly or indirectly, through one or more intermediaries, control, are controlled by or are under common control with the Company during the periods described herein.

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  • Definition of Good Reason For purposes hereof, “Good Reason” shall mean:

  • Additional Definition Section 1.02 of the Credit Agreement is hereby amended to add thereto in alphabetical order the following definition which shall read in full as follows:

  • Certain Additional Definitions As used in this Agreement, the following terms shall have the respective meanings ascribed thereto in the respective sections of this Agreement set forth opposite each such term below: Term Section Accounting Firm Section 2.7(c)(iv) Agreement Preamble Budget Commitment Section 2.8(b) Certificate of Merger Section 2.4 CGCL Section 3.2(a) Change in the Company Recommendation Section 6.4(b) Claim Certificate Section 9.4(a) Claim Dispute Notice Section 9.4(b) Closing Section 2.3 Closing Date Section 2.3 Closing Date Schedule Section 2.7(b) Company Preamble Company Board of Directors Section 4.2(a) Company Board Recommendation Section 4.2(b) Company Certificates Section 2.6(b)(ii) Company Disclosure Schedule Article IV Company Financial Statements Section 4.5(a) Company Indemnified Parties Section 6.6(a) Company Material Contract(s) Section 4.14(a) Company Stockholder Approval Recitals Consideration Spreadsheet Section 6.12 Continuing Employee Section 6.13(a) Determination Section 2.7(c)(iv) Dispute Notice Section 2.7(c)(ii) Dissenting Shares Section 3.2(a) Effective Time Section 2.4 Effectiveness Period Section 2.9(d) Employee Options Payment Amount Section 3.1(a)(iii) Enforceability Exceptions Section 4.2(a) Equityholders Representative Recitals Estimated Closing Debt Section 2.7(a) Estimated Net Working Capital Amount Section 2.7(a) Estimated Net Working Capital Deficit Section 2.7(a) Estimated Net Working Capital Surplus Section 2.7(a) Estimated Unpaid Company Transaction Expenses Section 2.7(a) Excess Payment Section 2.7(d)(ii) Expiration Date Section 9.1 FCPA Section 4.22(a) Holder of Registrable Securities Section 2.9(g) Indemnitee Section 9.5 Indemnitor Section 9.5 Invoice Section 6.10 Joinder and Release Agreement Recitals Lease Section 4.15 Leased Real Property Section 4.15 Letter of Transmittal Section 3.1(b)(i) Liens Section 4.11(e) Major Suppliers Section 4.23 Material Product and Trial Information Section 4.21(g) Merger Recitals Term Section Merger Sub Preamble New Plans Section 6.13(b) 6.13(b) Non-Competition and Non-Solicitation Agreements Recitals Non-Solicitation Agreement Recitals Offer Letter Recitals Option Cancellation Agreement Section 3.1(a)(iii) Option Consideration Section 2.6(d)(i) Option Payment Section 2.6(d)(i) Option Shares Section 2.6(d)(i) Optionholder Section 2.6(d)(i) Optionholder Deliverables Section 3.1(b)(ii)B Options Payment Amount Section 2.6(d)(i) Outside Date Section 8.1(d) Parent Preamble Parent Acquisition Section 2.8(c)(ii) Parent Disclosure Schedule Article V Parent Prepared Returns Section 6.8

  • Key Definitions As used herein, the following terms shall have the following respective meanings:

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