Exhibit Batch definition

Exhibit Batch means the representative manufacturing batches in similar or identical processes to the commercial purpose for submission of regulatory dossier required by authorities.
Sample 1Sample 2
Exhibit Batch means a full commercial size GMP batch manufactured and tested by Elite to accommodate the CBE-30 filing.
Sample 1

Examples of Exhibit Batch in a sentence

  • The mere availability of TA funds in the grant budgets has not been sufficient to meet the demand for TA.

  • Stage 13: Exhibit Batch (ANDA Submission) • Batch size at least 100,000 units or 1/10th of the commercial batch.

  • The parties shall refer to the JERS Exhibit Batch Import Requirements on the Court’s website and may email the Courtroom Deputy with any questions about the JERS system.

  • We note that Exhibit Batch EH15031 is being used as the test treatment in the ongoing BE study (14-VIN-648) in multiple myeloma patientsWhen available, provide the clinical study report of this study so that FDA may consider the PK, PD and safety findings as supportive evidence in the review of the biowaiver request for the intravenous route.

  • AsAlkem used the same in vitro assay conditions as those disclosed in the patent, Plaintiff contends Alkem’s ANDA Product meets the term “rapidly” because average results of Alkem’s dissolution testing for 12 tablets from Exhibit Batch Number 7142492 showed 64.08% ibuprofen and 79.58% famotidine were released within 20 minutes.

  • Payment: Prior to each lot production Timing: Engineering [***] L - September 2009 Exhibit Batch [***] X - Xxxxxxx 0000 Xxxxxxxxxxx [***] X - X0 0000 Process Validation/Commercial - Q2 2010 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED.

  • While Merck’s expert, Dr. Matzger, attempted to show conversion from MFA to MFM in the Exhibit Batch samples produced by Amneal, he did so by, among other steps, adding MFM to the Exhibit Batch samples and mixing for 27 days.

  • Merck argues that the district court also erred in relying on the Exhibit Batch samples because the Exhibit Batches were not manufac- tured according to Amneal’s ANDA specification.

  • The re-suspended pellet was then used to prepare smears for acid fast bacteria (AFB) microscopy and for inoculation of MGIT tube and LJ slope.

  • The failure of a location to achieve the required target/s will not prejudice the position of the other locations to achieve payment of the performance payments, based on their respective targets.

Related to Exhibit Batch

  • Exhibit 1 means Exhibit 1 to this Schedule C.

  • Exhibit C Form xx Xxxxx B-4, B-5 or B-6 Certificate.................... Exhibit D: (Resexxxx)................................................... Exhibit E: Form of Reverse of Certificates.............................. Exhibit F: Form of Initial Certification of Master Servicer............. Exhibit G: Form of Final Certification of Master Servicer...............

  • Exhibit 2 Standard File Codes – Delinquency Reporting, Continued The FNMA Delinquent Reason Code field should show the Reason for Delinquency as follows: Delinquency Code Delinquency Description 001 FNMA-Death of principal mortgagor 002 FNMA-Illness of principal mortgagor 003 FNMA-Illness of mortgagor’s family member 004 FNMA-Death of mortgagor’s family member 005 FNMA-Marital difficulties 006 FNMA-Curtailment of income 007 FNMA-Excessive Obligation 008 FNMA-Abandonment of property 009 FNMA-Distant employee transfer 011 FNMA-Property problem 012 FNMA-Inability to sell property 013 FNMA-Inability to rent property 014 FNMA-Military Service 015 FNMA-Other 016 FNMA-Unemployment 017 FNMA-Business failure 019 FNMA-Casualty loss 022 FNMA-Energy environment costs 023 FNMA-Servicing problems 026 FNMA-Payment adjustment 027 FNMA-Payment dispute 029 FNMA-Transfer of ownership pending 030 FNMA-Fraud 031 FNMA-Unable to contact borrower INC FNMA-Incarceration

  • Exhibit B means [Vendor]’s Response.

  • ATTACHMENT C STANDARD STATE PROVISIONS FOR CONTRACTS AND GRANTS REVISED DECEMBER 15, 2017

  • Exhibit F The awarded category pricing from the Contractor’s submitted Price Sheet from 3rd Bid RFP 15-80101507-SA-D

  • Exhibit D means Exhibit D to the Judgment;

  • Exhibit E means Exhibit E to the Judgment;

  • technical specification means, with respect to any Software, the document setting forth the technical specifications for such Software and included in the Statement of Work.

  • Brand Name Specification means a specification limited to one or more items by manufacturers’ names or catalogue number.

  • Specification Schedule means the Schedule containing details of the Specification.

  • Exhibit A means collectively Exhibits A-1 through A-n which incorporate into the Agreement the specific terms and conditions for each TCK licensed hereunder.

  • The Specification means the Specification annexed to or issued with G.T.C.C. and shall include the schedules & drawings attached thereto as well as all samples and pattern, if any.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Functional Specifications means the descriptions of features and functions of the Application as expressly set forth in Quote.

  • Swap Specification means, with respect to any Swap, the Rules or other trading protocols containing specifications for such Swap, as adopted, amended, supplemented or otherwise modified from time to time by BSEF.

  • Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.

  • Brand Name or Equal Specification means a specification which uses one or more manufacturer’s names or catalogue numbers to describe the standard of quality, performance, and other characteristics needed to meet District requirements, and which provides for the submission of equivalent products.

  • Attachment point means a point on the network at which network assets are connected to assets owned by another person.

  • Contract Specifications means the principal trading terms in CFD (for example Spread, Swaps, Lot Size, Initial Margin, Necessary Margin, Hedged Margin, the minimum level for placing Stop Loss, Take Profit and Limit Orders, financing charges, charges etc) for each type of CFD as determined by the Company from time to time.

  • Service Specification means and include detailed description, statements to technical data, performance characteristics, and standards (Indian as well as) as applicable and as specified in the Contract as well as those specifications relating to Industry standards and codes applicable to the performance of the work, work performance quality and the specifications affecting the works or any additional specification required to be produced by the DCO to meet the design criteria.

  • TENDER SPECIFICATION means “Specific conditions, technical specifications, appendices, site information and drawing pertaining to the work in which the tenderers are required to submit their offer. Individual specification number will be assigned to each tender specification.

  • Contract Schedule means a schedule to this Contract;

  • Product Schedule means PTC’s standard order form entitled “PTC Product Schedule” (including all schedules, attachments and other document(s) specifically referenced therein) or such alternative order form as may be submitted by Customer and accepted by PTC, in each case that specifies (i) the Licensed Products and/or Services ordered; and (ii) for Licensed Products, the installation address (including the Designated Country) and the Licence Term.

  • Attachment A is an itemized list of the estimated election expenses for this Joint Election and the amounts that each Participating Political Subdivision must deposit with the Dallas County Elections Department. It also includes the Deposit Detail for each entity. The Elections Administrator will amend “Attachment A” to reflect the changing estimates of election expenses that are caused by changing circumstances and by the withdrawal of Participating Political Subdivision(s), if any, from this Election Services Contract.