Batch Accompanying Documentation Sample Clauses

Batch Accompanying Documentation. LTS will give a copy of the batch records to NeurogesX for clinical and PD batches (Production Demonstration). The following documents shall be forwarded to NeurogesX with each delivery of the product: • Certificate of Production Compliance • Certificate of Analysis • List of raw materials used, date raw materials were released and retest or expiration date • Manufacturing record for lots released by LTS • Packaging record (if applicable) • Labeling record (if applicable) • Translation of comments made on records • Deviations, including investigation/resolution documentation • Out of Specification test results including investigation/resolution documentation for lots released by LTS* • Analytical testing results for in-process and finished product testing • Lot production tree (i.e. a list of all the lots (post raw material lots) used toward production of the final lot of drug product) • Certificate of Batch Review by Quality • Batch Record Document Inventory Checklist (list of documents sent to NGX for each batch) • Copy of any clinical labels applied to drug product • Copy of the shipping labels * If an OOS result is confirmed, the batch will be rejected by QC. This batch will not be shipped to NGX or other destination and therefore NGX will not receive batch documentation Section V Conditions for Storage, Packaging and Shipment See • May 29, 2001 Memorandum of Understanding Section VI NeurogesX, Inc. (NGX) [***] VP, Regulatory Affairs [***] [***] [***] VP, Pharmaceutical Science [***] [***] [***] Sr. Manager, Quality Assurance [***] [***] LTS XXXXXXX Therapie-Systeme AG (LTS) [***] Head of Quality Control [***] [***] [***] Head of Production [***] [***] [***] Acting Head of Quality Assurance [***] [***] [***] Head of Regulatory Affairs [***] [***] *** 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.
Sample 1
AutoNDA by SimpleDocs
Batch Accompanying Documentation. Formosa will provide an authentic copy of the batch records to NeurogesX for clinical and commercial batches in compliance with Formosa’s API release procedure (current version). The following documents shall be provided to NeurogesX with each delivery of the API to the NGX specified recipient: [***] [***] 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.
Sample 1

Related to Batch Accompanying Documentation

  • Supporting Documentation Upon request, the HSP will provide the LHIN with proof of the matters referred to in this Article.

  • Licensed Documentation If commercially available, Licensee shall have the option to require the Contractor to deliver, at Contractor’s expense: (i) one (1) hard copy and one (1) master electronic copy of the Documentation in a mutually agreeable format; (ii) based on hard copy instructions for access by downloading from the Internet

  • Required Documentation The AGENCY is responsible for ensuring that all documents required by this Contract are current and available for the COUNTY’S review upon request. These documents may include, but are not limited to, certificate(s) of insurance, job descriptions and background check confirmations of staff.

  • Closing Documentation, etc For purposes of determining compliance with the conditions set forth in §12, each Lender that has executed this Credit Agreement shall be deemed to have consented to, approved or accepted, or to be satisfied with, each document and matter either sent, or made available, by any Agent or any Co-Lead Arranger to such Lender for consent, approval, acceptance or satisfaction, or required thereunder to be consented to or approved by or acceptable or satisfactory to such Lender, unless an officer of the Administrative Agent active upon the Borrowers’ account shall have received notice from such Lender prior to the Closing Date specifying such Lender’s objection thereto and such objection shall not have been withdrawn by notice to the Administrative Agent to such effect on or prior to the Closing Date.

  • Closing Documentation The Buyer shall have received the following documents, agreements and instruments from the Sellers:

  • Product Documentation You should review the policy documents carefully to ensure they accurately reflect the cover, conditions, limits, and other terms that you require. Particular attention should be paid to policy conditions and warranties as failure to comply with these could invalidate your policy. It is important that you retain and keep safely all documents associated with your policy so that you can refer to them in the event of a claim.

  • Source Documentation Accounting records must be supported by such source documentation as canceled checks, bank statements, invoices, paid bills, donor letters, time and attendance records, activity reports, travel reports, contractual and consultant agreements, and subaward documentation. All supporting documentation should be clearly identified with the Award and general ledger accounts which are to be charged or credited.

  • Tax Documentation Xxxxxx agrees to provide a completed IRS 1099 for its payments to, and Xxxxxxx agrees to provide IRS W-9 forms for, each of the following payees under this Settlement Agreement:

  • Technical Documentation Prior to commencement of the Tests on Completion, the Contractor shall supply to the Engineer the technical documentation as specified in the Employer’s Requirements. The Works or Section shall not be considered to be completed for the purposes of taking- over under sub-clause 10.1 [Taking Over of the Works and Sections] until the Engineer has received the technical documentation as defined in this sub-clause 5.7, the "history file" including design calculations and certain certification as well as any other documents required to meet the CE Marking requirements.

  • Other Documentation Administrative Agent shall have received all documents and instruments that Administrative Agent has then reasonably requested, in addition to those described in this Section 4.1. All such additional documents and instruments shall be reasonably satisfactory to Administrative Agent in form, substance and date.

Time is Money Join Law Insider Premium to draft better contracts faster.