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 [***] VP, Regulatory Affairs [***] [***] [***] VP, Pharmaceutical Science [***] [***] [***] Sr. Manager, Quality Assurance [***] [***] [***] 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.
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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.
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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 Contractor shall not begin work without a valid Purchase Order or other appropriate commitment document under the law of the Purchasing Entity.

  • Closing Documentation The Parent shall have received the --------------------- following documents, agreements and instruments from the Company: (i) an opinion of ▇▇▇▇ ▇▇▇▇ ▇▇▇▇ & Freidenrich LLP, dated the Closing Date and addressed to the Parent and Newco, in substantially the form of Exhibit F hereto; --------- (ii) certificates dated as of a recent date from the Secretary of State of the States of Delaware and any other applicable states to the effect that each of the Company and its Subsidiaries is duly incorporated and in good standing in such state and stating that the Company and its Subsidiaries owes no franchise taxes in such state and listing all documents of the Company and its Subsidiaries on file with said Secretary of State; (iii) a copy of the Certificate of Incorporation of the Company, including all amendments thereto, certified as of a recent date by the Secretary of State of the State of Delaware; (iv) evidence, reasonably satisfactory to the Parent, of the authority and incumbency of the persons acting on behalf of the Company in connection with the execution of any document delivered in connection with this Agreement; (v) Uniform Commercial Code Search Reports on Form UCC-11 with respect to the Company and its Subsidiaries from the states and local jurisdictions where the principal place of business of the Company and its Subsidiaries and their respective assets are located, the search reports of which shall confirm compliance with Section 3.15 (and Schedule thereto) of this Agreement; (vi) the corporate minute books and stock record books of the Company and its Subsidiaries; (vii) estoppel letters of lenders to the Company, in form and substance reasonably satisfactory to the Parent, with respect to amounts (including any pre-payment penalties) owing by the Company as of the Closing; and (viii) such other instruments and documents as the Parent shall reasonably request not inconsistent with the provisions hereof.

  • 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. Claims can arise, under certain types of insurance contract, long after the expiry of the policy. It is therefore important that you retain and keep safely all documents associated with your policy.