Master Packaging Document Sample Clauses

Master Packaging Document. 7.2.1 The master packaging document specifies the packaging process and packaging Additional Materials used to package a specific Product (“Master Packaging Document”). Strakan shall, or shall cause its Contract Manufacturer(s), to develop and maintain the Master Packaging Documents, and Strakan shall supply * Confidential treatment requested. such Master Packaging Documents to Aptalis. Strakan shall notify Aptalis in accordance with the provisions of Section 17.1 of the License Agreement and Aptalis shall approve in writing all modifications to the Master Packaging Document. Aptalis, with the assistance of Strakan, shall ensure that those documents are consistent with the Marketing Authorization file of the Product. Strakan shall provide Aptalis with copies of all revised Master Packaging Documents on a timely basis. Aptalis shall retain a copy of the Master Packaging Document. 7.2.2 Strakan shall, or shall cause its Contract Manufacturer(s), to maintain the Batch Records consisting of Manufacturing, packaging, quality control, quality assurance and delivery documentation for each Lot of Product (including any supporting documentation) for a period required by Law. 7.2.3 Strakan will maintain copies of documents provided for batch review together with certificates and the Batch release register used to document the authorization for shipping of each Lot of the Product. 7.2.4 Aptalis will maintain all documentation for final release to market for finished packs.
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Master Packaging Document. The master packaging document specifies the packaging process and packaging materials used to package a specific Product (“Master Packaging Document”). UMAN shall develop and maintain the Master Packaging Document that must be approved in a timely manner by CLIENT prior to its use. CLIENT, with the assistance of UMAN, shall ensure that those documents are consistent with the regulatory applications of the relevant Product. Original Master Packaging Documents shall be maintained on-site by UMAN and remain available for inspection and review by CLIENT. UMAN shall provide CLIENT with copies of all revised Master Packaging Documents on a timely basis. CLIENT shall receive a copy of the Master Packaging Document.
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Master Packaging Document. The Master Packaging Document specifies the packaging process and packaging materials used to package a specific Product. Axcan, with the assistance of Paddock, has the responsibility to assure that those documents are consistent with the Product Marketing Authorization. The Master Packaging Document will be developed by Paddock and must be approved within five business days by Axcan prior to its use. Original Master Packaging Documents will be maintained on-site by Paddock and remain available for inspection and review by Axcan and/or its agents. Paddock shall provide copies of all revised master packaging documents to Axcan on a timely basis. Axcan will retain a copy of the Original Master Packaging Document in its file.
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Related to Master Packaging Document

  • Closing Documentation The Parent shall have received the --------------------- following documents, agreements and instruments from the Company: (i) an opinion of Xxxx Xxxx Xxxx & 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.

  • Controlling Document If any provision of any agreement, plan, program, policy, arrangement or other written document between or relating to the Company and the Executive conflicts with any provision of this Agreement, the provision of this Agreement shall control and prevail.

  • ODUF Packing Specifications 6.3.1 A pack will contain a minimum of one message record or a maximum of 99,999 message records plus a pack header record and a pack trailer record. One transmission can contain a maximum of 99 packs and a minimum of one pack.

  • Contract Formation Subject to FAR Sections 1.601(a) and 43.102, the Government Order must be signed by a duly warranted contracting officer, in writing. The same requirement applies to contract modifications affecting the rights of the parties. All terms and conditions intended to bind the Government must be included within the contract signed by the Government.

  • 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.

  • 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

  • Certificate of Analysis Seller shall provide a certificate of analysis and other documents as defined in the Quality Agreement for any Product to be released hereunder, in a form in accordance with the cGMPs and all other applicable Regulatory Requirements and Product Specifications and as shall be agreed upon by the parties. For any batch that initially failed to meet any Product Specification, the certificate of analysis shall document the exception. Products that do not meet dissolution specifications at USP Stage I and II testing shall not be accepted by Buyer (and such requirement shall be included in the Product Specifications/Quality Manual).

  • Packing Specifications 7.3.1 A pack will contain a minimum of one message record or a maximum of 99,999 message records plus a pack header record and a pack trailer record. One transmission can contain a maximum of 99 packs and a minimum of one pack.

  • Statistical Sampling Documentation a. A copy of the printout of the random numbers generated by the “Random Numbers” function of the statistical sampling software used by the IRO.‌ b. A description or identification of the statistical sampling software package used by the IRO.‌

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

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