Manufacturing Approval definition

Manufacturing Approval means all necessary or appropriate approvals, licenses, permits, registrations and authorizations in respect of the manufacture and Quality Control of the Licensed Product.
Manufacturing Approval means a Product License (yao pin ▇▇▇▇▇ ▇▇▇▇ xu ▇▇ ▇▇▇▇▇ 药品生产许可证) or any other license issued by a Governmental Authority in the Territory that authorizes a party to conduct manufacturing of the Product for commercial sale.
Manufacturing Approval means sufficient approval or a Permit from the applicable Governmental Entity(ies) as necessary to perform any Manufacturing activities relating to a therapeutic product or compound or other intervention in humans in the facility concerned.

Examples of Manufacturing Approval in a sentence

  • NK shall develop and submit to the MHW (in Aspect's name and on Aspect's behalf) the application dossier which is necessary for Aspect to obtain each such Foreign Manufacturing Approval.

  • For each Product for which the approval of the MHW is required (I.E., for which a Shon▇▇ ▇▇ necessary), Aspect shall obtain a Foreign Manufacturing Approval (I.E., Gaikoku Seiz▇ ▇▇▇▇▇▇) ▇▇d NK shall be Aspect's In-Country Caretaker (I.E., Kokunai Kanrinin, as this term is defined in 19-2 of Japan's Pharmaceutical Affairs Law).

  • THIRD PARTY SALES Supplier agrees not to sell to any third party (except the United States Government) any items covered by this contract for which the sole known application is for use in any aircraft product unless Supplier or its customer has obtained from the FAA either a Type Certificate, Technical Standard Order Approval or Parts Manufacturing Approval (PMA) pursuant to ss.21.303 of the Federal Aviation Regulations, covering said items.

  • Following the Closing, the Company will, and Buyer shall cause the Company to, use commercially reasonable efforts to complete the Technology Transfer and achieve FDA Manufacturing Approval, the Primary COGS Milestone and the Secondary COGS Milestone as promptly as possible.

  • Defiante, its Affiliates and/or Sub-Licensees agrees to register this Agreement and any related sub-license agreement with any foreign governmental agency within the Territory which requires such registration with any Commercial Marketing Approval authority and/or Manufacturing Approval authority; and Defiante, its Affiliates and/or Sub-Licensees shall pay all costs and fees in connection therewith.

  • Part; (c) comparing a Buyer Part design with another part design; (d) obtaining Parts Manufacturing Approval (PMA) from the Federal Aviation Administration (FAA) pursuant to Part 21.303 of the Federal Aviation Regulations; (e) obtaining approval from a Designated Engineering Representative (DER) under FAA Order 8110.4 to repair a Buyer Part; or (f) obtaining any other governmental approval to manufacture or repair a Buyer Part.

  • Document Type: Document No.: 774RSRM**.02 Specification Effective Date: 22 APR 2003 Material Description: Page: 1 of 1 Prepared by: Date: /s/ ▇▇▇▇ Ferantello 08-Apr-2003 Manufacturing Approval: Date: /s/ ▇.

  • Manufacturing Approval including: Part approval, Virtual verification of manufacturing requirements including deviation approvals.

  • In order for a Vendor to deliver Vendor parts directly to Buyer, Vendor may be required to obtain Parts Manufacturing Approval (PMA) for such parts.

  • VISA and ABNH (collectively hereinafter the “Parties”) signed a VISA International Holographic Magnetic Stripe Tape Manufacturing Approval Agreement dated April 8, 2005, inter alia obliging ABNH to manufacture holographic magnetic stripe tape (“HMS”) bearing the trade or service marks of VISA (“HMS Manufacturing Agreement”).


More Definitions of Manufacturing Approval

Manufacturing Approval means all authorizations, permissions, applications and/or registrations from the relevant regulatory and/or local government health authorities in each of the countries in the Territory, which are necessary and required for the manufacture of the Bulk Active Material.
Manufacturing Approval means a Product License (yao pin sheng chan xu ke zheng 药品生产许可证) or any other license issued by a Governmental Authority in the Territory that authorizes a party to conduct manufacturing of the Product for commercial sale.
Manufacturing Approval. The term "Manufacturing Approval" (I.E. ▇▇▇▇▇ ▇▇▇▇▇▇) shall mean the approval granted by the MHW to manufacture a drug or medical device for sale in Japan.
Manufacturing Approval means all filings, applications, licenses, permits, and other authorizations which are required for the manufacture of LX Bulk Drug Substance in compliance with applicable laws and regulations of the country of manufacture.
Manufacturing Approval means the act of a Regulatory Authority necessary for the Manufacture of the Product in a country or regulatory jurisdiction.
Manufacturing Approval means approval granted by FDA or other applicable regulatory authority for the jurisdiction in which the Product will be produced, used, or sold authorizing DSM as a qualified and valid manufacturing source of the Product for AMAG.