Manufacturing Approval Sample Clauses
Manufacturing Approval. Vertex shall have sole authority to obtain and maintain Regulatory Approval to Manufacture Licensed Products and Combination Products. Vertex will promptly send to Alios copies of each Regulatory Approval of any Licensed Product or Combination Product (including English translations thereof, if Vertex has in its possession such an English translation) and any material related correspondence with any Governmental Authority in Major Market Countries relating to the Manufacture of any Licensed Products or Combination Products.
Manufacturing Approval. Centaur will prepare a Plant Master File for ---------------------- Bulk Product containing all relevant Synthesis Data (collectively the "Documentation") in accordance with the requirements as applicable at any time of relevant regulatory authorities in the Territory and the United States.
Manufacturing Approval. CENTAUR will prepare a Drug Master ---------------------- File and/or a Plant Master File, as applicable for each Substance (collectively the "DOCUMENTATION") in accordance with the requirements of relevant regulatory authorities in countries where ASTRA intends to use and sell Licensed Product. The Documentation will comply with relevant regulations and standards existing from time to time in the EC countries, the United States and Japan.
Manufacturing Approval. “Manufacturing Approval” shall mean 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.
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.