Manufacturing Authorization Clause Samples
Manufacturing Authorization. Notwithstanding the other provisions of this Section 7.8, Manufacturer will be responsible for obtaining and maintaining, at all times during the Term, all approvals, permits, licenses, registrations, DUNS number, authorizations, or qualifications required from any Authority (including any Pharmaceutical Regulatory Authority) required in order for it to operate in all respects the Manufacturing Site in order to conduct the Manufacturing Services as contemplated herein. Without limiting the foregoing, Manufacturer shall at all times during the Term have and maintain a manufacturing authorization from the FDA in respect of the Manufacturing Site in order to conduct the Manufacturing Services as contemplated herein. The Parties will coordinate as needed to ensure that Manufacturer has such approvals, permits, licenses, registrations, authorizations and qualifications in place as of the Closing. Manufacturer will be responsible for ensuring the accuracy and completeness of documents provided to Pharmaceutical Regulatory Authorities by Acorda (to the extent of information provided by Manufacturer to Acorda for incorporation in such documents or confirmed by Manufacturer by way of review of draft documents submitted by Acorda to Manufacturer for review) or Manufacturer with respect to the Manufacturing Site, and shall ensure through use of the change control process specified in the Quality Agreement that Acorda is provided with the current manufacturing information needed to enable Acorda to comply with the requirements of applicable Marketing Authorizations for Marketed Product.
Manufacturing Authorization. NEI shall deliver the Manufacturing Package to, and authorize use of the Manufacturing Package by, Designees per the terms of the Letter Authorization included as Attachment 2.
Manufacturing Authorization. 3.1 CBSMA's Premises shall be inspected regularly by the competent national regulatory authorities. CBSMA and GTC shall comply with the terms of Section 3.7 of the Service Agreement with respect to such inspections.
3.2 CBSMA shall inform GTC of legal actions with or by governmental agencies relating to the Premises or manufacturing and quality control operations that may impact on the Premises or the Finished Product.
Manufacturing Authorization. CP will maintain its manufacturing authorization to cover the manufacture of Pramlintide Injection Product.