Establishment Registration definition
Examples of Establishment Registration in a sentence
No such Product License or Establishment Registration contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, except where such untruth or omission could not reasonably be expected to have a adverse effect on the Business or the Purchased Assets.
No such Product Approval or Establishment Registration contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements therein, in light of the circumstances under which they were made, not misleading.
No such Product License or Establishment Registration contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements therein, in light of the circumstances under which they were made, not misleading, except where such untruth or omission could not reasonably be expected to have an adverse effect on the Business or the Purchased Assets.
Cambridge will maintain a Medical Device Establishment Registration (as defined under the Act) as manufacturer and specifications developer for the Products, as is required by law or regulation.
GBI shall maintain a Medical Device Establishment Registration (as defined under the Act) as manufacturer and Specifications developer for the Products, as is required.
AM shall be responsible for the annual Establishment Registration Fee.
This includes but is not limited to registering the UBS facility (ies) with regulatory authorities as required (e.g., US FDA Establishment Registration, Japan Foreign Manufacturer Authorization, etc.).
These documents include, but are not limited to, the Mirage(TM) and Deltaloc(TM) 510(K) filings, Medical Device Reports (MDR's), recalls, market withdrawals, Establishment Registration and Service listings, Establishment Inspection reports including inspectional observations responses, FDA Form 483, and package inserts.
In particular, but not by way of limitation of the foregoing, AYTU shall be responsible for payment of any FDA Drug Establishment Registration Fees associated with Biovest’s Development and/or Manufacture of Product in accordance with this Agreement and any Project Addendum executed hereunder.
HJL shall maintain a Medical Device Establishment Registration (as defined under the Act) as Manufacturer of Record and Specifications developer for the Products, as is required.