Brightstock definition
Brightstock means oral solid dose tablets that contain Bulk Drug Product in sealed unlabeled bottles as set forth in the applicable specifications provided by Agios.
Brightstock means finished unlabeled vials imprinted with information required by cGMP and other applicable current laws, at minimum lot number. “Drug Product” and “finished unlabeled vials” shall mean drug product that has been formulated, sterile filtered, aseptically filled into vials, lyophilized, and hermetically sealed, tested and bulk packaged.
Examples of Brightstock in a sentence
Licensee shall be responsible for the labeling and packaging of Bulk Drug Product or Brightstock supplied by Agios for clinical use in the Territory at its sole expense.
Subject to the Supply Agreements, in the event that, following a Manufacturing Technology Transfer, Licensee experiences difficulty in obtaining a sufficient quantity of Bulk Drug Product, Licensee shall promptly notify Agios and Agios may then supply Licensee with API Bulk Drug Substance, Bulk Drug Product or Brightstock, notwithstanding the foregoing in this Article VII.