Bulk Manufacturing definition
Examples of Bulk Manufacturing in a sentence
Ophidian shall have principal responsibility for the Bulk Manufacturing Program, and Lilly shall have principal responsibility for the Product Manufacturing Program.
As more fully described below, Ophidian will have principal responsibility for the Bulk Drug Substance Process Development Program, the Bulk Manufacturing Program and the manufacture (either itself or through a third party acceptable to Lilly) of Bulk Drug Substance for clinical and commercial supply.
Any price movement, either a reduction or increase, in the price of R134a, after that period will be reflected in the Bulk Manufacturing Price and Royalty Fee.
The term of this Agreement shall be from the Effective Date until the earlier of the completion of a Formulated Bulk Manufacturing Technology Transfer or termination of the LA.
Vertex (assuming it exercises the Vertex Commercial Supply Option referenced in Section 10.1; otherwise Lilly) shall have principal responsibility for the Bulk Manufacturing Program, and Lilly shall have principal responsibility for the Product Manufacturing Program.
Except for the qualification, validation and calibration in connection with the Tech Transfer Activities which are part of the Bulk Manufacturing Services, the CDE PM Program shall be considered Non-Bulk Manufacturing Services and the fees for the CDE PM Program shall be set forth in Exhibit F.