Intermediate Drug Product definition

Intermediate Drug Product means the formulated Intermediate Drug Substance as a bulk lyophilized powder, prior to filling and finishing, for use in the Product, as further described in the applicable Specifications.
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Intermediate Drug Product or “IDP” means [*********].
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Examples of Intermediate Drug Product in a sentence

  • Lifecore will be responsible for compliance with all applicable FDA and EMA requirements for the manufacture of the Finished Final Drug Product, Final Drug Product, and Intermediate Drug Product, and for the performance of services on the behalf of Heron under this Agreement; provided that Heron ▇▇▇▇ reimburse Lifecore for the EMA audit and certification costs at the rates set forth in Exhibit B, and provided that Lifecore shall inform Heron of the anticipated costs in advance of incurring them.

  • By no later than [***], MediWound shall fund, at its sole cost, the expansion of its annual manufacturing capacity to be [***] of Intermediate Drug Product (whether provided in that form or in the form of the equivalent amount of Finished Product).

  • If the product is in the Intermediate Drug Product or Final Drug Product stage the price will be [*********] of the Finished Final Drug Product Price.

  • Lifecore will package all Intermediate Drug Product, Final Drug Product, and Finished Final Drug Product per Heron’s written instructions and in accord with the MQA.

  • During the first five (5) years of the Term, with respect to the Bulk Vehicle Gel, Intermediate Drug Product and Finished Product, Vericel shall order and purchase such Products exclusively from MediWound in accordance with the terms of this Agreement; provided, however, Vericel may Manufacture or have Manufactured the Products (a) upon the occurrence of a Supply Failure with respect to any Product hereunder, or (b) as otherwise permitted under the terms of the License Agreement or this Agreement.

  • The Parties agree and acknowledge that, as of the Effective Date, MediWound’s current Facility can fill orders from Vericel for use in the Territory up to [***] of Intermediate Drug Product, whether provided in that form or in the form of the equivalent amount of Finished Product within a calendar year (“Maximum Capacity”).