Bulk Drug Product definition

Bulk Drug Product means formulated Bulk Drug Substance in bulk form prior to filling and finishing.

Bulk Drug Product means a Product that has been Manufactured into a final pharmaceutical product, including drug substance (e.g., tablets or granules) for administration to humans in accordance with Applicable Laws, but has not been Packaged for use in Clinical Trials or for Commercialization.

Bulk Drug Product means drug Product in bulk form (not packaged and labeled), to be supplied to Company under this Agreement, meeting the Specifications.

Examples of Bulk Drug Product in a sentence

• As the Importer of Record, Company shall be responsible for all aspects of importing such Bulk Drug Product, including: (i) customs and other regulatory clearance; (ii) payment of all tariffs, duties, customs, fees, expenses and charges payable in connection with the importation and delivery; and (iii) keeping all records, documents, correspondence and tracking information required by Applicable Law arising out of or in connection with the importation or delivery.

• Except as provided in Section 4(C), any and all other communications from and to Regulatory Authorities related to the manufacture of Bulk Drug Product to be supplied under this Agreement will be handled in accordance with the terms and conditions of the Quality Agreement, or as otherwise agreed in writing by Takeda and Company.

• Claims for which Company does not provide notice to Takeda prior to expiry of the shelf life for the Bulk Drug Product shall be forever waived and barred.

• Upon delivery of Bulk Drug Product in accordance with the terms of Section 7, Takeda shall invoice Company for the applicable Purchase Price of such Bulk Drug Product.

• Takeda has no obligation to supply Bulk Drug Product to Company in any form or quantity other than as expressly provided in this Agreement.

More Definitions of Bulk Drug Product

Bulk Drug Product means Product that has been manufactured into a final pharmaceutical product following a specific formulation and set of specifications, including drug substance (e.g., tablets or granules) for administration to humans but has not been packaged for use or for commercialization.

Bulk Drug Product means unlabeled vials of Licensed Product that have been filled and crimped, but have not completed the testing contemplated by clause (b) of the definition of “Fill/Finish”.

Bulk Drug Product means [***], (a) in bulk form, prior to being in finished, labelled and packaged form, and (b) otherwise identical to the [***] comprising the VANTAS® product manufactured for use in the United States, except that if otherwise defined in Marketing Authorizations in the Territory or otherwise requested by Orion in Purchase Orders submitted in accordance with this Agreement, [***] may be marked with the Indevus production lot number.

Bulk Drug Product means Product, prior to being in its labeled and packaged form.

Bulk Drug Product means the Product as bulk drug product for Commercial use in the VIT Territory.

Bulk Drug Product means the bulk drug product after Processing by AMRI in accordance with the Master Batch Record. For the avoidance of doubt, unless expressly agreed by the Parties in writing the Processing of Bulk Drug Product pursuant to this Agreement shall in no event include Secondary Packaging.

Bulk Drug Product means cGMP-conforming lipid nanoparticle pharmaceutical product formulated with the Bulk Drug Substance, but that has not been filled or finished.