Bulk Drug Product definition

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

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

• The Evaluation Framework, similar to the Planning Framework, depends on data that accurately measures Rural Generalists and their scope of practice, alongside other rural workforce, and links this with other data from rural health services and rural communities.

• Company shall, and shall ensure that its Affiliates, Third Party subcontractors and any employees and agents of Company involved in the use of Bulk Drug Product comply with the requirements and restrictions of any licenses and permits and Applicable Law concerning the use of Bulk Drug Product in the Territory.

• For the sake of clarity, any undisputed amount in (i) any invoice due for additional services or (ii) any invoice due for Bulk Drug Product that the Company has not ordered despite its obligation to order as provided for under Section 5(A) shall be paid by the Company within thirty (30) days of the date of invoice.

• Company shall, at its sole expense, store, handle, transport, and package, distribute and use Bulk Drug Product delivered to Company in compliance with the requirements set out in the Quality Agreement, the Product Regulatory Approval and all Applicable Law.

• 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.

More Definitions of Bulk Drug Product

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 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 encapsulated Product as manufactured for the Indevus Territory, in the form prior to being in its finished and packaged form.

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

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

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.