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.

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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

Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product).
For the avoidance of doubt, (1) this subsection (b) applies to Forecasts for API and Bulk Drug Product and (2) the Forecast with respect to Finished Product shall apply to the roll-up level of the Bulk Drug Product that is incorporated into the Finished Product.
MedCo agrees to consider, and the Parties agree to discuss in good faith, the manufacture and supply of Bulk Drug Substance, Bulk Drug Product and/or Finished Product by Alnylam (or its designee) to MedCo for MedCo’s further Development activities and/or for Commercial sale in the Territory; provided, however, that nothing in the foregoing sentence shall be construed to require the Parties to agree to such an arrangement.
Company shall promptly, but in no event later than [***] after delivery of the Bulk Drug Product notify Takeda of the existence and nature of any defect in or failure of the Bulk Drug Product to comply with Section 4(A) or Section 14(B) that could have been detected by a reasonable physical inspection of the Bulk Drug Product at the time of delivery (“Detectable Defects”).
In addition to any other payment obligations provided for hereunder, Orion shall pay Indevus not later than the effective date of such termination, the then current Supply Price for all Bulk Drug Product and Insertion Tools that were subject to a Firm Commitment portion of a Rolling Forecast or Purchase Order provided by Orion hereunder and/or that constitute inventory held in accordance with Section 6.7.

More Definitions of Bulk Drug Product

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.

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 [***], (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 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”.