Bulk Intermediate definition
Examples of Bulk Intermediate in a sentence
For RELYPSA’s submission to the FDA to qualify DSM as a Manufacturer of Bulk Intermediate and Bulk Drug, DSM shall perform the activities described in Appendix 1 and RELYPSA shall pay DSM Euro [***] upon FDA approval of DSM and the Facility and receipt of DSM’s proper invoice.
No Raw Materials, Bulk Intermediate, in-process materials, Bulk Drug and/or derivatives shall be used or transferred to any Third Party without prior written approval of RELYPSA and shall be used solely to perform this Agreement.
DSM covenants, represents and warrants that it has the authority to enter into this Agreement without the consent of any Third Party, and to its knowledge as of the Effective Date, with respect to DSM Intellectual Property, the Manufacture of Bulk Intermediate and Bulk Drug does not infringe or misappropriate any valid intellectual property rights of any Third Party.
DSM shall be responsible and liable for any loss of or damage to Raw Materials, Bulk Intermediate, in-process materials, Ca Bulk Drug, Bulk Drug and/or derivatives while in the possession or under the control of DSM, unless such loss or damage is caused by force majeure.
In the event that LANXESS fails to Release any Batch of Bulk Intermediate because it is Nonconforming, LANXESS shall re-Manufacture or rework such Nonconforming Bulk Intermediate at its expense and remain responsible for performing all of its obligations under this Agreement with respect to the Manufacture, Release and delivery of the quantities of Bulk Drug subject to the Firm Orders.
DSM acknowledges the importance to RELYPSA of consistent timely delivery of Third Party Intermediate and Bulk Drug in accordance with Firm Orders and the associated costs to RELYPSA of untimely deliveries which may result in delays in further processing Bulk Intermediate into Bulk Drug and Bulk Drug into Product and the delivery of finished Product to end users.
For purposes of clarity, refund or replacement of Nonconforming Bulk Intermediate or Bulk Drug is not RELYPSA's exclusive remedy and RELYPSA retains all remedies available to it in law or equity.
Alkermes will use Genentech Materials, Dedicated Equipment and Genentech Equipment solely and exclusively for Processing, and Alkermes will dedicate the necessary suite or suites in the Facilities solely and exclusively to manufacture Bulk Intermediate or vialing during each Campaign during the Term.
DSM shall assist RELYPSA in the preparation of documentation in relation to the Manufacture of Bulk Intermediate and/or Bulk Drug as may be reasonably required by RELYPSA in support of RELYPSA's submissions to Regulatory Authorities in respect of the Product and the Manufacture of Bulk Intermediate and Bulk Drug by DSM.
The Parties are committed to continuous improvement initiatives in an effort to achieve cost savings in the Manufacture of Bulk Intermediate and Bulk Drug, including reducing the acquisition cost of Raw Materials and achieving efficiencies in the Manufacturing process without adversely impacting safety, quality, Manufacturing capability or compliance with cGMP and the Specifications (“Improvements”).