Bulk Tablets definition
Examples of Bulk Tablets in a sentence
Thereafter, Sepracor shall not appoint any other third party manufacturer nor change the location of any part of the manufacturing process for the manufacture of Bulk Tablets for GSK without GSK’s prior written consent, not to be unreasonably withheld, and subject to the change control procedure set out in the Quality Agreement.
At least [***] prior to the last day of the Bulk Supply Term, Buyer shall submit a final forecast specifying the quantities of Bulk Tablets that it wishes to buy from AstraZeneca during the period prior to the end of the Bulk Supply Term (the “Final Forecast”).
In addition to the execution of the Supply Agreement, the Parties will enter into a Quality Agreement and a Pharmacovigilance Agreement incorporating terms required in the License Agreement and such other terms appropriate for manufacture of Bulk Tablets for commercial distribution (including physician samples) and Clinical Supplies.
Otsuka shall supply BMS, free of charge, Compound and/or Bulk Tablets in quantities reasonably necessary to carry out the Product Development Plan, up to a maximum of one thousand kilograms (1,000 kg) of Compound, whether supplied in the form of Compound or as Bulk Tablets, which quantity shall be in addition to the Compound and Bulk Tablets required for the Ongoing Clinical Studies.
The Parties anticipate that the specifications for Bulk Tablets for the Otsuka Territory as set forth in the Supply Agreement will be the same in all material respects as the then-current FDA-approved specifications for Bulk Tablets.
BMS shall acquire additional quantities of Compound and Bulk Tablets, beyond the 1,000 kilograms to be provided under this Section 4.4, in accordance with Section 5.11.2(a)(5).
FURTHER, SUBJECT TO THE LIMITATIONS SET FORTH ABOVE, NOTWITHSTANDING ANYTHING TO THE CONTRARY SET FORTH IN THIS LEASE, THE LIABILITY OF LANDLORD TO TENANT, WHETHER UNDER THIS SECTION 17.3 OR ANY OTHER PROVISION OF THIS LEASE, SHALL BE LIMITED TO SUIT FOR DIRECT AND PROXIMATE DAMAGES, AND TENANT VOLUNTARILY AND INTENTIONALLY WAIVES ALL CLAIMS TO EXEMPLARY, PUNITIVE, SPECIAL OR CONSEQUENTIAL DAMAGES.
If Amarin exercises its right to acquire Bulk Substance or Bulk Tablets as provided in Section 5.3, Lilly shall grant to Amarin a paid-up sole license, with a right to sublicense, under the Patent Rights and Lilly's Know-How to Formulate the Bulk Substance into Bulk Tablets and/or to Package the Bulk Tablets, as appropriate, to allow Amarin to exercise its rights in accordance with the terms and conditions set forth in this Agreement.
On the Actual Delivery Date, the Product shall have the following minimum remaining shelf life: (x) in the case which Lonza manufactures, releases, and packages Product - Bradstock, the minimum remaining shelf life shall be [***]; and (y) in the case which Lonza manufactures and releases Product- Bulk Tablets, the minimum remaining shelf life shall be [***].
Except as set forth below, each Forecast will be non-binding and will represent only GSK’s good faith estimate of expected orders for the Bulk Tablets.