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.
Esperion shall provide all assistance reasonably requested by Otsuka in connection with such preparation and filing of Regulatory Documentation and communications with Regulatory Authorities, and, at the request of Otsuka, Esperion shall send representative(s) of Esperion to attend in-person meetings with Regulatory Authorities in the Otsuka Territory relating to the Manufacture of API(s) or Bulk Tablets, all at Esperion’s cost and expense.
By: ---------------------------- Title: ------------------------- SCHEDULE A GRANUTEC PRODUCTS Form, Shape, Product Size & Color Price (in U.S.$) ------- -------------- ----------------- Loperamide 2 mg Strips of 6 $190.00 per thousand strips Naproxen Sodium 220 mg Bulk Tablets or Caplets $23.93 per thousand Ranitidine 75 mg Strips of 10 $224.47* per thousand strips Cimetidine 200 mg.
Based on the Forecast as described herein, Sepracor shall maintain at all times sufficient capacity to meet all GSK’s, GSK’s Affiliates’ and GSK’s Sublicensees’ requirements for Bulk Tablets to enable them to meet their respective needs for Product for the GSK Territory.
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.
If BMS fails to commence marketing of Product in any country within such time period, unless such failure is caused by Otsuka’s failure to supply Compound, Bulk Tablets or Product, as the case may be, to BMS in a timely fashion - the parties will immediately meet to discuss the reason(s) for such delay and agree upon measures and a Schedule to remedy the situation.
GSK shall, at the written request of Sepracor, continue to package the Bulk Tablets at costs to be negotiated in good faith at the time until Sepracor notifies GSK in writing that it has made other arrangements.
Bulk Tablets supplied to GSK will be appropriately packaged and labeled based upon specifications agreed between the Parties and in accordance with all applicable laws and regulations.
Esperion shall have the sole right and responsibility to Manufacture the Licensed Products for the DS Territory, subject to the terms of this Agreement (including DS’s right and responsibility to conduct primary and secondary packaging of the Bulk Tablets as set forth below), the Supply Agreement and the Quality Agreement; provided, however, that Esperion’s responsibility to Manufacture the Licensed Products for the DS Territory shall be limited to Manufacturing such Licensed Products in Bulk Tablet form.
GSK shall have [**] from its receipt of the Bulk Tablets at GSK’s designated facility to notify Sepracor of its rejection of the Bulk Tablets for any defects which are apparent from carrying out incoming inspection and control procedures (to be further defined in the Quality Agreement).