Pharmaceutical Excipients definition
Examples of Pharmaceutical Excipients in a sentence
Penwest shall notify Penford in writing of any decision by Penwest to acquire Pharmaceutical Excipients from such bona fide third party, and this Agreement shall thereafter be terminable with respect to such Pharmaceutical Excipient at any time at Penford's election.
The term “cGMP’s” shall mean current good manufacturing practices for the methods to be used in, and the facilities and controls to be used for, the manufacture, preparation, packing and holding of pharmaceutical excipients, all as set forth from time to time by the U.S. Pharmacopoeia General Chapter <1078> Good Manufacturing Practices For Bulk Excipients and International Pharmaceutical Excipients Council’s IPEC/PQG GMP Guide For Pharmaceutical Excipients, and any successors thereto.
In the event that Penwest chooses to purchase any Pharmaceutical Excipients from a bona fide third party supplier pursuant to Sections 5.1 and 5.2, Penford shall cooperate with such third party supplier and shall make available, free of charge, any and all technology which is necessary or required to enable the third party supplier selected by Penwest to manufacture such Pharmaceutical Excipients.
Penford shall manufacture and sell Pharmaceutical Excipients to Penwest in bulk form.
In addition, Penford warrants that all Pharmaceutical Excipients delivered hereunder shall be produced in accordance with cGMP and all applicable laws, rules and regulations.
The form of purchase order to be used by Penwest shall be agreed upon by the parties in advance of Penwest submitting firm orders for Pharmaceutical Excipients.
Except as otherwise set forth herein, commencing as of the Distribution Date (as defined in the Separation and Distribution Agreement) (the "Effective Date"), Penwest shall purchase exclusively from Penford, Penwest's requirements for Pharmaceutical Excipients.
Exhibit D may be updated from time to time by written agreement among the Parties in accordance with revisions to The IPEC Significant Change Guide for Pharmaceutical Excipients or as may be otherwise agreed among the Parties, including in accordance with Applicable Laws.
The price at which Penford shall sell Pharmaceutical Excipients to Penwest (the "Purchase Price") shall be as set forth in EXHIBIT A.
Upon receipt of such written notice and substantiating evidence, the impaired amount of Pharmaceutical Excipients shall be replaced by Penford with an equal amount of Pharmaceutical Excipients conforming with the Specifications (as defined below), as promptly as practicable, however, in no event later than forty-five (45) days.