Qualified Persons. 15.1 Flamel shall at all times: (a) employ a Qualified Person in accordance with Directive 2001/83/EC who shall be responsible for confirming by his/her signature on the appropriate Batch Record that each batch of the Intermediate Product conforms with the requirements of the Intermediate Product License and the Specification(s) therefore and is Manufactured in accordance with this Agreement and Good Manufacturing Practice; (b) promptly notify GSK in writing of any change in the identity of the Qualified Person and person or persons responsible for quality assurance in respect of the Intermediate Product; and, (c) immediately following completion of the Manufacture of each batch of the Intermediate Product supply to GSK or any party nominated by GSK a Batch Record and a Certificate of Analysis duly signed by the Qualified Person. 15.2 The Qualified Person shall be responsible for the release of each batch of the Intermediate Product after the Batch Record and Certificate of Analysis (which shall be signed by the Qualified Person) for each batch of the Intermediate Product has been produced.
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Sources: Supply Agreement (Flamel Technologies Sa), Supply Agreement (Flamel Technologies Sa)