Key Intermediate definition
Examples of Key Intermediate in a sentence
All such notices shall be sent to the attention of the: Director, Medical Affairs at NABRIVA Facsimile number [**] NABRIVA shall promptly provide SEL with copies of any complaints received by NABRIVA relating to the pharmaceutical product containing Key Intermediate if such complaints might relate to the manufacture or bulk packaging of the Key Intermediate.
SEL or its authorized representative will send to NABRIVA a Certificate of Analysis and a Certificate of Compliance (together with any other documentation required under the Quality Technical Agreement(including Wood Pallets Declaration, Melamine Declaration, TSE and Jatropha Declaration, Residual Solvents Declaration, Elemental Impurities Declaration and Change Control Commitment) prior to, or together with, each shipment of Key Intermediate.
FOUNTAIN shall invoice NABRIVA the Purchase Price for all Key Intermediate delivered as set forth in Schedule D attached hereto.
SEL will also inform NABRIVA of any action taken by any governmental agency against SEL or any of its officers and employees which may reasonably be expected to adversely affect the Key Intermediate or SEL’s ability to supply Key Intermediate hereunder within 24 hours after the action is taken.
All Key Intermediate manufactured and sold by SEL to NABRIVA under this Agreement will meet the Key Intermediate specifications and minimum shelf life requirements set forth in Schedule A hereto (the “Specifications”), as well as the quality assurance standards established in the Quality Technical Agreement.
SEL will promptly inform NABRIVA of any contact, inspection or audit by any governmental agency related to or affecting the Key Intermediate.
NABRIVA or its affiliates shall have responsibility for reporting all complaints relating to the pharmaceutical product containing Key Intermediate to the FDA and any other regulatory authorities, including, but not limited to, complaints relating to the manufacture or bulk packaging of the Key Intermediate as well as adverse experience (AE) reports.
NABRIVA THERAPEUTICS IRELAND DAC By: /s/ ▇▇▇▇▇ ▇▇▇▇▇ Name: ▇▇▇▇▇ ▇▇▇▇▇ Title: CEO SEL BIOCHEM Xinjiang Co, LTD By: /s/ ▇▇▇▇▇ ▇▇ Name: ▇▇▇▇▇ ▇▇ Title: Vice President FOUNTAIN INTERNATIONAL DEVELOPMENT HOLDING LIMITED By: /s/ ▇▇▇▇ Bu Name: ▇▇▇▇ Bu Title: General manager Schedule A The Parties have agreed upon all those applicable specifications for the Key Intermediate (Pleuromutilin) as set forth hereunder.
SEL will assist NABRIVA in investigating complaints relating to the pharmaceutical product containing Key Intermediate if such complaints relate to the manufacture or bulk packaging of the Key Intermediate, by analyzing Key Intermediate and manufacturing processes to determine the nature and cause of an alleged Key Intermediate manufacturing defect or alleged Key Intermediate failure.
SEL has suitable facilities and equipment and sufficient qualified personnel to perform their respective services as set forth in the Agreement, manufacture Key Intermediate in bulk form, and is willing to provide such Key Intermediate on the terms and conditions set forth below.