Excipients. “Excipients” shall mean the raw materials, other than Active Pharmaceutical Ingredients and packaging, required to manufacture each Product in accordance with the Product Specifications, as such Excipients are listed in the Product Addendum in ANNEX 1 for each Product to be manufactured hereunder, including the specifications and the analytical methodology related thereto, as such specifications may be amended from time to time in accordance with Section 5.6.1.
Excipients. Strakan shall, or shall cause its Contract Manufacturer(s), to utilize only excipients defined in the Master Manufacturing Document. Excipients shall either comply with the most recent Pharmacopoeia monograph (EP and USP) or Strakan’ Specifications where such excipients are not included in a Pharmacopoeia monograph. In all cases, Strakan shall supply to Aptalis a control copy of the Specifications of each excipient for review and approval. Strakan shall, or shall cause its Contract Manufacturer(s), to source excipients from reputable companies previously approved by Strakan.
Excipients. UMAN shall utilise only excipients defined in the Master Manufacturing Document. Excipients shall either comply with the most recent Pharmacopoeia monograph (EP and USP) or UMAN’s Specifications where such excipients are not included in a Pharmacopoeia monograph. In all cases, UMAN shall supply to CLIENT a control copy of the Specifications of each excipient for review and approval. UMAN shall source excipients from reputable companies.
Excipients. UMAN shall utilize laboratories listed in annex III to test excipients. UMAN may use reputable sub-contractor laboratories previously approved by UMAN; such sub-contractor laboratory must be disclosed to CLIENT. UMAN QC unit shall issue final approval of the CoA and shall ensure that the results comply with the Specifications.
Excipients. Each Partner shall ensure that the vaccine formulation excipients that it uses or procures are on the FDA’s Generally Recognised as Safe (“GRAS”) excipient list. Each Partner shall promptly inform CEPI if a novel excipient, which is not on the FDA’s GRAS excipient list, is being considered by such Partner (or a third party acting on such Partner’s behalf) for use in connection with a Project Vaccine and if so, such Partner shall (or shall cause such third party to), undertake a detailed risk assessment and seek advice from the relevant Regulatory Authorities regarding such novel excipient including the extent of data required to demonstrate the safety of such novel excipient, which may include preclinical toxicology study design and data generation during clinical development. Before use of such novel excipient in connection with a Project Vaccine, the relevant Partner shall notify CEPI and provide such information regarding such excipient to CEPI as CEPI may reasonably request.
Excipients. TEST METHOD (LB SOP NO. CRITERION NUMBER) SPECIFICATION ------------------------------------------------------------------ 1.13 [ * * * ] [ * * * ] [ * * * ]
Excipients. Paddock will utilize only excipients as defined in the Master Manufacturing Document. Excipients will either comply with the most recent Pharmacopoeia monograph or Axcan specifications when such an excipients is not included in a Pharmacopoeia monograph. In all cases, Paddock will supply to Axcan a controlled copy of their specification for review and approval. Paddock will source excipients from reputable companies previously approved by Paddock. Any proposed change in the sourcing of excipients will be communicated to Axcan for approval prior to its implementation.
Excipients. Paddock will utilize only reputable sub-contractor laboratory previously approved by Paddock and disclosed to Axcan to conduct testing of excipients. Paddock QC unit will have the responsibility for the final approval of the CoA and shall ensure that the results comply with the specification of the excipient.
Excipients. Sanofi-aventis at its cost shall procure, and test in accordance with the Production Site receipt procedures, all Excipients for the manufacture of the Product in quantities sufficient to meet Horizon’s requirements of Product as further set forth herein. If the supplier of Excipient(s), and or an Excipient, is not used by sanofi-aventis or its Affiliates for the manufacture of any product other than Product, Horizon shall be responsible for the cost of any such supplier audit. Audit frequency will be determined by sanofi-aventis based on local procedures and regulatory requirements.
