API sourcing Clause Samples

API sourcing. It is estimated that sufficient quantities of fully released GMP clarithromycin API and GMP clofazimine API are available at Corealis and the Client at its own cost will ship to Corealis sufficient quantities of GMP rifabutin API (collectively the clarithromycin API, the clofazimine API and the rifabutin API are called “APIs” and individually “API”). Upon reception of the GMP rifabutin API Corealis will execute a full release testing of the material according to GMP requirements. Should additional APIs be required, the sourcing will be the exclusive responsibility of the Client. Upon request by the Client, Corealis could characterize and analyze the APIs which will be considered Extra Work. Cost: [****] * It is estimated that sufficient quantities of each of GMP clarithromycin API and GMP clofazimine API are available at Corealis to execute the manufacture of the CTM. However the Client will source and ship to Corealis sufficient quantities of GMP rifabutin API for the manufacture of the Drug product included in this Agreement. The cost includes: • the reception of one lot of GMP rifabutin API (i.e., documentation review, material registration in Corealis inventory, and material sampling following GMP requirements) (If API lot is in more than one container then the sampling and ID testing of each of the additional containers will be considered Extra Work at 200$/additional container), • the full testing for the release of one lot of GMP rifabutin API using validated method. (Client will ship the GMP rifabutin API to Corealis with the complete certificate of analysis and related documentation to assure API conformity to the appropriate regulatory authorities), • the GMP warehousing of the Client’s Materials (e.g., API, raw material, objects, inactive ingredients) for the period where the Project is active and for a volume not exceeding 1 m3. If the material need to be stored for a longer period of time or the volume of the material is more than 1 m3 then the storage cost will be considered Extra Work or the material shipped at Client. The cost does not include: • The purchase of the analytical reference materials to be used as a standard, if needed, reference impurities (synthesis by-products, Related Substances, metabolites) of known purity, HPLC columns, and any dedicated peripherals (e.g., guard column) and reagents. • The release testing of any additional material (i.e., additional API) should the Client change the drug product material specifications o...