Implementation Batches Clause Samples

Implementation Batches. 6.6.1 After the FEASIBILITY STUDY and the performance of the CONFIRMATORY BATCHES, BI Austria shall produce two (2) ** working volume IMPLEMENTATION BATCHES for DRUG SUBSTANCE, media fills and two (2) IMPLEMENTATION BATCHES for DRUG PRODUCT. Pursuant to the mutually agreed production requirements set forth in Exhibit 20 BI Austria shall establish a ** fermentation scale and for purification a scale with a yield of ** grams DRUG SUBSTANCE per sublot. 6.6.2 The IMPLEMENTATION BATCHES shall be produced in the GMP production units at BI Austria to ensure the technical equipment is qualified with respect to the specific requirements for the later GMP manufacture of DRUG PRODUCT. 6.6.3 BI Austria shall ferment and purify each IMPLEMENTATION BATCH in accordance with the process description which shall be established in a MASTER BATCH RECORD, to be drawn up by BI Austria, reviewed by Corautus and released by BI Austria Quality Management. 6.6.4 BI Austria shall conduct in-process control testing on each manufacturing run and also conduct release testing of the IMPLEMENTATION BATCHES according to the DRUG PRODUCT SPECIFICATIONS. Corautus will conduct any release testing for methods not transferred to BI Austria. 6.6.5 BI Austria shall warehouse DRUG PRODUCT produced in the IMPLEMENTATION BATCHES as requested by Corautus. Corautus shall decide on either disposing, or, provided the DRUG PRODUCT meets SPECIFICATIONS, shipping such DRUG PRODUCT to Corautus. 6.6.6 As the DRUG PRODUCT from the IMPLEMENTATION BATCHES is of experimental nature and does not meet all GMP requirements, Corautus warrants that it shall not use such DRUG PRODUCT in humans. 6.6.7 The PARTIES shall consider the yield and purity of the IMPLEMENTATION BATCHES and if the IMPLEMENTATION BATCHES do not meet the expected purity standards or expected yields based on the DRUG PRODUCT SPECIFICATIONS the PARTIES will come to an agreement on further steps. In such events both PARTIES shall use commercially reasonable efforts to arrive at a mutually acceptable solution. For work packages in Exhibit 16 which are not marked as “estimates” prices shall be final prices. However, if the scope of certain work packages is changed upon written agreement by both PARTIES prices shall be adjusted accordingly. ** Confidential provision omitted and filed separately with the Securities and Exchange Commission (“SEC”), based upon a request for confidential treatment filed with the SEC.