In Process. Specifications mean the chemical, physical, biological and microbial testing methods and results required for the commercial manufacture of Product in accordance with Process, and which are listed in Exhibit B herein, provided that such specifications shall at all times comply with the relevant regulations of the FDA or other regulatory agency in the country of sale, and provided that such specifications may be modified from time to time in accordance with this Agreement.
Appears in 2 contracts
Sources: Manufacturing Agreement (Cubist Pharmaceuticals Inc), Manufacturing and Supply Agreement (Cubist Pharmaceuticals Inc)