Voluntary Changes. 10.1.1 Paratek may propose any change to the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the sources of Materials or the Methods of Analysis by delivering a written notice to CIPAN of such proposed change. Within ten (10) Business Days of receiving such notice, CIPAN shall inform Paratek of any and all reasonable costs associated with implementing such change and if Paratek agrees to reimburse CIPAN for such costs, CIPAN shall implement such change as promptly as practicable in consultation in Paratek; provided, however, that, if CIPAN notifies Paratek that it has determined in good faith that such change is not in compliance with applicable laws or regulations (including cGMP), the Parties shall submit such dispute to a Third Party expert for resolution. 10.1.2 CIPAN shall not make any changes to the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the sources of Materials or the Methods of Analysis without the prior written consent of Paratek.
Appears in 2 contracts
Sources: Manufacturing and Services Agreement (Paratek Pharmaceuticals, Inc.), Manufacturing and Services Agreement (Paratek Pharmaceuticals, Inc.)
Voluntary Changes. 10.1.1 11.1.1 Paratek may propose any change to the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the sources of Materials or the Methods of Analysis by delivering a written notice to CIPAN of such proposed change. Within ten (10) Business Days of receiving such notice, CIPAN shall inform Paratek of any and all reasonable costs associated with implementing such change and if Paratek agrees to reimburse CIPAN for such costs, CIPAN shall implement such change as promptly as practicable in consultation in Paratek; provided, however, that, if CIPAN notifies Paratek that it has determined in good faith that such change is not in compliance with applicable laws or regulations (including cGMP), the Parties shall submit such dispute to a Third Party expert for resolution.
10.1.2 11.1.2 CIPAN shall not make any changes to the Manufacturing process, the Manufacturing equipment, the Specifications, the Materials, the sources of Materials or the Methods of Analysis without the prior written consent of Paratek.
Appears in 1 contract
Sources: Manufacturing Agreement (Paratek Pharmaceuticals, Inc.)