Material Safety Data Sheet (MSDS); Acceptable Materials. Client shall provide Xxxxxx a material safety data sheet for Bulk Compound or other Client-Supplied Components and Client Product and Xxxxxx shall conform to established safety practices and procedures set forth therein and shall store and handle Bulk Compound and Client Product as required by the MBR and all applicable laws and regulations. Xxxxxx is under no obligation to produce, nor shall Client ship or cause to be shipped to Xxxxxx without specific prior written approval, any materials which: (a) contain [***] or (b) have an Occupational Exposure Limit of less than [***]. Xxxxxx understands and agrees that the Bulk Compound may have unpredictable and unknown biological and/or chemical properties and should be used with caution and are not to be used for testing in or treatment of humans. Xxxxxx shall immediately notify Client of any unusual health or environmental occurrence of which it has knowledge relating to Client Product, including, but not limited to any claim or complaint by any employee of Xxxxxx or any of its Affiliates or third party contractors. Xxxxxx agrees to advise Client immediately of any safety or toxicity problems of which it becomes aware regarding the Client Product. Client shall ensure such MSDSs are promptly updated as needed.
Material Safety Data Sheet (MSDS); Acceptable Materials. Client shall provide Xxxxxx a material safety data sheet for Bulk Compound or other Client-Supplied Components and Client Product and Xxxxxx shall materially conform to established safety practices and procedures set forth therein and shall store and handle Bulk Compound and Client Product as required by the MBR and all Regulations. Xxxxxx is under no obligation to produce, nor shall Client ship or cause to be shipped to Xxxxxx without specific prior written approval, any materials which: (a) contain a penicillin, cephalosporin, high-potent product other than the [ * ] botulinum neurotoxin type A Client Product, DEA controlled substance or radio label or (b) have an Occupational Exposure Limit of less than [ * ]. Xxxxxx understands and agrees that the Bulk Compound may have unpredictable and unknown biological and/or chemical properties and should be used with caution and are not to be used for testing in or treatment of humans. Xxxxxx shall immediately notify Client of any unusual health or environmental occurrence of which it has knowledge relating to Client Product, including, but not limited to any claim or complaint by any employee of Xxxxxx or any of its Affiliates or third party contractors. Xxxxxx agrees to advise Client immediately of any safety or toxicity problems of which it becomes aware regarding the Client Product. Client shall ensure such MSDSs are promptly updated as needed. Xxxxxx requires all projects to include a complete MSDS as well as a calculated OEL for the active pharmaceutical ingredients prior to manufacturing activities. Within 30 days of receipt of such information, Xxxxxx has the right to terminate the relevant Statement(s) of Work upon notice if Xxxxxx cannot handle the relevant Production based on a safety assessment by Althea’s health and safety group. Provided however, the previous sentence and the calculated OEL shall not apply to the [ * ] botulinum neurotoxin type A Client Product, provided that an MSDS for such Product has been provided to Xxxxxx prior to execution of this Agreement.
