New Regulatory Requirements. Either party shall promptly notify the other party new Regulatory Requirements of which it obtains actual knowledge and which are relevant to the Services under this Agreement and which are required by the FDA, other applicable Regulatory Authority, or other applicable laws or governmental regulations and the parties shall confer with each other with respect to the best means to comply with such requirements.
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Samples: CGMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp), CGMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp), CGMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp)
New Regulatory Requirements. Either Each party shall promptly notify the other party of new Regulatory Requirements or amended regulatory requirements of which it obtains actual knowledge and which becomes aware that are relevant to the Services Processing of the Sources under this Agreement and which that are required by the FDA, other applicable Regulatory Authority, any governmental entity or other applicable laws or governmental regulations regulations, and the parties shall confer with each other with respect to the best means to comply with such requirements.
Appears in 1 contract
Samples: Manufacturing Agreement (International Isotopes Inc)
New Regulatory Requirements. Either Each party shall promptly notify the other party of new Regulatory Requirements or amended regulatory requirements of which it obtains actual knowledge and which becomes aware that are relevant to the Services Processing of the Product under this Agreement and which that are required by the FDA, other applicable Regulatory Authority, governmental entity or other applicable laws or governmental regulations regulations, and the parties shall confer with each other with respect to the best means to comply with such requirements.
Appears in 1 contract
Samples: Clinical Manufacture and Supply Agreement (Neorx Corp)
New Regulatory Requirements. Either party Each Party shall promptly notify the other party of new Regulatory Requirements regulatory requirements of which it obtains actual knowledge and becomes aware which are relevant to the Services manufacture of any Product under this Agreement and which are required by the FDARegulatory Authorities, other applicable Regulatory Authority, or other applicable laws or governmental regulations and the parties as applicable. The Parties shall confer with each other with respect to the best means to implement and comply with such requirements. Any reasonable costs for modifications or additions to the facility required as a result of new regulatory requirements shall be borne by [***].
Appears in 1 contract
