Environmental and Other Laws and Regulations. In carrying out its obligations under this Agreement, Patheon shall comply with all applicable environmental and health and safety laws (current or as amended or added), and shall be solely responsible for determining how to comply with same in carrying out these obligations. Notwithstanding the foregoing, nothing provided to Patheon by Santarus, by way of materials, specifications, processing information or otherwise, is meant to diminish Patheon's responsibility for such compliance. Patheon shall obtain and maintain all necessary licenses, permits and governmental approvals (except for product-related Regulatory Approvals such as NDA's) required to perform its manufacturing and supply services hereunder, including licensure and permitting of its manufacturing facilities by the FDA and Foreign Regulatory Authorities. Patheon shall promptly notify Santarus of any circumstances, including the receipt of any notice, warning, citation, finding, report or service of process or the occurrence of any release, spill, upset, or discharge of hazardous substances (as may be defined under Applicable Laws) relating to Patheon's compliance with this Section 4.6 and which relates to the manufacture of Finished Product. Santarus reserves the right to conduct an environmental inspection of the Facility, at reasonable intervals during normal business hours and with reasonable advance notice, for the purpose of determining compliance with this Section 4.6. Such inspection shall not relieve Patheon of its obligation to comply with all applicable environmental and health and safety laws and does not constitute a waiver of any right otherwise available to Santarus.
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Samples: Manufacturing and Supply Agreement (Santarus Inc), Manufacturing and Supply Agreement (Santarus Inc)
Environmental and Other Laws and Regulations. In carrying out its obligations under this Agreement, Patheon shall comply with all applicable environmental and health and safety laws (current or as amended or added), and shall be solely responsible for determining how to comply with same in carrying out these obligations. Notwithstanding the foregoing, nothing provided to Patheon by Santarus, by way of materials, specifications, processing information or otherwise, is meant to diminish Patheon's ’s responsibility for such compliance. Patheon shall obtain and maintain all necessary licenses, permits and governmental approvals (except for product-related Regulatory Approvals such as NDA's’s) required to perform its manufacturing and supply services hereunder, including licensure and permitting of its manufacturing facilities by the FDA and Foreign Regulatory Authorities. Patheon shall promptly notify Santarus of any circumstances, including the receipt of any notice, warning, citation, finding, report or service of process or the occurrence of any release, spill, upset, or discharge of hazardous substances (as may be defined under Applicable Laws) relating to Patheon's ’s compliance with this Section 4.6 and which relates to the manufacture of Finished Product. Santarus reserves the right to conduct an environmental inspection of the Facility, at reasonable intervals during normal business hours and with reasonable advance notice, for the purpose of determining compliance with this Section 4.6. Such inspection shall not relieve Patheon of its obligation to comply with all applicable environmental and health and safety laws and does not constitute a waiver of any right otherwise available to Santarus.
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Environmental and Other Laws and Regulations. In carrying out its obligations under this Agreement, Patheon Manufacturer shall comply with all applicable environmental and health and safety laws (current or as amended or added), and shall be solely responsible for determining how to comply with same in carrying out these obligations. Notwithstanding the foregoing, nothing provided to Patheon Manufacturer by Santarus, by way of materials, specifications, processing information or otherwise, is meant to diminish Patheon's Manufacturer’s responsibility for such compliance. Patheon Manufacturer shall obtain and maintain all necessary licenses, permits and governmental approvals (except for product-related Regulatory Approvals such as NDA's’s) required to perform its manufacturing and supply services hereunder, including licensure and permitting of its manufacturing facilities by the FDA and Foreign Regulatory Authorities. Patheon Manufacturer shall promptly notify Santarus of any circumstances, including the receipt of any notice, warning, citation, finding, report or service of process or the occurrence of any release, spill, upset, or discharge of hazardous substances (as may be defined under Applicable Laws) relating to Patheon's Manufacturer’s compliance with this Section 4.6 and which relates to the manufacture of Finished Product. Santarus reserves the right to conduct an environmental inspection of the Facility, at reasonable intervals during normal business hours and with reasonable advance notice, for the purpose of determining compliance with this Section 4.6. Such inspection shall not relieve Patheon Manufacturer of its obligation to comply with all applicable environmental and health and safety laws and does not constitute a waiver of any right otherwise available to Santarus.
Appears in 1 contract
Samples: Manufacturing and Supply Agreement (Salix Pharmaceuticals LTD)
Environmental and Other Laws and Regulations. In carrying out its obligations under this Agreement, Patheon Manufacturer shall comply with all applicable environmental and health and safety laws (current or as amended or added), and shall be solely responsible for determining how to comply with same in carrying out these obligations. Notwithstanding the foregoing, nothing provided to Patheon Manufacturer by Santarus, by way of materials, specifications, processing information or otherwise, is meant to diminish PatheonManufacturer's responsibility for such compliance. Patheon Manufacturer shall obtain and maintain all necessary licenses, permits and governmental approvals (except for product-related Regulatory Approvals such as NDA's) required to perform its manufacturing and supply services hereunder, including licensure and permitting of its manufacturing facilities by the FDA and Foreign Regulatory Authorities. Patheon Manufacturer shall promptly notify Santarus of any circumstances, including the receipt of any notice, warning, citation, finding, report or service of process or the occurrence of any release, spill, upset, or discharge of hazardous substances (as may be defined under Applicable Laws) relating to PatheonManufacturer's compliance with this Section 4.6 and which relates to the manufacture of Finished Product. Santarus reserves the right to conduct an environmental inspection of the Facility, at reasonable intervals during normal business hours and with reasonable advance notice, for the purpose of determining compliance with this Section 4.6. Such inspection shall not relieve Patheon Manufacturer of its obligation to comply with all applicable environmental and health and safety laws and does not constitute a waiver of any right otherwise available to Santarus.
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Environmental and Other Laws and Regulations. In carrying out its obligations under this Agreement, Patheon shall comply with all applicable environmental and health and safety laws (current or as amended or added), and shall be solely responsible for determining how to comply with same in carrying out these obligations. Notwithstanding the foregoing, nothing provided to Patheon by Santarus, by way of materials, specifications, processing information or otherwise, is meant to diminish Patheon's ’s responsibility for such compliance. Patheon shall obtain and maintain all necessary licenses, permits and governmental approvals (except for product-related Regulatory Approvals such as NDA's’s) required to perform its manufacturing and supply services hereunder, including licensure and permitting of its manufacturing facilities by the FDA and Foreign Regulatory Authorities. Patheon shall promptly notify Santarus of any circumstances, including the receipt of any notice, warning, citation, finding, report or service of process or the occurrence of any release, spill, upset, or discharge of *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. hazardous substances (as may be defined under Applicable Laws) relating to Patheon's ’s compliance with this Section 4.6 and which relates to the manufacture of Finished Product. Santarus reserves the right to conduct an environmental inspection of the Facility, at reasonable intervals during normal business hours and with reasonable advance notice, for the purpose of determining compliance with this Section 4.6. Such inspection shall not relieve Patheon of its obligation to comply with all applicable environmental and health and safety laws and does not constitute a waiver of any right otherwise available to Santarus.
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