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.
Environmental and Other Laws and Regulations. In carrying out its obligations under this Agreement, Genchem Pharma shall cause Sicor to 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 carry out these obligations. Notwithstanding any other provision in this Agreement to the contrary, nothing provided to Genchem Pharma or Sicor by Anthra, by way of materials, specifications, processing information or otherwise, shall diminish Genchem Pharma's sole responsibility for compliance with this Section 7.10. Genchem Pharma also represents and warrants that it and Sicor have the appropriate skills, personnel, equipment, permits, or approvals necessary to perform their respective services under this Agreement in compliance with all applicable environmental and health and safety laws. Genchem Pharma shall immediately notify Anthra, in writing, 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 relating to the compliance by Genchem Pharma or Sicor with this Section 7.10 or which may impose environmental liability upon Genchem Pharma or Sicor and which relates to the Manufacture of AD32.
Environmental and Other Laws and Regulations. In carrying out its obligations under this Agreement, NTC shall comply with all applicable environmental and health and safety laws, regulations, ordinances, guidelines and policies (current or as amended or added) (hereinafter "Laws"), and shall be solely responsible for determining how to carry out these obligations. Notwithstanding any other provision in this Agreement to the contrary, nothing provided to NTC by S-P, by way of materials, specifications, processing information or otherwise, is meant to diminish this as NTC's sole responsibility. NTC also represents and warrants that it has the appropriate skills, personnel, equipment, permits, approvals or the like necessary to perform its services or provide materials under this Agreement in compliance with all applicable Laws. NTC shall immediately notify S-P, in writing, or 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, relating to NTC's compliance with this Section 7.10 or which may impose environmental liability upon NTC. NTC's noncompliance with this Section 7.10 is considered a material breach of this Agreement. S-P reserves the right to conduct an environmental inspection of NTC's facility or facilities, during normal business hours and with reasonable advance notice, for the purpose of determining compliance with this Section 7.10. S-P will share the results of any environmental inspection with NTC. Such inspection, if it occurs, does not relieve NTC of its sole obligation to comply with all applicable Laws and does not constitute a waiver of any right otherwise available to S-P.
Environmental and Other Laws and Regulations. (a) In carrying out its obligations under this Agreement, CIMA shall comply with all applicable environmental, health and safety laws (current or as amended or added, collectively "Laws"), and shall be solely responsible for determining how to comply with same. CIMA represents and warrants that it has the appropriate skills, personnel, equipment, permits or approvals necessary to perform its services under this Agreement in compliance with all applicable Laws.
(b) CIMA shall notify WCH, in writing, no later than one (1) business day after the event, of any circumstances, including the receipt of any notice, warning, citation, finding, report or service of process, relating to compliance with the Laws, or the occurrence of any release, spill, upset or discharge of "Hazardous Substances" as defined by the Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended, which relates to CIMA's ability to manufacture or supply Product. WCH reserves the right to conduct an environmental inspection of CIMA's facility(ies), during normal business hours and with reasonable advance notice, for the purpose of determining compliance with this Section 2.12(b), no more frequently than once per year during the term hereof and under conditions of confidentiality as provided under Article VIII. Upon CIMA's request, WCH shall share the results of any environmental inspection with CIMA. Such inspection, if it occurs, does not relieve CIMA of its sole obligation to comply with the Laws and does not constitute a waiver of any right otherwise available to WCH.
Environmental and Other Laws and Regulations. In carrying out its obligations under this Agreement, Impax shall have sole responsibility for compliance with all applicable Laws, including without limitation environmental and health and safety laws, as amended from time to time. Impax shall immediately notify Schering in writing of any event, 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 wastes or substances, relating to the Manufacture of the Product that may give rise to liability on the part of Impax under the Laws or this Agreement. Schering reserves the right to conduct an environmental inspection of Impax's facility, during normal business hours and with reasonable advance notice, for the purpose of determining compliance with this Section 8.8. Schering shall share the results of any such environmental inspection with Impax. Such inspection, if any, shall not relieve Impax of its sole obligation to comply with the Laws and does not constitute a waiver of any right otherwise available to Schering.
Environmental and Other Laws and Regulations. In carrying out its obligations under this Agreement, RIBI shall have sole responsibility for compliance with all applicable environmental and health and safety laws, as amended from time to time (the "Laws"). RIBI represents and warrants that [*]. RIBI shall [*] notify SP Ltd. [*] of any event, including [*] give rise to liability on the part of RIBI under the Laws. SP Ltd. reserves the right to conduct an environmental inspection of RIBI's facility, during normal business hours and with reasonable advance notice, for the purpose of determining compliance with this Section 8.10. SP Ltd. shall share the results of any such environmental inspection with RIBI. Such inspection, if any, shall not relieve RIBI of its sole obligation to comply with the Laws and does not constitute a waiver of any right otherwise available to SP Ltd.
Environmental and Other Laws and Regulations. 3.9.1 In carrying out its obligations under this Agreement, GalaGen and/or its sub-contractor shall comply with all applicable environmental, health and safety laws (current or as amended or added, collectively "Laws"), and shall be solely responsible for determining how to comply with same. GalaGen represents and warrants that it and/or its sub-contractor(s) have the appropriate skills, personnel, equipment, permits or approvals necessary to perform its services under this Agreement in compliance with all applicable Laws.
3.9.2 GalaGen shall notify Wyeth-Ayerst, in writing, no later than one (1) business day after the event, of any circumstances, including the receipt of any notice, warning, citation, finding, report or service of process, relating to compliance with the Laws, or the occurrence of any release, spill, upset or discharge of "Hazardous Substances" as defined by the Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended, which relates to GalaGen's or sub-contractor's ability to Manufacture or supply the Ingredient. Wyeth-Ayerst reserves the right to conduct an environmental inspection of GalaGen's or its sub-contractors' facility, during normal business hours and with reasonable advance notice, for the purpose of determining compliance with this Section 3.9, no more frequently than once per year during the term hereof and under conditions of confidentiality as provided under Article 10. Upon GalaGen's request Wyeth-Ayerst shall share the results of any environmental inspection with GalaGen. Such inspection, if it occurs, does not relieve GalaGen of its sole obligation to comply with the Laws and does not constitute a waiver of any right otherwise available to Wyeth-Ayerst.
Environmental and Other Laws and Regulations. In carrying out its obligations under this Agreement, RIBI shall have sole responsibility for compliance with all applicable environmental and health and safety laws, as amended from time to time (the "Laws"). RIBI represents and warrants that [*]. RIBI shall [*] notify Schering [*] of any event, including [*] give rise to liability on the part of RIBI under the Laws. Schering reserves the right to conduct an environmental inspection of RIBI's facility, during normal business hours and with reasonable advance notice, for the purpose of determining compliance with this Section 8.
Environmental and Other Laws and Regulations. In carrying out its obligations under this Agreement, Siegfried Hameln 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 the same in carrying out these obligations. Siegfried Hameln shall obtain and maintain all necessary licenses, permits and governmental approvals (except for product-related Regulatory Approvals) required to perform manufacturing by the competent authority at the location of the Facility. Siegfried Hameln shall promptly notify Xxxxx 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 Siegfried Hameln’s compliance herewith and which directly impacts the manufacture of Finished Product. Such inspection shall not relieve Siegfried Hameln 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 Xxxxx.
Environmental and Other Laws and Regulations. In carrying out its obligations under this Agreement, Supplier shall comply and have Manufacturer 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.
