Common use of Health, Safety and Environmental Compliance Clause in Contracts

Health, Safety and Environmental Compliance. 3.6.1. Dispensing and other Manufacturing operations are to be performed by BVL using appropriate safety measures and containment techniques as dictated by Applicable Law and industry standards. BVL shall be solely responsible for implementing and maintaining health and safety procedures for the Manufacture of Product and performance of services under this Agreement and for the handling of any materials or hazardous waste used in or generated by such activities. BVL, in consultation with Customer, shall develop safety and handling procedures for API and Product; provided, however, that Customer shall have no responsibility for BVL’s health and safety program. The generation, collection, storage, handling, transportation, movement and release of hazardous materials and waste generated in connection with the Manufacture of Product and other services under this Agreement shall be the responsibility of BVL at BVL’s cost and expense, unless otherwise agreed to in writing by the Parties for special situations or conditions. Without limiting other legally applicable requirements, BVL shall prepare, execute and maintain, as the generator of waste, all licenses, registrations, approvals, authorizations, notices, shipping documents and waste manifests required under Applicable Law. Notwithstanding the foregoing, Customer shall be solely responsible for the disposal of any waste generated by Customer disposition of Customer-supplied Composition or finished Product. 3.6.2. Customer has established a program for systematic assessment of its suppliers’ EHS programs (“TPM EHS Assessment Program”) and BVL agrees to participate and reasonably cooperate with Customer in effectively implementing this TPM EHS Assessment Program. 3.6.3. BVL will review Customer’s TPM EHS Assessment Program and, if applicable, provide quotations for additional resources required to address the program. BVL policies will govern except in the event that Customer is willing to bear the cost of compliance. Specifically, BVL agrees to: 3.6.3.1. Promptly respond to reasonable Customer requests for non-confidential information made as part of TPM EHS Assessment Program. Customer will provide a questionnaire to BVL and BVL is expected to provide the complete response within thirty (30) calendar days; 3.6.3.2. Reasonably cooperate with Customer to clarify and supplement any information related to its facilities and operations; and 3.6.3.3. Provide to Customer, upon request, copies of BVL’s environmental, health and safety permits required by any governmental authority which are associated with the Products and all facility operations related thereto. 3.6.4. BVL agrees that Customer or its appointed Agent(s) (which Agent shall be disclosed to BVL not less than 30-days in advance of an audit and which shall not be rejected by BVL in the absence of good cause shown) shall be entitled to conduct inspections and audits upon reasonable notice (at Customer’s cost) and mutually convenient times of any areas or facilities used to produce the Products or required for production of the Products, including for the following reasons: 3.6.4.1. to assist in completion of TPM EHS Assessment Program described in this Section 3.6.2; and 3.6.4.2. to allow for a loss prevention inspection of the Facility by Customer’s fire insurance underwriting company as necessary for Customer to obtain contingent business interruption insurance. 3.6.5. BVL shall take reasonable and appropriate precautions to ensure that its personnel (including its employees, contractors, and Agents) are protected from Product and/or the Product’s Manufacturing process exposures through either engineering infrastructure, personnel protective equipment or a combination of both. Upon request, within ninety (90) days, BVL shall provide workplace monitoring data which demonstrates the effectiveness of controls. For testing of Customer-supplied Composition or API, Customer will provide sampling method and media to allow samples to be collected at Customer’s cost. If testing methods for the API or Customer-supplied Composition in question are unavailable, surrogates may be used. Workplace monitoring data will be performed in accordance with proposals provided to Customer.

Health, Safety and Environmental Compliance. 3.6.1. Dispensing and other Manufacturing operations are to be performed by BVL using appropriate safety measures and containment techniques as dictated by Applicable Law and industry standards. BVL shall be solely responsible for implementing and maintaining health and safety procedures for the Manufacture of Product and performance of services under this Agreement and for the handling of any materials or hazardous waste used in or generated by such activities. BVL, in consultation with Customer, shall develop safety and handling procedures for API and Product; provided, however, that Customer shall have no responsibility for BVL’s health and safety program. The generation, collection, storage, handling, transportation, movement and release of hazardous materials and waste generated in connection with the Manufacture of Product and other services under this Agreement shall be the responsibility of BVL at BVL’s cost and expense, unless otherwise agreed to in writing by the Parties for special situations or conditions. Without limiting other legally applicable requirements, BVL shall prepare, execute and maintain, as the generator of waste, all licenses, registrations, approvals, authorizations, notices, shipping documents and waste manifests required under Applicable Law. Notwithstanding the foregoing, Customer shall be solely responsible for the disposal of any waste generated by Customer disposition of Customer-supplied Composition or finished Product. 3.6.2. Customer has established a program for systematic assessment of its suppliers’ EHS programs (“TPM EHS Assessment Program”) and BVL agrees to participate and reasonably cooperate with Customer in effectively implementing this TPM EHS Assessment Program. 3.6.3. BVL will review Customer’s TPM EHS Assessment Program and, if applicable, provide quotations for additional resources required to address the program. BVL policies will govern except in the event that Customer is willing to bear the cost of compliance. Specifically, BVL agrees to: 3.6.3.1. Promptly respond to reasonable Customer requests for non-confidential information made as part of TPM EHS Assessment Program. Customer will provide a questionnaire to BVL and BVL is expected to provide the complete response within thirty (30) calendar days; 3.6.3.2. Reasonably cooperate with Customer to clarify and supplement any information related to its facilities and operations; and 3.6.3.3. Provide to Customer, upon request, copies of BVL’s environmental, health and safety permits required by any governmental authority which are associated with the Products and all facility operations related thereto. 3.6.4. BVL agrees that Customer or its appointed Agent(s) (which Agent shall be disclosed to BVL not less than 30-days in advance of an audit and which shall not be rejected by BVL in the absence of good cause shown) shall be entitled to conduct inspections and audits upon reasonable notice (at Customer’s cost) and mutually convenient times of any areas or facilities used to produce the Products or required for production of the Products, including for the following reasons: 3.6.4.1. to assist in completion of TPM EHS Assessment Program described in this Section 3.6.2; and 3.6.4.2. to allow for a loss prevention inspection of the Facility by Customer’s fire insurance underwriting company as necessary for Customer to obtain contingent business interruption insurance. 3.6.5. BVL shall take reasonable and appropriate precautions to ensure that its personnel (including its employees, contractors, and Agents) are protected from Product and/or the Product’s Manufacturing process exposures through either engineering infrastructure, personnel protective equipment or a combination of both. Upon request, within ninety (90) 90 days, BVL shall provide workplace monitoring data which demonstrates the effectiveness of controls. For testing of Customer-supplied Composition or API, Customer will provide sampling method and media to allow samples to be collected at Customer’s cost. If testing methods for the API or Customer-supplied Composition in question are unavailable, surrogates may be used. Workplace monitoring data will be performed in accordance with proposals provided to Customer.

Health, Safety and Environmental Compliance. 3.6.1. Dispensing and other Manufacturing operations are to be performed by BVL using appropriate safety measures and containment techniques as dictated by Applicable Law and industry standards. BVL shall be solely responsible for implementing and maintaining health and safety procedures for the Manufacture of Product and performance of services under this Agreement and for the handling of any materials or hazardous waste used in or generated by such activities. BVL, in consultation with Customer, shall develop safety and handling procedures for API and Product; provided, however, that Customer shall have no responsibility for BVL’s health and safety program. The generation, collection, storage, handling, handling transportation, movement and release of hazardous materials and waste generated in connection with the Manufacture of Product and other services under this Agreement shall be the responsibility of BVL at BVL’s cost and expense, unless otherwise agreed to in writing by the Parties for special situations or conditions. Without limiting other legally applicable requirements, BVL shall prepare, execute and maintain, as the generator of waste, all licenses, registrations, approvals, authorizations, notices, shipping documents and waste manifests required under Applicable Law. Notwithstanding the foregoing, Customer shall be solely responsible for the disposal of any waste generated by Customer disposition of Customer-supplied Customer Supplied Composition or finished Product. 3.6.2. Customer has established a program for systematic assessment of its suppliers’ EHS programs (“TPM EHS Assessment Program”) and BVL agrees to participate and reasonably cooperate with Customer in effectively implementing this TPM EHS Assessment Program. 3.6.3. BVL will review Customer’s TPM EHS Assessment Program and, if applicable, provide quotations for additional resources required to address the program. BVL policies will govern except in the event that Customer is willing to bear the cost of compliance. SpecificallySpecially, BVL agrees to: 3.6.3.1. Promptly respond to reasonable Customer requests for non-confidential information made as part of TPM EHS Assessment Program. Customer will provide a questionnaire to BVL and BVL is expected to provide the complete response within thirty (30) calendar days; 3.6.3.2. Reasonably cooperate with Customer to clarify and supplement any information related to its facilities and operations; and 3.6.3.3. Provide to Customer, upon request, copies of BVL’s environmental, health and safety permits required by any governmental authority which are associated with the Products and all facility operations related thereto. 3.6.4. BVL agrees that Customer or its appointed Agent(s) (which Agent shall be disclosed to BVL not less than 30-days in advance of an audit and which shall not be rejected by BVL in the absence of good cause shown) shall be entitled to conduct inspections and audits upon reasonable notice (at Customer’s cost) and mutually convenient times of any areas or facilities used to produce the Products or required for production of the Products, including for the following reasons: 3.6.4.1. to assist in completion of TPM EHS Assessment Program described in this Section 3.6.2; and 3.6.4.2. to allow for a loss prevention inspection of the Facility by Customer’s fire insurance underwriting company as necessary for Customer to obtain contingent business interruption insurance. 3.6.5. BVL shall take reasonable and appropriate precautions to ensure that its personnel (including its employees, contractors, and Agents) are protected from Product and/or the Product’s Manufacturing process exposures through either engineering infrastructure, personnel protective equipment or a combination of both. Upon request, within ninety (90) 90 days, BVL shall provide workplace monitoring data which demonstrates the effectiveness of controls. For testing of Customer-supplied Composition or API, Customer will provide sampling method and media to allow samples to be collected at Customer’s cost. If testing methods for the API or Customer-supplied Composition in question are unavailable, surrogates may be used. Workplace monitoring data will be performed in accordance with proposals provided to Customer.