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

Health, Safety and Environmental Compliance. (a) Manufacturing operations are to be performed by HSL using appropriate safety measures and containment techniques as dictated by applicable law, regulations and industry standards. HSL 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. HSL, in consultation with LMI, shall develop safety and handling procedures for Product; provided, however, that LMI shall have no responsibility for HSL’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 HSL, at HSL’s cost and expense, unless otherwise agreed to in writing by the Parties for special situations and conditions. Without limiting other legally applicable requirements, HSL shall prepare, execute and maintain, as the generator of waste, all licenses, registrations, approvals and authorizations, notices, shipping documents and waste manifests required under applicable law and regulations. (b) LMI has established a program for systematic assessment of its supplier’s EHS programs (“TPM EHS Assessment Program”) and HSL agrees to participate and reasonably cooperate with LMI in effectively implementing this TPM EHS Assessment Program. (c) HSL will review LMI’s TPM EHS Assessment Program and, if applicable, provide quotations for additional resources required to address the program. HSL policies will govern the implementation and use of such resources, except in the event that LMI is willing to bear the cost of compliance (including, without limitation, allocations of cost of HSL internal personnel) stated in such quotations and otherwise. Specifically and subject to the foregoing, HSL agrees to: (i) promptly respond to reasonable requests from LMI for non-confidential information made as part of LMI’s TPM EHS Assessment Program. LMI will provide a questionnaire to HSL and HSL is expected to provide the complete response within thirty (30) days; (ii) reasonably cooperate with LMI to clarify and supplement any information related to its facilities and operations; and (iii) provide to LMI, upon request, copies of HSL’s environmental, health and safety permits required by any governmental authority which are associated with the Products and all facility operation related thereto. (d) HSL agrees that LMI or its appointed agent(s) (subject to entering into suitable confidentiality agreements reasonably acceptable to HSL, provided such agents(s) are reasonably acceptable to HSL) shall be entitled to conduct inspections and audits no more than once per year upon **** notice and mutually convenient times of any areas or facilities used to produce the Products or required for production of the Products no more than **** (such audit to be conducted with the audit of Section 5.5, if any, for no more than two days and using no more than two individuals) including the following reasons (i) to assist in completion of LMI’s TPM EHS Assessment Program; and (ii) to allow for a loss prevention inspection of the facility by LMI’s insurance underwriting company as necessary for LMI to obtain contingent business interruption insurance. (e) HSL shall take reasonable and appropriate precautions to ensure that its personnel (including its employees, contractors and agents) are protected from the 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, HSL shall provide workplace monitoring data which demonstrates the effectiveness of controls.

Health, Safety and Environmental Compliance. (a) Manufacturing operations are to be performed by HSL CMO using appropriate safety measures and containment techniques as dictated by applicable law, regulations and industry standards. HSL CMO 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. HSLCMO, in consultation with LMI, shall develop safety and handling procedures for Product; provided, however, that LMI shall have no responsibility for HSLCMO’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 any Product and other services under this Agreement shall be the responsibility of HSLCMO, at HSLCMO’s cost and expense, unless otherwise agreed to in writing by the Parties for special situations and conditions. Without limiting other legally applicable requirements, HSL CMO shall prepare, execute and maintain, as the generator of waste, all licenses, registrations, approvals and authorizations, notices, shipping documents and waste manifests required under applicable law and regulations. (b) LMI has established a program for systematic assessment of its supplier’s EHS programs (“TPM EHS Assessment Program”) and HSL CMO agrees to participate and reasonably cooperate with LMI in effectively implementing this TPM EHS Assessment Program. (c) HSL CMO will review LMI’s TPM EHS Assessment Program and, if applicable, provide quotations and cooperate with LMI in developing a reasonable plan for additional resources required CMO’s compliance with respect to address the program. HSL policies will govern the implementation and use of such resources, except in the event that LMI is willing to bear the cost of compliance (including, without limitation, allocations of cost of HSL internal personnel) stated in such quotations and otherwiseProduct(s). Specifically and subject to the foregoing, HSL CMO agrees to: (i) promptly respond to reasonable requests from LMI for non-confidential information made as part of LMI’s TPM EHS Assessment Program. ; LMI will provide a questionnaire to HSL CMO and HSL CMO is expected to provide the complete response within thirty **** (30****) days; (ii) reasonably cooperate with LMI to clarify and supplement any information related to its facilities and operations; and (iii) provide to LMI, upon request, copies of HSLCMO’s environmental, health and safety permits required by any governmental authority which are associated with the Products Product(s) and all facility operation related thereto. (d) HSL CMO agrees that LMI or its appointed agent(s) (subject to entering into suitable confidentiality agreements reasonably acceptable to HSLCMO, provided such agents(s) are reasonably acceptable to HSLCMO) shall be entitled to conduct inspections and audits no more than once per year upon **** notice and mutually convenient times of any areas or facilities used to produce the Products Product(s) or required for production of the Products no more than **** (such audit to be conducted with the audit of Section 5.5, if any, for no more than two days and using no more than two individualsProduct(s) including the following reasons in order (i) to assist in completion of LMI’s TPM EHS Assessment Program; Program and (ii) to allow for a loss prevention inspection of the facility by LMI’s insurance underwriting company as necessary for LMI to obtain contingent business interruption insurance; provided that, if LMI discovers any issues during such audit or inspection requiring remediation, then LMI shall be entitled to reaudit or reinspect such areas or facilities under this Section 5.9(d) within the later of **** (****) days or CMO’s written notice to LMI that such remediation has been completed. (e) HSL CMO shall take reasonable and appropriate precautions to ensure that its personnel (including its employees, contractors and agents) are protected from the 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, HSL CMO shall provide workplace monitoring data which demonstrates the effectiveness of controls.