REGULATORY AND ENVIRONMENTAL COMPLIANCE Sample Clauses

REGULATORY AND ENVIRONMENTAL COMPLIANCE. Seller shall comply with all federal, state and local laws and government rules and regulations of the United States of America and other countries as applicable to Seller's authorized supplier, manufacturing facility, sale, import or export of the Items (inclusive of packaging and marking) or the performance of services covered by this order, including but not limited to: the import and export laws/regulations of the United States or recognized governments or agencies in all appropriately contracted countries. Likewise, Seller shall comply with all Environmental Regulations governing the manufacture, use, and distribution of the Items furnished under this Order at Seller's own expense. For this purpose, "Environmental Regulations" means all laws, regulations, directives, ordinances, orders and decrees of any kind, adopted or implemented in any country, state, province, region or jurisdiction governing: (i) the use of hazardous substances; (ii) waste electrical and electronic equipment; (iii) conflict minerals; (iv) batteries, accumulators and waste batteries and accumulators; (v) packaging and packaging waste; and (vi) the registration, evaluation, authorization and restriction of chemicals. Environmental Regulations include, but are not limited to, Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011, Restriction on the Use of certain Hazardous Substances in Electrical and Electronic Equipment, (RoHS 3") and/or ("EU RoHS"), European Directive (EC) No 2015/863 on the Registration, Evaluation, Authorization, and restrictions of Chemicals ("EU REACH-SVHC- 10/2019") xxxxx://xxxx.xxxxxx.xx/candidate-list-table, ("WEEE COMPLIANCE-2/2003"), ("US CALIFORNIA PROP. 65 – 8/1986") and notification of use of "Conflict Minerals" under Section 1502 of the United States Xxxx‐Xxxxx Xxxx Street Reform and Consumer Protection Act(s), each as currently amended. Seller shall provide written certification and proof of its compliance under this Buyer Flow-Down Requirement --- upon request. Seller will defend, indemnify and hold Buyer harmless against any liability (including attorneys' fees) arising out of Seller's failure to meet any of its foregoing regulatory or environmental compliance obligations.
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REGULATORY AND ENVIRONMENTAL COMPLIANCE. (a) To the extent an Adverse Event of which a Party becomes aware implicates supply of the Product, such Party shall promptly inform the other Party of such Adverse Event and shall disclose to the other Party any information it has regarding that Adverse Event. (b) If any Governmental Authority shall take any action which shall require a response or action by either Party with respect to Products, Product Specifications, or any operating procedure affecting the Products, the Parties shall immediately notify each other of the required response or action. This specifically includes receiving and responding to 483s and/or Warning Letters or items of a similar nature issued by an inspecting authority. (c) In carrying out its obligations under this Agreement, the Parties shall comply in all respects with Applicable Laws in effect.
REGULATORY AND ENVIRONMENTAL COMPLIANCE. 6.8.1 The Seller and each of its Subsidiaries have conducted their respective businesses so as to comply with all applicable Requirements of Law relating to the operations, conduct or ownership of the property or business of the Seller or any Subsidiary, the failure to comply with which would, individually or in the aggregate, have a material adverse effect on the Condition of the Seller. "REQUIREMENTS OF LAW" means (i) the charter or by-laws or other organizational or governing documents of the Seller, or (ii) any statute, law (including common law), treaty, rule, regulation or ordinance (including, without limitation, environmental, pollution control, occupational health and safety and food and drug regulations) or permit or any judgment, decree, injunction, order or legally binding determination of any Governmental Body applicable to the Seller or any of its Subsidiaries existing as of the date hereof.
REGULATORY AND ENVIRONMENTAL COMPLIANCE. (i) As provided in the Quality Agreement, Company shall promptly report to Cangene any and all information reported to Company relating to any adverse experience, whether expected or unexpected, relating to the use of the Product. (ii) Inspections: If Company is notified that the Products or the manufacturing facility at which the Products are manufactured and identified in Exhibit A will be subject to an inspection in relation to, or that could impact, the Product by any Governmental Authority, Company shall: (i) within [**] Business Days advise Cangene regarding such inspection; (ii) fully cooperate with and allow any such inspection to the extent required by Laws; (iii) promptly provide inspection summaries to Cangene; and (iv) promptly send to Cangene a copy of any inspection report observations issued by a Governmental Authority related to the manufacture, generation, processing, storage, treatment, disposal or other management of the Products, as well as responses to any inspection reports prepared in accordance with this Section. Nothing shall oblige Company to disclose information to Cangene relating to any other customer of Company or such products to which the inspection relates, unless such information relates specifically to the Products or is of a general nature relating to the manufacturing facility at which Company manufactures Products, in which case the information shall promptly be disclosed to Cangene.
REGULATORY AND ENVIRONMENTAL COMPLIANCE. Rovi shall promptly report to Emergent any and all information that is reported to them relating to any adverse experience relating to the use of Product. X If Rovi is notified that the Product or Product manufacturing facility will be subject to an inspection by any Governmental Authority, Rovi will notify Emergent within [**] business days after receipt of such notice. X Rovi will promptly send to Emergent a copy of any inspection report observations [redacted], issued by a Governmental Authority, that relate to the manufacture, generation, processing, testing, storage, treatment, or other management of the Product, as well as those observations that are of a general nature relating to the Product manufacturing facility. X Emergent shall have the opportunity to review and contribute to any response that Rovi prepares, that is directly related to Product, prior to the response being submitted. X X A copy of Rovi responses [redacted] to any inspection observations, relating to Product, shall be promptly sent to Emergent once approved. X Rovi Contract Manufacturing S.L. – SUPPLIER QUALITY AGREEMENT CONFIDENTIAL & PROPRIETARY A copy of the Governmental Authority’s acceptance of Rovi responses shall be forwarded to Emergent upon receipt of same. X Establish and maintain an effective Pest Control Plan X Refrain to manufacture, process or store any Critical Compounds in the same building where Products are Manufactured or stored X MANUFACTURER shall Manufacture the Product(s) in full compliance with the requirements of the DMF, including without limitation the Manufacturing processes and testing monographs (including the Specifications and testing methods X MANUFACTURER shall submit the master batch record to Emergent for review and approval prior to Manufacture of the first batch of Product(s). X X Document that manufacturing and packaging process are fit for purpose. Demonstrate the commissioning of critical systems and equipment used in the manufacture and control of the Product(s). Demonstrate that cleaning procedures are appropriate and their effectiveness has been demonstrated. Rovi shall retain samples of the Product(s) for a period of [**] years from the date of Manufacture. X Adequate retained sample program shall be established. Finished Product(s) samples will be retained for each batch/ lot of Product(s) manufactured. X Rovi shall provide prior notification to Emergent of any lot(s)/ batch(es) that have been reworked in a manner that is not consiste...
REGULATORY AND ENVIRONMENTAL COMPLIANCE. 6.8.1 The Seller and each of its Subsidiaries have conducted their respective businesses so as to comply with all applicable Requirements of Law relating to the operations, conduct or ownership of the property or business of the Seller or any Subsidiary, the failure to comply with which would, individually or in the aggregate, have a material adverse effect on the
REGULATORY AND ENVIRONMENTAL COMPLIANCE. Borrower shall comply with all Governmental Requirements applicable to its business and to the use of its Properties, including, without limitation, all Environmental Requirements. As used herein, "Environmental Requirements" means all applicable present and future federal, state, and local statutes, regulations, ordinances, orders, actions, policies, or common law relating to the protection of human health or the environment.
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REGULATORY AND ENVIRONMENTAL COMPLIANCE a. To the extent and Adverse Event of which a Party becomes aware implicates manufacturing of the Product, such Party shall promptly inform the other Party of such Adverse Event and shall disclose to the other Party any information it has regarding that Adverse Event. b. If any Governmental Authority shall take any action which shall require a response or action by Company with respect to Products, Purchase Specifications, or the manufacturing facility at which Products are manufactured, or any operating procedure affecting the Products, Company shall immediately notify OBI of the required response or action. c. In carrying out its obligations under this Agreement, Company shall comply in all respects with Applicable Laws in effect from time to time. d. Company is solely responsible for the safety and health of its employees, consultants and visitors and compliance with all Applicable Laws related to health, safety and the environment, including, without limitation, providing its employees, consultants and visitors, with all appropriate information and training concerning any potential hazards involved in the manufacture, packaging, storage and supply of the Products and/or materials and taking any precautionary measures to protect its employees from any such hazards. Exfluor Research Corporation Supply Agreement November 2009

Related to REGULATORY AND ENVIRONMENTAL COMPLIANCE

  • O.S.H.A. and Environmental Compliance (a) Except as could not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, each Borrower has duly complied with, and its facilities, business, assets, property, leaseholds, Real Property and Equipment are in compliance in all material respects with, the provisions of the Federal Occupational Safety and Health Act, the Environmental Protection Act, RCRA and all other Environmental Laws; there have been no outstanding citations, notices or orders of non-compliance issued to any Borrower or relating to its business, assets, property, leaseholds or Equipment under any such laws, rules or regulations. (b) Except as could not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, each Borrower has been issued all required federal, state and local licenses, certificates or permits relating to all applicable Environmental Laws. (i) There are no visible signs of material releases, spills, discharges, leaks or disposal (collectively referred to as “Releases”) of Hazardous Substances at, upon, under or within any Real Property including any premises leased by any Borrower; (ii) to the best knowledge of Borrowers, there are no underground storage tanks or polychlorinated biphenyls on the Real Property including any premises leased by any Borrower, (iii) to the best knowledge of Borrowers, the Real Property including any premises leased by any Borrower has never been used as a treatment, storage or disposal facility of Hazardous Waste; and (iv) to the best knowledge of Borrowers, no Hazardous Substances are present on the Real Property including any premises leased by any Borrower, excepting such quantities as are handled in accordance with all applicable manufacturer’s instructions and governmental regulations and in proper storage containers and as are necessary for the operation of the commercial business of any Borrower or of its tenants.

  • Environmental Compliance (a) No Loan Party or Restricted Subsidiary (i) has failed to comply in all material respects with applicable Environmental Law or to obtain, maintain or comply with any Environmental Permit, (ii) has become subject to any Environmental Liability, (iii) has received notice of any claim with respect to any material Environmental Liability or (iv) has a Responsible Officer with knowledge of any basis for any material Environmental Liability, except, in each case, as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. (i) None of the properties currently or formerly owned or operated by any Loan Party or Restricted Subsidiary is or was listed or, to the knowledge of any Responsible Officer was proposed for listing on the NPL or on the CERCLIS or any analogous state or local list at any time while such property was owned by such Loan Party or, to the knowledge of any Responsible Officer, at any time prior to or after such property was owned by such Loan Party, and, to the knowledge of any Responsible Officer, no property currently owned or operated by any Loan Party or Restricted Subsidiary is adjacent to any such property, in each case in connection with any matter for which any Loan Party or Restricted Subsidiary would have any material Environmental Liability; (ii) there are no, or, to the knowledge of any Responsible Officer, never have been any underground or above-ground storage tanks or any surface impoundments, septic tanks, pits, sumps or lagoons in which Hazardous Materials are being or have been treated, stored or disposed on any property currently owned or operated by any Loan Party or Restricted Subsidiary in violation of any Environmental Laws or, to the knowledge of any Responsible Officer, on any property formerly owned or operated by any Loan Party or Restricted Subsidiary; (iii) there is no friable asbestos or friable asbestos-containing material on any property currently owned or operated by any Loan Party or Restricted Subsidiary; (iv) Hazardous Materials have not been Released, discharged or disposed of on any property currently or formerly owned or operated by any Loan Party or Restricted Subsidiary in violation of any Environmental Laws; and (v) to the knowledge of any Responsible Officer, there are no pending or threatened Liens under or pursuant to any applicable Environmental Laws on any real property or other assets owned or leased by any Loan Party or Restricted Subsidiary, and to the knowledge of any Responsible Officer, no actions by any Governmental Authority have been taken or are in process which would subject any of such properties or assets to such Liens, except, in the case of clauses (i) through (v) above, as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. (c) No Loan Party or Restricted Subsidiary is undertaking, and no Loan Party or Restricted Subsidiary has completed, either individually or together with other potentially responsible parties, any investigation or assessment or remedial or response action relating to any actual or threatened Release, discharge or disposal of Hazardous Materials at any site, location or operation, either voluntarily or pursuant to the order of any Governmental Authority or the requirements of any Environmental Law that has or would reasonably be expected to have a Material Adverse Effect; and all Hazardous Materials generated, used, treated, handled or stored at, or transported to or from, any property currently or formerly owned or operated by any Loan Party or Restricted Subsidiary have been disposed of in a manner not reasonably expected, individually or in the aggregate, to have a Material Adverse Effect.

  • Compliance with Environmental Laws; Environmental Reports (a) Comply and use commercially reasonable efforts to cause all lessees and other persons occupying Real Property owned or operated by any Company to comply, in all material respects with all Environmental Laws and Environmental Permits applicable to its operations and property and obtain and renew all material Environmental Permits applicable to its operations and property and conduct any Response in accordance with Environmental Laws; provided, however, that no Company shall be required to undertake any Response to the extent that its obligation to do so is being contested in good faith and by proper proceedings and appropriate reserves are being maintained with respect to such circumstances in accordance with GAAP. (b) If a Default caused by reason of a breach of Section 3.17 or Section 5.09(a) shall have occurred and be continuing for more than 20 Business Days without the Companies commencing activities reasonably likely to cure such Default, at the written request of the Required Lenders through the Administrative Agent, provide to the Lenders within 45 days after such request, at the expense of Borrower, an environmental site assessment report regarding the matters which are the subject of such default, including where appropriate, any soil and/or groundwater sampling, prepared by an environmental consulting firm and in form and substance reasonably acceptable to the Administrative Agent and indicating the presence or absence of Hazardous Materials and the estimated cost of any compliance or Response to address them in connection with such Default.

  • Environmental Law Compliance The use which the Borrower or any of its Restricted Subsidiaries intends to make of any real Property owned by it will not result in the disposal or other release of any Hazardous Substance or solid waste on or to such real Property in violation of any Environmental Law, except any such violation which is not, and would not reasonably be expected to cause, a Material Adverse Change. As used herein, the term "release" as used in this Section shall have the meanings specified in CERCLA (as defined in the definition of applicable Environmental Laws), and the terms "solid waste" and "disposal" shall have the meaning specified in RCRA (as defined in the definition of applicable Environmental Laws); provided, however, that if CERCLA or RCRA is amended so as to broaden or narrow the meaning of any term defined thereby, such broader or narrower meaning shall apply subsequent to the effective date of such amendment; and provided further, to the extent that any other law applicable to the Borrower, any of its Restricted Subsidiaries or any of their properties and assets establishes a meaning for "hazardous substance," "release," "solid waste," or "disposal" which is broader than that specified in either CERCLA or RCRA, such broader meaning shall apply. The Borrower and each Restricted Subsidiary agrees to indemnify and hold the Administrative Agent and each Lender harmless from and against, and to reimburse them with respect to, any and all claims, damages, losses, liabilities and expenses (including reasonable attorneys' fees and courts costs) asserted or awarded against or incurred by any of them by reason of or arising out of transactions contemplated by this Agreement and (a) the failure of the Borrower or any of its Restricted Subsidiaries to perform any obligation hereunder regarding asbestos or applicable Environmental Laws, (b) any violation by the Borrower or Restricted Subsidiary on or before the Release Date of any applicable Environmental Law in effect on or before the Release Date, and (c) any act, omission, event or circumstance existing or occurring on or prior to the Release Date, involving the presence on such real Property or release from such real Property of Hazardous Substances or solid wastes disposed of or otherwise released on or prior to the Release Date, resulting from or in connection with the ownership by the Borrower or any Restricted Subsidiary of the real Property, regardless of whether the act, omission, event or circumstance constituted a violation of any applicable Environmental Law at the time of its existence or occurrence, or whether the act, omission, event or circumstance is caused by or relates to the negligence of any indemnified Person; provided, that the Borrower shall not be under any obligation to indemnify the Administrative Agent or any Lender to the extent that any such liability arises as the result of the gross negligence or willful misconduct of such Person, as finally judicially determined by a court of competent jurisdiction. The provisions of this Section shall survive the Release Date and shall continue thereafter in full force and effect.

  • Environmental Compliance and Reports Borrower shall comply in all respects with any and all Environmental Laws; not cause or permit to exist, as a result of an intentional or unintentional action or omission on Borrower’s part or on the part of any third party, on property owned and/or occupied by Borrower, any environmental activity where damage may result to the environment, unless such environmental activity is pursuant to and in compliance with the conditions of a permit issued by the appropriate federal, state or local governmental authorities; shall furnish to Lender promptly and in any event within thirty (30) days after receipt thereof a copy of any notice, summons, lien, citation, directive, letter or other communication from any governmental agency or instrumentality concerning any intentional or unintentional action or omission on Borrower’s part in connection with any environmental activity whether or not there is damage to the environment and/or other natural resources. Additional Assurances. Make, execute and deliver to Lender such promissory notes, mortgages, deeds of trust, security agreements, assignments, financing statements, instruments, documents and other agreements as Lender or its attorneys may reasonably request to evidence and secure the Loans and to perfect all Security Interests.

  • Compliance with Environmental Laws Except as otherwise described in the Prospectus, and except as would not, individually or in the aggregate, result in a Material Adverse Change (i) neither the Company nor any of its subsidiaries is in violation of any federal, state, local or foreign law or regulation relating to pollution or protection of human health or the environment (including, without limitation, ambient air, surface water, groundwater, land surface or subsurface strata) or wildlife, including without limitation, laws and regulations relating to emissions, discharges, releases or threatened releases of chemicals, pollutants, contaminants, wastes, toxic substances, hazardous substances, petroleum and petroleum products (collectively, “Materials of Environmental Concern”), or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport or handling of Materials of Environmental Concern (collectively, “Environmental Laws”), which violation includes, but is not limited to, noncompliance with any permits or other governmental authorizations required for the operation of the business of the Company or its subsidiaries under applicable Environmental Laws, or noncompliance with the terms and conditions thereof, nor has the Company or any of its subsidiaries received any written communication, whether from a governmental authority, citizens group, employee or otherwise, that alleges that the Company or any of its subsidiaries is in violation of any Environmental Law; (ii) there is no claim, action or cause of action filed with a court or governmental authority, no investigation with respect to which the Company has received written notice, and no written notice by any person or entity alleging potential liability for investigatory costs, cleanup costs, governmental responses costs, natural resources damages, property damages, personal injuries, attorneys’ fees or penalties arising out of, based on or resulting from the presence, or release into the environment, of any Material of Environmental Concern at any location owned, leased or operated by the Company or any of its subsidiaries, now or in the past (collectively, “Environmental Claims”), pending or, to the Company’s knowledge, threatened against the Company or any of its subsidiaries or any person or entity whose liability for any Environmental Claim the Company or any of its subsidiaries has retained or assumed either contractually or by operation of law; and (iii) to the best of the Company’s knowledge, there are no past or present actions, activities, circumstances, conditions, events or incidents, including, without limitation, the release, emission, discharge, presence or disposal of any Material of Environmental Concern, that reasonably could result in a violation of any Environmental Law or form the basis of a potential Environmental Claim against the Company or any of its subsidiaries or against any person or entity whose liability for any Environmental Claim the Company or any of its subsidiaries has retained or assumed either contractually or by operation of law.

  • Compliance with Environmental Requirements 50.1 The Contractor shall provide the goods and/or Services required under the Contract in accordance with applicable laws and the Authority’s environmental policy, which is to conserve energy, water and other resources, reduce waste and phase out the use of ozone depleting substances and minimise the release of greenhouse gases, volatile organic compounds and other substances damaging to health and the environment. 50.2 The Authority is committed to promoting a low carbon, high growth, global economy. The Contractor shall work with the Authority regarding any environmental or sustainability issues as the Authority considers relevant, comply with contractual obligations and carry out any reasonable request to ensure the protection of the environment, society and the economy and promotion of sustainable development and sustainable procurement throughout the Contract Period. 50.3 All written outputs, including reports, produced in connection with the Contract shall (unless otherwise specified) be produced on recycled paper containing at least 80% post consumer waste and used on both sides where appropriate. 50.4 Nothing in this Condition 50 shall relieve the obligations of the Contractor to comply with its statutory duties and Good Industry Practice.

  • Compliance with Environmental Law To the knowledge of the Company, the Adviser and the Administrator, the Company, its subsidiaries and each controlled Portfolio Company (i) are in compliance with any and all applicable foreign, federal, state and local laws and regulations relating to the protection of human health and safety, the environment or hazardous or toxic substances or wastes, pollutants or contaminants (“Environmental Laws”); (ii) have received all permits, licenses or other approvals required of them under applicable Environmental Laws to conduct their respective businesses; and (iii) are in compliance with all terms and conditions of any such permit, license or approval, except where such noncompliance with Environmental Laws, failure to receive required permits, licenses or other approvals or failure to comply with the terms and conditions of such permits, licenses or approvals would not, individually or in the aggregate, have a Material Adverse Effect.

  • Periodic Review of Costs of Environmental Compliance In the ordinary course of its business, the Company conducts a periodic review of the effect of Environmental Laws on the business, operations and properties of the Company and its subsidiaries, in the course of which it identifies and evaluates associated costs and liabilities (including, without limitation, any capital or operating expenditures required for clean-up, closure of properties or compliance with Environmental Laws or any permit, license or approval, any related constraints on operating activities and any potential liabilities to third parties). On the basis of such review and the amount of its established reserves, the Company has reasonably concluded that such associated costs and liabilities would not, individually or in the aggregate, result in a Material Adverse Change.

  • Environmental and Safety Matters (a) The Company and its Subsidiaries have at all times complied in all material respects with all applicable Environmental and Safety Requirements, which compliance has included obtaining and complying in all material respects at all times with all material permits, licenses and other authorizations required pursuant to Environmental and Safety Requirements for the occupation of their facilities and the operation of their respective businesses. (b) Except as set forth in Section 4.27(b) of the Disclosure Schedule, since February 19, 2008, neither the Company nor any of its Subsidiaries has received any notice, report, order, or directive regarding any, and is not subject to any litigation, proceedings or order regarding any, actual or alleged violation of Environmental and Safety Requirements, or any liability or potential liability arising under Environmental and Safety Requirements, in effect prior to and as of the date of the applicable Closing, relating to the business, the Owned Real Property or Leased Real Property. (c) Except as set forth in Section 4.27(c) of the Disclosure Schedule, neither the Company nor any of its Subsidiaries has treated, stored, disposed of, arranged for or permitted the disposal of, transported, handled, released, or exposed any Person to, any substance (including without limitation any hazardous substance), owned or operated any property or facility which is or has been contaminated by any substance, so as to give rise to any current or future liabilities under any Environmental and Safety Requirements in effect at the time of such treatment, storage, disposal, transportation, handling, release or exposure. (d) Except as set forth in Section 4.27(d) of the Disclosure Schedule, neither the Company nor any of its Subsidiaries has assumed, undertaken, or provided any indemnity with respect to, any liability of any other Person relating to Environmental and Safety Requirements. (e) The Company has furnished to Investor true and correct copies of all environmental audits, reports, assessments and all other documents materially bearing on environmental, health or safety liabilities relating to the past or current operations or facilities of the Company and all of its Subsidiaries, in each case which are in its possession or under its reasonable control.

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