Common use of Environmental and Regulatory Matters Clause in Contracts

Environmental and Regulatory Matters. (a) The Borrower and its Subsidiaries (i) are in compliance with any and all applicable Mexican and 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 and are in compliance with all permits, licenses or other approvals required of them under applicable Environmental Laws to conduct their respective businesses; and (iii) have not received notice of any actual or potential liability under any Environmental Law, except, in the case of clauses (i) through (iii), where such non-compliance with Environmental Laws, permits, licenses or other approvals, failure to receive required permits, licenses or other approvals, or liability would not, individually or in the aggregate, have a Material Adverse Effect. Except as set forth in Schedule 3.16, neither the Borrower nor any of its Subsidiaries has been named as a “potentially responsible party” under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended. (b) In the ordinary course of its business, the Borrower periodically reviews the effect of Environmental Laws on the business, operations and properties of the Borrower 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, the Borrower has reasonably concluded that such associated costs and liabilities could not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect. (c) The operations of the Borrower and its Subsidiaries are and have been conducted at all times in compliance with applicable financial recordkeeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, the money laundering statutes of all jurisdictions, the rules and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any governmental agency (collectively, the “Money Laundering Laws”) and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Borrower or any of its Subsidiaries with respect to the Money Laundering Laws is pending or, to the best knowledge of the Borrower, threatened. (d) None of the Borrower, any of its Subsidiaries or, to the knowledge of the Borrower, any director, officer, agent, employee or Affiliate of the Borrower or any of its Subsidiaries is currently subject to any U.S. sanctions administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury (“OFAC”); and the Borrower will not directly or indirectly use the proceeds of the Loans, or lend, contribute or otherwise make available such proceeds to any subsidiary, joint venture partner or other person or entity, for the purpose of financing the activities of any person currently subject to any U.S. sanctions administered by OFAC.

Environmental and Regulatory Matters. (a) The Borrower and its Subsidiaries (i) are in compliance with any and all applicable Mexican and 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 and are in compliance with all permits, licenses or other approvals required of them under applicable Environmental Laws to conduct their respective businesses; and (iii) have not received notice of any actual or potential liability under any Environmental Law, except, in the case of clauses (i) through (iii), where such non-compliance with Environmental Laws, permits, licenses or other approvals, failure to receive required permits, licenses or other approvals, or liability would not, individually or in the aggregate, have a Material Adverse Effect. Except as set forth in Schedule 3.16, neither the Borrower nor any of its Subsidiaries has been named as a “potentially responsible party” under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended. (b) In the ordinary course of its business, the Borrower periodically reviews the effect of Environmental Laws on the business, operations and properties of the Borrower 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, the Borrower has reasonably concluded that such associated costs and liabilities could not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect. (c) The operations of the Borrower and its Subsidiaries are and have been conducted at all times in compliance with applicable financial recordkeeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, the money laundering statutes of all jurisdictions, the rules and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any governmental agency (collectively, the “"Money Laundering Laws”") and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Borrower or any of its Subsidiaries with respect to the Money Laundering Laws is pending or, to the best knowledge of the Borrower, threatened. (d) None of the Borrower, any of its Subsidiaries or, to the knowledge of the Borrower, any director, officer, agent, employee or Affiliate of the Borrower or any of its Subsidiaries is currently subject to any U.S. sanctions administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury (“"OFAC”"); and the Borrower will not directly or indirectly use the proceeds of the Loans, or lend, contribute or otherwise make available such proceeds to any subsidiary, joint venture partner or other person or entity, for the purpose of financing the activities of any person currently subject to any U.S. sanctions administered by OFAC.

Environmental and Regulatory Matters. (a) The Borrower and its Subsidiaries (i) are in compliance with any and all applicable Mexican and foreign, federal, state and local laws and regulations relating Except as would not reasonably be expected 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 and are in compliance with all permits, licenses or other approvals required of them under applicable Environmental Laws to conduct their respective businesses; and (iii) have not received notice of any actual or potential liability under any Environmental Law, except, in the case of clauses (i) through (iii), where such non-compliance with Environmental Laws, permits, licenses or other approvals, failure to receive required permits, licenses or other approvals, or liability would nothave, individually or in the aggregate, have a Material Adverse Effect: (i) Seller is, and has been during the past three (3) years, in compliance with all applicable Environmental Laws imposing obligations on or otherwise related to the Business, Product, Assumed Liabilities and Acquired Assets; (ii) Seller possesses all material permits and approvals issued pursuant to any applicable Law relating to the protection of the environment or, as such relates to exposure to Hazardous Substances, to health and safety that are required to conduct the Business, and are, and have been during the past three (3) years, in compliance with all such permits and approvals; (iii) no releases of Hazardous Substances have occurred at, on, from or under any real property currently leased by Seller in a manner that would (b) Seller has made available to Purchaser true and complete copies of all material Regulatory Documentation and Regulatory Authorizations from or with the FDA and all other applicable Regulatory Authorities filed, submitted, exchanged, or held by Seller relating to the Product or necessary or useful to conduct the Business. Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, all such Regulatory Authorizations, if any, are (i) in full force and effect, (ii) validly registered and on file with applicable Regulatory Authorities, (iii) in compliance with all material filing and maintenance requirements, and (iv) in good standing, valid and enforceable. Seller has fulfilled and performed all of its material obligations with respect to such Regulatory Authorizations, and no event has occurred which allows, or after notice or lapse of time would allow, lapse, revocation, or termination thereof. (c) Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, (i) Seller is in compliance in all material respects with all applicable Health Laws that affect the Acquired Assets, the Assumed Liabilities or the Business, (ii) as of the date of this Agreement, Seller has not received any written or oral notice or other communication from any Regulatory Authority (A) withdrawing or placing any application or authorization applicable to the Product on “clinical hold” or requiring the termination or suspension or investigation of any pre-clinical studies or clinical trials of the Product or (B) alleging any violation of any Health Law and (iii) there are no investigations, suits, claims, Actions or proceedings pending, or to the Knowledge of Seller, threatened which allege any violation by Seller or any third party engaged by Seller with respect to the Product of any such Health Law. (d) All clinical trials conducted or being conducted with respect to the Products by or at the direction of Seller have been and are being conducted in compliance in all respects with the required experimental protocols, procedures and controls and in all material respects with all applicable Health Laws. Except as set forth in Schedule 3.16at Section 3.12(d) of the Seller Disclosure Schedule, neither the Borrower nor any of its Subsidiaries no clinical trial conducted by or, on behalf of, Seller has been named as terminated or suspended by any Regulatory Authority and Seller has not received any notification or other communication from any institutional review board, ethics committee or safety monitoring committee raising any issues that may result in a “potentially responsible party” under clinical hold or otherwise delay, materially restrict or otherwise limit or impair the Comprehensive Environmental Responseuse of any clinical studies proposed or currently conducted by, Compensationor on behalf of, and Liability Act Seller, or in which Seller has participated and, to the Knowledge of 1980Seller, as amendedno such action has been threatened. (be) In None of Seller or, to the ordinary course Knowledge of its business, the Borrower periodically reviews the effect of Environmental Laws on the business, operations and properties of the Borrower and its Subsidiaries, in the course of which it identifies and evaluates associated costs and liabilities (including, without limitationSeller, any capital or operating expenditures required for clean-upPerson acting on Seller’s behalf has, 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, the Borrower has reasonably concluded that such associated costs and liabilities could not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect. (c) The operations of the Borrower and its Subsidiaries are and have been conducted at all times in compliance with applicable financial recordkeeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, the money laundering statutes of all jurisdictions, the rules and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any governmental agency (collectively, the “Money Laundering Laws”) and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Borrower or any of its Subsidiaries with respect to the Money Laundering Laws is pending orProduct, to the best knowledge of the Borrower, threatened. (di) None of the Borrower, any of its Subsidiaries or, to the knowledge of the Borrower, any director, officer, agent, employee or Affiliate of the Borrower or any of its Subsidiaries is currently been subject to a Regulatory Authority shutdown or import or export prohibition or (ii) received any U.S. sanctions administered by the Office of Foreign Assets Control of the U.S. Department of the Treasury (“OFAC”); and the Borrower will not directly or indirectly use the proceeds of the LoansFDA Form 483, or lendother written Regulatory Authority notice of inspectional observations, contribute “warning letters,” “untitled letters” or otherwise make available such proceeds to any subsidiary, joint venture partner or other person or entity, for the purpose of financing the activities of any person currently subject to any U.S. sanctions administered by OFAC.written