Common use of Compliance with Law; Permits; Regulatory Matters Clause in Contracts

Compliance with Law; Permits; Regulatory Matters. (a) Except as set forth on Schedule 4.10(a) or, with respect to clause (i) only, as would not reasonably be expected to have a Material Adverse Effect, since January 1, 2008, (i) the Companies and (with respect to the Associated Assets and their conduct of the Business) Sellers have been and are in compliance in all respects with all Applicable Laws and (ii) none of the Companies or (with respect to the Associated Assets and their conduct of the Business) any Seller has received any written notice to the effect that, or otherwise been advised that, it is not in compliance with any Applicable Law. (b) Schedule 4.10(b) lists (i) the jurisdictions in which each of the Insurance Companies is licensed to write and the types of insurance and other products that the Insurance Companies are licensed to write in each such jurisdiction and (ii) each jurisdiction in which each Renewal Rights Seller is licensed to write Subject Policies. Other than as set forth in Schedule 4.10(b) and other than in the ordinary course of regularly scheduled financial and market conduct examinations, none of the Insurance Companies is the subject of any material pending or, to the Knowledge of Seller Parent, threatened regulatory proceedings. Schedule 4.10(b) lists the state of domicile of each Insurance Company. None of the Insurance Companies is a “commercially domiciled insurer” under the laws of any jurisdiction or is otherwise treated as domiciled in a jurisdiction other than its jurisdiction of organization. (i) The Companies hold all material Permits necessary for the ownership and conduct of their business in each of the jurisdictions in which the Companies conduct or operate their business in the manner now conducted, and all such Permits are in full force and effect, (ii) the Renewal Rights Sellers hold all material Permits necessary for the ownership and conduct of the Business in each of the jurisdictions in which the Business is conducted or operated by them in the manner now conducted, and all such Permits are in full force and effect,

Compliance with Law; Permits; Regulatory Matters. (a) Except as set forth The Seller’s and its Affiliates’ use of the Purchased Assets has been and is being conducted in compliance in all material respects with all applicable Laws. (b) To the Knowledge of the Seller, the Existing Product is being and has been developed in material compliance with applicable Law, including those requirements relating to good manufacturing practice, good laboratory practice and good clinical practice. Neither the Seller nor any of its Affiliates have received (and, to the Knowledge of the Seller, neither Eisai nor any of its Affiliates has received) any (i) written notice from the FDA or any other Governmental Authority, including the Office of Inspector General, any United States Attorney, the Department of Justice or any attorney general of any jurisdiction, alleging that the Seller, Eisai or any of their respective Affiliates has been or is in violation of any Applicable Healthcare Industry Laws or other applicable Laws, or commencing or indicating an intention to conduct an investigation, audit, or review, in each case, in connection with the conduct of the Business or the Purchased Assets; (ii) written notice of inspectional observation (including those recorded on Schedule 4.10(aform FDA 483), warning letter, penalty, fine, sanction, request for recall or other remedial action in connection with the conduct of the Business or the Purchased Assets; or (iii) orother written documents issued by the FDA or any other Governmental Authority alleging lack of compliance with any Applicable Healthcare Industry Laws or other applicable Laws by the Seller, Eisai or any of their respective Affiliates, or any Person engaged by the Seller, Eisai or any of their respective Affiliates, to provide any service with respect to clause any Existing Product or otherwise in connection with the conduct of the Business or the Purchased Assets. (ic) onlySeller holds all Permits which are required by the Seller to conduct the Business as it currently being conducted, as except where failure to hold any Permit would not reasonably be expected to have have, individually or in the aggregate, a Material Adverse Effect. (d) Neither the Seller nor any of its Affiliates (nor, since January 1to the Knowledge of the Seller, 2008Eisai or any Affiliate of Eisai) has made an untrue statement or fraudulent statement of material fact to the FDA or any other Governmental Authority or to any physician or customer, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority or to any physician or customer, or committed any material act, made any material statement, or failed to make any material statement, that would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Fact, Bribery, and Illegal Gratuities”, set forth in FDA’s Compliance Policy Guide Sec. 120.100 (iCPG 7150.09) the Companies and (with respect to the Associated Assets and Existing Product. Neither the Seller (nor any of its Affiliates or its or their conduct respective directors, officers or employees who has been involved in the development of the BusinessExisting Product) Sellers have nor, to the Knowledge of the Seller, Eisai or any Affiliate of Eisai (or any officers, employees, or agents of any of the foregoing) or any agent of the Seller has (i) been and are convicted of any crime or engaged in compliance in all respects with all Applicable Laws and any conduct that would reasonably be expected to result in, or that has resulted in, debarment, disqualification or exclusion by any Governmental Authority or under applicable Law, including 21 U.S.C. §335a, or (ii) none any knowledge of the Companies or (with respect facts that would lead to the Associated Assets and their conduct of the Business) any Seller has received any written notice to the effect thata false claim, or otherwise been advised thatdebarment, it is not and there are no proceedings pending or threatened that would result in compliance with criminal liability or debarment or disqualification by any Applicable LawGovernmental Authority. (be) Schedule 4.10(b) lists Neither the Seller, nor, to the Knowledge of the Seller, any Affiliate, director, manager, officer, equity holder or employee of the Seller has (i) the jurisdictions used any funds for contributions, gifts, entertainment or other expenses in which each violation in any material respect of the Insurance Companies is licensed to write and the types of insurance and other products that the Insurance Companies are licensed to write in each such jurisdiction and applicable Law, (ii) each jurisdiction paid any bribe, kickback or other similar payment, directly or indirectly, to any foreign government official or employee in which each Renewal Rights Seller is licensed to write Subject Policies. Other than as set forth in Schedule 4.10(b) and other than in the ordinary course of regularly scheduled financial and market conduct examinations, none violation of the Insurance Companies is the subject Foreign Corrupt Practices Act of 1977 or other applicable Law, (iii) made any other payment of any material pending kind in violation of any Law, to secure any improper advantage for the Purchased Assets or the Seller or any of its Affiliates, or (iv) knowingly incorrectly recorded any transactions in any of the foregoing categories on the books and records of the Seller or any of its Affiliates. No claims, actions or proceedings or, to the Knowledge of Seller Parentthe Seller, actual or threatened regulatory proceedings. Schedule 4.10(b) lists investigations that would be reasonably expected to result in such a debarment, disqualification or exclusion are pending or to the state of domicile of each Insurance Company. None Knowledge of the Insurance Companies is a “commercially domiciled insurer” under Seller, threatened, against the laws Seller or its Affiliates, Eisai or its Affiliates or any of any jurisdiction their respective officers, employees or is otherwise treated as domiciled in a jurisdiction other than its jurisdiction of organizationagents. (f) All ongoing and completed preclinical studies and clinical trials conducted by the Seller or its Affiliates or, to the Knowledge of the Seller, Eisai or any of its Affiliates, or by third-party vendors on behalf of any of them, with respect Products have been conducted in all material respects in accordance with the applicable Good Clinical Practice regulations described in 21 CFR Parts 50, 54, 56 and 312, and applicable Good Laboratory Practice regulations as described in 21 CFR Part 58 and comparable applicable Law solely to the extent the foregoing are applicable to such studies and/or trials. (g) Seller has made available to Purchaser (or its agents) true, correct and complete copies of (i) The Companies hold the IND relating to the Existing Product and (ii) any other material documents received from the FDA or equivalent non-US regulatory agency in the possession or control of Seller or any of its Affiliates, including documents that indicate or suggest lack of compliance with the regulatory requirements of the FDA or other regulatory agencies, in each case to the extent related to any Product (or the development or approval of any Product) or any Purchased Asset. Seller has made available to Purchaser for review all material Permits necessary for correspondence to or from the ownership and conduct FDA, material minutes of their business in meetings, including material documents concerning communications to or from the FDA or other regulatory agencies, or prepared by the FDA or other regulatory agency or which bear on the ability to obtain approval of the Existing Product or compliance with regulatory requirements with respect to any of the foregoing, each of the jurisdictions in which foregoing, to the Companies conduct or operate their business extent in the manner now conductedpossession or control of Seller or any of its Affiliates. (h) To the Knowledge of the Seller and without making any due inquiry, the Seller is unaware of any material correspondence to or from the FDA on the one hand, and all such Permits Eisai or its Affiliates on the other hand, that indicate a lack of compliance with the regulatory requirements of the FDA with respect to the Existing Product in the Territory, or which bear in any material respect on the ability to obtain approval of the Existing Product in the Territory, which (i) are in full force and effectnot part of the IND relating to the Existing Product that has been made available to Purchaser, or (ii) the Renewal Rights Sellers hold all material Permits necessary for the ownership and conduct of the Business in each of the jurisdictions in which the Business is conducted or operated by them in the manner now conducted, and all such Permits are in full force and effect,has not otherwise been made available to Purchaser.

Compliance with Law; Permits; Regulatory Matters. (a) Except as set forth on Schedule 4.10(a) or5.10(a), with respect to clause (i) only, as would not reasonably be expected to the Company and the Acquired Company Subsidiaries have a Material Adverse Effect, been since January 1, 2008, (i) the Companies 2004 and (with respect to the Associated Assets and their conduct of the Business) Sellers have been and currently are in compliance in all material respects with all Applicable Laws and (ii) none of Laws. Neither the Companies or (with respect to Company nor the Associated Assets and their conduct of the Business) any Seller has Acquired Company Subsidiaries have received any written notice since January 1, 2004 to the effect that, or otherwise been advised that, it is that they are not in compliance in all material respects with any Applicable Law and, to the Knowledge of the Company, there are no currently existing circumstances that are likely to result in the Company or the Acquired Company Subsidiaries being in violation in any material respect of any Applicable Law. (b) Schedule 4.10(b5.10(b) lists (i) the jurisdictions in which each of the Insurance Companies is are licensed to write insurance policies and the types of insurance and other products that the Insurance Companies are licensed to write in each such jurisdiction and (ii) each jurisdiction in which each Renewal Rights Seller is licensed to write Subject Policiesjurisdiction. Other than Except as set forth in on Schedule 4.10(b) and other than in the ordinary course of regularly scheduled financial and market conduct examinations5.10(b), none of the Insurance Companies is the subject of any material supervision, conservation, rehabilitation, liquidation, receivership, insolvency or other similar proceeding, pending regulatory proceedings or, to the Knowledge of Seller Parentthe Company, threatened material regulatory proceedings. Schedule 4.10(b5.10(b) lists the state of domicile of each Insurance Company. None of the Insurance Companies is a “"commercially domiciled insurer” " under the laws Laws of any jurisdiction or is otherwise treated as domiciled in a jurisdiction other than its jurisdiction of organization. (c) Except as set forth on Schedule 5.10(c), (i) The Companies the Company and the Acquired Company Subsidiaries hold all material Permits necessary for the ownership and conduct of their the business of the Company and the Acquired Company Subsidiaries in each of the jurisdictions in which the Companies Company and the Acquired Company Subsidiaries conduct or operate their business in the manner now conducted, and all such Permits are in full force and effect, with such exceptions which singularly and in the aggregate have not had nor would reasonably be expected to have a Material Adverse Effect on the Company or the Acquired Company Subsidiaries, (ii) the Renewal Rights Sellers hold Company and the Acquired Company Subsidiaries are, and at all times since January 1, 2004 have been, in compliance in all material Permits necessary respects with the terms of the Permits, (iii) neither the Company nor any Acquired Company Subsidiary has received, at any time since January 1, 2004, any notice or other communication (whether written or oral) from any Governmental Authority or any other Person regarding (1) any actual, alleged, possible, or potential violation of, or failure on the part of the Company or any Acquired Company Subsidiary to comply with, any term or requirement of any material Permit or (2) any actual, proposed, possible, or potential revocation, withdrawal, suspension, cancellation, termination of, or modification to any material Permit, (iv) to the Knowledge of the Company, no event has occurred or circumstance exists that (with or without the giving of notice or lapse of time or both) (1) constitutes or would reasonably be expected to result in, directly or indirectly, a violation of, or a failure to comply in any material respect with, any Applicable Law or any term or requirement of any Permit, or (2) has resulted or would reasonably be expected to result, directly or indirectly, in the revocation, withdrawal, suspension, cancellation, or termination of, or any modification to, any material Permit, and (v) all applications required to have been filed for the ownership renewal of each such material Permit have been duly filed on a timely basis with the appropriate Governmental Authority, and conduct all other filings required to have been made with respect to each such material Permit have been duly made on a timely basis with the appropriate Governmental Authority. Subject to the receipt of the Business in each of the jurisdictions consents and approvals set forth on Schedules 5.3 and 6.3 and compliance by Sellers and/or Buyer with the HSR Act and the applicable change of control insurance laws, regulations and other requirements of the states of domiciliary of the Acquired Company Subsidiaries, the consummation of the transactions contemplated by this Agreement will not result in any revocation, cancellation, suspension or nonrenewal of any such material Permit. (d) Except as set forth in Schedule 5.10(d), none of the Company or the Acquired Company Subsidiaries or any of their properties or assets relating thereto is subject to any outstanding order of, or is a party to any written agreement, consent agreement or memorandum of understanding with, or is a party to any commitment letter or similar undertaking to, or is subject to any order or directive by, or is a recipient of any supervisory letter from or has adopted any resolutions at the request of, any Governmental Authority that by its terms restricts in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its management or its business (each, a "Regulatory Agreement"), nor has the Company or any Acquired Company Subsidiary been advised in writing since January 1, 2004 by any Governmental Authority that it is considering issuing or requesting any such Regulatory Agreement. (e) All outstanding Insurance Contracts issued by the Insurance Companies, or which are being issued by the Insurance Companies as of the date hereof, are in compliance, and at their respective dates of issuance were in compliance, in all material respects with all Applicable Laws and, to the extent required under Applicable Law in all material respects, are on forms approved by the applicable Governmental Authorities or on forms that have been filed and not objected to (or such objection has been withdrawn or resolved) by such Governmental Authorities within the period provided for objection. All forms of Insurance Contracts currently outstanding together with all amendments thereto, are on the forms that have been previously provided to Buyer. (f) All premium rates established by the Insurance Companies that are required to be filed with or approved by any Governmental Authorities have been so filed or approved, the premiums charged conform to the premiums so filed or approved and comply (or complied at the relevant time) with the insurance laws applicable thereto in all material respects. (g) There are no in force Insurance Contracts of any Insurance Company under which the Business is conducted holders or operated by them in the manner now conductedowners of such Insurance Contracts have any rights with respect to dividends, and all such Permits are in full force and effect,surplus, profits, participation or voting rights.

Compliance with Law; Permits; Regulatory Matters. (a) Except as set forth on Schedule 4.10(a) or, with respect where failure to clause comply (i) only, as does not and would not reasonably be expected to have a Material Adverse Effect, since January 1, 2008, (i) the Companies and (with respect to the Associated Assets and their conduct of the Business) Sellers have been and are in compliance in all respects with all Applicable Laws and Effect or (ii) none arises out of or results from acts or omissions by Purchasers and/or one or more of their Affiliates, (A) each Seller and each of its Affiliates is, and since the Companies or later of (with respect to 1) the Associated date the applicable Seller acquired any rights in the Acquired Assets and their conduct of the Business(2) any Seller [***] has received any written notice to the effect thatbeen, or otherwise been advised that, it is not in compliance with all Laws applicable to the Acquired Assets and (B) each Seller and each of its Affiliates is, and since the later of (1) the date the applicable Seller acquired any Applicable Lawrights in the Acquired Assets and (2) [***] has been, in compliance with the Acquired Regulatory Approvals, including any FDA post- approval requirements or commitments relating to the Product. No loss or expiration of any Acquired Regulatory Approval held by a Seller or any Affiliate of a Seller is pending or, to Seller’s Knowledge, threatened or reasonably foreseeable. (b) Schedule 4.10(b) lists Except where failure to comply (i) the jurisdictions in which each of the Insurance Companies is licensed does not and would not reasonably be expected to write and the types of insurance and other products that the Insurance Companies are licensed to write in each such jurisdiction and have a Material Adverse Effect or (ii) each jurisdiction arises out of or results from acts or omissions by a Purchaser or one or more of its Affiliates, the Product has been and is being developed, tested, stored, distributed, promoted, advertised, imported, exported, sold, marketed and otherwise commercialized, as applicable, in compliance with (A) the FDA Act, the PHS Act and guidance by the FDA, (B) all federal, state, local, and foreign healthcare-related fraud and abuse and physician sunshine act laws, including the Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the civil False Claims Act (31 U.S.C. § 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. § 1320a- 7a(a)(5)), the civil monetary penalty laws (42 U.S.C. § 1320a-7a), the exclusion laws (42 U.S.C. § 1320a-7), the criminal false claims statutes under 18 U.S.C. §§ 287 and 1001; (C) the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (42 U.S.C. § 1320 et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. § 17921 et seq.), and any state or foreign counterpart thereof or other law or regulation the purpose of which each Renewal Rights Seller is licensed to write Subject Policies. Other than as set forth in Schedule 4.10(bprotect the privacy of patients or prescribers; and (D) federal and other than in the ordinary course of regularly scheduled financial state Law relating to all Governmental Programs, and market conduct examinations, none of the Insurance Companies is Sellers or any of their respective Affiliates have received any written notice of such non-compliance from the subject of FDA or any material pending or, other Governmental Entity relating to the Knowledge of Seller ParentProduct, threatened regulatory proceedings. Schedule 4.10(b) lists including any Form FDA 483 observations, or any warning or untitled letters from the state of domicile of each Insurance Company. None of the Insurance Companies is a “commercially domiciled insurer” under the laws of any jurisdiction or is otherwise treated as domiciled in a jurisdiction other than its jurisdiction of organizationFDA. (ic) The Companies hold all material Permits necessary for the ownership One or more Sellers validly holds and conduct of their business in each of the jurisdictions in which the Companies conduct or operate their business in the manner now conducted, and all such Permits are has in full force and effect, (ii) the Renewal Rights Sellers hold effect all material Permits necessary for the ownership and conduct of the Business in each of the jurisdictions in which the Business is conducted or operated by them in the manner now conductedPermits, and there has occurred no continuing violation of, or continuing default (with or without notice or lapse of time or both) under, or event giving to any other Person any current right of termination, amendment or cancellation of, any such Permit. (d) To Seller’s Knowledge, all such Permits are reports, documents, claims, notices and other records required to be filed, maintained, or furnished to the FDA or any other drug regulatory agency by Sellers or any of their respective Affiliates with respect to the Product, including reports of adverse experience, have been so filed, maintained or furnished and were complete and correct in full force and effect,all material respects on the date filed (or were corrected in or supplemented by a subsequent filing).

Compliance with Law; Permits; Regulatory Matters. (a) Except as set forth on Schedule 4.10(a) orEach of the Sellers and their respective Affiliates are, and since [***], have been, in compliance with respect all Laws applicable to clause the ownership and use of the Acquired Assets and the operation of the Product Business, including (i) onlythe FDCA and any applicable Laws governing the approval, as Manufacture, sale, marketing, promotion, or distribution of drugs and the purchase or prescription of or reimbursement for drugs by any Governmental Entity, private health plan or entity, or individual and (ii) all applicable Laws regulating the pharmaceutical industry, except, in each case, where the failure to so comply would not not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, since January 1, 2008, (i) materially and adversely affect the Companies and (with respect to the Associated Acquired Assets and their conduct of the Product Business) Sellers have been and are in compliance in all respects with all Applicable Laws and (ii) none of the Companies or (with respect to the Associated Assets and their conduct of the Business) any Seller has received any written notice to the effect that, or otherwise been advised that, it is not in compliance with any Applicable Lawtaken together as a whole. (b) Schedule 4.10(bNone of the Sellers or any of their respective Affiliates or, to the Sellers’ knowledge, any Third Party engaged by the Sellers or their respective Affiliates, has received since [***] any written or, to the Sellers’ knowledge, unwritten notice of any inspectional observation (including 483 observations) lists or any warning or untitled letters, in each case, from any Governmental Entity relating to any Product, and none of the Sellers or any of their respective Affiliates has received any other written or, to the Sellers’ knowledge, unwritten notices from or issued by any Governmental Entity that alleges a lack of compliance with applicable Laws of the FDA or other comparable Governmental Entity by the Sellers or their respective Affiliates relating to any Product. Since [***], none of the Sellers nor their respective Affiliates have had any Product or site at which the Products are manufactured (whether owned by the Sellers or their respective Affiliates or that of a contract manufacturer for the Products) subject to an FDA (or other comparable Governmental Entity) shutdown or import or export prohibition. The Sellers and their respective Affiliates have provided Purchaser with copies of all written communications made between the Sellers or their respective Affiliates and any Governmental Entity relating to the activities described in FDA’s August 1, 2012 letter to Dr. Xxxxx Xxx, Associate Director, Regulatory Affairs, Forest Laboratories, Inc. (c) The Sellers or their respective Affiliates are the sole and exclusive owner of each of the Acquired Regulatory Approvals and have not granted any right of reference that is currently in effect with respect thereto. Each such Acquired Regulatory Approval (i) has been validly issued or acknowledged by the jurisdictions appropriate Governmental Entity and is in which each of the Insurance Companies is licensed to write full force and the types of insurance and other products that the Insurance Companies are licensed to write in each such jurisdiction effect and (ii) each jurisdiction in which each Renewal Rights Seller is licensed transferable to write Subject PoliciesPurchaser. Other than as set forth in Schedule 4.10(b) and other than in the ordinary course of regularly scheduled financial and market conduct examinationsSince [***], none of the Insurance Companies is the subject of any material pending neither Sellers nor their respective Affiliates have received written or, to the Knowledge Sellers’ knowledge, unwritten notice from any Governmental Entity that there are any circumstances currently existing that would reasonably be expected to lead to (x) any loss of Seller Parent, threatened regulatory proceedings. Schedule 4.10(bor refusal to renew any Acquired Regulatory Approvals relating to a Product or (y) lists renewal on terms less advantageous to the state Sellers or their respective Affiliates than the terms of domicile of each Insurance Company. None of the Insurance Companies is a “commercially domiciled insurer” under the laws of any jurisdiction or is otherwise treated as domiciled those Acquired Regulatory Approvals currently in a jurisdiction other than its jurisdiction of organizationforce. (d) All reports, documents, claims and notices required to be filed, maintained or furnished to the FDA or any other drug regulatory agency by any of the Sellers or their respective Affiliates with respect to any Product have been so filed, maintained or furnished and were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing), except as would not, individually or in the aggregate, reasonably be expected to materially and adversely affect the Acquired Assets and the Product Business, taken together as a whole. The Sellers or their respective Affiliates possess, and are in material compliance with, all Permits necessary to conduct the Product Business as currently conducted, except where the failure to possess or comply with any such Permit would not, individually or in the aggregate, reasonably be expected to materially and adversely affect the Product Business and the Acquired Assets, taken together as a whole. (e) Since [***], all human clinical trials with respect to the Products conducted by the Sellers or any of their respective Affiliates or, to the knowledge of the Sellers, by any Third Party on behalf of any Seller or any of their respective Affiliates, have, in each case, been and are being conducted in all material respects in compliance with all applicable Law and protocols, including cGCP and the provisions relating to the registration and reporting of results of clinical trials contained in Section 402 of the Public Health Service Act. Neither the Sellers nor any of their respective Affiliates, nor, to the knowledge of the Sellers, any Third Party acting on behalf of the Sellers or any of their respective Affiliates, have received any written or, to the Sellers’ knowledge, unwritten notice that (i) any Governmental Entity or Institutional Review Board has initiated, or threatened to initiate, any clinical hold or other action to suspend any clinical trial or suspend or terminate any IND sponsored by or on behalf of the Sellers or their respective Affiliates, or otherwise restrict the preclinical research on or clinical study of any Product or (ii) to the effect that any protocol is not appropriately designed to support approval of any Products or indications that the ongoing clinical trials are intended to support. (f) The Companies hold Sellers and their respective Affiliates have made available to Purchaser (i) true and complete copies of all material Permits necessary new drug applications and INDs for the ownership and conduct of their business in each of the jurisdictions in which the Companies conduct or operate their business in the manner now conducted, and all such Permits are in full force and effectProducts, (ii) the Renewal Rights Sellers hold copies of all material Permits necessary for the ownership and conduct of the Business in each of the jurisdictions in which the Business is conducted correspondence since [***] to or operated by them in the manner now conductedfrom any Governmental Entity or Institutional Review Board, and all such Permits are other material documents concerning communications to or from any Governmental Entity or Institutional Review Board, in full force each case concerning (A) any Product, (B) Sellers’ or any of their respective Affiliates’ compliance with Law relating to any Product, or (C) the likelihood or timing of approval of any Product; and effect,(iii) all material information in their possession or control concerning the safety, efficacy, side effects or toxicity of any Product (including information and documentation regarding studies, investigations or tests) that has been submitted to a Governmental Entity since [***]. (g) None of the Sellers nor any of their respective Affiliates, nor, to the knowledge of the Sellers, (i) any of their respective officers or employees or (ii) any Third Party, in each case, who has undertaken any activities with respect to the Exploitation of the Products, has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in (A) debarment under 21 U.S.C. Section 335a or any similar Law, or (B) exclusion from participating in any federal health care programs under Section 1128 of the Social Security Act or any similar Law. (h) None of the Sellers or their respective Affiliates is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders or similar agreements with or imposed by any Governmental Entity.

Compliance with Law; Permits; Regulatory Matters. (a) Except as set forth on Schedule 4.10(a) orEach of the Sellers and their respective Affiliates are, and since [***], have been, in compliance with respect all Laws applicable to clause the ownership and use of the Acquired Assets and the operation of the Product Business, including (i) onlythe FDCA and any applicable Laws governing the approval, as Manufacture, sale, marketing, promotion, or distribution of drugs and the purchase or prescription of or reimbursement for drugs by any Governmental Entity, private health plan or entity, or individual and (ii) all applicable Laws regulating the pharmaceutical industry, except, in each case, where the failure to so comply would not not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, since January 1, 2008, (i) materially and adversely affect the Companies and (with respect to the Associated Acquired Assets and their conduct of the Product Business) Sellers have been and are in compliance in all respects with all Applicable Laws and (ii) none of the Companies or (with respect to the Associated Assets and their conduct of the Business) any Seller has received any written notice to the effect that, or otherwise been advised that, it is not in compliance with any Applicable Lawtaken together as a whole. (b) Schedule 4.10(b) lists (i) the jurisdictions in which each None of the Insurance Companies is licensed Sellers or any of their respective Affiliates or, to write and the types Sellers’ knowledge, any Third Party engaged by the Sellers or their respective Affiliates, has received since [***] any written or, to the Sellers’ knowledge, unwritten notice of insurance and other products that the Insurance Companies are licensed to write any inspectional observation (including 483 observations) or any warning or untitled letters, in each such jurisdiction case, from any Governmental Entity relating to any Product, and (ii) each jurisdiction in which each Renewal Rights Seller is licensed none of the Sellers or any of their respective Affiliates has received any other written or, to write Subject Policiesthe Sellers’ knowledge, unwritten notices from or issued by any Governmental Entity that alleges a lack of compliance with applicable Laws of the FDA or other comparable Governmental Entity by the Sellers or their respective Affiliates relating to any Product. Other than as set forth in Schedule 4.10(b) and other than in the ordinary course of regularly scheduled financial and market conduct examinationsSince [***], none of the Insurance Companies is Sellers nor their respective Affiliates have had any Product or site at which the Products are manufactured (whether owned by the Sellers or their respective Affiliates or that of a contract manufacturer for the Products) subject to an FDA (or other comparable Governmental Entity) shutdown or import or export prohibition. The Sellers and their respective Affiliates have provided Purchaser with copies of all written communications made between the Sellers or their respective Affiliates and any material pending or, Governmental Entity relating to the Knowledge of Seller Parentactivities described in FDA’s August 1, threatened regulatory proceedings. Schedule 4.10(b) lists the state of domicile of each Insurance Company. None of the Insurance Companies is a “commercially domiciled insurer” under the laws of any jurisdiction or is otherwise treated as domiciled in a jurisdiction other than its jurisdiction of organization. (i) The Companies hold all material Permits necessary for the ownership and conduct of their business in each of the jurisdictions in which the Companies conduct or operate their business in the manner now conducted2012 letter to Dr. Xxxxx Xxx, and all such Permits are in full force and effectAssociate Director, (ii) the Renewal Rights Sellers hold all material Permits necessary for the ownership and conduct of the Business in each of the jurisdictions in which the Business is conducted or operated by them in the manner now conductedRegulatory Affairs, and all such Permits are in full force and effect,Forest Laboratories, Inc.

Compliance with Law; Permits; Regulatory Matters. (a) Except as set forth on Schedule 4.10(a) or5.10(a), with respect to clause (i) only, as would not reasonably be expected to the Companies have a Material Adverse Effect, been since January 1, 2008, (i) the Companies 2004 and (with respect to the Associated Assets and their conduct of the Business) Sellers have been and currently are in compliance in all material respects with all Applicable Laws and (ii) Laws. Except as set forth on Schedule 5.10(a), none of the Companies or (with respect to the Associated Assets and their conduct of the Business) any Seller has received any written notice since January 1, 2004 to the effect that, or otherwise been advised that, it is that they are not in compliance in all material respects with any Applicable Law and, to the Knowledge of the Companies, there are no currently existing circumstances that are likely to result in the Companies being in violation in any material respect of any Applicable Law. (b) Schedule 4.10(b5.10(b) lists (i) the jurisdictions in which each of the Insurance Companies AA-BIC is licensed to write insurance policies and the types of insurance and other products that the Insurance Companies are AA-BIC is licensed to write in each such jurisdiction jurisdiction. The Companies have provided to Buyer true and (ii) each jurisdiction in which each Renewal Rights Seller is licensed to write Subject Policiescomplete copies of all such licenses. Other than Except as set forth on Schedule 5.10(b) or in Schedule 4.10(b) and other than connection with applications for licenses, or rate or form filings made in the ordinary course of regularly scheduled financial business and market conduct examinationsconsistent with past practice, none of the Insurance Companies AA-BIC is not the subject of (i) any material supervision, conservation, rehabilitation, liquidation, receivership, insolvency or other similar proceeding, (ii) pending disciplinary action, (iii) other Regulatory Proceedings or, (iv) to the Knowledge of Seller Parentthe Companies, threatened regulatory proceedingsdisciplinary action or other Regulatory Proceedings. Schedule 4.10(b) lists the The state of domicile of each Insurance CompanyAA-BIC is Texas. None of the Insurance Companies AA-BIC is not a “commercially domiciled insurer” under the laws of any jurisdiction or is otherwise treated as domiciled in a jurisdiction other than its jurisdiction of organizationTexas. (c) Except as set forth on Schedule 5.10(c), (i) The the Companies hold all material Permits necessary for the ownership and conduct of their the business of the Companies in each of the jurisdictions in which the Companies conduct or operate their business in the manner now conducted, and all such Permits are in full force and effect, with such exceptions which singularly and in the aggregate have not had nor would reasonably be expected to have a Material Adverse Effect on the Companies, (ii) the Renewal Rights Sellers hold Companies are, and at all times since January 1, 2004 have been, in compliance in all material Permits necessary respects with the terms of the Permits, (iii) none of the Companies has received, at any time since January 1, 2004, any notice or other communication (whether written or oral) from any Governmental Authority or any other Person regarding (1) any actual, alleged, possible, or potential violation of, or failure on the part of any Company to comply with, any term or requirement of any material Permit or (2) any actual, proposed, possible, or potential revocation, withdrawal, suspension, cancellation, termination of, or modification to any material Permit, (iv) to the Knowledge of the Companies, no event has occurred or circumstance exists that (with or without the giving of notice or lapse of time or both) (1) constitutes or would reasonably be expected to result in, directly or indirectly, a violation of, or a failure to comply in any material respect with, any Applicable Law or any term or requirement of any Permit, or (2) has resulted or would reasonably be expected to result, directly or indirectly, in the revocation, withdrawal, suspension, cancellation, or termination of, or any modification to, any material Permit, and (v) all applications required to have been filed for the ownership renewal of each such material Permit have been duly filed on a timely basis with the appropriate Governmental Authority, and conduct all other filings required to have been made with respect to each such material Permit have been duly made on a timely basis with the appropriate Governmental Authority. Subject to the receipt of the Business in each of the jurisdictions consents and approvals set forth on Schedules 5.3 and 6.3 and compliance by Sellers and/or Buyer with the HSR Act and the applicable change of control insurance laws, regulations and other requirements of the State of Texas and each other jurisdiction in which one or more of the Business Companies is conducted either (x) licensed to write insurance policies or operated (y) licensed to conduct business, the consummation of the transactions contemplated by them this Agreement will not result in any revocation, cancellation, suspension or nonrenewal of any such material Permit. (d) None of the Companies or any of their properties or assets relating thereto is subject to any outstanding order of, or is a party to any written agreement, consent agreement or memorandum of understanding with, or is a party to any commitment letter or similar undertaking to, or is subject to any order or directive by, or is a recipient of any supervisory letter from or has adopted any resolutions at the request of, any Governmental Authority that by its terms restricts in any material respect the conduct of its business or that in any manner now conductedrelates to its capital adequacy, its management or its business (each, a “Regulatory Agreement”), nor has any Company been advised in writing since January 1, 2004 by any Governmental Authority that it is considering issuing or requesting any such Regulatory Agreement. (e) All outstanding Insurance Contracts issued by AA-BIC, or which are being issued by AA-BIC as of the date hereof, are in compliance, and at their respective dates of issuance were in compliance, in all material respects with all Applicable Laws and, to the extent required under Applicable Law in all material respects, are on forms approved by the FCIC or the applicable Governmental Authorities or on forms that have been filed and not objected to (or such Permits objection has been withdrawn or resolved) by such Governmental Authorities within the period provided for objection. All forms of Insurance Contracts currently outstanding together with all amendments thereto, are on the forms that have been previously provided to Buyer. (f) All premium rates established by AA-BIC that are required to be filed with or approved by any Governmental Authorities have been so filed or approved, the premiums charged conform to the premiums so filed or approved and comply (or complied at the relevant time) with the insurance laws applicable thereto in full all material respects. (g) There are no in force and effectInsurance Contracts of AA-BIC under which the holders or owners of such Insurance Contracts have any rights with respect to dividends, surplus, profits, participation or voting rights. (h) The Company does not have any uncertain tax positions, as that term is defined in Statement of Financial Accounting Standards No. 109, “Accounting for Income Taxes,” as interpreted by Financial Accounting Standards Board Interpretation No. 48.