Compliance with Law; Permits; Regulatory Matters. (a) The Company Entities hold, and are operating in material compliance with, all Health Care Regulatory Authorizations required for the conduct of its business as currently conducted. The Company Entities have fulfilled and performed all of their material obligations with respect to the Health Care Regulatory Authorizations. The Company Entities have complied, and remain in compliance, in all material respects with all Laws applicable to the business, properties, assets and activities of the Company Entities. No Company Entity has received notice of or, to the Knowledge of the Company, been subject to or threatened with, any finding of deficiency or non-compliance; penalty, fine or sanction; request for corrective or remedial action; or pending or, to the Knowledge of the Company, threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action by the FDA or any other Governmental Body relating to any of (i) the Company Products, (ii) the ingredients in the Company Products or (iii) the facilities at which such Company Products are manufactured, packaged or initially distributed, whether issued by the FDA, the United States Federal Trade Commission (the “FTC”), the United States Drug Enforcement Administration (“DEA”), the United States Department of Agriculture (“USDA”) or by any other Governmental Body having responsibility for the regulation of such Company Products. To the Knowledge of the Company, there is no threatened suspension, revocation or withdrawal of any Health Care Regulatory Authorization. To the Knowledge of the Company, there is no condition that would preclude the renewal of a Health Care Regulatory Authorization upon its expiration.
Compliance with Law; Permits; Regulatory Matters. (a) Each of the Sellers and their respective Affiliates are, and since [***], have been, in compliance with all Laws applicable to the ownership and use of the Acquired Assets and the operation of the Product Business, including (i) the FDCA and any applicable Laws governing the approval, 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, 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.
Compliance with Law; Permits; Regulatory Matters. (a) Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and each Parent Subsidiary is, and at all times since the later of January 1, 2013, or its respective date of formation or organization has been, in compliance with all applicable Laws and is not in default under or in violation of any applicable Laws.
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.
Compliance with Law; Permits; Regulatory Matters. JT and its Affiliates are, and during the past [*] years, have been in compliance with all Laws and industry self-regulations applicable to the ownership and use of the Assigned Assets and the operation of the Japan HIV Products Business, including (a) any applicable Laws governing the approval, manufacture, sale, marketing, promotion, or distribution of drugs and the purchase or prescription of or reimbursement for drugs by any applicable Governmental Authority and (b) all applicable Laws regulating the pharmaceutical industry, except where the failure to so comply would not, individually or in the aggregate, reasonably be expected to materially and adversely affect the Assigned Assets or the Japan HIV Products Business. JT and its Affiliates have conducted all activities with respect to the Assigned Assets or the Japan HIV Products Business [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED that are subject to the jurisdiction of any applicable Governmental Authority, including the manufacturing, labeling, storing, shipping and testing of the HIV Products, in compliance in all material respects with all applicable Laws, regulations and guidance documents issued or adopted by such Governmental Authorities and industry associations (collectively, the “Regulatory Requirements”). Neither JT nor its Affiliates have received any notice or other communication from any Governmental Authority alleging any violation of any Regulatory Requirement by JT or its applicable Affiliate relating to any such activity.
Compliance with Law; Permits; Regulatory Matters. (a) Except as set forth on Schedule 5.10(a), the Company and the Acquired Company Subsidiaries have been since January 1, 2004 and currently are in compliance in all material respects with all Applicable Laws. Neither the Company nor the Acquired Company Subsidiaries have received any written notice since January 1, 2004 to the effect 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.
Compliance with Law; Permits; Regulatory Matters. (a) The Acquired Regulatory Approvals are in full force and effect. All maintenance, fees under the Prescription Drug User Fee Act (as amended), and other fees related to the Acquired Regulatory Approvals occurring or accruing prior to the Closing Date have been paid. All Acquired Regulatory Approvals and all related records have been maintained in accordance with all applicable Laws.
Compliance with Law; Permits; Regulatory Matters. (a) 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.
Compliance with Law; Permits; Regulatory Matters. (a)Except as set forth on Schedule 5.10(a), the Companies have been since January 1, 2004 and currently are in compliance in all material respects with all Applicable Laws. Except as set forth on Schedule 5.10(a), none of the Companies has received any written notice since January 1, 2004 to the effect 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.
Compliance with Law; Permits; Regulatory Matters. (a) Except as set forth on Schedule 4.17, the Company and the Subsidiaries are in compliance with all applicable laws, statutes, ordinances and regulations, whether Federal, foreign, state or local, except where the failure to comply would not, individually or in the aggregate, have a Material Adverse Effect on the Company and the Subsidiaries, taken as a whole. Since January 1, 1993, none of the Company or any Subsidiary has received any written notice to the effect that, or otherwise been advised that, it is not in compliance with any such statute, regulation, order, ordinance or other law where the failure to comply would, prior to June 30, 1998, individually or in the aggregate, have a Material Adverse Effect on the Company and the Subsidiaries, taken as a whole.
