Common use of Compliance; Permits; Restrictions Clause in Contracts

Compliance; Permits; Restrictions. (a) The Company and each of its Subsidiaries are, and since January 1, 2013 have been, in compliance in all material respects with all applicable Laws, including the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act and any other similar Law administered or promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (each, a “Drug Regulatory Agency”), except for any noncompliance, either individually or in the aggregate, which would not be material to the Company. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending Table of Contents or, to the Knowledge of the Company, threatened against the Company or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon the Company or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company or any of its Subsidiaries, any acquisition of material property by the Company or any of its Subsidiaries or the conduct of business by the Company or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.

Compliance; Permits; Restrictions. (a) The Company Parent and each of its Subsidiaries areSubsidiaries, and since January 1, 2013 2019 have been, in compliance in all material respects with all applicable Laws, including the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act PHSA and any other similar Law administered or promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (each, a “Drug Regulatory Agency”), except for any noncompliance, either individually or in the aggregate, which would not be material to Parent and its Subsidiaries, taken as a whole. As of the Company. No date of this Agreement, no investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending Table of Contents or, to the Knowledge of the CompanyParent’s Knowledge, threatened against the Company Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon the Company Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company Parent or any of its Subsidiaries, any acquisition of material property by the Company Parent or any of its Subsidiaries or the conduct of business by the Company Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on the CompanyParent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.

Compliance; Permits; Restrictions. (a) The Company and each of its Subsidiaries are, and since January 1, 2013 2014 have been, in compliance in all material respects with all applicable Laws, including the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Act and any other similar Law administered or promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (each, a “Drug Regulatory Agency”), except for any noncompliance, either individually or in the aggregate, which would not be material to the Company. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending Table of Contents or, to the Knowledge of the Company, threatened against the Company or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon the Company or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company or any of its Subsidiaries, any acquisition of material property by the Company or any of its Subsidiaries or the conduct of business by the Company or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.

Compliance; Permits; Restrictions. (a) The Company Parent and each of its Subsidiaries are, and since January 1, 2013 2020, have been, in compliance in all material respects with all applicable Laws, including the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Public Health Service Act and any other similar Law administered or promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (each, a “Drug Regulatory Agency”), except for any noncompliance, either individually or in the aggregate, which would not be material to the CompanyParent. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending Table of Contents or, to the Knowledge of the CompanyParent’s Knowledge, threatened against the Company Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree by or with a Drug Regulatory Agency binding upon the Company Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company Parent or any of its Subsidiaries, any acquisition of material property by the Company Parent or any of its Subsidiaries or the conduct of business by the Company Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on the CompanyParent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.

Compliance; Permits; Restrictions. (a) The Company Parent and each of its Subsidiaries are, and since January 1, 2013 2020 have been, in compliance in all material respects with all applicable Laws, including the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Substances Act, the Public Health Service Act and any other similar Law administered or promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (each, a “Drug Regulatory Agency”), except for any noncompliance, either individually or in the aggregate, which would not be material to the CompanyParent. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending Table of Contents or, to the Knowledge of the CompanyParent’s Knowledge, threatened against the Company Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon the Company Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company Parent or any of its Subsidiaries, any acquisition of material property by the Company Parent or any of its Subsidiaries or the conduct of business by the Company Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on the CompanyParent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.. 41

Compliance; Permits; Restrictions. (a) The Company Parent and each of its Subsidiaries are, and since January 1, 2013 2020 have been, in compliance in all material respects with all applicable Laws, including the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Substances Act, the Public Health Service Act and any other similar Law administered or promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (each, a “Drug Regulatory Agency”), except for any noncompliance, either individually or in the aggregate, which would not be material to the CompanyParent. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending Table of Contents or, to the Knowledge of the CompanyParent’s Knowledge, threatened against the Company Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon the Company Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company Parent or any of its Subsidiaries, any acquisition of material property by the Company Parent or any of its Subsidiaries or the conduct of business by the Company Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on the CompanyParent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.

Compliance; Permits; Restrictions. (a) The Company and each of its Subsidiaries are, and since January 1, 2013 2016 have been, in compliance in all material respects with all applicable Laws, including the Federal Food, Drugregulations adopted thereunder, and Cosmetic Act (“FDCA”), any other similar Law administered or promulgated by the Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act and any other similar Law administered or promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (each, a “Drug Regulatory Agency”), except for any noncompliance, either individually or in the aggregate, which would not be material to the Company. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending Table of Contents or, to the Knowledge of the Company, threatened against the Company or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon the Company or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company or any of its Subsidiaries, any acquisition of material property by the Company or any of its Subsidiaries or the conduct of business by the Company or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.

Compliance; Permits; Restrictions. (a) The Company Parent and each of its Subsidiaries are, and since January 1, 2013 2020 have been, in compliance in all material respects with all applicable Laws, including the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Food and Drug Administration (“FDA”) FDA regulations adopted thereunder, the Controlled Substance Act thereunder and any other similar Law administered or promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (each, a “Drug Regulatory Agency”), except for any noncompliance, either individually or in the aggregate, which would not be material to the CompanyParent. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending Table of Contents or, to the Knowledge of the CompanyParent’s Knowledge, threatened against the Company Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon the Company Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company Parent or any of its Subsidiaries, any acquisition of material property by the Company Parent or any of its Subsidiaries or the conduct of business by the Company Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on the CompanyParent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.

Compliance; Permits; Restrictions. (a) The Company Parent and each of its Subsidiaries are, and since January 1, 2013 2022, have been, in compliance in all material respects with all applicable Laws, including the Federal FoodFTC, DrugCPSC, and Cosmetic Act (“FDCA”)CPSIA, the Food and Drug Administration (“FDA”) regulations adopted thereunder, the Controlled Substance Act thereunder and any other similar Law administered or promulgated by the FDA FTC, CPSC, CPSIA, or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug products (each, a “Drug Regulatory Agency”), except for any noncompliance, either individually or in the aggregate, which would not be material to the CompanyParent. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending Table of Contents or, to the Knowledge of the CompanyParent’s Knowledge, threatened against the Company Parent or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon the Company Parent or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company Parent or any of its Subsidiaries, any acquisition of material property by the Company Parent or any of its Subsidiaries or the conduct of business by the Company Parent or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on the CompanyParent’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions.