Common use of Compliance with Applicable Laws; Permits Clause in Contracts

Compliance with Applicable Laws; Permits. (i) The Company and each Subsidiary has complied in all material respects with all Applicable Laws and is not in violation in any material respect of, and has not received any written notices of suspected, potential or actual violation with respect to, any Applicable Laws. Each consent, license, permit, grant or other authorization (A) pursuant to which the Company or any Subsidiary currently operates or holds any interest in any of its properties or (B) which is required for the operation of the Company’s and the Subsidiaries’ business as currently conducted or the holding of any such interest (collectively, “Company Authorizations”) has been issued or granted to the Company or the applicable Subsidiaries, except where the failure to have any such Company Authorization so issued or granted is not and would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries, taken as a whole. The Company and each Subsidiary has at all times been in compliance in all material respects with all Company Authorizations. The Company Authorizations are in full force and effect and constitute all Company Authorizations required to permit the Company to operate or conduct its business or hold any interest in its properties or assets, except where the failure to have any such Company Authorization is not and would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries, taken as a whole. Except as set forth in Disclosure Schedule 3.1(l)(i), the operation of the Business, including the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing, and distribution of all Company Products, is and at all times has been in material compliance with all Applicable Laws, Permits, and orders administered by any Governmental Entity, including the Food and Drug Administration (“FDA”). Except as set forth in Disclosure Schedule 3.1(l)(i), during the three year period ending on the date of this Agreement, the Company has not had any product or manufacturing site subject to a Governmental Entity (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Entity notice of inspectional observations, “warning letters,” “untitled letters,” or similar correspondence or written notice from the FDA or other Governmental Entity alleging or asserting noncompliance with any Applicable Law, Permit or such correspondence or notice from any Governmental Entity, and, to the Knowledge of the Company, neither the FDA nor any Governmental Entity is considering such action. All preclinical and clinical trials in respect of the Company Business being conducted by or on behalf of the Company that have been or will be submitted to any Governmental Entity, including the FDA and its counterparts worldwide, in connection with any Permit, are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls pursuant to Applicable Law. To the Knowledge of the Company, neither the Company nor any Subsidiaries is the subject of any pending or threatened investigation in respect of the Company or Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Without limiting the foregoing, the Company and each Subsidiary has conducted its sales and marketing activity in compliance in all material respects with the U.S. Telephone Consumer Protection Act.

Compliance with Applicable Laws; Permits. (i) The Company and each Subsidiary has complied in all material respects with all Applicable Laws and is Except as would not in violation in any material respect of, and has not received any written notices of suspected, potential have or actual violation with respect to, any Applicable Laws. Each consent, license, permit, grant or other authorization (A) pursuant to which the Company or any Subsidiary currently operates or holds any interest in any of its properties or (B) which is required for the operation of the Company’s and the Subsidiaries’ business as currently conducted or the holding of any such interest (collectively, “Company Authorizations”) has been issued or granted to the Company or the applicable Subsidiaries, except where the failure to have any such Company Authorization so issued or granted is not and would not reasonably be expected to behave, individually or in the aggregate, material to a Company Material Adverse Effect, (a) the Company and its Subsidiariesthe Company Subsidiaries are, taken as a whole. The and at all times since January 1, 2015, have been in compliance with all applicable Laws (including Anti- Corruption Laws) and all material Permits applicable to the business and operations of the Company and the Company Subsidiaries or by which the Company or any of the Company Subsidiaries or their respective businesses or properties are bound, and (b) the Company and each Company Subsidiary has hold, and are in compliance with, and at all times since January 1, 2015, have held and have been in compliance in with, all material respects with all Company AuthorizationsPermits required by Law for the conduct of their respective businesses. The Company Authorizations are in full force and effect and constitute all Company Authorizations required to permit Since January 1, 2015, neither the Company nor any Company Subsidiary has received any written notice or notification, or to operate the Company’s Knowledge, any other communication from any Governmental Entity regarding any actual or conduct its business possible violation of, or hold failure to comply with, any interest in its properties or assetsapplicable Law, except where the failure to have any such Company Authorization is not and violations or non- compliance would not reasonably be expected to behave, individually or in the aggregate, material a Company Material Adverse Effect. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, all Permits held by the Company and its Subsidiariesthe Company Subsidiaries are valid and in full force and effect. No suspension, taken as a whole. Except as set forth in Disclosure Schedule 3.1(l)(i)cancellation, the operation non-renewal, or adverse modifications of any Permits of the Business, including the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing, and distribution of all Company Products, or any Company Subsidiary is and at all times has been in material compliance with all Applicable Laws, Permits, and orders administered by any Governmental Entity, including the Food and Drug Administration (“FDA”). Except as set forth in Disclosure Schedule 3.1(l)(i), during the three year period ending on the date of this Agreement, the Company has not had any product or manufacturing site subject to a Governmental Entity (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Entity notice of inspectional observations, “warning letters,” “untitled letters,” or similar correspondence or written notice from the FDA or other Governmental Entity alleging or asserting noncompliance with any Applicable Law, Permit or such correspondence or notice from any Governmental Entity, andpending or, to the Knowledge of the Company, neither threatened, except for any such suspension or cancellation which would not reasonably be expected to have, individually or in the FDA nor any Governmental Entity is considering such actionaggregate, a Company Material Adverse Effect. All preclinical and clinical trials in respect None of the Company Business being conducted by or on behalf of Company, the Company that have been or will be submitted Subsidiaries or, to any Governmental Entity, including the FDA and its counterparts worldwide, in connection with any Permit, are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls pursuant to Applicable Law. To the Knowledge of the Company, neither their respective directors, officers, employees, agents or representatives: (i) is a Designated Person, (ii) is a Person that is owned or controlled by a Designated Person; (iii) is located, organized or resident in a Sanctioned Country; or (iv) has or is now, in connection with the Company nor any Subsidiaries is the subject of any pending or threatened investigation in respect business of the Company or Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Without limiting the foregoing, the Company Subsidiaries, engaged in, any dealings or transactions (A) with any Designated Person, (B) in any Sanctioned Country, or (C) otherwise in material violation of Sanctions. This Section 3.12 does not relate to Taxes; Company Benefit Plans or Company Benefit Agreements (including their compliance with any applicable Law) or ERISA; Environmental Permits, Environmental Laws, Environmental Claims, Releases, Hazardous Materials or other environmental matters; or Intellectual Property, which are addressed in Sections 3.08, 3.09, 3.14 and each Subsidiary has conducted its sales and marketing activity in compliance in all material respects with the U.S. Telephone Consumer Protection Act3.17, respectively.

Compliance with Applicable Laws; Permits. (i) The Company and each Subsidiary has complied in all material respects with all Applicable Laws and is not in violation in any material respect of, and has not received any written notices of suspected, potential or actual violation with respect to, any Applicable Laws. Each consent, license, permit, grant or other authorization (A) pursuant to which the Company or any Subsidiary currently operates or holds any interest in any of its properties or (B) which is required for the operation of the Company’s and the Subsidiaries’ business Except as currently conducted or the holding of any such interest (collectively, “Company Authorizations”) has been issued or granted to the Company or the applicable Subsidiaries, except where the failure to have any such Company Authorization so issued or granted is not and would not reasonably be expected to benot, individually or in the aggregate, reasonably be expected to be material to the Company and its Subsidiaries, taken as a whole. The , the Company and each Subsidiary has at all times been the Company Subsidiaries are, and since December 31, 2016, have been, in compliance in all material respects with all applicable Laws. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Authorizations. The Material Adverse Effect, (a) all Permits applicable to the business and operations of the Company Authorizations and the Company Subsidiaries are in full force and effect and constitute all Company Authorizations required to permit the Company to operate or conduct its business or hold any interest in its properties or assets, except where the failure to have any such Company Authorization is are not and would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries, taken as a whole. Except as set forth in Disclosure Schedule 3.1(l)(i), the operation of the Business, including the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing, and distribution of all Company Products, is and at all times has been in material compliance with all Applicable Laws, Permits, and orders administered by any Governmental Entity, including the Food and Drug Administration (“FDA”). Except as set forth in Disclosure Schedule 3.1(l)(i), during the three year period ending on the date of this Agreement, the Company has not had any product or manufacturing site subject to a Governmental Entity (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Entity notice of inspectional observations, “warning letters,” “untitled letters,” or similar correspondence or written notice from the FDA or other Governmental Entity alleging or asserting noncompliance with any Applicable Law, Permit or such correspondence or notice from any Governmental Entity, andpending or, to the Knowledge of the Company, neither threatened administrative or judicial proceeding that would reasonably be expected to result in modification, termination or revocation thereof, and (b) the FDA nor any Governmental Entity is considering such action. All preclinical Company and clinical trials in respect each of the Company Business being conducted by Subsidiaries is, and since December 31, 2016, has been, in compliance with the terms and requirements of such Permits. Except as would not reasonably be expected to have, individually or on behalf in the aggregate, a Company Material Adverse Effect, since December 31, 2016, neither the Company nor any of the Company Subsidiaries has received any written notice that have the Company or any of the Company Subsidiaries is or has been in violation of any Law applicable to the Company or will be submitted to any Governmental Entity, including the FDA and of its counterparts worldwide, in connection with Subsidiaries or any Permit. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, there are being or have been conducted no actions pending, threatened in compliance in all material respects with the required experimental protocolswriting or, procedures and controls pursuant to Applicable Law. To the Knowledge of the Company, neither otherwise threatened that would reasonably be expected to result in the Company nor any Subsidiaries is the subject revocation, withdrawal, suspension, nonrenewal, termination, revocation or adverse modification or limitation of any pending or threatened investigation in respect such Permit applicable to the business and operations of the Company or Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Without limiting the foregoing, the Company and each Subsidiary has conducted its sales and marketing activity in compliance in all material respects with the U.S. Telephone Consumer Protection ActSubsidiaries.

Compliance with Applicable Laws; Permits. (i) The Company and each Subsidiary has complied in all material respects with all Applicable Laws and is Except as would not in violation in any material respect of, and has not received any written notices of suspected, potential have or actual violation with respect to, any Applicable Laws. Each consent, license, permit, grant or other authorization (A) pursuant to which the Company or any Subsidiary currently operates or holds any interest in any of its properties or (B) which is required for the operation of the Company’s and the Subsidiaries’ business as currently conducted or the holding of any such interest (collectively, “Company Authorizations”) has been issued or granted to the Company or the applicable Subsidiaries, except where the failure to have any such Company Authorization so issued or granted is not and would not reasonably be expected to behave, individually or in the aggregate, material to a Company Material Adverse Effect, (a) the Company and its Subsidiariesthe Company Subsidiaries are, taken as a whole. The and at all times since January 1, 2015, have been in compliance with all applicable Laws (including Anti- Corruption Laws) and all material Permits applicable to the business and operations of the Company and the Company Subsidiaries or by which the Company or any of the Company Subsidiaries or their respective businesses or properties are bound, and (b) the Company and each Company Subsidiary has hold, and are in compliance with, and at all times since January 1, 2015, have held and have been in compliance in with, all material respects with all Company AuthorizationsPermits required by Law for the conduct of their respective businesses. The Company Authorizations are in full force and effect and constitute all Company Authorizations required to permit Since January 1, 2015, neither the Company nor any Company Subsidiary has received any written notice or notification, or to operate the Company’s Knowledge, any other communication from any Governmental Entity regarding any actual or conduct its business possible violation of, or hold failure to comply with, any interest in its properties or assetsapplicable Law, except where the failure to have any such Company Authorization is not and violations or non-compliance would not reasonably be expected to behave, individually or in the aggregate, material a Company Material Adverse Effect. Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, all Permits held by the Company and its Subsidiariesthe Company Subsidiaries are valid and in full force and effect. No suspension, taken as a whole. Except as set forth in Disclosure Schedule 3.1(l)(i)cancellation, the operation non-renewal, or adverse modifications of any Permits of the Business, including the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing, and distribution of all Company Products, or any Company Subsidiary is and at all times has been in material compliance with all Applicable Laws, Permits, and orders administered by any Governmental Entity, including the Food and Drug Administration (“FDA”). Except as set forth in Disclosure Schedule 3.1(l)(i), during the three year period ending on the date of this Agreement, the Company has not had any product or manufacturing site subject to a Governmental Entity (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Entity notice of inspectional observations, “warning letters,” “untitled letters,” or similar correspondence or written notice from the FDA or other Governmental Entity alleging or asserting noncompliance with any Applicable Law, Permit or such correspondence or notice from any Governmental Entity, andpending or, to the Knowledge of the Company, neither threatened, except for any such suspension or cancellation which would not reasonably be expected to have, individually or in the FDA nor any Governmental Entity is considering such actionaggregate, a Company Material Adverse Effect. All preclinical and clinical trials in respect None of the Company Business being conducted by or on behalf of Company, the Company that have been or will be submitted Subsidiaries or, to any Governmental Entity, including the FDA and its counterparts worldwide, in connection with any Permit, are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls pursuant to Applicable Law. To the Knowledge of the Company, neither their respective directors, officers, employees, agents or representatives: (i) is a Designated Person, (ii) is a Person that is owned or controlled by a Designated Person; (iii) is located, organized or resident in a Sanctioned Country; or (iv) has or is now, in connection with the Company nor any Subsidiaries is the subject of any pending or threatened investigation in respect business of the Company or Company Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Without limiting the foregoing, the Company Subsidiaries, engaged in, any dealings or transactions (A) with any Designated Person, (B) in any Sanctioned Country, or (C) otherwise in material violation of Sanctions. This Section 3.12 does not relate to Taxes; Company Benefit Plans or Company Benefit Agreements (including their compliance with any applicable Law) or ERISA; Environmental Permits, Environmental Laws, Environmental Claims, Releases, Hazardous Materials or other environmental matters; or Intellectual Property, which are addressed in Sections 3.08, 3.09, 3.14 and each Subsidiary has conducted its sales and marketing activity in compliance in all material respects with the U.S. Telephone Consumer Protection Act3.17, respectively.

Compliance with Applicable Laws; Permits. (i) The Company and each Subsidiary has complied in all material respects with all Applicable Laws and is Except as would not in violation in any material respect of, and has not received any written notices of suspected, potential have or actual violation with respect to, any Applicable Laws. Each consent, license, permit, grant or other authorization (A) pursuant to which the Company or any Subsidiary currently operates or holds any interest in any of its properties or (B) which is required for the operation of the Company’s and the Subsidiaries’ business as currently conducted or the holding of any such interest (collectively, “Company Authorizations”) has been issued or granted to the Company or the applicable Subsidiaries, except where the failure to have any such Company Authorization so issued or granted is not and would not reasonably be expected to behave, individually or in the aggregate, material to a Company Material Adverse Effect, (a) the Company is, and its Subsidiaries, taken as a whole. The Company and each Subsidiary has at all times been since January 1, 2017, has been, in compliance in all material respects with all Company Authorizations. The Company Authorizations are in full force applicable Laws (including Anti-Corruption Laws) and effect all Permits applicable to the business and constitute all Company Authorizations required to permit operations of the Company, and (b) the Company to operate or holds, and is in compliance with, all Permits required by Law for the conduct of its business as it is now being conducted. Since January 1, 2017, the Company has not received any written notice or hold notification, or to the Knowledge of the Company, any interest in its properties other communication from any Governmental Entity regarding any actual or assetspossible violation of, or failure to comply with, any applicable Law, except where the failure to have any such Company Authorization is not and violations or non-compliance would not reasonably be expected to behave, individually or in the aggregate, material to the a Company and its Subsidiaries, taken as a wholeMaterial Adverse Effect. Except as set forth would not reasonably be expected to have, individually or in Disclosure Schedule 3.1(l)(i)the aggregate, a Company Material Adverse Effect, all Permits held by the operation Company are valid and in full force and effect. No suspension, cancellation, non-renewal, or adverse modifications of any Permits of the Business, including the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing, and distribution of all Company Products, is and at all times has been in material compliance with all Applicable Laws, Permits, and orders administered by any Governmental Entity, including the Food and Drug Administration (“FDA”). Except as set forth in Disclosure Schedule 3.1(l)(i), during the three year period ending on the date of this Agreement, the Company has not had any product or manufacturing site subject to a Governmental Entity (including FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other Governmental Entity notice of inspectional observations, “warning letters,” “untitled letters,” or similar correspondence or written notice from the FDA or other Governmental Entity alleging or asserting noncompliance with any Applicable Law, Permit or such correspondence or notice from any Governmental Entity, andpending or, to the Knowledge of the Company, neither threatened, except for any such suspension or cancellation which would not reasonably be expected to have, individually or in the FDA nor any Governmental Entity is considering such actionaggregate, a Company Material Adverse Effect. All preclinical and clinical trials in respect None of the Company Business being conducted by or on behalf of the Company that have been or will be submitted Company, or, to any Governmental Entity, including the FDA and its counterparts worldwide, in connection with any Permit, are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls pursuant to Applicable Law. To the Knowledge of the Company, neither its directors, officers, employees, agents or representatives: (i) is a Designated Person, (ii) is a Person that is owned or controlled by a Designated Person; (iii) is located, organized or resident in a Sanctioned Country; or (iv) has or is now, in connection with the Company nor any Subsidiaries is the subject of any pending or threatened investigation in respect business of the Company Company, engaged in, any dealings or Company Productstransactions (A) with any Designated Person, by (B) in any Sanctioned Country, or (C) otherwise in material violation of Sanctions. For at least the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 previous five (September 10, 19915) and any amendments thereto. Without limiting the foregoingyears, the Company has maintained and each Subsidiary has conducted its sales implemented policies, procedures and marketing activity controls to ensure compliance with all Anti-Corruption Laws applicable to the Company. This Section 3.12 does not relate to Taxes; Company Benefit Plans or Company Benefit Agreements (including their compliance with any applicable Law) or ERISA; Environmental Permits, Environmental Laws, Environmental Claims, Releases, Hazardous Materials or other environmental matters; or Intellectual Property, which are addressed in compliance in all material respects with the U.S. Telephone Consumer Protection ActSections 3.08, 3.09, 3.14 and 3.17, respectively.