Common use of FDA and Related Matters Clause in Contracts

FDA and Related Matters. (a) Foamix and the Foamix Subsidiary possess all Regulatory Authorizations required by the FDA, the EMA, and all other applicable Regulatory Authorities in connection with the Foamix Products and the conduct of their businesses as currently conducted. All such Regulatory Authorizations are (i) in full force and effect, (ii) in compliance in all material respects with all formal filing and maintenance requirements, and (iii) in good standing, valid and enforceable. Foamix and the Foamix Subsidiary have filed all material required notices and responses to notices, supplemental applications, reports (including adverse experience reports) and other required information with the FDA, the EMA and all other applicable Regulatory Authorities. (b) The conduct of Foamix and Foamix Subsidiary businesses and the Foamix Products are in compliance in all material respects with (1) all applicable Laws and Orders of the FDA, EMA and other Regulatory Authorities and (2) all Regulatory Authorizations. Foamix and the Foamix Subsidiary have not received any warning letters, notice of adverse findings, or similar documents that assert a material failure to comply with any applicable Laws or Orders that have not been fully resolved to the satisfaction of the FDA, the EMA or any other Regulatory Authorities, as applicable, and neither Foamix nor the Foamix Subsidiary has Knowledge (or has been notified in writing by a third party) of any pending or threatened action, investigation or inquiry by any Regulatory Authority (other than non-material routine or periodic inspections or reviews) against any of Foamix and the Foamix Subsidiary, the Foamix Products, or any Foamix Partner. Neither Foamix nor the Foamix Subsidiary has made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA or any other Regulatory Authority nor have they failed to disclose any material fact required to be disclosed to the FDA, the EMA or any other Regulatory Authority, and to Foamix’s Knowledge, no Foamix Partner has made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA or any other Regulatory Authority relating to the Foamix Products, nor to Foamix’s Knowledge, has any Foamix Partner failed to disclose any material facts required to be disclosed to the FDA, the EMA or any other Regulatory Authority relating to the Foamix Products. (c) Neither Foamix nor the Foamix Subsidiary has Knowledge (or has been notified in writing by a Foamix Partner) of any pending regulatory action of any sort (other than non-material routine or periodic inspections or reviews) against any Person which develops products pursuant to a development, commercialization or other collaboration arrangement with Foamix or the Foamix Subsidiary (each, a “Foamix Partner”) by the FDA, the EMA or any other Regulatory Authority. (d) Foamix has made available to Menlo copies of all Regulatory Authorizations and regulatory dossiers relating thereto, all serious adverse event reports, periodic adverse event reports and other pharmacovigilance reports and data, and all other material Regulatory Authority communications, documents and other information submitted to or received from the FDA, the EMA or any Regulatory Authority, including inspection reports, warning letters and similar documents, relating to Foamix or the Foamix Subsidiary, the conduct of their business, or the Foamix Products. (e) All preclinical studies and clinical trials conducted or being conducted by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix Products, any Foamix Partner have been and are being conducted in material compliance with all applicable Laws of the FDA, EMA and other Regulatory Authorities, including, without limitation, the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312. No clinical trial conducted by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix Products, any Foamix Partner has been terminated or suspended by the FDA, EMA or any other Regulatory Authority, and neither the FDA, EMA nor any other Regulatory Authority has commenced or, to Foamix’s Knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix Products, any Foamix Partner.

FDA and Related Matters. (a) Foamix Section 4.9 of the Company Disclosure Letter sets forth a true and the Foamix Subsidiary possess complete list of all Regulatory Authorizations required by from the FDA, the EMA, EMEA and all other applicable Regulatory Authorities owned by the Company or held by Company Partners (as defined in Section 4.9(b) hereof) and relating to the Core Product and used in the conduct of the Company’s business, and there are no other material Regulatory Authorizations required for the Company or the Core Product in connection with the Foamix Products and the conduct of their businesses the Company’s business as currently conducted. All such Regulatory Authorizations are owned by the Company are, and to the knowledge of the Company all other Regulatory Authorizations are, (i) in full force and effect, (ii) validly registered and on file with applicable Regulatory Authorities, (iii) in compliance in all material respects with all formal filing and maintenance requirements, and (iiiiv) in good standing, valid and enforceable. Foamix and the Foamix Subsidiary have The Company has filed all material required notices and responses to notices, supplemental applications, reports (including adverse experience reports) and other required information with the FDA, the EMA EMEA and all other applicable Regulatory AuthoritiesAuthorities except where the failure to file any such information would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. (b) The Without limiting the generality of any other representations and warranties made by the Company under this Agreement, to the knowledge of the Company, the conduct of Foamix and Foamix Subsidiary businesses and the Foamix Products are business of the Company as currently conducted is in compliance in all material respects with (1) all written communications, requirements and applicable Laws and Orders of the FDA, EMA EMEA and other Regulatory Authorities and (2) all Regulatory Authorizations. Foamix , including all requirements of the FDA, the EMEA and the Foamix Subsidiary have not received any all other Regulatory Authorities in warning letters, notice notices of adverse findings and Section 305 notices and similar letters or notices, and in connection with all product recalls, notifications and safety alerts, and any request from the FDA, the EMEA or any Regulatory Authority requesting the Company to cease to investigate, test or market any product, and all consent decrees (including plea agreements) issued with respect to the Company. There are no, and have not been, any inspection reports, warning letters, notices of adverse findings, Section 305 notices or similar written documents received by the Company or, to the knowledge of the Company, by any Company Partner, that assert a material failure to comply lack of compliance with any applicable Laws Laws, Orders, or Orders regulatory requirements that have not been fully resolved to the satisfaction of the FDA, the EMA EMEA or any other Regulatory Authorities, as applicable, . The Company has no knowledge (and neither Foamix nor the Foamix Subsidiary has Knowledge (or has not been notified in writing by a third party) of any pending or threatened regulatory action, investigation or inquiry of any sort by the FDA, EMEA or any other Regulatory Authority (other than non-material routine or periodic inspections or reviews) against any of Foamix and the Foamix SubsidiaryCompany, the Foamix Products, Core Product or any Foamix Person that manufactures, develops or distributes the Core Product pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company (each, a “Company Partner”), and, to the knowledge of the Company, there is no reasonable basis for any adverse regulatory action. Neither Foamix nor Without limiting the Foamix Subsidiary foregoing, (i) to the knowledge of the Company, there have been no product recalls, warnings, notifications or safety alerts conducted or issued by the Company, the FDA, the EMEA or any other Regulatory Authorities with respect to the Core Product, none of the foregoing has been requested or demanded by the FDA, the EMEA or any other Regulatory Authorities, and to the Company’s knowledge, and there is no reasonable basis for any of the foregoing; (ii) none of the Company or, to the knowledge of the Company, any of its respective agents or subcontractors, has been convicted of any crime or engaged in any conduct which would reasonably be expected to result in criminal liability, debarment or disqualification by the FDA, the EMEA or any other Regulatory Authority, and (iii) no criminal, injunctive, seizure or civil penalty actions have at any time been commenced or threatened by any Regulatory Authority against the Company or, to the knowledge of the Company, any of its respective agents or subcontractors, and there are no consent decrees (including plea agreements) or similar actions to which the Company is bound or which relate to the Core Product. The Company is not, to the knowledge of the Company, employing or utilizing the services of any individual who has been debarred, temporarily denied approval or suspended under any applicable Law or Order. To the knowledge of the Company, the Company has not made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA EMEA or any other Regulatory Authority nor have they failed to disclose any material fact required to be disclosed to the FDA, the EMA EMEA or any other Regulatory Authority, and to Foamix’s Knowledgethe knowledge of the Company, no Foamix Company Partner (as defined below) has made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA EMEA or any other Regulatory Authority relating to the Foamix ProductsCore Product, nor to Foamix’s Knowledgethe knowledge of the Company, has any Foamix Company Partner failed to disclose any material facts required to be disclosed to the FDA, the EMA EMEA or any other Regulatory Authority relating to the Foamix ProductsCore Product. (c) Neither Foamix nor the Foamix Subsidiary has Knowledge (or has been notified in writing by a Foamix Partner) of any pending regulatory action of any sort (other than non-material routine or periodic inspections or reviews) against any Person which develops products pursuant to a development, commercialization or other collaboration arrangement with Foamix or the Foamix Subsidiary (each, a “Foamix Partner”) by the FDA, the EMA or any other Regulatory Authority. (d) Foamix The Company has made available to Menlo Parent complete and accurate copies of all Regulatory Authorizations and regulatory dossiers compiled by the Company relating thereto, all serious adverse event reports, periodic adverse event reports and other pharmacovigilance pharmacoviligence reports and data, and all other material Regulatory Authority communications, documents and other information submitted by the Company to or received by the Company from the FDA, the EMA EMEA or any equivalent Regulatory Authority, including inspection reports, warning letters and similar documents, relating to Foamix or the Foamix SubsidiaryCompany, the conduct of their its business, or the Foamix ProductsCore Product. (ed) All preclinical studies and clinical trials conducted or being conducted by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix Products, any Foamix Partner Core Product by or at the direction of the Company have been and are being conducted in material compliance with the applicable requirements of Good Laboratory Practices and Good Clinical Practices and applicable regulations and guidances that relate to the conduct of clinical studies, and, the Company (1) is not aware of any failure by any Company Partner to conduct clinical studies in material compliance with such applicable requirements, regulations and guidances and (2) has not received any notifications from any institutional review board (IRB) raising any issues. All results of studies, tests and trials related to the Core Product and conducted by or at the direction of the Company, and all other material information related to such studies, tests and trials, have been made available to Parent. (e) The manufacture of products by the Company is, or, in the case of any products manufactured by a Company Partner, to the knowledge of the Company is, being conducted in material compliance with the applicable requirements of current Good Manufacturing Practices. In addition, the Company and, to the knowledge of the Company, its respective Company Partners, are in material compliance with all applicable registration and listing requirements, including, for example, those set forth in 21 U.S.C. Section 360 and 21 C.F.R. Parts 207 and 807 and all similar applicable Laws and Orders. To the knowledge of the Company, no Product sold by the Company or held in inventory by the Company has been adulterated or misbranded. All labeling is in compliance with FDA, EMA EMEA and other Regulatory Authorities, including, without limitation, the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58Authority requirements, and 312. No clinical trial conducted by or on behalf all advertising and promotional materials of Foamix, the Foamix Subsidiary or, Company are in material compliance with respect to the Foamix Products, any Foamix Partner has been terminated or suspended by the FDA, EMA or any EMEA and other Regulatory Authority, and neither the FDA, EMA nor any other applicable Regulatory Authority has commenced or, to Foamix’s Knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix Products, any Foamix Partnerrequirements.

FDA and Related Matters. (a) Foamix and the Foamix Subsidiary possess Menlo possesses all Regulatory Authorizations required by the FDA, the EMA, and all other applicable Regulatory Authorities in connection with the Foamix Menlo Products and the conduct of their businesses as currently conducted. All such Regulatory Authorizations are (i) in full force and effect, (ii) in compliance in all material respects with all formal filing and maintenance requirements, and (iii) in good standing, valid and enforceable. Foamix and the Foamix Subsidiary have Menlo has filed all material required notices and responses to notices, supplemental applications, reports (including adverse experience reports) and other required information with the FDA, the EMA and all other applicable Regulatory Authorities. (b) The conduct of Foamix and Foamix Subsidiary businesses Menlo’s business and the Foamix Menlo Products are in compliance in all material respects with (1) all applicable Laws and Orders of the FDA, EMA and other Regulatory Authorities and (2) all Regulatory Authorizations. Foamix and the Foamix Subsidiary Menlo have not received any warning letters, notice of adverse findings, or similar documents that assert a material failure to comply with any applicable Laws or Orders that have not been fully resolved to the satisfaction of the FDA, the EMA or any other Regulatory Authorities, as applicable, and neither Foamix nor the Foamix Subsidiary Menlo has no Knowledge (or has been notified in writing by a third party) of any pending or threatened action, investigation or inquiry by any Regulatory Authority (other than non-material routine or periodic inspections or reviews) against any of Foamix and the Foamix SubsidiaryMenlo, the Foamix Menlo Products, or any Foamix Menlo Partner. Neither Foamix nor the Foamix Subsidiary Menlo has not made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA or any other Regulatory Authority nor have they failed to disclose any material fact required to be disclosed to the FDA, the EMA or any other Regulatory Authority, and to FoamixMenlo’s Knowledge, no Foamix Menlo Partner has made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA or any other Regulatory Authority relating to the Foamix Menlo Products, nor to FoamixMenlo’s Knowledge, has any Foamix Menlo Partner failed to disclose any material facts required to be disclosed to the FDA, the EMA or any other Regulatory Authority relating to the Foamix Menlo Products. (c) Neither Foamix nor the Foamix Subsidiary has Menlo does not have Knowledge (or and has not been notified in writing by a Foamix Menlo Partner) of any pending regulatory action of any sort (other than non-material routine or periodic inspections or reviews) against any Person which develops products pursuant to a development, commercialization or other collaboration arrangement with Foamix or the Foamix Subsidiary Menlo (each, a “Foamix Menlo Partner”) by the FDA, the EMA or any other Regulatory Authority. (d) Foamix Menlo has made available to Menlo Foamix copies of all Regulatory Authorizations and regulatory dossiers relating thereto, all serious adverse event reports, periodic adverse event reports and other pharmacovigilance reports and data, and all other material Regulatory Authority communications, documents and other information submitted to or received from the FDA, the EMA or any Regulatory Authority, including inspection reports, warning letters and similar documents, relating to Foamix or the Foamix SubsidiaryMenlo, the conduct of their its business, or the Foamix Menlo Products. (e) All preclinical nonclinical studies and clinical trials conducted or being conducted by or on behalf of Foamix, the Foamix Subsidiary Menlo or, with respect to the Foamix Menlo Products, any Foamix Menlo Partner have been and are being conducted in material compliance with all applicable Laws of the FDA, EMA and other Regulatory Authorities, including, without limitation, the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312. No clinical trial conducted by or on behalf of Foamix, the Foamix Subsidiary Menlo or, with respect to the Foamix Menlo Products, any Foamix Menlo Partner has been terminated or suspended by the FDA, EMA or any other Regulatory Authority, and neither the FDA, EMA nor any other Regulatory Authority has commenced orcommenced, or to FoamixMenlo’s Knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of Foamix, the Foamix Subsidiary Menlo or, with respect to the Foamix Menlo Products, any Foamix Menlo Partner.

FDA and Related Matters. (a) Foamix and Except as set forth in Section 3.22 of the Foamix Subsidiary possess all Regulatory Authorizations required by the FDACompany Disclosure Letter, the EMACompany and its Subsidiaries are and, and all other applicable Regulatory Authorities in connection with to the Foamix Products and Knowledge of the conduct of their businesses as currently conducted. All such Regulatory Authorizations are (i) in full force and effectCompany, (ii) have been since January, 1 2008, in compliance in all material respects with all formal filing and maintenance requirements, and (iii) in good standing, valid and enforceable. Foamix and the Foamix Subsidiary have filed all material required notices and responses to notices, supplemental applications, reports (including adverse experience reports) and other required information with the FDA, the EMA and all other applicable Regulatory Authorities. (b) The conduct of Foamix and Foamix Subsidiary businesses and the Foamix Products are in compliance in all material respects with (1) all applicable Applicable Laws (including all rules, regulations and Orders policies) of the FDA, EMA DEA, EMEA and other Healthcare Regulatory Authorities and (2) all Healthcare Regulatory Authorizations. Foamix and the Foamix Subsidiary have not received any warning letters, notice of adverse findings, or similar documents that assert a material failure to comply with any applicable Laws or Orders that have not been fully resolved to the satisfaction including all requirements of the FDA, DEA, the EMA or any EMEA and all other Healthcare Regulatory Authorities, as applicablethat are applicable to the Company and its Subsidiaries, or by which any property, product, or other asset of the Company and its Subsidiaries is bound or affected, except, in each case, where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. As of the date of this Agreement, neither Foamix the Company nor the Foamix Subsidiary its Subsidiaries has Knowledge (or has been notified in writing by a third party) received any written notification of any pending or threatened actionor, investigation or inquiry by any Regulatory Authority (other than non-material routine or periodic inspections or reviews) against any of Foamix and the Foamix Subsidiary, the Foamix Products, or any Foamix Partner. Neither Foamix nor the Foamix Subsidiary has made any materially untrue statement of fact or fraudulent statement to the FDAKnowledge of the Company, the EMA threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any other Regulatory Authority nor have they failed to disclose any material fact required to be disclosed to the FDA, the EMA or any other Healthcare Regulatory Authority, and except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to Foamix’s Knowledgehave, no Foamix Partner has made any materially untrue statement of fact or fraudulent statement to the FDAa Material Adverse Effect. (b) Since January 1, 2008, the EMA Company and its Subsidiaries have held all Healthcare Regulatory Authorizations required for the conduct of their respective businesses, and all such Healthcare Regulatory Authorizations are and have been in full force and effect, except where the failure to hold a Healthcare Regulatory Authorization or the failure to be in full force and effect would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. No event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder of any such Healthcare Regulatory Authority relating Authorization, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to the Foamix Productshave, nor to Foamix’s Knowledge, has any Foamix Partner failed to disclose any material facts required to be disclosed to the FDA, the EMA or any other Regulatory Authority relating to the Foamix Productsa Material Adverse Effect. (c) Neither Foamix the Company nor the Foamix Subsidiary any of its Subsidiaries has Knowledge (or has been notified in writing by a Foamix Partner) of received any pending regulatory action of material written information since January 1, 2008 from any sort (other than non-material routine or periodic inspections or reviews) against any Person which develops products pursuant to a development, commercialization or other collaboration arrangement with Foamix or the Foamix Subsidiary (each, a “Foamix Partner”) by the FDA, the EMA Healthcare Regulatory Authority or any other state or federal regulatory agencies with jurisdiction over the marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing of its products which would reasonably be expected to lead: (i) to the revocation, withdrawal, or denial of any application for marketing approval before such Healthcare Regulatory Authority, except for any such revocations, withdrawals or denials which, individually or in the aggregate, would not reasonably be expected to have, a Material Adverse Effect; or (ii) to the revocation, withdrawal, denial or restriction of producing or marketing of any Company Product currently in development or offered for sale which does not require marketing approval, except for any such revocations, withdrawals, denials or restrictions which, individually or in the aggregate, would not reasonably be expected to have, a Material Adverse Effect. (d) Foamix has made available to Menlo copies Except as set forth in Section 3.22 of all Regulatory Authorizations and regulatory dossiers relating theretothe Company Disclosure Letter, all serious material reports, documents, claims and notices required or requested to be filed, maintained, or furnished to any Healthcare Regulatory Authority by the Company and its Subsidiaries since January 1, 2008 have been so filed, maintained or furnished and, to the Knowledge of the Company, were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing), except where the failure to do so would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole. The Company and its Subsidiaries are and have been, since January 1, 2008, in compliance with current good manufacturing practices and maintain appropriate mechanisms, policies and procedures to ensure the prompt collection and reporting of adverse event reports, periodic adverse event reports and other pharmacovigilance reports and data, and all other material Regulatory Authority communications, documents and other information submitted to or received from the FDA, the EMA or any Regulatory Authorityother safety or efficacy data related to their products, including inspection reportsexcept where the failure to do so would not, warning letters individually or in the aggregate, have or reasonably be expected to have, a material and similar documentsadverse effect on the Company and its Subsidiaries, relating to Foamix or the Foamix Subsidiary, the conduct of their business, or the Foamix Productstaken as a whole. (e) All preclinical studies Except where such action would not, individually or in the aggregate, have or reasonably be expected to have, a material and clinical trials adverse effect on the Company and its Subsidiaries, taken as a whole, the Company and its Subsidiaries have not since January 1, 2008 voluntarily or involuntarily initiated, conducted or being issued, or caused to be initiated, conducted or issued, any recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating to an alleged lack of safety, efficacy, or regulatory compliance of any product manufactured, distributed or marketed by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix Products, any Foamix Partner have been and are being conducted in material compliance with all applicable Laws of the FDA, EMA and other Regulatory Authorities, including, without limitation, the FDCA Company and its applicable implementing regulations at 21 C.F.R. Parts 50Subsidiaries. Neither the Company nor any of its Subsidiaries has received any written notice since January 1, 54, 56, 58, and 312. No clinical trial conducted by or on behalf of Foamix, 2008 that the Foamix Subsidiary or, with respect to the Foamix Products, any Foamix Partner has been terminated or suspended by the FDA, EMA FDA or any other Regulatory Authority, and neither the FDA, EMA nor any other Regulatory Governmental Authority has commenced or(i) commenced, to Foamix’s Knowledge, or threatened to initiate, any action to place revoke or withdraw a clinical hold order onproduct approval, or otherwise terminaterequest the recall of any product, delay(ii) commenced, suspend or materially restrict threatened to initiate, any proposed action to enjoin manufacture or ongoing distribution of any product or (iii) commenced, or threatened to initiate, any action to enjoin the manufacture or distribution of any product produced at any facility where any product is manufactured, tested, processed, packaged or held for sale, except in each case where such action would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole. (f) With respect to each matter disclosed in Section 3.22(e) of the Company Disclosure Letter, the Company and its Subsidiaries have in their possession a “close out” letter or similar written communication from FDA or other applicable Governmental Authority attesting to the termination of the matter. The Company and its Subsidiaries have made available to Parent true, correct and complete copies of all such “close out” letters and similar written communications. (g) All pre-clinical trial conducted or proposed to be studies conducted by or on behalf of Foamixor sponsored by the Company or its Subsidiaries, or in which the Company and its Subsidiaries or their products have participated were and, if still pending, are being conducted in accordance with standard medical and scientific research procedures and all Applicable Law, including good laboratory practice requirements, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. The Company and its Subsidiaries have not received since January 1, 2008 any written notices, correspondence or other communication from any Healthcare Regulatory Authority requiring the termination or suspension of any clinical studies conducted by, or on behalf of, the Foamix Subsidiary Company or any of its Subsidiaries, or in which the Company or the any of its Subsidiaries have participated, except where such termination or suspension would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. (h) The Company and its Subsidiaries have not engaged and are not engaging in any clinical studies as sponsor, investigator or monitor. (i) Neither the Company nor any of its Subsidiaries has received any FDA Form 483, notice of adverse finding, warning letters, untitled letters or other notices from any Healthcare Regulatory Authority related to the safety, purity, efficacy, labeling, marketing or promotion of any of the Company’s or its Subsidiaries’ products, and there is no action or proceeding pending or, to the Knowledge of the Company, threatened by any such Healthcare Regulatory Authority, contesting the approval of, the uses of, or the labeling or promotion of, or otherwise alleging any violation of law with respect to, any product manufactured, distributed or marketed by or on behalf of the Company or its Subsidiaries, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Material Adverse Effect. (j) Neither the Company nor any of its Subsidiaries is the subject of any pending or, to the Knowledge of the Company, threatened investigation regarding the Company, its Subsidiaries, or their 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 (the “Final Policy”). Neither the Company nor any of its Subsidiaries, nor to the Knowledge of the Company, any officer, employee, agent, contractor or distributor of the Company or any of its Subsidiaries, has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law. Neither the Company nor any of its Subsidiaries, nor, to the Knowledge of the Company, any officer, employee, agent, contractor or distributor of the Company or any of its Subsidiaries, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Applicable Law. As of the date hereof, no claims, actions, proceedings or investigations that would reasonably be expected to result in a material debarment or exclusion are pending or, to the Knowledge of the Company, threatened, against the Company or, to the Knowledge of the Company, any of its directors, officers, employees or agents. The Company has made available to Parent a true, correct and complete listing of fees, payments and reimbursements paid by the Company and its Subsidiaries, including the identity of the recipients of such fees, payments and reimbursements, related to advertising, promotions, conferences, speakerships and sponsorships together with the subject matters thereof, and the Company and its Subsidiaries have been and are fully in compliance with the PhRMA Code on Interactions with Healthcare Professionals, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole. (k) To the Knowledge of the Company, no new drug applications (“NDAs”) or ANDAs submitted by the Company or any of its Subsidiaries to any Health Regulatory Authority for approval contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading. To the Knowledge of the Company, all NDAs and ANDAs submitted by the Company or any of its Subsidiaries are true, complete and correct and none is deficient by virtue of any failure to submit a modification, amendment or supplement thereto or for failure to pay any requisite fee, penalty or other charge or expense. Neither the Company nor any of its Subsidiaries has used or engaged the services of any debarred individual in connection with the preparation or submission of any marketing applications for its products. (l) Neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has requested, required, demanded or ordered the Company, its Subsidiaries or any of their officers or employees to cease all or a significant portion of the manufacturing operations at the Company’s manufacturing facilities, and, to the Knowledge of the Company, neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has taken any action that could reasonably be expected to lead to such a request, requirement, demand or order, except in each case where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a material and adverse effect on the Company and its Subsidiaries, taken as a whole. (m) The Company and its Subsidiaries have made available to Parent true, correct and complete copies of all internal and third party facility audits completed at and on behalf of the Company during the past three years. All material facility registrations and product listings required of the Company and its Subsidiaries are timely, complete and correct in all material respects. Section 3.22(m) of the Company Disclosure Letter contains a complete list of the Company’s and its Subsidiaries’ registered facilities and listed products, including an indication of any such products’ identified status as “grandfathered”, “monograph”, ANDA or NDA. The Company and its Subsidiaries have not developed, manufactured or distributed and do not currently develop, manufacture or distribute any biological product subject to a biologics license application (as defined in 21 CFR 601.2). (n) Neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has requested, required, demanded or ordered the Company, its Subsidiaries or any of their officers or employees to discontinue, or notified the Company, its Subsidiaries or any of their officers or employees of the potential discontinuance of, all or a significant portion of the commercialization of fluticasone propionate, and to the Knowledge of the Company, neither the FDA nor any other Health Regulatory Authority of competent jurisdiction has taken any action that could reasonably be expected to lead to such a request, requirement, demand or order. (o) For the purposes of this Section 3.22, “product” with respect to products of the Foamix ProductsCompany or any of its Subsidiaries includes products marketed, developed or produced, as applicable, by the Company or any Foamix Partnerof its Subsidiaries and products and product candidates being evaluated by the Company or any of its Subsidiaries, whether in clinical trials as to which the Company or any of its Subsidiaries holds the applicable investigational new drug applications or in earlier stages of development. For purposes of this Section 3.22 only, clause (12) of the definition of “Material Adverse Effect” shall be inapplicable.

FDA and Related Matters. (a) Foamix Section 4.9 of the Company Disclosure Letter sets forth a true and the Foamix Subsidiary possess complete list of all Regulatory Authorizations required by from the FDA, the EMA, EMEA and all other applicable Regulatory Authorities owned by the Company or the Company Subsidiaries or held by Company Partners (as defined in Section 4.9(b) hereof) and relating to the Core Products (as defined in Section 9.14(h)) and used in the conduct of the Company’s business, and there are no other Regulatory Authorizations required for the Company, the Company Subsidiaries or the Core Products in connection with the Foamix Products and the conduct of their businesses the Company’s business as currently conducted. All such Regulatory Authorizations are owned by the Company or a Company Subsidiary are, and to the knowledge of the Company all other Regulatory Authorizations are, in all material respects, (i) in full force and effect, (ii) validly registered and on file with applicable Regulatory Authorities, (iii) in compliance in all material respects with all formal filing and maintenance requirements, and (iiiiv) in good standing, valid and enforceable. Foamix The Company and the Foamix Subsidiary Company Subsidiaries have filed all material required notices and responses to notices, supplemental applications, reports (including adverse experience reports) and other required information with the FDA, the EMA EMEA and all other applicable Regulatory Authorities. (b) The Without limiting the generality of any other representations and warranties made by the Company under this Agreement, to the knowledge of the Company, the conduct of Foamix and Foamix Subsidiary businesses the business of the Company and the Foamix Products are Company Subsidiaries as currently conducted is in compliance in all material respects with (1) all written communications, requirements and applicable Laws and Orders of the FDA, EMA EMEA and other Regulatory Authorities and (2) all Regulatory Authorizations. Foamix , including all requirements of the FDA, the EMEA and the Foamix Subsidiary have not received any all other Regulatory Authorities in warning letters, notice notices of adverse findings and Section 305 notices and similar letters or notices, and in connection with all product recalls, notifications and safety alerts, and any request from the FDA, the EMEA or any Regulatory Authority requesting the Company or any Company Subsidiary to cease to investigate, test or market any product, and all consent decrees (including plea agreements) issued with respect to the Company or any Company Subsidiary. There are no, and have not been, any inspection reports, warning letters, notices of adverse findings, Section 305 notices or similar written documents received by the Company or, to the knowledge of the Company, by any Company Partner, that assert a material failure to comply lack of compliance with any applicable Laws Laws, Orders, or Orders regulatory requirements that have not been fully resolved to the satisfaction of the FDA, the EMA EMEA or any other Regulatory Authorities, as applicable, and neither Foamix nor . None of the Foamix Subsidiary Company or any of the Company Subsidiaries has Knowledge knowledge (or has been notified in writing by a third party) of any pending or threatened regulatory action, investigation or inquiry of any sort by the FDA, EMEA or any other Regulatory Authority (other than non-material routine or periodic inspections or reviews) against any of Foamix and the Foamix Company, a Company Subsidiary, the Foamix Core Products or any Person that manufactures, develops or distributes the Core Products pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company or any Company Subsidiary (each, a “Company Partner”), and, to the knowledge of the Company, there is no basis for any adverse regulatory action. Without limiting the foregoing, (i) to the knowledge of the Company, there have been no product recalls, warnings, notifications or safety alerts conducted or issued by the Company or Company Subsidiaries, the FDA, the EMEA or any other Regulatory Authorities with respect to the Company’s and the Company Subsidiaries’ Products, none of the foregoing has been requested or demanded by the FDA, the EMEA or any Foamix Partnerother Regulatory Authorities, and to the Company’s knowledge, and there is no reasonable basis for any of the foregoing; (ii) none of the Company, the Company Subsidiaries or, to the knowledge of the Company, any of their respective agents or subcontractors, has been convicted of any crime or engaged in any conduct which would reasonably be expected to result in criminal liability, debarment or disqualification by the FDA, the EMEA or any other Regulatory Authority, and (iii) no criminal, injunctive, seizure or civil penalty actions have at any time been commenced or threatened by any Regulatory Authority against the Company or any Company Subsidiary or, to the knowledge of the Company, any of their respective agents or subcontractors, and there are no consent decrees (including plea agreements) or similar actions to which the Company or any Company Subsidiary is bound or which relate to the Core Products. Neither Foamix the Company nor any Company Subsidiary is, to the Foamix knowledge of the Company, employing or utilizing the services of any individual who has been debarred, temporarily denied approval or suspended under any applicable Law or Order. To the knowledge of the Company, neither the Company nor any Company Subsidiary has made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA EMEA or any other Regulatory Authority nor have they failed to disclose any material fact required to be disclosed to the FDA, the EMA EMEA or any other Regulatory Authority, and to Foamix’s Knowledgethe knowledge of the Company, no Foamix Company Partner (as defined below) has made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA EMEA or any other Regulatory Authority relating to the Foamix Products, nor to Foamix’s Knowledgethe knowledge of the Company, has any Foamix Company Partner failed to disclose any material facts required to be disclosed to the FDA, the EMA EMEA or any other Regulatory Authority relating to the Foamix Products. (c) Neither Foamix nor The Company and the Foamix Subsidiary has Knowledge (or has been notified in writing by a Foamix Partner) of any pending regulatory action of any sort (other than non-material routine or periodic inspections or reviews) against any Person which develops products pursuant to a development, commercialization or other collaboration arrangement with Foamix or the Foamix Subsidiary (each, a “Foamix Partner”) by the FDA, the EMA or any other Regulatory Authority. (d) Foamix has Company Subsidiaries have made available to Menlo Parent complete and accurate copies of all Regulatory Authorizations and regulatory dossiers relating thereto, all serious adverse event reports, periodic adverse event reports and other pharmacovigilance pharmacoviligence reports and data, and all other material Regulatory Authority communications, documents and other information submitted by the Company to or received by the Company from the FDA, the EMA EMEA or any equivalent Regulatory Authority, including inspection reports, warning letters and similar documents, relating to Foamix the Company or the Foamix any Company Subsidiary, the conduct of their business, or the Foamix Core Products. (ed) (d) All preclinical studies and clinical trials conducted or being conducted by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix Products, Company’s and the Company Subsidiaries’ Products by or at the direction of the Company or any Foamix Partner Company Subsidiary have been and are being conducted in material compliance with the applicable requirements of Good Laboratory Practices and Good Clinical Practices and applicable regulations and guidances that relate to the conduct of clinical studies, and, the Company (1) is not aware of any failure by any Company Partner to conduct clinical studies in compliance with such applicable requirements, regulations and guidances and (2) has not received any notifications from any institutional review board (IRB) raising any issues. All results of studies, tests and trials related to the Core Products and conducted by or at the direction of the Company, and all other material information related to such studies, tests and trials, have been made available to Parent. (e) The manufacture of products by the Company and any Company Subsidiary is, or, in the case of any products manufactured by a Company Partner, to the knowledge of the Company is, being conducted in material compliance with the applicable requirements of current Good Manufacturing Practices. In addition, the Company and each Company Subsidiary and, to the knowledge of the Company, their respective Company Partners, are in material compliance with all applicable registration and listing requirements, including, for example, those set forth in 21 U.S.C. Section 360 and 21 C.F.R. Parts 207 and 807 and all similar applicable Laws and Orders. To the knowledge of the Company, no Product sold by the Company or held in inventory by the Company has been adulterated or misbranded. All labeling is in compliance with FDA, EMA EMEA and other Regulatory Authorities, including, without limitation, the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58Authority requirements, and 312. No clinical trial conducted by or on behalf all advertising and promotional materials of Foamix, the Foamix Company and each Company Subsidiary or, are in material compliance with respect to the Foamix Products, any Foamix Partner has been terminated or suspended by the FDA, EMA or any EMEA and other Regulatory Authority, and neither the FDA, EMA nor any other applicable Regulatory Authority has commenced or, to Foamix’s Knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix Products, any Foamix Partnerrequirements.

FDA and Related Matters. (a) Foamix Except as would not have a Parent Material Adverse Effect, Parent’s and the Foamix Subsidiary possess all Parent Subsidiaries’ Regulatory Authorizations required by from the FDA, the EMA, EMEA and all other applicable Regulatory Authorities in connection with relating to the Foamix Parent Products and the conduct of their businesses as currently conducted. All such Regulatory Authorizations are business (i) in full force are validly registered and effecton file with the FDA, the EMEA and other Regulatory Authorities, (ii) are in compliance in all material respects with all formal filing and maintenance requirements, and (iii) are in good standing, valid and enforceable. Foamix and the Foamix Subsidiary , (iv) have had filed all material required notices and responses to notices, supplemental applications, reports (including adverse experience reports) and other required information with the FDA, the EMA EMEA and all other applicable Regulatory Authorities, and (v) constitute all Regulatory Authorizations required for the conduct of Parent’s and the Parent Subsidiaries’ businesses as currently conducted. (b) The Without limiting the generality of any other representations and warranties made by Parent under this Agreement, including the representations and warranties contained in Sections 4.4 and 4.6, to Parent’s knowledge, Parent and the Parent Subsidiaries, the conduct of Foamix and Foamix Subsidiary businesses their business and the Foamix Parent Products are in compliance in all material respects with (1) all applicable Laws and Orders Orders, of the FDA, EMA EMEA and other Regulatory Authorities and (2) all Regulatory Authorizations. Foamix There are no, and the Foamix Subsidiary have not received been, any inspection reports, warning letters, notice of adverse findings, Section 305 notices or similar documents that assert a material failure to comply lack of substantial compliance with any applicable Laws Laws, Orders or Orders regulatory requirements that have not been fully resolved to the satisfaction of the FDA, the EMA EMEA or any other Regulatory Authorities, as applicable, and neither Foamix Parent nor the Foamix any Parent Subsidiary has Knowledge knowledge (or has been notified in writing by a third party) of any pending or threatened regulatory action, investigation or inquiry by of any Regulatory Authority sort (other than non-material routine or periodic inspections or reviews) against Parent or any of Foamix and the Foamix Parent Subsidiary, the Foamix Parent Products, or any Foamix Partnermanufacturer, developer, or distributor of the Parent Products, and, to Parent’s knowledge, there is no basis for any adverse regulatory action. Without limiting the foregoing, (i) there have been no product recalls, warnings, notifications or safety alerts conducted or issued by Parent, any Parent Subsidiary, the FDA, the EMEA or any other Regulatory Authorities or otherwise with respect to the Parent Products, none of the foregoing has been requested or demanded by the FDA, the EMEA or any other Regulatory Authorities, and there is no reasonable basis for any of the foregoing; and (ii) none of Parent, the Parent Subsidiaries or, to the knowledge of Parent, any of their respective agents or subcontractors, has been convicted of any crime or engaged in any conduct which would reasonably be expected to result in criminal liability, debarment or disqualification by the FDA, the EMEA or any other Regulatory Authority, no criminal, injunctive, seizure or civil penalty actions have at any time been commenced or threatened by any Regulatory Authority against Parent or the Parent Subsidiaries or, to the knowledge of Parent, any of their respective agents or subcontractors, and there are no consent decrees (including plea agreements) or similar actions to which Parent or any Parent Subsidiary are bound or which relate to the Parent Products. Neither Foamix Parent nor any Parent Subsidiary is, to Parent’s knowledge, employing or utilizing the Foamix services of any individual who has been debarred, temporarily denied approval or suspended under any applicable Law or Order. To Parent’s knowledge, neither the Parent nor any Parent Subsidiary has made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA EMEA or any other Regulatory Authority Authority, nor have they failed to disclose any material fact required to be disclosed to the FDA, the EMA EMEA or any other Regulatory Authority, and to Foamixthe Parent’s Knowledgeknowledge, no Foamix Parent Partner (as defined below) has made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA EMEA or any other Regulatory Authority relating to the Foamix Parent Products, nor to Foamixthe Parent’s Knowledgeknowledge, has any Foamix Parent Partner failed to disclose any material facts required to be disclosed to the FDA, the EMA EMEA or any other Regulatory Authority relating to the Foamix Parent Products. (c) To the extent of any disclosure in the Parent Disclosure Letter with respect to any of the representations and warranties in Section 3.9(b) and otherwise, Parent and each of Parent’s Subsidiaries is in compliance in all material respects with all written communications and requirements of the FDA, the EMEA and all other Regulatory Authorities relating thereto, including all requirements of the FDA, the EMEA and all other Regulatory Authorities in warning letters, notices of adverse findings and Section 305 notices and similar letters or notices, and in connection with all product recalls, notifications and safety alerts, and any request from the FDA, the EMEA or any Regulatory Authority requesting Parent or any Parent Subsidiary to cease to investigate, test or market any product, and all consent decrees (including plea agreements) issued with respect to Parent or any Parent Subsidiary. (d) Neither Foamix Parent nor the Foamix any Parent Subsidiary has Knowledge knowledge (or has been notified in writing by a Foamix Parent Partner) of any pending regulatory action of any sort (other than non-material routine or periodic inspections or reviews) against any of Parent, the Parent Subsidiaries or any Person which manufactures, develops or distributes products pursuant to a development, commercialization commercialization, manufacturing, supply or other collaboration arrangement with Foamix Parent or the Foamix any Parent Subsidiary (each, a “Foamix Parent Partner”) by the FDA, the EMA EMEA or any other Regulatory Authority. (de) Foamix has Parent and the Parent Subsidiaries have made available to Menlo the Company complete and accurate copies of all Regulatory Authorizations and regulatory dossiers relating thereto, all serious adverse event reports, periodic adverse event reports and other pharmacovigilance pharmacoviligence reports and data, and all other material Regulatory Authority communications, documents and other information submitted to or received from the FDA, the EMA EMEA or any Regulatory Authority, including inspection reports, warning letters and similar documents, relating to Foamix Parent or the Foamix any Parent Subsidiary, the conduct of their business, or the Foamix Parent Products. (ef) All To Parent’s knowledge, all preclinical studies and clinical trials conducted or being conducted by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix Products, Parent Products by Parent or any Foamix Parent Subsidiary or Parent Partner have been and are being conducted in material compliance with the applicable requirements of Good Laboratory Practices and those regulations that relate to the conduct of clinical studies. All results of such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to the Company. (g) The manufacture of products by Parent and any Parent Subsidiary is, or, in the case of any products manufactured by a Parent Partner, to the knowledge of Parent is, being conducted in material compliance with the applicable requirements of Current Good Manufacturing Practices. In addition, Parent and each Parent Subsidiary and, to the knowledge of Parent, their respective Parent Partners, are in material compliance with all applicable registration and listing requirements, including, for example, those set forth in 21 U.S.C. Section 360 and 21 C.F.R. Parts 207 and 807 and all similar applicable Laws and Orders. To the knowledge of the Parent, no Parent Product sold or in inventory has been adulterated or misbranded. All labeling is in compliance with FDA, EMA EMEA, and other Regulatory Authorities, including, without limitation, the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58Authority requirements, and 312. No clinical trial conducted by all advertising and promotional materials of Parent or on behalf of Foamix, the Foamix any Parent Subsidiary or, are in material compliance with respect to the Foamix Products, any Foamix Partner has been terminated or suspended by the FDA, EMA or any EMEA and other Regulatory Authority, and neither the FDA, EMA nor any other applicable Regulatory Authority has commenced or, to Foamix’s Knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix Products, any Foamix Partnerrequirements.

FDA and Related Matters. (a) Foamix and Except as disclosed in Section (29)(a) of the Foamix Subsidiary possess all Regulatory Authorizations required by the FDAGreenbrook Disclosure Letter, the EMA, and all other applicable Regulatory Authorities in connection with the Foamix Products and the conduct of their businesses as currently conducted. All such Regulatory Authorizations are Greenbrook: (i) is and, since January 1, 2020, has been in full force material compliance with all statutes, rules or regulations of the FDA and effectother comparable Governmental Entities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by Greenbrook, if any; and (ii) since January 1, 2020, has not received any Form FDA 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any Governmental Entity alleging or asserting material noncompliance with any applicable Laws set forth in compliance in all material respects with all formal filing Section (a)(i) above, or any licenses, certificates, approvals, clearances, exemptions, Authorizations, permits and maintenance requirementssupplements or amendments thereto required by any such applicable Laws, and (iii) in good standingto the knowledge of Greenbrook, valid and enforceableneither the FDA nor any Governmental Entity are considering such action against Greenbrook or any of its Subsidiaries. Foamix and the Foamix Subsidiary have filed all material required notices and responses to noticesNone of Greenbrook or any of its Subsidiaries requires any additional insurance license, supplemental applicationsclinic license, reports laboratory license, facility license, clearance (including adverse experience reports510(k) clearances or pre-market notifications, pre-market approvals, investigational new drug applications or device exemptions, product recertifications, device establishment registrations, manufacturing approvals and other required information with the FDAauthorizations, the EMA XX Xxxxx, pricing and all other applicable Regulatory Authoritiesreimbursement approvals, labeling approvals, registration notifications or their foreign equivalent). (b) The conduct To the knowledge of Foamix and Foamix Subsidiary businesses and Greenbrook, there are no actual or threatened enforcement actions by the Foamix Products are in compliance in all material respects with (1) all applicable Laws and Orders of the FDA, EMA and other Regulatory Authorities and (2) all Regulatory Authorizations. Foamix and the Foamix Subsidiary have not received any warning letters, notice of adverse findings, or similar documents that assert a material failure to comply with any applicable Laws or Orders that have not been fully resolved to the satisfaction of the FDA, the EMA FDA or any other Regulatory AuthoritiesGovernmental Entity which has jurisdiction over the operations of Greenbrook or any of its Subsidiaries against Greenbrook or any of its Subsidiaries. Since January 1, as applicable2020, and neither Foamix Greenbrook nor the Foamix Subsidiary any of its Subsidiaries has Knowledge (or has been notified in writing by a third party) received written notice of any pending or threatened actionclaim, investigation audit, termination or inquiry suspension by any Regulatory Authority (other than non-material routine or periodic inspections or reviews) against any of Foamix and the Foamix Subsidiary, the Foamix Products, or any Foamix Partner. Neither Foamix nor the Foamix Subsidiary has made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA FDA or any other Regulatory Authority nor have they failed to disclose any material fact required to be disclosed to Governmental Entity which has jurisdiction over the FDA, the EMA operations of Greenbrook or any other Regulatory Authorityof its Subsidiaries against Greenbrook or any of its Subsidiaries, and to Foamix’s Knowledgethe knowledge of Greenbrook, no Foamix Partner has made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA or any other Regulatory Authority relating to the Foamix Products, nor to Foamix’s Knowledge, has any Foamix Partner failed to disclose any material facts required to be disclosed to the FDA, the EMA or any other Regulatory Authority relating to the Foamix ProductsGovernmental Entity is considering such action. (c) Neither Foamix nor Since January 1, 2020, all material reports, documents, claims and notices required to be filed, maintained or furnished to the Foamix Subsidiary has Knowledge (or has been notified in writing by a Foamix Partner) of any pending regulatory action of any sort (other than non-material routine or periodic inspections or reviews) against any Person which develops products pursuant to a development, commercialization or other collaboration arrangement with Foamix or the Foamix Subsidiary (each, a “Foamix Partner”) by the FDA, the EMA FDA or any other Regulatory Authority. (d) Foamix has made available similar Governmental Entity, including all registrations and reports required to Menlo copies be filed with xxxxxxxxxxxxxx.xxx, by Greenbrook or any of all Regulatory Authorizations and regulatory dossiers relating theretoits Subsidiaries have been so filed, all serious adverse event maintained or furnished. All such reports, periodic adverse event reports and other pharmacovigilance reports and data, and all other material Regulatory Authority communications, documents and other information submitted to or received from the FDA, the EMA or any Regulatory Authority, including inspection reports, warning letters and similar documents, relating to Foamix or the Foamix Subsidiary, the conduct of their business, or the Foamix Products. (e) All preclinical studies claims and clinical trials conducted or being conducted by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix Products, any Foamix Partner have been notices were complete and are being conducted correct in material compliance with all applicable Laws of the FDA, EMA and other Regulatory Authorities, including, without limitation, the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312. No clinical trial conducted by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix Products, any Foamix Partner has been terminated or suspended by the FDA, EMA or any other Regulatory Authority, and neither the FDA, EMA nor any other Regulatory Authority has commenced or, to Foamix’s Knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix Products, any Foamix Partner.all

FDA and Related Matters. (a) Foamix and the Foamix Subsidiary possess all All Regulatory Authorizations required by from the FDA, the EMA, EMEA and all other applicable Regulatory Authorities in connection with relating to the Foamix Company and the Company Subsidiaries, their Products and the conduct of their businesses as currently conducted. All such Regulatory Authorizations are business are, in all material respects, (i) in full force validly registered and effecton file with applicable Regulatory Authorities, (ii) in compliance in all material respects with all formal filing and maintenance requirements, and (iii) in good standing, valid and enforceable. Foamix The Company and the Foamix Subsidiary Company Subsidiaries have filed all material required notices and responses to notices, supplemental applications, reports (including adverse experience reports) and other required information with the FDA, the EMA EMEA and all other applicable Regulatory Authorities. The Company and the Company Subsidiaries possess all Regulatory Authorizations required for the conduct of their businesses as currently conducted. (b) The Without limiting the generality of any other representations and warranties made by the Company under this Agreement, including the representations and warranties contained in Sections 3.4 and 3.6, to the Company’s knowledge, the Company and the Company Subsidiaries, the conduct of Foamix their business and Foamix Subsidiary businesses and the Foamix their Products are in compliance in all material respects with (1) all applicable Laws and Orders of the FDA, EMA EMEA and other Regulatory Authorities and (2) all Regulatory Authorizations. Foamix There are no, and the Foamix Subsidiary have not received been, any inspection reports, warning letters, notice of adverse findings, Section 305 notices or similar documents that assert a material failure to comply lack of substantial compliance with any applicable Laws Laws, Orders, or Orders regulatory requirements that have not been fully resolved to the satisfaction of the FDA, the EMA EMEA or any other Regulatory Authorities, as applicable, none of the Company and neither Foamix nor the Foamix Subsidiary Company Subsidiaries has Knowledge knowledge (or has been notified in writing by a third party) of any pending or threatened regulatory action, investigation or inquiry by of any Regulatory Authority sort (other than non-material routine or periodic inspections or reviews) against any of Foamix the Company and the Foamix SubsidiaryCompany Subsidiaries, their Products or any manufacturer, developer or distributor of the Products, and, to the Company’s knowledge, there is no basis for any adverse regulatory action. Without limiting the foregoing, (i) there have been no product recalls, warnings, notifications or safety alerts conducted or issued by the Company or Company Subsidiaries, the Foamix FDA, the EMEA or any other Regulatory Authorities or otherwise with respect to the Company’s and the Company Subsidiaries’ Products, none of the foregoing has been requested or demanded by the FDA, the EMEA or any Foamix Partnerother Regulatory Authorities, and there is no reasonable basis for any of the foregoing; and (ii) none of the Company, the Company Subsidiaries or, to the knowledge of the Company, any of their respective agents or subcontractors, has been convicted of any crime or engaged in any conduct which would reasonably be expected to result in criminal liability, debarment or disqualification by the FDA, the EMEA or any other Regulatory Authority, no criminal, injunctive, seizure or civil penalty actions have at any time been commenced or threatened by any Regulatory Authority against the Company or any Company Subsidiaries or, to the knowledge of the Company, any of their respective agents or subcontractors, and there are no consent decrees (including plea agreements) or similar actions to which the Company or any Company Subsidiaries are bound or which relate to their Products. Neither Foamix the Company nor any Company Subsidiary is, to the Foamix Company’s knowledge, employing or utilizing the services of any individual who has been debarred, temporarily denied approval or suspended under any applicable Law or Order. To the Company’s knowledge, neither the Company nor any Company Subsidiary has made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA EMEA or any other Regulatory Authority nor have they failed to disclose any material fact required to be disclosed to the FDA, the EMA EMEA or any other Regulatory Authority, and to Foamixthe Company’s Knowledgeknowledge, no Foamix Company Partner (as defined below) has made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA EMEA or any other Regulatory Authority relating to the Foamix Products, nor to Foamixthe Company’s Knowledgeknowledge, has any Foamix Company Partner failed to disclose any material facts required to be disclosed to the FDA, the EMA EMEA or any other Regulatory Authority relating to the Foamix Products. (c) To the extent of any disclosure in the Company Disclosure Letter with respect to any of the representations and warranties in Section 3.9(b) and otherwise, the Company and each Company Subsidiary is in compliance in all material respects with all written communications and requirements of the FDA, the EMEA and all other Regulatory Authorities relating thereto, including all requirements of the FDA, the EMEA and all other Regulatory Authorities in warning letters, notices of adverse findings and Section 305 notices and similar letters or notices, and in connection with all product recalls, notifications and safety alerts, and any request from the FDA, the EMEA or any Regulatory Authority requesting the Company or any Company Subsidiary to cease to investigate, test or market any product, and all consent decrees (including plea agreements) issued with respect to the Company or any Company Subsidiary. (d) Neither Foamix the Company nor the Foamix any Company Subsidiary has Knowledge knowledge (or has been notified in writing by a Foamix Company Partner) of any pending regulatory action of any sort (other than non-material routine or periodic inspections or reviews) against any of the Company, Company Subsidiaries or any Person which manufactures, develops or distributes products pursuant to a development, commercialization commercialization, manufacturing, supply or other collaboration arrangement with Foamix the Company or the Foamix any Company Subsidiary (each, a “Foamix Company Partner”) by the FDA, the EMA EMEA or any other Regulatory Authority. (de) Foamix has The Company and the Company Subsidiaries have made available to Menlo Parent complete and accurate copies of all Regulatory Authorizations and regulatory dossiers relating thereto, all serious adverse event reports, periodic adverse event reports and other pharmacovigilance pharmacoviligence reports and data, and all other material Regulatory Authority communications, documents and other information submitted to or received from the FDA, the EMA EMEA or any Regulatory Authority, including inspection reports, warning letters and similar documents, relating to Foamix the Company or the Foamix any Company Subsidiary, the conduct of their business, or the Foamix their Products. (ef) All To the Company’s knowledge, all preclinical studies and clinical trials conducted or being conducted by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix ProductsCompany and the Company Subsidiaries’ Products by the Company, any Foamix Company Subsidiary or Company Partner have been and are being conducted in material compliance with the applicable requirements of Good Laboratory Practices and those regulations that relate to the conduct of clinical studies. All results of such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to Parent. (g) The manufacture of products by the Company and any Company Subsidiary is, or, in the case of any products manufactured by a Company Partner, to the knowledge of the Company is, being conducted in material compliance with the applicable requirements of Current Good Manufacturing Practices. In addition, the Company and each Company Subsidiary and, to the knowledge of the Company, their respective Company Partners, are in material compliance with all applicable registration and listing requirements, including, for example, those set forth in 21 U.S.C. Section 360 and 21 C.F.R. Parts 207 and 807 and all similar applicable Laws and Orders. To the knowledge of the Company, no Product sold or in inventory has been adulterated or misbranded. All labeling is in compliance with FDA, EMA EMEA and other Regulatory Authorities, including, without limitation, the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58requirements, and 312. No clinical trial conducted by all advertising and promotional materials of the Company or on behalf of Foamix, the Foamix any Company Subsidiary or, are in material compliance with respect to the Foamix Products, any Foamix Partner has been terminated or suspended by the FDA, EMA or any EMEA and other Regulatory Authority, and neither the FDA, EMA nor any other applicable Regulatory Authority has commenced or, to Foamix’s Knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix Products, any Foamix Partnerrequirements.

FDA and Related Matters. (ai) Foamix Section 3.9(c) of the Parent Schedules sets forth a list, for the period between January 1, 1996 and the Foamix Subsidiary possess date hereof, of (A) all Regulatory Authorizations or Warning Letters, Notices of Adverse Findings and Section 305 Notices and similar letters or notices issued by the FDA (or any other Regulatory Agency) to the Parent or any of its subsidiaries that, individually or in the aggregate, would have a Material Adverse Effect on the Parent, (B) all product recalls, notifications and safety alerts conducted by the Parent or any of its subsidiaries, whether or not required by the FDA, and any request from the EMAFDA or any Regulatory Agency requesting the Parent or any of its subsidiaries to cease to investigate, test or market any product, which recalls, notifications, safety alerts or requests would, individually or in the aggregate, have a Material Adverse Effect on the Parent, and (C) any criminal, injunctive, seizure or civil penalty actions begun or threatened by the FDA or any Regulatory Agency against the Parent or any of its subsidiaries of which the Parent has knowledge, and all other applicable Regulatory Authorities related consent decrees (including plea agreements) issued with respect to the Parent or any of its subsidiaries. Copies of all documents referred to in connection with Section 3.9(c) of the Foamix Products and Parent Schedules have been made available to the conduct of their businesses as currently conducted. All such Regulatory Authorizations are (i) in full force and effect, Company. (ii) in compliance in all The Parent has made submissions to obtain material respects with all formal filing approvals, certifications, authorizations, clearances and maintenance requirementspermits for marketing, and (iii) in good standinghas made filings with, valid and enforceable. Foamix and the Foamix Subsidiary have filed all material required notices and responses to notices, supplemental applications, reports (including adverse experience reports) and other required information with the FDAor notifications to, the EMA FDA and all other Regulatory Agencies (or has documented a basis for not making such filings or notifications) pursuant to applicable Regulatory Authorities. (b) The conduct of Foamix and Foamix Subsidiary businesses and the Foamix Products are in compliance in all material respects with (1) all applicable Laws and Orders requirements of the FDAFDA Act, EMA and other Regulatory Authorities applicable laws, regulations and rules with respect to each of the products sold by the Parent that is listed on Section 3.9(c) of the Parent Schedules. The products listed on Section 3.9(c) of the Parent Schedules collectively constitute in excess of 95% of the gross revenues generated during the twelve (2) all Regulatory Authorizations. Foamix and 12)-month period ending December 31, 1997 by that portion of the Foamix Subsidiary have not received any warning letters, notice business of adverse findings, or similar documents that assert a material failure to comply with any applicable Laws or Orders that have not been fully resolved the Parent which is subject to the satisfaction jurisdiction of the FDAFDA or any Regulatory Agency. The Parent has no knowledge that any of the material approvals, clearances, authorizations, registrations, certifications, permits, filings or notifications that it or any of its subsidiaries has received or made to the EMA FDA or any Regulatory Agency that relate to the marketing of the products listed on Section 3.9(c) of the Parent Schedules have been or are being revoked; provided, however, that the Company understands and acknowledges that the FDA or any other Regulatory AuthoritiesAgency may disagree with the Parent's assessment and undertake actions, as applicableat any time, and neither Foamix nor the Foamix Subsidiary has Knowledge (or has been notified in writing by a third party) of to remove from commercial distribution any pending or threatened action, investigation or inquiry by any Regulatory Authority (other than non-material routine or periodic inspections or reviews) against any of Foamix and the Foamix Subsidiary, the Foamix Products, or any Foamix Partner. Neither Foamix nor the Foamix Subsidiary has made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA or any other Regulatory Authority nor have they failed to disclose any material fact required to be disclosed to the FDA, the EMA or any other Regulatory Authority, and to Foamix’s Knowledge, no Foamix Partner has made any materially untrue statement of fact or fraudulent statement to the FDA, the EMA or any other Regulatory Authority relating to the Foamix Products, nor to Foamix’s Knowledge, has any Foamix Partner failed to disclose any material facts required to be disclosed to the FDA, the EMA or any other Regulatory Authority relating to the Foamix Productssuch product. (ciii) Neither Foamix nor Except as disclosed in Section 3.9(c) of the Foamix Subsidiary Parent Schedules, the Parent has Knowledge (or has been notified in writing by a Foamix Partner) no knowledge of any pending regulatory action of any sort (other than non-material routine or periodic inspections or of reviews) against the Parent or any Person which develops products pursuant to a development, commercialization or other collaboration arrangement with Foamix or the Foamix Subsidiary (each, a “Foamix Partner”) Contract Manufacturer by the FDAFDA or any Regulatory Agency or any other duly authorized governmental authority which regulates the sale of drugs or medical devices in any jurisdiction which could have a Material Adverse Effect on the Parent, or in any material way limit or restrict the ability of the Parent to market its existing products. Except as set forth on Section 3.9(c) of the Parent Schedules, neither the Parent, nor, to the knowledge of the Parent, the EMA Contract Manufacturer, has knowingly committed or permitted to exist any violation of the rules and regulations of the FDA or any Regulatory Agency or any other duly authorized governmental authority which regulates the sale of drugs or medical devices which has not been cured by the Parent, or, to the knowledge of the Parent, the Contract Manufacturer or waived by the FDA or any such Regulatory Agency authority, provided, however, that the Company understands and acknowledges that the FDA or any other Regulatory AuthorityAgency may disagree with the Parent's assessment and undertake enforcement actions at any time. (d) Foamix has made available to Menlo copies of all Regulatory Authorizations and regulatory dossiers relating thereto, all serious adverse event reports, periodic adverse event reports and other pharmacovigilance reports and data, and all other material Regulatory Authority communications, documents and other information submitted to or received from the FDA, the EMA or any Regulatory Authority, including inspection reports, warning letters and similar documents, relating to Foamix or the Foamix Subsidiary, the conduct of their business, or the Foamix Products. (e) All preclinical studies and clinical trials conducted or being conducted by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix Products, any Foamix Partner have been and are being conducted in material compliance with all applicable Laws of the FDA, EMA and other Regulatory Authorities, including, without limitation, the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312. No clinical trial conducted by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix Products, any Foamix Partner has been terminated or suspended by the FDA, EMA or any other Regulatory Authority, and neither the FDA, EMA nor any other Regulatory Authority has commenced or, to Foamix’s Knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of Foamix, the Foamix Subsidiary or, with respect to the Foamix Products, any Foamix Partner.